[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
----------------------------------------------------------------------------------------------------------------
                                                                     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
----------------------------------------------------------------------------------------------------------------
                                                    Reporting
----------------------------------------------------------------------------------------------------------------
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...........
----------------------------------------------------------------------------------------------------------------
                                                 Record Keeping
----------------------------------------------------------------------------------------------------------------
Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from              2,000               1               4           8,000
 Awardee Institutions...........................
----------------------------------------------------------------------------------------------------------------
                                                   Disclosure
----------------------------------------------------------------------------------------------------------------
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