Document ID: FDA-2015-N-0002-0010
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Change of
Sponsor
Posted Date: 2015-06-16T04:00Z

[Federal Register Volume 80, Number 115 (Tuesday, June 16, 2015)]
[Rules and Regulations]
[Pages 34276-34279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14734]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 526, and 528

[Docket No. FDA-2015-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect application-related actions for new animal 
drug applications (NADAs) and

[[Page 34277]]

abbreviated new animal drug applications (ANADAs) during March and 
April 2015. 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 several nonsubstantive changes. These technical 
amendments are being made to improve the accuracy of the regulations.

DATES: This rule is effective June 16, 2015.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during March and April 
2015, 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 CVM 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.

                                Table 1--Original and Supplemental NADAs and ANADAs Approved During March and April 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                New animal drug product                               21 CFR
    NADA/ANADA               Sponsor                     name                     Action             sections       FOIA summary         NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-557...........  Putney, Inc., One          Tiletamine-Zolazepam      Original approval as a       522.2470  yes................  CE \1\ \2\.
                     Monument Sq., suite 400,   Injectable Solution       generic copy of NADA
                     Portland, ME 04101.        (tiletamine HCl and       106-111.
                                                zolazepam HCl).
200-578...........  Belcher Pharmaceuticals,   Carprofen Flavored        Original approval as a        520.304  yes................  CE \1\ \2\.
                     LLC, 6911 Bryan Dairy      Tablets (carprofen).      generic copy of NADA
                     Rd., Largo, FL 33777.                                141-053.
200-579...........  Ceva Sant[eacute]          Altrenogest Solution      Original approval as a         520.48  yes................  CE \1\ \2\.
                     Animale, 10 Avenue de la   (altrenogest).            generic copy of NADA
                     Ballasti[egrave]re,                                  141-222.
                     33500 Libourne, France.
141-238...........  Zoetis Inc., 333 Portage   SPECTRAMAST LC            Supplemental approval         526.313  yes................  CE \1\ \3\.
                     St., Kalamazoo, MI 49007.  (ceftiofur intramammary   for treatment of
                                                suspension) Sterile       diagnosed subclinical
                                                Suspension.               mastitis associated
                                                                          with coagulase-negative
                                                                          staphylococci and
                                                                          Streptococcus
                                                                          dysgalactiae in
                                                                          lactating dairy cattle.
200-134...........  Intervet, Inc., 2 Giralda  FERTAGYL (gonadorelin)    Supplemental approval        522.1077  yes................  EA/FONSI \4\.
                     Farms, Madison, NJ 07940.  Sterile Solution.         under section 512(b)(1)
                                                                          of the FD&C Act for use
                                                                          with cloprostenol
                                                                          injection to
                                                                          synchronize estrous
                                                                          cycles to allow for
                                                                          fixed time artificial
                                                                          insemination (FTAI) in
                                                                          lactating dairy cows.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined 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 have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).
\3\ CE granted under 21 CFR 25.33(d)(5).
\4\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

    In addition during March and April 2015, ownership of, and all 
rights and interest in, the following approved applications have been 
transferred as follows:

----------------------------------------------------------------------------------------------------------------
                                                New animal drug product                                 21 CFR
    NADA/ANADA           Previous sponsor                 name                   New sponsor           section
----------------------------------------------------------------------------------------------------------------
140-883...........  Bayer HealthCare LLC,      LEGEND (hyaluronate        Merial, Inc., 3239            522.1145
                     Animal Health Division,    sodium) Injectable         Satellite Blvd., Bldg.
                     P.O. Box 390, Shawnee,     Solution.                  500, Duluth, GA 30096.
                     Mission, KS 66201.
141-188...........  Bayer HealthCare LLC,      MARQUIS (ponazuril)        Merial, Inc., 3239            520.1855
                     Animal Health Division,    Antiprotozoal Oral Paste.  Satellite Blvd., Bldg.
                     P.O. Box 390, Shawnee,                                500, Duluth, GA 30096.
                     Mission, KS 66201.
141-294...........  rEVO Biologics, 175        Bc6 rDNA construct in GTC  LFB USA, Inc., 175            528.1070
                     Crossing Blvd.,            155-92 goats.              Crossing Blvd.,
                     Framingham, MA 01702.                                 Framingham, MA 01702.
----------------------------------------------------------------------------------------------------------------

At this time, the regulations are being amended to reflect these 
changes of sponsorship.
    Following these changes of sponsorship, LFB USA, Inc., is now the 
sponsor of an approved application. Accordingly, Sec.  510.600 (21 CFR 
510.600) is being amended to add this

[[Page 34278]]

firm to the list of sponsors of approved applications.
    The animal drug regulations are also being amended to reflect 
several non-substantive changes. These technical amendments are 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.

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 528

    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 parts 510, 
520, 522, 526, and 528 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), remove the entry 
for ``Abbott Laboratories'' and add in alphabetical order an entry for 
``LFB USA, Inc.''; and in the table in paragraph (c)(2), remove the 
entry for 000044 and add in numerical order an entry for ``086047'' 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
------------------------------------------------------------------------
 
                                * * * * *
LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702.          086047
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
           Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
086047.................................  LFB USA, Inc., 175 Crossing
                                          Blvd., Framingham, MA 01702
 
                                * * * * *
------------------------------------------------------------------------

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.  520.48, revise paragraph (b) to read as follows:

Sec.  520.48  Altrenogest.

* * * * *
    (b) Sponsors. See Nos. 000061 and 013744 in Sec.  510.600(c) of 
this chapter.
* * * * *

Sec.  520.88g  [Amended]

0
5. In Sec.  520.88g, in paragraph (c)(2)(i), remove ``(1 milliliter)''.
0
6. In Sec.  520.154a:
0
a. Revise the section heading;
0
b. In paragraphs (d)(1)(ii), (d)(2)(i)(A), (d)(2)(ii)(A), and 
(d)(4)(ii), remove ``bacitracin methylene disalicylate'' and in its 
place add ``bacitracin methylenedisalicylate''; and
0
c. In paragraph (d)(3)(ii), remove ``Treponema hyodysenteriae'' and in 
its place add ``Brachyspira hyodysenteriae''.
    The revision reads as follows:

Sec.  520.154a  Bacitracin methylenedisalicylate.

* * * * *

Sec.  520.304  [Amended]

0
7. In Sec.  520.304, in paragraph (b)(3), remove ``No. 026637'' and in 
its place add ``Nos. 026637 and 062250''.

Sec.  520.804  [Amended]

0
8. In Sec.  520.804, redesignate paragraphs (c)(i), (c)(ii), and 
(c)(iii), as paragraphs (c)(1), (c)(2), and (c)(3).

0
9. In Sec.  520.1660d, revise paragraph (a)(4) to read as follows:

Sec.  520.1660d  Oxytetracycline powder.

    (a) * * *
    (4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 
2.46 and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb).
* * * * *

Sec.  520.1855  [Amended]

0
10. In Sec.  520.1855, in paragraph (b), remove ``000859'' and in its 
place add ``050604''.

0
11. In Sec.  520.2218, revise paragraphs (d)(1)(i)(A) and (B), and 
paragraphs (d)(2)(i)(A) and (B) to read as follows:

Sec.  520.2218  Sulfamerazine, sulfamethazine, and sulfaquinoxaline 
powder.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (A) As an aid in the control of coccidiosis caused by Eimeria 
tenella and E. necatrix susceptible to sulfamerazine, sulfamethazine, 
and sulfaquinoxaline: Provide medicated water (0.04 percent solution) 
for 2 to 3 days, then plain water for 3 days, then medicated water 
(0.025 percent solution) for 2 days. If bloody droppings appear, repeat 
at 0.025 percent level for 2 more days. Do not change litter.
    (B) As an aid in the control of acute fowl cholera caused by 
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 
to 3 days. If disease recurs, repeat treatment.
* * * * *
    (2) * * *
    (i) * * *
    (A) As an aid in the control of coccidiosis caused by Eimeria 
meleagrimitis and E. adenoeides susceptible to sulfamerazine, 
sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.025 
percent solution) for 2 days, then plain water for 3 days, then 
medicated water (0.025 percent solution) for 2 days, then plain water 
for 3 days, then medicated water (0.025 percent solution) for 2 days. 
Repeat if necessary. Do not change litter.
    (B) As an aid in the control of acute fowl cholera caused by 
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 
to 3 days. If disease recurs, repeat treatment.
* * * * *

Sec.  520.2640  [Amended]

0
12. In Sec.  520.2640, in paragraphs (e)(2)(iii) and (e)(3)(iii), 
remove the first sentence.

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

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

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

Sec. Sec.  522.1073 and 522.1075  [Removed]

0
14. Remove Sec. Sec.  522.1073 and 522.1075.

[[Page 34279]]

0
15. Revise Sec.  522.1077 to read as follows:

Sec.  522.1077  Gonadorelin.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 43 micrograms ([micro]g) of gonadorelin as gonadorelin acetate;
    (2) 100 [micro]g of gonadorelin as gonadorelin acetate;
    (3) 50 [micro]g of gonadorelin as gonadorelin diacetate 
tetrahydrate; or
    (4) 50 [micro]g of gonadorelin as gonadorelin hydrochloride.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 000061 for use of the 43-[micro]g/mL product described in 
paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of 
this section.
    (2) No. 068504 for use of the 100-[micro]g/mL product described in 
paragraph (a)(2) as in paragraphs (d)(1)(ii), (d)(1)(v), and (d)(2) of 
this section.
    (3) Nos. 000859 and 050604 for use of the 50-[micro]g/mL product 
described in paragraph (a)(3) as in paragraphs (d)(1)(ii) and (d)(2) of 
this section.
    (4) No. 054771 for use of the 50-[micro]g/mL product described in 
paragraph (a)(4) as in paragraphs (d)(1)(iii), (d)(1)(vi), and (d)(2) 
of this section.
    (c) Special considerations. Concurrent luteolytic drug use is 
approved as follows:
    (1) Cloprostenol injection for use as in paragraph (d)(1)(iv) of 
this section as provided by No. 000061 in Sec.  510.600(c) of this 
chapter.
    (2) Cloprostenol injection for use as in paragraph (d)(1)(v) of 
this section as provided by No. 000061 or No. 068504 in Sec.  
510.600(c) of this chapter.
    (3) Dinoprost injection for use as in paragraph (d)(1)(vi) of this 
section as provided by No. 054771 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use in cattle--(1) Indications for use and 
amounts--(i) For the treatment of ovarian follicular cysts in dairy 
cattle: Administer 86 [mu]g gonadorelin by intramuscular or intravenous 
injection.
    (ii) For the treatment of ovarian follicular cysts in dairy cattle: 
Administer 100 [mu]g gonadorelin by intramuscular or intravenous 
injection.
    (iii) For the treatment of ovarian follicular cysts in cattle: 
Administer 100 [mu]g gonadorelin by intramuscular injection.
    (iv) For use with cloprostenol injection to synchronize estrous 
cycles to allow for fixed-time artificial insemination (FTAI) in 
lactating dairy cows: Administer to each cow 86 [mu]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 500 [mu]g 
cloprostenol by intramuscular injection, followed 30 to 72 hours later 
by 86 [mu]g gonadorelin by intramuscular injection.
    (v) For use with cloprostenol injection to synchronize estrous 
cycles to allow for fixed-time artificial insemination (FTAI) in 
lactating dairy cows and beef cows: Administer to each cow 100 [mu]g 
gonadorelin by intramuscular injection, followed 6 to 8 days later by 
500 [mu]g cloprostenol by intramuscular injection, followed 30 to 72 
hours later by 100 [mu]g gonadorelin by intramuscular injection.
    (vi) For use with dinoprost injection to synchronize estrous cycles 
to allow fixed-time artificial insemination (FTAI) in lactating dairy 
cows: Administer to each cow 100 to 200 [mu]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost 
by intramuscular injection, followed 30 to 72 hours later by 100 to 200 
[mu]g gonadorelin by intramuscular injection.
    (2) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  522.1145  [Amended]

0
16. In Sec.  520.1145, in paragraph (e)(2)(i), remove ``000859'' and in 
its place add ``050604''.

0
17. In Sec.  522.2470, revise paragraph (b) to read as follows:

Sec.  522.2470  Tiletamine and zolazepam for injection.

* * * * *
    (b) Sponsors. See Nos. 026637 and 054771 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
18. In Sec.  522.2483, revise paragraph (b) to read as follows:

Sec.  522.2483  Triamcinolone.

* * * * *
    (b) Sponsors. See Nos. 000010 and 054628 in Sec.  510.600(c) of 
this chapter.
* * * * *

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
20. In Sec.  526.313, revise paragraph (d)(1)(ii) to read as follows:

Sec.  526.313  Ceftiofur.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For use in lactating dairy cattle:
    (A) For the treatment of clinical mastitis associated with 
coagulase-negative staphylococci, Streptococcus dysgalactiae, and 
Escherichia coli; and
    (B) For the treatment of diagnosed subclinical mastitis associated 
with coagulase-negative staphylococci and S. dysgalactiae.
* * * * *

PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

0
21. The authority citation for 21 CFR part 528 continues to read as 
follows:

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

Sec.  528.1070  [Amended]

0
22. In Sec.  528.1070, in paragraph (b), remove ``042976'' and in its 
place add ``086047''.

    Dated: June 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-14734 Filed 6-15-15; 8:45 am]
 BILLING CODE 4164-01-P