For HHS/OASH Consultation Process, Institutional Review Board (IRB) Records

Forms and Documents

Document Name	Status
Supporting StatementvNew PRA_30-Day_IRB Records for HHS Consultation Process_December 2021.pdf Supporting Statement A	2021-12-30
Response to Commenter_New ICR _IRB Records for HHS Consultation Process_10 2021.pdf Supplementary Document	2021-12-14
45 CFR part 46.pdf Supplementary Document	2021-07-27

IC Document Collections

IC ID	Document Title	Status
248565	Protection of Human Subjects	New

ICR Details

OMB Control No:	ICR Reference No: 202107-0990-004
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: For HHS/OASH Consultation Process, Institutional Review Board (IRB) Records
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/05/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	10	0
Time Burden (Hours)	10	0
Cost Burden (Dollars)	0	0

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Abstract: The Office for Human Research Protections is requesting a new approval from the Office of Management and Budget of an Office for Human Research Protections (OHRP) requirement that Institutional Review Board records be submitted when an IRB or its institution request an HHS consultation process, for proposed research involving, respectively: (1) pregnant women, human fetuses or neonates; (2) prisoners; or, (3) children, as subjects that are not otherwise approvable by an IRB.

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Authorizing Statute(s): PL: Pub.L. 99 - 158 491(a) Name of Law: Protection of Human Subjects
  

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:
	86 FR 40860	07/29/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 462	01/05/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Protection of Human Subjects

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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	10	0	0	10	0	0
Annual Time Burden (Hours)	10	0	0	10	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: New

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Annual Cost to Federal Government: $9,981

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.     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: 01/05/2022

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