[Federal Register Volume 60, Number 74 (Tuesday, April 18, 1995)]
[Notices]
[Pages 19403-19405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9576]



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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 [[Page 19404]] will be updated when such changes are made.
MEETINGS: The following advisory committee meetings are announced:
Microbiology Devices Panel of the Medical Devices Advisory Committee
    Date, time, and place.  May 1, 1995, 9:45 a.m., and May 2, 1995, 
8:45 a.m., Holiday Inn--Gaithersburg, Walker and Whetstone Rooms, Two 
Montgomery Village Ave., Gaithersburg, MD. A limited number of 
overnight accommodations have been reserved at the Holiday Inn--
Gaithersburg. Attendees requiring overnight accommodations may contact 
the hotel at 301-948-8900 and reference the FDA Panel meeting block. 
Reservations will be confirmed at the group rate based on availability.
    Type of meeting and contact person. Open public hearing, May 1, 
1995, 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.; 
open public hearing, May 2, 1995, 8:45 a.m. to 10 a.m., unless public 
participation does not last that long; open committee discussion, 10 
a.m. to 11:30 a.m.; closed presentation of data, 11:30 a.m. to 12:30 
p.m.; open committee discussion, 12:30 p.m. to 6:30 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 April 25, 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. On May 1, 1995, the committee will 
discuss a premarket approval application (PMA) for an in vitro 
diagnostic device intended for use in the determination of anti-
neoplastic resistance to tumor cells with specific chemotherapeutic 
agents. On May 2, 1995, the committee will discuss a PMA for an in 
vitro diagnostic, target-amplified nucleic acid device for the 
detection of Mycobacterium tuberculosis complex in sediments prepared 
from sputum (induced or expectorated), bronchial specimens, or tracheal 
specimens.
     Closed presentation of data. On May 2, 1995, the committee will 
discuss trade secret and/or confidential commercial information 
regarding the target-amplified nucleic acid device for the detection of 
Mycobacterium tuberculosis complex. This portion of the meeting will be 
closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).
    FDA is giving less than 15 days public notice of the Microbiology 
Devices Panel of the Medical Devices Advisory Committee meeting. The 
agency decided that it is in the public interest to hold this meeting 
May 1 and 2, 1995, even if there was not sufficient time for the 
customary 15-day public notice.
Science Advisory Board to the National Center for Toxicological 
Research
    Date, time, and place.  May 9, 1995, 8:30 a.m., Bldg. 12, 
conference room, National Center for Toxicological Research, Jefferson, 
AR.
     Type of meeting and contact person. Open committee discussion, 
8:30 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 4 p.m.; closed committee deliberations, 4 p.m. to 
5 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. Any interested persons may present 
data, information, or views, orally or in writing, on issues pending 
before the committee. Those desiring to make a formal presentation 
should notify the contact person before April 21, 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 requested to make their comments.
     Open board discussion. The board will conduct a review of the 
Science Advisory Board's (SAB's) Site Visit Team draft report on the 
Analytical Methods Development Program, engage in discussions on this 
report, and come to a final conclusion on the recommendations to be 
made to the Director concerning this center program. The center will 
provide progress reports on the recommendations of previously reviewed 
research programs: (1) The Transgenics Program, and (2) Biochemical and 
Molecular Markers of Cancer Program. The center will also provide a 
review and examination of the process and the product of the Site Visit 
Teams over the past 3 years, and develop a future agenda for the SAB. A 
final agenda will be available on May 4, 1995, from the contact person.
     Closed board deliberations. The board will discuss personal 
information concerning individuals associated with these review 
programs, 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)).
    The Commissioner approves the scheduling of meetings at locations 
outside of the Washington, DC, area on the basis of the criteria of 21 
CFR 14.22 of FDA's regulations relating to public advisory committees.
    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 [[Page 19405]] 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: April 13, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-9576 Filed 4-13-95; 4:14 pm]
BILLING CODE 4160-01-F