[Federal Register Volume 64, Number 64 (Monday, April 5, 1999)]
[Rules and Regulations]
[Pages 16347-16348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 26

[Docket No. 98N-0185]
RIN 0910-ZA11


Mutual Recognition of Pharmaceutical Good Manufacturing Practice 
Inspection Reports, Medical Device Quality System Audit Reports, and 
Certain Medical Device Product Evaluation Reports Between the United 
States and the European Community; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of November 6, 1998 (63 FR 
60122). The document amended FDA's regulations under an international 
agreement between the United States and the European Community. FDA 
took this action to enhance its ability to ensure the safety and 
effectiveness of pharmaceuticals and medical devices through more 
efficient utilization of its regulatory resources. The document was 
published with some inadvertent errors. This document corrects those 
errors.

EFFECTIVE DATE: March 31, 1999.

FOR FURTHER INFORMATION CONTACT: Merton V. Smith, Office of 
International

[[Page 16348]]

Affairs (HFG-1), Office of External Affairs, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0910, 
or e-mail ``MS[email protected]''.
SUPPLEMENTARY INFORMATION: In FR Doc. 98-29609, appearing on page 
60122, in the Federal Register of Friday, November 6, 1998, the 
following corrections are made:
    1. In the preamble, on page 60137, in the third column, in the 
fifth paragraph, in the third line, after ``to the following:'', ``that 
only'' is removed.


Sec. 26.1  [Corrected]

    2. On page 60142, in the first column, in Sec. 26.1(c), in the 
fourth line, ``that only'' is removed.


Sec. 26.50  [Corrected]

    3. On page 60153, in Appendix B of subpart B in Sec. 26.50, in 
Table 2, in the first column, under the subheading ``Clinical 
Thermometers:'', the third entry beginning with ``AN 868.5925 * * *'' 
is removed; in that same table, under the subheading ``Hypodermic 
Needles and Syringes (except anti-stick and self-destruct):'', the 
third entry beginning with ``OR 888.3020 * * * is removed; and in that 
same table, the subheading ``External Fixators (except devices with no 
external components):'' and the two entries that follow are removed.

    Dated: March 30, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-8199 Filed 3-31-99; 11:57 am]
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