[Federal Register Volume 68, Number 7 (Friday, January 10, 2003)]
[Notices]
[Page 1469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-494]


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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.

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