[Federal Register Volume 65, Number 74 (Monday, April 17, 2000)]
[Notices]
[Pages 20478-20479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9443]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Institute of Environmental Health Sciences, NIH; 
National Toxicology Program; Peer Review Meeting on Low-Dose Issues for 
Endocrine Disruptors; Scope of Information Considered for Review 
Broadened, Deadline for Receipt of Information Extended, and Date for 
Meeting Delayed

Summary

    The National Toxicology Program (NTP) is organizing a Peer Review 
to evaluate whether chemicals can cause hormone-related effects at 
doses lower than those typically used in the standard toxicological 
dose-setting paradigm. The U.S. Environmental Protection Agency (EPA) 
Endocrine Disruptor Screening Program will use the results from this 
peer review to assist in determining how to identify and characterize 
potential low-dose effects that may arise during endocrine disruptor 
screening, testing, and hazard assessment.
    On January 6, 2000 the NTP published a Federal Register notice 
[Volume 65, Number 4, pages 784-787] outlining plans for the Peer 
Review meeting and soliciting public input into the process. This 
notice broadens the request for research studies and data to be 
considered and extends previously announced deadlines for receipt for 
research information for use in this peer review.

Broader Request for Research Studies to be Considered for the Peer 
Review

    On January 6, 2000, the NTP published a Federal Register notice 
[Volume 65, Number 4, pages 784-787] providing details about a Peer 
Review meeting to evaluate scientific data on the potential low-dose 
effects associated with exposure to endocrine disruptors. In that 
notice, the NTP solicited comments on the planned scope and process of 
the proposed peer review, nominations of studies for inclusion in this 
review, as well as nominations of individuals for the Peer Review 
panel. The notice also detailed the criteria for selection of studies 
for review.
    The NTP Selection/Organizing Committee will review the nominated 
studies and designate them as either critical to resolution of the low-
dose issue or background information. The January 6th notice stipulated 
that studies nominated for consideration in this peer review should 
have been published or accepted for publication by April 1, 2000. The 
NTP is now broadening the scope of studies to be considered for this 
peer review to include relevant data from unpublished studies. 
Submission of unpublished studies should include an abstract of the 
study describing the hypothesis being tested, experimental design 
[model system (cell line, species, strain, number per group, etc.), 
dosing regimen, duration of treatment and follow-up], endpoints 
evaluated, and results (if available).
    If an unpublished study is nominated for consideration, the NTP 
will contact the principal investigator for an update of the study's 
status and to obtain additional information about the study. If 
selected by the NTP Selection/Organizing Committee, the studies will be 
distributed to the Peer Review panel for its review and evaluation. The 
NTP may need access to raw data for subsequent independent analysis by 
the Panel. As with published studies and studies accepted for 
publication but not yet published, all information given to the Peer 
Review Panel will simultaneously be made available to the public. 
Therefore, studies, which are unpublished by the date of their 
distribution to the Panel, will require approval from the author (and 
publisher if accepted for publication) in order to be included in the 
Peer Review. A list of the studies included in the Peer Review will be 
posted on the NTP web page (http://ntp-server.niehs.nih.gov) and 
available from NTP Liaison and Scientific Review Office (NIEHS/NTP, 
P.O. Box 12233, Research Triangle Park, NC 27709; t: 919-541-0530; f: 
919-541-0295). Federal Register announcement. Planning for the Peer 
Review Meeting is ongoing and the date and location will be announced 
in the Federal Register in the near future.

Solicitation of Public Comment

    Comments about the scope and process for the Peer Review are 
welcome. The deadline for submission of comments, identified by docket 
control number OPPTS-42208A, is extended from February 22, 2000 to May 
22, 2000.

Guidelines for Submission of Public Comment

    The EPA will manage the record-keeping aspects of the Peer Review 
as part of the Endocrine Disruptor Screening Program. General 
information about the U.S. EPA Endocrine Disruptor Screening Program is 
available from the Internet at http://www.epa.gov/scipoly/oscpendo/index.htm or by contacting Mr. James Kariya (contact information 
provided below).
    The EPA has established an official record for this action under 
docket control number OPPTS-42208A. The official record consists of the 
document specifically referenced in this action, any public comments 
received during an applicable comment period, and other information 
related to this action. This official record includes the documents 
that are physically located in the docket, as well as the documents 
that are referenced in those documents. The public version of the 
official record does not include any information claimed as 
confidential business information (CBI). The public version of the 
official record, which includes printed, paper versions of any 
electronic comments submitted during an applicable comment period, is 
available for inspection in the TSCA Nonconfidential Information 
Center, North East Mall Room B-607, Waterside Mall, 401 M. Street, SW, 
Washington, DC. The Center is open from noon to 4 PM., Monday through 
Friday, excluding legal holidays. The telephone number of the Center is 
(202) 260-7099.
    Comments can be submitted through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
the docket control number OPPTS-42208A is identified in the subject 
line on the first page of the comments.
    1. By mail: Submit comments to: Document Control Office (7407), 
Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
    2. In person or by courier: Deliver comments to: OPPT Document 
Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St. 
SW, Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
DCO is (202) 260-7093.
    3. Electronically: Submit comments electronically by e-mail to: 
``[email protected],'' or mail the computer disk to the Document 
Control Office (address identified above). The form must be identified 
by docket

[[Page 20479]]

control number OPTTS-42208A. Electronic comments may also be filed 
online at many Federal Depository Libraries.
    Do not submit any information that you consider is CBI. If you 
believe that relevant information will be overlooked because of this 
restriction, please consult James P. Kariya, Office of Science 
Coordination and Policy (7203), Office of Prevention, Pesticides, and 
Toxic Substances, U.S. EPA, 1200 Pennsylvania Avenue NW, Washington, DC 
20460; t: 202-260-2916; email: [email protected].

    Dated: April 6, 2000.
Samuel H. Wilson,
Deputy Director, National Toxicology Program.
[FR Doc. 00-9443 Filed 4-14-00; 8:45 am]
BILLING CODE 4140-01-M