Proposed Requirements for Tobacco Product Manufacturing Practice; Public Hearing; Request for Comments

Streszczenie

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public oral hearing entitled "Proposed Requirements for Tobacco Product Manufacturing Practice." The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to prescribe current good manufacturing practice (cGMP) or hazard analysis and critical control point methodology (HACCP) regulations related to the manufacture, preproduction design validation, packing, and storage of tobacco products to protect public health and ensure compliance with the FD&C Act. In accordance with this provision, FDA is proposing requirements for tobacco product manufacturing practice (TPMP) elsewhere in this issue of the Federal Register. The FD&C Act further requires FDA to afford an opportunity for an oral hearing on the proposed regulation. We are holding this public oral hearing to carry out this statutory mandate and obtain information and views on the proposed TPMP requirements.