Document ID: FDA-2012-N-0002-0010
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin
Posted Date: 2012-05-17T04:00Z

[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Rules and Regulations]
[Pages 29216-29218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11937]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 558

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

New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; 
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 March 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 17, 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 (CVM) 
is adopting use of a monthly Federal Register document to codify 
approval actions for NADAs and abbreviated 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 March 
2012, as listed in table 1 of this document. FDA is also informing the 
public of the availability of environmental review documents required 
under the National Environmental Policy Act (NEPA), where applicable. 
For actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA) 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.

[[Page 29217]]

                 Table 1--Original and Supplemental NADAs and ANADAs Approved During March 2012
----------------------------------------------------------------------------------------------------------------
                                   New animal drug                       21 CFR        FOIA
  NADA/ANADA         Sponsor        product name         Action         Section      summary       NEPA review
----------------------------------------------------------------------------------------------------------------
118-980.......  Elanco Animal     MONTEBAN          Supplement            558.363  Yes........  Environmental
                 Health, A         (narasin) Type    increasing the                              assessment (EA)/
                 Division of Eli   A medicated       upper dose                                  Finding of no
                 Lilly & Co.,      article.          limit for                                   significant
                 Lilly Corporate                     narasin in                                  impact (FONSI).
                 Center,                             broiler feed.
                 Indianapolis,
                 IN 46285.
111-636.......  Pharmacia &       LINCOMIX          Supplement          520.1263c  Yes........  Categorically
                 Upjohn Co., a     (lincomycin       adding an                                   excluded
                 Division of       hydrochloride)    indication for                              (CE).\1\
                 Pfizer, Inc.,     Soluble Powder.   control of
                 235 East 42d                        American
                 St., New York,                      foulbrood in
                 NY 10017.                           honey bees.
200-421.......  Hospira, Inc.,    Ceftiofur for     Original             522.313c  Yes........  CE.
                 275 N. Field      Injection         approval of
                 Dr., Lake         (ceftiofur        generic copy of
                 Forest, IL        sodium) Sterile   NADA 140-338.
                 60045.            Powder.
200-455.......  Cross Vetpharm    TYLOMED-WS        Supplement           520.2640  Yes........  CE.\1\
                 Group, Ltd.,      (tylosin          adding an
                 Broomhill Rd.,    tartrate)         indication for
                 Tallaght,         Soluble Powder.   control of
                 Dublin 24,                          porcine
                 Ireland.                            proliferative
                                                     enteropathies.
200-473.......  Huvepharma AD,    TYLOVET Soluble   Supplement           520.2640  Yes........  CE.\1\
                 33 James          (tylosin          adding an
                 Boucher Blvd.,    tartrate).        indication for
                 Sophia 1407,                        control of
                 Bulgaria.                           porcine
                                                     proliferative
                                                     enteropathies.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is CE from the requirement to submit an 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.

    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 Parts 520 and 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 510, 
520, 522, and 558 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 ``Hospira, Inc.''; and in the table in paragraph 
(c)(2), numerically add an entry for ``000409'' to read as follows:

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

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

------------------------------------------------------------------------
                                                           Drug labeler
                 Firm name and address                         code
------------------------------------------------------------------------
 
                                * * * * *
Hospira, Inc., 275 North Field Dr., Lake Forest, IL              000409
 60045.................................................
 
                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
         Drug labeler  code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
000409..............................  Hospira Inc., 275 North Field Dr.,
                                       Lake Forest, IL 60045.
 
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
4. In Sec.  520.1263c, revise paragraph (b) and add paragraph (d)(3) to 
read as follows:

Sec.  520.1263c  Lincomycin powder.

* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter for use as in paragraph (d) of this section.
    (1) No. 000009 for use as in paragraph (d) of this section.
    (2) Nos. 046573, 054925, 061623, and 076475 for use as in 
paragraphs (d)(1) and (d)(2) of this section.
* * * * *
    (d) * * *
    (3) Honey bees--(i) Amount. Mix 100 milligrams lincomycin with 20 
grams confectioners'/powdered sugar and dust over the top bars of the 
brood chamber once weekly for 3 weeks.
    (ii) Indications for use. For the control of American foulbrood 
(Paenibacillus larvae).
    (iii) Limitations. The drug should be fed early in the spring or 
late in the fall and consumed by the bees before the main honey flow 
begins to avoid contamination of production honey. Complete treatments 
at least 4 weeks before main honey flow.

0
5. In Sec.  520.2640, revise paragraph (b) introductory text to read as 
follows:

Sec.  520.2640  Tylosin.

* * * * *
    (b) Sponsors. See Nos. 000986, 016592, and 061623 in Sec.  
510.600(c) of this chapter.
* * * * *

[[Page 29218]]

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.  522.313c, revise paragraphs (b), (e)(2)(ii), (e)(3)(ii), 
(e)(4)(ii), and (e)(8)(i) to read as follows:

Sec.  522.313c  Ceftiofur sodium.

* * * * *
    (b) Sponsors. See Nos. 000009, 000409, and 068330 in Sec.  
510.600(c) of this chapter.
* * * * *
    (e) * * *
    (2) * * *
    (ii) Indications for use. For treatment of bovine respiratory 
disease (shipping fever, pneumonia) associated with Mannheimia 
haemolytica, Pasteurella multocida, and Histophilus somni. Also, for 
the treatment of acute bovine interdigital necrobacillosis (foot rot, 
pododermatitis) associated with Fusobacterium necrophorum and 
Bacteroides melaninogenicus.
* * * * *
    (3) * * *
    (ii) Indications for use. For treatment of sheep respiratory 
disease (sheep pneumonia) associated with Mannheimia haemolytica and 
Pasteurella multocida.
* * * * *
    (4) * * *
    (ii) Indications for use. For treatment of caprine respiratory 
disease (goat pneumonia) associated with Mannheimia haemolytica and 
Pasteurella multocida.
* * * * *
    (8) * * *
    (i) Amount. 1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous 
injection. Treatment should be repeated at 24-hour intervals for 5 to 
14 days.
* * * * *

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

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

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

0
9. In Sec.  558.363, revise paragraph (d)(1)(i) introductory text to 
read as follows:

Sec.  558.363  Narasin.

* * * * *
    (d) * * *
    (1) * * *
    (i) Amount per ton. Narasin, 54 to 90 grams.
* * * * *

    Dated: May 7, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-11937 Filed 5-16-12; 8:45 am]
BILLING CODE 4160-01-P