[Federal Register Volume 73, Number 192 (Thursday, October 2, 2008)]
[Notices]
[Pages 57365-57366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23171]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Approval; Comment Request; Extension of 
Approved Collection; 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 C

SUMMARY: Under the provisions of 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 to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on July 14, 2008 (Vol. 73, No. 135, p. 40354-40355) and 
allowed 60-days for public comment. There were no public comments 
received during this time. 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.

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: Extension 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.

[[Page 57366]]



                                         TABLE--Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
     Type of respondents based on          Number of     Frequency of   Average burden hours per    Annual hour
   applicable section of  regulation      respondents      response              response             burden
----------------------------------------------------------------------------------------------------------------
                                                    Reporting
----------------------------------------------------------------------------------------------------------------
Initial Reports under 42 CFR Sec.              \i\ 300               1  80 Hours................           24000
 50.604 (g)(2) or 45 CFR 94.4(g) (2)
 from Institutions.
Subsequent Reports under 42 CFR Sec.           \ii\ 40               1  2 Hours.................              80
 50.604 (g)(2) or 45 CFR 94.4(g)(2)
 from Institutions.
Subsequent Reports under 42 CFR Sec.          \iii\ 20               1  10 Hours................             200
 50.606 (a) or 45 CFR 94.6 from
 Institutions.
----------------------------------------------------------------------------------------------------------------
                                                 Record Keeping
----------------------------------------------------------------------------------------------------------------
Under 42 CFR Sec.   50.604 (e) or 45        \iv\ 25000               1  4 Hours.................          100000
 CFR 94.4 (e)--Institutional files.
----------------------------------------------------------------------------------------------------------------
                                                   Disclosure
----------------------------------------------------------------------------------------------------------------
Under 42 CFR Sec.   50.604(a) or 45           \v\ 2800               1  20 Hours................           56000
 CFR 94.4 (a)--Institutions.
Under 42 CFR Sec.   50.604(c) or 45         \vi\ 40000               1  1 Hour..................           40000
 CFR 94.4 (c)--Investigators.
    Totals............................           68160  ..............  ........................         220280
----------------------------------------------------------------------------------------------------------------
\i\ Although not more than 300 reports of Conflict of Interest are expected, the responding institutions must
  review all financial disclosures associated with PHS funded 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 the
  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 may 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 conflict of interest policy has biased the design,
  conduct or reporting of the research. ``Objectivity in Research, Final Rule'' 60 FR 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 conflict of interest
  result from regulations.

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate 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) Evaluate 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) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) 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.

Direct Comments to OMB

    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 Attention: NIH Desk 
Officer, Office of Management and Budget, at [email protected] or by fax to 202-395-6974. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans 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: 
[email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

    Dated: September 25, 2008.
Joe Ellis,
Director, Office of Policy of Extramural Research Administration, 
National Institutes of Health.
 [FR Doc. E8-23171 Filed 10-1-08; 8:45 am]
BILLING CODE 4140-01-P