Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents, 1428-1429 [2016-00326]
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Federal Register / Vol. 81, No. 7 / Tuesday, January 12, 2016 / Notices
subsequent discussion paper (see
SUPPLEMENTARY INFORMATION). FDA will
do its best to accommodate requests to
make public comment. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the focused sessions. All requests to
make oral presentations must be
received by February 2, 2016. FDA will
determine the amount of time allotted to
each presenter and the approximate
time each oral presentation is to begin,
and will select and notify participants
by February 8, 2016. If selected for
presentation, any presentation materials
must be emailed to Jennifer Dickey (see
FOR FURTHER INFORMATION CONTACT) no
later than February 16, 2016, at 4 p.m.
No commercial promotional material
will be permitted to be presented or
distributed at this public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information Office address
is available on the Agency’s Web site at
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transcripts will also be available
approximately 45 days after the public
workshop on the Internet at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
tkelley on DSK3SPTVN1PROD with NOTICES
III. Reference
The following reference is on display
in the Division of Dockets Management
(see ADDRESSES) and is available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; it is also available electronically
at https://www.regulations.gov. FDA has
verified the Web site address, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
1. Please refer to FDA’s Web site on
companion diagnostics, available at
https://www.fda.gov/
companiondiagnostics.
Dated: January 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–00328 Filed 1–11–16; 8:45 am]
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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.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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
regulations restricting the sale and
distribution of cigarettes and smokeless
tobacco to protect children and
adolescents.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by March 14, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
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
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
PO 00000
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless
Tobacco to Protect Children and
Adolescents.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. 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
E:\FR\FM\12JAN1.SGM
12JAN1
1429
Federal Register / Vol. 81, No. 7 / Tuesday, January 12, 2016 / Notices
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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
SUPPLEMENTARY INFORMATION:
21 CFR 1140.30 ..............................
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.
Reporting .......................................
Regulations Restricting the Sale and
Distribution of Cigarettes and
Smokeless Tobacco to Protect Children
and Adolescents—21 CFR 1140
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 § 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.
The requirements are as follows:
Directs persons to notify FDA if they intend to use a form of advertising that is not originally described in the March 19, 2010, final
rule.
FDA estimates the burden of this
collection of information as follows:
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) ...........................................................................
300
1
300
1
300
tkelley on DSK3SPTVN1PROD with NOTICES
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.
Section 1140.30 requires
manufacturers, distributors, and
retailers: (1) To observe certain format
and content requirements for labeling
and advertising, and (2) to notify FDA
if they intend to use an advertising
medium that is not listed in the
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20:14 Jan 11, 2016
Jkt 238001
regulations. The concept of permitted
advertising in § 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. Therefore, FDA
estimates that the total time required for
this collection of information is 300
hours.
PO 00000
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Dated: January 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–00326 Filed 1–11–16; 8:45 am]
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Agencies
[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Notices]
[Pages 1428-1429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00326]
-----------------------------------------------------------------------
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 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 March 14, 2016.
ADDRESSES: You may submit comments as follows:
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 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Regulations Restricting the Sale
and Distribution of Cigarettes and Smokeless Tobacco to Protect
Children and Adolescents.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management 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 Division of Dockets Management. 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
[[Page 1429]]
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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
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 Sec. 897.24) and Sec. 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. The
requirements are as follows:
------------------------------------------------------------------------
------------------------------------------------------------------------
21 CFR 1140.30................ Reporting........ Directs persons to
notify FDA if they
intend to use a form
of advertising that
is not originally
described in the
March 19, 2010,
final rule.
------------------------------------------------------------------------
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.
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.
Section 1140.30 requires manufacturers, distributors, and
retailers: (1) To observe certain format and content requirements for
labeling and advertising, and (2) 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. Therefore, FDA estimates that the total
time required for this collection of information is 300 hours.
Dated: January 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00326 Filed 1-11-16; 8:45 am]
BILLING CODE 4164-01-P