[Federal Register Volume 84, Number 94 (Wednesday, May 15, 2019)]
[Notices]
[Pages 21787-21790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09997]


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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 (PRA).

DATES: Fax written comments on the collection of information by June 
14, 2019.

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: Amber Sanford, Office of Operations,

[[Page 21788]]

Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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 Family Smoking Prevention and Tobacco Control 
Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The 
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) by adding, among other things, 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. The Tobacco Control Act created 
new requirements for the tobacco industry. Section 101 of the Tobacco 
Control Act amended the FD&C Act by adding sections 905 and 904 (21 
U.S.C. 387e and 387d).
    Section 905 of the FD&C Act requires the annual registration of any 
``establishment in any State engaged in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco products.'' 
Section 905 requires this registration be completed by December 31 of 
each year. The Secretary of Health and Human Services (Secretary) has 
delegated to the Commissioner of Food and Drugs the responsibility for 
administering the FD&C Act, including section 905. Section 905 of the 
FD&C Act requires owners or operators of each establishment to 
register: (1) Their name; (2) places of business; (3) a list of all 
tobacco products that are manufactured by that person; (4) a copy of 
all labeling and a reference to the authority for the marketing of any 
tobacco product subject to a tobacco product standard under section 907 
of the FD&C Act (21 U.S.C. 387g) or to premarket review under section 
910 of the FD&C Act (21 U.S.C. 387j); (5) a copy of all consumer 
information and other labeling; (6) a representative sampling of 
advertisements; (7) upon request made by the Secretary for good cause, 
a copy of all advertisements for a particular tobacco product; and (8) 
upon request made by the Secretary, if the registrant has determined 
that a tobacco product contained in the product list is not subject to 
a tobacco product standard established under section 907 of the FD&C 
Act, a brief statement of the basis upon which the registrant made such 
determination.
    FDA collects the information submitted pursuant to section 905 of 
the FD&C Act through an electronic portal, and through paper forms 
(Forms FDA 3741 and FDA 3741a) for those individuals who choose not to 
use the electronic portal.
    FDA has also published a guidance for industry entitled 
``Registration and Product Listing for Owners and Operators of Domestic 
Tobacco Product Establishments'' (https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf). This 
guidance is intended to assist persons making tobacco product 
establishment registration and product listing submissions to FDA.
    Section 904(a)(1) of the FD&C Act requires that each tobacco 
product manufacturer or importer submit ``a listing of all ingredients, 
including tobacco, substances, compounds, and additives that are, as of 
such date, added by the manufacturer to the tobacco, paper, filter, or 
other part of each tobacco product by brand and by quantity in each 
brand and subbrand'' by December 22, 2009. This section applies only to 
those tobacco products manufactured and distributed before June 22, 
2009, and which are still manufactured as of the date of the ingredient 
listing submission.
    Section 904(c) of the FD&C Act requires that a tobacco product 
manufacturer: (1) Provide all information required under section 904(a) 
of the FD&C Act to FDA ``at least 90 days prior to the delivery for 
introduction into interstate commerce of a tobacco product not on the 
market on the date of enactment'' of the Tobacco Control Act; (2) 
advise FDA in writing at least 90 days prior to adding any new tobacco 
additive or increasing in quantity an existing tobacco additive, except 
for those additives that have been designated by FDA through regulation 
as not a human or animal carcinogen, or otherwise harmful to health 
under intended conditions of use; and (3) advise FDA in writing at 
least 60 days prior to eliminating or decreasing an existing additive, 
or adding or increasing an additive that has been designated by FDA 
through regulation as not a human or animal carcinogen, or otherwise 
harmful to health under intended conditions of use.
    FDA collects the information submitted pursuant to sections 
904(a)(1) and (c) of the FD&C Act through an electronic portal, and 
through a paper form (Form FDA 3742) for those individuals who choose 
not to use the electronic portal.
    In addition to the development of the electronic portal and paper 
form, FDA published a guidance entitled ``Listing of Ingredients in 
Tobacco Products.'' This guidance is intended to assist persons making 
tobacco product ingredient listing submissions. FDA also provides a 
technical guide, embedded hints, and a web tutorial to the electronic 
portal.
    The Tobacco Control Act also gave FDA the authority to issue a 
regulation deeming all other products that meet the statutory 
definition of a tobacco product to be subject to chapter 9 of the FD&C 
Act (section 901(b) (21 U.S.C. 387a(b)). On May 10, 2016, FDA issued 
that rule, extending FDA's tobacco product authority to all products 
that meet the definition of tobacco product in the law (except for 
accessories of newly regulated tobacco products), including electronic 
nicotine delivery systems, cigars, hookah, pipe tobacco, nicotine gels, 
dissolvables that were not already subject to the FD&C Act, and other 
tobacco products that may be developed in the future (81 FR 28974 at 
28976) (``the final deeming rule'').
    In the Federal Register of October 23, 2018 (83 FR 53478), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received; however, neither 
were PRA related.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 21789]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                               Number of
    FDA form/activity/FD&C act section         Number of     responses per   Total annual            Average burden per response            Total hours
                                              respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Product Establishment Initial                  100               1             100  1.6.........................................             160
 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                3,578               1           3,578  0.16 (10 minutes)...........................             572
 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 Listing; Form FDA 3742                  10               1              10  2...........................................              20
 Listing of Ingredients (Electronic and
 Paper submissions); Section 904(a)(1).
Tobacco Product Listing; Form FDA 3742                  35               2              70  0.40 (24 minutes)...........................              28
 Listing of Ingredients (Electronic and
 Paper submissions); Section 904(c).
Obtaining a Dun and Bradstreet D-U-N-S                 100               1             100  0.5 (30 minutes)............................              50
 Number.
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ............................................             830
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The PRA burden estimates have been updated to fully incorporate the 
use of an electronic system known as FURLS for submitting registration 
and product listing information to FDA. With the FURLS, manufacturers 
can enter information quickly and easily. For example, product label 
pictures can be uploaded directly. We anticipate that most, if not all 
companies, already have electronic versions of their labels for 
printing, sales, or marketing purposes.
    Product listing information is provided at the time of 
registration. Currently, registration and listing requirements only 
apply to domestic establishments engaged in the manufacture, 
preparation, compounding, or processing of a tobacco product. This 
includes importers to the extent that they engage in the manufacture, 
preparation, compounding, or processing of a tobacco product, including 
repackaging or otherwise changing the container, wrapper, or labeling 
of any tobacco product package. Foreign establishments are not required 
to register and list until FDA issues regulations establish such 
requirements in accordance with section 905(h) of the FD&C Act. To 
account for the foregoing, we include both domestic manufacturing 
establishments and importers in our estimates.
    Because the deadline for initial establishment registration and 
product listing for both statutorily regulated and deemed products has 
passed, FDA estimates that few (up to 100) new establishments will 
submit 1 initial establishment registration and product listing report 
each year. Such new establishments potentially include new vape shop 
locations that mix or assemble products on the market as of the final 
deeming rule effective date. The Agency estimates that up to 100 
tobacco establishments will each submit 1 initial establishment 
registration and product listing report each year, which is expected to 
take 1.6 hours, for a total 160 burden hours.
    FDA estimates that the confirmation or updating of establishment 
registration and product listing information as required by section 905 
of the FD&C Act will take 10 minutes annually per confirmation or 
update per establishment. Based on FDA's experience with current 
establishment registration and product listings submitted to the 
Agency, the Agency estimates that on average 3,578 establishments will 
each submit 1 confirmation or updated report each year, which is 
expected to take 0.16 hour (10 minutes) for a total 572 burden hours.
    FDA estimates that we have received most tobacco product ingredient 
submissions for large manufacturers of deemed products. Small 
manufacturers' deadline for ingredient submissions is November 2018. 
This is based on the counts we have to date (July 2018), including 
statutorily regulated products (based on information in our tracking 
system).
    FDA estimates that the submission of ingredient listings required 
by section 904(a)(1) of the FD&C Act for each establishment will take 2 
hours initially. Because this burden estimate covers a timeframe of 3 
years, we anticipate almost all section 904(a)(1) tobacco ingredient 
submissions to have been received before the expiration of the current 
approval (prior to November 8, 2018, for small manufacturers and for 
large manufacturers, May 8, 2018). We are estimating approximately 30 
manufacturers may miss their deadline. This is based on estimates of 
how many large manufacturers we are aware of that have missed their 
deadline. Because this burden estimate covers 3 years, we are dividing 
by 3, to yield 10 respondents as a yearly average for this estimate. 
Therefore, FDA estimates that 10 establishments will initially submit 1 
report annually at 2 hours per report, for a total of 20 hours.
    Submissions under 904(c) of the FD&C Act are for any new product 
that is not yet on the market (e.g., if on the market due to deeming 
compliance period); newly deemed product manufacturers should have 
submitted under section 904(a)(1) of the FD&C Act. This includes any 
statutorily regulated product that would receive a marketing 
authorization and any new deemed product not subject to the deeming 
compliance period. For deemed product categories, while we anticipate 
receiving a large number of premarket applications, there is a portion 
of these applicants who will have reported their

[[Page 21790]]

ingredients under section 904(a)(1) as most of these submissions are 
expected to be for products subject to the deeming compliance period.
    Based on FDA's experience and the actual number of product 
ingredient listings submitted over the past 3 years, FDA estimates that 
35 establishments will each submit 2 reports (1 every 6 months). FDA 
also estimates that the confirmation or updating of product 
(ingredient) listing information required by section 904(c) of the FD&C 
Act is expected to take 0.40 hour (24 minutes) and will take 48 minutes 
annually for two confirmations or updates per establishment, for a 
total 28 burden hours. FDA estimates that obtaining a DUNS (data 
universal numbering system) number will take 30 minutes. FDA assumes 
that all new establishment facilities that will be required to 
initially register under section 905 of the FD&C Act would obtain a 
DUNS number. FDA estimates that up to 100 establishments would need to 
obtain this number each year. The total industry burden to obtain a 
DUNS number is 50 hours.
    FDA estimates the total burden for this collection to be 830 hours. 
We have adjusted our burden estimate, which has resulted in a decrease 
of 93,086 hours to the currently approved burden. Based on data we 
reviewed from the past 3 years and projecting the number of remaining 
establishments that have not registered and submitted product 
ingredient listings, we revised the number of respondents and burden 
hours in this information collection.

    Dated: May 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09997 Filed 5-14-19; 8:45 am]
 BILLING CODE 4164-01-P


