[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
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Total.......................................................... ............... ............... ............... ............... 300
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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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