[Federal Register Volume 60, Number 54 (Tuesday, March 21, 1995)]
[Notices]
[Pages 14950-14952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7069]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Committee Meetings; 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 meeting of the Nonprescription Drugs
Advisory Committee. This meeting was announced in the Federal Register
of February 17, 1995 (60 FR 9335 at 9336). The amendment is being made
to announce the cancellation of the joint session with the Dermatologic
and Ophthalmic Drugs Advisory Committee; the cancellation of the
session with [[Page 14951]] Pulmonary-Allergy Drugs Advisory Committee
representation; the addition of joint sessions with the
Gastrointestinal Drugs Advisory Committee and the Arthritis Advisory
Committee; the addition of closed sessions to the agenda and consequent
adjustment in times; and the correction of the new drug application
(NDA) number announced under open committee discussion scheduled for
March 28, 1995. 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 Liz Ortuzar,
Center for Drug Evaluation and Research (HFD-9), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455,
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Nonprescription Drugs Advisory
Committee, code 12541.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 17,
1995, FDA announced that the Nonprescription Drugs Advisory Committee
would hold a joint meeting with the Dermatologic and Ophthalmic Drugs
Advisory Committee, followed by a session with the Pulmonary-Allergy
Drugs Advisory Committee representation, and a joint meeting with the
Arthritis Advisory Committee on March 27 and 28, 1995.
On page 9336, in column 2, the ``Date, time, and place'' portion of
this meeting is amended as follows:
Date, time, and place. March 27, 1995, 1 p.m., and March 28, 1995,
8 a. m., Parklawn Bldg., conference rooms D and E, 5600 Fishers Lane,
Rockville, MD.
On page 9336, in column 2, the ``Type of meeting and contact
person'' portion of this meeting is amended as follows:
Type of meeting and contact person. Open committee discussion,
March 27, 1995, 1 p.m. to 3 p.m.; open public hearing, 3 p.m. to 3:30
p.m., unless public participation does not last that long; open
committee discussion, 3:30 p.m. to 5 p.m.; closed committee
deliberations for the Nonprescription Drugs Advisory Committee only, 5
p.m. to 6 p.m.; open committee discussion, March 28, 1995, 8 a.m. to
11:30 a.m.; open public hearing, 11:30 a.m. to 12 m., unless public
participation does not last that long; joint closed committee
deliberations, 12 m. to 12:30 p.m.; open committee discussion, 12:30
p.m. to 4 p.m.; Lee L. Zwanziger or Liz Ortuzar, Center for Drug
Evaluation and Research (HFD-9), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Nonprescription Drugs Advisory Committee, code
12541.
On page 9336, in column 2, the ``General function of the
committees'' portion is amended as follows:
General function of the committees. The Nonprescription Drugs
Advisory Committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (nonprescription) human
drug products for use in the treatment of a broad spectrum of human
symptoms and diseases. 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.
The Arthritis Advisory Committee reviews and evaluates data on the
safety and effectiveness of marketed and investigational human drugs
for use in arthritic conditions.
On page 9336, in column 3, the ``Open committee discussion''
portion is amended as follows:
Open committee discussion. On March 27, 1995, the Nonprescription
Drugs Advisory Committee and the Gastrointestinal Drugs Advisory
Committee will discuss SmithKline Beecham's NDA 20-238 for over-the-
counter (OTC) Tagamet (cimetidine) tablets for the treatment
of heartburn. On the morning of March 28, 1995, the Nonprescription
Drugs Advisory Committee and the Arthritis Advisory Committee will
discuss data relevant to NDA 20-516 for ibuprofen suspension
(Motrin, McNeil Consumer Products) for the treatment of fever
and of pain in children between 2 and 12 years of age. On the afternoon
of March 28, 1995, the Nonprescription Drugs Advisory Committee and the
Arthritis Advisory Committee will discuss recommendations regarding
appropriate OTC indication(s) for muscle relaxants, OTC dose(s) and
duration of use, safety profiles, abuse potential, and pharmacokinetic
information.
After the ``Open committee discussion'' portion, a ``Closed
committee deliberations'' portion is added as follows:
Closed committee deliberations. On March 27 and 28, 1995, the
committees will discuss trade secret and/or confidential commercial
information relevant to pending investigational new drug applications.
These portions 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 [[Page 14952]] 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: March 16, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-7069 Filed 3-17-95; 3:46 pm]
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