[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
