68 FR 14 pg. 3033 - Establishment of Medical Device User Fee Rates for Fiscal Year2003 and Interim Procedures; Correction
Type: NOTICEVolume: 68Number: 14Page: 3033
FR document: [FR Doc. 03-1381 Filed 1-16-03; 3:21 pm]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Establishment of Medical Device User Fee Rates for Fiscal Year2003 and Interim Procedures; Correction
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice; correction.
SUMMARY:
The Food and Drug Administration (FDA) iscorrecting a correction notice that appeared in the FederalRegister of January 10, 2003 (68 FR 1469). The document corrected anotice that appeared in the Federal Register of November 21,2002 (67 FR 70228), which announced the rates and interim procedures formedical device user fees for fiscal year (FY) 2003. The November 21, 2002,document was inadvertently published with confusing language regarding thefee that must be paid by a small business that submits a 510(k) premarketnotification for FDA review during FY 2003. The document intended to statethat all 510(k)s submitted for FDA review during FY 2003 are subject to astandard 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 documentcorrects the error in the correction notice.
ADDRESSES:
Persons with access to the Internet may obtainfurther information on the Medical Device User Fee and Modernization Act of2002 at http://www.fda.gov/cdrh/mdufma orhttp://www.fda.gov/cber/mdufma/mdufma.htm.
FOR FURTHER INFORMATION CONTACT:
Frank Claunts, Officeof 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, thefollowing correction is made:
1. On page 1469, in the second column, atthe bottom of the page, item 3 is revised to read "On page 70229, intable 1, in the fourth column, in the last row, correct `None in FY 2003'to read `2.1871 '."
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