[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]
BILLING CODE 4160-01-F