Women’s Health Needs Study: The Health of US-Resident Women from Countries with Prevalent Female Genital Mutilation/Cutting (FGM/C)

Forms and Documents

Document Name	Status
0920-1264_Change Packet 2_052120.docx Justification for No Material/Nonsubstantive Change	2020-06-10
0920-1264_Change Request reimbursement_01 22 2020.docx Justification for No Material/Nonsubstantive Change	2020-01-27
SSA WHNS _5_15_2019.docx Supporting Statement A	2019-05-23
Attachment J_Study Contact Information.docx Supplementary Document	2019-02-07
Attachment I WHNS Study Invite Card.docx Supplementary Document	2019-02-07
Att E CDC IRB approval WHNS.doc Supplementary Document	2019-02-07
Att D_PIA WHNS (09-28-18).pdf Supplementary Document	2019-02-07
Att C1_60 Day FRN.pdf Supplementary Document	2019-02-07
Att B Advisory Panel Experts Consulted_11-13-2017.docx Supplementary Document	2019-02-07
Att A Authorizing Legislation - WHNS_PHS Act (42 USC 241).pdf Supplementary Document	2019-02-07
SS B_WHNS_5_15_2019.docx Supporting Statement B	2019-05-23

IC Document Collections

IC ID	Document Title	Status
234873	Women's Health Needs STUDY_QUESTIONNAIRE Other-WORD Somali translations	Modified
234870	Women's Health Needs STUDY_SCREENER Other-WORD: French translation	Modified

ICR Details

OMB Control No: 0920-1264	ICR Reference No: 202006-0920-006
Status: Historical Active	Previous ICR Reference No: 202001-0920-016
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1264-20OZ
Title: Women’s Health Needs Study: The Health of US-Resident Women from Countries with Prevalent Female Genital Mutilation/Cutting (FGM/C)
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: 06/23/2020
	Date Received in OIRA: 06/11/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2022	05/31/2022	05/31/2022
Responses	5,744	0	1,067
Time Burden (Hours)	604	0	356
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this change request is to seek approval for changes based on the pilot results. These changes include: 1) changes in the language translations in which study materials will be provided; 2) modifications to the screening instrument and study questionnaire based on pilot feedback; and 3) an increase in the sample size and burden estimates. This study will assess the health characteristic, experiences, and needs of women living in the United States who have experienced Female Genital Mutilation/Cutting (FGM/C) or are at risk for FGM/C because they or their mothers were born in a country where FGM/C is prevalent. Using a venue-based and respondent-driven sampling method for recruiting hard-to-reach populations, women who are eligible and consent will be asked to complete a one-time survey. This is a request to increase the incentive amounts to improve participation rates.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	83 FR 12194	03/20/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 2509	02/07/2019
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
Women's Health Needs STUDY_QUESTIONNAIRE	0920-1264	Women's Health Need Study (revised)
Women's Health Needs STUDY_SCREENER	0920-1264	Women's Health Need STUDY_ Eligibility Screener

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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	5,744	1,067	0	4,677	0	0
Annual Time Burden (Hours)	604	356	0	248	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: Revising the study's screener helped to eliminates unnecessary questions and adds more explicit interviewer instructions. We are requesting to increase to the initially approved total sample size of 1,200 to 2,000 completed interviews. Because 101 pilot interviews have already been completed, we propose to interview 1,899 for the full study. In order to obtain 2,000 completed interviews, assuming that 35% of women screened will not be eligible and now including an estimated refusal rate of 17% among eligible women, we would need to increase the number of women screened from 2,000 to approximately 3,744 women. Overall, we estimate an annualized increase of 248 burden hours (from 356 to 604 Total Annualized Burden Hours)

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Annual Cost to Federal Government: $261,019

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: 06/11/2020

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