[Federal Register: July 1, 2002 (Volume 67, Number 126)]
[Notices]               
[Page 44219-44220]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jy02-84]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

 
Submission for OMB Review; Comment Request; Responsibility of 
Applicants for Promoting Objectivity in Research for Which Public 
Health Service Funding is Sought and Responsible Prospective 
Contractors--42 CFR Part 50, Subpart F

SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Office of the Director (OD), the National 
Institutes of Health (NIH) has submitted to the Office of Management 
and Budget (OMB) a request for review and approval of the information 
collection listed below. This proposed information collection was 
previously published in the Federal Register on October 9, 2001, pages 
51440-51441 and allowed 60 days for public comment. No public comments 
were received. 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 
Responsible Prospective Contractors--42 CFR part 50, subpart F, Type of 
Information Collection Request: Revision of OMB No. 0925-0417, 
expiration date 4/30/02. Need and Use of Information Collections: 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 Responsible Prospective Contractors: 45 CFR part 94. The 
purpose of the regulations is to promote objectivity in research by 
requiring institutions to establish standards which ensure that there 
is no reasonable expection 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 Respondent: 
Any public or private entity or organization. The annual reporting 
burden is as follows;

[[Page 44220]]

Estimated Number of Respondents: 42,800; Estimated Number of Responses 
per Respondent: 1.60; Average Burden Hours per Response: 3.40; and 
Estimated Total Annual Burden Hours Requested: 232, 080. The annualized 
costs to respondents is estimated at: $8,120,000. Operating costs and/
or Maintenance Costs are $4,633.

Request 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 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.

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: Office of 
Management and Budget, Office of Regulatory Affairs, New Executive 
Office Building, Room 10235, Washington, DC 20503, Attention: Desk 
Officer for NIH. To request more information on the proposed project or 
to obtain a copy of the data collection plans and instruments, contact: 
Charles MacKay, Ph.D., Chief, Project Clearance Branch, Office of 
Extramural Research (OER), Office of Policy for Extramural Research 
Administration (OPERA), 6705 Rockledge Drive, Room 3509, Bethesda, MD 
20892-7974 or call non-toll-free number (301) 435-0978 or E-mail your 
request including your address to: MACKAY@OD.NIH.GOV.

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: June 20, 2002.
Regina H. White,
Director, Office of Policy for Extramural Research Administration, OER, 
NIH.
[FR Doc. 02-16429 Filed 6-28-02; 8:45 am]
BILLING CODE 4140-01-M