National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Peer Review Panel Report on the Validation Status of New Versions and Applications of the Murine Local Lymph Node Assay (LLNA): A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of Availability and Request for Public Comments, 29136-29137 [E8-11195]

Download as PDF 29136 Federal Register / Vol. 73, No. 98 / Tuesday, May 20, 2008 / Notices Martin Building is located on C Street, NW., between 20th and 21st Streets. The Council’s function is to advise the Board on the exercise of the Board’s responsibilities under various consumer financial services laws and on other matters on which the Board seeks its advice. Time permitting, the Council will discuss the following topics: • Proposed rules regarding credit cards and overdraft services. Members will discuss the Board’s proposal under the Federal Trade Commission Act to prohibit unfair or deceptive acts or practices by banks in connection with credit card accounts and overdraft services for deposit accounts. The proposed changes to the Board’s Regulation AA (Unfair or Deceptive Acts or Practices) would be complemented by separate proposals under the Truth in Lending Act (Regulation Z) and the Truth in Savings Act (Regulation DD). • Proposed rules on risk-based pricing notices. Members will discuss proposed regulations that generally would require a creditor to provide a consumer with a risk-based pricing notice when, based in whole or in part on the consumer’s credit report, the creditor offers or provides credit to the consumer on terms less favorable than those it offers or provides to other consumers. The proposal would implement section 311 of the Fair and Accurate Credit Transactions Act of 2003, which amends the Fair Credit Reporting Act. Reports by committees and other matters initiated by Council members also may be discussed. Persons wishing to submit views to the Council on any of the above topics may do so by sending written statements to Jennifer Kerslake, Secretary of the Consumer Advisory Council, Division of Consumer and Community Affairs, Board of Governors of the Federal Reserve System, Washington, DC 20551. Information about this meeting may be obtained from Ms. Kerslake, 202–452–6470. jlentini on PROD1PC65 with NOTICES Board of Governors of the Federal Reserve System, May 14, 2008. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E8–11161 Filed 5–19–08; 8:45 am] BILLING CODE 6210–01–P VerDate Aug<31>2005 20:00 May 19, 2008 Jkt 214001 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 the Validation Status of New Versions and Applications of the Murine Local Lymph Node Assay (LLNA): A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of Availability and Request for Public Comments National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for comments. AGENCY: SUMMARY: NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), convened an independent international scientific peer review panel on March 4–6, 2008 to evaluate new versions and applications of the LLNA for assessing the allergic contact dermatitis potential of chemicals and products. 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/ immunotox/llna_PeerPanel.htm or by contacting NICEATM at the address given below. DATES: Written comments on the Panel report should be received by July 7, 2008. ADDRESSES: Comments should be submitted preferably electronically via the NICEATM–ICCVAM Web site at http://iccvam.niehs.nih.gov/contact/ FR_pubcomment.htm. Comments can also be submitted by e-mail to niceatm@niehs.nih.gov. Written comments can be sent by mail or fax to Dr. William S. Stokes, Director, NICEATM, NIH/NIEHS, P.O. Box 12233, MD EC–17, Research Triangle Park, NC 27709, (phone) 919–541–2384, (fax) 919–541–0947. Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709. FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director, NICEATM (919–541–2384 or niceatm@niehs.nih.gov). PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION: Background In January 2007, the Consumer Product Safety Commission submitted a nomination to NICEATM and ICCVAM to assess the validation status of (1) The use of the LLNA to determine potency for hazard classification purposes; (2) LLNA protocols using non-radioactive procedures; (3) the LLNA limit dose procedure; and (4) the use of the LLNA to test mixtures, aqueous solutions, and metals (i.e., an updated assessment of the applicability domain of the LLNA). In June 2007, the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) endorsed these activities as high priorities for ICCVAM. NICEATM, on behalf of ICCVAM, also sought input from the public on these activities and requested data from studies using the LLNA or modified versions of the LLNA (Federal Register Vol. 72, No. 95, pages 27815–27817, May 17, 2007). After considering all comments received, ICCVAM endorsed carrying out these activities as high priorities. ICCVAM also developed draft LLNA performance standards to facilitate evaluation of modified LLNA protocols that are functionally and mechanistically similar to the traditional LLNA. These draft LLNA performance standards were made public and comments were requested via the Federal Register (Vol. 72, No. 176, pages 52130–52131, Sept. 12, 2007). ICCVAM and NICEATM prepared draft background review documents (BRDs) that provided comprehensive reviews of available data and relevant information for each of the modifications and new applications of the LLNA. ICCVAM also developed draft test method recommendations regarding the proposed usefulness and limitations, standardized protocols, and future studies. Both the draft BRDs and draft recommendations were made available for public comment, and a public peer review meeting was announced in the Federal Register (Vol. 73, No. 5, pages 1360–1362, Jan. 8, 2008). The Panel met in public session on March 4–6, 2008. The Panel reviewed the draft ICCVAM BRDs for completeness, errors, and omissions of any existing relevant data or information. The Panel evaluated the information in the BRDs to determine the extent to which each of the applicable criteria for validation and acceptance of toxicological test methods (ICCVAM, 2003) had been appropriately addressed. The Panel then considered the ICCVAM draft test method E:\FR\FM\20MYN1.SGM 20MYN1 Federal Register / Vol. 73, No. 98 / Tuesday, May 20, 2008 / Notices recommendations (i.e., proposed test method uses, proposed recommended standardized protocol, proposed test method performance standards, and proposed additional studies) and commented on whether the recommendations were supported by the information provided in the draft BRDs. The Panel’s conclusions and recommendations are detailed in the Peer Review Panel Final Report: Validation Status of New Versions and Applications of the Murine Local Lymph Node Assay (LLNA): A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products (available at http:// iccvam.niehs.nih.gov/methods/ immunotox/llna_PeerPanel.htm). The draft BRDs, draft ICCVAM test method recommendations, and the draft LLNA Performance Standards are available at http://iccvam.niehs.nih.gov/methods/ immunotox/immunotox.htm. jlentini on PROD1PC65 with NOTICES 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, e-mail, and sponsoring organization, if applicable). All comments received will be made publicly available on the NICEATM– ICCVAM Web site at http://ntpapps.niehs.nih.gov/iccvampb/ searchPubCom.cfm. In addition, there will be an opportunity for oral public comments on the Panel’s report during an upcoming meeting of SACATM scheduled for June 18–19, 2008. Information concerning the SACATM meeting will be published in a separate Federal Register notice and available on the SACATM Web site at http:// ntp.niehs.nih.gov/go/7441. ICCVAM will consider the Panel report along with SACATM and public comments when finalizing test method recommendations. An ICCVAM test method evaluation report, which will include the final ICCVAM recommendations, will be forwarded to relevant Federal agencies for their consideration. The evaluation report will also be available to the public on the NICEATM–ICCVAM Web site and by request from NICEATM (see ADDRESSES above). 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 VerDate Aug<31>2005 18:23 May 19, 2008 Jkt 214001 toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes scientific validation, regulatory acceptance, and national and international harmonization 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) 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 Federal agencies. Additional information about ICCVAM and NICEATM can be found at the NICEATM–ICCVAM 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. References ICCVAM, 2003, ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods. NIH Publication No. 03–4508. Research Triangle Park, NC: NIEHS. Available at: http:// iccvam.niehs.nih.gov. Dated: May 8, 2008. Samuel H. Wilson, Acting Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E8–11195 Filed 5–19–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0230] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 29137 ‘‘Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays.’’ This guidance document describes a means by which antigen detection assays for Plasmodium species may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls). This guidance document is immediately in effect as the special control for antigen detection assays for Plasmodium species, but it remains subject to comment in accordance with the agency’s good guidance practices. DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 240–276–3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Freddie Poole, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration,2098 Gaither Rd., Rockville, MD 20850, 240–276– 0712. SUPPLEMENTARY INFORMATION: I. Background Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying Plasmodium species antigen detection assays into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(c)(f)(2)). This E:\FR\FM\20MYN1.SGM 20MYN1

Agencies

[Federal Register Volume 73, Number 98 (Tuesday, May 20, 2008)]
[Notices]
[Pages 29136-29137]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11195]


=======================================================================
-----------------------------------------------------------------------

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 the Validation Status of New Versions and Applications 
of the Murine Local Lymph Node Assay (LLNA): A Test Method for 
Assessing the Allergic Contact Dermatitis Potential of Chemicals and 
Products: Notice of Availability and Request for Public Comments

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

ACTION: Request for comments.

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

SUMMARY: NICEATM, in collaboration with the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM), convened 
an independent international scientific peer review panel on March 4-6, 
2008 to evaluate new versions and applications of the LLNA for 
assessing the allergic contact dermatitis potential of chemicals and 
products. 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/immunotox/llna_PeerPanel.htm or by 
contacting NICEATM at the address given below.

DATES: Written comments on the Panel report should be received by July 
7, 2008.

ADDRESSES: Comments should be submitted preferably electronically via 
the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/contact/FR_
pubcomment.htm. Comments can also be submitted by e-mail to 
niceatm@niehs.nih.gov. Written comments can be sent by mail or fax to 
Dr. William S. Stokes, Director, NICEATM, NIH/NIEHS, P.O. Box 12233, MD 
EC-17, Research Triangle Park, NC 27709, (phone) 919-541-2384, (fax) 
919-541-0947. Courier address: NICEATM, 79 T.W. Alexander Drive, 
Building 4401, Room 3128, Research Triangle Park, NC 27709.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director, 
NICEATM (919-541-2384 or niceatm@niehs.nih.gov).

SUPPLEMENTARY INFORMATION: 

Background

    In January 2007, the Consumer Product Safety Commission submitted a 
nomination to NICEATM and ICCVAM to assess the validation status of (1) 
The use of the LLNA to determine potency for hazard classification 
purposes; (2) LLNA protocols using non-radioactive procedures; (3) the 
LLNA limit dose procedure; and (4) the use of the LLNA to test 
mixtures, aqueous solutions, and metals (i.e., an updated assessment of 
the applicability domain of the LLNA). In June 2007, the Scientific 
Advisory Committee on Alternative Toxicological Methods (SACATM) 
endorsed these activities as high priorities for ICCVAM. NICEATM, on 
behalf of ICCVAM, also sought input from the public on these activities 
and requested data from studies using the LLNA or modified versions of 
the LLNA (Federal Register Vol. 72, No. 95, pages 27815-27817, May 17, 
2007). After considering all comments received, ICCVAM endorsed 
carrying out these activities as high priorities. ICCVAM also developed 
draft LLNA performance standards to facilitate evaluation of modified 
LLNA protocols that are functionally and mechanistically similar to the 
traditional LLNA. These draft LLNA performance standards were made 
public and comments were requested via the Federal Register (Vol. 72, 
No. 176, pages 52130-52131, Sept. 12, 2007).
    ICCVAM and NICEATM prepared draft background review documents 
(BRDs) that provided comprehensive reviews of available data and 
relevant information for each of the modifications and new applications 
of the LLNA. ICCVAM also developed draft test method recommendations 
regarding the proposed usefulness and limitations, standardized 
protocols, and future studies. Both the draft BRDs and draft 
recommendations were made available for public comment, and a public 
peer review meeting was announced in the Federal Register (Vol. 73, No. 
5, pages 1360-1362, Jan. 8, 2008).
    The Panel met in public session on March 4-6, 2008. The Panel 
reviewed the draft ICCVAM BRDs for completeness, errors, and omissions 
of any existing relevant data or information. The Panel evaluated the 
information in the BRDs to determine the extent to which each of the 
applicable criteria for validation and acceptance of toxicological test 
methods (ICCVAM, 2003) had been appropriately addressed. The Panel then 
considered the ICCVAM draft test method

[[Page 29137]]

recommendations (i.e., proposed test method uses, proposed recommended 
standardized protocol, proposed test method performance standards, and 
proposed additional studies) and commented on whether the 
recommendations were supported by the information provided in the draft 
BRDs.
    The Panel's conclusions and recommendations are detailed in the 
Peer Review Panel Final Report: Validation Status of New Versions and 
Applications of the Murine Local Lymph Node Assay (LLNA): A Test Method 
for Assessing the Allergic Contact Dermatitis Potential of Chemicals 
and Products (available at http://iccvam.niehs.nih.gov/methods/
immunotox/llna_PeerPanel.htm). The draft BRDs, draft ICCVAM test 
method recommendations, and the draft LLNA Performance Standards are 
available at http://iccvam.niehs.nih.gov/methods/immunotox/
immunotox.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, e-mail, and sponsoring 
organization, if applicable). All comments received will be made 
publicly available on the NICEATM-ICCVAM Web site at http://ntp-
apps.niehs.nih.gov/iccvampb/searchPubCom.cfm. In addition, there will 
be an opportunity for oral public comments on the Panel's report during 
an upcoming meeting of SACATM scheduled for June 18-19, 2008. 
Information concerning the SACATM meeting will be published in a 
separate Federal Register notice and available on the SACATM Web site 
at http://ntp.niehs.nih.gov/go/7441.
    ICCVAM will consider the Panel report along with SACATM and public 
comments when finalizing test method recommendations. An ICCVAM test 
method evaluation report, which will include the final ICCVAM 
recommendations, will be forwarded to relevant Federal agencies for 
their consideration. The evaluation report will also be available to 
the public on the NICEATM-ICCVAM Web site and by request from NICEATM 
(see ADDRESSES above).

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, regulatory 
acceptance, and national and international harmonization 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) 
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 Federal agencies. Additional information 
about ICCVAM and NICEATM can be found at the NICEATM-ICCVAM 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.

References

    ICCVAM, 2003, ICCVAM Guidelines for the Nomination and 
Submission of New, Revised, and Alternative Test Methods. NIH 
Publication No. 03-4508. Research Triangle Park, NC: NIEHS. 
Available at: http://iccvam.niehs.nih.gov.

    Dated: May 8, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
[FR Doc. E8-11195 Filed 5-19-08; 8:45 am]
BILLING CODE 4140-01-P