Notice2025-22153
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
December 8, 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, 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 90 Issue 233 (Monday, December 8, 2025)</title>
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[Federal Register Volume 90, Number 233 (Monday, December 8, 2025)]
[Notices]
[Pages 56775-56776]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22153]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0937-0198-30D]
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, 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 January 7,
2026.
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 particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sheila Garrity, Director, Office of
Research Integrity, <a href="/cdn-cgi/l/email-protection#4e011c07111e3b2c22272d110d2123232b203a3d0e26263d60292138"><span class="__cf_email__" data-cfemail="86c9d4cfd9d6f3e4eaefe5d9c5e9ebebe3e8f2f5c6eeeef5a8e1e9f0">[email protected]</span></a>. When submitting
comments or requesting information, please include the document
identifier 0937-0198-30D 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: Public Health Service Policies on Research
Misconduct (42 CFR part 93) .
Type of Collection: Revision.
OMB No. 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 behavioral 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 misuse of Federal funds and to protect the
public interest.
In accordance with 5 CFR Part Sec. 1320.8(d), 60-day notice was
published on September 30, 2025, in the Federal Register Volume 90,
Number 187, Pages 46901-46902 to solicit public comment on the revision
of form PHS-6349, the new collection instruments (the Institutional
Record Transmittal
[[Page 56776]]
form PHS-7092 and the Research Integrity Assurance Establishment form
PHS-7091), and the discontinuance of PHS-6315 reflecting changes in the
2024 Final Rule, 42 CFR part 93. There was one public comment. This
comment did not change ORI's burden estimates and without passion or
prejudice, ORI is proceeding with this 30-day comment period regarding
three-year OMB approval for its revised and new collection instruments.
Regarding the frequency of response for the collection instrument, form
PHS-6349 must be submitted by institutions conducting PHS-supported
research on an annual basis; form PHS-7091 must be submitted by
institutions to ORI once when seeking an ORI assurance for the first
time; PHS-7091 must be submitted to ORI by an institution on a case-by-
case basis at the conclusion of institutional research misconduct
proceedings.
Estimated Annualized Burden Hour Table
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Average
Respondents (if Number of Number of burden per Total
Forms (if necessary) necessary) respondents responses per response burden
respondents (minutes) hours
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Research Integrity Assurance and Awardee Institutions.. 6,619 1 10/60 1,103
Annual Report on Possible Research
Misconduct (PHS-6349).
Research Integrity Assurance New Awardee 428 1 10/60 71
Establishment form (PHS-7091). Institutions.
Institutional Record Transmittal Institutions.......... 230 1 10/60 38
form (PHS-7092).
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Total.......................... ...................... 7277 .............. ........... 1,212
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Catherine Howard,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2025-22153 Filed 12-5-25; 8:45 am]
BILLING CODE 4150-28-P
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