Document ID: FDA-2011-N-0003-0009
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Amikacin Sulfate, Ampicillin Trihydrate, Ceftiofur Hydrochloride, Cephapirin Benzathine, etc.; Correcting Amendments
Posted Date: 2011-03-29T04:00Z

[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
[Rules and Regulations]
[Pages 17336-17339]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7313]

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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.

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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