The Center for Tobacco Products (CTP) uses public dockets through the Federal Register to solicit information from all stakeholders on a number of specific issues related to implementation of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Learn More About Dockets, Guidance, Laws, and Regulations.
OPEN DOCKETS FOR PUBLIC COMMENT:
NAME: Draft Guidances for Industry and Staff: Substantial Equivalence Reports; Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product
Docket No. FDA–2014–D–0800
DATES: Submit either electronic or written comments on the draft guidance by September 15, 2014.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Substantial Equivalence Reports: Manufacturer Requests for Extensions or To Change the Predicate Tobacco Product.” This draft guidance provides information to tobacco product manufacturers about FDA's policies on manufacturer requests for extensions of time to respond to deficiencies that FDA has identified, and manufacturer requests to change the predicate tobacco product, in substantial equivalence (SE) reports.