[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Notices]
[Pages 67839-67840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32583]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Evaluation of NIH
Implementation of Section 491 of the Public Health Service Act,
Mandating a Program of Protection for Research Subjects
SUMMARY: Under the provisions of Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH), Office
of the Director (OD) 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 October 10, 1996, page 53228-53229
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: Evaluation of NIH Implementation of Section 491 of the
Public Health Service Act, Mandating a Program of Protection for
Research Subjects.
Type of Information Collection Request: Extension of OMB No. 0925-
0404, expiration 12/31/96.
Need and Use of Information Collection: This study will assess the
performance of the system of human subjects protections. It will
provide up-to-date comprehensive and systematic information on the
effectiveness and efficiency of procedural protections by measuring
outcome, output, process, and resources of the current system to
[[Page 67840]]
develop possible recommendations. The study will use survey, interview,
and record extraction methodologies. Development of the survey
instruments and methodology has involved representatives of the
affected public over the past 2 years.
Frequency of Response: One-time.
Affected Public: Individuals or households; Not-for-Profit
Institutions; State, Local, or Tribal Government.
Type of Respondents: University officials, staff, and faculty.
The annual reporting burden is as follows:
Estimated Number of Respondents: 2,358.
Estimated Number of Responses per Respondent: 1.
Average Burden per Response: 0.485 hours.
Estimated Total Annual Burden Hours Requested: 1,145. The
annualized cost to respondents is estimated at: $55,125. There are no
Capital Costs to report. There are no Operating or Maintenance Costs to
report.
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, D.C. 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:
Dr. Charles R. MacKay, Project Clearance Officer, Office of Policy for
Extramural Research Administration, Office of Extramural Research,
Office of the Director, NIH, Rockledge II, 6701 Rockledge Drive, MSC
7730, Room 2196, Bethesda, MD 20892-7730, or call nontoll-free number
(301) 435-0978 or E-Mail your request, including your address to:
cm13f@nih.gov.
Comments Due Date: Comments regarding this information collection are
best assured of having their full effect if received on or before
January 23, 1997.
Dated: December 17, 1996.
Geoffrey E. Grant,
Director, Office of Policy for Extramural Research Administration.
[FR Doc. 96-32583 Filed 12-23-96; 8:45 am]
BILLING CODE 4140-01-M
