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Start Preamble
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.
Start Further InfoFOR 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.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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.
Start List of SubjectsList 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:
End Amendment Part Start PartPART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
End Part Start Amendment Part1. The authority citation for 21 CFR part 558 continues to read as follows:
End Amendment Part Start Amendment Part2. In the table in paragraph (d) of § 558.366, alphabetically add new entries for “Bacitracin methylene disalicylate 4 to 50” and “Bacitracin methylene disalicylate 50” to read as follows:
End Amendment PartNicarbazin.* * * * *(d) * * *
Start SignatureNicarbazin in grams per ton Combination in grams per ton Indications for use Limitations Sponsor 113.5 (0.0125 pct) * * * * * * Bacitracin methylene disalicylate 4 to 50. Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. 046573 * * * * * * * Bacitracin methylene disalicylate 50. Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. 046573 * * * * * * * Start Printed Page 15885End Signature End Supplemental InformationDated: March 12, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-6063 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S
Document Information
- Effective Date:
- 3/26/2008
- Published:
- 03/26/2008
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- E8-6063
- Dates:
- This rule is effective March 26, 2008.
- Pages:
- 15884-15885 (2 pages)
- PDF File:
- e8-6063.pdf
- CFR: (1)
- 21 CFR 558.366