[Federal Register Volume 59, Number 207 (Thursday, October 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26672]
[[Page Unknown]]
[Federal Register: October 27, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Committee Meeting; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of the joint meeting of the Nonprescription
Drugs and the Pulmonary-Allergy Drugs Advisory Committees, which was
announced in the Federal Register of July 7, 1994 (59 FR 34847). The
amendment is being made to add an additional topic to the agenda of the
open session and to add a closed session for the Nonprescription Drugs
Advisory Committee. There are no other changes. This amendment will be
announced at the beginning of the open portion of the meeting.
FOR FURTHER INFORMATION CONTACT: Lee L. Zwanziger or Leander B. Madoo,
Center for Drug Evaluation and Research (HFD-9), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 7, 1994, FDA
announced that a joint meeting of the Nonprescription Drugs and the
Pulmonary-Allergy Drugs Advisory Committees would be held on November
14, 1994, to be extended to November 15, 1994, if sufficient interest
in participation was expressed. On page 34847, in column 1, the ``Type
of meeting and contact person'' portion of the meeting is amended as
follows:
Type of meeting and contact person. Open committee discussion,
November 14, 1994, 8:30 a.m. to 4 p.m.; open public hearing, 4 p.m. to
5 p.m., unless public participation does not last that long; closed
committee deliberations for Nonprescription Drugs Advisory Committee
only, 5 p.m. to 5:30 p.m.; open committee discussion, November 15,
1994, 8:30 a.m. to 4 p.m.; Lee L. Zwanziger or Leander B. Madoo, Center
for Drug Evaluation and Research (HFD-9), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-443-4695.
On page 34847, in column 2, the ``Open committee discussion''
portion of this meeting is amended as follows:
Open committee discussion. On November 14, 1994, possibly extended
to November 15, 1994, the committees will jointly discuss over-the-
counter (OTC) drug products for the treatment of asthma and will
address topics such as: (1) OTC bronchodilator drug products currently
available and possible pending changes in their marketing status; (2)
whether there is a population for which OTC antiasthma drug products
are appropriate; (3) the general question of whether antiasthma drug
products should be available OTC; (4) antiasthma drug products
currently available by prescription only that could be considered for
OTC status; and (5) data requirements necessary to support conversion
of prescription antiasthma drug products to OTC status. Public comments
are available for inspection in docket no. 94N-0232 at the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. If the meeting is extended to
November 15, 1994, the committees will hear a report by FDA personnel
of a meta-analysis of data on the use of antihistamines in the common
cold.
After the ``open committee discussion'' portion, a ``closed
committee deliberations'' portion is added as follows:
Closed committee deliberations. The Nonprescription Drugs Advisory
Committee will discuss trade secret and/or confidential commercial
information relevant to pending investigational new drug applications.
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: October 20, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-26672 Filed 10-26-94; 8:45 am]
BILLING CODE 4160-01-F
