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  4. Biosimilar User Fee Amendments
  5. Notice to applicants with pending submissions for biosimilars at the time of the government shutdown
  1. Biosimilar User Fee Amendments

Notice to applicants with pending submissions for biosimilars at the time of the government shutdown

Notice to applicants who owe annual BPD fees for FY 2014:

In accordance with BsUFA, 21 U.S.C. §379j-52(a)(1)(B)(ii), annual biosimilar biological product development fees for FY 2014 are due “on...the first business day after the enactment of an appropriations Act providing for the collection and obligation of [BsUFA] fees for fiscal year 2014.” Because the Continuing Resolution (an appropriations Act) for fiscal year 2014 was enacted on October 17, 2013, annual biosimilar biological product development fees assessed for fiscal year 2014 are due on October 18, 2013.

Notice to applicants with pending submissions for biosimilars at the time of the government shutdown:

For the biosimilar biological products program, for which carryover user fee funds were not available during the shutdown, the agency plans to extend the existing goal dates by the number of days the government was shut down. Even so, because of the need to reschedule certain internal meetings or meetings with product sponsors, some biosimilars goal dates may not be met.

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