[Federal Register: April 25, 2001 (Volume 66, Number 80)]
[Notices]               
[Page 20823-20824]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap01-68]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

 
National Toxicology Program (NTP); National Institute of 
Environmental Health Sciences; Center for the Evaluation of Risks to 
Human Reproduction (CERHR) Solicits Public Comments on Draft Guidelines 
for CERHR Expert Panel Members

Background

    The NTP and the National Institute of Environmental Health Sciences 
established the NTP Center for the Evaluation of Risks to Human 
Reproduction (CERHR) in 1998 to serve as an environmental health 
resource to the public and regulatory and health agencies. The CERHR 
provides scientifically based, uniform assessments of the potential for 
adverse effects on reproduction and development caused by agents to 
which humans may be exposed. The assessments are carried out through 
rigorous, independent evaluations of the scientific literature on these 
agents by panels of scientists. The products of these evaluations are 
Expert Panel Reports.
    The Expert Panel Report provides a consensus scientific judgement 
of the potential human reproductive and developmental toxicity of the 
chemical agent or mixture. The goals of the evaluations are to:
    (1) Evaluate the quality of the available scientific data and 
identify critical data needs so that research and testing priorities 
can be established;
    (2) Interpret scientific studies for and provide information to the 
general public about the strength of evidence that a given exposure 
poses a hazard to reproduction and/or to the health and welfare of the 
developing child; and
    (3) Provide regulatory agencies with objective and scientifically 
credible evaluations of reproductive/developmental health effects 
associated with exposure to specific chemicals or classes of chemicals, 
including descriptions of any uncertainties associated with the 
assessment of risks.

Availability of Draft Guidelines for CERHR Expert Panel Members

    In order to maintain consistency among the expert panel reviews and 
to provide guidance about these reviews and preparation of Expert Panel 
Reports, the CERHR has prepared draft guidelines for the expert panels 
and CERHR staff. The Guidelines cover the three phases of the Expert 
Panel review process: pre-meeting preparation, Expert

[[Page 20824]]

Panel Meeting, and completion of the Panel Report.
    A copy of the Draft Guidelines for CERHR Expert Panel Members can 
be obtained electronically from the CERHR web site (http://
cerhr.niehs.nih.gov). Hard copies can be obtained by contacting: Ms. 
Irma Velazquez, Special Assistant, CERHR, 111 T.W. Alexander Drive, PO 
Box 12233, MD EC-32, Research Triangle Park, NC 27709-2233; Telephone: 
919-316-4508, Facsimile: 919-316-4511; E-mail: velazqu2@niehs.nih.gov.

Request for Public Comment on Draft Guidelines

Written Comments

    CERHR invites written public comment on the Draft Guidelines 
through June 11, 2001. All comments should refer to the specific 
section of the guidelines being addressed. Persons submitting written 
comments should include the following information: name, address, 
affiliation, telephone, fax, e-mail, and sponsoring organization (if 
any). All comments received will be reviewed by NTP and CERHR staff and 
considered in making any revisions to the Draft Guidelines. Comments on 
the Draft Guidelines should be directed to: Michael D. Shelby, 
Director, CERHR, 111 T.W. Alexander Drive, PO Box 12233, MD EC-32, 
Research Triangle Park, NC 27709-2233; Telephone: 919-541-3455, 
Facsimile: 919-316-4511; E-mail: shelby@niehs.nih.gov.

Oral Comments

    A May 25, 2001 meeting of the NTP Board of Scientific Counselors 
provides an additional opportunity for public comment on the Draft 
Guidelines. The NTP Board provides external scientific oversight to 
CERHR, and an item on the May 25 agenda is presentation and discussion 
of the Draft Guidelines. This meeting will be held at the National 
Institute of Environmental Health Sciences (111 T.W. Alexander Drive, 
Research Triangle Park, NC 27709). For planning purposes, persons 
wishing to make oral comments are asked to contact the NTP Executive 
Secretary by May 16; registration will however be accepted at the 
meeting as well. It is important to contact the Executive Secretary to 
register, obtain additional details about the meeting, including a 
draft agenda, and information for members of the public wishing to 
speak. This information can also be found on the NTP web site (http://
ntp-server.niehs.nih.gov). Dr. Mary Wolfe, NTP Board Executive 
Secretary, 111 T.W. Alexander Drive, PO Box 12233, MD A3-07, Research 
Triangle Park, NC 27709-2233; Telephone: 919-541-3971, Facsimile: 919-
541-0295; E-mail: wolfe@niehs.nih.gov.

Additional Information About CERHR

    Information about CERHR including its chemical nomination and 
review process, Expert Panel Registry, the recently completed Expert 
Panel Review on Phthalates, and upcoming reviews can be obtained from 
the CERHR web site (http://cerhr.niehs.nih.gov). The CERHR maintains an 
expert registry of scientists qualified to participate in its Expert 
Panel Reviews. If you are interested in being included in the registry, 
send a description of expertise and curriculum vitae to Dr. Shelby at 
the address above.

    Dated: April 12, 2001.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Services.
[FR Doc. 01-10206 Filed 4-24-01; 8:45 am]
BILLING CODE 4140-01-P