Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices 13653

Diagnostic Systems chemistry systems

(i.e., COBAS MIRA , COBAS MIRA

S, and COBAS MIRA Plus) for the

quantitative analysis of cyclosporine

(CsA) in human whole blood as an aid

in the management of cyclosporine

therapy in kidney, heart, and liver

transplant patients.

On November 16, 1992, the Clinical

Chemistry and Toxicology Devices

Panel of the Medical Devices Advisory

Committee, an FDA advisory committee,

reviewed and recommended approval of

the application. On October 2, 1996,

CDRH approved the application by a

letter to the applicant from the Director

of the Office of Device Evaluation,

CDRH.

A summary of the safety and

effectiveness data on which CDRH

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

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 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 the 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 April 21, 1997, 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 Devices and

Radiological Health (21 CFR 5.53).

Dated: February 20, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–7134 Filed 3–20–97; 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

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:

Circulatory System Devices Panel of

the Medical Devices Advisory

Committee

Date, time, and place. April 7, 1997,

8:30 a.m., Corporate Bldg., conference

rm. 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 1–800–228–9290 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

Christie Wyatt, KRA Corp., 301–495–

1591, ext. 267.

Type of meeting and contact person.

Closed committee deliberations, 8:30

a.m. to 9:30 a.m.; open public hearing,

9:30 a.m. to 10:30 a.m., unless public

participation does not last that long;

open committee discussion, 10:30 a.m.

to 1:30 p.m.; closed presentation of data,

1:30 p.m. to 2:30 p.m.; open committee

discussion, 2:30 p.m. to 3:30 p.m.; John

E. Stuhlmuller, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8243, ext. 157, or FDA

Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Circulatory System Devices Panel, code

12625. 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 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 April 1, 1997, 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 discuss a new premarket

notification (510(k)) for a

transtelephonic cardiac event monitor

for over-the-counter use

(nonprescription). This device has

previously been cleared by the agency

for prescription use.

Closed presentation of data. The

sponsor may present trade secret and/or

confidential commercial information

regarding the cardiac monitor. This

portion of the meeting will be closed to

permit discussion of this information (5

U.S.C. 552b(c)(4)).
13654 Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices

Closed committee deliberations. FDA

staff will present to the committee trade

secret and/or confidential commercial

information relevant to cardiovascular

system devices that are currently being

evaluated by FDA. This portion of the

meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Antiviral Drugs Advisory Committee

Date, time, and place. April 14, 1997,

8:30 a.m.; Armory Place, 925 Wayne

Ave., rm. 204, Silver Spring, MD.

Type of meeting and contact person.

Open public hearing, 8:30 a.m. to 9:30

a.m., unless public participation does

not last that long; open committee

discussion, 9:30 a.m. to 3 p.m.; closed

committee deliberations, 3 p.m. to 5:30

p.m.; Rhonda W. Stover, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Antiviral Drugs

Advisory Committee, code 12531.

Please call the hotline for information

concerning any possible changes.

General function of the committee.

The committee reviews and evaluates

available data concerning the safety and

effectiveness of marketed and

investigational human drug products for

use in the treatment of acquired

immune deficiency syndrome (AIDS),

AIDS-related complex (ARC), and other

viral, fungal, and mycobacterial

infections.

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 April 7, 1997, 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 discuss data relevant to

a supplemental new drug application

for the approved drug, AmphotecTM,

(amphotericin B cholesteryl sulfate

complex, Sequus Pharmaceuticals, Inc.),

for use in the empiric therapy of febrile

neutropenic patients.

Closed committee deliberations. The

committee will review trade secret and/

or confidential information relevant to

pending investigational new drugs and

drug development plans. This portion of

the meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Joint Meeting of the Vaccines and

Related Biological Products Advisory

Committee and the Antiviral Drugs

Advisory Committee

Date, time, and place. April 15, 1997,

7:45 a.m., Armory Place, 925 Wayne

Ave., rm. 103, Silver Spring, MD. The

meeting will move to rm. 204 (same

location) at 1 p.m.

Type of meeting and contact person.

Open public hearing, 7:45 a.m. to 8:15

a.m. for the Vaccines and Related

Biological Products Advisory

Committee in room 103, unless public

participation does not last that long;

closed committee deliberations, 8:15

a.m. to 1 p.m.; closed joint committee

deliberations in room 204, 1 p.m. to 5:30

p.m.; open public hearing, 5:30 p.m. to

6 p.m., unless public participation does

not last that long; Nancy T. Cherry or

Denise H. Royster, Center for Biologics

Evaluation and Research (HFM–21),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington DC area), Vaccines and

Related Biological Products Advisory

Committee, code 12388; Antiviral Drugs

Advisory Committee, code 12531.

Please call the hotline for information

concerning any possible changes.

General function of the committees.

The Vaccines and Related Biological

Products Advisory Committee reviews

and evaluates data on the safety and

effectiveness of vaccines intended for

use in the diagnosis, prevention, or

treatment of human diseases. The

Antiviral Drugs Advisory Committee

reviews and evaluates available data

concerning the safety and effectiveness

of marketed and investigational human

drug products for use in the treatment

of acquired immune deficiency

syndrome (AIDS), AIDS-related complex

(ARC), and other viral, fungal, and

mycobacterial infections.

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 by April 8, 1997, 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.

Closed committee deliberations. The

committees will review trade secret

and/or confidential commercial

information relevant to pending

investigational new drug applications or

product licensing applications. These

portions 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
Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices 13655

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: March 17, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–7188 Filed 3–20–97; 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

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:

Technical Electronic Product

Radiation Safety Standards Committee

Date, time, and place. April 8 and 9,

1997, 8:30 a.m., Corporate Bldg.,

conference rm. 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 Advisory Committee

meeting block. Reservations will be

confirmed at the group rate based on

availability. Attendees with a disability

requiring special accommodations

should contact Christie Wyatt, KRA

Corp., 301–495–1591, ext. 267.

Type of meeting and contact person.

Open committee discussion, April 8,

1997, 8:30 a.m. to 10:15 a.m.; open

public hearing, 10:15 a.m. to 11 a.m.,

unless public participation does not last

that long; open committee 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 committee discussion, 4 p.m. to 5

p.m.; open committee discussion, April

9, 1997, 8:30 a.m. to 11 a.m.; open

public hearing, 11 a.m. to 12 m., unless

public participation does not last that

long; open committee discussion, 12 m.

to 2:15 p.m.; Orhan H. Suleiman, Center

for Devices and Radiological Health

(HFZ–240), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–594–3332, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Technical Electronic Product Radiation

Safety Standards Committee, code

12399. Please call the hotline for

information concerning any possible

changes.

General function of the committee.

The committee advises on technical

feasibility, reasonableness, and

practicability of performance standards

for electronic products to control the

emission of radiation under 42 U.S.C.

263f(f)(1)(A).

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