[Federal Register Volume 59, Number 123 (Tuesday, June 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15673]


[Federal Register: June 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520 and 558


Animal Drugs, Feeds, and Related Products; Febantel-Trichlorfon 
Paste and Tylosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to remove those portions of the regulations that 
reflect approval of two new animal drug applications (NADA's). One NADA 
is held by Miles, Inc., and provides for use of febantel-trichlorfon 
paste. The other NADA is held by Nutra-Blend Corp. and provides for 
manufacture of a Type A medicated article and Type B medicated feeds 
containing tylosin. In a notice published elsewhere in this issue of 
the Federal Register, FDA is withdrawing approval of the NADA's.

EFFECTIVE DATE: July 8, 1994.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0749.

SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this 
issue of the Federal Register, FDA is withdrawing approval of NADA 131-
412 for Combotel/Negabot-Plus (febantel-trichlorfon) Paste held by 
Miles, Inc., Agriculture Division, Animal Health Products, P.O. Box 
390, Shawnee Mission, KS 66201, and NADA 122-158 held by Nutra-Blend 
Corp., P.O. Box 485, Neosho, MO 64850, for manufacture of Type B 
medicated feeds containing 4, 5, 10, and 20 grams per pound (g/lb) of 
tylosin and a Type A medicated article containing 40 g/lb of tylosin. 
The sponsors requested withdrawal of approval of the NADA's. This 
document removes 21 CFR 520.903c and amends 21 CFR 558.625(b)(71) to 
reflect the withdrawal of approval of these NADA's.

List of Subjects

21 CFR Part 520

    Animal drugs.

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 parts 520 and 
558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 520.903c  [Removed]

    2. Section 520.903c Febantel-trichlorfon paste is removed.

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

    3. 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. 558.625  [Amended]

    4. Section 558.625 Tylosin is amended by removing and reserving 
paragraph (b)(71).

    Dated: June 15, 1994.
 Richard H. Teske,
 Acting Director, Center for Veterinary Medicine
[FR Doc. 94-15673 Filed 6-27-94; 8:45 am]
BILLING CODE 4160-01-F