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, 70139-70141 [2021-26652]
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Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices
70139
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
R. Sterility
No new entries at this time.
S. Tissue Engineering
No new entries at this time.
1 All
standard titles in this table conform to the style requirements of the respective organizations
IV. List of Recognized Standards
FDA maintains the current list of FDA
Recognized Consensus Standards in a
searchable database that may be
accessed at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has
recognized by notice published in the
Federal Register or that FDA has
decided to recognize but for which
recognition is pending (because a
periodic notice has not yet appeared in
the Federal Register). FDA will
announce additional modifications and
revisions to the list of recognized
consensus standards, as needed, in the
Federal Register once a year, or more
often if necessary.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To
be considered, such recommendations
should contain, at a minimum, the
information available at https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program#process.
Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26635 Filed 12–8–21; 8:45 am]
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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.
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.
SUMMARY:
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.
DATES:
PO 00000
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Sfmt 4703
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
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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-201509-18/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, PRAStaff@
fda.hhs.gov.
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
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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
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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 PreExisting 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/regulatoryinformation/search-fda-guidancedocuments/establishing-tobaccoproduct-was-commercially-marketedunited-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
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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Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices
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))).
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
No. of
respondents
Activity
Submit evidence of commercial marketing in the United
States as of February 15, 2007 .......................................
1 There
1,000
FDA estimates the burden of this
collection of information as follows:
Total annual
responses
1
Average
burden per
response
(in hours)
1,000
Total hours
5
5,000
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 PreExisting 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.
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
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No. of
responses per
respondent
of advertisements, dated catalog pages,
dated promotional material, and dated
bills of lading.
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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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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Fresenius Kabi Deutschland GmbH;
Withdrawal of Approval of New Drug
Application of Hydroxyethyl Starch
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of a new drug
application (NDA) BN 070012/0022 for
VOLUVEN (6 Percent Hydroxyethyl
Starch 130/0.4 in 0.9 Percent Sodium
Chloride Injection), held by Fresenius
Kabi Deutschland GmbH. Fresenius
Kabi Deutschland GmbH requested in
writing that the Agency’s approval of
the application be withdrawn because
the drug is no longer being marketed
and has waived its opportunity for a
hearing.
SUMMARY:
Approval is withdrawn as of
January 10, 2022.
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
DATES:
PO 00000
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Fresenius
Kabi Deutschland GmbH, Bad Homburg,
Germany (Authorized U.S. Agent:
Fresenius Kabi USA, LLC, Three
Corporate Dr., Lake Zurich, IL 60047),
has requested that FDA withdraw
approval of NDA BN 070012 sequence
0022, pursuant to § 314.150(c) (21 CFR
314.150(c)), because the drug is no
longer being marketed. By its request,
Fresenius Kabi Deutschland GmbH, has
also waived its opportunity for a
hearing. Withdrawal of approval of an
application under § 314.150(c) is
without prejudice to refiling.
SUPPLEMENTARY INFORMATION:
Application No.
[Docket No. FDA–2021–N–1194]
AGENCY:
Silver Spring, MD 20993–0002, 240–
402–7911.
Proprietary name
NDA BN
VOLUVEN (6% Hydroxyethyl
070012/0022.
Starch 130/0.4 in 0.9%
Sodium Chloride Injection)
Therefore, approval of the application
listed in the table, and all amendments
and supplements thereto, is hereby
withdrawn as of January 10, 2022.
Introduction or delivery for introduction
into interstate commerce for products
without a new drug application violates
section 301(a) and (d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
331(a) and (d)). The drug product that
is listed in the table above that is in
inventory on January 10, 2022 may
continue to be dispensed until the
inventory has been depleted or the drug
product has reached its expiration date
or otherwise becomes violative,
whichever occurs first.
Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26648 Filed 12–8–21; 8:45 am]
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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
