[Federal Register Volume 70, Number 146 (Monday, August 1, 2005)]
[Notices]
[Page 44105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

FOR FURTHER INFORMATION CONTACT:
    For further information on MDUFMA: Visit FDA's Internet site at 
http://www.fda.gov/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.

SUPPLEMENTARY INFORMATION: 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.

    Dated: July 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-15157 Filed 7-29-05; 8:45 am]
BILLING CODE 4160-01-S