[Federal Register: January 10, 2003 (Volume 68, Number 7)]

[Notices]               

[Page 1469]

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

[DOCID:fr10ja03-62]                         





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DEPARTMENT OF HEALTH AND HUMAN SERVICES





Food and Drug Administration





 

Establishment of Medical Device User Fee Rates for Fiscal Year 

2003 and Interim Procedures; Correction





AGENCY: Food and Drug Administration, HHS.





ACTION: Notice; correction.





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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 

that appeared in the Federal Register of November 21, 2002 (67 FR 

70228). The document announced the rates and interim procedures for 

medical device user fees for fiscal year (FY) 2003. The document was 

inadvertently published with confusing language regarding the fee that 

must be paid by a small business that submits a 510(k) premarket 

notification for FDA review during FY 2003. The document intended to 

state that all 510(k)s submitted for FDA review during FY 2003 are 

subject to a standard fee of $2,187, and that all submitters who are 

subject to a fee, including a small business, are required to pay this 

fee. This document corrects that error.





ADDRESSES: Persons with access to the Internet may obtain further 

information on the Medical Device User Fee and Modernization Act of 

2002 at http://www.fda.gov/cdrh/mdufma or http://www.fda.gov/cber/mdufma/mdufma

.htm.

mdufma/mdufma.htm.





FOR FURTHER INFORMATION CONTACT: Frank Claunts, Office of Management 

and Systems (HFA-20), Food and Drug Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301-827-4427.





SUPPLEMENTARY INFORMATION: In FR Doc. 02-29572, appearing on page 70228 

in the Federal Register of Thursday, November 21, 2002, the following 

corrections are made:

    1. On page 70228, in the third column, under ``III. Fee 

Calculations for FY 2003,'' the fourth sentence is corrected to read 

``Table 1 of this document summarizes the types of applications that 

are subject to a fee, the full fee amount expressed as a percent of the 

fee for a PMA, the full (standard) fee for FY 2003, and the fee that 

may be paid by a qualified small business.''

    2. On page 70229, in the second column, the first full sentence is 

corrected to read ``For premarket notification submissions, a small 

business will pay the full (standard) fee of $2,187.''

    3. On page 70229, in table 1, in the third column, in the last row, 

``2,187'' is corrected to read ``2,187\1\''.

    4. On page 70229, under table 1, add the following footnote to read 

as follows: ``\1\A small business will pay the full (standard) fee of 

$2,187 for a premarket notification submitted to FDA during FY 2003. A 

small business fee, set at 80 percent of the standard 510(k) fee, will 

be available beginning FY 2004.''





    Dated: January 6, 2003.

Margaret M. Dotzel,

Assistant Commissioner for Policy.

[FR Doc. 03-494 Filed 1-9-03; 8:45 am]



BILLING CODE 4160-01-S