New Animal Drugs for Use in Animal Feeds: Bacitracin Methylene Disalicylate and Nicarbazin
Federal Register: March 26, 2008 (Volume 73, Number 59)
Rules and Regulations
Page 15884-15885
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr26mr08-14
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 and Nicarbazin
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 Alpharma, Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing bacitracin methylene disalicylate and nicarbazin to formulate two-way combination drug Type C medicated feeds for broiler chickens.
DATES: This rule is effective March 26, 2008.
FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma, Inc., 440 Rt. 22, Bridgewater, NJ 08807, filed NADA 141-279 that provides for use of BMD (bacitracin methylene disalicylate) and NICARB (nicarbazin) Type A medicated articles to formulate two-way combination drug Type C medicated feeds for broiler chickens. The NADA is approved as of February 21, 2008, and the regulations are amended in 21 CFR 558.366 to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR part 20 and 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 Division of Dockets Management
(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.
This rule does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds. 0
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 0 1. The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371. 0 2. In the table in paragraph (d) of Sec. 558.366, alphabetically add new entries for ``Bacitracin methylene disalicylate 4 to 50'' and
``Bacitracin methylene disalicylate 50'' to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(d) * * *
Nicarbazin
Combination in grams per in grams per
Indications
Limitations
Sponsor ton
ton
for use
113.5
*
* *
* *
*
(0.0125 pct)
Bacitracin
Broiler
Feed
046573 methylene
chickens; aid continuously disalicylate in preventing as sole 4 to 50.
outbreaks of ration from cecal
time chicks
(Eimeria
are placed on tenella) and litter until intestinal
past the time
(E.
when acervulina,
coccidiosis
E. maxima, E. is ordinarily necatrix, and a hazard; do
E. brunetti) not use as a coccidiosis; treatment for for increased outbreaks of rate of
coccidiosis; weight gain
do not use in and improved flushing feed
mashes; do efficiency.
not feed to laying hens; withdraw 4 days before slaughter.
* * * * * * *
Bacitracin
Broiler
Feed
046573 methylene
chickens; aid continuously disalicylate in preventing as sole 50.
outbreaks of ration from cecal
time chicks
(Eimeria
are placed on tenella) and litter until intestinal
past the time
(E.
when acervulina,
coccidiosis
E. maxima, E. is ordinarily necatrix, and a hazard; do
E. brunetti) not use as a coccidiosis; treatment for as an aid in outbreaks of the
coccidiosis; prevention of do not use in necrotic
flushing enteritis
mashes; do caused or
not feed to complicated
laying hens; by
withdraw 4
Clostridium
days before spp. or other slaughter. organisms susceptible to bacitracin.
* * * * * * *
Page 15885
Dated: March 12, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FR Doc. E8-6063 Filed 3-25-08; 8:45 am
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