Document ID: FDA-2012-N-0002-0005
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Ceftiofur Crystalline Free Acid; Gamithromycin; Tylosin
Posted Date: 2012-05-03T04:00Z

[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Rules and Regulations]
[Pages 26161-26162]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10632]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 558

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Ceftiofur Crystalline Free Acid; Gamithromycin; 
Tylosin

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 actions for new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during February 2012. FDA is also informing the public of the 
availability of summaries of the basis of approval and of environmental 
review documents, where applicable.

DATES: This rule is effective May 3, 2012.

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, 
email:george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA's Center for Veterinary Medicine is 
adopting the use of a monthly Federal Register document to codify 
approval actions for NADAs and ANADAs. CVM will no longer publish a 
separate rule for each action. This approach will allow a more 
efficient use of available resources.
    In this document, FDA is amending the animal drug regulations to 
reflect the original and supplemental approval actions during February 
2012, as listed in table 1 of this document. FDA is also informing the 
public of the availability of summaries of the basis of approval (FOI 
Summaries) under the Freedom of Information Act (FOIA) and of 
environmental review documents required under the National 
Environmental Policy Act (NEPA), where applicable.

[[Page 26162]]

                                    Table 1--Original and Supplemental NADAs and ANADAs Approved During February 2012
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                                                            New animal drug product                             21 CFR
           NADA/ ANADA                     Sponsor                    name                    Action           Section      FOIA Summary     NEPA Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-328.........................  Merial Ltd., 3239         ZACTRAN (gamithromycin)  Supplement adding         522.1014  yes...............  CE\1\
                                   Satellite Blvd., Bldg.    Injectable Solution.     treatment of bovine
                                   500, Duluth, GA 30096-                             respiratory disease
                                   4640.                                              (BRD) associated with
                                                                                      M. bovis.
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141-209.........................  Pharmacia & Upjohn Co.,   EXCEDE (ceftiofur        Supplement adding         522.313a  yes...............  CE
                                   a Division of Pfizer,     crystalline free acid)   treatment of acute
                                   Inc., 235 East 42d St.,   Sterile Suspension.      bovine metritis in
                                   New York, NY 10017.                                lactating dairy cows;
                                                                                      and modified injection
                                                                                      techniques.
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200-484.........................  Huvepharma AD, 33 James   TYLOVET 100 (tylosin     Original approval as       558.625  yes...............  CE
                                   Boucher Blvd., Sophia     phosphate) Type A        generic copy of NADA
                                   1407, Bulgaria.           medicated Article.       012-491.
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\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment (EA) or an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant
  effect on the human environment.

    The basis of approval of actions requiring review of safety or 
effectiveness data is discussed in an FOI Summary that 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.

List of Subjects

21 CFR Part 522

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    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 522 and 
558 are amended as follows:

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

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

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

0
2. In 522.313a, revise paragraphs (e)(2)(i), (e)(2)(ii), and 
(e)(2)(iii) to read as follows:

Sec.  522.313a  Ceftiofur crystalline free acid.

* * * * *
    (e) * * *
    (2) * * *
    (i) Amount. For subcutaneous (SC) injection in the posterior aspect 
of the ear where it attaches to the head (base of the ear) in lactating 
dairy cattle. For SC injection in the middle third of the posterior 
aspect of the ear or in the base of the ear in beef and non-lactating 
dairy cattle.
    (A) Single-dose regimen: 6.6 mg ceftiofur equivalents per kg of 
body weight as a single injection.
    (B) Two-dose regimen: 6.6 mg ceftiofur equivalents per kg of body 
weight given as two injections in the base of the ear approximately 72 
hours apart.
    (ii) Indications for use--(A) Single-dose regimen: For the 
treatment of bovine respiratory disease (BRD, shipping fever, 
pneumonia) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni in beef, non-lactating dairy, and 
lactating dairy cattle. For the control of respiratory disease in beef 
and non-lactating dairy cattle which are at high risk of developing BRD 
associated with M. haemolytica, P. multocida, and H. somni. For the 
treatment of bovine foot rot (interdigital necrobacillosis) associated 
with Fusobacterium necrophorum and Porphyromonas levii in beef, non-
lactating dairy, and lactating dairy cattle.
    (B) Two-dose regimen: For the treatment of acute metritis (0-to 10-
days postpartum) associated with bacterial organisms susceptible to 
ceftiofur in lactating dairy cattle.
    (iii) Limitations. Following label use as either a single-dose or 
2-dose regimen, a 13-day pre-slaughter withdrawal period is required 
after the last treatment. A withdrawal period has not been established 
in preruminating calves. Do not use in calves to be processed for veal.
* * * * *

0
3. In 522.1014, revise paragraph (d)(1)(ii) to read as follows:

Sec.  522.1014  Gamithromycin.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, Histophilus somni, and Mycoplasma bovis in beef and non-
lactating dairy cattle; and for the control of respiratory disease in 
beef and non-lactating dairy cattle at high risk of developing BRD 
associated with M. haemolytica and P. multocida.
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
4. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
5. In Sec.  558.625, add paragraph (b)(90) to read as follows:

Sec.  558.625  Tylosin.

* * * * *
    (b) * * *
    (90) No. 016592: 100 grams per pound for use as in paragraph (f) of 
this section.
* * * * *

    Dated: April 26, 2012.
 Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-10632 Filed 5-2-12; 8:45 am]
BILLING CODE 4160-01-P