Federal Register / Vol. 66, No. 115 / Thursday, June 14, 2001 / Notices 32359

SUMMARY: Notice is hereby given that a

noncompetitive grant award is being

made to the University of Hawaii to

develop a virtual Data Center for

Children and Families that contains the

most comprehensive collection of data

and information on Hawaii’s children

and families. As a Congressional

setaside, this one-year project is being

funded noncompetitively. The cost of

this one-year project is $100,000.

FOR FURTHER INFORMATION CONTACT: K.A.

Jagannathan, Administration for

Children and Families, Office of

Planning, Research and Evaluation, 370

L’Enfant Promenade, SW., Washington,

DC 20447, Phone: 202–205–4829.

Dated: June 7, 2001.

Howard Rolston,

Director, Office of Planning, Research and

Evaluation.

[FR Doc. 01–15032 Filed 6–13–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

A Conversation About Cancer Drug

Development With Cancer Patient

Advocates

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration

(FDA) is announcing the following

meeting: A Conversation About Cancer

Drug Development With Cancer Patient

Advocates. The topics to be discussed

are: Fast track, compassionate use,

quality of life, the Patient Consultant

Program, and other issues as they arise.

Date and Time: The meeting will be

held on June 29, 2001, 2 p.m. to 4 p.m.

Location: The meeting will be held at

the Westin Fairfax Hotel, Whitehall

Room, 2100 Massachusetts Ave. NW.,

Washington, DC 20008, 202–293–2100.

Contacts: Patricia C. Delaney and

JoAnn M. Minor, Office of Special

Health Issues, Cancer Liaison Program,

Office of International and Constituent

Relations, Office of the Commissioner,

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–4460, FAX: 301–443–4555, or

e-mail: pdelaney@oc.fda.gov and

jminor@oc.fda.gov.

Registration: Send registration

information (including name, title, firm

name, address, telephone, fax number

and/or e-mail address) to either contact

person by June 22, 2001.

If you need special accommodations

due to a disability, please contact

Patricia C. Delaney or JoAnn M. Minor

at least 7 days in advance.

Dated: June 8, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–14930 Filed 6–13–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee for

Pharmaceutical Science; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Advisory

Committee for Pharmaceutical Science.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 19, 2001, from 8:30 a.m. to

5:30 p.m. and July 20, 2001, from 8:30

a.m. to 3 p.m.

Location: Center for Drug Evaluation

and Research Advisory Committee

conference room 1066, 5630 Fishers

Lane, Rockville, MD.

Contact: Nancy Chamberlin, Center

for Drug Evaluation and Research (HFD–

21), Food and Drug Administration,

5600 Fishers Lane (for express delivery,

5630 Fishers Lane, rm. 1076), Rockville,

MD 20857, 301–827–7001, or e-mail:

CHAMBERLINN@cder.fda.gov, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12539.

Please call the Information Line for upto-date information on this meeting.

Agenda: On July 19, 2001, the

committee will: (1) Discuss specific

recommendations of the Orally Inhaled

and Nasal Drug Products Subcommittee

regarding dose response of locally acting

nasal sprays and nasal aerosols, with

particular application to bioequivalence

studies; (2) hear reports and provide

direction to the Nonclinical Studies

Subcommittee; (3) provide comments

and advice to the Risk-Based Chemistry,

Manufacturing, and Controls Review

Working Group for establishment of a

list of low risk drugs; (4) discuss and

provide direction on optimal

applications of inline process controls

in pharmaceutical production; and (5)

discuss problems and provide

comments to form a scientific basis for

establishment of acceptance limits for

microbiological tests that use newly

developed technologies that do not rely

on colony counts, and their application

as process controls and product release

criteria. On July 20, 2001, the committee

will: (1) Provide comments and advice

on methods to determine drug transfer

into breast milk and interpretation of

data; and (2) discuss and provide

comments on the feasibility, scientific

challenges, and approaches for

establishment of pharmaceutical

equivalence, bioavailability, and

bioequivalence of liposome drug

products.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 12, 2001. Oral

presentations from the public will be

scheduled between approximately 1:15

p.m. to 2:15 p.m. on July 19, 2001, and

between approximately 10:15 a.m. to

11:15 a.m. on July 20, 2001. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before July 12, 2001, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 6, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–14928 Filed 6–13–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Orally Inhaled and Nasal Drug

Products Subcommittee of the

Advisory Committee for

Pharmaceutical Science; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration