Proposed Collection; Proposed Revision of Approved Collection; Comment Request; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought, 42 CFR Part 50, Subpart F and for Responsible Prospective Contractors, 45 CFR Part 94, 40354-40355 [E8-15826]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 73, Number 135 (Monday, July 14, 2008)]
[Notices]
[Pages 40354-40355]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15826]



[[Page 40354]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Proposed Revision of Approved Collection; 
Comment Request; Responsibility of Applicants for Promoting Objectivity 
in Research for Which Public Health Service Funding Is Sought, 42 CFR 
Part 50, Subpart F and for Responsible Prospective Contractors, 45 CFR 
Part 94

    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), the 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.
    Proposed Collection:
    Title: Responsibility of Applicants for Promoting Objectivity in 
Research for which Public Health Service Funding is Sought and for 
Responsible Prospective Contractors, 42 CFR Part 50, Subpart F, and 45 
CFR Part 94.
    Type of Information Collection Request: Revision of OMB No. 0925-
0417, expiration date November 30, 2008.
    Need and Use of the Information Collection: This is a request for 
OMB Approval for the information collection and recordkeeping 
requirements contained in the final rule 42 CFR Part 50, Subpart F and 
related recordkeeping requirements regarding contractors in 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 
research will be biased by a conflicting financial interest of an 
investigator.
    Frequency of Response: On occasion.
    Affected Public: Individuals or households; business or other for-
profit; not-for-profit institutions; State, Local or tribal government.
    Type of Respondents: Any public or private entity or organization. 
The annual reporting burden is as follows:
    Estimated Number of Respondents: 67,860;
    Estimated Number of Responses Per Respondent: 1.60;
    Averaged Burden Hours per Response: 3.40.; and
    Estimated Total Annual Burden Hours Requested: 220,280.
    The annualized cost to the public is estimated at $8,120,000.
    Operating Costs and/or maintenance costs are $4,633.00.

                                         Table--Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
                                                                                  Average burden
    Type of respondents based on applicable        Number of      Frequency of      hours per       Annual hour
             section of regulation                respondents       response         response         burden
----------------------------------------------------------------------------------------------------------------
Reporting:                                      ..............  ...............  ...............  ..............
    Initial Reports under 42 CFR Sec.                  \i\ 300               1               80            24000
     50.604(g)(2) or 45 CFR 94.4(g)(2) from
     Institutions.............................
    Subsequent Reports under 42 CFR Sec.               \ii\ 40               1                2               80
     50.604(g)(2) or 45 CFR 94.4(g)(2) from
     Institutions.............................
    Subsequent Reports under 42 CFR Sec.              \iii\ 20               1               10              200
     50.606(a) or 45 CFR 94.6 from
     Institutions.............................
----------------------------------------------------------------------------------------------------------------
Recordkeeping: Under 42 CFR Sec.   50.604(e)        \iv\ 25000               1                4           100000
 or 45 CFR 94.4(e)--Institutional files.......
----------------------------------------------------------------------------------------------------------------
Disclosure:                                     ..............  ...............  ...............  ..............
    Under 42 CFR Sec.   50.604(a) or 45 CFR           \v\ 2800               1               20            56000
     94.4(a)--Institutions....................
    Under 42 CFR Sec.   50.604(c) or 45 CFR         \vi\ 40000               1                1            40000
     94.4(c)--Investigators...................
                                               -----------------------------------------------------------------
        Totals................................           67860  ...............  ...............          220280
----------------------------------------------------------------------------------------------------------------
\i\ Although not more than 300 reports of Financial Conflict of Interest are expected, the responding
  institutions will need to review all financial disclosures associated with PHS funding awards to determine
  whether any conflicts of interest exist. Thus, the total burden of 24,000 hours is based upon estimates that
  it will take on average 4/5 of an hour to review each of 30,000 financial disclosures associated with PHS
  funding awards. (30,000 x 48 (minutes per file) = 1,440,000 / 60 minutes = 24,000 (total hours).
\ii\ The burden for subsequent reports of conflicts (made during the 12-month period following the initial
  report) is significantly less, because we do not expect many additional reportable conflicts and there will be
  only a limited number of disclosures to review.
\iii\ This burden was originally estimated in the 1995 Final Rule to be no more than 5 instances that the
  failure of an investigator to comply with the institution's FCOI policy has biased the design, conduct or
  reporting of the research. ``Objectivity in Research, Final Rule'' 60 Fed. Reg. 132 (July 11, 1995) pps. 35810-
  35819. This burden estimate, and others, was increased in 2002 ``due to increased numbers of institutions and
  investigators.''
\iv\ Assumes 2500 institutions, 10 responses per year per institution.
\v\ Assumes 2800 recipient institutions and 20 hours per institution informing each investigator of
  institutional policy.
\vi\ The financial disclosure burden estimate is based upon an investigator figure of 40,000 with an average
  response time of 1 hour. The estimated number of investigators has not changed since the 2002 Information
  Collection Request associated with the Final Rule. These estimates are for the burden imposed by disclosure,
  reporting and recordkeeping requirements. Not all activities of institutions related to FCOI result from
  regulations.

Requests for Comments

    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 functions of the agency, including whether 
the information shall have practical utility; (2) The accuracy of the 
agency's estimate of the burden (including hours and cost) of the 
proposed information collection; (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 respondents, 
including through the

[[Page 40355]]

use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.
    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. Mikia Currie, Assistant Project Clearance 
Officer, Office of Extramural Research, (OER), Office of Policy for 
Extramural Research Administration, (OPERA), 6705 Rockledge Drive, Room 
1198, Bethesda, MD 20892-7974, or call non-toll-free number 301-435-
0941 or e-mail your request, including your address, to: 
curriem@od.nih.gov.
    Comments 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.

    Dated: May 19, 2008.
Joe Ellis,
Director, Office of Policy of Extramural Research Administration, OER, 
National Institutes of Health.
[FR Doc. E8-15826 Filed 7-11-08; 8:45 am]
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