
[Federal Register Volume 80, Number 144 (Tuesday, July 28, 2015)]
[Notices]
[Pages 44971-44973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18410]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0386]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
27, 2015.

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 0910-0650. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 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 (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)

[[Page 44972]]

addresses foreign establishment registration requirements, which will 
go into effect when regulations are issued 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 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 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 portable document format (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.
    In the Federal Register of April 21, 2015 (80 FR 22202), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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                                     Total    operating and
         FDA Form/activity/TCA section            respondents    responses per     responses          Hours per  response         hours     maintenance
                                                                  respondent                                                                   costs
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Tobacco Product Establishment Initial                      135               1             135  2..............................      270           $0.66
 Registration and Listing; Form FDA 3741
 Registration and Product Listing for Owners
 and Operators of Domestic Establishments
 (Electronic and Paper submissions); Section
 905(b), (c), (d), (h), or (i).
Tobacco Product Establishment Renewal                      135               1             135  0.20 (12 minutes)..............       27            0.66
 Registration and Listing; Form FDA 3741
 Registration and Product Listing for Owners
 and Operators of Domestic Establishments
 (Electronic and Paper submissions); Section
 905(b), (c), (d), (h), or (i).
Tobacco Product Initial Ingredient Listing;                135               1             135  2..............................      270            0.66
 Form FDA 3742 Listing of Ingredients
 (Electronic and Paper submissions); Section
 904(a)(1) or (c).
Tobacco Product Renewal Ingredient Listing;                135               2             270  0.40 (24 minutes)..............      108            1.32
 Form FDA 3742 Listing of Ingredients
 (Electronic and Paper submissions); Section
 904(a)(1) or (c).
Obtaining a Dun and Bradstreet D-U-N-S Number.               8               1               8  0.5............................        4  ..............
Tobacco Product Ingredient Listing Electronic              135               1             135  3..............................      405            0.66
 and Paper submission.
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    Total.....................................  ..............  ..............  ..............  ...............................    1,084            3.96
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    On April 21, 2015, the FDA published a 60-day notice (80 FR 22202) 
requesting public comments in the Federal Register. In this notice, the 
total amount of burden hours for this collection was incorrectly listed 
as 1,354 hours. After an internal review of burden for this collection, 
FDA realized that the burden in the 60-day Federal Register notice did 
not take into account new information from another Federal Agency 
(which revised the number of respondents slightly upward), and the use 
of a new electronic registration and product listing submission system. 
To correct this oversight, FDA is revising the number of respondents 
upward, from 125 to 135 respondents. FDA also has incorporated the use 
of a new electronic system into this collection, so the total hours 
were revised from 1,354 hours to 1,084 hours in table 1.
    The burden estimates have been updated to fully incorporate the use 
of FDA's new electronic system known as FURLS for submitting 
registration and product listing information to FDA. This system allows 
companies to enter information quickly and easily. For example, product 
label pictures can be uploaded directly into the system and FDA 
anticipates that most, if not all companies already have electronic 
versions of their labels for printing, sales, or marketing purposes. 
FDA anticipates that the initial entry registration and initial product 
listing will each take 2 hours per entity.
    Under section 905, once information is entered into FURLS, the 
twice yearly conformation or updates to product lists are expected to 
be simplified as all information previously entered is maintained and 
visible in the system. Therefore, FDA expects that ongoing maintenance 
of the product listing information will take 30 minutes twice a year, 
or a total of 1 hour annually. This is broken down into 12 minutes for 
recurring Registration and Listing each year, and 24 minutes twice a 
year for recurring Product Ingredient Listings, or a total of 48 
minutes annually.

[[Page 44973]]

    Based on data shared by another Federal Agency, FDA estimates that 
135 establishments will initially submit one report, and then will 
submit confirmation or update reports on a semiannual basis.
    FDA estimates that the confirmation or updating of registration 
information as required by section 905 will take 12 minutes annually 
per confirmation or update per establishment.
    FDA estimates that the submission of product listings required by 
section 905 for each establishment will take 2 hours initially. FDA 
also estimates that the confirmation or updating of product listing 
information required by section 905 will take 48 minutes annually for 
two confirmations or updates per establishment.
    FDA estimates that obtaining an optional Dun and Bradstreet D-U-N-S 
number will take 0.5 hours, and that 8 respondents (1 percent x 135 = 
1.35 of establishments required to register under section 905, and 5 
percent x 135 = 6.75 of submitters required to list ingredients under 
section 904) will not already have a Dun and Bradstreet D-U-N-S number.
    FDA estimates that the submission of ingredient listing information 
as required by section 904 of the act will take 3 hours per tobacco 
product.

    Dated: July 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18410 Filed 7-27-15; 8:45 am]
 BILLING CODE 4164-01-P


