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2018-02-08
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Medical Device User Fee Rates for Fiscal Year 2017
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
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 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
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Vol. 81, no. 146
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2016-07-29
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https://www.govinfo.gov/app/details/FR-2016-07-29
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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
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