Document ID: FDA-2014-N-0002-0021
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
Posted Date: 2014-04-15T04:00Z

[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Rules and Regulations]
[Pages 21126-21127]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08445]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2014-N-0002]

New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

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 March 2014. FDA is also informing the public of the 
availability of summaries of the basis of approval and of environmental 
review documents, where applicable. The animal drug regulations are 
also being amended to reflect a change of sponsorship for an ANADA.

DATES: This rule is effective April 15, 2014.

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, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during March 2014, as 
listed in table 1. In addition, FDA is informing the public of the 
availability, where applicable, of documentation of environmental 
review required under the National Environmental Policy Act (NEPA) and, 
for actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA). These public documents 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. Persons with access to the Internet may 
obtain these documents at the Center for Veterinary Medicine FOIA 
Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing 
exclusivity and patent information may be accessed in FDA's 
publication, Approved Animal Drug Products Online (Green Book) at: 
http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
    Also, the regulations are being amended to reflect the previous 
approval of revised food safety warnings for ceftiofur sodium powder 
for injection. This amendment is being made to improve the accuracy 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.

[[Page 21127]]

                 Table 1--Original and Supplemental NADAs and ANADAs Approved During March 2014
----------------------------------------------------------------------------------------------------------------
                                    New animal drug                      21 CFR
  NADA/ ANADA         Sponsor        product name         Action        Section    FOIA  Summary   NEPA  Review
----------------------------------------------------------------------------------------------------------------
200-468........  Cross Vetpharm    GENTAMED-P for    Original           522.1044  yes...........  CE.1 2
                  Group Ltd.,       Poultry           approval as a
                  Broomhill Rd.,    (gentamicin       generic copy of
                  Tallaght,         sulfate)          NADA 101-862.
                  Dublin 24,        Injection.
                  Ireland.
200-529........  Cross Vetpharm    XYLAMED           Original           522.2662  yes...........  CE.1 2
                  Group Ltd.,       (xylazine)        approval as a
                  Broomhill Rd.,    Injection.        generic copy of
                  Tallaght,                           NADA 047-956.
                  Dublin 24,
                  Ireland.
----------------------------------------------------------------------------------------------------------------
\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 or an environmental impact statement because it is of a type
  that does not individually or cumulatively have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).

List of Subjects in 21 CFR Part 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 part 522 is 
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 522.313c, revise paragraph (d) to read as follows:

Sec.  522.313c  Ceftiofur sodium.

* * * * *
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian. Federal law prohibits 
extra-label use of this drug in cattle, swine, chickens, and turkeys 
for disease prevention purposes; at unapproved doses, frequencies, 
durations, or routes of administration; and in unapproved major food-
producing species/production classes.
* * * * *

Sec.  522.1044  [Amended]

0
3. In Sec.  522.1044, in paragraph (b)(4), remove ``No. 000859'' and in 
its place add ``Nos. 000859 and 061623''.

Sec.  522.2662  [Amended]

0
4. In Sec.  522.2662, in paragraph (b)(2), remove ``No. 000010'' and in 
its place add '' Nos. 000010 and 061623''.

    Dated: April 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-08445 Filed 4-14-14; 8:45 am]
BILLING CODE 4160-01-P