[Federal Register Volume 61, Number 208 (Friday, October 25, 1996)]
[Notices]
[Pages 55308-55309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27490]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice announces a forthcoming meeting of a public 
advisory committee of the Food and Drug Administration (FDA). This 
notice also summarizes the procedures for the meeting 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.
MEETING: The following advisory committee meeting is announced:
Science Board to the Food and Drug Administration
    Date, time, and place. November 7, 1996, 8:30 a.m., Sheraton 
National Hotel, North Ballrooms 1 and 2, 900 South Orme St. (Columbia 
Pike and Washington Blvd.), Arlington, VA.
    Type of meeting and contact person.  Closed board deliberations, 
8:30 a.m. to 11 a.m.; open board discussion, 11 a.m. to 3 p.m.; open 
public hearing, 3 p.m. to 4 p.m., unless public participation does not 
last that long; open board discussion, 4 p.m. to 4:30 p.m.; Susan K. 
Meadows, Office of Science (HF-33), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3340, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Science Board to the Food and Drug 
Administration, code 12603. Please call the hotline for information 
concerning any possible changes.
    General function of the board. The board shall provide advice 
primarily to the agency's Senior Science Advisor and, as needed, to the 
Commissioner and other appropriate officials on specific complex and 
technical issues as well as emerging issues within the scientific 
community in industry and academia. Additionally, the board will 
provide advice to the agency on keeping pace with technical and 
scientific evolutions in the fields of regulatory science; on 
formulating an appropriate research agenda; and on upgrading its 
scientific and research facilities to keep pace with these changes. It 
will also provide the means for critical review of agency-sponsored 
intramural and extramural scientific research programs.
    Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the board. Those desiring to make formal presentations must notify the 
contact person before October 31, 1996, and submit a brief statement of 
the general nature of the evidence or arguments they wish to present, 
and the names and addresses of proposed participants. Each presenter 
will be limited in time and not all requests to speak may be able to be 
accommodated. All written statements submitted in a timely fashion will 
be provided to the board.
    Open board discussion. The board will receive an update on the FDA 
Information Retrieval System developed within FDA's Office of Science, 
and an update on the creation of a Biomaterials Forum designed to 
foster information exchange on issues related to safety testing of 
biomaterials and new developments in biomaterials science. 
Additionally, the board will discuss the formation of a subcommittee on 
toxicology, which will address issues related to the research and 
development of toxicological methods and mechanisms that better predict 
adverse health effects. A complete agenda will be available in advance 
of the meeting.
    Closed board deliberations. The board will discuss information 
concerning nominations for the FDA award for scientific achievement; if 
these nominations are discussed in public, information of a personal 
nature would be disclosed which would constitute a clearly unwarranted 
invasion of

[[Page 55309]]

personal privacy (5 U.S.C. 552b(c)(6)). The board will also hear an 
interim status report from its subcommittee on FDA research. FDA 
believes that premature disclosure of the subcommittee's work is likely 
to significantly impede discussion of the issues being reviewed by the 
subcommittee and potential agency action on future recommendations (5 
U.S.C. 552b(c)(9)(B)). Thus, the interim status report from the 
subcommittee will be presented in a closed session. However, the issues 
related to FDA science and research being reviewed by the subcommittee 
will be presented to the board for public discussion at a later date.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the Science Board to the Food and Drug Administration meeting. 
Because the agency believes there is some urgency to bring these issues 
to public discussion and qualified members of the Science Board to the 
Food and Drug Administration were available at this time, the 
Commissioner concluded that it was in the public interest to hold this 
meeting even if there was not sufficient time for the customary 15-day 
public notice.
    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 the meeting(s) 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.
    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 (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: October 21, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-27490 Filed 10-24-96; 8:45 am]
BILLING CODE 4160-01-F