[Federal Register Volume 63, Number 137 (Friday, July 17, 1998)]
[Rules and Regulations]
[Pages 38474-38476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19025]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use In Animal Feeds; Bacitracin Methylene
Disalicylate, Decoquinate, and Roxarsone
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
[[Page 38475]]
animal drug regulations to reflect approval of a new animal drug
application (NADA) filed by Alpharma Inc. The NADA provides for using
approved bacitracin methylene disalicylate, decoquinate, and roxarsone
Type A medicated articles to make combination drug Type C medicated
broiler chicken feeds.
EFFECTIVE DATE: July 17, 1998.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1638.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, is sponsor of NADA 141-100 that provides for
combining approved Type A medicated articles containing BMD
(10, 25, 30, 40, 50, 60, or 75 grams per pound (g/lb) bacitracin
methylene disalicylate) with Deccox (6 percent or 27.2 g/lb
decoquinate), and 3-Nitro (45.4, 90, or 227 g/lb roxarsone)
to make Type C medicated broiler feeds containing 50 g/ton (g/t)
bacitracin methylene disalicylate, 27.2 g/t decoquinate, and 22.7 to
45.4 g/t roxarsone. The Type C medicated broiler feeds are used as an
aid in the prevention of necrotic enteritis, for the prevention of
coccidiosis, and for increased rate of weight gain, improved feed
efficiency, and improved pigmentation in broiler chickens. The NADA is
approved as of June 2, 1998, and the regulations are amended in 21 CFR
558.76(d)(3) and 558.195(d) by adding new entries, and 558.530(d)(5)(x)
is revised to reflect the approval. The basis for approval is discussed
in the freedom of information summary.
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.
This approval is for use of single ingredient Type A medicated
articles to make combination drug Type C medicated feeds. One
ingredient, roxarsone, is a Category II drug as defined in 21 CFR
558.3(b)(1)(ii). Prior to enactment of the Animal Drug Availability Act
of 1996 (Pub. L. 104-250) (ADAA), an approved medicated feed
application (MFA) was required for feed mills to make Type C medicated
feeds from Type A medicated articles containing Category II drugs. The
ADAA revised the Federal Food, Drug, and Cosmetic Act to replace the
requirement for MFA's with a requirement for feed mill licenses.
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)(xv) to read
as follows:
Sec. 558.76 Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(3) * * *
(xv) Decoquinate and roxarsone as in Sec. 558.195.
3. Section 558.195 is amended in the table in paragraph (d) by
adding an entry for ``27.2 (0.003 pct)'' following the entry for
``Bacitracin 10 to 50'' and before the entry for ``Chlortetracycline
100 to 200'' to read as follows:
Sec. 558.195 Decoquinate.
* * * * *
(d) * * *
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Decoquinate in grams per ton grams per ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
27.2 (0.003 pct)................ Bacitracin Broiler chickens; Feed continuously 046573
methylene for prevention of as sole ration.
disalicylate 50 coccidiosis Withdraw 5 days
and roxarsone caused by Eimeria before slaughter.
22.7-45.4. tenella, E. Do not feed to
necatrix, E. laying chickens.
mivati, E. Not for use in
acervulina, E. breeder chickens.
maxima, E. Use as sole
brunetti; as an source of organic
aid in the arsenic. Poultry
prevention of should have
necrotic access to
enteritis caused drinking water at
or complicated by all times. Drug
Clostridium spp. overdosage or
or other lack of drinking
organisms water may result
susceptible to in leg weakness
bacitracin; for or paralysis.
increased rate of Decoquinate,
weight gain, bacitracin
improved feed methylene
efficiency, and disalicylate, and
improved roxarsone, as
pigmentation. provided by No.
046573 in Sec.
510.600(c) of
this chapter.
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
3. Section 558.530 is amended by removing and reserving paragraph
(c), and by revising paragraph (d)(5)(x) to read as follows:
Sec. 558.530 Roxarsone.
* * * * *
[[Page 38476]]
(c) [Reserved]
(d) * * *
(5) * * *
(x) Decoquinate alone or in combination as in Sec. 558.195.
* * * * *
Dated: July 9, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-19025 Filed 7-16-98; 8:45 am]
BILLING CODE 4160-01-F
