[Federal Register Volume 61, Number 198 (Thursday, October 10, 1996)]
[Notices]
[Pages 53228-53229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Proposed Collection; Comment Request; Evaluation of NIH 
Implementation of Section 491 of the Public Health Service Act, 
Mandating a Program of Protection for Research Subjects
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 National Institutes of Health 
(NIH), Office of the Director, 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: 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: 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 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 response. 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; Number of Responses per Respondent: 1; 
Average Burden per Response: 0.513 hr.; and Estimated Total Annual 
Burden Hours Requested: 1,210. The annualized cost to respondents is 
$57,605. There are no

[[Page 53229]]

Capital Costs to report. There are no Operating or Maintenance Costs to 
report.

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 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.

FOR FURTHER INFORMATION: 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 2, 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: [email protected].

COMMENTS DUE DATE: Comments regarding this information collection are 
best assured of having their full effect if received on or before 
December 9, 1996.

    Dated: October 3, 1996.
Geoffrey E. Grant,
Acting Deputy Director for Extramural Research, NIH.
[FR Doc. 96-25978 Filed 10-9-96; 8:45 am]
BILLING CODE 4140-01-M