8974 Federal Register / Vol. 74, No. 38 / Friday, February 27, 2009 / Notices 

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 nonradioactive 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) 

niceatm@niehs.nih.gov. 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 


rwilkins on PROD1PC63 with NOTICES2
Federal Register / Vol. 74, No. 38 / Friday, February 27, 2009 / Notices 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 governmentissued 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 

niceatm@niehs.nih.gov. 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 statutorilymandated 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Unsolicited Multi-Project 

(P01) Grant Applications. 

Date: March 20, 2009. 

Time: 11 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700– 

B Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Roberta Binder, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, NIAID, 6700B 

Rockledge Drive, Rm 2155, Bethesda, MD 

20892, 301–496–7966, rb169n@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: February 20, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–4191 Filed 2–26–09; 8:45 am] 

BILLING CODE 4140–01–P 


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