83 FR 11763 - 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, Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research (OER), Office of the Director, (OD)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 52 (March 16, 2018)

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), Office of the Director (OD) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11763-11765]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05384]


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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, Office of Policy for Extramural Research Administration 
(OPERA), Office of Extramural Research (OER), Office of the Director, 
(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), Office of the Director (OD) will publish 
periodic summaries of propose 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: Kathy 
Hancock, Asst. Grants Compliance Officer, Division of Grants Compliance 
and Oversight, Office of Policy for Extramural Research Administration, 
6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892 or call non-
toll-free number 301-435-0949 or Email your request 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

[[Page 11764]]

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 45 CFR part 50 Subpart F and Responsible Prospective 
Contractors 45 CFR part 94, 0925-0417,--REINSTATEMENT WITHOUT CHANGE 
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 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-
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 677,295.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
    Type of respondents based on        Number of respondents      Frequency of    per response    Total annual
  applicable section of regulation                                   responses      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
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)     CFR 50.605(a)(3)(ii) and
     or 45 CFR 94.5(a)(3)(iii) and    45 CFR 94.5(a)(3)(ii).
     (b)(2) from awardee
     Institutions.
                                     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     2,000......................               1               4           8,000
     CFR 94.4(i) from awardee
     institutions.
Disclosure:
    Under 42 CFR 50.604(a) or 45     3,000......................               1              81         243,000
     CFR 94.4 for Investigators.
    Under 42 CFR 50.604(b) or 45     38,000.....................               1           30/60          19,000
     CFR 94.4(e)(1) for
     Investigators.
    Under 42 CFR 50.604(b) or 45     2,000......................               1               6          12,000
     CFR 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     3,000 \4\..................               1               1           3,000
     CFR 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  950........................               1           30/60             475
     CFR 94.4(e)(3) for
     Investigators.
    Under 42 CFR 50.604(f) or 45     2,000......................               1               1           2,000
     CFR 94.4(f) for institutions
     \1\.
    Under 42 CFR 50.605(a)(1) or 45  2,000 \5\..................               1              82         164,000
     CFR 94.5(a)(1) for
     Institutions.
    Under 42 CFR 50.605(a)(3) or 45  500 \6\....................               1               3           1,500
     CFR 94.5(a)(3) for
     Institutions.
    Under 42 CFR 50.605(a)(3)(i) or  50 \7\.....................               1              80           4,000
     45 CFR 94.5(a)(3)(i).
    Under 42 CFR 50.605(a)(3)(ii)    50 \8\.....................               1              80           4,000
     or 45 CFR 94.5(a)(3)(ii).
    Under 42 CFR 50.605(a)(3)(iii)   50.........................               1               1              50
     or 45 CFR 94.5(a)(3)(iii).

[[Page 11765]]

 
    Under 42 CFR 50.605(a)(4) or 45  950........................               1              12          11,400
     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     50 \9\.....................          3 \10\           18/60              45
     CFR 94.6(c).
                                    ----------------------------------------------------------------------------
        Total......................  136,143....................         136,243  ..............         677,295
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\4\ Assuming that 3,000 Institutions solicit disclosures on an annual basis by sending a notification to all
  Investigators.
\5\ Although an estimated 950 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 950 cases = 76,000 hours.
\6\ Assuming that this is a rare occurrence based on prior experience.
\7\ Assuming only a fraction of the newly identified SFIs will constitute FCOI.
\8\ Assuming only a fraction of the newly identified SFIs will constitute FCOI.
\9\ 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.
\10\ Assuming an average of 3 publications annually.


    Dated: March 10, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-05384 Filed 3-15-18; 8:45 am]
 BILLING CODE 4140-01-P