[NCCDPHP] Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System

Forms and Documents

Document Name	Status
Form 0920-0612 WISEWOMAN Program Minimum Data Elements (MDE) Form and Instruction	Modified
Annual Progress Report Form and Instruction	Modified
Attachment 9 Summary Exhibits_Minor Changes_04082025.pdf Supplementary Document	2025-04-08
WISEWOMAN 0920-0612 SSB F_Updated_04072025.docx Supporting Statement B	2025-04-08
WISEWOMAN 0920-0612 SSA F_Updated_04072025.docx Supporting Statement A	2025-04-08
WISEWOMAN SPD-15 Justification.docx Supplementary Document	2025-03-12
Attachment 1b WISEWOMAN Program Managers Directors and Data Managers.pdf Supplementary Document	2025-03-12
Attachment 5b Web Portal Upload Screen Shot.pdf Supplementary Document	2025-03-12
Attachment 5a Web Portal Login Screen.pdf Supplementary Document	2025-03-12
Attachment 7b_WISEWOMANFederalRegisterNotice2024.pdf Supplementary Document	2025-03-12
Attachment 1a Map of WISEWOMAN Awardees.pdf Supplementary Document	2025-03-12
OMB Change Request_08182023.docx Justification for No Material/Nonsubstantive Change	2023-08-22
OMB Change Request_04182023.docx Justification for No Material/Nonsubstantive Change	2023-04-18
Att 7 Consent Guidance.pdf Supplementary Document	2022-08-11
60-day FRN_06022022.pdf Supplementary Document	2022-08-11
Att 2b WISEWOMAN Prg Mgrs Dirs Data Mgrs.pdf Supplementary Document	2022-08-11
Att 2a WISEWOMAN Awardees Map.png Supplementary Document	2022-08-11
Att 1b Sec 301 PHSA.pdf Supplementary Document	2022-08-11
Att 1a NBCCEDP Law Statute.pdf Supplementary Document	2022-08-11

IC Document Collections

IC ID	Document Title	Status
37802	WISEWOMAN Program Minimum Data Elements (MDE) Form and Instruction	Modified
191867	Annual Progress Report Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0612	ICR Reference No: 202502-0920-014
Status: Received in OIRA	Previous ICR Reference No: 202308-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0612
Title: [NCCDPHP] Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/25/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	120	0
Time Burden (Hours)	2,640	0
Cost Burden (Dollars)	0	0

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Abstract: The WISEWOMAN program focuses on reducing risk factors for cardiovascular disease (CVD) among at-risk participants. Addressing risk factors such as high blood pressure, elevated blood cholesterol, obesity, sedentary lifestyle, diabetes, and smoking, reduces a woman’s risk of CVD-related illness and death. CVD, is a primary contributor to mortality, morbidity, and decreased quality of life, especially among older participants. Health United States (2019) reported that CVD was the leading cause of death for women in the United States. Participants in lower income brackets, or without health insurance have an increased risk of CVD morbidity and mortality, because they have limited access to health services such as screenings, medications, healthy behavior support services to manage their risk factors. State, and tribal organizations awarded with WISEWOMAN grants are expected to report information pertaining to the aforementioned factors for the purposes of program evaluation. The WISEWOMAN program shares 8 data elements with the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) so the burden of collecting additional information by awardees (see Attachment 3) is minimized. Overall, there are no changes to the number of awardees (respondents), the information collection requirements, the estimated burden per response, or the total estimated annualized burden hours. This Revision request for WISEWOMAN Program replaces the current race MDE with OMB 2024 Statistical Policy Directive-15 Standard (Figure 2). Two additional questions from the PRAPARE Screening Tool will be added for program fidelity and data quality.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
   PL: Pub.L. 101 - 354 300 Name of Law: The Breast and Cervical Cancer Mortality Prevention Act of 1990
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 85213	10/25/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 24612	06/11/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Annual Progress Report	0920-0621, None	WISEWOMAN Annual Progress Report ,   WISEWOMAN-MDE_Annual Progress Report
WISEWOMAN Program Minimum Data Elements (MDE)	0920-0612, 0920-0621	WISEWOMAN Program MDE Manual Edition 18.3R ,   WISEWOMAN-MDE_Manual_23.1

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	120	0	0	0	0	120
Annual Time Burden (Hours)	2,640	0	0	0	0	2,640
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $382,756

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/25/2025

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