2016-17602. 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.

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 Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System. The WISEWOMAN program aims to reduce cardiovascular disease in women ages 40-64 by providing screening services, referrals to medical care, and lifestyle intervention programs.

DATES:

Written comments must be received on or before September 26, 2016.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2016-0070 by any of the following methods:

• Federal eRulemaking Portal: Regulations.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

Well-Integrated Screening and Evaluation for Women across the Nation (WISEWOMAN) Reporting System (OMB No. 0920-0612, exp. 12/31/2016)—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The WISEWOMAN program (Well-Integrated Screening and Evaluation for Women Across the Nation), sponsored by the CDC, was established to examine ways to improve the delivery of services for women who have limited access to health care and elevated risk factors for cardiovascular disease (CVD). The program focuses on reducing CVD risk factors and provides screening services for selected risk factors such as elevated blood cholesterol, hypertension, and abnormal blood glucose levels. The program also provides women with referrals to lifestyle programs and medical care. The WISEWOMAN program provides services to women who are jointly enrolled in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), also administered by CDC.

The WISEWOMAN program is administered by state health departments and tribal programs. In 2013, new cooperative agreements were awarded under Funding Opportunity Announcement DP13-1302. These awards are currently in the final year of funding, but may be extended by CDC for one additional year, subject to the availability of funds.

CDC collects two types of information from WISEWOMAN awardees. The hardcopy Annual Progress Report provides a narrative summary of each awardee's objectives and the activities undertaken to meet program goals. The estimated burden per response is 16 hours.

In addition, each WISEWOMAN awardee submits an electronic data file to CDC twice per year. The Minimum Data Elements (MDE) file contains de-identified, client-level information about the cardiovascular disease risk factors of women served by the program, and the number and type of lifestyle program sessions they attend. The estimated burden per response for the MDE file is 24 hours.

CDC seeks a one-year extension to enable reporting for the final year of activities funded under the current cooperative agreement and the option year, subject to the availability of funds. There are no changes to the information collected, the burden per response, reporting frequency, the number of awardees, or the total annualized burden hours.

CDC will continue to use the information collected from WISEWOMAN awardees to support program monitoring and improvement activities, evaluation, and assessment of program outcomes. The overall program evaluation is designed to demonstrate how WISEWOMAN can obtain more complete health data on vulnerable populations, promote public education about disease incidence, cardiovascular disease risk-factors, health promotion, improve the availability of screening and diagnostic services for under-served women, ensure the quality of services provided to underserved women, and develop strategies for improved interventions.

OMB approval is requested for one year. Participation in this information collection is required as a condition of cooperative agreement funding. There are no costs to respondents other than their time. The total annualized burden hours are 1,344.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
WISEWOMAN Awardees	Screening and Assessment and Lifestyle Program MDEs	21	2	24	1,008
	Annual Progress Report	21	1	16	336
Total					1,344

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.