Document ID: FDA-2008-N-0039-0021
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution
Posted Date: 2008-03-20T04:00Z

[Federal Register: March 20, 2008 (Volume 73, Number 55)]
[Rules and Regulations]               
[Page 14926]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20mr08-8]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Oxytetracycline Solution

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Norbrook Laboratories, Ltd. The 
supplemental NADA provides for changing scientific nomenclature for a 
bovine pathogen on labeling for 300 milligrams per milliliter (mg/mL) 
strength oxytetracycline injectable solution.

DATES: This rule is effective March 20, 2008.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8342, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry, BT35 6JP, Northern Ireland, filed a supplement to NADA 141-143 
for TETRADURE 300 (oxytetracycline) Injection used for the treatment of 
various bacterial diseases of cattle and swine. The supplemental NADA 
provides for changing a bovine pathogen genus from Haemophilus to 
Histophilus on product labeling. The supplemental NADA is approved as 
of February 8, 2008, and the regulations are amended in 21 CFR 
522.1660b to reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    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 Part 522

    Animal drugs.

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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 part 522 is 
amended as follows:

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

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

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

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2. In Sec.  522.1660, revise the section heading to read as follows:

Sec.  522.1660  Oxytetracycline injectable dosage forms.

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3. In Sec.  522.1660a, revise the section heading to read as follows:

Sec.  522.1660a  Oxytetracycline solution, 200 milligrams/milliliter.

Sec.  522.1660b  [Amended]

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4. In Sec.  522.1660b, in the section heading, remove ``injection, 300 
milligram/milliliter'' and in its place add ``solution, 300 milligrams/
milliliter''; in paragraph (e)(1)(i)(A), remove ``Haemophilus spp.'' 
and in its place add ``Histophilus spp.''; and in the fourth sentence 
in paragraph (e)(1)(ii), remove ``in cattle''.

    Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5598 Filed 3-19-08; 8:45 am]

BILLING CODE 4160-01-S