[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Pages 70139-70141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26652]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0125]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on Establishing That a Tobacco 
Product Was Commercially Marketed in the United States as of February 
15, 2007

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the 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 information collection aspects 
of the Guidance for Industry on Establishing That a Tobacco Product Was 
Commercially Marketed in the United States as of February 15, 2007.

DATES: Submit either electronic or written comments on the collection 
of information by February 7, 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 February 7, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 7, 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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-2011-D-0125 for ``Guidance for Industry on Establishing That a 
Tobacco Product Was Commercially Marketed in the United States as of 
February 15, 2007.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential

[[Page 70140]]

Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``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: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[email protected].

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.

Guidance for Industry on Establishing That a Tobacco Product Was 
Commercially Marketed in the United States as of February 15, 2007

OMB Control Number 0910-0775--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 
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 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended, 
defines a tobacco product as any product made or derived from tobacco 
that is intended for human consumption, including any component, part, 
or accessory of a tobacco product (except for raw materials other than 
tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). Section 910 of the FD&C Act (21 U.S.C. 387j) sets out 
premarket requirements for new tobacco products. The term new tobacco 
product is defined as any tobacco product (including those products in 
test markets) that was not commercially marketed in the United States 
as of February 15, 2007, or any modification (including a change in 
design, any component, any part, or any constituent, including a smoke 
constituent, or in the content, delivery, or form of nicotine, or any 
other additive or ingredient) of a tobacco product where the modified 
product was commercially marketed in the United States after February 
15, 2007 (section 910(a)(1) of the FD&C Act).
    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 IX of the FD&C 
Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). 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, 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).
    FDA refers to tobacco products that were commercially marketed 
(including those products in test markets) in the United States as of 
February 15, 2007, as Pre-Existing tobacco products.\1\ Pre-Existing 
tobacco products are not considered new tobacco products and are not 
subject to the premarket requirements of section 910 of the FD&C Act. 
The guidance document associated with this information collection 
entitled ``Establishing That a Tobacco Product Was Commercially 
Marketed in the United States as of February 15, 2007 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007), provides information on how a manufacturer may 
establish that a tobacco product was commercially marketed in the 
United States as of February 15, 2007. A Pre-Existing tobacco product 
(except such products exclusively in test markets) may also serve as 
the predicate tobacco product in a section 905(j) report (intended to 
be used toward demonstrating substantial

[[Page 70141]]

equivalence) for a new tobacco product (section 905(j)(1)A)(i) of the 
FD&C Act (21 U.S.C. 387e(j)(1)(A)(i))).
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    \1\ FDA changed the term from ``grandfathered tobacco product'' 
to ``Pre-Existing tobacco product'' in the recently published final 
SE (86 FR 55224) and PMTA (86 FR 55300) rules because it more 
appropriately describes these products by using the more precise 
``Pre-Existing'' in place of ``grandfathered.''
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    The guidance recommends that the manufacturer submit information 
adequate to demonstrate that the tobacco product was commercially 
marketed in the United States as of February 15, 2007. Examples of such 
information may include, but are not limited to, the following: Dated 
copies of advertisements, dated catalog pages, dated promotional 
material, and dated bills of lading.
    FDA estimates the burden of this collection of information as 
follows:

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                                                      No. of                      Average burden
            Activity                  No. of       responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
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Submit evidence of commercial              1,000               1           1,000               5           5,000
 marketing in the United States
 as of February 15, 2007........
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's estimate of the number of respondents is based on the fact 
that requesting an Agency determination of the Pre-Existing status of a 
tobacco product under the guidance is not required and also on the 
number of Pre-Existing tobacco product submissions received from 2011 
to October 2021. For deemed products that met the definition of a new 
tobacco product and were on the market as of August 8, 2016 (when the 
deeming rule took effect), FDA issued a compliance policy; this, in 
effect, provided more time for manufacturers of these products to 
submit their applications for marketing authorization. The deadline for 
the submission of applications for these products has now passed. As 
the result of a court order (and a subsequent extension due to the 
unique circumstances of the COVID-19 pandemic), applications for deemed 
new tobacco products on the market at that time were due to FDA by 
September 9, 2020.\2\ The court order also provided a 1-year period 
during which products with timely filed applications might remain on 
the market pending FDA review. The number of hours to gather the 
evidence is FDA's estimate of how long it might take a manufacturer to 
review, gather, and submit dated information if making a request for 
Agency determination.
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    \2\ On August 19, 2020, the U.S. District Court for the District 
of Columbia issued a ruling, in part, to prohibit FDA enforcement of 
the Tobacco Control Act's premarket authorization requirement for 
premium cigars until after the agency considers developing a 
streamlined substantial equivalence process specifically for premium 
cigars. Accordingly, FDA will not enforce the premarket review 
requirement against manufacturers of premium cigars that do not 
submit premarket applications for these products by the September 9, 
2020 deadline.
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    FDA further estimates it would take a manufacturer approximately 5 
hours to put together this collection of evidence and to submit the 
package to FDA for review. FDA estimates that it would take 
approximately 5,000 hours annually to respond to this collection of 
information.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: December 2, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26652 Filed 12-8-21; 8:45 am]
BILLING CODE 4164-01-P