Notice2022-03463
Proposed Collection; 60-Day Comment Request Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding Is Sought and Responsible Prospective Contractors (NIH/OD)
Primary source
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Published
February 17, 2022
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 87 Issue 33 (Thursday, February 17, 2022)</title>
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[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Pages 9075-9076]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03463]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request Responsibility of
Applicants for Promoting Objectivity in Research for Which Public
Health Service (PHS) Funding Is Sought and Responsible Prospective
Contractors (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: 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, MSC 7974, Bethesda, Maryland 20892-7974. or email
your request, including your address to: <a href="/cdn-cgi/l/email-protection#9af0f5fff6b4e9f4e3feffe8f7fbf4daf4f3f2b4fdf5ec"><span class="__cf_email__" data-cfemail="7b11141e17550815021f1e09161a153b151213551c140d">[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: 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 04/30/2022,
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, 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 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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Number of Average burden
Type of respondents based on Number of respondents responses per per response Total annual
applicable section of regulation respondent (in hrs.) burden hours
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Reporting:
Initial Reports under 42 CFR 992..................... 1 2 1,984
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 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
[[Page 9076]]
Annual Report under 42 CFR 2,031................... 1 1 2,031
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.
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 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 45 500..................... 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 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 45 992..................... 1 30/60 496
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 45 992..................... 1 12 11,904
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\.................. \7\ 3 18/60 45
94.6(c).
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Total......................... 136,282................. 136,282 .............. 677,820
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\1\ Assuming that 3000 institutions solicit disclosures on an annual basis 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: February 11, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-03463 Filed 2-16-22; 8:45 am]
BILLING CODE 4140-01-P
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