Notice2025-09000
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
May 20, 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 96 (Tuesday, May 20, 2025)</title>
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[Federal Register Volume 90, Number 96 (Tuesday, May 20, 2025)]
[Notices]
[Pages 21485-21486]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09000]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0481]
Agency Information Collection Request; 30-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 June 20, 2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Natalie Klein, <a href="/cdn-cgi/l/email-protection#307e5144515c59551e7b5c55595e705858431e575f46"><span class="__cf_email__" data-cfemail="5e103f2a3f32373b7015323b37301e36362d70393128">[email protected]</span></a>
or (240) 453-6900. When submitting comments or requesting information,
please include the document identifier 0990-0481-30D and project title
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: For HHS/OASH Consultation Process,
Institutional Review Board (IRB) Records.
Type of Collection: Reinstatement without changes.
OMB No. 0990-0481.
Abstract: The Office of the Assistant Secretary for Health (OASH),
Office for Human Research Protections (OHRP) is requesting
reinstatement of the Office of Management and Budget (OMB) information
collection request, OMB No. 0990-0481, For OASH/HHS Consultation
Process, Institutional Review Board (IRB) Records, with no changes, for
a three-year period. The previous information collection was approved
by OMB on February 14, 2022, and expired on February 28, 2025. The
purpose of the collection is for OHRP to receive IRB records when an
IRB or an institution requests an HHS consultation process for proposed
research that is not otherwise approvable by an IRB involving,
respectively: (1) pregnant women, human fetuses and neonates; (2)
prisoners; or, (3) children, as subjects. The information that must be
submitted to OHRP by an IRB or institution includes the research
protocol, consent form, parental permission and child assent forms (if
relevant), and other relevant IRB records (e.g., IRB minutes). The
Office of the Assistant Secretary for Health, on behalf of the
Secretary of HHS, may determine that such research can be conducted or
supported by HHS after consulting with experts and meeting other
procedural requirements.
Likely Respondents: IRBs.
Annualized Burden Hour Table
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Average
45 CFR part 46--HHS Consultation process Number of Number of burden per Total burden
provision Respondent type respondents respondents response (in hours
hours)
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subpart B, Sec. 46. 207...................... IRBs................................... 3 1 1 3
subpart C, Sec. 46.306(a)(2) (iii) and (iv).. IRBs................................... 3 1 1 3
subpart D, Sec. 46.407....................... IRBs................................... 4 1 1 4
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Total...................................... ....................................... .............. .............. .............. 10
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[[Page 21486]]
Susan R. Little,
Department Information Collection Clearance Officer, Paperwork
Reduction Act Program, Department of Health and Human Services.
[FR Doc. 2025-09000 Filed 5-19-25; 8:45 am]
BILLING CODE 4150-31-P
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