[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