[Federal Register Volume 63, Number 70 (Monday, April 13, 1998)]
[Rules and Regulations]
[Pages 17947-17948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9575]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Bacitracin Zinc; 
Corrections

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations for bacitracin zinc to correct several regulations 
concerning the use of new animal drugs in animal feeds. Those 
corrections concern a codified designated source of bacitracin zinc for 
use in combination with several other new animal drugs. This document 
corrects those errors.

EFFECTIVE DATE: April 13, 1998.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 4, 1992 (57 
FR 7652), FDA published a document reflecting the change of sponsor of 
several new animal drug applications from Pittman-Moore, Inc., to 
American Cyanamid Co. In that document, FDA failed to change several 
regulations regarding the source of bacitracin zinc in combination with 
other new animal drugs, namely at 21 CFR 558.175(d)(1)(iii)(b) and 
(d)(1)(iv)(b), 558.195(d) in the table under ``Limitations,'' 
558.311(e)(1)(ii) in the table under ``Limitations,'' and 
558.515(d)(1)(vi)(b). Consequently, FDA also failed to include these 
citations in a change of sponsor from American Cyanamid Co. to 
Hoffmann-La Roche, Inc. (61 FR 18081, April 24, 1996).

[[Page 17948]]

 Instead, they were incorrectly included in a change of sponsor from 
Mallinckrodt Veterinary, Inc. (formerly Pittmann-Moore, Inc.) to 
Schering-Plough Animal Health Corp. (62 FR 61624, November 19, 1997). 
Sections 558.175, 558.195, 558.311, and 558.515 are amended to reflect 
the correct source of bacitracin zinc.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec. 558.175   [Amended]

    2. Section 558.175 Clopidol is amended in paragraph (d)(1)(iii)(b) 
and (d)(1)(iv)(b) by removing ``000061'' and adding in its place 
``000004''.


Sec. 558.195   [Amended]

    3. Section 558.195 Decoquinate is amended in the table in paragraph 
(d) in the entry for ``27.2 (0.003 pct.), Roxarsone 11 to 45 (0.0012-
0.005 pct.) plus Bacitracin 12 to 50'' under the ``Limitations'' 
column, by removing ``No. 000061'' and adding in its place ``Nos. 
000004, 011716, and 046573''.


Sec. 558.311   [Amended]

    4. Section 558.311 Lasalocid is amended in the table in paragraph 
(e)(1)(ii), under the ``Limitations'' column, in the fifth paragraph, 
by removing ``000061'' and adding in its place ``000004''.


Sec. 558.515   [Amended]

    5. Section 558.515 Robenidine hydrochloride is amended in paragraph 
(d)(1)(vi)(b) by removing the phrase ``Nos. 000004, 000061,'' and 
adding in its place ``Nos. 000004''.

    Dated: March 26, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-9575 Filed 4-10-98; 8:45 am]
BILLING CODE 4160-01-F