Notice2022-08986
Submission for OMB Review; 30-Day Comment Request; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding is Sought 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
April 27, 2022
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 87 Issue 81 (Wednesday, April 27, 2022)</title>
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[Federal Register Volume 87, Number 81 (Wednesday, April 27, 2022)]
[Notices]
[Pages 25033-25034]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08986]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Responsibility
of Applicants for Promoting Objectivity in Research for Which Public
Health Service (PHS) Funding is Sought 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 within 30-days of the date of
this publication.
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. Joel A. Snyderman, Director, Division of
Grants Compliance and Oversight, 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) 435-0930 or Email your
request, including your address to: <a href="/cdn-cgi/l/email-protection#adc7c2c8c183dec3d4c9c8dfc0ccc3edc3c4c583cac2db"><span class="__cf_email__" data-cfemail="563c39333a7825382f3233243b373816383f3e78313920">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on February 17, 2022 (FR
87--page 9075 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: Responsibility of Applicants for Promoting
Objectivity in Research for which Public Health Service (PHS) Funding
is Sought 42 CFR part 50 Subpart F and Responsible Prospective
Contractors 45 CFR part 94, 0925-0417, expiration date 4/30/2022,
EXTENSION, 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 Without
Change of a currently approved collection resulting from the
development of revised regulations regarding the Responsibility of
Applicants for Promoting Objectivity in Research for which PHS Funding
is Sought (42 CFR part 50, subpart F) and Responsible Prospective
Contractors (45 CFR part 94). The purpose of these
[[Page 25034]]
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 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 677,820.
Estimated Annualized Burden Hours
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Average Total
Type of respondents based on applicable Number of burden per annual
section of regulation Number of respondents responses per response burden
respondent (in hrs.) hours
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Reporting
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Initial Reports under 42 CFR 50.605(b)(1) 992.......................... 1 2 1,984
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 42 CFR 1 2 100
50.605(a)(3)(iii) and (b)(2) or 45 CFR 50.605(a)(3)(ii) and 45 CFR
94.5(a)(3)(iii) and (b)(2) from awardee 94.5(a)(3)(ii).
Institutions.
5 mitigation reports......... 1 2 10
Annual Report under 42 CFR 50.605(b)(4) or 2,031........................ 1 1 2,031
45 CFR 94.5(b)(4) from awardee
Institutions.
Subsequent Reports under 42 CFR 50.606(a) 20........................... 1 10 200
or 45 CFR 94.6 from awardee Institutions.
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Recordkeeping
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Under 42 CFR 50.604(i) or 45 CFR 94.4(i) 2,000........................ 1 4 8,000
from awardee institutions.
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Disclosure
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Under 42 CFR 50.604(a) or 45 CFR 94.4 for 3,000........................ 1 81 243,000
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 94.4 for 3,000 \1\.................... 1 1 3,000
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 992.......................... 1 30/60 496
94.4(e)(3) for Investigators.
Under 42 CFR 50.604(f) or 45 CFR 94.4(f) 2,000........................ 1 1 2,000
for institutions.
Under 42 CFR 50.605(a)(1) or 45 CFR 2,000 \2\.................... 1 82 164,000
94.5(a)(1) for Institutions.
Under 42 CFR 50.605(a)(3) or 45 CFR 500 \3\...................... 1 3 1,500
94.5(a)(3) for Institutions.
Under 42 CFR 50.605(a)(3)(i) or 45 CFR 50 \4\....................... 1 80 4,000
94.5(a)(3)(i).
Under 42 CFR 50.605(a)(3)(ii) or 45 CFR 50 \5\....................... 1 80 4,000
94.5(a)(3)(ii).
Under 42 CFR 50.605(a)(3)(iii) or 45 CFR 50........................... 1 1 50
94.5(a)(3)(iii).
Under 42 CFR 50.605(a)(4) or 45 CFR 992.......................... 1 12 11,904
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 94.6(c).. 50 \6\....................... 3 \7\ 18/60 45
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Total................................. 136,282...................... 136,382 .......... 677,820
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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 992 reports of 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
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 992 cases = 79,360 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.
Dated: April 21, 2022.
Tara A. Schwetz,
Deputy Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-08986 Filed 4-26-22; 8:45 a.m.]
BILLING CODE 4140-01-P
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