[Federal Register: July 23, 1999 (Volume 64, Number 141)]
[Notices]               
[Page 40007-40008]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy99-85]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 
Submission for OMB Review; Comment Request; Attitudes of U.S. and 
Developing Country Researchers Regarding U.S. Human Subjects 
Regulations

SUMMARY: Under the provision of Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the National Bioethics Advisory Commission 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 December 18, 1998, page 70135-70136, and allowed 60 days 
for public comment. Comments were received from two parties concerning 
the inclusion of additional respondents in the data collection. The 
purpose of this notice is to allow an additional 30 days for public 
comment.

Proposed Collection

    Title: Attitudes of U.S. and Developing Country Researchers 
Regarding U.S. Human Subjects Regulations. Type of Information 
Collection Request: New. Need and Use of Information Collection: This 
project is an information collection commissioned by the National 
Bioethics Advisory Commission (NBAC) to assist the Commission in its 
review of U.S. policies and regulations regarding human subjects 
research conducted in developing countries. This study will collect 
information from researchers both in the U.S. and in developing 
countries who are involved with human subjects research, to ask them 
about their experiences with U.S. regulations and guidelines and with 
ethical issues in developing country research. The study consists of 
qualitative data collection in the form of focus groups and in-depth 
interviews, and quantitative data collection via a self-administered 
written survey. The respondents in this study are U.S.-based and 
developing country investigators who have conducted research in 
developing countries. U.S.-based respondents will include government, 
military, academic and private industry researchers. Developing country 
respondents will be identified through databases maintained by 
international organizations and will be researchers funded through a 
variety of sources and who work in developing countries throughout the 
world. Questions to be asked in focus groups, interviews and surveys 
include questions about informed consent procedures, about the 
appropriateness of U.S. regulations for developing country research 
activities, and about ethical challenges which researchers have faced 
in their developing country work. Frequency of Response: once. Affected 
Public: Individuals, business or other for-profit, not-for-profit 
institutions, Federal government. Type of Respondents: Researchers. 
Estimated Number of Respondents: 786. Estimated Number of Responses per 
Respondent: one. Average Burden Hours Per Response: 0.57. Estimated 
Total Annual Burden Hours Requested: 449. The annualized cost to 
respondents is estimated at: $34,800. There are no Capital Costs, 
Operating Costs, or Maintenance Costs to report.

Request for Comments

    Written comments and/or suggestions from the public and affected 
agencies

[[Page 40008]]

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: Office of 
Management and Budget, Office of Regulatory Affairs, New Executive 
Office Building, Room 10235, Washington, D.C. 20503, Attention: OMB 
Desk Officer. To request more information on the proposed project or to 
obtain a copy of the data collection plans and instruments, contact: 
Dr. Eric M. Meslin, National Bioethics Advisory Commission, 6100 
Executive Blvd., Suite 5B01, Rockville, MD 20892-7508, or contact the 
Commission by phone at 301-480-6900 or by e-mail at MeslinE@OD.NIH.GOV.

Comments Due Date

    Comments regarding this information collection are best assured of 
having their full effect if received on or before August 23, 1999.

    Dated: July 19, 1999.
Eric M. Meslin,
Executive Director, National Bioethics Advisory Commission.
[FR Doc. 99-18803 Filed 7-22-99; 8:45 am]
BILLING CODE 4160-17-P