Notice2022-01798
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
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Published
January 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 "Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products."
Full Text
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<title>Federal Register, Volume 87 Issue 19 (Friday, January 28, 2022)</title>
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[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4622-4625]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01798]
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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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 ``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 March 29, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 29, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 29, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0386 for ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments and Listing of
Ingredients in Tobacco Products.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the
[[Page 4623]]
``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
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,
<a href="/cdn-cgi/l/email-protection#16464457456277707056707277387e7e6538717960"><span class="__cf_email__" data-cfemail="346466756740555252745250551a5c5c471a535b42">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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 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 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 <a href="https://www.fda.gov/media/77915/download">https://www.fda.gov/media/77915/download</a> and FDA 3741a
<a href="https://www.fda.gov/media/99863/download">https://www.fda.gov/media/99863/download</a>) 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'' (<a href="https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf">https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf</a>). 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 <a href="https://www.fda.gov/media/77661/download">https://www.fda.gov/media/77661/download</a>) 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'' (<a href="https://www.fda.gov/media/101162/download">https://www.fda.gov/media/101162/download</a>). 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.
[[Page 4624]]
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'').
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
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Number of Average burden
FDA form; activity; tobacco Number of responses per Total annual per Total hours
control act section respondents respondent responses recordkeeping
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Tobacco Product Establishment 100 1 100 1.6............. 160
Initial 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 2,572 1 2,572 0.16 (10 412
Renewal Registration and minutes).
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 1 1 1 2............... 2
FDA 3742 Listing of
Ingredients (Electronic and
Paper submissions); section
904(a)(1).
Tobacco Product Listing; Form 35 10 350 0.40 (24 140
FDA 3742 Listing of minutes).
Ingredients (Electronic and
Paper submissions); section
904(c).
Obtaining a Dun and Bradstreet 100 1 100 0.5 (30 minutes) 50
(D-U-N-S) Number.
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Total..................... .............. .............. .............. ................ 764
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\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 Tobacco Registration & 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.
As 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 tobacco 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 2,572 establishments will
each submit 1 confirmation or updated report each year, which is
expected to take 0.16 hours (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. We expect all section 904(a)(1) tobacco ingredient
submissions to have been received prior to November 8, 2018, and for
small manufacturers and large manufacturers, May 8, 2018. 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 one respondent
as a yearly average for this estimate. Therefore, FDA
[[Page 4625]]
estimates that one establishment will initially submit one report
annually at 2 hours per report, for a total of 2 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 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 ingredients under
section 904(a)(1) of the FD&C Act as most of these submissions are
expected to be for products subject to the deeming compliance period.
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 35 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 hours (24 minutes) for a total 140 burden hours. FDA
estimates that obtaining a data universal numbering system (DUNS)
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 764 hours.
We have adjusted our burden estimate, which has resulted in a decrease
of 66 hours to the currently approved burden. Based on data we reviewed
from the past 3 years, we note a decrease in the number of
establishments submitting a renewal registration listing, an increase
of the number of applications received for deemed products and
potential modifications to those, and by 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: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01798 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P
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