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Medical Device User Fee Rates for Fiscal Year 2006; Delay in Publication

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing a delay in the publication of the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2006.

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For further information on MDUFMA: Visit FDA's Internet site at​oc/​mdufma.

For questions relating to this notice: Frank Claunts, Office of Management (HFA-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4427.

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The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), authorizes FDA to collect user fees for certain medical device applications in FY 2006 and FY 2007 only if certain conditions are met. Section 738 of the act (21 U.S.C. 379j) establishes fees for certain medical device applications and supplements. However, MDUFMA specifies that for FY 2006 fees may not be assessed if the total amounts appropriated for FY 2003 through FY 2005 for FDA's device and radiological health program are less than levels specified in MDUFMA (21 U.S.C. 379j(g)(1)(C)). Appropriations for FY 2003 through FY 2005 for FDA's device and radiological health program are below the amount specified in MDUFMA. Because of this, FDA is unable to assess or collect medical device user fees in FY 2006 unless additional legislation is enacted to modify those conditions (minimum appropriation levels for FY 2003 through FY 2005). Accordingly, FDA is not publishing the fee rates for FY 2006 at this time. If the required legislation is enacted, within 2 weeks of the date of enactment FDA will make available the fee rates for all applications and supplements submitted on or after October 1, 2005, and through September 30, 2006.

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Dated: July 22, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 05-15157 Filed 7-29-05; 8:45 am]