[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 ``MSmith@oc.fda.gov''.
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]
BILLING CODE 4160-01-F
