federal_register: 2016-10687

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2016-10687 Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request Proposed Rule The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems."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 This draft guidance is intended to assist persons with their PMTA submissions for ENDS products. 2016-05-10 2016 5 https://www.federalregister.gov/documents/2016/05/10/2016-10687/premarket-tobacco-product-applications-for-electronic-nicotine-delivery-systems-draft-guidance-for https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10687.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems."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...

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