[Federal Register Volume 61, Number 1 (Tuesday, January 2, 1996)]
[Notices]
[Pages 74-75]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31554]
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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:
Immunology Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. January 22, 1996, 9:30 a.m., Gaithersburg
Hilton Hotel, Salons D & E, 620 Perry Pkwy., Gaithersburg, MD. A
limited number of overnight accommodations have been reserved at the
hotel. Attendees requiring overnight accommodations may contact the
hotel at 301-977-8900 and reference FDA Panel meeting block.
Reservations will be confirmed at the group rate based on availability.
Type of meeting and contact person. Open public hearing, 9:30 a.m.
to 10:30 a.m., unless participation does not last that long; open
committee discussion, 10:30 a.m. to 4 p.m. For information regarding
the analyte specific reagents classification--Kaiser J. Aziz, Center
for Devices and Radiological Health (HFZ-440), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-3084.
For information regarding the conduct of the meeting--Peter E. Maxim,
Center for Devices and Radiological Health (HFZ-440), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1293, or
FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Immunology Devices Panel, code 12516.
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 8, 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. The committee will consider the
classification of analyte specific reagents as in vitro diagnostic
devices. FDA intends to develop a regulatory scheme to handle products
currently being used by clinical laboratories as materials for in-house
(``home brew'') assays. Analyte specific reagents are chemical, poly or
monoclonal antibodies, proteins, nucleic acid sequences, which, by
their physio-chemical reaction with substances in a specimen, allow a
test procedure to distinguish or quantify an individual chemical
substance or ligand in a biological specimen. These are used in the
production of in-house tests which are of high complexity under the
Clinical Laboratory Improvement Act of
[[Page 75]]
1988. They are considered medical devices. Currently, such reagents are
being made widely available to clinical laboratories under ``research
use only'' or ``investigational use only'' labeling or as unlabeled
components of a final test.
FDA believes that most analyte specific reagents may be considered
for classification as class I devices and exempted from the premarket
notification (510(k)) procedure in subpart E of 21 CFR part 807 if the
reagents do not make analytical or clinical performance claims. FDA is
currently considering an approach under which such analyte specific
reagents would be subject to other general controls: (1) Registration
and listing, (2) medical device reporting requirements, and (3) good
manufacturing practice requirements. FDA is also considering
establishing restrictions under section 520(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360j(e)) on the sale, distribution,
or use of the devices.
The issue of classification and the nature of appropriate
restrictions will be the subject of the panel meeting.
Although FDA believes that most analyte specific reagents may be
considered for regulation in this way, the agency also believes that a
small number of analyte specific reagents (e.g., those used to diagnose
communicable diseases through blood or other means) would be more
properly classified into class II or III and subject to the premarket
controls (510(k) or premarket approval) applicable to such
classification.
FDA public advisory committee meetings 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.
There are no closed portions for the meetings announced in this notice.
The dates and times reserved for the open 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.
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 21, 1995.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 95-31554 Filed 12-29-95; 8:45 am]
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