Notice2025-12897
Proposed Collection; 60-Day Comment Request; Promoting Objectivity in Research 42 CFR Part 50 Subpart F and Responsible Prospective Contractors 45 CFR Part 94 (NIH/OD)
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Published
July 10, 2025
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, Office of Policy and Extramural Research Administration (OPERA), Office of Extramural Research (OER) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Full Text
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<title>Federal Register, Volume 90 Issue 130 (Thursday, July 10, 2025)</title>
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[Federal Register Volume 90, Number 130 (Thursday, July 10, 2025)]
[Notices]
[Pages 30649-30651]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12897]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Promoting
Objectivity in Research 42 CFR Part 50 Subpart F and Responsible
Prospective Contractors 45 CFR Part 94 (NIH/OD)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Institutes of Health, Office of
Policy and Extramural Research Administration (OPERA), Office of
Extramural Research (OER) will publish periodic summaries of proposed
projects to be submitted to the Office of Management and Budget (OMB)
for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Brian E.
Sass-Hurst, Acting Director, Division of Grants Compliance and
Oversight, Office of Policy for Extramural Research Administration,
National Institutes of Health, 6705 Rockledge Drive, Suite 800, or call
non-toll-free number (301) 827-7581 or Email your request, including
your address to <a href="/cdn-cgi/l/email-protection#eeac9c878f80c0bd8f9d9dc3a69b9c9d9aae808786c0898198"><span class="__cf_email__" data-cfemail="91d3e3f8f0ffbfc2f0e2e2bcd9e4e3e2e5d1fff8f9bff6fee7">[email protected]</span></a>. Formal requests for
additional plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Promoting Objectivity in Research 42 CFR
part 50 Subpart F and Responsible Prospective Contractors 45 CFR part
94, 0925-0417, expiration date 06/30/2025, EXTENSION, Office of Policy
and Extramural Research Administration (OPERA), Office of Extramural
Research (OER), Office of the Director (OD), National Institutes of
Health (NIH).
Need and Use of Information Collection: This request is for an
Extension of a currently approved collection resulting from regulations
regarding Promoting Objectivity in Research (42 CFR part 50, subpart F)
and Responsible Prospective Contractors (45 CFR part 94). The purpose
of these regulations is to promote objectivity in research by requiring
institutions to establish standards to ensure that there is no
[[Page 30650]]
reasonable expectation that the design, conduct, or reporting of Public
Health Service (PHS) funded research will be biased by any Investigator
financial conflict of interest (FCOI).
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 680,473.
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\1\ Assuming that 3000 institutions solicit disclosures on an
annual basis to all Investigators.
\2\ Although an estimated 1,128 reports of Financial Conflict of
Interest are expected annually, the 2,000 responding Institutions
must review all financial disclosures associated with PHS-funded
awards to determine whether any financial conflicts of interest
exist. Thus, the review burden of 76,000 hours is based upon
estimates that it will take on the average 2 hours for an
institutional official(s) to review each of 38,000 financial
disclosures associated with PHS funded awards. The burden for
developing a management plan for identified FCOI is estimated at 80
hours x 1,128 cases = 90,240 hours.
\3\ Assuming that this is a rare occurrence based on prior
experience.
\4\ Assuming only a fraction of the newly identified SFIs will
constitute FCOI.
\5\ Assuming only a fraction of the newly identified SFIs will
constitute FCOI.
\6\ Number based on 50.605/94.5(a)(3)(i)--of those only a
fraction will relate to a project of clinical research whose purpose
is to evaluate the safety or effectiveness of a drug, medical
device, or treatment, but we are calculating the maximum estimated
burden.
\7\ Assuming an average of 3 publications annually.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents based on Number of respondents responses per per response (in Total annual
applicable section of regulation respondent hrs.) burden hours
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Reporting
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Initial Reports under 42 CFR 1,128.................. 1 2 2,256
50.605(b)(1) and (b)(3) or 45 CFR
94.5(b)(1) and (b)(3) from awardee
Institutions.
Subsequent Reports under 42 CFR 50 FCOI reports as in 1 2 100
50.605(a)(3)(iii) and (b)(2) or 45 42 CFR ............... ................ 10
CFR 94.5(a)(3)(iii) and (b)(2) from 50.605(a)(3)(ii) and ............... ................
awardee Institutions. 45 CFR 94.5(a)(3)(ii). ............... ................
5 mitigation reports... 1 2
Annual Report under 42 CFR 2,712.................. 1 1 2,712
50.605(b)(4) or 45 CFR 94.5(b)(4)
from awardee Institutions.
Subsequent Reports under 42 CFR 20..................... 1 10 200
50.606(a) or 45 CFR 94.6 from
awardee Institutions.
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Record Keeping
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Under 42 CFR 50.604(i) or 45 CFR 2,000.................. 1 4 8,000
94.4(i) from awardee institutions.
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Disclosure
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Under 42 CFR 50.604(a) or 45 CFR 3,000.................. 1 81 243,000
94.4 for Investigators.
Under 42 CFR 50.604(b) or 45 CFR 38,000................. 1 30/60 19,000
94.4(e)(1) for Investigators.
Under 42 CFR 50.604(b) or 45 CFR 2,000.................. 1 6 12,000
94.4(e)(1) for Institutions.
Under 42 CFR 50.604(c)(1) or 45 CFR 500.................... 1 1 500
94.4(c)(1) from subrecipients.
Under 42 CFR 50.604(d) or 45 CFR \1\ 3,000.............. 1 1 3,000
94.4 for Institutions.
Under 42 CFR 50.604(e)(1) or 45 CFR 38,000................. 1 4 152,000
94.4(e)(1) for Investigators.
Under 42 CFR 50.604(e)(2) or 45 CFR 38,000................. 1 1 38,000
94.4(e)(2) for Investigators.
Under 42 CFR 50.604(e)(3) or 45 CFR 1,128.................. 1 30/60 564
94.4(e)(3) for Investigators.
Under 42 CFR 50.604(f) or 45 CFR 2,000.................. 1 1 2,000
94.4(f) for institutions.
Under 42 CFR 50.605(a)(1) or 45 CFR \2\ 2,000.............. 1 82 164,000
94.5(a)(1) for Institutions.
Under 42 CFR 50.605(a)(3) or 45 CFR \3\ 500................ 1 3 1,500
94.5(a)(3) for Institutions.
Under 42 CFR 50.605(a)(3)(i) or 45 \4\ 50................. 1 80 4,000
CFR 94.5(a)(3)(i).
Under 42 CFR 50.605(a)(3)(ii) or 45 \5\ 50................. 1 80 4,000
CFR 94.5(a)(3)(ii).
Under 42 CFR 50.605(a)(3)(iii) or 45 50..................... 1 1 50
CFR 94.5(a)(3)(iii).
Under 42 CFR 50.605(a)(4) or 45 CFR 1,128.................. 1 12 13,536
94.5(a)(4).
Public Website Posting under 42 CFR 2,000.................. 1 5 10,000
50.605(a)(5) or 45 CFR 94.5(a)(5)
from awardee Institutions.
Under 42 CFR 50.606(c) or 45 CFR \6\ 50................. \7\ \6\ 3 18/60 45
94.6(c).
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Total........................... 137,371................ 137,371 ................ 680,473
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[[Page 30651]]
Dated: July 3, 2025.
Jon Lorsch,
Acting NIH Deputy Director for Extramural Research, National Institutes
of Health.
[FR Doc. 2025-12897 Filed 7-9-25; 8:45 am]
BILLING CODE 4140-01-P
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