Subpart C Research Certification Form

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0990-0473 HHS Subpart C Certification Form	Form	Modified	Repair queued
Form 0990-0473 HHS Subpart C Certification Form	Form	Modified	Available
Supporting Statement_ Subpart C Certification Form_November 2026.pdf	Supporting Statement A	Uploaded 2026-11-06	Repair queued
Supporting Statement_ Subpart C Certification Form_September 2026.pdf	Supporting Statement A	Uploaded 2026-09-14	Available
45 CFR part 46, Subpart C Regulations_04.14.2020.pdf	Supplementary Document	Uploaded 2020-04-14	Repair queued
45 CFR part 46, Subpart C Regulations_04.14.2020.pdf	Supplementary Document	Uploaded 2020-04-14	Available
42 U S C Section 289_04.14.2020.pdf	Supplementary Document	Uploaded 2020-04-14	Repair queued
42 U S C Section 289_04.14.2020.pdf	Supplementary Document	Uploaded 2020-04-14	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
259072	Subpart C Research Certification Form		Removed
241337	Subpart C Research Certification Form	Form	Modified	HHS Subpart C Certification Form
241337	Subpart C Research Certification Form	Form	Modified	HHS Subpart C Certification Form

ICR Details

OMB Control No: 0990-0473	ICR Reference No: 202609-0990-002
Status: Active	Previous ICR Reference No: 202303-0990-001
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Subpart C Research Certification Form
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/06/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/16/2026
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2029	36 Months From Approved	11/30/2026
Responses	85	0	65
Time Burden (Hours)	85	0	65
Cost Burden (Dollars)	0	0	0

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Abstract: The Office for Human Research Protections (OHRP) is requesting a three-year extension, without changes, for the currently approved collection for the OMB No. 0990-0473, HHS Subpart C Certification Form. The current form is approved through October 31, 2026. The purpose of the form is to provide a simplified, standardized procedure for institutions to electronically submit subpart C research certifications to OHRP in order to meet the regulatory requirements for including prisoners in non-exempt human subjects research that is conducted or supported by HHS. The form also simplifies the internal process used by OHRP to review and record such certifications, resulting in faster processing while reducing unnecessary and burdensome staff time. Respondents for this collection are institutions or organizations operating Institutional Review Boards (IRBs) that have enrolled or are planning to enroll prisoners in human subjects research conducted or supported by HHS.

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Authorizing Statute(s): US Code: 42 USC Section 289 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:
	91 FR 40543	07/02/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 58686	09/16/2026
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Subpart C Research Certification Form	0990-0473	HHS Subpart C Certification Form
Subpart C Research Certification Form

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ICR Summary of Burden

table that charts list 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	85	65	0	35	-15	0
Annual Time Burden (Hours)	85	65	0	35	-15	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: The burden calculation has been adjusted to account for the number of institutions that submitted for certifications, average responses per institution annually, and the time required to complete a certification. We estimate that an average of forty institutions will submit certifications: thirty-five of the institutions will submit two certifications (35 x 2= 70); five of the forty institutions will submit three certifications (5 x 3= 15); and that each certification will require 1 hour to complete, accounting for the estimated 85 response burden hours. This represents an increase in annual burden hours of 20 hours compared to the previously approved burden. The change accounts for agency adjustments based on data on the number of institutions that submitted certifications.

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Annual Cost to Federal Government: $137,701

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: 09/16/2026

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