Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35109

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

National Institute of Environmental

Health Sciences (NIEHS), National

Institutes of Health (NIH), National

Toxicology Program (NTP); Notice of

Peer Review Meeting on the Revised

Up-and-Down Procedure (UDP) as an

Alternative Test Method for Assessing

Acute Oral Toxicity; Request for

Comments

Summary

Pursuant to Public Law 103–43,

notice is hereby given of a public

meeting coordinated by the Interagency

Coordinating Committee on the

Validation of Alternative Methods

(ICCVAM) and the NTP Interagency

Center for the Evaluation of Alternative

Toxicological Methods (NICEATM) and

sponsored by NIEHS and the NTP. The

agenda topic is the scientific peer

review of the revised Up-and-Down

Procedure, a method proposed as a

replacement for the existing LD50 test

for evaluating the acute oral toxicity

potential of chemicals. The meeting will

take place on July 25, 2000, from 8:30

a.m. to 5:30 p.m. at the Sheraton Crystal

City Hotel, 1800 Jefferson Davis

Highway, Arlington, VA 22202. The

meeting is open to the public.

Background

ICCVAM, with participation by 14

Federal regulatory and research agencies

and programs, was established in 1997

to coordinate issues relating to the

development, validation, acceptance,

and national/international

harmonization of toxicological test

methods. ICCVAM seeks to promote the

scientific validation and regulatory

acceptance of new and improved test

methods applicable to Federal agencies

including methods that may reduce and

replace animal use, or that refine animal

use to reduce or eliminate pain and

distress. The Committee’s functions

include the coordination of interagency

reviews of toxicological test methods

and communication with stakeholders

throughout the process of test method

development and validation. The

following Federal regulatory and

research agencies and organizations

participate 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 NTP Center for the Evaluation of

Alternative Toxicological Methods

(NICEATM) was established in 1998 and

provides operational support for the

ICCVAM. NICEATM and ICCVAM seek

to promote the validation and regulatory

acceptance of new test methods that

will enhance agencies’ abilities to assess

risks, and that will refine, reduce, and

replace animal use. NICEATM and

ICCVAM collaborate to carry out

activities associated with the

development, validation, and regulatory

acceptance of proposed new and

improved test methods. These activities

may include:

Independent Peer Review Panel

Meetings, which are typically convened

following the completion of

comprehensive validation studies on a

test method. Independent peer review

has been determined to be an essential

prerequisite for consideration of a test

method for regulatory acceptance. Peer

Review Panels are asked to develop

scientific consensus on the usefulness

and limitations of test methods to

generate information for specific human

health and/or ecological risk assessment

purposes. Following the independent

peer review of a test method, ICCVAM

forwards recommendations on their

usefulness to agencies for their

consideration. Federal agencies then

determine the regulatory acceptability of

a method according to their mandates.

Expert Panel Meetings, which are

typically convened to evaluate the

validation status of a method following

the completion of initial development

and pre-validation studies. An Expert

Panel is asked to recommend additional

validation studies that might be helpful

in further characterizing the usefulness

of a method and to identify any

additional research and development

efforts that might enhance the

effectiveness of a method.

Test Method Workshops, which are

convened, as needed, to evaluate the

adequacy of current methods for

assessing specific toxicities, to identify

areas in need of improved or new

testing methods, to identify research

efforts that may be needed to develop

new test methods, and to identify

appropriate development and validation

activities for proposed new methods.

Agenda

The agenda topic is the scientific peer

review evaluation of the validation

status of the revised Up-and-Down

Procedure (UDP). This procedure is an

updated version of the Organization for

Economic Cooperation and

Development (OECD) Test Guideline

425 (OECD Guideline for the Testing of

Chemicals, Acute Oral Toxicity: Upand-Down Procedure. Guideline 425,

adopted September 21, 1998, OECD,

Paris, France, http://www.oecd.org/ehs/

test). The revised UDP is proposed as a

substitute for the existing OECD Test

Guideline 401 (OECD Guideline for the

Testing of Chemicals, Acute Oral

Toxicity, Guideline 401, adopted

February 24, 1987, OECD, Paris,

France). OECD has proposed that

Guideline 401 should be deleted since

three alternative methods are now

available [OECD Document ENV/JM (99)

19, Test Guidelines Programme, Acute

Oral Toxicity Testing: Data Needs and

Animal Welfare Considerations, 29th

Joint Meeting, June 8–11, 1999, Paris,

France]. Prior to deletion of Guideline

401, U.S. agencies have requested that

ICCVAM conduct an independent peer

review of the revised UDP to determine

the validity of the method as a

substitute for Guideline 401. An

Independent Peer Review Panel will (1)

evaluate the extent to which established

validation and acceptance criteria

(‘‘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

No. 97–3981, http://

ntpserver.niehs.nih.gov/htdocs/

ICCVAM/iccvam.html) have been

addressed, and (2) will provide

conclusions and recommendations

regarding the usefulness and limitations

of the method as a substitute for the

traditional acute oral toxicity test

method (OECD Guideline 401, 1987).

The UDP has the potential to reduce the

number of animals required to classify

chemicals for acute oral toxicity

compared to Guideline 401. A request

for nominations of expert scientists for

the Panel was previously published (FR

65, 8385–8386, February 18, 2000).

The meeting will begin at 8:30 a.m. on

July 25 and will conclude by 5 p.m.

There will be a brief orientation on

ICCVAM and the ICCVAM review

process, followed by a peer review of

the revised UDP and supporting

35110 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

information. The Peer Review Panel will

discuss the usefulness of the UDP as an

alternative to the traditional LD50

methods currently accepted by

government regulatory authorities for

the assessment of acute oral toxicity

potential of chemicals.

Background Document Available for

Comment

NICEATM has prepared a Background

Review Document that includes the

revised UDP protocol and documents

supporting the basis and validity of the

test method. Copies of the Up-andDown Procedure Background Review

Document and supporting

documentation may be obtained from

NICEATM, MD EC–17, P.O. Box 12233,

Research Triangle Park, NC, 27709,

Phone: 919–541–3398, Fax: 919–541–

0947, E-mail: ICCVAM@niehs.nih.gov. A

copy of the Background Review

Document and comments submitted

will be available for viewing Monday

through Friday, from 12 noon to 4 p.m.

EST at the U. S. Environmental

Protection Agency, Office of Prevention,

Pesticides and Toxic Substances, NonConfidential Information Center, Room

607B, Northeast Mall, 401 M Street, SW,

Washington, DC 20460. Thirty days

prior to the meeting, a detailed agenda

will be available on the web at: http://

iccvam.niehs.nih.gov or by contacting

NICEATM.

Persons requesting additional

information regarding the rationale for

the OECD proposal to delete the OECD

Guideline 401 can contact William T.

Meyer, U.S. Environmental Protection

Agency, Office of Pesticide Programs,

Phone: 703–305–7188; E-mail:

Meyer,WilliamT@epa.gov. Mail address:

Ariel Rios Bldg., 1200 Pennsylvania

Ave., NW, Mail Code 7506C,

Washington, DC 20460; Federal Express

address: 1921 Jefferson Davis Highway,

Room 1104H, Arlington, VA 22202.

Request for Comments

NICEATM invites the submission of

written comments on the revised Upand-Down Procedure, and submission of

other available information and data on

the UDP, including information about

completed, ongoing, or planned studies.

Written comments and additional

information should include name,

affiliation, mailing address, phone, fax,

e-mail and sponsoring organization (if

any), and should be sent by mail, fax,

or e-mail to NICEATM at the address

listed above. Comments may be

submitted anytime before the meeting;

however, comments should be

submitted by June 15 in order to ensure

time for adequate review by the Panel.

Written comments will be made

available to the Peer Review Panel

members, ICCVAM agency

representatives and experts, and

attendees at the meeting and will be

included in the resource materials

assembled on the UDP.

The Expert Panel Meeting will be

open to the public, and time will be

provided for presentation of public oral

comments at designated times during

the meeting. Speakers will be assigned

on a first-come, first-serve basis and up

to seven minutes will be allotted to each

speaker. In order to facilitate planning,

members of the public who wish to

present oral statements at the meeting

should contact NICEATM as soon as

possible, but no later than July 18, 2000.

Persons registering to make comments

are asked to provide, if possible, a

written copy of their statement in

advance so that copies can be made and

distributed to the Peer Review Panel

members for their timely consideration

prior to the meeting. Written statements

can supplement and expand the oral

presentation, and each speaker is asked

to provide his/her name, affiliation,

mailing address, phone, fax, e-mail and

supporting organization (if any).

Registration for making public

comments will also be available on-site.

If registering on-site to speak and

reading oral comments from printed

copy, the speaker is asked to bring 50

copies of the text. These copies will be

distributed to the Panel and supplement

the record.

Summary minutes from the meeting

and the final report from the Peer

Review Panel will be prepared and

made available upon request to

NICEATM (address provided above).

These documents will also be made

available via the internet at the website:

http://iccvam.niehs.nih.gov.

Additional information about

ICCVAM and NICEATM can be found at

the website:http://iccvam.niehs.nih.gov.

Dated: May 22, 2000.

Samuel H. Wilson,

Deputy Director, National Institute of

Environmental Health Sciences.

[FR Doc. 00–13734 Filed 5–31–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4563–N–06]

Notice of Proposed Information

Collection for Tenant Opportunities

Semi-Annual Report

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments Due Date: July 31,

2000.

ADDRESSES: Interested Persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control number and should be sent to:

Mildred M. Hamman, Reports Liaison

Officer, Public and Indian Housing,

Department of Housing and Urban

Development, 451 7th Street, SW, Room

4238, Washington, DC 20410–5000.

FOR FURTHER INFORMATION CONTACT:

Mildred M. Hamman, (202) 708–3642,

extension 4128, for copies of the

proposed forms and other available

documents. (This is not a toll-free

number).

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).

This Notice is soliciting comments

from members of the public and affected

agencies concerning the proposed

collection of information to: (1) Evaluate

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

agency, including whether the

information will have practical utility;

(2) evaluate the accuracy of the agency’s

estimate of the burden of the proposed

collection of information; (3) enhance

the quality, utility, and clarity of the

information to be collected; and (4)

minimize the burden of the collection of

information on those who are to

respond, including through the use of

appropriate automated collection

techniques or other forms of information

technology; e.g., permitting electronic

submission of responses.

This Notice also lists the following

information:

Title of Proposal: Tenant

Opportunities Semi-Annual Report.

OMB Control Number: 2577–0087.

Description of the need for the

information and proposed use: Grantees

participating in TOP are required to

submit Semiannual Report (Form HUD–

52370), which will evaluate the progress

in carrying out the approved TOP

workplan/budget. Grantees shall submit

the report on a semiannual basis for the