[Federal Register Volume 84, Number 96 (Friday, May 17, 2019)]
[Notices]
[Pages 22496-22498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10291]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 the information collection for the
regulations restricting the sale and distribution of cigarettes and
smokeless tobacco to protect children and adolescents.
DATES: Submit either electronic or written comments on the collection
of information by July 16, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 16, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your
[[Page 22497]]
comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0977 for ``Regulations Restricting the Sale and Distribution
of Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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 1140.30
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 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 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.
FDA estimates the burden of this collection of information as
follows:
[[Page 22498]]
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.... 25 1 25 1 25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10291 Filed 5-16-19; 8:45 am]
BILLING CODE 4164-01-P