Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Notices 26187

[Docket No. 95N–0212]

Epitope, Inc.; Premarket Approval of

OraSure HIV–1 Oral Specimen

Collection Device

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Epitope,

Inc., Beaverton, OR, for premarket

approval, under the Federal Food, Drug,

and Cosmetic Act (the act), of the

OraSure HIV–1 Oral Specimen

Collection Device. FDA’s Center for

Biologics Evaluation and Research

(CBER) notified the applicant, by letter

of December 23, 1994, of the approval

of the application. A revised approval

letter was issued on October 18, 1995.

DATES: Petitions for administrative

review by June 24, 1996.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Sukza Hwangbo, Center for Biologics

Evaluation and Research (HFM–380),

1401 Rockville Pike, Rockville, MD

20852–1448, 301–827–3524.

SUPPLEMENTARY INFORMATION: On May 9,

1991, Epitope, Inc., Beaverton, OR

97008, submitted to CBER an

application for premarket approval of

the OraSure HIV–1 Oral Specimen

Collection Device. The device is

intended for use in the collection of oral

fluid specimens by properly trained

individuals for the purpose of testing for

the presence of antibodies to human

immunodeficiency virus Type 1 (HIV–

1). The OraSure HIV–1 Oral Specimen

Collection Device consists of both an

absorbent cotton fiber pad treated with

a proprietary salt solution and gelatin

affixed to a plastic stick, and a

preservative solution supplied in a

plastic container. OraSure HIV–1 oral

fluid specimens are intended to be used

only with the Oral Fluid Vironostika

HIV–1 Microelisa System screening test

manufactured by Organon Teknika

Corp. The device is intended for use

with subjects 13 years of age or older.

On December 19, 1992, the premarket

approval application (PMA) was

referred to the Blood Products Advisory

Committee, an FDA advisory committee,

for review and recommendation. On

June 22, 1994, the PMA was referred to

the same advisory committee for

discussion of post-approval

requirements for surveillance studies.

On December 23, 1994, CBER

approved the application by a letter to

the applicant from the Acting Director,

Office of Blood Research and Review,

CBER. In response to additional

discussions between the manufacturer

and FDA, a revised approval letter was

issued on October 18, 1995.

FDA has determined that, to ensure

safe and effective use, the device is

restricted within the meaning of section

520(e) of the act (21 U.S.C. 360j(e))

under the authority of section

515(d)(1)(B)(ii) of the act (21 U.S.C.

360e(d)(1)(B)(ii)) insofar as: (1) Before

shipping the device to any customer,

Epitope, Inc., must have on file a ‘‘Letter

of Agreement for Physician’’ signed by

the physician who agrees to assume the

outlined responsibilities on behalf of the

customer; (2) the administration of the

device is restricted to individuals who

have been trained in the use of the

device according to approved labeling;

(3) testing of OraSure samples for

HIV–1 antibodies is restricted to the

Oral Fluid Vironostika HIV–1

Microelisa System screening test

manufactured by Organon Teknika

Corp.; (4) the device is not to be

provided to subjects for home use; (5)

the device is not to be used to screen

blood donors; and (6) prior to specimen

collection, a test subject must receive a

copy of the subject information sheet.

The sale, distribution, and use of the

device must not violate sections 502(q)

and (r) of the act (21 U.S.C. 352(q) and

352(r)).

A summary of the safety and

effectiveness data on which CBER based

its approval is on file in the Dockets

Management Branch (address above)

and is available from that office upon

written request. Requests should be

identified with the name of the device

and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CBER’s decision to approve this

application. A petitioner may request

either a formal hearing under part 12 (21

CFR part 12) of FDA’s administrative

practices and procedures regulations or

a review of the application and CBER’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under § 10.33(b) (21

CFR 10.33(b)). A petitioner shall

identify the form of review requested

(hearing or independent advisory

committee) and shall submit with the

petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before June 24, 1996, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Biologics Evaluation

and Research (21 CFR 5.53).

Dated: May 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13176 Filed 5–23–96; 8:45 am]

BILLING CODE 4160–01–F

Food and Drug Administration

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
26188 Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Notices

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. June 13, 1996,

8:30 a.m., Sheraton—Crystal City,

Ballroom A, 1800 Jefferson Davis Hwy.,

Arlington, VA.

Type of meeting and contact person.

Open committee discussion, 8:30 a.m. to

2:30 p.m.; open public hearing, 2:30

p.m. to 3:30 p.m., unless public

participation does not last that long;

open committee discussion, 3:30 p.m. to

5 p.m.; Susan Homire, 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 June 6, 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 continue its discussions related to

FDA’s approach to toxicity,

carcinogenicity and biomaterials testing.

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: May 20, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–13105 Filed 5–23–96; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committees; Notice of

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

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