[Federal Register Volume 61, Number 227 (Friday, November 22, 1996)]
[Notices]
[Pages 59447-59448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29830]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Advisory Committee; 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:

Blood Products Advisory Committee

    Date, time, and place. December 12 and 13, 1996, 1 a.m., Holiday 
Inn--Bethesda, Versailles Ballrooms III and IV, 8120 Wisconsin Ave., 
Bethesda, MD.
    Type of meeting and contact person. Open committee discussion, 
December 12, 1996, 8 a.m. to 10:30 a.m.; open public hearing. 10:30 
a.m. to 11 a.m., unless public participation does not last that 
long; open committee discussion, 11 a.m. to 12:15 p.m.; open public 
hearing, 12:15 p.m. to 12:30 p.m., unless public participation does 
not last that long; open committee discussion, 12:30 p.m. to 3 p.m.; 
open public hearing, 3 p.m. to 4 p.m., unless public participation 
does not last that long; open committee discussion, 4 p.m. to 5:30 
p.m.; open committee discussion, December 13, 1996, 8 a.m. to 9 
a.m.; open public hearing, 9 a.m. to 9:30 a.m., unless public 
participation does not last that long; open committee discussion, 
9:30 a.m. to 11:30 a.m.; open public hearing, 11:30 a.m. to 12 m., 
unless public participation does not last that long; open committee 
discussion, 12 m. to 12:30 p.m.; closed committee deliberations, 
12:30 p.m. to 1 p.m.; open committee discussion, 1 p.m. to 2:30 
p.m.; open public hearing, 2:30 p.m. to 3 p.m., unless public 
participation does not last that long; open committee discussion, 3 
p.m. to 3:30 p.m.; Linda A. Smallwood, Center for Biologics 
Evaluation and Research (HFM-350), Food and Drug Administration, 
1401 Rockville Pike, Rockville, MD 20852, 301-827-3514, or FDA 
Advisory Committee Information Hotline, 1-800-741-8138 (301-443-0572 
in the Washington, DC area). Blood Products Advisory Committee, code 
12388. 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, 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 6, 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 the morning of December 12, 1996, 
the committee will discuss the status of review of recombinant 
Factor IX, BeneFIX, Genetics Institutes, and review the FDA proposal 
on limiting plasma pool size for fractionated plasma products. In 
the afternoon, the committee will review issues of safety and 
efficacy concerning solvent detergent plasma, New York Blood Center. 
On the morning of December 13, 1996, the committee will review the 
status of HTLV-1/HTLV-II EIA, Abbott Laboratories, as in vitro 
dragnostic test kit to screen blood donors for the human 
tlymphotropic virus Types I and II, and the use of external controls 
with licensed infectious disease diagnostic test kits used for blood 
donor screening. In the afternoon, the committee will hear an 
informational report on the reinvention of the biologics license 
application (BLA) for blood products.
    Closed committee deliberations. On the afternoon of December 13, 
1996, the committee may review trade secret and/or confidential 
commercial information relevant to current and pending products. 
This portion of the meeting will be closed to permit discussion of 
this information (5 U.S.C. 552b(c)(4)).

Clincal Chemistry and Clinical Toxicology Devices Panel of the Medical 
Devices Advisory Committee

    Date, time, and place. December 20, 1996, 9 a.m., Corporate 
Bldg., conference room 020B, 9200 Corporate Blvd., Rockville, MD. A 
limited number of overnight accommodations have been reserved at the 
Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian 
Blvd., Gaithersburg, MD. Attendees requiring overnight 
accommodations may contact the hotel at 800-228-9290 or 301-590-0044 
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 Michelle 
Healy, KRA Corp. 301-495-1591. The availability of appropriate 
accommodations cannot be assured unless prior written notification 
is received.
    Type of meeting and contact person. Closed committee 
deliberations, 9 a.m. to 10 a.m.; open public hearing, 10 a.m. to 11 
a.m. unless public participation does not last that long; open 
committee discussion, 11 a.m. to 1 p.m.; closed presentation of 
data, 1 p.m. to 2 p.m.; open committee discussion, 2 p.m. to 5 p.m.; 
Cornelia B. Rooks, Center for Devices and Radiological Health (HFZ-
440) Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 
20850, 301-594-1243, or FDA Advisory Committee Information Hotline, 
1-800-741-8138, (301-443-0572, in the Washington, DC area), Clinical 
Chemistry and Clinical Toxicology Devices Panel, code 12514. Please 
call the hotline for information concerning any possible change.
    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

[[Page 59448]]

formal presentations should notify the contact person before 
December 1, 1996, to 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 consider a 
premarket approval application (PMA) for a device which calculates a 
composite index from currently available serum-based clinical 
laboratory tests to provide additional information, which can assist 
in identifying osteopenia in women with three or more National 
Osteoporosis Foundation Risk Factors.
    Closed committee deliberations. FDA staff will present to the 
committee trade secret and/or confidential commercial information 
regarding present and future FDA issues. This portion of the meeting 
will be closed to permit discussion of this information (5 U.S.C. 
552b(c)(4)).
    Closed presentation of data. The sponsor of the PMA will present 
to the committee trade secret and/or confidential information. This 
portion of the meeting will be closed to permit discussion of this 
information (5 U.S.C. 552b(c)(4)).

    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: November 15, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-29830 Filed 11-21-96; 8:45 am]
BILLING CODE 4160-01-M