Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act; Availability, 20030-20034 [2012-7766]
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Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices
completed and submitted to the FDA
before clinical (human subjects) work
commences, and [FDA should establish]
that there is a reasonable expectation
based on preclinical work that a
reduction or lack of harm will be seen
in humans.’’ Should FDA address
expected sequencing of studies in its
guidance? If the Agency should, what
guidance should the Agency provide?;
and
• IOM’s Recommendation 10: ‘‘MRTP
sponsors should consider use of
independent third parties to undertake
one or more key functions, including
the design and conduct of research, the
oversight of specific studies, and the
distribution of sponsor funds for
research. Such independent third
parties should be approved by the FDA
in advance of the research.’’ Should
FDA recommend such an approach in
its guidance? If the Agency should, what
guidance should the Agency provide?
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. 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 the
draft guidance document at https://
www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceCompliance
RegulatoryInformation/default.htm.
Dated: March 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–7908 Filed 3–30–12; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2012–D–0049]
Draft Guidance for Industry: Reporting
Harmful and Potentially Harmful
Constituents in Tobacco Products and
Tobacco Smoke Under the Federal
Food, Drug, and Cosmetic Act;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Reporting Harmful
and Potentially Harmful Constituents in
Tobacco Products and Tobacco Smoke
Under Section 904(a)(3) of the Federal
Food, Drug, and Cosmetic Act.’’ The
purpose of this draft guidance is to
assist persons reporting to FDA the
quantities of harmful and potentially
harmful constituents (HPHCs) in
tobacco products and tobacco smoke
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act). The draft
guidance explains that FDA does not
intend, at this time, to enforce reporting
on the entire established HPHC list
where a manufacturer or importer
completes testing and reporting for an
abbreviated list of HPHCs within the
timeframes specified in the guidance.
DATES: Although you can comment on
any guidance at any time (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 June 4, 2012.
Submit either electronic or written
comments on the proposed collection of
information by June 4, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document 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
a fax number to which the draft
guidance may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit electronic comments on the
draft guidance, including comments on
the proposed collection of information
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.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: James
Flahive, Center for Tobacco Products,
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850–
3229, 1–877–287–1373,
james.flahive@fda.hhs.gov.
With regard to the proposed
collection of information: Daniel
Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
SUMMARY:
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SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (the Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amends the
FD&C Act and 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
904(a)(3) of the FD&C Act (21 U.S.C.
387d(a)(3)) requires each tobacco
product manufacturer or importer, or an
agent, to begin reporting to FDA no later
than June 22, 2012, ‘‘all constituents,
including smoke constituents, identified
by [FDA] as harmful or potentially
harmful to health in each tobacco
product, and as applicable in the smoke
of each tobacco product.’’ Reports must
be by the brand and by quantity in each
brand and subbrand. Section 904(c)(1)
states that manufacturers of tobacco
products not on the market as of June
22, 2009, must also provide information
reportable under section 904(a)(3) at
least 90 days prior to introducing the
product into interstate commerce.
FDA has taken several steps to
identify HPHCs to be reported under
section 904(a)(3), including issuing a
final guidance discussing FDA’s current
thinking on the meaning of ‘‘harmful
and potentially harmful constituent’’ in
the context of implementing the HPHC
list requirement (76 FR 5387, January
31, 2011). The guidance is available on
the Internet at https://www.fda.gov/
TobaccoProducts/
GuidanceComplianceRegulatory
Information/ucm241339.htm. In
addition, on August 12, 2011, FDA
issued a document (the HPHC notice; 76
FR 50226) in the Federal Register
describing the criteria we tentatively
concluded we would use in identifying
the HPHCs for the established list,
including a table of the 96 HPHCs we
identified using those criteria, and
asking the public and interested parties
to submit relevant scientific and other
information by October 11, 2011. FDA
reviewed comments received in
response to the HPHC notice. Elsewhere
in this issue of the Federal Register,
FDA is publishing a notice announcing
the established list of HPHCs as
required by section 904(e) of the FD&C
Act.
This draft guidance discusses the
information to be reported on HPHCs in
tobacco products and tobacco smoke
under section 904(a)(3) of the FD&C Act.
This draft guidance document
discusses, among other things: The
statutory requirement for testing and
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reporting quantities of HPHCs, who tests
and reports quantities of HPHCs to FDA,
what HPHCs will be the focus of FDA
enforcement at this time, when reports
are submitted to FDA, what information
is reported to FDA, and how the reports
should be submitted to FDA. The draft
guidance notifies manufacturers and
importers that at this time, while
industry is developing laboratory
capacity to comply with section
904(a)(3), FDA does not intend to
enforce the statutory requirement to
submit quantities of all constituents
identified by FDA as HPHCs by June 22,
2012, where manufacturers or importers
complete testing and reporting for an
abbreviated list of HPHCs as set forth in
the draft guidance. In particular, at this
time, for products that were first
marketed before June 22, 2012, FDA
does not intend to enforce the section
904(a)(3) requirement to test and report
quantities of all HPHCs on FDA’s
established list where: (1) A
manufacturer or importer (or agents
thereof), other than a small tobacco
product manufacturer, submits
quantities of the HPHCs on an
abbreviated list described in the draft
guidance for all of its products, by brand
and subbrand, no later than September
22, 2012; or (2) a small tobacco product
manufacturer (or agents thereof) submits
quantities of HPHCS on the abbreviated
list for all of its products, by brand and
subbrand, by December 22, 2012. In
addition, for products first marketed on
or after June 22, 2012, the draft guidance
explains that FDA does not intend, at
this time, to enforce the requirement in
section 904(c)(1) to test and report
quantities of all HPHCs on FDA’s
established list for products not
previously on the market if a
manufacturer or importer reports
quantities for the abbreviated list of
HPHCs at least 90 days prior to
marketing the product in the United
States. In addition, the draft guidance
explains that at this time, FDA intends
to enforce the HPHC reporting
requirements with respect to
manufacturers of finished tobacco
products for consumer use—cigarettes,
smokeless tobacco, and roll-your-own
tobacco—and not with respect to
manufacturers and importers of other
products, such as components sold to
manufacturers or consumers for
incorporation into finished products.
Although this draft guidance
announces an intent to exercise
enforcement discretion for a limited
time, FDA intends to move toward full
implementation and enforcement of the
statutory requirement to test and report
quantities of all HPHCs on FDA’s
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established list, as appropriate. We
anticipate that this guidance will be
revised or withdrawn as we move
toward full implementation. We intend
to use the information submitted under
sections 904(a)(3) and 904(c)(1) of the
FD&C Act to meet the requirements of
section 904(e) of the FD&C Act
regarding a list of HPHCs in each
tobacco product by brand and by
quantity in each brand and subbrand.
Also, the information will be used to
comply with section 904(d)(1) of the
FD&C Act, which requires FDA to
publish a list of HPHCs, by brand and
by quantity in each brand and subbrand,
in a format that is understandable and
not misleading to lay persons.
II. Significance of Guidance
FDA is issuing this draft guidance
document consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the Agency’s
current thinking on reporting HPHCs in
tobacco products and tobacco smoke
under section 904(a)(3) of the FD&C Act.
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
of 1995 (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
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing a notice
of the proposed collection of
information set forth in the draft
guidance for industry entitled
‘‘Reporting Harmful and Potentially
Harmful Constituents in Tobacco
Products and Tobacco Smoke Under
Section 904(a)(3) of the Federal Food,
Drug, and Cosmetic Act.’’
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
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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: Reporting
Harmful and Potentially Harmful
Constituents in Tobacco Products and
Tobacco Smoke Under Section 904(a)(3)
of the Federal Food, Drug, and Cosmetic
Act (OMB Control Number 0910–NEW)
The purpose of the proposed
information collection is to allow FDA
to collect statutorily mandated
information regarding HPHCs in tobacco
products and tobacco smoke, by brand
and by quantity in each brand and
subbrand. The draft guidance provides
an abbreviated list of HPHCs on which
FDA intends to focus enforcement at
this time for each of the following:
Cigarette smoke, smokeless tobacco
products, and roll-your-own tobacco
and cigarette filler.
To facilitate the submission of HPHC
information, FDA has developed forms
in both paper and electronic formats.
Manufacturers or importers, or an agent,
may submit information either
electronically or in paper format. The
FDA eSubmitter tool provides electronic
forms to streamline the data entry and
submission process for reporting
HPHCs. Users of eSubmitter may also
populate an Excel file and import data
into eSubmitter. FDA also provides
paper forms for the submission of
section 904(a)(3) reports. FDA intends to
place draft copies of the paper forms
and screen shots of the electronic form
and spreadsheet in this docket.
Whether respondents decide to
submit reports electronically or on
paper, each form provides instructions
for filling out and submitting HPHC
information to FDA. The forms contain
fields for company information, product
information, and HPHC information.
The draft guidance provides an
abbreviated list of HPHCs on which
FDA intends to focus enforcement at
this time, and information to assist in
the testing and reporting of HPHCs for
cigarette smoke and filler, smokeless
tobacco, and roll-your-own tobacco.
FDA has created forms to assist in the
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reporting of HPHC information for each
of these product types.
Description of Respondents: The
respondents to this collection of
information include manufacturers or
importers who complete testing and
reporting for HPHCs in tobacco products
and tobacco smoke under section
904(a)(3) of the FD&C Act. Respondents
could also include agents of
manufacturers or importers who
complete HPHC testing and reporting.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Information collected
Total
annual
responses
Average
burden per
response
Total hours
Part 1—Section 904(a)(3) of the FD&C Act (Annualized Estimate of One-time Reporting) 2
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
Cigarette .....................................................................
Roll-Your-Own ............................................................
Smokeless ..................................................................
120
46
200
10.10
3.22
1.44
1,212
148
288
2
2
2
2,424
296
576
Total .....................................................................
........................
..........................
........................
........................
3,296
Cigarette Filler ............................................................
Roll-Your-Own ............................................................
Smokeless ..................................................................
120
46
200
10.1
3.22
1.44
1,212
148
288
9.42
9.42
12.06
11,417
1,394
3,473
Total .....................................................................
........................
..........................
........................
........................
16,284
1,212
1,212
23.64
23.64
28,652
28,652
2. Testing of HPHC Quantities in Products
3. Testing of HPHC Quantities in Mainstream Smoke
Cigarette: International Organization for Standardization (ISO) Regimen .................................................
Cigarette: Health Canada Regimen ...........................
120
120
Total .....................................................................
........................
..........................
........................
........................
57,304
Total Section 904(a)(3) Annualized One-Time
Burden ..............................................................
........................
..........................
........................
........................
76,884
10.1
10.1
Part 2—Reporting of Section 904(c)(1) New Products (15% of One-Time Burden Totals) 3
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
Cigarette .....................................................................
Roll-Your-Own ............................................................
Smokeless ..................................................................
18
7
30
10.10
3.22
1.44
182
23
43
2
2
2
364
46
86
Total .....................................................................
........................
..........................
........................
........................
496
Cigarette Filler ............................................................
Roll-Your-Own ............................................................
Smokeless ..................................................................
18
7
30
10.1
3.22
1.44
182
23
43
9.42
9.42
12.06
1,714
217
519
Total .....................................................................
........................
..........................
........................
........................
2,450
182
182
23.64
23.64
4,302
4,302
2. Reporting of HPHC Quantities in Products
3. Reporting of HPHC Quantities in Mainstream Smoke
18
18
Total .....................................................................
........................
..........................
........................
........................
8,604
Total Section 904(c)(1) Burden ...........................
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Cigarette: ISO Regimen .............................................
Cigarette: Health Canada Regimen ...........................
10.1
10.1
........................
..........................
........................
........................
11,550
Total Reporting Burden Hours ............................
........................
..........................
........................
........................
88,434
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
actual first year burden hours have been annualized over the 3-year OMB period of approval to avoid overcounting the burden
each year.
3 Annual new product reporting under section 904(c)(1) is estimated to be 15% of the annualized one-time burden.
2 One-time
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FDA estimates the one-time reporting
burden for this guidance would be
230,652 hours during the first year for
section 904(a)(3) reporting plus ongoing
annual burden of 11,550 hours for
section 904(c)(1) reporting. The burden
estimate for this collection of
information includes the time it will
take to read the guidance document, test
the products, and prepare the HPHC
report.
To avoid overcounting the one-time
reporting burden, FDA has divided the
first year burden by three, annualizing
the one-time burden over the 3-year
expected OMB period of approval to
avoid double-counting the one-time
projected burden. The one-time burden
for year one is located in part 1 of table
1 of this document, and includes burden
for collections of information gathered
under section 904(a)(3). The annualized
total one-time burden in part 1 of table
1 is 76,884 hours (230,652 hours
divided by 3), which includes 3,296
hours for reporting manufacturer or
importer company and product
information, 16,284 hours for reporting
HPHC quantities in products, and
57,304 hours for reporting HPHC
quantities in mainstream smoke.
As shown in table 1, the total annual
burden for this collection of information
is estimated to be 88,434 hours, which
is the annualized one-time burden
estimate for section 904(a)(3) associated
with the submission of an HPHC (76,884
hours) and the annual burden estimate
for section 904(c)(1) (11,550 hours). We
have assumed a one-time burden for
section 904(a)(3) because this draft
guidance is intended to remain in effect
while industry is developing laboratory
capacity to comply fully with section
904(a)(3) of the FD&C Act. We also
assume any new product reporting
requirements under section 904(c)(1)
will be provided annually to FDA. We
also anticipate this guidance will be
revised or withdrawn as FDA moves
toward full implementation and
enforcement of the statutory
requirement to report quantities by
brand and subbrand of all HPHCs on
FDA’s established HPHC list.
Part one of table 1 estimates that 366
respondents (120 cigarette
manufacturers or importers, 200
smokeless manufacturers, and 46 rollyour-own tobacco manufacturers) will
submit 4,942 HPHC reports on a onetime basis (e.g., 1,648 reports on an
annualized basis). As noted previously,
FDA estimates that it will take the
manufacturer, importer, or their agents
230,652 hours on a one time basis, or
76,884 hours annually, to collect the
information necessary to test the
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products and submit an HPHC report by
brand and subbrand.
Part one, section one of table 1
addresses the time required for
manufacturers and importers to report
their company information: Company
name; mailing address; telephone and
FAX numbers; FDA Establishment
Identifier (FEI) number; Data Universal
Numbering System (D–U–N–S) number;
and point of contact name, mailing
address, and telephone and FAX
numbers. The first section of table 1 also
addresses the time required for
manufacturers and importers to report
their product information by entering
testing information onto the forms:
Brand and subbrand name; unique
product identification number; type of
product identification number; product
category and subcategory; and mean
weight and standard deviation of
tobacco in product. We estimate that the
burden is no more than 2 hours per
response to report company and product
information testing regardless of
whether the paper or electronic form
(Form FDA 3787) is used. This estimate
is not dependent on product type, so the
estimated burden is the same for
cigarettes, roll-your-own tobacco, and
smokeless tobacco products. We
estimate that there are 3,636 cigarette
subbrands, 445 roll-your-own tobacco
subbrands, and 861 smokeless tobacco
subbrands (4,942 total subbrands) that
must comply with section 904(a)(3) of
the FD&C Act. Therefore, the total
annualized burden for reporting
company and product information is
3,296 hours (4,942 respondents × 2
hours = 9,884 one-time hours divided
by 3).
Part one, section two of table 1
addresses the time required from
manufacturers and importers to report
quantities for HPHCs in their products:
Number of replicate measurements; test
date range; manufacture date range;
extraction method; separation method;
detection method; and mean quantity
and standard deviation of HPHCs. The
burden hour estimates in this section
include the time needed to test the
tobacco products, draft testing reports,
draft the report for FDA, and submit the
report to FDA. For cigarette filler,
smokeless, and roll your own products,
we estimate the burden to draft testing
reports, draft the report for FDA, and
submit the report to FDA to be 48,852
one-time hours, or 16,284 annualized
burden hours. The burden for each
product type reflects our estimate of the
burden to test the tobacco products (i.e.,
carry out laboratory work). The perresponse burden for testing cigarette
filler and roll-your-own tobacco is the
same, as the same HPHCs must be
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measured for both product types. The
per-response burden for testing
smokeless products is greater than that
for the other two product types because
more HPHCs must be tested for
smokeless products than the other two
product types.
Part one, section three of table 1
addresses the time required for
manufacturers and importers to report
quantities for HPHCs in cigarette smoke:
The number of replicate measurements;
test date range; manufacture date range;
extraction method; separation method;
detection method; and mean quantity
and standard deviation of HPHCs. The
burden estimates include the burden to
test the tobacco products, draft testing
reports, draft the report for FDA, and
submit the report to FDA. We estimate
the one-time burden for this section to
be 171,912 hours, or 57,304 annualized
hours. The annualized burden reflects
our estimate of the burden to test the
tobacco products (i.e., carry out
laboratory work). The burden estimate
assumes that manufacturers and
importers report HPHC quantities in
cigarette mainstream smoke according
to the two recommended smoking
regimens. The total annualized burden
for part one of table 1 (section 904(a)(3)
reporting) is 76,884 hours (3,296 hours
plus 16,284 hours plus 57,304 hours).
Part two of table 1 contains estimates
for new product information received
under section 904(c)(1). Manufacturers
and importers must report HPHC
information under section 904(c)(1) at
least 90 days prior to delivery for
introduction into interstate commerce.
We estimate that approximately 15
percent of FDA currently regulated
tobacco products in any given year will
require submission of this information.
The estimated total annual burden for
section 904(c)(1) is 11,550 hours, which
includes 496 hours to report
manufacturer/importer company and
product information, 2,450 hours to
report HPHC quantities in products, and
8,604 hours to report HPHC quantities
in mainstream smoke.
The estimated total annual burden for
the reporting of HPHC under sections
904(a)(3) and 904(c)(1) is 88,434 hours
(76,884 annualized burden hours for
section 904(a)(3) reporting plus 11,550
annual burden hours for section
904(c)(1) reporting).
We have not estimated any capital
costs because we do not believe there
are any capital costs associated with this
collection. However, you may comment
on any specific capital costs that you
have identified.
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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. Identify comments with the
docket number found in brackets in the
heading of this document. Received
documents 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
guidance document at https://www.
regulations.gov and https://www.fda.gov/
TobaccoProducts/GuidanceC
omplianceRegulatoryInformation/
default.htm.
Dated: March 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–7766 Filed 3–30–12; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0143]
Harmful and Potentially Harmful
Constituents in Tobacco Products and
Tobacco Smoke; Established List
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; establishment of a list.
The Food and Drug
Administration (FDA) is establishing a
list of harmful and potentially harmful
constituents (HPHCs) in tobacco
products and tobacco smoke (the
established HPHC list) as required by
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act).
FOR FURTHER INFORMATION CONTACT:
Carol Drew, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 877–287–
1373.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
I. Introduction
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 amended the
FD&C Act (21 U.S.C. 301 et seq.) by,
among other things, adding a new
chapter granting FDA important new
authority to regulate the manufacture,
VerDate Mar<15>2010
16:19 Apr 02, 2012
Jkt 226001
marketing, and distribution of tobacco
products to protect the public health.
Section 904(e) of the FD&C Act (21
U.S.C. 387d(e)), as added by the
Tobacco Control Act, requires FDA to
establish, and periodically revise as
appropriate, ‘‘a list of harmful and
potentially harmful constituents,
including smoke constituents, to health
in each tobacco product by brand and
by quantity in each brand and
subbrand.’’
The Agency has considered comments
solicited from the public, as well as
scientific and other information, and
has developed a list of tobacco product
constituents it currently believes are
harmful or potentially harmful to
health. We are establishing this list as
table 1 of this document as required by
section 904(e) of the FD&C Act. In this
document, we are also providing
information about related actions,
including the Agency’s guidance
discussing the meaning of HPHC, the
criteria the Agency used to help develop
the established HPHC list, the reasons
the Agency may add or remove
constituents from the established HPHC
list consistent with the directive of
section 904(e), and the addition of
quantities to the list.
II. Background
On January 31, 2011, FDA announced
the availability of a guidance entitled
‘‘ ‘Harmful and Potentially Harmful
Constituents’ in Tobacco Products as
Used in Section 904(e) of the Federal
Food, Drug, and Cosmetic Act’’ (76 FR
5387) (available at www.fda.gov/
TobaccoProducts/GuidanceCompliance
RegulatoryInformation) (HPHC final
guidance). This guidance represents the
Agency’s current thinking on the
meaning of the term ‘‘harmful and
potentially harmful constituent’’ in the
context of implementing section 904(e)
of the FD&C Act. It states: ‘‘FDA
believes that the phrase ‘harmful and
potentially harmful constituent’
includes any chemical or chemical
compound in a tobacco product or in
tobacco smoke: (a) That is or potentially
is inhaled, ingested, or absorbed into the
body; and (b) that causes or has the
potential to cause direct or indirect
harm to users or non-users of tobacco
products’’ (HPHC final guidance at page
2). The HPHC final guidance includes
examples of constituents that have the
potential to cause direct harm and
examples of constituents that have the
potential to cause indirect harm:
‘‘Examples of constituents that have the
‘potential to cause direct harm’ to users
or non-users of tobacco products
include constituents that are toxicants,
carcinogens, and addictive chemicals
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
and chemical compounds. Examples of
constituents that have the ‘potential to
cause indirect harm’ to users or nonusers of tobacco products include
constituents that may increase the
exposure to the harmful effects of a
tobacco product constituent by: (1)
Potentially facilitating initiation of the
use of tobacco products; (2) potentially
impeding cessation of the use of tobacco
products; or (3) potentially increasing
the intensity of tobacco product use
(e.g., frequency of use, amount
consumed, depth of inhalation).
Another example of a constituent that
has the ‘potential to cause indirect
harm’ is a constituent that may enhance
the harmful effects of a tobacco product
constituent’’ (HPHC final guidance at
page 2).
On May 1, 2010, a subcommittee of
the Tobacco Products Scientific
Advisory Committee (TPSAC),1 the
Tobacco Product Constituents
Subcommittee (the subcommittee), was
established and charged with making
preliminary recommendations to
TPSAC on the HPHCs in tobacco
products and tobacco smoke. The
subcommittee held public meetings on
June 8 and 9, 2010, and July 7, 2010.
Prior to these meetings, FDA solicited
data, information, and/or views on
HPHCs in tobacco products and tobacco
smoke from the public.2 At these
meetings the subcommittee:
• Reviewed example lists of HPHCs
in tobacco products and tobacco smoke
developed by other countries and
organizations;
• Identified criteria for selecting
carcinogens, toxicants, and addictive
chemicals or chemical compounds in
tobacco products and tobacco smoke;
• Identified chemicals or chemical
compounds that met the identified
criteria;
• Confirmed the existence of methods
for measuring each chemical or
chemical compound identified; and
• Identified other potentially
important information or criteria for
measuring HPHCs in tobacco products
or tobacco smoke, such as smoking
machine regimens to be used in
measuring HPHCs.
1 Information about TPSAC as well as information
and background materials on TPSAC meetings are
available at https://www.fda.gov/
AdvisoryCommittees/CommitteesMeetingMaterials/
TobaccoProductsScientificAdvisoryCommittee/
default.htm.
2 See 75 FR 22147 (April 27, 2010) and 75 FR
33814 (June 15, 2010). Information submitted to the
public docket for each of these meetings is available
at https://www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/TobaccoProducts
ScientificAdvisoryCommittee/ucm222977.htm and
https://www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/TobaccoProducts
ScientificAdvisoryCommittee/ucm222978.htm.
E:\FR\FM\03APN1.SGM
03APN1
]]>Agencies
[Federal Register Volume 77, Number 64 (Tuesday, April 3, 2012)]
[Notices]
[Pages 20030-20034]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7766]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0049]
Draft Guidance for Industry: Reporting Harmful and Potentially
Harmful Constituents in Tobacco Products and Tobacco Smoke Under the
Federal Food, Drug, and Cosmetic Act; Availability
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 ``Reporting
Harmful and Potentially Harmful Constituents in Tobacco Products and
Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and
Cosmetic Act.'' The purpose of this draft guidance is to assist persons
reporting to FDA the quantities of harmful and potentially harmful
constituents (HPHCs) in tobacco products and tobacco smoke under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance
explains that FDA does not intend, at this time, to enforce reporting
on the entire established HPHC list where a manufacturer or importer
completes testing and reporting for an abbreviated list of HPHCs within
the timeframes specified in the guidance.
DATES: Although you can comment on any guidance at any time (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 June 4, 2012. Submit either electronic or written comments
on the proposed collection of information by June 4, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance document 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 a fax number to which the draft guidance may be sent.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
Submit electronic comments on the draft guidance, including
comments on the proposed collection of information 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.
FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance:
James Flahive, Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 1-877-
287-1373, james.flahive@fda.hhs.gov.
With regard to the proposed collection of information: Daniel
Gittleson, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-5156, daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L.
111-31) into law. The Tobacco Control Act amends the FD&C Act and
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 904(a)(3) of the FD&C Act (21
U.S.C. 387d(a)(3)) requires each tobacco product manufacturer or
importer, or an agent, to begin reporting to FDA no later than June 22,
2012, ``all constituents, including smoke constituents, identified by
[FDA] as harmful or potentially harmful to health in each tobacco
product, and as applicable in the smoke of each tobacco product.''
Reports must be by the brand and by quantity in each brand and
subbrand. Section 904(c)(1) states that manufacturers of tobacco
products not on the market as of June 22, 2009, must also provide
information reportable under section 904(a)(3) at least 90 days prior
to introducing the product into interstate commerce.
FDA has taken several steps to identify HPHCs to be reported under
section 904(a)(3), including issuing a final guidance discussing FDA's
current thinking on the meaning of ``harmful and potentially harmful
constituent'' in the context of implementing the HPHC list requirement
(76 FR 5387, January 31, 2011). The guidance is available on the
Internet at https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm. In addition, on
August 12, 2011, FDA issued a document (the HPHC notice; 76 FR 50226)
in the Federal Register describing the criteria we tentatively
concluded we would use in identifying the HPHCs for the established
list, including a table of the 96 HPHCs we identified using those
criteria, and asking the public and interested parties to submit
relevant scientific and other information by October 11, 2011. FDA
reviewed comments received in response to the HPHC notice. Elsewhere in
this issue of the Federal Register, FDA is publishing a notice
announcing the established list of HPHCs as required by section 904(e)
of the FD&C Act.
This draft guidance discusses the information to be reported on
HPHCs in tobacco products and tobacco smoke under section 904(a)(3) of
the FD&C Act. This draft guidance document discusses, among other
things: The statutory requirement for testing and
[[Page 20031]]
reporting quantities of HPHCs, who tests and reports quantities of
HPHCs to FDA, what HPHCs will be the focus of FDA enforcement at this
time, when reports are submitted to FDA, what information is reported
to FDA, and how the reports should be submitted to FDA. The draft
guidance notifies manufacturers and importers that at this time, while
industry is developing laboratory capacity to comply with section
904(a)(3), FDA does not intend to enforce the statutory requirement to
submit quantities of all constituents identified by FDA as HPHCs by
June 22, 2012, where manufacturers or importers complete testing and
reporting for an abbreviated list of HPHCs as set forth in the draft
guidance. In particular, at this time, for products that were first
marketed before June 22, 2012, FDA does not intend to enforce the
section 904(a)(3) requirement to test and report quantities of all
HPHCs on FDA's established list where: (1) A manufacturer or importer
(or agents thereof), other than a small tobacco product manufacturer,
submits quantities of the HPHCs on an abbreviated list described in the
draft guidance for all of its products, by brand and subbrand, no later
than September 22, 2012; or (2) a small tobacco product manufacturer
(or agents thereof) submits quantities of HPHCS on the abbreviated list
for all of its products, by brand and subbrand, by December 22, 2012.
In addition, for products first marketed on or after June 22, 2012, the
draft guidance explains that FDA does not intend, at this time, to
enforce the requirement in section 904(c)(1) to test and report
quantities of all HPHCs on FDA's established list for products not
previously on the market if a manufacturer or importer reports
quantities for the abbreviated list of HPHCs at least 90 days prior to
marketing the product in the United States. In addition, the draft
guidance explains that at this time, FDA intends to enforce the HPHC
reporting requirements with respect to manufacturers of finished
tobacco products for consumer use--cigarettes, smokeless tobacco, and
roll-your-own tobacco--and not with respect to manufacturers and
importers of other products, such as components sold to manufacturers
or consumers for incorporation into finished products.
Although this draft guidance announces an intent to exercise
enforcement discretion for a limited time, FDA intends to move toward
full implementation and enforcement of the statutory requirement to
test and report quantities of all HPHCs on FDA's established list, as
appropriate. We anticipate that this guidance will be revised or
withdrawn as we move toward full implementation. We intend to use the
information submitted under sections 904(a)(3) and 904(c)(1) of the
FD&C Act to meet the requirements of section 904(e) of the FD&C Act
regarding a list of HPHCs in each tobacco product by brand and by
quantity in each brand and subbrand. Also, the information will be used
to comply with section 904(d)(1) of the FD&C Act, which requires FDA to
publish a list of HPHCs, by brand and by quantity in each brand and
subbrand, in a format that is understandable and not misleading to lay
persons.
II. Significance of Guidance
FDA is issuing this draft guidance document consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the Agency's current thinking on
reporting HPHCs in tobacco products and tobacco smoke under section
904(a)(3) of the FD&C Act. 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 of 1995 (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 before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing a notice
of the proposed collection of information set forth in the draft
guidance for industry entitled ``Reporting Harmful and Potentially
Harmful Constituents in Tobacco Products and Tobacco Smoke Under
Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act.''
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: Reporting Harmful and Potentially Harmful
Constituents in Tobacco Products and Tobacco Smoke Under Section
904(a)(3) of the Federal Food, Drug, and Cosmetic Act (OMB Control
Number 0910-NEW)
The purpose of the proposed information collection is to allow FDA
to collect statutorily mandated information regarding HPHCs in tobacco
products and tobacco smoke, by brand and by quantity in each brand and
subbrand. The draft guidance provides an abbreviated list of HPHCs on
which FDA intends to focus enforcement at this time for each of the
following: Cigarette smoke, smokeless tobacco products, and roll-your-
own tobacco and cigarette filler.
To facilitate the submission of HPHC information, FDA has developed
forms in both paper and electronic formats. Manufacturers or importers,
or an agent, may submit information either electronically or in paper
format. The FDA eSubmitter tool provides electronic forms to streamline
the data entry and submission process for reporting HPHCs. Users of
eSubmitter may also populate an Excel file and import data into
eSubmitter. FDA also provides paper forms for the submission of section
904(a)(3) reports. FDA intends to place draft copies of the paper forms
and screen shots of the electronic form and spreadsheet in this docket.
Whether respondents decide to submit reports electronically or on
paper, each form provides instructions for filling out and submitting
HPHC information to FDA. The forms contain fields for company
information, product information, and HPHC information. The draft
guidance provides an abbreviated list of HPHCs on which FDA intends to
focus enforcement at this time, and information to assist in the
testing and reporting of HPHCs for cigarette smoke and filler,
smokeless tobacco, and roll-your-own tobacco. FDA has created forms to
assist in the
[[Page 20032]]
reporting of HPHC information for each of these product types.
Description of Respondents: The respondents to this collection of
information include manufacturers or importers who complete testing and
reporting for HPHCs in tobacco products and tobacco smoke under section
904(a)(3) of the FD&C Act. Respondents could also include agents of
manufacturers or importers who complete HPHC testing and reporting.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Information collected Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Part 1--Section 904(a)(3) of the FD&C Act (Annualized Estimate of One-time Reporting) \2\
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
Cigarette................... 120 10.10 1,212 2 2,424
Roll-Your-Own............... 46 3.22 148 2 296
Smokeless................... 200 1.44 288 2 576
---------------
Total................... .............. .............. .............. .............. 3,296
----------------------------------------------------------------------------------------------------------------
2. Testing of HPHC Quantities in Products
----------------------------------------------------------------------------------------------------------------
Cigarette Filler............ 120 10.1 1,212 9.42 11,417
Roll-Your-Own............... 46 3.22 148 9.42 1,394
Smokeless................... 200 1.44 288 12.06 3,473
---------------
Total................... .............. .............. .............. .............. 16,284
----------------------------------------------------------------------------------------------------------------
3. Testing of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
Cigarette: International 120 10.1 1,212 23.64 28,652
Organization for
Standardization (ISO)
Regimen....................
Cigarette: Health Canada 120 10.1 1,212 23.64 28,652
Regimen....................
---------------
Total................... .............. .............. .............. .............. 57,304
---------------
Total Section 904(a)(3) .............. .............. .............. .............. 76,884
Annualized One-Time
Burden.................
----------------------------------------------------------------------------------------------------------------
Part 2--Reporting of Section 904(c)(1) New Products (15% of One-Time Burden Totals) \3\
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
Cigarette................... 18 10.10 182 2 364
Roll-Your-Own............... 7 3.22 23 2 46
Smokeless................... 30 1.44 43 2 86
---------------
Total................... .............. .............. .............. .............. 496
----------------------------------------------------------------------------------------------------------------
2. Reporting of HPHC Quantities
in Products
----------------------------------------------------------------------------------------------------------------
Cigarette Filler............ 18 10.1 182 9.42 1,714
Roll-Your-Own............... 7 3.22 23 9.42 217
Smokeless................... 30 1.44 43 12.06 519
---------------
Total................... .............. .............. .............. .............. 2,450
----------------------------------------------------------------------------------------------------------------
3. Reporting of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
Cigarette: ISO Regimen...... 18 10.1 182 23.64 4,302
Cigarette: Health Canada 18 10.1 182 23.64 4,302
Regimen....................
---------------
Total................... .............. .............. .............. .............. 8,604
---------------
Total Section 904(c)(1) .............. .............. .............. .............. 11,550
Burden.................
---------------
Total Reporting Burden .............. .............. .............. .............. 88,434
Hours..................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One-time actual first year burden hours have been annualized over the 3-year OMB period of approval to avoid
overcounting the burden each year.
\3\ Annual new product reporting under section 904(c)(1) is estimated to be 15% of the annualized one-time
burden.
[[Page 20033]]
FDA estimates the one-time reporting burden for this guidance would
be 230,652 hours during the first year for section 904(a)(3) reporting
plus ongoing annual burden of 11,550 hours for section 904(c)(1)
reporting. The burden estimate for this collection of information
includes the time it will take to read the guidance document, test the
products, and prepare the HPHC report.
To avoid overcounting the one-time reporting burden, FDA has
divided the first year burden by three, annualizing the one-time burden
over the 3-year expected OMB period of approval to avoid double-
counting the one-time projected burden. The one-time burden for year
one is located in part 1 of table 1 of this document, and includes
burden for collections of information gathered under section 904(a)(3).
The annualized total one-time burden in part 1 of table 1 is 76,884
hours (230,652 hours divided by 3), which includes 3,296 hours for
reporting manufacturer or importer company and product information,
16,284 hours for reporting HPHC quantities in products, and 57,304
hours for reporting HPHC quantities in mainstream smoke.
As shown in table 1, the total annual burden for this collection of
information is estimated to be 88,434 hours, which is the annualized
one-time burden estimate for section 904(a)(3) associated with the
submission of an HPHC (76,884 hours) and the annual burden estimate for
section 904(c)(1) (11,550 hours). We have assumed a one-time burden for
section 904(a)(3) because this draft guidance is intended to remain in
effect while industry is developing laboratory capacity to comply fully
with section 904(a)(3) of the FD&C Act. We also assume any new product
reporting requirements under section 904(c)(1) will be provided
annually to FDA. We also anticipate this guidance will be revised or
withdrawn as FDA moves toward full implementation and enforcement of
the statutory requirement to report quantities by brand and subbrand of
all HPHCs on FDA's established HPHC list.
Part one of table 1 estimates that 366 respondents (120 cigarette
manufacturers or importers, 200 smokeless manufacturers, and 46 roll-
your-own tobacco manufacturers) will submit 4,942 HPHC reports on a
one-time basis (e.g., 1,648 reports on an annualized basis). As noted
previously, FDA estimates that it will take the manufacturer, importer,
or their agents 230,652 hours on a one time basis, or 76,884 hours
annually, to collect the information necessary to test the products and
submit an HPHC report by brand and subbrand.
Part one, section one of table 1 addresses the time required for
manufacturers and importers to report their company information:
Company name; mailing address; telephone and FAX numbers; FDA
Establishment Identifier (FEI) number; Data Universal Numbering System
(D-U-N-S) number; and point of contact name, mailing address, and
telephone and FAX numbers. The first section of table 1 also addresses
the time required for manufacturers and importers to report their
product information by entering testing information onto the forms:
Brand and subbrand name; unique product identification number; type of
product identification number; product category and subcategory; and
mean weight and standard deviation of tobacco in product. We estimate
that the burden is no more than 2 hours per response to report company
and product information testing regardless of whether the paper or
electronic form (Form FDA 3787) is used. This estimate is not dependent
on product type, so the estimated burden is the same for cigarettes,
roll-your-own tobacco, and smokeless tobacco products. We estimate that
there are 3,636 cigarette subbrands, 445 roll-your-own tobacco
subbrands, and 861 smokeless tobacco subbrands (4,942 total subbrands)
that must comply with section 904(a)(3) of the FD&C Act. Therefore, the
total annualized burden for reporting company and product information
is 3,296 hours (4,942 respondents x 2 hours = 9,884 one-time hours
divided by 3).
Part one, section two of table 1 addresses the time required from
manufacturers and importers to report quantities for HPHCs in their
products: Number of replicate measurements; test date range;
manufacture date range; extraction method; separation method; detection
method; and mean quantity and standard deviation of HPHCs. The burden
hour estimates in this section include the time needed to test the
tobacco products, draft testing reports, draft the report for FDA, and
submit the report to FDA. For cigarette filler, smokeless, and roll
your own products, we estimate the burden to draft testing reports,
draft the report for FDA, and submit the report to FDA to be 48,852
one-time hours, or 16,284 annualized burden hours. The burden for each
product type reflects our estimate of the burden to test the tobacco
products (i.e., carry out laboratory work). The per-response burden for
testing cigarette filler and roll-your-own tobacco is the same, as the
same HPHCs must be measured for both product types. The per-response
burden for testing smokeless products is greater than that for the
other two product types because more HPHCs must be tested for smokeless
products than the other two product types.
Part one, section three of table 1 addresses the time required for
manufacturers and importers to report quantities for HPHCs in cigarette
smoke: The number of replicate measurements; test date range;
manufacture date range; extraction method; separation method; detection
method; and mean quantity and standard deviation of HPHCs. The burden
estimates include the burden to test the tobacco products, draft
testing reports, draft the report for FDA, and submit the report to
FDA. We estimate the one-time burden for this section to be 171,912
hours, or 57,304 annualized hours. The annualized burden reflects our
estimate of the burden to test the tobacco products (i.e., carry out
laboratory work). The burden estimate assumes that manufacturers and
importers report HPHC quantities in cigarette mainstream smoke
according to the two recommended smoking regimens. The total annualized
burden for part one of table 1 (section 904(a)(3) reporting) is 76,884
hours (3,296 hours plus 16,284 hours plus 57,304 hours).
Part two of table 1 contains estimates for new product information
received under section 904(c)(1). Manufacturers and importers must
report HPHC information under section 904(c)(1) at least 90 days prior
to delivery for introduction into interstate commerce. We estimate that
approximately 15 percent of FDA currently regulated tobacco products in
any given year will require submission of this information. The
estimated total annual burden for section 904(c)(1) is 11,550 hours,
which includes 496 hours to report manufacturer/importer company and
product information, 2,450 hours to report HPHC quantities in products,
and 8,604 hours to report HPHC quantities in mainstream smoke.
The estimated total annual burden for the reporting of HPHC under
sections 904(a)(3) and 904(c)(1) is 88,434 hours (76,884 annualized
burden hours for section 904(a)(3) reporting plus 11,550 annual burden
hours for section 904(c)(1) reporting).
We have not estimated any capital costs because we do not believe
there are any capital costs associated with this collection. However,
you may comment on any specific capital costs that you have identified.
[[Page 20034]]
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. Identify
comments with the docket number found in brackets in the heading of
this document. Received documents 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 guidance document at https://www.regulations.gov and
https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: March 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7766 Filed 3-30-12; 11:15 am]
BILLING CODE 4160-01-P
