Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act, 27638-27640 [2019-12472]
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27638
Federal Register / Vol. 84, No. 114 / Thursday, June 13, 2019 / Notices
premarket submissions for other devices
that are intended to contact gametes
and/or embryos during their use.
However, there are no voluntary
consensus standards that describe how
to conduct the MEA. This draft
guidance provides recommendations for
conducting the MEA to support
premarket submissions for devices that
are intended to contact gametes and/or
embryos and to comply with the special
controls for those devices classified
under 21 CFR 884 that require MEA
testing or information.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Mouse Embryo Assay for Assisted
Reproduction Technology Devices.’’ It
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Mouse Embryo Assay for Assisted
Reproduction Technology Devices’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 16015 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in the
following FDA regulations have been
approved by OMB as listed in the
following table:
OMB Control
No.
21 CFR Part
Topic
807, subpart E ...........................................
800, 801, and 809 .....................................
Premarket Notification ..................................................................................................
Medical Device Labeling Regulations ..........................................................................
Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12430 Filed 6–12–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0190]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Requirements
Under the Comprehensive Smokeless
Tobacco Health Education Act of 1986,
as Amended by the Family Smoking
Prevention and Tobacco Control Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
khammond on DSKBBV9HB2PROD with NOTICES
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
VerDate Sep<11>2014
16:55 Jun 12, 2019
Jkt 247001
response to the notice. This notice
solicits comments on the information
collection ‘‘Requirements Under the
Comprehensive Smokeless Tobacco
Health Education Act of 1986, as
Amended by the Family Smoking
Prevention and Tobacco Control Act.’’
DATES: Submit either electronic or
written comments on the collection of
information by August 12, 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 August 12,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 12, 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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
0910–0120
0910–0485
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): 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–
2013–N–0190 for ‘‘Requirements Under
E:\FR\FM\13JNN1.SGM
13JNN1
27639
Federal Register / Vol. 84, No. 114 / Thursday, June 13, 2019 / Notices
khammond on DSKBBV9HB2PROD with NOTICES
the Comprehensive Smokeless Tobacco
Health Education Act of 1986, as
Amended by the Family Smoking
Prevention and Tobacco Control Act.’’
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/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.
Requirements Under the
Comprehensive Smokeless Tobacco
Health Education Act of 1986, as
Amended by the Family Smoking
Prevention and Tobacco Control Act
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.
OMB Control Number 0910–0671—
Extension
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.
SUPPLEMENTARY INFORMATION:
The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) was enacted on June 22, 2009,
amending the Federal Food, Drug, and
Cosmetic Act and providing FDA with
the authority to regulate tobacco
products (Pub. L. 111–31). Section 3 of
the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (the
Smokeless Tobacco Act) (15 U.S.C.
4402), as amended by section 204 of the
Tobacco Control Act, requires, among
other things, that all smokeless tobacco
product packages and advertisements
bear one of four required warning
statements. Section 3(b)(3)(A) of the
Smokeless Tobacco Act requires that the
warnings be displayed on packaging and
advertising for each brand of smokeless
tobacco ‘‘in accordance with a plan
submitted by the tobacco product
manufacturer, importer, distributor, or
retailer’’ to, and approved by, FDA.
This information collection, the
submission to FDA of warning plans for
smokeless tobacco products, is
statutorily mandated. The warning
plans will be reviewed by FDA, as
required by the Smokeless Tobacco Act,
to determine whether the companies’
plans for the equal distribution and
display of warning statements on
packaging and the quarterly rotation of
warning statements in advertising for
each brand of smokeless tobacco
products comply with section 3 of the
Smokeless Tobacco Act, as amended.
Additionally, FDA considers a
submission to be a supplement if the
submitter is seeking approval of a
change to an FDA-approved warning
plan.
Based on FDA’s experience over the
past several years, FDA believes the
estimate of 60 hours to complete an
initial rotational plan continues to be
accurate. If a supplement to an
approved plan is submitted, FDA
estimates it will take half the time per
response (30 hours).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Activity
Submission of Initial rotational plans for health warning statements ...............
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4
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Number of
responses
per
respondent
Total annual
responses
1
E:\FR\FM\13JNN1.SGM
Average
burden per
response
4
13JNN1
60
Total hours
Total capital
costs
240
$48
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Federal Register / Vol. 84, No. 114 / Thursday, June 13, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued
Number of
respondents
Activity
Number of
responses
per
respondent
Total annual
responses
Total hours
Total capital
costs
Supplement to approved plan ...........................................................................
10
1
10
30
300
120
Total ...........................................................................................................
....................
....................
....................
....................
540
168
FDA estimates a total of 4 respondents
will submit a new original warning plan
and take 60 hours to complete a
rotational warning plan for a total of 240
burden hours. In addition, 10
respondents will submit a supplement
to an approved warning plan at 30 hours
per response for a total of 300 hours.
The total burden for this collection is
estimated to be 540 hours.
Capital costs are based on 14
respondents mailing in their submission
at a postage rate of $12 for a 5-pound
parcel (business parcel post mail
delivered from the furthest delivery
zone). Therefore, FDA estimates that the
total postage cost for mailing the
rotational warning plans FDA to be
$168.
We have adjusted our burden
estimate, which has resulted in a
decrease of 5,460 hours and 86
respondents to the currently approved
burden. We received a total number of
44 original smokeless warning plans,
and a total of 17 supplements. After
receiving the initial influx of original
warnings plans, FDA does not expect to
receive as many original warning plans
annually. We expect that a few
supplements will continue to be
received as new products are marketed
or as warning plans are revised. We
anticipate a total number of 10
supplements submitted annually and 4
original smokeless warning plans.
Dated: June 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
The Office of the Assistant
Secretary for Health published a
document in the Federal Register of
June 3, 2019, announcing the Pain
Management Best Practices InterAgency Task Force’s virtual public
meeting. This document is announcing
a change in the meeting date.
FOR FURTHER INFORMATION CONTACT: Ms.
Alicia Richmond Scott, 240–453–2816;
paintaskforce@hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Correction
In the Federal Register of June 3,
2019, in FR Doc. 2019–11473, on page
25548, in the first column, correct the
DATES caption to read:
DATES: The Task Force meeting will be
held on Wednesday, June 26, 2019 from
5:00 p.m. to 6:30 p.m. Eastern Time
(ET). The agenda will be posted on the
Task Force website at https://
www.hhs.gov/ash/advisory-committees/
pain/.
Dated: June 6, 2019.
Vanila M. Singh,
Chief Medical Officer, Chair, Pain
Management Best Practices Inter-Agency
Task Force, Office of the Assistant Secretary
for Health.
[FR Doc. 2019–12482 Filed 6–12–19; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
[FR Doc. 2019–12472 Filed 6–12–19; 8:45 am]
BILLING CODE 4164–01–P
Center for Scientific Review; Notice of
Closed Meetings
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
Office of the Assistant Secretary for
Health
khammond on DSKBBV9HB2PROD with NOTICES
Average
burden per
response
Meeting of the Pain Management Best
Practices Inter-Agency Task Force;
Correction
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice; correction.
AGENCY:
VerDate Sep<11>2014
16:55 Jun 12, 2019
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR17–094:
Maximizing Investigators’ Research Award
(R35).
Date: July 9, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Baishali Maskeri, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2022,
Bethesda, MD 20892, 301–827–2864,
maskerib@mail.nih.gov
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA Panel:
Healthy Brain and Child Development Study
(Healthy BCD).
Date: July 11, 2019.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Capital View, 2850
South Potomac Avenue, Arlington, VA 22202
Contact Person: Heidi B. Friedman, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1012A,
MSC 7770, Bethesda, MD 20892, 301–379–
5632, hfriedman@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Chronic Disease and the Reduction of Health
Disparities.
Date: July 12, 2019.
Time: 10:30 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Karen Nieves Lugo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, Bethesda, MD 20892,
karen.nieveslugo@nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group;
Population and Public Health Approaches to
HIV/AIDS Study Section
Date: July 15–16, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications,
Place: Hotel Nikko San Francisco, 222
Mason Street, San Francisco, CA 94102
Contact Person: Jose H. Guerrier, Ph.D.,
Scientific Review Officer, Center for
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]]>Agencies
[Federal Register Volume 84, Number 114 (Thursday, June 13, 2019)]
[Notices]
[Pages 27638-27640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0190]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Requirements Under the Comprehensive Smokeless Tobacco
Health Education Act of 1986, as Amended by the Family Smoking
Prevention and Tobacco Control Act
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 ``Requirements Under
the Comprehensive Smokeless Tobacco Health Education Act of 1986, as
Amended by the Family Smoking Prevention and Tobacco Control Act.''
DATES: Submit either electronic or written comments on the collection
of information by August 12, 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 August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 12, 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 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-2013-N-0190 for ``Requirements Under
[[Page 27639]]
the Comprehensive Smokeless Tobacco Health Education Act of 1986, as
Amended by the Family Smoking Prevention and Tobacco Control Act.''
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.
Requirements Under the Comprehensive Smokeless Tobacco Health Education
Act of 1986, as Amended by the Family Smoking Prevention and Tobacco
Control Act
OMB Control Number 0910-0671--Extension
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) was enacted on June 22, 2009, amending the Federal Food,
Drug, and Cosmetic Act and providing FDA with the authority to regulate
tobacco products (Pub. L. 111-31). Section 3 of the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (the Smokeless Tobacco
Act) (15 U.S.C. 4402), as amended by section 204 of the Tobacco Control
Act, requires, among other things, that all smokeless tobacco product
packages and advertisements bear one of four required warning
statements. Section 3(b)(3)(A) of the Smokeless Tobacco Act requires
that the warnings be displayed on packaging and advertising for each
brand of smokeless tobacco ``in accordance with a plan submitted by the
tobacco product manufacturer, importer, distributor, or retailer'' to,
and approved by, FDA.
This information collection, the submission to FDA of warning plans
for smokeless tobacco products, is statutorily mandated. The warning
plans will be reviewed by FDA, as required by the Smokeless Tobacco
Act, to determine whether the companies' plans for the equal
distribution and display of warning statements on packaging and the
quarterly rotation of warning statements in advertising for each brand
of smokeless tobacco products comply with section 3 of the Smokeless
Tobacco Act, as amended. Additionally, FDA considers a submission to be
a supplement if the submitter is seeking approval of a change to an
FDA-approved warning plan.
Based on FDA's experience over the past several years, FDA believes
the estimate of 60 hours to complete an initial rotational plan
continues to be accurate. If a supplement to an approved plan is
submitted, FDA estimates it will take half the time per response (30
hours).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total Average Total
Activity respondents per annual burden per Total hours capital
respondent responses response costs
----------------------------------------------------------------------------------------------------------------
Submission of Initial rotational 4 1 4 60 240 $48
plans for health warning
statements.......................
[[Page 27640]]
Supplement to approved plan....... 10 1 10 30 300 120
-----------------------------------------------------------------------------
Total......................... ........... ........... ........... ........... 540 168
----------------------------------------------------------------------------------------------------------------
FDA estimates a total of 4 respondents will submit a new original
warning plan and take 60 hours to complete a rotational warning plan
for a total of 240 burden hours. In addition, 10 respondents will
submit a supplement to an approved warning plan at 30 hours per
response for a total of 300 hours. The total burden for this collection
is estimated to be 540 hours.
Capital costs are based on 14 respondents mailing in their
submission at a postage rate of $12 for a 5-pound parcel (business
parcel post mail delivered from the furthest delivery zone). Therefore,
FDA estimates that the total postage cost for mailing the rotational
warning plans FDA to be $168.
We have adjusted our burden estimate, which has resulted in a
decrease of 5,460 hours and 86 respondents to the currently approved
burden. We received a total number of 44 original smokeless warning
plans, and a total of 17 supplements. After receiving the initial
influx of original warnings plans, FDA does not expect to receive as
many original warning plans annually. We expect that a few supplements
will continue to be received as new products are marketed or as warning
plans are revised. We anticipate a total number of 10 supplements
submitted annually and 4 original smokeless warning plans.
Dated: June 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12472 Filed 6-12-19; 8:45 am]
BILLING CODE 4164-01-P
