[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)]
[Rules and Regulations]
[Page 11599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6078]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Chlortetracycline, 
Sulfathiazole, Penicillin; 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 January 15, 1998 (63 FR 
2306). The document amended the animal drug regulations to reflect 
approval of Hoffmann-La Roche, Inc.'s, abbreviated new animal drug 
regulation (ANADA). ANADA 200-167 provides for use of 
Aureozol, a Type A medicated article containing 
chlortetracycline, sulfathiazole, and penicillin to make Type C 
medicated swine feeds. The amendment to Sec. 558.155(a)(2) (21 CFR 
558.155(a)(2)), reflecting the approval, incorrectly provided for 
sponsor No. 054273 when it should have provided for Nos. 000004 and 
000010. This document corrects that error.

EFFECTIVE DATE: January 15, 1998.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 15, 1998 
(63 FR 2306), FDA published a document reflecting approval of Hoffmann-
La Roche, Inc.'s, ANADA 200-167. The approval was for 
Aureozol, a Type A medicated article containing 
chlortetracycline calcium complex equivalent to 40 grams (g) of 
chlortetracycline hydrochloride, 8.8 percent (40 g) sulfathiazole, and 
procaine penicillin equivalent in activity to 20 g of penicillin per 
pound, to make Type C medicated swine feeds containing 100 g of 
chlortetracycline, 100 g of sulfathiazole, and 50 g of penicillin per 
ton of feed. Hoffmann-La Roche's ANADA 200-167 was approved as a 
generic copy of Boehringer Ingelheim Animal Health, Inc.'s, NADA 39-077 
CSP 500 Fermazole Brand (chlortetracycline (as hydrochloride), 
sulfathiazole, penicillin (from procaine penicillin)). The regulations 
that were amended in Sec. 558.155(a)(2) to reflect the approval 
provided the incorrect drug labeler number. This document corrects the 
error by providing for ``Nos. 000004 and 000010''.
    In FR Doc. 98-703, appearing on page 2306 in the Federal Register 
of Thursday, January 15, 1998, the following correction is made:


Sec. 558.155  [Corrected]

    1. On page 2307, in the second column, amendment no. 2 is corrected 
to read ``Section 558.155 Chlortetracycline, sulfathiazole, penicillin 
is amended in paragraph (a)(2) by removing `000010' and adding in its 
place `Nos. 000004 and 000010'''.

    Dated: February 26, 1998.
Steven D. Vaughn,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-6078 Filed 3-9-98; 8:45 am]
BILLING CODE 4160-01-F