[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Notices]
[Pages 58721-58722]
[FR Doc No: 2019-23934]

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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.

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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
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-

395-7285, or emailed to<EMAIL_ADDRESS>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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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\
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                                                     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....................
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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.
    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


? Need to return call by / at/ between and . Signature: Project No.: 0<IP_ADDRESS> DISTRIBUTION Page __ 1_ of _ 1_

Project Name: Petroleum Refining Detailed Study TELEPHONE CALL RECORD Outgoing Call Date: 10/ 23/ 2003 Time: 11 AM Company Name: ERG, Cincinatti Contact Name: Walt Koucky Phone No.: 513 281 3047 Name: Betsy Bicknell Eastern Research Group, Inc.

GENERAL SUBJECT : Petroleum Refinery Wastewater Issues TOPICS DISCUSSED AND ACTION TAKEN Walt Koucky is experienced issues related to Clean Air Act enforcement at petroleum refineries, particularly PSD/ NSR analysis.

Mr. Koucky didn't have any suggestions about the process sources of dioxins, metals, or PACs. He did not have any suggestions for vendors that specialized in the petroleum refining industry.

Mr. Koucky mentioned that a lot of the wastewater treatment at refineries is in impoundments. He suggested that the OSW surface impoundment survey might be a source of data characterizing untreated petroleum refinery wastewater.