Notice2025-09001
Agency Information Collection Request; 60-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
May 21, 2025
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, is publishing the following summary of a proposed collection for public comment.
Full Text
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<title>Federal Register, Volume 90 Issue 97 (Wednesday, May 21, 2025)</title>
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[Federal Register Volume 90, Number 97 (Wednesday, May 21, 2025)]
[Notices]
[Pages 21784-21785]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09001]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0279]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: 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, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before July 21, 2025.
ADDRESSES: Submit your comments to Natalie Klein, <a href="/cdn-cgi/l/email-protection#4f012e3b2e23262a6104232a26210f27273c61282039"><span class="__cf_email__" data-cfemail="d997b8adb8b5b0bcf792b5bcb0b799b1b1aaf7beb6af">[email protected]</span></a>
and <a href="/cdn-cgi/l/email-protection#50000211103838237e373f26"><span class="__cf_email__" data-cfemail="75252734351d1d065b121a03">[email protected]</span></a> or by calling (240) 453-6900.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier ``0990-0279-60D''
and project title, ``Department of Health and Human Services (HHS)
Registration of an Institutional Review Board Form'' for reference, to
Natalie Klein, email: <a href="/cdn-cgi/l/email-protection#8ec0effaefe2e7eba0c5e2ebe7e0cee6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="307e5144515c59551e7b5c55595e705858431e575f46">[email protected]</span></a>, <a href="/cdn-cgi/l/email-protection#45151704052d2d366b222a33"><span class="__cf_email__" data-cfemail="de8e8c9f9eb6b6adf0b9b1a8">[email protected]</span></a> or by calling
(240) 453-6900.
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) Registration of an Institutional Review Board Form.
Type of Collection: Revision.
OMB No.: 0990-0279.
Abstract: The Office for Human Research Protections (OHRP) and the
Food and Drug Administration (FDA) are requesting a revision of the
currently approved collection for the Office of Management and Budget
(OMB) No. 0990-0279, Department of Health and Human Services (HHS)
Institutional Review Board (IRB) Registration Form. The revision
request involves implementing a burden reducing change. Specifically,
OHRP is seeking to
[[Page 21785]]
remove the IRB roster membership information from the IRB registration
form. This change will align the IRB registration form with the 2018
Requirements at 45 CFR 46.103. The change, when implemented, is
anticipated to result in a shorter, simplified IRB registration process
for respondents. Updates to the software applications OHRP uses to
manage IRB registration will be deployed to enable such changes.
The current form is approved through June 30, 2025. The purpose of
the form is to provide a simplified procedure for: (1) IRBs to satisfy
the requirements for IRB registration at 45 CFR part 46, subpart E; and
(2) IRBs in the United States (US) to satisfy the FDA requirements for
IRB registration at 21 CFR 56.106.
Institutions engaged in nonexempt human subjects research conducted
or supported by HHS, or another Common Rule department or agency, are
required by the terms of the Federalwide Assurance (FWA) to rely upon
only IRBs registered with OHRP for review of research to which the FWA
applies, and must designate a registered IRB on the institution's FWA
submission to OHRP. In this way, OHRP's FWA submission process,
established pursuant to the requirements for assurances at 45 CFR
46.103, is linked to the regulatory requirements for IRB registration.
The respondents for this information collection are institutions or
organizations operating IRBs that review human subjects research
conducted or supported by HHS; or, in the case of FDA's requirements,
each IRB in the United States that reviews clinical investigations
regulated by FDA under sections 505(i) or 520(g) of the Federal Food,
Drug and Cosmetic Act; and each IRB in the United States that reviews
clinical investigations that are intended to support applications for
research or marketing permits for FDA-regulated products. Many of the
IRBs also review research conducted or supported by other Common Rule
departments and agencies.
Annualized Burden Hour Table
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Average
Number of Number of burden per Total burden
Form name respondents responses per response hours
respondent (in hours)
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IRB Registration 0990-0279 Update and Renew......... 5,350 1 0.33 1,766
IRB-Registration 0990-0279 Initial and Update....... 350 2 0.5/0.33 291
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Total........................................... ............ ............... ........... 2,057
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Susan R. Little,
Department Information Collection Clearance Officer, Paperwork
Reduction Act Program, Department of Health and Human Services.
[FR Doc. 2025-09001 Filed 5-20-25; 8:45 am]
BILLING CODE 4150-36-P
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