Public Meeting on User Fees for OTC Monograph Drugs

Federal Register Notice: FDA will hold a public meeting 6/10 to gather stakeholder input on the potential development of a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user-fee program would provide funding to supplement congressional non-user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. The agency invites public comment on a potential OTC monograph user-fee program and also invites suggestions regarding the features such a user-fee program should include. The meeting will be held from 9 a.m. to 5 p.m. EDT at FDA’s White Oak Campus, Bldg. 31 Conference Center, 10903 New Hampshire Ave., the Great Room (Rm. 1503A), Silver Spring, MD. Contact Amy Bertha, (301) 796-1647, email: OTCMonographUserFeeProgram@fda.hhs.gov. To view this notice, click here.