Document ID: FDA-2014-N-0002-0001
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin G
Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib;
Sulfadimethoxine; Change of Sponsor; Change of Sponsor’s Address
Posted Date: 2014-02-27T05:00Z

[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Rules and Regulations]
[Pages 10963-10965]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01959]

[[Page 10963]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 526, 529, and 558

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

New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin 
G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib; 
Sulfadimethoxine; Change of Sponsor; Change of Sponsor's Address

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 actions for new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during December 2013. 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 of an NADA and a 
change to a sponsor's address.

DATES: This rule is effective February 27, 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 December 2013, 
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.
    In addition, West Agro, Inc., 11100 North Congress Ave., Kansas 
City, MO 64153 has informed FDA that it has transferred ownership of, 
and all rights and interest in, NADA 055-028 for QUARTERMASTER 
(penicillin G procaine and dihydrostreptomycin sulfate) Dry Cow 
Treatment to HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, 
Paramus, NJ 07652. Following this change of sponsorship, West Agro, 
Inc., is no longer a sponsor of an approved NADA, and HQ Specialty 
Pharma Corp. is now the sponsor of an approved NADA. Also, Putney, 
Inc., 400 Congress St., Suite 200, Portland, ME 04101 has informed FDA 
of a change of address to One Monument Sq., Suite 400, Portland, ME 
04101. Accordingly, the Agency is amending the regulations to reflect 
this change of sponsorship and change of sponsor's address.

                                    Table 1--Original and Supplemental NADAs and ANADAs Approved During December 2013
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  New animal drug                               21 CFR
      NADA/ANADA               Sponsor              product name             Action             Section         FOIA  summary           NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-419...............  Huvepharma AD, 5th     COYDEN 25 (clopidol)   Original approval as         558.95,  Yes..................  CE.1 2
                         Floor, 3A Nikolay      plus FLAVOMYCIN        an aid in                   558.175
                         Haytov St., 1113       (bambermycins) Type    prevention of
                         Sophia, Bulgaria.      A medicated articles.  coccidiosis caused
                                                                       by Eimeria tenella,
                                                                       E. necatrix, E.
                                                                       acervulina, E.
                                                                       maxima, E.
                                                                       brunetti, and E.
                                                                       mivati; and for
                                                                       increased rate of
                                                                       weight gain and
                                                                       improved feed
                                                                       efficiency in
                                                                       broiler chickens.
200-523...............  Cross Vetpharm Group   SULFAMED               Original approval as        522.2220  Yes..................  CE.1 3
                         Ltd., Broomhill Rd.,   (sulfadimethoxine)     a generic copy of
                         Tallaght, Dublin 24,   40% Injectable         NADA 041-245.
                         Ireland.               Solution.
200-564...............  Merial Ltd., 3239      Ivermectin Paste       Original approval as         \4\ N/A  Yes..................  CE.1 3
                         Satellite Blvd.,       1.87%.                 a generic copy of
                         Bldg. 500, Duluth,                            NADA 134-314.
                         GA 30096-4640.
141-200...............  Zoetis Inc., 333       EAZI-BREED CIDR        Supplemental                529.1940  Yes..................  EA/FONSI.\5\
                         Portage St.,           (progesterone          approval for
                         Kalamazoo, MI 49007.   intravaginal insert)   induction of
                                                Cattle Insert.         estrous cycles in
                                                                       anestrous lactating
                                                                       dairy cattle.
141-320...............  Novartis Animal        ONSIOR (robenacoxib)   Supplemental                520.2075  Yes..................  CE.1 6
                         Health US, Inc.,       Tablets.               approval lowering
                         3200 Northline Ave.,                          age at treatment
                         Suite 300,                                    from 6 months to 4
                         Greensboro, NC 27408.                         months.

[[Page 10964]]

 
200-341...............  Sparhawk               SPARMECTIN-E           Supplemental                520.1195  Yes..................  CE.1 3
                         Laboratories, Inc.,    (ivermectin) Liquid.   approval adding
                         12340 Santa Fe Trail                          pathogens off
                         Dr., Lenexa, KS                               exclusivity to
                         66215.                                        labeling.
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\1\ The Agency has determined under Sec.   25.33 (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 because it is of a type that does not individually or cumulatively have a
  significant effect on the human environment.
\2\ CE granted under Sec.   25.33(a)(2).
\3\ CE granted under Sec.   25.33(a)(1).
\4\ 21 CFR 520.1192 already contains a drug labeler code entry for this sponsor.
\5\ The Agency has carefully considered an EA of the potential environmental impact of this action and has made a finding of no significant impact
  (FONSI).
\6\ CE granted under Sec.   25.33(d)(1).

    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, 522, 526, and 529

    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, 526, 529, 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 ``HQ Specialty Pharma Corp.'', revise the entry for 
``Putney, Inc.'', and remove the entry for ``West Agro, Inc.''; and in 
the table in paragraph (c)(2), revise the entry for ``026637'', remove 
the entry for ``033392'', and numerically add an entry for ``042791'' 
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
------------------------------------------------------------------------
 
                                * * * * *
HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130,          042791
 Paramus, NJ 07652......................................
 
                                * * * * *
Putney, Inc., One Monument Sq., Suite 400, Portland, ME           026637
 04101..................................................
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
             Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
026637....................................  Putney, Inc., One Monument
                                             Sq., Suite 400, Portland,
                                             ME 04101.
 
                                * * * * *
042791....................................  HQ Specialty Pharma Corp.,
                                             120 Rte. 17 North, Suite
                                             130, Paramus, NJ 07652.
 
                                * * * * *
------------------------------------------------------------------------

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.  520.1195, revise paragraphs (b)(1) and (b)(2) to read as 
follows:

Sec.  520.1195  Ivermectin liquid.

* * * * *
    (b) * * *
    (1) Nos. 000859, 050604, 054925, and 058005 for use of product 
described in paragraph (a)(1) of this section as in paragraphs 
(e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.
    (2) No. 058829 for use of product described in paragraph (a)(1) of 
this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) 
of this section.
* * * * *

Sec.  520.2075  [Amended]

0
5. In Sec.  520.2075, in paragraph (c)(2), remove ``at least 6 months 
of age'' and in its place add ``at least 4 months of age''.

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.  522.2220, revise paragraphs (a)(1), (a)(2), and (a)(3)(iii) 
to read as follows:

Sec.  522.2220  Sulfadimethoxine.

    (a)(1) Specifications. Each milliliter of solution contains 400 
milligrams (mg) sulfadimethoxine.
    (2) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter for conditions of use as in paragraph (a)(3) of this section:
    (i) No. 054771 for use as in paragraph (a)(3) of this section.
    (ii) Nos. 000859, 057561, and 061623 for conditions of use as in 
paragraph (a)(3)(iii) of this section.
    (3) * * *
    (iii) Cattle--(a) Amount. Administer an initial dose of 25 mg per 
pound of body weight by intravenous injection followed by 12.5 mg per 
pound of body weight every 24 hours until the animal is asymptomatic 
for 48 hours.
    (b) Indications for use. For the treatment of bovine respiratory 
disease complex (shipping fever complex) and bacterial pneumonia 
associated with Pasteurella spp. sensitive to sulfadimethoxine; 
necrotic pododermatitis (foot rot) and calf diphtheria caused by 
Fusobacterium necrophorum sensitive to sulfadimethoxine.

[[Page 10965]]

    (c) Limitations. Milk taken from animals during treatment and for 
60 hours (5 milkings) after the latest treatment must not be used for 
food. Do not administer within 5 days of slaughter. A withdrawal period 
has not been established for this product in preruminating calves. Do 
not use in calves to be processed for veal.
* * * * *

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
8. The authority citation for 21 CFR part 526 continues to read as 
follows:

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

Sec.  526.1696c  [Amended]

0
9. In paragraph (b) of Sec.  526.1696c, remove ``033392'' and in its 
place add ``042791''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
10. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

0
11. In Sec.  529.1940, in paragraphs (b) and (e)(1)(iii), remove 
``000009'' and in its place add ``054771''; in paragraph (c), remove 
``Sec.  556.540(a)'' and in its place add ``Sec.  556.540''; and add 
paragraph (e)(1)(ii)(D) to read as follows:

Sec.  529.1940  Progesterone intravaginal inserts.

* * * * *
    (e) * * *
    (1) * * *
    (ii) * * *
    (D) For induction of estrous cycles in anestrous lactating dairy 
cows.
* * * * *

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

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

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

0
13. In paragraph (d)(5) of Sec.  558.95, redesignate paragraphs 
(d)(5)(iii) through (d)(5)(x) as paragraphs (d)(5)(iv) through 
(d)(5)(xi); and add new paragraph (d)(5)(iii) to read as follows:

Sec.  558.95  Bambermycins.

* * * * *
    (d) * * *
    (5) * * *
    (iii) Clopidol as in Sec.  558.175.
* * * * *

0
14. In Sec.  558.175:
0
a. Redesignate paragraph (d)(9) as paragraph (d)(11).
0
b. Redesignate paragraphs (d)(5) through (d)(8) as paragraphs (d)(6) 
through (d)(9).
0
c. Add new paragraphs (d)(5) and (d)(10).
    The additions read as follows:

Sec.  558.175  Clopidol.

* * * * *
    (d) * * *

----------------------------------------------------------------------------------------------------------------
Clopidol in grams per  Combination in grams
         ton                  per ton           Indications for use            Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(5) 113.5............  Bambermycins 1 to 2.  Broiler chickens: As an    Feed continuously as the          016592
                                              aid in prevention of       sole ration. Do not
                                              coccidiosis caused by      feed to chickens over
                                              Eimeria tenella, E.        16 weeks of age
                                              necatrix, E. acervulina,
                                              E. maxima, E. brunetti,
                                              and E. mivati; and for
                                              increased rate of weight
                                              gain and improved feed
                                              efficiency
 
                                                  * * * * * * *
(10) 227.............  Bambermycins 1 to 2.  Broiler chickens: As an    Feed continuously as              016592
                                              aid in prevention of       sole ration until 5
                                              coccidiosis caused by      days before slaughter.
                                              Eimeria tenella, E.        Withdraw 5 days before
                                              necatrix, E. acervulina,   slaughter or feed 113.5
                                              E. maxima, E. brunetti,    g/ton clopidol and 1 to
                                              and E. mivati; and for     2 g/ton bambermycins
                                              increased rate of weight   during those 5 days
                                              gain and improved feed     before slaughter. Do
                                              efficiency                 not feed to chickens
                                                                         over 16 weeks of age
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    Dated: January 27, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-01959 Filed 2-26-14; 8:45 am]
BILLING CODE 4160-01-P