Document ID: FDA-2012-N-0977-0009
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2019-11-01T04:00Z

[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Notices]
[Pages 58721-58722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23934]

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

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 
December 2, 2019.

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-

[[Page 58722]]

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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.

Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco To Protect Children and Adolescents--21 CFR 1140.30

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 21 CFR 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 (21 CFR 1140.30), which directs persons to notify FDA if 
they intend to use a form of advertising that is not addressed in the 
regulations and not originally described in the March 19, 2010, final 
rule. Section 1140.30 requires manufacturers, distributors, and 
retailers to (1) observe certain format and content requirements for 
labeling and advertising and (2) 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.
    In the Federal Register of May 17, 2019 (84 FR 22496), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received that was PRA 
related. The commenter stated that this program is ineffective and has 
no effect on whether Americans smoke. FDA disagrees. Section 1140.30 is 
intended to help protect children and adolescents by reducing the 
appeal of cigarettes and smokeless tobacco to them. Section 1140.30, in 
part, contains a comprehensive list of permissible forms of advertising 
and labeling; in the unlikely event that a person wishes to use a form 
of advertising or labeling that is not described in Sec.  1140.30, the 
section directs respondents to notify FDA of the form of advertising or 
labeling they intend to use.
    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                 25               1              25               1              25
 forms of labeling and
 advertising....................
----------------------------------------------------------------------------------------------------------------
\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.
    FDA estimates that approximately 25 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 25 
hours.
    We have adjusted our burden estimate to approximately 25 
notifications annually, which more accurately reflects the current 
number of submissions under this regulation. This is a decrease to the 
currently approved burden. The decrease in notifications is not 
unexpected given that the regulation applies to cigarettes and 
smokeless tobacco and many of the alternative media notifications have 
been made in previous years.

    Dated: October 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23934 Filed 10-31-19; 8:45 am]
 BILLING CODE 4164-01-P