[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22202-22204]
[FR Doc No: 2015-09092]

-----------------------------------------------------------------------

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.

ACTION: Notice.

-----------------------------------------------------------------------

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 listing of ingredients in tobacco products.

DATES: Submit either electronic or written comments on the collection
of information by June 22, 2015.

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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
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) by, among
other things, adding a chapter granting FDA important 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. 387e(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 FDA the name, places of business, and all
establishments owned or 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
section 905(b) or 905(c) of the FD&C Act 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) of the FD&C Act 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 (21
U.S.C. 387d(a)(1)), 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 sub-brand. Since the Tobacco Control
Act was enacted on June 22, 2009, the information required under
section 904(a)(1) of the FD&C Act 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'' and (2) ``Listing of Ingredients in Tobacco Products''
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 electronic submission applications to
streamline the data entry process for registration and product listing
and for ingredient listing. These tools allow for importation of large
quantities of structured data, attachment of files (e.g., in PDFs and
certain media files), and automatic acknowledgement of FDA's receipt of
submissions.
    FDA also developed paper forms (Form FDA 3741--Registration and
Listing for Owners and Operators of Domestic Tobacco Product
Establishments, and Form FDA 3742--Listing of Ingredients in Tobacco
Products) as an alternative submission tool. Both the electronic
submission 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:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                            Number of       Number of      Total annual       Average                      operating and
                        Activity                           respondents    responses per      responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3741: Registration and Product Listing for                 125              1.6             200            3.75             750           $0.98
 Owners and Operators of Domestic Establishments
 (Electronic and Paper Submission)/Section 905(b),
 905(c), 905(d) 905(h), or 905(i) of the FD&C Act......
Form FDA 3742: Listing of Ingredients (Electronic and               125              1.6             200               3             600            0.98
 Paper Submissions)/Section 904(a)(1) or 904(c) of the
 FD&C Act..............................................
Obtaining a DUNS Number (10% of Total Respondents).....               8              1                 8          .5 (30               4  ..............
                                                                                minutes)
                                                        ------------------------------------------------------------------------------------------------
    Total..............................................  ..............  ...............  ..............  ..............           1,354            1.96
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Since this collection of information was last approved by OMB on
October 15, 2012, its burden has remained the same at 1,354 reporting
hours. This burden estimate was determined as a result of FDA
experience over the past 3 years in the regulation of tobacco products
and is based on the actual number of establishment registration and
product listings and product ingredient submissions received during
this time period. 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 and, based on the actual number of
registration information submitted in the past 3 years and its
experience, the Agency estimates that approximately 200 registrations
will be submitted from 125 tobacco product establishments annually, for
a total of 750 reporting burden hours. FDA estimates that the
submission of ingredient listing information as required by section 904
of the FD&C Act will remain at 3 hours per tobacco product and, based
on the actual number of product ingredient listings submitted over the
past 3 years and its experience, the Agency estimates that
approximately 200 ingredient listings will be submitted from 125
tobacco establishments, for a total of 600 reporting burden hours.
    FDA also 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 is estimated to
be 4 hours. Total burden hours for this collection, therefore is 1,354
hours.

    Dated: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09092 Filed 4-20-15; 8:45 am]
 BILLING CODE 4164-01-P