[Federal Register Volume 74, Number 38 (Friday, February 27, 2009)]
[Notices]
[Pages 8974-8975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4280]



[[Page 8974]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP); NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Announcement 
of a Second Meeting of the Independent Scientific Peer Review Panel on 
the Murine Local Lymph Node Assay; Availability of Draft Background 
Review Documents (BRD); Request for Comments

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

ACTION: Meeting announcement and request for comments.

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

SUMMARY: NICEATM, in collaboration with the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM), announces 
a second meeting of an independent scientific peer review panel 
(hereafter, Panel) to evaluate three non-radioactive modified versions 
and new applications for the Murine Local Lymph Node Assay (LLNA). The 
LLNA is an alternative test method that can be used to determine the 
allergic contact dermatitis potential of chemicals and products.
    The Panel will consider additional data and information for the 
three non-radioactive modified versions and new applications of the 
LLNA obtained by NICEATM subsequent to the original Panel meeting in 
March 2008. Based on this new information, the Panel will review the 
following:
     The validation status of three modified LLNA test methods.
     The proposed applicability domain of the LLNA.
    The Panel will peer review revised draft BRDs for each topic and 
evaluate the extent that established validation and acceptance criteria 
have been appropriately addressed. The Panel also will be asked to 
comment on the extent to which draft ICCVAM test method recommendations 
are supported by the data analyses provided in the BRDs.
    NICEATM invites public comments on the draft BRDs and draft ICCVAM 
test recommendations. All documents will be available on the NICEATM-
ICCVAM Web site at http://iccvam.niehs.nih.gov/methods/immunotox/llna_PeerPanel.htm by March 3, 2009.

DATES: The meeting is scheduled for April 28-29, 2009 from 8:30 a.m. to 
5 p.m. each day. The deadline for registration and submission of 
written comments is April 14, 2009.

ADDRESSES: The meeting will be held at the Natcher Conference Center, 
National Institutes of Health, 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). 
Requests should be made at least seven business days in advance of the 
event.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, 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) 
[email protected]. Courier address: NICEATM, NIEHS, 530 Davis 
Drive, Room 2035, Mail Stop: K2-16, Durham, NC 27713.

SUPPLEMENTARY INFORMATION:

Background

    In January 2007, the U.S. Consumer Product Safety Commission (CPSC) 
submitted a nomination to NICEATM (http://iccvam.niehs.nih.gov/methods/immunotox/llnadocs/CPSC_LLNA_nom.pdf) requesting that ICCVAM assess 
the validation status of (1) the LLNA limit dose procedure; (2) three 
modified LLNA test method protocols that use non-radioactive probe 
chemicals; (3) the use of the LLNA to test mixtures, aqueous solutions, 
and metals (applicability domain for the LLNA); and (4) the use of the 
LLNA to determine potency (potential for causing allergic contact 
dermatitis). NICEATM compiled draft BRDs that provided comprehensive 
reviews of the available data and relevant information, which were used 
as the basis for draft ICCVAM test method recommendations. These 
documents were released to the Panel and the public for review and 
comment in January 2008 (73FR1360).
    In March 2008, NICEATM and ICCVAM convened the public Panel meeting 
during which the Panel concluded that more information and data were 
required for the three modified LLNA test methods before 
recommendations could be made regarding their use for regulatory safety 
testing. Similarly, the Panel concluded that more data would be needed 
before a recommendation on the usefulness and limitations on the 
current applicability domain of the traditional LLNA could be made. The 
Panel's conclusions are detailed in a report, which was made available 
in May 2008 (73FR29136), and includes consideration of public comments 
made prior to and during their deliberations.
    Subsequent to the Panel meeting, NICEATM received additional LLNA 
data for pesticide formulations and other products, as well as new data 
for the three modified LLNA test methods. Using the additional 
information, NICEATM revised the BRDs for each of these modified test 
methods and new applications of the LLNA. The revised draft BRDs 
provide all of the data and analyses supporting the scientific validity 
of the modified test methods and proposed applications. ICCVAM prepared 
revised draft test method recommendations regarding the proposed 
usefulness and limitations, standardized protocol, and future studies. 
NICEATM will reconvene the Panel to consider the additional information 
and revised recommendations.

Peer Review Panel Meeting

    This meeting will take place April 28-29, 2009, at the Natcher 
Conference Center, National Institutes of Health, 45 Center Drive, 
Bethesda, Maryland, 20892. It will begin at 8:30 a.m. and is scheduled 
to conclude at approximately 5 p.m. on each day. The meeting is open to 
the public at no charge, with attendance limited only by the space 
available. The Panel will consider the revised draft BRDs for each of 
these modified versions and new applications of the LLNA and evaluate 
the extent that established validation and acceptance criteria are 
appropriately addressed for each test method and application (as 
described in the ICCVAM document, Validation and Regulatory Acceptance 
of Toxicological Test Methods: A Report of the ad hoc Interagency 
Coordinating Committee on the Validation of Alternative Methods, NIH 
Publication No. 97-3981, available at http://iccvam.niehs.nih.gov/docs/about_docs/validate.pdf). The Panel will then comment on the extent to 
which each of the revised draft ICCVAM test method recommendations is 
supported by the information provided in the corresponding revised 
draft BRDs. The Panel is expected first to review the three modified 
LLNA test methods, and then review the use of the LLNA for testing 
pesticide formulations and other products.
    Additional information about the Panel meeting, including a roster 
of the Panel members and the draft agenda, will be made available two 
weeks prior to the meeting on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov). This information will also be available after 
that date by

[[Page 8975]]

contacting NICEATM (see FOR FURTHER INFORMATION CONTACT above).

Attendance and Registration

    In order to facilitate planning for this meeting, persons wishing 
to attend are asked to register by April 14, 2009, via the NICEATM-
ICCVAM Web site (http://iccvam.niehs.nih.gov/contact/reg_LLNAPanel.htm). Visitor parking is located in the multi-level parking 
garage accessible via NIH Gateway Drive. All visitors should proceed to 
the Gateway Center to receive a visitor badge. Note: parking is limited 
and a government-issued ID is required for access (an area map, driving 
directions, and NIH contact information are available at http://www.nih.gov/about/visitor/index.htm).

Availability of the Revised Documents

    The revised draft BRDs and revised draft ICCVAM test method 
recommendations will be available from the NICEATM-ICCVAM Web site 
(http://iccvam.niehs.nih.gov/methods/immunotox/llna_PeerPanel.htm) by 
March 3, 2009, or by contacting NICEATM (see FOR FURTHER INFORMATION 
CONTACT above).

Request for Public Comments

    NICEATM invites the submission of written comments on the revised 
draft BRDs and revised draft ICCVAM test method recommendations and 
prefers that comments be submitted by April 14, 2009, electronically 
via the NICEATM-ICCVAM Web site http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm or via e-mail at [email protected]. Written 
comments may also be sent by mail, fax, or e-mail to Dr. William 
Stokes, Director of NICEATM, at the address listed above (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). All comments received will 
be placed on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov), 
and identified by the individual's name and affiliation or sponsoring 
organization (if applicable). Comments will also be provided to the 
Panel and ICCVAM agency representatives, and made available at the 
meeting.
    Time will be provided for the presentation of oral comments by the 
public at designated times during the peer review. Members of the 
public who wish to present oral statements at the meeting (one speaker 
per organization) should contact NICEATM (see FOR FURTHER INFORMATION 
CONTACT above) by April 14, 2009 and provide a written copy of their 
comments. Each speaker is asked to provide contact information (name, 
affiliation, mailing address, phone, fax, e-mail, and sponsoring 
organization, if applicable) when registering to make oral comments. Up 
to seven minutes will be allotted per speaker. If this is not possible, 
please bring 40 copies of your comments to the meeting for distribution 
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 and performance standards for these 
methods.

Background Information on ICCVAM, NICEATM, and the Scientific Advisory 
Committee on Alternative Toxicological Methods (SACATM)

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that use, generate, or 
disseminate toxicological information. ICCVAM conducts technical 
evaluations of new, revised, and alternative methods with regulatory 
applicability and promotes the scientific validation and regulatory 
acceptance of toxicological test methods that more accurately assess 
the safety and hazards of chemicals and products and that refine, 
reduce, and replace animal use. The ICCVAM Authorization Act of 2000 
(42 U.S.C. 285l-3) 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 evaluate new and 
improved test methods applicable to the needs of U.S. Federal agencies. 
Additional information about ICCVAM and NICEATM can be found on their 
Web site (http://iccvam.niehs.nih.gov).
    SACATM was established January 9, 2002, and is composed of 
scientists from the public and private sectors (67 FR 11358). SACATM 
provides advice to the Director of the NIEHS, to ICCVAM, and to NICEATM 
regarding the statutorily-mandated duties of ICCVAM and activities of 
NICEATM. Additional information about SACATM, including the charter, 
roster, and records of past meetings, can be found at http://ntp.niehs.nih.gov/; see ``Advisory Board & Committees'' (or directly at 
http://ntp.niehs.nih.gov/go/167).

    Dated: February 19, 2009.
John R. Bucher,
Associate Director, NTP.
[FR Doc. E9-4280 Filed 2-26-09; 8:45 am]
BILLING CODE 4140-01-P