[Federal Register Volume 76, Number 15 (Monday, January 24, 2011)]
[Notices]
[Pages 4113-4115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Independent Scientific Peer Review Panel Meeting on an In Vitro 
Estrogen Receptor Transcriptional Activation Test Method for Endocrine 
Disruptor Chemical Screening; National Toxicology Program (NTP); NTP 
Interagency Center for the Evaluation of Alternative Toxicological 
Methods (NICEATM); Announcement of an Independent Scientific Peer 
Review Panel Meeting on an In Vitro Estrogen Receptor Transcriptional 
Activation Test Method for Endocrine Disruptor Chemical Screening; 
Availability of Draft Background Review Document (BRD); Request for 
Comments

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH), HHS.

ACTION: Meeting announcement and request for comments.

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SUMMARY: NICEATM, in collaboration with the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM), announces 
a public meeting of an independent scientific peer review panel (Panel) 
to evaluate the validation status of LUMI-CELL[supreg] ER (BG1Luc ER 
TA), an in vitro transcriptional activation (TA) assay used to identify 
chemicals that can interact with human estrogen receptors (ERs). 
Validated assays that can detect the interaction of chemicals with 
specific hormone receptors, including ERs, have been accepted and 
included in the U.S. Environmental Protection Agency (EPA) Endocrine 
Disruptor Screening Program (EDSP) (http://www.epa.gov/endo/pubs/assayvalidation/status.htm). Consequently, the BG1Luc ER TA may be 
applicable for addressing the ER TA component of the EPA EDSP Tier 1 
screening battery.
    At this meeting, the Panel will review the draft BRD for the BG1Luc 
ER TA and evaluate the extent to which established validation and 
acceptance criteria have been appropriately addressed. The Panel also 
will be asked to comment on the extent to which the information 
included in the BRD supports ICCVAM's draft test method 
recommendations.
    NICEATM invites public comments on the draft BRD and draft ICCVAM 
test method recommendations. These documents are available on the 
NICEATM-ICCVAM Web site at: http://iccvam.niehs.nih.gov/methods/endocrine/PeerPanel11.htm.

DATES: The meeting will be held on March 29-30, 2011, from 8:30 a.m. to 
5 p.m. each day. In order to facilitate planning for this meeting, 
persons wishing to attend are asked to register by March 15, 2011, via 
the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov/contact/reg-form-EDpanel.htm). Comments should be sent by March 10, 2011.

ADDRESSES: The meeting will be held at the National Institutes of 
Health (NIH), William H. Natcher Conference Center, 45 Center Drive, 
Bethesda, MD 20892. Persons needing special assistance in order to 
attend, such as sign language interpretation or other reasonable 
accommodation, should contact 301-402-8180 (voice) or 301-435-1908 TTY 
(text telephone) at least seven business days before the event.

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Deputy Director, 
NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research Triangle 
Park, NC 27709, (telephone) 919-541-2384, (fax) 919-541-0947, (e-mail)

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[email protected]. Courier address: NICEATM, NIEHS, 530 Davis 
Drive, Room 2035, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:

Background

    In January 2004, Xenobiotics Detection Systems, Inc. (XDS, Durham, 
NC) nominated their LUMI-CELL[supreg] TA (BG1Luc ER TA) Test Method for 
an interlaboratory validation study to be coordinated by NICEATM. This 
method uses BG-1 cells, a human ovarian carcinoma cell line that was 
stably transfected with an estrogen-responsive luciferase reporter 
gene, to measure whether and to what extent a substance induces or 
inhibits TA activity via ER mediated pathways. Included in the 
nomination package were test results from XDS for 56 of the 78 ICCVAM 
Reference Substances for agonist activity and 16 of the 78 ICCVAM 
Reference Substances for antagonist activity. These studies were funded 
primarily by a Small Business Innovation Research (SBIR) grant 
(SBIR43ES010533-01) from the NIEHS.
    In accordance with the ICCVAM nomination process, NICEATM conducted 
a pre-screen evaluation of the nomination package to determine the 
extent to which it addressed the ICCVAM prioritization criteria and 
adherence to the ICCVAM recommendations for the standardization and 
validation of in vitro endocrine disruptor test methods. Based on this 
evaluation, ICCVAM recommended a high priority for validation studies 
for the BG1Luc ER TA test method. The NIEHS subsequently agreed to 
support the validation study in light of its participation as one of 
the three NTP agencies, whose mission includes the development and 
validation of improved testing methods.
    The international interlaboratory validation study of the BG1Luc ER 
TA test method has been completed. The study included three 
laboratories sponsored by NICEATM, the European Centre for the 
Validation of Alternative Methods, and the Japanese Center for the 
Validation of Alternative Methods.
    NICEATM and ICCVAM have prepared a draft BRD that provides 
comprehensive summaries of data, analyses of test method accuracy and 
reliability, and related information characterizing the current 
validation status of the test method. The draft BRD forms the basis for 
ICCVAM test method recommendations on usefulness and limitations, 
standardized test method protocols, future studies, and performance 
standards.

Peer Review Panel Meeting

    This meeting will take place March 29-30, 2011, at the National 
Institutes of Health (NIH) William H. Natcher Conference Center, 45 
Center Drive, Bethesda, MD 20892. It will begin at 8:30 a.m. and is 
scheduled to conclude each day at approximately 5 p.m. The meeting is 
open to the public at no charge, with attendance limited only by the 
space available. The Panel will consider the draft ICCVAM BRD, 
recommendations, and performance standards for the test method and 
evaluate the extent to which the draft ICCVAM test method 
recommendations are supported by the information provided in the draft 
BRD.
    Additional information about the meeting, including a roster of the 
Panel members and the draft agenda, will be posted on the NICEATM-
ICCVAM Web site at http://iccvam.niehs.nih.gov/methods/endocrine/PeerPanel11.htm two weeks before the meeting. This information will 
also be available after that date by contacting NICEATM (see FOR 
FURTHER INFORMATION CONTACT).

Attendance and Registration

    In order to facilitate planning for this meeting, persons wishing 
to attend are asked to register by March 15, 2011, via the NICEATM-
ICCVAM Web site at http://iccvam.niehs.nih.gov/contact/reg-form-EDpanel.htm.

Availability of the Documents

    The draft BRD and draft ICCVAM test method recommendations will be 
posted no later than February 1, 2011 on the NICEATM-ICCVAM Web site 
(http://iccvam.niehs.nih.gov/methods/endocrine/PeerPanel11.htm) or may 
be obtained by contacting NICEATM (see FOR FURTHER INFORMATION 
CONTACT).

Request for Public Comments

    NICEATM invites the submission of written comments on the draft 
BRD, draft ICCVAM test method recommendations, and draft performance 
standards by March 10, 2011. NICEATM prefers that comments be submitted 
electronically via the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm) or via e-mail to 
[email protected]. Written comments may also be sent by mail, fax, 
or e-mail to Dr. Casey (see FOR FURTHER INFORMATION CONTACT). When 
submitting written comments, please refer to this Federal Register 
notice and include appropriate contact information (name, affiliation, 
mailing address, phone, fax, e-mail, and sponsoring organization, if 
applicable). NICEATM will post all comments on the NICEATM-ICCVAM Web 
site (http://iccvam.niehs.nih.gov) identified by the individual's name 
and affiliation or sponsoring organization (if applicable). NICEATM 
will provide these comments to the Panel and ICCVAM agency 
representatives and make them available to the public at the meeting.
    Opportunity will be provided for members of the public to present 
oral comments at designated times during the peer review. Up to seven 
minutes will be allotted per speaker. If you wish to present oral 
statements at the meeting (one speaker per organization), contact 
NICEATM (see FOR FURTHER INFORMATION CONTACT) by March 2, 2011. Please 
provide a written copy of your comments with contact information (name, 
affiliation, mailing address, phone, fax, e-mail, and sponsoring 
organization, if applicable) when registering to make oral comments. If 
it is not possible to provide a copy of your statement in advance, 
please bring 40 copies to the meeting for distribution to the Panel and 
to supplement the record. Written statements can supplement and expand 
the oral presentation. Please provide NICEATM with copies of any 
supplementary written statement using the guidelines outlined above.
    Summary minutes and the Panel's final report will be available 
following the meeting on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov). ICCVAM will consider the Panel's conclusions and 
recommendations and any public comments received in finalizing their 
test method recommendations for the test method.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that use or generate 
toxicological and safety testing information. ICCVAM conducts technical 
evaluations of new, revised, and alternative methods with regulatory 
applicability and promotes the scientific validation and regulatory 
acceptance of toxicological and safety-testing methods that more 
accurately assess the safety and hazards of chemicals and products and 
that reduce, refine (decrease or eliminate pain and distress), and 
replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 
285l-3, available at http://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf) established ICCVAM as a permanent interagency committee 
of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides 
scientific and operational support for ICCVAM-related activities. 
NICEATM and ICCVAM work collaboratively to

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evaluate new and improved test methods applicable to the needs of 
Federal agencies. Additional information about ICCVAM and NICEATM is 
available on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov.

    Dated: January 13, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-1329 Filed 1-21-11; 8:45 am]
BILLING CODE 4140-01-P