Notice2021-21010
Applications for Premarket Review of New Tobacco Products; Draft Guidance for Industry; Withdrawal
Primary source
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Published
October 5, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the withdrawal of a draft guidance for industry entitled "Applications for Premarket Review of New Tobacco Products." We are withdrawing this guidance because the topics discussed in the draft guidance are addressed in the final rule entitled "Premarket Tobacco Product Applications and Recordkeeping Requirements."
Full Text
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<title>Federal Register, Volume 86 Issue 190 (Tuesday, October 5, 2021)</title>
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[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Page 55440]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21010]
Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 /
Notices
[[Page 55440]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0212]
Applications for Premarket Review of New Tobacco Products; Draft
Guidance for Industry; Withdrawal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
withdrawal of a draft guidance for industry entitled ``Applications for
Premarket Review of New Tobacco Products.'' We are withdrawing this
guidance because the topics discussed in the draft guidance are
addressed in the final rule entitled ``Premarket Tobacco Product
Applications and Recordkeeping Requirements.''
DATES: The draft guidance is withdrawn as of October 5, 2021.
FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
email: <a href="/cdn-cgi/l/email-protection#df9c8b8f8dbab8aab3beabb6b0b1ac9fb9bbbef1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="2d6e797d7f484a58414c594442435e6d4b494c0345455e034a425b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of a draft
guidance for industry entitled ``Applications for Premarket Review of
New Tobacco Products,'' the notice of availability for which appeared
in the Federal Register of September 28, 2011 (76 FR 60055). The draft
guidance was intended to assist persons submitting premarket tobacco
product applications (PMTAs) for new tobacco products under section
910(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 387j(b)(1)). The draft guidance discussed, among other things,
when and how to submit PMTAs, what information the FD&C Act requires a
PMTA to contain, and what information FDA recommends that applicants
submit to demonstrate its new tobacco product should receive a
marketing granted order. We are withdrawing this draft guidance and not
finalizing it because the final rule entitled ``Premarket Tobacco
Product Applications and Recordkeeping Requirements'' covers the topics
described in the draft guidance.
Dated: September 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21010 Filed 10-4-21; 8:45 am]
BILLING CODE 4164-01-P
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