[Federal Register Volume 61, Number 186 (Tuesday, September 24, 1996)]
[Notices]
[Pages 50031-50034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Advisory Committees; Notice of Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice announces forthcoming meetings of public advisory 
committees of the Food and Drug Administration (FDA). This notice also 
summarizes the procedures for the meetings 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

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information on FDA advisory committee meetings. The advisory committee 
hotline, which will disseminate current information and information 
updates, 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.
MEETINGS: The following advisory committee meetings are announced:
 Joint Meeting of the Nonprescription Drug Advisory Committee and the 
Arthritis Drugs Advisory Committee
    Date, time, and place. October 9, 1996, 8:30 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms I, II, and III, 8120 Wisconsin Ave., 
Bethesda, MD.
    Type of meeting and contact person. Open public hearing, 8:30 a.m. 
to 9:30 a.m., unless public participation does not last that long; open 
committee discussion, 9:30 a.m. to 5 p.m.; Kennerly K. Chapman or 
Kathleen R. Reedy, Center for Drug Evaluation and Research (HFD-21), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-443-5455, or e-mail [email protected], or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Nonprescription Drugs Advisory Committee, code 
12541, or Arthritis Advisory Committee, code 12532. Please call the 
hotline for information concerning any possible changes.
    General function of the committees. The Nonprescription Drugs 
Advisory Committee reviews and evaluates available data concerning the 
safety and effectiveness of over-the-counter (OTC) (nonprescription) 
human drug products for use in the treatment of a broad spectrum of 
human symptoms and 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.
    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 October 2, 1996, 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 committees will discuss new drug 
application (NDA) 20-373, S+ Ibuprofen (dexibuprofen, Sterling 
Winthrop/Bayer) 200-milligram caplet, indicated for the temporary 
relief of minor aches and pains associated with the common cold, 
headache, toothache, muscular aches, back ache, menstrual cramps, minor 
pain of arthritis, and for the temporary reduction of fever for OTC 
status.
Pulmonary-Allergy Drugs Advisory Committee
     Date, time, and place. October 9, 1996, 9:30 a.m., Holiday Inn--
Gaithersburg, Walker Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Type of meeting and contact person. Open public hearing, 9:30 a.m. 
to 10:30 a.m., unless public participation does not last that long; 
open committee discussion, 10:30 a.m. to 5 p.m.; Leander B. Madoo, 
Center for Drug Evaluation and Research (HFD-21), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4695, 
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Pulmonary-Allergy Drugs Advisory 
Committee, code 12545. Please call the hotline for information 
concerning any possible changes.
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational human drugs for use in the treatment of pulmonary 
disease and diseases with allergic and/or immunologic mechanisms.
     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 October 1, 1996, 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 discuss Genentech's 
clinical labeling supplement to modify the current prescribing 
information for Pulmozyme (dornase alfa) pertaining to cystic 
fibrosis patients with forced vital capacity of the lung, less than 40 
percent of predicted capacity.
 Joint Meeting of the Nonprescription Drugs Advisory Committee and the 
Pulmonary-Allergy Drugs Advisory Committee
    Date, time, and place. October 10 and 11, 1996, 8:30 a.m., Holiday 
Inn--Bethesda, Versailles Ballrooms II and III, 8120 Wisconsin Ave., 
Bethesda, MD.
    Type of meeting and contact person. Open public hearing, October 
10, 1996, 8:30 a.m. to 9:30 a.m., unless public participation does not 
last that long; open committee discussion, 9:30 a.m. to 5 p.m.; open 
public hearing, October 11, 1996, 8:30 a.m. to 9:30 a.m., unless public 
participation does not last that long; open committee discussion, 9:30 
a.m. to 5 p.m.; Kennerly K. Chapman or Leander B. Madoo, Center for 
Drug Evaluation and Research (HFD-21), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-4695, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Nonprescription Drugs Advisory Committee, code 
12541, Pulmonary-Allergy Drugs Advisory Committee, code 12545. Please 
call the hotline for information concerning any possible changes.
    General function of the committees. The Nonprescription Drugs 
Advisory Committee reviews and evaluates available data concerning the 
safety and effectiveness of OTC (nonprescription) human drug products 
for use in the treatment of a broad spectrum of human symptoms and 
diseases. The Pulmonary-Allergy Drugs Advisory Committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational human drugs for use in the treatment of pulmonary 
disease and diseases with allergic and/or immunologic mechanisms.
    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 October 1, 1996, 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. On October 10, 1996, the committees will

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jointly consider NDA 20-463, Nasalcrom (Cromolyn Sodium Nasal 
Solution, United States Pharmacopeia) for OTC treatment of seasonal 
allergic rhinitis sponsored by McNeil Consumer Products Co. On October 
11, 1996, the committees will jointly consider the prescription to OTC 
switch of NDA 19-589, Vancenase AQ Nasal Spray 
(Beclomethasone Dipropionate) for the treatment of seasonal allergic 
rhinitis sponsored by Schering-Plough Pharmaceutical Co.
National Mammography Quality Assurance Advisory Committee
    Date, time, and place. October 21 and 22, 1996, 9 a.m., and October 
23, 1996, 8 a.m., Sheraton Reston Hotel, meeting rooms 1 and 2, 11810 
Sunrise Valley Dr., Reston, VA. A limited number of overnight 
accommodations have been reserved at the Sheraton Reston Hotel. 
Attendees requiring overnight accommodations may contact the hotel at 
703-620-9000 and reference the FDA committee meeting block. 
Reservations will be confirmed at the group rate based on availability.
    Type of meeting and contact person. Open public hearing, October 
21, 1996, 9 a.m. to 10 a.m., unless public participation does not last 
that long; open committee discussion, 10 a.m. to 5 p.m.; open committee 
discussion, October 22, 1996, 9 a.m. to 5 p.m.; open committee 
discussion, October 23, 1996, 8 a.m. to 9 a.m.; open public hearing, 9 
a.m. to 10 a.m., unless public participation does not last that long; 
open committee discussion, 10 a.m. to 5 p.m.; Charles K. Showalter, 
Center for Devices and Radiological Health (HFZ-240), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332, or 
FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), National Mammography Quality 
Assurance Advisory Committee, code 12397. Please call the hotline for 
information concerning any possible changes.
    General function of the committee. The committee advises on 
developing appropriate quality standards and regulations for the use of 
mammography facilities.
    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 October 7, 1996, 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. On October 21 and 22, 1996, the 
committee will discuss regulation of interventional mammography under 
the Mammography Quality Standards Act (MQSA) of 1992. On October 23, 
1996, the committee will discuss: (1) The request of the American Board 
of Certification in Radiology to be designated as eligible to certify 
interpreting physicians under the MQSA and (2) controversial areas of 
the proposed final regulations (see 61 FR 14856, April 3, 1996 (21 CFR 
part 900)). Copies of the proposed final regulations may be requested 
in writing from MQSA, c/o KRA Corp., 1010 Wayne Ave., suite 850, Silver 
Spring, MD, 20910, or FAX 301-495-9410.
    FDA public advisory committee meetings 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. 
There are no closed portions for the meetings announced in this notice. 
The dates and times reserved for the open 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, 5600 Fishers Lane, rm. 12A-16, 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, 12420 Parklawn Dr., rm. 1-23, 
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.




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    This notice is issued under section 10(a)(1) and (a)(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: September 18, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-24453 Filed 9-23-96; 8:45 am]
BILLING CODE 4160-01-F