Certain other dosage form new animal drugs (21 CFR 529.40-529.2620)

376 21 CFR Ch. I (4–1–16 Edition) Pt. 528 days. Following any extended duration of therapy (infusion longer than twice at a 24-hour interval, up to 8 consecu tive days), animals must not be slaugh tered for 21 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [58 FR 58486, Nov. 2, 1993, as amended at 65 FR 61091, Oct. 16, 2000; 73 FR 811, Jan. 4, 2008; 79 FR 10973, Feb. 27, 2014] PART 528—NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANI MALS Sec. 528.1070 Bc6 recombinant deoxyribonucleic acid construct. 528.1092 opAFP–GHc2 recombinant deoxyribonucleic acid construct. 528.2010 Human lysosomal acid lipase re combinant deoxyribonucleic acid con struct. AUTHORITY: 21 U.S.C. 360b. SOURCE: 74 FR 6823, Feb. 11, 2009, unless otherwise noted. § 528.1070 Bc6 recombinant deoxyribonucleic acid construct. (a) Specifications and indications for use. Five copies of a human Bc6 recom binant deoxyribonucleic acid (rDNA) construct located at the GTC 155–92 site in a specific hemizygous diploid line of dairy breeds of domestic goats (Capra aegagrus hircus) directing the expression of the human gene for antithrombin (which is intended for the treatment of humans) in the mam mary gland of goats derived from lin eage progenitor 155–92. (b) Sponsor. See No. 086047 in § 510.600 of this chapter. (c) Limitations. Food or feed from GTC–155–92 goats is not permitted in the food or feed supply. [74 FR 6823, Feb. 11, 2009, as amended at 80 FR 34279, June 16, 2015] § 528.1092 opAFP–GHc2 recombinant deoxyribonucleic acid construct. (a) Specifications. A single copy of the a-form of the opAFP–GHc2 recombinant deoxyribonucleic acid (rDNA) con struct at the a-locus in the EO–1 a lin eage of triploid, hemizygous, all-female Atlantic salmon (Salmo salar). (b) Sponsor. See No. 086053 in § 510.600 of this chapter. (c) Indications for use. Significantly more of these Atlantic salmon grow to at least 100 grams within 2,700 Celsius degree-days than their comparators. (d) Limitations. These Atlantic salm on are produced as eyed-eggs and grown-out only in physically-con tained, freshwater culture facilities specified in an FDA-approved applica tion. [80 FR 73104, Nov. 24, 2015] § 528.2010 Human lysosomal acid lipase recombinant deoxyribonucleic acid construct. (a) Specifications. A single copy of a human lysosomal acid lipase (hLAL) recombinant deoxyribonucleic acid (rDNA) gene construct located at the SYN LAL–C site in chromosome 6 in a specific, diploid line (SBC LAL–C) of hemizygous and homozygous domestic chickens (Gallus gallus), derived from the lineage progenitor XLL 109. (b) Sponsor. See No. 069334 in § 510.600 of this chapter. (c) Conditions of use—(1) Intended use. The gene construct directs the expres sion of that encoding gene such that recombinant, human lysosomal acid lipase (rhLAL) protein intended for the treatment of human disease is present in SBC LAL–C chicken egg whites. (2) Limitations. Food or feed from XLL 109 chickens is not permitted in the food or feed supply. [81 FR 17608, Mar. 30, 2016] PART 529—CERTAIN OTHER DOS AGE FORM NEW ANIMAL DRUGS Sec. 529.40 Albuterol. 529.56 Amikacin. 529.382 Chloramine-T. 529.400 Chlorhexidine tablets and suspen sion. 529.536 Detomidine. 529.539 Dexmedetomidine. 529.778 Doxycycline. 529.1030 Formalin. 529.1044 Gentamicin in certain other dosage forms. 529.1044a Gentamicin solution for infusion. 529.1044b Gentamicin solution for dipping eggs. 529.1115 Halothane. 529.1150 Hydrogen peroxide. 529.1186 Isoflurane. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00386 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 377 Food and Drug Administration, HHS § 529.400 1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may Continued 529.1350 Meloxicam. 529.1660 Oxytetracycline. 529.1940 Progesterone intravaginal inserts. 529.2150 Sevoflurane. 529.2464 Ticarcillin. 529.2503 Tricaine methanesulfonate. 529.2620 Triptorelin. AUTHORITY: 21 U.S.C. 360b. SOURCE: 40 FR 13881, Mar. 27, 1975, unless otherwise noted. § 529.40 Albuterol. (a) Specifications. A net weight of 6.7 grams of formulated albuterol sulfate is supplied in a pressurized aluminum canister within an actuator system equipped with a detachable nasal deliv ery bulb. (b) Approvals. See No. 000010 in § 510.600(c) of this chapter for uses as in paragraph (d) of this section. (c) Conditions of use—(1) Amount. Each valve actuation (puff) of the de vice delivers 120 micrograms (mcg) of albuterol sulfate. One dose is three (3) puffs, totaling 360 mcg. (2) Indications for use. For the imme diate relief of bronchospasm and bronchoconstriction associated with reversible airway obstruction in horses. (3) Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed vet erinarian. [67 FR 7072, Feb. 15, 2002, as amended at 79 FR 10973, Feb. 27 , 2014] § 529.56 Amikacin. (a) Specifications. Each milliliter (mL) of solution contains 250 milli grams of amikacin as amikacin sulfate. (b) Sponsors. See Nos. 000859 and 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 2 grams (8 mL) di luted with 200 mL of sterile physio logical saline by intrauterine infusion daily for 3 consecutive days. (2) Indications for use. For treating genital tract infections (endometritis, metritis, and pyometra) in mares caused by susceptible organisms in cluding Escherichia coli, Pseudomonas spp., and Klebsiella spp. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [76 FR 17339, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, 2014] § 529.382 Chloramine-T. (a) Specifications. Chloramine-T tri hydrate powder for solution. (b) Sponsor. See No. 086009 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.118 of this chapter. (d) Conditions of use—(1) Freshwater reared salmonids—(i) Amount. 12 to 20 milligrams per liter (mg/L) water in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments. (ii) Indications for use. For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium spp. (2) Walleye—(i) Amount. 10 to 20 mg/L water in a continuous flow water sup ply or as a static bath once per day for 60 minutes on consecutive or alter native days for three treatments. (ii) Indications for use. For the control of mortality in walleye due to external columnaris disease associated with Flavobacterium columnare. (3) Freshwater-reared warmwater finfish—(i) Amount. 20 mg/L water in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments. (ii) Indications for use. For the control of mortality in freshwater-reared warmwater finfish due to external columnaris disease associated with F. columnare. [79 FR 37621, July 2, 2014] § 529.400 Chlorhexidine tablets and suspension. (a) Specification. Each tablet and each 28-milliliter syringe of suspension con tain 1 gram of chlorhexidine dihydrochloride.1 VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00387 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 378 21 CFR Ch. I (4–1–16 Edition) § 529.536 require bioequivalency and safety informa tion. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Place 1 or 2 tablets deep in each uter ine horn; or infuse a solution of 1 tab let disolved in an appropriate amount of clean boiled water; or infuse one sy ringe of suspension into the uterus. (2) Indications for use. For prevention or treatment of metritis and vaginitis in cows and mares when caused by pathogens sensitive to chlorhexidine dihydrochloride. (3) Limitations. Prior to administra tion, remove any unattached placental membranes, any excess uterine fluid or debris, and carefully clean external genitalia. Use a clean, sterile insemi nating pipette for administrating solu tions and suspensions. Treatment may be repeated in 48 to 72 hours. [43 FR 10705, Feb. 23, 1979, as amended at 79 FR 10973, Feb. 27, 2014] EDITORIAL NOTE: At 79 FR 10973, Feb. 27, 2014, § 529.400 was amended by revising the section heading, however, the section head ing was not provided, therefore, the amend ment could not be incorporated because of an inaccurate amendatory instruction. § 529.536 Detomidine. (a) Specifications. Each milliliter of gel contains 7.6 milligrams (mg) of detomidine hydrochloride. (b) Sponsor. See No. 052483 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 0.018 mg per pound (mg/lb) (0.040 mg/kilogram (kg) sublin gually. (2) Indications for use. For sedation and restraint. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consump tion. [75 FR 21163, Apr. 23, 2010, as amended at 76 FR 16533, Mar. 24, 2011] § 529.539 Dexmedetomidine. (a) Specifications. Each milliliter of gel contains 0.09 milligrams (mg) dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride). (b) Sponsor. See No. 052483 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Ad minister onto the oral mucosa between the dog’s cheek and gum at a dose of 125 micrograms per square meter. (2) Indications for use. For the treat ment of noise aversion in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [81 FR 17608, Mar. 30, 2016] § 529.778 Doxycycline. (a) Specifications. Doxycycline hyclate solution contains 8.5 percent doxycycline activity. A syringe of N methyl-2-pyrrolidone and poly (DL lactide) mixed with a syringe of doxycycline produces 0.5 milliliter of solution. (b) Sponsor. See 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Apply subgingivally to peri odontal pocket(s) of affected teeth. (2) Indications for use. For treatment and control of periodontal disease. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 10973, Feb. 27, 2014] § 529.1030 Formalin. (a) Specifications. Formalin is an aqueous solution containing approxi mately 37 percent by weight of form aldehyde gas, U.S.P. (b) Sponsors. See Nos. 049968, 050378, and 067188 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use. It is added to en vironmental water as follows: (1) Indications for use. (i) Penaeid shrimp. For control of external proto zoan parasites Bodo spp., Epistylis spp., and Zoothamnium spp. (ii) All finfish. For control of exter nal protozoa Ichthyophthirius spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp. (iii) All finfish eggs: For control of fungi of the family Saprolegniaceae. (2) Amount. The drug concentrations required are as follows: VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00388 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 379 Food and Drug Administration, HHS § 529.1044b (i) For control of external protozoan parasites on shrimp: Shrimp Concentration of formalin (microliters per liter) Tanks and race ways (up to 4 hours daily) Earthen ponds (single treatment) Penaeid Shrimp ... 50 to 100 1 ............ 25 2 1 Treat for up to 4 hours daily. Treatment may be repeated daily until parasite control is achieved. Use the lower con centration when the tanks and raceways are heavily loaded. 2 Single treatment. Treatment may be repeated in 5 to 10 days if needed. (ii) For control of external parasites on finfish: Aquatic species Administer in tanks and raceways for up to 1 hour (microliter/liter or part per million (μL/L or ppm)) Administer in earthen ponds in definitely (μL/L or ppm) Salmon and trout: Above 50 °F Up to 170 15 to 25 1 2 Below 50 °F Up to 250 15 to 25 1 2 All other finfish Up to 250 15 to 25 1 2 1 Use the lower concentration when ponds, tanks, or race ways are heavily loaded with phytoplankton or fish to avoid oxygen depletion due to the biological oxygen demand by decay of dead phytoplankton. Alternatively, a higher con centration may be used if dissolved oxygen is strictly mon itored. 2 Although the indicated concentrations are considered safe for cold and warm water finfish, a small number of each lot or pond to be treated should always be used to check for any unusual sensitivity to formalin before proceeding. (iii) For control of fungi of the fam ily Saprolegniaceae on finfish eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000 μL/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 μL/L (ppm) for 15 minutes. (3) Limitations. Fish tanks and race ways may be treated daily until para site control is achieved. Pond treat ment may be repeated in 5 to 10 days if needed. However, pond treatments for Ichthyophthirius should be made at 2 day intervals until control is achieved. Egg tanks may be treated as often as necessary to prevent growth of fungi. Do not use formalin which has been subjected to temperatures below 40 °F, or allowed to freeze. Do not treat ponds containing striped bass. Treatments in tanks should never exceed 1 hour even if fish show no signs of stress. Do not apply formalin to ponds with water warmer than 27 °C (80 °F), when a heavy bloom of phytoplankton is present, or when the concentration of dissolved oxygen is less than 5 milli grams per liter. [51 FR 11441, Apr. 3, 1986, as amended at 58 FR 59169, Nov. 8, 1993; 59 FR 60076, Nov. 22, 1994; 63 FR 38304, July 16, 1998; 68 FR 5563; Feb. 4, 2003; 72 FR 45158, Aug. 13, 2007; 76 FR 17339, Mar. 29, 2011; 79 FR 2786, Jan. 16, 2014] § 529.1044 Gentamicin in certain other dosage forms. § 529.1044a Gentamicin solution for in fusion. (a) Specifications. Each milliliter of solution contains 50 or 100 milligrams gentamicin sulfate. (b) Sponsors. See Nos. 000061, 000859, 054628, 054771, 057561, 058005, and 061623 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Infuse 2 to 2.5 grams per day for 3 to 5 days during estrus. (2) Indications for use. For control of bacterial infections of the uterus (me tritis) and as an aid in improving con ception in mares with uterine infec tions caused by bacteria sensitive to gentamicin. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [71 FR 51727, Aug. 31, 2006, as amended at 78 FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013; 79 FR 10973, Feb. 27, 2014] § 529.1044b Gentamicin solution for dipping eggs. (a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin base. (b) Sponsors. See Nos. 000061 and 054925 in § 510.600(c) of this chapter. (c) Conditions of use in turkeys—(1) Amount. The drug is added to clean water to provide a dip solution with a gentamicin concentration of 250 to 1,000 parts per million. A concentration of 500 parts per million is rec ommended. Clean eggs should be held submerged in the gentamicin solution under a vacuum of about 27.5 to 38 cen timeters of mercury for 5 minutes fol lowed by additional soaking in gentamicin solution for approximately 10 minutes at atmospheric pressure. Eggs can also be treated by warming them for 3 to 6 hours at approximately VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00389 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 380 21 CFR Ch. I (4–1–16 Edition) § 529.1115 100 °F then immediately submerging them in gentamicin solution main tained at about 40 °F, keeping the eggs submerged for 10 to 15 minutes. (2) Indications for use. As an aid in the reduction or elimination of the fol lowing microorganisms from turkey hatching eggs: Arizona hinshawii (paracolon), Salmonella Saintpaul, and Mycoplasma meleagridis. (3) Limitations. For use in the dipping treatment of turkey-hatching eggs only. Eggs which have been dipped in the drug shall not be used for food. [40 FR 13881, Mar. 27, 1975, as amended at 52 FR 7833, Mar. 13, 1987; 62 FR 22889, Apr. 28, 1997; 71 FR 13543, Mar. 16, 2006; 79 FR 10973, Feb. 27, 2014] § 529.1115 Halothane. (a) Specifications. The drug is a color less, odorless, nonflammable, nonexplo sive, heavy liquid containing 0.01 per cent thymol as a preservative. (b) Sponsor. See Nos. 012164 and 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Two to 5 percent of inhaled atmosphere for induction of anesthesia; 0.5 to 2 percent for maintenance of anesthesia. (2) Indications for use. For nonfood animals for the induction and mainte nance of anesthesia. (3) Limitations. Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [46 FR 27915, May 22, 1981, as amended at 62 FR 29014, May 29, 1997; 79 FR 10973, Feb. 27, 2014] § 529.1150 Hydrogen peroxide. (a) Specifications. Each milliliter of solution contains 396.1 milligrams (mg) hydrogen peroxide (a 35% w/w solu tion). (b) Sponsor. See No. 050378 in § 510.600(c) of this chapter. (c) Conditions of use in finfish—(1) Amount—(i) Freshwater-reared finfish eggs: 500 to 1,000 mg per liter (/L) of culture water for 15 minutes in a con tinuous flow system once per day on consecutive or alternate days until hatch for all coldwater and coolwater species of freshwater-reared finfish eggs or 750 to 1,000 mg/L for 15 minutes in a continuous flow system once per day on consecutive or alternate days until hatch for all warmwater species of freshwater-reared finfish eggs. (ii) Freshwater-reared salmonids: 100 mg/L for 30 minutes or 50 to 100 mg/L for 60 minutes once per day on alter nate days for three treatments in a continuous flow water supply or as a static bath. (iii) Coolwater species of freshwater reared finfish fingerlings and adults (except northern pike & paddlefish) and channel catfish fingerlings and adults: 50 to 75 mg/L for 60 minutes once per day on alternate days for three treat ments in continuous flow water supply or as a static bath. Coolwater species of freshwater-reared finfish fry (except northern pike, pallid sturgeon & paddlefish) and channel catfish fry: 50 mg/L for 60 minutes once per day on al ternate days for three treatments in continuous flow water supply or as a static bath. (2) Indications for use. For control of mortality in freshwater-reared finfish eggs due to saprolegniasis; for control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchiophilum; and for control of mor tality in freshwater-reared coolwater finfish and channel catfish due to ex ternal columnaris disease associated with Flavobacterium columnare (Flexibacter columnaris). (3) Limitations. Initial bioassay on a small number is recommended before treating the entire group. Eggs: Some strains of rainbow trout eggs are sen sitive to hydrogen peroxide treatment at a time during incubation concurrent with blastopore formation through clo sure, about 70 to 140 Daily Temperature Units, °C. Consider withholding treat ment or using an alternate therapeutant during that sensitive time to reduce egg mortalities due to drug toxicity. Finfish: Use with cau tion on walleye. Preharvest withdrawal time: zero days. [72 FR 5330, Feb. 6, 2007, as amended at 78 FR 73698, Dec. 9, 2013] § 529.1186 Isoflurane. (a) Specifications. The drug is a clear, colorless, stable liquid. (b) Sponsors. See Nos. 010019, 012164, 054771, 065085, and 066794 in § 510.600(c) of this chapter. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00390 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 381 Food and Drug Administration, HHS § 529.1940 (c) Conditions of use. Administer by inhalation: (1) Amount—(i) Horses: For induction of surgical anesthesia: 3 to 5 percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen). (ii) Dogs: For induction of surgical anesthesia: 2 to 2.5 percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen). (2) Indications for use. For induction and maintenance of general anesthesia in horses and dogs. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [51 FR 594, Jan. 7, 1986, as amended at 54 FR 23472, June 1, 1989; 58 FR 17346, Apr. 2, 1993; 59 FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, 1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, May 1, 1998; 66 FR 17510, Apr. 2, 2001; 71 FR 43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009; 76 FR 16533, Mar. 24, 2011; 78 FR 14669, Mar. 7, 2013; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, Apr. 8, 2015] § 529.1350 Meloxicam. (a) Specifications. Each milliliter of solution contains 5 milligrams (mg) meloxicam. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 0.1 mg per kilo gram of body weight once daily using the metered dose pump. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [77 FR 76863, Dec. 31, 2012, as amended at 80 FR 18776, Apr. 8, 2015] § 529.1660 Oxytetracycline. (a) Specifications—(1) Each gram of powder contains 366 milligrams (mg) oxytetracycline hydrochloride. (2) Each gram of powder contains 753 mg oxytetracycline hydrochloride. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use of products described in paragraph (a) of this section as in paragraph (d) of this section. (1) Nos. 054771 and 061623 for use of product in paragraph (a)(1) of this sec tion. (2) Nos. 048164, 054771, and 061623 for use of product described in paragraph (a)(2) of this section. (c) Related tolerances. See § 556.500 of this chapter. (d) Conditions of use in finfish—(1) Amount. Immerse fish in a solution containing 200 to 700 mg oxytetra cycline hydrochloride (buffered) per liter of water for 2 to 6 hours. (2) Indications for use. For skeletal marking of finfish fry and fingerlings. [69 FR 6557, Feb. 11, 2004, as amended at 69 FR 61999, Oct. 22, 2004; 70 FR 41140, July 18, 2005; 72 FR 26289, May 9, 2007; 76 FR 17026, Mar. 28, 2011; 79 FR 10973, Feb. 27, 2014] § 529.1940 Progesterone intravaginal inserts. (a) Specifications. Each insert con tains: (1) 1.38 grams (g) progesterone in molded silicone over a nylon spine. (2) 0.3 g progesterone in molded sili cone over a flexible nylon spine. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of the product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section; and the product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section. (c) Related tolerances. See § 556.540 of this chapter. (d) Special considerations. Product la beling shall bear the following warn ing: ‘‘Avoid contact with skin by wear ing protective gloves when handling in serts. Store removed inserts in a seal able container until they can be dis posed of in accordance with applicable local, state, and Federal regulations.’’ (e) Conditions of use—(1) Cows—(i) Amount. Administer one intravaginal insert per animal for 7 days. When used for indications listed in paragraph (e)(1)(ii)(A) of this section, administer 25 mg dinoprost as a single intramuscular injection 1 day prior to insert removal (Day 6). When used for indications listed in paragraph (e)(1)(ii)(B) of this section, administer 25 mg dinoprost as a single VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00391 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 382 21 CFR Ch. I (4–1–16 Edition) § 529.2150 intramuscular injection on the day of insert removal (Day 7). (ii) Indications for use—(A) For syn chronization of estrus in suckled beef cows and replacement beef and dairy heifers; for advancement of first postpartum estrus in suckled beef cows; and for advancement of first pu bertal estrus in replacement beef heif ers. (B) For synchronization of estrus in lactating dairy cows. (C) For synchronization of the return to estrus in lactating dairy cows in seminated at the immediately pre ceding estrus. (D) For induction of estrous cycles in anestrous lactating dairy cows. (iii) Limitations. Do not use in beef or dairy heifers of insufficient size or age for breeding or in animals with abnor mal, immature, or infected genital tracts. Do not use in beef cows that are fewer than 20 days postpartum. Do not use an insert more than once. To pre vent the potential transmission of ve nereal and bloodborne diseases, the in serts should be disposed after a single use. Administration of vaginal inserts for periods greater than 7 days may re sult in reduced fertility. Dinoprost in jection for use in paragraphs (e)(1)(ii)(A) and (e)(1)(ii)(B) of this sec tion as in § 522.690 of this chapter, pro vided by No. 054771 in § 510.600(c) of this chapter. (2) Ewes—(i) Amount. Administer one intravaginal insert per animal for 5 days. (ii) Indications for use. For induction of estrus in ewes (sheep) during sea sonal anestrus. (iii) Limitations. Do not use in ani mals with abnormal, immature, or in fected genital tracts; or in ewes that have never lambed. Do not use an in sert more than once. To prevent the potential transmission of venereal and bloodborne diseases, the inserts should be disposed after a single use. [74 FR 59074, Nov. 17, 2009, as amended at 75 FR 63085, Oct. 14, 2010; 79 FR 10965, 10974, Feb. 27, 2014; 79 FR 44278, July 31, 2014] § 529.2150 Sevoflurane. (a) Specifications. Sevoflurane liquid. (b) Sponsors. See Nos. 012164, 054771, and 066794 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. For induction of surgical anesthesia: up to 7 percent sevoflurane. For maintenance of surgical anesthesia: 3.7 to 4 percent sevoflurane with oxygen in the absence of premedication and 3.3 to 3.6 percent in the presence of premedication. (2) Indications for use. For induction and maintenance of general anesthesia in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [64 FR 71640, Dec. 22, 1999, as amended at 73 FR 25508, May 7, 2008; 74 FR 10484, Mar. 11, 2009, 75 FR 1021, Jan. 8, 2010; 76 FR 16533, Mar. 24, 2011; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, Apr. 8, 2015] § 529.2464 Ticarcillin. (a) Specifications. Each vial contains ticarcillin disodium powder equivalent to 6 grams of ticarcillin for reconstitu tion with 25 milliliters of sterile water for injection or sterile physiological saline. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 6 grams daily by intrauterine infusion for 3 consecutive days during estrus. (2) Indications for use. For the treat ment of endometritis caused by beta hemolytic streptococci. (3) Limitations. Do not use in horses intended for human consumption. Fed eral law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 10974, Feb. 27, 2014] § 529.2503 Tricaine methanesulfonate. (a) Specifications. The drug is ethyl-m amino-benzoate methanesulfonate. (b) Sponsor. See Nos. 050378 and 051212 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. It is used as follows: (i) Fish. The drug is added to ambient water at a concentration of from 15 to 330 milligrams per liter depending upon the degree of anesthetization or seda tion desired, the species and size of the fish, and the temperature and softness of the water. Preliminary tests of solu tions must be made with small num bers of fish to determine the desired rates of sedation or anesthesia and the VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00392 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 383 Food and Drug Administration, HHS § 530.1 appropriate exposure times for the spe cific lots of fish under prevailing condi tions. (ii) Amphibians and other aquatic cold blooded animals. The drug is added to ambient water in concentrations of from 1:1000 to 1:20,000 depending upon species and stage of development. (2) Indications for use. For the tem porary immobilization of fish, amphib ians, and other aquatic coldblooded animals (poikilotherms) as an aid in handling during manual spawning (fish stripping), weighing, measuring, mark ing, surgical operations, transport, photography, and research. (3) Limitations. Do not use within 21 days of harvesting fish for food. Use in fish intended for food should be re stricted to Ictaluridae, Salmonidae, Esocidae, and Percidae, and water tem perature exceeding 10 °C (50 °F). In other fish and in coldblooded animals, the drug should be limited to hatchery or laboratory use. [79 FR 10974, Feb. 27, 2014] § 529.2620 Triptorelin. (a) Specifications. Each milliliter of gel contains 100 micrograms (mcg) triptorelin as triptorelin acetate. (b) Sponsor. See No. 051233 in § 510.600(c) of this chapter. (c) Conditions of use in swine—(1) Amount. Administer 200 mcg intravaginally approximately 96 hours after weaning. (2) Indications for use. For the syn chronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination. (3) Limitations. Not approved for use in gilts. Safety and effectiveness have not been evaluated in these animals. Should not be used in sows with obvi ous reproductive tract abnormalities. [77 FR 64717, Oct. 23, 2012] PART 530—EXTRALABEL DRUG USE IN ANIMALS Subpart A—General Provisions Sec. 530.1 Scope. 530.2 Purpose. 530.3 Definitions. 530.4 Advertising and promotion. 530.5 Veterinary records. Subpart B—Rules and Provisions for Extralabel Uses of Drugs in Animals 530.10 Provision permitting extralabel use of animal drugs. 530.11 Limitations. 530.12 Labeling. 530.13 Extralabel use from compounding of approved new animal and approved human drugs. Subpart C—Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals 530.20 Conditions for permitted extralabel animal and human drug use in food-pro ducing animals. 530.21 Prohibitions for food-producing ani mals. 530.22 Safe levels and analytical methods for food-producing animals. 530.23 Procedure for setting and announcing safe levels. 530.24 Procedure for announcing analytical methods for drug residue quantification. 530.25 Orders prohibiting extralabel uses for drugs in food-producing animals. Subpart D—Extralabel Use of Human and Animal Drugs in Animals Not Intended for Human Consumption 530.30 Extralabel drug use in nonfood ani mals. Subpart E—Safe Levels for Extralabel Use of Drugs in Animals and Drugs Prohibited From Extralabel Use in Animals 530.40 Safe levels and availability of analyt ical methods. 530.41 Drugs prohibited for extralabel use in animals. AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 379e. SOURCE: 61 FR 57743, Nov. 7, 1996, unless otherwise noted. Subpart A—General Provisions § 530.1 Scope. This part applies to the extralabel use in an animal of any approved new animal drug or approved new human drug by or on the lawful order of a li censed veterinarian within the context of a valid veterinary-client-patient re lationship. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00393 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B