-
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 InfoFOR 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 InformationSUPPLEMENTARY 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 044-759 FLAVOMYCIN (bambermycins) Type A medicated article NADA 095-543 AMPROL HI-E / FLAVOMYCIN NADA 095-547 AMPROL HI-E / FLAVOMYCIN / 3-NITRO NADA 095-548 AMPROL / 3-NITRO / FLAVOMYCIN NADA 095-549 AMPROL PLUS / 3-NITRO / FLAVOMYCIN NADA 098-340 FLAVOMYCIN / MONENSIN NADA 098-341 FLAVOMYCIN / 3-NITRO / COBAN NADA 101-628 FLAVOMYCIN / 3-NITRO / ZOALENE NADA 101-629 FLAVOMYCIN / ZOALENE NADA 130-185 FLAVOMYCIN / AMPROLIUM NADA 130-661 FLAVOMYCIN / CARB-O-SEP NADA 130-951 STENOROL (halofuginone hydrobromide) Start Printed Page 27955 NADA 137-483 FLAVOMYCIN / STENOROL NADA 139-473 STENOROL / STAFAC NADA 140-339 FLAVOMYCIN / NICARB NADA 140-340 STENOROL / LINCOMIX NADA 140-533 STENOROL / 3-NITRO / BMD NADA 140-584 STENOROL / BMD NADA 140-824 STENOROL Type A medicated article NADA 140-843 MONTEBAN / FLAVOMYCIN / 3-NITRO NADA 140-845 FLAVOMYCIN / MONTEBAN NADA 140-918 STENOROL / FLAVOMYCIN NADA 140-919 STENOROL / BMD NADA 141-034 GAINPRO (bambermycins) Type A medicated article NADA 141-129 AVATEC / FLAVOMYCIN ANADA 200-075 SACOX (salinomycin sodium) Type A medicated article ANADA 200-080 SACOX / 3-NITRO / FLAVOMYCIN ANADA 200-081 SACOX / 3-NITRO / BMD ANADA 200-082 SACOX / BMD ANADA 200-083 SACOX / FLAVOMYCIN ANADA 200-086 SACOX / ALBAC / 3-NITRO ANADA 200-089 SACOX / BACIFERM ANADA 200-090 SACOX / LINCOMIX / 3-NITRO ANADA 200-091 SACOX / 3-NITRO / AUREOMYCIN ANADA 200-092 SACOX / STAFAC ANADA 200-093 SACOX / LINCOMIX ANADA 200-094 SACOX / STAFAC / 3-NITRO ANADA 200-095 SACOX / AUREOMYCIN ANADA 200-096 SACOX / TERRAMYCIN ANADA 200-097 SACOX / 3-NITRO ANADA 200-143 SACOX / 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 SubjectsList of Subjects
21 CFR Part 510
- Administrative practice and procedure
- Animal drugs
- Labeling
- Reporting and recordkeeping requirements
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 parts 510 and 558 are amended as follows:
End Amendment Part Start PartPART 510—NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment Part Start Amendment Part2. 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 PartNames, addresses, and drug labeler codes of sponsors of approved applications.* * * * *(c) * * *
(1) * * *
Firm name and address Drug labeler code * * * * * Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria 016592 * * * * * (2) * * *
Start PartDrug labeler code Firm name and address * * * * * 016592 Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria * * * * * PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
End Part Start Amendment Part3. The authority citation for 21 CFR part 558 continues to read as follows:
End Amendment Part[Amended]4. Amend § 558.55 as follows:
End Amendment Part Start Amendment Parta. 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 Partb. 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 Partc. In the table in paragraph (d)(2)(iii), in the “Limitations” column and “Sponsor” column in the entry for Start Printed Page 27956“Bambermycins 1 to 4”, remove “057926” and add in its place “016592”.
End Amendment Part Start Amendment Part5. Amend § 558.58 as follows:
End Amendment Part Start Amendment Parta. Revise paragraph (a);
End Amendment Part Start Amendment Partb. Redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e);
End Amendment Part Start Amendment Partc. Add new paragraph (b);
End Amendment Part Start Amendment Partd. 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 Parte. 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 Partf. 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 PartThe 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 ton Combination in grams per ton Indications for use Limitations Sponsor (i) Amprolium 113.5 (0.0125%) and ethopabate 3.6 (0.0004%). * * * * * * Bambermycins, 1 to 3; plus roxarsone, 22.8 to 34.1 Broiler 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 * * * * * * * * * * * *6. Amend § 558.95 as follows:
End Amendment Part Start Amendment Parta. In paragraphs (a)(1), (a)(2), and (a)(5), remove “057926” and add in its place “016592”;
End Amendment Part Start Amendment Partb. Remove and reserve paragraph (d)(1)(ii);
End Amendment Part Start Amendment Partc. Remove paragraphs (d)(1)(iii) through (d)(1)(xiv) and paragraphs (d)(3)(iii) and (d)(3)(iv); and
End Amendment Part Start Amendment Partd. Revise paragraph (d)(5).
End Amendment PartThe 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 Part7. In § 558.120, add paragraph (d)(1)(iv) and remove paragraph (d)(2)(iii) to read as follows:
End Amendment PartCarbarsone (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 Part8. 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 PartHalofuginone 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 Part9. Amend § 558.311 as follows:
End Amendment Part Start Amendment Parta. 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 Partb. 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 Partc. Remove and reserve paragraph (e)(5)(ii).
End Amendment PartThe addition reads as follows:
Lasalocid.* * * * *(e) * * *
(1) * * *
Start Printed Page 27957Lasalocid in grams per ton Combination in grams per ton Indications for use Limitations Sponsor * * * * * * * (ii) 68 (0.0075 pct) to 113 (0.0125 pct). * * * * * * * * * * * * Bambermycins 1 to 2 Broiler 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 Part10. In § 558.355, in paragraphs (b)(10), (f)(2)(v)( b), and (f)(2)(vi)(b), remove “057926” and add in its place “016592”; and revise paragraphs (f)(1)(vi), (f)(1)(vii), and (f)(1)(xvii) to read as follows:
End Amendment PartMonensin.* * * * *(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 Part11. Amend § 558.363 as follows:
End Amendment Part Start Amendment Parta. In paragraphs (a)(4), (a)(5), and (d)(1)(vii)(B), remove “057926” and add in its place “016592”;
End Amendment Part Start Amendment Partb. In paragraph (d)(1)(iv)(B) add a new sentence at the end of the paragraph; and
End Amendment Part Start Amendment Partc. Remove paragraph (d)(1)(xii).
End Amendment PartThe 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 Part12. 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 PartNicarbazin.* * * * *(d) * * *
Start Amendment PartNicarbazin in grams per ton Combination in grams per ton Indications for use Limitations Sponsor * * * * * * * 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 2 Broiler 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 2 Broiler 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 * * * * * * * 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 PartOxytetracycline.* * * * *(d) * * *
(3) * * *
(v) Salinomycin as in § 558.550.
Start Amendment Part14. In § 558.550, in paragraphs (d)(1)(xv)( c) and (d)(1)(xvi)(c), remove “057926” and add in its place “016592”; add paragraphs (d)(1)(xxiii) and (d)(1)(xxiv); and revise paragraphs (b)(2) and (d)(4) to read as follows:
End Amendment PartSalinomycin.* * * * *(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 Part15. 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 PartZoalene.* * * * *(d) * * *
(1) * * *
Start Printed Page 27959Zoalene in grams per ton Combination in grams per ton Indications for use Limitations (ii) 113.5 (0.0125%). * * * * * * * Bacitracin 100 to 500 * * * * * Bambermycins 1 Broiler 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 22.7 Broiler 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 SignatureDated: May 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 06-4505 Filed 5-12-06; 8:45 am]
BILLING CODE 4160-01-S
Document Information
- Effective Date:
- 5/15/2006
- Published:
- 05/15/2006
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule; technical amendment.
- Document Number:
- 06-4505
- Dates:
- This rule is effective May 15, 2006.
- Pages:
- 27954-27959 (6 pages)
- PDF File:
- 06-4505.pdf
- CFR: (13)
- 21 CFR 510.600
- 21 CFR 558.55
- 21 CFR 558.58
- 21 CFR 558.95
- 21 CFR 558.120
- More ...