[Federal Register Volume 87, Number 81 (Wednesday, April 27, 2022)]
[Notices]
[Pages 25033-25034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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
----------------------------------------------------------------------------------------------------------------
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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