[Federal Register Volume 63, Number 52 (Wednesday, March 18, 1998)]
[Rules and Regulations]
[Pages 13123-13124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6905]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Narasin, Bambermycins, 
and Roxarsone

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 reflect approval of a new animal drug application 
(NADA) filed by Hoechst Roussel Vet. The NADA provides for using 
approved single ingredient Type A medicated articles to make Type C 
medicated broiler feeds containing narasin, bambermycins, and 
roxarsone.

EFFECTIVE DATE: March 18, 1998.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2604.

SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, 30 Independence Blvd., 
P.O. Box 4915, Warren, NJ 07059, filed NADA 140-843 that provides for 
using approved single ingredient Type A medicated articles, 
Monteban (45 grams (g) narasin activity per pound (/lb)), 
Flavomycin (4 and 10 g bambermycins activity/lb), and 3-
Nitro (45.4, 90, and 227 g roxarsone/lb), to make Type C 
medicated broiler feeds containing 54 to 72 g narasin, 1 to 2 g 
bambermycins, and 22.7 to 45.4 g roxarsone/ton of feed. The Type C 
medicated broiler feed is used for the prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, 
and E. brunetti, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation in broiler chickens. NADA 140-843 
is approved as of March 18, 1998.
    Accordingly Secs. 558.363 and 558.366 (21 CFR 558.363 and 558.366) 
are amended to reflect the approval. The basis for approval is 
discussed in the freedom of information summary. In addition, 21 CFR 
558.95(d)(5) is amended by adding new paragraph (d)(5)(iii) to provide 
a cross-reference to the 3-way combination drug Type C medicated feed.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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. to 4 p.m., Monday through Friday.
    This approval is for use of approved Type A medicated articles to 
make combination Type C medicated feeds. One ingredient, roxarsone, is 
a Category II drug as defined in 21 CFR 558.3(b)(1)(ii). As provided in 
21 CFR 558.4(b), an approved form FDA 1900 is required for making a 
Type B or Type C medicated feed as in this application. Under section 
512(m) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360b(m)), as amended by the Animal Drug Availability Act of 1996 (Pub. 
L. 104-250), medicated feed applications have been replaced by a 
requirement for feed mill licenses. Therefore, use of narasin, 
bambermycins, and roxarsone Type A medicated articles to make Type C 
medicated feeds as provided in NADA 140-843 requires a feed mill 
license rather than an approved FDA Form 1900.
    Under section 512(c)(2)(F)(ii) of the act, this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning March 18, 1998 because the application contains substantial 
evidence of the effectiveness of the drug involved, any studies of 
animal safety or, in the case of food producing animals, human food 
safety studies (other than bioequivalence or residue studies) required 
for approval and conducted or sponsored by the applicant.
    FDA has determined under 21 CFR 25.33(a)(2) 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

[[Page 13124]]

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.

    2. Section 558.95 is amended by adding paragraph (d)(5)(iii) to 
read as follows:


Sec. 558.95  Bambermycins.

* * * * *
     (d) * * *
     (5) * * *
     (iii) Narasin and roxarsone as in Sec. 558.363.
    3. Section 558.363 is amended by revising paragraph (a), 
redesignating paragraph (c) as paragraph (d) and reserving paragraph 
(c), and by adding paragraph (d)(1)(vii), to read as follows:


Sec. 558.363  Narasin.

    (a) Approvals. Type A medicated articles containing specified 
levels of narasin approved for sponsors identified in Sec. 510.600(c) 
of this chapter for use as in paragraph (d) of this section are as 
follows:
    (1) To 000986: 36, 45, 54, 72, and 90 grams per pound, paragraph 
(d)(1)(i) of this section.
    (2) To 000986: 36, 45, 54, 72, and 90 grams per pound, with 10, 20, 
50, and 80 percent roxarsone, paragraph (d)(1)(ii) of this section.
    (3) To 000986: 36 grams per pound, with 36 grams per pound 
nicarbazin, paragraph (d)(1)(iii) of this section.
    (4) To 012799: 36, 45, 54, 72, and 90 grams per pound, with 2 and 
10 grams per pound bambermycins, paragraph (d)(1)(iv) of this section.
    (5) To 012799: 45 grams per pound, with 4 and 10 grams per pound 
bambermycins, and 45.4, 90, and 227 grams per pound roxarsone, 
paragraph (d)(1)(vii) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (vii) Amount per ton. Narasin 54 to 72 grams, bambermycins 1 to 2 
grams, and roxarsone 22.7 to 45.4 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and 
E. brunetti, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation in broiler chickens.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Do not allow adult turkeys or 
horses or other equines access to formulations containing narasin. 
Ingestion of narasin by these animals has been fatal. Use as sole 
source of organic arsenic. Poultry should have access to drinking water 
at all times. Drug overdosage or lack of water intake may result in leg 
weakness or paralysis. Withdraw 5 days before slaughter. Narasin as 
provided by 000986 in Sec. 510.600(c) of this chapter, bambermycins by 
012799, and roxarsone by 046573.
* * * * *


Sec. 558.366  [Amended]

    4. Section 558.366 Nicarbazin is amended, in paragraph (c) in the 
table in the first entry, under the column ``Limitations'' by removing 
``558.363(c)(1)(iii)'' and by adding in its place 
``558.363(d)(1)(iii).''

    Dated: February 22, 1998.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 98-6905 Filed 3-17-98; 8:45 am]
BILLING CODE 4160-01-F