[Federal Register Volume 59, Number 122 (Monday, June 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15479]
[[Page Unknown]]
[Federal Register: June 27, 1994]
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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]
BILLING CODE 4160-01-F
