FDA waiver of user fees

Executive Summary

Agency is considering the creation of an industry/agency advisory committee to consider the final rule on the waiver provisions of the User Fee Act of 1992. Speaking at a Drug Information Association Orphan Drug Development Conference in Bethesda, Md. Nov. 2, Office of Chief Mediator and Ombudsman Regulatory Counsel Suzanne O'Shea said it is "the first time FDA has actively considered using [negotiated rulemaking] for issuing a rule." Later, O'Shea indicated that the agency is in the early stages of considering the option. FDA's next step would be to assess, in a formal setting, the suitability of negotiated rulemaking and to determine what are the relevant interests