User fee waiver request draft guidance revised

User fee waiver or reduction requests were revised in a draft guidance published by the FDA for applicants considering the process. Titled “User Fee Waivers, Reductions, and Refunds for Drug and Biological Products,” the revised draft guidance describes the types of waivers and reductions permitted under the user fee provisions of the FDC Act, and the procedures for submitting requests for waivers or reductions and requests for reconsideration and appeal. The FDA will grant a waiver of or reduction in one or more user fees assessed under section 736(a) of the FDC Act where it finds that an applicant meets the eligibility criteria under one of the following provisions: (1) a waiver or reduction is necessary to protect the public health; (2) the assessment of the fee would present a significant barrier to innovation because of limited resources available to the person or other circumstances; or (3) the applicant is a small business submitting its first human drug application for review. The revised draft guidance also provides clarification on related issues such as user fee exemptions for orphan drugs. Written or electronic comments must be received by June 13, 2011. FDA Notice, ¶42,092

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