Federal Register / Vol. 60, No. 101 / Thursday, May 25, 1995 / Notices 27735

Dated: May 19, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–12835 Filed 5–24–95; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting 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.

MEETING: The following advisory

committee meeting is announced:

Fertility and Maternal Health Drugs

Advisory Committee With Generic

Drugs and Endocrinologic and

Metabolic Drugs Advisory Committee

Representation

Date, time, and place. July 27 and 28,

1995, 9 a.m., Parklawn Bldg., conference

rooms D and E, 5600 Fishers Lane,

Rockville, MD.

Type of meeting and contact person.

Open public hearing, July 27, 1995, 9

a.m. to 10 a.m., unless public

participation does not last that long;

open committee discussion, 10 a.m. to

5 p.m.; open committee discussion, July

28, 1995, 9 a.m. to 5 p.m.; Philip A.

Corfman, Center for Drug Evaluation

and Research (HFD–510), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

3510, or Kimberly Topper, Center for

Drug Evaluation and Research (HFD–9),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Fertility and

Maternal Health Drugs Advisory

Committee, code 12537.

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 the practice of obstetrics

and gynecology.

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 July 7, 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 the necessary

components of conjugated estrogens as

they relate to clinical efficacy of

conjugated estrogens and other estrogen

replacement drug products for approved

indications. Copies of the draft agenda

will be available June 1, 1995, from

CDER Executive Secretariat Staff (HFD–

8), Center for Drug Evaluation and

Research, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. The final agenda

will be available at the meeting.

FDA public advisory committee

meetings 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. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open 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.

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.
27736 Federal Register / Vol. 60, No. 101 / Thursday, May 25, 1995 / Notices

Dated: May 17, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–12909 Filed 5–24–95; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[OPL–005–N]

Medicare Program; June 12, 1995

Meeting of the Practicing Physicians

Advisory Council

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the Practicing Physicians Advisory

Council. This meeting is open to the

public.

DATES: The meeting is scheduled for

June 12, 1995, from 8 a.m. until 4 p.m.

e.d.t. (Additional meetings are

tentatively scheduled for September 11

and December 11, 1995.)

ADDRESSES: The meeting will be held in

Room 800, 8th Floor, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW., Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Sam

Shekar, M.D., Executive Director,

Practicing Physicians Advisory Council,

Room 435–H, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW., Washington, DC 20201, (202) 690–

7874.

SUPPLEMENTARY INFORMATION: The

Secretary of Health and Human Services

(the Secretary) is mandated by section

1868 of the Social Security Act, to

appoint a Practicing Physicians

Advisory Council (the Council) based

on nominations submitted by medical

organizations representing physicians.

The Council meets quarterly to discuss

certain proposed changes in regulations

and carrier manual instructions related

to physicians’ services, as identified by

the Secretary. To the extent feasible and

consistent with statutory deadlines, the

consultation must occur before

publication of the proposed changes.

The Council submits an annual report

on its recommendations to the Secretary

and the Administrator of the Health

Care Financing Administration not later

than December 31 of each year.

The Council consists of 15 physicians,

each of whom has submitted at least 250

claims for physicians’ services under

Medicare in the previous year. Members

of the Council include both

participating and nonparticipating

physicians, and physicians practicing in

rural and underserved urban areas. At

least 11 members must be doctors of

medicine or osteopathy authorized to

practice medicine and surgery by the

States in which they practice. Members

have been invited to serve for

overlapping 4-year terms. In accordance

with section 14 of the Federal Advisory

Committee Act, terms of more than 2

years are contingent upon the renewal

of the Council by appropriate action

before the end of the 2-year term.

The Council held its first meeting on

May 11, 1992.

The current members are: Richard

Bronfman, D.P.M.; Gary C. Dennis,

M.D.; Catalina E. Garcia, M.D.; Harvey

P. Hanlen, O.D.; Kenneth D. Hansen,

M.D.; Ardis Hoven, M.D.; Sandral

Hullett, M.D.; Jerilynn S. Kaibel, D.C.;

Marie G. Kuffner, M.D.; Marc Lowe,

M.D.; Katherine L. Markette, M.D.;

Isadore Rosenfeld, M.D.; Richard B.

Tompkins, M.D.; Kenneth M. Viste, Jr.,

M.D.; and James C. Waites, M.D. The

chairperson is Kenneth M. Viste, Jr.,

M.D.

The next meeting of the Council will

be held on June 12, 1995. The following

topics will be discussed at that meeting:

• The Office of the Inspector General

study of physician control of

nonphysician services.

• The revision of certificates of

medical necessity for durable medical

equipment.

• Medicare and Medicaid legislative

issues.

Individuals or organizations who

wish to make 5-minute oral

presentations on the above issues

should contact the Executive Director by

12:00 noon, June 2, 1995, to be

scheduled. For the name, address, and

telephone number of the Executive

Director, see the FOR FURTHER

INFORMATION CONTACT section at the

beginning of this notice. The number of

oral presentations may be limited by the

time available. A written copy of the

oral presentation should be submitted to

the Executive Director no later than

12:00 noon, June 5, 1995.

Anyone who is not scheduled to

speak may submit written comments to

the Executive Director by 12:00 noon,

June 9, 1995. The meeting is open to the

public, but attendance is limited to the

space available on a first-come basis.

(Section 1868 of the Social Security Act (42

U.S.C. 1395ee) and section 10(a) of Public

Law 92–463 (5 U.S.C. App. 2, section 10(a));

45 C.F.R. Part 11)

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: May 22, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 95–12849 Filed 5–24–95; 8:45 am]

BILLING CODE 4120–01–P

Health Resources and Services

Administration

Notification of Expiring Project Periods

for Community and Migrant Health

Centers

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice.

SUMMARY: The Health Resources and

Services Administration (HRSA)

announces that a total of 273

Community Health Center and Migrant

Health Center (C/MHC) grantees will

reach the end of their project periods

during fiscal year (FY) 1996. It is the

intent of HRSA to continue to support

health services in the areas served by

these grantees, given the need inherent

in their designation as medically

underserved, within these geographic

areas. This notice provides interested

parties the opportunity to gather

information and decide whether to

pursue Federal funding as a community

or migrant health center. During this

process, communication with Regional

Office staff is essential (see Appendix I).

DUE DATES: Current grant expiration

dates vary by grantee throughout FY

1996. Applications for competing grants

are normally due 120 days prior to the

expiration of the current grant award.

SUPPLEMENTARY INFORMATION: The C/

MHC programs are carried out currently

under the authority of Sections 330 and

329 of the Public Health Service Act.

The program regulations are codified in

Title 42 of the Code of Federal

Regulations (CFR), Parts 51c and 56.

The C/MHC programs are designed to

promote the development and operation

of community-based primary health care

service systems in medically

underserved areas for medically

underserved populations.

The list of areas for which a current

Section 329/330 grant project period

expires in FY 1996 is set forth in

Appendix II. The service areas are listed

by city and county. Detailed information

for each service area, such as census

tracts, can be obtained by contacting the

appropriate PHS regional office (see

Appendix I).

A project period is the total amount

of time for which a grant has been

programmatically approved. For

purposes of this notice, grant awards