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

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