[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Notices]
[Pages 20923-20924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08034]


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

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.

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

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 May 8, 
2013.

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 [email protected]. 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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

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.

Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco To Protect Children and Adolescents--21 CFR Part 1140 
(OMB Control Number 0910-0312)--Revision

    This is a request for an extension 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--which included striking 
subpart C (with Sec.  897.24) and Sec.  897.32(c) 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 
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. 
Disclosure requirements for Sec.  1140.32 state 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 Sec.  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:
     Reporting--Sec.  1140.30 directs persons to notify FDA if 
they intend to use a form of advertising that is not described in Sec.  
1140.30(a)(1).
     Disclosure--Sec.  1140.32 requires firms to use black text 
on white backgrounds in labeling and advertising.
     Recordkeeping--Sec.  1140.32 indicates that firms 
advertising in ``adult'' magazines or publications may need survey 
evidence demonstrating that the publication meets the criteria for an 
``adult'' publication.
    For the disclosure and recordkeeping requirements under Sec.  
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.
    In the Federal Register of September 28, 2012 (77 FR 59622), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR Section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.30 (Scope of permissible forms of labeling and advertising)...             300                1              300                1              300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


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


[[Page 20924]]


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR Section                               Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.32............................................................               1                1                1                1                1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Sec. Sec.  897.24 and 897.32(c)).
    Section 1140.30 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 
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.
    For the recordkeeping and disclosure requirements, Sec.  1140.32 
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 Sec.  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: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08034 Filed 4-5-13; 8:45 am]
BILLING CODE 4160-01-P