
[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22202-22204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-09092]


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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.

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 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, PRAStaff@fda.hhs.gov.

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

[[Page 22203]]

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
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                                                                                                                                               Total
                                                            Number of       Number of      Total annual       Average                      operating and
                        Activity                           respondents    responses per      responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
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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
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    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.


[[Page 22204]]


    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


