Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents, 22496-22498 [2019-10291]
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22496
Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
and spousal support above a threshold
to the Department of State, which will
then deny passports to these
individuals. On an ongoing basis, child
support enforcement agencies submit to
OCSE the names, Social Security
numbers, and the amount(s) of past-due
child and spousal support of
noncustodial parents who are
delinquent in making payments.
The information collection activities
pertaining to the Federal Tax Refund
Offset, Administrative Offset, and
Passport Denial programs are authorized
by: (1) 42 U.S.C. 652(b), 42 U.S.C. 664,
26 U.S.C. 6402(c), 31 CFR 285.3, 45 CFR
302.60, and 45 CFR 303.72, which
require state child support agencies to
submit information pertaining to pastdue support cases meeting specific
criteria for the offset of the federal tax
refund of the noncustodial parent; (2) 31
U.S.C. 3701 et seq., 31 U.S.C. 3716(h),
and 31 CFR 285.1, which require state
child support agencies to submit
information pertaining to past-due
support cases meeting specific criteria
for the administrative offset of federal
payments other than federal tax refunds
of the noncustodial parent; (3) 42 U.S.C.
652(k), 42 U.S.C. 654(31), and 22 CFR
51.60, which require state child support
agencies to submit information to OCSE
pertaining to past-due support cases
meeting specific criteria for the denial,
revocation, restriction, or limitation of
the passport of the noncustodial parent;
and (4) 42 U.S.C. 654(31), 42 U.S.C. 664,
31 CFR 285.1, and 31 CFR 285.3, which
require state child support agencies to
submit the Annual Certification Letter
to OCSE asserting that each case
submitted for the Federal Tax Refund
Offset, Administrative Offset, and
Passport Denial programs meets federal
requirements.
Respondents: Child Support
Enforcement Agencies
ANNUAL BURDEN ESTIMATES
Number of
respondents
Information collection instrument
Input Record ....................................................................................................
Output Record .................................................................................................
Payment File ....................................................................................................
Certification Letter ............................................................................................
Portal Processing screens ...............................................................................
Estimated Total Burden Hours: 3,020.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201,
Attention Reports Clearance Officer. All
requests should be identified by the
information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
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BILLING CODE 4184–41–P
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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.
Frm 00067
Fmt 4703
52
52
52
1
280.65
Average
burden hours
per response
.3
.46
.135
.4
.01
Total burden
hours
842.4
1291.7
379.1
21.6
485.52
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.
ADDRESSES:
Electronic Submissions
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.
SUMMARY:
PO 00000
Number of
responses per
respondent
Sfmt 4703
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
E:\FR\FM\17MYN1.SGM
17MYN1
Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
jbell on DSK3GLQ082PROD with NOTICES
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
VerDate Sep<11>2014
17:05 May 16, 2019
Jkt 247001
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/201523389.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, PRAStaff@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
PO 00000
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22497
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 § 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 § 1140.30 is
sufficiently broad to encompass most
forms of advertising.
FDA estimates the burden of this
collection of information as follows:
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22498
Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 17,
2019.
Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2019–10291 Filed 5–16–19; 8:45 am]
BILLING CODE 4164–01–P
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Tobacco Products, User Fees,
Requirements for the Submission of
Data Needed To Calculate User Fees for
Domestic Manufacturers and Importers
of Tobacco Products
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3031]
OMB Control Number 0910–0749—
Extension
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Tobacco Products,
User Fees, Requirements for the
Submission of Data Needed To
Calculate User Fees for Domestic
Manufacturers and Importers of
Tobacco Products
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (the Tobacco Control Act)
(Pub. L. 111–31) was signed into law.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) and granted FDA authority
to regulate the manufacture, marketing,
and distribution of tobacco products to
protect public health generally and to
reduce tobacco use by minors.
FDA issued a final rule that requires
domestic manufacturers and importers
of cigars and pipe tobacco to submit
information needed to calculate the
amount of user fees assessed under the
FD&C Act (https://www.govinfo.gov/
content/pkg/FR-2016-05-10/pdf/2016-
AGENCY:
Food and Drug Administration,
HHS.
jbell on DSK3GLQ082PROD with NOTICES
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 0910–0749. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
SUMMARY:
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17:05 May 16, 2019
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PO 00000
Frm 00069
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Sfmt 4703
10688.pdf). FDA expanded its authority
over tobacco products by issuing
another final rule, ‘‘Deeming Tobacco
Products To Be Subject to the Federal
Food, Drug, and Cosmetic Act, as
Amended by the Family Smoking
Prevention and Tobacco Control Act;
Restrictions on the Sale and Distribution
of Tobacco Products and Required
Warning Statements for Tobacco
Products’’ (Deeming rule), deeming all
products that meet the statutory
definition of ‘‘tobacco product,’’ except
accessories of the newly deemed
tobacco products, to be subject to the
FD&C Act (https://www.govinfo.gov/
content/pkg/FR-2016-05-10/pdf/201610685.pdf). The Deeming rule, among
other things, subjected domestic
manufacturers and importers of cigars
and pipe tobacco to the FD&C Act’s user
fee requirements. Consistent with the
Deeming rule and the requirements of
the FD&C Act, the user fee final rule
requires the submission of the
information needed to calculate user fee
assessments for each manufacturer and
importer of cigars and pipe tobacco to
FDA.
As noted, FDA issued a final rule that
requires domestic tobacco product
manufacturers and importers to submit
information needed to calculate the
amount of user fees assessed under the
FD&C Act. The U.S. Department of
Agriculture (USDA) had been collecting
this information and provided FDA with
the data the Agency needed to calculate
the amount of user fees assessed to
tobacco product manufacturers and
importers. USDA ceased collecting this
information in fiscal year 2015 (October
2014). USDA’s information collection
did not require OMB approval, per an
exemption by Public Law 108–357,
section 642(b)(3). Consistent with the
requirements of the FD&C Act, FDA
requires the submission of this
information to FDA now instead of
USDA. FDA took this action to ensure
that the Agency continues to have the
information needed to calculate, assess,
and collect user fees from domestic
manufacturers and importers of tobacco
products.
Section 919(a) of the FD&C Act (21
U.S.C. 387s(a)) requires FDA to ‘‘assess
user fees on, and collect such fees from,
E:\FR\FM\17MYN1.SGM
17MYN1
]]>Agencies
[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
