[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Pages 72603-72604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27719]


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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for Tobacco Products; Draft Guidance for Industry; Availability; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Validation and Verification of Analytical Testing Methods used for 
Tobacco Products'' and requesting comments, including scientific and 
other information, concerning the recommendations set forth in the 
draft guidance. The draft guidance, when finalized, would provide 
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 This draft guidance would help 
industry produce more consistent and reliable analytical data used to 
support regulatory submissions for finished tobacco products.

DATES: Submit either electronic or written comments on the draft 
guidance by February 22, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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.'' 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 the draft guidance to 
the Center for Tobacco Products, Food and Drug Administration, 10903 
New Hampshire Ave., Document Control Center, 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 electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Nathan Mease or Matthew Brenner, 
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

    We are announcing the availability of a draft document entitled 
``Validation and Verification of Analytical Testing Methods used for 
Tobacco Products; Draft Guidance for Industry.'' This draft guidance, 
when finalized, provides information and recommendations on how tobacco 
product manufacturers can produce validation and verification data for 
the analytical procedures and

[[Page 72604]]

methods used to support regulatory submissions for finished tobacco 
products including substantial equivalence (SE) applications, premarket 
tobacco product applications (PMTA), and modified risk tobacco product 
applications (MRTPA). These recommendations include analytical testing 
of tobacco product constituents, ingredients, and additives, as well as 
stability testing of finished tobacco products. The principles in this 
guidance may also be used for finished tobacco product testing and 
reporting of harmful and potentially harmful constituents (HPHCs) in 
tobacco products and tobacco smoke.
    The FD&C Act requires, among other things, premarket review for new 
tobacco products and modified risk tobacco products (see sections 910 
and 911 (21 U.S.C. 387j and 21 U.S.C. 387k) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act)), and also reporting of HPHCs under section 
904 of the FD&C Act (21 U.S.C. 387d). Information about constituents, 
for example, might be required by law or otherwise support the findings 
for premarket authorization. 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 method. In these cases, the applicant will 
want to use analytical methods that are sufficiently precise, accurate, 
selective, and sensitive. Validation involves documenting, through the 
use of specific laboratory investigations, that the performance 
characteristics of the method are suitable and reliable for the 
intended analytical applications, in terms of precision, accuracy, 
selectivity, and sensitivity. When finalized, 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 applications, PMTAs, MRTPAs, and for finished tobacco 
product testing and reporting of HPHCs in tobacco products and tobacco 
smoke.
    FDA is issuing this draft guidance consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    We believe that the information collection provisions in the draft 
guidance do not create a new burden for respondents. We believe the 
recordkeeping provisions are part of usual and customary business 
practice. Tobacco manufacturers would have in-house analysts or 
contractual agreements with outside analytical laboratories and 
suppliers, as applicable for the type of tobacco product, to address 
all these information collection provisions.
    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; and 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.

III. Electronic Access

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

    Dated: December 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27719 Filed 12-21-21; 8:45 am]
BILLING CODE 4164-01-P


