Notice2021-27719
Validation and Verification of Analytical Testing Methods Used for Tobacco Products; Draft Guidance for Industry; Availability; Request for Comments
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Published
December 22, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Validation and Verification of Analytical Testing Methods used for Tobacco Products" and requesting comments, including scientific and other information, concerning the recommendations set forth in the draft guidance. The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test methods, including analytical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 This draft guidance would help industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products.
Full Text
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<title>Federal Register, Volume 86 Issue 243 (Wednesday, December 22, 2021)</title>
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[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Pages 72603-72604]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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for Tobacco Products; Draft Guidance for Industry; Availability;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announcing the availability of a draft guidance for industry entitled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draft guidance. The draft guidance, when finalized, would provide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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<a href="/cdn-cgi/l/email-protection#b1f2e5e1e3d4d6c4ddd0c5d8dedfc2f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="2c6f787c7e494b59404d584543425f6c4a484d0244445f024b435a">[email protected]</span></a>.
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 <a href="https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance">https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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