Federal Register / Vol. 62, No. 49 / Thursday, March 13, 1997 / Notices 11901

Act of 1995. This document announces

the OMB approval number.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 24, 1996

(61 FR 50030), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance. In accordance with the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501–3520), OMB has approved

the information collection and assigned

OMB control number 0910–0212. The

approval expires on October 31, 1999.

Under 5 CFR 1320.5(b), an agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless it displays a

currently valid OMB control number.

Dated: March 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–6361 Filed 3–12–97; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Mental Health;

Closed Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings of the National Institute of

Mental Health Special Emphasis Panel:

Agenda/Purpose: To review and evaluate

grant applications.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: March 17, 1997.

Time: 9:30 a.m.

Place: Parklawn, Room 9C–26, 5600

Fishers Lane, Rockville, MD 20857.

Contact Person: Sheri L. Schwartzback,

Parklawn, Room 9C–26, 5600 Fishers Lane,

Rockville, MD 20857, Telephone: 301, 443–

4843.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: March 25, 1997.

Time: 1 p.m.

Place: Parklawn, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857.

Contact Person: Jean K. Paddock,

Parklawn, Room 9C–18, 5600 Fishers Lane,

Rockville, MD 20857, Telephone: 301, 443–

4868.

The meetings will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

This notice is being published less than

fifteen days prior to the meetings due to the

urgent need to meet timing limitations

imposed by the review and funding cycle.

(Catalog of Federal Domestic Assistance

Program Numbers 93.242, 93.281, 93.282)

LaVerne Y. Stringfield,

Committee Management Officer, National

Institutes of Health.

[FR Doc. 97–6287 Filed 3–12–97; 8:45 am]

BILLING CODE 4140–01–M

Public Health Service

National Institute of Environmental

Health Sciences; Validation and

Regulatory Acceptance of

Toxicological Test Methods: A Report

of the ad hoc Interagency Coordinating

Committee on the Validation of

Alternative Methods, Now Available

The publication Validation and

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 is now

available and may be obtained as

described in this notice.

Background

The National Institutes of Health

Revitalization Act of 1993 (Pub. L. 103–

43, Section 1301) directed the National

Institute of Environmental Health

Sciences of the National Institutes of

Health (NIEHS/NIH) to ‘‘(a) establish

criteria for the validation and regulatory

acceptance of alternative testing

methods, and (b) recommend a process

through which scientifically validated

alternative methods can be accepted for

regulatory use’’ (Appendix F).

In response to these mandates, NIEHS

established an ad hoc Interagency

Coordinating Committee on the

Validation of Alternative Methods

(ICCVAM) (the Committee) in 1994 to

develop a report recommending criteria

and processes for validation and

regulatory acceptance of toxicological

testing methods that would be useful to

Federal agencies and the scientific

community. The following Federal

regulatory and research agencies and

organizations participated in this effort:

Consumer Product Safety Commission

Department of Agriculture

Agriculture Research Service

Animal and Plant Health Inspection

Service

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 Institute of Health

National Cancer Institute

National Institute of Environmental

Health Sciences

National Library of Medicine

Office of Laboratory Animal Research

Department of the Interior

Department of Labor

Occupational Safety and Health

Administration

Department of Transportation

Research and Special Programs

Administration

Environmental Protection Agency

The Committee met initially in

September 1994, and then monthly or

bimonthly until completion of the

report in October 1996. The Committee

interpreted its charge as the

development of general criteria and

processes for the validation and

regulatory acceptance of new and

revised toxicological test methods.

The specific goals of this Report are

to:

• Communicate the criteria and

procedures that Federal agencies should

employ in considering new and revised

test methods,

• Encourage the development of new

and revised test methods that will

provide for improved assessment of the

potential toxicity of agents to human

health and other organisms in the

environment,

• Provide effective guidance for

scientists for the validation and

evaluation of new and revised test

methods,

• Contribute to the increased

likelihood of regulatory acceptance of

scientifically valid new and revised test

methods,

• Encourage the use of validated and

accepted new and revised test methods,

• Encourage, when scientifically

feasible, the reduction and refinement of

animal use in testing and the

replacement of animal methods with

non-animal methods or of animal

species with phylogenetically lower

species.

In developing the initial draft report,

the Committee considered information

obtained from the following sources: (1)

A questionnaire completed by each

agency on their criteria and processes

for test method validation and

acceptance, (2) public comments

submitted in response to a Federal

Register notice published December 7,