0910-AF51 200410 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 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses products containing bismuth subsalicylate for relief of symptoms of upset stomach due to overindulgence resulting from food and drink. Routine and Frequent First Time Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 201 21 CFR 310 21 CFR 330 to 358 21 USC 321p 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 360a 21 USC 371 21 USC 371a 21 USC 331 No NPRM (Amendment) 02/00/2005 Yes Businesses None NA Not Collected Gerald Rachanow M. 0910 Food and Drug Administration FDA 301 827-2241 301 827-2315 gerald.rachanow@fda.hhs.gov HFD-560, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Lane, Rockville MD 20857