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 2016_register executive 2018-02-08 article Notices D09002ee1c7f53878 D09002ee1c7f53c06 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 fee rates and payment procedures for medical device user fees for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2017, which apply from October 1, 2016, through September 30, 2017. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2017, you should not submit a FY 2017 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2017 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees. 81 FR 49987 https://www.govinfo.gov/app/details/FR-2016-07-29/2016-17903 2016-17903 fr29jy16-89 4164-01-P Docket No. FDA-2016-N-0007 https://www.govinfo.gov/app/details/FR-2016-07-29/2016-17903 https://www.govinfo.gov/content/pkg/FR-2016-07-29/html/2016-17903.htm https://www.govinfo.gov/content/pkg/FR-2016-07-29/pdf/2016-17903.pdf 7 p. 49987 49993 81 FR 49987 Medical Device User Fee Rates for Fiscal Year 2017; Federal Register Vol. 81, Issue NOTICE 2016-17903 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2016-N-0007 4164-01-P 2016-17903 Notice.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2017, which apply from October 1, 2016, through September 30, 2017. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2017, you should not submit a FY 2017 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2017 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

For information on Medical Device User Fees: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ ucm20081521.htm. Medical Device User Fee Rates for Fiscal Year 2017 , reglist@cdrh.fda.gov http://data.bls.gov/cgi-bin/surveymost?cu http://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm https://userfees.fda.gov/OA_HTML/furls.jsp https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp https://userfees.fda.gov/pay Pay.gov Vol. 81, no. 146 Office of the Federal Register, National Archives and Records Administration 2016-07-29 continuing daily deposited born digital 438 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-07-29 P0b002ee1985bcb6c 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr29jy16 https://www.govinfo.gov/app/details/FR-2016-07-29 https://www.govinfo.gov/content/pkg/FR-2016-07-29/pdf/FR-2016-07-29.pdf https://www.govinfo.gov/content/pkg/FR-2016-07-29/xml/FR-2016-07-29.xml fdlp 49855 50281 DGPO 2018-02-08 2024-06-01 FR-2016-07-29 machine generated eng FR FR-2016-07-29 81 146