Advisory Committees; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Advisory Committees; Notice of Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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.

MEETINGS: The following advisory committee meetings are announced:

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory

Committee

Date, time, and place. September 1 and 2, 1994, 8:30 a.m., Parklawn

Bldg., conference rms. G, H, and I, 5600 Fishers Lane, Rockville, MD. A

limited number of overnight accommodations have been reserved at the

Holiday Inn Crowne Plaza, 1750 Rockville Pike, Rockville, MD. Attendees

requiring overnight accommodations may contact the hotel at 301-468-

1100 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, September

1, 1994, 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 3:30 p.m.;

closed presentation of data, 3:30 p.m. to 5:30 p.m.; open public

hearing, September 2, 1994, 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 4:30 p.m.; Colin M. Pollard, Center for Devices and

Radiological Health (HFZ-470), Food and Drug Administration, 1390

Piccard Dr., Rockville, MD 20850, 301-594-1180.

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 August 29, 1994, 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 September 1, 1994, the committee will

discuss general issues relating to devices to aid breast self exams. On

September 2, 1994, the committee will discuss general issues relating

to home uterine activity monitors.

Closed presentation of data. On September 1, 1994, the committee

will discuss trade secret and/or confidential commercial information

regarding various medical devices used in obstetrics and gynecology

that are currently being evaluated by FDA. This portion of the meeting

will be closed to permit discussion of this information (5 U.S.C.

552b(c)(4)).

Anesthesiology and Respiratory Therapy Devices Panel of the Medical

Devices Advisory Committee

Date, time, and place. September 2, 1994, 10 a.m., Holiday Inn

Crowne Plaza, Plaza III Ballroom, 1750 Rockville Pike, Rockville, MD. A

limited number of overnight accommodations have been reserved at the

Holiday Inn Crowne Plaza. Attendees requiring overnight accommodations

may contact the hotel at 301-468-1100 and reference the FDA Panel

meeting block. Reservations will be confirmed at the group rate based

on availability.

Type of meeting and contact person. Closed committee deliberations,

10 a.m. to 1 p.m.; open public hearing, 1 p.m. to 2:30 p.m., unless

public participation does not last that long; open committee

discussion, 2:30 p.m. to 4:30 p.m.; Michael G. Bazaral, Center for

Devices and Radiological Health (HFZ-450), Food and Drug

Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-594-2623.

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 August 29, 1994, 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 revision to

the guidance document for clinical data to support premarket

notification for apnea monitors.

Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information regarding present and

future device applications. This portion of the meeting will be closed

to permit discussion of this information (5 U.S.C. 552b(c)(4)).

Oncologic Drugs Advisory Committee

Date, time, and place. September 12, 1994, 8 a.m., Parklawn Bldg.,

conference rms. D and E, 5600 Fishers Lane, Rockville, MD.

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 12 m.; closed committee deliberations,

12 m. to 4:30 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.

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 September 2, 1994, 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: (1) New drug

application (NDA) 20-452, Photofrin (Sterile Porfimer Sodium,

QLT Phototherapeutics, Inc.), ``for the reduction of obstruction and

palliation of dysphagia in patients with completely or partially

obstructing esophageal cancer.''

Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information relevant to

investigational new drug applications 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)).

Neurological Devices Panel of the Medical Devices Advisory Committee

Date, time, and place. September 16, 1994, 9:45 a.m., Piccard

Bldg., conference rm. 100, 1390 Piccard Dr., Rockville, MD.

Type of meeting and contact person. Open committee discussion, 9:45

a.m. to 10:15 a.m.; open public hearing, 10:15 a.m. to 11:15 a.m.,

unless public participation does not last that long; open committee

discussion, 11:15 a.m. to 1:30 p.m.; closed committee deliberations,

1:30 p.m. to 4 p.m.; Levering Keely, Center for Devices and

Radiological Health (HFZ-450), Food and Drug Administration, 1390

Piccard Dr., Rockville, MD 20850, 301-594-1523.

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 September 2, 1994, 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 proposed

guidance for biocompatibility of implanted neurological devices and the

clinical utility of electroencephalograph devices.

Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information regarding present and

future FDA issues. This portion of the meeting will be closed to permit

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

General and Plastic Surgery Devices Panel of the Medical Devices

Advisory Committee

Date, time, and place. September 21, 1994, 8 a.m., Holiday Inn--

Gaithersburg, Whetstone Rm., Two Montgomery Village Ave., Gaithersburg,

MD. A limited number of overnight accommodations have been blocked 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 a.m. to

9 a.m., unless public participation does not last that long; open

committee discussion, 9 a.m. to 1 p.m.; closed committee deliberations,

1 p.m. to 5 p.m.; Daniel G. Schultz, Center for Devices and

Radiological Health (HFZ-410), Food and Drug Administration, 1390

Piccard Dr., Rockville, MD 20850, 301-594-2092.

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 September 2, 1994, 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 following

draft guidance documents: (1) Electrosurgical devices, (2) medical

lasers, (3) noninteractive wound and burn dressing, (4) interactive

wound and burn dressing, and (5) sun protective clothing. Single copies

of the draft guidance documents are available from the Division of

Small Manufacturers Assistance, Center for Devices and Radiological

Health (HFZ-220), Food and Drug Administration, 5600 Fishers Lane,

Rockville, MD 20857, 800-638-2041 or 301-443-6597.

Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information regarding issues

related to new technologies currently under review. This portion of the

meeting will be closed to permit discussion of this information (5

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

Joint Meeting of the Clinical Chemistry and Clinical Toxicology Devices

Panel and the Microbiology Devices Panel of the Medical Devices

Advisory Committee

Date, time, and place. September 22, 1994, 1 p.m., and September

23, 1994, 9 a.m., Holiday Inn--Gaithersburg, Whetstone/Walker Rms., Two

Montgomery Village Ave., Gaithersburg, MD. A limited number of

overnight accommodations have been blocked 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. Closed committee deliberations,

September 22, 1994, 1 p.m. to 5 p.m.; open public hearing, September

23, 1994, 9 a.m. to 10 a.m., unless public participation does not last

that long; open committee discussion, 10 a.m. to 6 p.m.; Cornelia B.

Rooks or Freddie M. Poole, Center for Devices and Radiological Health

(HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville,

MD 20850, 301-594-1243 or 594-2096.

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 September 8, 1994, 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 use of

alternate matrices: saliva, sweat, tears, hair, etc., for in vitro

diagnostic devices, and replacement reagents for devices already

cleared by the 510(k) process or approved by premarket approval

application. In addition, the committee will discuss a draft document:

``Points to Consider for Collection of Data in Support of In Vitro

Diagnostic Device Submissions for 510(k)'s.'' These documents will be

available at the meeting.

Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information regarding pending or

future device submissions. This portion of the meeting will be closed

to permit discussion of this information (5 U.S.C. 552b(c)(4)).

Dermatologic Drugs Advisory Committee

Date, time, and place. September 22 and 23, 1994, 8:30 a.m.,

Parklawn Bldg., conference rms. D and E, 5600 Fishers Lane, Rockville,

MD.

Type of meeting and contact person. Closed committee deliberations,

September 22, 1994, 8:30 a.m. to 12 m.; open committee discussion, 12

m. to 1 p.m.; open public hearing, 1 p.m. to 2 p.m., unless public

participation does not last that long; open committee discussion, 2

p.m. to 5 p.m.; open committee discussion, September 23, 1994, 8:30

a.m. to 12 m.; Ermona B. McGoodwin or Valerie M. Mealy, Center for Drug

Evaluation and Research (HFD-9), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-443-5455.

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 treatment of dermatologic

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 September 16, 1994, 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 onychomycosis

and determination of endpoints for clinical trials investigating

treatment of onychomycosis.

Closed committee deliberations. On September 22, 1994, the

committee will discuss trade secret and/or confidential commercial

information relevant to pending investigational new drug applications.

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 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 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: August 10, 1994.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 94-19984 Filed 8-15-94; 8:45 am]

BILLING CODE 4160-01-F