New Animal Drugs:

Federal Register: March 29, 2011 (Volume 76, Number 60)

Rules and Regulations

Page 17336-17339

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

DOCID:fr29mr11-4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Parts 520, 522, 526, and 529

Docket No. FDA-2011-N-0003

New Animal Drugs; Amikacin Sulfate, Ampicillin Trihydrate,

Ceftiofur Hydrochloride, Cephapirin Benzathine, Chlortetracycline,

Fenbendazole, Formalin, Furosemide, Glucose/Glycine/Electrolyte,

Pyrantel Pamoate, Sulfadimethoxine, Sulfamethazine, and Tetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect revised human food safety warnings or updated pathogen nomenclature on dosage form new animal drug product labeling that have not been codified. The regulations are also being amended to correct the wording of certain other conditions of use, to correct minor errors, and to revise some sections to reflect a current format. These actions are being taken to comply with the Federal Food,

Drug, and Cosmetic Act (FD&C Act) and to improve the accuracy and readability of the regulations.

DATES: This rule is effective March 29, 2011.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for

Veterinary Medicine (HFV-6), Food and Drug Administration, 7519

Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA has found that the animal drug regulations do not reflect certain human food safety warnings or the scientific nomenclature of pathogens that have been updated on labeling of various dosage form new animal drug products. At this time, the regulations are being amended to reflect approved labeling. The regulations are also being amended to correct the wording of certain other conditions of use and to correct minor errors. As the opportunity has presented itself, some sections have been revised to a current format. These actions are being taken to comply with the FD&C Act and to improve the accuracy and readability of the regulations.

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 Parts 520, 522, 526, and 529

Animal drugs.

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 parts 520, 522, 526, and 529 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part 520 continues to read as follows:

Authority: 21 U.S.C. 360b. 0 2. In Sec. 520.550, revise the section heading and paragraph (a), the first sentence in paragraph (c)(1), and paragraph (c)(3) to read as follows:

Sec. 520.550 Glucose/glycine/electrolyte.

(a) Specifications. The product is distributed in packets each of which contains the following ingredients: Sodium chloride 8.82 grams, potassium phosphate 4.20 grams, citric acid anhydrous 0.5 gram, potassium citrate 0.12 gram, aminoacetic acid (glycine) 6.36 grams, and glucose 44.0 grams.

(c) * * *

(1) Glucose/glycine/electrolyte is indicated for use in the control of dehydration associated with diarrhea (scours) in calves.* * *

* * * * *

(3) The product should not be used in animals with severe dehydration (down, comatose, or in a state of shock). Such animals need intravenous therapy. A veterinarian should be consulted in severely scouring calves. The product is not nutritionally complete if administered by itself for long periods of time. It should not be administered beyond the recommended treatment period without the addition of milk or milk replacer. 0 3. In Sec. 520.905a, revise paragraphs (e)(2)(i), (e)(2)(iii),

(e)(3)(i), and (e)(3)(iii) to read as follows:

Sec. 520.905a Fenbendazole suspension.

* * * * *

(e) * * *

(2) * * *

(i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb).

Retreatment may be needed after 4 to 6 weeks.

* * * * *

(iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not

Page 17337

been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(3) * * *

(i) Amount. Administer orally 10 mg/kg of body weight (2.3 mg/lb).

Retreatment may be needed after 4 to 6 weeks.

* * * * *

(iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

* * * * * 0 4. In Sec. 520.905c, revise paragraph (e)(2)(iii) to read as follows:

Sec. 520.905c Fenbendazole paste.

* * * * *

(e) * * *

(2) * * *

(iii) Limitations. Cattle must not be slaughtered within 8 days following last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. 0 5. In Sec. 520.1422, revise paragraph (b) to read as follows:

Sec. 520.1422 Metoserpate hydrochloride.

* * * * *

(b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.

* * * * * 0 6. In Sec. 520.2043, revise paragraph (d)(1)(iii) to read as follows:

Sec. 520.2043 Pyrantel pamoate suspension.

* * * * *

(d) * * *

(1) * * *

(iii) Limitations. Do not use in horses intended for human consumption. When the drug is for administration by stomach tube, it shall be labeled: ``Federal law restricts this drug to use by or on the order of a licensed veterinarian.''

* * * * * 0 7. In Sec. 520.2044, revise paragraph (d)(2) to read as follows:

Sec. 520.2044 Pyrantel pamoate paste.

* * * * *

(d) * * *

(2) Limitations. Do not use in horses intended for human consumption. 0 8. In Sec. 520.2220a, revise paragraph (d)(3)(ii) to read as follows:

Sec. 520.2220a Sulfadimethoxine oral solution and soluble powder.

* * * * *

(d) * * *

(3) * * *

(ii) Indications for use. For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

* * * * * 0 9. In Sec. 520.2220b, revise paragraph (d) to read as follows:

Sec. 520.2220b Sulfadimethoxine tablets and boluses.

* * * * *

(d) Conditions of use--(1) Cattle--(i) Amount. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day; treat for 4 to 5 days.

(ii) Indications for use. For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.

(iii) Limitations. Do not administer within 7 days of slaughter; milk that has been taken from animals during treatment and 60 hours (5 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(2) Dogs and cats--(i) Amount. Administer 25 milligrams per pound of body weight on the first day followed by 12.5 milligrams per pound of body weight per day until the animal is free of symptoms for 48 hours.

(ii) Indications for use. Treatment of sulfadimethoxine-susceptible bacterial infections.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Beef cattle and nonlactating dairy cattle--(i) Amount.

Administer one 12.5-gram-sustained-release bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight.

Do not repeat treatment for 7 days.

(ii) Indications for use. Treatment of shipping fever complex and bacterial pneumonia associated with organisms such as Pasteurella spp. sensitive to sulfadimethoxine; calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.

(iii) Limitations. Do not use in female dairy cattle 20 months of age or older. Do not administer within 12 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 10. In Sec. 520.2260a, revise paragraph (a)(3)(iii) to read as follows:

Sec. 520.2260a Sulfamethazine oblet, tablet, and bolus.

(a) * * *

(3) * * *

(iii) Limitations. Administer daily until animal's temperature and appearance are normal. If symptoms persist after using for 2 or 3 days consult a veterinarian. Fluid intake must be adequate. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed 5 consecutive days. Follow dosages carefully. Do not treat cattle within 10 days of slaughter. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption.

* * * * * 0 11. In Sec. 520.2261a, revise the section heading; the first sentence in paragraph (c)(2)(iii); and paragraph (c)(3) to read as follows:

Sec. 520.2261a Sulfamethazine solution.

* * * * *

(c) * * *

(2) * * *

(iii) Chickens and turkeys. In chickens for control of infectious coryza (Avibacterium paragallinarum), coccidiosis (Eimeria tenella,

Eimeria necatrix), acute fowl cholera (Pasteurella multocida), and pullorum disease (Salmonella pullorum). * * *

(3) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked.

Have only medicated water available during treatment. Withdraw medication from cattle, chickens, and turkeys 10 days prior to slaughter for food. Withdraw medication from swine 15 days before slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days in cattle or swine. Medicated cattle, swine, chickens, and turkeys must actually consume enough medicated water which provides the recommended dosages. Do not use in female dairy cattle 20 months of age or

Page 17338

older. Use of sulfamethazine in this class of cattle may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.

* * * * * 0 12. In Sec. 520.2261b, revise paragraph (d)(1)(ii) and paragraph

(d)(4)(iii) to read as follows:

Sec. 520.2261b Sulfamethazine powder.

* * * * *

(d) * * *

(1) * * *

(ii) Indications for use. For control of infectious coryza

(Avibacterium paragallinarum), coccidiosis (Eimeria tenella, E. necatrix), acute fowl cholera (Pasteurella multocida), and pullorum disease (Salmonella pullorum).

* * * * *

(4) * * *

(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication from cattle 10 days prior to slaughter for food. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days. Medicated cattle must actually consume enough medicated water which provides the recommended dosages.

Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. 0 13. In Sec. 520.2345d, revise paragraph (b)(2), the first sentence in paragraph (d)(1)(iii), and paragraph (d)(2)(iii) to read as follows:

Sec. 520.2345d Tetracycline powder.

* * * * *

(b) * * *

(2) No. 000010: 25, 102.4, and 324 grams per pound as in paragraph

(d) of this section.

* * * * *

(d) * * *

(1) * * *

(iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 4 days of treatment for No. 000010 and within 5 days of treatment for Nos. 046573, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline.

* * *

(2) * * *

(iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 7 days of treatment for No. 000010 and within 4 days of treatment for Nos. 046573, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline.

* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 14. The authority citation for 21 CFR part 522 continues to read as follows:

Authority: 21 U.S.C. 360b. 0 15. Revise Sec. 522.56 to read as follows:

Sec. 522.56 Amikacin.

(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of amikacin as amikacin sulfate.

(b) Sponsors. See Nos. 000856 and 059130 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in dogs--(1) Amount. 5 mg/pound (lb) of body weight twice daily by intramuscular or subcutaneous injection.

(2) Indications for use. For treatment of genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli and Proteus spp. and skin and soft tissue infections caused by susceptible strains of Pseudomonas spp. and E. coli.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 16. In Sec. 522.90b, revise the section heading and paragraphs (a),

(b), and (d) to read as follows:

Sec. 522.90b Ampicillin trihydrate.

(a) Specifications. Each milliliter of aqueous suspension constituted from ampicillin trihydrate powder contains 50, 100, or 250 milligrams (mg) ampicillin equivalents.

(b) Sponsors. See Nos. 000010 and 010515 in Sec. 510.600(c) of this chapter.

* * * * *

(d) Conditions of use--(1) Dogs and cats--(i) Amount. 3 mg/pound

(lb) of body weight twice daily by subcutaneous or intramuscular injection.

(ii) Indications for use. For treatment of strains of organisms susceptible to ampicillin and associated with respiratory tract infections, urinary tract infections, gastrointestinal infections, skin infections, soft tissue infections, and postsurgical infections.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cattle--(i) Amount. 2 to 5 mg/lb of body weight once daily by intramuscular injection.

(ii) Indications for use. For treatment of respiratory tract infections caused by organisms susceptible to ampicillin, bacterial pneumonia (shipping fever, calf pneumonia, and bovine pneumonia) caused by Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus spp., Pasteurella multocida, and Escherichia coli.

(iii) Limitations. Do not treat cattle for more than 7 days. Milk from treated cows must not be used for food during treatment or for 48 hours (4 milkings) after the last treatment. Cattle must not be slaughtered for food during treatment or for 144 hours (6 days) after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 17. In Sec. 522.313b, revise paragraph (a) to read as follows:

Sec. 522.313b Ceftiofur hydrochloride.

(a) Specifications. Each milliliter of ceftiofur hydrochloride suspension contains 50 milligrams (mg) ceftiofur equivalents.

* * * * * 0 18. In Sec. 522.1010, redesignate paragraph (d)(3)(iii) as paragraph

(d)(2)(iii); and add new paragraph (d)(3)(iii) to read as follows:

Sec. 522.1010 Furosemide.

* * * * *

(d) * * *

(3) * * *

(iii) Limitations. Treatment not to exceed 48 hours post- parturition. Milk taken during treatment and for 48 hours (four milkings) after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS 0 19. The authority citation for 21 CFR part 526 continues to read as follows:

Authority: 21 U.S.C. 360b. 0 20. In Sec. 526.363, revise paragraph (d)(1) and the first sentence in paragraph (d)(3) to read as follows:

Sec. 526.363 Cephapirin benzathine.

* * * * *

(d) * * *

(1) Amount. Infuse the contents of one syringe into each quarter.

* * * * *

(3) Limitations. Infuse each quarter following last milking, but no later than 30 days before calving. * * *

Page 17339

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 0 21. The authority citation for 21 CFR part 529 continues to read as follows:

Authority: 21 U.S.C. 360b.

Sec. 529.50 [Redesignated as Sec. 529.56 and Amended] 0 22. Redesignate Sec. 529.50 as Sec. 529.56 and revise it to read as follows:

Sec. 529.56 Amikacin.

(a) Specifications. Each milliliter (mL) of solution contains 250 milligrams of amikacin as amikacin sulfate.

(b) Sponsors. See Nos. 000856 and 059130 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in horses--(1) Amount. Administer 2 grams (8 mL) diluted with 200 mL of sterile physiological 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 including Escherichia coli, Pseudomonas spp., and Klebsiella spp.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 23. In Sec. 529.1030, revise paragraphs (d)(1)(i) and (d)(1)(iv) to read as follows:

Sec. 529.1030 Formalin.

* * * * *

(d) * * *

(1) * * *

(i) Select finfish. For control of external protozoa

Ichthyophthirius spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes

Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp., on salmon, trout, catfish, largemouth bass, and bluegill.

* * * * *

(iv) All finfish. For control of external protozoa Ichthyophthirius spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp.

* * * * *

Dated: March 23, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

FR Doc. 2011-7313 Filed 3-28-11; 8:45 am

BILLING CODE 4160-01-P