[Federal Register Volume 61, Number 55 (Wednesday, March 20, 1996)]
[Proposed Rules]
[Pages 11349-11350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6788]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 801, 803, 804, and 897

[Docket No. 95N-0253]


Regulations Restricting the Sale and Distribution of Cigarettes 
and Smokeless Tobacco Products To Protect Children and Adolescents; 
Reopening of the Comment Period as to Specific Documents

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period as to specific 
documents.

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SUMMARY: The Food and Drug Administration (FDA) is reopening to April 
19, 1996, as to specific documents, the comment period on its proposed 
regulations restricting the sale and distribution of nicotine-
containing cigarettes and smokeless tobacco products to children and 
adolescents, which was published in the Federal Register of August 11, 
1995 (60 FR 41314). FDA is reopening the comment period for 30 days for 
the sole purpose of inviting public comments on the information being 
added to the administrative record. Elsewhere in this issue of the 
Federal Register, FDA is reopening the comment period, as to specific 
documents, for a document entitled ``Analysis Regarding Food and Drug 
Administration Jurisdiction Over Nicotine-Containing Cigarettes and 
Smokeless Tobacco Products,'' which also was published in the Federal 
Register of August 11, 1995 (60 FR 41453).

DATES: Written comments must be received or postmarked on or before 
April 19, 1996. Comments postmarked after such date will not be 
considered.

ADDRESS: Submit written comments to the Dockets Management Branch (HFA-
305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

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: In the Federal Register of August 11, 1995 
(60 FR 41314), FDA issued a proposed rule that would restrict the sale 
and distribution of nicotine-containing cigarettes and smokeless 
tobacco products in order to protect children and adolescents. The 
proposed rule would reduce easy access to these products by children 
and adolescents and decrease the amount of imagery that makes these 
products attractive to children and adolescents. The proposed rule 
contains provisions stating that 18 years of age would be the Federal 
minimum age of purchase and that would prohibit cigarette vending 
machines, free samples, mail order sales, and self-service displays. 
The rule also proposed to require that retailers comply with certain 
conditions regarding tobacco sales, such as verifying the purchaser's 
age. In addition, the proposed rule contains provisions to limit 
advertising and labeling to which children and adolescents are exposed 
to a text-only format; to ban the sale or distribution of branded, non-
tobacco items (such as hats and tee shirts); to restrict sponsorship of 
events to the corporate name only; and to require manufacturers to 
establish and maintain a national public education campaign.
    By announcement in the Federal Register of October 16, 1995 (60 FR 
53560), FDA extended to January 2, 1996, the comment period on the 
proposed rule. (By that extension, the agency provided a comment period 
of more than 140 days on the notice of

[[Page 11350]]

proposed rulemaking. FDA provided a comment period of more than 90 days 
from the date--September 29, 1995--that additional documents were 
placed on display.) FDA provided a similar extension for the notice 
that set forth the jurisdictional analysis (60 FR 53620). On December 
1, 1995, FDA published in the Federal Register (60 FR 61670) the 
results of several focus group studies that it conducted and invited 
public comments by January 2, 1996.-
    FDA is adding two documents to the administrative record that 
further explain the basis for certain provisions of the proposed rule. 
The agency is providing the public an opportunity to comment on them.
    FDA believes that 30 days to comment is ample in this case, as the 
agency is specifically limiting its reopening of the comment period to 
comments on the documents being added. Comments are invited, and will 
be considered, only to the extent they are focused on the information 
being newly added to the record and only to the extent the comments 
regarding such information raise new issues not already raised by the 
person submitting the comment.
    The documents being added to the record are as follows:
    1. Food and Drug Administration, Memorandum to the Record: Section 
897.32--definition of adult publications, March 11, 1996.
    2. Food and Drug Administration, Memorandum to the Record: Section 
897.30(b)--billboards, March 11, 1996.
    Interested persons may, on or before April 19, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
the documents described above. Four 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. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 15, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-6788 Filed 3-18-96; 8:45 am]
BILLING CODE 4160-01-F