98-33488. National Bioethics Advisory Commission; Proposed Information Collection; Comment Request; American Investigators' Attitudes Regarding U.S. Human Subjects Regulations

[Federal Register Volume 63, Number 243 (Friday, December 18, 1998)]
[Notices]
[Pages 70135-70136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33488]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Bioethics Advisory Commission; Proposed Information 
Collection; Comment Request; American Investigators' Attitudes 
Regarding U.S. Human Subjects Regulations

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 Bioethics Advisory 
Commission will publish periodic summaries of proposed projects to be 
submitted to the Office of Management and Budget (OMB) for review and 
approval.

BACKGROUND: The National Bioethics Advisory Commission (NBAC), 
appointed by President Clinton, is examining international research 
ethics as one of its focus areas. NBAC has commissioned this study to 
analyze how American investigators view current regulatory 
requirements. The results of this study will contribute to NBAC's 
examination of whether U.S. policies regarding human subjects research 
in developing countries should

[[Page 70136]]

be changed and, if so, to develop recommendations for such change.
    Proposed Collection: Title: American Investigators' Attitudes 
Regarding U.S. Human Subjects Regulations. Type of Information 
Collection Request: New. Need and Use of Information Collection: This 
is an effort by the National Bioethics Advisory Commission to provide 
information that is currently not available to assist the Commission in 
its upcoming deliberations on international bioethics issues. The 
respondents are individual U.S. researchers who have conducted or are 
currently conducting research in developing countries, funded by the 
U.S. government and therefore subject to U.S. human subject protection 
regulations. The following research questions will be addressed: What 
are the attitudes and experiences of US-based health researchers 
working in developing countries regarding US-generated ethical 
guidelines and human subjects regulations? What recommendations do such 
researchers make for revising the U.S. guidelines for research 
conducted in developing world settings? This study will employ two 
phases: Phase 1 will consist of focus groups with American 
investigators; and Phase 2 will entail mailing a self-administered 
survey to a randomly selected sample of researchers funded by the 
Federal government or private entities to conduct health research in 
developing countries. Frequency of Response: One time. Affected Public: 
Individuals. Type of Respondents: Researchers . The annual reporting 
burden is as follows: Estimated Number of Respondents: 245; Estimated 
Number of Responses per Respondent: 1; Average Burden Hour per 
Respondent: .776; and Estimated Total Annual Burden Hours Requested: 
190. The annualized cost to respondents is estimated at $4,750. There 
are no Operating or Maintenance Costs to report.
    Request for Comments: Written comments and/or suggestions from 
public individuals or organizations should be sent to 6100 Executive 
Boulevard, Suite 5B01, Rockville, MD 20892-7508, or to the Commission's 
website at www.bioethics.gov. Responses can also be faxed to 301-480-
6900. Responses should address ways that enhance the quality, utility, 
and clarity of the information sought.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact in writing Ms. Patricia Norris at the address 
shown above or via the NBAC website.
    Comments Due Date: Comments regarding this information collection 
are best assured of having a full effect if received within 60 days of 
the date of this publication.

    Dated: December 14, 1998.
Eric M. Meslin,
Executive Director, National Bioethics Advisory Commission.
[FR Doc. 98-33488 Filed 12-17-98; 8:45 am]
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