Senior Regulatory Counsel

0910-AH06 202310 The Regulatory Plan and the 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 06/00/2025 Undetermined None No No Yes Annette Marthaler Senior Regulatory Counsel 0910 Food and Drug Administration FDA 240 753-3043 annette.marthaler@fda.hhs.gov Office of Combination Products, 10903 New Hampshire Avenue, WO32, Room 5129, Silver Spring MD 20993