3146 Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by FAX by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844. Submit

written comments on the document to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance document entitled

‘‘Guidance for Industry: For the

Submission of Chemistry,

Manufacturing and Controls and

Establishment Description Information

for Human Plasma-Derived Biological

Products or Animal Plasma or SerumDerived Products.’’ The draft guidance

provides general information for the

CMC and establishment description

section of the BLA, Form FDA 356h for

human plasma-derived biological

products, animal plasma, or serumderived products. In the Federal Register of July 8, 1997

(62 FR 36558), FDA announced the

availability of a new harmonized Form

FDA 356h entitled ‘‘Application to

Market a New Drug, Biologic, or an

Antibiotic for Human Use.’’ The new

harmonized form is intended to be used

by applicants for all drug and biological

products. The new harmonized form

when fully implemented will allow

biological product manufacturers to

submit a single application, the BLA,

instead of two separate license

application submissions, a product

license application (PLA) and an

establishment license application (ELA). The draft guidance document

represents the agency’s current thinking

on content and format of the CMC, and

establishment description information

section of a license application for

human plasma-derived biological

products, animal plasma, or serumderived products. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the applicable statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this document to be all inclusive

and cautions that not all information

may be applicable to all situations. The

document is intended to provide

information and does not set forth

requirements.

II. Comments

The draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit written comments to the Dockets

Management Branch (address above)

regarding the draft guidance document.

Written comments may be submitted at

any time, however, comments should be

submitted by April 21, 1998, to ensure

their adequate consideration in

preparation of the final document. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments and

requests for copies should be identified

with the docket number found in the

brackets in the heading of this

document. A copy of the draft guidance

document and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the draft guidance document

by using the World Wide Web (WWW).

For WWW access connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm.’’ Received comments will be

considered in determining whether

further revision of the draft guidance

document is warranted.

Dated: January 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1293 Filed 1–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0261]

Frequently Asked Questions About the

New FDA Tobacco Regulations: Draft

Guidance; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration is announcing the

availability of a new section to the draft

guidance entitled ‘‘Frequently Asked

Questions About the New FDA Tobacco

Regulations.’’ The draft guidance

addresses the questions most frequently

asked by retailers, consumers and others

about the age and photo identification

requirements of the final rule restricting

the sale of cigarettes and smokeless

tobacco to protect children and

adolescents. The new section on

enforcement procedures addresses

questions raised by retailers and others

concerning the amount of penalties that

FDA intends to seek for third and

subsequent violations of the age and

identification requirements.

DATES: Submit written comments on the

draft guidance by April 21, 1998.

ADDRESSES: The draft guidance entitled

‘‘Frequently Asked Questions About the

New FDA Tobacco Regulations,’’ and

the amendment are available on the

Internet at

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

may be ordered free of charge by calling

1–888–FDA–4KIDS.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Mary M. Lyda, Office of Policy (HF–11),

Food and Drug Administration, 5600

Fishers Lane, rm. 14–101, Rockville, MD

20857, 301–827–3360.

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 (21CFR part 897). The final

rule covers three general classes of

nicotine-containing tobacco products:

Cigarettes, loose cigarette tobacco, and

smokeless tobacco. The final rule

applies to manufacturers, distributors,

retailers and importers who make,

distribute, sell, and import such

products.

Since February 28, 1997, the final rule

has prohibited retailers from selling

cigarettes, loose cigarette tobacco or

smokeless tobacco to persons under the

age of 18, and has required retailers to

verify the age of customers under the

age of 27 by checking an identification

(ID) card which contains the bearer’s

photograph and birth date.

The draft guidance answers questions

most frequently asked by retailers,

consumers, and others concerning these

requirements and the agency’s

enforcement plans. To ensure that

retailers are complying with the

requirements, FDA has commissioned

State officials to conduct compliance

checks, during which adolescents,

accompanied by State officials, attempt

to purchase cigarettes or smokeless

tobacco from retailers. The guidance
Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices 3147

states that for a first violation of the age

and identification requirements, FDA

will issue a letter notifying the retailer

that it was out of compliance and

informing the retailer that FDA will

schedule a followup compliance check.

The guidance explains that the second

time a retailer is out of compliance FDA

will seek civil money penalties in the

amount of $250.00.

The new section that FDA is making

available addresses questions

concerning the amount of penalties that

FDA intends to seek for third and

subsequent violations of the age and

photo ID provisions of the regulation.

FDA intends to seek $1,500.00 for a

third violation, $5,000.00 for a fourth

violation, and $10,000.00 for a fifth

violation. The new section provides

more information concerning the civil

money penalty process under which a

retailer may pay the penalty or request

a hearing to contest it. Because some of

the answers contained in the new

section represent FDA’s current

interpretation of new regulatory

requirements, the additions constitute

guidance. Therefore, FDA is publishing

the new section in draft and is soliciting

public comment. FDA will review

received comments and, if appropriate,

revise the document in response to

comments.

The draft guidance does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public.

Interested persons may, on or before

April 21, 1998, submit written

comments regarding this draft guidance

to the Dockets Management Branch,

address above. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guidance and received comments may

be seen in the office above between 9

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

Friday.

Dated: January 12, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–1344 Filed 1-20-98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Center for Scientific Review; Notice of

Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following Center

for Scientific Review Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda: To review Small

Business Innovation Research.

Name of SEP: Biological and Physiological

Sciences.

Date: February 23, 1998.

Time: 2 p.m.

Place: NIH, Rockledge 2, Room 4212,

Telephone Conference.

Contact Person: Dr. Nabeeh Mourad,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4212, Bethesda, MD

20892, (301) 435–1222.

Name of SEP: Biological and Physiological

Sciences.

Date: March 2–3, 1998.

Time: 8 a.m.

Place: Bethesda Marriott Hotel, Bethesda,

MD.

Contact Person: Dr. Nabeeh Mourad,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4212, Bethesda, MD

20892, (301) 435–1222.

The meetings will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Nos. 93.306, 93.333, 93.337, 93.393–

93.396, 93.837–93.844, 93.846–93.878,

93.892, 93.893, National Institutes of Health,

HHS)

Dated: January 14, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–1317 Filed 1–20–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Notice of Meeting of the National

Advisory Council for Human Genome

Research

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

National Advisory Council for Human

Genome Research, National Human

Genome Research Institute, February

12–13, 1998, Holiday Inn, 5520

Wisconsin Avenue, Chevy Chase, MD.

This meeting will be open to the

public on Thursday, February 12, 8:30

a.m. to approximately 3 p.m., to discuss

administrative details or other issues

relating to committee activities.

Attendance by the public will be limited

to space available.

In accordance with the provisions set

forth in secs. 552b(c)(4) and 552b(c)(6),

Title 5, U.S.C. and sec. 10(d) of Pub. L.

92–463, the meeting will be closed to

the public on February 12, from 3 p.m.

to recess, and on February 13, from 8:30

a.m. to adjournment, for the review,

discussion and evaluation of individual

grant applications. The applications and

the discussions could reveal

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Dr. Elke Jordan, Deputy Director,

National Human Genome Research

Institute, National Institutes of Health,

Building 31, Room 4B09, Bethesda, MD

20892, (301) 496–0844, will furnish the

meeting agenda, rosters of Committee

members and consultants, and

substantive program information upon

request.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Ms. Jane Ades, (301) 594–0654,

two weeks in advance of the meeting.

(Catalogue of Federal Domestic Assistance

Program No. 93.172, Human Genome

Research)

Dated: January 14, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–1321 Filed 1–20–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Neurological

Disorders and Stroke; Amended Notice

of Meeting

Notice is hereby given of a change in

the meeting of the National Advisory

Neurological Disorders and Stroke

Council of the National Institute of

Neurological Disorders and Stroke,

February 12–13, 1998, Building 31,

Conference Room 6, National Institutes

of Health, which was published in the

Federal Register on December 29, 1997,

(62 FR 67645).

The information regarding the date

and time for the closed session was

incorrect. The Council meeting will be

open to the public on February 12 from

8:30 a.m. to approximately 3 p.m. and

will be closed on February 12,

approximately 3 p.m. to recess and

February 13, 8:30 a.m. to adjournment.