United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2018-02-23 article Notices D09002ee1c7f74bbf D09002ee1c7f74c50 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar biological products are made, and a biosimilar biological product fee for each biosimilar biological product approved in a biosimilar biological product application. BsUFA directs FDA to establish, before the beginning of each fiscal year, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees. These fees are effective on October 1, 2015, and will remain in effect through September 30, 2016. 80 FR 46005 https://www.govinfo.gov/app/details/FR-2015-08-03/2015-18908 2015-18908 fr03au15-73 4164-01-P Docket No. FDA-2015-N-0007 https://www.govinfo.gov/app/details/FR-2015-08-03/2015-18908 https://www.govinfo.gov/content/pkg/FR-2015-08-03/html/2015-18908.htm https://www.govinfo.gov/content/pkg/FR-2015-08-03/pdf/2015-18908.pdf 3 p. 46005 46007 80 FR 46005 Biosimilar User Fee Rates for Fiscal Year 2016; Federal Register Vol. 80, Issue NOTICE 2015-18908 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2015-N-0007 4164-01-P 2015-18908 Notice.

The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar biological products are made, and a biosimilar biological product fee for each biosimilar biological product approved in a biosimilar biological product application. BsUFA directs FDA to establish, before the beginning of each fiscal year, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees. These fees are effective on October 1, 2015, and will remain in effect through September 30, 2016.

No later than 5 calendar days after FDA grants the sponsor's request for a BPD meeting for that product or upon the date of submission of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application. The sponsor will be assessed an annual BPD fee beginning with the first fiscal year after payment of the reactivation fee. Rachel Richter, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14216, Silver Spring, MD 20993-0002, 301-796-7111. Biosimilar User Fee Rates for Fiscal Year 2016 , http://www.fda.gov/bsufa Pay.gov Vol. 80, no. 148 Office of the Federal Register, National Archives and Records Administration 2015-08-03 continuing daily deposited born digital 350 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-08-03 P0b002ee1988a95dc 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr03au15 https://www.govinfo.gov/app/details/FR-2015-08-03 https://www.govinfo.gov/content/pkg/FR-2015-08-03/pdf/FR-2015-08-03.pdf https://www.govinfo.gov/content/pkg/FR-2015-08-03/xml/FR-2015-08-03.xml fdlp 45841 46180 DGPO 2018-02-23 2024-06-02 FR-2015-08-03 machine generated eng FR FR-2015-08-03 80 148