[Federal Register Volume 59, Number 222 (Friday, November 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28636]


[[Page Unknown]]

[Federal Register: November 18, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 

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 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:

Dental Products Panel of the Medical Devices Advisory Committee

    Date, time, and place. December 5, 6, and 7, 1994, 9 a.m., 
Renaissance Hotel at Tech World, Salons A and B of the Renaissance 
Ballroom, 999 Ninth St. NW., Washington, DC.
    Type of meeting and contact person. Closed committee deliberations, 
December 5, 1994, 9 a.m. to 1 p.m.; open public hearing, 1 p.m. to 2 
p.m., unless public participation does not last that long; open 
committee discussion, 2 p.m. to 5 p.m.; open public hearing, December 
6, 1994, 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 public 
hearing, December 7, 1994, 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.; Carolyn A. Tylenda, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD, 301-443-8897, or FDA Advisory Committee Information 
Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC area), 
Dental Products Panel of the Medical Devices Advisory Committee, code 
12518.
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational devices and makes recommendations for their regulation.
    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 November 28, 1994, 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 December 5, 1994, the committee will 
discuss: (1) Dental device ingredient labeling, and (2) a draft 
guidance document for temporomandibular joint implants. On December 6, 
1994, the committee and the Dental Drug Products Panel Plaque 
Subcommittee will discuss over-the-counter (OTC) drug products bearing 
antiplaque and antiplaque-related claims. On December 7, 1994, the 
committee will discuss draft guidance documents for: (1) Dental 
endosseous implants, and (2) dental handpieces. The guidance documents 
are available through FDA's Division of Small Manufacturers' Assistance 
at 1-800-638-2041.
    Closed committee deliberations. The committee will discuss trade 
secret and/or confidential commercial information regarding a pending 
new drug application (NDA). This portion of the meeting will be closed 
to permit discussion of this information (5 U.S.C. 552b(c)(4)).

Biological Response Modifiers Advisory Committee

    Date, time, and place. December 8 and 9, 1994, 8 a.m., Holiday 
Inn--Bethesda, Versailles Ballroom I, 8120 Wisconsin Ave., Bethesda, 
MD.
    Type of meeting and contact person. Open public hearing, December 
8, 1994, 8 a.m. to 9 a.m., unless public participation does not last 
that long; open committee discussion, 9 a.m. to 10:30 a.m.; closed 
committee deliberations, 10:30 a.m. to 5 p.m.; closed committee 
deliberations, December 9, 1994, 8 a.m. to 12:30 p.m.; open committee 
discussion, 12:30 p.m. to 1:30 p.m.; William Freas or Pearline 
Muckelvene, Scientific Advisors and Consultants Staff (HFM-21), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, Rockville, MD 20852, 301-594-1054, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Biological Response Modifiers Advisory Committee, 
code 12388.
    General function of the committee. The committee reviews and 
evaluates data relating to the safety, effectiveness, and appropriate 
use of biological response modifiers which are intended for use in the 
prevention and treatment of a broad spectrum of human diseases.
    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 December 2, 1994, 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 December 8, 1994, the committee will 
clarify issues related to the safety and efficacy of hematopoietic 
support regimens in the setting of myelotoxic chemotherapy as discussed 
in the May 25 and 26, 1994, Biological Response Modifiers Advisory 
Committee meeting. The committee will also discuss prophylaxis for 
renal allograft rejection.
    Closed committee deliberations. On December 8 and 9, 1994, the 
committee will discuss trade secret and/or confidential commercial 
information relevant to pending IND's . This portion of the meeting 
will be closed to permit discussion of this information (5 U.S.C. 
552b(c)(4)).

Medical Imaging Drugs Advisory Committee

    Date, time, and place. December 9, 1994, 9 a.m., Parklawn Bldg., 
conference rms. D and E, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open public hearing, 9 a.m. to 
10 a.m, unless public participation does not last that long; closed 
committee deliberations, 10 a.m. to 3 p.m.; Leander B. Madoo, Center 
for Drug Evaluation and Research (HFD-9), 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), Medical Imaging Drugs Advisory Committee, code 
12540.
    General function of the committee. The committee reviews and 
evaluates data concerning the safety and effectiveness of marketed and 
investigational human drug products for use in diagnostic and 
therapeutic procedures using radioactive pharmaceuticals and contrast 
media used in diagnostic radiology.
    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 November 25, 1994, 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.
    Closed committee deliberations. The committee will discuss trade 
secret and/or confidential commercial information relevant to pending 
IND's and pending NDA's. This portion of the meeting will be closed to 
permit discussion of this information (5 U.S.C. 552b (c)(4)).

Blood Products Advisory Committee

    Date, time, and place. December 15 and 16, 1994, 8 a.m., Parklawn 
Bldg., conference rms. D and E, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open committee discussion, 
December 15, 1994, 8 a.m. to 9:30 a.m.; 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 2 p.m.; open public hearing, 2 
p.m. to 2:30 p.m., unless public participation does not last that long; 
open committee discussion, 2:30 p.m. to 4 p.m.; open public hearing, 4 
p.m. to 4:30 p.m., unless public participation does not last that long; 
open committee discussion, 4:30 p.m. to 5 p.m.; open committee 
discussion, December 16, 1994, 8 a.m. to 11 a.m.; open public hearing, 
11 a.m. to 11:30 a.m., unless public participation does not last that 
long; open committee discussion, 11:30 a.m. to 2:15 p.m.; closed 
committee deliberations, 2:15 p.m. to 3 p.m.; Linda A. Smallwood, 
Office of Blood Research and Review (HFM-350), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1448, 301-594-6700, or FDA Advisory Committee 
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), Blood Products Advisory Committee, code 12388.
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness, and appropriate use of 
blood products intended for use in the diagnosis, prevention, or 
treatment of human diseases.
    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 December 5, 1994, 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 the morning of December 15, 1994, the 
committee will: (1) Discuss and provide recommendations on product 
recalls related to inadvertent collections from donors with 
Creutzfeldt-Jakob disease; and (2) hear a presentation and discuss 
donor safety and product dose issues on collection of two units of red 
cells at a single donation. In the afternoon, the committee will 
discuss the retrieval of products that originate from donors who 
subsequently test positive for viral markers of bloodborne 
transmissible infections. The agency is announcing the intent to make 
available 3 weeks prior to the meeting, a draft document on the latter 
issue to be discussed at the meeting. Requests for single copies of the 
draft document may be made to the Division of Congressional, 
International, and Consumer Affairs (HFM-11), Center for Biologics 
Evaluation and Research, rm. 200N, 1401 Rockville Pike, Rockville, MD 
20857, 301-594-2000. On the morning of December 16, 1994, the committee 
will: (1) Hear an informational presentation on Hepatitis C virus 
safety of immune globulins, and (2) discuss issues pertaining to the 
clinical validation of nucleic acid assays used for patient and drug 
monitoring in human immune deficiency virus disease. In the afternoon, 
the committee will discuss the report of the intramural scientific 
review for the Laboratory of Hepatitis, Division of Transfusion 
Transmitted Diseases, Office of Blood and Blood Research, Center for 
Biologics Evaluation and Research.
    Closed committee deliberations. On December 16, 1994, the committee 
will discuss information relevant to the intramural scientific review 
report, disclosure of which would constitute a clearly unwarranted 
invasion of personal privacy. This portion of the meeting will be 
closed to permit discussion of this information (5 U.S.C. 552b(c)(6)).
    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: November 15, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-28636 Filed 11-17-94; 8:45 am]
BILLING CODE 4160-01-F