42 C.F.R. Subpart B: Sterilization of Persons in Federally Assisted Family Planning Projects

Forms and Documents

Document Name	Status
Form 0937-0166 Record-keeping for Sterilization Consent Form Form	Modified
30 Day FRN sterilization.pdf Supplementary Document	2022-05-09
Updated 05092022_FINAL Supporting Statement - 0937-0166 sterilization 2022 30-day_clean.docx Supporting Statement A	2022-05-09
2022-03130 60D FRN.pdf Supplementary Document	2022-04-28

IC Document Collections

IC ID	Document Title	Status
7740	Information disclosure for sterilization consent forms Other-disclosure consent form	Modified
191181	Record-keeping for Sterilization Consent Form Form	Modified

ICR Details

OMB Control No: 0937-0166	ICR Reference No: 202204-0937-001
Status: Received in OIRA	Previous ICR Reference No: 201810-0937-003
Agency/Subagency: HHS/OASH	Agency Tracking No:
Title: 42 C.F.R. Subpart B: Sterilization of Persons in Federally Assisted Family Planning Projects
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: 05/09/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	200,000	0
Time Burden (Hours)	125,000	0
Cost Burden (Dollars)	0	0

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Abstract: These regulations and informed consent procedures are associated with Federally funding sterilization services. Selected consent forms are audited during the site visits and program reviews by Federal programs to ensure compliance with the regulations and protection of individual's rights.

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Authorizing Statute(s): PL: Pub.L. 42 - 241 301 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:
	87 FR 8594	02/15/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 27651	05/09/2022
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
Information disclosure for sterilization consent forms
Record-keeping for Sterilization Consent Form	0937-0166	Sterilization Consent Form

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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	200,000	0	0	0	0	200,000
Annual Time Burden (Hours)	125,000	0	0	0	0	125,000
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: $27,500

Does this IC contain surveys, censuses, or employ statistical methods? No

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.     Yes

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.     Yes

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: 05/09/2022

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