Applications for Exemption From Preemption of State and Local Requirements Pertaining to the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 808

[Docket No. 96N-0249]

Applications for Exemption From Preemption of State and Local

Requirements Pertaining to the Sale and Distribution of Cigarettes and

Smokeless Tobacco to Protect Children and Adolescents

Agency: Food and Drug Administration, HHS.

[[Page 33784]]

Action: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the

comment period for a proposed rule that appeared in the Federal

Register of February 19, 1997 (62 FR 7390). The comment period is being

opened for 14 days to accept additional comments on the agency's

proposal to grant exemptions from preemption for certain cigarette and

smokeless tobacco requirements in the States of Alabama, Alaska, and

Utah.

DATES: Written comments must be received or postmarked by July 7, 1997.

Comments postmarked after such date will not be considered.

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: Anne M. Kirchner, Office of Policy

(HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-827-5321.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 28, 1996

(61 FR 44396), FDA published a final rule (the tobacco rule)

restricting the sale and distribution of nicotine-containing cigarettes

and smokeless tobacco in order to protect children and adolescents.

Because FDA is regulating these products as nicotine-delivery devices

under the Federal Food, Drug, and Cosmetic Act (the act), any State or

local requirement that is different from, or in addition to, specific

requirements for cigarettes or smokeless tobacco under the tobacco rule

is preempted under section 521(a) of the act (21 U.S.C. 360k). Section

521(b) of the act provides that FDA may, upon application by a State or

political subdivision, and by regulation issued after notice and

opportunity for an oral hearing, exempt a State or local device

requirement from Federal preemption.

In the Federal Register of February 19, 1997 (62 FR 7390), FDA

issued a proposed rule that would grant exemption from Federal

preemption for certain cigarette and smokeless tobacco requirements in

the States of Alabama, Alaska, and Utah.The proposed rule would allow

those States to enforce State requirements that are more stringent than

FDA counterpart requirements. FDA received approximately one dozen

comments to the proposal and one requested that FDA extend the comment

period for 14 days.

The request stated that an extension was necessary because the

comment stated that the scope of preemption under section 521(a) of the

act was explained differently in the tobacco rule than it was in the

proposal (62 FR 7390). In order to ensure that all interested parties

have a fair opportunity to comment, FDA is extending the comment period

for 14 days. Comments must be either received or postmarked by July 7,

1997 in order to be considered. The agency intends to issue a final

rule as soon after the comment period closes as is practicable.

Interest persons may, on or before July 7, 1997, submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. Two 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: June 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-16309 Filed 6-20-97; 8:45 am]

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