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2013-08-02
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Biosimilar User Fee Rates for Fiscal Year 2014
Notices
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United States
Department of Health and Human Services
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United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), which was signed by the President on July 9, 2012, authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, for certain applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological product products are made, and on biosimilar biological products after approval. 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, 2013, and will remain in effect through September 30, 2014.
78 FR 46962
https://www.govinfo.gov/app/details/FR-2013-08-02/2013-18621
2013-18621
fr02au13-73
4160-01-P
Docket No. FDA-2013-N-0007
https://www.govinfo.gov/app/details/FR-2013-08-02/2013-18621
https://www.govinfo.gov/content/pkg/FR-2013-08-02/html/2013-18621.htm
https://www.govinfo.gov/content/pkg/FR-2013-08-02/pdf/2013-18621.pdf
2 p.
46962
46963
78 FR 46962
Biosimilar User Fee Rates for Fiscal Year 2014; Federal Register Vol. 78, Issue
NOTICE
2013-18621
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-N-0007
4160-01-P
2013-18621
Notice.
The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), which was signed by the President on July 9, 2012, authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, for certain applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological product products are made, and on biosimilar biological products after approval. 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, 2013, and will remain in effect through September 30, 2014.
David Miller, Office of Financial Management (HFA-100), Food and Drug Administration, 1350 Piccard Dr., PI50, Rm. 210J, Rockville, MD 20850, 301-796-7103.
Biosimilar User Fee Rates, Fiscal Year 2014
,
http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/default.htm
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Vol. 78, no. 149
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2013-08-02
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https://www.govinfo.gov/app/details/FR-2013-08-02
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https://www.govinfo.gov/app/details/FR-2013-08-02
https://www.govinfo.gov/content/pkg/FR-2013-08-02/pdf/FR-2013-08-02.pdf
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