Skip to Content

Rule

New Animal Drugs; Change of Sponsor

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 25 approved new animal drug applications (NADAs) and 16 approved abbreviated new animal drug applications (ANADAs) for Type A medicated articles and feed use combinations from Intervet, Inc., to Huvepharma AD.

DATES:

This rule is effective May 15, 2006.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: david.newkirk@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Intervet, Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 25 approved NADAs and 16 approved ANADAs for Type A medicated articles and feed use combinations to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria:

Application No.Trade Name(s)
NADA 044-759FLAVOMYCIN (bambermycins) Type A medicated article
NADA 095-543AMPROL HI-E / FLAVOMYCIN
NADA 095-547AMPROL HI-E / FLAVOMYCIN / 3-NITRO
NADA 095-548AMPROL / 3-NITRO / FLAVOMYCIN
NADA 095-549AMPROL PLUS / 3-NITRO / FLAVOMYCIN
NADA 098-340FLAVOMYCIN / MONENSIN
NADA 098-341FLAVOMYCIN / 3-NITRO / COBAN
NADA 101-628FLAVOMYCIN / 3-NITRO / ZOALENE
NADA 101-629FLAVOMYCIN / ZOALENE
NADA 130-185FLAVOMYCIN / AMPROLIUM
NADA 130-661FLAVOMYCIN / CARB-O-SEP
NADA 130-951STENOROL (halofuginone hydrobromide)
Start Printed Page 27955
NADA 137-483FLAVOMYCIN / STENOROL
NADA 139-473STENOROL / STAFAC
NADA 140-339FLAVOMYCIN / NICARB
NADA 140-340STENOROL / LINCOMIX
NADA 140-533STENOROL / 3-NITRO / BMD
NADA 140-584STENOROL / BMD
NADA 140-824STENOROL Type A medicated article
NADA 140-843MONTEBAN / FLAVOMYCIN / 3-NITRO
NADA 140-845FLAVOMYCIN / MONTEBAN
NADA 140-918STENOROL / FLAVOMYCIN
NADA 140-919STENOROL / BMD
NADA 141-034GAINPRO (bambermycins) Type A medicated article
NADA 141-129AVATEC / FLAVOMYCIN
ANADA 200-075SACOX (salinomycin sodium) Type A medicated article
ANADA 200-080SACOX / 3-NITRO / FLAVOMYCIN
ANADA 200-081SACOX / 3-NITRO / BMD
ANADA 200-082SACOX / BMD
ANADA 200-083SACOX / FLAVOMYCIN
ANADA 200-086SACOX / ALBAC / 3-NITRO
ANADA 200-089SACOX / BACIFERM
ANADA 200-090SACOX / LINCOMIX / 3-NITRO
ANADA 200-091SACOX / 3-NITRO / AUREOMYCIN
ANADA 200-092SACOX / STAFAC
ANADA 200-093SACOX / LINCOMIX
ANADA 200-094SACOX / STAFAC / 3-NITRO
ANADA 200-095SACOX / AUREOMYCIN
ANADA 200-096SACOX / TERRAMYCIN
ANADA 200-097SACOX / 3-NITRO
ANADA 200-143SACOX / 3-NITRO / BACIFERM

Accordingly, the agency is amending the regulations in 21 CFR 558.55, 558.58, 558.95, 558.120, 558.265, 558.311, 558.355, 558.363, 558.366, 558.450, 558.550, and 558.680 to reflect the transfer of ownership and a current format.

In addition, Huvepharma AD has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c) is being amended to add entries for the firm.

Also, FDA has found that the April 1, 2005, edition of Title 21, parts 500 to 599 of the Code of Federal Regulations (CFR) does not accurately reflect the use limitations for amprolium in single-ingredient, medicated broiler chicken feeds. The existing entry erroneously includes limitations normally associated with the use of arsenicals in feed. At this time, the regulations are being amended in § 558.55 to correct this error. FDA is also taking this opportunity to consolidate entries for similar combination medicated feeds in the same section of part 558, and to eliminate duplicate entries. These actions are being taken to improve the accuracy and readability of the regulations.

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 Subjects

List of Subjects

End List of Subjects Start Amendment Part

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,

End Amendment Part Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority Start Amendment Part

2. In § 510.600, in the table in paragraph (c)(1) alphabetically add an entry for “Huvepharma AD”; and in the table in paragraph (c)(2) numerically add an entry for “016592” to read as follows:

End Amendment Part
Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria016592
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
016592Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria
*    *    *    *    *
Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

3. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b, 371.

End Authority
[Amended]
Start Amendment Part

4. Amend § 558.55 as follows:

End Amendment Part Start Amendment Part

a. In the table in paragraph (d)(2)(ii), in the “Limitations” column in the entry for “Amprolium 72.6 to 113.5 grams per ton”, remove the first sentence;

End Amendment Part Start Amendment Part

b. In the table in paragraph (d)(2)(iii), in the “Limitations” column in the entry for “Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1 (0.0025% to 0.00375%)”, remove “057926” and add in its place “016592”; and in the “Sponsor” column add “016592” and

End Amendment Part Start Amendment Part

c. In the table in paragraph (d)(2)(iii), in the “Limitations” column and “Sponsor” column in the entry for

End Amendment Part Start Amendment Part

5. Amend § 558.58 as follows:

End Amendment Part Start Amendment Part

a. Revise paragraph (a);

End Amendment Part Start Amendment Part

b. Redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e);

End Amendment Part Start Amendment Part

c. Add new paragraph (b);

End Amendment Part Start Amendment Part

d. In the table in newly redesignated paragraph (e)(1)(i), add an entry for “Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1”;

End Amendment Part Start Amendment Part

e. In the table in newly redesignated paragraph (e)(1)(ii), in the “Limitations” column in the entries for “Bambermycins 2 to 3 plus roxarsone 22.8 to 34.1”, remove “057926” and add in its place “016592”; and in the “Sponsor” column add “016592”; and

End Amendment Part Start Amendment Part

f. In the table in newly redesignated paragraph (e)(1)(iii), in the “Limitations” column in the entries for “Bambermycins 1 to 3” and “Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1”, remove “057926” and add in its place “016592”; and in the “Sponsor” column add “016592”.

End Amendment Part

The revisions and additions read as follows:

Amprolium and ethopabate.

(a) Specifications. Type A medicated articles containing:

(1) 25 percent amprolium and 8 percent ethopabate or 5 percent amprolium and 1.6 percent ethopabate;

(2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent amprolium and 0.16 percent ethopabate.

(b) Approvals. See No. 050604 in § 510.600(c) of this chapter.

* * * * *

(e) * * *

(1) * * *

Amprolium and ethopabate in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) Amprolium 113.5 (0.0125%) and ethopabate 3.6 (0.0004%).*      *   *       *         *  *  
Bambermycins, 1 to 3; plus roxarsone, 22.8 to 34.1Broiler chickens: As an aid in the prevention of coccidiosis; and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.Feed continuously as the sole ration; as sole source of amprolium and organic arsenic; withdraw 5 d before slaughter; roxarsone provided by No. 046573, bambermycins by No. 016592 in § 510.600(c) of this chapter.016592
*         *         *         *         *         *         *
* * * * *
Start Amendment Part

6. Amend § 558.95 as follows:

End Amendment Part Start Amendment Part

a. In paragraphs (a)(1), (a)(2), and (a)(5), remove “057926” and add in its place “016592”;

End Amendment Part Start Amendment Part

b. Remove and reserve paragraph (d)(1)(ii);

End Amendment Part Start Amendment Part

c. Remove paragraphs (d)(1)(iii) through (d)(1)(xiv) and paragraphs (d)(3)(iii) and (d)(3)(iv); and

End Amendment Part Start Amendment Part

d. Revise paragraph (d)(5).

End Amendment Part

The revision reads as follows:

Bambermycins.
* * * * *

(d) * * *

(5) Bambermycins may also be used in combination with:

(i) Amprolium alone or with roxarsone as in § 558.55.

(ii) Amprolium and ethopabate alone or with roxarsone as in § 558.58.

(iii) Diclazuril as in § 558.198.

(iv) Halofuginone as in § 558.265.

(v) Lasalocid alone or with roxarsone as in § 558.311.

(vi) Monensin alone or with roxarsone as in § 558.355.

(vii) Narasin alone or with nicarbazin or roxarsone as in § 558.363.

(viii) Nicarbazin as in § 558.366.

(ix) Salinomycin alone or with roxarsone as in § 558.550.

(x) Zoalene alone or with roxarsone as in § 558.680.

Start Amendment Part

7. In § 558.120, add paragraph (d)(1)(iv) and remove paragraph (d)(2)(iii) to read as follows:

End Amendment Part
Carbarsone (not U.S.P.).
* * * * *

(d) * * *

(1) * * *

(iv) Grams per ton. 227 carbarsone, plus 1 or 4 grams per ton bambermycins.

(a) Indications for use. As an aid in the prevention of blackhead; and for increased rate of weight gain (4 grams per ton bambermycins) or improved feed efficiency (1 gram per ton bambermycins).

(b) Limitations. Feed continuously 2 weeks before blackhead is expected and continue as long as prevention is needed. Withdraw 5 days before slaughter. As sole source of organic arsenic. Bambermycins provided by No. 046573 in § 510.600(c) of this chapter.

* * * * *
Start Amendment Part

8. In § 558.265, revise paragraph (a); redesignate paragraphs (b) and (c) as paragraphs (c) and (d); and add new paragraph (b) to read as follows:

End Amendment Part
Halofuginone hydrobromide.

(a) Specifications. Type A medicated articles containing 6 grams of halofuginone hydrobromide per kilogram.

(b) Approvals. See No. 016592 in § 510.600(c) of this chapter.

* * * * *
Start Amendment Part

9. Amend § 558.311 as follows:

End Amendment Part Start Amendment Part

a. In the table in paragraph (e)(1)(ii) in the entry in the “Combination in grams per ton” column for “Roxarsone 45.4 plus bambermycins 1”, in the “Limitations” column remove “012799” and add in its place “016592”;

End Amendment Part Start Amendment Part

b. In the table in paragraph (e)(1)(ii) following the entry in the “Combination in grams per ton” column for “Roxarsone 45.4 plus bambermycins 1”, add an entry for “Bambermycins 1 to 2”; and

End Amendment Part Start Amendment Part

c. Remove and reserve paragraph (e)(5)(ii).

End Amendment Part

The addition reads as follows:

Lasalocid.
* * * * *

(e) * * *

(1) * * *

Start Printed Page 27957
Lasalocid in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(ii) 68 (0.0075 pct) to 113 (0.0125 pct).   *      *   *       *       *
*         *         *         *         *         *         *
Bambermycins 1 to 2Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter.016592
*         *         *         *         *         *         *
* * * * *
Start Amendment Part

10. In § 558.355, in paragraphs (b)(10), (f)(2)(v)(

End Amendment Part
Monensin.
* * * * *

(f) * * *

(1) * * *

(vi) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins, 1 to 2 grams.

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; and as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Feed continuously as sole ration; do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter.

(vii) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins, 1 gram; plus roxarsone, 22.7 to 45.4 grams

(a) Indications for use. For increased rate of weight gain and improved feed efficiency; and as an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Feed continuously as sole ration; use as sole source of organic arsenic; withdraw 5 d before slaughter; do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter; roxarsone provided by No. 046573.

* * * * *

(xvii) Amount per ton. Bambermycins, 1 to 2 grams plus monensin, 90 to 110 grams plus roxarsone, 22.7 to 45.4 grams.

(a) Indications for use. For increased rate of weight gain; and as an aid in prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

(b) Limitations. Feed continuously as sole ration; use as sole source of organic arsenic; withdraw 5 d before slaughter; do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter; roxarsone provided by No. 046573.

* * * * *
Start Amendment Part

11. Amend § 558.363 as follows:

End Amendment Part Start Amendment Part

a. In paragraphs (a)(4), (a)(5), and (d)(1)(vii)(B), remove “057926” and add in its place “016592”;

End Amendment Part Start Amendment Part

b. In paragraph (d)(1)(iv)(B) add a new sentence at the end of the paragraph; and

End Amendment Part Start Amendment Part

c. Remove paragraph (d)(1)(xii).

End Amendment Part

The addition reads as follows:

Narasin.
* * * * *

(d) * * *

(1) * * *

(iv) * * *

(B) * * * Narasin as provided by No. 000986; bambermycins by No. 016592 in § 510.600(c) of this chapter.

* * * * *
Start Amendment Part

12. In the table in paragraph (d) of § 558.366, alphabetically add new entries for “Narasin 27 to 45, and bambermycins 1 to 2” and “Bambermycins 1 to 2” to read as follows:

End Amendment Part
Nicarbazin.
* * * * *

(d) * * *

Nicarbazin in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
Narasin 27 to 45, and bacitracin methylene disalicylate 50, and roxarsone 22.7 to 45.4   *       *     *       *  *  
Start Printed Page 27958
Narasin 27 to 45, and bambermycins 1 to 2Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; and 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 coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Bambermycins provided by No. 016592; nicarbazin and narasin by No. 066104 in § 510.600(c) of this chapter..000986
*         *         *         *         *         *         *
113.5 (0.0125 pct)*      *   *       *     *       *  *  
Bacitracin zinc 4 to 50   *        *     *       *  *  
Bambermycins 1 to 2Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter.016592
*         *         *         *         *         *         *
Start Amendment Part

13. In the table in paragraph (d)(1)(vii) of § 558.450, remove the entry for “Salinomycin 40 to 60 g/ton”; and add paragraph (d)(3)(v) to read as follows:

End Amendment Part
Oxytetracycline.
* * * * *

(d) * * *

(3) * * *

(v) Salinomycin as in § 558.550.

Start Amendment Part

14. In § 558.550, in paragraphs (d)(1)(xv)(

End Amendment Part
Salinomycin.
* * * * *

(b) * * *

(2) No. 016592 for use as in paragraphs (d)(1)(i), (d)(1)(iii) through (d)(1)(xvi), (d)(1)(xxiii) and (d)(1)(xxiv), (d)(2)(i), (d)(3)(i), and (d)(4) of this section.

* * * * *

(d) * * *

(1) * * *

(xxiii) Amount per ton. Salinomycin, 40 to 60 grams; plus bambermycins, 1 to 3 grams.

(a) Indications for use. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for improved feed efficiency.

(b) Limitations. Feed continuously as sole ration. Do not feed to laying chickens; not approved for use with pellet binders; may be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided by Nos. 046573 and 016592; bambermycins by No. 016592 in § 510.600(c) of this chapter.

(xxiv) Amount per ton. Salinomycin, 40 to 60 grams; plus bambermycins, 1 to 2 grams; plus roxarsone, 45.4 grams.

(a) Indications for use. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.

(b) Limitations. Feed continuously as sole ration. Do not feed to laying chickens; as sole source or organic arsenic; withdraw 5 days before slaughter; not approved for use with pellet binders; may be fatal if accidentally fed to adult turkeys or horses; Salinomycin as provided by Nos. 046573and 016592; bambermycins by No. 016592; roxarsone by No. 046573 in § 510.600(c) of this chapter.

* * * * *

(4) Chickens: It is used in chicken feed as follows:

(i) Amount per ton. Salinomycin, 40 to 60 grams; plus oxytetracycline, 500 grams.

(a) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for reduction of mortality due to air sacculitis (air-sac-infection) caused by Escherichia coli susceptible to oxytetracycline.

(b) Limitations. Feed continuously for 5 days; do not feed to chickens producing eggs for human consumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter. Salinomycin as provided by Nos. 046573 and 016592; oxytetracycline as provided by No. 066104 in § 510.600(c) of this chapter.

(ii) [Reserved]

Start Amendment Part

15. In § 558.680, alphabetically add two entries to the table in paragraph (d)(1)(ii); and revise paragraph (d)(2) to read as follows:

End Amendment Part
Zoalene.
* * * * *

(d) * * *

(1) * * *

Start Printed Page 27959
Zoalene in grams per tonCombination in grams per tonIndications for useLimitations
(ii) 113.5 (0.0125%).*      *    *       *  *      *      *
Bacitracin 100 to 500*       *      *   *      *    
Bambermycins 1Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Do not feed to chickens over 14 weeks of age. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.
Bambermycins 1 plus roxarsone 22.7Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency.Feed continuously as sole ration. Do not feed to chickens over 14 weeks of age; feed as sole source of organic arsenic; withdraw 5 days before slaughter. Bambermycins as provided by No. 016592, roxarsone by No. 046573 in § 510.600(c) of this chapter.
*         *         *         *         *         *         *

(2) Zoalene may also be used in combination with roxarsone as in § 558.530.

Start Signature

Dated: May 3, 2006.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. 06-4505 Filed 5-12-06; 8:45 am]

BILLING CODE 4160-01-S