[Federal Register: April 5, 1999 (Volume 64, Number 64)] [Rules and Regulations] [Page 16347-16348] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr05ap99-9] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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