National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Draft Performance Standards for the Murine Local Lymph Node Assay: Request for Comments, 52130-52131 [E7-18011]

Download as PDF 52130 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices A. Federal Reserve Bank of Cleveland (Douglas A. Banks, Vice President) 1455 East Sixth Street, Cleveland, Ohio 44101–2566: 1. KeyCorp, and KYCA Corporation, both of Cleveland, Ohio; to merge with U.S.B. Holding Co. Inc., Orangeburg, New York, and thereby indirectly acquire Union State Bank, Nanuet, New York. In connection with this application, KYCA Corporation; has applied to become a bank holding company by acquiring 100 percent of the voting shares of Union State Bank, Nanuet, New York. Board of Governors of the Federal Reserve System, September 7, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7–17944 Filed 9–11–07; 8:45 am] BILLING CODE 6210–01–S FEDERAL RESERVE SYSTEM Sunshine Act Meeting Board of Governors of the Federal Reserve System. TIME AND DATE: 12:00 p.m., Monday, September 17, 2007. PLACE: Marriner S. Eccles Federal Reserve Board Building, 20th and C Streets, N.W., Washington, D.C. 20551. STATUS: Closed. MATTERS TO BE CONSIDERED: 1. Personnel actions (appointments, promotions, assignments, reassignments, and salary actions) involving individual Federal Reserve System employees. 2. Any items carried forward from a previously announced meeting. FOR FURTHER INFORMATION CONTACT: Michelle Smith, Director, or Dave Skidmore, Assistant to the Board, Office of Board Members at 202–452–2955. SUPPLEMENTARY INFORMATION: You may call 202–452–3206 beginning at approximately 5 p.m. two business days before the meeting for a recorded announcement of bank and bank holding company applications scheduled for the meeting; or you may contact the Board’s Web site at https:// www.federalreserve.gov for an electronic announcement that not only lists applications, but also indicates procedural and other information about the meeting. jlentini on PROD1PC65 with NOTICES AGENCY HOLDING THE MEETING: Board of Governors of the Federal Reserve System, September 7, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 07–4492 Filed 9–7–07; 5:02 pm] BILLING CODE 6210–01–S VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Draft Performance Standards for the Murine Local Lymph Node Assay: Request for Comments National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for comments. AGENCY: SUMMARY: The Murine Local Lymph Node Assay (LLNA) is the first alternative test method evaluated and recommended by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). It was subsequently accepted by regulatory authorities to determine the allergic contact dermatitis potential of chemicals and products. In January 2007, the U.S. Consumer Product Safety Commission (CSPC) submitted a nomination requesting that NICEATM and ICCVAM assess the validation status of (1) The LLNA as a stand-alone assay for potency determination for hazard classification purposes; (2) modified LLNA protocols; (3) the LLNA limit test; (4) the use of LLNA to test mixtures, aqueous solutions, and metals; and (5) the applicability domain for LLNA. In order to facilitate the review of the modified LLNA protocols, ICCVAM proposed developing performance standards for the LLNA. In May 2007, a Federal Register notice was published (Vol. 72, No. 95, pages 27815–27817, May 17, 2007) requesting comments and data relevant to these nominated activities. In June 2007, the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) endorsed the nominated activities as high priorities for ICCVAM. In response to SACATM comments, along with those provided by the public in response to the previous Federal Register notice, ICCVAM also endorsed these activities as high priorities. ICCVAM subsequently prepared draft performance standards for the LLNA and now requests public comments on this draft document, which is available on the NICEATM/ICCVAM Web site at: (https://iccvam.niehs.nih.gov/methods/ immunotox/immunotox.htm) or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below). DATES: Submit comments on or before October 29, 2007. ADDRESSES: Dr. William S. Stokes, NICEATM Director, NIEHS, P.O. Box PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 12233, MD EC–17, Research Triangle Park, NC 27709, (fax) 919–541–0947, (email) niceatm@niehs.nih.gov. Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709. Responses can be submitted electronically at the ICCVAM–NICEATM Web site: https:// iccvam.niehs.nih.gov/contact/ FR_pubcomment.htm or by e-mail, mail, or fax. FOR FURTHER INFORMATION CONTACT: Other correspondence should be directed to Dr. William S. Stokes (919– 541–2384 or niceatm@niehs.nih.gov). SUPPLEMENTARY INFORMATION: Background The LLNA is an alternative test method used for skin sensitization testing that reduces the number of animals needed, reduces the time required for testing, and can substantially reduce or avoid pain and distress associated with traditional guinea pig testing methods. The LLNA was the first alternative test method evaluated and recommended by ICCVAM and based on the recommendations of ICCVAM and an independent scientific peer review panel, the LLNA has been accepted by U.S. and international regulatory authorities as an alternative to the guinea pig maximization test and Buehler test for assessing allergic contact dermatitis (EPA 2003; ISO 2002; OECD 2002). Since 2003, ICCVAM has routinely developed performance standards for test methods; however, because the concept of performance standards was not developed by ICCVAM until 2003, they were not developed during the ICCVAM evaluation of the LLNA in 1998 (NIH Publication No. 99–4494, available: (https://iccvam.niehs.nih.gov/docs/ immunotox_docs/llna/llnarep.pdf). In January 2007, CSPC submitted a nomination requesting that NICEATM and ICCVAM assess the validation status of (1) The LLNA as a stand-alone assay for potency determination for classification purposes; (2) modified LLNA protocols; (3) the LLNA limit test; (4) the use of LLNA to test mixtures, aqueous solutions, and metals; and (5) the applicability domain for LLNA. ICCVAM endorsed the nomination and also decided to develop performance standards to facilitate evaluation of modified LLNA protocols to the traditional LLNA. In May 2007, a Federal Register notice was published requesting comments and data relevant to these activities (Vol. 72, No. 95, pages 27815–27817, May 17, 2007; available, E:\FR\FM\12SEN1.SGM 12SEN1 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices https://iccvam.niehs.nih.gov/SuppDocs/ FedDocs/FR/FR_E7_9544.pdf). In June 2007, SACATM endorsed these activities as high priorities for ICCVAM. In response to SACATM comments, along with those provided by the public in response to the previous Federal Register notice, ICCVAM endorsed these activities, including the development of performance standards, as high priorities. ICCVAM subsequently prepared draft performance standards for the LLNA, which are available on the NICEATM/ ICCVAM Web site at: (https:// iccvam.niehs.nih.gov/methods/ immunotox/immunotox.htm). These draft test method performance standards are proposed to evaluate the performance of LLNA test methods that incorporate specific modifications to the measurement of lymphocyte proliferation in the traditional LLNA. These modifications focus specifically on incorporating non-radioactive procedures to evaluate lymphocyte proliferation in the draining auricular lymph nodes rather than incorporation of radioactivity (i.e., 3H-thymidine), which is used in the traditional LLNA. Public comments received in response to the draft LLNA performance standards will be considered by ICCVAM during development of a revised draft version of this document. A public meeting is planned for early 2008 where an international, independent, peer review panel will evaluate the revised draft LLNA performance standards and review the other nominated LLNA related activities. Following this meeting, the recommendations of the peer review panel will be made available for public and SACATM comment. ICCVAM will consider the panel report and public and SACATM comments in preparing final LLNA performance standards. jlentini on PROD1PC65 with NOTICES Request for Public Comments NICEATM invites the submission of written comments on the draft LLNA performance standards. 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 by the deadline listed above will be placed on the NICEATM/ICCVAM Web site (https:// ntp-apps.niehs.nih.gov/iccvampb/ searchPubCom.cfm) and made available to the peer review panel and ICCVAM. VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 52131 Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 federal regulatory and research agencies that use or generate 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, or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3, available at https:// iccvam.niehs.nih.gov/about/ PL106545.htm) 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 is available on the following Web site: https://iccvam.niehs.nih.gov. Register on June 28, 2007 and allowed 60 days for public comment. Public comments were received and have been addressed in the supporting statement, available upon request. The purpose of this notice is to allow an additional 30 days for public comment. Dated: September 5, 2007. Samuel H. Wilson, Acting Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7–18011 Filed 9–11–07; 8:45 am] The MEPS–IC, an annual survey of the characteristics of employersponsored health insurance, was first conducted by AHRQ in 1997 for the calendar year 1996. The survey has since been conducted annually for calendar years 1997 through 2006. AHRQ proposes to continue this annual survey of establishments for calendar years 2008 and 2009. The survey data for calendar year 2008 will be collected in that year. Likewise, calendar year 2009 data will be collected in 2009. This is a change from earlier MEPS–IC collections, when survey data for a calendar year were collected in the following year (i.e., 2005 survey data were collected in 2006). This changeover means that there will be no data collected for the year 2007. However, the data for 2008 and 2009 will now be released a year earlier than would have occurred under the former collection scheme. This survey will be conducted for AHRQ by the Bureau of Census using a sample comprised of an annual sample of employers selected from Census Bureau lists of private sector employers and governments. Data to be collected from each employer will include a description of the business (e.g., size, industry) and descriptions of health insurance plans available, plan enrollments, total plan costs and costs to employees. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to allow the proposed information collection project: ‘‘2008– 2009 Medical Expenditure Panel Survey—Insurance Component (MEPS– IC).’’ In accordance with the Paperwork Reduction Act of 1995, Public Law 104– 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 Comments on this notice must be received by October 12, 2007. DATES: Written comments should be submitted to: Karen Matsuoka by fax at (202) 395–6974 (attention: AHRQ’s desk officer) or by e-mail at OIRA_submission@omb.eop.gov (attention: AHRQ’s desk officer). Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477. SUPPLEMENTARY INFORMATION: Proposed Project 2008 and 2009 Medical Expenditure Panel Survey—Insurance Component (MEPS–IC) E:\FR\FM\12SEN1.SGM 12SEN1

Agencies

[Federal Register Volume 72, Number 176 (Wednesday, September 12, 2007)]
[Notices]
[Pages 52130-52131]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP) Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Draft 
Performance Standards for the Murine Local Lymph Node Assay: Request 
for Comments

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

ACTION: Request for comments.

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

SUMMARY: The Murine Local Lymph Node Assay (LLNA) is the first 
alternative test method evaluated and recommended by the Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM). It was subsequently accepted by regulatory authorities to 
determine the allergic contact dermatitis potential of chemicals and 
products. In January 2007, the U.S. Consumer Product Safety Commission 
(CSPC) submitted a nomination requesting that NICEATM and ICCVAM assess 
the validation status of (1) The LLNA as a stand-alone assay for 
potency determination for hazard classification purposes; (2) modified 
LLNA protocols; (3) the LLNA limit test; (4) the use of LLNA to test 
mixtures, aqueous solutions, and metals; and (5) the applicability 
domain for LLNA. In order to facilitate the review of the modified LLNA 
protocols, ICCVAM proposed developing performance standards for the 
LLNA. In May 2007, a Federal Register notice was published (Vol. 72, 
No. 95, pages 27815-27817, May 17, 2007) requesting comments and data 
relevant to these nominated activities. In June 2007, the Scientific 
Advisory Committee on Alternative Toxicological Methods (SACATM) 
endorsed the nominated activities as high priorities for ICCVAM. In 
response to SACATM comments, along with those provided by the public in 
response to the previous Federal Register notice, ICCVAM also endorsed 
these activities as high priorities. ICCVAM subsequently prepared draft 
performance standards for the LLNA and now requests public comments on 
this draft document, which is available on the NICEATM/ICCVAM Web site 
at: (https://iccvam.niehs.nih.gov/methods/immunotox/immunotox.htm) or by 
contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below).

DATES: Submit comments on or before October 29, 2007.

ADDRESSES: Dr. William S. Stokes, NICEATM Director, NIEHS, P.O. Box 
12233, MD EC-17, Research Triangle Park, NC 27709, (fax) 919-541-0947, 
(e-mail) niceatm@niehs.nih.gov. Courier address: NICEATM, 79 T.W. 
Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 
27709. Responses can be submitted electronically at the ICCVAM-NICEATM 
Web site: https://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm or by 
e-mail, mail, or fax.

FOR FURTHER INFORMATION CONTACT: Other correspondence should be 
directed to Dr. William S. Stokes (919-541-2384 or 
niceatm@niehs.nih.gov).

SUPPLEMENTARY INFORMATION: 

Background

    The LLNA is an alternative test method used for skin sensitization 
testing that reduces the number of animals needed, reduces the time 
required for testing, and can substantially reduce or avoid pain and 
distress associated with traditional guinea pig testing methods. The 
LLNA was the first alternative test method evaluated and recommended by 
ICCVAM and based on the recommendations of ICCVAM and an independent 
scientific peer review panel, the LLNA has been accepted by U.S. and 
international regulatory authorities as an alternative to the guinea 
pig maximization test and Buehler test for assessing allergic contact 
dermatitis (EPA 2003; ISO 2002; OECD 2002). Since 2003, ICCVAM has 
routinely developed performance standards for test methods; however, 
because the concept of performance standards was not developed by 
ICCVAM until 2003, they were not developed during the ICCVAM evaluation 
of the LLNA in 1998 (NIH Publication No. 99-4494, available: (https://
iccvam.niehs.nih.gov/docs/immunotox_docs/llna/llnarep.pdf).
    In January 2007, CSPC submitted a nomination requesting that 
NICEATM and ICCVAM assess the validation status of (1) The LLNA as a 
stand-alone assay for potency determination for classification 
purposes; (2) modified LLNA protocols; (3) the LLNA limit test; (4) the 
use of LLNA to test mixtures, aqueous solutions, and metals; and (5) 
the applicability domain for LLNA. ICCVAM endorsed the nomination and 
also decided to develop performance standards to facilitate evaluation 
of modified LLNA protocols to the traditional LLNA. In May 2007, a 
Federal Register notice was published requesting comments and data 
relevant to these activities (Vol. 72, No. 95, pages 27815-27817, May 
17, 2007; available,

[[Page 52131]]

https://iccvam.niehs.nih.gov/SuppDocs/FedDocs/FR/FR_E7_9544.pdf). In 
June 2007, SACATM endorsed these activities as high priorities for 
ICCVAM. In response to SACATM comments, along with those provided by 
the public in response to the previous Federal Register notice, ICCVAM 
endorsed these activities, including the development of performance 
standards, as high priorities. ICCVAM subsequently prepared draft 
performance standards for the LLNA, which are available on the NICEATM/
ICCVAM Web site at: (https://iccvam.niehs.nih.gov/methods/immunotox/
immunotox.htm).
    These draft test method performance standards are proposed to 
evaluate the performance of LLNA test methods that incorporate specific 
modifications to the measurement of lymphocyte proliferation in the 
traditional LLNA. These modifications focus specifically on 
incorporating non-radioactive procedures to evaluate lymphocyte 
proliferation in the draining auricular lymph nodes rather than 
incorporation of radioactivity (i.e., 3H-thymidine), which 
is used in the traditional LLNA.
    Public comments received in response to the draft LLNA performance 
standards will be considered by ICCVAM during development of a revised 
draft version of this document. A public meeting is planned for early 
2008 where an international, independent, peer review panel will 
evaluate the revised draft LLNA performance standards and review the 
other nominated LLNA related activities. Following this meeting, the 
recommendations of the peer review panel will be made available for 
public and SACATM comment. ICCVAM will consider the panel report and 
public and SACATM comments in preparing final LLNA performance 
standards.

Request for Public Comments

    NICEATM invites the submission of written comments on the draft 
LLNA performance standards. 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 by 
the deadline listed above will be placed on the NICEATM/ICCVAM Web site 
(https://ntp-apps.niehs.nih.gov/iccvampb/searchPubCom.cfm) and made 
available to the peer review panel and ICCVAM.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 federal regulatory and research agencies that use or generate 
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, or replace 
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3, 
available at https://iccvam.niehs.nih.gov/about/PL106545.htm) 
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 is available on the following Web site: http:/
/iccvam.niehs.nih.gov.

    Dated: September 5, 2007.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E7-18011 Filed 9-11-07; 8:45 am]
BILLING CODE 4140-01-P
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