Notice2025-18909
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
September 30, 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 Information Collection Request (ICR) for public comment.
Full Text
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<title>Federal Register, Volume 90 Issue 187 (Tuesday, September 30, 2025)</title>
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[Federal Register Volume 90, Number 187 (Tuesday, September 30, 2025)]
[Notices]
[Pages 46901-46902]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18909]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0937-0198]
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
Information Collection Request (ICR) for public comment.
DATES: Comments on the ICR must be received on or before November 28,
2025.
ADDRESSES: Submit your comments to Sheila Garrity, Director, Office of
Research Integrity <a href="/cdn-cgi/l/email-protection#5619041f090623343a3f350915393b3b33382225163e3e2578313920"><span class="__cf_email__" data-cfemail="97d8c5dec8c7e2f5fbfef4c8d4f8fafaf2f9e3e4d7ffffe4b9f0f8e1">[email protected]</span></a>.
[[Page 46902]]
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0937-0198-60D and
project title for reference, to Sheila Garrity, Director, Office of
Research Integrity <a href="/cdn-cgi/l/email-protection#59160b1006092c3b35303a061a3634343c372d2a1931312a773e362f"><span class="__cf_email__" data-cfemail="b2fde0fbede2c7d0dedbd1edf1dddfdfd7dcc6c1f2dadac19cd5ddc4">[email protected]</span></a>.
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: Public Health Service Policies on Research
Misconduct (42 CFR part 93).
Type of Collection: Revision.
OMB No. OS-0937-0198.
Abstract: The Office of Research Integrity (ORI) is seeking a
revision of its collection instruments to reflect updates in the Public
Health Service Policies on Research Misconduct (42 CFR part 93)
published on September 17, 2024. The purpose of the Institutional
Assurance and Annual Report on Possible Research Misconduct form PHS-
6349 is to provide data on the amount of research misconduct activity
(e.g., allegations of research misconduct and assessments, inquiries,
and/or investigations of such allegations) occurring at institutions
conducting PHS-supported research. These data enable the ORI to monitor
institutional compliance with the PHS regulation. Form PHS-6349 has
undergone minor revisions, but its function is unchanged. The purpose
of the Assurance of Compliance by Sub-Award Recipients form PHS-6315
establishes an assurance of compliance for a sub-awardee institution.
Form PHS-6315 is being discontinued. In its place, ORI developed a new
form, the Research Integrity Assurance Establishment form PHS-7091.
This form allows all institutions subject to 42 CFR part 93 to
establish an assurance with ORI, regardless of sub-awardee status.
Additionally, ORI developed a second new form, the Institutional Record
Transmittal form PHS-7092, which accounts for the varied types of
information collection that can occur during the course of
institutional research misconduct proceedings. ORI continues to utilize
the Small Institution Statement to assist small institutions as part of
the assurance process, which has been updated to reflect new regulatory
language. This statement is an addendum that can be included with form
PHS-6349 and PHS-7091, where applicable.
Need and Proposed Use: The information is needed to fulfill section
493 of the Public Health Service Act (42 U.S.C. 289b), which requires
assurances from institutions that apply for financial assistance under
the Public Health Service Act for any project or program that involves
the conduct of biomedical or behavior research. In addition, the
information is also required to fulfill the assurance and annual
reporting requirements of 42 CFR part 93. ORI uses the information to
monitor institutional compliance with the regulation. Lastly, the
information may be used to respond to congressional requests for
information to prevent the misuse of Federal funds and to protect the
public interest.
Estimated Annualized Burden Hour Table
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Number of Average burden
Forms Respondents Number of responses per per response Total burden
respondents respondent (in hours) hours
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Research Integrity Assurance Awardee 6,619 1 .1666 1,103
and Annual Report on Possible Institutions.
Research Misconduct (PHS-
6349).
Research Integrity Assurance New Awardee 428 1 .1666 71
Establishment form (PHS-7091). Institutions.
Institutional Record Institutions.... 230 1 .1666 38
Transmittal form (PHS-7092).
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Total..................... ................ 7,277 3 .............. 1,212
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Catherine Howard,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2025-18909 Filed 9-29-25; 8:45 am]
BILLING CODE 4150-28-P
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