Document ID: FDA-2011-N-0003-0027
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Ampicillin Trihydrate, Bacitracin Methylene Disalicylate, Flunixin, etc.; Correcting Amendments
Posted Date: 2011-08-25T04:00Z

[Federal Register Volume 76, Number 165 (Thursday, August 25, 2011)]
[Rules and Regulations]
[Pages 53050-53051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21721]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 522

[Docket No. FDA-2011-N-0003]

New Animal Drugs; Ampicillin Trihydrate, Bacitracin Methylene 
Disalicylate, Flunixin, Gonadotropin Releasing Factor Analog-Diphtheria 
Toxoid Conjugate, Methylprednisolone, and Sulfamethazine

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

DATES: This rule is effective August 25, 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 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 and 522

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and 
522 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.  520.154a, revise the section heading and paragraphs 
(d)(1)(i), (d)(2)(i), (d)(2)(ii), (d)(2)(ii)(A), and (d)(4)(i) to read 
as follows:

Sec.  520.154a  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. 400 milligrams (mg) per gallon (gal) in drinking water.
* * * * *
    (2) * * *
    (i) Amount. 100 mg per gal in drinking water.
* * * * *

[[Page 53051]]

    (ii) Amount. 200 to 400 mg per gal in drinking water. Administer 
continuously 5 to 7 days or as long as clinical signs persist, then 
reduce to prevention levels (100 mg/gal).
    (A) Indications for use. Treatment of necrotic enteritis caused by 
C. perfringens susceptible to bacitracin methylene disalicylate.
* * * * *
    (4) * * *
    (i) Amount. 400 mg per gal in drinking water.
* * * * *

0
3. Revise Sec.  520.970 to read as follows:

Sec.  520.970  Flunixin.

    (a) Specifications. (1) Each 10-gram (g) packet of granules 
contains flunixin meglumine equivalent to 250 milligrams (mg) of 
flunixin.
    (2) Each 30-g syringe of paste contains flunixin meglumine 
equivalent to 1,500 mg of flunixin.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 0.5 mg of flunixin per 
pound of body weight per day.
    (2) Indications for use. For alleviation of inflammation and pain 
associated with musculoskeletal disorders.
    (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.

Sec.  520.970a  [Removed]

0
4. Remove Sec.  520.970a.

Sec.  520.970b  [Removed]

0
5. Remove Sec.  520.970b.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
7. In Sec.  522.90b, revise paragraph (d)(2)(iii) to read as follows:

Sec.  522.90b  Ampicillin trihydrate.

* * * * *
    (d) * * *
    (2) * * *
    (iii) Limitations. Do not treat cattle for more than 7 days. Milk 
from treated cows must not be used for food during treatment and for 48 
hours (4 milkings) after the last treatment. Cattle must not be 
slaughtered for food during treatment and 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
8. In Sec.  522.1083, revise the section heading and paragraph (a) to 
read as follows:

Sec.  522.1083  Gonadotropin releasing factor analog-diphtheria toxoid 
conjugate.

    (a) Specifications. Each milliliter of solution contains 0.2 
milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid 
conjugate.
* * * * *

0
9. In Sec.  522.1410, revise the section heading, remove and reserve 
paragraph (c), and revise paragraphs (a) and (d) to read as follows:

Sec.  522.1410  Methylprednisolone.

    (a) Specifications. Each milliliter of suspension contains 20 or 40 
milligrams (mg) of methylprednisolone acetate.
    (b) * * *
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. Administer 2 to 40 mg 
(up to 120 mg in extremely large breeds or dogs with severe 
involvement) by intramuscular injection or up to 20 mg by intrasynovial 
injection.
    (ii) Indications for use. For treatment of inflammation and related 
disorders; treatment of allergic and dermatologic disorders; and as 
supportive therapy to antibacterial treatment of severe infections.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 10 to 20 mg by intramuscular 
injection.
    (ii) Indications for use. For treatment of inflammation and related 
disorders; treatment of allergic and dermatologic disorders; and as 
supportive therapy to antibacterial treatment of severe infections.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Horses--(i) Amount. Administer 200 mg by intramuscular 
injection or 40 to 240 mg by intrasynovial injection.
    (ii) Indications for use. For treatment of inflammation and related 
disorders.
    (iii) 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
10. In Sec.  522.2260, revise paragraphs (a), (d)(1), and (d)(3) to 
read as follows:

Sec.  522.2260  Sulfamethazine.

    (a) Specifications. Each milliliter (mL) of solution contains 250 
milligrams (mg) sulfamethazine sodium.
* * * * *
    (d) * * *
    (1) Amount. Initially administer 20 mL for each 50 pounds (lb) of 
body weight (100 mg/lb) by intravenous injection, followed by 20 mL per 
100 lb of body weight (50 mg/lb) by intravenous injection, daily 
thereafter. Treatment should not exceed a total of 5 consecutive days.
* * * * *
    (3) Limitations. Withdraw medication from cattle 10 days prior to 
slaughter. Do not use in female dairy cattle 20 months of age or older. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: August 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-21721 Filed 8-24-11; 8:45 am]
BILLING CODE 4160-01-P