62906 Federal Register / Vol. 69, No. 208 / Thursday, October 28, 2004 / Notices 

in advance of the meeting. The meeting 

will be closed to the public as indicated 

below in accordance with the provisions 

set forth in section 552b(c)(6), Title 

U.S.C., as amended for the review, 

discussion, and evaluation of individual 

intramural programs and projects 

conducted by the National Institute of 

Diabetes and Digestive and Kidney 

Diseases, including consideration of 

personnel qualifications and 

performance, and the competence of 

individual investigators, the disclosure 

of which would constitute a clearly 

unwarranted invasion of personal 

privacy.

Name of Committee: Board of Scientific 

Counselors, NIDDK. 

Date: November 29–December 1, 2004. 

Open: November 29, 2004, 6 p.m. to 6:30 

p.m. 

Agenda: Introductions and Overview. 

Place: National Institutes of Health, 

Building 5, Room 127, Bethesda, MD 20892. 

Closed: November 29, 2004, 6:30 p.m. to 

adjournment. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 5, Room 127, Bethesda, MD 20892. 

Closed: November 30, 2004, 8 a.m. to 

adjournment. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 5, Room 127, Bethesda, MD 20892. 

Closed: December 1, 2004, 8 a.m. to 

adjournment. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 5, Room 127, Bethesda, MD 20892. 

Contact Person: Marvin C Gershengorn, 

MD, Scientific Director, Division of 

Intramural Research, National Institute of 

Diabetes and Digestive and Kidney Diseases, 

National Institutes of Health, 9000 Rockville 

Pike, Bldg. 10, Rm. 9N222, Bethesda, MD 

20892, (301) 496–4129. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

into the building by non-government 

employees. Persons without a government 

I.D. will need to show a photo I.D. and signin at the security desk upon entering the 

building.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research; National Institutes 

of Health, HHS)

Dated: October 21, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–24087 Filed 10–27–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Public Health Service 

National Toxicology Program; The 

National Toxicology Program (NTP) 

Center for the Evaluation of Risks to 

Human Reproduction (CERHR), 

Announces Availability of Draft Expert 

Panel Reports on Amphetamines and 

Methylphenidate and Expert Panel 

Meeting; Requests Public Comments 

on the Draft Reports 

Summary 

The NTP CERHR announces: 

(1) The availability of sections 1–4 of 

the draft expert panel reports for 

amphetamines and methylphenidate on 

November 15, 2004. Written public 

comments on the draft report must be 

received by December 29, 2004. 

(2) The expert panel meeting for 

amphetamines and methylphenidate 

will be held on January 10–12, 2005, at 

the Holiday Inn Old Town Select 

Alexandria, Virginia. The public is 

invited to present oral comments at this 

meeting. 

Questions and public comments 

should be directed to Dr. Michael 

Shelby, CERHR Director (contact 

information below). 

Draft Expert Panel Reports on 

Amphetamines and Methylphenidate 

Available 

The CERHR announces the 

availability of the draft expert panel 

reports on amphetamines and 

methylphenidate on November 15, 2004 

on the CERHR Web site (http://

cerhr.niehs.nih.gov) or in printed text 

from the CERHR (contact information 

below). Amphetamines and 

methamphetamine are central nervous 

system stimulants. Amphetamine is 

indicated for the treatment of 

narcolepsy and attention deficit 

hyperactivity disorder (ADHD), and 

methamphetamine is indicated for the 

treatment of ADHD and for short-term 

treatment of obesity. These chemicals 

are available for pharmaceutical use as 

various salts and enantiomer 

preparations. The most common 

proprietary amphetamine preparation is 

Adderall, a mixture of d- and lamphetamine salts in a 3:1 ratio. dMethamphetamine is used in 

pharmaceutical preparations in the 

United States and is also manufactured 

and used as an illicit drug. 

Methylphenidate (CAS RN 298–59–9) is 

a central nervous system stimulant 

approved by the Food and Drug 

Administration for the treatment of 

ADHD and narcolepsy in persons six 

years and older. d, l-Methylphenidate is 

marketed under the names Ritalin, 

Metadate, Methylin, and Concerta. 

The d-enantiomer is marketed under the 

name FocalinTM. The CERHR selected 

amphetamines and methylphenidate for 

expert panel evaluation because of 

widespread usage in children, 

availability of developmental studies in 

children and experimental animals, and 

public concern about the effects of these 

stimulants on child development. 

Each draft expert panel report has the 

following sections:

1.0 Chemistry, Use, and Human 

Exposure 

2.0 General Toxicological and 

Biological Effects 

3.0 Developmental Toxicity Data 

4.0 Reproductive Toxicity Data 

5.0 Summary, Conclusions, and 

Critical Data Needs (to be prepared at 

expert panel meeting)

Sections 1–4 will be available to the 

public by the November 15th in PDF 

format on the CERHR Web site (http://

cerhr.niehs.nih.gov) or in hard copy or 

as a PDF file on compact disk by 

contacting Dr. Michael Shelby, Director 

CERHR [NIEHS, 79 T.W. Alexander 

Drive, Building 4401, Room 103, PO 

Box 12233, MD EC–32, Research 

Triangle Park, NC 27709, telephone: 

(919) 541–3455; facsimile: (919) 316–

4511; shelby@niehs.nih.gov]. 

Request for Written Comments on Draft 

Expert Panel Report 

The CERHR (invites written public 

comments on sections 1–4 of the draft 

expert panel reports on amphetamines 

and methylphenidate. Comments can be 

submitted in hard copy or electronic 

format and must be received by the 

CERHR on or before December 29, 2004. 

Any comments received by this date 

will be posted on the CERHR Web site 

prior to the meeting and distributed to 

the expert panel and CERHR staff for 

their consideration in revising the draft 

reports and in preparing for the expert 

panel meeting. Written comments 

should be sent to Dr. Michael Shelby at 

the address provided above. Persons 

submitting written comments are asked 

to include their name and contact 

information (affiliation, mailing address, 

telephone and facsimile numbers, email, and sponsoring organization, if 

any). 

Expert Panel Meeting Planned 

The CERHR will hold an expert panel 

meeting January 10–12, 2005, at the 

Holiday Inn Old Town Select 480 King 

Street, Alexandria, VA 22314 

(telephone: 703–549–6080, facsimile: 

703–684–6508). The expert panel will 

review the scientific evidence regarding

Federal Register / Vol. 69, No. 208 / Thursday, October 28, 2004 / Notices 62907

the potential reproductive and/or 

developmental toxicity associated with 

exposure to amphetamines and 

methylphenidate. The expert panel will 

review and revise the draft expert panel 

report and reach conclusions regarding 

whether exposure to amphetamines 

and/or methylphenidate is a hazard to 

human development or reproduction. 

The expert panel will also identify data 

gaps and research needs. 

This meeting is open to the public 

and attendance is limited only by the 

available meeting room space. The 

meeting will begin at 8:30 a.m. each 

day. On January 10 and 11, it is 

anticipated that a lunch break will occur 

from noon–1 p.m. and the meeting will 

adjourn 5–6 p.m. The meeting is 

expected to adjourn by noon on January 

12; however, adjournment may occur 

earlier or later depending upon the time 

needed by the expert panel to complete 

its work. Anticipated agenda topics for 

each day are listed below. Following the 

expert panel meeting and completion of 

the expert panel report, the CERHR will 

post the report on its web site and 

solicit public comment on it through a 

Federal Register notice.

Preliminary Meeting Agenda 

Meeting begins at 8:30 am each day 

Lunch break anticipated from noon–1 

p.m. 

January 10, 2005

Opening remarks 

Oral public comments (7 minutes per 

speaker; one representative per group, 

see below) 

Review of sections 1–4 of the draft 

expert panel reports on amphetamines 

and methylphenidate 

Discussion of Section 5.0 Summary, 

Conclusions, and Critical Data Needs 

January 11, 2005

Discussion of Section 5.0 Summary, 

Conclusions, and Critical Data Needs 

Preparation of draft summaries and 

conclusion statements 

January 12, 2005

Presentation, discussion of, and 

agreement on summaries and 

conclusions 

Closing comments 

Oral Public Comments Welcome at 

Expert Panel Meeting 

Time is set-aside on January 10, 2005, 

for the presentation of oral public 

comments at the expert panel meeting. 

To facilitate planning, those persons 

wishing to make oral public comments 

are asked to contact Dr. Shelby by 

January 5 (contact information provided 

above). Seven minutes will be available 

for each speaker (one speaker per 

organization). When registering to 

comment orally, please provide your 

name, affiliation, mailing address, 

telephone and facsimile numbers, email 

and sponsoring organization (if any). If 

possible, also send a copy of the 

statement or talking points to Dr. Shelby 

by January 5. This statement will be 

provided to the expert panel to assist 

them in identifying issues for discussion 

and will be noted in the meeting record. 

Registration for presentation of oral 

comments will also be available at the 

meeting on January 10, 2005 from 7:30–

8:30 a.m. Those persons registering at 

the meeting are asked to bring 20 copies 

of their statement or talking points for 

distribution to the expert panel and for 

the record. 

Amphetamines and Methylphenidate 

Expert Panel 

The CERHR expert panel is composed 

of independent scientists selected for 

their scientific expertise in reproductive 

and/or developmental toxicology and 

other areas of science relevant for this 

review. 

Expert Panel Members and Affiliation 

Mari S. Golub, Ph.D., Chair, University 

of California, Davis, CA 

Lucio G. Costa, Ph.D., University of 

Washington, Seattle, WA 

Kevin M. Crofton, Ph.D., U.S. 

Environmental Protection Agency 

Research, Triangle Park, NC 

Deborah A. Frank, M.D., Boston Medical 

Center, Boston, MA 

Peter A. Fried, Ph.D., Carleton 

University, Ottawa, Ontario, Canada 

Beth C. Gladen, Ph.D., National Institute 

of Environmental Health Sciences 

Research, Triangle Park, NC 

Rogene F. Henderson, Ph.D., Lovelace 

Respiratory Research Institute, 

Albuquerque, NM 

Erica L. Liebelt, M.D., University of 

Alabama School of Medicine, 

Birmingham, AL 

Shari I. Lusskin, M.D., New York 

University School of Medicine, New 

York, NY 

M. Sue (Pahl) Marty, Ph.D., The Dow 

Chemical Company, Midland, MI 

Andrew S. Rowland, Ph.D., University 

of New Mexico, Albuquerque, NM 

John Vincent Scialli, M.D., Consultant & 

Private Practice, Phoenix, AZ 

Mary Vore, Ph.D., University of 

Kentucky, Lexington, KY 

Background Information About the 

CERHR 

The NTP established the NTP CERHR 

in June 1998 [Federal Register, 

December 14, 1998 (Volume 63, Number 

239, page 68782)]. The CERHR is a 

publicly accessible resource for 

information about adverse reproductive 

and/or developmental health effects 

associated with exposure to 

environmental and/or occupational 

exposures. Expert panels conduct 

scientific evaluations of agents selected 

by the CERHR in public forums. 

The CERHR invites the nomination of 

agents for review or scientists for its 

expert registry. Information about 

CERHR and the nomination process can 

be obtained from its homepage (http://

cerhr.niehs.nih.gov) or by contacting Dr. 

Shelby (contact information provided 

above). The CERHR selects chemicals 

for evaluation based upon several 

factors including production volume, 

extent of human exposure, public 

concern, and published evidence of 

reproductive or developmental toxicity. 

CERHR follows a formal, multi-step 

process for review and evaluation of 

selected chemicals. The formal 

evaluation process was published in the 

Federal Register notice July 16, 2001 

(Volume 66, Number 136, pages 37047–

37048) and is available on the CERHR 

web site under ‘‘About CERHR’’ or in 

printed copy from the CERHR.

Dated: October 18, 2004. 

Samuel H. Wilson, 

Deputy Director, National Institute of 

Environmental Health Sciences.

[FR Doc. 04–24088 Filed 10–27–04; 8:45 am] 

BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

U.S. Fire Administration Policy and 

Program Advisory Board

AGENCY: Federal Emergency 

Management Agency, Emergency 

Preparedness and Response Directorate, 

Department of Homeland Security.

ACTION: Committee management: Notice 

of committee establishment. 

SUMMARY: The Secretary of the 

Department of Homeland Security has 

determined that the establishment of the 

U.S. Fire Administration Policy and 

Program Advisory Board is necessary 

and in the public interest in connection 

with the performance of duties of the 

Under Secretary of the Emergency 

Preparedness and Response Directorate. 

This determination follows consultation 

with the Committee Management 

Secretariat, General Services 

Administration.