PROPOSED RULE: Protection of Human Subjects and Institutional Review Boards; Harmonization with the Common Rule

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
HSP and IRBs Proposed Rule SSA SEPT 2022 RIN AI07.docx	Supporting Statement A	Uploaded 2024-02-12	Repair queued
RIN AI07 PRIA SEPT 2022 FDA-2021-N-0286.pdf	Supplementary Document	Uploaded 2024-02-12	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
265142	21 CFR part 812 revisions - disclosure		New
265141	21 CFR parts 50 and 56 revisions - recordkeeping		New
265140	21 CFR parts 50 and 56 revisions - disclosures		New

ICR Details

OMB Control No: 0910-0926	ICR Reference No: 202402-0910-002
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: OC/OCPP
Title: PROPOSED RULE: Protection of Human Subjects and Institutional Review Boards; Harmonization with the Common Rule
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 03/21/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/13/2024
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection requests supports implementation of FDA rulemaking (RIN 0910-AI07). We are proposing to revise agency regulations to harmonize with other statutory provisions of the Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the 21st Century Cures Act (Cures Act).

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Authorizing Statute(s): US Code: 42 USC 289 Name of Law: Institutional Review Boards; Ethics guidance program
  

Citations for New Statutory Requirements: PL: Pub.L. 114 - 255 3023 Name of Law: 21st Century Cures Act; Protection of human research subjects.

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AI07	Proposed rulemaking	87 FR 58733	09/28/2022

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
21 CFR part 812 revisions - disclosure
21 CFR parts 50 and 56 revisions - disclosures
21 CFR parts 50 and 56 revisions - recordkeeping

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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: If finalized, the rulemaking will result in an additional 829,048 responses and 422,642 hours, annually, to FDA's approved information collection inventory. Upon implementation of any final rule, we ultimately expect the resulting burden to be absorbed into OMB control nos. 0910-0130 (Protection of Human Subjects and Institutional Review Boards) and 0910-0078 (Investigational Device Exemptions), respectively.

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Annual Cost to Federal Government: $1,300,000

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: 02/13/2024

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