[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Notices]
[Pages 44636-44639]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18442]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0049]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reporting Harmful and
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
Under the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under Paperwork
Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
29, 2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title ``Reporting Harmful and Potentially Harmful Constituents in
Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and
Cosmetic Act.'' Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Reporting Harmful and Potentially Harmful Constituents in Tobacco
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic
Act--(OMB Control Number 0910-NEW)
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Public Law 111-31) into law. This
law amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
grants FDA authority to
[[Page 44637]]
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)
of the FD&C Act 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 harmful and potentially
harmful constituents (HPHCs) to be reported under sections 904(a)(3)
and (c)(1) of the FD&C Act, 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 http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm. In addition, in
the Federal Register of April 3, 2012 (77 FR 20034), FDA published a
notice (the HPHC list notice) announcing the established list of HPHCs
as required by section 904(e) of the FD&C Act and describing the
criteria we used in identifying the HPHCs for the established list.
Previously, FDA sought comment on both the criteria that would be used
to identify HPHCs for the established list and a list of chemicals and
chemical compounds that met the proposed criteria.
In the Federal Register of April 3, 2012 (77 FR 20030), FDA
announced the availability of a draft guidance entitled ``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'' (904(a)(3) draft guidance)
discussing the information to be reported on HPHCs in tobacco products
and tobacco smoke under sections 904(a)(3) and (c)(1) of the FD&C Act.
The 904(a)(3) draft guidance discusses, among other things: The
statutory requirement for testing and 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 904(a)(3) draft guidance notifies
manufacturers and importers that, at this time, while industry is
developing laboratory capacity to comply with section 904(a)(3) of the
FD&C Act, 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
904(a)(3) 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 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 904(a)(3) draft guidance explains that FDA does not
intend, at this time, to enforce the requirement in section 904(c)(1)
of the FD&C Act 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. The 904(a)(3) 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.
The purpose of the proposed information collection is for FDA to
collect statutorily mandated information regarding HPHCs in tobacco
products and tobacco smoke, by quantity in each brand and subbrand. The
904(a)(3) 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
Form 3787 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 placed 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 (including the
specific HPHCs identified in the 904(a)(3) draft guidance).
The Federal Register notice announcing the availability of the
904(a)(3) draft guidance included a 60-day notice requesting public
comment on the proposed collection of information. FDA received 16
comments that were PRA-related, including but not limited to the
following issues:
Suggestions to enhance the quality, utility, and clarity
of the information to be collected (i.e., comments specific to FDA's
eSubmitter tool and paper forms);
Cost associated with the collection of information to
comply with section 904(a)(3) of the FD&C Act, particularly for small
tobacco product manufacturers; and
Use of the proposed information collection, especially
because specific test methods are not prescribed to determine HPHC
quantities.
Section 904(a)(3) of the FD&C Act requires HPHC testing and
reporting. We have stated that we intend to exercise enforcement
discretion for manufacturers who test for 20 rather than 93 HPHCs at
this time. In addition, we have recognized that small tobacco product
manufacturers are likely to rely on contract testing laboratories and
intend to exercise enforcement discretion for those who submit
quantities of HPHCs 6 months after the statutory deadline (i.e.,
December 22, 2012), and 3 months after submissions by other tobacco
product manufacturers. Our abbreviated list of HPHCs, along with the
timeframes described in the
[[Page 44638]]
draft guidance, represent a reasonable approach to implementing section
904(a)(3) of the FD&C Act.
Based on comments received, FDA has revised the instructions for
FDA Form 3787 to explain that if the HPHC quantity is below the limit
of detection or limit of quantitation, zero should be entered in the
space identified for form. We have also made minor cosmetic changes to
clarify instructions and to allow accurate data entry. FDA has not
revised the burden estimate for this collection of information.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Information collected Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Part 1--Section 904(a)(3) of the FD&C Act (Annualized estimate of one-time reporting) \2\
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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
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Total................... .............. .............. .............. .............. 3,296
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2. Testing of HPHC Quantities in Products
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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
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Total................... .............. .............. .............. .............. 16,284
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3. Testing of HPHC Quantities in Mainstream Smoke
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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....................
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Total................... .............. .............. .............. .............. 57,304
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Total Section .............. .............. .............. .............. 76,884
904(a)(3)
Annualized One-Time
Burden.............
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Part 2--Reporting of Section 904(c)(1) New Products (15% of One-Time Burden Totals) \3\
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1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
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Cigarette................... 18 10.10 182 2 364
Roll-Your-Own............... 7 3.22 23 2 46
Smokeless................... 30 1.44 43 2 86
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Total................... .............. .............. .............. .............. 496
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2. Reporting of HPHC Quantities in Products
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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
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Total................... .............. .............. .............. .............. 2,450
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3. Reporting of HPHC Quantities in Mainstream Smoke
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Cigarette: ISO Regimen...... 18 10.1 182 23.64 4,302
Cigarette: Health Canada 18 10.1 182 23.64 4,302
Regimen....................
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Total................... .............. .............. .............. .............. 8,604
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Total Section .............. .............. .............. .............. 11,550
904(c)(1) Burden...
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Total Reporting .............. .............. .............. .............. 88,434
Burden Hours...
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\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
over counting the burden each year.
\3\ Annual new product reporting under section 904(c)(1) of the FD&C Act is estimated to be 15 percent of the
annualized one-time burden.
[[Page 44639]]
FDA estimates the one-time reporting burden for this guidance would
be 230,652 hours during the first year for section 904(a)(3) of the
FD&C Act 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
annualized the one-time burden over the 3-year expected OMB period of
approval. The annualized one-time burden of 76,884 hours is located in
part one of table 1 of this document, and includes burden for
collections of information gathered under section 904(a)(3) of the FD&C
Act. 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) of the FD&C Act associated with the
submission of HPHC reports and the annual burden estimate for section
904(c)(1). Table 1 of this document estimates 366 respondents will
submit HPHC reports on a one-time basis. Table 1 of this document
addresses the time required for manufacturers and importers to report
their company information. We estimate that the burden is no more than
2 hours per response to report company and product information,
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 also estimate that 3,636 cigarette subbrands, 445
roll-your-own tobacco subbrands, and 861 smokeless tobacco subbrands
(4,942 total subbrands) 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.
Table 1 of this document also addresses the time required for
manufacturers and importers to report quantities of HPHCs in their
products. The burden hour estimates 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 test the product, draft
testing reports, draft the report for FDA, and submit the report to FDA
to be 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).
In addition to addressing the time required to report quantities of
HPHCs in tobacco products, table 1 of this document addresses the time
required for manufacturers and importers to report quantities for HPHCs
in cigarette smoke. The burden estimates include testing the tobacco
products, drafting testing reports, drafting the report for FDA, and
submitting the report to FDA. We estimate the annualized burden for
this section to be 57,304 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.
Table 1 of this document also contains estimates for new product
information received annually under section 904(c)(1) of the FD&C Act.
Manufacturers and importers must report HPHC information under section
904(c)(1) of the FD&C Act 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) of the FD&C Act is 11,550 hours,
which includes reporting manufacturer/importer company and product
information, reporting HPHC quantities in products, and reporting HPHC
quantities in mainstream smoke.
The estimated total annual burden for the reporting of HPHC under
section 904(a)(3) and (c)(1) of the FD&C Act is 88,434 hours, which
includes the section 904(a)(3) annualized reporting burden plus the
section 904(c)(1) annual reporting burden.
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.
Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18442 Filed 7-27-12; 8:45 am]
BILLING CODE 4160-01-P