[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78452-78453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30355]
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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 42 CFR Part 50 Subpart F and
Responsible Prospective Contractors 45 CFR Part 94 (OD)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the Office of the Director (OD),
National Institutes of Health (NIH), will publish periodic summaries of
proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited on 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.
To submit comments and for further information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Ms. Kathy
Hancock, Assistant Grants Compliance Officer, Division of Grants
Compliance and Oversight, Office of Policy for Extramural Research
Administration (OPERA), 6705 Rockledge Drive, Room 3523, Bethesda, MD
20892, or call non-toll-free number (301) 435-1962, or Email your
request, including your address to: [email protected]. Formal
requests for additional plans and instruments must be requested in
writing.
DATES: Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
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 OMB# 0925-0417, Expiration Date: 02/2015,
EXTENSION, National Institutes of Health (NIH), Office of the Director
(OD).
Need and Use of Information Collection: This is a request for OMB
Approval for an extension of the information collection and
recordkeeping requirements contained in the final rule 42 CFR part 50,
subpart F and 45 CFR part 94. The purpose of these regulations is to
promote objectivity in research by requiring institutions to establish
standards that provide a reasonable expectation that the design,
conduct, and reporting of research funded under PHS grants, cooperative
agreements and contracts will be free from bias resulting from
Investigator financial conflicts of interest.
OMB approval is requested for an extension of 3 years. There are
operating costs and/or maintenance costs per response. The total
estimated annualized burden hours are 676,130.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent based on applicable section Number of responses per per response Total annual
of regulation respondents respondent (in hours) burden hour
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Reporting
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Initial Reports under 42 CFR 50.605(b)(1) and 950 1 2 1,900
(b)(3) or 45 CFR 94.5(b)(1) and (b)(3) from
Awardee Institutions...........................
Subsequent Reports under 42 CFR 50 1 2 100
50.605(a)(3)(iii) and (b)(2) or 45 CFR
94.5(a)(iii) and (b)(2) from Awardee
Institutions...................................
Mitigation Reports under 45 CFR 94.5(a)(3)(iii) 5 1 2 10
and (b)(2) from Awardee Institutions...........
Annual Report under 42 CFR 50.605(b)(4) or 45 950 1 1 950
CFR 94.5(b)(4) from Awardee Institution........
Subsequent Reports under 42 CFR 60.606(a) or 45 20 1 10 200
CFR 94.6(a) from Awardee Institution...........
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Record Keeping
----------------------------------------------------------------------------------------------------------------
Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from 2,000 1 4 8,000
Awardee Institutions...........................
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Disclosure
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Under 42 CFR 50.604(a) or 45 CFR 94.4(a) for 3,000 1 81 243,000
Investigators..................................
Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for 38,000 1 30/60 19,000
Investigators..................................
Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for 2,000 1 6 12,000
Institutions...................................
[[Page 78453]]
Under 42 CFR 50.604(c)(1) or 45 CFR 94(c)(1) 500 1 1 500
from Sub-recipients............................
Under 42 CFR 50.604(d) or 45 CFR 94.4(d) 3,000 1 1 3,000
Institutions...................................
Under 42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) 38,000 1 4 152,000
for Investigators..............................
Under 42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) 38,000 1 1 38,000
for Investigators..............................
Under 42 CFR 50.604(e)(3) or 45 CFR 94.4(e)(3) 950 1 30/60 475
for Investigators..............................
Under 42 CFR 50.604(f) or 45 CFR 94.4(f) for 2,000 1 1 2,000
Institutions...................................
Under 42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) 2,000 1 82 164,000
for Institutions...............................
Under 42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) 500 1 3 1,500
for Institutions...............................
Under 42 CFR 50.605(a)(3)(i) or 45 CFR 50 1 80 4,000
94.5(a)(3)(i) for Institutions.................
Under 42 CFR 50.605(a)(3)(ii) or 45 CFR 50 1 80 4,000
94.5(a)(3)(ii) for Institutions................
Under 42 CFR 50.605(a)(3)(iii) or 45 CFR 50 1 1 50
94.5(a)(3)(iii) for Institutions...............
Under 42 CFR 50.605(a)(4) or 45 CFR 94.5(a)(4) 950 1 12 11,400
for Institutions...............................
Under 42 CFR 50.605(a)(5) or 45 CFR 94.5(a)(5) 2,000 1 5 10,000
for Institutions...............................
Under 42 CFR 50.606(c) or 45 CFR 94.6(c) for 50 1 30/60 45
Institutions...................................
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Dated: December 17, 2014.
Lawrence Tabak,
Deputy Director, Office of the Director, NIH.
[FR Doc. 2014-30355 Filed 12-29-14; 8:45 am]
BILLING CODE 4140-01-P