[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Notices]
[Pages 26395-26396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8896]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP), NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Peer Review 
Panel Report on Five In Vitro Pyrogen Test Methods: Availability and 
Request for Public Comments

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

ACTION: Request for comments.

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SUMMARY: NICEATM in collaboration with the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM) convened an 
independent scientific peer review panel meeting on February 6, 2007, 
to evaluate the validation status of five in vitro pyrogen test methods 
proposed as replacements for the Rabbit Pyrogen Test (RPT). The peer 
review panel (``the Panel'') report from this meeting is now available. 
The report contains (1) the Panel's evaluation of the validation status 
of the methods and (2) the Panel's comments and conclusions on draft 
ICCVAM test method recommendations. NICEATM invites public comment on 
the Panel's report. The report is available on the NICEATM/ICCVAM Web 
site at (http://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm) or by 
contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below).

DATES: Written comments on the Panel report should be received by June 
25, 2007.

ADDRESSES: Comments should preferably be submitted electronically via 
the NICEATM/ICCVAM Web site: http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm. Comments can also be submitted by e-mail to 
[email protected]. Written comments can be sent by mail or fax to 
Dr. William S. Stokes, NICEATM Director, NIH/NIEHS, P.O. Box 12233, MD 
EC-17, Research Triangle Park, NC 27709, (fax) 919-541-0947, (e-mail) 
[email protected]. Courier address: NICEATM, 79 T.W. Alexander 
Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709.

FOR FURTHER INFORMATION CONTACT: Other correspondence should be 
directed to Dr. William S. Stokes, NICEATM Director (919-541-2384 or 
[email protected]).

SUPPLEMENTARY INFORMATION

Background

    The European Centre for the Validation of Alternative Methods 
(ECVAM) submitted five in vitro pyrogen test methods to ICCVAM for 
evaluation in 2006. The proposed test methods include:
    1. The Human Whole Blood (WB)/IL-1 In Vitro Pyrogen Test: 
Application of Cryopreserved Human WB
    2. The Monocytoid Cell Line Mono Mac 6 (MM6)/IL-6 In Vitro Pyrogen 
Test
    3. The Human PBMC/IL-6 In Vitro Pyrogen Test
    4. The Human WB/IL-1 In Vitro Pyrogen Test
    5. The Human WB/IL-6 In Vitro Pyrogen Test

These test methods are based on the measurement of proinflammatory 
cytokines released from either fresh or cryopreserved human blood cells 
or a human monocytoid line in response to the presence of Gram-negative 
endotoxin in parenteral pharmaceuticals. NICEATM and ICCVAM prepared a 
comprehensive background review document (BRD) that included the 
available data for the five test methods and a separate document 
containing ICCVAM test method recommendations. At the peer review 
meeting, the Panel reviewed the BRD and evaluated the extent to which 
the ICCVAM criteria for validation and acceptance had been adequately 
addressed for the intended purpose of these test methods. The Panel 
also provided comments on the ICCVAM draft test method recommendations 
regarding the proposed usefulness and limitations, standardized 
protocols, performance standards, and future studies. The Panel's 
conclusions and recommendations on the five in vitro pyrogen test 
methods are described in the Peer Review Panel Final Report: Five In 
Vitro Pyrogen Test Methods (available at: http://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm). The draft BRD and the draft test method 
recommendations are available at http://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm.

Request for Comments

    NICEATM invites the submission of written comments on the Panel's 
report. When submitting written comments please refer to this Federal 
Register notice and include appropriate contact information (name, 
affiliation, mailing address, phone, fax, email, and sponsoring 
organization, if applicable). All comments received by the deadline 
listed above will be placed on the NICEATM/ICCVAM Web site (http://ntp-apps.niehs.nih.gov/iccvampb/searchPubCom.cfm) and made available to 
ICCVAM. In addition, there will be an opportunity for oral public 
comments on the Panel's report during a meeting of the Scientific 
Advisory Committee on Alternative Toxicological Methods (SACATM) 
scheduled for June 12, 2007. Information concerning the SACATM meeting 
will be published in a separate Federal Register notice and available 
on the SACATM website: (http://ntp.niehs.nih.gov/go/7441). Any written 
comments on the Panel report received prior to June 7, 2007, will be 
distributed to SACATM.
    ICCVAM will consider the Panel report along with the SACATM and 
public comments as it finalizes recommendations for the five in vitro 
pyrogen test methods. An ICCVAM test method evaluation report, which 
includes the ICCVAM final recommendations, will be forwarded to 
appropriate federal agencies for their consideration. This report will 
also be available to the public on the NICEATM/ICCVAM Web site and by 
request from NICEATM.

Background Information on ICCVAM, NICEATM, and 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 scientific validation and regulatory 
acceptance of toxicological test methods that more accurately assess 
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, available at http://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf) establishes 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 Federal agencies. Additional 
information about ICCVAM and NICEATM can be found at the ICCVAM/NICEATM 
Web site (http://iccvam.niehs.nih.gov).
    Additional information about SACATM, including the charter, roster, 
and records of past meetings, can be found at http://ntp.niehs.nih.gov/go/167.


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    Dated: April 30, 2007.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E7-8896 Filed 5-8-07; 8:45 am]
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