[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
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
0920-0612 SSB_08032022.docx Supporting Statement B	2022-08-11
0920-0612 SSA_08032022.docx Supporting Statement A	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: 202308-0920-009
Status: Active	Previous ICR Reference No: 202304-0920-005
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0612-23HT
Title: [NCCDPHP] Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/23/2023
	Date Received in OIRA: 08/23/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2025	03/31/2025	03/31/2025
Responses	120	0	105
Time Burden (Hours)	2,640	0	2,310
Cost Burden (Dollars)	0	0	0

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Abstract: CDC requests OMB approval for 11 additional data elements that align with the current purpose and scope of existing WISEWOMAN data elements. The additional MDE will strengthen: • Program fidelity: Proposed additional elements will involve ascertaining social needs and will help decipher ways to mitigate barriers that are preventing active participation in the WISEWOMAN program. These proposed changes will improve CDC’s ability to improve CVD risk analysis and program efficacy. • Data Quality: Proposed changes to MDEs provide companion data to existing data elements to provide a more complete picture for underserved women in the WISEWOMAN Program. This request is a refinement of our current data approach of continuously serving underserved populations and also in line with HHS’s current health equity goals.

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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:
	87 FR 33487	06/02/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 49848	08/12/2022
Did the Agency receive public comments on this ICR? No

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

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

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ICR Summary of Burden

	Total Approved	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	105	0	15	0	0
Annual Time Burden (Hours)	2,640	2,310	0	330	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This request is a refinement of our current data approach of continuously serving underserved populations and also in line with HHS’s current health equity goals. The additional data element and refinement of an existing data element emanate from the upcoming cooperative agreement (CDC-RFA-DP-23-0003) that was published in late March and application process is ongoing. This additional MDE and refinement of an existing MDE will help improve analytical utility, program fidelity, and data quality and will have negligible impact on burden hours. Overall, if approved the total number of MDEs will be 71. CDC is submitting this change request to OMB to provide Minimum Data Elements implementation guidance to programs for the new program year, which begins at the end of September 2023. The change in burden with the addition of one MDE and minor revision of an existing MDE question in non-substantive. Only the total estimated annualized burden hours are being updated to reflect 40 programs.

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Annual Cost to Federal Government: $384,750

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: 08/23/2023

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