E9-7349. Revision of Organization and Conforming Changes to Regulations

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organizational changes in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.

DATES:

This rule is effective April 1, 2009.

FOR FURTHER INFORMATION CONTACT:

Vanessa Starks, Office of Management Programs (HFA-410), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4654; or Sharon Burgess, Office of Management Programs (HFA-410), 5600 Fishers Lane, Rockville, MD 20857, 301-827-2065.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is issuing this final rule to amend the agency's regulations by updating the organizational information in part 5 (21 CFR part 5). The agency has updated the references to part 5, subpart M.

The portion of this final rule updating the organizational information in part 5, subpart M is a rule of agency organization, procedure, or practice. FDA is issuing these provisions as a final rule without publishing a general notice of proposed rulemaking because such notice is not required for rules of agency organization, procedure, or practice under 5 U.S.C. 553(b)(3)(A). For the conforming changes to the other regulations, the agency finds good cause under 5 U.S.C. 553(b)(3)(B) to dispense with prior notice and comment, and good cause under 5 U.S.C. 553(d)(3) to make these conforming changes effective less than 30 days after publication because such notice and comment and delayed effective date are unnecessary and contrary to the public interest. As discussed previously, these conforming changes merely update the footnotes in part 5, subpart M. These changes do not result in any substantive change in the regulations.

II. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the principles identified in the Executive order. In addition, the final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule simply updates the organizational information, it does not impose any additional costs on industry. Consequently, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $130 million, using the most current (2007) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

III. Paperwork Reduction Act of 1995

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

IV. Environmental Impact

FDA has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

V. Federalism

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 5

• Authority delegations (Government agencies)
• Imports
• Organization and functions (Government agencies)

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority of the Commissioner of Food and Drugs, 21 CFR part 5 is amended as follows:

1. Revise part 5 to read as follows:

PART 5—ORGANIZATION

Subparts A-L—[Reserved]

Subpart M—Organization

5.1100 5.1105 5.1110

Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.

Subparts A-L—[Reserved]

Subpart M—Organization

§ 5.1100

Headquarters.

The central organization of the Food and Drug Administration consists of the following:

OFFICE OF THE COMMISSIONER.^[1]

Office of the Chief Counsel.^[2]

Office of the Administrative Law Judge.

Office of Chief of Staff.

Office of Executive Secretariat.

Office of Public Affairs.

Office of Legislation.^[3]

Office of External Relations.

Office of the Ombudsman.

Office of Scientific and Medical Programs.

Office of Critical Path.

Office of Science and Health Coordination.

Office of Orphan Products Development.

Office of Women's Health.

National Center for Toxicology Research.^[4]

Office of Management, NCTR.

Office of Executive Programs and Services, NCTR.

Office of Scientific Coordination, NCTR.

Office of Research, NCTR.

Division of Biochemical Toxicology, NCTR.

Division of Genetic and Reproductive Toxicology, NCTR.

Division of Personalized Nutrition and Medicine, NCTR.

Division of Microbiology, NCTR.

Division of Neurotoxicology, NCTR.

Division of Veterinary Services, NCTR.

Office of Regulatory Compliance and Risk Management, NCTR.

Office of Management, NCTR.

Office of Executive Programs and Services, NCTR.

Office of Scientific Coordination, NCTR.

Office of Research, NCTR.

Division of Biochemical Toxicology, NCTR.

Division of Genetic and Reproductive Toxicology, NCTR.

Division of Personalized Nutrition and Medicine, NCTR.

Division of Microbiology, NCTR.

Division of Neurotoxicology, NCTR.

Division of Veterinary Services, NCTR.

Office of Regulatory Compliance and Risk Management, NCTR.

Office of International Activities and Strategic Initiatives.³

Office of International Programs.³

Office of Pediatric Therapeutics.³

Office of Combination Products.^[5]

Office of Operations.¹

Office of Information Management.³

Division of Business Partnership and Support.

Division of Chief Information Officer Support.

Division of Systems Management.

Division of Infrastructure Operations.

Division of Technology.

Office of Management.¹

Office of Management Programs.³

Division of Human Capital Management.

Division of Freedom of Information.

Division of Dockets Management.^[6]

Office of Shared Services.⁶

Office of Acquisitions and Grants Services.

Division of Contracts and Grants Management.

Office of Financial Services.

Division of Travel Services.

Division of Payment Services.

Office of Equal Employment Opportunity and Diversity Management.³

Office of Real Property.⁶

Division of Portfolio Development.

Division of Engineering Services.

Division of Facilities Operations.

Division of Logistic Services.

Office of Field Financial and Acquisition Services.⁶

FDA Bioscience Library.⁶

Office of Financial Management.³

Division of Financial Support Services.

Division of Accounting.

Division of Budget Execution and Control.

Office of Executive Operations.³

Office of Crisis Management.¹

Office of Emergency Operations.³

Office of Security Operations.⁶

Office of Policy, Planning, and Preparedness.¹

Office of Counter-Terrorism and Emerging Threats.¹

Office of Integrity and Accountability.¹

Office of Policy and Planning.³

Office of Policy.³

Office of Planning.³

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH.^[7]

Office of the Center Director.

Office of Management.

Regulatory Information Management Staff.

Division of Planning, Evaluation, and Budget.

Division of Management Services.

Office of Compliance and Biologics Quality.

Division of Case Management.

Division of Inspection and Surveillance.

Division of Manufacturing and Product Quality.

Office of Biostatistics and Epidemiology.

Division of Biostatistics.

Division of Epidemiology.

Office of Information Management.

Division of Vaccines and Related Products Applications.

Office of Communication, Training, and Manufacturers Assistance.

Division of Disclosure and Oversight Management.

Division of Manufacturers Assistance and Training.

Division of Communication and Consumer Affairs.

Office of Biostatistics and Epidemiology.

Division of Biostatistics.

Division of Epidemiology.

Office of Information Management.

Division of Information Operations.

Division of Information Development.

Office of Cellular, Tissue, and Gene Therapies.

Division of Cell and Gene Therapies.

Division of Clinical Evaluation and Pharmacology/Toxicology Review.

Division of Human Tissues.

Information Technology Staff.

Division of Information Operations.

Division of Information Development.

Office of Blood Research and Review.

Division of Emerging and Transfusion Transmitted Diseases.

Division of Hematology.

Division of Blood Applications.

Office of Vaccines Research and Review.

Analytical Chemistry Staff.

Standards and Testing Staff.

Program Operation Staff.

Division of Bacterial, Parasitic, and Allergenic Products.

Division of Viral Products.

Division of Vaccines and Related Product Applications.

Office of Cellular, Tissue, and Gene Therapies.

Regulatory Management Staff.

Division of Cell and Gene Therapies.

Division of Clinical Evaluation and Pharmacology/Toxicology Review.

Division of Human Tissues.

Office of Communication, Training, and Manufacturers Assistance.

Division of Disclosure and Oversight Management.

Division of Manufacturers Assistance and Training.

Division of Communication and Consumer Affairs.

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION.^[8]

Office of the Center Director.

Senior Science Advisor Staff.

Executive Operations Staff.

International Staff.

Office of Management Systems.

Division of Planning and Financial Resources Management.

Division of Program Support Services.

Office of Food Defense, Communication and Emergency Response.

Division of Education and Communication.

Division of Public Health and Biostatistics.

Office of Food Safety.

Retail Food and Cooperative Programs Support Staff

Division of Seafood Science and Technology.

Division of Food Processing Science and Technology.

Division of Plant and Dairy Food Safety.

Division of Seafood Safety.

Office of Cosmetics and Colors.

Cosmetic Staff.

Division of Color Certification and Technology.

Office of Regulatory Science.

Division of Analytical Chemistry.

Division of Microbiology.

Division of Bioanalytical Chemistry.

Office of Food Additive Safety.

Senior Science and Policy Staff.

Division of Food Contact Notifications.

Division of Biotechnology and GRAS Notice Review.

Office of Compliance.

Division of Enforcement.

Division of Field Programs and Guidance.

Office of Applied Research and Safety Assessment.

Muirkirk Technical Operations Staff.

Division of Molecular Biology.

Division of Virulence Assessment.

Division of Toxicology.

Office of Regulations, Policy and Social Sciences.

Regulations and Special Government Employees Management Staff.

Office of Nutrition, Labeling and Dietary Supplements.

Food Labeling and Standards Staff.

Nutrition Programs Staff.

Infant Formula and Medical Foods Staff.

Division of Dietary Supplement Programs.

CENTER FOR DRUG EVALUATION AND RESEARCH.¹

Office of the Center Director.

Equal Employment Opportunity Staff.

Controlled Substance Staff.

Office of Regulatory Policy.

Division of Regulatory Policy I.

Division of Regulatory Policy II.

Division of Information Disclosure Policy.

Office of Management.

Division of Management and Budget.

Division of Management Services.

Office of Training and Communication.

Medwatch Staff.

Division of Library and Information Services.

Division of Training and Development.

Division of Public Affairs.

Division of Drug Information.

Office of Surveillance Research and Communication Support.

Division of Medical Errors and Technical Support.

Division of Drug Risk Evaluation.

Office of Compliance.

Division of Compliance Risk Management and Surveillance.

Division of New Drugs and Labeling Compliance.

Division of Manufacturing and Product Quality.

Division of Scientific Investigations.

Office of New Drugs.

Office of Drug Evaluation I.

Division of Cardiorenal Drug Products.

Division of Neuropharmacological Drug Products.

Division of Metabolic and Endocrine Drug Products.

Division of Pulmonary and Allergy Drug Products.

Division of Anesthetic, Critical Care and Addiction Drug Products.

Division of Oncology Drug Products.

Office of Drug Evaluation II.

Division of Metabolic and Endocrine Drug Products.

Division of Pulmonary and Allergy Drug Products.

Division of Anesthetic, Critical Care and Addiction Drug Products.

Office of Drug Evaluation III.

Division of Gastrointestinal and Coagulation Drug Products.

Division of Medical Imaging and Radiopharmaceutical Drug Products.

Division of Reproductive and Urologic Drug Products.

Office of Drug Evaluation IV.

Division of Anti-Infective Drug Products.

Division of Anti-Viral Drug Products.

Division of Special Pathogen and Immunologic Drug Products.

Office of Drug Evaluation V.

Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug Products.

Division of Dermatologic and Dental Drug Products.

Division of Over-The-Counter Drug Products.

Office of Drug Evaluation VI.

Division of Therapeutic Biological Oncology Products.

Division of Therapeutic Biological Internal Medicine Products.

Division of Review Management and Policy.

Office of Post-Marketing Drug Risk Assessment.

Division of Therapeutic Biological Oncology Products.

Division of Therapeutic Biological Internal Medicine Products.

Division of Review Management and Policy.

Office of Post-Marketing Drug Risk Assessment.

Extramural Programs Staff.

Information Technology Staff.

Division of Drug Risk Evaluation I.

Division of Drug Risk Evaluation II.

Office of Pediatric Drug Development and Program Initiatives.

Pediatric Therapeutics Staff.

Program Initiatives Staff.

Office of Pharmaceutical Science.

Quality Implementation Staff.

Operations Staff.

Informatics and Computational Safety Analysis Staff.

Office of Clinical Pharmacology and Biopharmaceutics.

Division of Pharmaceutical Evaluation I.

Division of Pharmaceutical Evaluation II.

Division of Pharmaceutical Evaluation III.¹

Office of Generic Drugs.^[9]

Division of Bioequivalence.

Division of Chemistry I.

Division of Chemistry II.

Division of Labeling and Program Support.

Division of Chemistry III.

Office of New Drug Chemistry.

Division of New Drug Chemistry I.

Division of New Drug Chemistry II.

Division of New Drug Chemistry III.

Office of Testing and Research.

Laboratory of Clinical Pharmacology.

Division of Applied Pharmacology Research.

Division of Pharmaceutical Analysis.

Division of Product Quality Research.

Office of Biotechnology Products.

Division of Monoclonal Antibodies.

Division of Therapeutic Protein.

Office of Information Technology.³

Division of Applications Development and Services.³

Division of Infrastructure Management and Service.

Office of Medical Policy.

Division of Drug Marketing, Advertising and Communication.

Office of Executive Programs.

Executive Operations Staff.

Quality Assurance Staff.

Advisors and Consultants Staff.³

Office of Translational Science.

Office of Biostatistics.

Division of Biometrics I.

Division of Biometrics II.

Division of Biometrics III.

Division of Biometrics IV.

Division of Biometrics V.

Division of Biometrics VI.

Office of Clinical Pharmacology.

Division of Clinical Pharmacology I.

Division of Clinical Pharmacology II.

Division of Clinical Pharmacology III.

Division of Clinical Pharmacology IV.

Division of Clinical Pharmacology V.

Office of Counter-Terrorism and Pediatric Drug Development.

OFFICE OF REGULATORY AFFAIRS.³

Equal Employment Opportunity Staff.

Office of Resource Management.³

Division of Planning, Evaluation, and Management.

Division of Human Resource Development.

Division of Management Operations.

Division of Personnel Operations.

Office of Information Technology.

Office of Enforcement.⁵

Division of Compliance Management and Operations.

Division of Compliance Policy.

Division of Compliance Information and Quality Assurance.

Office of Regional Operations.³

Division of Federal-State Relations.

Division of Field Science.

Division of Import Operations and Policy.

Division of Field Investigations.

Office of Criminal Investigations.^[10]

Mid-Atlantic Area Office.^[11]

Midwest Area Office.^[12]

Northeast Area Office.^[13]

Pacific Area Office.^[14]

Southeast Area Office.^[15]

Southwest Area Office.^[16]

CENTER FOR VETERINARY MEDICINE.^[17]

Office of the Center Director.

Office of Management.

Management Services Staff.

Information Resources Management Staff.

Office of New Animal Drug Evaluation.

Division of Therapeutic Drugs for Non-Food Animals.

Division of Biometrics and Production Drugs.

Division of Therapeutic Drugs for Food Animals.

Division of Human Safety.

Division of Manufacturing Technologies.

Division of Scientific Support.

Office of Surveillance and Compliance.

Division of Surveillance.

Division of Animal Feeds.

Division of Compliance.

Division of Epidemiology.

Office of Research.

Division of Residue Chemistry.

Division of Animal Research.

Division of Animal and Food Microbiology.

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH.^[18]

Office of the Center Director.

Office of Systems and Management.

Division of Ethics and Management Operations.

Division of Planning, Analysis and Finance.

Division of Information Dissemination.

Division of Information Technology.

Office of Compliance.

Promotion and Advertising Policy Staff.

Division of Bioresearch Monitoring.

Division of Program Operations.

Division of Enforcement A.

Division of Enforcement B.

Office of Device Evaluation.

Program Management Staff.

Program Operations Staff.

Division of Cardiovascular Devices.

Division of Reproductive, Abdominal, and Radiological Devices.

Division of General, Restorative, and Neurological Devices.

Division of Ophthalmic, and Ear, Nose and Throat Devices.

Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices.

Office of Science and Engineering Laboratories.¹

Division of Biology.

Management Support Staff.

Standards Management Staff.

Division of Chemistry and Materials Science.

Division of Solid and Fluid Mechanics.

Division of Physic.

Division of Imaging and Applied Mathematics.

Office of Communication, Education and Radiation Programs.

Program Operations Staff.

Regulations Staff.

Staff College.

Division of Device User Programs and Systems Analysis.

Division of Small Manufacturers Assistance.

Division of Mammography Quality and Radiation Programs.

Division of Communication Media.

Office of Surveillance and Biometrics.

Issues Management Staff.

Division of Biostatistics.

Division of Postmarket Surveillance.

Division of Surveillance Systems.

Office of In Vitro Diagnostic Device Evaluation and Safety.

Division of Chemistry and Toxicology Devices.

Division of Immunology and Hematology Devices.

Division of Microbiology.

§ 5.1105

Chief Counsel, Food and Drug Administration.

The Office of the Chief Counsel's mailing address is 5600 Fishers Lane, rm. 6-05, Rockville, MD 20857.^[1]

§ 5.1110

FDA public information offices.

(a) Division of Dockets Management (HFA-305). The Division of Dockets Management public room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852, Telephone: [phone].

(b) Division of Freedom of Information (HFI-35). The Freedom of Information public room is located in rm. 6-30, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857, Telephone: [phone].

(c) Press Relations Staff (HFI-40). Press offices are located at 10903 New Hampshire Ave., Bldg. 1, Silver Spring, MD 20993-0002, Telephone: [phone]; and at 5100 Paint Branch Pkwy., College Park, MD 20740, Telephone: [phone].

Dated: March 27, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

Footnotes

1.  Mailing address: 10903 New Hampshire Ave., Bldg. 1, Silver Spring, MD 20993-0002.

2.  The Office of the Chief Counsel (also known as the Food and Drug Division, Office of the General Counsel, Department of Health and Human Services), while administratively within the Office of the Commissioner, is part of the Office of the General Counsel of the Department of Health and Human Services.

3.  Mailing address: 5600 Fishers Lane, Rockville, MD 20852.

4.  Mailing address: 3900 NCTR Rd., Jefferson, AR 72079.

5.  Mailing address: 15800 Crabbs Branch Way, Rockville, MD 20855.

6.  Mailing address: Mailing address: 5630 Fishers Lane, Rockville, MD 20852.

7.  Mailing address: 5515 Security Ln., Rockville, MD 20852.

8.  Mailing address: 5100 Paint Branch Pkwy., College Park, MD 20740-3835.

9.  Mailing address: 7519 Standish Pl., Rockville, MD 20855.

10.  Mailing address: 7500 Standish Pl., Rockville, MD 20855.

11.  Mailing address: 11750 Beltsville Dr., Beltsville, MD 20705.

12.  Mailing address: 901 Warrenville Rd., Lisle, IL 60532.

13.  Mailing address: 10 Exchange Pl., Jersey City, NJ 07302.

14.  Mailing address: 201 Avenida Fabricante, San Clemente, CA 92672.

15.  Mailing address: 865 SW., 78th Ave., Plantation, FL 33324.

16.  Mailing address: 5799 Broadmoor St., Mission, KS 66202.

17.  Mailing address: 7500 Standish Pl. (MPN-2), Rockville, MD 20855.

18.  Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.

1.  The Office of the Chief Counsel (also known as the Food and Drug Division, Office of the General Counsel, Department of Health and Human Services), while administratively within the Office of the Commissioner, is part of the Office of the General Counsel of the Department of Health and Human Services.