[Federal Register Volume 60, Number 71 (Thursday, April 13, 1995)]
[Rules and Regulations]
[Pages 18740-18741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9177]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs; Technical Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the correct drug labeler code for Rhone
Poulenc, Inc. The agency codified an incorrect drug labeler code. This
document corrects that error.
EFFECTIVE DATE: April 13, 1995.
FOR FURTHER INFORMATION CONTACT: Judith M. O'Haro, Center for
Veterinary Medicine (HFV-238), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1737.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 28, 1994
(59 FR 33196), FDA published a document to correct the drug labeler
code for Hess & Clark, Inc., from 011801 to 050749. Several regulations
were amended including those for roxarsone used in combinations in 21
CFR 558.95, 558.311, 558.355, and 558.550. This amendment inadvertently
created an error in the regulations. However, in the
[[Page 18741]]
Federal Register of February 13, 1981 (46 FR 10462), the agency amended
the regulations to reflect a change of sponsor for several new animal
drugs (NADA's) from Hess & Clerk, Inc., Division of Rhone-Poulenc,
Inc., to Hess & Clark, Inc. The roxarsone combinations mentioned above
were improperly assigned to Hess & Clark, Inc. This document corrects
that error by replacing the drug labeler code ``050749'' with the
correct drug labeler code, ``011526.'' Accordingly, 21 CFR 588.95,
558.311, 558.355, and 558.550 are amended to reflect the correct drug
labeler code for Rhone-Poulenc, Inc.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
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: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.95 [Amended]
2. Section 558.95 Bambermycins is amended in paragraphs
(b)(1)(x)(b) and (b)(1)(xi)(b) by removing ``050749'' and adding in its
place ``011526''.
Sec. 558.311 [Amended]
3. Section 558.311 Lasalocid is amended in the table in paragraph
(e)(1), in entry (ii), in the ``Limitations'' column for the
combinations with ``Roxarsone 45.4'', ``Roxarsone 45.4 plus
bambermycins 1'', ``Roxarsone 45.4 plus lincomycin 2.0'', ``Roxarsone
45.4 plus bacitracin 10 to 25'', and ``Roxarsone 45.4 plus bacitracin
10 or 30'', by removing ``050749'' and adding in its place ``011526''.
Sec. 558.355 [Amended]
4. Section 558.355 Monensin is amended in paragraphs
(f)(1)(xii)(b) and (f)(1)(xx)(b) by removing ``050749'' and adding in
its place ``011526''.
Sec. 558.550 [Amended]
5. Section 558.550 Salinomycin is amended in paragraph
(b)(1)(ii)(c) by removing ``050749'' and adding in its place
``011526''.
Dated: March 13, 1995.
George A. Mitchell,
Director, Office of Surveillance and Compliance, Center for Veterinary
Medicine.
[FR Doc. 95-9177 Filed 4-12-95; 8:45 am]
BILLING CODE 4160-01-F
