[Federal Register Volume 61, Number 217 (Thursday, November 7, 1996)]
[Notices]
[Pages 57685-57687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28681]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is inviting State and
local governments to file applications for exemption from preemption
for requirements governing the sale and distribution of cigarettes and
smokeless tobacco to protect children and adolescents. FDA's
regulations provide that the agency may, under certain conditions,
exempt a State or local requirement from preemption. This action is
intended to ensure that the objectives of the final rule pertaining to
the sale and distribution of cigarettes and smokeless tobacco to
children and adolescents are reached. In order to facilitate and
expedite review of these applications for exemption from preemption,
FDA will consider the applications in two separate groups. The two
groups are based on the effective dates for different requirements
under the final rule. State and local governments seeking exemption
from preemption must submit a separate application for each of the two
groups. In determining whether to grant or deny exemptions for
submitted applications, FDA intends to consolidate all of the
applications within each group and to use a separate proceeding for
each of the two groups.
DATES: Submit applications for group 1 (i.e., requirements that are
different from or in addition to requirements under 21 CFR 897.14(a)
and (b)) by December 9, 1996; submit applications for Group 2 (i.e.,
requirements that are different from or in addition to all other
requirements in 21 CFR part 897) by May 6, 1997.
ADDRESSES: Applications to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 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:
I. Background
Under section 521(a) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360k(a)), any State or local requirement
applicable to a device is preempted if such requirement: (1) Is
different from, or in addition to, any requirement applicable under the
act to the device; and (2) relates to the safety or effectiveness of
the device or to any other matter included in a requirement applicable
to the device under the act.
In implementing section 521 of the act, FDA has historically
interpreted that provision narrowly and has found it to have preemptive
effect only for those State and local requirements that, in fact,
clearly impose specific requirements with respect to specific devices
that are manifestly in addition to analogous Federal requirements (see
Sec. 808.1(d) (21 CFR 808.1(d))). In addition, section 521 of the act
``does not preempt State or local requirements that are equal to, or
substantially identical to, requirements imposed by or under the act''
(Sec. 808.1(d)(2)).
In the Federal Register of August 28, 1996 (61 FR 44396), FDA
issued a final rule (the final rule) governing the sale and
distribution of nicotine-containing
[[Page 57686]]
cigarettes and smokeless tobacco in order to protect children and
adolescents. FDA has determined that cigarettes and smokeless tobacco
are nicotine-delivery devices under the act. The final rule will become
effective on August 28, 1997, except for the following sections: (1)
Section 897.14(a) (21 CFR 897.14(a)), which prohibits sales of
cigarettes or smokeless tobacco to any person younger than 18 years of
age, will become effective on February 28, 1997; (2) Sec. 897.14(b),
which requires retailers to verify that purchasers of cigarettes and
smokeless tobacco are at least 18 years old, will become effective on
February 28, 1997; and (3) Sec. 897.34(c), which places certain
restrictions on event sponsorships, will become effective on August 28,
1998. Once a requirement under the final rule becomes effective,
analogous State and local requirements that are different from, or in
addition to, that requirement will be preempted under section 521(a) of
the act.
The agency's assertion of jurisdiction over cigarettes and
smokeless tobacco does not preclude State or local requirements other
than those expressly preempted by section 521(a) of the act. Moreover,
State and local requirements that are preempted by the final rule may
be exempted from preemption in accordance with section 521(b) of the
act and its implementing regulations (part 808 (21 CFR part 808)).
II. Exemptions from Preemption
Section 521(b) of the act and its implementing regulations provide
that FDA may, by regulation issued after notice and an opportunity for
an oral hearing, exempt a State or local requirement from preemption
under such conditions as the Commissioner of Food and Drugs (the
Commissioner) may prescribe if the State or local requirement is: (1)
More stringent than a requirement under the act that would be
applicable to the device if an exemption were not in effect; or (2)
required by compelling local conditions, and compliance with the State
or local requirement would not cause the device to be in violation of
any requirement applicable under the act.
In this document and consistent with the final rule, FDA is
inviting all State and local governments to submit applications to
exempt from preemption those State or local requirements pertaining to
cigarettes or smokeless tobacco that are preempted by the agency's
final rule. Under Sec. 808.25(g), State or local requirements
pertaining to cigarettes or smokeless tobacco may be exempted from
preemption under section 521(b) of the act if the State or local
requirement: (1) Meets the exemption requirements established under
section 521(b) of the act; and (2) is in the best interest of public
health and is consistent with the goals of the final rule. Exemptions
from preemption granted by FDA apply only to preemption under section
521 of the act.
Exemptions from preemption will be granted only for those
requirements that have the force and effect of law, i.e., have been
enacted, promulgated, or issued in final form. However, an application
may be submitted after the establishment of the statute or regulation
by the State or local government, but before the effective date of the
requirement. With regard to any State or local requirements that have
not yet been enacted, promulgated, or issued in final form, any State,
political subdivision, or other interested party may seek, in
accordance with Sec. 808.5, an advisory opinion as to whether such
State or local requirements would be preempted once established. To the
extent that requirements are enacted, promulgated, or issued in final
form in the future, and such requirements are preempted under section
521(a) of the act, State or local governments may submit applications
for exemption from preemption for such requirements at that time.
III. Applications
In order to facilitate and expedite review of the applications
submitted by State and local governments according to this document,
FDA will consider the applications in two separate groups. The groups,
which are based on the effective dates for different requirements under
the final rule, are as follows:
(1) Group 1: State and local requirements governing the sale or
distribution of cigarettes or smokeless tobacco that are different
from, or in addition to, FDA requirements under Sec. 897.14(a) and
Sec. 897.14(b) of the final rule. Section 897.14(a) prohibits retailers
from selling cigarettes or smokeless tobacco to anyone younger than 18
years of age. Section 897.14(b) requires retailers (except in certain
situations) to verify, by means of photographic identification
containing the bearer's date of birth, that the person purchasing the
product is not younger than 18 years of age. No such verification is
required for any person over the age of 26.
(2) Group 2: State and local requirements governing the sale or
distribution of cigarettes or smokeless tobacco that are different
from, or in addition to, all other FDA requirements under the final
rule.
State and local governments that want to file an application for
exemption from preemption pursuant to this document should submit a
separate application for each group. Applications for exemption from
preemption for existing requirements that are preempted may be
submitted now or at any time in the future. In order to be considered
as part of the proceedings described in this notice, however,
applications for Group 1 should be submitted by December 9, 1996 and
applications for Group 2 should be submitted by May 6, 1997. Until
exemptions are granted for preempted State or local requirements, the
requirements may not be enforced.
Each application should be in the form of a letter to the
Commissioner. The application should be identified with the docket
number found in brackets in the heading of this document, as well as
the group number under which exemption is being sought. An original and
two copies of the application, and any accompanying material,
subsequent reports, or correspondence concerning the application,
should be submitted to the Dockets Management Branch (address above).
The application letter must be signed by an individual who is
authorized to request the exemption on behalf of the State or local
government. In the past, most exemption requests have been submitted by
State Attorneys General. In some States or localities, other officials
may also be authorized under State or local law to submit requests.
The envelope of the application, report, or correspondence should
indicate that it concerns an application for exemption from preemption
of device requirements. In addition, the envelope should be identified
with the docket number found in brackets in the heading of this
document, as well as the group number under which exemption is being
sought.
The application must be accompanied by sufficient information and
data to enable FDA to determine whether the requirement in question is
preempted by section 521(a) of the act and, if so, whether the
Commissioner should grant the exemption as provided in section 521(b)
of the act. Specifically, for each requirement for which an exemption
is sought, the application shall include the following information to
the extent possible, or an explanation of why such information has not
been included:
(1) Identification and a current copy of the relevant statute,
rule, regulation, or ordinance, as well as the date of enactment,
promulgation, or issuance in final form.
[[Page 57687]]
(2) Copies of relevant background material, including any
legislative history, hearing reports, or similar materials pertinent to
enactment, promulgation, or issuance of the requirement, to enable the
Commissioner to determine the intent behind the State or local
requirement.
(3) Copies of any judicial or administrative interpretations of the
State or local requirement.
(4) A comparison of the requirement of the State or political
subdivision and any Federal requirements under the act or the final
rule to show similarities and differences.
(5) Information on the nature of the problem addressed by the
requirement of the State or political subdivision.
(6) Identification of which (or both) of the following bases is
relied upon for seeking an exemption from preemption:
(a) The requirement is more stringent than a requirement applicable
to cigarettes or smokeless tobacco under the act or the final rule. If
the State or political subdivision relies upon this basis for exemption
from preemption, the application should include information or an
explanation as to how and why the requirement of the State or political
subdivision is more stringent than requirements under the act or the
final rule.
(b) The requirement is required by compelling local conditions, and
compliance with the requirement would not cause cigarettes or smokeless
tobacco to be in violation of any applicable requirement under the act
or the final rule. If the State or political subdivision relies upon
this basis for exemption from preemption, the application should
include information or an explanation as to why compliance with the
requirement of the State or political subdivision would not cause
cigarettes or smokeless tobacco to be in violation of any applicable
requirement under the act and why the requirement is required by
compelling local conditions.
(7) The title of the chief administrative or legal officers of the
State or local agency that has primary responsibility for
administration of the requirement.
(8) If requested by FDA, any records concerning administration of
the requirement.
(9) Information on how the public health may be benefitted and how
interstate commerce may be affected, if an exemption is granted.
(10) Any other pertinent information respecting the requirement
voluntarily submitted by the applicant.
(11) For local requirements that have been preempted under State
law, a copy of the relevant State preemptive provision and an
explanation of why the local requirement is no longer preempted under
State law.
IV. Procedures for Processing Applications
Because FDA anticipates that the issues raised within each group by
the applications for exemption will be similar or related, the agency
intends to consolidate all of the applications within each group and to
use a separate proceeding for each of the two groups. FDA notes that
the agency has consolidated proceedings on such matters in the past
(e.g., hearing aids). The process for each consolidated proceeding will
be as follows:
(1) Upon receipt of an application, FDA will evaluate the
application on its own merits and the circumstances applicable to the
jurisdiction submitting the application in order to determine whether
to grant or deny an exemption.
(2) FDA will issue a single Federal Register document (proposed
rule) for each group that will, for each applying State or local
government, propose to grant or deny exemptions from preemption for
existing State and local government requirements that fall within that
group. At the same time, FDA will issue a notice in the Federal
Register providing an opportunity to request an oral hearing. If a
hearing is granted, it will cover all applications for exemption from
preemption for those requirements that fall within the applicable
group, and it will be conducted under FDA regulations in 21 CFR parts
15 and 808.
(3) For each group, FDA will review all written comments submitted
on the proposed rule and the administrative record of the oral hearing,
if an oral hearing is granted, and will publish in the Federal Register
a final rule identifying each requirement for which an exemption from
preemption is granted, conditionally granted, or denied.
Specific details regarding the procedures under which applications
will be processed can be found in Sec. 808.25.
Applications submitted after the applicable dates set forth in this
document will be considered by FDA in the order that they are received
after the agency completes the proceedings described in this document.
Dated: November 1, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-28681 Filed 11-6-96; 8:45 am]
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