[Federal Register Volume 61, Number 55 (Wednesday, March 20, 1996)]
[Notices]
[Pages 11419-11420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6789]



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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; Reopening of the Comment Period as to Specific Documents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; 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 analysis 
regarding FDA's jurisdiction over these products, which was published 
in the Federal Register of August 11, 1995 (60 FR 41453). 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 its 
proposed rule entitled ``Regulations Restricting the Sale and 
Distribution of Cigarettes and Smokeless Tobacco Products to Protect 
Children and Adolescents.''

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

ADDRESSES: 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 41453), FDA published a notice

[[Page 11420]]

containing an analysis of FDA's jurisdiction over nicotine-containing 
cigarettes and smokeless tobacco products. The 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 Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321-395).
     In the Federal Register of October 16, 1995 (60 FR 53620), FDA 
extended to January 2, 1996, the comment period on the notice that set 
forth the jurisdictional analysis.
    FDA is adding three statements from former industry scientists and 
employees to the administrative record. These statements, describe 
among other things, the industry's understanding of nicotine and 
industry practice with respect to the control of nicotine levels in 
cigarette manufacture.
    FDA might rely on these statements in support of any final decision 
it may make on its jurisdiction. The agency is therefore 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 statements 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. Uydess, Ian L., Declaration of Ian L. Uydess, Ph.D., February 
29, 1996.
    2. Farone, William A., Ph.D., ``The Manipulation and Control of 
Nicotine and Tar in the Design and Manufacture of Cigarettes: A 
Scientific Perspective,'' March 8, 1996.
    3. Rivers, Jerome K., Declaration of Jerome K. Rivers, March 7, 
1996.
    As part of its ongoing investigation, the agency has compiled 
information that includes notes and transcripts of interviews with 
former industry scientists and employees. These notes and transcripts 
have been referenced in this proceeding (Federal Register of December 
27, 1995 (60 FR 66981)), but have not been included in the public 
docket because, among other reasons, they would likely disclose the 
identity of sources that furnished information to FDA on a confidential 
basis (60 FR 66981), they were obtained under assurances of 
confidentiality, and in some cases they contain trade secret or other 
confidential information. Among these documents are notes and 
transcripts reflecting conversations with Dr. Uydess, Dr. Farone, and 
Mr. Rivers, whose statements are identified above. Since the agency may 
rely on these statements, the agency is making them available for 
public comment now. The agency will not rely on any notes or 
transcripts made by the agency reflecting conversations with any former 
industry scientists and employees.
    Interested persons may, on or before April 19, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
the documents listed 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 18, 1996
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-6789 Filed 3-18-96; 8:45 am]
BILLING CODE 4160-01-F