Agency Information Collection Request; 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, submitted an Information Co...
Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), Office of the Secretary, HHS.
ACTION:
Notice.
SUMMARY:
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. OMB will accept further comments from the public during the review and approval period.
DATES:
Comments on the ICR must be received on or before October 16, 2026.
ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice via
www.reginfo.gov/public/do/PRAMain.
Find this information collection by selecting “Currently under Review” and “Select Agency: Department of Health and Human Services”.
FOR FURTHER INFORMATION CONTACT:
Natalie Klein,
Natalie.Klein@hhs.gov
or (240) 453-6900. If requesting information, please include the document identifier 0990-0473-30D and project title, “Department of Health and Human Services (HHS) Subpart C Certification Form” for reference.
SUPPLEMENTARY INFORMATION:
Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Title of the Collection:
Department of Health and Human Services (HHS) Subpart C Certification Form.
Type of Collection:
Renewal.
OMB No.:
0990-0473.
Abstract:
The Office for Human Research Protections (OHRP) is requesting a three-year extension of OMB No. 0990-0473, the HHS Subpart C Certification Form. The purpose of this form is to provide a simplified, standardized procedure for institutions to submit subpart C research certifications to OHRP in order to obtain authorization to include prisoners in HHS-conducted or supported human subjects research. 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.
Likely Respondents:
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.
Estimated Annualized Burden Hour Table
Form name
Respondents
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
burden
hours
Subpart C Certification Form
Institutions or Organizations operating Institutional Review Boards (IRBs)
40
2.13
1.0
85
Total
40
2.13
1.0
85
The estimate of the number of respondents is based upon the current number of institutions certifying HHS-conducted or -supported subpart C human subjects research to OHRP. In 2025, OHRP received fifty-one certifications from thirty-eight institutions or organizations, and one hundred percent of the respondents submitted their certification information electronically. We project that, annually, forty institutions will submit certifications. Most respondents will submit the form twice annually; however, some respondents may submit the form 3 times annually. Consistent with 5 CFR 1320.5(a)(1)(iv)(5), therefore, we believe this estimate represents the
( printed page 58687)
total annual reporting and recordkeeping burden that will result from the collection of information.
The burden is estimated to average one hour per Subpart C Certification Form and the total annual burden hours are projected to be eighty-five.
Catherine Howard,
Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary.
www.reginfo.gov/public/do/PRAMain
5 CFR 1320.5(a)(1)(iv)(5)