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.
66982 Federal Register / Vol. 60, No. 248 / Wednesday, December 27, 1995 / Notices

FDA did not place in the public docket

trade secret and confidential commercial

information, or information the disclosure of

which would constitute a clearly

unwarranted invasion of personal privacy.

An index listing these documents was

created by the agency and is available to the

public. However, unless the information in

these documents was inextricably

intertwined with the other information

contained in the document, FDA redacted the

trade secret, confidential commercial, or

privacy information and placed the

remainder of the document in the public

docket.

In addition, FDA did not include in the

public docket certain documents developed

during the course of the agency’s

investigation of the tobacco industry because

these documents could disclose the identity

of sources that furnished information to the

agency on a confidential basis. The agency’s

policy with respect to confidential sources in

this investigation was discussed at the

hearings before the House Subcommittee on

Health and the Environment (see Regulation

of Tobacco Products (Part 1) (March 25,

1994), pp. 35–37; Regulation of Tobacco

Products (Part 3) (June 21, 1994), pp. 87–96).

In the agency’s view, there can be no

reasonable expectation of confidentiality for

information submitted to a public docket in

a rulemaking proceeding. Therefore, an

agency is under no legal obligation to

scrutinize documents submitted to a public

docket to determine whether they may

contain proprietary information. However,

because it is aware of the sensitivity and

importance of such information, FDA has

long followed certain procedures to try to

ensure that clearly proprietary information is

not unwittingly made available to the public.

FDA scans documents submitted to a docket

for obvious trade secrets (e.g., formulas) or

personal privacy information. In addition,

any document marked confidential is

referred to the appropriate Center Freedom of

Information Act officer for a determination as

to whether it would be exempt from public

disclosure under Exemption 4 of the

Freedom of Information Act (trade secrets

and commercial or financial information

obtained from a person and privileged or

confidential). Before documents containing

such information are placed on the record,

the Center consults with the submitter to

determine whether the submitter intended to

make the document publicly available by

placing it on the record. The agency is

following these procedures in the tobacco

proceeding.

Dated: December 21, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–31368 Filed 12–22–95; 11:18

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:

Subcommittee Meeting of the National

Mammography Quality Assurance

Advisory Committee

Date, time, and place. January 10 and

11, 1996, 9 a.m., Hyatt Regency—

Bethesda, Baccarat Suite, One Bethesda

Metro Center, Bethesda, MD. A limited

number of overnight accommodations

have been reserved at the hotel.

Attendees requiring overnight

accommodations may contact the hotel

at 301–657–1234, and reference the FDA

Committee meeting block. Reservations

will be confirmed at the group rate

based on availability.

Type of meeting and contact person.

Open public hearing, January 10, 1996,

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

participation does not last that long;

open subcommittee discussion, 10 a.m.

to 5 p.m.; open subcommittee

discussion, January 11, 1996, 9 a.m. to

1 p.m.; Charles K. Showalter, 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), National

Mammography Quality Assurance

Advisory Committee, code 12397.

General function of the committee.

The committee advises on developing

appropriate quality standards and

regulations for the use of mammography

facilities.

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 3, 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 subcommittee discussion. On

January 10 and 11, 1996, the Access to

Mammography Services subcommittee

will meet. The subcommittee will

discuss the ongoing work which is

necessary to make the determinations

and subsequently prepare the reports as

mandated in the Mammography Quality

Standards Act. Upon completion, the

subcommittee report will be reviewed

by the committee prior to submission to

the Secretary and Congress.

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