Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act, 48813-48814 [2016-17569]
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Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
such recommendations should contain,
at a minimum, the following
information: (1) Title of the standard, (2)
any reference number and date, (3)
name and address of the national or
international standards development
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply, and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
Food and Drug Administration
[Docket No. FDA–2013–N–0190]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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:
VI. Electronic Access
Food and Drug Administration,
HHS.
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. The Center for Devices and
Radiological Health (CDRH) maintains a
site on the Internet for easy access to
information including text, graphics,
and files that you may download to a
personal computer with access to the
Internet. Updated on a regular basis, the
CDRH home page, https://www.fda.gov/
MedicalDevices, includes a link to
standards-related documents including
the guidance and the current list of
recognized standards. After publication
in the Federal Register, this notice
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 044’’ will be available at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. You may
access ‘‘Guidance on the Recognition
and Use of Consensus Standards,’’ and
the searchable database for ‘‘FDA
Recognized Consensus Standards’’ at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards.
Dated: July 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17570 Filed 7–25–16; 8:45 am]
BILLING CODE 4164–01–P
srobinson on DSK5SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 25,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0671. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
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 (the Tobacco
Control Act) was enacted on June 22,
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48813
2009, amending the Federal Food, Drug,
and Cosmetic Act and providing FDA
with the authority to regulate tobacco
products (Pub. L. 111–31; 123 Stat.
1776). 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.
Based on the Federal Trade
Commission’s (FTC’s) previous
experience with the submission of
warning plans and FDA’s experience,
FDA estimates that there are 52
companies affected by this information
collection. To account for the entry of
new smokeless tobacco companies that
may be affected by this information
collection, FDA is conservatively
estimating the total number of annual
respondents to this collection of
information to be 100.
When the FTC requested an extension
of their approved warning plan
information collection in 2007, based on
over 20 years implementing the warning
plan requirements and taking into
account increased computerization and
improvements in electronic
communication, the FTC estimated
submitting an initial plan would take 60
hours. 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
reasonable.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\26JYN1.SGM
26JYN1
48814
Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Numbers of
respondents
Numbers of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Submission of rotational plans for health
warning statements ..............................
100
1
100
60
6,000
1 There
$1,200
are no operating and maintenance costs associated with this collection of information.
FDA estimates a total of 100
respondents will respond to this
collection of information and take 60
hours to complete a rotational warning
plan for a total of 6,000 burden hours.
In addition, capital costs are based on
100 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 to
FDA to be $1,200.
In the Federal Register of February,
19, 2016 (81 FR 8505), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was PRA
related comment was received.
(Comment) The comment believes
that warning plans should not be
renewed every year, but should remain
in force as long as necessary after their
approval
(Response) FDA does not require that
a previously FDA-approved warning
plan be resubmitted. FDA reviews and
approves warning plans only once,
unless a submitter seeks to change the
distribution or display of warnings on
packages or rotation of warnings in
advertisements, in which case the
submission would be considered a
supplement. The purpose of FDA’s
proposed extension is to account for the
entry of new smokeless tobacco product
brands and advertising onto the market
place.
Dated: July 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17569 Filed 7–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1853]
Unique Device Identification System:
Form and Content of the Unique
Device Identifier; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability and
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; request
for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance for
industry and FDA staff entitled ‘‘Unique
Device Identification System: Form and
Content of the Unique Device Identifier
(UDI).’’ When finalized, this draft
document will define the expected
content and forms of the unique device
identifier (UDI), to assist both labelers
and FDA-accredited issuing agencies
better ensure the UDIs developed under
systems for the issuance of UDIs are in
compliance with the unique device
identification system rule (UDI Rule).
This draft guidance is not the final
version of the guidance nor is it in effect
at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 26,
2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
srobinson on DSK5SPTVN1PROD with NOTICES
Total capital
costs
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
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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–
2016–D–1853 for ‘‘Unique Device
Identification System: Form and
Content of the Unique Device Identifier
(UDI).’’ 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
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]]>Agencies
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48813-48814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17569]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0190]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
25, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0671.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 (the 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; 123 Stat. 1776). 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.
Based on the Federal Trade Commission's (FTC's) previous experience
with the submission of warning plans and FDA's experience, FDA
estimates that there are 52 companies affected by this information
collection. To account for the entry of new smokeless tobacco companies
that may be affected by this information collection, FDA is
conservatively estimating the total number of annual respondents to
this collection of information to be 100.
When the FTC requested an extension of their approved warning plan
information collection in 2007, based on over 20 years implementing the
warning plan requirements and taking into account increased
computerization and improvements in electronic communication, the FTC
estimated submitting an initial plan would take 60 hours. 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
reasonable.
FDA estimates the burden of this collection of information as
follows:
[[Page 48814]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Numbers of
Activity Numbers of responses per Total annual Average burden Total hours Total capital
respondents respondent responses per response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of rotational plans for health warning 100 1 100 60 6,000 $1,200
statements........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
FDA estimates a total of 100 respondents will respond to this
collection of information and take 60 hours to complete a rotational
warning plan for a total of 6,000 burden hours. In addition, capital
costs are based on 100 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 to
FDA to be $1,200.
In the Federal Register of February, 19, 2016 (81 FR 8505), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was PRA related comment was
received.
(Comment) The comment believes that warning plans should not be
renewed every year, but should remain in force as long as necessary
after their approval
(Response) FDA does not require that a previously FDA-approved
warning plan be resubmitted. FDA reviews and approves warning plans
only once, unless a submitter seeks to change the distribution or
display of warnings on packages or rotation of warnings in
advertisements, in which case the submission would be considered a
supplement. The purpose of FDA's proposed extension is to account for
the entry of new smokeless tobacco product brands and advertising onto
the market place.
Dated: July 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17569 Filed 7-25-16; 8:45 am]
BILLING CODE 4164-01-P
