Document ID: FDA-2009-N-0665-0035
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Ceftiofur Sodium - Final Rule
Posted Date: 2009-07-15T04:00Z

[Federal Register: July 15, 2009 (Volume 74, Number 134)]
[Rules and Regulations]               
[Page 34235-34236]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy09-10]                         

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2009-N-0665]

 
New Animal Drugs; Ceftiofur Sodium

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an original abbreviated new 
animal drug application (ANADA) filed by Cephazone Pharma, LLC. The 
ANADA provides for the use of ceftiofur sodium powder for injection as 
a solution in dogs, horses, cattle, swine, day old chickens, turkey 
poults, sheep, and goats as therapy for various bacterial infections.

DATES: This rule is effective July 15, 2009.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Cephazone Pharma, LLC, 250 East Bonita Ave., 
Pomona, CA 91767, filed ANADA 200-420 that provides for use of 
Ceftiofur Sodium Sterile Powder, as an injectable solution, in dogs, 
horses, cattle, swine, day-old chickens, turkey poults, sheep, and 
goats as therapy for various bacterial infections. Cephazone Pharma, 
LLC's Ceftiofur Sodium Sterile Powder is approved as a generic copy of 
NAXCEL (ceftiofur sodium) Sterile Powder for Injection, sponsored by 
Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 140-338. 
The ANADA is approved as of May 27, 2009, and the regulations are 
amended in 21 CFR 522.313c to reflect the approval.
    In addition, Cephazone Pharma, LLC, has not been previously listed 
in the animal drug regulations as a sponsor of an approved application. 
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this 
firm.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33 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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    Animal drugs.

0
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 510 and 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1) alphabetically 
add an entry for ``Cephazone Pharma, LLC''; and in the table in 
paragraph (c)(2) numerically add an entry for ``068330'' to read as 
follows:

[[Page 34236]]

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
Cephazone Pharma, LLC, 250 East Bonita Ave.,  068330
 Pomona, CA 91767
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
068330                       Cephazone Pharma, LLC, 250 East Bonita
                              Ave., Pomona, CA 91767
                                * * * * *
------------------------------------------------------------------------

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

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

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

0
4. In Sec.  522.313c, revise paragraph (b) to read as follows:

Sec.  522.313c  Ceftiofur sodium

* * * * *
    (b) Sponsors. See Nos. 000009 and 068330 in Sec.  510.600(c) of 
this chapter.
* * * * *

    Dated: July 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-16734 Filed 7-14-09; 8:45 am]

BILLING CODE 4160-01-S