Medical devices: Medical device user fee rates; publication delay,

[Federal Register: August 1, 2005 (Volume 70, Number 146)]

[Notices]

[Page 44105]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr01au05-48]

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.

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