[Federal Register Volume 62, Number 120 (Monday, June 23, 1997)]
[Proposed Rules]
[Pages 33783-33784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16309]


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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]
BILLING CODE 4160-01-F