[Federal Register: July 10, 2007 (Volume 72, Number 131)] [Rules and Regulations] [Page 37437-37439] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr10jy07-7] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use in Animal Feeds; Ivermectin 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 supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA revises the approved concentration of ivermectin in Type C medicated feed administered as a top dress to adult and breeding swine for the treatment and control of various internal and external parasites. DATES: This rule is effective July 10, 2007. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: joan.gotthardt@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, filed a supplement to NADA 140-974 that provides for use of IVOMEC (ivermectin) Premix for Swine, a Type A medicated article, for the treatment and control of various internal and external parasites. The supplement revises the approved concentration of ivermectin in Type C medicated feed administered as a top dress to adult and breeding swine. The supplemental NADA is approved as of June 15, 2007, and the regulations in 21 CFR 558.300 are amended to reflect the approval and a current format. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. FDA has determined under 21 CFR 25.33(a)(1) 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. 0 Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 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. Revise Sec. 558.300 to read as follows: Sec. 558.300 Ivermectin. (a) Specifications. Type A medicated article containing 2.72 grams ivermectin per pound (g/lb). (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter. (c) Related tolerances. See Sec. 556.344 of this chapter. (d) Special considerations. See Sec. 500.25 of this chapter. (e) Conditions of use in swine. It is used in feed as follows: ---------------------------------------------------------------------------------------------------------------- Ivermectin in g/ton Combination in g/ton of feed of feed Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (1) 1.8 (to provide .................... Weaned, growing-finishing swine: Feed as the only feed 050604 0.1 milligram per For treatment and control of for 7 consecutive days. kilogram (mg/kg) gastrointestinal roundworms Withdraw 5 days before of body weight per (Ascaris suum, adults and slaughter. day) fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth- stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). ---------------------------------------------------------------------------------------------------------------- (2) 1.8 (to provide Bacitracin methylene Weaned, growing-finishing swine: For use in swine feed 050604 0.1 mg/kg of body disalicylate, 10 to As in paragraph (e)(1) of this only. Feed as the only weight per day) 30 section; and for increased rate feed for 7 consecutive of weight gain and improved days. Withdraw 5 days feed efficiency. before slaughter. ---------------------------------------------------------------------------------------------------------------- [[Page 37438]] (3) 1.8 (to provide Bacitracin methylene Weaned, growing-finishing swine: For use in swine feed 050604 0.1 mg/kg of body disalicylate, 250 As in paragraph (e)(1) of this only. Feed as the only weight per day) section; and for control of feed for 7 consecutive swine dysentery associated with days. Withdraw 5 days Treponema hyodysenteriae on before slaughter. premises with a history of swine dysentery, but where symptoms have not yet occurred, or following an approved treatment of disease condition. ---------------------------------------------------------------------------------------------------------------- (4) 1.8 (to provide Lincomycin, 20 Weaned, growing-finishing swine: Feed as the only feed 050604 0.1 mg/kg of body For treatment and control of for 7 consecutive days. weight per day) gastrointestinal roundworms Not to be fed to swine (Ascaris suum, adults and that weigh more than fourth-stage larvae; Ascarops 250 lbs. Withdraw 5 strongylina, adults; days before slaughter. Hyostrongylus rubidus, adults Also see paragraphs and fourth-stage larvae; (c)(1) and (c)(2) in Oesophagostomum spp., adults Sec. 558.325 of this and fourth-stage larvae); chapter. kidneyworms (Stephanurus dentatus, adults and fourth- stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis); and for increased rate of weight gain. ---------------------------------------------------------------------------------------------------------------- (5) 1.8 (to provide Lincomycin, 40 Weaned, growing-finishing swine: Feed as the only feed 050604 0.1 mg/kg of body As in paragraph (e)(4) of this for 7 consecutive days. weight per day) section; and for control of Not to be fed to swine swine dysentery on premises that weigh more than with a history of swine 250 lbs. Also see dysentery, but where symptoms paragraphs (c)(1) and have not yet occurred. (c)(2) in Sec. 558.325 of this chapter. Withdraw 5 days before slaughter. A separate feed containing 40 g/ton lincomycin may be continued to complete the lincomycin treatment. ---------------------------------------------------------------------------------------------------------------- (6) 1.8 (to provide Lincomycin, 100 Weaned, growing-finishing swine: Feed as the only feed 050604 0.1 mg/kg of body As in paragraph (e)(4) of this for 7 consecutive days weight per day) section; and for treatment of followed by a separate swine dysentery. feed containing 100 g/ ton lincomycin for an additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 lbs. Also see paragraphs (c)(1) and (c)(2) in Sec. 558.325 of this chapter. ---------------------------------------------------------------------------------------------------------------- (7) 1.8 (to provide Lincomycin, 200 Weaned, growing-finishing swine: Feed as the only feed 050604 0.1 mg/kg of body As in paragraph (e)(4) of this for 7 consecutive days weight per day) section; and for reduction in followed by a separate severity of swine mycoplasmal feed containing 200 g/ pneumonia caused by Mycoplasma ton lincomycin for an hyopneumoniae. additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 lbs. Also see paragraphs (c)(1) and (c)(2) in Sec. 558.325 of this chapter. ---------------------------------------------------------------------------------------------------------------- (8) 1.8 to 11.8 (to .................... Adult and breeding swine: For Feed as the only feed 050604 provide 0.1 mg/kg treatment and control of for 7 consecutive days. of body weight per gastrointestinal roundworms Withdraw 5 days before day) (Ascaris suum, adults and slaughter. fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth- stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). ---------------------------------------------------------------------------------------------------------------- [[Page 37439]] (9) 1.8 to 11.8 (to Bacitracin methylene Pregnant sows: As in paragraph Feed as the only feed 050604 provide 0.1 mg/kg disalicylate, 250 (e)(8) of this section; and for for 7 consecutive days. of body weight per control of clostridial Withdraw 5 days before day) enteritis caused by Clostridium slaughter. Feed perfringens in suckling bacitracin methylene piglets. disalicylate Type C medicated feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. ---------------------------------------------------------------------------------------------------------------- (10) 18.2 to 120 .................... Adult and breeding swine: As in Top dress on daily 050604 (to provide 0.1 mg/ paragraph (e)(8) of this ration for individual kg of body weight section. treatment for 7 per day) consecutive days. Withdraw 5 days before slaughter. ---------------------------------------------------------------------------------------------------------------- Dated: June 27, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-13369 Filed 7-9-07; 8:45 am] BILLING CODE 4160-01-S
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