[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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