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.

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 [[Page 19404]] will be updated when such changes are made.

MEETINGS: The following advisory committee meetings are announced:

Microbiology Devices Panel of the Medical Devices Advisory Committee

Date, time, and place. May 1, 1995, 9:45 a.m., and May 2, 1995,

8:45 a.m., Holiday Inn--Gaithersburg, Walker and Whetstone Rooms, 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, May 1,

1995, 9:45 a.m. to 10:45 a.m., unless public participation does not

last that long; open committee discussion, 10:45 a.m. to 6:30 p.m.;

open public hearing, May 2, 1995, 8:45 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.; closed presentation of data, 11:30 a.m. to 12:30

p.m.; open committee discussion, 12:30 p.m. to 6:30 p.m.; Freddie M.

Poole, Center for Devices and Radiological Health (HFZ-440), Food and

Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 30l-594-

2096, or FDA Advisory Committee Information Hotline, 1-800-741-8138

(301-443-0572 in the Washington, DC area), Microbiology Devices Panel,

code 12517.

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 April 25, 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 May 1, 1995, the committee will

discuss a premarket approval application (PMA) for an in vitro

diagnostic device intended for use in the determination of anti-

neoplastic resistance to tumor cells with specific chemotherapeutic

agents. On May 2, 1995, the committee will discuss a PMA for an in

vitro diagnostic, target-amplified nucleic acid device for the

detection of Mycobacterium tuberculosis complex in sediments prepared

from sputum (induced or expectorated), bronchial specimens, or tracheal

specimens.

Closed presentation of data. On May 2, 1995, the committee will

discuss trade secret and/or confidential commercial information

regarding the target-amplified nucleic acid device for the detection of

Mycobacterium tuberculosis complex. This portion of the meeting will be

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

FDA is giving less than 15 days public notice of the Microbiology

Devices Panel of the Medical Devices Advisory Committee meeting. The

agency decided that it is in the public interest to hold this meeting

May 1 and 2, 1995, even if there was not sufficient time for the

customary 15-day public notice.

Science Advisory Board to the National Center for Toxicological

Research

Date, time, and place. May 9, 1995, 8:30 a.m., Bldg. 12,

conference room, National Center for Toxicological Research, Jefferson,

AR.

Type of meeting and contact person. Open committee discussion,

8:30 a.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 4 p.m.; closed committee deliberations, 4 p.m. to

5 p.m.; Ronald F. Coene, National Center for Toxicological Research

(HFT-10), Food and Drug Administration, 5600 Fishers Lane, Rockville,

MD 20857, 301-443-3155, or FDA Advisory Committee Information Hotline,

1-800-741-8138 (301-443-0572 in the Washington, DC area), Science

Advisory Board to the National Center for Toxicological Research, code

12559.

General function of the board. The board advises on establishment

and implementation of a research program that will assist the

Commissioner of Food and Drugs to fulfill regulatory responsibilities.

Agenda--Open public hearing. Any interested persons may present

data, information, or views, orally or in writing, on issues pending

before the committee. Those desiring to make a formal presentation

should notify the contact person before April 21, 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 requested to make their comments.

Open board discussion. The board will conduct a review of the

Science Advisory Board's (SAB's) Site Visit Team draft report on the

Analytical Methods Development Program, engage in discussions on this

report, and come to a final conclusion on the recommendations to be

made to the Director concerning this center program. The center will

provide progress reports on the recommendations of previously reviewed

research programs: (1) The Transgenics Program, and (2) Biochemical and

Molecular Markers of Cancer Program. The center will also provide a

review and examination of the process and the product of the Site Visit

Teams over the past 3 years, and develop a future agenda for the SAB. A

final agenda will be available on May 4, 1995, from the contact person.

Closed board deliberations. The board will discuss personal

information concerning individuals associated with these review

programs, disclosure of which would constitute a clearly unwarranted

invasion of personal privacy. This portion of the meeting will be

closed to permit discussion of this information (5 U.S.C. 552b(c)(6)).

The Commissioner approves the scheduling of meetings at locations

outside of the Washington, DC, area on the basis of the criteria of 21

CFR 14.22 of FDA's regulations relating to public advisory committees.

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 [[Page 19405]] 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: April 13, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95-9576 Filed 4-13-95; 4:14 pm]

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