40302 Federal Register / Vol. 63, No. 144 /Tuesday, July 28, 1998 / Notices

HEALTH SCIENTIST ADMINISTRATOR,

OFFICE OF EXTRAMURAL PROGRAMS,

NATIONAL LIBRARY OF MEDICINE, 6705

ROCKLEDGE DRIVE, SUITE 301,

BETHESDA, MD 20892.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalog of Federal Domestic Assistance

Program Nos. 93.879, Medical Library

Assistance, National Institutes of Health,

HHS).

Dated: July 21, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–20045 Filed 7–27–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

National Toxicology Program; Meeting

of the Advisory Committee on

Alternative Toxicological Methods

Pursuant to Public Law 92–463,

notice is hereby given of a meeting of

the National Toxicology Program (NTP)

Advisory Committee on Alternative

Toxicological Methods, U.S. Public

Health Service. The meeting will be

held from 8:45 a.m. to 4:00 p.m. on

September 25, 1998 in the Conference

Center, Building 101, South Campus,

NIEHS, 111 Alexander Drive, Research

Triangle Park, North Carolina, 27709.

The meeting will be open to the public

from 8:45 a.m. to adjournment with

attendance limited only by space

available.

Background

Under authority of 42 U.S.C. 217a,

Section 222 of the Public Health Service

Act, as amended, the Department of

Health and Human Services has

established an Advisory Committee on

Alternative Toxicological Methods. The

Committee functions to provide advice

on the activities and priorities of the

National Toxicology Program (NTP)

Interagency Center for the Evaluation of

Alternative Toxicological Methods

(Center) and the Interagency

Coordinating Committee on the

Validation of Alternative Methods

(ICCVAM), and to provide advice on

ways to foster partnership activities and

productive interactions among all

stakeholders. The Advisory Committee

is composed of knowledgeable

representatives drawn from academia,

industry, public interest organizations,

other state and Federal agencies, and the

international community.

The National Toxicology Program

established the Center and ICCVAM to

fulfill specific mandates provided to the

National Institute of Environmental

Health Sciences by P.L. 103–43, Section

1301. The NIEHS was directed to (1)

develop and validate toxicological

testing methods, including alternative

methods than can reduce or eliminate

the use of animals in acute or chronic

toxicity testing, (2) establish criteria for

the validation and regulatory acceptance

of alternative testing methods, and (3)

recommend a process through which

scientifically validated alternative

methods can be accepted for regulatory

use. Criteria and processes for

validation and regulatory acceptance

were developed in conjunction with 14

other Federal agencies and programs

with broad input from the public. These

are described in the document

‘‘Validation and Regulatory Acceptance

of Toxicological Test Methods: A Report

of the Ad Hoc Intragency Coordination

Committee on the Validation of

Alternative Methods’’ NIH publication

97–3981, March 1997, which is

available on the internet at http://ntpserver.niehs.nih.gov/htdocs/ICCVAM/

ICCVAM htm, or by request to the

Center at the address provided below.

A standing Intragency Coordinating

Committee on the Validation of

Alternative Methods (ICCVAM) was

subsequently established as a

collaborative effort by NIEHS and 13

other Federal regulatory and research

agencies and programs. The ICCVAM

facilities cross-agency communication

and coordination on issues relating to

validation, acceptance, and national/

international harmonization of

toxicological test methods. The

ICCVAM works with the Center to carry

out the scientific review of proposed

methods of multi-agency interest, and

provides recommendations regarding

their usefulness to appropriate agencies.

The ICCVAM also provides a

mechanism for interagency

communication with stakeholders

throughout the process of test method

development and validation. The

following Federal regulatory and

research agencies and organizations are

participating in this effort:

Consumer Product Safety Commission

Department of Defense

Department of Energy

Department of Health and Human

Services

Agency for Toxic Substances and

Disease Registry

Food and Drug Administration

National Institute for Occupational

Safety and Health/CDC

National Institutes of Health

National Cancer Institute

National Institute of Environmental

Health Sciences

National Library of Medicine

Department of the Interior

Department of Labor

Occupational Safety and Health

Administration

Department of Transportation

Research and Special Programs

Administration

Environmental Protection Agency

The Center was established to provide

operational support for the ICCVAM

and to assist Federal Agencies by

coordinating and facilitating (1) the

interagency review and adoption of

toxicological test methods of multiagency interest and (2) the participation

and communication with other

stakeholders throughout the process of

test methods development and

validation. The Center organizes, in

collaboration with ICCVAM,

independent scientific peer reviews and

workshops for test methods of interest

to Federal agencies. Peer review panels

are convened to develop scientific

consensus on the usefulness of test

methods to generate information for

specific human health and/or ecological

risk assessment purposes. Expert

workshops are convened to evaluate the

adequacy of current test methods for

assessing specific toxicities, to identity

areas in need of improved or new

methods, to evaluate proposed

validation studies, and to evaluate the

validation status of methods. The Center

provides an opportunity for

partnerships with other agencies and

organizations to facilitate the

development, validation, and review of

alternative testing methods. The Center

and ICCVAM seek to promote the

scientific validation and regulatory

acceptance of toxicological test methods

that will enhance agencies’ ability to

assess risks and make decisions, and

that will refine, reduce, and replace

animal use whenever possible. The

Center Office is located at NIEHS and

can be contacted by telephone at 919–

541–3398, fax 919–541–0947, or e-mail,

iccvam@niehs.nih.gov.

Agenda

The primary agenda topics are

concerned with presentations and

discussions relating to processes,

priorities, and recent and proposed

activities of the NTP Interagency Center

for the Evaluation of Alternative

Toxicological Methods and the

Interagency Coordinating Committee on

the Validation of Alternative Methods.

The Executive Secretary, Dr. Larry

Hart, Environmental Toxicology

Program, P.O. Box 12233, NIEHS,
Federal Register / Vol. 63, No. 144 /Tuesday, July 28, 1998 / Notices 40303

Research Triangle Park, North Carolina

27709, telephone (919) 541–3971, FAX

(919) 541–0295, will have available an

agenda with times and a roster of

Committee members prior to the

meeting and summary minutes

subsequent to the meeting.

Dated: June 17, 1998.

Samuel H. Wilson,

Deputy Director, National Institute of

Environmental Health Sciences.

[FR Doc. 98–20041 Filed 7–27–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

National Institute of Environmental

Health Sciences; National Toxicology

Program; Request for Comments on

Test Methods Undergoing Review by

the Interagency Coordinating

Committee on the Validation of

Alternative Methods (ICCVAM) and the

National Toxicology Program

Interagency Center for the Evaluation

of Alternative Methods

Background

The Interagency Coordinating

Committee on the Validation of

Alternative Methods (ICCVAM), with

participation by 14 Federal regulatory

and research agencies and programs,

was established in 1997 to facilitate

cross-agency communication and

coordination on issues relating to

validation, acceptance, and national/

international harmonization of

toxicological test methods. The

Committee seeks to promote the

scientific validation and regulatory

acceptance of toxicological test methods

that will enhance agencies’s ability to

assess risks and make decision, and that

will refine, reduce, and replace animal

use whenever possible. The National

Toxicology Program Interagency Center

for the Evaluation of Alternative

Toxicological Methods (Center), in

collaboration with ICCVAM, carries out

related activities such as independent

peer reviews and workshops for test

methods of interest to Federal agencies.

Peer review panels are convened to

develop scientific consensus on the

usefulness of test methods to generate

information for specific human heath

and/or ecological risk assessment

purposes. Expert workshops are

convened as needed to evaluate the

adequacy of current methods for

assessing specific toxicities, to identify

areas in need of improved or new

methods, to evaluate proposed

validation studies, and to evaluate the

validation status of methods. Following

the peer review of proposed test

methods, the ICCVAM forwards

recommendations regarding their

usefulness to appropriate agencies for

their consideration. Federal agencies

then determine the regulatory

acceptability of a method according to

their mandates.

Additional information on the

activities and functions of the ICCVAM

can be found in the publication:

Validation on Regulatory Acceptance of

Toxicological Test Methods, a Report of

the ad hoc Interagency Coordinating

Committee on the Validation of

Alternative Methods (NIH Publication

97–3981, March 1997). This report was

prepared in response to the National

Institutes of Health (NIH) Revitalization

Act of 1993 (Pub. L. 103–43), which

required the NIEHS to develop criteria

and recommended processes for the

validation and regulatory acceptance of

alternative toxicological test methods.

The report is available on the internet at

http://ntp-server.niehs.nih.gov/htdocs/

ICCVAM/ICCVAM html, or may be

requested from the NTP Center address

listed below.

Request for Comments

Interested parties are encouraged to

submit information and data that would

be helpful in evaluating the usefulness

of two test methods for which upcoming

independent scientific peer review

meetings are being planned. The

methods are: (1) Corrositex, an in vitro

method proposed for assessing the

dermal corrosivity potential of

chemicals and products; and (2) the

Frog Embryo Teratogeneisis Assay in

Xenopus (FETAX), a method for

demonstrating developmental toxicity.

Potential regulatory applications of

FETAX to human health developmental

toxicity assessments include screening

and prioritizing compounds for further

testing, evaluating complex mixtures in

environmental samples, and as

supplemental information in a weightof-evidence evaluation of human

developmental toxicity hazards.

The Center would welcome receiving

information and data from completed,

ongoing, or planned studies using or

evaluating these test methods. Data and

information submitted should address

one or more of the criteria for validation

and regulatory acceptance as provided

in NIH publication 97–3981,

‘‘Validation and Regulatory Acceptance

of Toxicological Test Methods: A Report

of the AD Hoc Interagency Coordinating

Committee on the Validation of

Alternative Methods’’. Where possible,

data and information should adhere to

the guidance provided in the document

‘‘Evaluation of the Validation Status of

Toxicological Methods: General

Guidelines for Submissions to

ICCVAM’’, which is available on request

from the NTP Center at the address

provided below. Relevant information

submitted in response to this request

will be used to prepare test methods

background review documents for use

by peer review and expert panels. Peer

review meetings and/or workshops for

these methods will be announced in

future notices as they are scheduled.

Information on these test methods

should sent by mail, fax, or e-mail to the

NTP Interagency Center for the

Evaluation of Alternative Toxicological

Methods within 45 days of the

appearance of this notice. The NTP

Center mailing address, phone, fax, and

e-mail are as follows: MD EC–17, P.O.

Box 12233, Research Triangle Park, NC

27709; 919–541–3398 (phone); 919–

541–0947 (FAX); ICCVAM@niehs.

nih.gov (e-mail). Additional information

can be obtained from: Dr. William S.

Stokes, NTP Interagency Center for the

Evaluation of Alternative Toxicological

Methods, Environmental Toxicology

Program, NIEHS/NTP, P.O. Box 12233,

Research Triangle Park, North Carolina

27709, telephone (919) 541–3398, FAX

(919) 541–0947,

emailstokes@niehs.nih.gov.

Dated: July 17, 1998.

Samuel H. Wilson,

Deputy Director, National Institute of

Environmental Health Sciences.

[FR Doc. 98–20040 Filed 7–27–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Information Collection Renewal To be

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and Budget (OMB) for Approval Under

the Paperwork Reduction Act

AGENCY: Fish and Wildlife Service,

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ACTION: Notice of information collection;

request for comments.

SUMMARY: The collection of information

listed below has been submitted to the

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of the Paperwork Reduction Act. Copies

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