[Federal Register Volume 87, Number 154 (Thursday, August 11, 2022)]
[Notices]
[Pages 49593-49596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17248]


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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: Submit written comments (including recommendations) on the 
collection of information by September 12, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 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, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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, among others, 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 of the FD&C Act 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 which are

[[Page 49594]]

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 https://www.fda.gov/media/77915/download and 3741a 
https://www.fda.gov/media/99863/download) 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 of such action of 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 section 
904(a)(1) and 904(c) of the FD&C Act through an electronic portal, and 
through a paper form (Form FDA 3742 https://www.fda.gov/media/77661/download) 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'' (https://www.fda.gov/media/101162/download). 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) of the FD&C Act (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 tobacco, pipe 
tobacco, nicotine gels, and 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 January 28, 2022 (87 FR 4622), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received that was not PRA 
related.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
   FDA form; activity; Tobacco Control Act        Number of     responses per   Total annual        Average burden per recordkeeping        Total hours
                   section                       respondents     respondent       responses
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Tobacco Product Establishment Initial                     200               1             200  1.6......................................             320
 Registration and Listing; Form FDA 3741
 Registration and Product Listing for Owners
 and Operators of Domestic Establishments
 (Electronic and Paper submissions); sections
 905(b)-(d), 905(h), or 905(i).
Tobacco Product Establishment Renewal                   2,572               1           2,572  0.16 (10 minutes)........................             412
 Registration and Listing; Form FDA 3741
 Registration and Product Listing for Owners
 and Operators of Domestic Establishments
 (Electronic and Paper submissions); sections
 905(b)-(d), 905(h), or 905(i).
Tobacco Product Listing; Form FDA 3742                     16               1              16  2........................................              32
 Listing of Ingredients (Electronic and Paper
 submissions); section 904(a)(1).
Tobacco Product Listing; Form FDA 3742                     37              10             370  0.40 (24 minutes)........................             148
 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....................................  ..............  ..............  ..............  .........................................             962
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Since the publishing of the 60-day notice, the Consolidated 
Appropriations Act of 2022 (the Appropriations Act, Pub. L. 117-103), 
enacted on March 15, 2022, amended the definition of the term ``tobacco 
product'' in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) to 
include products that contain nicotine from any source. As a result,

[[Page 49595]]

non-tobacco nicotine (NTN) products that were not previously subject to 
the FD&C Act (e.g., products containing synthetic nicotine) are now 
subject to all of the tobacco product provisions in the FD&C Act 
beginning on April 14, 2022. Based on this new authority the owners and 
operators of establishments engaged in the manufacture, preparation, 
compounding, or processing of tobacco products containing NTN must 
register with the FDA and list all these tobacco products that they 
manufacture, prepare, compound, or process for commercial distribution. 
As such we have revised the estimates in the burden chart to account 
for products containing NTN.
    The PRA burden estimates have been updated to fully incorporate the 
use of an electronic system known as Tobacco Registration and Product 
Listing Module Next Generation (TRLM NG) for submitting registration 
and product listing information to FDA. With the TRLM NG, 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 establishing 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.
    The deadline for initial establishment registration and product 
listing for both statutorily regulated and deemed products has passed. 
However, pursuant to the new authority provided by the Appropriations 
Act, the FD&C Act now includes specific language that makes clear FDA 
has the authority the owners and operators of establishments engaged in 
the manufacture, preparation, compounding, or processing of tobacco 
products containing NTN must register with the FDA and list all these 
tobacco products that they manufacture, prepare, compound, or process 
for commercial distribution.
    FDA estimates up to 200 new establishments will submit one initial 
establishment registration and product listing report each year. Such 
new establishments potentially include manufacturers of NTN products, 
new vape shop locations that mix or assemble tobacco products on the 
market as of the final deeming rule effective date. The Agency 
estimates that up to 200 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 320 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 2,572 establishments will 
each submit one confirmation or updated report each year, which is 
expected to take 0.16 hour (10 minutes) for a total 412 burden hours.
    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. Ingredients may be submitted electronically through 
the Center for Tobacco Products portal or if unable to submit 
ingredients electronically then by mail using Form FDA 3742. We expect 
all 904(a)(1) tobacco ingredient submissions to have been received 
prior to November 8, 2018, for small manufacturers and large 
manufacturers, May 8, 2018, for cigarettes, cigarette tobacco, roll-
your-own, smokeless tobacco, and deemed tobacco products. While all 
manufacturers have been expected to submit 904(a)(1) tobacco ingredient 
submissions, there may be a small number of firms that have missed this 
deadline. We are estimating approximately three manufacturers may have 
missed their deadline. This is based on estimates of how many late 
submissions FDA has received after the deadline. Because this burden 
estimate covers 3 years, we are dividing by 3, to yield 1 respondent as 
a yearly average for this estimate. Additionally, manufacturers for 
tobacco products containing nicotine that is not made or derived from 
tobacco must complete initial tobacco ingredient submissions for such 
products per section 904(a)(1) of the FD&C Act. Therefore, FDA 
estimates that 16 establishments will initially submit one report 
annually at 2 hours per report, for a total of 32 hours.
    Submissions under section 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, 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, any new deemed product not subject to the deeming 
compliance period, and any new NTN products not on the market as of 
April 14, 2022. For deemed product categories and NTN products, there 
is a portion of these applicants who will have reported their 
ingredients under section 904(a)(1) of the FD&C Act as most of these 
submissions are expected to be for products subject to section 
904(a)(1) requirements.
    Based on FDA's experience and the number of new products authorized 
to be introduced or delivered for introduction into interstate commerce 
submitted over the past 3 years, FDA estimates that 37 establishments 
will each submit 10 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) for a total 148 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 that 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 962 hours. 
We have adjusted our burden estimate, which has resulted in an increase 
of 132 hours to the currently approved burden. As a result, NTN 
products that were not previously subject to the FD&C Act (e.g., 
products containing synthetic nicotine) are now subject to all of the 
tobacco product provisions in the FD&C Act beginning on April 14, 2022. 
Based on this new authority the owners and operators of establishments 
engaged in the manufacture, preparation, compounding, or processing of 
tobacco products containing NTN must register with the FDA and list all 
these tobacco products that they manufacture, prepare, compound, or 
process for commercial distribution. As such we have revised the 
estimates in the burden

[[Page 49596]]

chart to account for products containing NTN.

    Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17248 Filed 8-10-22; 8:45 am]
BILLING CODE 4164-01-P