[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)] [Unknown Section] [Pages 79459-79708] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2010-30473] [[Page 79459]] DEPARTMENT OF AGRICULTURE -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 1 Wholesale Pork Reporting Program 0581-AD07 Proposed Rule Stage 2 National Dairy Promotion and Research Program; Dairy Import Assessments, DA-08-0050 0581-AC87 Final Rule Stage 3 Animal Welfare; Regulations and Standards for Birds 0579-AC02 Proposed Rule Stage 4 Plant Pest Regulations; Update of General Provisions 0579-AC98 Proposed Rule Stage 5 Importation of Live Dogs 0579-AD23 Proposed Rule Stage 6 Animal Disease Traceability 0579-AD24 Proposed Rule Stage 7 Importation of Plants for Planting; Establishing a New Category of Plants for Planting Not 0579-AC03 Final Rule Stage Authorized for Importation Pending Pest Risk Analysis 8 Multi-Family Housing (MFH) Reinvention 0575-AC13 Final Rule Stage 9 Enforcement of the Packers and Stockyards Act 0580-AB07 Final Rule Stage 10 Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation, and 0584-AD87 Proposed Rule Energy Act of 2008 Stage 11 Supplemental Nutrition Assistance Program: Farm Bill of 2008 Retailer Sanctions 0584-AD88 Proposed Rule Stage 12 Fresh Fruit and Vegetable Program 0584-AD96 Proposed Rule Stage 13 Child and Adult Care Food Program: Improving Management and Program Integrity 0584-AC24 Final Rule Stage 14 Direct Certification of Children in Food Stamp Households and Certification of Homeless, Migrant, 0584-AD60 Final Rule Stage and Runaway Children for Free Meals in the NSLP, SBP, and SMP 15 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC 0584-AD77 Final Rule Stage Food Packages 16 Egg Products Inspection Regulations 0583-AC58 Proposed Rule Stage 17 New Poultry Slaughter Inspection 0583-AD32 Proposed Rule Stage 18 Mandatory Inspection of Catfish and Catfish Products 0583-AD36 Proposed Rule Stage 19 Electronic Imported Product Inspection Applications; Electronic Foreign Imported Product and 0583-AD39 Proposed Rule Foreign Establishment Certifications; Deletion of Streamlined Inspection Procedures for Canadian Stage Product 20 Electronic Export Application and Certification as a Reimbursable Service and Flexibility in the 0583-AD41 Proposed Rule Requirements for Official Export Inspection Marks, Devices, and Certificates Stage 21 Performance Standards for the Production of Processed Meat and Poultry Products; Control of 0583-AC46 Final Rule Stage Listeria Monocytogenes in Ready-To-Eat Meat and Poultry Products 22 Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products 0583-AC60 Final Rule Stage 23 Notification, Documentation, and Recordkeeping Requirements for Inspected Establishments 0583-AD34 Final Rule Stage 24 Federal-State Interstate Shipment Cooperative Inspection Program 0583-AD37 Final Rule Stage 25 Value-Added Producer Grant Program 0570-AA79 Final Rule Stage 26 Rural Broadband Access Loans and Loan Guarantees 0572-AC06 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF COMMERCE -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 27 Designation of Critical Habitat for the North Atlantic Right Whale 0648-AY54 Proposed Rule Stage 28 Certification of Nations Whose Fishing Vessels Are Engaged in Illegal, Unreported, and Unregulated 0648-AV51 Final Rule Stage Fishing or Bycatch of Protected Living Marine Resources [[Page 79460]] 29 Critical Habitat Designation for Cook Inlet Beluga Whale Under the Endangered Species Act 0648-AX50 Final Rule Stage 30 Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Amendments 20 and 21; Trawl 0648-AY68 Final Rule Stage Rationalization Program -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF DEFENSE -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 31 Voluntary Education Programs 0790-AI50 Final Rule Stage 32 TRICARE; Reimbursement of Sole Community Hospitals 0720-AB41 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF EDUCATION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 33 Title IV of the Higher Education Act of 1965, as Amended 1840-AD05 Proposed Rule Stage 34 Program Integrity: Gainful Employment--Measures 1840-AD06 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF ENERGY -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 35 Energy Efficiency Standards for Clothes Dryers and Room Air Conditioners 1904-AA89 Proposed Rule Stage 36 Energy Efficiency Standards for Residential Central Air Conditioners and Heat Pumps 1904-AB47 Proposed Rule Stage 37 Energy Efficiency Standards for Fluorescent Lamp Ballasts 1904-AB50 Proposed Rule Stage 38 Energy Efficiency Standards for Residential Furnaces 1904-AC06 Proposed Rule Stage 39 Energy Efficiency Standards for Manufactured Housing 1904-AC11 Proposed Rule Stage 40 Energy Efficiency Standards for Residential Refrigerators, Refrigerator-Freezers, and Freezers 1904-AB79 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 41 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information 0991-AB57 Final Rule Stage Technology for Economic and Clinical Health Act 42 Transparency Reporting 0950-AA07 Proposed Rule Stage 43 Rate Review 0950-AA03 Final Rule Stage 44 Uniform Explanation of Benefits, Coverage Facts, and Standardized Definitions 0950-AA08 Final Rule Stage 45 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 0910-AC52 Proposed Rule Stage 46 Unique Device Identification 0910-AG31 Proposed Rule Stage 47 Cigarette Warning Label Statements 0910-AG41 Proposed Rule Stage [[Page 79461]] 48 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines 0910-AG56 Proposed Rule Stage 49 Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants 0910-AG57 Proposed Rule Stage 50 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification 0910-AF27 Final Rule Stage Requirements; Records and Reports; and Quality Factors 51 Medical Device Reporting; Electronic Submission Requirements 0910-AF86 Final Rule Stage 52 Electronic Registration and Listing for Devices 0910-AF88 Final Rule Stage 53 Requirements for Long-Term Care Facilities: Notification of Facility Closure (CMS-3230-IFC) 0938-AQ09 Proposed Rule Stage 54 Medicare Shared Savings Program: Accountable Care Organizations (CMS-1345-P) 0938-AQ22 Proposed Rule Stage 55 Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and 0938-AQ24 Proposed Rule FY 2012 Rates and to the Long-Term Care Hospital PPS and RY 2012 Rates (CMS-1518-P) Stage 56 Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2012 (CMS-1524-P) 0938-AQ25 Proposed Rule Stage 57 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center 0938-AQ26 Proposed Rule Payment System for CY 2012 (CMS-1525-P) Stage 58 Civil Money Penalties for Nursing Homes (CMS-2435-F) 0938-AQ02 Final Rule Stage 59 Designation Renewal of Head Start Grantees 0970-AC44 Proposed Rule Stage 60 Community Living Assistance Services and Supports Enrollment and Eligibility Rules Under the 0985-AA07 Proposed Rule Affordable Care Act Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 61 Secure Handling of Ammonium Nitrate Program 1601-AA52 Proposed Rule Stage 62 Collection of Alien Biometric Data Upon Exit From the United States at Air and Sea Ports of 1601-AA34 Final Rule Stage Departure; United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT) 63 Asylum and Withholding Definitions 1615-AA41 Proposed Rule Stage 64 Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of Aliens Subject 1615-AB71 Proposed Rule to Numerical Limitations Stage 65 Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, and 1615-AB89 Proposed Rule Withholding of Removal Stage 66 New Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T 1615-AA59 Final Rule Stage Nonimmigrant Status 67 Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant Status 1615-AA60 Final Rule Stage 68 New Classification for Victims of Criminal Activity; Eligibility for the ``U'' Nonimmigrant Status 1615-AA67 Final Rule Stage 69 E-2 Nonimmigrant Status for Aliens in the Commonwealth of the Northern Mariana Islands With Long- 1615-AB75 Final Rule Stage Term Investor Status 70 Commonwealth of the Northern Mariana Islands Transitional Worker Classification 1615-AB76 Final Rule Stage 71 Application of Immigration Regulations to the Commonwealth of the Northern Mariana Islands 1615-AB77 Final Rule Stage 72 Outer Continental Shelf Activities 1625-AA18 Proposed Rule Stage [[Page 79462]] 73 Inspection of Towing Vessels 1625-AB06 Proposed Rule Stage 74 Assessment Framework and Organizational Restatement Regarding Preemption for Certain Regulations 1625-AB32 Proposed Rule Issued by the Coast Guard Stage 75 Updates to Maritime Security 1625-AB38 Proposed Rule Stage 76 Standards for Living Organisms in Ships' Ballast Water Discharged in U.S. Waters 1625-AA32 Final Rule Stage 77 Importer Security Filing and Additional Carrier Requirements 1651-AA70 Final Rule Stage 78 Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization 1651-AA72 Final Rule Stage (ESTA) Program 79 Establishment of Global Entry Program 1651-AA73 Final Rule Stage 80 Implementation of the Guam-CNMI Visa Waiver Program 1651-AA77 Final Rule Stage 81 Large Aircraft Security Program, Other Aircraft Operator Security Program, and Airport Operator 1652-AA53 Proposed Rule Security Program Stage 82 Public Transportation and Passenger Railroads--Security Training of Employees 1652-AA55 Proposed Rule Stage 83 Freight Railroads--Security Training of Employees 1652-AA57 Proposed Rule Stage 84 Over-the-Road Buses--Security Training of Employees 1652-AA59 Proposed Rule Stage 85 Aircraft Repair Station Security 1652-AA38 Final Rule Stage 86 Air Cargo Screening 1652-AA64 Final Rule Stage 87 Continued Detention of Aliens Subject to Final Orders of Removal 1653-AA60 Proposed Rule Stage 88 Continued Detention of Aliens Subject to Final Orders of Removal 1653-AA13 Final Rule Stage 89 Extending Period for Optional Practical Training by 17 Months for F-1 Nonimmigrant Students With 1653-AA56 Final Rule Stage STEM Degrees and Expanding the CAP-GAP Relief for All F-1 Students With Pending H-1B Petitions 90 Update of FEMA's Public Assistance Regulations 1660-AA51 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 91 Title I Energy Retrofit Property Improvement Loans (FR-5445) 2502-AI93 Proposed Rule Stage 92 Housing Counseling: New Program Requirements (FR-5446) 2502-AI94 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF JUSTICE -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 93 National Standards to Prevent, Detect, and Respond to Prison Rape 1105-AB34 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF LABOR -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 94 Construction Contractor Affirmative Action Requirements 1250-AA01 Proposed Rule Stage [[Page 79463]] 95 Persuader Agreements: Employer and Labor Relations Consultant Reporting Under the LMRDA 1245-AA03 Proposed Rule Stage 96 Right To Know Under the Fair Labor Standards Act 1235-AA04 Proposed Rule Stage 97 Labor Certification Process and Enforcement for Temporary Employment in Occupations Other Than 1205-AB58 Proposed Rule Agriculture or Registered Nursing in the United States (H-2B Workers) Stage 98 Equal Employment Opportunity in Apprenticeship and Training, Amendment of Regulations 1205-AB59 Proposed Rule Stage 99 Lifetime Income Options for Participants and Beneficiaries in Retirement Plans 1210-AB33 Prerule Stage 100 Definition of ``Fiduciary'' 1210-AB32 Proposed Rule Stage 101 Respirable Crystalline Silica Standard 1219-AB36 Proposed Rule Stage 102 Lowering Miners' Exposure to Coal Mine Dust, Including Continuous Personal Dust Monitors 1219-AB64 Proposed Rule Stage 103 Safety and Health Management Programs for Mines 1219-AB71 Proposed Rule Stage 104 Pattern of Violations 1219-AB73 Proposed Rule Stage 105 Maintenance of Incombustible Content of Rock Dust in Underground Coal Mines 1219-AB76 Proposed Rule Stage 106 Proximity Detection Systems for Underground Mines 1219-AB65 Final Rule Stage 107 Infectious Diseases 1218-AC46 Prerule Stage 108 Injury and Illness Prevention Program 1218-AC48 Prerule Stage 109 Backing Operations 1218-AC52 Prerule Stage 110 Occupational Exposure to Crystalline Silica 1218-AB70 Proposed Rule Stage 111 Occupational Injury and Illness Recording and Reporting Requirements--Modernizing OSHA's Reporting 1218-AC49 Proposed Rule System Stage 112 Hazard Communication 1218-AC20 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 113 Enhancing Airline Passenger Protections--Part 2 2105-AD92 Final Rule Stage 114 Qualification, Service, and Use of Crewmembers and Aircraft Dispatchers 2120-AJ00 Proposed Rule Stage 115 Air Ambulance and Commercial Helicopter Operations; Safety Initiatives and Miscellaneous Amendments 2120-AJ53 Proposed Rule Stage 116 Flight and Duty Time Limitations and Rest Requirements 2120-AJ58 Final Rule Stage 117 Carrier Safety Fitness Determination 2126-AB11 Proposed Rule Stage 118 Electronic On-Board Recorders and Hours of Service Supporting Documents 2126-AB20 Proposed Rule Stage 119 Hours of Service 2126-AB26 Proposed Rule Stage 120 Drivers of Commercial Vehicles: Restricting the Use of Cellular Phones 2126-AB29 Proposed Rule Stage 121 National Registry of Certified Medical Examiners 2126-AA97 Final Rule Stage 122 Passenger Car and Light Truck Corporate Average Fuel Economy Standards MYs 2017 and Beyond 2127-AK79 Prerule Stage 123 Federal Motor Vehicle Safety Standard No. 111, Rearview Mirrors 2127-AK43 Proposed Rule Stage [[Page 79464]] 124 Commercial Medium- and Heavy-Duty On-Highway Vehicles and Work Truck Fuel Efficiency Standards 2127-AK74 Proposed Rule Stage 125 Ejection Mitigation 2127-AK23 Final Rule Stage 126 Hours of Service: Passenger Train Employees 2130-AC15 Proposed Rule Stage 127 Major Capital Investment Projects 2132-AB02 Proposed Rule Stage 128 Hazardous Materials: Limiting the Use of Mobile Telephones by Highway 2137-AE65 Proposed Rule Stage 129 Hazardous Materials: Limiting the Use of Electronic Devices by Highway 2137-AE63 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 130 Review of the National Ambient Air Quality Standards for Carbon Monoxide 2060-AI43 Proposed Rule Stage 131 Review of the National Ambient Air Quality Standards for Particulate Matter 2060-AO47 Proposed Rule Stage 132 Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of 2060-AO72 Proposed Rule Sulfur Stage 133 National Emission Standards for Hazardous Air Pollutants for Coal- and Oil-Fired Electric Utility 2060-AP52 Proposed Rule Steam Generating Units Stage 134 Control of Greenhouse Gas Emissions From Medium and Heavy-Duty Vehicles 2060-AP61 Proposed Rule Stage 135 Review of the National Ambient Air Quality Standards for Lead 2060-AQ44 Proposed Rule Stage 136 NPDES Electronic Reporting Rule 2020-AA47 Proposed Rule Stage 137 Regulations To Facilitate Compliance With the Federal Insecticide, Fungicide, and Rodenticide Act 2070-AJ32 Proposed Rule by Producers of Plant-Incorporated Protectants (PIPs) Stage 138 Mercury; Regulation of Use in Certain Products 2070-AJ46 Proposed Rule Stage 139 Nanoscale Materials; Reporting Under TSCA Section 8(a) 2070-AJ54 Proposed Rule Stage 140 Nanoscale Materials; Significant New Use Rule (SNUR) 2070-AJ67 Proposed Rule Stage 141 Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides 2070-AJ76 Proposed Rule Stage 142 Hazardous Waste Management Systems: Identification and Listing of Hazardous Waste: Carbon Dioxide 2050-AG60 Proposed Rule (CO2) Injectate in Geological Sequestration Activities Stage 143 Financial Responsibility Requirements Under CERCLA Section 108(b) for Classes of Facilities in the 2050-AG61 Proposed Rule Hard Rock Mining Industry Stage 144 NPDES Permit Requirements for Municipal Sanitary and Combined Sewer Collection Systems, Municipal 2040-AD02 Proposed Rule Satellite Collection Systems, Sanitary Sewer Overflows, and Peak Excess Flow Treatment Facilities Stage 145 Criteria and Standards for Cooling Water Intake Structures 2040-AE95 Proposed Rule Stage 146 Stormwater Regulations Revision To Address Discharges From Developed Sites 2040-AF13 Proposed Rule Stage [[Page 79465]] 147 National Pollutant Discharge Elimination System (NPDES) Permit Regulations for New Dischargers and 2040-AF17 Proposed Rule the Appropriate Use of Offsets With Regard to Water Quality Permitting Stage 148 Concentrated Animal Feeding Operations (CAFO) Information Collection Request Rule 2040-AF22 Proposed Rule Stage 149 National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, Commercial, 2060-AM44 Final Rule Stage and Institutional Boilers 150 Transport Rule (CAIR Replacement Rule) 2060-AP50 Final Rule Stage 151 Revision to Pb Ambient Air Monitoring Requirements 2060-AP77 Final Rule Stage 152 Reconsideration of the 2008 Ozone Primary and Secondary National Ambient Air Quality Standards 2060-AP98 Final Rule Stage 153 Revisions to Motor Vehicle Fuel Economy Label 2060-AQ09 Final Rule Stage 154 National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial, 2060-AQ25 Final Rule Stage and Institutional Boilers and Process Heaters 155 Lead; Clearance and Clearance Testing Requirements for the Renovation, Repair, and Painting Program 2070-AJ57 Final Rule Stage 156 Identification of Non-Hazardous Secondary Materials That Are Solid Wastes 2050-AG44 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- EQUAL EMPLOYMENT OPPORTUNITY COMMISSION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 157 Regulations To Implement the Equal Employment Provisions of the Americans With Disabilities Act 3046-AA85 Final Rule Stage Amendments Act -------------------------------------------------------------------------------------------------------------------------------------------------------- NATIONAL ARCHIVES AND RECORDS ADMINISTRATION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 158 Office of Government Information Services 3095-AB62 Proposed Rule Stage 159 Declassification of National Security Information 3095-AB64 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- SMALL BUSINESS ADMINISTRATION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 160 Small Business Jobs Act: Multiple Award Contracts and Small Business Set-Asides 3245-AG20 Proposed Rule Stage 161 Small Business Size Regulations; (8)a Business Development/Small Disadvantaged Business Status 3245-AF53 Final Rule Stage Determination 162 Small Business Jobs Act: 504 Loan Program Debt Refinancing 3245-AG17 Final Rule Stage 163 Small Business Jobs Act: Small Business Intermediary Lending Pilot Program 3245-AG18 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- SOCIAL SECURITY ADMINISTRATION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 164 Revised Medical Criteria for Evaluating Respiratory System Disorders (859P) 0960-AF58 Proposed Rule Stage 165 Revised Medical Criteria for Evaluating Hematological Disorders (974P) 0960-AF88 Proposed Rule Stage [[Page 79466]] 166 Revised Medical Criteria for Evaluating Endocrine System Disorders (436P) 0960-AD78 Final Rule Stage 167 Revised Medical Criteria for Evaluating Mental Disorders (886P) 0960-AF69 Final Rule Stage 168 Reestablishing Uniform National Disability Adjudication Provisions (3502F) 0960-AG80 Final Rule Stage 169 Amendments to Regulations Regarding Major Life-Changing Events Affecting Income-Related Monthly 0960-AH06 Final Rule Stage Adjustments Amounts to Medicare Part B Premiums (3574F) 170 Amendments to Regulations Regarding Withdrawals of Applications and Voluntary Suspension of 0960-AH07 Final Rule Stage Benefits (3573I) -------------------------------------------------------------------------------------------------------------------------------------------------------- CONSUMER PRODUCT SAFETY COMMISSION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 171 Testing, Certification, and Labeling of Certain Consumer Products 3041-AC71 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- NATIONAL INDIAN GAMING COMMISSION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 172 Tribal Background Investigation Submission Requirements and Timing 3141-AA15 Proposed Rule Stage 173 Class II and Class III Minimum Internal Control Standards 3141-AA27 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- POSTAL REGULATORY COMMISSION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 174 Periodic Reporting Exceptions 3211-AA06 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- [FR Doc. 2010-30473 Filed 12-17-10;8:45 am] BILLING CODE 6820-27-S <###doc> [[Page 79467]] <###doc>
DEPARTMENT OF AGRICULTURE (USDA) <###doc> Statement of Regulatory Priorities USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA established the following goals: Assist rural communities to create prosperity so they are self-sustaining, re-populating, and economically thriving. USDA is the leading advocate for rural America. The Department supports rural communities and enhances quality of life for rural residents by improving their economic opportunities, community infrastructure, environmental health, and the sustainability of agricultural production. The common goal is to help create thriving rural communities where people want to live and raise families, and where children have economic opportunities and a bright future. Ensure that all of America's children have access to safe, nutritious, and balanced meals. A plentiful supply of safe and nutritious food is essential to the well-being of every family and the healthy development of every child in America. USDA provides nutrition assistance to children and low-income people who need it and works to improve the healthy eating habits of all Americans, especially children. In addition, the Department safeguards the quality and wholesomeness of meat, poultry, and egg products and addresses and prevents loss and damage from pests and disease outbreaks. Ensure our national forests and private working lands are conserved, restored, and made more resilient to climate change, while enhancing our water resources. America's prosperity is inextricably linked to the health of our lands and natural resources. Forests, farms, ranches, and grasslands offer enormous environmental benefits as a source of clean air, clean and abundant water, and wildlife habitat. These lands generate economic value by supporting the vital agriculture and forestry sectors, attracting tourism and recreation visitors, sustaining green jobs, and producing ecosystem services, food, fiber, timber and non- timber products, and energy. They are also of immense social importance, enhancing rural quality of life, sustaining scenic and culturally important landscapes, and providing opportunities to engage in outdoor activity and reconnect with the land. Help America promote agricultural production and biotechnology exports as America works to increase food security. A productive agricultural sector is critical to increasing global food security. For many crops, a substantial portion of domestic production is bound for overseas markets. USDA helps American farmers and ranchers use efficient, sustainable production, biotechnology, and other emergent technologies to enhance food security around the world and find export markets for their products. Important regulatory activities supporting the accomplishment of these goals in 2011 will include the following: Rural Development and Renewable Energy. USDA priority regulatory actions for the Rural Development mission will be to finalize regulations for bioenergy programs, including the Biorefinery Assistance Program. While USDA utilized notices of funding availability to implement many of these programs in fiscal years 2009 and 2010, regulations are required for permanent implementation. Access to affordable broadband to all rural Americans is another priority. USDA will finalize reform of its on-going broadband access program through an interim rule. Rural Development will utilize comments received from the proposed rule, address statutory changes required by the 2008 Farm Bill, and incorporate lessons learned from implementing the American Recovery and Reinvestment Act program to develop the interim rule. USDA will continue to promote sustainable economic opportunities to revitalize rural communities through the purchase and use of renewable, environmentally friendly biobased products through its BioPreferred Program. USDA will continue to designate groups of biobased products to receive procurement preference from Federal agencies and contractors. In addition, USDA will finalize a rule establishing the Voluntary Labeling Program for biobased products. Nutrition Assistance. As changes are made to the nutrition assistance programs, USDA will work to foster actions that expand access to program benefits, improve program integrity, improve diets and healthy eating through nutrition education, and promote physical activity consistent with the national effort to reduce obesity. In support of these activities in 2011, the Food and Nutrition Service (FNS) will propose a rule updating nutrition standards in the school meals program, finalize a rule updating the WIC food packages, and establish permanent rules for the Fresh Fruit and Vegetable Program. FNS will continue to work to implement rules that minimize participant and vendor fraud in its nutrition assistance programs. Food Safety. In the area of food safety, USDA will continue to develop science-based regulations that improve the safety of meat, poultry, and processed egg products in the least burdensome and most cost-effective manner. Regulations will be revised to address emerging food safety challenges, streamlined to remove excessively prescriptive regulations, and updated to be made consistent with hazard analysis and critical control point principles. FSIS will propose regulations to establish new systems for poultry slaughter inspection, catfish inspection, as well as a new voluntary Federal-State cooperative inspection program. To assist small entities to comply with food safety requirements, the Food Safety and Inspection Service will continue to collaborate with other USDA agencies and State partners in the enhanced small business outreach program. Farm Loans and Disaster Assistance. USDA will work to ensure a strong U.S. agricultural system through farm income support and farm loan programs. In addition, USDA will implement a new disaster assistance program authorized by the 2008 Farm Bill, the Emergency Forest Restoration Program. Regulations are also being developed for conservation loan programs intended to help producers finance the construction of conservation measures. Forestry and Conservation. USDA has completed all rulemaking for the new and reauthorized 2008 Farm Bill conservation programs and will focus on their continued implementation in 2011. In the forestry area, the Department will focus on developing a new planning rule that improves the National forests' planning process, decisionmaking, and the legal defensibility of land management plans. In 2011, the Department plans to complete the transition from the [[Page 79468]] 2000 planning rule that is now in effect to the new planning rule that will update planning procedures to reflect contemporary collaborative planning practices. Marketing and Regulatory Programs. USDA will work to support the organic sector and continue regulatory work to protect the health and value of U.S. agricultural and natural resources. USDA will also implement regulations to enhance enforcement of the Packers and Stockyards Act. In addition, USDA is working with stakeholders to develop acceptable animal disease traceability standards. Regarding plant health, USDA anticipates revising the permitting of plant pests and biological control organisms. USDA will also amend regulations for importing nursery stock to better address plant health risks associated with propagative material. For the Animal Welfare Act, USDA will propose specific standards for the humane care of birds and dogs imported for resale. USDA will also implement regulations to implement dairy promotion and research provisions of the 2008 Farm Bill. Reducing Paperwork Burden on Customers USDA continues to make substantial progress in implementing the goal of the Paperwork Reduction Act of 1995 to reduce the burden of information collection on the public. To meet the requirements of the E-Government Act, agencies across USDA are providing electronic alternatives to their traditionally paper-based customer transactions. As a result, producers increasingly have the option to electronically file forms and all other documentation online. To facilitate the expansion of electronic government, USDA implemented an electronic authentication capability that allows customers to ``sign-on'' once and conduct business with all USDA agencies. Supporting these efforts are ongoing analyses to identify and eliminate redundant data collections and streamline collection instructions. The end result of implementing these initiatives is better service to our customers, enabling them to choose when and where to conduct business with USDA. Major Regulatory Priorities This document represents summary information on prospective significant regulations as called for in Executive Order 12866. The following USDA agencies are represented in this regulatory plan, along with a summary of their mission and key regulatory priorities in 2011: Food and Nutrition Service Mission: FNS increases food security and reduces hunger in partnership with cooperating organizations by providing children and low-income people access to food, a healthful diet, and nutrition education in a manner that supports American agriculture and inspires public confidence. Priorities: In addition to responding to provisions of legislation authorizing and modifying Federal nutrition assistance programs, FNS' 2011 regulatory plan supports USDA's goal to ensure that all of America's children have access to safe, nutritious, and balanced meals: Increase Access to Nutritious Food. This objective represents FNS' efforts to improve nutrition by providing access to program benefits (food consumed at home, school meals, commodities) and distributing State administrative funds to support program operations. To advance this objective, FNS plans to publish a proposed rule to codify provisions of the 2008 Farm Bill that expand access to Supplemental Nutrition Assistance Program (SNAP) benefits and address other eligibility, certification, employment, and training issues. An interim rule implementing provisions of the Child Nutrition and WIC Reauthorization Act of 2004 to establish automatic eligibility for homeless children for school meals further supports this objective. Promote Healthy Diet and Physical Activity Behaviors.This objective represents FNS' efforts to improve the diets of its clients through nutrition education, support the national effort to reduce obesity by promoting healthy eating and physical activity, and to ensure that program benefits meet appropriate standards to effectively improve nutrition for program participants. In support of this objective, FNS plans to propose a rule updating the nutrition standards in the school meals programs, finalize a rule updating the WIC food packages, and establish permanent rules for the Fresh Fruit and Vegetable Program, which currently operates in a select number of schools in each State, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands. Food Safety and Inspection Service Mission: The Food Safety and Inspection Service (FSIS) is responsible for ensuring that meat, poultry, egg, and catfish products in interstate and foreign commerce are wholesome, not adulterated, and properly marked, labeled, and packaged. Priorities: FSIS is committed to developing and issuing science-based regulations intended to ensure that meat, poultry, egg, and catfish products are wholesome and not adulterated or misbranded. FSIS regulatory actions support the objective to protect public health by ensuring that food is safe under USDA's goal to ensure access to safe food. To reduce the number of foodborne illnesses and increase program efficiencies, FSIS will continue to review its existing authorities and regulations to ensure that it can address emerging food safety challenges, to streamline excessively prescriptive regulations, and to revise or remove regulations that are inconsistent with the FSIS' hazard analysis and critical control point (HACCP) regulations. FSIS is also working with the Food and Drug Administration (FDA) to improve coordination and increase the effectiveness of inspection activities. FSIS' priority initiatives are as follows: Rulemakings that support initiatives of the President's Food Safety Working Group: - Poultry Slaughter Inspection. FSIS plans to amend poultry products inspection regulations to put in place a system in which the establishment sorts the carcasses for defects and FSIS verifies that the system is under control and producing safe and wholesome product. FSIS will propose to adopt performance standards designed to ensure that the establishments are carrying out slaughter, dressing, and chilling operations in a manner that ensures no significant growth of pathogens. - Revision of Egg Products Inspection Regulations. FSIS is planning to propose requirements for federally inspected egg product plants to develop and implement HACCP systems and sanitation standard operating procedures. FSIS will be proposing pathogen reduction performance standards for egg products and will remove prescriptive requirements for egg product plants. Initiatives that provide for disclosure or that enable economic growth. FSIS plans to issue two final rules to promote disclosure of information to the public or that provide flexibility for the adoption of new technologies and that promote economic growth: - Nutrition Labeling of Single-Ingredient Products and Ground or [[Page 79469]] Chopped Meat and Poultry Products. Regulations have been proposed to require nutrition information on the major cuts of single-ingredient, raw meat and poultry products to appear on the product label or at the point of purchase, unless an exemption applies. These regulations would also require nutrition labeling on all ground or chopped meat or poultry products unless an exemption applies. - Permission to Use Air Inflation of Meat Carcasses and Parts. FSIS has proposed to revise the Federal meat inspection regulations to permit establishments that slaughter livestock or prepare livestock carcasses and parts to inflate carcasses and parts with air if they develop, implement, and maintain written controls to ensure that the procedure does not cause insanitary conditions or adulterate product. In addition, FSIS has proposed to amend its regulations to remove the approved methods for inflating livestock carcasses and parts by air and the requirement that establishments seek approval from FSIS for inflation procedures not listed in the regulations. Interstate Shipment of State-Inspected Meat and Poultry Products. As authorized by the 2008 Farm Bill, FSIS will issue final regulations to implement a new voluntary Federal-State cooperative inspection program under which State-inspected establishments with 25 or fewer employees would be eligible to ship meat and poultry products in interstate commerce. Notification, Documentation, and Recordkeeping Requirements for Inspected Establishments. As authorized by the 2008 Farm Bill, FSIS will issue final regulations that will require establishments that are subject to inspection to promptly notify FSIS when an adulterated or misbranded product received by or originating from the establishment has entered into commerce. The regulations also will require the establishments to prepare and maintain current procedures for the recall of all products produced and shipped by the establishments and to document each reassessment of the establishments' process control plans. Catfish Inspection. FSIS is developing regulations to implement provisions of the 2008 Farm Bill provisions that make catfish an amenable species under the Federal Meat Inspection Act (FMIA). Public Health Information System. To support its food safety inspection activities, FSIS is developing the Public Health Information System (PHIS). PHIS, which is user-friendly and Web-based, will replace many of FSIS' current systems and automate many business processes. To facilitate the implementation of some PHIS components, FSIS is proposing to provide for electronic export and import application and certification processes as alternatives to the current paper-based systems for these certifications. Other planned initiatives. FSIS plans to finalize a February 2001 proposed rule to establish food safety performance standards for all processed ready-to-eat (RTE) meat and poultry products and for partially heat-treated meat and poultry products that are not ready-to-eat. Some provisions of the proposal addressed post-lethality contamination of RTE products with Listeria monocytogenes. In June 2003, FSIS published an interim final rule requiring establishments to prevent L. monocytogenes contamination of RTE products. FSIS has carefully reviewed its economic analysis of the interim final rule and is planning to affirm the interim rule as a final rule with changes. FSIS small business implications. The great majority of businesses regulated by FSIS are small businesses. Some of the regulations listed above substantially affect small businesses. Some rulemakings can benefit small businesses. For example, the rule on interstate shipment of State- inspected products will open interstate markets to some small State-inspected establishments that previously could only sell their products within State boundaries. FSIS conducts a small business outreach program that provides critical training, access to food safety experts, and information resources (such as compliance guidance and questions and answers on various topics) in forms that are uniform, easily comprehended, and consistent. FSIS collaborates in this effort with other USDA agencies and cooperating State partners. For example, FSIS makes plant owners and operators aware of loan programs, available through USDA's Rural Business and Cooperative programs, to help them in upgrading their facilities. FSIS employees meet with small and very small plant operators to learn more about their specific needs and provide joint training sessions for small and very small plants and FSIS employees. Animal and Plant Health Inspection Service Mission: A major part of the mission of the Animal and Plant Health Inspection Service (APHIS) is to protect the health and value of American agricultural and natural resources. APHIS regulatory actions support USDA's goal of ensuring access to safe, plentiful, and nutritious food by minimizing major diseases and pests that have the potential for reducing agricultural productivity. In support of this goal, APHIS conducts programs to prevent the introduction of exotic pests and diseases into the United States and conducts surveillance, monitoring, control, and eradication programs for pests and diseases in this country. These activities enhance agricultural productivity and competitiveness and contribute to the national economy and the public health. APHIS also conducts programs to ensure the humane handling, care, treatment, and transportation of animals under the Animal Welfare Act. Priorities: With respect to animal health, APHIS is working with State and tribal representatives to identify a regulatory approach that will provide national traceability standards for livestock moved interstate while allowing each State and tribe the flexibility to work with their producers to develop standards that will work best for them. In the area of animal welfare, APHIS plans to propose standards for the humane handling, care, treatment, and transportation of birds covered under the Animal Welfare Act and to establish regulations to ensure the humane treatment of dogs imported into the United States for resale. Regarding plant health, APHIS anticipates publishing a proposed rule that would revise the current regulations governing the permitting of plant pests and biological control organisms. APHIS is also preparing a final rule that will conclude the first phase of its comprehensive revision to its regulations for importing nursery stock (plants for planting) to better address plant health risks associated with propagative material. Agricultural Marketing Service Mission: The Agricultural Marketing Service (AMS) provides marketing services to producers, manufacturers, distributors, importers, exporters, and consumers of food products. The AMS [[Page 79470]] also manages the government's food purchases, supervises food quality grading, maintains food quality standards, and supervises the Federal research and promotion programs. AMS programs contribute to the achievement of a number of objectives under the Department's goal to assist rural communities to create prosperity and the goal to ensure that all of America's children have access to safe, nutritious, and balanced meals. Priorities: National Organic Program (NOP). AMS' priority items for the next year include several rulemakings that impact the organic industry. Statistics indicating rapid growth in the organic sector have highlighted issues that need to be addressed, including: - Origin of Livestock. On October 24, 2008, NOP published a proposed rule with request for comments on the access to pasture requirements for ruminants. This proposed rule included a change in the origin of livestock requirements for dairy animals under section 205.236 of the NOP regulations. Many of the comments received on the October 2008 proposed rule suggested that the origin of livestock issue should be pursued through a separate rulemaking from access to pasture. As a result, the proposed change to the origin of livestock requirements was not retained in the final rule on access to pasture published on February 17, 2010. AMS plans to develop a proposed rule specific to origin of livestock under the NOP during fiscal year (FY) 2011. - Periodic Pesticide Residue Testing. The Organic Foods Production Act (OFPA) of 1990 included language requiring certifying agents to conduct periodic residue testing of organic products produced or handled in accordance with the NOP. This requirement was meant to identify organic products that contained pesticides or other nonorganic residues in violation with the NOP or other applicable laws. In March 2010, an Office of Inspector General (OIG) audit of the NOP suggested that a legal review by the Office of General Counsel (OGC) of the current NOP regulations was needed to assess whether the existing regulations are in compliance with the residue testing requirement under OFPA. As a result of the legal opinion received by the NOP on this issue, AMS will publish a proposed rule on new periodic pesticide residue testing requirements in 2011. - Streamlining Enforcement Related Actions. The March 2010 Office of Inspector General (OIG) audit of the NOP raised issues related to the program's process for imposing enforcement actions. One concern was that organic producers and handlers facing revocation or suspension of their certification are able to market their products as organic during what can be a lengthy appeals process. As a result, AMS will publish a proposed rule in 2011 to streamline the NOP appeals process such that appeals are reviewed and responded to in a timely manner. Dairy Promotion and Research Program (Dairy Import Assessments). AMS has entered the final stage of establishing the National Dairy Promotion and Research Program. The Dairy Production Stabilization Act of 1983 (Dairy Act) authorized USDA to create a national producer program for dairy product promotion, research, and nutrition education as part of a comprehensive strategy to increase human consumption of milk and dairy products. Dairy farmers fund this self-help program through a mandatory assessment on all milk produced in the contiguous 48 States and marketed commercially. Dairy farmers administer the national program through the National Dairy Promotion and Research Board (Dairy Board). The 2008 Farm Bill extended the program to include producers in Alaska, Hawaii, and Puerto Rico, who will pay an assessment of $0.15 per hundredweight of milk production. Imported dairy products will be assessed at $0.075 per hundredweight of fluid milk equivalent. AMS published proposed regulations establishing the program in the May 19, 2009, Federal Register. The proposal had a 30-day comment period. The final rule is expected to be published by the end of 2010. Grain, Inspection, Packers and Stockyards Administration Mission: The Grain Inspection, Packers and Stockyards Administration (GIPSA) facilitates the marketing of livestock, poultry, meat, cereals, oilseeds, and related agricultural products and promotes fair and competitive trading practices for the overall benefit of consumers and American agriculture.GIPSA's activities contribute significantly to the Department's goal to increase prosperity in rural areas by supporting a competitive agricultural system. Priorities: GIPSA intends to issue a final rule that will define practices or conduct that are unfair, unjustly discriminatory, or deceptive, and/or that represent the making or giving of an undue or unreasonable preference or advantage, and ensure that producers and growers can fully participate in any arbitration process that may arise relating to livestock or poultry contracts. This regulation is being finalized in accordance with the authority granted to the Secretary by the Packers and Stockyards Act of 1921 and with the requirements of sections 11005 and 11006 of the 2008 Farm Bill. Farm Service Agency Mission: The Farm Service Agency's (FSA) mission is to equitably serve all farmers, ranchers, and agricultural partners through the delivery of effective, efficient agricultural programs, which contributes to two USDA goals. The goal of assisting rural communities in creating prosperity so they are self-sustaining, re-populating, and economically thriving; and the goal to enhance the Nation's natural resource base by assisting owners and operators of farms and ranches to conserve and enhance soil, water, and related natural resources. It supports the first goal by stabilizing farm income, providing credit to new or existing farmers and ranchers who are temporarily unable to obtain credit from commercial sources, and helping farm operations recover from the effects of disaster. FSA supports the second goal by administering several conservation programs directed toward agricultural producers. The largest program is the Conservation Reserve Program (CRP), which protects nearly 32 million acres of environmentally sensitive land. Priorities: Disaster Assistance. Regulations will be issued to establish a new disaster assistance program, the Emergency Forest Restoration Program. This program requires new regulations and minor revisions to the existing related Emergency Conservation Program regulations. Biomass Crop Assistance Program. Final regulations were published to complete implementation of the Biomass Crop Assistance Program. This program supports the Administration's energy initiative to accelerate the investment in and production of biofuels. The program will provide financial assistance to [[Page 79471]] agricultural and forest land owners and operators to establish and produce eligible crops, including woody biomass, for conversion to bioenergy, and the collection, harvest, storage, and transportation of eligible material for use in a biomass conversion facility. Farm Loan Programs. FSA will develop and issue regulations to amend programs for farm operating loans, down payment loans, and emergency loans to include socially disadvantaged farmers, increase loan limits, loan size, funding targets, interest rates, and graduating borrowers to commercial credit. In addition, the regulations will establish a new direct and guaranteed loan program to assist farmers in implementing conservation practices. Forest Service Mission: The mission of the Forest Service is to sustain the health, productivity, and diversity of the Nation's forests and rangelands to meet the needs of present and future generations. This includes protecting and managing National Forest System lands, providing technical and financial assistance to States, communities, and private forest landowners, and developing and providing scientific and technical assistance and scientific exchanges in support of international forest and range conservation. Forest Service regulatory priorities support the accomplishment of the Department's goal to ensure our National forests are conserved, restored, and made more resilient to climate change, while enhancing our water resources. Priorities: Land Management Planning Rule. The Forest Service is required to issue rulemaking for National Forest System land management planning under 16 U.S.C. 1604. The first planning rule was adopted in 1979 and amended in 1982. The Forest Service published a new planning rule on April 21, 2008 (73 FR 21468). On June 30, 2009, the United States District Court for the Northern District of California invalidated the Forest Service's 2008 Planning Rule published at 36 CFR 219 based on violations of NEPA and ESA in the rulemaking process. The District Court vacated the 2008 rule, enjoined the USDA from further implementing it, and remanded it to the USDA for further proceedings. USDA has determined that the 2000 planning rule is now in effect, including its transition provisions as amended in 2002 and 2003, and as clarified by interpretative rules issued in 2001 and 2004, which allows the use of the provisions of the 1982 planning rule to amend or revise plans. The Forest Service is now in the 2000 planning rule transition period. The Forest Service is proposing a new planning rule. In so doing, the Forest Service plans to correct deficiencies that have been identified over two decades of forest planning and update planning procedures to reflect contemporary collaborative planning practices. Community Forest and Open Space Conservation Program. The purpose of the Community Forest Program is to achieve community benefits through financial assistance grants to local governments, tribal governments, and nonprofit organizations to establish community forests by acquiring and protecting private forestlands. Community forest benefits are specified in the authorizing statute and include economic benefits from sustainable forest management, natural resource conservation, forest-based educational programs, model forest stewardship activities, and recreational opportunities. Closure of NFS Lands to Protect Privacy of Tribal Activities. There is currently no provision for a special closure of NFS lands to protect the privacy of tribal activities for traditional and cultural purposes. The Forest Service will amend its regulations to allow special closure of NFS land to protect the privacy of tribal activities for traditional and cultural purposes. Rural Business-Cooperative Service Mission: Promoting a dynamic business environment in rural America is the goal of the Rural Business-Cooperative Service (RBS). Business Programs works in partnership with the private sector and the community-based organizations to provide financial assistance and business planning, and helps fund projects that create or preserve quality jobs and/or promote a clean rural environment. The financial resources are often leveraged with those of other public and private credit source lenders to meet business and credit needs in under-served areas. Recipients of these programs may include individuals, corporations, partnerships, cooperatives, public bodies, nonprofit corporations, Indian tribes, and private companies. The mission of Cooperative Programs of RBS is to promote understanding and use of the cooperative form of business as a viable organizational option for marketing and distributing agricultural products. Priorities: In support of the Department's goal to increase the prosperity of rural communities, RBS regulatory priorities will facilitate sustainable renewable energy development and enhance the opportunities necessary for rural families to thrive economically. RBS's priority will be to publish regulations to fully implement the 2008 Farm Bill. This includes promulgating regulations for the Biorefinery Assistance Program (sec. 9003), the Repowering Assistance Program (sec. 9004), the Bioenergy Program for Advanced Biofuels (sec. 9005), and the Rural Microentrepreneur Assistance Program (RMAP). RBS has been administering sections 9003, 9004, and 9005 through the use of Notices of Funds Availability and Notices of Contract Proposals. Revisions to the Rural Energy for America Program (sec. 9007) will be made to incorporate Energy Audits and Renewable Energy Development Assistance and Feasibility Studies for Rural Energy Systems as eligible grant purposes, as well as other Farm Bill initiatives and various technical changes throughout the rule. In addition, revisions to the Business and Industry Guaranteed Loan Program will be made to implement 2008 Farm Bill provisions and other program initiatives. These rules will minimize program complexity and burden on the public while enhancing program delivery and RBS oversight. Rural Utilities Service Mission: The mission of the Rural Utilities Service is to improve the quality of life in rural America by providing investment capital for the deployment of critical rural utilities telecommunications, electric, and water and waste disposal infrastructure. Financial assistance is provided to rural utilities, municipalities, commercial corporations, limited liability companies, public utility districts, Indian tribes, and cooperative, nonprofit, limited-dividend, or mutual associations. The public-private partnership, which is forged between the Rural Utilities Service (RUS) and these industries, results in billions of dollars in rural infrastructure development and creates thousands of jobs for the American economy. Priorities: RUS' regulatory priorities will be to achieve the President's goal to bring affordable broadband to all rural Americans. To accomplish this, RUS will continue to improve the Broadband Program established by the 2002 Farm [[Page 79472]] Bill. The 2002 Farm Bill authorized RUS to approve loans and loan guarantees for the costs of construction, improvement, and acquisition of facilities and equipment for broadband service in eligible rural communities. The 2008 Farm Bill is significantly changing the statutory requirements of the Broadband Loan Program. As such, RUS will be issuing an interim rule to implement the statutory changes and will request comments on the section of the rule that was not part of the proposed rule that was published in May 2007. In addition, the regulations will be issued to implement provisions of the American Recovery and Reinvestment Act that expanded RUS's authority to make loans and provided new authority to make grants to facilitate broadband deployment in rural areas. Departmental Management Mission: Departmental Management's mission is to provide management leadership to ensure that USDA administrative programs, policies, advice, and counsel meet the needs of USDA program organizations, consistent with laws and mandates, and provide safe and efficient facilities and services to customers. Priorities: In support of the Department's goal to increase rural prosperity, USDA's Departmental Management will finalize regulations establishing a program allowing manufacturers and vendors of eligible products made from biobased feedstocks to display the label on their packaging and marketing materials. Once completed, this regulation will implement a section of the 2008 Farm Bill and will promote alternative uses of agriculture and forest materials. Aggregate Costs and Benefits USDA will ensure that its regulations provide benefits that exceed costs, but is unable to provide an estimate of the aggregated impacts of its regulations. Problems with aggregation arise due to differing baselines, data gaps, and inconsistencies in methodology and the type of regulatory costs and benefits considered. In addition, aggregation omits benefits and costs that cannot be reliably quantified, such as improved health resulting from increased access to more nutritious foods, higher levels of food safety, and increased quality of life derived from investments in rural infrastructure. Some benefits and costs associated with rules listed in the regulatory plan cannot currently be quantified as the rules are still being formulated. For 2011, the Department's focus will be to implement the changes to programs in such a way as to provide benefits while minimizing program complexity and regulatory burden for program participants. _______________________________________________________________________ <###doc> USDA--Agricultural Marketing Service (AMS) ----------- PROPOSED RULE STAGE ----------- <###doc> 1. WHOLESALE PORK REPORTING PROGRAM Priority: Other Significant Legal Authority: 7 USC 1635 to 1636 CFR Citation: 7 CFR 59 Legal Deadline: Final, Statutory, March 28, 2012. With the passage of S. 3656, the Mandatory Price Reporting Act of 2010, the Secretary of Agriculture is required to amend chapter 3 of subtitle B of the Agricultural Marketing Act of 1946 by adding a new section for mandatory reporting of wholesale pork cuts. To make these amendments, the Secretary was directed to promulgate a final rule no later than one and a half years after the date of the enactment of the Act. Accordingly, a final rule will be promulgated by March 28, 2012. Abstract: On September 15, 2010, Congress passed the Mandatory Price Reporting Act of 2010 reauthorizing Livestock Mandatory Reporting for 5 years and adding a provision for mandatory reporting of wholesale pork cuts. The Act was signed by the President on September 28, 2010. Congress directed the Secretary to engage in negotiated rulemaking to make required regulatory changes for mandatory wholesale pork reporting. Further, Congress required that the negotiated rulemaking committee include representatives from (i) organizations representing swine producers; (ii) organizations representing packers of pork, processors of pork, retailers of pork, and buyers of wholesale pork; (iii) the Department of Agriculture; and (iv) among interested parties that participate in swine or pork production. Statement of Need: Implementation of mandatory pork reporting is required by Congress. Congress delegated responsibility to the Secretary for determining what information is necessary and appropriate. The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-234) directed the Secretary to conduct a study to determine advantages, drawbacks, and potential implementation issues associated with adopting mandatory wholesale pork reporting. The report from this study generally concluded that voluntary wholesale pork price reporting is thin and becoming thinner, and some degree of support for moving to mandatory price reporting exists at every segment of the industry interviewed. The report was delivered to Congress on March 25, 2010. Summary of Legal Basis: Livestock Mandatory Reporting is authorized under the Agricultural Marketing Act (7 U.S.C. 1635 to 1636). The Livestock and Seed Program of USDA's Agricultural Marketing Service has day-to-day responsibility for collecting and disseminating LMR data. Alternatives: There are no alternatives, as this rulemaking is a matter of law based on the Mandatory Price Reporting Act of 2010. Anticipated Cost and Benefits: Estimation of costs will follow the previous methodology used in earlier Livestock Mandatory Reporting rulemaking. The focus of the cost estimation is the burden placed on reporting companies in providing pork marketing data to the Livestock and Seed Program. Previous rulemaking cost estimates of boxed beef reporting of similar data found the burden to be an annual total of 65 hours in additional reporting requirements per firm. Because no official USDA grade standards are used in the marketing of pork, and fewer cutting styles, the burden for pork reporting firms in comparison with beef reporting firms could be lower. However, the impact is not truly known at this stage. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Notice 12/00/10 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None [[Page 79473]] Agency Contact: Warren Preston Department of Agriculture Agricultural Marketing Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-6231 Fax: 202 690-3732 Email: warren.preston@usda.gov RIN: 0581-AD07 _______________________________________________________________________ <###doc> USDA--AMS ----------- FINAL RULE STAGE ----------- <###doc> 2. NATIONAL DAIRY PROMOTION AND RESEARCH PROGRAM; DAIRY IMPORT ASSESSMENTS, DA-08-0050 Priority: Other Significant Legal Authority: 7 USC 4501 to 4514; 7 USC 7401 CFR Citation: 7 CFR 1150 Legal Deadline: Final, Statutory, September 19, 2008, Assessments on imported dairy products must be implemented by deadline. With the passage of section 1507 in the 2008 Farm Bill, the Dairy Act was amended to apply certain assessments to Alaska, Hawaii, the District of Columbia, and the Commonwealth of Puerto Rico. The 2008 Farm Bill authorized the Secretary to issue regulations to implement the mandatory dairy import assessment without providing a notice and comment period. However, due to the interest of affected parties, a notice and comment period was provided. Abstract: The Dairy Act authorizes the Order for dairy product promotion, research, and nutrition education as part of a comprehensive strategy to increase human consumption of milk and dairy products and to reduce milk surpluses. The program functions to strengthen the dairy industry's position in the marketplace by maintaining and expanding domestic and foreign consumption of fluid milk and dairy products. Amendments to the Order are pursuant to the 2002 and 2008 Farm Bills. The 2002 Farm Bill mandates that the Order be amended to implement an assessment on imported dairy products to fund promotion and research. The 2008 Farm Bill specifies a mandatory assessment rate of 7.5-cent per hundredweight of milk, or equivalent thereof, on dairy products imported into the United States. Additionally, in accordance with the 2008 Farm Bill, the term ``United States'' is the Dairy Act is amended to mean all States, the District of Columbia, and the Commonwealth of Puerto Rico. Producers in these areas will be assessed 15 cents per hundredweight for all milk produced and marketed. Statement of Need: In response to the May 19, 2009 (74 FR 23359), proposed rule (National Dairy Promotion and Research Program; Proposed Rule on Amendments to the Order), AMS received 189 timely comments from consumers, dairy producers, foreign governments, importers, exporters, manufacturers, members of Congress, trade associations, and other interested parties. The comments covered a wide range of topics, including 39 in opposition to the proposal and 150 in support of the proposal. Opponents of the proposal expressed concern over the lack of a referendum requirement among those affected; default assessment rates; lack of ability to no longer promote State-branded dairy products; lack of importer organizations eligible to become a Qualified Program; disputed the cost-benefit analysis for importers and producers; and cited unreasonable importer paperwork and record keeping burdens. Proponents of the proposal expressed support for an expedited implementation of the dairy import assessment; cited the enhanced benefits both domestic producers and importers will receive as a result of implementation; recommended new Harmonized Tariff Schedule codes; use of a default assessment rate; recommended regular reporting of the products and assessments on imports; and all thresholds for compliance with U.S. trade obligations have been met. AMS plans to issue a final rule implementing the dairy import assessment in the near future. In response to the comments received and after consultation with USTR, AMS is addressing, in the final rule, referenda, alternative assessment rates, and compliance and enforcement activity. All remaining changes are miscellaneous and minor in nature in order to clarify regulatory text. Summary of Legal Basis: The National Dairy Promotion and Research Program (National Program) is authorized under the authorized under the provisions of the Dairy Production Stabilization Act of 1983 (7 U.S.C. 4501 to 4514), and the Dairy Promotion and Research Order (7 CFR part 1150). The Dairy Programs unit of USDA's Agricultural Marketing Service has day--to--day oversight responsibilities for the National Program. Alternatives: There are no alternatives, as this rulemaking is a matter of law based on the 2002 and 2008 Farm Bills. Anticipated Cost and Benefits: Assessments to dairy producers under the Order are relatively small compared to producer revenue. If dairy producers in Alaska, Hawaii, the District of Columbia, and the Commonwealth of Puerto Rico had paid assessments of $0.15 per hundredweight of milk marketed in 2007, it is estimated that $1.1 million would have been paid. This is about 0.6 percent of the $192 million total value of milk produced and marketed in these areas. Benefits to producers in these areas are assumed to be similar to those benefits received by producers of other U.S. geographical regions. Cornell University has conducted an independent economic analysis of the Program that is included in the annual report to Congress. Cornell determined that from 1998 through 2007, each dollar invested in generic dairy marketing by dairy farmers during the period would return between $5.52 and $5.94, on average, in net revenue to farmers. Assessments collected from importers under the National Program will be relatively small compared to the value of dairy imports. If importers had been assessed $0.075 per hundredweight, or equivalent thereof, for imported dairy products in 2007 as specified in this rule, it is estimated that less than $6.1 million would have been paid. This is about 0.3 percent of the $2.4 billion value of the dairy products imported in 2007. Risks: If the amendments are not implemented, USDA would be in violation of the 2002 and 2008 Farm Bills. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 05/19/09 74 FR 23359 [[Page 79474]] NPRM Comment Period End 06/18/09 Final Action 03/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Whitney Rick Promotion and Research Branch Chief Department of Agriculture Agricultural Marketing Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-6909 Fax: 202 720-0285 Email: whitney.rick@usda.gov RIN: 0581-AC87 _______________________________________________________________________ <###doc> USDA--Animal and Plant Health Inspection Service (APHIS) ----------- PROPOSED RULE STAGE ----------- <###doc> 3. ANIMAL WELFARE; REGULATIONS AND STANDARDS FOR BIRDS Priority: Other Significant Legal Authority: 7 USC 2131 to 2159 CFR Citation: 9 CFR 1 to 3 Legal Deadline: None Abstract: APHIS intends to establish standards for the humane handling, care, treatment, and transportation of birds other than birds bred for use in research. Statement of Need: The Farm Security and Rural Investment Act of 2002 amended the definition of animal in the Animal Welfare Act (AWA) by specifically excluding birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research. While the definition of animal in the regulations contained in 9 CFR part 1 has excluded rats of the genus Rattus and mice of the genus Mus bred for use in research, that definition has also excluded all birds (i.e., not just those birds bred for use in research). In line with this change to the definition of animal in the AWA, APHIS intends to establish standards in 9 CFR part 3 for the humane handling, care, treatment, and transportation of birds other than those birds bred for use in research and to revise the regulations in 9 CFR parts 1 and 2 to make them applicable to birds. Summary of Legal Basis: The Animal Welfare Act (AWA) authorizes the Secretary of Agriculture to promulgate standards and other requirements governing the humane handling, care, treatment, and transportation of certain animals by dealers, research facilities, exhibitors, operators of auction sales, and carriers and immediate handlers. Animals covered by the AWA include birds that are not bred for use in research. Alternatives: To be identified. Anticipated Cost and Benefits: To be determined. Risks: Not applicable. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 08/00/11 NPRM Comment Period End 11/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Agency Contact: Johanna Briscoe Veterinary Medical Officer and Avian Specialist, Animal Care Department of Agriculture Animal and Plant Health Inspection Service 4700 River Road, Unit 84 Riverdale, MD 20737-1234 Phone: 301 734-0658 RIN: 0579-AC02 _______________________________________________________________________ <###doc> USDA--APHIS <###doc> 4. PLANT PEST REGULATIONS; UPDATE OF GENERAL PROVISIONS Priority: Other Significant Legal Authority: 7 USC 450; 7 USC 2260; 7 USC 7701 to 7772; 7 USC 7781 to 7786; 7 USC 8301 to 8817; 19 USC 136; 21 USC 111; 21 USC 114a; 21 USC 136 and 136a; 31 USC 9701; 42 USC 4331 to 4332 CFR Citation: 7 CFR 318 to 319; 7 CFR 330; 7 CFR 352 Legal Deadline: None Abstract: We are proposing to revise our regulations regarding the movement of plant pests. We are proposing to regulate the movement of not only plant pests, but also biological control organisms and associated articles. We are proposing risk-based criteria regarding the movement of biological control organisms, and are proposing to exempt certain types of plant pests from permitting requirements for their interstate movement and movement for environmental release. We are also proposing to revise our regulations regarding the movement of soil, and to establish regulations governing the biocontainment facilities in which plant pests, biological control organisms, and associated articles are held. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document. This proposal would clarify the factors that would be considered when assessing the risks associated with the movement of certain organisms, facilitate the movement of regulated organisms and articles in a manner that also protects U.S. agriculture, and address gaps in the current regulations. Statement of Need: APHIS is preparing a proposed rule to revise its regulations regarding the movement of plant pests. The revised regulations would address the importation and interstate movement of plant pests, biological control organisms, and associated articles and the release into the environment of biological control organisms. The revision would also address the movement of soil and establish regulations governing the biocontainment facilities in which [[Page 79475]] plant pests, biological control organisms, and associated articles are held. This proposal would clarify the factors that would be considered when assessing the risks associated with the movement of certain organisms, facilitate the movement of regulated organisms and articles in a manner that also protects U.S. agriculture, and address gaps in the current regulations. Summary of Legal Basis: Under section 411(a) of the Plant Protection Act (PPA), no person shall import, enter, export, or move in interstate commerce any plant pest, unless the importation, entry, exportation, or movement is authorized under a general or specific permit and in accordance with such regulations as the Secretary of Agriculture may issue to prevent the introduction of plant pests into the United States or the dissemination of plant pests within the United States. Under section 412 of the PPA, the Secretary may restrict the importation or movement in interstate commerce of biological control organisms by requiring the organisms to be accompanied by a permit authorizing such movement and by subjecting the organisms to quarantine conditions or other remedial measures deemed necessary to prevent the spread of plant pests or noxious weeds. That same section of the PPA also gives the Secretary explicit authority to regulate the movement of associated articles. Alternatives: The alternatives we considered were taking no action at this time or implementing a comprehensive risk reduction plan. This latter alternative would be characterized as a broad risk mitigation strategy that could involve various options such as increased inspection, regulations specific to a certain organism or group of related organisms, or extensive biocontainment requirements. We decided against the first alternative because leaving the regulations unchanged would not address the needs identified immediately above. We decided against the latter alternative, because available scientific information, personnel, and resources suggest that it would be impracticable at this time. Anticipated Cost and Benefits: Undetermined at this time. Risks: Unless we issue such a proposal, the regulations will not provide a clear protocol for obtaining permits that authorize the movement and environmental release of biological control organisms. This, in turn, could impede research to explore biological control options for various plant pests and noxious weeds known to exist within the United States, and could indirectly lead to the further dissemination of such pests and weeds. Moreover, unless we revise the soil regulations, certain provisions in the regulations will not adequately address the risk to plants, plant parts, and plant products within the United States that such soil might present. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Notice of Intent to Prepare an Environmental Impact Statement 10/20/09 74 FR 53673 Notice Comment Period End 11/19/09 NPRM 01/00/11 NPRM Comment Period End 03/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: Local, State, Tribal International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Agency Contact: Shirley Wager-Page Chief, Pest Permitting Branch, Plant Health Programs, PPQ Department of Agriculture Animal and Plant Health Inspection Service 4700 River Road, Unit 131 Riverdale, MD 20737-1236 Phone: 301 734-8453 RIN: 0579-AC98 _______________________________________________________________________ <###doc> USDA--APHIS <###doc> 5. IMPORTATION OF LIVE DOGS Priority: Other Significant Legal Authority: 7 USC 2148 CFR Citation: 9 CFR 1 and 2 Legal Deadline: None Abstract: This rulemaking would amend the Animal Welfare Act (AWA) regulations to regulate dogs imported for resale as required by a recent amendment to the AWA. Importation of dogs for resale would be prohibited unless the dogs are in good health, have all necessary vaccinations, and are 6 months of age or older. This proposal will also reflect the exemptions provided in the amendment to the AWA for dogs imported for research purposes or veterinary treatment and for dogs legally imported into the State of Hawaii from the British Isles, Australia, Guam, or New Zealand. Statement of Need: The Food, Conservation, and Energy Act of 2008 mandates that the Secretary of Agriculture promulgate regulations to implement and enforce new provisions of the Animal Welfare Act (AWA) regarding the importation of dogs for resale. In line with the changes to the AWA, APHIS intends to amend the regulations in 9 CFR parts 1 and 2 to regulate the importation of dogs for resale. Summary of Legal Basis: The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, signed into law on June 18, 2008) added a new section to the Animal Welfare Act (7 U.S.C. 2147) to restrict the importation of live dogs for resale. As amended, the AWA now prohibits the importation of dogs into the United States for resale unless the Secretary of Agriculture determines that the dogs are in good health, have received all necessary vaccinations, and are at least 6 months of age. Exceptions are provided for dogs imported for research purposes or veterinary treatment. An exception to the 6-month age requirement is also provided for dogs that are lawfully imported into Hawaii for resale purposes from the British Isles, Australia, Guam, or New Zealand in compliance with the applicable regulations of Hawaii, provided the dogs are vaccinated, are in good health, and are not transported out of Hawaii for resale purposes at less than 6 months of age. [[Page 79476]] Alternatives: To be identified. Anticipated Cost and Benefits: To be determined. Risks: Not applicable. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 12/00/10 NPRM Comment Period End 02/00/11 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Agency Contact: Gerald Rushin Veterinary Medical Officer, Animal Care Department of Agriculture Animal and Plant Health Inspection Service 4700 River Road, Unit 84 Riverdale, MD 20737-1234 Phone: 301 734-0954 RIN: 0579-AD23 _______________________________________________________________________ <###doc> USDA--APHIS <###doc> 6. ANIMAL DISEASE TRACEABILITY Priority: Other Significant Legal Authority: 7 USC 8305 CFR Citation: 9 CFR 90 Legal Deadline: None Abstract: This rulemaking would establish a new part in the Code of Federal Regulations containing general identification and documentation requirements for livestock moving interstate. The purpose of the new regulations is to improve our ability to trace livestock in the event that disease is found. The regulations will provide national traceability standards for livestock moved interstate and allow each State and tribe the flexibility to develop ways of meeting the standards that will work best for them. Statement of Need: Preventing and controlling animal disease is the cornerstone of protecting American animal agriculture. While ranchers and farmers work hard to protect their animals and their livelihoods, there is never a guarantee that their animals will be spared from disease. To support their efforts, USDA has enacted regulations to prevent, control, and eradicate disease, and to increase foreign and domestic confidence in the safety of animals and animal products. Traceability helps give that reassurance. Traceability does not prevent disease, but knowing where diseased and at-risk animals are, where they have been, and when, is indispensable in emergency response and in ongoing disease programs. The primary objectives of these proposed regulations are to improve our ability to trace livestock in the event that disease is found and to provide national standards to ensure the smooth flow of livestock in interstate commerce, while also allowing States and tribes the flexibility to develop systems for tracing animals within their State and tribal lands that work best for them. Summary of Legal Basis: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Secretary of Agriculture may prohibit or restrict the interstate movement of any animal to prevent the introduction or dissemination of any pest or disease of livestock, and may carry out operations and measures to detect, control, or eradicate any pest or disease of livestock. The Secretary may promulgate such regulations as may be necessary to carry out the Act. Alternatives: As part of its ongoing efforts to safeguard animal health, APHIS initiated implementation of the National Animal Identification System (NAIS) in 2004. More recently, the Agency launched an effort to assess the level of acceptance of NAIS through meetings with the Secretary, listening sessions in 14 cities, and public comments. Although there was some support for NAIS, the vast majority of participants were highly critical of the program and of USDA's implementation efforts. The feedback revealed that NAIS has become a barrier to achieving meaningful animal disease traceability in the United States in partnership with America's producers. The option we are proposing pertains strictly to interstate movement and gives States and tribes the flexibility to identify and implement the traceability approaches that work best for them. Anticipated Cost and Benefits: A workable and effective animal traceability system would enhance animal health programs, leading to more secure market access and other societal gains. Traceability can reduce the cost of disease outbreaks, minimizing losses to producers and industries by enabling current and previous locations of potentially exposed animals to be readily identified. Trade benefits can include increased competitiveness in global markets generally, and when outbreaks do occur, the mitigation of export market losses through regionalization. Markets benefit through more efficient and timely epidemiological investigation of animal health issues. Other societal benefits include improved animal welfare during natural disasters. Costs of an animal traceability system would include those for tags and tagging and would vary, depending on the method of identification chosen (e.g., metal tags vs. microchip implants). Costs are expected to vary by both type of operation and whether traceability would be by individual animal or by lot or group. Per head costs of traceability programs for the principal farm animals are estimated to be highest for cattle operations, followed by sheep, swine, and poultry operations. Larger operations would likely reap economies of scale, that is, incur lower costs per head than smaller operations. However, there will be exemptions for small producers who raise animals to feed themselves, their families, and their immediate neighbors. In addition, only operations moving livestock interstate would be required to comply with the regulations. Risks: This rulemaking is being undertaken to address the animal health risks posed by gaps in the existing regulations concerning identification of livestock being moved interstate. The current lack of a comprehensive animal traceability program is impairing our ability to trace animals that may be affected with disease. [[Page 79477]] Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 04/00/11 NPRM Comment Period End 06/00/11 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: State, Tribal Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Agency Contact: Neil Hammerschmidt NAIS Coordinator, Surveillance and Identification Programs, NCAHP, VS Department of Agriculture Animal and Plant Health Inspection Service 4700 River Road, Unit 200 Riverdale, MD 20737-1231 Phone: 301 734-5571 RIN: 0579-AD24 _______________________________________________________________________ <###doc> USDA--APHIS ----------- FINAL RULE STAGE ----------- <###doc> 7. IMPORTATION OF PLANTS FOR PLANTING; ESTABLISHING A NEW CATEGORY OF PLANTS FOR PLANTING NOT AUTHORIZED FOR IMPORTATION PENDING PEST RISK ANALYSIS (RULEMAKING RESULTING FROM A SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 7 USC 450; 7 USC 7701 to 7772; 7 USC 7781 to 7786; 21 USC 136 and 136a CFR Citation: 7 CFR 319 Legal Deadline: None Abstract: This rulemaking will amend the regulations to establish a new category of regulated articles in the regulations governing the importation of nursery stock, also known as plants for planting. This category will list taxa of plants for planting whose importation is not authorized pending pest risk analysis. If scientific evidence indicates that a taxon of plants for planting is a quarantine pest or a host of a quarantine pest, we will publish a notice that will announce our determination that the taxon is a quarantine pest or a host of a quarantine pest, cite the scientific evidence we considered in making this determination, and give the public an opportunity to comment on our determination. If we receive no comments that change our determination, the taxon will subsequently be added to the new category. We will allow any person to petition for a pest risk analysis to be conducted for a taxon that has been added to the new category. After the pest risk analysis is completed, we will remove the taxon from the category and allow its importation subject to general requirements, allow its importation subject to specific restrictions, or prohibit its importation. We will consider applications for permits to import small quantities of germplasm from taxa whose importation is not authorized pending pest risk analysis, for experimental or scientific purposes under controlled conditions. This new category will allow us to take prompt action on evidence that the importation of a taxon of plants for planting poses a risk while continuing to allow for public participation in the process. Statement of Need: APHIS typically relies on inspection at a Federal plant inspection station or port of entry to mitigate the risks of pest introduction associated with the importation of plants for planting. Importation of plants for planting is further restricted or prohibited only if there is specific evidence that such importation could introduce a quarantine pest into the United States. Most of the taxa of plants for planting currently being imported have not been thoroughly studied to determine whether their importation presents a risk of introducing a quarantine pest into the United States. The volume and the number of types of plants for planting have increased dramatically in recent years, and there are several problems associated with gathering data on what plants for planting are being imported and on the risks such importation presents. In addition, quarantine pests that enter the United States via the importation of plants for planting pose a particularly high risk of becoming established within the United States. The current regulations need to be amended to better address these risks. Summary of Legal Basis: The Secretary of Agriculture may prohibit or restrict the importation or entry of any plant if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States of a plant pest or noxious weed (7 U.S.C. 7712). Alternatives: APHIS has identified one alternative to the approach we are considering. We could prohibit the importation of all nursery stock pending risk evaluation, approval, and notice-and-comment rulemaking, similar to APHIS' approach to regulating imported fruits and vegetables. This approach would lead to a major interruption in international trade and would have significant economic effects on both U.S. importers and U.S. consumers of plants for planting. Anticipated Cost and Benefits: Undetermined. Risks: In the absence of some action to revise the nursery stock regulations to allow us to better address pest risks, increased introductions of plant pests via imported nursery stock are likely, causing extensive damage to both agricultural and natural plant resources. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 07/23/09 74 FR 36403 NPRM Comment Period End 10/21/09 Final Rule 12/00/10 Regulatory Flexibility Analysis Required: No Government Levels Affected: None International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. [[Page 79478]] Agency Contact: Arnold T. Tschanz Senior Plant Pathologist, Risk Management and Plants for Planting Policy, RPM, PPQ Department of Agriculture Animal and Plant Health Inspection Service 4700 River Road, Unit 133 Riverdale, MD 20737-1231 Phone: 301 734-0627 RIN: 0579-AC03 _______________________________________________________________________ <###doc> USDA--Rural Housing Service (RHS) ----------- FINAL RULE STAGE ----------- <###doc> 8. MULTI-FAMILY HOUSING (MFH) REINVENTION Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 5 USC 301; 42 USC 1490a; 7 USC 1989; 42 USC 1475; 42 USC 1479; 42 USC 1480; 42 USC 1481; 42 USC 1484; 42 USC 1485; 42 USC 1486 CFR Citation: 7 CFR 1806; 7 CFR 1822; 7 CFR 1902; 7 CFR 1925; 7 CFR 1930; 7 CFR 1940; 7 CFR 1942; 7 CFR 1944; 7 CFR 1951; 7 CFR 1955; 7 CFR 1956; 7 CFR 1965; 7 CFR 3560; 7 CFR 3565 Legal Deadline: None Abstract: The Rural Housing Service has consolidated and streamlined the regulations pertaining to section 515 Rural Rental Housing, section 514 Farm Labor Housing Loans, section 516 Farm Labor Housing Grants, and section 521 Rental Assistance Payments. Fourteen published regulations have been reduced to one regulation and handbooks for program administration. This will simplify loan origination and portfolio management for applicants, borrowers, and housing operators, as well as Rural Development field staff. This also provides flexibility for program modifications to reflect current and foreseeable changes. The consolidated regulations save time and simplify costs. Finally, the regulation is more customer friendly and responsive to the needs of the public. Statement of Need: The new regulation for the program known as the Multi-Family Housing Loan and Grant Programs will be more user-friendly for lenders, borrowers, and Agency staff. These changes are essential to allow for improved service to the public and for an expanded program with increased impact on rural housing opportunities without a corresponding expansion in Agency staff. The regulations will be shorter, better organized, and more simple and clear. Many documentation requirements will be eliminated or consolidated into more convenient formats. Summary of Legal Basis: The existing statutory authority for the MFH programs was established in title V of the Housing Act of 1949, which gave authority to the RHS (then the Farmers Home Administration) to make housing loans to farmers. As a result of this Act, the Agency established single-family and multi-family housing programs. Over time, the sections of the Housing Act of 1949 addressing MFH have been amended a number of times. Amendments have involved issues such as the provision of interest credit, broadening definitions of eligible areas and populations to be served, participation of limited profit entities, the establishment of a rental assistance program, and the imposition of a number of restrictive use provisions and prepayment restrictions. Alternatives: To not publish the rule would substantially restrict RHS' ability to effectively administer the programs and cost the Agency significant credibility with the public and oversight organizations. Anticipated Cost and Benefits: Based on analysis of the proposed rule, the following impacts may occur, some of which could be considered significant: There would be cost savings due to reduced paperwork, estimated to be about $1.8 million annually for the public and about $10.1 million for the Government. Risks: Without the streamlining, there will be a decrease in the ability of the Agency to provide safe, decent, and sanitary housing to program beneficiaries. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 06/02/03 68 FR 32872 NPRM Comment Period End 08/01/03 Interim Final Rule 11/26/04 69 FR 69032 Interim Final Rule Comment Period End 12/27/04 Interim Final Rule Effective 02/22/05 70 FR 8503 Final Action 10/00/11 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Laurence Anderson MFH Preservation and Direct Loans Department of Agriculture Rural Housing Service STOP 0781 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-1611 Email: laurence.anderson@wdc.usda.gov Related RIN: Merged with 0575-AC24 RIN: 0575-AC13 _______________________________________________________________________ <###doc> USDA--Grain Inspection, Packers and Stockyards Administration (GIPSA) ----------- FINAL RULE STAGE ----------- <###doc> 9. ENFORCEMENT OF THE PACKERS AND STOCKYARDS ACT Priority: Other Significant Legal Authority: 7 USC 181 CFR Citation: 9 CFR 201 Legal Deadline: Final, Statutory, June 18, 2010. Abstract: GIPSA is proposing regulations under the Packers and Stockyards Act, 1921, that clarify when certain conduct in the livestock and poultry industries represents the making or giving of an undue or unreasonable preference or advantage or subjects a person or locality to an undue or unreasonable prejudice or disadvantage. These proposed regulations also establish criteria GIPSA will consider in determining whether a live poultry [[Page 79479]] dealer has provided reasonable notice to poultry growers of any suspension of the delivery of birds under a poultry growing arrangement; when a requirement of additional capital investments over the life of a poultry growing arrangement or swine production contract constitutes a violation of the P&S Act; and whether a live poultry dealer or swine contractor has provided a reasonable period of time for a poultry grower or a swine production contract grower to remedy a breach of contract that could lead to termination of the poultry growing arrangement or swine production contract. The Farm Bill also instructed the Secretary to promulgate regulations to ensure that producers and growers are afforded the opportunity to fully participate in the arbitration process if they so choose. Statement of Need: In enacting title XI of the Food, Conservation, and Energy Act of 2008 (Farm Bill) (Pub. L. 110-246), Congress recognized the nature of problems encountered in the livestock and poultry industries and amended the Packers and Stockyards Act (P&S Act). These amendments established new requirements for participants in the livestock and poultry industries and required the Secretary of Agriculture (Secretary) to establish criteria to consider when determining that certain other conduct is in violation of the P&S Act. The Grain Inspection, Packers and Stockyards Administration's (GIPSA) attempts to enforce the broad prohibitions of the P&S Act have been frustrated, in part because it has not previously defined what conduct constitutes an unfair practice or the giving of an undue preference or advantage. The new regulations that GIPSA is proposing describe and clarify conduct that violates the P&S Act and allow for more effective and efficient enforcement by GIPSA. They will clarify conditions for industry compliance with the P&S Act and provide for a fairer market place. In accordance with the Farm Bill, GIPSA is proposing regulations under the P&S Act that would clarify when certain conduct in the livestock and poultry industries represents the making or giving of an undue or unreasonable preference or advantage or subjects a person or locality to an undue or unreasonable prejudice or disadvantage. These proposed regulations also establish criteria that GIPSA will consider in determining whether a live poultry dealer has provided reasonable notice to poultry growers of a suspension of the delivery of birds under a poultry growing arrangement; when a requirement of additional capital investments over the life of a poultry growing arrangement or swine production contract constitutes a violation of the P&S Act; and whether a packer, swine contractor or live poultry dealer has provided a reasonable period of time for a grower or a swine producer to remedy a breach of contract that could lead to termination of the growing arrangement or production contract. The Farm Bill also instructed the Secretary to promulgate regulations to ensure that poultry growers, swine production contract growers and livestock producers are afforded the opportunity to fully participate in the arbitration process, if they so choose. We are proposing a required format for providing poultry growers, swine production contract growers, and livestock producers the opportunity to decline the use of arbitration in contracts requiring arbitration. We are also proposing criteria that we will consider in finding that poultry growers, swine production contract growers, and livestock producers have a meaningful opportunity to participate fully in the arbitration process if they voluntarily agree to do so. We will use these criteria to assess the overall fairness of the arbitration process. In addition to proposing regulations in accordance with the Farm Bill, GIPSA is proposing regulations that would prohibit certain conduct because it is unfair, unjustly discriminatory or deceptive, in violation of the P&S Act. These additional proposed regulations are promulgated under the authority of section 407 of the P&S Act and complement those required by the Farm Bill to help ensure fair trade and competition in the livestock and poultry industries. These regulations are intended to address the increased use of contracting in the marketing and production of livestock and poultry by entities under the jurisdiction of the P&S Act, and practices that result from the use of market power and alterations in private property rights, which violate the spirit and letter of the P&S Act. The effect increased contracting has had, and continues to have, on individual agricultural producers has significantly changed the industry and the rural economy as a whole, making these proposed regulations necessary. Summary of Legal Basis: Section 407 of the P&S Act (7 U.S.C. 228) provides that the Secretary ``may make such rules, regulations, and orders as may be necessary to carry out the provisions of this Act.'' Sections 11005 and 11006 of the Farm Bill became effective June 18, 2008, and instruct the Secretary to promulgate additional regulations as described in this notice of proposed rulemaking. Alternatives: The Farm Bill explicitly directs the Secretary to promulgate certain regulations. GIPSA determined that additional regulations are necessary to provide notice to all regulated entities of types of practices and conduct that GIPSA considers ``unfair'' so that regulated entities are fully informed of actions or practices that are considered ``unfair'' and, therefore, prohibited. Within both the mandatory and discretionary regulatory provisions, we considered alternative options. For example, GIPSA considered shorter notice periods in situations when a live poultry dealer suspends delivery of birds to a poultry grower. These alternatives would not have provided adequate trust and integrity in the livestock and poultry markets. Other alternatives may have been more restrictive. We considered prohibiting the use of arbitration to resolve disputes; however, that option goes against a popular method of dispute resolution in other industries and is not in line with the spirit of the 2008 Farm Bill. GIPSA believes that this proposed rule represents the best option to level the playing field between packers, swine contractors, live poultry dealers, and the Nation's poultry growers, swine production contract growers, or livestock producers for the benefit of more efficient marketing and public good. Anticipated Cost and Benefits: Costs: Costs are aggregated into three major types: 1) Administrative costs, which include items such as office work, postage, filing, and copying; 2) costs of analysis, such as a business conducting a profit-loss analysis; and 3) adjustment costs, such as costs related to changing business behavior to achieve compliance with the proposed regulation. Benefits: Benefits are also aggregated into three major groups: 1) Increased pricing [[Page 79480]] efficiency; 2) allocation efficiency; and 3) competitive efficiency. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 06/22/10 75 FR 35338 NPRM Comment Period End 08/23/10 Final Action 03/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: H. Tess Butler Regulatory Liaison Department of Agriculture Grain Inspection, Packers and Stockyards Administration 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-7486 Fax: 202 690-2173 Email: h.tess.butler@usda.gov RIN: 0580-AB07 _______________________________________________________________________ <###doc> USDA--Food and Nutrition Service (FNS) ----------- PROPOSED RULE STAGE ----------- <###doc> 10. ELIGIBILITY, CERTIFICATION, AND EMPLOYMENT AND TRAINING PROVISIONS OF THE FOOD, CONSERVATION, AND ENERGY ACT OF 2008 Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 110-246; PL 104-121 CFR Citation: 7 CFR 273 Legal Deadline: None Abstract: This proposed rule would amend the regulations governing the Supplemental Nutrition Assistance Program (SNAP) to implement provisions from the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246) (FCEA) concerning the eligibility and certification of SNAP applicants and participants and SNAP employment and training. In addition, this proposed rule would revise the SNAP regulations throughout 7 CFR part 273 to change the program name from the Food Stamp Program to SNAP and to make other nomenclature changes as mandated by the FCEA. The statutory effective date of these provisions was October 1, 2008. Food and Nutrition Service (FNS) is also proposing two discretionary revisions to SNAP regulations to provide State agencies options that are currently available only through waivers. These provisions would allow State agencies to average student work hours and to provide telephone interviews in lieu of face-to-face interviews. FNS anticipates that this rule would impact the associated paperwork burdens (08-006). Statement of Need: This proposed rule would amend the regulations governing SNAP to implement provisions from the FCEA concerning the eligibility and certification of SNAP applicants and participants and SNAP employment and training. In addition, this proposed rule would revise the SNAP regulations throughout 7 CFR part 273 to change the program name from the Food Stamp Program to SNAP and to make other nomenclature changes as mandated by the FCEA. The statutory effective date of these provisions was October 1, 2008. FNS is also proposing 2 discretionary revisions to SNAP regulations to provide State agencies options that are currently available only through waivers. These provisions would allow State agencies to average student work hours and to provide telephone interviews in lieu of face-to-face interviews. FNS anticipates that this rule would impact the associated paperwork burdens. Summary of Legal Basis: Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246). Alternatives: Because this proposed rule is under development, alternatives are not yet articulated. The rule would implement statutory requirements set forth by the Food, Conservation, and Energy Act of 2008 concerning SNAP eligibility and certification rules. Anticipated Cost and Benefits: FNS is currently developing estimates of the anticipated costs and benefits of this rule. Anticipated principle effects would be on paperwork burdens. Risks: The statutory changes and discretionary ones under consideration would streamline program operations. The changes are expected to reduce the risk of inefficient operations. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 01/00/11 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State Agency Contact: James F. Herbert Regulatory Review Specialist Department of Agriculture Food and Nutrition Service 10th Floor 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2572 Email: james.herbert@fns.usda.gov RIN: 0584-AD87 _______________________________________________________________________ <###doc> USDA--FNS <###doc> 11. SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM: FARM BILL OF 2008 RETAILER SANCTIONS Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 110-246 CFR Citation: 7 CFR 276 Legal Deadline: None Abstract: This proposed rule would implement provisions under section 4132 of the Food, Conservation, and Energy Act of 2008, also referred to as the Farm Bill of 2008. Under section 4132, the Department of Agriculture's Food and Nutrition Service (FNS) is provided with greater authority and flexibility when sanctioning retail or wholesale food stores that violate Supplemental Nutrition Assistance Program (SNAP) rules. Specifically, the Department is authorized to assess a civil penalty and to disqualify a retail or wholesale food [[Page 79481]] store authorized to participate in SNAP. Previously, the Department could assess a civil penalty or disqualification, but not both. Section 4132 also eliminates the minimum disqualification period which was previously set at 6 months. In addition to implementing statutory provisions, this rule proposes to provide a clear administrative penalty when an authorized retailer or wholesale food store redeems a SNAP participant's Program benefits without the knowledge of the participant. All Program benefits are issued through the Electronic Benefits Transfer (EBT) system. The EBT system establishes data that may be used to identify fraud committed by retail food stores. While stealing Program benefits could be prosecuted under current statute, Program regulations do not provide a clear penalty for these thefts. The proposed rule would establish an administrative penalty for such thefts equivalent to the penalty for trafficking in Program benefits, which is the permanent disqualification of a retailer or wholesale food store from SNAP participation. Finally, the Department proposes to identify additional administrative retail violations and the associated sanction that would be imposed against the retail food store for committing the violation. For instance, to maintain integrity, FNS requires retail and wholesale food stores to key enter EBT card data in the presence of the actual EBT card. The proposed rule would codify this requirement and identify the specific sanction that would be imposed if retail food stores are found to be in violation (08-007). Statement of Need: This proposed rule would implement provisions under section 4132 of the Food, Conservation, and Energy Act of 2008, also referred to as the Farm Bill of 2008. Under section 4132, the Department of Agriculture's Food and Nutrition Service (FNS) is provided with greater authority and flexibility when sanctioning retail or wholesale food stores that violate Supplemental Nutrition Assistance Program (SNAP) rules. Specifically, the Department is authorized to assess a civil penalty and to disqualify a retail or wholesale food store authorized to participate in SNAP. Previously, the Department could assess a civil penalty or disqualification, but not both. Section 4132 also eliminates the minimum disqualification period which was previously set at six months. In addition to implementing statutory provisions, this rule proposes to provide a clear administrative penalty when an authorized retailer or wholesale food store redeems a SNAP participant's Program benefits without the knowledge of the participant. All Program benefits are issued through the Electronic Benefits Transfer (EBT) system. The EBT system establishes data that may be used to identify fraud committed by retail food stores. While stealing Program benefits could be prosecuted under current statute, Program regulations do not provide a clear penalty for these thefts. The proposed rule would establish an administrative penalty for such thefts equivalent to the penalty for trafficking in Program benefits, which is the permanent disqualification of a retailer or wholesale food store from SNAP participation. Finally, the Department proposes to identify additional administrative retail violations and the associated sanction that would be imposed against the retail food store for committing the violation. For instance, to maintain integrity, FNS requires retail and wholesale food stores to key enter EBT card data in the presence of the actual EBT card. The proposed rule would codify this requirement and identify the specific sanction that would be imposed if retail food stores are found to be in violation. Summary of Legal Basis: Section 4132, Food, Conservation, and Energy Act of 2008 (Pub. L. 110- 246). Alternatives: Because this proposed rule is under development alternatives are not yet articulated. Anticipated Cost and Benefits: Because this proposed rule is under development anticipated costs and benefits have not yet been articulated. Risks: The risk that retail or wholesale food stores will violate SNAP rules, or continue to violate SNAP rules, is expected to be reduced by refining program sanctions for participating retailers and wholesalers. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/00/11 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Additional Information: Note: This RIN replaces the previously issued RIN 0584-AD78. Agency Contact: James F. Herbert Regulatory Review Specialist Department of Agriculture Food and Nutrition Service 10th Floor 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2572 Email: james.herbert@fns.usda.gov RIN: 0584-AD88 _______________________________________________________________________ <###doc> USDA--FNS <###doc> 12. FRESH FRUIT AND VEGETABLE PROGRAM Priority: Other Significant Legal Authority: Food, Conservation, and Energy Act of 2008; National School Lunch Act (NSLA); 42 USC 1769(a) CFR Citation: 7 CFR 211 Legal Deadline: None Abstract: The Food, Conservation, and Energy Act of 2008 amended the National School Lunch Act (NSLA) to add section 19, the Fresh Fruit and Vegetable Program (FFVP). Section 19 establishes the FFVP as a permanent national program in a select number of schools in each State, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands. Schools in all States must apply annually for FFVP funding. This proposed rule would implement statutory requirements currently established through program policy and guidance for operators at the State and local level. The proposed rule would set forth requirements detailed in the statute for school selection and participation, State agency outreach to needy schools, the yearly application process, and the funding and allocation processes for schools and States. The proposed rule would also include the statutory per student funding range and the requirement for a program evaluation. [[Page 79482]] In addition, the proposed rule would establish oversight activity and reporting and recordkeeping requirements that are not included in FFVP statutory requirements. Implementation of this rule is not expected to result in expenses for program operators because they receive funding to cover food purchases and administrative costs (09-007). Statement of Need: The Food, Conservation, and Energy Act of 2008 amended the National School Lunch Act (NSLA) to add section 19, the Fresh Fruit and Vegetable Program (FFVP). Section 19 establishes the FFVP as a permanent national program in a select number of schools in each State, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands. Schools in all States must apply annually for FFVP funding. This proposed rule would implement statutory requirements currently established through program policy and guidance for operators at the State and local level. The proposed rule would set forth requirements detailed in the statute for school selection and participation, State agency outreach to needy schools, the yearly application process, and the funding and allocation processes for schools and States. The proposed rule would also include the statutory per student funding range and the requirement for a program evaluation. Summary of Legal Basis: Section 19, Food, Conservation, and Energy Act of 2008. National School Lunch Act (NSLA). 42 U.S.C. 1769(a). Alternatives: Because this proposed rule is under development, alternatives are not yet articulated. The rule would implement statutory requirements set forth by the Food, Conservation, and Energy Act of 2008 by adding section 19, the Fresh Fruit and Vegetable Program (FFVP), to the National School Lunch Act. Alternatives to this process are not known or being pursued at this time. Anticipated Cost and Benefits: Implementation of this rule is not expected to result in expenses for program operators because they receive funding to cover food purchases and administrative costs. Risks: No risks by implementing this proposed rule have been identified at this time. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 02/00/11 NPRM Comment Period End 04/00/11 Final Action 08/00/11 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State Agency Contact: James F. Herbert Regulatory Review Specialist Department of Agriculture Food and Nutrition Service 10th Floor 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2572 Email: james.herbert@fns.usda.gov RIN: 0584-AD96 _______________________________________________________________________ <###doc> USDA--FNS ----------- FINAL RULE STAGE ----------- <###doc> 13. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM INTEGRITY Priority: Other Significant Legal Authority: 42 USC 1766; PL 103-448; PL 104-193; PL 105-336 CFR Citation: 7 CFR 226 Legal Deadline: None Abstract: This rule amends the Child and Adult Care Food Program (CACFP) regulations. The changes in this rule result from the findings of State and Federal program reviews and from audits and investigations conducted by the Office of Inspector General. This rule revises: State agency criteria for approving and renewing institution applications; program training and other operating requirements for child care institutions and facilities; and State and institution-level monitoring requirements. This rule also includes changes that are required by the Healthy Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub. L. 104-193), and the William F. Goodling Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336). The changes are designed to improve program operations and monitoring at the State and institution levels and, where possible, to streamline and simplify program requirements for State agencies and institutions (95-024). Statement of Need: In recent years, State and Federal program reviews have found numerous cases of mismanagement, abuse, and, in some instances, fraud by child care institutions and facilities in the CACFP. These reviews revealed weaknesses in management controls over program operations and examples of regulatory noncompliance by institutions, including failure to pay facilities or failure to pay them in a timely manner; improper use of program funds for non-program expenditures; and improper meal reimbursements due to incorrect meal counts or to mis-characterized or incomplete income eligibility statements. In addition, audits and investigations conducted by the Office of Inspector General (OIG) have raised serious concerns regarding the adequacy of financial and administrative controls in CACFP. Based on its findings, the OIG recommended changes to CACFP review requirements and management controls. Summary of Legal Basis: Some of the changes proposed in the rule are discretionary changes being made in response to deficiencies found in program reviews and OIG audits. Other changes codify statutory changes made by the Healthy Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub. L. 104-193), and the William F. Goodling Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336). Alternatives: This proposed interim final rule is under development and alternatives are not yet articulated. FNS is working with State agencies to identify reasonable alternatives to implement the changes mandated by law. FNS will be developing extensive guidance materials in conjunction with agency [[Page 79483]] cooperators to meet the objectives of the statute. Anticipated Cost and Benefits: This rule contains changes designed to improve management and financial integrity in the CACFP. When implemented, these changes would affect all entities in CACFP, from USDA to participating children and children's households. These changes will primarily affect the procedures used by State agencies in reviewing applications submitted by, and monitoring the performance of, institutions which are participating or wish to participate in the CACFP. Those changes which would affect institutions and facilities will not, in the aggregate, have a significant economic impact. Data on CACFP integrity is limited, despite numerous OIG reports on individual institutions and facilities that have been deficient in CACFP management. While program reviews and OIG reports clearly illustrate that there are weaknesses in parts of the program regulations and that there have been weaknesses in oversight, neither program reviews, OIG reports, nor any other data sources illustrate the prevalence and magnitude of CACFP fraud and abuse. This lack of information precludes USDA from estimating the amount of money lost due to fraud and abuse or the reduction in fraud and abuse the changes in this rule will realize. Risks: With the interim final rule in place and operational, risk of integrity problems is reduced. The final rule will use comments from stakeholders to further improve the rule. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/12/00 65 FR 55103 NPRM Comment Period End 12/11/00 Interim Final Rule 06/27/02 67 FR 43448 Interim Final Rule Effective 07/29/02 Interim Final Rule Comment Period End 12/24/02 Interim Final Rule 09/01/04 69 FR 53502 Interim Final Rule Effective 10/01/04 Interim Final Rule Comment Period End 09/01/05 Final Action 02/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: James F. Herbert Regulatory Review Specialist Department of Agriculture Food and Nutrition Service 10th Floor 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2572 Email: james.herbert@fns.usda.gov Related RIN: Merged with 0584-AC94 RIN: 0584-AC24 _______________________________________________________________________ <###doc> USDA--FNS <###doc> 14. DIRECT CERTIFICATION OF CHILDREN IN FOOD STAMP HOUSEHOLDS AND CERTIFICATION OF HOMELESS, MIGRANT, AND RUNAWAY CHILDREN FOR FREE MEALS IN THE NSLP, SBP, AND SMP Priority: Other Significant Legal Authority: PL 108-265, sec 104 CFR Citation: 7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 245 Legal Deadline: None Abstract: In response to Public Law 108-265, which amended the Richard B. Russell National School Lunch Act, 7 CFR 245, Determining Eligibility for Free and Reduced Price Meals and Free Milk in Schools, will be amended to establish categorical (automatic) eligibility for free meals and free milk upon documentation that a child is (1) homeless as defined by the McKinney-Vento Homeless Assistance Act; (2) a runaway served by grant programs under the Runaway and Homeless Youth Act; or (3) migratory as defined in section 1309(2) of the Elementary and Secondary Education Act. The rule also requires phase-in of mandatory direct certification for children who are members of households receiving food stamps and continues discretionary direct certification for other categorically eligible children (04-018). Statement of Need: The changes made to the Richard B. Russell National School Lunch Act concerning direct certification are intended to improve program access, reduce paperwork, and improve the accuracy of the delivery of free meal benefits. This regulation will implement the statutory changes and provide State agencies and local educational agencies with the policies and procedures to conduct mandatory and discretionary direct certification. Summary of Legal Basis: These changes are being made in response to provisions in Public Law 108-265. Anticipated Cost and Benefits: This regulation will reduce paperwork, target benefits more precisely, and will improve program access of eligible school children. Risks: This regulation may require adjustments to existing computer systems to more readily share information between schools, food stamp offices, and other agencies. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Interim Final Rule 02/00/11 Interim Final Rule Comment Period End 05/00/11 Final Action 10/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: James F. Herbert Regulatory Review Specialist Department of Agriculture Food and Nutrition Service 10th Floor 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2572 Email: james.herbert@fns.usda.gov Related RIN: Merged with 0584-AD62 RIN: 0584-AD60 [[Page 79484]] _______________________________________________________________________ <###doc> USDA--FNS <###doc> 15. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN (WIC): REVISIONS IN THE WIC FOOD PACKAGES Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 1786 CFR Citation: 7 CFR 246 Legal Deadline: Final, Statutory, November 2006. CN and WIC Reauthorization Act of 2004 (Pub. L. 108-265) requires issuance of a final rule within 18 months of release of IOM Report. Abstract: This final rule will affirm and address comments from stakeholders on the interim final rule that went into effect October 1, 2009, and for which the comment period ended February 1, 2010. Significant changes to the rule are not anticipated. The rule amended regulations governing the WIC food packages to align them more closely with updated nutrition science and the infant feeding practice guidelines of the American Academy of Pediatrics, promote and support more effectively the establishment of successful long-term breastfeeding, provide WIC participants with a wider variety of food, and provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences. The final rule considers public comments submitted on the impacts of the changes and how they might be refined to assist State agencies and recipients. Statement of Need: As the population served by WIC has grown and become more diverse over the past 20 years, the nutritional risks faced by participants have changed, and though nutrition science has advanced, the WIC supplemental food packages have remained largely unchanged. A rule is needed to implement recommended changes to the WIC food packages based on the current nutritional needs of WIC participants and advances in nutrition science. Summary of Legal Basis: The Child Nutrition and WIC Reauthorization Act of 2004, enacted on June 30, 2004, requires the Department to issue a final rule within 18 months of receiving the Institute of Medicine's report on revisions to the WIC food packages. This report was published and released to the public on April 27, 2005. Alternatives: FNS developed a regulatory impact analysis that addressed a variety of alternatives that were considered in the interim final rulemaking. The regulatory impact analysis was published as an appendix to the interim rule. FNS developed a regulatory impact analysis that addressed a variety of alternatives that were considered in the interim final rulemaking. That regulatory impact analysis was published as an appendix to the interim rule. Anticipated Cost and Benefits: The regulatory impact analysis for this rule provided a reasonable estimate of the anticipated effects of the rule. This analysis estimated that the provisions of the rule would have a minimal impact on the costs of overall operations of the WIC Program over 5 years. The regulatory impact analysis was published as an appendix to the interim rule. Risks: This rule applies to WIC State agencies with respect to their selection of foods to be included on their food lists. As a result, vendors will be indirectly affected and the food industry will realize increased sales of some foods and decreases in other foods, with an overall neutral effect on sales nationally. The rule may have an indirect economic affect on certain small businesses because they may have to carry a larger variety of certain foods to be eligible for authorization as a WIC vendor. With the high degree of State flexibility allowable under this final rule, small vendors will be impacted differently in each State depending upon how that State chooses to meet the new requirements. It is, therefore, not feasible to accurately estimate the rule's impact on small vendors. Since neither FNS nor the State agencies regulate food producers under the WIC Program, it is not known how many small entities within that industry may be indirectly affected by the rule. FNS has, however, modified the new food provision in an effort to mitigate the impact on small entities. This rule adds new food items, such as fruits and vegetables and whole grain breads, which may require some WIC vendors, particularly smaller stores, to expand the types and quantities of food items stocked in order to maintain their WIC authorization. In addition, vendors also have to make available more than one food type from each WIC food category, except for the categories of peanut butter and eggs, which may be a change for some vendors. To mitigate the impact of the fruit and vegetable requirement, the rule allows canned, frozen, and dried fruits and vegetables to be substituted for fresh produce. Opportunities for training on and discussion of the revised WIC food packages will be offered to State agencies and other entities as necessary. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 08/07/06 71 FR 44784 NPRM Comment Period End 11/06/06 Interim Final Rule 12/06/07 72 FR 68966 Interim Final Rule Effective 02/04/08 Interim Final Rule Comment Period End 02/01/10 Final Action 06/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Federal, Local, State, Tribal URL For More Information: www.fns.usda.gov/wic URL For Public Comments: www.fns.usda.gov/wic Agency Contact: James F. Herbert Regulatory Review Specialist Department of Agriculture Food and Nutrition Service 10th Floor 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2572 Email: james.herbert@fns.usda.gov RIN: 0584-AD77 [[Page 79485]] _______________________________________________________________________ <###doc> USDA--Food Safety and Inspection Service (FSIS) ----------- PROPOSED RULE STAGE ----------- <###doc> 16. EGG PRODUCTS INSPECTION REGULATIONS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 21 USC 1031 to 1056 CFR Citation: 9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR 590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 591; . . . Legal Deadline: None Abstract: The Food Safety and Inspection Service (FSIS) is proposing to require egg products plants and establishments that pasteurize shell eggs to develop and implement Hazard Analysis and Critical Control Points (HACCP) systems and Sanitation (SOPs). FSIS also is proposing pathogen reduction performance standards that would be applicable to egg products and pasteurized shell eggs. FSIS is proposing to amend the Federal egg products inspection regulations by removing current requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment prior to their use in official plants. The Agency also plans to eliminate the prior label approval system for egg products. This proposal will not encompass shell egg packers. In the near future, FSIS will initiate non-regulatory outreach efforts for shell egg packers that will provide information intended to help them safely process shell eggs intended for human consumption or further processing. Statement of Need: The actions being proposed are part of FSIS' regulatory reform effort to improve FSIS' shell egg and egg products food safety regulations, better define the roles of Government and the regulated industry, encourage innovations that will improve food safety, remove unnecessary regulatory burdens on inspected egg products plants, and make the egg products regulations as consistent as possible with the Agency's meat and poultry products regulations. FSIS also is taking these actions in light of changing inspection priorities and recent findings of Salmonella in pasteurized egg products. This proposal is directly related to FSIS' PR/HACCP initiative. Summary of Legal Basis: This proposed rule is authorized under the Egg Products Inspection Act (21 U.S.C. 1031 to 1056). It is not the result of any specific mandate by the Congress or a Federal court. Alternatives: A team of FSIS economists and food technologists is conducting a cost- benefit analysis to evaluate the potential economic impacts of several alternatives on the public, egg products industry, and FSIS. These alternatives include: (1) Taking no regulatory action; (2) requiring all inspected egg products plants to develop, adopt, and implement written sanitation SOPs and HACCP plans; and (3) converting to a lethality-based pathogen reduction performance standard many of the current highly prescriptive egg products processing requirements. The team will consider the effects of a uniform, across-the-board standard for all egg products; a performance standard based on the relative risk of different classes of egg products; and a performance standard based on the relative risks to public health of different production processes. Anticipated Cost and Benefits: FSIS is analyzing the potential costs of this proposed rulemaking to industry, FSIS, and other Federal agencies, State and local governments, small entities, and foreign countries. The expected costs to industry will depend on a number of factors. These costs include the required lethality, or level of pathogen reduction, and the cost of HACCP plan and sanitation SOP development, implementation, and associated employee training. The pathogen reduction costs will depend on the amount of reduction sought and on the classes of product, product formulations, or processes. Relative enforcement costs to FSIS and Food and Drug Administration may change because the two agencies share responsibility for inspection and oversight of the egg industry and a common farm-to-table approach for shell egg and egg products food safety. Other Federal agencies and local governments are not likely to be affected. Egg product inspection systems of foreign countries wishing to export egg products to the U.S. must be equivalent to the U.S. system. FSIS will consult with these countries, as needed, if and when this proposal becomes effective. This proposal is not likely to have a significant impact on small entities. The entities that would be directly affected by this proposal would be the approximately 80 federally inspected egg products plants, most of which are small businesses, according to Small Business Administration criteria. If necessary, FSIS will develop compliance guides to assist these small firms in implementing the proposed requirements. Potential benefits associated with this rulemaking include: Improvements in human health due to pathogen reduction; improved utilization of FSIS inspection program resources; and cost savings resulting from the flexibility of egg products plants in achieving a lethality-based pathogen reduction performance standard. Once specific alternatives are identified, economic analysis will identify the quantitative and qualitative benefits associated with each alternative. Human health benefits from this rulemaking are likely to be small because of the low level of (chiefly post-processing) contamination of pasteurized egg products. In light of recent scientific studies that raise questions about the efficacy of current regulations, however, it is likely that measurable reductions will be achieved in the risk of foodborne illness. The preliminary anticipated annualized costs of the proposed action are approximately $7 million. The preliminary anticipated benefits of the proposed action are approximately $90 million per year. Risks: FSIS believes that this regulatory action may result in a further reduction in the risks associated with egg products. The development of a lethality-based pathogen reduction performance standard for egg products, replacing command-and-control regulations, will remove unnecessary regulatory obstacles to, and provide incentives for, innovation to improve the safety of egg products. To assess the potential risk-reduction impacts of this rulemaking on the [[Page 79486]] public, an intra-Agency group of scientific and technical experts is conducting a risk management analysis. The group has been charged with identifying the lethality requirement sufficient to ensure the safety of egg products and the alternative methods for implementing the requirement. FSIS has developed new risk assessments for Salmonella Enteritidis in eggs and for Salmonella spp. in liquid egg products to evaluate the risk associated with the regulatory alternatives. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: None Agency Contact: Victoria Levine Program Analyst, Policy Issuances Division Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-5627 Fax: 202 690-0486 Email: victoria.levine@fsis.usda.gov RIN: 0583-AC58 _______________________________________________________________________ <###doc> USDA--FSIS <###doc> 17. NEW POULTRY SLAUGHTER INSPECTION Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 21 USC 451 et seq CFR Citation: 9 CFR 381.66; 9 CFR 381.67; 9 CFR 381.76; 9 CFR 381.83; 9 CFR 381.91; 9 CFR 381.94 Legal Deadline: None Abstract: FSIS is proposing a new inspection system for young poultry slaughter establishments that would facilitate public health-based inspection. This new system would be available initially only to young chicken slaughter establishments. Establishments that slaughter broilers, fryers, roasters, and Cornish game hens (as defined in 9 CFR 381.170) would be considered as ``young chicken establishments.'' FSIS is also proposing to revoke the provisions that allow young chicken slaughter establishments to operate under the current Streamlined Inspection System (SIS) or the New Line Speed (NELS) Inspection System. The proposed rule would establish new performance standards to reduce pathogens. FSIS anticipates that this proposed rule would provide the framework for action to provide public health-based inspection in all establishments that slaughter amenable poultry species. Under the proposed new system, young chicken slaughter establishments would be required to sort chicken carcasses and to conduct other activities to ensure that carcasses are not adulterated before they enter the chilling tank. Statement of Need: Because of the risk to the public health associated with pathogens on young chicken carcasses, FSIS is proposing a new inspection system that would allow for more effective inspection of young chicken carcasses, would allow the Agency to more effectively allocate its resources, would encourage industry to more readily use new technology, and would include new performance standards to reduce pathogens. This proposed rule is an example of regulatory reform because it would facilitate technological innovation in young chicken slaughter establishments. It would likely result in more cost-effective dressing of young chickens that are ready to cook or ready for further processing. Similarly, it would likely result in more efficient and effective use of Agency resources. Summary of Legal Basis: The Secretary of Agriculture is charged by the Poultry Products Inspection Act (PPIA--21 U.S.C. 451 et seq.) with carrying out a mandatory poultry products inspection program. The Act requires post- mortem inspection of all carcasses of slaughtered poultry subject to the Act and such reinspection as deemed necessary (21 U.S.C. 455(b)). The Secretary is authorized to promulgate such rules and regulations as are necessary to carry out the provisions of the Act (21 U.S.C. 463(b)). The Agency has tentatively determined that this rule would facilitate FSIS post-mortem inspection of young chicken carcasses. The proposed new system would likely result in more efficient and effective use of Agency resources and in industry innovations. Alternatives: FSIS considered the following options in developing this proposal: 1) No action. 2) Propose to implement HACCP-Based Inspection Models Pilot in regulations. 3) Propose to establish a mandatory, rather than a voluntary, new inspection system for young chicken slaughter establishments. 4) Propose standards of identity regulations for young chickens that include trim and processing defect criteria and that take into account the intended use of the product. 5) Propose a voluntary new inspection system for young chicken slaughter establishments and propose standards of identity for whole chickens, regardless of the products' intended use. Anticipated Cost and Benefits: The proposed performance standards and the implementation of public health-based inspection would likely improve the public health. FSIS is conducting a risk assessment for this proposed rule to assess the likely public health benefits that the implementation of this rule may achieve. Establishments that volunteer for this proposed new inspection system alternative would likely need to make capital investments in facilities and equipment. They may also need to add labor (trained employees). However, one of the beneficial effects of these investments would likely be the lowering of the average cost per pound to dress poultry properly. Cost savings would likely result because of increased line speeds, increased productivity, and increased flexibility to industry. The expected lower average unit cost for dressing poultry would likely give a marketing advantage to establishments under the new system. Consumers would likely benefit from lower retail prices for high quality poultry products. The rule would also likely provide opportunities for the industry to innovate because of the increased flexibility it would allow poultry slaughter establishments. In addition, in the public sector, benefits would accrue to FSIS from the more effective deployment of FSIS inspection program personnel to verify process [[Page 79487]] control based on risk factors at each establishment. Risks: Salmonella and other pathogens are present on a substantial portion of poultry carcasses inspected by FSIS. Foodborne Salmonella cause a large number of human illnesses that at times lead to hospitalization and even death. There is an apparent relationship between human illness and prevalence levels for salmonella in young chicken carcasses. FSIS believes that through better allocation of inspection resources and the use of performance standards, it would be able to reduce the prevalence of salmonella and other pathogens in young chickens. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 10/00/11 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Dr. Daniel L. Engeljohn Deputy Assistant Administrator, Office of Policy and Program Development Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 205-0495 Fax: 202 401-1760 Email: daniel.engeljohn@fsis.usda.gov RIN: 0583-AD32 _______________________________________________________________________ <###doc> USDA--FSIS <###doc> 18. MANDATORY INSPECTION OF CATFISH AND CATFISH PRODUCTS Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 21 USC 601 et seq; PL 110-249, sec 11016 CFR Citation: 9 CFR ch III, subchapter F (new) Legal Deadline: Final, Statutory, December 2009, Final regulations NLT 18 months after enactment of PL 110-246. Abstract: The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, sec. 11016), known as the 2008 Farm Bill, amended the Federal Meat Inspection Act (FMIA) to make catfish an amenable species under the FMIA. Amenable species must be inspected, so this rule will define inspection requirements for catfish. The regulations will define ``catfish'' and the scope of coverage of the regulations to apply to establishments that process farm-raised species of catfish and to catfish and catfish products. The regulations will take into account the conditions under which the catfish are raised and transported to a processing establishment. Statement of Need: The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, sec. 11016), known as the 2008 Farm Bill, amended the Federal Meat Inspection Act (FMIA) to make catfish an amenable species under the FMIA. The Farm Bill directs the Department to issue final regulations implementing the FMIA amendments not later than 18 months after the enactment date (June 18, 2008) of the legislation. Summary of Legal Basis: 21 U.S.C. 601 to 695 and Public Law 110-246, section 11016 Alternatives: The option of no rulemaking is unavailable. The Agency has considered alternative methods of implementation and levels of stringency, and the effects on foreign and domestic commerce and on small business associated with the alternatives. Anticipated Cost and Benefits: FSIS anticipates benefits from uniform standards and the more extensive and intensive inspection service that FSIS provides (compared with current voluntary inspection programs). FSIS would apply requirements for imported catfish that would be equivalent to those applying to catfish raised and processed in the United States. Risks: In preparing regulations on catfish and catfish products, the Agency will consider any risks to public health or other pertinent risks associated with the production, processing, and distribution of the products. FSIS will determine, through scientific risk assessment procedures, the magnitude of the risks associated with catfish and how they compare with those associated with other foods in FSIS's jurisdiction. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 12/00/10 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Quita Bowman Blackwell Acting Assistant Administrator, Office of Catfish Inspection Program Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-5735 Fax: 202 690-1742 RIN: 0583-AD36 _______________________________________________________________________ <###doc> USDA--FSIS <###doc> 19. ELECTRONIC IMPORTED PRODUCT INSPECTION APPLICATIONS; ELECTRONIC FOREIGN IMPORTED PRODUCT AND FOREIGN ESTABLISHMENT CERTIFICATIONS; DELETION OF STREAMLINED INSPECTION PROCEDURES FOR CANADIAN PRODUCT Priority: Other Significant Legal Authority: Federal Meat Inspection Act (FMIA) (21 USC 601 to 695), the Poultry Products Inspection Act (PPIA) (21 USC 451 to 470); Egg Products Inspection Act (EPIA) (21 USC 1031 to 1056) CFR Citation: 9 CFR 304.3; 9 CFR 327.2 and 327.4; 9 CFR 381.196 to 381.198; 9 CFR 590.915 and 590.920 Legal Deadline: None Abstract: FSIS is proposing to amend the meat, poultry, and egg products import inspection regulations to provide for an electronic application, and electronic imported product and foreign establishment certification system. FSIS [[Page 79488]] is also proposing to delete the ``streamlined'' import inspection procedures for Canadian product. In addition, the Agency is proposing that official import inspection establishment must develop, implement, and maintain written Sanitation SOPs, as provided in 9 CFR 416.11 through 416.17. Statement of Need: FSIS is proposing these regulations to provide for the electronic import system, which will be available through the Agency's Public Health Information System (PHIS), a computerized, Web-based inspection information system. The import system will enable applicants to electronically submit and track import inspection applications that are required for all commercial entries of FSIS regulated products imported in to the U.S. FSIS inspection program personnel will be able to access the PHIS system to assign appropriate imported product inspection activities. The electronic import system will also facilitate the foreign imported product and annual foreign establishment certifications by providing immediate and direct electronic government- to-government exchange of information. The Agency is proposing to delete the Canadian streamlined import inspection procedures because they have not been in use since 1990 and are obsolete. Sanitation SOPs are written procedures establishments develop, implement, and maintain to prevent direct contamination or adulteration of meat or poultry products. To ensure that imported meat and poultry products do not become contaminated while undergoing reinspection prior to entering the U.S., FSIS is proposing to clarify that official import inspection establishments must develop written Sanitation SOPs. Summary of Legal Basis: The authorities for this proposed rule are: the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 to 695), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470), Egg Products Inspection Act (EPIA)(21 U.S.C. 1031 to 1056) and the regulations that implement these Acts. Alternatives: The use of the electronic import system is voluntary. The Agency will continue to accept and process paper import inspection applications, and foreign establishment and foreign imported product certificates. The Canadian streamlined import inspection procedures are not currently in use. Proposing Sanitation SOPs in official import inspection establishments will prevent direct contamination or adulteration of product. Therefore, no alternatives were considered. Anticipated Cost and Benefits: Under this proposed rule, the industry will have the option of filing inspection applications electronically and submitting electronic foreign product and establishment certificates through the PHIS. Since the electronic option is voluntary; applicants and the foreign countries that choose to file electronically will do so only if the benefits outweigh the cost. Sanitation (SOPs) are a condition of approval for official import inspection establishments, and as a requirement for official import inspection establishments to continue to operate under Federal inspection. The proposed rule will clarify that official import inspection establishments must have developed written Sanitation SOPs before being granted approval and that existing official import inspection establishments must meet Sanitation SOP requirements. Since, in practice, FSIS has always expected official import inspection establishments to maintain Sanitation SOPs during the reinspection of imported products, the proposed amendment for these sanitation requirements will have little, if any, cost impact on the industry. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 12/00/10 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Mary Stanley Director, International Policy Division Office of Policy and Program Department of Agriculture Food Safety and Inspection Service Room 2125 1400 Independence Avenue SW. Washington, DC 20250 Phone: 202 720-0287 RIN: 0583-AD39 _______________________________________________________________________ <###doc> USDA--FSIS <###doc> 20. ELECTRONIC EXPORT APPLICATION AND CERTIFICATION AS A REIMBURSABLE SERVICE AND FLEXIBILITY IN THE REQUIREMENTS FOR OFFICIAL EXPORT INSPECTION MARKS, DEVICES, AND CERTIFICATES Priority: Other Significant Legal Authority: Federal Meat Inspection Act (FMIA) (21 USC 601 to 695); Poultry Products Inspection Act (PPIA) (21 USC 451 to 470); Egg Products Inspection Act (EPIA) (21 USC 1031 to 1056) CFR Citation: 9 CFR 312.8; 9 CFR 322.1 and 322.2; 9 CFR 350.7; 9 CFR 362.5; 9 CFR 381.104 to 381.106; 9 CFR 590.407; 9 CFR 592.20 and 592.500 Legal Deadline: None Abstract: The Food Safety and Inspection Service (FSIS) is proposing to amend the meat, poultry, and egg product inspection regulations to provide an electronic export application and certification process. FSIS is proposing to charge users for the use of the proposed system. FSIS is also proposing to provide establishments that export meat, poultry, and egg products with flexibility in the official export inspection marks, devices, and certificates. In addition, FSIS is proposing egg product export regulations that parallel the meat and poultry export regulations. Statement of Need: FSIS is proposing these regulations to facilitate the electronic processing of export applications and certificates through the Public Health Information System (PHIS), a computerized, Web-based inspection information system. The current export application and [[Page 79489]] certification regulations provide only for a paper-based process. This proposed rule will provide this electronic export system as a reimbursable certification service charged to the exporter. Summary of Legal Basis: The authorities for this proposed rule are: The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 to 695), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470), the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 to 1056), and the regulations that implement these Acts. FSIS is proposing to charge for the electronic export application and certification system under the Agricultural Marketing Act (7 U.S.C. 1622(h)) that provides the Secretary of Agriculture with the authority to: ``Inspect, certify, and identify the class, quality, quantity, and condition of agricultural products when shipped or received in interstate commerce, under such rules and regulations as the Secretary of Agriculture may prescribe, including assessment and collection of such fees as will be reasonable and as nearly as may be to cover the cost of the service rendered, to the end that agricultural products may be marketed to the best advantage, that trading may be facilitated, and that consumers may be able to obtain the quality product which they desire.`` Alternatives: The electronic export applications and certification system is being proposed as a voluntary service, therefore, exporters have the option of continuing to use the current paper-based system. Therefore, no alternatives were considered. Anticipated Cost and Benefits: FSIS is proposing to charge exporters that choose to utilize the system $90.00 per application submitted. Automating the export application and certification process will facilitate the exportation of U.S. meat, poultry, and egg products by streamlining and automating the processes that are in use while ensuring that foreign regulatory requirements are met. The direct cost to exporters would be approximately $22.5 million to $31.5 million per year, if they choose to file electronically. However, the total cost to an exporter would depend on the number of electronic applications processed. An exporter that processes only a few applications per year would not be likely to experience a significant economic impact. Under this proposal, inspection personnel workload is reduced through the elimination of the physical handling and processing of applications and certificates. When an electronic government-to-government system interface or data exchange is used, fraudulent transactions, such as false alterations and reproductions, will be significantly reduced, if not eliminated. The electronic export system is designed to ensure authenticity, integrity, and confidentiality. Exporters will be provided a more efficient and effective application and certification process. The proposed egg product export regulations provide the same export requirements across all products regulated by FSIS and consistency in the export application and certification process. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 12/00/10 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Dr. Ron Jones Assistant Administrator, Office of International Affairs Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-3473 RIN: 0583-AD41 _______________________________________________________________________ <###doc> USDA--FSIS ----------- FINAL RULE STAGE ----------- <###doc> 21. PERFORMANCE STANDARDS FOR THE PRODUCTION OF PROCESSED MEAT AND POULTRY PRODUCTS; CONTROL OF LISTERIA MONOCYTOGENES IN READY-TO-EAT MEAT AND POULTRY PRODUCTS Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 21 USC 451 et seq; 21 USC 601 et seq CFR Citation: 9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR 319; 9 CFR 320; 9 CFR 325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430; 9 CFR 431 Legal Deadline: None Abstract: FSIS has proposed to establish pathogen reduction performance standards for all ready-to-eat (RTE) and partially heat-treated meat and poultry products, and measures, including testing, to control Listeria monocytogenes in RTE products. The performance standards spell out the objective level of pathogen reduction that establishments must meet during their operations in order to produce safe products, but allow the use of customized, plant-specific processing procedures other than those prescribed in the earlier regulations. With HACCP, food safety performance standards give establishments the incentive and flexibility to adopt innovative, science-based food safety processing procedures and controls, while providing objective, measurable standards that can be verified by Agency inspectional oversight. This set of performance standards will include and be consistent with standards already in place for certain ready-to-eat meat and poultry products. Statement of Need: Although FSIS routinely samples and tests some ready-to-eat products for the presence of pathogens prior to distribution, there are no specific regulatory pathogen reduction requirements for most of these products. The proposed performance standards are necessary to help ensure [[Page 79490]] the safety of these products; give establishments the incentive and flexibility to adopt innovative, science-based food safety processing procedures and controls; and provide objective, measurable standards that can be verified by Agency oversight. Summary of Legal Basis: Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the Poultry Product Inspection Act (21 U.S.C. 451 to 470), FSIS issues regulations governing the production of meat and poultry products prepared for distribution in commerce. The regulations, along with FSIS inspection programs, are designed to ensure that meat and poultry products are safe, not adulterated, and properly marked, labeled, and packaged. Alternatives: As an alternative to all of the proposed requirements, FSIS considered taking no action. As alternatives to the proposed performance standard requirements, FSIS considered end-product testing and requiring ``use- by'' date labeling on ready-to-eat products. Anticipated Cost and Benefits: Benefits are expected to result from fewer contaminated products entering commercial food distribution channels as a result of improved sanitation and process controls and in-plant verification. FSIS believes that the benefits of the rule would exceed the total costs of implementing its provisions. FSIS currently estimates net benefits from the 2003 interim final rule at $470 to $575 million, with annual recurring costs at $150.4 million, if FSIS discounts the capital cost at 7 percent. FSIS is continuing to analyze the potential impact of the other provisions of the proposal. The other main provisions of the proposed rule are: Lethality performance standards for Salmonella and E. coli O157:H7 and stabilization performance standards for C. perfringens that firms must meet when producing RTE meat and poultry products. Most of the costs of these requirements would be associated with one-time process performance validation in the first year of implementation of the rule and with revision of HACCP plans. Benefits are expected to result from the entry into commercial food distribution channels of product with lower levels of contamination resulting from improved in-plant process verification and sanitation. Consequently, there will be fewer cases of foodborne illness. Risks: Before FSIS published the proposed rule, FDA and FSIS had estimated that each year L. monocytogenes caused 2,540 cases of foodborne illness, including 500 fatalities. The Agencies estimated that about 65.3 percent of these cases, or 1660 cases and 322 deaths per year, were attributable to RTE meat and poultry products. The analysis of the interim final rule on control of L. monocytogenes conservatively estimated that implementation of the rule would lead to an annual reduction of 27.3 deaths and 136.7 illnesses at the median. FSIS is continuing to analyze data on production volume and Listeria controls in the RTE meat and poultry products industry and is using the FSIS risk assessment model for L. monocytogenes to determine the likely risk reduction effects of the rule. Preliminary results indicate that the risk reductions being achieved are substantially greater than those estimated in the analysis of the interim rule. FSIS is also analyzing the potential risk reductions that might be achieved by implementing the lethality and stabilization performance standards for products that would be subject to the proposed rule. The risk reductions to be achieved by the proposed rule and that are being achieved by the interim rule are intended to contribute to the Agency's public health protection effort. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 02/27/01 66 FR 12590 NPRM Comment Period End 05/29/01 NPRM Comment Period Extended 07/03/01 66 FR 35112 NPRM Comment Period End 09/10/01 Interim Final Rule 06/06/03 68 FR 34208 Interim Final Rule Effective 10/06/03 Interim Final Rule Comment Period End 01/31/05 NPRM Comment Period Reopened 03/24/05 70 FR 15017 NPRM Comment Period End 05/09/05 Affirmation of Interim Final Rule 03/00/11 Final Action 06/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Dr. Daniel L. Engeljohn Deputy Assistant Administrator, Office of Policy and Program Development Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 205-0495 Fax: 202 401-1760 Email: daniel.engeljohn@fsis.usda.gov RIN: 0583-AC46 _______________________________________________________________________ <###doc> USDA--FSIS <###doc> 22. NUTRITION LABELING OF SINGLE-INGREDIENT PRODUCTS AND GROUND OR CHOPPED MEAT AND POULTRY PRODUCTS Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 21 USC 601 et seq; 21 USC 451 et seq CFR Citation: 9 CFR 317; 9 CFR 381 Legal Deadline: None Abstract: FSIS has proposed to amend the Federal meat and poultry products inspection regulations to require nutrition labeling for the major cuts of single-ingredient, raw meat and poultry products, either on their label or at their point-of-purchase, unless an exemption applies. FSIS also proposed to require nutrition information on the label of ground or chopped meat and poultry products, unless an exemption applies. The requirements for ground or chopped products will be consistent with those for multi-ingredient products. FSIS also proposed to amend the nutrition labeling regulations to provide that when a ground or chopped product does not meet the regulatory criteria to be labeled ``low fat,'' a lean percentage claim may be included on the label or in labeling, as long as a statement of the fat percentage also is displayed on the label or in labeling. Statement of Need: The Agency will require that nutrition information be provided for the major [[Page 79491]] cuts of single-ingredient, raw meat and poultry products, either on their label or at their point of purchase, because during the most recent surveys of retailer, the Agency did not find significant participation in the voluntary nutrition labeling program for single- ingredient, raw meat and poultry products. Ground or chopped products are similar to multi-ingredient products. This rule is necessary so that consumers can have the information they need to construct healthy diets. Summary of Legal Basis: This action is authorized under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the Poultry Products Inspection Act (21 U.S.C. 451 to 470). Alternatives: No action; nutrition labels required on all single-ingredient, raw products (major cuts and non-major cuts) and all ground or chopped products; nutrition labels required on all major cuts of single- ingredient, raw products (but not non-major cuts) and all ground or chopped products; nutrition information at the point of purchase required for all single-ingredient, raw products (major and non-major cuts) and for all ground or chopped products. Anticipated Cost and Benefits: Cost will include the equipment for making labels, labor, and materials used for labels for ground or chopped products. The cost of providing nutrition labeling for the major cuts of single-ingredient, raw meat and poultry products should not be significant, because retail establishments would have the option of providing nutrition information through point-of-purchase materials. Benefits of the nutrition labeling rule would result consumers modify their diets in response to new nutrition information concerning ground or chopped products and the major cuts of single-ingredient, raw products. Reductions in consumption of fat and cholesterol are associated with reduced incidence of cancer and coronary heart disease. FSIS has concluded that the quantitative benefits will exceed the quantitative costs of the supplemental proposed rule. FSIS estimates that the annualized benefits of the proposed rule will range from approximately $185.6 to $230.8 million, using a 7 percent discount rate over 20 years. FSIS estimates that the annualized costs will range from approximately $26.7 to $44.8 million, using a 7 percent discount rate over 20 years. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 01/18/01 66 FR 4970 NPRM Comment Period End 04/18/01 Extension of Comment Period 04/20/01 66 FR 20213 NPRM Comment Period End 07/17/01 Supplemental Proposed Rule 12/18/09 74 FR 67736 Supplemental Proposed Rule Comment Period End 02/16/10 Final Action 12/00/10 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Rosalyn Murphy-Jenkins Director, Labeling and Program Delivery Division Department of Agriculture Food Safety and Inspection Service 5601 Sunnyside Avenue Beltsville, MD 20705-5000 Phone: 301 504-0878 Fax: 301 504-0872 Email: rosalyn.murphy-jenkins@fsis.usda.gov RIN: 0583-AC60 _______________________________________________________________________ <###doc> USDA--FSIS <###doc> 23. NOTIFICATION, DOCUMENTATION, AND RECORDKEEPING REQUIREMENTS FOR INSPECTED ESTABLISHMENTS Priority: Other Significant Legal Authority: 21 USC 612 to 613; 21 USC 459 CFR Citation: 9 CFR 417.4; 9 CFR 418 Legal Deadline: None Abstract: The Food Safety and Inspection Service (FSIS) has proposed to require establishments subject to inspection under the Federal Meat Inspection Act and the Poultry Products Inspection Act to promptly notify the Secretary of Agriculture that an adulterated or misbranded product received by or originating from the establishment has entered into commerce, if the establishment believes or has reason to believe that this has happened. FSIS has also proposed to require these establishments to: (1) Prepare and maintain current procedures for the recall of all products produced and shipped by the establishment and (2) document each reassessment of the process control plans of the establishment. Statement of Need: The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, sec. 11017), known as the 2008 Farm Bill, amended the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) to require establishments subject to inspection under these Acts to promptly notify the Secretary that an adulterated or misbranded product received by or originating from the establishment has entered into commerce, if the establishment believes or has reason to believe that this has happened. Section 11017 also requires establishments subject to inspection under the FMIA and PPIA to: (1) Prepare and maintain current procedures for the recall of all products produced and shipped by the establishment; and (2) document each reassessment of the process control plans of the establishment. Summary of Legal Basis: 21 U.S.C. 612 and 613; 21 U.S.C. 459, and Public Law 110-246, sec. 11017. Alternatives: The option of no rulemaking is unavailable. Anticipated Cost and Benefits: Approximate costs: $5.0 million for labor and costs; $5.2 million for first year costs; $0.7 million average costs adjusted with a 3.0 percent inflation rate for following years. Total approximate costs: $10.2 million. The average cost of this final rule to small entities is expected to be less than one tenth of one cent of meat and poultry food products per annum. Therefore, FSIS has determined that this rule will not have a significant economic impact on a substantial number of small entities. Approximate benefits: Benefits have not been monetized because quantified data [[Page 79492]] on benefits attributable to this final rule are not available. Non- monetary benefits include improved protection of the public health, improved HACCP plans, and improved recall effectiveness. Risks: In preparing regulations on the shipment of adulterated meat and poultry products by meat and poultry establishments, the preparation and maintenance of procedures for recalled products produced and shipped by establishments, and the documentation of each reassessment of the process control plans by the establishment, the Agency considered any risks to public health or other pertinent risks associated with these actions. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 03/25/10 75 FR 14361 NPRM Comment Period End 05/24/10 Final Action 09/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Victoria Levine Program Analyst, Policy Issuances Division Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-5627 Fax: 202 690-0486 Email: victoria.levine@fsis.usda.gov RIN: 0583-AD34 _______________________________________________________________________ <###doc> USDA--FSIS <###doc> 24. FEDERAL-STATE INTERSTATE SHIPMENT COOPERATIVE INSPECTION PROGRAM Priority: Other Significant Legal Authority: PL 110-246, sec 11015 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, December 18, 2009. Abstract: FSIS has proposed regulations to implement a new voluntary Federal- State cooperative inspection program under which State-inspected establishments with 25 or fewer employees would be eligible to ship meat and poultry products in interstate commerce. State-inspected establishments selected to participate in this program would be required to comply with all Federal standards under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). These establishments would receive inspection services from State inspection personnel that have been trained and certified to assist with enforcement of the FMIA and PPIA. Meat and poultry products produced under the program that have been inspected and passed by selected State-inspection personnel would bear a Federal mark of inspection. FSIS is proposing these regulations in response to the Food, Conservation, and Energy Act, enacted on June 18, 2008 (the 2008 Farm Bill). Section 11015 of 2008 Farm Bill provides for the interstate shipment of State-inspected meat and poultry product from selected establishments and requires that FSIS promulgate implementing regulations no later than 18 months from the date of its enactment. Statement of Need: This action is needed to implement a new Federal-State cooperative program that will permit certain State-inspected establishments to ship meat and poultry products in interstate commerce. Inspection services for establishments selected to participate in the program will be provided by State inspection personnel that have been trained and certified in the administration and enforcement of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) Meat and poultry products produced by establishments selected to participate in the program will bear a Federal mark of inspection. Summary of Legal Basis: This action is authorized under section 11015 of the Food, Conservation, and Energy Act of 2008 (the 2008 Farm Bill) (Pub. L. 110- 246). Section 11015 amends the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) to establish an optional Federal-State cooperative program under which State-inspected establishments would be permitted to ship meat and poultry products in interstate commerce. The law requires that FSIS promulgate implementing regulations no later than 18 months after the date of enactment. Alternatives: 1. No action: FSIS did not consider the alternative of no action because section 11015 of the 2008 Farm Bill requires that it promulgate regulations to implement the new Federal-State cooperative program. The Agency did consider alternatives on how to implement the new program. 2. Limit participation in the program to State-inspected establishments with 25 or fewer employees on average: Under the law, State-inspected establishments that have 25 or fewer employees on average are permitted to participate in the program. The law also provides that FSIS may select establishments that employ more than 25 but fewer than 35 employees on average as of June 18, 2008 (the date of enactment), to participate in the program. Under the law, if these establishments employ more than 25 employees on average 3 years after FSIS promulgates implementing regulations, they are required to transition to a Federal establishment. FSIS rejected the option of limiting the program to establishment that employ 25 or fewer employees on average to give additional small establishments the opportunity to participate in the program and ship their meat and poultry products in interstate commerce. 3. Permit establishments with 25 to 35 employees on average as of June 18, 2008, to participate in the program. FSIS chose the option of permitting these establishments to be selected to participate in the program to give additional small establishments the opportunity to ship their meat and poultry products in interstate commerce. Under this option, FSIS will develop a procedure to transition any establishment that employs more than 25 people on average to a Federal establishment. Establishments that employee 24 to 35 employees on average as of June 18, 2008, would be subject to the transition procedure beginning on the date 3 years after the Agency promulgates implementing regulations. Anticipated Cost and Benefits: FSIS is analyzing the costs of this proposed rule to industry, FSIS, State and local governments, small entities, and foreign countries. Participation in [[Page 79493]] the new Federal-State cooperative program will be optional. Thus, the costs and benefits associated with the proposed rule will depend on the number of States and establishments that choose to participate. Very small and certain small establishments State-inspected establishments that are selected to participate in the program are likely to benefit from the program because they will be permitted sell their products to consumers in other States and foreign countries. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/16/09 74 FR 47648 NPRM Comment Period End 12/16/09 Final Action 05/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Rachel Edelstein Director, Policy Issuances Division Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-0399 Fax: 202 690-0486 Email: rachel.edelstein@fsis.usda.gov RIN: 0583-AD37 _______________________________________________________________________ <###doc> USDA--Rural Business-Cooperative Service (RBS) ----------- FINAL RULE STAGE ----------- <###doc> 25. VALUE-ADDED PRODUCER GRANT PROGRAM Priority: Other Significant Legal Authority: PL 110-246 CFR Citation: 7 CFR 1951, subpart E; 7 CFR 4284, subpart J Legal Deadline: None Abstract: The Agency proposes to modify 7 CFR part 4284, subpart J, to include the definitions for mid-tier value chain and value-added agricultural product to include an agricultural commodity or product that is aggregated and marketed as a locally produced agricultural food product. Additionally, the proposed rule will expand the grant term not to exceed 3 years; implement a simplified application process for project proposals less than $50,000; provide for priority to projects that increase opportunities for beginning farmers or ranchers, socially disadvantaged farmers or ranchers, and operators of small- and medium sized farms and ranches that are structured as a family farm; and implement a reservation of funds for projects to benefit beginning farmers or ranchers, socially disadvantaged farmers or ranchers, and mid-tier value chains. The Agency is also proposing to amend 7 CFR part 1951, subpart E, to allow the delegation of the servicing of the program to USDA State Office personnel. Statement of Need: The modifications to the Value Added Producer Grant program will streamline program regulations resulting in better quality applications. It is expected that all of the changes will result in time and resource savings to the applicant and the Agency. Publication of the final rule is crucial to program implementation. The program will directly create new businesses, assist with the expansion of existing businesses, create jobs, increase the flow of tax dollars to rural communities, and add lasting value in terms of rural community impact. Summary of Legal Basis: The program was authorized by the Agriculture Risk Protection Act of 2000, section 231 (Pub. L. 106-224). The purpose of the Value Added Producer Grant (VAPG) program is to help eligible independent producers of agricultural commodities, agricultural producer groups, farmer and rancher cooperatives, and majority-owned, producer-based business ventures develop business plans for viable marketing opportunities and develop strategies to create marketing opportunities. Alternatives: An alternative is to continue under the interim rule. The interim rule is scheduled to be published and remain in effect until a final rule is adopted. A notice announcing FY 2010 funding will be published after the interim rule. FY 2010 funding will be expendable in FY 2011. Anticipated Cost and Benefits: Costs: The anticipated costs associated with this process are contract services. An exact dollar amount cannot be determined at this time, but it will not have an annual effect on the economy of $100 million or more. No change in FTE needs is anticipated. Minimal automation changes are anticipated. Benefits: The intended action is to fine tune the program regulations, making them easier to use for the public and Agency staff, while incorporate changes designed to reduce the cost to the Government and the subsidy rate. Risks: Program risks include risk of loss in the loans guaranteed under this program. We anticipate mitigating these risks with improved regulatory and administrative guidance and appropriate training. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 05/28/10 75 FR 29920 NPRM Comment Period End 06/28/10 Interim Final Rule 12/00/10 Interim Final Rule Effective 01/00/11 Interim Final Rule Comment Period End 02/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None [[Page 79494]] Agency Contact: Jermolowicz Andrew Assistant Deputy Administrator Department of Agriculture Rural Business-Cooperative Service STOP 3250 1400 Independence Avenue SW. Washington, DC 20250-3250 Phone: 202 720-8460 Fax: 202 720-4641 Email: andrew.jermolowicz@wdc.usda.gov RIN: 0570-AA79 _______________________________________________________________________ <###doc> USDA--Rural Utilities Service (RUS) ----------- FINAL RULE STAGE ----------- <###doc> 26. RURAL BROADBAND ACCESS LOANS AND LOAN GUARANTEES Priority: Other Significant Legal Authority: PL 107-171; 7 USC 901 et seq CFR Citation: 7 CFR 1738 Legal Deadline: None Abstract: On February 17, 2009, President Obama signed the American Recovery and Reinvestment Act of 2009 (Recovery Act) into law. The essential goal of the Recovery Act is to provide a ``direct fiscal boost to help lift our Nation from the greatest economic crisis in our lifetimes and lay the foundation for future growth.'' The Recovery Act expanded Rural Utilities Service's (RUS') existing authority to make loans and provides new authority to make grants to facilitate broadband deployment in rural areas. RUS has been tasked with the time-sensitive priority of developing the regulation for this new authority. The Agency will, however, also continue to develop a final rule for the Broadband Program as authorized by The Farm Security and Rural Investment Act of 2002, Public Law 107-171 (2002 Farm Bill). There has been more than $1.7 billion in loans for broadband deployment with more than 1,900 rural communities that will receive broadband services. Even with this level of success, the program needs to be adjusted to better serve unserved or underserved communities. In response, the RUS, an agency of the United States Department of Agriculture, revised the broadband rule to address this and other critical issues, and further facilitate the deployment of broadband service in rural America as directed by Congress by: (1) Clearly defining served and underserved markets based on service availability and existing competitors and target unserved in underserved areas; (2) providing potential applicants with a clear definition of which communities are eligible for funding; (3) establishing a minimum data transmission rate that the facilities financed must be able to deliver to the consumer; (4) establishing equity requirements that mitigate risks; (5) modifying market survey requirements based on service territories and existing availability of service; and (6) imposing new time limits for build-out and deployment to ensure prudent use of loan funds and timely delivery services to rural customers. A proposed rule was published in May 2007 seeking comments from interested parties. Subsequently, the rulemaking process was suspended in light of new statutory requirements provided in the 2008 Farm Bill, thus requiring further rulemaking activities. Statement of Need: Since the Broadband Loan Program's inception, the Agency has faced and continues to face significant challenges in administering the program, including the fierce competitive nature of the broadband market, the fact that many companies proposing to offer broadband service are start-up organizations with limited resources, continually evolving technology, and economic factors such as the higher cost of serving rural communities. Because of these challenges, the Agency has been reviewing the characteristics of the Broadband Loan Program and has determined that modifications are required to accelerate the deployment of broadband service to the rural areas of the country. The Broadband Loan Program is important to the revitalization of our rural communities and their economies. A lack of private capital has been cited as a reason for slow broadband deployment. However, an adequate supply of investment capital alone may not be sufficient to universally deploy broadband facilities in rural America--primarily due to the high cost of deployment outside of more densely populated areas. Due to market uncertainties and risks associated with startup ventures, non-Federal sources of funding are restricting and raising the cost of capital, particularly in costly rural markets. Better access to low- cost capital is a primary initiative of this program in facilitating an increase in the rate of rural broadband deployment. Summary of Legal Basis: On May 13, 2002, the Farm Security and Rural Investment Act of 2002, Public Law 107-171 (``2002 Farm Bill''), was signed into law. Title VI of the Farm Bill authorized the Agency to approve loans and loan guarantees for the costs of construction, improvement, and acquisition of facilities and equipment for broadband service in eligible rural communities. On June 18, 2008, the Food, Conservation, and Energy Act of 2008 (``2008 Farm Bill'') became law, significantly changing the statutory requirements of the Broadband Loan Program. As such, the Agency will be issuing a Interim Rule that implements the statutory changes and requests comment on sections of the rule that were not part of the Proposed Rule published in May 2007. Anticipated Cost and Benefits: The program costs associated with lending activity are relatively low. The average subsidy rate since the program's inception is 2.4 percent, or $24,000 in appropriated budget authority for every $1 million in loans. The residents and businesses of rural communities are the beneficiaries. Rural Development is responsible for helping rural America transition from an agricultural base economy to a platform for new business and economic opportunity. Rural Development seeks to leverage its financial resources with private investment to facilitate the development of the changing rural economy. The Broadband Loan Program provides rural America with the platform on which to achieve these goals. With access to the same advanced telecommunications networks as its urban counterparts, especially broadband networks designed to accommodate distance learning, telework, and telemedicine, rural America will eventually see improving educational opportunities, health care, economies, safety and security, and ultimately higher employment. The Agency shares the assessment of Congress, State and local officials, industry representatives, and rural residents that broadband service is a critical component to the future of rural America. The Agency is committed to ensuring that rural America will have access to affordable, reliable, broadband [[Page 79495]] services, and to provide a healthy, safe and prosperous place to live and work. Risks: Building broadband infrastructure in sparsely populated rural communities is very capital intensive. The Broadband Loan Program continues to face risk factors that pose challenges in ensuring that proposed projects can and do deliver robust, affordable broadband services to rural consumers. These factors include the competitive nature of the broadband market, the fact that many companies proposing to offer broadband service are start-up organizations with limited resources, rapidly evolving technology, and economic factors such as the higher cost of serving rural communities. While many of the smallest rural communities understand the importance of broadband infrastructure to their economic development, they often have difficulty attracting service providers to their communities. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 05/11/07 72 FR 26742 NPRM Comment Period End 07/10/07 Interim Final Rule 12/00/10 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Michele L. Brooks Director, Program Development and Regulatory Analysis Department of Agriculture Rural Utilities Service Room 5159 South Building STOP 1522 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 690-1078 Fax: 202 720-8435 Email: michele.brooks@usda.gov RIN: 0572-AC06 BILLING CODE 3410-90-S [[Page 79496]] <###doc> DEPARTMENT OF COMMERCE (DOC) <###doc> Statement of Regulatory and Deregulatory Priorities The President's fiscal year (FY) 2010 Budget details how this Administration plans to lift our economy out of recession and lay a new foundation for long-term growth and prosperity. The Department of Commerce (the ``Department'' or ``Commerce'') is aligning itself to contribute to both of these goals. Established in 1903, the Department of Commerce is one of the oldest Cabinet-level agencies in the Federal Government. The Department's mission is to create the conditions for economic growth and opportunity by promoting innovation, entrepreneurship, competitiveness, and environmental stewardship. Commerce has 12 operating units, which are responsible for managing a diverse portfolio of programs and services, ranging from trade promotion and economic development assistance to broadband and the National Weather Service. The Department currently employs approximately 53,000 people around the world, although this workforce doubled temporarily in 2010, due to the decennial census. The Department touches Americans daily, in many ways--making possible the daily weather reports and survey research; facilitating technology that all of us use in the workplace and in the home each day; supporting the development, gathering, and transmission of information essential to competitive business; enabling the diversity of companies and goods found in America's and the world's marketplace; and supporting environmental and economic health for the communities in which Americans live. Commerce has a clear and compelling vision for itself, for its role in the Federal Government, and for its roles supporting the American people, now and in the future. To achieve this vision, the Department works in partnership with businesses, universities, communities, and workers to: Innovate by creating new ideas through cutting-edge science and technology from advances in nanotechnology, to ocean exploration, to broadband deployment, and by protecting American innovations through the patent and trademark system; Support entrepreneurship and commercialization by enabling community development and strengthening minority businesses and small manufacturers; Maintain U.S. economic competitiveness in the global marketplace by promoting exports, ensuring a level playing field for U.S. businesses, and ensuring that technology transfer is consistent with our Nation's economic and security interests; Provide effective management and stewardship of our Nation's resources and assets to ensure sustainable economic opportunities; and Make informed policy decisions and enable better understanding of the economy by providing accurate economic and demographic data. The Department is a vital resource base, a tireless advocate, and Cabinet-level voice for job creation. The Regulatory Plan tracks the most important regulations that implement these policy and program priorities, several of which involve regulation of the private sector by the Department. Responding to the Administration's Regulatory Philosophy and Principles The vast majority of the Department's programs and activities do not involve regulation. Of the Department's 12 primary operating units, only the National Oceanic and Atmospheric Administration (NOAA) will be planning actions that are considered the ``most important'' significant preregulatory or regulatory actions for FY 2010. During the next year, NOAA plans to publish four rulemaking actions that are designated as Regulatory Plan actions. Further information on these actions is provided below. The Department has a long-standing policy to prohibit the issuance of any regulation that discriminates on the basis of race, religion, gender, or any other suspect category and requires that all regulations be written so as to be understandable to those affected by them. The Secretary also requires that the Department afford the public the maximum possible opportunity to participate in departmental rulemakings, even where public participation is not required by law. National Oceanic and Atmospheric Administration NOAA establishes and administers Federal policy for the conservation and management of the Nation's oceanic, coastal, and atmospheric resources. It provides a variety of essential environmental and climate services vital to public safety and to the Nation's economy, such as weather forecasts, drought forecasts, and storm warnings. It is a source of objective information on the state of the environment. NOAA plays the lead role in achieving the departmental goal of promoting stewardship by providing assessments of the global environment. Recognizing that economic growth must go hand-in-hand with environmental stewardship, the Department, through NOAA, conducts programs designed to provide a better understanding of the connections between environmental health, economics, and national security. Commerce's emphasis on ``sustainable fisheries'' is designed to boost long-term economic growth in a vital sector of the U.S. economy while conserving the resources in the public trust and minimizing any economic dislocation necessary to ensure long-term economic growth. The Department is where business and environmental interests intersect, and the classic debate on the use of natural resources is transformed into a ``win-win'' situation for the environment and the economy. Three of NOAA's major components, the National Marine Fisheries Services (NMFS), the National Ocean Service (NOS), and the National Environmental Satellite, Data, and Information Service (NESDIS), exercise regulatory authority. NMFS oversees the management and conservation of the Nation's marine fisheries, protects threatened and endangered marine and anadromous species and marine mammals, and promotes economic development of the U.S. fishing industry. NOS assists the coastal States in their management of land and ocean resources in their coastal zones, including estuarine research reserves; manages the Nation's national marine sanctuaries; monitors marine pollution; and directs the national program for deep-seabed minerals and ocean thermal energy. NESDIS administers the civilian weather satellite program and licenses private organizations to operate commercial land-remote sensing satellite systems. The Department, through NOAA, has a unique role in promoting stewardship of the global environment through effective management of the Nation's marine and coastal resources and in monitoring and predicting changes in the Earth's environment, thus linking trade, development, and technology with environmental issues. NOAA has the primary Federal responsibility for providing sound scientific observations, [[Page 79497]] assessments, and forecasts of environmental phenomena on which resource management, adaptation, and other societal decisions can be made. In the environmental stewardship area, NOAA's goals include: Rebuilding and maintaining strong U.S. fisheries by using market-based tools and ecosystem approaches to management; increasing the populations of depleted, threatened, or endangered species and marine mammals by implementing recovery plans that provide for their recovery while still allowing for economic and recreational opportunities; promoting healthy coastal ecosystems by ensuring that economic development is managed in ways that maintain biodiversity and long-term productivity for sustained use; and modernizing navigation and positioning services. In the environmental assessment and prediction area, goals include: Understanding climate change science and impacts, and communicating that understanding to government and private sector stakeholders enabling them to adapt; continually improving the National Weather Service; implementing reliable seasonal and interannual climate forecasts to guide economic planning; providing science-based policy advice on options to deal with very long-term (decadal to centennial) changes in the environment; and advancing and improving short-term warning and forecast services for the entire environment. Magnuson-Stevens Fishery Conservation and Management Act Magnuson-Stevens Fishery Conservation and Management Act (Magnuson- Stevens Act) rulemakings concern the conservation and management of fishery resources in the U.S. Exclusive Economic Zone (generally 3-200 nautical miles). Among the several hundred rulemakings that NOAA plans to issue in fiscal year 2010, a number of the preregulatory and regulatory actions will be significant. The exact number of such rulemakings is unknown, since they are usually initiated by the actions of eight regional Fishery Management Councils (FMCs) that are responsible for preparing fishery management plans (FMPs) and FMP amendments, and for drafting implementing regulations for each managed fishery. NOAA issues regulations to implement FMPs and FMP amendments. Once a rulemaking is triggered by an FMC, the Magnuson-Stevens Act places stringent deadlines upon NOAA by which it must exercise its rulemaking responsibilities. FMPs and FMP amendments for Atlantic highly migratory species, such as bluefin tuna, swordfish, and sharks, are developed directly by NOAA, not by FMCs. FMPs address a variety of issues including maximizing fishing opportunities on healthy stocks, rebuilding overfished stocks, and addressing gear conflicts. One of the problems that FMPs may address is preventing overcapitalization (preventing excess fishing capacity) of fisheries. This may be resolved by market-based systems such as catch shares, which permit shareholders to harvest a quantity of fish and which can be traded on the open market. Harvest limits based on the best available scientific information, whether as a total fishing limit for a species in a fishery or as a share assigned to each vessel participant, enable stressed stocks to rebuild. Other measures include staggering fishing seasons or limiting gear types to avoid gear conflicts on the fishing grounds and establishing seasonal and area closures to protect fishery stocks. The FMCs provide a forum for public debate and, using the best scientific information available, make the judgments needed to determine optimum yield on a fishery-by-fishery basis. Optional management measures are examined and selected in accordance with the national standards set forth in the Magnuson-Stevens Act. This process, including the selection of the preferred management measures, constitutes the development, in simplified form, of an FMP. The FMP, together with draft implementing regulations and supporting documentation, is submitted to NMFS for review against the national standards set forth in the Magnuson-Stevens Act, in other provisions of the Act, and other applicable laws. The same process applies to amending an existing approved FMP. Marine Mammal Protection Act The Marine Mammal Protection Act of 1972 (MMPA) provides the authority for the conservation and management of marine mammals under U.S. jurisdiction. It expressly prohibits, with certain exceptions, the take of marine mammals. Exceptions allow for permitting the collection of wild animals for scientific research or public display or to enhance the survival of a species or stock. NMFS initiates rulemakings under the MMPA to establish a management regime to reduce marine mammal mortalities and injuries as a result of interactions with fisheries. The Act also established the Marine Mammal Commission, which makes recommendations to the Secretaries of the Departments of Commerce and the Interior and other Federal officials on protecting and conserving marine mammals. The Act underwent significant changes in 1994 to allow for takings incidental to commercial fishing operations, to provide certain exemptions for subsistence and scientific uses, and to require the preparation of stock assessments for all marine mammal stocks in waters under U.S. jurisdiction. Endangered Species Act The Endangered Species Act of 1973 (ESA) provides for the conservation of species that are determined to be ``endangered'' or ``threatened,'' and the conservation of the ecosystems on which these species depend. The ESA authorizes both NMFS and the Fish and Wildlife Service (FWS) to jointly administer the provisions of the Act. NMFS manages marine and ``anadromous'' species, and FWS manages land and freshwater species. Together, NMFS and FWS work to protect critically imperiled species from extinction. Of the 1,310 listed species found in part or entirely in the United States and its waters, NMFS has jurisdiction over approximately 60 species. NMFS' rulemaking actions are focused on determining whether any species under its responsibility is an endangered or threatened species and whether those species must be added to the list of protected species. NMFS is also responsible for designating, reviewing, and revising critical habitat for any listed species. In addition, under the ESA's procedural framework, Federal agencies consult with NMFS on any proposed action authorized, funded, or carried out by that agency that may affect one of the listed species or designated critical habitat, or is likely to jeopardize proposed species or adversely modify proposed critical habitat that is under NMFS' jurisdiction. NOAA's Regulatory Plan Actions While most of the rulemakings undertaken by NOAA do not rise to the level necessary to be included in the Department's regulatory plan, NMFS is undertaking four actions that rise to the level of ``most important'' of the Department's significant regulatory actions and thus are included in this year's regulatory plan. The four actions implement provisions of the Magnuson-Stevens Fishery Conservation and Management Act, as reauthorized in 2006. The first action may be of [[Page 79498]] particular interest to international trading partners as it concerns the Certification of Nations Whose Fishing Vessels are Engaged in Illegal, Unreported, or Unregulated Fishing or Bycatch of Protected Living Marine Resources. A description of the four regulatory plan actions is provided below. 1. Certification of Nations Whose Fishing Vessels Are Engaged in Illegal, Unreported, or Unregulated Fishing or Bycatch of Protected Living Marine Resources (0648-AV51). NOAA's NMFS is establishing a process of identification and certification to address illegal, unreported, or unregulated (IUU) activities and bycatch of protected species in international fisheries. Nations whose fishing vessels engage, or have been engaged, in IUU fishing would be identified in a biennial report to Congress, as required under section 403 of the Magnuson-Stevens Fishery Conservation and Management Act. NMFS would subsequently certify whether identified nations have taken appropriate corrective action with respect to the activities of its fishing vessels. 2. Pacific Coast Groundfish Trawl Rationalization Program--Program Components Rulemaking (0648-AY68): Due to the complexity of the fishery management measures, NMFS is implementing the Pacific Coast Groundfish Trawl Rationalization Program through multiple rulemakings. A previous rulemaking (i.e., the Initial Issuance rule) creates and issues quota shares to qualified participants and establishes an appeals process. The program components rulemaking would implement the second phase of the trawl rationalization program. In particular, this rulemaking includes requirements for observers and compliance monitors, retention requirements, coop permits and agreements, first receiver site licenses, vessel accounts and mandatory economic data collection. 3. Designation of Critical Habitat for Cook Inlet Beluga Whale (0648- AX50): This rule would designate critical habitat in two areas of Cook Inlet totaling 3,016 square miles. Critical habitat would include intertidal and subtidal waters near high and medium flow anadromous fish streams. The deadline for publication is October 20, 2010. 4. Critical Habitat for North Atlantic Right Whales (0648-AY54): Northern right whales have been listed as endangered since 1973. In 2008, NOAA removed Northern right whales from the list of endangered species and replaced it with two separate species (North Pacific and North Atlantic right whales). NOAA had designated critical habitat for Northern right whales but has not yet designated critical habitat for the new North Atlantic right whale species. Several environmental groups threaten litigation over the failure to designate critical habitat for the species listed in 2008. NOAA is discussing a possible schedule for critical habitat designation that would avoid litigation. At this time, NOAA is unable to determine the aggregate cost of the identified Regulatory Plan actions as several of these actions are currently under development. Bureau of Industry and Security The Bureau of Industry and Security (BIS) advances U.S. national security, foreign policy, and economic objectives by maintaining and strengthening an adaptable, efficient, and effective export control and treaty compliance systems. BIS also administers programs to prioritize certain contracts to promote the national defense and to protect and enhance the defense industrial base. In August 2009, the President directed a broad-based interagency review of the U.S. export control system with the goal of strengthening national security and the competitiveness of key U.S. manufacturing and technology sectors by focusing on the current threats and adapting to the changing economic and technological landscape. In August 2010, the President outlined an approach under which agencies that administer export controls will apply new criteria for determining what items need to be controlled and a common set of policies for determining when an export license is required. The control list criteria are to be based on transparent rules, which will reduce the uncertainty faced by our Allies, U.S. industry, and its foreign partners, and will allow the government to erect higher walls around the most sensitive items in order to enhance national security. Under the President's approach, agencies will apply the criteria and revise the lists of munitions and dual use items that are controlled for export so that they: Are ``tiered'' to distinguish the types of items that should be subject to stricter or more permissive levels of control for different destinations, end-uses, and end-users; Create a ``bright line'' between the two current control lists to clarify jurisdictional determinations and reduce government and industry uncertainty about whether particular items are subject to the control of the State Department or the Commerce Department; and Are structurally aligned so that they potentially can be combined into a single list of controlled items. BIS' current regulatory plan action is designed to implement the initial phase of the President's directive. Major Programs and Activities BIS administers four sets of regulations. The Export Administration Regulations (EAR) regulate exports and reexports to protect national security, foreign policy, and short supply interests. The EAR also regulate participation of U.S. persons in certain boycotts administered by foreign governments. The National Defense Industrial Base Regulations provide for prioritization of certain contracts and allocations of resources to promote the national defense, require reporting of foreign government imposed offsets in defense sales, and address the effect of imports on the defense industrial base. The Chemical Weapons Convention Regulations implement declaration, reporting, and on-site inspection requirements in the private sector necessary to meet United States treaty obligations under Chemical Weapons Convention treaty. The Additional Protocol Regulations implement similar requirements with respect to an agreement between the United States and the International Atomic Energy Agency. BIS also has an enforcement component with eight field offices in the United States. BIS export control officers are stationed at several U.S. embassies and consulates abroad. BIS works with other U.S. Government agencies to promote coordinated U.S. Government efforts in export controls and other programs. BIS participates in U.S. Government efforts to strengthen multilateral export control regimes and to promote effective export controls through cooperation with other governments. BIS' Regulatory Plan Actions As the agency responsible for leading administration and enforcement of the [[Page 79499]] U.S. dual-use export control system, BIS is playing a central role in the Administration's efforts to fundamentally reform the export control system. Changing what we control, how we control it and how we enforce and manage our controls will help strengthen our national security by focusing our efforts on controlling the most critical products and technologies and by enhancing the competitiveness of key U.S. manufacturing and technology sectors. In accordance with the President's directive to develop a system that is tiered to distinguish the types of items that should be subject to stricter or more permissive levels of control for different destinations, end-uses, and end-users, BIS is developing a rule to implement an Export Control Tier Based License Exception. This rule would allow certain dual-use items to be exported and reexported with conditions to specific countries without a license that would otherwise be required. BIS will also be developing other rules to implement additional aspects of the export control reform as those aspects are identified and decided. International Trade Administration The International Trade Administration (ITA) assists in the development of U.S. trade policy in the global economy; creates jobs and economic growth by promoting U.S. companies; strengthens American competitiveness across all industries; addresses market access and compliance issues; administers U.S. trade laws; and undertakes a range of trade promotion and trade advocacy efforts. Import Administration The Import Administration (IA) is the ITA's lead unit on enforcing trade laws and agreements to prevent unfairly traded imports and to safeguard jobs and the competitive strength of American industry. From working to resolve disputes to implementing measures when violations are found, we are there to protect U.S. companies from unfair trade practices. The primary role of IA is to enforce effectively the U.S. unfair trade laws (i.e., the antidumping duty (AD) and countervailing duty (CVD) laws) and to develop and implement other policies and programs aimed at countering foreign unfair trade practices. IA also administers the Foreign Trade Zones program, the Statutory Import Program and certain sector-specific agreements and programs, such as the Textiles and Apparel Program and the Steel Import Monitoring and Analysis licensing system. AD proceedings focus on whether foreign producers/exporters are selling their merchandise in the United States at less than fair value. CVD proceedings focus on whether foreign producers/exporters are benefitting from subsidies provided by their governments. Parties who participate in AD/CVD proceedings include U.S. manufacturers, U.S. importers, and foreign exporters and manufacturers, some of whom are affiliated with U.S. companies. ITA's Regulatory Plan Actions IA is developing a rule entitled, ``Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures'' to implement an electronic filing and records management system called IA's Antidumping and Countervailing Duty Centralized Electronic Service System (IA ACCESS). The Department's regulations currently require parties to submit multiple copies of a public document, and additional copies if the document contains business proprietary information. Alternatively, under the current regulations, if a document contains business proprietary information, a party must submit one hard copy original and five hard copies of a business proprietary document and three copies of a public version. The proposed rule will require interested parties to use IA ACCESS to file submissions electronically, unless an exception for manual, hard copy filing is applicable. If a document must be filed manually, the proposed rule also reduces the required number of copies for manual submissions such that only one paper copy of the submission will need to be filed with the Department. In addition to electronic filing, the goal of the IA ACCESS system is to expand the public's access to information in AD/CVD proceedings by making all publicly filed documents available on the internet. It will also allow interested parties to file all submissions (both public and business proprietary) with the Department using an internet connection. The Department envisions that such a system will create efficiencies in both the process and costs associated with filing and maintaining the documents. The ease of document submission will increase accessibility of submission to the Department by interested parties located within and outside the Washington, DC area. Foreign-Trade Zones Board The Foreign-Trade Zones (FTZ) Board is an interagency board composed of the Secretary of Commerce and the Secretary of the Treasury. The Secretary of Commerce is the chairman of the Board. The FTZ Board administers the Foreign-Trade Zones Act of 1934, as amended (19 U.S.C. section 81a et seq.) (FTZ Act). Major Program and Activities The FTZ Board administers the FTZ program of the United States, pursuant to the FTZ Act and the FTZ regulations, codified at 15 CFR part 400. FTZs are restricted-access sites in or near U.S. Customs and Border Protection (CBP) ports of entry licensed by the FTZ Board and operated under the supervision of CBP. FTZs are locations into which foreign and domestic merchandise may be moved for operations involving storage, exhibition, assembly, manufacture, or other processing not prohibited by law. FTZs are considered outside of U.S. customs territory, which means that the usual customs entry procedures and payment of duties are not required on foreign merchandise admitted into an FTZ unless and until that merchandise enters U.S. customs territory for domestic consumption. The fact that FTZs are considered outside of U.S. customs territory makes them a valuable resource for many businesses. An FTZ user can avoid payment of U.S. customs duties on foreign merchandise admitted into an FTZ and then re-exported after further processing or manufacturing. Further, in some circumstances an FTZ user can admit foreign merchandise into an FTZ for use in manufacturing, and then, upon entry of the manufactured product into the U.S. customs territory, pay customs duties at the rate for the manufactured product. This can result in significant duty savings. Therefore, the FTZ program encourages retention of employment in the United States and promotion of export activity. The FTZ Board reviews and approves applications for authority to establish FTZs and to conduct certain activity within FTZs. It has the authority to restrict or prohibit activity in FTZs. Under the FTZ Act, FTZs must be operated under public utility principles and provide uniform treatment to all that apply to use the FTZ. The FTZ Board ensures that FTZs are operated in the public interest. [[Page 79500]] The FTZ Board's Regulatory Plan Actions The FTZ Board is in the process of revising its regulations, which have been in effect since 1990, in a proposed rule entitled, ``Foreign-Trade Zones in the United States.'' The new proposed rule was sent to OMB for review on August 31, 2010 (RIN 0625-AA81). The proposed rule will streamline application procedures and improve access to FTZs. For example, the FTZ Board is proposing to eliminate the need for advance Board approval of many types of manufacturing operations. This will allow businesses, including small businesses, to take advantage of manufacturing opportunities in FTZs more quickly and more in keeping with the pace of modern business, because they will not need to wait through the sometimes lengthy application process. Further, the proposed rule will provide guidance on the FTZ Act's requirements that FTZs be operated as public utilities with uniform access to all users. This aspect of the proposed rule will improve access to the job- retention and export-promotion benefits of FTZs. The proposed rule also will provide greater clarity on various other aspects of the FTZ program, such as the FTZ Board's statutory fining authority. _______________________________________________________________________ <###doc> DOC--National Oceanic and Atmospheric Administration (NOAA) ----------- PROPOSED RULE STAGE ----------- <###doc> 27. DESIGNATION OF CRITICAL HABITAT FOR THE NORTH ATLANTIC RIGHT WHALE Priority: Other Significant Legal Authority: 16 USC 1361 et seq; 16 USC 1531 to 1543 CFR Citation: 50 CFR 226; 50 CFR 229 Legal Deadline: None Abstract: In June 1970, the Northern right whale was listed as endangered under the Endangered Species Conservation Act, the precursor to the Endangered Species Act (ESA)(35 FR 8495; codified at 50 CFR 17.11). Subsequently, right whales were listed as endangered under the ESA in 1973, and as depleted under the Marine Mammal Protection Act (MMPA) the same year. In 1994, NMFS designated critical habitat for the Northern right whale, a single species thought at the time to include right whales in both the North Atlantic and the North Pacific. In 2006, NMFS published a comprehensive right whale status review that concluded that recent genetic data provided unequivocal support to distinguish three right whale lineages (including the southern right whale) as separate phylogenetic species (Rosenbaum et al. 2000). Rosenbaum et al. (2000) concluded that the right whale should be regarded as the following three separate species: (1) The North Atlantic right whale (Eubalaena glacialis) ranging in the North Atlantic Ocean; (2) the North Pacific right whale (Eubalaena japonica), ranging in the North Pacific Ocean; and (3) the southern right whale (Eubalaena australis), historically ranging throughout the southern hemisphere's oceans. Based on these findings, NMFS published a proposed and final determination listing right whales in the North Atlantic and North Pacific as separate endangered species under the ESA (71 FR 77704, December 27, 2006; 73 FR 12024, March 6, 2008). Based on the new listing determination, NMFS is required by the ESA to designate critical habitat separately for both the North Atlantic right whale and the North Pacific right whale. In April 2008, a final critical habitat determination was published for the North Pacific right whale (73 FR 19000; April 8, 2008). At this time, NMFS is preparing a proposal to designate critical habitat for the North Atlantic right whale. Statement of Need: In June 1970, the Northern right whale was listed as endangered under the Endangered Species Conservation Act, the precursor to the Endangered Species Act (ESA)(35 FR 8495; codified at 50 CFR 17.11). Subsequently, right whales were listed as endangered under the ESA in 1973 and as depleted under the Marine Mammal Protection Act (MMPA) the same year. In 1994, NMFS designated critical habitat for the Northern right whale, a single species thought at the time to include right whales in both the North Atlantic and the North Pacific. In 2006, NMFS published a comprehensive right whale status review that concluded that recent genetic data provided unequivocal support to distinguish three right whale lineages (including the southern right whale) as separate phylogenetic species (Rosenbaum et al. 2000). Rosenbaum et al. (2000) concluded that the right whale should be regarded as the following three separate species: (1) The North Atlantic right whale (Eubalaena glacialis) ranging in the North Atlantic Ocean; (2) the North Pacific right whale (Eubalaena japonica), ranging in the North Pacific Ocean; and (3) the southern right whale (Eubalaena australis), historically ranging throughout the southern hemisphere's oceans. Based on these findings, NMFS published a proposed and final determination listing right whales in the North Atlantic and North Pacific as separate endangered species under the ESA (71 FR 77704, December 27, 2006; 73 FR 12024, March 6, 2008). Based on the new listing determination, NMFS is required by the ESA to designate critical habitat separately for both the North Atlantic right whale and the North Pacific right whale. In April 2008, a final critical habitat determination was published for the North Pacific right whale (73 FR 19000; April 8, 2008). At this time, NMFS is preparing a proposal to designate critical habitat for the North Atlantic right whale. Summary of Legal Basis: Endangered Species Act Alternatives: Because this rule is presently in the beginning stages of development, no alternatives have been formulated or analyzed at this time. Anticipated Cost and Benefits: Because this rule is presently in the beginning stages of development, no analysis has been completed at this time to assess costs and benefits. Risks: Loss of critical habitat for a species listed as protected under the ESA and MMPA, as well as potential loss of right whales due to habitat loss. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 12/00/10 Regulatory Flexibility Analysis Required: No Small Entities Affected: No [[Page 79501]] Government Levels Affected: None Agency Contact: Marta Nammack Office of Protected Resources Department of Commerce National Oceanic and Atmospheric Administration 1315 East-West Highway Silver Spring, MD 20910 Phone: 301 713-1401 Fax: 301 427-2523 Email: marta.nammack@noaa.gov RIN: 0648-AY54 _______________________________________________________________________ <###doc> DOC--NOAA ----------- FINAL RULE STAGE ----------- <###doc> 28. CERTIFICATION OF NATIONS WHOSE FISHING VESSELS ARE ENGAGED IN ILLEGAL, UNREPORTED, AND UNREGULATED FISHING OR BYCATCH OF PROTECTED LIVING MARINE RESOURCES Priority: Other Significant Legal Authority: 16 USC 1801 et seq; 16 USC 1826(d) to 1826(k) CFR Citation: 50 CFR 300 Legal Deadline: Final, Statutory, January 12, 2011, Report due to Congress 16 USC 1826h. Report on countries identified as having vessels engaged in IUU fishing. Abstract: The National Marine Fisheries Service (NMFS) is establishing a process of identification and certification to address illegal, unreported, or unregulated (IUU) activities and bycatch of protected species in international fisheries. Nations whose fishing vessels engage, or have been engaged, in IUU fishing or bycatch of protected living marine resources would be identified in a biennial report to Congress, as required under section 403 of the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (MSRA) of 2006. NMFS would subsequently certify whether identified nations have taken appropriate corrective action with respect to the activities of its fishing vessels, as required under section 403 of MSRA. Statement of Need: The National Oceanic and Atmospheric Administration (NOAA) National Marine Fisheries Service (NMFS) proposes regulations to set forth identification and certification procedures for nations whose vessels engage in illegal, unregulated, and unreported (IUU) fishing activities or bycatch of protected living marine resources pursuant to the High Seas Fishing Moratorium Protection Act (Moratorium Protection Act). Specifically, the Moratorium Protection Act requires the Secretary of Commerce to identify in a biennial report to Congress those foreign nations whose vessels are engaged in IUU fishing or fishing that results in bycatch of protected living marine resources. The Moratorium Protection Act also requires the establishment of procedures to certify whether nations identified in the biennial report are taking appropriate corrective actions to address IUU fishing or bycatch of protected living marine resources by fishing vessels of that nation. Based upon the outcome of the certification procedures developed in this rulemaking, nations could be subject to import prohibitions on certain fisheries products and other measures under the authority provided in the High Seas Driftnet Fisheries Enforcement Act if they are not positively certified by the Secretary of Commerce. Summary of Legal Basis: NOAA is proposing these regulations pursuant to its rulemaking authority under sections 609 and 610 of the High Seas Driftnet Fishing Moratorium Protection Act (16 U.S.C. 1826j and k), as amended by the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act. Alternatives: NMFS developed alternatives for the Secretary of Commerce to make a positive certification that a nation, once identified as having vessels engaged in illegal, unregulated, and unreported (IUU) fishing, has taken sufficient corrective action against those vessels or is a member of a regional fishery management organization that has adopted effective measures to address the IUU activities. NMFS also developed alternatives for the Secretary of Commerce to make a positive certification that a nation, once identified as having vessels engaged in bycatch of protected living marine resources (PLMR), has adopted a regulatory program to conserve those PLMR that is comparable in effectiveness to the United States and which collects data to support international assessment and conservation efforts. Anticipated Cost and Benefits: Because this rule is under development, NMFS does not currently have estimates of the amount of product that is imported into the United States from other nations whose vessels are engaged in illegal, unreported, and unregulated (IUU) fishing or bycatch of protected living marine resources. Therefore, quantification of the economic impacts of this rulemaking is not possible at this time. This rulemaking has not been determined to be economically significant under E.O. 12866; however, it is considered significant because it raises novel or legal or policy issues arising out of legal mandates, the President's Priorities, and the principles set forth in the Executive order. Risks: The risks associated with not pursuing the proposed rulemaking include allowing IUU fishing activities and/or bycatch of protected living marine resources by foreign vessels to continue without an effective tool to aid in combating such activities. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ ANPRM 06/11/07 72 FR 33436 ANPRM Comment Period End 07/05/07 NPRM 01/14/09 74 FR 2019 NPRM Comment Period End 05/14/09 Final Action 12/00/10 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. [[Page 79502]] Agency Contact: Christopher Rogers Division Chief Department of Commerce National Oceanic and Atmospheric Administration 1315 East-West Highway Silver Spring, MD 20910 Phone: 301 713-9090 Fax: 301 713-9106 Email: christopher.rogers@noaa.gov Related RIN: Related to 0648-AV23 RIN: 0648-AV51 _______________________________________________________________________ <###doc> DOC--NOAA <###doc> 29. CRITICAL HABITAT DESIGNATION FOR COOK INLET BELUGA WHALE UNDER THE ENDANGERED SPECIES ACT Priority: Other Significant Legal Authority: 16 USC 1531 et seq CFR Citation: 50 CFR 226 Legal Deadline: None Abstract: The National Marine Fisheries Service (NMFS) listed the Cook Inlet beluga whale Distinct Population Segment as endangered under the Endangered Species Act on October 17, 2009. NMFS is required to designate critical habitat no later than one year after the publication of a listing. NMFS intends to publish a proposed rule by October 17, 2009. Statement of Need: The National Marine Fisheries Service (NMFS) listed the Cook Inlet beluga whale Distinct Population Segment as endangered under the Endangered Species Act on October 17, 2009. NMFS is required to designate critical habitat no later than one year after the publication of a listing. NMFS intends to publish a proposed rule by October 17, 2009. Summary of Legal Basis: Endangered Species Act Alternatives: Alternative 1. No action (status quo): NMFS would not designate critical habitat (CH) in Cook Inlet, Alaska, for the Cook Inlet beluga whale. Conservation and recovery of the listed species would depend exclusively upon the protections provided under the ``jeopardy'' provisions of Section 7 of the ESA. Alternative 2. Designate Area 1 and Area 2, which encompass all of upper-Cook Inlet, north of a line at 60[deg] 25' north latitude, and portions of mid- and lower-Cook Inlet, extending south along the west side of the Cook Inlet, following the tidal flats into Kamishak Bay to Douglas Reef, between MHHW and waters within two nautical miles of shore. It further includes all waters of Kachemak Bay, eastward of 151[deg] 30' west longitude and seaward of MHHW. Anticipated Cost and Benefits: The post-designation incremental costs are estimated to range from $187,000 to $571,000, in present value terms, at a 3 percent discount rate, and from $157,000 to $472,000 at a 7 percent discount rate. Approximately six Federal action agencies for section 7 consultations are anticipated to bear 70 percent ($398,000) of these costs, while 26 percent ($148,000) are expected to accrue to NMFS, as the consulting agency. The remaining four percent ($25,000) of these costs may be borne by third parties, during the consultations. Of the total costs to Federal action agencies, the DOD is anticipated to bear approximately 76 percent ($302,000). This is followed by USACE (9 percent; $37,000), NMFS (7 percent; $28,000), FERC (7 percent; $28,000), EPA (1 percent; $3,000), and FHWA (less than 1 percent; less than $1,000). Benefits are qualitative: Area more attractive to workers in various industrial sectors; anticipated conservation and recovery species; and the general stability in associated environs should provide increases in welfare to tourists, recreationists, wildlife watchers, Cook Inlet Ferry passengers, and future cruise ship passengers. This should result in higher revenues for relevant businesses. Other wildlife and fish species will benefit, resulting in overall improvements in commercial, recreational, personal use, and subsistence uses. The increase in Cook Inlet beluga whale populations, in the longer term, will provide more frequent subsistence harvest opportunities to the Alaska Natives and allow future generations to practice their traditional ways. It will enhance passive-use benefits among those who value this species and the myriad elements and aspects of the natural habitat that sustains it. Finally, as the ESA is carried out, there are expected to be scientific and educational benefits to the Nation. Risks: Loss of critical habitat for the Cook Inlet beluga whale Distinct Population Segment and connected loss of Cook Inlet beluga whale members. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ ANPRM 04/14/09 74 FR 17131 ANPRM Comment Period End 05/14/09 NPRM 12/02/09 74 FR 63080 NPRM Comment Period Extended 01/12/10 75 FR 1582 NPRM Comment Period End 02/01/10 Final Action 12/00/10 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Marta Nammack Office of Protected Resources Department of Commerce National Oceanic and Atmospheric Administration 1315 East-West Highway Silver Spring, MD 20910 Phone: 301 713-1401 Fax: 301 427-2523 Email: marta.nammack@noaa.gov RIN: 0648-AX50 _______________________________________________________________________ <###doc> DOC--NOAA <###doc> 30. FISHERIES OFF WEST COAST STATES; PACIFIC COAST GROUNDFISH FISHERY; AMENDMENTS 20 AND 21; TRAWL RATIONALIZATION PROGRAM Priority: Other Significant Legal Authority: 16 USC 1801 et seq CFR Citation: 50 CFR 660 Legal Deadline: None Abstract: The trawl rationalization program creates an individual fishing quota [[Page 79503]] (IFQ) program for the shore-based trawl fleet; and cooperative (coop) programs for the at-sea trawl fleet in the Pacific Coast Groundfish Fishery. This rulemaking includes regulations to implement Amendments 20 and 21 to the Pacific Coast Groundfish Fishery Management Plan (FMP). Amendment 20 creates the structure and management details of the trawl rationalization program, which would be a limited access privilege program (LAPP) under the Magnuson-Stevens Fishery Conservation and Management Act (MSA), as reauthorized in 2007. Amendment 21, intersector allocation, allocates the groundfish stocks between trawl and non-trawl fisheries. Statement of Need: The trawl rationalization program is intended to increase net economic benefits, create individual economic stability, provide full utilization of the trawl sector allocation, consider environmental impacts, and achieve individual accountability of catch and bycatch. This rule would establish the key components that would be necessary to implement the trawl rationalization program at the start of the 2011 fishery. Summary of Legal Basis: Section 303A of the Magnuson-Stevens Act. Alternatives: The Pacific Fishery Management Council (the Council) prepared two environmental impact statement (EIS) documents: Amendment 20-- Rationalization of the Pacific Coast Groundfish Limited Entry Trawl Fishery, which would create the structure and management details of the trawl fishery rationalization program; and Amendment 21--Allocation of Harvest Opportunity Between Sectors of the Pacific Coast Groundfish Fishery, which would allocate the groundfish stocks between trawl and non-trawl fisheries. These EISs covered a range of alternatives. The Regulatory Impact Review and Initial Regulatory Flexibility Analysis (RIR/IRFA) for this rule focuses on the two key alternatives--the No- Action Alternative and the Preferred Alternative. By focusing on the two key alternatives (no action and preferred) in the RIR/IRFA, it encompasses parts of the other alternatives and informs the reader of these proposed regulations. Under the no action alternative, the current, primary management tool used to control the Pacific coast groundfish trawl catch includes a system of two month cumulative landing limits for most species and season closures for Pacific whiting. This management program would continue under the no action alternative. The analysis of the preferred alternative describes what is likely to occur as a result of the proposed action. Under the preferred alternative, the existing shore-based whiting and shore-based non-whiting sectors of the Pacific Coast groundfish limited entry trawl fishery would be managed as one sector under a system of IFQs, and the at-sea whiting sectors of the fishery would be managed under a system of sector-specific harvesting cooperatives (coops). Anticipated Cost and Benefits: The RIR/IRFA reviewed and summarized the benefits and costs, and the economic effects of the Council's recommendations. The major conclusions of the economic model suggest that (with landings held at 2004 levels), the current groundfish fleet (non-whiting component), which consisted of 117 vessels in 2004, will be reduced by roughly 50 percent to 66 percent, or 40 to 60 vessels under an IFQ program. The reduction in fleet size implies cost savings of $18 to $22 million for the year 2004 (most recent year of the data). Vessels that remain active will, on average, be more cost efficient and will benefit from economies of scale that are currently unexploited under controlled access regulations in the fishery. The cost savings estimates are significant, amounting to approximately half of the costs incurred currently, suggesting that IFQ management may be an attractive option for the Pacific Coast Groundfish Fishery. The increase in profits that commercial harvesters are expected to experience under the preferred alternative may render them better able to sustain the costs of complying with the new reporting and monitoring requirements. The costs of at-sea observers may reduce profits by about $2.2 million, depending on the fee structure. However, the profits earned by the non-whiting sector would still be substantially higher under the preferred alternative than under the no action alternative. Risks: Under the no action alternative, cumulative landing limits for target species have to be set lower because the bycatch of overfished species cannot be directly controlled. Introducing accountability at the individual vessel level by means of IFQs provides a strong incentive for bycatch avoidance. There will likely be a lower motivation to ``race for fish'' due to coop harvest privileges. This is expected to result in improved product quality, slower-paced harvest activity, increased yield (which should increase ex-vessel prices), and enhanced flexibility and ability for business planning. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Notice of Availability 05/12/10 75 FR 26702 First Proposed Rule 06/10/10 75 FR 32994 First Proposed Rule Correction 06/30/10 75 FR 37744 First Proposed Rule Comment Period End 07/12/10 Second Proposed Rule 08/31/10 75 FR 53379 Second Proposed Rule Comment Period End 09/30/10 First Final Rule 10/01/10 75 FR 60868 Second Final Rule 12/00/10 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Barry Thom Regional Administrator, Northwest Region, NMFS Department of Commerce National Oceanic and Atmospheric Administration Building 1, 7600 Sand Point Way NE. Seattle, WA 48115-0070 Phone: 206 526-6150 Fax: 206 526-6426 Email: barry.thom@noaa.gov Related RIN: Related to 0648-AX98 RIN: 0648-AY68 BILLING CODE 3510-12-S [[Page 79504]] <###doc> DEPARTMENT OF DEFENSE (DOD) <###doc> Statement of Regulatory Priorities Background The Department of Defense (DoD) is the largest Federal department consisting of 3 Military departments (Army, Navy, and Air Force), 10 Unified Combatant Commands, 14 Defense agencies, and 10 DoD Field Activities. It has 1,434,761 military personnel and 770,569 civilians assigned as of June 30, 2010, and over 200 large and medium installations in the continental United States, U. S. territories, and foreign countries. The overall size, composition, and dispersion of DoD, coupled with an innovative regulatory program, presents a challenge to the management of the Defense regulatory efforts under Executive Order 12866 ``Regulatory Planning and Review'' of September 30, 1993. Because of its diversified nature, DoD is affected by the regulations issued by regulatory agencies such as the Departments of Energy, Health and Human Services, Housing and Urban Development, Labor, Transportation, Treasury, Commerce, and State, and the Office of Personnel Management, General Services Administration, and Environmental Protection Agency. In order to develop the best possible regulations that embody the principles and objectives embedded in Executive Order 12866, there must be coordination of proposed regulations among the regulatory agencies and the affected DoD components. Coordinating the proposed regulations in advance throughout an organization as large as DoD is straightforward, yet a formidable undertaking. DoD is not a regulatory agency, but occasionally it issues regulations that have an effect on the public. These regulations, while small in number compared to the regulating agencies, can be significant as defined in Executive Order 12866. In addition, some of DoD's regulations may affect the regulatory agencies. DoD, as an integral part of its program, not only receives coordinating actions from the regulating agencies, but coordinates with the agencies that are affected by its regulations as well. Overall Priorities The Department needs to function at a reasonable cost, while ensuring that it does not impose ineffective and unnecessarily burdensome regulations on the public. The rulemaking process should be responsive, efficient, cost-effective, and both fair and perceived as fair. This is being done in DoD while reacting to the contradictory pressures of providing more services with fewer resources. The Department of Defense, as a matter of overall priority for its regulatory program, fully incorporates the provisions of the President's priorities and objectives under Executive Order 12866. The Department also participates with GSA, NASA, and OFPP to form the Federal Acquisition Regulatory Council. The FAR Council assists in the direction and coordination of Government wide procurement policy and Government wide procurement regulator activities in the Federal Government (41 U.S.C. 421). Together, DOD, GSA, and NASA jointly issue and maintain the Federal Acquisition Regulation. Administration Priorities: 1. Rulemakings that promote open Government and that use disclosure as a regulatory tool. The Department plans to: Revise the Federal Acquisition Regulation (FAR) to inform contractors of this statutory requirement to make Federal Awardee Performance and Integrity Information System information, excluding past performance reviews, available to the public; Finalize the FAR rule that implements the requirement for reporting first-tier subcontracting data for new contracts using Recovery Act funds; and Finalize the FAR rule that implements the Federal Funding Accountability and Transparency Act of 2006, which requires the Office of Management and Budget (OMB) to establish a free, public, website containing full disclosure of all Federal contract award information. This rule requires contractors to report executive compensation and first-tier subcontractor awards on unclassified contracts expected to be $25,000 or more, except contracts with individuals. 2. Rulemakings that simplify or streamline regulations and reduce or eliminate unjustified burdens. The Department plans to: Revise the FAR to delete part 2 of the SF 330, which collects general qualifications data not related to a particular planned contract action. The Online Representations and Certifications Application (ORCA) now collects this data centrally from interested Architect-Engineer vendors at the time they complete the other representations and certifications in ORCA; Revise the FAR to incorporate changes from a final Department of Labor rule that removes the requirement to submit complete social security numbers and home addresses of individual workers in weekly payroll submissions. Removal of this personal information from payroll records avoids unnecessary disclosure issues; Finalize the revision of DFARS requirements for reporting the loss, theft, damage, or destruction of Government property; Review of the DFARS requirements for reporting Government Furnished Equipment and Government Furnished Material in the DoD Item Unique Identification (IUID) registry; Remove the DFARS requirement to use DD Forms 2626 and 2631 to report past performance information for construction and architect/engineer services instead of the standard FAR procedures; Revise the DFARS to permit offerors to provide alternative line-item structure from that shown in the solicitation to reflect the offeror's business practices for selling and billing commercial items and initial provisioning spares for weapon systems; Delete redundant DFARS text that limits placement of orders against contracts with contractors that have been debarred suspended or proposed for debarment. This requirement is now incorporated into the FAR; Propose changes to simplify and clarify the DFARS coverage of patents, data, and copyrights, dramatically reducing the amount of regulatory text and the number of required clauses; Simplify and clarify the DFARS coverage of multiyear acquisitions; Establish a method in the DFARS for electronic issuance of orders; and Improve the contract closeout process. 3. Regulations of Particular Interest to Small Business Of interest to small businesses are regulations to: Implement in the FAR changes to the requirement for small disadvantaged businesses certification; Revise the FAR to implement changes in the HUBZone Program, in accordance with Small Business Administration regulations; [[Page 79505]] Consider revisions to the FAR to address the findings of the Rothe case that Federal contracting programs for minority- owned and other small businesses that implement 10 U.S.C. 2323 are ``facially'' unconstitutional; Establish a DoD program to enhance participation of Historically Black Colleges and Universities and Minority- Serving Institutions in defense research programs; Conform the DFARS to the FAR with respect to the use of the Electronic Subcontracting Reporting System; and Require public disclosure of justification and approval documents for noncompetitive 8(a) contracts over $20 million. 4. Regulations with international effects or interest Of international effect or interest are regulations to: Implement in the FAR statutory certification requirement that each offeror does not engage in any activity for which sanctions may be imposed under section 5 of the Iran Sanctions Act. Also implements a procurement prohibition relating to contracts with persons that export sensitive technology to Iran; Establish in the FAR processes and criteria for waiver of the prohibition on contracting with entities that conduct restricted business operations in Sudan; Implement in the DFARS the determinations regarding participation of South Caucasus/Central and South Asian states in acquisitions in support of operations in Afghanistan; Finalize the FAR rule that prohibits Government contracts with any foreign incorporated entity that is treated as an inverted domestic corporation under section 835(b) of the Homeland Security Act of 2002 or any subsidiary of such entity; Implement in the FAR and DFARS the annual consolidated appropriation act exemption from the Buy American Act/ Balance of Payments Program restrictions on the acquisition of foreign commercial information technology items as construction material; and Finalize in the FAR and DFARS the rules that increase trade agreements thresholds, as specified by the United States Trade Representative. Specific DoD Priorities: For this Regulatory Plan, there are seven specific DoD priorities, all of which reflect the established regulatory principles. In those areas where rulemaking or participation in the regulatory process is required, DoD has studied and developed policy and regulations that incorporate the provisions of the President's priorities and objectives under the Executive order. DoD has focused its regulatory resources on the most serious environmental, health, and safety risks. Perhaps most significant is that each of the priorities described below promulgates regulations to offset the resource impacts of Federal decisions on the public or to improve the quality of public life, such as those regulations concerning acquisition, security, homeowners, education, and health affairs. 1. Regulatory Program of the U.S. Army Corps of Engineers In 1988, the Army Corps of Engineers published as appendix B of 33 CFR part 325, a rule that governs compliance with the National Environmental Policy Act (NEPA) for the Army's Regulatory Program. On April 2, 2010, the Assistant Secretary of the Army for Civil Works announced that the Army Corps of Engineers would conduct rulemaking to modify appendix B to reflect a limited change in policy addressing permit applications for surface coal mining activities in Appalachia. The modification of appendix B will focus on the NEPA scope of review for considering the effects of surface coal mining in Appalachia on the aquatic environment, to enhance protection of aquatic resources. 2. Defense Procurement and Acquisition Policy The Department of Defense continuously reviews the DFARS and continues to lead Government efforts to: Revise the DFARS to implement the Weapons System Acquisition Reform Act of 2009 - including acquisition strategies to ensure competition throughout life-cycle of major defense acquisition programs and address organizational conflicts of interest in major defense acquisition programs; Revise DFARS to ensure continuation of contractor services in support of mission essential functions during an emergency, such as an influenza pandemic; Clarify DoD policy in the DFARS regarding the definition and administration of contractor business systems to improve the effectiveness of DCMA/DCAA oversight of contractor business systems; Implement in the DFARS statutory requirement to inspect military facilities, infrastructure, and equipment for safety and habitability prior to use; Revise the FAR to implement the Executive orders relating to allowability of labor relations costs, non-displacement of qualified workers, notification of employee rights under Federal labor laws, and Federal leadership in environmental, energy, and economic performance; Revise the FAR to adopt biobased procurement preferences and collect contractor information on use of biobased products; Revise the FAR to address service contractor employee personal conflicts of interest and organizational conflicts of interest and limit contractor access to information; and Provide enhanced competition for task- and delivery-order contracts and additional market research before awarding a task or delivery order in excess of the simplified acquisition threshold. 3. Logistics and Materiel Readiness, Department of Defense The Department of Defense published or plans to publish rules on contractors supporting the military in contingency operations: Final Rule: Private Security Contractors (PSCs) Operating in Contingency Operations. In order to meet the mandate of section 862 of the 2008 National Defense Authorization Act, this rule establishes policy, assigns responsibilities and provides procedures for the regulation of the selection, accountability, training, equipping, and conduct of personnel performing private security functions under a covered contract during contingency operations. It also assigns responsibilities and establishes procedures for incident reporting, use of and accountability for equipment, rules for the use of force, and a process for administrative action or the removal, as appropriate, of PSCs and PSC personnel. DoD published an interim final rule on July 17, 2009 (74 FR 34690 to 34694) with an effective date of July 17, 2009. The comment period ended August 31, 2009. DoD, in coordination with the Department of State and the United States Agency [[Page 79506]] for International Development, have prepared a final rule, which includes the responses to the public comments, and incorporates changes to the interim final rule, where appropriate. The final rule is expected to be published the first or second quarter of FY 2011. Interim Final Rule: Operational Contract Support for Contingency Operations. This rule will incorporate the latest changes and lessons learned into policy and procedures for program management for the preparation and execution of contracted support and the integration of DoD contractor personnel into military contingency operations outside the United States. DoD anticipates publishing the interim final rule in the first or second quarter of FY 2011. 4. Installations and Environment, Department of Defense The Department of Defense published a rule to assist eligible military and civilian Federal employee homeowners: Final Rule: This rule authorizes the Homeowners Assistance Program (HAP) under section 3374 of title 42, United States Code, to assist eligible military and civilian Federal employee homeowners when the real estate market is adversely affected by closure or reduction-in-scope of operations. In accordance with DoD Directive 5101.1, ``DoD Executive Agent,'' designates the Secretary of the Army as the DoD Executive Agent for administering, managing, and executing the HAP. Additionally, this rule allows the Department of Defense to temporarily expand the existing HAP in compliance with section 1001 of the American Recovery and Reinvestment Act of 2009. This temporary expansion covers certain persons affected by BRAC 2005, certain persons on permanent change of station orders, and certain wounded persons and surviving spouses. This rule updates policy, delegates authority, and assigns responsibilities for managing Expanded HAP. This is an economically significant rule. DoD published an interim final rule on September 30, 2009 (74 FR 50109-50115), with an effective date of September 30, 2009. The comment period ended October 30, 2009. The final rule published November 16, 2010 (75 FR 69871) with an effective date of January 18, 2011. 5. Military Personnel Policy, Department of Defense The Department of Defense published or plans to publish a rule implementing the Post-9/11 Veterans Educational Assistance Act of 2008, title V, Public Law 110-252 (the ``Post-9/11 GI Bill''): Interim Final Rule: This rule establishes policy, assigns responsibilities, and prescribes procedures for carrying out the Post-9/11 GI Bill. It establishes policy for the use of supplemental educational assistance ``kickers,'' for members with critical skills or specialties, or for members serving additional service; for authorizing the transferability of education benefits; and for the DoD Education Benefits Fund Board of Actuaries. DoD published an interim final rule on June 25, 2009 (74 FR 30212 to 30220) with an effective date of June 25, 2009. The comment period ended July 27, 2009. DoD anticipates finalizing this rule in the spring of 2011. 6. Military Community and Family Policy, Department of Defense The Department of Defense published or plans to publish a rule to implement policy, assign responsibilities, and prescribe procedures for the operation of voluntary education programs within DoD. Proposed Rule: This rule implements policy, assigns responsibilities, and prescribes procedures for the operation of voluntary education programs within DoD. Included are: Procedures for Service members participating in education programs; guidelines for establishing, maintaining, and operating voluntary education programs; procedures for obtaining on-base voluntary education programs and services; minimum criteria for selecting institutions to deliver higher education programs and services on military installations; and the Memorandum of Understanding between educational institutions and DoD prior to the disbursement of tuition assistance funds. This is an economically significant rule. The proposed rule published August 6, 2010 (75 FR 47504-47515). The comment period ends October 5, 2010. DoD anticipates finalizing this rule in the spring or fall of FY 2011. 7. Health Affairs, Department of Defense The Department of Defense is able to meet its dual mission of wartime readiness and peacetime health care by operating an extensive network of medical treatment facilities. This network includes DoD's own military treatment facilities supplemented by civilian health care providers, facilities, and services under contract to DoD through the TRICARE program. TRICARE is a major health care program designed to improve the management and integration of DoD's health care delivery system. The program's goal is to increase access to health care services, improve health care quality, and control health care costs. The TRICARE Management Activity has published or plans to publish the following rules: Final rule on CHAMPUS/TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals. This rule provided an additional opportunity for comment on the final rule of March 17, 2009, implementing provisions of section 703 of the National Defense Authorization Act for Fiscal Year 2008. This statute extended pharmaceutical Federal Ceiling Prices to TRICARE Retail Pharmacy Program prescriptions. The Department of Defense (DoD) issued a final rule on March 17, 2009, implementing the law. On November 30, 2009, the U.S. District Court for the District of Columbia ``ordered that the final rule is remanded without vacatur for the Defense Department to consider in its discretion whether to readopt the current iteration of the rule or adopt another approach to implement 10 U.S.C. 1074g(f).'' As part of DoD's reconsideration, DoD solicited public comments on the implementation of the statute, DoD's resulting regulations, and the matters addressed for DoD's consideration in the Court's Memorandum Opinion. The proposed rule was published February 9, 2010 (75 FR 6335- 6336). The comment period ended on March 11, 2010. DoD anticipates publishing a second final rule in the first quarter of FY 2011. Final rule on TRICARE: Relationship Between the TRICARE Program and Employer-Sponsored Group Health Coverage. This rule implements section 1097c of title 10, United States Code. This law prohibits employers from offering incentives to TRICARE-eligible employees to not enroll, or to terminate enrollment, in an employer-offered Group Health Plan (GHP) that is or would be primary to TRICARE. Cafeteria plans that comport with section 125 of the Internal Revenue Code will be permissible so long as the plan treats all employees the same and does not illegally take TRICARE eligibility into account. The proposed rule was published March 28, 2008 [[Page 79507]] (73 FR 16612). The comment period ended May 27, 2008. The final rule published April 9, 2010 (75 FR 18051 to 18055) with an effective date of June 18, 2010. Proposed rule on TRICARE: Sole Community Hospital Payment Reform. This rule implements the statutory provision in section 1079(j)(2) of title 10, United States Code that TRICARE payment methods for institutional care shall be determined to the extent practicable in accordance with the same reimbursement rules as those that apply to payments to providers of services of the same type under Medicare. This proposed rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for services provided by sole community hospitals. DoD anticipates publishing a proposed rule in the first or second quarter of FY 2011. Proposed rule on TRICARE: Long Term Care Hospital Prospective Payment System. This rule adopts a reimbursement methodology for Long Term Care Hospitals similar to Medicare's Long Term Care Hospital Prospective Payment System. DoD anticipates publishing a proposed rule in the spring of FY 2011. 8. Networks and Information Integration, Department of Defense The Department of Defense will publish a rule regarding Defense Industrial Base Voluntary Cyber Security and Information Assurance Information Sharing: Interim Final Rule: This rule establishes cyber threat information sharing, reporting, and analysis mechanisms between DoD and cleared Defense Industrial Base (DIB) contractors to enhance cyber threat situational awareness and threat response. The rule establishes a voluntary information sharing environment with DIB partners to address the unacceptable risk and imminent threat to national and economic security stemming from the unauthorized access by U.S. adversaries or business competitors to critical DoD unclassified information resident on, or transiting, DIB unclassified networks. The rule describes the collaborative DoD and DIB corporate- level partnership to enhance security of DIB networks; increase USG and industry knowledge of advanced cyber threats; provide near-real time cyber threat information sharing and understand the impact of data compromise on DoD operational activities. Participation in the DIB Cyber Security/Information Assurance program is voluntary and open to all qualified cleared contractors. DoD anticipates publishing an interim final rule in the second quarter of FY 2011. _______________________________________________________________________ <###doc> DOD--Office of the Secretary (OS) ----------- FINAL RULE STAGE ----------- <###doc> 31. VOLUNTARY EDUCATION PROGRAMS Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 10 USC 2005; 10 USC 2007 CFR Citation: 32 CFR 68 Legal Deadline: None Abstract: This rule implements policy, assigns responsibilities, and prescribes procedures for the operation of voluntary education programs within DoD. Included are: Procedures for Service members participating in education programs; guidelines for establishing, maintaining, and operating voluntary education programs, including but not limited to, instructor-led courses offered on-installation and off-installation, as well as via distance learning; procedures for obtaining on-base voluntary education programs and services; minimum criteria for selecting institutions to deliver higher education programs and services on military installations; the establishment of a DoD Voluntary Education Partnership Memorandum of Understanding between DoD and educational institutions receiving tuition assistance payments; and procedures for other education programs for Service members and their adult family members. Statement of Need: This rule implements policy, assigns responsibilities, and prescribes procedures for the operation of voluntary education programs within DoD. Included are: Procedures for Service members participating in education programs; guidelines for establishing, maintaining, and operating voluntary education programs, including but not limited to, instructor-led courses offered on-installation and off-installation, as well as via distance learning; procedures for obtaining on-base voluntary education programs and services; minimum criteria for selecting institutions to deliver higher education programs and services on military installations; the establishment of a DoD Voluntary Education Partnership Memorandum of Understanding between DoD and educational institutions receiving tuition assistance payments; and procedures for other education programs for Service members and their adult family members. Summary of Legal Basis: sections 2005 and 2007 of title 10, United States Code Alternatives: None. Anticipated Cost and Benefits: Voluntary Education Programs include: High School Completion /Diploma; Military Tuition Assistance (TA); Postsecondary Degree Programs; Independent Study and Distance Learning Programs; College Credit Examination Program; Academic Skills Program; and Certification/ Licensure Programs. Funding for Voluntary Education Programs during 2009 was $800 million, which included tuition assistance and operational costs. This funding provided more than 650,000 individuals (Service members and their adult family members) the opportunity to participate in Voluntary Education Programs around the world. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 08/06/10 75 FR 47504 NPRM Comment Period End 10/05/10 Final Action 04/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None [[Page 79508]] Agency Contact: Kerrie Tucker Department of Defense Office of the Secretary Defense Pentagon Washington, DC 20301 Phone: 703 602-4949 RIN: 0790-AI50 _______________________________________________________________________ <###doc> DOD--Office of Assistant Secretary for Health Affairs (DODOASHA) ----------- PROPOSED RULE STAGE ----------- <###doc> 32. TRICARE; REIMBURSEMENT OF SOLE COMMUNITY HOSPITALS Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 5 USC 301; 10 USC ch 55 CFR Citation: 32 CFR 199 Legal Deadline: None Abstract: This proposed rule is to implement the statutory provision at 10 U.S.C. 1079(j)(2) that TRICARE payment methods for institutional care be determined, to the extent practicable, in accordance with the same reimbursement rules as those that apply to payments to providers of services of the same type under Medicare. This proposed rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for inpatient services provided by Sole Community Hospitals (SCHs). It will be phased in over a several-year period. Statement of Need: This rule is being published to implement the statutory provision in 10 U.S.C. 1079(j)(2), that TRICARE payment methods for institutional care be determined, to the extent practicable, in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under Medicare. This proposed rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for inpatient services provided by Sole Community Hospitals. Summary of Legal Basis: There is a statutory basis for this proposed rule: 10 U.S.C. 1079(j)(2). Alternatives: Alternatives were considered for phasing in the needed reform and an alternative was selected for a gradual, smooth transition. Anticipated Cost and Benefits: We estimate the total reduction (from the proposed changes in this rule) in hospital revenues under the SCH reform for its first year of implementation (assumed for purposes of this RIA to be FY 2011), compared to expenditures in that same period without the proposed SCH changes, to be approximately $190 million. The estimated impact for FYs 2012 through 2015 (in $ millions) is $208, $229, $252, and $278 respectively. Risks: Failure to publish this proposed rule would result in noncompliance with a statutory provision. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 12/00/10 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Marty Maxey Department of Defense Office of Assistant Secretary for Health Affairs 1200 Defense Pentagon Washington, DC 20301 Phone: 303 676-3627 RIN: 0720-AB41 BILLING CODE 5001-06-S [[Page 79509]] <###doc> DEPARTMENT OF EDUCATION (ED) <###doc> Statement of Regulatory Priorities I. Introduction The U.S. Department of Education (Department) supports States, local communities, institutions of higher education, and others in improving education nationwide and in helping to ensure that all Americans receive a quality education. We provide leadership and financial assistance for education at all levels to a wide range of stakeholders and individuals, including State educational agencies, local school districts, early learning programs, elementary and secondary schools, institutions of higher education, vocational schools, not-for-profit organizations, members of the public, and many others. These efforts are helping to ensure that all students will be ready for college and careers, and that all students have the opportunity to attend postsecondary education. We also vigorously monitor and enforce the implementation of Federal civil rights laws in educational programs and activities that receive Federal financial assistance, and support innovation and research, evaluation, technical assistance, and dissemination of research findings to improve the quality of education. Overall, the programs we administer will affect nearly every American during his or her life. Indeed, in the 2010 to 2011 school year, more than 1.5 million children, ages birth through 5 years, will participate in early learning programs under the Individuals with Disabilities Education Act (IDEA) and title I of the Elementary and Secondary Education Act of 1965, as amended (ESEA); about 50 million students will attend an estimated 99,000 elementary and secondary schools in approximately 13,800 public school districts; and about 20 million students will enroll in degree-granting postsecondary schools. All of these students may benefit from some degree of financial assistance or support from the Department. In developing and implementing regulations, guidance, technical assistance, and approaches to compliance related to our programs, we are committed to working closely with affected persons and groups. Specifically, we work with a broad range of interested parties and the general public, including parents, students, and educators; other Federal agencies and State, local, and tribal governments; and neighborhood groups, schools, colleges, rehabilitation service providers, professional associations, advocacy organizations, community-based organizations, businesses, and labor organizations. We also continue to seek greater and more useful public participation in our rulemaking activities through the use of transparent and interactive rulemaking procedures and new technologies. If we determine that it is necessary to develop regulations, we seek public participation at the key stages in the rulemaking process. We invite the public to submit comments on all proposed regulations through the Internet or by regular mail. To facilitate the public's involvement, we participate in the Federal Docketing Management System (FDMS), an electronic single Governmentwide access point (www.regulations.gov) that enables the public to submit comments on different types of Federal regulatory documents and read and respond to comments submitted by other members of the public during the public comment period. This system provides the public the opportunity to submit a comment electronically on any notice of proposed rulemaking or interim final regulations open for comment, as well as read and print any supporting regulatory documents. We are continuing to streamline information collections, reduce the burden on information providers involved in our programs, and make information easily accessible to the public. II. Regulatory Priorities A. American Recovery and Reinvestment Act of 2009 On February 17, 2009, President Obama signed into law the American Recovery and Reinvestment Act of 2009 (ARRA), historic legislation designed to stimulate the economy, support job creation, and invest in critical sectors, including education. The ARRA lays the foundation for education reform by supporting investments in innovative strategies that are most likely to lead to improved results for children and youth, long-term gains in school and school system capacity, and increased productivity and effectiveness. The ARRA provided funding for several key discretionary grant programs, including the Race to the Top Fund and the Investing in Innovation Fund. The Department issued regulations for these programs in 2009 and 2010. To the extent Congress reauthorizes and appropriates funds for these programs in FY 2011, we may need to amend the regulations for these programs. B. Elementary and Secondary Education Act of 1965, as Amended On March 13, 2010, the Obama administration released the Blueprint for Reform: The Reauthorization of the Elementary and Secondary Education Act, the President's plan for revising the ESEA. The blueprint can be found at the following Web site: http://www2.ed.gov/policy/elsec/leg/ blueprint/index.html. We look forward to congressional reauthorization of the ESEA that will build on many of the reforms States and LEAs will be implementing under the ARRA grant programs described in this statement of regulatory priorities. As necessary, we intend to amend current regulations to reflect the reauthorization of this statute. In the interim, we may propose other amendments to the current regulations. C. Higher Education Act of 1965, as Amended In early 2011, the Department plans to issue final regulations to establish measures for determining whether certain postsecondary educational programs lead to gainful employment in a recognized occupation. These regulations also address the conditions under which these educational programs remain eligible for the student financial assistance programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA). On March 30, 2010, the President signed into law the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, title II of which is the SAFRA Act. SAFRA made a number of changes to the Federal student financial aid programs under title IV of the HEA. One of the most significant changes made by SAFRA is to end new loans under the Federal Family Education Loan (FFEL) Program authorized by title IV, part B, of the HEA as of July 1, 2010. During the coming year, we plan to amend our regulations to address issues related to the termination of the FFEL Program and the Department's origination of all new loans under the William D. Ford Direct Loan Program, as well as other statutory provisions enacted under SAFRA. Unless subject to an exemption, regulations to reflect changes to the student financial aid programs under title IV of the HEA must [[Page 79510]] generally go through the negotiated rulemaking process. D. Individuals with Disabilities Education Act We plan to issue final regulations implementing changes to the part C program--the early intervention program for infants and toddlers with disabilities--under the IDEA. E. Family Educational Rights and Privacy Act Given the President's emphasis on improving the collection and use of data as a key element of educational reform, we intend to issue a notice of proposed rulemaking to amend our current regulations for the Family Educational Rights and Privacy Act of 1974 (FERPA) to ensure that States are able to effectively establish and expand robust statewide longitudinal data systems while protecting student privacy. F. Other Potential Regulatory Activities Congress may legislate to reauthorize the Adult Education and Family Literacy Act (AEFLA) (title II of the Workforce Investment Act of 1998) and the Rehabilitation Act of 1973, as amended. The Administration is working with Congress to ensure that any changes to these laws (1) improve the State grant and other programs providing assistance for adult basic education under the AEFLA and for vocational rehabilitation and independent living services for persons with disabilities under the Rehabilitation Act of 1973 and (2) provide greater accountability in the administration of programs under both statutes. Changes to our regulations may be necessary as a result of the reauthorization of these two statutes. III. Principles for Regulating Over the next year, other regulations may be needed because of new legislation or programmatic changes. In developing and promulgating regulations, we follow our Principles for Regulating, which determine when and how we will regulate. Through consistent application of the following principles, we have eliminated unnecessary regulations and identified situations in which major programs could be implemented without regulations or with limited regulatory action. In deciding when to regulate, we consider the following: Whether regulations are essential to promote quality and equality of opportunity in education. Whether a demonstrated problem cannot be resolved without regulation. Whether regulations are necessary to provide a legally binding interpretation to resolve ambiguity. Whether entities or situations subject to regulation are so diverse that a uniform approach through regulation does more harm than good. Whether regulations are needed to protect the Federal interest; that is, to ensure that Federal funds are used for their intended purpose and to eliminate fraud, waste, and abuse. In deciding how to regulate, we are mindful of the following principles: Regulate no more than necessary. Minimize burden to the extent possible and promote multiple approaches to meeting statutory requirements if possible. Encourage coordination of federally funded activities with State and local reform activities. Ensure that the benefits justify the costs of regulation. To the extent possible, establish performance objectives rather than specify compliance behavior. Encourage flexibility, to the extent possible, so institutional forces and incentives achieve desired results. _______________________________________________________________________ <###doc> ED--Office of Postsecondary Education (OPE) ----------- PROPOSED RULE STAGE ----------- <###doc> 33. TITLE IV OF THE HIGHER EDUCATION ACT OF 1965, AS AMENDED Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 20 USC title IV; PL 111-152 CFR Citation: 34 CFR ch VI Legal Deadline: None Abstract: The Secretary proposes to amend its title IV, HEA student assistance regulations, to (1) reflect the termination of the Federal Family Education Loan Program pursuant to title II of the Health Care and Education Reconciliation Act of 2010, which is the SAFRA Act, and (2) reflect other statutory changes resulting from the SAFRA Act. Statement of Need: These regulations are needed to reflect the provisions of the SAFRA Act (title II of the Health Care and Education Reconciliation Act of 2010), which terminated the Federal Family Education Loan (FFEL) program, and to reflect other amendments to the HEA resulting from the SAFRA Act. Summary of Legal Basis: Health Care and Education Reconciliation Act of 2010, Public Law 111- 152. Alternatives: The Department is still developing these proposed regulations; our discussion of alternatives will be included in the notice of proposed rulemaking. Anticipated Cost and Benefits: Estimates of the costs and benefits are currently under development and will be published in the proposed regulations. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 05/00/11 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None URL For Public Comments: www.regulations.gov Agency Contact: David Bergeron Department of Education Office of Postsecondary Education Room 8022 1990 K Street NW. Washington, DC 20006 Phone: 202 502-7815 Email: david.bergeron@ed.gov RIN: 1840-AD05 [[Page 79511]] _______________________________________________________________________ <###doc> ED--OPE ----------- FINAL RULE STAGE ----------- <###doc> 34. PROGRAM INTEGRITY: GAINFUL EMPLOYMENT--MEASURES Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 20 USC 1001 to 1003; 20 USC 1070g; 20 USC 1085; 20 USC 1088; 20 USC 1091 to 1092; 20 USC 1094; 20 USC 1099c; 20 USC 1099c-1; . . . CFR Citation: 34 CFR 668 Legal Deadline: None Abstract: The Secretary amends the Student Assistance General Provisions to establish measures for determining whether certain postsecondary educational programs lead to gainful employment in recognized occupations, and the conditions under which those educational programs remain eligible for the student financial assistance programs authorized under title IV of the Higher Education Act of 1965, as amended. Statement of Need: These regulations are needed to establish measures for determining whether certain postsecondary educational programs lead to gainful employment in a recognized occupation. Summary of Legal Basis: Title IV of the Higher Education Act of 1965, as amended. Alternatives: A discussion of alternatives was outlined in the Notice of Proposed Rulemaking published on July 26, 2010. Anticipated Cost and Benefits: Estimates of anticipated costs and benefits are set forth in the Notice of Proposed Rulemaking published on July 26, 2010. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 07/26/10 75 FR 43616 NPRM Comment Period End 09/09/10 Final Action 02/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: None URL For Public Comments: www.regulations.gov Agency Contact: John A. Kolotos Department of Education Office of Postsecondary Education Room 8018 1990 K Street NW. Washington, DC 20006-8502 Phone: 202 502-7762 Email: john.kolotos@ed.gov Fred Sellers Department of Education Office of Postsecondary Education Room 8021 1990 K Street NW. Washington, DC 20006 Phone: 202 502-7502 Email: fred.sellers@ed.gov Related RIN: Previously reported as 1840-AD04 RIN: 1840-AD06 BILLING CODE 4000-01-S [[Page 79512]] <###doc> DEPARTMENT OF ENERGY (DOE) <###doc> Statement of Regulatory and Deregulatory Priorities The Department of Energy (Department or DOE) makes vital contributions to the Nation's welfare through its activities focused on improving national security, energy supply, energy efficiency, environmental remediation, and energy research. The Department's mission is to: Promote dependable, affordable, and environmentally sound production and distribution of energy; Advance energy efficiency and conservation; Provide responsible stewardship of the Nation's nuclear weapons; Provide a responsible resolution to the environmental legacy of nuclear weapons production; Strengthen U.S. scientific discovery, economic competitiveness, and improving quality of life through innovations in science and technology. The Department's regulatory activities are essential to achieving its critical mission and to implementing major initiatives of the President's National Energy Policy. Among other things, The Regulatory Plan and the Unified Agenda contain the rulemakings the Department will be engaged in during the coming year to fulfill the Department's commitment to meeting deadlines for issuance of energy conservation standards and related test procedures. The Regulatory Plan and Unified Agenda also reflect the Department's continuing commitment to cut costs, reduce regulatory burden, and increase responsiveness to the public. Energy Efficiency Program for Consumer Products and Commercial Equipment The Energy Policy and Conservation Act (EPCA) requires DOE to set appliance efficiency standards at levels that achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. The standards already published in 2010 have a net benefit to the Nation of between $7.7 billion (7 percent discount rate) and 23.5 billion (3 percent discount rate) over 30 years. By 2045, these standards will have saved enough energy to operate all U.S. homes for 4 months. The Department continues to follow its schedule for setting new appliance efficiency standards. These rulemakings are expected to save American consumers billions of dollars in energy costs. The 5-year plan to implement the schedule outlines how DOE will address the appliance standards rulemaking backlog and meet the statutory requirements established in EPCA and the Energy Policy Act of 2005 (EPACT 2005). The 5-year plan, which was developed considering the public comments received on the appliance standards program, provides for the issuance of one rulemaking for each of the 22 products in the backlog. The plan also provides for setting appliance standards for products required under EPACT 2005. The overall plan for implementing the schedule is contained in the Report to Congress under section 141 of EPACT 2005 that was released on January 31, 2006. This plan was last updated in the August 2010 report to Congress and now includes the requirements of the Energy Independence and Security Act of 2007 (EISA 2007). The reports to Congress are posted at: http://www.eere.energy.gov/appliance_standards/schedule_setting.html. The August 2010 report identifies all products for which DOE has missed the deadlines established in EPCA (42 U.S.C. sec. 6291 et seq.). It also describes the reasons for such delays and the Department's plan for expeditiously prescribing new or amended standards. Information and timetables concerning these actions can also be found in the Department's regulatory agenda, which is posted online at: www.reginfo.gov. Estimate of Combined Aggregate Costs and Benefits The regulatory actions included in this regulatory plan for residential refrigerators and freezers, fluorescent lamp ballasts, residential central air conditioners and heat pumps, residential furnaces, manufactured housing, and clothes dryers and room air conditioners provide significant benefits to the Nation. DOE believes that the benefits to the Nation of the proposed energy standards for residential refrigerators and freezers (energy savings, consumer average life-cycle cost savings, national net present value increase, and emissions reductions) outweigh the costs (loss of industry net present value and life-cycle cost increases for some consumers). DOE estimates that these refrigerator and freezer regulations will produce an energy savings of 4.5 quads over 30 years. The benefit to the Nation will be between $2.44 billion (7 percent discount rate) and $18.57 billion (3 percent discount rate). DOE believes that the proposed energy standards for fluorescent lamp ballasts, central air conditioners and heat pumps, residential furnaces, manufactured housing, and clothes dryers and room air conditioners will also be beneficial to the Nation. Because DOE has not yet proposed candidate standard levels for this equipment, however, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that will provide the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment. _______________________________________________________________________ <###doc> DOE--Energy Efficiency and Renewable Energy (EE) ----------- PROPOSED RULE STAGE ----------- <###doc> 35. ENERGY EFFICIENCY STANDARDS FOR CLOTHES DRYERS AND ROOM AIR CONDITIONERS Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 42 USC 6295(c) and (g) CFR Citation: 10 CFR 430 Legal Deadline: Final, Judicial, June 30, 2011. Abstract: The Energy Policy and Conservation Act, as amended, establishes initial energy efficiency standard levels for many types of major residential appliances and generally requires DOE to undertake two subsequent rulemakings, at specified times, to determine whether the existing standard for a covered product should be amended. This is the second review of the standards for clothes dryers and room air conditioners. [[Page 79513]] Statement of Need: The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances from the market. Summary of Legal Basis: Title III of EPCA sets forth a variety of provisions designed to improve energy efficiency. Part A of title III (42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program for Consumer Products other than Automobiles. EPCA covers consumer products and certain commercial equipment, including clothes dryers and room are conditioners that are the subject of the rulemaking (42 U.S.C. 6292(a)(2)-(8)). EPCA prescribes energy conservation standards for room air conditioners (42 U.S.C. 6295(c)) and directs DOE to conduct two cycles of rulemaking to determine whether to adopt amended standards (42 U.S.C. 6295(c)(3)(A)). For clothes dryers, EPCA sets a prescriptive requirement (42 U.S.C. 6294(g)(3)) and directs DOE to conduct a cycle of rulemaking to determine whether to adopt amended standards (42 U.S.C. 6294(g)(4)). This rulemaking represents the second and first round of amendments to the standards for room air conditioners and dryers respectively. Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is a technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute. Anticipated Cost and Benefits: Because DOE has not yet proposed candidate standard levels for these products, DOE cannot provide an estimate of combine aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasibly and economically justified. Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Notice: Public Meeting, Framework Document Availability 10/09/07 72 FR 57254 Notice: Public Meeting, Data Availability 02/23/10 75 FR 7987 Comment Period End 04/26/10 NPRM 03/00/11 Final Action 06/00/11 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Local, State Federalism: Undetermined Additional Information: This rulemaking is the second of two rulemakings required for this equipment. Comments pertaining to this rule may be submitted electronically to aham2-2008-TP-0010@hq.doe.gov. URL For More Information: www1.eere.energy.gov/buildings--standards/residential/clothes-- dryers.html URL For Public Comments: www.regulations.gov Agency Contact: Stephen Witkowski Office of Building Technologies Program, EE-2J Department of Energy Energy Efficiency and Renewable Energy 1000 Independence Avenue SW. Washington, DC 20585 Phone: 202 586-7463 Email: stephen.witkowski@ee.doe.gov Related RIN: Merged with 1904-AB51, Related to 1904-AB76, Related to 1904-AC02 RIN: 1904-AA89 _______________________________________________________________________ <###doc> DOE--EE <###doc> 36. ENERGY EFFICIENCY STANDARDS FOR RESIDENTIAL CENTRAL AIR CONDITIONERS AND HEAT PUMPS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 42 USC 6295(d) CFR Citation: 10 CFR 430 Legal Deadline: Final, Judicial, June 30, 2011. Abstract: DOE is reviewing and updating energy efficiency standards, as required by the Energy Policy and Conservation Act, to reflect technological advances. All amended standards must be technologically feasible and economically justified. This is the second review of the statutory standards for residential central air conditioners and air conditioning heat pumps. Statement of Need: The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market. Summary of Legal Basis: Title III of EPCA sets forth a variety of provisions designed to improve energy efficiency. Part A of title III (42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program for Consumer Products other than Automobiles. Amendments expanded title III of EPCA to include certain commercial and industrial equipment. (42 U.S.C. 6292(3)) The National Appliance Energy Conservation Act of 1987 (NAECA), Pub. L. 100--12, established energy conservation standards for central air conditioners and heat pumps as well as requirements for determining whether these standards should be amended. NAECA also required that DOE conduct two cycles of rulemakings to determine if more stringent standards are economically justified and technologically feasible. (42 U.S.C. 6295(d)(3)) On January 22, 2001, DOE published a final rule in the Federal Register, which completed the first rulemaking cycle to amend energy conservation standards for residential central air conditioners and heat pumps. 66 FR 7170. This rulemaking encompasses DOE's second cycle of review to determine whether the standards in effect for residential central air conditioners and heat pumps should be amended. [[Page 79514]] Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute. Anticipated Cost and Benefits: Because DOE has not yet proposed candidate standard levels for this equipment, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Notice: Public Meeting, Framework Document Availability 06/06/08 73 FR 32243 Notice: Public Meetings, Data Availability 03/25/10 75 FR 14368 NPRM 12/00/10 Final Action 06/00/11 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State Federalism: Undetermined Additional Information: This rulemaking is the second of two rulemakings required for this equipment. Comments pertaining to this rule may be submitted electronically to Res_Central_AC_HP@ee.doe.gov. URL For More Information: www1.eere.energy.gov/buildings/appliance--standards/residential/ central--ac--hp.html URL For Public Comments: www.regulations.gov Agency Contact: Wes Anderson Mechanical Engineer, Office of Building Technologies Program, EE-2J Department of Energy Energy Efficiency and Renewable Energy 1000 Independence Avenue SW. Washington, DC 20585 Phone: 202 586-7335 Email: wes.anderson@ee.doe.gov Related RIN: Related to 1904-AB94 RIN: 1904-AB47 _______________________________________________________________________ <###doc> DOE--EE <###doc> 37. ENERGY EFFICIENCY STANDARDS FOR FLUORESCENT LAMP BALLASTS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 42 USC 6295(g) CFR Citation: 10 CFR 430 Legal Deadline: Final, Judicial, June 30, 2011. Abstract: DOE is reviewing and updating energy efficiency standards, as required by the Energy Policy and Conservation Act, to reflect technological advances. All amended energy efficiency standards must be technologically feasible and economically justified. This is the second review of the statutory standards for fluorescent lamp ballasts. Statement of Need: The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market. Summary of Legal Basis: The Energy Policy and Conservation Act (EPCA) of 1975 (42 U.S.C. 6291 to 6309) established an energy conservation program for major household appliances. Amendments to EPCA in the National Appliance Energy Conservation Amendments of 1988 (NAECA 1988) established energy conservation standards for fluorescent lamp ballasts. These amendments also required that DOE (1) conduct two rulemaking cycles to determine whether these standards should be amended and (2), for each rulemaking cycle, determine whether the standards in effect for fluorescent lamp ballasts should be amended to apply to additional fluorescent lamp ballasts. (42 U.S.C. 6295(g)(7)(A)--(B)). On September 19, 2000, DOE published a final rule in the Federal Register, which completed the first rulemaking cycle to amend energy conservation standards for fluorescent lamp ballasts. 65 FR 56740. This rulemaking encompasses DOE's second cycle of review to determine whether the standards in effect for fluorescent lamp ballasts should be amended and whether the standards should be applicable to additional fluorescent lamp ballasts. Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute. Anticipated Cost and Benefits: Because DOE has not yet proposed candidate standard levels for this equipment, however, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Notice: Public Meeting, Framework Document Availability 01/22/08 73 FR 3653 Notice: Public Meetings, Data Availability 03/24/10 75 FR 14319 NPRM 12/00/10 Final Action 06/00/11 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State [[Page 79515]] Federalism: Undetermined Additional Information: This rulemaking is the second of two rulemakings required for this equipment. Comments pertaining to this rule may be submitted electronically to ballasts.rulemaking@ee.doe.gov. URL For More Information: www1.eere.energy.gov/ buildings/appliance--standards/residential. fluorescent--lamp.ballasts.html URL For Public Comments: www.regulations.gov Agency Contact: Linda Graves Office of Building Technologies Program, EE-2J Department of Energy Energy Efficiency and Renewable Energy 1000 Independence Avenue SW. Washington, DC 20585 Phone: 202 586-1851 Email: linda.graves@ee.doe.gov Related RIN: Related to 1904-AB77, Related to 1904-AA99 RIN: 1904-AB50 _______________________________________________________________________ <###doc> DOE--EE <###doc> 38. ENERGY EFFICIENCY STANDARDS FOR RESIDENTIAL FURNACES Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 42 USC 6295(f) and (m) CFR Citation: 10 CFR 430 Legal Deadline: Final, Judicial, June 30, 2011. Abstract: DOE published an energy conservation standard final rule for residential furnaces and boilers in the Federal Register on November 19, 2007 (72 FR 65136). Petitioners challenged this final rule on several grounds. DOE filed a motion for voluntary remand to allow the agency to consider: 1) The application of regional standards in additional to national standards for furnaces, authorized by Energy Independence and Security Act of 2007 (enacted Dec. 19, 2007) and 2) the effect of alternative standards on natural gas prices. This motion for voluntary remand was granted on April 21, 2009. DOE has initiated this rulemaking to consider amended energy conservation standards for residential furnaces. Statement of Need: The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market. Summary of Legal Basis: Title III of EPCA sets forth a variety of provisions designed to improve energy efficiency. Part A of title III (42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program for Consumer Products other than Automobiles. The program covers certain commercial and industrial equipment, including residential furnaces. (42 U.S.C. 6292(a)(5)) EPCA prescribed the initial energy conservation standards for residential furnaces. (42 U.S.C. 6295(f)(1)--(2)) The statute further provides DOE with the authority to conduct rulemakings to determine whether to amend these standards. (42 U.S.C. 6295(f)(4)). Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute. Anticipated Cost and Benefits: Because DOE has not yet proposed candidate standard levels for this equipment, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Notice: Public Meeting, Rulemaking Analysis Plan Availability 03/15/10 75 FR 12144 NPRM 12/00/10 Final Action 06/00/11 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: Undetermined URL For More Information: http://www1.eere.energy.gov/buildings/appliance--standards/residential/ furnaces--boilers.html URL For Public Comments: www.regulations.gov Agency Contact: Mohammed Khan Office of Building Technologies Program, EE-2J Department of Energy Energy Efficiency and Renewable Energy 1000 Independence Avenue SW. Washington, DC 20585 Phone: 202 586-7892 Email: mohammed.khan@ee.doe.gov RIN: 1904-AC06 _______________________________________________________________________ <###doc> DOE--EE <###doc> 39. ENERGY EFFICIENCY STANDARDS FOR MANUFACTURED HOUSING Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 42 USC 17071 CFR Citation: 10 CFR 460 Legal Deadline: Final, Statutory, December 19, 2011. Abstract: The rule would establish energy efficiency standards for manufactured housing and a system to ensure compliance with, and enforcement of, the standards. [[Page 79516]] Statement of Need: The Energy Independence and Security Act requires increased energy efficiency standards for manufactured housing. Summary of Legal Basis: Section 413 of the Energy Independence and Security Act of 2007 (EISA), 42 U.S.C. 17071 directs DOE to develop and publish energy standards for manufactured housing. Alternatives: The statute requires DOE to conduct a rulemaking to establish standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute. Anticipated Cost and Benefits: Because DOE has not yet proposed candidate standard levels, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the increased energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ ANPRM 02/22/10 75 FR 7556 ANPRM Comment Period End 03/24/10 NPRM 04/00/11 Final Action 12/00/11 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None URL For Public Comments: www.regulations.gov Agency Contact: Jean J. Boulin Project Manager, Office of Building Technologies Program, EE-2J Department of Energy Energy Efficiency and Renewable Energy 1000 Independence Avenue SW. Washington, DC 20585 Phone: 202 586-9870 Email: jean.boulin@ee.doe.gov RIN: 1904-AC11 _______________________________________________________________________ <###doc> DOE--EE ----------- FINAL RULE STAGE ----------- <###doc> 40. ENERGY EFFICIENCY STANDARDS FOR RESIDENTIAL REFRIGERATORS, REFRIGERATOR-FREEZERS, AND FREEZERS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: 42 USC 6295(b)(4) CFR Citation: 10 CFR 430 Legal Deadline: Final, Statutory, December 31, 2010. Abstract: The Energy Independence and Security Act of 2007 amended the Energy Policy and Conservation Act and directed the Secretary to issue a final rule to determine whether to amend the standards for refrigerators, refrigerator-freezers, and freezers. The final rule will contain any amended standards. Statement of Need: The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market. Summary of Legal Basis: Title III of EPCA sets forth a variety of provisions designed to improve energy efficiency. Part A of title III (42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program for Consumer Products other than Automobiles. EPCA covers consumer products and certain commercial equipment, including the types of refrigeration products that are the subject of this rulemaking. (42 U.S.C. 6292(a)(1)) EPCA prescribes energy conservation standards for these products (42 U.S.C. 6295(b)(1)-(2)) and directs DOE to conduct three cycles of rulemakings to determine whether to adopt amended standards. (42 U.S.C. 6295(b)(3)(A)(i), (b)(3)(B)-(C), and (b)(4)) This rulemaking represents the third round of amendments to the standards for refrigeration products. Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute Anticipated Cost and Benefits: DOE believes that the benefits to the Nation of the proposed energy standards for residential refrigerators and freezers (energy savings, consumer average lifecycle cost (LCC) savings, national net present value (NPV) increase, and emission reductions) outweigh the burdens (loss of INPV and LCC increases for some small electric motor users). DOE estimates that energy savings from electricity will be 4.5 quads over 30 years and the benefit to the Nation will be between $2.56 billion and $18.80 billion. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Notice: Public Meeting, Framework Document Availability 09/18/08 73 FR 54089 Notice: Public Meeting, Data Availability 11/16/09 74 FR 58915 NPRM 09/27/10 75 FR 59470 NPRM Comment Period End 11/26/10 Final Action 12/00/10 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State [[Page 79517]] Federalism: This action may have federalism implications as defined in EO 13132. Additional Information: Comments pertaining to this rule may be submitted electronically to ResRefFreez-2008-STD-0012@hq.doe.gov. URL For More Information: www.eere.energy.gov/buildings/appliance_standards/residential/ refrigerators_freezer.html URL For Public Comments: www.regulations.gov Agency Contact: Subid Wagley Office of Building Technologies Program, EE-2J Department of Energy Energy Efficiency and Renewable Energy 1000 Independence Avenue SW. Washington, DC 20585 Phone: 202 287-1414 Email: subid.wagley@ee.doe.gov Related RIN: Related to 1904-AB92 RIN: 1904-AB79 BILLING CODE 6450-01-S [[Page 79518]] <###doc> DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) <###doc> Statement of Regulatory Priorities for FY 2011 The Department of Health and Human Services (HHS) is the Federal Government's principal agency charged with protecting the health of all Americans and providing essential human services. HHS' responsibilities include: Medicare, Medicaid, support for public health preparedness and emergency response, biomedical research, substance abuse and mental health treatment and prevention, assurance of safe and effective drugs and other medical products, protection of our Nation's food supply, assistance to low-income families, the Head Start program, services to older Americans, and direct health services delivery. Significantly, the Congress tasked HHS as the primary Department to implement the Affordable Care Act of 2010. These programs constitute a substantial portion of the priorities of the Federal Government, and as such, the HHS budget represents almost a quarter of all Federal outlays, and the Department administers more grant dollars than all other agencies combined. Significantly, the Congress tasked HHS as the primary Department to implement the Affordable Care Act of 2010. The Department has met the statutory deadlines related to the key provisions of this law through the issuance of regulations, bulletins, and other guidance documents. The principle objective of the Department will continue to be implementation of the Affordable Care Act in a manner that promotes consumer protections, improves quality and safety, incentivizes more efficient care delivery, and slows the growth of health care costs. These policies reflect the Department's commitment to put consumers first, to provide stability in private insurance markets, and reform the health care delivery system. Since assuming the leadership of HHS last year, Secretary Kathleen G. Sebelius has sought to prioritize efforts to promote early childhood health and development, help Americans achieve and maintain healthy weight, prevent and reduce tobacco use, protect the health and safety of Americans in public health emergencies, accelerate the process of scientific discovery to improve patient care, implement a 21st century food safety system, and ensure program integrity and responsible stewardship. Further, the Secretary has worked devotedly to enact meaningful reform of the country's health care system, and the Department has and will continue to focus considerable effort on implementation of the landmark health care reform bill passed by the Congress and signed into law by President Obama in March of 2010. The Obama Administration has prioritized the use of rulemaking to promote open government and to identify regulatory approaches that maximize net benefits. HHS regulatory priorities in the upcoming fiscal year reflect these goals in two ways. First, they advance transparency through the use of disclosure as a regulatory tool. Second, they maximize the net benefits conferred on society by utilizing rigorous cost-benefit analyses in the development of regulations. Below is an overview of the Department's regulatory priorities for FY 2011 that best exemplify these objectives. Promotion of Open Government 1. Transparency for Consumers Under the Affordable Care Act Two regulations to be promulgated by the Department in FY 2011 will require that insurers submit certain information on how they pay claims and set their premiums. One of these regulations will require certain statistics and information on claims, rating processes, and cost sharing to be disclosed to the State and Federal Government, as well as to consumers. HHS estimates the benefits of this regulation to come from improved information for consumers and regulators, which will in turn result in a more efficient insurance market. Improved information for consumers will allow them to make better health insurance choices-- to choose higher quality insurers and ones that more closely match their preferences with respect to plan design. This could result in increased satisfaction and decreased morbidity. In addition, consumers may be more likely to choose insurers with more efficient processes, which could result in a reduction in administrative costs. Improved information for regulators will allow for monitoring of the markets to track current industry practices, which will allow for better enforcement of current market regulations through more targeted audits that are based upon insurer responses. Additionally, reporting requirements and the threat of targeted audits will likely influence issuer behavior to motivate compliance. It is not possible to quantify the benefits at this time. The direct costs imposed by the regulation are the reporting requirements. These requirements are still being developed, and will be quantified in the regulation. The other regulation will ensure that all insurers use a uniform, easily understood format for accurate summaries of benefits and coverage explanations. Together, these two regulations will improve availability of meaningful information about health insurance to consumers, enabling them to better assess the coverage they currently have and/or make choices among different coverage options. HHS estimates the benefits of this regulation to come from improved information for consumers and regulators, which will in turn result in a more efficient insurance market. Improved information for consumers will allow them to make better health insurance choices--to choose higher quality insurers and ones that more closely match their preferences with respect to plan design. This could result in increased satisfaction and decreased morbidity. It is not possible to quantify the benefits at this time. The direct costs imposed by the regulation are the creation and provision of summary documents to consumers at the time of application, prior to enrollment and at reenrollment. There will also be costs imposed by the creation of the coverage facts label section of the summary documents. These requirements are still being developed and will be quantified in the regulation. 2. Public Health and Nutrition Three rules to be promulgated by the FDA in the upcoming fiscal year will propose new labeling requirements aimed at better disclosing to the public critical information to enable them to make informed decisions about food and drugs that they choose to consume. One proposed rule will require color graphics on cigarette packages depicting the health consequences of smoking. The largest benefits of this proposed rule stem from increased life expectancies for individuals who are induced not to smoke. Other quantifiable benefits come from reductions in cases of non-fatal emphysema, reductions in fire losses, and reductions in medical expenditures. Unquantifiable benefits come from reductions in smokers' non-fatal illnesses other than emphysema, reductions in passive smoking, and reductions in infant and child health effects due to mothers' smoking during pregnancy. Large, one-time costs will arise from the need to change cigarette package labels and remove point-of-sale promotions that do not comply with the new advertising restrictions. [[Page 79519]] Additionally, there will be smaller ongoing FDA enforcement costs. Two other key rules will implement provisions of the Affordable Care Act that require certain chain restaurants and vending machine operators to disclose nutritional information about their offerings. In the case of chain restaurants, these businesses will bear the cost of analysis of their menu items for nutritional information where this analysis does not already exist, and the cost of revising existing menus and other displays to note the required information. In the case of vending machines, the bulk of the costs associated with this rule will be in managing the actual disclosure of calories at the machine. Because almost all vending machines sell food that is previously manufactured and packaged, most vended foods are subject to the Nutrition Labeling and Education Act, which means that calorie content is already collected. The requirements of these rules, specifically that calorie and other nutrition information appear at the point of purchase, solves the apparent market failure in information provision stemming from present-biased preferences. 3. Enhanced Insurance Appeal and External Review Processes Under the Affordable Care Act With a goal of empowering patient consumers, the Affordable Care Act provides individuals with the right to appeal decisions made by their private health insurer to an outside, independent decisionmaker, regardless of consumers' State of residence or type of health insurance. One rule to be promulgated by the Department in FY 2011 will ensure that non-grandfathered plans and issuers comply with State or Federal external review processes. This rule will advance the Administration's objective of transparency by making certain that all consumers--regardless of whether their plan has grandfather status--are afforded an opportunity to appeal the decisions of their health carrier before an independent body. HHS estimates the benefits of the regulation to come from the transformation of the current, highly variable health claims and appeals process into a more uniform and structured process. This will result in a reduction in the incidence of excessive delays and inappropriate denials, averting serious, avoidable lapses in health care quality and resultant injuries and losses to participants; enhance enrollees' level of confidence in and satisfaction with their health care benefits and improve plans' awareness of participant concerns, prompting plan responses that improve quality; helping ensure prompt and precise adherence to contract terms and improving the flow of information between plans and enrollees to bolster the efficiency of labor, health care, and insurance markets. It is not possible to quantify these benefits at this time. The primary sources of costs are those required to administer and conduct the internal and external review process, prepare and distribute required disclosures and notices, and bring plan and issuers' internal and external claims and appeals procedures into compliance with the new requirements. In addition, there are start-up costs for issuers in the individual market to bring themselves into compliance and the costs and transfers associated with the reversal of denied claims. These costs are estimated to total $50.4 million in 2011, $78.8 million in 2012, and $101.1 million in 2013. 4. Notification Requirements for Long-Term Care Facility Closures A rule to be promulgated by CMS in the upcoming fiscal year will require that, in the case of a long-term care facility closure, the facility administrator provides written notification of closure and the plan for the relocation of residents at least 60 days prior to the impending closing. Such transparency will afford patients and family members a greater opportunity to meaningfully participate in decisions regarding relocation. The costs associated with the implementation of this rule are related to the efforts made by each facility to develop a plan for closure. The benefits would include the protection of residents' health and safety and a smooth transition for residents who need to be relocated, as well as their family members and facility staff. In addition to the aforementioned rules, the Department's regulatory priorities in the upcoming fiscal year include: Eliminating Insurance Company Abuses Under the Affordable Care Act The Affordable Care Act made important changes that will improve the affordability and transparency of private health insurance in the United States. Specifically, the law calls for the annual State review of unreasonable increases in health insurance premiums, which will help protect consumers from unjustified and/or excessive premium increases. In developing a process for the review of rate increases, HHS will propose standards for when and how health insurance issuers will be required to report rate increases, as well as detail the relevant data and documentation that must be submitted in support of rate increases. The proposed rule will detail criteria for how determinations of unreasonableness will be made by HHS and also sets forth the conditions under which HHS will adopt unreasonableness determinations made by States. The rule will also propose standards for when and how health insurance issuers must provide justifications for rate increases determined to be unreasonable and when such justifications must be posted on the issuer's website. It will explain that HHS will post information regarding rate increases on its website to ensure the public disclosure of information on rate increases, including increases determined to be unreasonable. Finally, the proposed rule will address the development by HHS of annual summaries of data on rate trends. The CLASS Act and Improving Long-Term Care The Department will promulgate a significant rule in FY 2011 that will improve the quality of long-term care for affected Americans. Implementation of the CLASS (Community Living Assistance Services and Support) Act will provide a new opportunity for all Americans to prepare themselves financially to remain independent under a variety of future health circumstances as they age. While this program may help reduce spending down to Medicaid, costs to implement the proposed regulation have not yet been estimated. Food Safety The Department is committed to improvements in our food safety system guided in part by the findings of the President's Food Safety Working Group, which adopted a public-health approach based on three core principles: Prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery if prevention fails. The goal of this new agenda is to shift emphasis away from mitigating public health harm by removing unsafe products from the market place to a new overriding objective--preventing harm by keeping unsafe food from entering commerce in the first place. As such, an FDA regulation will aim squarely at protecting the youngest and most vulnerable Americans by finalizing a modernization of existing requirements [[Page 79520]] on current good manufacturing practices for infant formula. Streamlining Drug and Device Requirements Two Food and Drug Administration (FDA) final rules will standardize the electronic submission of registrations and listings for devices, data from studies evaluating drugs and biologics for humans, and data on adverse events involving medical devices. Standardization of clinical data structure, terminology, and code sets will increase the efficiency of the Agency review process. FDA estimates that the costs resulting from the proposal would include substantial one-time costs, additional waves of one-time costs as standards mature, and possibly some annual recurring costs. One-time costs would include, among other things, the cost of converting data to standard structures, terminology, and cost sets (i.e., purchase of software to convert data); the cost of submitting electronic data (i.e., purchase of file transfer programs); and the cost of installing and validating the software and training personnel. Additional annual recurring costs may result from software purchases and licensing agreements for use of proprietary terminologies. The proposal could result in many long-term benefits associated with reduced time for preparing applications, including reduced preparation costs and faster time to market for beneficial products. In addition, the proposed rule would improve patient safety through faster, more efficient, comprehensive, and accurate data review, as well as enhanced communication among sponsors and clinicians. Additionally, a new proposed rule will establish a unique identification system that will identify a device through distribution and use. FDA estimates that the affected industry would incur one-time and recurring costs, including administrative costs, to change and print labels that include the required elements of a unique device identifier (UDI), costs to purchase equipment to print and verify the UDI, and costs to purchase software, integrate and validate the UDI into existing IT systems. Certain entities would be required to submit information about each UDI and the relevant medical device into a database. FDA anticipates that implementation of a UDI system would help improve the efficiency of recalled medical devices and medical device adverse event reporting. The proposed rule would also standardize how medical devices are identified and contribute to future potential public health benefits of initiatives aimed at optimizing the use of automated systems in healthcare. Most of these benefits, however, require complementary developments and innovations in the private and public sectors. Together, these rules will enable the FDA to more quickly and efficiently process and review information submitted on devices, drugs, and biologics, furthering their ability to both better protect the public safety and more rapidly advance innovations to the market. Medicare Modernization The Regulatory Plan highlights three final rules that would adjust payment amounts under Medicare for physicians' services, hospital inpatient, and hospital outpatient services for fiscal year 2012. These new payment rules reflect continuing experience with regulating these systems and will implement modernizations to ensure that the Medicare program best serves its beneficiaries, fairly compensates providers, and remains fiscally sound. Additionally, another rule promulgated under the Affordable Care Act will propose a Medicare shared savings program for provider groups to establish Accountable Care Organizations and share in savings generated for Medicare by meeting certain benchmarks. Health Information Technology The Department will issue a rule that will modify the existing HIPAA privacy and security enforcement regulations to comply with the provisions of the HITECH Act. This rule will ensure that Americans can be confident that their medical data is kept private as the country increasingly moves to electronic health records. These modifications to the HIPAA Privacy, Security, and Enforcement Rules will benefit health care consumers by strengthening the privacy and security protections afforded their health information by HIPAA covered entities and their business associates. The Agency believes the primary cost associated with this regulation will be for covered entities to revise and redistribute their notices of privacy practices to ensure health care consumers are informed of their new rights and protections. The Agency estimates the cost of revising and redistributing these notices to total approximately $166.1 million over the first year following the effective date of the regulation. Of this total, the cost to health care providers is estimated to be approximately $46 million and to health plans to be approximately $120.1 million. The Agency does not believe that the additional modifications to the Privacy, Security, or Enforcement Rules required by this regulation will significantly increase covered entity or business associate costs. It is estimated that the changes to the HIPAA authorization and access requirements will impose little to no additional costs on covered entities and their business associates, and in some cases will reduce burden. Further, it is expected that the costs of modifying business associate contracts will be mitigated both by the additional one-year transition period which will allow the costs of modifying contracts to be incorporated into the normal renegotiation of contracts as the contracts expire, as well as sample business associate contract language to be provided by the Agency. Head Start Program Integrity The Department will finalize a rule in FY 2011 that will implement statutory requirements requiring a re-evaluation of Head Start grantees every 5 years to ensure that taxpayer dollars are spent in the most effective possible manner by this critical program. The Administration on Children and Families estimates the costs of implementing the new reporting requirements described in the rule will be approximately $20,000 annually. In addition, at least 25 percent of grantees reviewed in a year will be required to submit a competitive application for a new 5-year grant, at an estimated cost of less than $1,500 for each grantee. In terms of benefits, the proposed system will fund only high- performing grantees in order to ensure the best services for Head Start children are provided and child outcomes are improved. Small Business Impact Finally, HHS actively seeks to minimize regulatory burdens on small business. Over 95 per cent of the entities that we regulate - hospitals, doctors' practices, social service providers, medical device firms, universities and many others - qualify as ``small entities'' under the Regulatory Flexibility Act (RFA). All of the aforementioned actions have been developed in light of and with serious consideration of the small-business impact analysis. [[Page 79521]] _______________________________________________________________________ <###doc> HHS--Office of the Secretary (OS) ----------- FINAL RULE STAGE ----------- <###doc> 41. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 111-5, secs 13400 to 13410 CFR Citation: 45 CFR 160; 45 CFR 164 Legal Deadline: NPRM, Statutory, February 17, 2010. Abstract: The Department of Health and Human Services Office for Civil Rights will issue rules to modify the HIPAA Privacy, Security, and Enforcement Rules as necessary to implement the privacy, security, and certain enforcement provisions of subtitle D of the Health Information Technology for Economic and Clinical Health Act (title XIII of the American Recovery and Reinvestment Act of 2009). Statement of Need: The Office for Civil Rights will issue rules to modify the HIPAA Privacy, Security, and Enforcement Rules to implement the privacy and security provisions in sections 13400 to 13410 of the Health Information Technology for Economic and Clinical Health Act (title XIII of Division A of the American Recovery and Reinvestment Act of 2009, Pub. L. 111-5). These regulations will improve the privacy and security protection of health information. Summary of Legal Basis: Subtitle D of the Health Information Technology for Economic and Clinical Health Act (title XIII of the American Recovery and Reinvestment Act of 2009) requires the Office for Civil Rights to modify certain provisions of the HIPAA Privacy and Security Rules to implement sections 13400 to 13410 of the Act. Alternatives: The Office for Civil Rights is statutorily mandated to make modifications to the HIPAA Privacy and Security Rules to implement the privacy provisions at sections 13400 to 13410 of the Health Information Technology for Economic and Clinical Health Act (title XIII of the American Recovery and Reinvestment Act of 2009). Anticipated Cost and Benefits: These modifications to the HIPAA Privacy, Security, and Enforcement Rules will benefit health care consumers by strengthening the privacy and security protections afforded their health information by HIPAA covered entities and their business associated. The Agency believe the primary cost associate with this regulation will be for covered entities to revise and redistribute their notices of privacy practices to ensure health care consumers are informed of their new rights and protections. The Agency estimates the cost of revising and redistributing these notices to total approximates $166.1 million over the first year following the effective date of the regulation. Of this total, the cost heal care providers is estimated to be approximately $46 million and to health plans to be approximately $120.1 million. The Agency does not believe that the additional modification to Privacy, Security, or Enforcement Rules required by this regulation will significantly increase covered entity or business associates and in some cases will reduce burden. Further, it is expected that the costs of modifying business associate contracts will be mitigated both by the additional one-year transition period which will allow the costs of modifying contracts to be incorporated into the normal renegotiation of contracts as the contracts expire, as well as sample business associate contract language to be provided by the Agency. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Final Action 03/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Andra Wicks Department of Health and Human Services 200 Independence Avenue SW. Washington, DC 20201 Phone: 202 205-2292 Fax: 202 205-4786 Email: andra.wicks@hhs.gov RIN: 0991-AB57 _______________________________________________________________________ <###doc> HHS--Office of Consumer Information and Insurance Oversight (OCIIO) ----------- PROPOSED RULE STAGE ----------- <###doc> 42. TRANSPARENCY REPORTING Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: PL 111-148, title I, subtitle A, sec 1001 PHS Act, sec 2715A CFR Citation: 45 CFR 153, Insurance Rules (sec 2715A) Legal Deadline: None Abstract: The Affordable Care Act requires group health plans and health insurance issuers to submit specific information to the Secretary, the State insurance commissioner, and to make the information available to the public. This includes information on claims payment policies, the number of claims denied, data on rating practices and other information as determined by the Secretary. The provision also requires plans and issuers to provide to individuals upon request the amount of cost sharing that the individual would be responsible for paying for a specific item or service provided by a participating provider. This interim final rule would implement information disclosure provisions in section 2715A of the Public Health Service Act, as added by the Affordable Care Act. Statement of Need: The Department of Health and Human Services, along with the Department of Labor and the Treasury Department, will issue interim final rules to implement the information disclosure [[Page 79522]] provisions in section 2715A of the Public Health Service Act, as added by the Affordable Care Act. This regulation will improve the transparency of information about how health coverage works so consumers will have better information to use and assess the coverage they have now, and/or make choices among different coverage options. Summary of Legal Basis: Title I, subtitle A, section 1001 of the Affordable Care Act adds section 2715A to the Public Health Service Act that will require group health plans and health insurance issuers to make certain disclosures to the Secretary, the State insurance commissioner, the public, and in some cases, individuals. Alternatives: None--statutory requirement. Anticipated Cost and Benefits: HHS estimates the benefits of this regulation to come from improved information for consumers and regulators, which will in tern result in a more efficient insurance market. Improved information for consumers will allow them to make better health insurance choices -- to choose higher quality insurers and ones that more closely match their preferences with respect to plan design. This could result in increased satisfaction and decreased morbidity. In addition, consumers may be more likely to choose insurers with more efficient processes, which could result in a reduction in administrative costs. Improved information for regulators will allow for monitoring of the markets to track current industry practices, which will allow for better enforcement of current market regulations through more targeted audits that are based upon insurer responses. Additionally, reporting requirements and the threat of targeted audit will likely influence issuer behavior to motivate compliance. I is not possible to quantify the benefits at this time. The direct costs imposed by the regulation are reporting requirements. These requirements are still being developed, and will be quantified in the regulation. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 03/00/11 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Kaye L. Pestaina Office of Consumer Support Department of Health and Human Services Office of Consumer Information and Insurance Oversight 200 Independence Avenue SW. Washington, DC 20201 Phone: 301 492-4227 Email: kaye.pestaina@hhs.gov RIN: 0950-AA07 _______________________________________________________________________ <###doc> HHS--OCIIO ----------- FINAL RULE STAGE ----------- <###doc> 43. RATE REVIEW Priority: Other Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: PL 111-148 CFR Citation: 45 CFR 154 Legal Deadline: None Abstract: The Affordable Care Act requires the Secretary to work with states to establish an annual review of unreasonable rate increases, to monitor premium increases and to award grants to states to carry out their rate review process. This interim final rule would implement the rate review process. Statement of Need: The Affordable Care Act requires standards to be set for the review of rate increases. The proposed rule will detail standards for when and how health insurance issuers will be required to report rate increases, as well as detail the relevant data and documentation that must be submitted in support of the rate increases. The proposed rule will detail criteria for how determinations of unreasonableness will be made by HHS, and also sets forth the conditions under which HHS will adopt unreasonableness determinations made by States. This regulation is part of the health insurance market reform and will increase affordability of health insurance for all Americans. Summary of Legal Basis: The Affordable Care Act. Alternatives: There are no alternatives, as this rulemaking is a matter of law based on the Affordable Care Act. Anticipated Cost and Benefits: HHS expects that costs associated with this rulemaking will be minimal as insurers routinely report to States on rate increases. Insurers may experience slight additional costs in connection with completion of policy rate data collection forms and any necessary submission of justification forms for rates that trigger unreasonable designations. The benefits of these requirements include increased consumer protections around unsubstantiated premium rate increases, reduced health insurance rate increases, increased transparency and consumer confidence in the products they buy, and ensuring financially solvent companies that can pay promised benefits. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Interim Final Rule 07/03/10 75 FR 45014 Interim Final Rule Comment Period End 09/28/10 Final Action 12/00/10 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: James Mayhew Department of Health and Human Services Office of Consumer Information and Insurance Oversight Mail Stop C2-12016 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-9244 Email: james.mayhew@cms.hhs.gov RIN: 0950-AA03 [[Page 79523]] _______________________________________________________________________ <###doc> HHS--OCIIO <###doc> 44. UNIFORM EXPLANATION OF BENEFITS, COVERAGE FACTS, AND STANDARDIZED DEFINITIONS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: PL 111-148, title I, subtitle A, sec 1001 (Public Health Service Act, sec 2715) CFR Citation: 45 CFR 153, Insurance Rules (sec 2715) Legal Deadline: None Abstract: The Affordable Care Act requires the Secretary to develop standards for use by group health plans and health insurance issuers in compiling and providing a summary of benefits and coverage explanation that accurately describes benefits and coverage. The Secretary must also set standards for the definitions of terms used in health insurance coverage, including specific terms set out in the statute. Plans and issuers must provide information according to these standards no later than 24 months after enactment. This interim final rule would implement the information disclosure provisions in section 2715 of PHSA , as added by the Affordable Care Act. Statement of Need: The Department of Health and Human Services, along with the Departments of Labor and the Treasury, will issue interim final rules to implement the information disclosure provisions in section 2715 of PHSA, as added by the Affordable Care Act. This regulation will provide consumers with a simplified and uniform overview of their benefits, specific ``Coverage Facts'' or scenarios for the costs of coverage for specific episodes of care, and standardized consumer-friendly health coverage definitions. This will allow consumers to better understand the coverage that they have and allow consumers choosing coverage to better compare coverage options. Summary of Legal Basis: Title I, subtitle A, section 1001, of the Affordable Care Act adds section 2715 to the Public Health Service Act that will require group health plans and health insurance issuers to provide a summary of benefits and coverage explanations and standardized definitions to applicants, enrollees, and policyholders. Alternatives: None--statutory requirement. Anticipated Cost and Benefits: HHS estimates the benefits of this regulation to come from improved information for consumers and regulators, which will in turn result in a more efficient insurance market. Improved information for consumers will allow them to make better health insurance choices--to chose higher quality insurers and ones that more closely match their preference with respect to plan design. This could result in increased satisfaction and decreased morbidity. It is not possible to quantify the benefits at this time. The direct costs imposed by the regulation are the creation and provision of summary documents to consumers at the time of application, prior to enrollment and at re-enrollment. There will also be costs imposed by the creation of the coverage facts label section of the summary documents. These requirements are still being developed and will be quantified in the regulation. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Interim Final Rule 03/00/11 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Kaye L. Pestaina Office of Consumer Support Department of Health and Human Services Office of Consumer Information and Insurance Oversight 200 Independence Avenue SW. Washington, DC 20201 Phone: 301 492-4227 Email: kaye.pestaina@hhs.gov RIN: 0950-AA08 _______________________________________________________________________ <###doc> HHS--Food and Drug Administration (FDA) ----------- PROPOSED RULE STAGE ----------- <###doc> 45. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 314.96 Legal Deadline: None Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDA can process, review, and archive. Statement of Need: Before a drug is approved for marketing, FDA must determine that the drug is safe and effective for its intended use. This determination is based in part on clinical study data and bioequivalence data that are submitted as part of the marketing application. Study data submitted to FDA in electronic format have generally been more efficient to process and review. FDA's proposed rule would address the submission of study data in a standardized electronic format. Electronic submission of study data would improve patient safety and enhance health care delivery by enabling FDA to process, review, and archive data more efficiently. Standardization would also enhance the ability to share study data and communicate results. Investigators and industry would benefit from the use of [[Page 79524]] standards throughout the lifecycle of a study--in data collection, reporting, and analysis. The proposal would work in concert with ongoing Agency and national initiatives to support increased use of electronic technology as a means to improve patient safety and enhance health care delivery. Summary of Legal Basis: Our legal authority to amend our regulations governing the submission and format of clinical study data and bioequivalence data for human drugs and biologics derives from sections 505 and 701 of the Act (U.S.C. 355 and 371) and section 351 of the Public Health Service Act (42 U.S.C. 262). Alternatives: FDA considered issuing a guidance document outlining the electronic submission and the standardization of study data, but not requiring electronic submission of the data in the standardized format. This alternative was rejected because the Agency would not fully benefit from standardization until it became the industry standard, which could take up to 20 years. We also considered a number of different implementation scenarios, from shorter to longer time-periods. The 2-year time-period was selected because the Agency believes it would provide ample time for applicants to comply without too long a delay in the effective date. A longer time-period would delay the benefit from the increased efficiencies, such as standardization of review tools across applications, and the incremental cost savings to industry would be small. Anticipated Cost and Benefits: Standardization of clinical data structure, terminology, and code sets will increase the efficiency of the Agency review process. FDA estimates that the costs resulting from the proposal would include substantial one-time costs, additional waves of one-time costs as standards mature, and possibly some annual recurring costs. One-time costs would include, among other things, the cost of converting data to standard structures, terminology, and cost sets (i.e., purchase of software to convert data); the cost of submitting electronic data (i.e., purchase of file transfer programs); and the cost of installing and validating the software and training personnel. Additional annual recurring costs may result from software purchases and licensing agreements for use of proprietary terminologies. The proposal could result in many long-term benefits associated with reduced time for preparing applications, including reduced preparation costs and faster time to market for beneficial products. In addition, the proposed rule would improve patient safety through faster, more efficient, comprehensive and accurate data review, as well as enhanced communication among sponsors and clinicians. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 06/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Martha Nguyen Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 51, Room 6352 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Phone: 301 796-3471 Fax: 301 847-8440 Email: martha.nguyen@fda.hhs.gov RIN: 0910-AC52 _______________________________________________________________________ <###doc> HHS--FDA <###doc> 46. UNIQUE DEVICE IDENTIFICATION Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 15 USC 1451 to 1461; 21 USC 141 to 149, 321 to 394, 467f, 679, 821, 1034; 28 USC 2112; 42 USC 201 to 262, 263a and 263b, 264, 271, 364 CFR Citation: 21 CFR 16, 801, 803, 806, 810, 814, 820, 821, Legal Deadline: None Abstract: The Food and Drug Administration Amendments Act of 2007, amended the Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to promulgate regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number. Statement of Need: A unique device identification system will help reduce medical errors; will allow FDA, the healthcare community, and industry to more rapidly review and organize adverse event reports; identify problems relating to a particular device (even down to a particular lot or batch, range of serial numbers, or range of manufacturing or expiration dates); and thereby allow for more rapid, effective, corrective actions that focus sharply on the specific devices that are of concern. Summary of Legal Basis: This rule is provided for/mandated by FDAAA. Section 519(f) of the FD&C Act (added by sec. 226 of the Food and Drug Administration Amendments Act of 2007) directs the Secretary to promulgate regulations establishing a unique device identification (UDI) system for medical devices, requiring the label of devices to bear a unique identifier that will adequately identify the device through its distribution and use. Alternatives: FDA considered several alternatives that allow certain requirements of the proposed rule to vary, such as the required elements of a UDI and the scope of affected devices. Anticipated Cost and Benefits: FDA estimates that the affected industry would incur one-time and recurring costs, including administrative costs, to change and print labels that include the required elements of a UDI, costs to purchase equipment to print and verify the UDI, and costs to purchase software, integrate and validate the UDI into existing IT systems. Certain entities would be required to submit information about each UDI and the relevant medical device into a database, FDA would incur costs to develop, [[Page 79525]] implement, and administer a database that would serve as a repository of information to facilitate the identification of medical devices through their distribution and use. FDA anticipates that implementation of a UDI system would help improve the efficiency of recalled medical devices and medical device adverse event reporting. The proposed rule would also standardize how medical devices are identified and contribute to future potential public health benefits of initiatives aimed at optimizing the use of automated systems in healthcare. Most of these benefits, however, require complementary developments and innovations in the private and public sectors. Risks: This rule is intended to substantially eliminate existing obstacles to the adequate identification of medical devices used in the Unites States. By providing the means to rapidly and definitely identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use. The rule will fulfill a statutory directive to establish a unique device identification system. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 06/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: John J. Crowley Senior Advisor for Patient Safety Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health WO 66, Room 2315 10903 New Hampshire Avenue Silver Spring, MD 20993 Phone: 301 980-1936 Email: jay.crowley@fda.hhs.gov RIN: 0910-AG31 _______________________________________________________________________ <###doc> HHS--FDA <###doc> 47. CIGARETTE WARNING LABEL STATEMENTS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: PL 111-31, The Family Smoking Prevention and Tobacco Control Act, sec 201 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, June 22, 2011. Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by section 201 of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act), requires FDA to issue regulations no later than 24 months after the date of enactment of the Tobacco Control Act that require color graphics depicting the negative health consequences of smoking. Abstract: Section 4 of the FCLAA, as amended by section 201 of the Tobacco Control Act, requires FDA to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany required warning statements. FDA also may adjust the type size, text and format of the required label statements on product packaging and advertising if FDA determines that it is appropriate so that both the graphics and the accompanying label statements are clear, conspicuous, legible and appear within the specified area. Statement of Need: This proposed rule is necessary to amend FDA's regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements and to specify the color graphics that must accompany each textual warning statement. Summary of Legal Basis: The proposed rule would implement a provision of the Tobacco Control Act that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany the nine new textual warning statements that will be required under the Tobacco Control Act. The Tobacco Control Act amends the FCLAA to require each cigarette package and advertisement to bear one of nine new textual warning statements. Alternatives: The Agency will compare the proposed rule to two hypothetical alternatives: An otherwise identical rule with a 24-month compliance period and an otherwise identical rule with a 6-month compliance period. Although we will compare the rule to two hypothetical alternatives, they are not viable regulatory options as they are inconsistent with FDA's statutory mandate. Anticipated Cost and Benefits: The largest benefits of this proposed rule stem from increased life expectancies for individuals who are induced not to smoke. Other quantifiable benefits come from reductions in cases of non-fatal emphysema, reductions in fire losses, and reductions in medical expenditures. Unquantifiable benefits come from reductions in smokers' non-fatal illnesses other than emphysema, reductions in passive smoking, and reductions in infant and child health effects due to mothers' smoking during pregnancy.Large, one-time costs will arise from the need to change cigarette package labels and remove point-of-sale promotions that do not comply with the new advertising restrictions. Additionally, there will be smaller ongoing FDA enforcement costs. Risks: This proposed rule would reduce the risk to the public by helping to clearly and effectively convey the negative health consequences of smoking on cigarette packages and in cigarette advertisements, which would help both to discourage non-smokers, including minor children, from initiating cigarette [[Page 79526]] use and to encourage current smokers to consider cessation. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 11/12/10 75 FR 69524 NPRM Comment Period End 01/11/11 Final Action 06/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Gerie Voss Regulatory Counsel Department of Health and Human Services Food and Drug Administration 9200 Corporate Boulevard Rockville, MD 20850 Phone: 877 287-1373 Fax: 240 276-4193 Email: gerie.voss@fda.hhs.gov RIN: 0910-AG41 _______________________________________________________________________ <###doc> HHS--FDA <###doc> 48. FOOD LABELING: NUTRITION LABELING FOR FOOD SOLD IN VENDING MACHINES Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 21 USC 343; 21 USC 371 CFR Citation: Not Yet Determined Legal Deadline: NPRM, Statutory, March 23, 2011, Proposed rule to be published 1 year after enactment. Abstract: The Food and Drug Administration (FDA) is proposing regulations to establish requirements for nutrition labeling of food sold in vending machines. FDA is also proposing the terms and conditions for registering to voluntarily be subject to the requirements of section 4205. FDA is taking this action to carry out the provisions of section 4205 of the Patient Protection and Affordable Care Act (``Affordable Care Act'' or ``ACA''), which was signed into law on March 23, 2010. Statement of Need: This proposed rule was mandated by section 4205 of the Affordable Care Act. Summary of Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act by creating new clause (H) to require that vending machine operators, who own or operate 20 or more machines, disclose calories for food items. FDA has the authority to issue this proposed rule under section 403(q)(5)(H) and 701(a) (21 U.S.C. 343(q)(5)(H), and 371(a)). Section 701(a) of the act vests the Secretary (and, by delegation, the FDA) with the authority to issue regulations for the efficient enforcement of the act. Alternatives: Section 4205 requires the Secretary (and, by delegation, the FDA) to establish, by regulation, requirements for calorie disclosure of food items for vending machine operators, who own or operate 20 or more machines. Therefore, there are no alternatives to rulemaking. Anticipated Cost and Benefits: The bulk of the costs associated with this rule will be in managing the actual disclosure of calories at the machine. Since almost all vending machines sell food that is previously manufactured and packaged, most vended foods are subject to the Nutrition Labeling Education Act, which means that calorie content is already collected. A likely scenario for response to vending machine labeling is that food manufacturers include a set of calorie label stickers in each case of product. Since consumers of vended foods do not generally have access to nutrition information prior to purchase, requiring that operators make that information available should benefit consumers. Consumers may ignore future costs of overeating, relative to the current gains from eating, even when they understand the connection. Therefore, consumers do not generally demand calorie and other nutrition information for food away from home, even when they do, given a wider frame of reference, value that information. Given the costs and the uncertain reception for calorie information that many consumers appear not to care about, most vending machine operators have chosen not to display calorie information. The requirements of the proposed rule, specifically, that calorie and other nutrition information appear at the point of purchase, solves the apparent market failure in providing information provision stemming from present-biased preferences. Risks: For some vending machine foods, consumers cannot view the nutrition facts panel or otherwise see nutrition information prior to purchasing the item. Completion of this rulemaking will provide consumers information about the nutritional content of food to empower them to make healthier food choices from vending machines. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 03/00/11 NPRM Comment Period End 06/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Federal, Local, State Federalism: Undetermined Agency Contact: Geraldine A. June Supervisor, Product Evaluation and Labeling Team Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-820) 5100 Paint Branch Parkway College Park, MD 20740 Phone: 301 436-1802 Fax: 301 436-2636 Email: geraldine.june@fda.hhs.gov RIN: 0910-AG56 [[Page 79527]] _______________________________________________________________________ <###doc> HHS--FDA <###doc> 49. FOOD LABELING: NUTRITION LABELING OF STANDARD MENU ITEMS IN CHAIN RESTAURANTS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 21 USC 343; 21 USC 371 CFR Citation: Not Yet Determined Legal Deadline: NPRM, Statutory, March 23, 2011, Proposed rule to be published 1 year after enactment. Abstract: The Food and Drug Administration (FDA) is proposing regulations to establish requirements for nutrition labeling of standard menu items for chain restaurants and similar retail food establishments. FDA is also proposing the terms and conditions for registering to voluntarily be subject to the requirements of section 4205. FDA is taking this action to carry out the provisions of section 4205 of the Patient Protection and Affordable Care Act (``Affordable Care Act'' or ``ACA''), which was signed into law on March 23, 2010. Statement of Need: This proposed rule was mandated by section 4205 of the Affordable Care Act. Summary of Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act by creating new clause (H) to require that chain restaurants, with 20 or more locations, require certain nutrient disclosure. Specifically, section 4205 required the Secretary of Health and Human Services to issue a proposed regulation to carry out clause (H) of the ACA no later than 1 year of enactment of this clause (i.e., Mar. 23, 2011). FDA has the authority to issue this proposed rule under section 403(q)(5)(H) and 701(a) (21 U.S.C. 343(q)(5)(H), and 371(a)). Section 701(a) of the act vests the Secretary (and, by delegation, the FDA) with the authority to issue regulations for the efficient enforcement of the act. As directed by section 4205, FDA is proposing requirements for menu calorie declaration, as well as other nutrition information declaration to implement the provisions of 403(q)(5)(H). FDA is also proposing the terms and conditions for registering to voluntarily be subject to the requirements of section 4205. Alternatives: Section 4205 requires the Secretary (and, by delegation, the FDA) to establish, by regulation, requirements for nutrition labeling of standard menu items for chain restaurants and similar retail food establishments. Therefore, there are no alternatives to rulemaking. Anticipated Cost and Benefits: Chain restaurants operating in local jurisdictions that impose different nutrition labeling requirements will benefit from having a uniform national standard. Any restaurant, with fewer than 20 locations, may opt in to the national standard to receive this benefit. Many chain restaurants, with 20 or more locations, will bear costs for adding nutrition information to menus and menu boards. Consumers will benefit from having important nutrition information for the approximately 30 per cent of calories consumed away from home. Risks: Americans now consume an estimated one-third of their total calories on foods prepared outside the home and spend almost half of their food dollars on such foods. Unlike packaged foods that are labeled with nutrition information, foods in restaurants, for the most part, do not have nutrition information. Completion of this rulemaking will provide consumers information about the nutritional content of food to empower them to make healthier food choices. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 03/00/11 NPRM Comment Period End 06/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Federal, Local, State Federalism: Undetermined Agency Contact: Geraldine A. June Supervisor, Product Evaluation and Labeling Team Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-820) 5100 Paint Branch Parkway College Park, MD 20740 Phone: 301 436-1802 Fax: 301 436-2636 Email: geraldine.june@fda.hhs.gov RIN: 0910-AG57 _______________________________________________________________________ <###doc> HHS--FDA ----------- FINAL RULE STAGE ----------- <###doc> 50. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND QUALITY FACTORS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . . CFR Citation: 21 CFR 106 and 107 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products. Statement of Need: The agency published a proposed rule on July 9, 1996, that would establish current good manufacturing practice regulations, quality control procedures, quality factors, notification requirements, records and reports for the production of infant formula. This proposal was issued in response to the [[Page 79528]] 1986 Amendments to the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the comment period to update comments on the proposal. The comment was extended on June 27, 2003 and ended on August 26, 2003. The comment period was reopened on August 1, 2006 and ended on September 15, 2006. Summary of Legal Basis: The Infant Formula Act of 1980 (the 1980 Act) (Pub. L. 96-359) amended the Federal Food, Drug, and Cosmetic Act (the Act) to include section 412 (21 U.S.C. 350a). This law is intended to improve protection of infants consuming infant formula products by establishing greater regulatory control over the formulation and production of infant formula. In 1982, FDA adopted infant formula recall procedures in subpart D of 21 CFR part 107 of its regulations (47 FR 18832, Apr. 30, 1982), and infant formula quality control procedures in subpart B of 21 CFR part 106 (47 FR 17016, Apr. 20, 1982). In 1985, FDA further implemented the 1980 Act by establishing subparts B, C, and D in 21 CFR part 107 regarding the labeling of infant formula, exempt infant formulas, and nutrient requirements for infant formula, respectively (50 FR 1833, Jan. 14, 1985; 50 FR 48183, Nov. 22, 1985; and 50 FR 45106, Oct. 30, 1985). In 1986, Congress, as part of the Anti-Drug Abuse Act of 1986 (Pub. L. 99-570) (the 1986 amendments), amended section 412 of the act to address concerns that had been expressed by Congress and consumers about the 1980 Act and its implementation related to the sufficiency of quality control testing, CGMP, recordkeeping, and recall requirements. The 1986 amendments: (1) State that an infant formula is deemed to be adulterated if it fails to provide certain required nutrients, fails to meet quality factor requirements established by the Secretary (and, by delegation, FDA), or if it is not processed in compliance with the CGMP and quality control procedures established by the Secretary; (2) require that the Secretary issue regulations establishing requirements for quality factors and CGMP, including quality control procedures; (3) require that infant formula manufacturers regularly audit their operations to ensure that those operations comply with CGMP and quality control procedure regulations; (4) expand the circumstances in which firms must make a submission to the Agency to include when there is a major change in an infant formula or a change that may affect whether the formula is adulterated; (5) specify the nutrient quality control testing that must be done on each batch of infant formula; (6) modify the infant formula recall requirements; and (7) give the Secretary authority to establish requirements for retention of records, including records necessary to demonstrate compliance with CGMP and quality control procedures. In 1989, the Agency implemented the provisions on recalls (secs. 412(f) and (g) of the act) by establishing subpart E in 21 CFR part 107 (54 FR 4006, Jan. 27, 1989). In 1991, the Agency implemented the provisions on record and record retention requirements by revising 21 CFR 106.100 (56 FR 66566, Dec. 24, 1991). The Agency has already promulgated regulations that respond to a number of the provisions of the 1986 amendments. The final rule would address additional provisions of these amendments. Alternatives: The 1986 amendments require the Secretary (and, by delegation, FDA) to establish, by regulation, requirements for quality factors and CGMPs, including quality control procedures. Therefore, there are no alternatives to rulemaking. Anticipated Cost and Benefits: FDA estimates that the costs from the final rule to producers of infant formula would include first year and recurring costs (e.g., administrative costs, implementation of quality controls, records, audit plans and assurances of quality factors in new infant formulas). FDA anticipates that the primary benefits would be a reduced risk of illness due to Cronobacter sakazakii and Salmonella spp in infant formula. Additional benefits stem from the quality factors requirements that would assure the healthy growth of infants consuming infant formula. Monetized estimates of costs and benefits for this final rule are not available at this time. The analysis for the proposed rule estimated costs of less than $1 million per year. FDA was not able to quantify benefits in the analysis for the proposed rule. Risks: Special controls for infant formula manufacturing are especially important because infant formula, particularly powdered infant formula, is an ideal medium for bacterial growth and because infants are at high risk of foodborne illness because of their immature immune systems. In addition, quality factors are of critical need to assure that the infant formula supports healthy growth in the first months of life when infant formula may be an infant's sole source of nutrition. The provisions of this rule will address weaknesses in production that may allow contamination of infant formula, including, contamination with C. sakazakii and Salmonella spp which can lead to serious illness with devastating sequelae and/or death. The provisions would also assure that new infant formulas support healthy growth in infants. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 07/09/96 61 FR 36154 NPRM Comment Period End 12/06/96 NPRM Comment Period Reopened 04/28/03 68 FR 22341 NPRM Comment Period Extended 06/27/03 68 FR 38247 NPRM Comment Period End 08/26/03 NPRM Comment Period Reopened 08/01/06 71 FR 43392 NPRM Comment Period End 09/15/06 Final Action 06/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Benson Silverman Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-850) 5100 Paint Branch Parkway College Park, MD 20740 Phone: 301 436-1459 Email: benson.silverman@fda.hhs.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF27 [[Page 79529]] _______________________________________________________________________ <###doc> HHS--FDA <###doc> 51. MEDICAL DEVICE REPORTING; ELECTRONIC SUBMISSION REQUIREMENTS Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 21 USC 321, 331, 351, 352, 360c, 360e, 360i to 360j, 371, 374, 381, 393; 42 USC 264, 271 CFR Citation: 21 CFR 803 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is amending its postmarket medical device reporting (MDR) regulations to require that manufacturers, importers, and user facilities submit mandatory reports of medical device adverse events to the Agency in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The proposed change would help the Agency to more quickly review safety reports and identify emerging public health issues. Statement of Need: The final rule would require user facilities and medical device manufacturers and importers to submit medical device adverse event reports in electronic format instead of using a paper form. FDA is taking this action to improve its adverse event reporting program by enabling it to more quickly receive and process these reports. Summary of Legal Basis: The Agency has legal authority under section 519 of the Federal Food, Drug, and Cosmetic Act to require adverse event reports. The final rule would require manufacturers, importers, and user facilities to change their procedures to send reports of medical device adverse events to FDA in electronic format instead of using a hard copy form. Alternatives: There are two alternatives. The first alternative is to allow the voluntary submission of electronic MDRs. If a substantial number of reporters fail to voluntarily submit electronic MDRs, FDA will not obtain the benefits of standardized formats and quicker access to medical device adverse event data. The second alternative is to allow small entities more time to comply. Because so many device companies are small entities, this would significantly postpone the benefits of the rule. Anticipated Cost and Benefits: The principal benefit would be to public health because the increased speed in the processing and analysis of 173,000 medical device reports currently submitted annually on paper. In addition, requiring electronic submission would reduce FDA annual operating costs by $1.9 million and generate industry savings of about $9.8 million. The total one-time cost for modifying SOPs and establishing electronic submission capabilities is estimated to range from $81.4 million to $101.0 million. Annually recurring costs totaled $8.8 million and included maintenance of electronic submission capabilities, including renewing the electronic certificate, and for some firms, the incremental cost to maintain high-speed Internet access. Risks: None Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 08/21/09 74 FR 42310 NPRM Comment Period End 11/19/09 Final Action 06/00/11 Regulatory Flexibility Analysis Required: No Government Levels Affected: None International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Nancy Pirt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health WO 66 Room 4438 10903 New Hampshire Avenue Silver Spring, MD 20993 Phone: 301 796-6248 Fax: 301 847-8145 Email: nancy.pirt@fda.hhs.gov RIN: 0910-AF86 _______________________________________________________________________ <###doc> HHS--FDA <###doc> 52. ELECTRONIC REGISTRATION AND LISTING FOR DEVICES Priority: Other Significant Legal Authority: PL 110-85; PL 107-188, sec 321; PL 107-250, sec 207; 21 USC 360(a) through 360(j); 21 USC 360(p) CFR Citation: 21 CFR 807 Legal Deadline: None Abstract: This rule will convert registration and listing to a paperless process. However, for those companies that do not have access to the Web, FDA will offer an avenue by which they can register, list, and update information with a paper submission. The rule also will amend part 807 to reflect the timeframes for device establishment registration and listing established by sections 222 and 223 of Food and Drug Administration Amendment Act (FDAAA) and to reflect the requirement in section 510(i) of the Act, as amended by section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act (BT Act), that foreign establishments provide FDA with additional pieces of information as part of their registration. Statement of Need: FDA is amending the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the electronic submission requirements in section 510(p) of the Act, which was added by section 207 of MDUFMA and later amended by section 224 of FDAAA. FDA also is amending 21 CFR part 807 to reflect [[Page 79530]] the requirements in section 321 of the BT Act for foreign establishments to furnish additional information as part of their registration. This rule will improve FDA's device establishment registration and listing system and utilize the latest technology in the collection of this information. Summary of Legal Basis: The statutory basis for our authority includes sections 510(a) through (j), 510(p), 701, 801, and 903 of the Act. Alternatives: The alternatives to this rulemaking include not updating the registration and listing regulations. Because of the new FDAAA statutory requirements and the advances in data collection and transmission technology, FDA believes this rulemaking is the preferable alternative. Anticipated Cost and Benefits: The Agency believes that there may be some one-time costs associated with the rulemaking, which involve resource costs of familiarizing users with the electronic system. Recurring costs related to submission of the information by domestic firms would probably remain the same or decrease because a paper submission and postage is not required. There might be some increase in the financial burden on foreign firms since they will have to supply additional registration information as required by section 321 of the BT Act. Risks: None Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 03/26/10 75 FR 14510 NPRM Comment Period End 06/24/10 Final Rule 09/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Nancy Pirt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health WO 66 Room 4438 10903 New Hampshire Avenue Silver Spring, MD 20993 Phone: 301 796-6248 Fax: 301 847-8145 Email: nancy.pirt@fda.hhs.gov RIN: 0910-AF88 _______________________________________________________________________ <###doc> HHS--Centers for Medicare & Medicaid Services (CMS) ----------- PROPOSED RULE STAGE ----------- <###doc> 53. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: NOTIFICATION OF FACILITY CLOSURE (CMS-3230-IFC) Priority: Other Significant Legal Authority: PL 111-148, sec 6113 CFR Citation: 42 CFR 483; 42 CFR 488; 42 CFR 489 Legal Deadline: Final, Statutory, March 23, 2011. Abstract: This rule would ensure that, in the case of a facility closure, any individual who is the administrator of the facility provides written notification of closure and the plan for the relocation of residents at least 60 days prior to the impending closure, or if the facility's participation in Medicare or Medicaid is terminated, not later than the date the HHS Secretary determines appropriate. Statement of Need: Section 6113 of the Affordable Care Act of 2010 (ACA) amends the Act by setting forth certain requirements for LTC facility closures to ensure that, among other things, in the case of a facility closure, any individual who is the administrator of the facility provides written notification of the closure and a plan for the relocation of residents at least 60 days prior to the impending closure or, if the Secretary terminates the facility's participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate. Summary of Legal Basis: Sections 1819(b)(1)(A) of the Social Security Act (the Act) for NFs and 1919 (b)(1)(A) for SNFs state that a skilled nursing facility must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident. Sections 1819(c)(2)(A) and 1919 (c)(2)(A) of the Act state that, in general, with certain specified exceptions, a nursing facility must permit each resident to remain in the facility and must not transfer or discharge the resident from the facility. Section 6113 of ACA amends section 1128I of the Act by setting forth certain requirements for LTC facility closures. Alternatives: None. This implements a statutory requirement. Anticipated Cost and Benefits: The costs associated with the implementation of this rule are related to the efforts made by each facility to develop a plan for closure. The benefits would include the protection of residents' health and safety and a smooth transition for residents who need to be relocated, as well as their family members and facility staff. Risks: LTC facility closures have implications related to access, the quality of care, availability of services, and the overall health of residents. Without an organized process for facilities to follow in the event of a nursing home closure, there is a risk to the health and safety of residents. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 02/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None [[Page 79531]] Agency Contact: Patricia Brooks Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Office of Clinical Standards and Quality Mailstop S3-02-01 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-4561 Email: patricia.brooks@cms.hhs.gov RIN: 0938-AQ09 _______________________________________________________________________ <###doc> HHS--CMS <###doc> 54. MEDICARE SHARED SAVINGS PROGRAM: ACCOUNTABLE CARE ORGANIZATIONS (CMS-1345-P) Priority: Other Significant Legal Authority: PL 111-148, sec 3022 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, January 1, 2012. Abstract: This rule would propose a shared savings program for provider groups to establish Accountable Care Organizations, agree to meet quality measures, and share in savings generated for Medicare by meeting certain benchmarks. Consistent with section 3022 of the Affordable Care Act of 2010, the shared savings program must be established by January 1, 2012. Statement of Need: This rule would propose a shared savings program for provider groups to establish Accountable Care Organizations (ACOs), agree to meet quality measures, and share in savings generated for Medicare by meeting certain cost and quality benchmarks beginning January 1, 2012. This rule is aimed at improving quality and Medicare expenditures for Medicare beneficiaries and the Medicare program. Summary of Legal Basis: Section 3022 of the Affordable Care Act of 2010 requires the Secretary to establish a shared savings program by January 1, 2012. Alternatives: None. This is a statutory requirement. Anticipated Cost and Benefits: Medicare expenditures will be adjusted beginning January 1, 2012. Risks: If this regulation is not published, the shared savings program will not be established by January 1, 2012, as required by ACA, thereby violating the statute. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 01/00/11 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Terri Postma Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C5-01-14 7500 Seurity Boulevard Baltimore, MD 21244 Phone: 410 786-4169 Email: terri.postma@cms.hhs.gov RIN: 0938-AQ22 _______________________________________________________________________ <###doc> HHS--CMS <###doc> 55. PROPOSED CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2012 RATES AND TO THE LONG-TERM CARE HOSPITAL PPS AND RY 2012 RATES (CMS-1518-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: sec 1886(d) of the Social Security Act CFR Citation: 42 CFR 412 Legal Deadline: NPRM, Statutory, April 1, 2011. Final, Statutory, August 1, 2011. Abstract: This annual major proposed rule would revise the Medicare hospital inpatient and long-term care prospective payment systems (IPPS) for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems. Statement of Need: CMS annually revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. In addition, we describe the proposed changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. Also, CMS annually updates the payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The proposed rule solicits comments on the proposed IPPS and LTCH payment rates and new policies. CMS will issue a final rule containing the payment rates for the FY 2012 IPPS and LTCHs at least 60 days before October 1, 2011. Summary of Legal Basis: The Social Security Act (the Act) sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. The Act requires the Secretary to pay for the capital-related costs of hospital inpatient and Long-Term Care stays under a PPS. Under these PPSs, Medicare payment for hospital inpatient and Long-Term Care operating and capital-related costs is made at predetermined, specific rates for each hospital discharge. These changes would be applicable to services furnished on or after October 1, 2011. Alternatives: None. This implements a statutory requirement. Anticipated Cost and Benefits: Total expenditures will be adjusted for FY 2012. Risks: If this regulation is not published timely, inpatient hospital and LTCH services will not be paid appropriately beginning October 1, 2011. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 04/00/11 Regulatory Flexibility Analysis Required: Yes [[Page 79532]] Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Tiffany Swygert Health Insurance Specialist, Division of Acute Care, Hospital and Ambulatory Policy Group Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop C4-25-11 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-4642 Email: tiffany.swygert@cms.hhs.gov RIN: 0938-AQ24 _______________________________________________________________________ <###doc> HHS--CMS <###doc> 56. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE AND PART B FOR CY 2012 (CMS-1524-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Social security Act, sec 1102; Social Security Act, sec 1871 CFR Citation: 42 CFR 405; 42 CFR 410 to 411; 42 CFR 413 to 414; 42 CFR 426 Legal Deadline: Final, Statutory, November 1, 2011. The statute requires that the final rule be issued by November. Abstract: This proposed rule would revise payment polices under the physician fee schedule, as well as other policy changes to payment under Part B. These changes would be applicable to services furnished on or after January 1, annually. Statement of Need: The statute requires that we establish each year, by regulation, payment amounts for all physicians' services furnished in all fee schedule areas. This major proposed rule would make changes affecting Medicare Part B payment to physicians and other Part B suppliers. The final rule has a statutory publication date of November 1, 2011, and an implementation date of January 1, 2012. Summary of Legal Basis: Section 1848 of the Social Security Act (the Act) establishes the payment for physician services provided under Medicare. Section 1848 of the Act imposes a deadline of no later than November 1 for publication of the final physician fee schedule rule. Alternatives: None. This implements a statutory requirement. Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2012. Risks: If this regulation is not published timely, physician services will not be paid appropriately. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 06/00/11 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Carol Bazell Director, Division of Practitioner Services Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C4-03-06 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-6960 Email: carol.bazell@cms.hhs gov RIN: 0938-AQ25 _______________________________________________________________________ <###doc> HHS--CMS <###doc> 57. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2012 (CMS- 1525-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: sec 1833 of the Social Security Act CFR Citation: 42 CFR 410; 42 CFR 416 ; 42 CFR 419 Legal Deadline: Final, Statutory, November 1, 2011. Abstract: This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The proposed rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the Ambulatory Surgical Center Payment System list of services and rates. Statement of Need: Medicare pays over 4,000 hospitals for outpatient department services under the hospital outpatient prospective payment system (OPPS). The OPPS is based on groups of clinically similar services called ambulatory payment classification groups (APCs). CMS annually revises the APC payment amounts based on the most recent claims data, proposes new payment policies, and updates the payments for inflation using the hospital operating market basket. The proposed rule solicits comments on the proposed OPPS payment rates and new policies. Medicare pays roughly 5,000 Ambulatory Surgical Centers (ASCs) under the ASC payment system. CMS annually revises the payment under the ASC payment system, proposes new policies, and updates payments for inflation using the Consumer Price Index for All Urban Consumers (CPI-U). CMS will issue a final rule containing the payment rates for the 2012 OPPS and ASC payment system at least 60 days before January 1, 2012. Summary of Legal Basis: Section 1833 of the Social Security Act establishes Medicare payment for hospital outpatient services and ASC services. The final rule revises the Medicare hospital OPPS and ASC payment system to implement applicable statutory requirements. In addition, the proposed and final rules describe changes to the outpatient APC system, relative payment weights, outlier adjustments, and other amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the [[Page 79533]] prospective payment system as well as changes to the rates and services paid under the ASC payment system. These changes would be applicable to services furnished on or after January 1, 2012. Alternatives: None. This is a statutory requirement. Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2012. Risks: If this regulation is not published timely, outpatient hospital and ASC services will not be paid appropriately beginning January 1, 2012. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 06/00/11 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Federalism: Undetermined Agency Contact: Alberta Dwivedi Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop C5-01-26 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-0763 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938-AQ26 _______________________________________________________________________ <###doc> HHS--CMS ----------- FINAL RULE STAGE ----------- <###doc> 58. CIVIL MONEY PENALTIES FOR NURSING HOMES (CMS-2435-F) Priority: Other Significant Legal Authority: 42 USC 1302 and 1395 (hh) CFR Citation: 42 CFR 488 Legal Deadline: Final, Statutory, March 23, 2011, 1 year after enactment of PPACA. Abstract: This rule revises and expands current Medicare and Medicaid regulations regarding the imposition of civil money penalties by CMS when nursing homes are not in compliance with Federal participation requirements. Statement of Need: The intent of this final rule is to improve the efficiency and effectiveness of the nursing home enforcement process, particularly as it relates to civil money penalties imposed by CMS. The new provisions will reduce the delay between the identification of problems with noncompliance and the effect of certain penalties that are intended to motivate a nursing home to maintain continuous compliance with basic expectations regarding the provision of quality care. The new provisions also eliminate a facility's ability to significantly defer the direct financial effect of an applicable civil monetary penalty until after an often long litigation process. Specifically, this rule would allow for civil money penalty reductions when facilities self- report and promptly correct their noncompliance; offer, in cases where civil money penalties are imposed, an independent informal dispute resolution process where interests of both facilities and residents are represented and balanced; provide for the establishment of an escrow account where civil money penalties may be placed until any applicable administrative appeal processes have been completed; and improve the extent to which civil money penalties collected from Medicare facilities can benefit nursing home residents. Through the proposed revisions, we intend to directly promote and improve the health, safety, and overall well-being of residents. Summary of Legal Basis: Section 6111 of the Affordable Care Act of 2010 amended the Act to incorporate specific provisions pertaining to the imposition and collection of civil money penalties when facilities do not meet Medicare and Medicaid participation requirements. Alternatives: None. This rule implements a statutory requirement. The proposed rule was published on July 12, 2010. Alternatives proposed by commenters will be considered in the preparation of the final rule. Anticipated Cost and Benefits: The regulatory impact statement provides that these regulatory proposals would have no consequential effect on State, local, or tribal governments or on the private sector. The anticipated benefits of this regulation include stronger protections for nursing home residents, improved due process for nursing homes, incentives for prompt self- correction of deficiencies, and increased quality improvement. Risks: CMS does not expect any additional risks to providers and/or States as a result of the implementation of this rule. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 07/12/10 75 FR 39641 NPRM Comment Period End 08/11/10 Final Action 03/00/11 Regulatory Flexibility Analysis Required: No Government Levels Affected: State Agency Contact: Dr. Lori Chapman Acting Director, Division of State Demonstrations and Waivers Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21220 Phone: 410 786-9254 Email: lori.chapman@cms.hhs.gov RIN: 0938-AQ02 _______________________________________________________________________ <###doc> HHS--Administration for Children and Families (ACF) ----------- PROPOSED RULE STAGE ----------- <###doc> 59. DESIGNATION RENEWAL OF HEAD START GRANTEES Priority: Other Significant Legal Authority: Improving Head Start for School Readiness Act of 2007, PL 110-134 CFR Citation: Not Yet Determined [[Page 79534]] Legal Deadline: None Abstract: This rule would implement provisions of the Improving Head Start for School Readiness Act of 2007 (Pub. L. 110-134), requiring the Secretary to develop a system that will evaluate each grantee's performance every 5 years to determine which grantees are providing services of such high quality that they should be given another 5-year grant without needing to recompete for the grant. Statement of Need: The Administration for Children and Families will issue rules to amend 45 CFR chapter XIII by adding a new part 1307, Policies and Procedures for Designation Renewal of Head Start and Early Head Start Grantees, in order to respond to the statutory requirements of The Improving Head Start for School Readiness Act of 2007, which establishes that Head Start grantees will be awarded grants for a 5-year period and only grantees delivering high quality services will be given another 5-year grant non-competitively. These regulations will describe the proposed system for designation renewal, including a proposal to transition all current continuous grants into 5-year grants over a 3-year period. These regulations will encourage excellence, establish accountability for poor performance, and open up Head Start to new energetic organizations that may have great capacity to run high quality programs. Summary of Legal Basis: Section 641 of the Head Start Act requires the Secretary of HHS to develop and implement a system for designation renewal (e.g., Designation Renewal System (DRS)) to determine if a Head Start agency is delivering a high-quality and comprehensive Head Start program that meets the educational, health, nutritional, and social needs of the children and families it serves and publish a notice in the Federal Register describing a proposed system for designation renewal, including a proposal for the transition to such system. Alternatives: The Administration for Children and Families is statutorily mandated to develop and implement a system for designation renewal. As a precursor to developing the system, the Head Start Act required the Secretary to establish an Advisory Committee to inform the development of a DRS and make recommendations to the Secretary. We are proposing to adopt the majority of the Advisory Committee's recommendations in whole or with minor modifications. In addition, we are considering additional and alternative criteria to be incorporated into the system for designation renewal, and ask for public comments regarding numerous provisions of the rule, as described in the preamble. Anticipated Cost and Benefits: The Agency estimates the costs of implementing the new reporting requirements described in the rule will be approximately $20,000 annually. In addition, at least 25 percent of grantees reviewed in a year will be required to submit a competitive application for a new 5- year grant, at an estimated cost of less than $1,500 for each grantee. In terms of benefits, the proposed system will fund only high- performing grantees in order to ensure the best services for Head Start children are provided and child outcomes are improved. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/22/10 75 FR 57704 NPRM Comment Period End 12/21/10 Final Action 09/00/11 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Collen Rathgeb Department of Health and Human Services Administration for Children and Families 1250 Maryland Avenue SW. Washington, DC 20447 Phone: 202 205-7378 Email: crathgeb@acf.hhs.gov RIN: 0970-AC44 _______________________________________________________________________ <###doc> HHS--Administration on Aging (AOA) ----------- PROPOSED RULE STAGE ----------- <###doc> 60.