Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices 37405

concerns. The tentative program

follows:

Wednesday, September 23, 1998

Opening Comments

The NIEHS—Dr. Carl Barrett, National

Institute of Environmental Health

Sciences

The National Toxicology Program—Dr.

George Lucier, National Institute of

Environmental Health Sciences

Comments from NIH Office of Dietary

Supplements—Dr. Bernadette

Marriott, National Institutes of

Health

DHHS Office of Disease Prevention and

Health Promotion—Dr. Kenneth D.

Fisher, Dept. of Health & Human

Services

Society for the Advancement of

Women’s Health Research—Ms.

Phyllis Greenberger, Society for the

Advancement of Women’s Health

Research

Keynote Speaker: ‘‘Science, Politics,

Public Opinion and Herbal Dietary

Supplements’’—Dr. Norman B.

Farnsworth, University of Illinois,

Chicago

Session I: Benefits and Risks Associated

with the Use of Medicinal Herbs—

Dr. H.B. Matthews, (Session

Moderator)

Commonly Used Medicinal Herbs in the

United States—Mr. Mark

Blumenthal, American Botanical

Council

Ranking Possible Toxic and

Carcinogenic Hazards of Natural

and Synthetic Chemicals—Dr. Lois

Gold, Lawrence Berkeley National

Laboratory

USP Panel on the Identification and

Standardization of Natural

Products—Dr. V. Srini Srinivasan,

U.S. Pharmacopoeia

Session II: International Research on the

Efficacy and Safety of Dietary

Supplements and Medicinal Herbs

Worldwide—Dr. Bernadette

Marriott (Session Moderator)

Research of Medicinal Herbs in

Germany—Dr. Prof. Hildebert

Wagner, Institute for

Pharmaceutical Biologie

Ancient-Modern Concordance in

Ayurvedic Medicinal Plants—Dr.

Sukh Dev, New Friends Colony,

India

Medicinal Herbs in Japan—Prof. Yutaka

Sashida, Tokyo Pharmaceutical

University

Open Discussion & Public Comment

Thursday, September 24, 1998

Session III: Research on Medicinal

Herbs and Dietary Supplements in

the U.S.—Dr. Norman Farnsworth

(Session Moderator)

Methodology and Testing to Insure

Product Content and Quality—Dr.

Joe Betz & Dr. William Obermeyer,

Food & Drug Administration

Research on Dietary Supplements: An

Industry Perspective—Loren D.

Israelsen, Utah Natural Products

Alliance

Current Research Programs of the U.S.

Dietary Supplement Industry—Dr.

Jill Ellis, National Nutritional Foods

Association

Session IV: Panel Discussion on

Research Needs to Assure Safety of

Medicinal Herbs and Dietary

Supplements in the U.S.—Dr.

Kenneth D. Fisher (Session

Moderator)

Dr. Bernadette Marriott, Director, NIH

Office of Dietary Supplements

Dr. Wayne B. Jonas, Director, NIH Office

of Alternative Medicine

Dr. Linda D. Meyers, Deputy Director for

Science and Nutrition DHHS, Office

of Disease Prevention and Nutrition

Dr. Elizabeth A. Yetley, Director, Office

of Special Nutrition, US FDA

Mr. Loren Israelsen, Executive Director,

Utah Natural Products Alliance

Dr. Jill Ellis, Scientific Director, NNFA

Dr. Rossanne M. Philen, Chief

Environmental Hazards

Epidemiology Section, NCEH

Mr. David Schardt, Associate

Nutritionist, Center for Science in

the Public Interest

Session V: Open Discussion on Research

Needs to Assure Safety of Medicinal

Herbs and Dietary Supplements in

the U.S.—Dr. H.B. Matthews

(Session Moderator)

Workshop Adjourns

Co-sponsors for the workshop include

National Institutes of Health’s Office of

Dietary Supplements and National

Institute of Environmental Health

Sciences; the Department of Health and

Human Services National Toxicology

Program and Office of Disease

Prevention and Health Promotion; the

Food and Drug Administration’s Office

of Special Nutrition and the Society for

the Advancement of Women’s Health

Research.

The meeting is open to the public,

limited only by space available. The

program includes time for open

discussion. In addition time will be

allotted to persons wishing to make oral

comments. Those wishing to speak are

encouraged to pre-register. The time

allotted for each presenter will be

dependent on the number of speakers.

To register, please submit the

following: name, address, institutional

affiliation, department, address, city,

state, phone, fax and email address to

Jaime Edge, NIEHS, P.O. Box 12233,

Research Triangle Park, NC 27709 (fax:

919–541–0295 or email to

edge@niehs.nih.gov.

For further information on the

meeting plans contact Dr. Matthews at

(919) 541–3252; for any other

information on the workshop contact

Alma Britton (919) 541–0530; Fax

(919)–541–0295 or email:

britton@niehs.nih.gov.

Dated: June 30, 1998.

Kenneth Olden,

Director, National Institute of Environmental

Health Sciences.

[FR Doc. 98–18319 Filed 7–9–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

National Institute of Environmental

Health Sciences (NIEHS); Notice of

Meeting to Review the Murine Local

Lymph Node Assay (LLNA) as an

Alternative Test Method for Contact

Hypersensitivity; Request for

Comments

SUMMARY: Pursuant to Public Law 103–

43, notice is hereby given of a public

meeting sponsored by the NIEHS and

the National Toxicology Program (NTP),

and 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 (NTP Center).

The agenda topic is the scientific peer

review of the murine local lymph node

assay (LLNA), which is proposed as an

alternative toxicological test method for

assessing contact hypersensitivity

(allergic contact dermatitis) potential of

chemicals and products. The meeting

will be held on September 17, 1998, at

the Gaithersburg Hilton, 620 Perry

Parkway, Gaithersburg, Maryland. The

meeting will take place from 8:30 a.m.

to 4:30 p.m. and is open to the public.

Background

Public Law 103–43 directed the

NIEHS to develop and validate

alternative methods that can reduce or

eliminate the use of animals in acute or

chronic toxicity testing, establish

criteria for the validation and regulatory

acceptance of alternative testing

methods, and 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 13

other Federal agencies and programs
37406 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices

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 Interagency Coordinating

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. An Interagency

Coordinating Committee on the

Validation of Alternative Methods

(ICCVAM) was subsequently established

in a collaborative effort by NIEHS and

13 other Federal regulatory and research

agencies and programs. 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 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 LLNA was proposed to the

ICCVAM for consideration as a standalone test to identify chemicals that

have a potential to cause contact

hypersensitivity (allergic contact

dermatitis). An ICCVAM

Immunotoxicity Working Group

composed of Federal employees

determined that there was sufficient

information available to merit an

independent scientific peer review of

the LLNA test method. Peer review has

been determined to be an essential

prerequisite for consideration of a

method for regulatory acceptance. The

peer review panel will be charged with

developing a scientific consensus on the

usefulness of the test method to generate

information for various human health

risk assessment purposes. Following

evaluation at this peer review meeting,

the proposed test method and results of

the peer review will be forwarded by

ICCVAM to Federal agencies for

consideration. Federal agencies will

determine the regulatory acceptability of

a method according to their mandates.

Agenda

There will be a brief orientation on

the ICCVAM and the ICCVAM review

process, followed by peer review of the

proposed LLNA test method and

supporting information. The peer

review panel will discuss the usefulness

of the LLNA as an alternative to test

methods currently accepted by

government regulatory authorities for

the assessment of the contact

hypersensitivity potential of chemicals

and products. Copies of the proposed

LLNA Test Method Protocol and

supporting documentation may be

obtained from the NTP Center for the

Evaluation of Alternative Toxicological

Methods, MD EC–17, P.O. Box 12233,

Research Triangle Park, NC, 27709

(919–541–3398), FAX (919–541–0947),

e-mail: ICCVAM@niehs.nih.gov. The

LLNA test method documents and

copies of written public comments can

also be viewed at the Documents

Management Branch, Food and Drug

Administration, 5630 Fishers Lane,

Room 1061, Rockville, MD, 20852 on

Monday through Friday from 9:00 a.m.

to 4:00 p.m.

Public Comment

The NTP Center invites the

submission of written comments on the

proposed LLNA test method, and other

available information regarding the

usefulness of the LLNA, including

information about completed, ongoing,

or planned studies. Written comments

and additional information should be

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

Center at the address listed above by

August 14th. Written comments will be

made available to the peer review panel

members, ICCVAM agency

representatives and experts, and will be

made available for attendees at the

meeting. Members of the public who

wish to present oral statements at the

meeting should also contact the NTP

Center as soon as possible, but not later

than September 11, 1998. Speakers will

be assigned on a first-come, first-serve

basis and will be limited to a maximum

of five minutes in presentation length.

Written comments accompanying the

oral statement should be submitted in

advance so that copies can be made and

distributed to the peer panel members.

The NTP Center will furnish an

agenda and a roster of peer review panel

members just prior to the meeting.

Summary minutes and a final report of

the LLNA peer review meeting will be

available subsequent to the meeting

upon request to the Center. Persons

needing special assistance, such as sign

language interpretation or other special

accommodations should contact the

NTP Center as described above.

Dated: June 30, 1998.

Kenneth Olden,

Director, National Toxicology Program.

[FR Doc. 98–18320 Filed 7–9–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4341–N–18]

Federal Property Suitable as Facilities

to Assist the Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

EFFECTIVE DATE: July 10, 1998.

FOR FURTHER INFORMATION CONTACT:

Mark Johnston, Department of Housing

and Urban Development, Room 7256,

451 Seventh Street SW, Washington, DC

20410; telephone (202) 708–1226; TTY

number for the hearing- and speechimpaired (202) 708–2565, (these

telephone numbers are not toll-free), or

call the toll-free Title V information line

at 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with the December 12, 1998

court order in National Coalition for the

Homeless v. Veterans Administration,

No. 88–2503–OG (D.D.C.), HUD

publishes a Notice, on a weekly basis,

identifying unutilized, underutilized,

excess and surplus Federal buildings

and real property that HUD has

reviewed for suitability for use to assist

the homeless. Today’s Notice is for the

purpose of announcing that no

additional properties have been

determined suitable or unsuitable this

week.

Dated: July 2, 1998.

Fred Karnas, Jr.,

Deputy Assistant Secretary for Economic

Development.

[FR Doc. 98–18049 Filed 7–9–98; 8:45 am]

BILLING CODE 4210–29–M