[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
