[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