Federal Register: RULES New Animal Drugs for Use in Animal Feeds: [21 CFR Part 558]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: New Animal Drugs for Use in Animal Feeds:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Nicarbazin

DATES: This rule is effective March 26, 2008.

DOCUMENT 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, singleingredient Type A medicated articles containing bacitracin methylene disalicylate and nicarbazin to formulate twoway combination drug Type C medicated feeds for broiler chickens.

SUMMARY: Bacitracin Methylene Disalicylate and Nicarbazin,

SUPPLEMENTAL INFORMATION

Alpharma, Inc., 440 Rt. 22, Bridgewater, NJ 08807, filed NADA 141279 that provides for use of BMD (bacitracin methylene disalicylate) and NICARB (nicarbazin) Type A medicated articles to formulate twoway 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 (HFA305), 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. 801808.
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 558NEW 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. 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. E86063 Filed 32508; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Timothy Schell, Center for Veterinary Medicine (HFV128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 2402768116, email: timothy.schell@fda.hhs.gov.