Document ID: FDA-2014-N-0002-0057
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon;
Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and
Sulfadiazine; Tylosin; Change of Sponsor
Posted Date: 2014-10-28T04:00Z

[Federal Register Volume 79, Number 208 (Tuesday, October 28, 2014)]
[Rules and Regulations]
[Pages 64114-64117]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25588]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 556

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

New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and 
Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; 
Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

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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 August 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 of two NADAs and 
one ANADA, and to reflect a revised food safety warning.

DATES: This rule is effective October 28, 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 August 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 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.
    In addition, Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort 
Collins, CO 80525 has transferred ownership of, and all rights and 
interest in ANADA 200-033 for UNIPRIM (trimethoprim and sulfadiazine) 
Powder to Neogen Corp. (Neogen), 944 Nandino Blvd., Lexington, KY 
40511. In 2004, Hess & Clark, Inc., transferred ownership of, and all 
rights and interest in NADA 011-154 for NFZ Puffer (nitrofurazone 
soluble powder) and NADA 140-851 for NFZ Wound Dressing (nitrofurazone 
ointment) to Neogen. At this time, the regulations are being amended to 
reflect these transfers.
    Following these changes of sponsorship, Macleod Pharmaceuticals, 
Inc., and Hess & Clark, Inc., will no longer be the sponsor of an 
approved application. Accordingly, 21 CFR 510.600(c) is being amended 
to remove the entries for these firms.
    Also, the animal drug regulations are being amended in 21 CFR 
522.690 to revise a human food safety warning for dinoprost 
tromethamine injectable solution. 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.

                                     Table 1--Original and Supplemental NADAs and ANADAs Approved During August 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              New animal drug
    NADA/ANADA             Sponsor              product name              Action           21 CFR  Sections        FOIA  Summary         NEPA Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
140-833...........  Merial Ltd., 3239      IVOMEC Plus            Supplemental approval  522.1193............  yes.................  CE.1 2
                     Satellite Blvd.,       (ivermectin and        reducing the          556.344.............
                     Bldg. 500, Duluth,     clorsulon) Injection   preslaughter
                     GA 30096-4640.         for Cattle.            withdrawal period
                                                                   from 49 days to 21
                                                                   days.
141-043...........  Zoetis Inc., 333       SYNOVEX CHOICE         Supplemental approval  522.2478............  yes.................  EA/FONSI.\3\
                     Portage St.,           (trenbolone and        for increased rate
                     Kalamazoo, MI 49007.   estradiol implant).    of weight gain and
                                                                   improved feed
                                                                   efficiency in
                                                                   heifers fed in
                                                                   confinement for
                                                                   slaughter.
141-342...........  Jurox Pty. Ltd., 85    ALFAXAN (alfaxalone)   Supplemental approval  522.52..............  no..................  CE.1 4
                     Gardiner Rd.,          Injectable             adding a label
                     Rutherford, NSW        Anesthetic for Dogs    statement that
                     2320, Australia.       and Cats.              alfaxalone is a
                                                                   Class IV controlled
                                                                   substance.

[[Page 64115]]

 
141-348...........  Zoetis Inc., 333       SYNOVEX ONE FEEDLOT    Original approval for  522.2478............  yes.................  EA/FONSI.1 3
                     Portage St.,           (trenbolone and        increased rate of
                     Kalamazoo, MI 49007.   estradiol extended     weight gain and
                                            release implant).      improved feed
                                           SYNOVEX ONE GRASS       efficiency for up to
                                            (trenbolone and        200 days in steers
                                            estradiol extended     and heifers fed in
                                            release implant).      confinement for
                                                                   slaughter.
                                                                  Original approval for
                                                                   increased rate of
                                                                   weight gain for up
                                                                   to 200 days in
                                                                   pasture steers and
                                                                   heifers (slaughter,
                                                                   stocker, and feeder).
200-455 \5\.......  Cross Vetpharm Group   TYLOMED-WS (tylosin    Supplemental approval  520.2640............  no..................  CE.1 6
                     Ltd. Broomhill Rd.,    tartrate) Soluble      of a change to
                     Tallaght,.             Powder.                veterinary
                    Dublin 24, Ireland...                          prescription (Rx)
                                                                   marketing status to
                                                                   conform with
                                                                   reference (pioneer)
                                                                   product.
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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 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).
\3\ 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).
\4\ CE granted under 21 CFR 25.33(d)(1).
\5\ This application was listed as being affected by guidance for industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination Products
  Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product
  Use Conditions with GFI #209'', December 2013.
\6\ CE granted under 21 CFR 25.33(a)(1).

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.
    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, 524, and 556 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 
entries for ``Macleod Pharmaceuticals, Inc.'' and ``Hess & Clark, 
Inc.'' and alphabetically add an entry for ``Neogen Corp.''; and in the 
table in paragraph (c)(2), remove the entries for ``058711'' and 
``050749'' and numerically add an entry for ``059051'' 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
------------------------------------------------------------------------
 
                              * * * * * * *
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511....          059051
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
 Drug labeler
     code                         Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
        059051  Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511

[[Page 64116]]

 
 
                              * * * * * * *
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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.

Sec.  520.2613  [Amended]

0
4. In paragraph (b) of Sec.  520.2613, remove ``058711'' and in its 
place add ``059051''.
0
5. In Sec.  520.2640, revise paragraphs (b), (d), and (e)(2)(ii) to 
read as follows:

Sec.  520.2640  Tylosin.

* * * * *
    (b) Sponsors--(1) No. 000986 for use as in paragraph (e) of this 
section.
    (2) Nos. 016592 and 061623 for use as in paragraphs (e)(1)(i)(A), 
(e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this section.
* * * * *
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (e) * * *
    (2) * * *
    (ii) Indications for use. For the reduction in severity of effects 
of infectious sinusitis associated with Mycoplasma gallisepticum.
* * * * *

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.  522.52, in paragraph (c)(3), add a second sentence to read 
as follows:

Sec.  522.52  Alfaxalone.

* * * * *
    (c) * * *
    (3) * * * Alfaxalone is a Class IV controlled substance.

0
8. In Sec.  522.690, revise paragraph (d)(1)(iii) to read as follows:

Sec.  522.690  Dinoprost.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Do not use in horses intended for human 
consumption.
* * * * *

0
9. In Sec.  522.1193, revise paragraph (e)(3) to read as follows:

Sec.  522.1193  Ivermectin and clorsulon.

* * * * *
    (e) * * *
    (3) Limitations. For No. 050604: Do not treat cattle within 21 days 
of slaughter. For Nos. 055529 and 058005: Do not treat cattle within 49 
days of slaughter. Because a withdrawal time in milk has not been 
established, do not use in female dairy cattle of breeding age. A 
withdrawal period has not been established for preruminating calves. Do 
not use in calves to be processed for veal.

0
10. In Sec.  522.2478, revise paragraphs (a), (d)(1)(i) introductory 
text, (d)(1)(ii) introductory text, and (d)(2); and add paragraphs 
(d)(1)(iii) and (d)(3) to read as follows:

Sec.  522.2478  Trenbolone acetate and estradiol benzoate.

    (a) Specifications--(1) Each implant consists of:
    (i) 8 pellets, each pellet containing 25 milligrams (mg) trenbolone 
acetate and 3.5 mg estradiol benzoate.
    (ii) 4 pellets, each pellet containing 25 mg trenbolone acetate and 
3.5 mg estradiol benzoate.
    (2) Each extended release implant consists of:
    (i) 8 pellets with a porous polymer film coating, each pellet 
containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.
    (ii) 6 pellets with a porous polymer film coating, each pellet 
containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.
* * * * *
    (d) * * *
    (1) * * *
    (i) For an implant as described in paragraph (a)(1)(i) of this 
section:
* * * * *
    (ii) For an implant as described in paragraph (a)(1)(ii) of this 
section:
* * * * *
    (iii) For an implant as described in paragraph (a)(2)(i) of this 
section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate 
in an extended release implant.
    (B) Indications for use. For increased rate of weight gain and 
improved feed efficiency for up to 200 days.
    (C) Limitations. Implant subcutaneously in ear only. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.
    (2) Heifers fed in confinement for slaughter--(i) For an implant as 
described in paragraph (a)(1)(i) of this section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate.
    (B) Indications for use. For increased rate of weight gain.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in 
dairy or beef replacement heifers. Safety and effectiveness have not 
been established in veal calves. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (ii) For an implant as described in paragraph (a)(1)(ii) of this 
section:
    (A) Amount. 100 mg trenbolone acetate and 14 mg estradiol benzoate.
    (B) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in 
dairy or beef replacement heifers. Safety and effectiveness have not 
been established in veal calves. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (iii) For an implant as described in paragraph (a)(2)(i) of this 
section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate 
in an extended release implant.
    (B) Indications for use. For increased rate of weight gain and 
improved feed efficiency for up to 200 days.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in 
dairy or beef replacement heifers. Safety and effectiveness have not 
been established in veal calves. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (3) Pasture steers and heifers (slaughter, stocker, and feeder)--
(i) For an implant as described in paragraph (a)(2)(ii) of this 
section:
    (A) Amount. 150 mg trenbolone acetate and 21 mg estradiol benzoate 
in an extended release implant.
    (B) Indications for use. For increased rate of weight gain for up 
to 200 days.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in 
dairy or beef replacement heifers.

[[Page 64117]]

Safety and effectiveness have not been established in veal calves. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (ii) [Reserved]

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
11. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec.  524.1580a  [Amended]

0
12. In paragraph (b)(1) of Sec.  524.1580a, remove ``Nos. 050749, 
054628, 054925, 058005, and 061623'' and add in its place ``Nos. 
054628, 054925, 058005, 059051, and 061623''.

Sec.  524.1580b  [Amended]

0
13. In paragraph (b) of Sec.  524.1580b, remove ``No. 054628'' and in 
its place add ``Nos. 054628 and 059051''.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
14. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

0
15. In Sec.  556.344, revise paragraphs (a), (b)(1)(i), and (b)(2)(ii); 
and add paragraph (c) to read as follows:

Sec.  556.344  Ivermectin.

    (a) Acceptable Daily Intake (ADI). The ADI for total residues of 
ivermectin is 5 micrograms per kilogram of body weight per day.
    (b) * * *
    (1) * * *
    (i) Cattle. 1.6 parts per million.
    (2) * * *
    (ii) Cattle. 650 parts per billion.
    (c) Related conditions of use. See Sec. Sec.  520.1192, 520.1195, 
520.1197, 522.1192, 522.1193, 524.1193, and 558.300 of this chapter.

    Dated: October 23, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-25588 Filed 10-27-14; 8:45 am]
BILLING CODE 4164-01-P