2016-00939. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the information collection project entitled “Colorectal Cancer Control Program CRCCP) Monitoring Activities”. CDC is requesting a reinstatement with change of OMB No. 0920-1074 to include a redesigned survey and a new clinic-level data collection.

DATES:

Written comments must be received on or before March 21, 2016.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2016-0006 by any of the following methods:

Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.

Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

Please note:

All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

Proposed Project

Colorectal Cancer Control Program (CRCCP) Monitoring Activities—(OMB No. 0920-1074, exp. 12/31/2015)—Reinstatement with Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is requesting a reinstatement with change of the information collection with the OMB Control number 0920-1074, formerly entitled “Annual Survey of Colorectal Cancer Control Activities Conducted by States and Tribal Organizations.” In the previous OMB approval period, information collection consisted of an annual grantee survey. In the next OMB approval period, information collection will consist of a redesigned survey and a new clinic-level data collection. The number of respondents will increase and the total estimated annualized burden will increase.

Among cancers that affect both men and women, colorectal cancer (CRC) is the second leading cause of death from cancer in the United States. CRC screening has been shown to reduce incidence of and death from the disease. Screening for CRC can detect disease early when treatment is more effective and prevent cancer by finding and removing precancerous polyps. Of individuals diagnosed with early stage CRC, more than 90% live five or more years. Despite strong evidence supporting screening, only 65% of adults currently report being up-to-date with CRC screening as recommended by the U.S. Preventive Services Task Force, with more than 22 million age-eligible adults estimated to be untested. To reduce CRC morbidity, mortality, and associated costs, use of CRC screening tests must be increased among age-eligible adults with the lowest CRC screening rates.

CDC's Colorectal Cancer Control Program (CRCCP) currently provides funding to 31 grantees under “Organized Approaches to Increase Colorectal Cancer Screening” (CDC-RFA-DP15-1502). CRCCP grantees include state governments or bona-fide agents, universities, and tribal organizations. The purpose of the new cooperative agreement program is to increase CRC screening rates among an applicant defined target population of persons 50-75 years of age within a partner health system serving a defined geographical area or disparate population.

The CRCCP was significantly redesigned in 2015 and has two components. Under Component 1, all 31 CRCCP grantees receive funding to support partnerships with health systems to implement up to four priority evidence-based interventions (EBIs) described in the Guide to Community Preventive Services, as well as other supporting strategies. Grantees must implement at least two EBIs in each partnering health system. Under Component 2, 6 of the 31 CRCCP grantees will provide direct screening and follow-up clinical services for a limited number of individuals aged 50-64 in the program's priority population who are asymptomatic, at average risk for CRC, have inadequate or no health insurance for CRC screening, and are low income

Based on the redesigned CRCCP, the information collection plan has also been redesigned to address the two program components. The new cooperative agreement program (CDC-RFA-DP15-1502) requires that CDC monitor and evaluate the CRCCP and individual grantee performance using both process and outcome evaluation. Two forms of data collection are proposed. First, the CRCCP grantee survey was redesigned to align with new CRCCP goals. The grantee survey will be submitted to CDC annually. Second, CDC proposes to collect clinic-level data to assess changes in CDC's primary outcome of interest, i.e., CRC screening rates within partner health systems. Each grantee will complete a clinic-level data template once per month. All information will be reported to CDC electronically.

The information collection will enable CDC to gauge progress in meeting CRCCP program goals and to monitor implementation activities, evaluate outcomes, and identify grantee technical assistance needs. In addition, findings will inform program improvement and help identify successful activities that need to be maintained, replicated, or expanded.

OMB approval is requested for three years. Participation is required for CRCCP awardees. There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hr)	Total burden (in hr)
CRCCP Grantees	CRCCP Annual Grantee Survey	31	1	45/60	23
	CRCCP Clinic-level Data Collection Template	31	12	30/60	186
Total					209

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.