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	Available
Form 0990-0473 Subpart C Research Certification Form	Form	Modified	Repair queued
Supporting Statement - Renewed HHS Subpart C Certification Form_May 2023.pdf	Supporting Statement A	Uploaded 2023-05-25	Available
45 CFR part 46, Subpart C Regulations_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	Repair queued

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0990-0473	ICR Reference No: 202303-0990-001
Status: Active	Previous ICR Reference No: 202004-0990-004
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Subpart C Research Certification Form
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/12/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/26/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2026	36 Months From Approved	10/31/2023
Responses	65	0	80
Time Burden (Hours)	65	0	80
Cost Burden (Dollars)	0	0	0

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Abstract: The Office for Human Research Protections (OHRP) is requesting a three-year extension of OMB No. 0990-0473, the HHS Subpart C Research Certification Form, currently approved through July 31, 2023. This information collection request includes three new information elements (Name(s) of Institutions Relying on the IRB of Record; Program Officer’s Email Address; and the IRB Determination Regarding the Risk Level of the Study) and clarification in two information elements (Name and address of the IRB of Record Institution; and Contact information for the IRB of record) on the current Subpart C Research Certification Form. The purpose of the Subpart C Research Certification Form is to provide a simplified, standardized procedure for institutions to 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 information collection are institutions or organizations which operate the IRB of record that approved the research, or the non-institutional IRBs that serve as the IRB of record.

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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:
	88 FR 16275	03/16/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 39855	06/20/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

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	65	80	0	-15	0	0
Annual Time Burden (Hours)	65	80	0	-15	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The annual burden estimates changed compared to the current burden estimates. The changes 7 are due to agency adjustments. The total annual burden in the current OMB-approved information collection (eighty hours and $1,392.80, respectively) is projected to be sixty-five hours and $2,681.25, respectively, in this information collection request.

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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: 06/26/2023

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