[Federal Register Volume 67, Number 66 (Friday, April 5, 2002)]
[Notices]
[Pages 16415-16416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; National Institute of Environmental 
Health Sciences (NIEHS); National Institutes of Health (NIH) Notice of 
an Expert Panel Meeting To Assess the Current Validation Status of In 
Vitro Endocrine Disruptor Screening Methods; Request for Comments

SUMMARY: Pursuant to Public Law 103-43, notice is hereby given of a 
meeting sponsored by the NIEHS and the National Toxicology Program 
(NTP), and organized by the NTP Interagency Center for the Evaluation 
of Alternative Toxicological Methods (NICEATM) in collaboration with 
the Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM). At this meeting, an expert panel (Panel) will assess 
the current validation status of in vitro endocrine disruptor screening 
methods and develop recommendations for their further validation. The 
meeting will take place on May 21-22, 2002, from 8:30 a.m. to 5 p.m., 
at the Sheraton Imperial Hotel and Convention Center, 4700 Emperor 
Boulevard, Durham, NC 27703. The meeting is open to the public with 
attendance limited only by the space available.

Evaluation of In Vitro Endocrine Disruptor Screening Methods

    A request for data evaluating the performance and reliability of 
endocrine disruptor screening methods and the nomination of expert 
scientists was previously published (Federal Register, Vol. 66, No. 57, 
pp. 16278-16279, March 23, 2001, available at http://iccvam.niehs.nih.gov/methods/endocrine.htm). This notice also announced 
that ICCVAM and NICEATM are coordinating an expert panel meeting to 
assess the current validation status of in vitro estrogen receptor (ER) 
and androgen receptor (AR) binding and transcriptional activation 
assays and to review proposed minimum performance criteria for defining 
an acceptable screening assay. During development of

[[Page 16416]]

the Background Review Documents (BRDs) for the in vitro ER and AR 
assays being considered at this review, ICCVAM and NICEATM determined 
that no validation studies have been completed. With agreement from 
EPA, the NICEATM and ICCVAM decided to proceed with an expert panel 
evaluation of the current status of ER and AR binding and 
transcriptional activation assays and with development of 
recommendations for their future validation. At this meeting, the Panel 
will review each of four BRDs (see below) and develop conclusions and 
recommendations on the following:
     The relative priority that should be given to specific 
assays recommended for further evaluation in validation studies.
     The adequacy of the specific protocols recommended for 
validation studies.
     The adequacy of the minimum procedural standards 
recommended for each type of assay.
     The adequacy and appropriateness of substances recommended 
for validation studies.
    Following the completion and submission of validation studies on in 
vitro ER and AR assays, an independent peer review panel will be 
convened to review these studies and propose minimum performance 
criteria.

Agenda

    The public meeting will take place May 21-22, 2002, at the Sheraton 
Imperial Hotel and Convention Center, 4700 Emperor Boulevard, Durham, 
NC 27703. The meeting will begin at 8:30 a.m. and conclude at 5 p.m. 
each day. On the morning of May 21st, there will be a brief orientation 
on ICCVAM and the ICCVAM test method review process, followed by the 
Panel's evaluation of the BRDs for the ER binding and transcriptional 
activation assays. It is anticipated that review of the ER BRDs will 
continue on the morning of May 22nd, after which the review of the BRDs 
for the AR binding and transcriptional activation assays will take 
place. The Panel will evaluate the current status of each of the four 
different types of in vitro assays and develop recommendations for 
their future validation. A detailed agenda will be available prior to 
the meeting at the ICCVAM/NICETATM web site (http://iccvam.niehs.nih.gov) or by contacting NICEATM (contact information 
below). Summary minutes and a final report of the Panel will be 
available following the meeting at the ICCVAM/NICEATM web site. Persons 
needing special assistance, such as sign language interpretation or 
other special accommodations, should contact NICEATM.

Availability of Background Review Documents

    NICEATM has prepared four BRDs, one for each type of assay being 
evaluated (ER and AR binding assays and ER and AR transcriptional 
activation assays). Copies of each BRD may be obtained on the ICCVAM/
NICEATM web site at http://iccvam.niehs.nih.gov, or by contacting 
NICEATM, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC, 
27709, (phone) 919-541-3398, (fax) 919-541-0947, (email) 
[email protected].

Request for Comments

    NICEATM invites the submission of written comments on each of the 
BRDs. When submitting written comments please include appropriate 
contact information (name, affiliation, mailing address, phone, fax, 
email and sponsoring organization, if applicable). Written comments and 
additional information should be sent by mail, fax, or email to NICEATM 
at the address listed above by noon, May 10, 2002. All written comments 
received before the meeting will be posted on the ICCVAM/NICEATM web 
site and made available to the Panel members, ICCVAM agency 
representatives and experts, and also to attendees at the meeting.
    The meeting is open to the public and time will be provided for the 
presentation of public oral comments at designated times during the 
Panel review. Members of the public who wish to present oral statements 
at the meeting (one speaker per organization) should contact NICEATM 
(at the address above) no later than noon, May 10, 2002. Speakers will 
be assigned on a consecutive basis and up to seven minutes will be 
allotted per speaker. Persons registering to make comments are asked to 
provide a written copy of their statement in advance so that copies can 
be distributed to the Panel. Written statements can supplement and 
expand the oral presentation. Each speaker is asked to provide contact 
information (name, affiliation, mailing address, phone, fax, email and 
sponsoring organization, if applicable).

Background Information on ICCVAM and NICEATM

    ICCVAM was established in 1997 to coordinate cross-agency issues 
relating to the validation, acceptance, and national/international 
harmonization of toxicological testing methods. Composed of 
representatives from fifteen Federal regulatory and research agencies 
that use or generate toxicological information, ICCVAM promotes the 
scientific validation and regulatory acceptance of toxicological test 
methods that enhance agencies' ability to make decisions on health 
risks, while refining, reducing, and replacing animal use wherever 
possible. ICCVAM was authorized as a permanent interagency committee of 
the NIEHS, under the NICEATM, on December 19, 2000, through passage of 
the ICCVAM Authorization Act of 2000 (Public Law 106-545, available at 
http://iccvam.niehs.nih.gov/PL106545.htm). Public Law 106-545 directs 
the ICCVAM to coordinate the technical review of new, revised, and 
alternative test methods of interagency interest. NICEATM provides 
operational and scientific support for ICCVAM and ICCVAM-related 
activities. NICEATM and ICCVAM work collaboratively to evaluate new and 
improved test methods applicable to the needs of federal agencies. 
Additional information about ICCVAM and NICEATM can be found at the 
following web site: 
http://iccvam.niehs.nih.gov.

    Dated: March 27, 2002.
Kenneth Olden,
Director, National Institute of Environmental Health Sciences.
[FR Doc. 02-8328 Filed 4-4-02; 8:45 am]
BILLING CODE 4140-01-P