Intramammary dosage form new animal drugs (21 CFR 526.88-526.1810)

370 21 CFR Ch. I (4–1–16 Edition) § 524.2620 (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [71 FR 13542, Mar. 16, 2006, as amended at 73 FR 79318, Dec. 29, 2008. Redesignated and amended at 75 FR 10168, Mar. 5, 2010; 77 FR 60302, Oct. 3, 2012] § 524.2620 Liquid crystalline trypsin, Peru balsam, castor oil. (a) Specifications—(1) Each gram of liquid or aerosol contains 0.12 milli gram of crystalline trypsin, 87.0 milli grams of Peru balsam, and 788.0 milli grams of castor oil. (2) Each gram of liquid or aerosol contains 0.1 milligram of crystalline trypsin, 72.5 milligrams of Peru bal sam, and 800 milligrams of castor oil. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) in this section: (1) No. 051079 for use of product de scribed in paragraph (a)(1). (2) No. 017135 for use of product de scribed in paragraph (a)(2). (c) Conditions of use—(1) Amount. Apply directly to the wound site. (2) Indications for use. As an aid in the treatment of external wounds and as sists healing by facilitating the re moval of necrotic tissue, exudate, and organic debris. [79 FR 10973, Feb. 27, 2014] PART 526—INTRAMAMMARY DOS AGE FORM NEW ANIMAL DRUGS Sec. 526.88 Amoxicillin trihydrate for intramammary infusion. 526.313 Ceftiofur. 526.363 Cephapirin benzathine. 526.365 Cephapirin sodium. 526.464 Cloxacillin intramammary dosage forms. 526.464a Cloxacillin benzathine. 526.464b Cloxacillin benzathine for intramammary infusion, sterile. 526.464c Cloxacillin sodium for intramammary infusion, sterile. 526.820 Erythromycin. 526.1130 Hetacillin infusion. 526.1590 Novobiocin infusion. 526.1696 Penicillin intramammary dosage forms. 526.1696a Penicillin G procaine. 526.1696b Penicillin G procaine-dihydro streptomycin in soybean oil for intramammary infusion (dry cows). 526.1696c Penicillin G procaine-dihydro streptomycin sulfate for intramammary infusion (dry cows). 526.1696d Penicillin G procaine-novobiocin for intramammary infusion. 526.1810 Pirlimycin. AUTHORITY: 21 U.S.C. 360b. § 526.88 Amoxicillin trihydrate for intramammary infusion. (a) Specifications. Each single dose sy ringe contains amoxicillin trihydrate equivalent to 62.5 milligrams of amoxicillin. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of this chapter. (d) Conditions of use—Lactating cows— (1) Amount. One syringe (equivalent to 62.5 milligrams amoxicillin) per quar ter. (2) Indications for use. For the treat ment of subclinical infectious bovine mastitis due to Streptococcus agalactiae and Straphylococcus aureus (penicillin sensitive). (3) Limitations. Administer after milking. Clean and disinfect the teat. Use one syringe per infected quarter every 12 hours for a maximum of 3 doses. Do not use milk taken from treated animals for food purposes with in 60 hours (5 milkings) after last treat ment. Do not slaughter treated ani mals for food purposes within 12 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37334, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, 2003] § 526.313 Ceftiofur. (a) Specifications. Each single-use, 10 milliliter syringe of ceftiofur hydro chloride suspension contains 125 milli grams (mg) or 500 mg ceftiofur equiva lents. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.113 of this chapter. (d) Conditions of use in cattle—(1) Lac tating cows—(i) Amount. Infuse 125 mg per affected quarter. Repeat treatment in 24 hours. Once daily treatment may be repeated for up to 8 consecutive days. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00380 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 371 Food and Drug Administration, HHS § 526.365 (ii) Indications for use. For use in lac tating dairy cattle: (A) For the treatment of clinical mastitis associated with coagulase negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli; and (B) For the treatment of diagnosed subclinical mastitis associated with coagulase-negative staphylococci and S. dysgalactiae. (iii) Limitations. Milk taken from cows during treatment (a maximum of eight daily infusions) and for 72 hours after the last treatment must not be used for human consumption. Fol lowing label use for up to 8 consecutive days, a 2-day preslaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law pro hibits extra-label use of this drug in lactating dairy cattle for disease pre vention purposes; at unapproved doses; frequencies, durations, or routes of ad ministration; and in unapproved major food producing species/production classes. (2) Dry cows—(i) Amount. Infuse 500 mg per affected quarter at the time of dry off. (ii) Indications for use. For the treat ment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Strepto coccus dysgalactiae, and Streptococcus uberis. (iii) Limitations. Milk taken from cows completing a 30-day dry-off period may be used for food with no milk dis card due to ceftiofur residues. Fol lowing intramammary infusion, a 16 day preslaughter withdrawal period is required for treated cows. Following label use, no preslaughter withdrawal period is required for neonatal calves from treated cows regardless of colos trum consumption. Federal law re stricts this drug to use by or on the order of a licensed veterinarian. Fed eral law prohibits extra-label use of this drug in dry dairy cattle for disease prevention purposes; at unapproved doses; frequencies, durations, or routes of administration; and in unapproved major food producing species/produc tion classes. [70 FR 9516, Feb. 28, 2005, as amended at 70 FR 20048, Apr. 18, 2005. Redesignated and amended at 71 FR 39545, July 13, 2006; 79 FR 10973, Feb. 27, 2013; 79 FR 18159, Apr. 1, 2014; 80 FR 34279, June 16, 2015] § 526.363 Cephapirin benzathine. (a) Specifications. Each 10 milliliter disposable syringe contains 300 milli grams of cephapirin activity (as cephapirin benzathine) in a peanut-oil gel. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.115 of this chapter. (d) Conditions of use—(1) Amount. In fuse the contents of one syringe into each quarter. (2) Indications for use. Use in dry cows for treatment of mastitis caused by susceptible strains of Streptococcus agalactiae and Staphylococcus aureus, including penicillin-resistant strains. (3) Limitations. Infuse each quarter following last milking, but no later than 30 days before calving. Milk from treated cows must not be used for food during the first 72 hours after calving. Animals infused with this product must not be slaughtered for food until 42 days after the latest infusion. For use in dry cows only. [43 FR 37174, Aug. 22, 1978, as amended at 53 FR 27851, July 25, 1988; 73 FR 12262, Mar. 7, 2008; 75 FR 10168, Mar. 5, 2010; 76 FR 17338, Mar. 29, 2011] § 526.365 Cephapirin sodium. (a) Specifications. Each 10-milliliter dose contains 200 milligrams of cephapirin sodium activity in a peanut oil gel. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.115 of this chapter. (d) Conditions of use in lactating cows—(1) Amount. Infuse one dose into each infected quarter immediately after the quarter has been completely milked out. Do not milk out for 12 hours. Repeat once only in 12 hours. (2) Indications for use. For the treat ment of mastitis in lactating cows caused by susceptible strains of Strepto coccus agalactiae and Staphylococcus VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00381 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 372 21 CFR Ch. I (4–1–16 Edition) § 526.464 aureus including strains resistant to penicillin. (3) Limitations. If improvement is not noted within 48 hours after treatment, consult your veterinarian. Milk that has been taken from animals during treatment and for 96 hours after the last treatment must not be used for food. Treated animals must not be slaughtered for food until 4 days after the last treatment. [40 FR 57455, Dec. 10, 1975, as amended at 53 FR 27852, July 25, 1988. Redesignated at 63 FR 8349, Feb. 19, 1998; 65 FR 20733, Apr. 18, 2000; 73 FR 3181, Jan. 17, 2008; 75 FR 10168, Mar. 5, 2010] § 526.464 Cloxacillin intramammary dosage forms. § 526.464a Cloxacillin benzathine. (a) Specifications. Each dose contains cloxacillin benzathine equivalent to 500 milligrams of cloxacillin. (b) Related tolerances. See § 556.165 of this chapter. (c) Sponsor. See No. 000010 in § 510.600(c) of this chapter for use in dairy cows. (1) Amount. Administer aseptically into each quarter immediately after last milking. (2) Indications for use. For the treat ment of mastitis caused by Staphy lococcus aureus and Streptococcus agalactiae including penicillin resistant strains in dairy cows during the dry pe riod. (3) Limitations. For use in dry cows only. Not to be used within 30 days of calving. Animals infused with this product must not be slaughtered for food use for 30 days after the latest in fusion. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37334, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 75 FR 10168, Mar. 5, 2010; 75 FR 71017, Nov. 22, 2010; 79 FR 10973, Feb. 27, 2014] § 526.464b Cloxacillin benzathine for intramammary infusion, sterile. (a) Specifications. Each 6 milliliter dose contains cloxacillin benzathine equivalent to 500 milligrams of cloxacillin. (b) Related tolerances. See § 556.165 of this chapter. (c) Sponsor. See No. 055529 in § 510.600(c) of this chapter. (1) Amount. 6 milliliters per infected quarter aseptically immediately after last milking at the time of drying-off of the cow. (2) Indications for use. Treatment of mastitis caused by Staphylococcus aureus and Streptococus agalactiae in dairy cows at the time of drying-off of the cow. (3) Limitations. For use in dry cows only. Not to be used within 30 days of calving. Milk taken from treated cows prior to 72 hours (6 milkings) after calving must not be used for human food. Animals infused with this product must not be slaughtered for food from the time of infusion until 72 hours after calving. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (1) Amount. One dose per infected quarter immediately after last milk ing. (2) Indications for use. Treatment and prophylaxis of bovine mastitis in non lactating cows due to Streptococcus agalactiae and Staphylococcus aureus. (3) Limitations. For use in dry cows only. Not to be used within 4 weeks (28 days) of calving. Animals infused with this product must not be slaughtered for food use for 4 weeks (28 days) after the latest infusion. Federal law re stricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37334, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 60 FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, 2003] § 526.464c Cloxacillin sodium for intramammary infusion, sterile. (a) Specifications. Each milliliter con tains cloxacillin sodium equivalent to 20.0 milligrams of cloxacillin. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.165 of this chapter. (d) Conditions of use. Lactating cows— (1) Amount. 10 milliliters (one dose of 200 milligrams) per infected quarter. (2) Indications for use. Treatment of mastitis in lactating cows due to Strep tococcus agalactiae and Staphylococcus VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00382 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 373 Food and Drug Administration, HHS § 526.1590 aureus, nonpenicillinase-producing strains. (3) Limitations. Administer after milking, cleaning, and disinfecting, and as early as possible after detection. Treatment should be repeated at 12 hour intervals for a total of three doses. Milk taken from treated animals within 48 hours (four milkings) after the latest treatment should not be used for food. Treated animals should not be slaughtered for food within 10 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37335, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, 2003] § 526.820 Erythromycin. (a) Specifications. (1) Each 6-milliliter, single-dose, disposable syringe con tains 300 milligrams of erythromycin (as the base), 0.45 milligram of butylated hydroxyanisole, and 0.45 mil ligram of butylated hydroxytoluene. (2) Each 12-milliliter, single-dose, dis posable syringe contains 600 milligrams of erythromycin (as the base), 0.90 mil ligram of butylated hydroxyanisole, and 0.90 milligram of butylated hy droxytoluene. (3) The vehicle is triglyceride of satu rated fatty acids from coconut oil. (4) The drug may or may not be ster ile. (b) Sponsor. See Nos. 054771 and 061623 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. (i) Lactating cows: After milking, clean ing, and disinfecting, infuse contents of a single 6-milliliter syringe into each infected quarter; repeat procedure at 12-hour intervals for a maximum of 3 consecutive infusions. (ii) Dry cows: After milking, clean ing, and disinfecting, infuse contents of a single 12-milliliter syringe into each infected quarter at the time of drying off. (2) Indications for use. Treatment of mastitis due to Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis in lactating or dry cows. (3) Limitations. Milk taken from ani mals during treatment and for 36 hours (3 milkings) after the latest treatment must not be used for food. [47 FR 15772, Apr. 13, 1982, as amended at 66 FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 79 FR 10973, Feb. 27, 2014] § 526.1130 Hetacillin infusion. (a) Specifications. Each 10 milliliter syringe contains hetacillin potassium equivalent of 62.5 milligrams of ampi cillin. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use. Lactating cows— (1) Amount. 10 milliliters of hetacillin potassium equivalent to 62.5 milli grams ampicillin into each infected quarter. Repeat at 24-hour intervals until a maximum of three treatments has been given. (2) Indications for use. Treating acute, chronic, or subclinical bovine mastitis in lactating cows caused by susceptible strains of Streptococcus agalactiae, Streptococcus dysgalactiae, Staphy lococcus aureus, and Escherichia coli. (3) Limitations. Milk that has been taken from animals during treatment and for 72 hours (6 milkings) after the latest treatment must not be used for food. Treated animals must not be slaughtered for food until 10 days after the latest treatment. Federal law re stricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37335, Aug. 18, 1992, as amended at 75 FR 10168, Mar. 5, 2010] § 526.1590 Novobiocin infusion. (a)(1) Specifications. Each 10 milli liters of oil suspension contains the equivalent of 400 milligrams of novobiocin (present as sodium novobiocin). (2) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (3) Related tolerances. See § 556.460 of this chapter. (4) Conditions of use—(i) Amount. Ten milliliters (equivalent to 400 milli grams of novobiocin) infused in each quarter. (ii) Indications for use. It is used in dry cows for the treatment of mastitis caused by susceptible strains of Staphy lococcus aureus and Streptococcus agalactiae. (iii) Limitations. Infuse each quarter at the time of drying off, but not less VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00383 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 374 21 CFR Ch. I (4–1–16 Edition) § 526.1696 than 30 days prior to calving. Do not slaughter treated animals for food use for 30 days following udder infusion. For udder installation for the treat ment of mastitis in dry cows only. (b)(1) Specifications. Each 10 milli liters of oil suspension contains the equivalent of 150 milligrams of novobiocin (present as sodium novobiocin). (2) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (3) Related tolerances. See § 556.460 of this chapter. (4) Conditions of use—(i) Amount. In fuse 10 milliliters (equivalent to 150 milligrams of novobiocin) in each quar ter after milking. Repeat treatment once after 24 hours. (ii) Indications for use. Use in lac tating cows for treatment of mastitis caused by susceptible strains of Staphy lococcus aureus. (iii) Limitations. Do not milk for at least 6 hours after treatment; after wards, milk at regular intervals. Milk taken from treated animals within 72 hours (6 milkings) after latest treat ment must not be used for food. Do not slaughter treated animals for food for 15 days following latest treatment. If redness, swelling, or abnormal milk persists or increases after treatment, discontinue use and consult a veteri narian. For udder instillation in lac tating cattle only. Federal law re stricts this drug to use by or on the order of a licensed veterinarian. [43 FR 10554, Mar. 14, 1978, as amended at 79 FR 10973, Feb. 27, 2014] § 526.1696 Penicillin intramammary dosage forms. § 526.1696a Penicillin G procaine. (a) Specifications. Each 10-milliliter single-dose syringe contains penicillin G procaine equivalent to 100,000 units of penicillin G. (b) Related tolerances. See § 556.510 of this chapter. (c) Sponsors. See Nos. 010515 and 061623 in § 510.600(c) of this chapter. (d) Conditions of use in lactating cows—(1) Amount. Infuse one 10-milli liter dose into each infected quarter. Treatment may be repeated at 12-hour intervals for not more than three doses, as indicated by clinical response. (2) Indications for use. For the treat ment of mastitis caused by Strepto coccus agalactiae, S. dysgalactiae, and S. uberus in lactating cows. (3) Limitations. Milk that has been taken from animals during treatment and for 60 hours after the latest treat ment must not be used for food. Ani mals must not be slaughtered for food during treatment or within 3 days after the latest treatment. (e) Conditions of use in dry cows—(1) Amount. Infuse one 10-milliliter dose into each infected quarter at time of drying-off. (2) Indications of use. For the treat ment of mastitis caused by Strepto coccus agalactiae in dry cows. (3) Limitations. Discard all milk for 72 hours (6 milkings) following calving, or later as indicated by the marketable quality of the milk. Animals must not be slaughtered for food within 14 days postinfusion. [73 FR 18442, Apr. 4, 2008, as amended at 74 FR 18990, Apr. 27, 2009] § 526.1696b Penicillin G procaine-dihy drostreptomycin in soybean oil for intramammary infusion (dry cows). (a) Specifications. Each 10 milliliters of suspension contains penicillin G pro caine equivalent to 200,000 units of pen icillin G and dihydrostreptomycin sul fate equivalent to 300 milligrams of di hydrostreptomycin. (b) Sponsor. See No. 054628 in § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.200 and 556.510 of this chapter. (d) Conditions of use. Dairy cows—(1) Amount. One syringe into each quarter at the last milking prior to drying off. (2) Indications for use. Intramammary treatment of subclinical mastitis in dairy cows at the time of drying off, specifically against infections caused by Staphylococcus aureus and Strepto coccus agalactiae. (3) Limitations. Not to be used within 6 weeks of calving. For use in dry cows only. Milk taken from cows within 24 hours (2 milkings) after calving must not be used for food. Animals infused with this drug must not be slaughtered for food within 60 days of treatment nor within 24 hours after calving. [57 FR 37336, Aug. 18, 1992, as amended at 78 FR 21060, Apr. 9, 2013] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00384 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 375 Food and Drug Administration, HHS § 526.1810 § 526.1696c Penicillin G procaine-dihy drostreptomycin sulfate for intramammary infusion (dry cows). (a) Specifications. Each 10 milliliters of suspension contains penicillin G pro caine equivalent to 1 million units of penicillin G and dihydrostreptomycin sulfate equivalent to 1 gram of dihy drostreptomycin. (b) Sponsor. See No. 042791 in § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.200 and 556.510 of this chapter. (d) Conditions of use. Dairy cows—(1) Amount. One syringe per quarter at the last milking prior to drying off. (2) Indications for use. Intramammary use to reduce the frequency of existing infection and to prevent new infections with Staphylococcus aureus in dry cows. (3) Limitations. Not to be used within 6 weeks of freshening. Not for use in lactating cows. Milk taken from ani mals within 96 hours (8 milkings) after calving must not be used for feed. Ani mals infused with this drug must not be slaughtered for food within 60 days from the time of infusion nor within 96 hours after calving. Federal law re stricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 79 FR 10965, Feb. 27, 2014] § 526.1696d Penicillin G procaine novobiocin for intramammary infu sion. (a) Specifications. For lactating cat tle: each 10-milliliter dose contains 100,000 units of penicillin G procaine and 150 milligrams of novobiocin as novobiocin sodium. For dry cows: 200,000 units of penicillin G procaine and 400 milligrams of novobiocin as novobiocin sodium. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Lactating cows—(i) Amount. 10 milliliters in each infected quarter after milking. Repeat once after 24 hours. (ii) Indications for use. Treating lac tating cows for mastitis caused by sus ceptible strains of Staphylococcus aureus, Streptococcus agalactiae, Strepto coccus dysgalactiae, and Streptococcus uberis. (iii) Limitations. For udder instilla tion in lactating cattle only. Do not milk for at least 6 hours after treat ment; thereafter, milk at regular inter vals. Milk taken from treated animals within 72 hours (6 milkings) after the latest treatment must not be used for food. Treated animals must not be slaughtered for food for 15 days fol lowing the latest treatment. If redness, swelling, or abnormal milk persists, discontinue use and consult a veteri narian. (2) Dry cows—(i) Amount. 10 milli liters in each quarter at time of drying off. (ii) Indications for use. Treatment of subclinical mastitis caused by suscep tible strains of Staphylococcus aureus and Streptococcus agalactiae. (iii) Limitations. For udder instilla tion in dry cows only. Do not use less than 30 days prior to calving. Milk from treated cows must not be used for food during the first 72 hours after calving. Treated animals must not be slaughtered for food for 30 days fol lowing udder infusion. [57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 79 FR 10973, Feb. 27, 2014] § 526.1810 Pirlimycin. (a) Specifications. Each 10-milliliter syringe contains 50 milligrams (mg) pirlimycin (as pirlimycin hydro chloride). (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.515 of this chapter. (d) Conditions of use in cattle—(1) Amount. Infuse 50 mg into each infected quarter. Repeat treatment after 24 hours. Daily treatment may be re peated at 24-hour intervals for up to 8 consecutive days. (2) Indications for use. For the treat ment of clinical and subclinical mas titis in lactating dairy cattle associ ated with Staphylococcus species such as Staphylococcus aureus and Strepto coccus species such as Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis. (3) Limitations. Milk taken from ani mals during treatment and for 36 hours following the last treatment must not be used for food regardless of treat ment duration. Following infusion twice at a 24-hour interval, treated ani mals must not be slaughtered for 9 VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00385 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 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