[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Pages 9075-9076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: [email protected]. 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