2022-17990. 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 effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on an existing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an existing information collection project titled WISEWOMAN National Program Evaluation. The goal of the study is to assess the implementation of the WISEWOMAN program under the current cooperative agreement and measure the effect of the program on individual, organizational, and community-level outcomes.

DATES:

CDC must receive written comments on or before October 21, 2022.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2022-0093 by either of the following methods:

• Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments.

• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal (www.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 Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS H21-8, Atlanta, Georgia 30329; Telephone: [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 the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Proposed Project

WISEWOMAN National Program Evaluation (OMB Control No. 0920-1279, Exp. 12/31/2022)—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The CDC has supported the WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation) program since 1995. The WISEWOMAN program is designed to serve low-income women ages 40-64 who have elevated risk factors for cardiovascular disease (CVD) and have no health insurance, or are underinsured for medical and preventive care services. Through the WISEWOMAN program, women have access to screening services for selected CVD risk factors such as elevated blood cholesterol, hypertension, and abnormal blood glucose levels; referrals to heathy behavior support programs; and referrals to medical care. WISEWOMAN participants must be co-enrolled in the CDC-sponsored National Breast and Cervical Cancer Early Detection Program (NBCCEDP).

The WISEWOMAN program is administered through cooperative agreements with state, territorial, or tribal health departments. Each WISEWOMAN recipient submits to CDC an annual progress report that describes program objectives and activities, and semi-annual data reports (known as minimum data elements, or MDEs) on the screening, assessment, and healthy behavior support services offered to women who participate in the program. Participant-level MDE are de-identified prior to transmission to CDC.

In 2018, CDC released the fifth funding opportunity announcement (FOA) for the WISEWOMAN program (DP18-1816), which resulted in five-year cooperative agreements with 24 state, territorial, and tribal health departments, including six new and 18 continuing awardees from the previous funding opportunity. Key program elements were retained ( e.g., provision of screening services, promotion of healthy lifestyle behaviors, and linkage to healthy behavior support services and community based resources), but a number of changes were incorporated into the program at that time. The current FOA reflects increased emphasis on three strategies to reduce CVD risk and support hypertension control and management, including: (1) tracking and monitoring clinical measures; (2) implementing team-based care; and (3) linking community resources and clinical services to support care coordination, self-management, and lifestyle change.

CDC seeks to conduct a multi-component evaluation to assess the effectiveness of the program on individual, organizational, and community-level outcomes. The in-depth assessment is designed to complement the routine progress and MDE information already being collected from WISEWOMAN program recipients. The data collection focuses on obtaining qualitative and quantitative information at the organizational and community levels about process and procedures implemented, and barriers, facilitators, and other contextual factors that affect program implementation and participant outcomes. Data collection activities include a Program Survey with all WISEWOMAN awardee programs, administered in the second and fourth program years, and a one-time site visit to each recipient spread across the three-year data collection effort. During site visits, semi-structured interviews will be conducted with WISEWOMAN staff members and staff at partner organizations, such as clinical providers and community-based resource providers, who are positioned to provide a variety of perspectives on program implementation.

OMB approval is requested for a one-year Extension. CDC requests approval for an estimated 84 annual burden hours. Participation is voluntary and there are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
WISEWOMAN Recipient Administrators	Program survey	16	1	1	16
	Site Visit Discussion Guide	8	1	90/60	12
	Innovation Site Visit Discussion Guide	2	1	45/60	2
Recipient partners	Site Visit Discussion Guide	16	1	1	16
	Innovation Site Visit Discussion Guide	2	1	45/60	2
Healthy behavior support staff	Site Visit Discussion Guide	16	1	1	16
	Innovation Site Visit Discussion Guide	2	1	45/60	2
Clinical providers	Site Visit Discussion Guide	16	1	1	16
	Innovation Site Visit Discussion Guide	2	1	45/60	2
Total					84

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.