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The draft guidance does not create or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comments regarding this draft guidance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.