[Federal Register Volume 76, Number 80 (Tuesday, April 26, 2011)]
[Notices]
[Pages 23323-23324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Scientific Advisory Committee on Alternative 
Toxicological Methods (SACATM)

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

ACTION: Meeting announcement and request for comments.

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SUMMARY: Pursuant to section 10(a) of the Federal Advisory Committee 
Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a 
meeting of SACATM on June 16-17, 2011, at the Hilton Arlington Hotel, 
950 North Stafford Street, Arlington, VA 22203. The meeting is open to 
the public with attendance limited only by the space available. The 
meeting will be videocast through a link at (http://www.niehs.nih.gov/news/video/live). SACATM advises the Interagency Coordinating Committee 
on the Validation of Alternative Methods (ICCVAM), the NTP Interagency 
Center for the Evaluation of Alternative Toxicological Methods 
(NICEATM), and the Director of the NIEHS and NTP regarding statutorily 
mandated duties of ICCVAM and activities of NICEATM.

DATES: The SACATM meeting will be held on June 16 and 17, 2011. The 
meeting is scheduled from 8:30 a.m. Eastern Daylight Time to 5:30 p.m. 
on June 16 and 8:30 a.m. until adjournment on June 17. All individuals 
who plan to attend are encouraged to register online at the NTP Web 
site (http://ntp.niehs.nih.gov/go/32822) by June 9, 2011. In order to 
facilitate planning, persons wishing to make an oral presentation are 
asked to notify Dr. Lori White, NTP Designated Federal Officer, via 
online registration, phone, or email by June 9, 2011 (see ADDRESSES 
below). Written comments should also be received by June 9, 2011, to 
enable review by SACATM and NIEHS/NTP staff before the meeting.

ADDRESSES: The SACATM meeting will be held at the Hilton Arlington 
Hotel, 950 North Stafford Street, Arlington, VA 22203. Public comments 
and other correspondence should be directed to Dr. Lori White (NTP 
Office of Liaison, Policy and Review, NIEHS, P.O. Box 12233, MD K2-03, 
Research Triangle Park, NC 27709; telephone: 919-541-9834 or e-mail: 
[email protected]). Courier address: NIEHS, 530 Davis Drive, Room 
2136, Morrisville, NC 27560. Persons needing interpreting services in 
order to attend should contact 301-402-8180 (voice) or 301-435-1908 
(TTY). Requests should be made at least 7 days in advance of the 
meeting.

SUPPLEMENTARY INFORMATION: 

Preliminary Agenda Topics and Availability of Meeting Materials

    Preliminary agenda topics include:
     NICEATM-ICCVAM Update
     Regulatory Acceptance of ICCVAM-Recommended Alternative 
Test Methods
     Report on Peer Review Panel Meeting: Evaluation of an In 
Vitro Estrogen Receptor Transcriptional Activation Test Method for 
Endocrine Disruptor Chemical Screening
     Federal Agency Research, Development, Translation, and 
Validation Activities Relevant to the NICEATM-ICCVAM Five-Year Plan
     Nominations to ICCVAM: Botulinum In Vitro Assays, In Vitro 
Pyrogen Assay Validation
     Outcome/Recommendations from the ICCVAM Workshop Series on 
Best Practices for Regulatory Safety Testing
     Outcomes/Recommendations from the International Workshop 
on Alternative Methods to Reduce, Refine, and Replace the Use of 
Animals in Vaccine Potency Testing: State of the Science and Future 
Directions
     Update from the Korean Center for the Validation of 
Alternative Methods
     Update from Health Canada
     Update from the Japanese Center for the Validation of 
Alternative Methods
     Update from the European Centre for the Validation of 
Alternative Methods
    A copy of the preliminary agenda, committee roster, and additional 
information, when available, will be posted on the NTP Web site (http://ntp.niehs.nih.gov/go/32822) or available upon request (see ADDRESSES 
above). Following the SACATM meeting, summary minutes will be prepared 
and available on the NTP Web site or upon request.

Request for Comments

    Both written and oral public input on the agenda topics is invited. 
Written comments received in response to this notice will be posted on 
the NTP Web site. Persons submitting written comments should include 
their name, affiliation (if applicable), and sponsoring organization 
(if any) with the document. Time is allotted during the meeting for 
presentation of oral comments and each organization is allowed one time 
slot per public comment period. At least 7 minutes will be allotted for 
each speaker, and if time permits, may be extended up to 10 minutes at 
the discretion of the chair. Registration for oral comments will also 
be available on-site, although time allowed for presentation by on-site 
registrants may be less than for pre-registered speakers and will be 
determined by the number of persons who register at the meeting. In 
addition to in-person oral comments at the meeting, public comments can 
be presented by teleconference line. There will be 50 lines for this 
call; availability will be on a first-come, first-served basis. The 
available lines will be open from 8 a.m. until 5 p.m. on June 16 and 
8:30 a.m. to adjournment on June 17, although public comments will be 
received only during the formal public comment periods, which will be 
indicated on the preliminary agenda. The access number for the 
teleconference line will be provided to registrants by email prior to 
the meeting.
    Persons registering to make oral comments are asked to do so 
through the online registration form (http://ntp.niehs.nih.gov/go/32822) and to send a copy of their statement to Dr. White (see 
ADDRESSES above) by June 9, 2011, to enable review by SACATM, NICEATM-
ICCVAM, and NIEHS/NTP staff prior to the meeting. Written statements 
can supplement and may expand the oral presentation. If registering on-
site and reading from written text, please bring 40 copies of the 
statement for distribution and to supplement the record.

Background Information on ICCVAM, NICEATM, and SACATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that require, use, 
generate, or disseminate toxicological and safety testing information. 
ICCVAM conducts technical evaluations of new, revised, and alternative 
safety testing 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), or 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

[[Page 23324]]

NICEATM. NICEATM administers ICCVAM, provides scientific and 
operational support for ICCVAM-related activities, and conducts 
independent validation studies to assess the usefulness and limitations 
of new, revised, and alternative test methods and strategies. NICEATM 
and ICCVAM work collaboratively to evaluate new and improved test 
methods and strategies applicable to the needs of U.S. Federal 
agencies. NICEATM and ICCVAM welcome the public nomination of new, 
revised, and alternative test methods and strategies for validation 
studies and technical evaluations. Additional information about ICCVAM 
and NICEATM can be found on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov).
    SACATM was established in response to the ICCVAM Authorization Act 
[Section 285l-3(d)] and is composed of scientists from the public and 
private sectors. SACATM advises ICCVAM, NICEATM, and the Director of 
the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and 
activities of NICEATM. SACATM provides advice on priorities and 
activities related to the development, validation, scientific review, 
regulatory acceptance, implementation, and national and international 
harmonization of new, revised, and alternative toxicological test 
methods. Additional information about SACATM, including the charter, 
roster, and records of past meetings, can be found at http://ntp.niehs.nih.gov/go/167.

    Dated: April 18, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-10020 Filed 4-25-11; 8:45 am]
BILLING CODE 4140-01-P