Guidance Documents Referencing Pre-Existing Tobacco Products; Guidance for Industry; Availability; Withdrawal, 71873-71875 [2023-22976]

Download as PDF Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 71873 FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section; activity 80.21 and 80.22; Request for certification accompanied by sample. 1 There Number of responses per respondent 67 112 Average burden per response Total annual responses 7,504 0.22 (13 minutes) .......... Total hours 1,651 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section; activity 80.39; Record of distribution ................................ 1 There Dated: October 13, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–22971 Filed 10–17–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–4128] Guidance Documents Referencing PreExisting Tobacco Products; Guidance for Industry; Availability; Withdrawal Food and Drug Administration, ddrumheller on DSK120RN23PROD with NOTICES1 HHS. ACTION: 67 Average burden per recordkeeping Total annual records 112 7,504 0.25 (15 minutes) ......... Total hours 1,876 are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimate on our review of the certification requests received over the past 3 years. Using information from industry personnel, we estimate that an average of 0.22 hour per response is required for reporting (preparing certification requests and accompanying samples) and an average of 0.25 hour per response is required for recordkeeping. Based on a review of the information collection since our last request for OMB approval, we have slightly decreased our burden estimate based on our experience with this program. As a result, although the number of respondents increased, the number of responses per respondent decreased. AGENCY: Number of records per recordkeeper Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of revised final guidances for industry entitled ‘‘Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions,’’ and SUMMARY: VerDate Sep<11>2014 18:01 Oct 17, 2023 Jkt 262001 ‘‘Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.’’ Following the issuance of the final rules entitled ‘‘Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports’’ (SE) and ‘‘Premarket Tobacco Product Applications and Recordkeeping Requirements’’ (PMTA), FDA has made minor updates to these guidances for consistency with the terminology used in those rules. FDA is also announcing the withdrawal of the final guidances entitled ‘‘Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products,’’ and ‘‘Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods,’’ and a draft guidance entitled ‘‘Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product,’’ which are obsolete due to the issuance of the SE final rule or the end of the compliance period for deemed, finished tobacco products that were on the U.S. market on August 8, 2016. DATES: The announcement of the guidance is published in the Federal Register on October 18, 2023. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: 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, PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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– 2023–D–4128 for ‘‘Guidance Documents Referencing Pre-Existing Tobacco Products.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential E:\FR\FM\18OCN1.SGM 18OCN1 71874 Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of these guidances to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the guidances may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance documents. FOR FURTHER INFORMATION CONTACT: Natalie Gibson, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, 877–287–1373, email: CTPRegulations@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111–31) (Tobacco Control Act) was signed into law. The Tobacco Control Act grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by youth. FDA is announcing the availability of revised final guidances for industry, collectively entitled ‘‘Guidance Documents Referencing PreExisting Tobacco Products.’’ In the PMTA final rule (86 FR 55300, October 5, 2021) and the SE final rule (86 FR 55224, October 5, 2021), FDA has changed the term ‘‘grandfathered tobacco product’’ to ‘‘pre-existing tobacco product’’ because it more appropriately describes these products. Specifically, FDA considers a ‘‘preexisting tobacco product’’ to mean a tobacco product that was commercially marketed in the United States as of February 15, 2007. FDA also made other minor changes to the revised guidances to reflect updated terminology used in the SE final rule, when appropriate. Details of the changes are described in the revision history page included with each guidance. FDA is also withdrawing three guidances that are obsolete due to the issuance of the SE final rule or due to the end of the compliance period for deemed, finished tobacco products that were on the U.S. market on August 8, 2016. The guidances along with their docket numbers and status are listed in table 1. ddrumheller on DSK120RN23PROD with NOTICES1 TABLE 1—REVISED AND WITHDRAWN GUIDANCES Title Docket No. Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions. Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007. Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods. Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products ............. Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product, Draft Guidance. FDA–2011–D–0147 .... Revised. FDA–2011–D–0125 .... Revised. FDA–2016–D–3276 .... Withdrawn. FDA–2010–D–0635 .... FDA–2014–D–0800 .... Withdrawn. Withdrawn. The revised final guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115) and represent the current thinking of FDA on, among other things, the incorporation of the term ‘‘preexisting tobacco product.’’ They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. VerDate Sep<11>2014 18:01 Oct 17, 2023 Jkt 262001 II. Paperwork Reduction Act of 1995 While these guidances contain no collections of information, they do refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in FDA’s guidance entitled ‘‘Establishing That a PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Status Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007’’ have been approved under OMB control number 0910–0775. III. Electronic Access Persons with access to the internet may obtain an electronic version of the guidances at https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, https:// www.fda.gov/TobaccoProducts/ E:\FR\FM\18OCN1.SGM 18OCN1 Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices Electronic Submissions Labeling/RulesRegulationsGuidance/ default.htm, or https:// www.regulations.gov. Dated: October 13, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–22976 Filed 10–17–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–3595] Agency Information Collection Activities; Proposed Collection; Comment Request; Improving the Quality and Representativeness of the Treatment Center Program Data—Data Modifications to the Current Survey Instrument Format to Minimize Misclassification AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection entitled ‘‘Improving the Quality and Representativeness of the Treatment Center Program Data—Data Modifications to the Current Survey Instrument Format to Minimize Misclassification.’’ SUMMARY: Either electronic or written comments on the collection of information must be submitted by December 18, 2023. DATES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. eastern time at the end of December 18, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. ddrumheller on DSK120RN23PROD with NOTICES1 ADDRESSES: VerDate Sep<11>2014 18:01 Oct 17, 2023 Jkt 262001 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– 2023–N–3595 for ‘‘Improving the Quality and Representativeness of the Treatment Center Program Data—Data Modifications to the Current Survey Instrument Format to Minimize Misclassification.’’ 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 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 71875 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: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, 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 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 before submitting the collection to OMB for approval. To comply with this E:\FR\FM\18OCN1.SGM 18OCN1

Agencies

[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71873-71875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22976]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4128]


Guidance Documents Referencing Pre-Existing Tobacco Products; 
Guidance for Industry; Availability; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of revised final guidances for industry entitled 
``Demonstrating the Substantial Equivalence of a New Tobacco Product: 
Responses to Frequently Asked Questions,'' and ``Establishing That a 
Tobacco Product Was Commercially Marketed in the United States as of 
February 15, 2007.'' Following the issuance of the final rules entitled 
``Content and Format of Substantial Equivalence Reports; Food and Drug 
Administration Actions on Substantial Equivalence Reports'' (SE) and 
``Premarket Tobacco Product Applications and Recordkeeping 
Requirements'' (PMTA), FDA has made minor updates to these guidances 
for consistency with the terminology used in those rules. FDA is also 
announcing the withdrawal of the final guidances entitled ``Section 
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco 
Products,'' and ``Investigational Use of Deemed, Finished Tobacco 
Products That Were on the U.S. Market on August 8, 2016, During the 
Deeming Compliance Periods,'' and a draft guidance entitled 
``Substantial Equivalence Reports: Manufacturer Requests for Extensions 
or to Change the Predicate Tobacco Product,'' which are obsolete due to 
the issuance of the SE final rule or the end of the compliance period 
for deemed, finished tobacco products that were on the U.S. market on 
August 8, 2016.

DATES: The announcement of the guidance is published in the Federal 
Register on October 18, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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-2023-D-4128 for ``Guidance Documents Referencing Pre-Existing 
Tobacco Products.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential

[[Page 71874]]

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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of these guidances to the 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a Fax number to which 
the guidances may be sent. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance documents.

FOR FURTHER INFORMATION CONTACT: Natalie Gibson, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 
877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law. The 
Tobacco Control Act grants FDA authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect public 
health generally and to reduce tobacco use by youth. FDA is announcing 
the availability of revised final guidances for industry, collectively 
entitled ``Guidance Documents Referencing Pre-Existing Tobacco 
Products.''
    In the PMTA final rule (86 FR 55300, October 5, 2021) and the SE 
final rule (86 FR 55224, October 5, 2021), FDA has changed the term 
``grandfathered tobacco product'' to ``pre-existing tobacco product'' 
because it more appropriately describes these products. Specifically, 
FDA considers a ``pre-existing tobacco product'' to mean a tobacco 
product that was commercially marketed in the United States as of 
February 15, 2007. FDA also made other minor changes to the revised 
guidances to reflect updated terminology used in the SE final rule, 
when appropriate. Details of the changes are described in the revision 
history page included with each guidance.
    FDA is also withdrawing three guidances that are obsolete due to 
the issuance of the SE final rule or due to the end of the compliance 
period for deemed, finished tobacco products that were on the U.S. 
market on August 8, 2016. The guidances along with their docket numbers 
and status are listed in table 1.

                Table 1--Revised and Withdrawn Guidances
------------------------------------------------------------------------
              Title                   Docket No.            Status
------------------------------------------------------------------------
Demonstrating the Substantial     FDA-2011-D-0147...  Revised.
 Equivalence of a New Tobacco
 Product: Responses to
 Frequently Asked Questions.
Establishing That a Tobacco       FDA-2011-D-0125...  Revised.
 Product Was Commercially
 Marketed in the United States
 as of February 15, 2007.
Investigational Use of Deemed,    FDA-2016-D-3276...  Withdrawn.
 Finished Tobacco Products That
 Were on the U.S. Market on
 August 8, 2016, During the
 Deeming Compliance Periods.
Section 905(j) Reports:           FDA-2010-D-0635...  Withdrawn.
 Demonstrating Substantial
 Equivalence for Tobacco
 Products.
Substantial Equivalence Reports:  FDA-2014-D-0800...  Withdrawn.
 Manufacturer Requests for
 Extensions or to Change the
 Predicate Tobacco Product,
 Draft Guidance.
------------------------------------------------------------------------

    The revised final guidances are being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115) and represent the 
current thinking of FDA on, among other things, the incorporation of 
the term ``pre-existing tobacco product.'' They do not establish any 
rights for any person and are not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While these guidances contain no collections of information, they 
do refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in FDA's guidance entitled ``Establishing That a Tobacco Product Was 
Commercially Marketed in the United States as of February 15, 2007'' 
have been approved under OMB control number 0910-0775.

III. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the guidances at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/TobaccoProducts/

[[Page 71875]]

Labeling/RulesRegulationsGuidance/default.htm, or https://www.regulations.gov.

    Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22976 Filed 10-17-23; 8:45 am]
BILLING CODE 4164-01-P

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