[Federal Register: July 21, 2005 (Volume 70, Number 139)] [Rules and Regulations] [Page 41958-41963] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr21jy05-13] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Roxarsone; Semduramycin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is correcting the single-ingredient roxarsone Type A medicated article that may be used to formulate three-way, combination drug Type C medicated broiler chicken feeds containing semduramicin, virginiamycin, and roxarsone under a new animal drug application (NADA) recently approved for Phibro Animal Health. FDA is also amending the animal drug regulations to reflect two roxarsone Type A medicated articles [[Page 41959]] approved under separate new animal drug applications (NADAs) for different conditions of use. This action is being taken to improve the accuracy of the agency's regulations. DATES: This rule is effective July 21, 2005. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: ghaibel@cvm.fda.gov. SUPPLEMENTARY INFORMATION: FDA has found that the list of approved, single-ingredient Type A medicated articles used to formulate three- way, combination drug Type C medicated broiler chicken feeds containing semduramicin, virginiamycin, and roxarsone under NADA 141-226 is in error. The Federal Register document that described approval of that application for Phibro Animal Health on February 23, 2004 (69 FR 13221, March 22, 2004), listed 3-NITRO (roxarsone) Type A Medicated article as the source of roxarsone; however, the correct source for this combination feed is ROXARSONE (roxarsone) Type A Medicated article, approved under NADA 92-953. At this time, FDA is amending the regulations in 21 CFR 558.555 to reflect the roxarsone Type A medicated article approved for this combination and a current tabular format. In addition, FDA has found that the April 1, 2004, edition of parts 500 to 599 (21 CFR parts 500 to 599) of Title 21 of the Code of Federal Regulations (CFR) does not accurately reflect the approved conditions of use for roxarsone Type A medicated articles. Roxarsone is approved as single-ingredient Type A medicated articles under two separate applications, NADA 7-891 for 3-NITRO and NADA 92-953 for ROXARSONE, held by Alpharma, Inc. In error, portions of the regulation describing approvals had been consolidated in July 2000 (65 FR 45711, July 25, 2000). At this time, FDA is amending the regulations in Sec. 558.530 to reflect two separate approvals for roxarsone Type A medicated articles with different approved conditions of use and a current tabular format. Also, FDA has found that the approved conditions of use codified for NADA 92-953 prior to the July 2000 change were in error. A specific technical amendment to remove turkeys as an approved species (49 FR 30927, August 2, 1984) was reversed in a subsequent change that implemented revised terminology for feed premixes (51 FR 7400, March 3, 1986). At this time, FDA is amending the regulations in Sec. 558.530 to reflect approval of NADA 92-953 for chickens only. 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 558 Animal drugs, Animal feeds. 0 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 0 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. 0 2. Section 558.530 is amended by revising paragraphs (a) through (d)(3); removing paragraph (d)(4); and by redesignating paragraph (d)(5) as paragraph (d)(4) to read as follows: Sec. 558.530 Roxarsone. (a) Specifications. Type A medicated articles containing 10, 20, 50, or 80 percent roxarsone. (b) Approvals. See sponsors in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 046573 for use of 10, 20, and 50 percent Type A medicated articles as in paragraph (d)(1)(i) of this section. (2) No. 046573 for use of 10, 20, 50, and 80 percent Type A medicated articles as in paragraphs (d)(1) through (d)(3) of this section. (c) Related tolerances. See Sec. 556.60 of this chapter. (d) Conditions of use--(1) Chickens. It is used in chicken feed as follows: ------------------------------------------------------------------------ Roxarsone in Combinations grams per in grams per Indications Limitations Sponsor ton ton for use ------------------------------------------------------------------------ (i) 22.7 to .............. Growing Feed 046573 45.4 chickens: continuously For throughout increased growing rate of period; do weight gain, not feed to improved chickens feed producing efficiency, eggs for and improved human pigmentation consumption; . withdraw 5 days before slaughter; as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. ------------------------------------------------------------------------ (ii) 22.7 to Chlortetracycl Growing As in ........... 45.4 ine 10 to 50 chickens: As paragraph in paragraph (d)(1)(i) of (d)(1)(i) of this section. this Chlortetracyc section. line as provided by No. 046573 in Sec. 510.600(c) of this chapter. ------------------------------------------------------------------------ (iii) 22.7 Chlortetracycl Growing As in ........... to 45.4 ine 100 to chickens: As paragraph 200 in paragraph (d)(1)(i) of (d)(1)(i) of this section this except feed section; and continuously for control for 7 to 14 of days. infectious Chlortetracyc synovitis line as caused by provided by Mycoplasma No. 046573 in synoviae Sec. susceptible 510.600(c) of to this chapter. chlortetracy cline. ------------------------------------------------------------------------ [[Page 41960]] (iv) 22.7 to Chlortetracycl Growing As in ........... 45.4 ine 200 to chickens: As paragraph 400 in paragraph (d)(1)(i) of (d)(1)(i) of this section this except feed section; and continuously for control for 7 to 14 of chronic days. respiratory Chlortetracyc disease line as (CRD) and provided by air sac No. 046573 in infection Sec. caused by M. 510.600(c) of gallisepticu this chapter. m and Escherichia coli susceptible to chlortetracy cline. ------------------------------------------------------------------------ (v) 22.7 to Chlortetracycl Growing As in ........... 45.4 ine 500 chickens: As paragraph in paragraph (d)(1)(i) of (d)(1)(i) of this section this except feed section; and continuously for for 5 days. reduction of Chlortetracyc mortality line as due to E. provided by coli No. 046573 in infections Sec. susceptible 510.600(c) of to this chapter. chlortetracy cline. ------------------------------------------------------------------------ (2) Turkeys. It is used in turkey feed as follows: ------------------------------------------------------------------------ Roxarsone in Combinations grams per in grams per Indications Limitations Sponsor ton ton for use ------------------------------------------------------------------------ (i) 22.7 to .............. Growing Feed 046573 45.4 turkeys: For continuously increased throughout rate of growing weight gain, period; do improved not feed to feed turkeys efficiency, producing and improved eggs for pigmentation human . consumption; withdraw 5 days before slaughter; as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. ------------------------------------------------------------------------ (ii) 22.7 to Chlortetracycl Growing As in ........... 45.4 ine 10 to 50 turkeys: As paragraph in paragraph (d)(2)(i) of (d)(2)(i) of this section. this Chlortetracyc section. line as provided by No. 046573 in Sec. 510.600(c) of this chapter. ------------------------------------------------------------------------ (iii) 22.7 Chlortetracycl Growing As in ........... to 45.4 ine 200 turkeys: As paragraph in paragraph (d)(2)(i) of (d)(2)(i) of this section this except feed section; and continuously for control for 7 to 14 of days. infectious Chlortetracyc synovitis line as caused by provided by Mycoplasma No. 046573 in synoviae Sec. susceptible 510.600(c) of to this chapter. chlortetracy cline. ------------------------------------------------------------------------ (iv) 22.7 to Chlortetracycl 1. Growing As in ........... 45.4 ine 400 turkeys: As paragraph in paragraph (d)(2)(i) of (d)(2)(i) of this section this except feed section; and continuously for control for 7 to 14 of days. hexamitiasis Chlortetracyc caused by line as Hexamita provided by meleagrides No. 046573 in susceptible Sec. to 510.600(c) of chlortetracy this chapter. cline. 2. Turkey poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracy cline. ------------------------------------------------------------------------ (v) 22.7 to Chlortetracycl Growing As in ........... 45.4 ine 25 mg/lb turkeys: As paragraph body weight in paragraph (d)(2)(i) of daily (d)(2)(i) of this section this except feed section; and continuously for control for 7 to 14 of days. complicating Chlortetracyc bacterial line as organisms provided by associated No. 046573 in with Sec. bluecomb 510.600(c) of (transmissib this chapter. le enteritis, coronaviral enteritis) susceptible to chlortetracy cline. ------------------------------------------------------------------------ (3) Swine. It is used in swine feed as follows: [[Page 41961]] ------------------------------------------------------------------------ Roxarsone in Combinations grams per in grams per Indications Limitations Sponsor ton ton for use ------------------------------------------------------------------------ (i) 22.7 to .............. Growing and Feed 046573 34.1 finishing continuously swine: For throughout increased growing rate of period; weight gain withdraw 5 and improved days before feed slaughter; as efficiency. sole source of organic arsenic. ------------------------------------------------------------------------ (ii) 22.7 to Chlortetracycl Growing and Feed for not ........... 34.1 ine 400 (to finishing more than 14 administer 10 swine: As in days; mg/lb body paragraph withdraw 5 weight) (d)(3)(i) of days before this slaughter; as section; and sole source for of organic treatment of arsenic. bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracy cline. ------------------------------------------------------------------------ (iii) 181.5 .............. Growing and Feed for not 046573 finishing more than 6 swine: For consecutive the days; if treatment of improvement swine is not dysentery. observed, consult a veterinarian; withdraw 5 days before slaughter; as a sole source of organic arsenic; animals must consume enough medicated feed to provide a therapeutic dose. ------------------------------------------------------------------------ (iv) 181.5 Chlortetracycl Growing and Feed for not ........... ine 10 to 50 finishing more than 6 swine: As in consecutive paragraph days; if (d)(3)(i) of improvement this is not section; and observed, for consult a treatment of veterinarian; swine withdraw 5 dysentery. days before slaughter; as a sole source of organic arsenic; animals must consume enough medicated feed to provide a therapeutic dose. ------------------------------------------------------------------------ (v) 181.5 Chlortetracycl Growing and Feed for not ........... ine 400 (to finishing more than 6 administer 10 swine: As in consecutive mg/lb body paragraph days; if weight) (d)(3)(iii) improvement of this is not section; and observed, for consult a treatment of veterinarian; bacterial withdraw 5 enteritis days before caused by E. slaughter; as coli and S. a sole source choleraesuis of organic and arsenic; bacterial animals must pneumonia consume caused by P. enough multocida medicated susceptible feed to to provide a chlortetracy therapeutic cline. dose. ------------------------------------------------------------------------ * * * * * 0 3. Section 558.555 is amended by revising paragraph (d) to read as follows: Sec. 558.555 Semduramicin. * * * * * (d) Conditions of use in chickens. It is used in chicken feed as follows: ------------------------------------------------------------------------ Semduramicin Combinations in grams per in grams per Indications Limitations Sponsor ton ton for use ------------------------------------------------------------------------ (1) 22.7 (25 ............. Broiler Do not feed to 066104 ppm) chickens: laying hens. For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/ E. mitis, E. necatrix, and E. tenella. ------------------------------------------------------------------------ (2) 22.7 Bacitracin Broiler Feed 066104 methylene chickens: continuously disalicylate As in as sole 10 to 50 paragraph ration. Do (d)(1) of not feed to this laying hens. section; Bacitracin for methylene improved disalicylate feed as provided efficiency. by No. 046573 in Sec. 510.600(c) of this chapter. ------------------------------------------------------------------------ [[Page 41962]] (3) 22.7 Bacitracin Broiler Feed 066104 methylene chickens: continuously disalicylate As in as sole 10 to 50 paragraph ration. Use plus (d)(4) of feed within 2 roxarsone this weeks of 45.4 section; production. for Do not feed improved to laying feed hens. Use as efficiency. sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. Withdraw 5 days before slaughter. Bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in Sec. 510.600(c) of this chapter. ------------------------------------------------------------------------ (4) 22.7 Roxarsone Broiler Feed 066104 45.4 chickens: continuously For the as sole prevention ration. For of broiler coccidiosis chickens caused by only. Do not Eimeria feed to acervulina, laying hens. E. Use as sole brunetti, source of E. maxima, organic E. mivati/ arsenic. E. mitis, Withdraw 5 E. days before necatrix, slaughter. and E. Roxarsone as tenella, provided by including No. 046573 in some field Sec. strains of 510.600(c) of E. tenella this chapter. that are more susceptible to semduramici n combined with roxarsone than semduramici n alone. ------------------------------------------------------------------------ (5) 22.7 Virginiamycin Broiler Feed 066104 5 chickens: continuously As in as sole paragraph ration. Do (d)(1) of not feed to this laying hens. section; Virginiamycin for as provided increased by No. 066104 rate of in Sec. weight gain 510.600(c) of and this chapter. improved feed efficiency. ------------------------------------------------------------------------ (6) 22.7 Virginiamycin Broiler Feed 066104 5 to 15 chickens: continuously As in as sole paragraph ration. Do (d)(1) of not feed to this laying hens. section; Virginiamycin for as provided increased by No. 066104 rate of in Sec. weight 510.600(c) of gain. this chapter. ------------------------------------------------------------------------ (7) 22.7 Virginiamycin Broiler Feed 066104 20 chickens: continuously As in as sole paragraph ration. Do (d)(1) of not feed to this laying hens. section; Virginiamycin for as provided prevention by No. 066104 of necrotic in Sec. enteritis 510.600(c) of caused by this chapter. Clostridium perfringens susceptible to virginiamyc in. ------------------------------------------------------------------------ (8) 22.7 Virginiamycin Broiler Feed 066104 20 plus chickens: continuously roxarsone As in as sole 22.7 to 45.4 paragraph ration (d)(1) of throughout this growing section; period. Do for not feed to prevention laying hens. of necrotic Use as sole enteritis source of caused by organic Clostridium arsenic. perfringens Poultry susceptible should have to access to virginiamyc drinking in; for water at all increased times. Drug rate of overdose or weight gain lack of water and may result in improved leg weakness. feed Roxarsone as efficiency; in Sec. and for 558.530(b)(1) improved of this pigmentatio chapter n. provided by No. 046573 in Sec. 510.600(c) of this chapter; semduramicin and virginiamycin as provided by No. 066104. ------------------------------------------------------------------------ [[Page 41963]] Dated: April 25, 2005. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation. [FR Doc. 05-14329 Filed 7-20-05; 8:45 am] BILLING CODE 4160-01-S