[Federal Register Volume 68, Number 14 (Wednesday, January 22, 2003)]
[Notices]
[Page 3033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1381]


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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 
correction notice that appeared in the Federal Register of January 10, 
2003 (68 FR 1469). The document corrected a notice that appeared in the 
Federal Register of November 21, 2002 (67 FR 70228), which announced 
the rates and interim procedures for medical device user fees for 
fiscal year (FY) 2003. The November 21, 2002, 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 the error in the correction notice.

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. 03-494, appearing in the Federal 
Register of January 10, 2003, the following correction is made:
    1. On page 1469, in the second column, at the bottom of the page, 
item 3 is revised to read ``On page 70229, in table 1, in the fourth 
column, in the last row, correct `None in FY 2003' to read 
`2.187\1\'.''

    Dated: January 16, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-1381 Filed 1-16-03; 3:21 pm]
BILLING CODE 4160-01-S