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2011-04-23
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Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.'' This draft guidance provides information on how a manufacturer may demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. In this draft guidance, FDA provides recommendations on the evidence that a manufacturer may use to demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. This draft guidance is not final nor is it in effect at this time.
76 FR 22903
https://www.govinfo.gov/app/details/FR-2011-04-25/2011-9939
2011-9939
fr25ap11-54
4160-01-P
Docket No. FDA-2011-D-0125
https://www.govinfo.gov/app/details/FR-2011-04-25/2011-9939
https://www.govinfo.gov/content/pkg/FR-2011-04-25/html/2011-9939.htm
https://www.govinfo.gov/content/pkg/FR-2011-04-25/pdf/2011-9939.pdf
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76 FR 22903
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; Federal Register Vol. 76, Issue
NOTICE
2011-9939
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-D-0125
4160-01-P
2011-9939
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.'' This draft guidance provides information on how a manufacturer may demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. In this draft guidance, FDA provides recommendations on the evidence that a manufacturer may use to demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. This draft guidance is not final nor is it in effect at this time.
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 of 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 June 24, 2011.
With regard to the draft guidance: Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287- 1373, e-mail: annette.marthaler@fda.hhs.gov.
Draft Guidance for Industry and Food and Drug Administration Staff; Availability:
Establishing a Tobacco Product Was Commercially Marketed as of February 15, 2007
,
annette.marthaler@fda.hhs.gov
Jonnalynn.Capezzuto@fda.hhs.gov
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm
http://www.regulations.gov
Federal Register
Vol. 76, no. 79
Office of the Federal Register, National Archives and Records Administration
2011-04-25
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2011-04-25
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https://www.govinfo.gov/app/details/FR-2011-04-25
https://www.govinfo.gov/content/pkg/FR-2011-04-25/pdf/FR-2011-04-25.pdf
https://www.govinfo.gov/content/pkg/FR-2011-04-25/xml/FR-2011-04-25.xml
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