Federal Register / Vol. 60, No. 33 / Friday, February 17, 1995 / Notices 9335

5, 1994, CDRH approved the application

by a letter to the applicant from the

Director of the Office of Device

Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under part 12 (21

CFR part 12) of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under § 10.33(b) (21

CFR 10.33(b)). A petitioner shall

identify the form of review requested

(hearing or independent advisory

committee) and shall submit with the

petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before March 20, 1995, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: February 7, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–4057 Filed 2–16–95; 8:45 am]

BILLING CODE 4160–01–F

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:

Radiological Devices Panel of the

Medical Devices Advisory Committee

Date, time, and place. March 6, 1995,

8 a.m., Corporate Bldg., conference

room 20G, 9200 Corporate Blvd.,

Rockville, MD. A limited number of

overnight accommodations have been

reserved at the Gaithersburg Marriott

Washingtonian Center, 9751

Washingtonian Blvd., Gaithersburg, MD.

Attendees requiring overnight

accommodations may contact the hotel

at 301–590–0044 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 a.m. to 9 a.m.,

unless public participation does not last

that long; open committee discussion, 9

a.m. to 4 p.m.; Robert A. Phillips, Center

for Devices and Radiological Health

(HFZ–470), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–1212, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Radiological Devices Panel, code 12526.

If anyone who is planning to attend the

meeting will need any special assistance

as defined under the Americans with

Disabilities Act, please communicate

with the contact person.

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 March 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 clinical data

requirements (experimental designs,

protocols, quality assurance, etc.) for

digital mammography submissions.

Copies of a draft protocol are available

from the contact person.

Blood Products Advisory Committee

Date, time, and place. March 23 and

24, 1995, 8 a.m., Parklawn Bldg.,

conference rooms D and E, 5600 Fishers

Lane, Rockville, MD.

Type of meeting and contact person.

Open committee discussion, March 23,

1995, 8 a.m. to 9:30 a.m.; open public

hearing, 9:30 a.m. to 10 a.m., unless

public participation does not last that

long ; open committee discussion, 10

a.m. to 11:30 a.m.; open public hearing,

11:30 a.m. to 12 m., unless public

participation does not last that long;

open committee discussion, 12 m. to

2:30 p.m.; open public hearing, 2:30

p.m. to 3:30 p.m., unless public

participation does not last that long;

open committee discussion, 3:30 p.m. to

5:30 p.m.; open committee discussion,

March 24, 1995, 8 a.m. to 9 a.m.; open

public hearing, 9 a.m. to 10:30 a.m.,

unless public participation does not last

that long; open committee discussion,

10:30 a.m. to 5:30 p.m.; Linda A.

Smallwood, Center for Biologics
9336 Federal Register / Vol. 60, No. 33 / Friday, February 17, 1995 / Notices

Evaluation and Research (HFD–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 March 13, 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 the

morning of March 23, 1995, the

committee will discuss and provide

recommendations for warnings in the

labeling for blood products regarding

potential transmission of viral agents.

Additionally, the committee will

discuss and provide recommendations

for the format of blood container

labeling. In the afternoon, the committee

will discuss the practice of alanine

aminotransferase (ALT) testing of blood

and plasma donors, and they will

provide recommendations. On the

morning of March 24, 1995, the

committee will discuss pool size for the

manufacture of plasma products and, in

the afternoon, the committee will

participate in a workshop entitled,

‘‘Human Tissue Intended for

Transplantation and Human

Reproductive Tissue: Donor Screening

and Infectious Disease Testing.’’ The

issues to be discussed at the workshop

are: (1) Recommendations for donor

screening and infectious disease testing

needed to clarify the interim rule for

human tissue intended for

transplantation (21 CFR 1270) that

published in the Federal Register of

December 13, 1993 (58 FR 65514), (2)

draft recommendations for screening

and testing donors of human

reproductive tissue, and (3) the draft

registration form. The agency is

announcing the availability, before the

meeting, of a draft document on the

issues to be discussed at the workshop.

Requests for single copies of the draft

document may be made to the Division

of Congressional, International, and

Consumer Affairs, Center for Biologics

Evaluation and Research (HFM–11),

1401 Rockville Pike, rm. 200N,

Rockville, MD 20857, 301–594–1800.

Joint Meeting of the Nonprescription

Drugs and the Dermatologic and

Ophthalmic Drugs Advisory

Committees, Followed by a Session

with Pulmonary-Allergy Drugs

Committee Representation, and a

Joint Meeting with the Arthritis

Advisory Committee

Date, time, and place. March 27 and

28, 1995, 8 a.m., Parklawn Bldg.,

conference rooms D and E, 5600 Fishers

Lane, Rockville, MD. Elsewhere in this

issue of the Federal Register, FDA is

publishing a notice announcing a

separate meeting of the Arthritis

Advisory Committee to be held on

March 27, 1995.

Type of meeting and contact person.

Open committee discussion, March 27,

1995, 8 a.m. to 10 a.m.; open public

hearing, 10 a.m. to 10:30 a.m., unless

public participation does not last that

long; open committee discussion, 10:30

a.m. to 3 p.m., open public hearing, 3

p.m. to 3:30 p.m., unless public

participation does not last that long;

open committee discussion, 3:30 p.m. to

5:30 p.m.; open committee discussion,

March 28, 1995, 8 a.m. to 11:30 a.m.;

open public hearing, 11:30 a.m. to 12

m., unless public participation does not

last that long; open committee

discussion, 12 m. to 4 p.m.; Lee L.

Zwanziger or Liz Ortuzar, 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), Nonprescription

Drugs Advisory Committee, code 12541.

General function of the committees.

The Nonprescription Drugs Advisory

Committee reviews and evaluates

available data concerning the safety and

effectiveness of over-the-counter (OTC)

(nonprescription) human drug products

for use in the treatment of a broad

spectrum of human symptoms and

diseases. The Dermatologic and

Ophthalmic Drugs Advisory Committee

reviews and evaluates available data on

the safety and effectiveness of marketed

and investigational human drug

products for use in the treatment of

dermatologic and ophthalmic disorders.

The Pulmonary-Allergy Drugs Advisory

Committee reviews and evaluates data

on the safety and effectiveness of

marketed and investigational human

drugs for use in the treatment of

pulmonary disease and diseases with

allergic and/or immunologic

mechanisms. The Arthritis Advisory

Committee reviews and evaluates data

on the safety and effectiveness of

marketed and investigational human

drugs for use in arthritic conditions.

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 March 22, 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. During

the morning of March 27, 1995, the

Nonprescription Drugs Advisory

Committee and the Dermatologic and

Ophthalmic Drugs Advisory Committee

will discuss data relevant to new drug

application (NDA) 18–751 to switch

econazole nitrate cream 1%

(Spectazole, Johnson & Johnson

Consumer Products, Inc.) from

prescription to OTC status for the

treatment of tinea pedis (athlete’s foot).

During the afternoon of March 27, 1995,

the Nonprescription Drugs Advisory

Committee and representatives of the

Pulmonary-Allergy Drugs Advisory

Committee will discuss data relevant to

the efficacy and use of antihistamines

for the treatment of the common cold.

In the morning on March 28, 1995, the

Nonprescription Drugs Advisory

Committee and the Arthritis Drugs

Advisory Committee will discuss data

relevant to NDA 20–512 for ibuprofen

suspension (Motrin, McNeil Consumer

Products) for the treatment of fever and

of pain in children between 2 and 12

years of age. During the afternoon, the

committees will discuss

recommendations regarding appropriate

OTC indication(s) for muscle relaxants,

OTC dose(s) and duration of use, safety

profiles, abuse potential, and

pharmacokinetic information.

Subcommittee Meeting of the Antiviral

Drugs Advisory Committee on

Immunosuppressive Drugs

Date, time, and place. March 30 and

31, 1995, 8 a.m., Holiday Inn, Plaza

Ballroom, 8777 Georgia Ave., Silver

Spring, MD.

Type of meeting and contact person.

Open committee discussion, March 30,

1995, 8 a.m. to 11:30 a.m.; open public

hearing, 11:30 a.m. to 12 m., unless

public participation does not last that
Federal Register / Vol. 60, No. 33 / Friday, February 17, 1995 / Notices 9337

long; open committee discussion, 12 m.

to 6 p.m.; open committee discussion,

March 31, 1995, 8 a.m. to 11:30 a.m.;

open public hearing, 11:30 a.m. to 12

m., unless public participation does not

last that long; open committee

discussion, 12 m. to 2 p.m.; Lee L.

Zwanziger or Liz Ortuzar, 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), Antiviral Drugs

Advisory Committee, code 12531.

General function of the committee.

The committee reviews and evaluates

available data concerning the safety and

effectiveness of marketed and

investigational human drug products for

use in the treatment of acquired

immune deficiency syndrome (AIDS),

AIDS-related complex (ARC), and other

viral, fungal, and mycobacterial

infections.

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 a

contact person before March 22, 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

March 30, 1995, the subcommittee will

discuss data relevant to NDA 20–513

(250 milligrams (mg) capsules) and NDA

20–514 (500 mg tablets), for

mycophenolate mofetil (CellCept,

Syntex Laboratories, Inc.), for use in the

prophylaxis of organ rejection and

treatment of refractory organ rejection in

patients receiving allergenic renal

transplants. On March 31, 1995, the

subcommittee will discuss data relevant

to NDA 50–715 (soft gelatin capsules)

and NDA 50–716 (oral solution) for

cyclosporine microemulsion (Neoral,

Sandoz Pharmaceuticals Corp.) for

prophylaxis of organ rejection in

kidney, liver, and heart allergenic

transplants.

Immunology Devices Panel of the

Medical Devices Advisory Committee

Date, time, and place. March 31,

1995, 9 a.m., Corporate Bldg., 9200

Corporate Blvd., main conference room,

Rockville, MD.

Type of meeting and contact person.

Open public hearing, 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.; Peter E. Maxim,

Center for Devices and Radiological

Health (HFZ–440), Food and Drug

Administration, 2098 Gaither Rd.,

Rockville, MD 20850, 301–594–1293, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Immunology Devices Panel, code 12516.

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 March 15, 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 a premarket

approval application for a software

computer program to assist physicians

and laboratory professionals in the database management, calculations, and

reporting of results from quantitative

measurements of alpha-fetoprotein as an

aid in the detection of fetal open neural

tube defects.

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.
9338 Federal Register / Vol. 60, No. 33 / Friday, February 17, 1995 / Notices

Dated: February 14, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–4194 Filed 2–16–95; 8:45 am]

BILLING CODE 4160–01–F

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:

Allergenic Products Advisory

Committee

Date, time, and place. March 10,

1995, 9 a.m., Woodmont Office Complex

I, conference room 400–N, 1401

Rockville Pike, Rockville, MD.

Type of meeting and contact person.

This meeting will be held by a

telephone conference call. A speaker

telephone will be provided in the

conference room to allow public

participation in the meeting. Open

committee discussion on review of

research, 9 a.m. to 10 a.m.; closed

committee deliberations, 10 a.m. to

11:05 a.m.; open public hearing, 11:05

a.m. to 12:05 p.m., unless public

participation does not last that long;

Jack Gertzog or Sandy Salins, Center for

Biologics Evaluation and Research

(HFM–21), Food and Drug

Administration, 1401 Rockville Pike,

Bethesda, MD 20852, 301–827–0314, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Allergenic Products Advisory

Committee, code 12388.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

allergenic biological products intended

for use in the diagnosis, prevention, or

treatment of human disease.

Agenda—Open public hearing.

Interested persons requesting to present

data, information, or views, orally or in

writing, on issues pending before the

committee, should communicate with

the contact person.

Open committee discussion. The

committee will discuss the intramural

scientific program of the Laboratory of

Immunobiochemistry and the clinical

research programs of individuals in the

Division of Allergenic Products and

Parasitology.

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, disclosure of

which would constitute a clearly

unwarranted invasion of personal

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

Arthritis Advisory Committee

Date, time, and place. March 27,

1995, 8:30 a.m., Holiday Inn—Silver

Spring, Plaza Ballroom, 8777 Georgia

Ave., Silver Spring, MD. Elsewhere in

this issue of the Federal Register, FDA

is publishing a notice announcing a

joint meeting on March 28, 1995, with

the Nonprescription Drugs Advisory

Committee.

Type of meeting and contact person.

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

a.m., unless public participation does

not last that long; open committee

discussion, 9:30 a.m. to 12:30 p.m.;

closed committee deliberations, 12:30

p.m. to 5:30 p.m.; Isaac F. Roubein,

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),

Arthritis Advisory Committee, code

12532.

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 arthritic conditions.

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 March 16, 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 new drug

application (NDA) 18–922, Lodine

(etodolac) Wyeth-Ayerst Laboratories,

which is proposed for the treatment of

rheumatoid arthritis.

Closed committee deliberations. The

committee will review trade secret and/

or confidential commercial information

relevant to pending investigational new

drugs. This portion of the meeting will

be closed to permit discussion of this

information (5 U.S.C. 552b(c)(4)).

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