[Federal Register Volume 65, Number 201 (Tuesday, October 17, 2000)]
[Notices]
[Page 61341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26581]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Survey of IRB Chairs 
Concerning the Implementation of Pediatric Research 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 Institutes of Health 
(NIH) 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: Survey of IRB Chairs Concerning the Implementation of 
Pediatric Research Regulations.
    Type of Information Collection Request: New.
    Need and Use of Information Collection: In order to assess the 
protection of children who are enrolled in clinical research, it is 
important to determine how Institutional Review Boards (IRBs) reviewing 
such research interpret and implement the Federal Regulations for 
research with children set forth in 45 CFR 46 Subpart D. This study 
aims to gather this information through telephone interviews with 
chairpersons of IRBs that review clinical research with children. In 
addition, we will solicit background information on each IRB from the 
IRB coordinator. In particular, the survey aims to assess how IRBs 
assess risk/benefit levels of research with children, when IRBs permit 
children's assent to be waived, what information IRBs require children 
to be presented during the asset process, and which children are 
excluded from participation in riskier research. In addition, the 
survey will attempt to determine how the recent NIH Policy and 
Guidelines on the Inclusion of Children as Participants in Research 
Involving Human Subjects has affected IRB review. Frequency of 
Response: Once. Affected Public: Individuals. Type of Respondents: IRB 
chairpersons and IRB coordinators. The annual reporting burden follows 
in the table below. The annualized cost to respondents is estimated at: 
$10,000. There are no Capital Costs to report. There are no Operating 
or Maintenance Cost to report.

                                   Respondent and Burden Estimate Information
----------------------------------------------------------------------------------------------------------------
                                                                                                      Estimated
                                                                            Estimated     Average       total
                                                               Estimated    number of      burden       annual
                     Type of respondents                       number of    responses    hours per      burden
                                                              respondents      per        response      hours
                                                                            respondent                requested
----------------------------------------------------------------------------------------------------------------
IRB chairs..................................................          200            1          0.5          100
IRB coordinators............................................          200            1          0.5          100
    Total...................................................  ...........  ...........  ...........          200
----------------------------------------------------------------------------------------------------------------

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 
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 CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Dave Wendler, Ph.D., Head, Unit on Vulnerable 
Populations, Department of Clinical Bioethics, NIH, Building 10, Room 
1C118, 9000 Rockville Pike, Bethesda, MD 20892, or call non-toll-free 
number (301) 435-8726 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 18, 2000.

    Dated: October 4, 2000.
Ezekiel Emanuel,
Chief, Department of Clinical Bioethics.
[FR Doc. 00-26581 Filed 10-16-00; 8:45 am]
BILLING CODE 4140-01-M