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]

Download as PDF 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] khammond on DSKJM1Z7X2PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 17:41 Dec 08, 2021 Jkt 256001 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 Frm 00058 Fmt 4703 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 E:\FR\FM\09DEN1.SGM 09DEN1 khammond on DSKJM1Z7X2PROD with NOTICES 70140 Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices 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 VerDate Sep<11>2014 17:41 Dec 08, 2021 Jkt 256001 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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.’’ E:\FR\FM\09DEN1.SGM 09DEN1 70141 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 khammond on DSKJM1Z7X2PROD with NOTICES 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. VerDate Sep<11>2014 17:41 Dec 08, 2021 Jkt 256001 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 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 Frm 00060 Fmt 4703 Sfmt 4703 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] BILLING CODE 4164–01–P E:\FR\FM\09DEN1.SGM 09DEN1

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))).
---------------------------------------------------------------------------

    \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.''
---------------------------------------------------------------------------

    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:

----------------------------------------------------------------------------------------------------------------
                                                      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........
----------------------------------------------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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
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