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 2017_register executive 2017-09-30 article Notices D09002ee1c7f0e994 D09002ee1c7f0ea48 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 or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the sponsors of material threat MCM applications that meet all of the requirements of this program upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2018 and outlines the payment procedures for such fees. 82 FR 45859 https://www.govinfo.gov/app/details/FR-2017-10-02/2017-21191 2017-21191 fr02oc17-88 4164-01-P Docket No. FDA-2017-N-0007 https://www.govinfo.gov/app/details/FR-2017-10-02/2017-21191 https://www.govinfo.gov/content/pkg/FR-2017-10-02/html/2017-21191.htm https://www.govinfo.gov/content/pkg/FR-2017-10-02/pdf/2017-21191.pdf 3 p. 45859 45861 82 FR 45859 Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2018; Federal Register Vol. 82, Issue NOTICE 2017-21191 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2017-N-0007 4164-01-P 2017-21191 Notice.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the sponsors of material threat MCM applications that meet all of the requirements of this program upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2018 and outlines the payment procedures for such fees.

Robert J. Marcarelli, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE-14202F, Silver Spring, MD 20993-0002, 301-796-7223. Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2018 , https://userfees.fda.gov/pay https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm566498.htm#prv Pay.gov Vol. 82, no. 189 Office of the Federal Register, National Archives and Records Administration 2017-10-02 continuing daily deposited born digital 287 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-10-02 P0b002ee1970efe76 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr02oc17 https://www.govinfo.gov/app/details/FR-2017-10-02 https://www.govinfo.gov/content/pkg/FR-2017-10-02/pdf/FR-2017-10-02.pdf https://www.govinfo.gov/content/pkg/FR-2017-10-02/xml/FR-2017-10-02.xml fdlp 45679 45954 DGPO 2017-09-30 2024-06-01 FR-2017-10-02 machine generated eng FR FR-2017-10-02 82 189