```

[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1159-1161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31541]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0756]

Validation and Verification of Analytical Testing Methods Used 
for Tobacco Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance for industry entitled 
``Validation and Verification of Analytical Testing Methods Used for 
Tobacco Products.'' The guidance provides information and 
recommendations related to the validation and verification of 
analytical test methods, including analytical testing of tobacco 
product constituents, ingredients, and additives, as well as stability 
testing of tobacco products. This guidance is intended to help industry 
produce more consistent and reliable analytical data used to support 
regulatory submissions for finished tobacco products. This guidance 
finalizes the draft guidance of the same title issued in December 2021.

DATES: The announcement of the guidance is published in the Federal 
Register on January 7, 2025.

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-2021-D-0756 for ``Validation and Verification of Analytical Testing 
Methods Used for Tobacco Products.''

[[Page 1160]]

Received comments 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 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 this guidance 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 guidance document may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Robert Schwartz or Nathan Mease, 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002, 1-877-287-1373, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Validation and Verification of Analytical Testing Methods 
Used for Tobacco Products.'' This guidance provides information and 
recommendations on how tobacco product manufacturers can produce 
validation and verification data for the analytical procedures and 
methods used to support regulatory submissions for finished tobacco 
products including substantial equivalence (SE) reports, premarket 
tobacco product applications (PMTA), and modified risk tobacco product 
applications (MRTPA). Additionally, the principles in this guidance may 
be used for finished tobacco product testing and reporting of harmful 
and potentially harmful constituents (HPHCs) in tobacco products and 
tobacco smoke.
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires, among 
other things, premarket review for new tobacco products and modified 
risk tobacco products (see sections 910 and 911 of the FD&C Act (21 
U.S.C. 387j and 21 U.S.C. 387k)) and reporting of harmful and 
potentially harmful constituents under section 904 of the FD&C Act (21 
U.S.C. 387d). Regulatory submissions often contain data from analytical 
testing, such as data about ingredients, constituents, and additives. 
In standard practice, analytical testing is done through validation of 
the analytical test method. In these cases, the applicant will want to 
use analytical test methods that are sufficiently precise, accurate, 
selective, and sensitive. Validation involves documenting, using 
specific laboratory investigations, that the performance 
characteristics of the test method are suitable and reliable for the 
intended analytical applications, in terms of precision, accuracy, 
selectivity, and sensitivity. This guidance is intended to help 
industry produce more consistent and reliable analytical data used to 
support regulatory submissions for finished tobacco products, such as 
SE, PMTA, MRTPA submissions, and for finished tobacco product testing 
and reporting of HPHCs in tobacco products and tobacco smoke.
    This guidance finalizes the draft guidance of the same title issued 
on December 22, 2021 (86 FR 72603). FDA considered comments received on 
the draft guidance and revised the final guidance as appropriate in 
response to the comments. Changes from the draft to the final guidance 
include:
     Updates to the Background section reflecting statutory 
revisions to the term ``tobacco product'' to include non-tobacco 
(synthetic) nicotine (see Pub. L. 117-103);
     Acknowledgment that alternative validation procedures and 
recommendations may differ from those in this guidance;
     Expression of the Agency's support for the use of national 
and international standard analytical test methods for the analysis of 
finished tobacco products;
     The addition of definitions for several new terms and 
revisions to several existing definitions to improve clarity;
     Updates reflecting PMTA rule and SE Report rule 
requirements for documenting laboratory accreditation;
     Updates to citations supporting the replicate 
recommendations in the guidance and for alternative validation 
procedures;
     Corrections, revisions, or clarifications to calculations, 
formulas or equations, or units of measure in the text and tables;
     The addition of an equation as an approach to adjust for 
interference bias when determining selectivity;
     Clarification of the Agency's thinking on the adequacy of 
linear regression (R\2\) for determining the linearity parameter as 
part of analytical test method validation;
     The addition of a spike and recovery approach for 
determining the limit of detection in order to provide flexibility in 
the analytical sampling procedure recommendations;
     Expansion on the discussion of tobacco product reference 
standards; and
     Editorial revisions to the text to improve clarity and 
consistency of terms used throughout the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Validation and Verification of Analytical 
Testing Methods Used for Tobacco Products.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements

[[Page 1161]]

of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information in section 910(c)(1)(A)(i) of the FD&C Act 
have been approved under OMB control number 0910-0768; the collections 
of information in section 905(j) of the FD&C Act (21 U.S.C. 387e(j)) 
have been approved under OMB control number 0910-0673; the collections 
of information in 21 CFR part 1107 have been approved under OMB control 
number 0910-0684; the collections of information in section 904(a)(3) 
of the FD&C Act have been approved under OMB control number 0910-0732, 
and the collections of information in 21 CFR part 1114 have been 
approved under OMB control number 0910-0879.

III. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/tobacco-products/rules-regulations-and-guidance-related-tobacco-products/guidance-related-tobacco-products, or https://www.regulations.gov.

    Dated: December 26, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31541 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
```