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 D09002ee1c7f74bc0 D09002ee1c7f74c51 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 fiscal year (FY) 2016 rates for the establishment and reinspection fees related to human drug compounding outsourcing facilities (outsourcing facilities) that elect to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities that have elected to register, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2016 rates for the small business establishment fee ($5,203), the non-small business establishment fee ($16,465), and the reinspection fee ($15,610) for outsourcing facilities; provides information on how the fees for FY 2016 were determined; and describes the payment procedures outsourcing facilities should follow. 80 FR 46007 https://www.govinfo.gov/app/details/FR-2015-08-03/2015-18916 2015-18916 fr03au15-74 4164-01-P Docket No. FDA-2015-N-0007 https://www.govinfo.gov/app/details/FR-2015-08-03/2015-18916 https://www.govinfo.gov/content/pkg/FR-2015-08-03/html/2015-18916.htm https://www.govinfo.gov/content/pkg/FR-2015-08-03/pdf/2015-18916.pdf 4 p. 46007 46010 80 FR 46007 Outsourcing Facility Fee Rates for Fiscal Year 2016; Federal Register Vol. 80, Issue NOTICE 2015-18916 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2015-N-0007 4164-01-P 2015-18916 Notice.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2016 rates for the establishment and reinspection fees related to human drug compounding outsourcing facilities (outsourcing facilities) that elect to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities that have elected to register, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2016 rates for the small business establishment fee ($5,203), the non-small business establishment fee ($16,465), and the reinspection fee ($15,610) for outsourcing facilities; provides information on how the fees for FY 2016 were determined; and describes the payment procedures outsourcing facilities should follow.

For information on pharmacy compounding and pharmacy compounding user fees: Visit FDA's Web site at http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ default.htm. Outsourcing Facility Fee Rates for Fiscal Year 2016 , http://data.bls.gov/cgi-bin/surveymost?cu http://wcms.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm https://userfees.fda.gov/pay 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