2013-12406. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-7570 or send comments to Ron Otten, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to [e-mail].

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; and (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. Written comments should be received within 60 days of this notice.

Proposed Project

Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System (OMB #0920-0612, exp. 1/31/2014)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Cardiovascular disease (CVD), which includes heart disease, myocardial infarction, and stroke, is the leading cause of death for women in the United States, and is largely preventable. The WISEWOMAN program (Well-Integrated Screening and Evaluation for Women Across the Nation), administered by the Centers for Disease Control and Prevention (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 CVD. The program focuses on reducing CVD risk factors and provides screening services for select 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 currently provides services to approximately 45,000 women who are jointly enrolled in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), also administered by CDC. The current cooperative agreements for WISEWOMAN awardees end June 30, 2013 and final submissions to CDC are due no later than October 31, 2013. CDC obtained OMB approval to collect information from these awardees through the “WISEWOMAN Reporting System,” OMB No. 0920-0612, exp. 1/31/2014. The information submitted to CDC includes semi-annual progress reports and minimum data elements (MDE) that are also submitted twice per year.

The WISEWOMAN program will continue under a new set of four-year cooperative agreements that begin July 1, 2013 and end June 30, 2017. The new funding period will reflect an increased emphasis on efficient oversight of program awardees and documenting program outcomes. As a result, the WISEWOMAN information collection will be revised to support updated program goals. Changes to be implemented in the new cooperative agreement funding cycle include a reduction in the frequency of progress report submission—from twice per year to once per year—and changes to the content of the MDE submissions. The first reports based on the revised reporting requirements will be submitted to CDC in April 2014.

The hardcopy progress report provides a narrative summary of each awardee's objectives and the activities undertaken to meet program goals, including public education and outreach. The estimated burden per response is 8 hours. In the new cooperative agreement cycle, the frequency of response will decrease from twice per year to once per year, resulting in a net decrease in respondent burden for progress reporting. In the future, CDC may transition from a hardcopy report to MIS-based progress reporting.

The MDE information submitted to CDC includes baseline and follow-up data (12 months post enrollment) for all women served through the WISEWOMAN program. The MDE describe risk factors for the women served in each program and the number and type of lifestyle program sessions they attend. The information allows CDC to assess the effectiveness of the WISEWOMAN program in reducing the burden of cardiovascular disease risk factors among women who utilize program services. MDE information may also be utilized in assessments of WISEWOMAN program impact and cost-effectiveness. MDE information has previously been submitted to CDC in two electronic transmissions: the burden for Screening and Assessment MDE was estimated at 16 hours per response and the burden for Lifestyle Intervention MDE was estimated at 8 hours per response. Under the new WISEWOMAN cooperative agreements, the MDE will be submitted as a single electronic file with a combined estimated burden per response of 24 hours. The total number of MDE variables will increase from 66 to 87. The number of variables relating to Lifestyle Interventions will decrease and the number of variables relating to Screening and Assessment will increase.

CDC will continue to use the information collected from WISEWOMAN awardees to support continuous 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, to improve the availability of screening and diagnostic services for under-served women, ensure the quality of services provided to under-served women, and develop strategies for improved interventions.

The estimated number of WISEWOMAN awardees is 21 but may be adjusted when new cooperative agreements are issued. Participation in this information collection is required as a condition of cooperative agreement funding. 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 hrs)	Total burden (in hrs)
WISEWOMAN Grantees	Screening and Assessment and Lifestyle Program MDEs	21	2	24	1,008
	Annual Progress Report	21	1	8	168
Total					1,176

Ron A. Otten,

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