Director, Office of Regulations

0910-AH06 202404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Investigational Tobacco Product Applications

The proposed rule would define an investigational tobacco product (ITP) and describe the procedures and requirements relating to the use of investigational tobacco products in a clinical investigation, including the procedures and requirements for the submission to, and review by, FDA of an ITP application. The proposed rule will also set forth responsibilities of those involved with the investigation along with reporting and recordkeeping requirements.

]]> Other Significant Previously Published in The Unified Agenda Long-Term Actions No No 21 CFR 1112 21 U.S.C. 387j(g), Federal Food, Drug, and Cosmetic Act 21 U.S.C. 371 No NPRM 12/00/2025 Undetermined None No No Yes May Nelson Director, Office of Regulations 0910 Food and Drug Administration FDA 877 287-1373 askctp@fda.hhs.gov Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring MD 20993