[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Pages 59622-59624]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0977]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Regulations Restricting 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 announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on regulations restricting the 
sale and distribution of cigarettes and smokeless tobacco to protect 
children and adolescents.

[[Page 59623]]


DATES: Submit either electronic or written comments on the collection 
of information by November 27, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
daniel.gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the 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, including 
each proposed extension of an existing 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.
    Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco to Protect Children and Adolescents--21 CFR 1140 (OMB 
Control Number 0910-0312)--Renewal
    This is a request for a renewal of OMB approval of the information 
collection requirements contained in FDA's regulations for cigarettes 
and smokeless tobacco containing nicotine. The regulations that are 
codified at 21 CFR Part 1140 (previously codified at 21 CFR Part 897) 
are authorized by section 102 of the Family Smoking Prevention and 
Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31). Section 102 
of the Tobacco Control Act required FDA to publish a final rule 
regarding cigarettes and smokeless tobacco identical in its provisions 
to the regulation issued by FDA in 1996 (61 FR 44396, August 28, 1996), 
with certain specified exceptions including subpart C (which included 
897.24) and 897.32(c) be removed from the reissued rule (section 
102(a)(2)(B)). The reissued final rule was published in the Federal 
Register on March 19, 2010 (75 FR 13225).
    This collection includes reporting information requirements for 
1140.30 (formerly 897.30) which directs persons to notify FDA if they 
intend to use a form of advertising that is not addressed in the 
regulations. Disclosure requirements for 1140.32 (formerly 897.32) 
states that the advertising must use black text on a white background, 
but that this particular requirement does not apply to adult 
newspapers, magazines, periodicals, or other publications. 
Recordkeeping requirements under 1140.32 indicate that competent and 
reliable survey evidence is required to determine whether a particular 
publication is an ``adult'' publication.
    The requirements are as follows:

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21 CFR 1140.30...........................  Reporting...............................  Directs persons to notify
                                                                                      FDA if they intend to use
                                                                                      a form of advertising that
                                                                                      is not originally
                                                                                      described in the March 19,
                                                                                      2010, final rule.
21 CFR 1140.32...........................  Disclosure..............................  Requires firms to use black
                                                                                      text on white backgrounds
                                                                                      in labeling and
                                                                                      advertising.
21 CFR 1140.32...........................  Recordkeeping...........................  Firms advertising in
                                                                                      ``adult'' magazines or
                                                                                      publications may need
                                                                                      survey evidence
                                                                                      demonstrating that the
                                                                                      publication meets the
                                                                                      criteria for an ``adult''
                                                                                      publication.
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    For the disclosure and recordkeeping requirements under 1140.32, 
FDA has decided to use its discretionary enforcement and has placed 
placeholders of 1 burden hour for disclosure and 1 burden hour for 
reporting because FDA does not intend to enforce the requirements for 
this section for the next 3 years.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                           21 CFR Section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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1140.30 (Scope of permissible forms of labeling and advertising)...             300                1              300                1              300
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ...............  ...............  ...............  ...............             300
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 59624]]


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                           21 CFR section                               Number of       records per      Total annual     per record-      Total hours
                                                                      record-keepers   record-keeper       records          keeping
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1140.32 (Format and content requirements for labeling and                         1                1                1                1                1
 advertising)......................................................
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    Total..........................................................  ...............  ...............  ...............  ...............               1
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                           21 CFR section                               Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
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1140.32............................................................               1                1                1                1                1
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden hour estimates for this collection of information were 
based on industry-prepared data and information regarding 
pharmaceutical advertising and cigarette and smokeless tobacco product 
advertising expenditures. The burden collection does not include 
reporting burdens associated with providing established names on labels 
and statements of intended use because section 102 of the Tobacco 
Control Act required that these provisions be struck from the reissued 
final rule (previously included in 897.24 and 897.32(c)).
    Section 1140.30 (previously 897.30) requires manufacturers, 
distributors, and retailers to observe certain format and content 
requirements for labeling and advertising, and requires manufacturers, 
distributors, and retailers to notify FDA if they intend to use an 
advertising medium that is not listed in the regulations. The concept 
of permitted advertising in 1140.30 is sufficiently broad to encompass 
most forms of advertising. FDA estimates that approximately 300 
respondents will submit an annual notice of alternative advertising, 
and the Agency has estimated it should take 1 hour to provide such 
notice.
    For the recordkeeping and disclosure requirements, 1140.32 
(previously 897.32) requires competent and reliable survey evidence to 
establish whether a newspaper, magazine, periodical, or other 
publication qualifies as an ``adult'' publication. Section 1140.32 also 
requires the use of a black text on a white background for labeling and 
advertising. The respondent and hourly burden for recordkeeping and 
disclosure under this section (2 burden hours total) reflect 
placeholders for the number of manufacturers who would keep records 
under this section.
    During the next 3 years, FDA does not intend to enforce the 
recordkeeping and disclosure requirements of 1140.32 and has revised 
the burden to act as a placeholder in the event FDA exercises its 
authority to enforce the requirements of this section in the future.
    FDA estimates that the total time required for this collection of 
information is 302 hours.

    Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23833 Filed 9-27-12; 8:45 am]
BILLING CODE 4160-01-P