[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55923-55927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23099]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0480]


Draft Guidance for Industry: Submission of Warning Plans for 
Cigarettes and Smokeless Tobacco Products; Availability; Agency 
Information Collection Activities; Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Submission of 
Warning Plans for Cigarettes and Smokeless Tobacco Products.'' This 
draft guidance document is intended to assist persons submitting 
warning plans to FDA under the Comprehensive Smokeless Tobacco Health 
Education Act, as amended by the Family Smoking Prevention and Tobacco 
Control Act; and under the Federal Cigarette Labeling and Advertising 
Act, as amended by the Family Smoking Prevention and Tobacco Control 
Act, when that requirement takes effect.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 8, 2011.
    Submit either electronic or written comments on the proposed 
collection of information by November 8, 2011.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments, including comments 
regarding the proposed collection of information, to the Division of 
Dockets Management (HFA-305), Food and Drug

[[Page 55924]]

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance 
document entitled ``Submission of Warning Plans for Cigarettes and 
Smokeless Tobacco Products'' to the Center for Tobacco Products, Food 
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-
3229. Send one self-addressed adhesive label to assist that office in 
processing your request or include a fax number to which the draft 
guidance may be sent. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: 
    With regard to the draft guidance: Gail Schmerfeld, Center for 
Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 1-877-287-1373, [email protected].
    With regard to the proposed collection of information: Jonna 
Capezzuto, Office of Information Management, Food and Drug 
Administration, 1350 Piccard Dr., P150-400B, Rockville, MD 20850, 301-
796-3794, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of the draft guidance entitled 
``Submission of Warning Plans for Cigarettes and Smokeless Tobacco 
Products.'' This guidance, when finalized, will provide industry with 
information on how to submit warning plans for smokeless tobacco 
products under section 3 of the Comprehensive Smokeless Tobacco Health 
Education Act of 1986 (Smokeless Tobacco Act) and warning plans for 
cigarettes under section 4 of the Federal Cigarette Labeling and 
Advertising Act (FCLAA) when that requirement takes effect.
    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act grants FDA authority to regulate 
the manufacture, marketing, and distribution of tobacco products to 
protect public health generally and to reduce tobacco use by minors. 
Section 201 of the Tobacco Control Act amended section 4 of FCLAA (15 
U.S.C. 1333). When it takes effect, section 4 of FCLAA will require the 
submission of warning plans for cigarette packaging and advertising to 
FDA. Section 204 of the Tobacco Control Act amended section 3 of the 
Smokeless Tobacco Act (15 U.S.C. 4402), requiring the submission of 
warning plans for smokeless tobacco product packaging and advertising 
to FDA. The warning plans must be submitted by the tobacco product 
manufacturer, importer, distributor, or retailer, be approved by FDA, 
and provide for the random display of specified health warnings on 
packages and quarterly rotation of those health warnings in 
advertisements.
    This draft guidance is intended to assist persons submitting 
warning plans for cigarettes and for smokeless tobacco products. The 
guidance discusses, among other things: The statutory requirement to 
submit a warning plan; definitions; who submits a warning plan; the 
scope of a warning plan; when to submit a warning plan; what 
information to include in a warning plan; where to submit; and what 
approval of a warning plan means.

II. Significance of Guidance

    FDA is issuing this draft guidance document consistent with FDA's 
good guidance practices regulations (21 CFR 10.115). The draft 
guidance, when finalized, will represent the Agency's current thinking 
on ``Submission of Warning Plans for Cigarettes and Smokeless Tobacco 
Products.'' It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3520), 
Federal Agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) 
and 5 CFR 1320.3(c) and includes Agency requests or requirements that 
members of the public submit reports, keep records, or provide 
information to a third party. Section 3506(c)(2)(A) of the PRA (44 
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
Draft Guidance for Industry: Submission of Warning Plans for Cigarettes 
and Smokeless Tobacco Products (OMB Control Number 0910--New)
    This draft guidance is intended to assist persons submitting 
warning plans for smokeless tobacco products under section 3 of the 
Smokeless Tobacco Act and for cigarettes under section 4 of FCLAA, when 
that requirement takes effect. The guidance document discusses, among 
other things: The statutory requirement to submit a warning plan; 
definitions; who submits a warning plan; the scope of a warning plan; 
when to submit a warning plan; what information should be submitted in 
a warning plan; where to submit a warning plan; and what approval of a 
warning plan means. FDA may collect statutorily mandated warning plan 
information for smokeless tobacco products under OMB control number 
0910-0671. The purpose of the proposed information collection is to 
allow FDA to collect statutorily mandated information regarding warning 
plans for cigarettes and administrative information related to warning 
plans for both cigarettes and smokeless tobacco products.
    Section 4 of FCLAA states that each cigarette package and 
advertisement must bear one of nine health warning statements and 
requires the submission of warning plans for cigarette packages and 
advertisements to FDA for review and approval. These requirements are 
currently not in effect. Section 4(d) of FCLAA (15 U.S.C. 1333(d)) 
requires FDA to issue regulations that require color graphics depicting 
the negative health consequences of smoking to accompany those warning 
statements. Section 201(b) of the Tobacco Control Act states that the 
requirements take effect 15 months after FDA issues these regulations. 
Under the provision, however, if a cigarette product was manufactured 
prior to the effective date of the final rule but its package does not 
contain a required warning, the product may be introduced into commerce 
in the United States within 30 days from such effective date. After the 
30-day period,

[[Page 55925]]

manufacturers must not introduce into domestic commerce any cigarette 
the package of which does not contain a required warning (i.e., a 
textual warning statement and accompanying graphic), irrespective of 
the date of manufacture. FDA published a proposed rule regarding these 
requirements on November 12, 2010 (see 75 FR 69524). FDA published the 
final rule on June 22, 2011 (see 76 FR 36628). This rule is effective 
September 22, 2012.

A. Warning Plans for Cigarettes

    The requirement for submission of warning plans for cigarettes, and 
the specific requirements relating to the random display of required 
warnings on cigarette packaging and quarterly rotation of required 
warnings in cigarette advertising, appear at 15 U.S.C. 1333(c). In 
particular, warning plans for cigarette packaging must provide that all 
of the required warnings are randomly displayed in each 12-month period 
on each brand of the product; are randomly displayed in as equal a 
number of times as is possible on each brand of the product; and are 
randomly distributed in all areas of the United States in which the 
product is marketed. For FDA to approve it, a warning plan must provide 
for the required equal distribution and display of required warnings on 
packaging and must assure that all of the required warnings will be 
displayed by the manufacturer, importer, distributor, or retailer at 
the same time.
    For FDA to approve it, a warning plan for cigarette advertising 
must provide that all of the required warnings are rotated quarterly in 
alternating sequence in advertisements for each brand of cigarettes.
    Section 3 of the Smokeless Tobacco Act states that each smokeless 
tobacco product package and advertisement must bear one of four 
required warning statements and requires the submission of warning 
plans for smokeless tobacco product packages and advertisements to FDA 
for review and approval. The requirement for an FDA approved warning 
plan became effective June 22, 2010. On June 8, 2010, FDA announced by 
guidance its intent not to enforce the requirement that a brand of 
smokeless tobacco product must have an FDA-approved warning plan so 
long as a warning plan for the brand was submitted to FDA by July 22, 
2010, and implemented (see 75 FR 32481). FDA expects to begin enforcing 
the requirement under Section 3 that there be an approved warning plan 
6 months after the publication of the notice of availability of a final 
guidance on the ``Submission of Warning Plans for Cigarettes and 
Smokeless Tobacco Products'' or 6 months after the publication of a 
final regulation regarding the submission of warning plans, whichever 
comes first.

B. Warning Plans for Smokeless Tobacco Products

    The requirement for submission of warning plans for smokeless 
tobacco products, and the specific requirements relating to the random 
display of required warning statements on smokeless tobacco packaging 
and quarterly rotation of required warning statements in smokeless 
tobacco product advertising, appear at 15 U.S.C. 4402(b)(3). In 
particular, warning plans for smokeless tobacco product packaging must 
provide that all of the required warnings are randomly displayed in 
each 12-month period on each brand of the product; are randomly 
displayed in as equal a number of times as is possible on each brand of 
the product; and are randomly distributed in all areas of the United 
States in which the product is marketed. For FDA to approve it, a 
warning plan must provide for the required equal distribution and 
display of required warning statements on packaging and must assure 
that all of the required warning statements will be displayed by the 
manufacturer, importer, distributor, or retailer at the same time.
    Warning plans for smokeless tobacco product advertising must 
provide that all of the required warning statements are rotated 
quarterly in alternating sequence in advertisements for each brand of 
smokeless tobacco product.
    In an important change from prior law, outdoor billboard 
advertising for smokeless tobacco products must now include the 
required warning statements. Prior to its amendment by the Tobacco 
Control Act, the Smokeless Tobacco Act exempted outdoor billboard 
advertising from the requirement that smokeless tobacco product 
advertisements bear required warning statements, but the Tobacco 
Control Act amendments eliminated this exemption (which had been 
codified at 15 U.S.C. 4402(a)(2)). Thus, it is unlawful for any 
smokeless tobacco product manufacturer, packager, importer, 
distributor, or retailer to advertise or cause to be advertised within 
the United States a smokeless tobacco product on an outdoor billboard 
unless the advertisement bears one of the required warning statements.
    Because section 9(1) of the Smokeless Tobacco Act, 15 U.S.C. 
4408(1) (as amended by section 101(c) of the Tobacco Control Act), 
defines ``smokeless tobacco,'' by reference to section 900(18) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387(18)), as ``any 
tobacco product that consists of cut, ground, powdered, or leaf tobacco 
and that is intended to be placed in the oral or nasal cavity,'' 
smokeless tobacco products intended to be placed in the nasal cavity 
must now comply with the warning requirements in section 3 of the 
Smokeless Tobacco Act. At this time, as an exercise of enforcement 
discretion, FDA does not intend to commence or recommend enforcement of 
the requirement that smokeless tobacco products marketed solely for use 
in the nasal cavity bear either the ``WARNING: This product can cause 
mouth cancer'' or the ``WARNING: This product can cause gum disease and 
tooth loss'' so long as a warning plan providing that packages and 
advertising for such products will bear the other two warnings has been 
submitted to FDA and implemented. FDA will give further consideration 
to the warnings smokeless tobacco products marketed solely for use in 
the nasal cavity should bear. FDA intends to provide further public 
notice prior to revising or rescinding this enforcement policy.

C. Description of Respondents

    The respondents to this collection of information are 
manufacturers, importers, distributors, and retailers of cigarettes 
and/or smokeless tobacco products who are required to submit warning 
plans for cigarettes and smokeless tobacco products to FDA under FCLAA 
and the Smokeless Tobacco Act.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 55926]]



                                Table 1--Cigarette Warning Plans Reporting Burden
                                         [New Collection of Information]
----------------------------------------------------------------------------------------------------------------
                                                                     Number of       Hours per     Total burden
                 Respondent by type of document                     respondents      response          hours
----------------------------------------------------------------------------------------------------------------
                                                  Cover Letter
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers......................             226               5           1,130
Retailers.......................................................             544               5           2,720
Total Cover Letters.............................................             770  ..............           3,850
----------------------------------------------------------------------------------------------------------------
                                                  Warning Plan
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers......................             226             120          27,120
Retailers.......................................................             544             120          65,280
Total Warning Plans.............................................             770  ..............          92,400
Total Burden Hours..............................................  ..............  ..............          96,250
----------------------------------------------------------------------------------------------------------------


                        Table 2--Smokeless Tobacco Product Warning Plans Reporting Burden
                           [New Cover Letter Plus Existing Collection of Information]
----------------------------------------------------------------------------------------------------------------
                                                                     Number of       Hours per     Total burden
                 Respondent by type of document                     respondents      response          hours
----------------------------------------------------------------------------------------------------------------
                                                  Cover Letter
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers......................              20               5             100
Retailers.......................................................              10               5              50
Total Cover Letters.............................................              30  ..............             150
----------------------------------------------------------------------------------------------------------------
                                                  Warning Plan
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers *....................  ..............  ..............  ..............
Retailers.......................................................              10             120           1,200
Total Warning Plans *...........................................              10  ..............           1,200
Total Burden Hours..............................................  ..............  ..............           1,350
----------------------------------------------------------------------------------------------------------------
* The burden for collection of the warning plans for Smokeless Tobacco Products from manufacturers,
  distributors, and importers is approved and covered under OMB control number 0910-0671.

    FDA's estimate of the number of respondents in table 1 of this 
Federal Register document is based on the number of warning plans for 
cigarettes submitted to the Federal Trade Commission prior to the 
implementation of the Tobacco Control Act on June 22, 2009, which 
grants FDA authority to regulate the manufacture, marketing, and 
distribution of tobacco products to protect public health generally and 
to reduce tobacco use by minors. Using data from 34 State retailer 
lists, FDA identified 544 cigarette retailers who have 20 or more 
locations, and thus, may be more likely than smaller retailers to 
create their own advertisements and submit warning plans to FDA for 
those advertisements.
    Thus, FDA estimates the number of manufacturers, importers, 
distributors, and retailers who are expected to submit warning plans 
for cigarette products in table 1 of this Federal Register document to 
be 770. Based on its experience, FDA estimates it may take between 2 
and 8 hours to prepare and submit a cover letter, depending on the 
number of products and brands submitted. FDA estimates it could take 2 
to 3 days for a person in a smaller firm to prepare warning plans, and 
up to a week for a person in a larger firm, depending on the number of 
products and brands submitted.
    The burden hours for the preparation and submission of warning 
plans by manufacturers, distributors, and importers for smokeless 
tobacco products in table 2 of this document have already been approved 
by OMB under OMB control number 0910-0671. Based on plans submitted to 
FDA to date, we estimate the number of retailers who will submit 
warning plans for smokeless tobacco products to be 10. FDA estimates 
the burden hours for retailers to prepare warning plans to be 1,200. 
FDA estimates the additional burden hours for preparation of the cover 
letter is 150 hours (100 burden hours for manufacturers, distributors, 
and importers and 50 burden hours for retailers).
    FDA estimates, therefore, that it will take an average of 5 hours 
to prepare and submit a cover letter and 120 hours to prepare and 
submit a warning plan for packaging and advertising. The total number 
of burden hours are estimated to be 1,350 hours ([150 cover letter 
burden hours] + [1,200 warning plan burden hours].)

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of this draft guidance document at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.


[[Page 55927]]


    Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23099 Filed 9-8-11; 8:45 am]
BILLING CODE 4160-01-P