27530 Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Notices

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be accepted as proof

of timely mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.(a) or

1.(b) above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicant.

Where To Obtain Additional

Information

A complete program description and

information on application procedures

are contained in the application

package. Business management

technical assistance may be obtained

from Albertha Carey, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers For Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300, Mail

Stop E–13, Atlanta, GA 30305,

telephone (404) 842–6508.

Programmatic technical assistance may

be obtained from Judy Pruden, M.Ed.,

R.D., Division of Nutrition, National

Center for Chronic Disease Prevention

and Health Promotion, Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., Mail Stop

K–26, Atlanta, GA, 30341–3724,

telephone (404) 488–4260.

Please refer to Announcement

Number 537 when requesting

information and submitting an

application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report; Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report; Stock No. 017–001–00473–1)

referenced in the ‘‘Introduction’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: May 15, 1995.

Joseph R. Carter

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC)

[FR Doc. 95–12762 Filed 5–23–95; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

Advisory Committees; Notice of

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces

forthcoming meetings of public advisory

committees of the Food and Drug

Administration (FDA). This notice also

summarizes the procedures for the

meetings and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETINGS: The following advisory

committee meetings are announced:

Oncologic Drugs Advisory Committee

Date, time, and place. June 8 and 9,

1995, 8 a.m., Parklawn Bldg., conference

rooms D and E, 5600 Fishers Lane,

Rockville, MD.

Type of meeting and contact person.

Open public hearing, June 8, 1995, 8

a.m. to 9 a.m., unless public

participation does not last that long;

open committee discussion, 9 a.m. to 5

p.m.; open committee discussion, June

9, 1995, 8 a.m. to 11:30 a.m.; closed

committee deliberations, 11:30 a.m. to 4

p.m.; Adele S. Seifried, Center for Drug

Evaluation and Research (HFD–9), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

4695, or FDA Advisory Committee

Information Hotline, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), Oncologic Drugs Advisory

Committee, code 12542.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in treatment of cancer.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before June 5, 1995, 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

required to make their comments.

Open committee discussion. On June

8, 1995, the committee will discuss: (1)

New drug application (NDA) 50–704,

Daunoxome Injection (liposomal

daunorubicin, Vestar, Inc.) ‘‘as the

primary therapy for the palliative

management of advanced, HIVassociated Kaposi’s Sarcoma,’’ and (2)

NDA 20–449, Taxotere (docetaxel,

Rhone-Poulenc Rorer), for treatment of

‘‘patients with locally advanced or

metastatic breast carcinoma in whom

previous therapy has failed; prior

therapy should have included an

anthracycline unless clinically

contraindicated.’’ On June 9, 1995, the

committee will discuss NDA 20–221,

Ethyol (amifostine injection, U.S.

Bioscience, Inc.) ‘‘as a cytoprotective

agent against the cumulative renal

toxicities associated with cisplatin and

the cumulative hematologic toxicity

associated with cyclophosphamide and

cisplatin in patients with advanced

solid tumors of non-germ cell origin.’’

Closed committee deliberations. On

June 9, 1995, the committee will discuss

trade secret and/or confidential

commercial information relevant to

investigational new drugs (IND’s) and

pending NDA’s. This portion of the

meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Orthopedic and Rehabilitation Devices

Panel of the Medical Devices Advisory

Committee

Date, time, and place. June 12, 1995,

8:30 a.m., Holiday Inn—Gaithersburg,

Ballroom, Two Montgomery Village

Ave., Gaithersburg, MD. A limited

number of overnight accommodations

have been reserved at the Holiday Inn—

Gaithersburg. Attendees requiring

overnight accommodations may contact

the hotel at 301–948–8900 and reference

the FDA panel meeting block.

Reservations will be confirmed at the

group rate based on availability.

Type of meeting and contact person.

Open public hearing, 8:30 a.m. to 9 a.m.,

unless public participation does not last

that long; open committee discussion, 9

a.m. to 12 m.; closed committee

deliberations, 12 m. to 1:30 p.m.; open

public hearing, 1:30 p.m. to 2 p.m.,

unless public participation does not last

that long; open committee discussion, 2

p.m. to 5 p.m.; Paula J. Wilkerson,
Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Notices 27531

Center for Devices and Radiological

Health (HFZ–410), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2036, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Orthopedic and Rehabilitation Panel,

code 12521.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational devices

and makes recommendations for their

regulation.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before June 1, 1995, 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

required to make their comments.

Open committee discussion. The

committee will discuss general issues

relating to a premarket approval

application for a total knee replacement

device. The committee will also hear an

FDA presentation on conditions of

approval and the gathering of long-term

data. The afternoon session will include

presentations and committee discussion

on hip replacement systems. Speakers

will examine components of clinical

protocol design including: Medical and

clinical aspects, rating systems, patient

selection, controls, and statistical

considerations.

Closed committee deliberations. The

committee will discuss trade secret and/

or confidential commercial information

relating to orthopedic devices. This

portion of the meeting will be closed to

permit discussion of this information (5

U.S.C. 552b(c)(4)).

Blood Products Advisory Committee

Date, time, and place. June 23, 1995,

8 a.m., Marriott—Bethesda,

Congressional Salons I, II, and III, 5151

Pooks Hill Rd., Bethesda, MD.

Type of meeting and contact person.

Open committee discussion, 8 a.m. to

10:45 a.m.; open public hearing, 10:45

a.m. to 11:45 a.m., unless public

participation does not last that long;

open committee discussion, 11:45 a.m.

to 3 p.m.; closed committee

deliberations, 3 p.m. to 3:30 p.m.; Linda

A. Smallwood, Center for Biologics

Evaluation and Research (HFM–350),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–6700, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Blood Products

Advisory Committee, code 12388.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness, and

appropriate use of blood products

intended for use in the diagnosis,

prevention, or treatment of human

diseases.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before June 12, 1995, 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

required to make their comments.

Open committee discussion. In the

morning, the committee will discuss

and provide recommendations on

human immunodeficiency virus (HIV)

antigen screening of blood donors. In

the afternoon, the committee will

discuss and review the report of the

intramural research site visit of the

Laboratory of Cellular Hematology,

Division of Hematology, Office of Blood

Research and Review, Center for

Biologics Evaluation and Research.

Closed committee deliberations. The

committee will discuss the intramural

scientific program. This portion of the

meeting will be closed to prevent

disclosure of personal information

concerning individuals associated with

the research program, a disclosure of

which would constitute a clearly

unwarranted invasion of personal

privacy (5 U.S.C. 552b(c)(6)).

Each public advisory committee

meeting listed above may have as many

as four separable portions: (1) An open

public hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. The dates and times reserved

for the separate portions of each

committee meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits
27532 Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Notices

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.

Dated: May 17, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–12661 Filed 5–23–95; 8:45 am]

BILLING CODE 4160–01–F

Office of Inspector General

Program Exclusions: April 1995

AGENCY: Office of Inspector General,

HHS.

ACTION: Notice of program exclusions.

During the month of April 1995, the

HHS Office of Inspector General

imposed exclusions in the cases set

forth below. When an exclusion is

imposed, no program payment is made

to anyone for any items or services

(other than an emergency item or

service not provided in a hospital

emergency room) furnished, ordered or

prescribed by an excluded party under

the Medicare, Medicaid, Maternal and

Child Health Services Block Grant and

Block Grants to States for Social

Services programs. In addition, no

program payment is made to any

business or facility, e.g., a hospital, that

submits bills for payment for items or

services provided by an excluded party.

Program beneficiaries remain free to

decide for themselves whether they will

continue to use the services of an

excluded party even though no program

payments will be made for items and

services provided by that excluded

party. The exclusions have national

effect and also apply to all other Federal

non-procurement programs.

Subject, City, State Effective

Date

Program-Related Convictions

Appel, Neal G, Brick, NJ ......................................................................................................................................................................... 05/07/95

Bessette, Marcia F, Somerset, MA ......................................................................................................................................................... 05/04/95

Campbell, Rose, Lubec, ME .................................................................................................................................................................... 05/04/95

Campis, Eva B, Miami Beach, FL. .......................................................................................................................................................... 05/09/95

Casey, Kathleen M, Monson, MA ............................................................................................................................................................ 05/04/95

Chaudhry, Baber Z, Metairie, LA ............................................................................................................................................................. 05/07/95

Curtis, Marianne, Costa Mesa, CA .......................................................................................................................................................... 05/04/95

Doshi, Bhupendrakumar, Brooklyn, NY ................................................................................................................................................... 05/07/95

Ehrlich, Leah L, Fort Collins, CA ............................................................................................................................................................. 05/04/95

Garcia, Jose A, Miami, FL ....................................................................................................................................................................... 05/09/95

Garrigo, Luis E, Miami, FL ...................................................................................................................................................................... 05/09/95

Gomez, Jose M, Miami, FL ..................................................................................................................................................................... 05/09/95

Goss, Louis, Montgomery, PA ................................................................................................................................................................. 05/07/95

Health Careers, Inc., North Wales, PA ................................................................................................................................................... 05/09/95

Kheang, Rithik, Ontario, CA .................................................................................................................................................................... 05/04/95

McAfee, Robert W, Firebaugh, CA .......................................................................................................................................................... 05/04/95

McDermott, Robert T, Easton, PA ........................................................................................................................................................... 05/09/95

Mom’s Taxi Corp, Carmel, NY ................................................................................................................................................................ 05/07/95

Muhammad, Bilal, I, Fremont, CA ........................................................................................................................................................... 05/04/95

Nnamdie, Oku J, Miami, FL ..................................................................................................................................................................... 05/09/95

Raggi, Mindi, North Wales, PA ................................................................................................................................................................ 05/09/95

Recovery Management Corp. III, Newport News, VA ............................................................................................................................. 05/11/95

Rodriguez-Suarez, Mercedes, FL ............................................................................................................................................................ 05/09/95

Tan, Teresita V, Brooklyn, NY ................................................................................................................................................................. 05/07/95

Vallen, Jerry, Carmel, NY ........................................................................................................................................................................ 05/07/95

Waters, Larry E, Canal Point, FL ............................................................................................................................................................ 05/04/95

Patient Abuse/Neglect Convictions

Araujo, Maria, Medford, MA .................................................................................................................................................................... 05/04/95