[Federal Register Volume 60, Number 160 (Friday, August 18, 1995)]
[Notices]
[Pages 43158-43160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20460]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: This notice announces a forthcoming meeting of a public
advisory committee of the Food and Drug Administration (FDA). This
notice also summarizes the procedures for the meeting 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
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,
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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.
MEETING: The following advisory committee meeting is announced:
Anesthesiology and Respiratory Therapy Devices Panel of the Medical
Devices Advisory Committee
Date, time, and place. September 8, 1995, 8 a.m., Corporate Bldg.,
rm. 20B, 9200 Corporate Blvd., Rockville, MD. A limited number of
overnight accommodations have been reserved at the Marriott
Washingtonian Hotel, 9751 Washingtonian Blvd., Gaithersburg, MD.
Attendees requiring overnight accommodations may contact the hotel at
301-590-0044 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 Ed
Rugenstein, Sociometrics, Inc., 301-608-2151. The availability of
appropriate accommodations cannot be assured unless prior written
notification is received.
Type of meeting and contact person. Closed committee deliberations,
8 a.m. to 9 a.m.; open public hearing, 9 a.m. to 11 a.m., unless public
participation does not last that long; open committee discussion, 11
a.m. to 4:30 p.m.; Michael Bazaral, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-443-8609, or the FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), Anesthesiology and Respiratory Therapy Devices Panel, code
12624.
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 August 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 hear presentations
and discuss a draft guidance document for data to support premarket
notification submissions for ventilators, including both conventional
positive pressure ventilators and positive pressure ventilators which
function using a continually open exhalation port associated with the
patient mask or other patient connection.
Single copies of the draft guidance document are available from the
contact person for this meeting. Copies may also be obtained through
the Division of Small Manufacturer's Assistance; requests should
reference document 500. For delivery by mail, fax requests to Les Grams
at 301-443-8818 (include mailing address). Copies are available from
Facts on Demand (1-800-899-0311) and are available from the Electronic
Docket via terminal or personal computer (1-800-252-1366); to receive
detailed instructions for requesting electronic transmission (including
fax), fax a request for !BP__DSMA.FAX to Geoffrey Clark at 301-443-
8818.
Closed committee deliberations. FDA staff will present to the
committee trade secret and/or confidential commercial information
regarding present and future FDA issues. 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.
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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: August 10, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-20460 Filed 8-17-95; 8:45 am]
BILLING CODE 4160-01-F
