[Federal Register Volume 60, Number 199 (Monday, October 16, 1995)]
[Notices]
[Pages 53620-53621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25671]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0253J]


Analysis Regarding the Food and Drug Administration's 
Jurisdiction Over Nicotine-Containing Cigarettes and Smokeless Tobacco 
Products; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to January 
2, 1996, the comment period for the notice that appeared in the Federal 
Register of August 11, 1995 (60 FR 41453). The document contained FDA's 
factual and legal analysis regarding nicotine in cigarettes and 
smokeless tobacco products and whether the products are drug delivery 
devices within the meaning of the Federal Food, Drug, and Cosmetic Act 
(the act). As a result of this extension, the agency is providing a 
comment period of more than 140 days on the notice, and a comment 
period of more than 90 days from the date that additional documents 
that the agency considered were placed on display.

DATES: Comments by January 2, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
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 41453), FDA issued a notice describing the results of FDA's 
extensive investigation of cigarettes and smokeless tobacco products. 
The notice contained a comprehensive analysis and detailed 
documentation regarding the agency's jurisdiction over such products. 
The results of the investigation and analysis supported a finding, at 
that time, that nicotine in cigarettes and smokeless tobacco products 
is a drug, and that these products are drug delivery devices within the 
meaning of the act. In issuing the notice, FDA also recognized the 
unique importance of the jurisdictional issue as well as the factual 
justification for any proposed rule concerning cigarettes and smokeless 
tobacco products and invited comment.
    On August 16, 1995, all documents referred to in the notice were 
placed on public display at the Dockets Management Branch, except for a 
small number of documents identified as confidential and articles for 
which publicly available journal citations were given in the notice. 
The notice and the documents cited by the agency in support of the 
notice (except for those documents that the agency identified as 
confidential) have been publicly available since August 16, 1995. On 
September 29, 1995, FDA placed additional documents that the agency 
considered on public display at the Dockets Management Branch. 
Accordingly, FDA is extending the comment period to January 2, 1996. A 
deadline of December 28, 1995, would provide a comment period of 90 
days from the date on which the agency placed additional documents that 
the agency considered on public display. Because December 28, 1995, is 
a Thursday and January 1, 1996, is a holiday, the agency does not 
anticipate that it will be able to undertake significant work on the 
comments until January 2, 1996. Therefore, the agency is extending the 
comment period until January 2, 1996.
    Because of the public health importance of this matter, the agency 
advises that it does not anticipate granting further extensions of the 
comment period beyond January 2, 

[[Page 53621]]
1996. In order to assure consideration by the agency, comments are to 
be filed by that date.
    Elsewhere in this issue of the Federal Register, the agency is 
publishing two graphs that were inadvertently omitted from the appendix 
to the notice. The appendix did not appear in the Federal Register on 
August 11, 1995, but can be purchased from the Government Printing 
Office (stock number 017012003737).
    Interested persons may, on or before December 28, 1995, submit to 
the Dockets Management Branch (address above) written comments 
regarding this notice. 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 Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 11, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-25671 Filed 10-12-95; 1:38 pm]
BILLING CODE 4160-01-F