National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Peer Review Panel Report on the Use of In Vitro, 39122-39123 [E6-10789]

Download as PDF 39122 Federal Register / Vol. 71, No. 132 / Tuesday, July 11, 2006 / Notices comments. Each organization is allowed one time slot per public comment period. At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes. Persons registering to make oral comments are asked, if possible, to send a copy of their statement to Dr. Kristina Thayer by July 25, 2006, to enable review by SACATM and NTP staff prior to the meeting. Please not that this teleconference provides an additional opportunity for the public to provide comment on the peer review panel’s conclusions regarding the draft ICCVAM test method recommendations. Written comments submitted to NICEATM in response to a NICEATM notice published in this issue of the Federal Register do not need to be resubmitted. Any written comments on the peer review report received prior to July 25, 2006, will be distributed to SACATM. Background Information on ICCVAM, NICEATM, and SACATM The SACATM was established January 9, 2002, to fulfill section 3(d) of the ICCVAM Authorization Act of 2000 [42 U.S.C. 285l–3(d)] and is composed of scientists from the public and private sectors (Federal Register: March 13, 2002: Vol. 67, No. 49, page 11358). The SACATM provides advice to the Director of the NIEHS, ICCVAM, and NICEATM regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Additional information about SACATM, including the charter, roster, and records of past meetings can be found at https:// ntp.niehs.nih.gov/go/167. Information about NICEATM and ICCVAM activities can be found at the NICEATM/ICCVAM Web site (https://iccvam.niehs.nih.gov) or by contacting the Director of NICEATM, Dr. William Stokes (telephone: 919–541–2384, or e-mail: niceatm@niehs.nih.gov). Dated: June 30, 2006. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E6–10790 Filed 7–10–06; 8:45 am] sroberts on PROD1PC70 with NOTICES BILLING CODE 4140–01–P VerDate Aug<31>2005 16:49 Jul 10, 2006 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: National Institutes of Health National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Peer Review Panel Report on the Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing and Request for Comments National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for comments. AGENCY: SUMMARY: The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), organized an independent, scientific peer review meeting on May 23, 2006, to evaluate the validation status of the in vitro 3T3 and normal human keratinocyte (NHK) neutral red uptake (NRU) basal cytotoxicity test methods. These two in vitro cytotoxicity test methods are proposed as adjuncts (for the purpose of determining the starting dose) to in vivo acute oral toxicity tests. The peer review report from this meeting, entitled Peer Review Panel Evaluation of the Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing, is now available. The report contains (1) a summary of the peer review evaluation and (2) the peer review panel’s (Panel) conclusions on the draft ICCVAM test method recommendations regarding the proposed usefulness, limitations, and validation status of the 3T3 and NHK cytotoxicity test methods. The NICEATM invites public comment on the Panel’s conclusions on the draft ICCVAM test method recommendations. Copies of the 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 should be received at NICEATM by August 25, 2006. ADDRESSES: Public comments and any other correspondence should be sent by mail, fax, or e-mail to Dr. William S. Stokes, NICEATM, NIEHS, P. O. Box 12233, MD EC–17, Research Triangle Park, NC, 27709, (phone) 919–541– PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 2384, (fax) 919–541–0947, (e-mail) niceatm@niehs.nih.gov. Background The 3T3 and NHK cytotoxicity test methods are proposed as adjuncts (for the purpose of determining the starting dose) to in vivo acute oral toxicity test methods (i.e., the Up-and-Down Procedure [EPA 2002a; OECD 2001a], the Acute Toxic Class method [OECD 2001b]) to refine (i.e., to lessen or avoid pain and distress) and/or reduce animal use. Both in vitro cytotoxicity test methods have been assessed in a NICEATM and European Centre on the Validation of Alternative Methods (ECVAM) collaborative independent validation study. At this peer review meeting, the Panel reviewed the background review document (BRD) on the 3T3 and NHK cytotoxicity test methods and evaluated the extent that established validation and acceptance criteria had been adequately addressed for the intended purpose of the test methods. The Panel also provided comments on draft ICCVAM recommendations regarding the proposed use of these test methods, draft test method protocols, draft performance standards, and draft recommended future studies. The Panel’s conclusions and recommendations on the two in vitro cytotoxicity test methods are described in the Peer Review Panel Evaluation of the Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing (available at https:// iccvam.niehs.nih.gov/). Prior to the Panel meeting, NICEATM issued Federal Register notices to (1) recommend that in vitro basal cytotoxicity test methods be considered as tools for estimating starting doses for in vivo acute systemic toxicity tests (66FR49686), (2) announce a request for nominations for Panel members and submission of existing in vivo and in vitro data (70FR14473), (3) announce the independent peer review meeting on the use of the 3T3 and NHK cytotoxicity test methods for estimating starting doses for acute oral systemic toxicity tests, and (4) request comments on the draft BRD and draft ICCVAM recommendations (71FR14229). All Federal Register notices, the draft BRD, and the draft ICCVAM recommendations are available at https:// iccvam.niehs.nih.gov/. Request for Comments NICEATM invites the submission of written comments on the Panel’s E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 71, No. 132 / Tuesday, July 11, 2006 / Notices sroberts on PROD1PC70 with NOTICES conclusions on the draft ICCVAM test method recommendations. 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 ICCVAM/NICEATM Web site and made available to ICCVAM. In addition, there will be an opportunity for oral public comments on the draft ICCVAM test method recommendations for the 3T3 and NHK cytotoxicity test methods during a teleconference meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) scheduled for August 3, 2006. Details of the SACATM teleconference are published as a separate Federal Register notice (available at https://ntp.niehs.nih.gov/go/ frn). Any written comments on the Panel report received prior to July 25, 2006, will be distributed to SACATM. ICCVAM will consider the Panel report along with SACATM and public comments received on that report as it prepares final ICCVAM recommendations for the 3T3 and NHK cytotoxicity test methods. An ICCVAM test method evaluation report, which will include the final ICCVAM recommendations, will be forwarded to the appropriate federal agencies for their consideration. This report also will be available to the public on the ICCVAM/ NICEATM website 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 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(d)] 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 VerDate Aug<31>2005 16:49 Jul 10, 2006 Jkt 208001 NICEATM can be found at the ICCVAMNICEATM Web site (https:// iccvam.niehs.nih.gov). SACATM was established January 9, 2002, to fulfill section 3(d) of the ICCVAM Authorization Act of 2000 and is composed of scientists from the public and private sectors (Federal Register: March 13, 2002: Vol. 67, No. 49, page 11358). SACATM provides advice to the Director of the NIEHS, ICCVAM, and NICEATM regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Additional information about SACATM, including the charter, roster, and records of past meetings can be found at https:// ntp.niehs.nih.gov/go/167. References EPA. 2002. Health Effects Test Guidelines OPPT 870.1100 Acute Oral Toxicity. EPA 712–C–02–190. Washington, DC: U.S. Environmental Protection Agency. Available at: https://www.epa.gov/opptsfrs/ publications/. 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: https://iccvam.niehs.nih.gov. OECD. 2001a. Guideline for Testing of Chemicals, 425, Acute Oral Toxicity—Upand-Down Procedure. Paris, France:OECD. Available at: https://www.oecd.org. OECD. 2001b. Guideline for Testing of Chemicals, 423, Acute Oral Toxicity— Acute Toxic Class Method. Paris, France:OECD. Available at: https:// www.oecd.org. Dated: June 30, 2006. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E6–10789 Filed 7–10–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT Office of Federal Housing Enterprise Oversight Privacy Act of 1974: Systems of Records Office of Federal Housing Enterprise Oversight, HUD. ACTION: Notice of new system of records. AGENCY: SUMMARY: In accordance with the Privacy Act of 1974, as amended, 5 U.S.C. 552a (Privacy Act), the Office of Federal Housing Enterprise Oversight (OFHEO) is issuing public notice of its intent to establish a new Privacy Act system of records. The new system is titled Telecommunications System. PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 39123 The records in this system will be used to verify OFHEO’s telecommunications usage and to resolve billing discrepancies. The records may also be used to identify unofficial telecommunications use. The purpose and effect of this system is to facilitate management of telecommunications devices; to analyze use detail information for verifying telecommunication device usage; to determine responsibility for use of telecommunications including placement of specific local and long distance calls; to prevent and detect the misuse of telecommunication resources; and to serve as the basis for appropriate disciplinary action in the event those resources have been misused. DATES: Written comments must be received before August 10, 2006. The proposed new system of records will become effective on August 21, 2006 unless OFHEO receives comments that would result in changes. ADDRESSES: You may submit your comments on the proposed new Privacy Act system of records, identified by ‘‘Telecommunications System’’, by any of the following methods: • U.S. Mail, United Parcel Post, Federal Express, or Other Mail Service: The mailing address for comments is: Alfred M. Pollard, General Counsel, Attention: Comments/System of Records, Office of Federal Housing Enterprise Oversight, Fourth Floor, 1700 G Street, NW., Washington, DC 20552. • Hand Delivery/Courier: The hand delivery address is: Alfred M. Pollard, General Counsel, Attention: Comments/ ‘‘Telecommunications System’’, Office of Federal Housing Enterprise Oversight, Fourth Floor, 1700 G Street, NW., Washington, DC 20552. The package should be logged at the Guard Desk, First Floor, on business days between 9 a.m. and 5 p.m. • E-mail: RegComments@OFHEO.gov. The e-mail address is: RegComments@OFHEO.gov. Please include ‘‘Telecommunications System’’ in the subject line of the message. FOR FURTHER INFORMATION CONTACT: Mary Alice Donner, Senior Counsel, telephone 202–343–1319 (not a toll-free number); Office of Federal Housing Enterprise Oversight, Fourth Floor, 1700 G Street, NW., Washington, DC 20552. The telephone number for the Deaf is (800) 877–8339. SUPPLEMENTARY INFORMATION: This notice informs the public that OFHEO proposes to establish and maintain a new system of records. This notice satisfies the Privacy Act requirement that an agency publish a system of records notice in the Federal Register E:\FR\FM\11JYN1.SGM 11JYN1

Agencies

[Federal Register Volume 71, Number 132 (Tuesday, July 11, 2006)]
[Notices]
[Pages 39122-39123]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10789]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP), NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Availability 
of Peer Review Panel Report on the Use of In Vitro Basal Cytotoxicity 
Test Methods for Estimating Starting Doses for Acute Oral Systemic 
Toxicity Testing and Request for Comments

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

ACTION: Request for comments.

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

SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM), in 
collaboration with the Interagency Coordinating Committee on the 
Validation of Alternative Methods (ICCVAM), organized an independent, 
scientific peer review meeting on May 23, 2006, to evaluate the 
validation status of the in vitro 3T3 and normal human keratinocyte 
(NHK) neutral red uptake (NRU) basal cytotoxicity test methods. These 
two in vitro cytotoxicity test methods are proposed as adjuncts (for 
the purpose of determining the starting dose) to in vivo acute oral 
toxicity tests. The peer review report from this meeting, entitled Peer 
Review Panel Evaluation of the Use of In Vitro Basal Cytotoxicity Test 
Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity 
Testing, is now available. The report contains (1) a summary of the 
peer review evaluation and (2) the peer review panel's (Panel) 
conclusions on the draft ICCVAM test method recommendations regarding 
the proposed usefulness, limitations, and validation status of the 3T3 
and NHK cytotoxicity test methods. The NICEATM invites public comment 
on the Panel's conclusions on the draft ICCVAM test method 
recommendations. Copies of the 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 should be received at NICEATM by August 25, 
2006.

ADDRESSES: Public comments and any other correspondence should be sent 
by mail, fax, or e-mail to Dr. William S. Stokes, 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.

SUPPLEMENTARY INFORMATION: 

Background

    The 3T3 and NHK cytotoxicity test methods are proposed as adjuncts 
(for the purpose of determining the starting dose) to in vivo acute 
oral toxicity test methods (i.e., the Up-and-Down Procedure [EPA 2002a; 
OECD 2001a], the Acute Toxic Class method [OECD 2001b]) to refine 
(i.e., to lessen or avoid pain and distress) and/or reduce animal use. 
Both in vitro cytotoxicity test methods have been assessed in a NICEATM 
and European Centre on the Validation of Alternative Methods (ECVAM) 
collaborative independent validation study. At this peer review 
meeting, the Panel reviewed the background review document (BRD) on the 
3T3 and NHK cytotoxicity test methods and evaluated the extent that 
established validation and acceptance criteria had been adequately 
addressed for the intended purpose of the test methods. The Panel also 
provided comments on draft ICCVAM recommendations regarding the 
proposed use of these test methods, draft test method protocols, draft 
performance standards, and draft recommended future studies. The 
Panel's conclusions and recommendations on the two in vitro 
cytotoxicity test methods are described in the Peer Review Panel 
Evaluation of the Use of In Vitro Basal Cytotoxicity Test Methods for 
Estimating Starting Doses for Acute Oral Systemic Toxicity Testing 
(available at https://iccvam.niehs.nih.gov/).
    Prior to the Panel meeting, NICEATM issued Federal Register notices 
to (1) recommend that in vitro basal cytotoxicity test methods be 
considered as tools for estimating starting doses for in vivo acute 
systemic toxicity tests (66FR49686), (2) announce a request for 
nominations for Panel members and submission of existing in vivo and in 
vitro data (70FR14473), (3) announce the independent peer review 
meeting on the use of the 3T3 and NHK cytotoxicity test methods for 
estimating starting doses for acute oral systemic toxicity tests, and 
(4) request comments on the draft BRD and draft ICCVAM recommendations 
(71FR14229). All Federal Register notices, the draft BRD, and the draft 
ICCVAM recommendations are available at https://iccvam.niehs.nih.gov/.

Request for Comments

    NICEATM invites the submission of written comments on the Panel's

[[Page 39123]]

conclusions on the draft ICCVAM test method recommendations. 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 ICCVAM/NICEATM Web site and made available to ICCVAM. In 
addition, there will be an opportunity for oral public comments on the 
draft ICCVAM test method recommendations for the 3T3 and NHK 
cytotoxicity test methods during a teleconference meeting of the 
Scientific Advisory Committee on Alternative Toxicological Methods 
(SACATM) scheduled for August 3, 2006. Details of the SACATM 
teleconference are published as a separate Federal Register notice 
(available at https://ntp.niehs.nih.gov/go/frn). Any written comments on 
the Panel report received prior to July 25, 2006, will be distributed 
to SACATM.
    ICCVAM will consider the Panel report along with SACATM and public 
comments received on that report as it prepares final ICCVAM 
recommendations for the 3T3 and NHK cytotoxicity test methods. An 
ICCVAM test method evaluation report, which will include the final 
ICCVAM recommendations, will be forwarded to the appropriate federal 
agencies for their consideration. This report also will be available to 
the public on the ICCVAM/NICEATM website 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 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(d)] 
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 
(https://iccvam.niehs.nih.gov).
    SACATM was established January 9, 2002, to fulfill section 3(d) of 
the ICCVAM Authorization Act of 2000 and is composed of scientists from 
the public and private sectors (Federal Register: March 13, 2002: Vol. 
67, No. 49, page 11358). SACATM provides advice to the Director of the 
NIEHS, ICCVAM, and NICEATM regarding statutorily mandated duties of 
ICCVAM and activities of NICEATM. Additional information about SACATM, 
including the charter, roster, and records of past meetings can be 
found at https://ntp.niehs.nih.gov/go/167.

References

EPA. 2002. Health Effects Test Guidelines OPPT 870.1100 Acute Oral 
Toxicity. EPA 712-C-02-190. Washington, DC: U.S. Environmental 
Protection Agency. Available at: https://www.epa.gov/opptsfrs/
publications/.
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: https://
iccvam.niehs.nih.gov.
OECD. 2001a. Guideline for Testing of Chemicals, 425, Acute Oral 
Toxicity--Up-and-Down Procedure. Paris, France:OECD. Available at: 
https://www.oecd.org.
OECD. 2001b. Guideline for Testing of Chemicals, 423, Acute Oral 
Toxicity--Acute Toxic Class Method. Paris, France:OECD. Available 
at: https://www.oecd.org.

    Dated: June 30, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E6-10789 Filed 7-10-06; 8:45 am]
BILLING CODE 4140-01-P

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