[Federal Register Volume 61, Number 96 (Thursday, May 16, 1996)]
[Rules and Regulations]
[Pages 24693-24694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12262]



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

[[Page 24694]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use In Animal Feed; Halofuginone 
Hydrobromide and Bambermycins

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Hoechst-Roussel Agri-Vet Co. The NADA provides for 
using approved single ingredient Type A medicated articles to make Type 
C medicated turkey feeds containing halofuginone hydrobromide and 
bambermycins.

EFFECTIVE DATE: May 16, 1996.

FOR FURTHER INFORMATION CONTACT: James F. McCormack, Center For 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1607.

SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., P.O. Box 2500, 
Route 202-206, Somerville, NJ 08876-1258, filed NADA 140-918 which 
provides for use of approved Stenorol<Register> (2.72 grams (g) of 
halofuginone hydrobromide activity per pound) and approved 
Flavomycin<Register> (4 and 10 g of bambermycins activity per pound) 
Type A medicated articles to make Type C medicated turkey feeds 
containing 1.36 to 2.72 g of halofuginone hydrobromide and 2 g of 
bambermycins per ton. The Type C medicated turkey feed is used for 
prevention of coccidiosis caused by Eimeria adenoides, E. 
meleagrimitis, and E. gallopavonis, and for increased rate of weight 
gain in growing turkeys. The NADA is approved as of May 16, 1996, and 
the regulations are amended in 21 CFR 558.265 by adding new paragraph 
(c)(2)(iii) to reflect the approval. The basis of approval is discussed 
in the freedom of information summary.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a 
summary of safety and effectiveness data and information submitted to 
support approval of this application may be seen in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    This approval is for use of single ingredient Type A medicated 
articles to make Type C medicated feeds. Halofuginone hydrobromide is a 
Catagory II drug which, as provided in 21 CFR 558.4, requires an 
approved form FDA 1900 for making a Type C medicated feed. Therefore, 
use of halofuginone hydrobromide and bambermycins Type A articles to 
make Type C medicated turkey feeds as in NADA 140-918 requires an 
approved form FDA 1900.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), approval of this 
application qualifies for 3 years of marketing exclusivity beginning 
May 16, 1996, because the application contains reports of new clinical 
or field investigations (other than bioequivalence or residue studies) 
or human food safety studies (other than bioequivalence or residue 
studies) essential to the approval and conducted or sponsored by the 
applicant.
    The agency has determined under 21 CFR 25.24 (d)(1)(ii) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

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).

    2. Section 558.265 is amended by adding new paragraph (c)(2)(iii) 
to read as follows:


Sec. 558.265  Halofuginone hydrobromide.

* * * * *
    (c) *  *  *
    (2) *  *  *
    (iii) Amount per ton. 1.36 to 2.72 grams of halofuginone 
hydrobromide plus 2 grams of bambermycins.
    (A) Indications for use. For the prevention of coccidiosis caused 
by Eimeria adenoides, E. meleagrimitis, and E. gallopavonis, and for 
increased rate of weight gain in growing turkeys.
    (B) Limitations. Feed continuously as sole ration. Withdraw 7 days 
before slaughter. Do not feed to laying chickens or waterfowl. 
Halofuginone hydrobromide is toxic to fish and other aquatic life. Keep 
out of lakes, ponds, and streams. Halofuginone hydrobromide is an eye 
and skin irritant. Avoid contact with skin, eyes, and clothing.
* * * * *
    Dated: May 1, 1996.
 Michael J. Blackwell,
 Acting Director, Center for Veterinary Medicine.
[FR Doc. 96-12262 Filed 5-15-96; 8:45 am]
BILLING CODE 4160-01-F