Notice2026-18950
Agency Information Collection Request; 30-Day Public Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 16, 2026
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 178 (Wednesday, September 16, 2026)</title>
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[Federal Register Volume 91, Number 178 (Wednesday, September 16, 2026)]
[Notices]
[Pages 58686-58687]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18950]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0473]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office for Human Research Protections (OHRP), Office of the
Assistant Secretary for Health (OASH), Office of the Secretary, HHS.
ACTION: Notice.
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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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this
information collection by selecting ``Currently under Review'' and
``Select Agency: Department of Health and Human Services''.
FOR FURTHER INFORMATION CONTACT: Natalie Klein, <a href="/cdn-cgi/l/email-protection#2d634c594c4144480366414844436d45455e034a425b"><span class="__cf_email__" data-cfemail="a7e9c6d3c6cbcec289eccbc2cec9e7cfcfd489c0c8d1">[email protected]</span></a>
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
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Number of Average burden Total
Form name Respondents Number of responses per per response burden
respondents respondent (in hours) hours
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Subpart C Certification Form. Institutions or 40 2.13 1.0 85
Organizations
operating
Institutional Review
Boards (IRBs).
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Total.................... ..................... 40 2.13 1.0 85
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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
[[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.
[FR Doc. 2026-18950 Filed 9-15-26; 8:45 am]
BILLING CODE 4150-36-P
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