Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices 8973

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:

Blood Products Advisory Committee

Date, time, and place. March 13,

1997, 8 a.m., and March 14, 1997, 8:30

a.m., Quality Suites Hotel—Shady

Grove, Potomac Rooms I, II, and III,

Three Research Ct., Rockville, MD.

Type of meeting and contact person.

Open committee discussion, March 13,

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

hearing, 10:30 a.m. to 11:30 a.m., unless

public participation does not last that

long; open committee discussion, 11:30

a.m. to 2 p.m.; open public hearing, 2

p.m. to 2:30 p.m., unless public

participation does not last that long;

open committee discussion, 2:30 p.m. to

4:30 p.m.; open public hearing, 4:30

p.m. to 5 p.m., unless public

participation does not last that long;

open committee discussion, 5 p.m. to

5:30 p.m.; open committee discussion,

March 14, 1997, 8:30 a.m. to 10 a.m.;

closed committee discussion, 10 a.m. to

10:30 a.m.; Linda A. Smallwood, Office

of Blood Research and Review (HFM–

350), Center for Biologics Evaluation

and Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 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 March 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. On the

morning of March 13, 1997, the

committee will discuss nucleic acid

testing of plasma pools. In the

afternoon, the committee will hear an

informational report on the reinvention

of the Biologics License Application

(BLA) for blood products and have a

discussion on the topic of patient

notification. On March 14, 1997, the

committee will review the final report of

the site visit of the Laboratory of Plasma

Derivatives, Division of Hematology,

Office of Blood Research and Review,

Center for Biologics Evaluation and

Research.

Closed committee discussion. On

March 14, 1997, the committee will

discuss confidential and personal

privacy information relevant to the

scientific site visit report. This portion

of the meeting will be closed to permit

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

552b(c)(4)).

Anesthetic and Life Support Drugs

Advisory Committee

Date, time, and place. March 24 and

25, 1997, 8:30 a.m., Holiday Inn—

Gaithersburg, Grand Ballroom, Two

Montgomery Village Ave., Gaithersburg,

MD.

Type of meeting and contact person.

Open public hearing, March 24, 1997,

8:45 a.m. to 9:15 a.m., unless public

participation does not last that long;

closed presentation of data, 9:15 a.m. to

1:30 p.m.; closed committee

deliberations, 1:30 p.m. to 5:30 p.m.;

open public hearing, March 25, 1997,

8:45 a.m. to 9:15 a.m., unless public

participation does not last that long;

closed presentation of data, 9:15 a.m. to

1:30 p.m.; closed committee

deliberations, 1:30 p.m. to 5 p.m.; Karen

Somers, 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),

Anesthetic and Life Support Drugs

Advisory Committee, code 12529.

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 human

drugs for use in the field of

anesthesiology and surgery.

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 March 14, 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 presentation of data. The

committee will hear trade secret and/or

confidential commercial information

relevant to pending investigational new

drugs (IND’s) and new drug applications

(NDA’s). This portion of the meeting

will be closed to permit discussion of

this information (5 U.S.C. 552b(c)(4)).

Closed committee deliberations. The

committee will review trade secret and/

or confidential commercial information

relevant to pending IND’s and NDA’s.

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
8974 Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices

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: February 24, 1997

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–4959 Filed 2–26–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97D–0041]

The Small Entity Compliance Guide

On: Regulations to Restrict the Sale

and Distribution of Cigarettes and

Smokeless Tobacco in Order to

Protect Children and Adolescents;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a revised compliance

guide entitled, ‘‘The Small Entity

Compliance Guide On: Regulations to

Restrict the Sale and Distribution of

Cigarettes and Smokeless Tobacco in

Order to Protect Children and

Adolescents (21 CFR Part 897).’’ The

revised compliance guide is intended to

help small entities comply with the

final rule restricting the sale and

distribution of cigarettes and smokeless

tobacco in order to protect children and

adolescents. This action is being taken

under the Small Business Regulatory

Enforcement Fairness Act.

DATES: Comments may be submitted at

any time.

ADDRESSES: The revised compliance

guide entitled ‘‘The Small Entity

Compliance Guide On: Regulations to

Restrict the Sale and Distribution of

Cigarettes and Smokeless Tobacco in

Order to Protect Children and

Adolescents (21 CFR Part 897)’’ is

available on the Internet at

‘‘http://www.fda.gov/’’, or a paper copy

may be ordered free of charge by calling

1–800–FDA–4KIDS. Submit written

comments on the revised compliance

guide to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments should be

identified with the docket number

found in brackets in the heading of this

document. The revised compliance

guide and received comments are

available for public examination in the