71 FR 62 pgs. 16222-16223 - New Animal Drugs for Use in Animal Feeds; Bacitracin; Nitarsone;Zoalene
Type: RULEVolume: 71Number: 62Pages: 16222 - 16223
Docket number: [Docket No. 2003N-0324]
FR document: [FR Doc. 06-3122 Filed 3-30-06; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. 2003N-0324]
New Animal Drugs for Use in Animal Feeds; Bacitracin; Nitarsone;Zoalene
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) isamending the animal drug regulations to reflect approval of threesupplemental new animal drug applications (NADAs) filed by Alpharma, Inc.Two of the supplemental NADAs provide for the use of approved,single-ingredient Type A medicated articles containing bacitracin methylenedisalicylate and zoalene, with or without roxarsone, to formulate two-wayor three-way combination drug Type C medicated feeds for replacementchickens. The third NADA provides for the use of bacitracin zinc andnitarsone single-ingredient Type A medicated articles for two-waycombination Type C medicated feeds for growing turkeys. These approvalsreflect FDA's effectiveness conclusions, which relied on the NationalAcademy of Sciences/National Research Council (NAS/NRC) Drug Efficacy StudyGroup's evaluation of the effectiveness of these drugs when used in animalfeed as single ingredients.
DATES:
This rule is effective March 31, 2006.
FOR FURTHER INFORMATION CONTACT:
Andrew J. Beaulieu,Center for Veterinary Medicine (HFV-50), 7519 Standish Pl.,Rockville, MD 20855, 240-276-9090, e-mail: andrew.beaulieu@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
In the FederalRegister of August 8, 2003 (68 FR 47332), as corrected October 7, 2003(68 FR 57911), as part of the Drug Efficacy Study Implementation (DESI)program CVM announced the effective conditions of use for several drugproducts and use combinations listed in 21 CFR 558.15. CVM proposed towithdraw the NADAs for those products or use combinations lackingsubstantial evidence of effectiveness following a 90-day opportunity tosupplement the NADAs with labeling conforming to the relevant findings ofeffectiveness. Alpharma, Inc., One Executive Dr., Fort Lee, NJ 07024,filed supplements to three of its approved NADAs to revise the labeling ofits products to comply with these findings of effectiveness.
Alpharma, Inc., filed a supplement to approved NADA 141-130 foruse of bacitracin methylene disalicylate and zoalene Type A medicatedarticles to formulate two-way combination drug Type C medicated feeds.This supplemental NADA provides for the use of combination feeds containingBMD (bacitracin methylene disalicylate) at 4 to 50 grams per ton (g/ton)and ZOAMIX (zoalene) at 36.3 to 113.5 g/ton of feed in replacement chickensfor increased rate of weight gain and improved feed efficiency; and fordevelopment of active immunity to coccidiosis.
Alpharma, Inc., also filed a supplement to approved NADA 141-131for use of bacitracin methylene disalicylate, zoalene, and roxarsonesingle-ingredient Type A medicated articles to make three-way combinationdrug Type C medicated feeds. This supplemental NADA provides for the useof combination feeds containing BMD (bacitracin methylene disalicylate) at4 to 50 g/ton, ZOAMIX (zoalene) at 36.3 to 113.5 g/ton, and 3-NITRO(roxarsone) at 22.7 to 45.4 g/ton of feed in replacement chickens forincreased rate of weight gain and improved feed efficiency; for developmentof active immunity to coccidiosis; and for improved pigmentation.
Alpharma, Inc., also filed a supplement to approved NADA 141-132for use of bacitracin zinc and nitarsone single-ingredient Type A medicatedarticles to make two-way combination drug Type C medicated feeds. Thissupplemental NADA provides for the use of combination feeds containingALBAC (bacitracin zinc) at 4 to 50 g/ton and HISTOSTAT (nitarsone) at 170g/ton (0.01875 percent) of feed in growing turkeys for increased rate ofweight gain and improved feed efficiency; and as an aid in the preventionof blackhead.
The DESI evaluation is concerned only with the effectiveness of the drugproducts and use combinations. Nothing in this document constitutes a barto further proceedings with respect to questions of safety of the subjectdrugs in treated animals or of the drugs or their metabolites in foodproducts derived from treated animals.
Products that comply with FDA's findings of effectiveness are eligiblefor copying as described in the Generic Animal Drug and PatentTerm Restoration Act Policy Letter Eight , August 21, 1991 (56 FR41561). Accordingly, sponsors may now obtain approval of abbreviated NADAsfor these three combination drug medicated feeds.
The NADAs are approved as of February 15, 2006, and the regulations areamended in 21 CFR 558.76, 558.78, 558.369, and 558.680 to reflect theapproval. Approval of these supplemental NADAs did not require review ofany new safety or effectiveness data. Therefore, a freedom of informationsummary was not prepared.
The agency has determined under 21 CFR 25.33(a)(2) that these actionsare of a type that do not individually or cumulatively have a significanteffect on the human environment. Therefore, neither an environmentalassessment 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 5U.S.C. 801-808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and underauthority delegated to the Commissioner of Food and Drugs and redelegatedto the Center for Veterinary Medicine, 21 CFR part 558 is amended asfollows:
PART 558-NEW ANIMAL DRUGS FOR USE IN ANIMALFEEDS
1. The authority citation for 21 CFR part 558 continues to read asfollows:
Authority:
21 U.S.C. 360b, 371.
§ 558.76 [Amended]
2. In § 558.76, amend paragraph (d)(3)(xviii) by adding"or roxarsone" after "arsanilicacid".
3. In § 558.78, amend paragraph (d)(3) by redesignatingparagraphs (d)(3)(x) through (d)(3)(xii) as paragraphs (d)(3)(xi) through(d)(3)(xiii); and add new paragraph (d)(3)(x) to read as follows:
§ 558.78 Bacitracinzinc.
(d) * * *
(3) * * *
(x) Nitarsone as in § 558.369.
§ 558.369 [Amended]
4. In § 558.369, amend paragraph (d)(2)(i) by adding"or bacitracin zinc" after"disalicylate".
5. In § 558.680, amend the table in paragraph(d)(1)(i), after the entry for "Arsanilic acid 90 (0.01%) pluspenicillin 2.4 to 50" by adding entries for "Bacitracin 4 to50" and "Bacitracin methylene disalicylate 4 to 50 plusroxarsone 22.7 to 45.4" to read as follows:
§ 558.680 Zoalene.
(d) * * *
(1) * * *
| Zoalene in grams/ton | Combination in grams/ton | Indications for use | Limitations |
|---|---|---|---|
| (i) * * * | |||
| Bacitracin 4 to 50 | Replacement chickens: For development of active immunity tococcidiosis; for increased rate of weight gain, improved feedefficiency | Feed as in subtable in § 558.680(d)(1)(i); grower rationnot to be fed to birds over 14 weeks of age. As bacitracin methylenedisalicylate provided by No. 046573 in § 510.600(c) of thischapter | |
| Bacitracin methylene disalicylate 4 to 50 plus roxarsone 22.7 to45.4 | Replacement chickens: For development of active immunity tococcidiosis; for increased rate of weight gain, improved feed efficiency,and improved pigmentation | Feed as in subtable in § 558.680(d)(1)(i); grower rationnot to be fed to birds over 14 weeks of age. Discontinue use 5 days beforeslaughter; as sole source of organic arsenic; drug overdose or lack ofwater may result in leg weakness. As bacitracin methylene disalicylate androxarsone provided by No. 046573 in § 510.600(c) of thischapter | |
| ******* | |||
Dated: March 22, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-3122 Filed 3-30-06; 8:45 am]
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