[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Notices]
[Pages 26281-26283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10645]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA-2012-N-0386]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments and Listing of
Ingredients in Tobacco Products
AGENCY: Food and Drug Administration, HHS.
[[Page 26282]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed extension of an
existing collection of information pertaining to registration and
product listing for owners and operators of domestic tobacco product
establishments and to listing of ingredients in tobacco products under
the Family Smoking Prevention and Tobacco Control Act (the Tobacco
Control Act).
DATES: Submit either electronic or written comments on the collection
of information by July 2, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments and Listing of Ingredients in Tobacco
Products (OMB Control Number 0910-0650)--Extension
On June 22, 2009, the President signed the Tobacco Control Act
(Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) by,
among other things, adding a new chapter granting the FDA important new
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and to reduce
tobacco use by minors.
Section 905(b) of the FD&C Act (21 U.S.C. 395(b)), as amended by
the Tobacco Control Act, requires that ``every person who owns or
operates any establishment in any State engaged in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products * * *'' register with the FDA the name, places of business,
and all establishments owned operated by that person. Every person must
register by December 31 of each year. Section 905(c) of the FD&C Act
requires that first-time persons ``engaging in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products shall register with the Secretary the name, places of
business, and all such establishments of that person.'' Section 905(d)
states that persons required to register under sections 905(b) or
905(c) shall register any additional establishment that they own or
operate in any state which begins the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products.
Section 905(h) addresses foreign establishment registration
requirements, which will go into effect when regulations are
promulgated by the Secretary. Section 905(i)(1) of the FD&C Act, as
amended by the Tobacco Control Act, requires that all registrants
``shall, at the time of registration under any such subsection, file
with [FDA] a list of all tobacco products which are being manufactured,
prepared, compounded, or processed by that person for commercial
distribution,'' along with certain accompanying consumer information,
such as all labeling and a representative sampling of advertisements.
Section 904(a)(1) of the FD&C Act, as amended by the Tobacco Control
Act, requires each tobacco product manufacturer or importer, or agent
thereof, to submit ``a listing of all ingredients, including tobacco,
substances, compounds, and additives that are * * * added by the
manufacturer to the tobacco, paper, filter, or other part of each
tobacco product by brand or by quantity in each brand and subbrand.''
Since the Tobacco Control Act was enacted on June 22, 2009, the
information required under section 904(a)(1) must be submitted to FDA
by December 22, 2009, and include the ingredients added as of the date
of submission. Section 904(c) of the FD&C Act also requires submission
of information whenever additives, or the quantities of additives, are
changed.
FDA issued guidance documents on both: (1) Registration and Product
Listing for Owners and Operators of Domestic Tobacco Product
Establishments (November 12, 2009, 74 FR 58298) and (2) Listing of
Ingredients in Tobacco Products (December 1, 2009, 74 FR 62795) to
assist persons making such submissions to FDA under the Tobacco Control
Act. While electronic submission of registration and product listing
information and ingredient listing information are not required, FDA is
strongly encouraging electronic submission to facilitate efficiency and
timeliness of data management and collection. To that end, FDA designed
the eSubmitter application to streamline the data entry process for
registration and product listing and for ingredient listing. This tool
allows for importation of large quantities of structured data,
attachment of files (e.g., in portable document format (PDFs) and
certain media files), and automatic acknowledgement of FDA's receipt of
submissions. FDA also developed paper forms (Form FDA 3742--
Registration and Listing for Owners and Operators of
[[Page 26283]]
Domestic Tobacco Product Establishments and Form FDA 3743--Listing of
Ingredients in Tobacco Products) as an alternative submission tool.
Both the eSubmitter application and the paper forms can be accessed at
http://www.fda.gov/tobacco.
FDA estimates the burden of this collection of information as
follows:
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Number of
FDA form/ activity/TCA section Number of responses per Total annual Hours per Total hours
respondents respondent responses response
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Form FDA 3742 Registration and 125 1.6 200 3.75 750
Product Listing for Owners and
Operators of Domestic
Establishments (Electronic and
Paper submission) Sections
905(b), 905(c), 905(d) 905(h),
or 905(i).......................
Form FDA 3743 Listing of 125 1.6 200 3.00 600
Ingredients (Electronic and
Paper Submissions) Sections
904(a)(1) or 904(c).............
Obtaining a DUNS Number (10% of 8 1 8 0.50 4
total respondents)..............
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Total........................ .............. ............. .............. .............. 1,354
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Since this collection of information was last approved by OMB on
December 2, 2010, its burden has decreased by 407,421 hours, from
408,775 to 1,354 reporting hours. This adjustment is a result of FDA
experience over the past 2 years in the regulation of tobacco products
and is based on the actual number of establishment registration and
product ingredient submissions received during this time period. In
2010, when this collection was first published for public comment in
the Federal Register, FDA attempted to determine the actual number of
tobacco manufacturers by using the Security and Exchange Commission's
Standard Industrial Classification (SIC) codes, which are identifying
codes that appear in a company's EDGAR filings to show the company's
type of business. When preparing the collection of information package
for publication in 2010, the tobacco industry codes indicated that over
10,000 tobacco manufacturers existed under the SIC codes for tobacco
products and cigarettes. However, upon further examination of these
codes, it appears that the number of tobacco manufacturers was greatly
inflated, as the SIC codes included tobacco retail in addition to
tobacco manufacturers. In addition, no comments were received from the
2010 initial 60-Day Federal Register Notice regarding either the number
of respondents or the number of reporting burden hours listed in the
notice, so FDA used the collection's SIC-researched manufacturer
numbers for this collection of information. Actual FDA registration and
product listing report submissions and FDA experience indicate in the
past 2 years, the number of tobacco manufacturers required to register
and list their products and ingredient listings is approximately 125, a
substantial decrease from the number of potential respondents listed in
2010. By applying the revised number of manufacturers to the burden
chart, the total burden for registration and listing now is currently
estimated to be 1,354 reporting burden hours, much less than the
408,775 OMB-approved reporting burden hours stated in 2010.
Based on the actual number of registration and product ingredient
listing reports received by FDA over the past 2 years, the number of
expected annual responses is projected to decrease from 100,000
registration responses to 200 annual responses, and from 11,000 annual
product ingredient listing responses to 200 annual product ingredient
responses. The Agency bases its estimate on the actual number of
registration and listing and product ingredient listing reports
received, its experience with the submission of registration and
listing requirements applicable to other FDA regulated products, and
ongoing interactions with industry. FDA estimates that the submission
of registration information as required by section 905 of the FD&C Act
will remain at 3.75 hours per establishment. Based on the actual number
of registration information submitted over the past 2 years and its
experience, the Agency estimates that approximately 200 registrations
will be submitted from 125 tobacco product establishments annually, for
a total 750 hour burden (125 respondents x 1.6 responses per respondent
x 3.75 hours per response).
FDA estimates that the submission of ingredient listing information
as required by section 904 of the FD&C Act will remain at 3.0 hours per
tobacco product. Based on the actual number of product ingredient
listings submitted over the past 2 years and its experience, the Agency
estimates that approximately 200 ingredient listings will be submitted
from 125 tobacco establishments, for a total 600 burden hours (125
respondents x 1.6 responses per respondent x 3.0 hours per response).
FDA estimates that obtaining a Dun and Bradstreet (DUNS) number
will take 0.5 hours, and that 8 respondents (1 percent (1.25) of
establishments required to register under section 905 and 5 percent
(6.25) of submitters required to list ingredients under section 904)
will not already have a DUNS number. The total burden, therefore, will
be 4 hours (8 respondents x 1 response per respondent x 0.5 hours per
response).
Total burden hours for this collection, therefore is 1,354 hours
(750 + 600 + 4 hours).
Dated: April 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10645 Filed 5-2-12; 8:45 am]
BILLING CODE 4160-01-P