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

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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:

Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Date, time, and place. January 22, 1996, 9:30 a.m., Holiday Inn--

Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD. A limited

number of overnight accommodations have been reserved at the hotel.

Attendees requiring overnight accommodations may contact the hotel at

301-948-8900 or 1-800-465-4329 and reference the FDA Panel meeting

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

availability. Attendees with a disability requiring special

accommodations should contact Sociometrics, Inc., 8300 Colesville Rd.,

suite 550, Silver Spring, MD 20910, 301-608-2151. The availability of

appropriate accommodations cannot be assured unless prior notification

is received.

Type of meeting and contact person. Open public hearing, 9:30 a.m.

to 10:30 a.m., unless public participation does not last that long;

open committee discussion, 10:30 a.m. to 1:30 p.m.; closed presentation

of data, 1:30 p.m. to 5:30 p.m.; Sara M. Thornton, Center for Devices

and Radiological Health (HFZ-460), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850, 301-594-2053, or FDA Advisory

Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the

Washington, DC area), Ophthalmic Devices Panel, code 12396.

-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 December 29, 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 review and recommend

the classification status for currently unclassified devices which may

include lacrimal system plugs, lacrimal system repair devices, and

scleral plugs. The Intraocular and Corneal Implants Branch will request

committee discussion on the clinical annex of the draft American

National Standards Institute (ANSI) standard for glaucoma drainage

devices.

-Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information relevant to

investigational device exemption applications and premarket approval

applications for vitreo-retinal, surgical, and diagnostic devices,

intraocular and corneal implants, and contact lenses. This portion of

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

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

Microbiology Devices Panel of the Medical Devices Advisory Committee

-Date, time, and place. January 25, 1996, 9:45 a.m., and January

26, 1996, 8:45 a.m., Gaithersburg Hilton, Grand Ballroom, 620 Perry

Pkwy., Gaithersburg, MD. A limited number of overnight accommodations

have been reserved at the Gaithersburg Hilton. Attendees requiring

overnight accommodations may contact the hotel at 301-977-8900 and

reference the FDA Panel meeting block. Reservations will be confirmed

at the group rate based on availability. Attendees with a disability

requiring special accommodations should contact Sociometrics, Inc.,

8300 Colesville Rd., suite 550, Silver Spring, MD 20910, 301-608-2151.

The availability of appropriate accommodations cannot be assured unless

prior notification is received.

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

25, 1996, 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.;

closed committee deliberations, January 26, 1996, 8:45 a.m. to 9:45

a.m.; open public hearing, 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 5 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 January 10, 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 25, 1996, the committee will

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

diagnostic, target-amplified nucleic acid device for the detection of

Mycobacterium tuberculosis complex in digested, decontaminated human

respiratory specimens. On January 26, 1996, the committee will discuss

issues concerning the accuracy of commercially available serological

kits for the detection of human anti-Toxoplasma IgM and anti-Borrelia

borgdorferi antibodies in relation to their indication for use.

-Closed committee deliberations. On January 26, 1996, FDA staff

will present to the committee trade secret and/or confidential

commercial information regarding pending and future device submissions.

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

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

Science Advisory Board to the National Center for Toxicological

Research

-Date, time, and place. January 29, 1996, 1 p.m., and January 30,

1996, 9 a.m., Bldg. 12, conference room, National Center for

Toxicological Research, Jefferson, AR.

-Type of meeting and contact person. Open board discussion, January

29, 1996, 1 p.m. to 4:30 p.m.; open board

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discussion, January 30, 1996, 9 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 board discussion, 2 p.m. to 3:30 p.m.; closed board deliberations,

3:30 p.m. to 4:30 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. 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 January 15, 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 board discussion. The board will be given a progress report

on its recommendation that resulted from the board's Site Visit Team

Report on the Center's Analytical Methods Development Program. The

board will be presented and asked to review the Center's integration of

the eight programs it has site visited and made recommendations. The

presentation will include a discussion of the resource allocation to

these programs as well as their relationship to the Center's strategic

vision and goals. A final agenda will be available on January 22, 1996,

from the contact person.

-Closed board deliberations. The board will discuss personal

information concerning individuals associated with the research

programs at the Center, 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)).

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

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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: December 19, 1995.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 95-31461 Filed 12-28-95; 8:45 am]

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