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FDA Submits A Collection Of Information Proposal To OMB

On November 5, 2018, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information on the Biosimilars User Fee Program was submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FDA’s Biosimilars User Fee Program was established under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amended the Public Health Service Act through the addition of Section 351(k). The BPCI Act also amended the Federal Food, Drug, and Cosmetic Act to include Section 351(k) under human drug applications for prescription drug user fees provisions. The Program is meant to “create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. This allows a company to apply for licensure of a biosimilar or interchangeable biological product.” In 2012, the Biosimilar User Fee Act (BsUFA) allowed FDA to assess and collect user fees for activities connected with biosimilar biological product development (BPD). Some of these activities include the submission and review of forms, as well as an annual survey of all BsUFA participants.

The information collection proposal estimates an annual reporting burden of 57 hours, based on the number of respondents, the number of responses per respondent, the total annual responses, and the average burden per response. OMB will be accepting comments on FDA’s collection of information proposal until December 5, 2018.

©2018 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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