[Federal Register Volume 61, Number 1 (Tuesday, January 2, 1996)]
[Pages 74-75]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31554]



Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 
    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 
    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]