[Federal Register Volume 64, Number 72 (Thursday, April 15, 1999)]
[Rules and Regulations]
[Pages 18574-18575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9454]
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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 and Nicarbazin
With Bacitracin Methylene Disalicylate 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 Alpharma Inc. The NADA provides for using approved
narasin and nicarbazin, bacitracin methylene disalicylate (BMD), and
roxarsone Type A medicated articles to make Type C medicated broiler
chicken feeds.
EFFECTIVE DATE: April 15, 1999.
FOR FURTHER INFORMATION CONTACT: Jeffrey M. Gilbert, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-1600.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, filed NADA 141-112 that provides for
combining approved MaxibanTM (27 grams per pound (g/lb) each
of narasin and nicarbazin), BMD (10, 25, 30, 40, 50, 60, or
75 g/lb BMD), and 3-Nitro (45.4, 90, or 227 g/lb roxarsone)
Type A medicated articles to make Type C medicated broiler chicken
feeds. The Type C feed contains 27 to 45 g/ton (t) each of narasin and
nicarbazin, 50 g/t BMD, and 22.7 to 45.4 g/t roxarsone. The Type C feed
is used for prevention of coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, as an
aid in the prevention of necrotic enteritis caused or complicated by
Clostridium spp. or other organisms susceptible to bacitracin, for
increased rate of weight gain, improved feed efficiency, and improved
pigmentation.
The NADA is approved as of March 4, 1999, and the regulations are
amended by adding 21 CFR 558.76(d)(3)(xxi), 558.363(d)(2)(iii), and
558.530(d)(5)(xxv), and by amending 21 CFR 558.366(c) to reflect the
approval. The basis for approval is discussed in the freedom of
information summary.
This approval is for use of Type A medicated articles to make
combination drug Type C medicated feeds. Narasin with nicarbazin and
roxarsone are Category II drugs 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
to make a Type C medicated feed from a Category II drug. Under 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 Type A medicated
articles to make Type C medicated feeds as provided in NADA 141-112 is
limited to manufacture in a licensed feed mill.
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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency 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 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 558.76 is amended by adding paragraph (d)(3)(xxi) to
read as follows:
Sec. 558.76 Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(3) * * *
(xxi) Narasin with nicarbazin and roxarsone as in Sec. 558.366.
3. Section 558.363 is amended by adding paragraph (d)(2)(iii) to
read as follows:
Sec. 558.363 Narasin.
* * * * *
(d) * * *
(2) * * *
(iii) Bacitracin methylene disalicylate, nicarbazin, and roxarsone
as in Sec. 558.366.
4. Section 558.366 is amended in the table in paragraph (c) under
entry ``27 to 45'' by alphabetically adding an entry for ``Naracin 27
to 45, bacitracin methylene disalicylate 50, and roxarsone 22.7 to
45.4'' to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(c) * * *
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Nicarbazin in grams Combination in grams
per ton per ton Indications for use Limitations Sponsor
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27 to 45
[[Page 18575]]
* * * * *
Narasin 27 to 45, Broiler chickens; Feed continuously as 046573
bacitracin methylene prevention of sole ration. Withdraw 5
disalicylate 50, and coccidiosis caused by days before slaughter.
roxarsone 22.7 to Eimeria tenella, E. Do not allow turkeys,
45.4. necatrix, E. acervulina, horses or other equines
E. maxima, E. brunetti, access to formulations
and E. mivati, as an aid containing narasin.
in the prevention of Ingestion of narasin by
necrotic enteritis these species has been
caused or complicated by fatal. Do not feed to
Clostridium spp. or laying hens. Use as
other organisms sole source of organic
susceptible to arsenic. Narasin and
bacitracin, for nicarbazin as provided
increased rate of weight by 000986, bacitracin
gain, improved feed methylene disalicylate
efficiency, and improved and roxarsone by
pigmentation. 046573.
* * * * * *
*
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5. Section 558.530 is amended by adding paragraph (d)(5)(xxv) to
read as follows:
Sec. 558.530 Roxarsone.
* * * * *
(d) * * *
(5) * * *
(xxv) Bacitracin methylene disalicylate, narasin, and nicarbazin as
in Sec. 558.366.
Dated: April 1, 1999.
George A. Mitchell,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 99-9454 Filed 4-15-99; 8:45 am]
BILLING CODE 4160-01-F
