Notice2026-19303
Submission for OMB review; 30-Day Comment Request; the Impact and Costs of Promoting Objectivity in Research 42 CFR Part 50 Subpart F and Responsible Prospective Contractors 45 CFR Part 94 (Office of the Director)
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 22, 2026
Effective
October 22, 2026
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Full Text
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<title>Federal Register, Volume 91 Issue 182 (Tuesday, September 22, 2026)</title>
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[Federal Register Volume 91, Number 182 (Tuesday, September 22, 2026)]
[Notices]
[Pages 60138-60140]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19303]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB review; 30-Day Comment Request; the Impact and
Costs of Promoting Objectivity in Research 42 CFR Part 50 Subpart F and
Responsible Prospective Contractors 45 CFR Part 94 (Office of the
Director)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collection listed below.
DATES: Comments regarding this information collection are best assured
of having their full effect if received by October 22, 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: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Mr. Romeo K. Tengey, Director, Division of
Compliance of Foreign Interference Research Misconduct, Harassment, and
Intellectual, Office of Policy for Extramural Research Administration,
Office of Extramural Research, National Institutes of Health, 6705
Rockledge Drive, Suite 800, Bethesda, MD 20892, or call non-toll-free
number (301) 402-0892 or email your request, including your address to:
<a href="/cdn-cgi/l/email-protection#386c5d565f5d414a785559515416565150165f574e"><span class="__cf_email__" data-cfemail="8edaebe0e9ebf7fccee3efe7e2a0e0e7e6a0e9e1f8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on July 10, 2025 (FR 90-
page 30649) and allowed 60 days for public comment. No comments were
received. The purpose of this notice is to allow an additional 30 days
for public comment. The National Institutes of Health may not conduct
or sponsor, and the respondent is not required to respond to, an
information collection that has been extended, revised, or implemented
on or after October 1, 1995, unless it displays a currently valid OMB
control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, the National Institutes of Health (NIH) has submitted to
the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below.
Proposed Collection: Promoting Objectivity in Research 42 CFR part
50 Subpart F and Responsible Prospective Contractors 45 CFR part 94,
0925-0417, expiration date 6/30/2025, Reinstatement With Change, Office
of Policy for Extramural Research Administration (OPERA), Office of
Extramural Research (OER), National Institutes of Health (NIH).
Need and Use of Information Collection: This request is for Office
of Management and Budget (OMB) approval of a Reinstatement With Change
of a currently approved collection resulting from the development of
revised regulations regarding the 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 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). NIH is
implementing a change or enhancement in the FCOI reporting requirement
within the eRA Commons FCOI Module to require the grant and cooperative
agreement respondent to identify foreign FCOIs and provide the type of
foreign entity and the name of the foreign country. This enhanced
requirement is insignificant on the part of respondents.
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.
Estimated Annualized Burden Hours
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Average
Type of respondents based on Number of burden per Total annual
applicable section of regulation Number of respondents responses per response (in burden hours
respondent hrs.)
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Reporting:
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.
[[Page 60139]]
Subsequent Reports under 42 CFR 50 FCOI reports as in 42 1 2 100
50.605(a)(3)(iii) and (b)(2) or CFR 50.605(a)(3)(ii)
45 CFR 94.5(a)(3)(iii) and (b)(2) and 45 CFR
from awardee Institutions. 94.5(a)(3)(ii).
5 mitigation reports.... 1 2 10
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(a) from
awardee Institutions.
Record Keeping:
Under 42 CFR 50.604(i) or 45 CFR 2,000................... 1 4 8,000
94.4(i) from awardee institutions.
Disclosure:
Under 42 CFR 50.604(a) or 45 CFR 3,000................... 1 81 243,000
94.4(a) for Investigators.
Under 42 CFR 50.604(b) or 45 CFR 38,000.................. 1 30/60 19,000
94.4(b) for Investigators.
Under 42 CFR 50.604(b) or 45 CFR 2,000................... 1 6 12,000
94.4(b) for Institutions.
Under 42 CFR 50.604(c)(1) or 45 500..................... 1 1 500
CFR 94.4(c)(1) from subrecipients.
Under 42 CFR 50.604(d) or 45 CFR 3,000 \1\............... 1 1 3,000
94.4(d) for Institutions.
Under 42 CFR 50.604(e)(1) or 45 38,000.................. 1 4 152,000
CFR 94.4(e)(1) for Investigators.
Under 42 CFR 50.604(e)(2) or 45 38,000.................. 1 1 38,000
CFR 94.4(e)(2) for Investigators.
Under 42 CFR 50.604(e)(3) or 45 1,128................... 1 30/60 564
CFR 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 2,000 \2\............... 1 82 164,000
CFR 94.5(a)(1) for Institutions.
Under 42 CFR 50.605(a)(3) or 45 500 \3\................. 1 3 1,500
CFR 94.5(a)(3) for Institutions.
Under 42 CFR 50.605(a)(3)(i) or 45 50 \4\.................. 1 80 4,000
CFR 94.5(a)(3)(i).
Under 42 CFR 50.605(a)(3)(ii) or 50 \5\.................. 1 80 4,000
45 CFR 94.5(a)(3)(ii).
Under 42 CFR 50.605(a)(3)(iii) or 50...................... 1 1 50
45 CFR 94.5(a)(3)(iii).
Under 42 CFR 50.605(a)(4) or 45 1,128................... 1 12 13,536
CFR 94.5(a)(4).
Public Website Posting under 42 2,000................... 1 5 10,000
CFR 50.605(a)(5) or 45 CFR
94.5(a)(5) from awardee
Institutions.
Under 42 CFR 50.606(c) or 45 CFR 50 \6\.................. 3 \7\ 18/60 45
94.6(c).
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Total......................... 137,371................. 137,471 .............. 680,473
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\1\ Assuming that 3,000 Institutions solicit disclosures on an annual basis by sending a notification 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.
[[Page 60140]]
The Deputy Director for Extramural Research, Jon Lorsch, having
reviewed and approved this document, authorizes Alycia Booth, who is
the Federal Register Liaison, to electronically sign this document for
purposes of publication in the Federal Register.
Dated: September 17, 2026.
Alycia Booth,
Federal Register Liaison, National Institutes of Health.
[FR Doc. 2026-19303 Filed 9-21-26; 8:45 am]
BILLING CODE 4140-01-P
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