[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Pages 37062-37063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17974]


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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Draft Guidance; Availability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 of availability.

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SUMMARY: The Food and Drug Administration is announcing the 
availability of a draft guidance entitled ``Frequently Asked Questions 
About the New FDA Tobacco Regulations.'' The draft guidance is intended 
to address the questions most frequently asked by retailers, consumers, 
and others about the age and identification requirements of the final 
rule restricting the sale of cigarettes and smokeless tobacco to 
protect children and adolescents.

DATES: Submit written comments on the draft guidance by September 8, 
1997.

ADDRESSES: The draft guidance entitled ``Frequently Asked Questions 
About the New FDA Tobacco Regulations,'' is 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    Submit written comments on the draft guidance to the Dockets 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: Anne M. Kirchner, Office of Policy 
(HF-11), 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 (21 CFR 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.
    Before the age and ID requirements took effect, FDA officials held 
a series of public meetings in 10 metropolitan areas and produced a 
national videoconference to explain the new requirements and to answer 
questions from retailers, consumers, public health officials, and 
others. FDA agreed to make available written answers to the questions 
most frequently asked at these meetings.
    The draft guidance that FDA is making available answers these 
questions, as well as questions that FDA has received on its toll-free 
hotline and

[[Page 37063]]

over the Internet. Because some of the answers contained in the 
document represent FDA's current interpretation of new regulatory 
requirements, the document constitutes guidance. Therefore, FDA is 
publishing the document in draft and soliciting public comment. FDA 
will review received comments and, if appropriate, amend the document 
in response to comments.
    Interested parties may submit written comments on the 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 should be identified with the docket number found in 
the heading of this document. The draft guidance and received comments 
are available for public examination in the office above between 9 a.m. 
and 4 p.m., Monday through Friday.
    This draft guidance does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. Alternative 
methods that comply with the tobacco regulations are acceptable. If a 
regulated company or person wishes or chooses to use an approach other 
than that set forth in this guidance document, FDA will, upon request, 
discuss with that company or person alternative methods of complying 
with the regulations.


    Dated: June 30, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-17974 Filed 7-9-97; 8:45 am]
BILLING CODE 4160-01-F