[Federal Register Volume 59, Number 38 (Friday, February 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4290]


[[Page Unknown]]

[Federal Register: February 25, 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:
Anti-Infective Drugs Advisory Committee
    Date, time, and place. March 17 and 18, 1994, 8:30 a.m., Plaza 
Ballroom, Holiday Inn, 8777 Georgia Ave., Silver Spring, MD.
    Type of meeting and contact person. Open public hearing, March 17, 
1994, 8:30 a.m. to 9:30 a.m., unless public participation does not last 
that long; closed committee deliberations, 9:30 a.m. to 4:30 p.m.; open 
committee discussion, March 18, 1994, 8:30 a.m. to 3 p.m.; Ermona B. 
McGoodwin or Mary Elizabeth Donahue, Center for Drug Evaluation and 
Research (HFD-9), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-5455.
    General function of the committee. The committee reviews and 
evaluates data relating to the safety and effectiveness of marketed and 
investigational human drugs for use in infectious and ophthalmic 
disorders.
    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 March 11, 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.
    Closed committee deliberations. On March 17, 1994, the committee 
will review trade secret and/or confidential commercial information. 
This portion of the meeting will be closed to permit discussion of this 
information (5 U.S.C. 552b(c)(4)). .
    Open committee discussion. On March 18, 1994, the committee will 
discuss new drug applications (NDA's) 20-266 and 20-271, 
Megalone (fleroxacin), Hoffmann-La Roche, Inc., tablets and 
injection, for treatment of specific infections.
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
    Date, time, and place. March 21 and 22, 1994, 8:30 a.m., Versailles 
Ballroom IV, Holiday Inn, 8120 Wisconsin Ave., Bethesda, MD.
    Type of meeting and contact person. Open public hearing, March 21, 
1994, 8:30 a.m. to 10 a.m., unless public participation does not last 
that long; closed committee deliberations, 10 a.m. to 11 a.m.; open 
committee discussion, 11 a.m. to 5 p.m.; open public hearing, March 22, 
1994, 8:30 a.m. to 10 a.m., unless public participation does not last 
that long; open committee discussion, 10 a.m. to 5 p.m.; Daniel W. C. 
Brown, Center for Devices and Radiological Health (HFZ-460), Food and 
Drug Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-594-
1744.
    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 March 4, 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 March 21, 1994, the committee will 
discuss general issues relating to the review of premarket approval 
applications (PMA's) for phototherapeutic keratectomy excimer lasers. 
There will be brief updates on surgical/laser issues. On March 22, 
1994, the committee will: (1) Hear presentations and have discussions 
on labeling issues regarding the ``A'' constant for power calculation 
for intraocular lenses; (2) be provided with an update on the status of 
daily wear contact lens reclassification; (3) discuss the comments 
received on the November 1993 guidance entitled ``Premarket 
Notification (510(k)) Guidance Document for Daily Wear Contact 
Lenses''; and (4) be provided with an update on policy initiatives on 
contact lenses. In addition, the period for public comment on the 
November 1993 guidance has been extended until February 15, 1994.
    Closed committee deliberations. The committee may discuss trade 
secret and/or confidential commercial information relevant to PMA's for 
contact lenses, surgical and diagnostic devices, or intraocular lenses. 
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: February 17, 1994.
 Jane E. Henney,
 Deputy Commissioner for Operations.
[FR Doc. 94-4290 Filed 2-24-94; 8:45 am]
BILLING CODE 4160-01-F