[Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
[Notices]
[Pages 67359-67362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31461]



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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 


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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:
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
    Date, time, and place. January 22, 1996, 9:30 a.m., Holiday Inn--
Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD. A limited 
number of overnight accommodations have been reserved at the hotel. 
Attendees requiring overnight accommodations may contact the hotel at 
301-948-8900 or 1-800-465-4329 and reference the FDA Panel meeting 
block. Reservations will be confirmed at the group rate based on 
availability. Attendees with a disability requiring special 
accommodations should contact Sociometrics, Inc., 8300 Colesville Rd., 
suite 550, Silver Spring, MD 20910, 301-608-2151. The availability of 
appropriate accommodations cannot be assured unless prior notification 
is received.
    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 1:30 p.m.; closed presentation 
of data, 1:30 p.m. to 5:30 p.m.; Sara M. Thornton, Center for Devices 
and Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2053, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Ophthalmic Devices Panel, code 12396.
    -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 December 29, 1995, 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 review and recommend 
the classification status for currently unclassified devices which may 
include lacrimal system plugs, lacrimal system repair devices, and 
scleral plugs. The Intraocular and Corneal Implants Branch will request 
committee discussion on the clinical annex of the draft American 
National Standards Institute (ANSI) standard for glaucoma drainage 
devices.
    -Closed committee deliberations. The committee will discuss trade 
secret and/or confidential commercial information relevant to 
investigational device exemption applications and premarket approval 
applications for vitreo-retinal, surgical, and diagnostic devices, 
intraocular and corneal implants, and contact lenses. This portion of 
the meeting will be closed to permit discussion of this information (5 
U.S.C. 552b(c)(4)).
Microbiology Devices Panel of the Medical Devices Advisory Committee
    -Date, time, and place. January 25, 1996, 9:45 a.m., and January 
26, 1996, 8:45 a.m., Gaithersburg Hilton, Grand Ballroom, 620 Perry 
Pkwy., Gaithersburg, MD. A limited number of overnight accommodations 
have been reserved at the Gaithersburg Hilton. Attendees requiring 
overnight accommodations may contact the hotel at 301-977-8900 and 
reference the FDA Panel meeting block. Reservations will be confirmed 
at the group rate based on availability. Attendees with a disability 
requiring special accommodations should contact Sociometrics, Inc., 
8300 Colesville Rd., suite 550, Silver Spring, MD 20910, 301-608-2151. 
The availability of appropriate accommodations cannot be assured unless 
prior notification is received.
    -Type of meeting and contact person. Open public hearing, January 
25, 1996, 9:45 a.m. to 10:45 a.m., unless public participation does not 
last that long; open committee discussion, 10:45 a.m. to 6:30 p.m.; 
closed committee deliberations, January 26, 1996, 8:45 a.m. to 9:45 
a.m.; open public hearing, 9:45 a.m. to 10:45 a.m., unless public 
participation does not last that long; open committee discussion, 10:45 
a.m. to 5 p.m.; Freddie M. Poole, Center for Devices and Radiological 
Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., 
Rockville, MD 20850, 30l-594-2096, or FDA Advisory Committee 
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), Microbiology Devices Panel, code 12517.
    -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 January 10, 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 January 25, 1996, the committee will 
discuss a premarket approval application (PMA) for an in vitro 
diagnostic, target-amplified nucleic acid device for the detection of 
Mycobacterium tuberculosis complex in digested, decontaminated human 
respiratory specimens. On January 26, 1996, the committee will discuss 
issues concerning the accuracy of commercially available serological 
kits for the detection of human anti-Toxoplasma IgM and anti-Borrelia 
borgdorferi antibodies in relation to their indication for use.
    -Closed committee deliberations. On January 26, 1996, FDA staff 
will present to the committee trade secret and/or confidential 
commercial information regarding pending and future device submissions. 
This portion of the meeting will be closed to permit discussion of this 
information (5 U.S.C. 552b(c)(4)).
Science Advisory Board to the National Center for Toxicological 
Research
    -Date, time, and place. January 29, 1996, 1 p.m., and January 30, 
1996, 9 a.m., Bldg. 12, conference room, National Center for 
Toxicological Research, Jefferson, AR.
    -Type of meeting and contact person. Open board discussion, January 
29, 1996, 1 p.m. to 4:30 p.m.; open board 

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discussion, January 30, 1996, 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 board discussion, 2 p.m. to 3:30 p.m.; closed board deliberations, 
3:30 p.m. to 4:30 p.m.; Ronald F. Coene, National Center for 
Toxicological Research (HFT-10), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-3155, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Science Advisory Board to the National Center for 
Toxicological Research, code 12559.
    General function of the board. The board advises on establishment 
and implementation of a research program that will assist the 
Commissioner of Food and Drugs to fulfill regulatory responsibilities.
    -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 January 15, 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 board discussion. The board will be given a progress report 
on its recommendation that resulted from the board's Site Visit Team 
Report on the Center's Analytical Methods Development Program. The 
board will be presented and asked to review the Center's integration of 
the eight programs it has site visited and made recommendations. The 
presentation will include a discussion of the resource allocation to 
these programs as well as their relationship to the Center's strategic 
vision and goals. A final agenda will be available on January 22, 1996, 
from the contact person.
    -Closed board deliberations. The board will discuss personal 
information concerning individuals associated with the research 
programs at the Center, 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 

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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: December 19, 1995.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 95-31461 Filed 12-28-95; 8:45 am]
BILLING CODE 4160-01-F