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: Enforcement Policy for Certain (Provisional) Tobacco Products That the Food and Drug Administration Finds Not Substantially Equivalent
ACTION: Draft Guidance.
Docket No. FDA-2013-D-1600
DATES: Submit either electronic or written comments on the draft guidance by April 28, 2014.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Enforcement Policy for Certain (Provisional) Tobacco Products That FDA Finds Not Substantially Equivalent.” This draft guidance provides information to tobacco retailers on FDA's enforcement policy regarding certain so-called provisional tobacco products that become subject to not substantially equivalent (NSE) orders issued under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
NAME: National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions
ACTION: Proposed Rule.
Docket No. FDA-2013-N-1282
DATES: Submit either electronic or written comments on the proposed rule by April 8, 2014.
SUMMARY: In accordance with the National Environmental Policy Act of 1969 (NEPA) and the Council on Environmental Quality (CEQ) Regulations Implementing NEPA (CEQ Regulations), the Food and Drug Administration (FDA) is proposing to revise its NEPA implementing regulations to provide categorical exclusions for certain actions related to substantial equivalence (SE) reports, SE exemption requests, and tobacco product applications, and the rescission (order withdrawing an order) or suspension of orders regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is also proposing to amend its NEPA implementing regulations to include tobacco products, where appropriate, in light of its new authority under the Tobacco Control Act.