Animal drugs, feeds, and related products: Bacitracin methylene disalicylate, etc.,

[Federal Register: August 22, 2000 (Volume 65, Number 163)]

[Rules and Regulations]

[Page 50914-50917]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr22au00-5]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate, Robenidine Hydrochloride, and Roxarsone

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) filedby Alpharma, Inc. The NADA provides for use of approved bacitracin methylene disalicylate (BMD), robenidine hydrochloride, and roxarsone Type A medicated articles to make three-way combination Type C medicated broiler chicken feeds used for prevention of coccidiosis; as an aid in the prevention and control of necrotic enteritis; and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

DATES: This rule is effective August 22, 2000.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filedNADA 141-155 that provides for use of BMD(10, 25, 30, 40, 50, 60, or 75 grams per pound (g/lb) BMD), ROBENZ(30 g/lb robenidine hydrochloride), and 3- NITRO(45.4, 90, 227, or 360 g/lb roxarsone) Type A medicated articles to make three-way combination Type C medicated feeds containing 30 g/ton robenidine hydrochloride, 22.7 to 45.4 g/ton roxarsone, and 50 or 100 to 200 g/ton BMD for use in broiler chickens.

The combination Type C medicated feeds containing 50 g/ton BMD are used for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. The combination Type C medicated feeds containing 100 to 200 g/ton BMD are used for prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. The NADA is approved as of July 3, 2000, and the regulations are amended in Secs. 558.76 and 558.515 (21 CFR 558.76 and 558.515) to reflect the approval. The basis of approval is discussed in the freedom of information summary.

Section 558.76 is also amended editorially to consolidate the cross-references for approved combinations in paragraph (d)(3) and list them in alphabetical order. Section 558.515 is amended editorially to display the conditions of use in paragraph (d) in a table format.

In accordance with the freedom of information provisions of 21 CFR part 20 and 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 Dockets Management Branch (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.

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 558--NEW 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. Section 558.76 is amended by revising paragraph (d)(3) to read as follows:

   [[Page 50915]]

   Sec. 558.76 Bacitracin methylene disalicylate.

   * * * * *

   (d) * * *

   (3) Bacitracin methylene disalicylate may also be used with:

   (i) Amprolium as in Sec. 558.55.

   (ii) Amprolium and ethopabate as in Sec. 558.58.

   (iii) Carbarsone (not USP) as in Sec. 558.120.

   (iv) Decoquinate alone and with roxarsone as in Sec. 558.195.

   (v) Fenbendazole as in Sec. 558.258.

   (vi) Halofuginone hydrobromide alone and with roxarsone as in Sec. 558.265.

   (vii) Hygromycin B as in Sec. 588.274.

   (viii) Ivermectin as in Sec. 558.300.

   (ix) Lasalocid sodium alone and with roxarsone as in Sec. 558.311.

   (x) Monensin alone and with roxarsone as in Sec. 588.355.

   (xi) Narasin alone and with roxarsone as in Sec. 558.363.

   (xii) Nicarbazin alone and with narasin and roxarsone as in Sec. 558.366.

   (xiii) Nitarsone as in Sec. 558.369.

   (xiv) Robenidine alone and with roxarsone as in Sec. 558.515.

   (xv) Salinomycin alone and with roxarsone as in Sec. 558.550.

   (xvi) Semduramicin alone and with roxarsone as in Sec. 558.555.

   (xvii) Zoalene alone and with arsanilic acid as in Sec. 558.680.

3. Section 558.515 is amended by revising paragraphs (c) and (d) to read as follows:

   Sec. 558.515 Robenidine hydrochloride.

   * * * * *

   (c) Related tolerances. See Sec. 556.580 of this chapter.

   (d) Conditions of use. It is used in feed for chickens as follows:

   Robenidine hydrochloride Combination Indications for Limitations Sponsor in grams/ton in grams/ton

   use

   30 (0.0033 pct)

   For broiler and Feed

   063238 fryer

   continuously chickens: As as sole an aid in the ration. Do prevention of not feed to coccidiosis layers. caused by E. Withdraw 5 mivati, E. days prior brunetti, E. to tenella, E. slaughter. acervulina, E. maxima, and E. necatrix. Bacitracin For broiler and Feed

   046573 (as

   fryer

   continuously bacitracin chickens: As as sole methylene an aid in the ration. Do disalicylate prevention of not feed to ) 4 to 30 coccidiosis laying caused by E. chickens. mivati, E. Withdraw 5 brunetti, E. days prior tenella, E. to acervulina, E. slaughter. maxima, and E. necatrix. For increased rate of weight gain. Bacitracin For broiler and Feed

   046573 (as

   fryer

   continuously bacitracin chickens: As as sole methylene an aid in the ration. Do disalicylate prevention of not feed to ) 27 to 50 coccidiosis laying caused by E. chickens. mivati, E. Withdraw 5 brunetti, E. days prior tenella, E. to acervulina, E. slaughter. maxima, and E. necatrix. For improved feed efficiency. Bacitracin For broiler Feed

   046573 (as

   chickens: As continuously bacitracin an aid in the as sole methylene prevention of ration. Use disalicylate coccidiosis as the sole ) 50 and caused by E. source of roxarsone mivati, E. organic 22.7 to 45.4 brunetti, E. arsenic; tenella, E. poultry acervulina, E. should have maxima, and E. access to necatrix. As water at all an aid in the times; drug prevention of overdose or necrotic

   lack of enteritis

   water intake caused or

   may result complicated by in leg Clostridium weakness or spp. or other paralysis. organisms

   Do not feed susceptible to to laying bacitracin. chickens. For increased Withdraw 5 rate of weight days prior gain, improved to feed

   slaughter. efficiency, and improved pigmentation.

   [[Page 50916]]

   Bacitracin For broiler To control 046573 (as

   chickens: As necrotic bacitracin an aid in the enteritis, methylene prevention of start disalicylate coccidiosis medication ) 100 to 200 caused by E. at first and

   mivati, E. clinical roxarsone brunetti, E. signs of 22.7 to 45.4 tenella, E. disease; acervulina, E. vary maxima, and E. bacitracin necatrix. As dosage based an aid in the on the control of severity of necrotic

   infection; enteritis

   administer caused or

   continuously complicated by for 5 to 7 Clostridium days or as spp. or other long as organisms

   clinical susceptible to signs bacitracin. persist, For increased then reduce rate of weight bacitracin gain, improved to feed

   prevention efficiency, level (50 g/ and improved ton). Use as pigmentation. the sole source of organic arsenic; poultry should have access to water at all times; drug overdose or lack of water intake may result in leg weakness or paralysis. Do not feed to laying chickens. Withdraw 5 days prior to slaughter. Bacitracin For broiler and Feed

   046573 (as

   fryer

   continuously 063238 bacitracin chickens: As as sole zinc) 4 to an aid in the ration. Do 30

   prevention of not feed to coccidiosis laying caused by E. chickens. mivati, E. Withdraw 5 brunetti, E. days prior tenella, E. to acervulina, E. slaughter. maxima, and E. necatrix. For increased rate of weight gain. Bacitracin For broiler and Feed

   046573 (as

   fryer

   continuously 063238 bacitracin chickens: As as sole zinc) 27 to an aid in the ration. Do 50

   prevention of not feed to coccidiosis laying caused by E. chickens. mivati, E. Withdraw 5 brunetti, E. days prior tenella, E. to acervulina, E. slaughter. maxima, and E. necatrix. For improved feed efficiency. Chlortetracyc For broiler and Feed line 100 to fryer

   continuously 200

   chickens: As as sole an aid in the ration up to prevention of 14 days. Do coccidiosis not feed to caused by E. chickens mivati, E. producing brunetti, E. eggs for tenella, E. human acervulina, E. consumption. maxima, and E. Withdraw 5 necatrix. For days prior control of to infectious slaughter. synovitis caused by Mycoplasma synoviae susceptible to chlortetracycl ine. Chlortetracyc For broiler and Feed line 200 to fryer

   continuously 400

   chickens: As as sole an aid in the ration up to prevention of 14 days. Do coccidiosis not feed to caused by E. chickens mivati, E. producing brunetti, E. eggs for tenella, E. human acervulina, E. consumption. maxima, and E. Withdraw 5 necatrix. For days prior control of to chronic

   slaughter. respiratory disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycl ine. Chlortetracyc For broiler and Feed

   063238 line 500 fryer

   continuously chickens: As as sole an aid in the ration up to prevention of 5 days. Do coccidiosis not feed to caused by E. chickens mivati, E. producing brunetti, E. eggs for tenella, E. human acervulina, E. consumption. maxima, and E. Withdraw 5 necatrix. As days prior an aid in the to reduction of slaughter. mortality due to E. coli susceptible to chlortetracycl ine.

   [[Page 50917]]

   Lincomycin 2 For broiler and Feed

   000009 fryer

   continuously chickens: As as the sole an aid in the ration. Do prevention of not feed to coccidiosis laying hens. caused by E. Withdraw 5 mivati, E. days before brunetti, E. slaughter. tenella, E. acervulina, E. maxima, and E. necatrix. For increase in rate of weight gain and improved feed efficiency. Oxytetracycli For broiler Feed

   000069 ne 400

   chickens: As continuously an aid in the for 7 to 14 prevention of days. Do not coccidiosis feed to caused by E. chickens mivati, E. producing brunetti, E. eggs for tenella, E. human acervulina, E. consumption. maxima, and E. Withdraw 5 necatrix. For days before control of CRD slaughter. and air sac infection caused by Mycoplasma gallisepticum and E. coli susceptible to oxytetracyclin e. Roxarsone For broiler and Feed

   046573 22.5 to 45.4 fryer

   continuously (0.005

   chickens: As as the sole percent) an aid in the ration. Use prevention of as sole coccidiosis source of caused by E. organic mivati, E. arsenic. Do brunetti, E. not feed to tenella, E. layers. acervulina, E. Withdraw 5 maxima, and E. days prior necatrix. For to increased rate slaughter. of weight gain.

   Dated: July 25, 2000. Stephen F. Sundlof, Director, Center for Veterinary Medicine.

   [FR Doc. 00-21412Filed8-21-00; 8:45 am]

   BILLING CODE 4160-01-F