Federal Register: December 1, 1998 (Volume 63, Number 230)Rules and RegulationsPage 66015-66017From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr01de98-8

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 343

Docket No. 77N-094AInternal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-The-Counter Human Use; Final Rule for Professional Labeling of Aspirin, Buffered Aspirin, and Aspirin in Combination With Antacid Drug Products; 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 October 23, 1998 (63 FR 56802). The document provided for professional labeling for over-the- counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products containing aspirin, buffered aspirin, and aspirin in combination with an antacid. The document published with some inadvertent editorial errors. This document corrects those errors.

EFFECTIVE DATE: The regulation is effective October 25, 1999.

FOR FURTHER INFORMATION CONTACT: Ida I. Yoder, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION: In FR Doc. 98-28519, appearing on page 56802, in the Federal Register of October 23, 1998, the following corrections are made: 1. On page 56809, in Table 5, in the second entry in the fourth column, ``-3.9'' is corrected to read ``-39''. 2. On page 56810, in the third column, in the eighteenth line, ``preoperative'' is corrected to read ``perioperative''. 3. On page 56812, in the first column, in the third paragraph, in the eighteenth line, ``were'' is corrected to read ``was''.

Sec. 343.80 [Corrected]

4. On page 56817, in Sec. 343.80(a)(1), the last paragraph is corrected to read ``REV: October 23, 1998''.

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5. On page 56818, in Sec. 343.80(a)(2), the entire page ``HIGHLIGHTS OF PRESCRIBING INFORMATION'' is corrected to read as follows:

Dated: November 20, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination.

FR Doc 98-31854Filed11-30-98; 8:45 amBILLING CODE 4160-01-F

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FR Doc. 98-31854Filed11-30-98; 8:45 amBILLING CODE 4160-01-C