66980 Federal Register / Vol. 60, No. 248 / Wednesday, December 27, 1995 / Notices

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 (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 18, 1995.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 95–31292 Filed 12–26–95; 8:45 am]

BILLING CODE 4160–01–F

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:

Cardiovascular and Renal Drugs

Advisory Committee

Date, time, and place. January 25,

1996, 8:30 a.m., and January 26, 1996,

9 a.m., National Institutes of Health,

Clinical Center, Bldg. 10, Jack Masur

Auditorium, 9000 Rockville Pike,

Bethesda, MD 20892. Parking in the

Clinical Center Visitor area is reserved

for clinical center patients and their

visitors. If you must drive, please use an

outlying lot such as Lot 41B. Free

shuttle bus service is provided from Lot

41B to the Clinical Center every 8

minutes during rush hour and every 15

minutes at other times.

Type of meeting and contact person.

Open public hearing, January 25, 1996,

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

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

January 26, 1996, 9 a.m. to 4:30 p.m.;

Joan C. Standaert (HFD–110), 419–259–

6211; or Valerie M. Mealy (HFD–21),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–4695, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area)

Cardiovascular Drugs Advisory

Committee, code 12533.

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 cardiovascular and

renal disorders.

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 13, 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. On

January 25, 1996, the committee will

discuss a Current Controversy: Calcium

Channel Blockers. On January 26, 1996,

the committee will review the Center for

Biologics Evaluation and Research’s

product license application 95–1210,

imciromaba pentetate (Myoscint,

Centocor), a monoclonal antibody for

use as an imaging agent for diagnosis of

cardiac necrosis.

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,
Federal Register / Vol. 60, No. 248 / Wednesday, December 27, 1995 / Notices 66981

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 18, 1995.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 95–31293 Filed 12–26–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–253S]

Procedures for Handling Confidential

Information in Rulemaking

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

statement regarding the procedures

generally followed by the agency with

respect to the use of confidential

commercial information, trade secrets,

and other confidential or sensitive

information during rulemaking. In brief,

FDA does not place into a public docket

trade secret, confidential commercial

information, or information whose

disclosure would constitute a clearly

unwarranted invasion of privacy or

would reveal the identity of confidential

sources. FDA tries to assure that clearly

proprietary information is not

unwittingly made available to the

public, but also advises that information

submitted to a public docket during a

rulemaking proceeding does not carry a

reasonable expectation of

confidentiality.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Office of Policy (HF–23),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–3380.

SUPPLEMENTARY INFORMATION: FDA has

received several inquiries regarding

certain information that FDA used in

developing the proposed rule and notice

pertaining to nicotine-containing

cigarettes and smokeless tobacco

products. The proposed rule, entitled

‘‘Regulations Restricting the Sale and

Distribution of Cigarettes and Smokeless

Tobacco Products to Protect Children

and Adolescents,’’ and an

accompanying document entitled

‘‘Nicotine in Cigarettes and Smokeless

Tobacco Products is a Drug and These

Products are Nicotine Delivery Devices

Under the Federal Food, Drug, and

Cosmetic Act,’’ appeared in the Federal

Register on August 11, 1995 (60 FR

41314 and 60 FR 41453 at 41454,

respectively). In general, the cigarette

and smokeless tobacco companies have

questioned or sought to limit FDA’s

ability to use or to receive certain

information, particularly documents

that were prepared by industry officials

but not submitted by the industry to

FDA during rulemaking.

In response, the agency has developed

a statement describing the procedures

generally followed by the agency with

respect to confidential information in a

rulemaking docket. In brief, FDA does

not place trade secret, confidential

commercial information, or information

whose disclosure would constitute a

clearly unwarranted invasion of privacy

or would reveal the identity of

confidential sources, into a public

docket. FDA tries to assure that clearly

proprietary information is not

unwittingly made available to the

public, but also advises that information

submitted to a public docket during a

rulemaking proceeding does not carry a

reasonable expectation of

confidentiality.

Although the agency has developed

this written statement to address

concerns raised in the tobacco

proceedings, the positions expressed in

the statement reflect docket

management procedures that the agency

has long used in other rulemaking

proceedings. Consequently, FDA is

publishing the statement in the Federal

Register.

The statement is as follows:

Statement of Procedures for Handling

Confidential Information in Rulemaking

FDA has received several inquiries

regarding the agency’s procedures for

handling confidential information in the

dockets compiled for the agency’s proposed

regulation restricting the sale and

distribution of cigarettes and smokeless

tobacco products to protect children and

adolescents, and the accompanying legal

analysis and factual findings, both of which

were published in the Federal Register on

August 11, 1995. This notice describes the

procedures followed by FDA generally with

respect to confidential information in a

rulemaking docket.

FDA compiled the docket for the proposed

regulation restricting the sale and

distribution of cigarettes and smokeless

tobacco products to protect children and

adolescents (the proposed rule) and the

document entitled ‘‘Nicotine in Cigarettes

and Smokeless Tobacco Products is a Drug

and These Products are Nicotine Delivery

Devices Under the Federal Food, Drug, and

Cosmetic Act’’ (the document) in accordance

with the requirements of the Administrative

Procedure Act, 5 U.S.C. 551, et seq. (APA),

and FDA’s existing regulations at 21 CFR

10.40. This docket includes existing factual

information and submitted information relied

upon by the agency decisionmakers in

support of the analysis and the proposed

rule. The agency has also included in the

docket factual material and submitted

information considered by agency

decisionmakers, except for the limited group

of documents discussed below.