[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Page 55440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21010]



  Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / 
Notices  

[[Page 55440]]


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

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Applications for Premarket Review of New Tobacco Products; Draft 
Guidance for Industry; Withdrawal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.

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

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withdrawal of a draft guidance for industry entitled ``Applications for 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guidance because the topics discussed in the draft guidance are 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DATES: The draft guidance is withdrawn as of October 5, 2021.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: CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of a draft 
guidance for industry entitled ``Applications for Premarket Review of 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 The draft 
guidance was intended to assist persons submitting premarket tobacco 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 The draft guidance discussed, among other things, 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 We are withdrawing this draft guidance and not 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described in the draft guidance.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


