[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
