Animal drugs, feeds, and related products: New drug applications— Spectinomycin solution,

[Federal Register: July 16, 1998 (Volume 63, Number 136)]

[Rules and Regulations]

[Page 38303-38304]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16jy98-12]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

Implantation or Injectable Dosage Form New Animal Drugs; Spectinomycin Solution; 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 May 1, 1998 (63 FR 24106). The document amended the animal drug regulations to reflect approval of a new animal drug application (NADA)

[[Page 38304]]

filedby Pharmacia & Upjohn Co. The NADA provides for veterinary prescription use of Adspec‹SUP›TM‹/SUP› (spectinomycin) sterile solution for cattle. The document incorrectly listed the tolerance for spectinomycin residues in cattle muscle. This document corrects that error.

EFFECTIVE DATE: July 16, 1998.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1644. SUPPLEMENTARY INFORMATION: In FR Doc. 98-11686 appearing on page 24106 in the Federal Register of Friday, May 1, 1998, the following correction is made:

Sec. 556.600 [Corrected]

1. On page 24107, in the second column, in Sec. 556.600 Spectinomycin, in paragraph (c), in the fourth line, ``0.4'' is corrected to read ``0.25''.

Dated: July 9, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine.

[FR Doc. 98-18956Filed7-15-98; 8:45 am]

BILLING CODE 4160-01-F