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
Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices 8975

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

FOR FURTHER INFORMATION CONTACT:

Anne M. Kirchner, Office of Policy (HF–

23), Food and Drug Administration,

5600 Fishers Lane, rm. 14–72, Rockville,

MD 20857, 301–827–0867.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 28, 1996 (61

FR 44396), FDA issued a final rule to

restrict the sale and distribution of

cigarettes and smokeless tobacco in

order to protect children and

adolescents. The final rule covers three

general classes of nicotine-containing

products: Cigarettes, cigarette tobacco,

and smokeless tobacco. The final rule

applies to manufacturers, distributors,

and retailers who make, distribute, or

sell such products.

Beginning on February 28, 1997,

Federal regulation will prohibit retailers

from selling cigarettes, cigarette tobacco,

or smokeless tobacco to persons under

the age of 18, and will require retailers

to verify the age of all customers under

the age of 27 by checking a

photographic identification for date of

birth. Under the current schedule,

starting August 28, 1997, the remaining

provisions of the rule will be effective,

except for the sponsorship provision,

which will be effective on August 28,

1998.

Under the Small Business Regulatory

Enforcement Act (Pub. 104–121), FDA is

announcing the availability of the

revised compliance guide which is

intended to help small businesses

comply with the requirements of the

new rule. An earlier version of the

compliance guide was previously

available on the Internet and in paper

form. The agency believes that the

rulemaking process provided ample

opportunity to comment on issues

concerning all the underlying regulatory

provisions of the rule. However, FDA is

soliciting comments on the guide itself

and may amend the guide periodically

as a result of comments received. The

agency is making available at this time

a revised compliance guide which

covers all of the access restrictions even

though it is the photographic

identification for date of birth

requirement that becomes effective first.

Therefore, in submitting comments,

persons should consider the

implementation dates of the provisions

described in the guide.

Dated: February 20, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4793 Filed 2–26–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Special Project Grants and

Cooperative Agreements; Maternal and

Child Health Services; Federal SetAside Program; Comprehensive

Hemophilia Centers, Genetic Services,

and Maternal and Child Health

Improvement Projects

AGENCY: Health Resources and Services

Administration (HRSA).

ACTION: Notice of availability of funds.

SUMMARY: The HRSA announces that

approximately $10.2 million in fiscal

year (FY) 1997 funds will be available

for grants and cooperative agreements

for the following activities: Maternal

and Child Health (MCH) Special

Projects of Regional and National

Significance (SPRANS), including

genetic disease testing, counseling and

information services; and special MCH

improvement projects (MCHIP) which

contribute to the health of mothers,

children, and children with special

health care needs (CSHCN). All awards

will be made under the program

authority of section 502(a) of the Social

Security Act, the MCH Federal SetAside Program. Within the HRSA,

SPRANS grants are administered by the

Maternal and Child Health Bureau

(MCHB). Grants for SPRANS research

and training are being announced in a

separate notice. No new SPRANS

hemophilia program grants will be

funded in FY 1997.

Of the approximately $52.1 million

available for SPRANS genetics and

MCHIP activities in FY 1997, about

$10.2 million will be available to

support approximately 63 new and

competing SPRANs renewal projects, at

a cost of about $161,900 per project. The

actual amounts available for awards and

their allocation may vary depending on

unanticipated program requirements

and the volume and quality of

applications. Awards are made for grant

periods which generally run from 1 to

5 years in duration. Funds for grants

under the MCH Federal Set-Aside

Program are appropriated by Public Law

104–208.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS-led national activity for setting

priority areas. The MCH Block Grant

Federal Set-Aside Program addresses

issues related to the Healthy People

2000 objectives of improving maternal,

infant, child and adolescent health and

developing service systems for children

with special health care needs. Potential

applicants may obtain a copy of Healthy

People 2000 (Full Report: Stock No.

017–001–00474–0) or Healthy People

2000 (Summary Report: Stock No. 017–

001–00473–1) through the

Superintendent of Documents,

Government Printing Office

Washington, DC 20402–9325

(telephone: 202–512–1800).

The PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and promote the non-use of

all tobacco products. In addition, Public

Law 103–227, the Pro-Children Act of

1994, prohibits smoking in certain

facilities (or in some cases, any portion

of a facility) in which regular or routine

education, library, day care, health care

or early childhood development

services are provided to children.

ADDRESSES: Federal Register notices

and application guidance for MCHB

programs are available on the World

Wide Web via the Internet at address:

http://www.os.dhhs.gov/hrsa/mchb.

Click on the file name you want to

download to your computer. It will be

saved as a self-extracting (Macintosh or)

WordPerfect 5.1 file. To decompress the

file once it is downloaded, type in the

file name followed by a <return>. The

file will expand to a WordPerfect 5.1

file.

For applicants for SPRANS grants and

cooperative agreements who are unable

to access application materials

electronically, a hard copy (Revised

PHS form 5161–1, approved under OMB

clearance number 0937–0189) may be

obtained from the HRSA Grants

Application Center. Requests should

specify the category or categories of

activities for which an application is

requested so that the appropriate forms,

information and materials may be

provided. The Center may be contacted

by: Telephone Number: 1–888–300–

HRSA, FAX Number: 301–309–0579, Email Address:

HRSA.GAC@ix.netcom.com. Completed

applications should be returned to:

Grants Management Officer, HRSA

Grants Application Center, 40 West

Gude Drive, Suite 100, Rockville,

Maryland 20850. Please indicate the

appropriate CFDA # for the application

being submitted (see table below).

DATES: Potential applicants are invited

to request application packages for the

particular program category in which

they are interested, and to submit their

applications for funding consideration.

Deadlines for receipt of applications

differ for the several categories of grants.

These deadlines are as follows: