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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the Paperwork Reduction Act

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of information collection;

request for comments.

SUMMARY: The collection of information

listed below has been submitted to the

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(OMB) for renewal under the provisions

of the Paperwork Reduction Act. Copies

of the specific information collection

requirements, related forms, and

explanatory material may be obtained

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Collection Clearance Officer at the

address listed below.