
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40319-40320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
21, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0312. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

[[Page 40320]]

Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco To Protect Children and Adolescents OMB Control 
Number 0910-0312--Extension

    This is a request for an extension of OMB approval for 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 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 
that subpart C (which included 21 CFR 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 of March 19, 2010 (75 FR 13225).
    This collection includes reporting information requirements for 
Sec.  1140.30 which directs persons to notify FDA if they intend to use 
a form of advertising that is not addressed in the regulations. The 
requirements are as follows:

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Sec.   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.
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    In the Federal Register of January 12, 2016 (81 FR 1428), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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              300                1              300                1              300
 Advertising........................................
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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 cigarette and 
smokeless tobacco product advertising expenditures.
    Section 1140.30 requires manufacturers, distributors, and 
retailers: (1) To observe certain format and content requirements for 
labeling and advertising and (2) to notify FDA if they intend to use an 
advertising medium that is not listed in the regulations. The concept 
of permitted advertising in Sec.  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. Therefore, FDA estimates that the total time 
required for this collection of information is 300 hours.

    Dated: June 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14628 Filed 6-20-16; 8:45 am]
 BILLING CODE 4164-01-P


