The FDA charges manufacturers of Over-the-Counter drugs an annual fee. Please see FDA’s Over-the-Counter Monograph Drug User Fee Program (OMUFA) webpage for detailed information, but the contact points at FDA: For questions about the program, or regarding refunds and waiver requests, contact FDA by email to CDERCollections@fda.hhs.gov or call to 301-796-7900 For questions about paying the fee or confirming the status of a payment, contact FDA by email to the User Fee Helpdesk at userfees@fda.gov or call to 301-796-7200.