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:

Pulmonary-Allergy Drugs Advisory Committee

Date, time, and place. July 14 and 15, 1994, 8 a.m., Parklawn

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

Type of meeting and contact person. Open committee discussion, July

14, 1994, 8 a.m. to 1:15 p.m., open public hearing, 1:15 p.m. to 2:15

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

committee discussion, 2:15 p.m to 3:30 p.m.; closed committee

deliberations, 3:30 p.m. to 4:30 p.m.; open committee discussion, July

15, 1994, 8 a.m. to 3 p.m.; Leander B. Madoo, 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 the treatment of pulmonary

disease and diseases with allergic and/or immunologic mechanisms.

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 June 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 July 14, 1994, the committee will

discuss new drug application (NDA) 20-291, Boehringer Ingelheim

Pharmaceuticals, Inc., Combivent Inhalation Aerosol:

(ipratropium bromide and albuterol sulfate) for the treatment of

bronchospasm associated with chronic obstructive pulmonary disease. The

committee will also be briefed on general points to consider for

inhalational drug product development. On July 15, 1994, the committee

will discuss: (1) NDA 20-393, Boehringer Ingelheim Pharmaceuticals,

Inc., Atrovent Nasal Spray 0.03% (ipratropium bromide) for

the symptomatic relief of rhinorrhea associated with perennial

rhinitis, and (2) NDA 20-394, Boehringer Ingelheim Pharmaceuticals,

Inc., Atrovent Nasal Spray 0.06% (ipratropium bromide) for

the symptomatic relief of rhinorrhea associated with the common cold.

Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information relevant to pending

NDA's. This portion of the meeting will be closed to permit discussion

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

Gastroenterology and Urology Devices Panel of the Medical Devices

Advisory Committee

Date, time, and place. July 14, 1994, 10 a.m., Parklawn Bldg.,

conference rm. G, 5600 Fishers Lane, Rockville, MD.

Type of meeting and contact person. Open public hearing, 10 a.m. to

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

committee discussion, 11 a.m. to 12 m.; closed committee deliberations,

12 m. to 6 p.m.; Mary J. Cornelius, Center for Devices and Radiological

Health (HFZ-470), Food and Drug Administration, 1390 Piccard Dr.,

Rockville, MD 20850, 301-594-2194.

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 July 6, 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 hear an update on the

progress of the draft guidance document for ``Premarket Testing and

Labeling for Hemodialyzers for Reuse.'' Single copies of the draft

guidance document 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, FAX 301-443-8818, or through the Electronic

Docket, 301-594-4802.

Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information regarding medical

devices. This portion of the meeting will be closed to permit

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

Orthopedic and Rehabilitation Devices Panel of the Medical Devices

Advisory Committee

Date, time, and place. July 21, 1994, 1 p.m., and July 22, 1994, 8

a.m., Gaithersburg Marriott Washingtonian Center, Grand Ballroom, 9751

Washingtonian Blvd., Gaithersburg, MD.

Type of meeting and contact person. Closed committee deliberations,

July 21, 1994, 1 p.m. to 3 p.m.; open public hearing, 3 p.m. to 4 p.m.,

unless public participation does not last that long; open committee

discussion, 4 p.m. to 5 p.m.; open public hearing, July 22, 1994, 8

a.m. to 11:30 a.m., unless public participation does not last that

long; open committee discussion, 11:30 a.m. to 5 p.m.; Paula J.

Wilkerson, 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 July 14, 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 July 21, 1994, the committee will

discuss seven orthopedic draft guidance documents on the following

topics: Absorbables, bone anchors, modular components, modified

metallic surfaces, ceramic ball hip systems, knees, and arthroscopes.

Single copies of the draft guidances 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, FAX 301-443-8818. On July 22, 1994,

the committee will discuss the current status of pedicle screw device

systems for spinal fixation.

Closed committee deliberations. On July 21, 1994, the committee

will discuss trade secret and/or confidential commercial information

relevant to pending device applications. This portion of the meeting

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

552b(c)(4)).

Gastrointestinal Drugs Advisory Committee

Date, time, and place. July 28, 1994, 9 a.m., Parklawn Bldg.,

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

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

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

committee discussion, 10 a.m. to 2 p.m.; closed committee

deliberations, 2 p.m. to 5 p.m.; Joan C. Standaert, Center for Drug

Evaluation and Research (HFD-180), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 419-259-6211, or Valerie M. Mealy,

Advisors and Consultants Staff, 301-443-4695.

General function of the committee. The Gastrointestinal Drugs

Advisory Committee reviews and evaluates data on the safety and

effectiveness of marketed and investigational human drugs for use in

gastrointestinal 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 July 20, 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 NDA 19-594

(supplement 015), Ciba-Geigy Corp., Actigall (ursodiol) for treatment

of primary biliary cirrhosis.

Closed committee deliberations. The committee will discuss trade

secret and/or confidential commercial information relevant to pending

investigational NDA's. 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: June 20, 1994.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 94-15479 Filed 6-24-94; 8:45 am]

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