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:

Anti-Infective Drugs Advisory Committee

Date, time, and place. March 17 and 18, 1994, 8:30 a.m., Plaza

Ballroom, Holiday Inn, 8777 Georgia Ave., Silver Spring, MD.

Type of meeting and contact person. Open public hearing, March 17,

1994, 8:30 a.m. to 9:30 a.m., unless public participation does not last

that long; closed committee deliberations, 9:30 a.m. to 4:30 p.m.; open

committee discussion, March 18, 1994, 8:30 a.m. to 3 p.m.; Ermona B.

McGoodwin or Mary Elizabeth Donahue, 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 relating to the safety and effectiveness of marketed and

investigational human drugs for use in infectious and ophthalmic

disorders.

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 11, 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.

Closed committee deliberations. On March 17, 1994, the committee

will review trade secret and/or confidential commercial information.

This portion of the meeting will be closed to permit discussion of this

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

Open committee discussion. On March 18, 1994, the committee will

discuss new drug applications (NDA's) 20-266 and 20-271,

Megalone (fleroxacin), Hoffmann-La Roche, Inc., tablets and

injection, for treatment of specific infections.

Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Date, time, and place. March 21 and 22, 1994, 8:30 a.m., Versailles

Ballroom IV, Holiday Inn, 8120 Wisconsin Ave., Bethesda, MD.

Type of meeting and contact person. Open public hearing, March 21,

1994, 8:30 a.m. to 10 a.m., unless public participation does not last

that long; closed committee deliberations, 10 a.m. to 11 a.m.; open

committee discussion, 11 a.m. to 5 p.m.; open public hearing, March 22,

1994, 8:30 a.m. to 10 a.m., unless public participation does not last

that long; open committee discussion, 10 a.m. to 5 p.m.; Daniel W. C.

Brown, Center for Devices and Radiological Health (HFZ-460), Food and

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

1744.

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 4, 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 March 21, 1994, the committee will

discuss general issues relating to the review of premarket approval

applications (PMA's) for phototherapeutic keratectomy excimer lasers.

There will be brief updates on surgical/laser issues. On March 22,

1994, the committee will: (1) Hear presentations and have discussions

on labeling issues regarding the ``A'' constant for power calculation

for intraocular lenses; (2) be provided with an update on the status of

daily wear contact lens reclassification; (3) discuss the comments

received on the November 1993 guidance entitled ``Premarket

Notification (510(k)) Guidance Document for Daily Wear Contact

Lenses''; and (4) be provided with an update on policy initiatives on

contact lenses. In addition, the period for public comment on the

November 1993 guidance has been extended until February 15, 1994.

Closed committee deliberations. The committee may discuss trade

secret and/or confidential commercial information relevant to PMA's for

contact lenses, surgical and diagnostic devices, or intraocular lenses.

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: February 17, 1994.

Jane E. Henney,

Deputy Commissioner for Operations.

[FR Doc. 94-4290 Filed 2-24-94; 8:45 am]

BILLING CODE 4160-01-F