Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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:

Circulatory System Devices Panel of the Medical Devices Advisory

Committee

Date, time and place. January 29, 1996, 8:30 a.m., rm. 020B, 9200

Corporate Blvd, Rockville, MD. Attendees with a disability requiring

special accommodations should contact Ed Rugenstein, Sociometrics,

Inc., 301-608-2151.

Type of meeting and contact person. Open public hearing, January

29, 1996, 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 1:30 p.m.;

Ramiah Subramanian Center for Devices and Radiological Health (HFZ-

450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD

20850, 301-443-8320, or FDA Advisory Committee Information Hotline, 1-

800-741-8138 (301-443-0572 in the Washington, D.C. area), Circulatory

System Devices Panel, code 12625.

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,

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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 January 24, 1996, 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 January 29, 1996, the committee will

discuss clinical data requirements (experimental designs, protocols,

quality assurance, etc.) to be incorporated in a draft guidance for

Automatic Implantable Pacer Cardioverter Defibrillator (AIPCD)

submissions. Single copies of the draft guidance document will be

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.

FDA regrets that it was unable to publish this notice 15 days prior

to the January 29, 1996, Circulatory System Devices Panel of the

Medical Devices Advisory Committee meeting. Because the agency feels

that the issue needs to be brought to public discussion urgently and

qualified members of the Advisory Panel were available at this time,

the agency decided that it was in the public interest to hold this

meeting even if there was not sufficient time for the customary 15-day

public notice.

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.

Dated: January 5, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96-470 Filed 1-11-96; 4:33 pm]

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