Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request, 55923-55927 [2011-23099]
Download as PDF
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
docket number found in brackets in the
heading of this document.
Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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
SUPPLEMENTARY INFORMATION:
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.
Filing Objections and Requests for a
Hearing on a Regulation or Order—21
CFR Part 12—(OMB Control Number
0910–0184)—Extension
The regulations in 21 CFR 12.22,
issued under section 701(e)(2) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 371(e)(2)), set forth the
55923
instructions for filing objections and
requests for a hearing on a regulation or
order under § 12.20(d) (21 CFR
12.20(d)). Objections and requests must
be submitted within the time specified
in § 12.20(e). Each objection for which
a hearing has been requested must be
separately numbered and specify the
provision of the regulation or the
proposed order. In addition, each
objection must include a detailed
description and analysis of the factual
information and any other document,
with some exceptions, supporting the
objection. Failure to include this
information constitutes a waiver of the
right to a hearing on that objection. FDA
uses the description and analysis to
determine whether a hearing request is
justified. The description and analysis
may be used only for the purpose of
determining whether a hearing has been
justified under 21 CFR 12.24 and do not
limit the evidence that may be
presented if a hearing is granted.
Respondents to this information
collection are those parties that may be
adversely affected by an order or
regulation.
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
12.22 ....................................................................................
3
1
3
20
60
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this
collection of information is based on
past filings. Agency personnel
responsible for processing the filing of
objections and requests for a public
hearing on a specific regulation or order
estimate approximately three requests
are received by the Agency annually,
with each requiring approximately 20
hours of preparation time.
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23106 Filed 9–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0480]
Draft Guidance for Industry:
Submission of Warning Plans for
Cigarettes and Smokeless Tobacco
Products; Availability; Agency
Information Collection Activities;
Proposed Collection; Comment
Request
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Submission of
Warning Plans for Cigarettes and
Smokeless Tobacco Products.’’ This
draft guidance document is intended to
assist persons submitting warning plans
to FDA under the Comprehensive
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:58 Sep 08, 2011
Jkt 223001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Smokeless Tobacco Health Education
Act, as amended by the Family Smoking
Prevention and Tobacco Control Act;
and under the Federal Cigarette
Labeling and Advertising Act, as
amended by the Family Smoking
Prevention and Tobacco Control Act,
when that requirement takes effect.
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 on 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 November 8,
2011.
Submit either electronic or written
comments on the proposed collection of
information by November 8, 2011.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments, including comments
regarding the proposed collection of
information, to the Division of Dockets
Management (HFA–305), Food and Drug
E:\FR\FM\09SEN1.SGM
09SEN1
55924
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance document
entitled ‘‘Submission of Warning Plans
for Cigarettes and Smokeless Tobacco
Products’’ to the Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229. Send one
self-addressed adhesive label to assist
that office in processing your request or
include a fax number to which the draft
guidance may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance:
Gail Schmerfeld, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 1–877–287–
1373, gail.schmerfeld@fda.hhs.gov.
With regard to the proposed collection
of information: Jonna Capezzuto, Office
of Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
P150–400B, Rockville, MD 20850, 301–
796–3794,
Jonnalynn.capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
the draft guidance entitled ‘‘Submission
of Warning Plans for Cigarettes and
Smokeless Tobacco Products.’’ This
guidance, when finalized, will provide
industry with information on how to
submit warning plans for smokeless
tobacco products under section 3 of the
Comprehensive Smokeless Tobacco
Health Education Act of 1986
(Smokeless Tobacco Act) and warning
plans for cigarettes under section 4 of
the Federal Cigarette Labeling and
Advertising Act (FCLAA) when that
requirement takes effect.
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act grants FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect public health
generally and to reduce tobacco use by
minors. Section 201 of the Tobacco
Control Act amended section 4 of
FCLAA (15 U.S.C. 1333). When it takes
effect, section 4 of FCLAA will require
the submission of warning plans for
cigarette packaging and advertising to
FDA. Section 204 of the Tobacco
Control Act amended section 3 of the
Smokeless Tobacco Act (15 U.S.C.
4402), requiring the submission of
VerDate Mar<15>2010
16:58 Sep 08, 2011
Jkt 223001
warning plans for smokeless tobacco
product packaging and advertising to
FDA. The warning plans must be
submitted by the tobacco product
manufacturer, importer, distributor, or
retailer, be approved by FDA, and
provide for the random display of
specified health warnings on packages
and quarterly rotation of those health
warnings in advertisements.
This draft guidance is intended to
assist persons submitting warning plans
for cigarettes and for smokeless tobacco
products. The guidance discusses,
among other things: The statutory
requirement to submit a warning plan;
definitions; who submits a warning
plan; the scope of a warning plan; when
to submit a warning plan; what
information to include in a warning
plan; where to submit; and what
approval of a warning plan means.
II. Significance of Guidance
FDA is issuing this draft guidance
document consistent with FDA’s good
guidance practices regulations (21 CFR
10.115). The draft guidance, when
finalized, will represent the Agency’s
current thinking on ‘‘Submission of
Warning Plans for Cigarettes and
Smokeless Tobacco Products.’’ It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
(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
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
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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.
Draft Guidance for Industry: Submission
of Warning Plans for Cigarettes and
Smokeless Tobacco Products (OMB
Control Number 0910—New)
This draft guidance is intended to
assist persons submitting warning plans
for smokeless tobacco products under
section 3 of the Smokeless Tobacco Act
and for cigarettes under section 4 of
FCLAA, when that requirement takes
effect. The guidance document
discusses, among other things: The
statutory requirement to submit a
warning plan; definitions; who submits
a warning plan; the scope of a warning
plan; when to submit a warning plan;
what information should be submitted
in a warning plan; where to submit a
warning plan; and what approval of a
warning plan means. FDA may collect
statutorily mandated warning plan
information for smokeless tobacco
products under OMB control number
0910–0671. The purpose of the
proposed information collection is to
allow FDA to collect statutorily
mandated information regarding
warning plans for cigarettes and
administrative information related to
warning plans for both cigarettes and
smokeless tobacco products.
Section 4 of FCLAA states that each
cigarette package and advertisement
must bear one of nine health warning
statements and requires the submission
of warning plans for cigarette packages
and advertisements to FDA for review
and approval. These requirements are
currently not in effect. Section 4(d) of
FCLAA (15 U.S.C. 1333(d)) requires
FDA to issue regulations that require
color graphics depicting the negative
health consequences of smoking to
accompany those warning statements.
Section 201(b) of the Tobacco Control
Act states that the requirements take
effect 15 months after FDA issues these
regulations. Under the provision,
however, if a cigarette product was
manufactured prior to the effective date
of the final rule but its package does not
contain a required warning, the product
may be introduced into commerce in the
United States within 30 days from such
effective date. After the 30-day period,
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
manufacturers must not introduce into
domestic commerce any cigarette the
package of which does not contain a
required warning (i.e., a textual warning
statement and accompanying graphic),
irrespective of the date of manufacture.
FDA published a proposed rule
regarding these requirements on
November 12, 2010 (see 75 FR 69524).
FDA published the final rule on June 22,
2011 (see 76 FR 36628). This rule is
effective September 22, 2012.
A. Warning Plans for Cigarettes
The requirement for submission of
warning plans for cigarettes, and the
specific requirements relating to the
random display of required warnings on
cigarette packaging and quarterly
rotation of required warnings in
cigarette advertising, appear at 15 U.S.C.
1333(c). In particular, warning plans for
cigarette packaging must provide that all
of the required warnings are randomly
displayed in each 12-month period on
each brand of the product; are randomly
displayed in as equal a number of times
as is possible on each brand of the
product; and are randomly distributed
in all areas of the United States in
which the product is marketed. For FDA
to approve it, a warning plan must
provide for the required equal
distribution and display of required
warnings on packaging and must assure
that all of the required warnings will be
displayed by the manufacturer,
importer, distributor, or retailer at the
same time.
For FDA to approve it, a warning plan
for cigarette advertising must provide
that all of the required warnings are
rotated quarterly in alternating sequence
in advertisements for each brand of
cigarettes.
Section 3 of the Smokeless Tobacco
Act states that each smokeless tobacco
product package and advertisement
must bear one of four required warning
statements and requires the submission
of warning plans for smokeless tobacco
product packages and advertisements to
FDA for review and approval. The
requirement for an FDA approved
warning plan became effective June 22,
2010. On June 8, 2010, FDA announced
by guidance its intent not to enforce the
requirement that a brand of smokeless
tobacco product must have an FDAapproved warning plan so long as a
warning plan for the brand was
submitted to FDA by July 22, 2010, and
implemented (see 75 FR 32481). FDA
expects to begin enforcing the
requirement under Section 3 that there
be an approved warning plan 6 months
after the publication of the notice of
availability of a final guidance on the
‘‘Submission of Warning Plans for
Cigarettes and Smokeless Tobacco
Products’’ or 6 months after the
publication of a final regulation
regarding the submission of warning
plans, whichever comes first.
B. Warning Plans for Smokeless
Tobacco Products
The requirement for submission of
warning plans for smokeless tobacco
products, and the specific requirements
relating to the random display of
required warning statements on
smokeless tobacco packaging and
quarterly rotation of required warning
statements in smokeless tobacco
product advertising, appear at 15 U.S.C.
4402(b)(3). In particular, warning plans
for smokeless tobacco product
packaging must provide that all of the
required warnings are randomly
displayed in each 12-month period on
each brand of the product; are randomly
displayed in as equal a number of times
as is possible on each brand of the
product; and are randomly distributed
in all areas of the United States in
which the product is marketed. For FDA
to approve it, a warning plan must
provide for the required equal
distribution and display of required
warning statements on packaging and
must assure that all of the required
warning statements will be displayed by
the manufacturer, importer, distributor,
or retailer at the same time.
Warning plans for smokeless tobacco
product advertising must provide that
all of the required warning statements
are rotated quarterly in alternating
sequence in advertisements for each
brand of smokeless tobacco product.
In an important change from prior
law, outdoor billboard advertising for
smokeless tobacco products must now
include the required warning
statements. Prior to its amendment by
the Tobacco Control Act, the Smokeless
Tobacco Act exempted outdoor
billboard advertising from the
requirement that smokeless tobacco
product advertisements bear required
warning statements, but the Tobacco
VerDate Mar<15>2010
16:58 Sep 08, 2011
Jkt 223001
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
55925
Control Act amendments eliminated
this exemption (which had been
codified at 15 U.S.C. 4402(a)(2)). Thus,
it is unlawful for any smokeless tobacco
product manufacturer, packager,
importer, distributor, or retailer to
advertise or cause to be advertised
within the United States a smokeless
tobacco product on an outdoor billboard
unless the advertisement bears one of
the required warning statements.
Because section 9(1) of the Smokeless
Tobacco Act, 15 U.S.C. 4408(1) (as
amended by section 101(c) of the
Tobacco Control Act), defines
‘‘smokeless tobacco,’’ by reference to
section 900(18) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
387(18)), as ‘‘any tobacco product that
consists of cut, ground, powdered, or
leaf tobacco and that is intended to be
placed in the oral or nasal cavity,’’
smokeless tobacco products intended to
be placed in the nasal cavity must now
comply with the warning requirements
in section 3 of the Smokeless Tobacco
Act. At this time, as an exercise of
enforcement discretion, FDA does not
intend to commence or recommend
enforcement of the requirement that
smokeless tobacco products marketed
solely for use in the nasal cavity bear
either the ‘‘WARNING: This product can
cause mouth cancer’’ or the
‘‘WARNING: This product can cause
gum disease and tooth loss’’ so long as
a warning plan providing that packages
and advertising for such products will
bear the other two warnings has been
submitted to FDA and implemented.
FDA will give further consideration to
the warnings smokeless tobacco
products marketed solely for use in the
nasal cavity should bear. FDA intends to
provide further public notice prior to
revising or rescinding this enforcement
policy.
C. Description of Respondents
The respondents to this collection of
information are manufacturers,
importers, distributors, and retailers of
cigarettes and/or smokeless tobacco
products who are required to submit
warning plans for cigarettes and
smokeless tobacco products to FDA
under FCLAA and the Smokeless
Tobacco Act.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\09SEN1.SGM
09SEN1
55926
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
TABLE 1—CIGARETTE WARNING PLANS REPORTING BURDEN
[New Collection of Information]
Number of
respondents
Respondent by type of document
Hours per
response
Total burden
hours
Cover Letter
Manufacturers, Distributors, and Importers .................................................................................
Retailers .......................................................................................................................................
Total Cover Letters ......................................................................................................................
226
544
770
5
5
........................
1,130
2,720
3,850
226
544
770
........................
120
120
........................
........................
27,120
65,280
92,400
96,250
Warning Plan
Manufacturers, Distributors, and Importers .................................................................................
Retailers .......................................................................................................................................
Total Warning Plans ....................................................................................................................
Total Burden Hours .....................................................................................................................
TABLE 2—SMOKELESS TOBACCO PRODUCT WARNING PLANS REPORTING BURDEN
[New Cover Letter Plus Existing Collection of Information]
Number of
respondents
Respondent by type of document
Hours per
response
Total burden
hours
Cover Letter
Manufacturers, Distributors, and Importers .................................................................................
Retailers .......................................................................................................................................
Total Cover Letters ......................................................................................................................
20
10
30
5
5
........................
100
50
150
........................
10
10
........................
........................
120
........................
........................
........................
1,200
1,200
1,350
Warning Plan
Manufacturers, Distributors, and Importers * ..............................................................................
Retailers .......................................................................................................................................
Total Warning Plans * ..................................................................................................................
Total Burden Hours .....................................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
* The burden for collection of the warning plans for Smokeless Tobacco Products from manufacturers, distributors, and importers is approved
and covered under OMB control number 0910–0671.
FDA’s estimate of the number of
respondents in table 1 of this Federal
Register document is based on the
number of warning plans for cigarettes
submitted to the Federal Trade
Commission prior to the
implementation of the Tobacco Control
Act on June 22, 2009, which grants FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect public health
generally and to reduce tobacco use by
minors. Using data from 34 State retailer
lists, FDA identified 544 cigarette
retailers who have 20 or more locations,
and thus, may be more likely than
smaller retailers to create their own
advertisements and submit warning
plans to FDA for those advertisements.
Thus, FDA estimates the number of
manufacturers, importers, distributors,
and retailers who are expected to submit
warning plans for cigarette products in
table 1 of this Federal Register
document to be 770. Based on its
experience, FDA estimates it may take
between 2 and 8 hours to prepare and
submit a cover letter, depending on the
number of products and brands
submitted. FDA estimates it could take
VerDate Mar<15>2010
18:57 Sep 08, 2011
Jkt 223001
2 to 3 days for a person in a smaller firm
to prepare warning plans, and up to a
week for a person in a larger firm,
depending on the number of products
and brands submitted.
The burden hours for the preparation
and submission of warning plans by
manufacturers, distributors, and
importers for smokeless tobacco
products in table 2 of this document
have already been approved by OMB
under OMB control number 0910–0671.
Based on plans submitted to FDA to
date, we estimate the number of retailers
who will submit warning plans for
smokeless tobacco products to be 10.
FDA estimates the burden hours for
retailers to prepare warning plans to be
1,200. FDA estimates the additional
burden hours for preparation of the
cover letter is 150 hours (100 burden
hours for manufacturers, distributors,
and importers and 50 burden hours for
retailers).
FDA estimates, therefore, that it will
take an average of 5 hours to prepare
and submit a cover letter and 120 hours
to prepare and submit a warning plan
for packaging and advertising. The total
number of burden hours are estimated
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
to be 1,350 hours ([150 cover letter
burden hours] + [1,200 warning plan
burden hours].)
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet
may obtain an electronic version of this
draft guidance document at either
https://www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23099 Filed 9–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0376]
Draft Guidance for Industry; Dietary
Supplements: New Dietary Ingredient
Notifications and Related Issues;
Availability; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA) is extending the
comment period by 60 days to
December 2, 2011, for the notice entitled
‘‘Draft Guidance for Industry; Dietary
Supplements: New Dietary Ingredient
Notifications and Related Issues;
Availability,’’ that appeared in the
Federal Register of July 5, 2011 (76 FR
39111). In that document, FDA
announced the availability of a draft
guidance for industry and requested
comments. The Agency is taking this
action in response to a request for an
extension to allow interested persons
additional time to submit comments.
DATES: Submit either electronic or
written comments by December 2, 2011.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Corey Hilmas, Center for Food Safety
and Applied Nutrition (HFS–810), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–2375.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
I. Background
In the Federal Register of July 5, 2011
(76 FR 39111), FDA published a notice
with a 90-day comment period to
request comments on the draft guidance
for industry entitled ‘‘Draft Guidance for
Industry; Dietary Supplements: New
Dietary Ingredient Notifications and
VerDate Mar<15>2010
16:58 Sep 08, 2011
Jkt 223001
Related Issues.’’ Comments on the draft
guidance will assist FDA in the
development of final guidance for
industry on new dietary ingredient
notifications and related issues.
The Agency has received a request for
a 45-day extension of the comment
period for this notice. FDA has
considered the request and is extending
the comment period for the notice
entitled ‘‘Draft Guidance for Industry;
Dietary Supplements: New Dietary
Ingredient Notifications and Related
Issues; Availability,’’ until December 2,
2011. The Agency believes that this
extension allows adequate time for
interested persons to submit comments
without significantly delaying action by
the Agency.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Always access an
FDA guidance document by using
FDA’s Web site listed previously to find
the most current version of the
guidance.
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23098 Filed 9–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0147]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Demonstrating the Substantial
Equivalence of a New Tobacco
Product: Responses to Frequently
Asked Questions; Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
ACTION:
55927
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked
Questions.’’ This draft guidance
provides responses to questions FDA
has received on the Family Smoking
Prevention and Tobacco Control Act’s
(Tobacco Control Act) provisions on
new tobacco products and substantial
equivalence, including questions on
changes to packaging and labeling. This
draft guidance is not final 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 November 8,
2011.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Identify comments with the docket
number found in brackets in the
heading of this document.
Submit written requests for single
copies of the draft guidance document
entitled ‘‘Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked
Questions’’ to the Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229. Send one
self-addressed adhesive label to assist
that office in processing your request or
include a fax number to which the
guidance document may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance:
Annette Marthaler, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373,
annette.marthaler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
This draft guidance provides
responses to questions we have received
on the Federal Food, Drug, and
Cosmetic Act’s (the FD&C Act)
provisions on new tobacco products and
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55923-55927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23099]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0480]
Draft Guidance for Industry: Submission of Warning Plans for
Cigarettes and Smokeless Tobacco Products; Availability; Agency
Information Collection Activities; Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Submission of
Warning Plans for Cigarettes and Smokeless Tobacco Products.'' This
draft guidance document is intended to assist persons submitting
warning plans to FDA under the Comprehensive Smokeless Tobacco Health
Education Act, as amended by the Family Smoking Prevention and Tobacco
Control Act; and under the Federal Cigarette Labeling and Advertising
Act, as amended by the Family Smoking Prevention and Tobacco Control
Act, when that requirement takes effect.
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 on 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 November 8, 2011.
Submit either electronic or written comments on the proposed
collection of information by November 8, 2011.
ADDRESSES: Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments, including comments
regarding the proposed collection of information, to the Division of
Dockets Management (HFA-305), Food and Drug
[[Page 55924]]
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance
document entitled ``Submission of Warning Plans for Cigarettes and
Smokeless Tobacco Products'' to the Center for Tobacco Products, Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-
3229. Send one self-addressed adhesive label to assist that office in
processing your request or include a fax number to which the draft
guidance may be sent. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Gail Schmerfeld, Center for
Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229, 1-877-287-1373, gail.schmerfeld@fda.hhs.gov.
With regard to the proposed collection of information: Jonna
Capezzuto, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., P150-400B, Rockville, MD 20850, 301-
796-3794, Jonnalynn.capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of the draft guidance entitled
``Submission of Warning Plans for Cigarettes and Smokeless Tobacco
Products.'' This guidance, when finalized, will provide industry with
information on how to submit warning plans for smokeless tobacco
products under section 3 of the Comprehensive Smokeless Tobacco Health
Education Act of 1986 (Smokeless Tobacco Act) and warning plans for
cigarettes under section 4 of the Federal Cigarette Labeling and
Advertising Act (FCLAA) when that requirement takes effect.
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act grants FDA authority to regulate
the manufacture, marketing, and distribution of tobacco products to
protect public health generally and to reduce tobacco use by minors.
Section 201 of the Tobacco Control Act amended section 4 of FCLAA (15
U.S.C. 1333). When it takes effect, section 4 of FCLAA will require the
submission of warning plans for cigarette packaging and advertising to
FDA. Section 204 of the Tobacco Control Act amended section 3 of the
Smokeless Tobacco Act (15 U.S.C. 4402), requiring the submission of
warning plans for smokeless tobacco product packaging and advertising
to FDA. The warning plans must be submitted by the tobacco product
manufacturer, importer, distributor, or retailer, be approved by FDA,
and provide for the random display of specified health warnings on
packages and quarterly rotation of those health warnings in
advertisements.
This draft guidance is intended to assist persons submitting
warning plans for cigarettes and for smokeless tobacco products. The
guidance discusses, among other things: The statutory requirement to
submit a warning plan; definitions; who submits a warning plan; the
scope of a warning plan; when to submit a warning plan; what
information to include in a warning plan; where to submit; and what
approval of a warning plan means.
II. Significance of Guidance
FDA is issuing this draft guidance document consistent with FDA's
good guidance practices regulations (21 CFR 10.115). The draft
guidance, when finalized, will represent the Agency's current thinking
on ``Submission of Warning Plans for Cigarettes and Smokeless Tobacco
Products.'' It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act (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 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.
Draft Guidance for Industry: Submission of Warning Plans for Cigarettes
and Smokeless Tobacco Products (OMB Control Number 0910--New)
This draft guidance is intended to assist persons submitting
warning plans for smokeless tobacco products under section 3 of the
Smokeless Tobacco Act and for cigarettes under section 4 of FCLAA, when
that requirement takes effect. The guidance document discusses, among
other things: The statutory requirement to submit a warning plan;
definitions; who submits a warning plan; the scope of a warning plan;
when to submit a warning plan; what information should be submitted in
a warning plan; where to submit a warning plan; and what approval of a
warning plan means. FDA may collect statutorily mandated warning plan
information for smokeless tobacco products under OMB control number
0910-0671. The purpose of the proposed information collection is to
allow FDA to collect statutorily mandated information regarding warning
plans for cigarettes and administrative information related to warning
plans for both cigarettes and smokeless tobacco products.
Section 4 of FCLAA states that each cigarette package and
advertisement must bear one of nine health warning statements and
requires the submission of warning plans for cigarette packages and
advertisements to FDA for review and approval. These requirements are
currently not in effect. Section 4(d) of FCLAA (15 U.S.C. 1333(d))
requires FDA to issue regulations that require color graphics depicting
the negative health consequences of smoking to accompany those warning
statements. Section 201(b) of the Tobacco Control Act states that the
requirements take effect 15 months after FDA issues these regulations.
Under the provision, however, if a cigarette product was manufactured
prior to the effective date of the final rule but its package does not
contain a required warning, the product may be introduced into commerce
in the United States within 30 days from such effective date. After the
30-day period,
[[Page 55925]]
manufacturers must not introduce into domestic commerce any cigarette
the package of which does not contain a required warning (i.e., a
textual warning statement and accompanying graphic), irrespective of
the date of manufacture. FDA published a proposed rule regarding these
requirements on November 12, 2010 (see 75 FR 69524). FDA published the
final rule on June 22, 2011 (see 76 FR 36628). This rule is effective
September 22, 2012.
A. Warning Plans for Cigarettes
The requirement for submission of warning plans for cigarettes, and
the specific requirements relating to the random display of required
warnings on cigarette packaging and quarterly rotation of required
warnings in cigarette advertising, appear at 15 U.S.C. 1333(c). In
particular, warning plans for cigarette packaging must provide that all
of the required warnings are randomly displayed in each 12-month period
on each brand of the product; are randomly displayed in as equal a
number of times as is possible on each brand of the product; and are
randomly distributed in all areas of the United States in which the
product is marketed. For FDA to approve it, a warning plan must provide
for the required equal distribution and display of required warnings on
packaging and must assure that all of the required warnings will be
displayed by the manufacturer, importer, distributor, or retailer at
the same time.
For FDA to approve it, a warning plan for cigarette advertising
must provide that all of the required warnings are rotated quarterly in
alternating sequence in advertisements for each brand of cigarettes.
Section 3 of the Smokeless Tobacco Act states that each smokeless
tobacco product package and advertisement must bear one of four
required warning statements and requires the submission of warning
plans for smokeless tobacco product packages and advertisements to FDA
for review and approval. The requirement for an FDA approved warning
plan became effective June 22, 2010. On June 8, 2010, FDA announced by
guidance its intent not to enforce the requirement that a brand of
smokeless tobacco product must have an FDA-approved warning plan so
long as a warning plan for the brand was submitted to FDA by July 22,
2010, and implemented (see 75 FR 32481). FDA expects to begin enforcing
the requirement under Section 3 that there be an approved warning plan
6 months after the publication of the notice of availability of a final
guidance on the ``Submission of Warning Plans for Cigarettes and
Smokeless Tobacco Products'' or 6 months after the publication of a
final regulation regarding the submission of warning plans, whichever
comes first.
B. Warning Plans for Smokeless Tobacco Products
The requirement for submission of warning plans for smokeless
tobacco products, and the specific requirements relating to the random
display of required warning statements on smokeless tobacco packaging
and quarterly rotation of required warning statements in smokeless
tobacco product advertising, appear at 15 U.S.C. 4402(b)(3). In
particular, warning plans for smokeless tobacco product packaging must
provide that all of the required warnings are randomly displayed in
each 12-month period on each brand of the product; are randomly
displayed in as equal a number of times as is possible on each brand of
the product; and are randomly distributed in all areas of the United
States in which the product is marketed. For FDA to approve it, a
warning plan must provide for the required equal distribution and
display of required warning statements on packaging and must assure
that all of the required warning statements will be displayed by the
manufacturer, importer, distributor, or retailer at the same time.
Warning plans for smokeless tobacco product advertising must
provide that all of the required warning statements are rotated
quarterly in alternating sequence in advertisements for each brand of
smokeless tobacco product.
In an important change from prior law, outdoor billboard
advertising for smokeless tobacco products must now include the
required warning statements. Prior to its amendment by the Tobacco
Control Act, the Smokeless Tobacco Act exempted outdoor billboard
advertising from the requirement that smokeless tobacco product
advertisements bear required warning statements, but the Tobacco
Control Act amendments eliminated this exemption (which had been
codified at 15 U.S.C. 4402(a)(2)). Thus, it is unlawful for any
smokeless tobacco product manufacturer, packager, importer,
distributor, or retailer to advertise or cause to be advertised within
the United States a smokeless tobacco product on an outdoor billboard
unless the advertisement bears one of the required warning statements.
Because section 9(1) of the Smokeless Tobacco Act, 15 U.S.C.
4408(1) (as amended by section 101(c) of the Tobacco Control Act),
defines ``smokeless tobacco,'' by reference to section 900(18) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387(18)), as ``any
tobacco product that consists of cut, ground, powdered, or leaf tobacco
and that is intended to be placed in the oral or nasal cavity,''
smokeless tobacco products intended to be placed in the nasal cavity
must now comply with the warning requirements in section 3 of the
Smokeless Tobacco Act. At this time, as an exercise of enforcement
discretion, FDA does not intend to commence or recommend enforcement of
the requirement that smokeless tobacco products marketed solely for use
in the nasal cavity bear either the ``WARNING: This product can cause
mouth cancer'' or the ``WARNING: This product can cause gum disease and
tooth loss'' so long as a warning plan providing that packages and
advertising for such products will bear the other two warnings has been
submitted to FDA and implemented. FDA will give further consideration
to the warnings smokeless tobacco products marketed solely for use in
the nasal cavity should bear. FDA intends to provide further public
notice prior to revising or rescinding this enforcement policy.
C. Description of Respondents
The respondents to this collection of information are
manufacturers, importers, distributors, and retailers of cigarettes
and/or smokeless tobacco products who are required to submit warning
plans for cigarettes and smokeless tobacco products to FDA under FCLAA
and the Smokeless Tobacco Act.
FDA estimates the burden of this collection of information as
follows:
[[Page 55926]]
Table 1--Cigarette Warning Plans Reporting Burden
[New Collection of Information]
----------------------------------------------------------------------------------------------------------------
Number of Hours per Total burden
Respondent by type of document respondents response hours
----------------------------------------------------------------------------------------------------------------
Cover Letter
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers...................... 226 5 1,130
Retailers....................................................... 544 5 2,720
Total Cover Letters............................................. 770 .............. 3,850
----------------------------------------------------------------------------------------------------------------
Warning Plan
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers...................... 226 120 27,120
Retailers....................................................... 544 120 65,280
Total Warning Plans............................................. 770 .............. 92,400
Total Burden Hours.............................................. .............. .............. 96,250
----------------------------------------------------------------------------------------------------------------
Table 2--Smokeless Tobacco Product Warning Plans Reporting Burden
[New Cover Letter Plus Existing Collection of Information]
----------------------------------------------------------------------------------------------------------------
Number of Hours per Total burden
Respondent by type of document respondents response hours
----------------------------------------------------------------------------------------------------------------
Cover Letter
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers...................... 20 5 100
Retailers....................................................... 10 5 50
Total Cover Letters............................................. 30 .............. 150
----------------------------------------------------------------------------------------------------------------
Warning Plan
----------------------------------------------------------------------------------------------------------------
Manufacturers, Distributors, and Importers *.................... .............. .............. ..............
Retailers....................................................... 10 120 1,200
Total Warning Plans *........................................... 10 .............. 1,200
Total Burden Hours.............................................. .............. .............. 1,350
----------------------------------------------------------------------------------------------------------------
* The burden for collection of the warning plans for Smokeless Tobacco Products from manufacturers,
distributors, and importers is approved and covered under OMB control number 0910-0671.
FDA's estimate of the number of respondents in table 1 of this
Federal Register document is based on the number of warning plans for
cigarettes submitted to the Federal Trade Commission prior to the
implementation of the Tobacco Control Act on June 22, 2009, which
grants FDA authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect public health generally and
to reduce tobacco use by minors. Using data from 34 State retailer
lists, FDA identified 544 cigarette retailers who have 20 or more
locations, and thus, may be more likely than smaller retailers to
create their own advertisements and submit warning plans to FDA for
those advertisements.
Thus, FDA estimates the number of manufacturers, importers,
distributors, and retailers who are expected to submit warning plans
for cigarette products in table 1 of this Federal Register document to
be 770. Based on its experience, FDA estimates it may take between 2
and 8 hours to prepare and submit a cover letter, depending on the
number of products and brands submitted. FDA estimates it could take 2
to 3 days for a person in a smaller firm to prepare warning plans, and
up to a week for a person in a larger firm, depending on the number of
products and brands submitted.
The burden hours for the preparation and submission of warning
plans by manufacturers, distributors, and importers for smokeless
tobacco products in table 2 of this document have already been approved
by OMB under OMB control number 0910-0671. Based on plans submitted to
FDA to date, we estimate the number of retailers who will submit
warning plans for smokeless tobacco products to be 10. FDA estimates
the burden hours for retailers to prepare warning plans to be 1,200.
FDA estimates the additional burden hours for preparation of the cover
letter is 150 hours (100 burden hours for manufacturers, distributors,
and importers and 50 burden hours for retailers).
FDA estimates, therefore, that it will take an average of 5 hours
to prepare and submit a cover letter and 120 hours to prepare and
submit a warning plan for packaging and advertising. The total number
of burden hours are estimated to be 1,350 hours ([150 cover letter
burden hours] + [1,200 warning plan burden hours].)
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet may obtain an electronic
version of this draft guidance document at either https://www.regulations.gov or https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
[[Page 55927]]
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23099 Filed 9-8-11; 8:45 am]
BILLING CODE 4160-01-P