[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45455-45457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19339]


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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 and Responsible Prospective 
Contractors (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/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
[email protected] or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

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: Ms. Diane Dean, 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, Room 3525, Bethesda, MD 20892, or call 
non-toll-free number (301) 435-0930 or Email your request, including 
your address to: [email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on March 16, 2018, (FR 83 
pages 11763-11765) and allowed 60 days for public comment. One public 
comment was 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 2/28/2015, 
REINSTATEMENT WITHOUT 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 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 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-

[[Page 45456]]

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 hours)     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
    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.................         136,382  ..............         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.



[[Page 45457]]

    Dated: August 30, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-19339 Filed 9-6-18; 8:45 am]
 BILLING CODE 4140-01-P