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2016-05-10
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Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Proposed Rules
D09002ee1bdc1b9ef
D09002ee1bdc1ba81
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.'' Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This draft guidance is intended to assist persons with their PMTA submissions for ENDS products.
81 FR 28781
https://www.govinfo.gov/app/details/FR-2016-05-10/2016-10687
2016-10687
fr10my16-25
4164-01-P
Docket No. FDA-2015-D-2496
https://www.govinfo.gov/app/details/FR-2016-05-10/2016-10687
https://www.govinfo.gov/content/pkg/FR-2016-05-10/html/2016-10687.htm
https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10687.pdf
3 p.
28781
28783
81 FR 28781
Code of Federal Regulations
Title 21 Part 1100
21 CFR Part 1100
Code of Federal Regulations
Title 21 Part 1140
21 CFR Part 1140
Code of Federal Regulations
Title 21 Part 1143
21 CFR Part 1143
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; Federal Register Vol. 81, Issue
PRORULE
2016-10687
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-D-2496
4164-01-P
2016-10687
Notification of availability.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.'' Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This draft guidance is intended to assist persons with their PMTA submissions for ENDS products.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 11, 2016.
With regard to the draft guidance: Colleen Lee, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000, 1-877-287-1373, AskCTP@fda.hhs.gov.
Guidance:
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems
,
AskCTP@fda.hhs.gov
PRAStaff@fda.hhs.gov
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 90
Office of the Federal Register, National Archives and Records Administration
2016-05-10
continuing
daily
deposited
born digital
433 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-05-10
P0b002ee18f662de2
0097-6326
0042-1219
0364-1406
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https://www.govinfo.gov/app/details/FR-2016-05-10
https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/FR-2016-05-10.pdf
https://www.govinfo.gov/content/pkg/FR-2016-05-10/xml/FR-2016-05-10.xml
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FR-2016-05-10
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FR-2016-05-10
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