National Toxicology Program; National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Expert Panel Report on the Evaluation of the Current Validation Status of In Vitro, 13513-13514 [05-5473]

Download as PDF Federal Register / Vol. 70, No. 53 / Monday, March 21, 2005 / Notices PL106545.htm) establishes ICCVAM as a permanent interagency committee of the NIEHS under the NICEATM. NICEATM administers the 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 following Web site: https://iccvam.niehs.nih.gov. NIEHS, P. O. Box 12233, MD EC–17, Research Triangle Park, NC 27709, (phone) 919–541–2384, (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. FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director of NICEATM, (phone) 919–541–2384, (email) niceatm@niehs.nih.gov. SUPPLEMENTARY INFORMATION: Dated: March 9, 2005. Samuel Wilson, Deputy Director, National Institute of Environmental Health Sciences. [FR Doc. 05–5471 Filed 3–18–05; 8:45 am] Background BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program; National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Expert Panel Report on the Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Availability of report and request for comments. AGENCY: The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the availability of a report entitled, ‘‘The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Expert Panel Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants.’’ The NICEATM invites public comment on the expert panel report. Copies of the expert panel report may be obtained on the ICCVAM/NICEATM Web site at https://iccvam.niehs.nih.gov, or by contacting NICEATM at the address given below. DATES: Written comments and additional information should be received by noon on May 5, 2005. ADDRESSES: Comments and additional information should be sent by mail, fax, or e-mail to Dr. William S. Stokes, Director of NICEATM, at NICEATM, SUMMARY: VerDate jul<14>2003 18:36 Mar 18, 2005 Jkt 205001 On January 11 and 12, 2005, NICEATM and ICCVAM held an expert panel meeting to evaluate the validation status for four in vitro ocular test methods nominated by the EPA: (1) The Bovine Corneal Opacity and Permeability (BCOP) test; (2) the Hen’s Egg Test—Chorion Allantoic Membrane (HET–CAM); (3) the Isolated Rabbit Eye (IRE) test; and (4) the Isolated Chicken Eye (ICE) test. At this meeting, the expert panel reviewed the Background Review Document (BRD) for each method and was asked to: • Evaluate the extent and adequacy that each method’s BRD addresses the applicable ICCVAM validation and acceptance criteria based on available information and data, or will address the criteria in proposed studies, focused on identifying ocular corrosives and severe irritants in a tiered testing strategy. • Develop conclusions and recommendations on: —The current usefulness and limitations of each of the four test methods for identifying ocular corrosives and severe/irreversible irritants. —The test method protocol that should be used for future testing and validation studies. —The adequacy of proposed optimization and/or validation studies. —The adequacy of reference substances proposed for future validation studies. The expert panel’s conclusions and recommendations on the four test methods are described in ‘‘The ICCVAM Expert Panel Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants’’. Prior to the expert panel meeting, NICEATM issued several Federal Register notices to (1) request public comment on the EPA nomination of ocular toxicity test methods and related activities and request data on chemicals evaluated by in vitro or in vivo ocular irritancy test methods (Federal Register, Vol. 69, No. 57, pp. 13859–13861, PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 13513 March 24, 2004, available at https:// iccvam.niehs.nih.gov/); (2) request the nomination of scientific experts to serve on the expert panel (Federal Register, Vol. 69, No. 77, pg. 21565, April 21, 2004, available at https:// iccvam.niehs.nih.gov/); and (3) request public comments on the BRDs prepared by NICEATM for each of the four test methods (Federal Register, Vol. 69, No. 212, pp. 64081–64082, November 3, 2004, and public comments are available at https://iccvam.niehs.nih.gov/). Request for Comments NICEATM invites the submission of written comments on the expert panel report. When submitting written comments please include appropriate contact information (name, affiliation, mailing address, phone, fax, email and sponsoring organization, if applicable). All written comments received by the deadline listed above will be posted on the ICCVAM/NICEATM Web site and made available to ICCVAM. ICCVAM will consider the expert panel report and any written public comments received on that report as it prepares final ICCVAM test method recommendations for the four in vitro ocular test methods. An ICCVAM test method evaluation report, which includes the ICCVAM recommendations, will be forwarded to appropriate Federal agencies for their consideration. This report also will be available to the public on the ICCVAM/ NICEATM Web site and by request to NICEATM. 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, and replace animal use. The ICCVAM Authorization Act of 2000 (Pub. L. 106–545, available at https://iccvam.niehs.nih.gov/about/ PL106545.htm) establishes ICCVAM as a permanent interagency committee of the NIEHS under the NICEATM. NICEATM administers the 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 E:\FR\FM\21MRN1.SGM 21MRN1 13514 Federal Register / Vol. 70, No. 53 / Monday, March 21, 2005 / Notices Federal agencies. Additional information about ICCVAM and NICEATM can be found at the following Web site: https://iccvam.niehs.nih.gov. Dated: March 9, 2005. Samuel Wilson, Deputy Director, National Institute of Environmental Health Sciences. [FR Doc. 05–5473 Filed 3–18–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. 2004 Inventory of Mental Health Organizations, General Hospital Mental Health Services, and Managed Care Organizations Survey (IMHO)—(OMB No. 0930–0119)—Revision The 2004 IMHO will be conducted by the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Center for Mental Health Services (CMHS). The design of the 2004 IMHO will be different from the 1998, 2000, and 2002 surveys. For 2004, we will return to just one data collection phase. This single phase, used by all surveys prior to 1998, will be a 100% enumeration of all known mental health organizations. The 2004 IMHO will utilize five separate questionnaires: (1) The Mental Health Organization Inventory; (2) The General Hospital Inventory; (3) The General Hospital Screener; (4) The Community Residential Organization Screener; and (5) The Managed Behavioral Healthcare Organization questionnaire. Organizational data, to be collected by the Inventory questionnaires, include service categories, client/patient census by basic demographics, revenues, expenditures, and staffing. The purpose of the two screener questionnaires will be to confirm whether direct and separate mental health services are being provided in these organizations. The resulting data base will be used to provide national estimates and will be the basis of the National Directory of Mental Health Services. In addition, data derived from the survey will be published by CMHS in Data Highlights, in Mental Health, United States, and in professional journals such as Psychiatric Services and the American Journal of Psychiatry. The publication Mental Health, United States is used by the general public, State governments, the U.S. Congress, university researchers, and other health care professionals. The following Table summarizes the burden for the survey. ESTIMATED TOTAL RESPONSE BURDEN FOR THE 2004 INVENTORY OF MENTAL HEALTH Responses per respondent Number of respondents Organizations types Average hours per response Total hour Burden Specialty Mental Health Organizations ......................................................... General Hospitals with Separate Psychiatric Units ....................................... General Hospitals without Separate Psychiatric Units .................................. Community Residential Organizations ........................................................... Managed Behavioral Healthcare Orgs .......................................................... 2,915 1,439 3,460 1,611 265 1 1 1 1 1 3 3 0.25 0.25 0.50 8,745 4,317 865 403 133 Total ........................................................................................................ 9,690 ........................ .......................... 14,463 Written comments and recommendations concerning the proposed information collection should be sent by April 20, 2005, to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB’s receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202–395–6974. DEPARTMENT OF HOMELAND SECURITY Customs and Border Protection; Department of Homeland Security. ACTION: General notice. required. This notice emphasizes that all relevant data elements (with a single exception, as explained in this notice) are required to be submitted in the automated truck manifest submission. Additionally, this notice re-publishes the data elements required for participation in the test. FOR FURTHER INFORMATION CONTACT: Mr. Jeremy Baskin, Office of Regulations and Rulings, via e-mail at jeremy.baskin@dhs.gov. SUPPLEMENTARY INFORMATION: Dated: March 4, 2005. Patricia S. Bransford, Acting Executive Officer, SAMHSA. [FR Doc. 05–5497 Filed 3–18–05; 8:45 am] SUMMARY: This document provides a modification to the Bureau of Customs and Border Protection’s (CBP) National Customs Automation Program (NCAP) test, announced in conjunction with the Department of Transportation, Federal Motor Carrier Safety Administration, concerning the transmission of automated truck manifest data. The original notice announcing this test stated that the transmission of certain data elements is requested, but not Background On September 13, 2004, Customs and Border Protection (CBP) published a General Notice in the Federal Register (69 FR 55167) announcing a test allowing participating Truck Carrier Accounts to transmit electronic manifest data in the Automated Commercial Environment (ACE), including advance cargo information as required by the final rule published by CBP to implement section 343 of the Trade Act BILLING CODE 4162–20–P VerDate jul<14>2003 18:36 Mar 18, 2005 Jkt 205001 Bureau of Customs and Border Protection Automated Commercial Environment (ACE): National Customs Automation Program Test of Automated Truck Manifest AGENCY: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\21MRN1.SGM 21MRN1

Agencies

[Federal Register Volume 70, Number 53 (Monday, March 21, 2005)]
[Notices]
[Pages 13513-13514]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5473]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program; National Toxicology Program (NTP) 
Interagency Center for the Evaluation of Alternative Toxicological 
Methods (NICEATM); Availability of Expert Panel Report on the 
Evaluation of the Current Validation Status of In Vitro Test Methods 
for Identifying Ocular Corrosives and Severe Irritants

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

ACTION: Availability of report and request for comments.

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

SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) announces 
the availability of a report entitled, ``The Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM) Expert 
Panel Evaluation of the Current Validation Status of In Vitro Test 
Methods for Identifying Ocular Corrosives and Severe Irritants.'' The 
NICEATM invites public comment on the expert panel report. Copies of 
the expert panel report may be obtained on the ICCVAM/NICEATM Web site 
at https://iccvam.niehs.nih.gov, or by contacting NICEATM at the address 
given below.

DATES: Written comments and additional information should be received 
by noon on May 5, 2005.

ADDRESSES: Comments and additional information should be sent by mail, 
fax, or e-mail to Dr. William S. Stokes, Director of NICEATM, at 
NICEATM, NIEHS, P. O. Box 12233, MD EC-17, Research Triangle Park, NC 
27709, (phone) 919-541-2384, (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.

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

SUPPLEMENTARY INFORMATION:

Background

    On January 11 and 12, 2005, NICEATM and ICCVAM held an expert panel 
meeting to evaluate the validation status for four in vitro ocular test 
methods nominated by the EPA: (1) The Bovine Corneal Opacity and 
Permeability (BCOP) test; (2) the Hen's Egg Test--Chorion Allantoic 
Membrane (HET-CAM); (3) the Isolated Rabbit Eye (IRE) test; and (4) the 
Isolated Chicken Eye (ICE) test. At this meeting, the expert panel 
reviewed the Background Review Document (BRD) for each method and was 
asked to:
     Evaluate the extent and adequacy that each method's BRD 
addresses the applicable ICCVAM validation and acceptance criteria 
based on available information and data, or will address the criteria 
in proposed studies, focused on identifying ocular corrosives and 
severe irritants in a tiered testing strategy.
     Develop conclusions and recommendations on:
--The current usefulness and limitations of each of the four test 
methods for identifying ocular corrosives and severe/irreversible 
irritants.
--The test method protocol that should be used for future testing and 
validation studies.
--The adequacy of proposed optimization and/or validation studies.
--The adequacy of reference substances proposed for future validation 
studies.
    The expert panel's conclusions and recommendations on the four test 
methods are described in ``The ICCVAM Expert Panel Evaluation of the 
Current Validation Status of In Vitro Test Methods for Identifying 
Ocular Corrosives and Severe Irritants''.
    Prior to the expert panel meeting, NICEATM issued several Federal 
Register notices to (1) request public comment on the EPA nomination of 
ocular toxicity test methods and related activities and request data on 
chemicals evaluated by in vitro or in vivo ocular irritancy test 
methods (Federal Register, Vol. 69, No. 57, pp. 13859-13861, March 24, 
2004, available at https://iccvam.niehs.nih.gov/); (2) request the 
nomination of scientific experts to serve on the expert panel (Federal 
Register, Vol. 69, No. 77, pg. 21565, April 21, 2004, available at 
https://iccvam.niehs.nih.gov/); and (3) request public comments on the 
BRDs prepared by NICEATM for each of the four test methods (Federal 
Register, Vol. 69, No. 212, pp. 64081-64082, November 3, 2004, and 
public comments are available at https://iccvam.niehs.nih.gov/).

Request for Comments

    NICEATM invites the submission of written comments on the expert 
panel report. When submitting written comments please include 
appropriate contact information (name, affiliation, mailing address, 
phone, fax, email and sponsoring organization, if applicable). All 
written comments received by the deadline listed above will be posted 
on the ICCVAM/NICEATM Web site and made available to ICCVAM.
    ICCVAM will consider the expert panel report and any written public 
comments received on that report as it prepares final ICCVAM test 
method recommendations for the four in vitro ocular test methods. An 
ICCVAM test method evaluation report, which includes the ICCVAM 
recommendations, will be forwarded to appropriate Federal agencies for 
their consideration. This report also will be available to the public 
on the ICCVAM/NICEATM Web site and by request to NICEATM.

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, and replace 
animal use. The ICCVAM Authorization Act of 2000 (Pub. L. 106-545, 
available at https://iccvam.niehs.nih.gov/about/PL106545.htm) 
establishes ICCVAM as a permanent interagency committee of the NIEHS 
under the NICEATM. NICEATM administers the 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

[[Page 13514]]

Federal agencies. Additional information about ICCVAM and NICEATM can 
be found at the following Web site: https://iccvam.niehs.nih.gov.

    Dated: March 9, 2005.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-5473 Filed 3-18-05; 8:45 am]
BILLING CODE 4140-01-P

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