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

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