82_FR_12206 82 FR 12167 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name

82 FR 12167 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 39 (March 1, 2017)

Page Range12167-12170
FR Document2017-03930

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2016. 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 the change of sponsorship of an application and a change of a sponsor's name.

Federal Register, Volume 82 Issue 39 (Wednesday, March 1, 2017) 
[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Rules and Regulations]
[Pages 12167-12170]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03930]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules 
and Regulations

[[Page 12167]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 529, and 558

[Docket No. FDA-2016-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of a New Animal Drug Application; Change of 
Sponsor; Change of Sponsor's Name

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during November and December 2016. 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 the change of 
sponsorship of an application and a change of a sponsor's name.

DATES: This rule is effective March 1, 2017, except for amendments 2.a 
and 2.c to 21 CFR 510.600, and the amendments to 21 CFR 522.313c and 
529.1186, which are effective March 13, 2017.

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, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during November and December 2016, 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 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 November and December 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  Effect of the
         Approval date              File No.            Sponsor            Product name          Species              action          Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
November 10, 2016..............         141-474  Elanco US, Inc.,      ITRAFUNGOL           Cats.............  Original approval    FOI Summary.
                                                  2500 Innovation       (itraconazole oral                      for the treatment
                                                  Way, Greenfield, IN   solution).                              of dermatophytosis
                                                  46140.                                                        caused by
                                                                                                                Microsporum canis
                                                                                                                in cats.
November 16, 2016..............         141-443  Elanco US Inc., 2500  ONSIOR               Dogs.............  Supplemental         FOI Summary.
                                                  Innovation Way,       (robenacoxib)                           approval for the
                                                  Greenfield, IN        Injection.                              control of
                                                  46140.                                                        postoperative pain
                                                                                                                and inflammation
                                                                                                                associated with
                                                                                                                soft tissue
                                                                                                                surgery in dogs by
                                                                                                                subcutaneous
                                                                                                                injection; and for
                                                                                                                the use of oral
                                                                                                                tablets to
                                                                                                                complete the
                                                                                                                dosing regimen of
                                                                                                                a maximum of 3
                                                                                                                days.
December 12, 2016..............         141-452  Zoetis Inc., 333      SIMPARICA            Dogs.............  Supplemental         FOI Summary.
                                                  Portage St.,          (sarolaner)                             approval for the
                                                  Kalamazoo, MI 49007.  Chewables.                              treatment and
                                                                                                                control of
                                                                                                                infestations of
                                                                                                                Ixodes scapularis
                                                                                                                (black-legged
                                                                                                                tick) in dogs.

[[Page 12168]]

 
December 16, 2016..............         141-473  Huvepharma AD, 5th    LINCOMIX             Chickens.........  Original approval    FOI Summary.
                                                  Floor, 3A Nikolay     (lincomycin                             for use in two-
                                                  Haytov Str., 1113     phosphate) plus                         way, combination
                                                  Sophia, Bulgaria.     STENOROL                                drug Type C
                                                                        (halofuginone                           medicated broiler
                                                                        hydrobromide) Type                      feeds for control
                                                                        C medicated feeds.                      of necrotic
                                                                                                                enteritis and
                                                                                                                prevention of
                                                                                                                coccidiosis in
                                                                                                                broiler chickens.
December 21, 2016..............         200-589  Med-Pharmex, Inc.,    FLORCON              Swine............  Original approval    FOI Summary.
                                                  2727 Thompson Creek   (florfenicol) 2.3%                      of a generic copy
                                                  Rd., Pomona, CA       Concentrate                             of NADA 141-206.
                                                  91767-1861.           Solution.
December 29, 2016..............         141-475  VetDC, Inc., 320 E.   TANOVEA-CA1          Dogs.............  Conditional          FOI Summary.
                                                  Vine Dr., Suite       (rabacfosadine for                      approval for the
                                                  218, Fort Collins,    injection).                             treatment of
                                                  CO 80524.                                                     lymphoma in dogs.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Following the conditional approval of NADA 141-175, VetDC, Inc. 
will now be included in the list of sponsors of approved applications 
in Sec.  510.600(c) (21 CFR 510.600(c)).

II. Change of Sponsorship

    ECO LLC, 344 Nassau St., Princeton, NJ 08540 has informed FDA that 
it has transferred ownership of, and all rights and interest in, ANADA 
200-600 for WORMX (pyrantel pamoate) Flavored Tablets to Sergeant's Pet 
Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. The 
regulations will be amended to reflect this change of sponsorship.

III. Withdrawals of Approval

    During November and December 2016, the following sponsors requested 
that FDA withdraw approval of the NADAs listed in the following table 
because the products are no longer manufactured or marketed:

----------------------------------------------------------------------------------------------------------------
                                                                                                      21 CFR
                File No.                            Sponsor                  Product name             section
----------------------------------------------------------------------------------------------------------------
135-773.................................  Baxter Healthcare Corp.,    AERRANE (isoflurane USP)..        529.1186
                                           One Baxter Pkwy.,
                                           Deerfield, IL 60015.
200-421.................................  Hospira, Inc., 275 North    Ceftiofur (ceftiofur              522.313c
                                           Field Dr., Lake Forest,     sodium) for Injection.
                                           IL 60045.
----------------------------------------------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 135-773 and ANADA 200-524, and all supplements 
and amendments thereto, is withdrawn, effective March 13, 2017. As 
provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect this voluntary withdrawal of 
approval. Following this withdrawal of approval, neither Baxter 
Healthcare Corp. nor Hospira, Inc. is the sponsor of an approved 
application.
    IV. Technical Amendments
    iVaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155 
has informed FDA that it has changed its name to Ivaoes Animal Health. 
Accordingly, we are amending Sec.  510.600 (c) to reflect this change 
of sponsor name. We are also making several technical amendments 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 Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 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, 
516, 520, 522, 529, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


0
2. Amend Sec.  510.600 as follows:
0
a. Effective March 13, 2017, in the table in paragraph (c)(1), remove 
the entries for ``Baxter Healthcare Corp.'' and ``Hospira, Inc.'';
0
b. Effective March 1, 2017, in the table in paragraph (c)(1), revise 
the entry for ``iVaoes Animal Health'' and alphabetically add an entry 
for ``VetDC, Inc.'';
0
c. Effective March 13, 2017, in the table in paragraph (c)(2), remove 
the entries for ``000409'' and ``010019''; and
0
d. Effective March 1, 2017, in the table in paragraph (c)(2), revise 
the entry for ``086064'' and numerically add an entry for ``086072''.

[[Page 12169]]

    The revisions and additions 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
------------------------------------------------------------------------
 
                              * * * * * * *
Ivaoes Animal Health, 4300 SW 73rd Ave., Suite 110,               086064
 Miami, FL 33155........................................
 
                              * * * * * * *
VetDC, Inc., 320 E. Vine Dr., Suite 218, Fort Collins,            086072
 CO 80524...............................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
086064......................  Ivaoes Animal Health, 4300 SW 73rd Ave.,
                               Suite 110, Miami, FL 33155.
 
                              * * * * * * *
086072......................  VetDC, Inc., 320 E Vine Dr., Suite 218,
                               Fort Collins, CO 80524.
 
                              * * * * * * *
------------------------------------------------------------------------

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for part 516 continues to read as follows:

    Authority: 360ccc, 360ccc-2, 371.


0
4. Add Sec.  516.2065 to read as follows:


Sec.  516.2065  Rabacfosadine.

    (a) Specifications. Each vial of powder contains 16.4 milligrams 
(mg) rabacfosadine. Each milliliter of constituted solution contains 
8.2 mg rabacfosadine.
    (b) Sponsor. See No. 086072 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer rabacfosadine 
at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once 
every 3 weeks, for up to 5 doses.
    (2) Indications for use. For the treatment of lymphoma in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. It is a violation of Federal law 
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for part 520 continues to read as follows:

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


Sec.  520.370  [Amended]

0
6. In Sec.  520.370, in paragraph (c)(2), remove ``(group G, -
hemolytic)'' and in its place add ``(group G, beta-hemolytic)''.

0
7. In Sec.  520.955, revise paragraph (b) to read as follows:


Sec.  520.955  Florfenicol.

* * * * *
    (b) Sponsors. See Nos. 000061, 054925, and 058198 in Sec.  
510.600(c) of this chapter.
* * * * *

0
8. Add Sec.  520.1189 to read as follows:


Sec.  520.1189  Itraconazole.

    (a) Specifications. Each milliliter (mL) of solution contains 10 
milligrams (mg) of itraconazole.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 5 mg/kilogram (kg) 
(0.5 mL/kg) of body weight once daily on alternating weeks for 3 
treatment cycles.
    (2) Indications for use. For the treatment of dermatophytosis 
caused by Microsporum canis in cats.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  520.2041  [Amended]

0
9. In Sec.  520.2041, in paragraph (b), remove ``017135, 051311, and 
066916'' and in its place add ``066916, 017135, and 051311''.

0
10. In Sec.  520.2086, revise paragraph (c)(2) to read as follows:


Sec.  520.2086  Sarolaner.

* * * * *
    (c) * * *
    (2) Indications for use. Kills adult fleas, and for the treatment 
and prevention of flea infestations (Ctenocephalides felis), and the 
treatment and control of tick infestations [Amblyomma americanum (lone 
star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor 
variabilis (American dog tick), Ixodes scapularis (black-legged tick), 
and Rhipicephalus sanguineus (brown dog tick)] for 1 month in dogs 6 
months of age or older and weighing 2.8 pounds or greater.
* * * * *


Sec.  520.2325b  [Amended]

0
11. In Sec.  520.2325b, in paragraph (b), remove ``050749'' and in its 
place add ``016592''.

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

0
12. The authority citation for part 522 continues to read as follows:

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


Sec.  522.313c  [Amended]

0
13. Effective March 13, 2017, in Sec.  522.313c, in paragraph (b), 
remove

[[Page 12170]]

``000409, 054771, and 068330'' and in its place add ``054771 and 
068330''.

0
14. In Sec.  522.2075, revise paragraph (c) to read as follows:


Sec.  522.2075  Robenacoxib.

* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.91 mg per 
pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a 
maximum of 3 days. After the initial subcutaneous dose, subsequent 
doses can be given by subcutaneous injection or as the oral tablet in 
dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of 
age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose 
per day. See Sec.  520.2075(c)(1) of this chapter.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with soft tissue surgery in dogs at least 4 
months of age for a maximum of 3 days.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 0.91 mg per pound (2 mg/kg) by 
subcutaneous injection, once daily, for a maximum of 3 days.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with orthopedic surgery, ovariohysterectomy, 
and castration in cats at least 4 months of age for a maximum of 3 
days.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
15. The authority citation for part 529 continues to read as follows:

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


Sec.  529.1186  [Amended]

0
16. Effective March 13, 2017, in Sec.  529.1186, in paragraph (b), 
remove ``010019,''.

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

0
17. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.


0
18. In Sec.  558.325, revise paragraph (e)(1)(ii) to read as follows:


Sec.  558.325  Lincomycin.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combination  in
     Lincomycin  grams/ton          grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 2........................  Halofuginone 2.72  Broiler chickens: For   Feed continuously as           016592
                                                    the control of          sole ration.
                                                    necrotic enteritis      Withdraw 4 days
                                                    caused or complicated   before slaughter. Do
                                                    by Clostridium spp.     not feed to laying
                                                    or other organisms      chickens or
                                                    susceptible to          waterfowl.
                                                    lincomycin; and the     Halofuginone
                                                    prevention of           hydrobromide as
                                                    coccidiosis caused by   provided by No.
                                                    Eimeria tenella, E.     016592 in Sec.
                                                    necatrix, E.            510.600 of this
                                                    acervulina, E.          chapter.
                                                    brunetti, E. mivati,
                                                    and E. maxima.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03930 Filed 2-28-17; 8:45 am]
 BILLING CODE 4164-01-P

12167 Rules and Regulations Federal Register Vol. 82, No. 39 Wednesday, March 1, 2017 This section of the FEDERAL REGISTER SUMMARY: The Food and Drug for NADAs and ANADAs during contains regulatory documents having general Administration (FDA or we) is November and December 2016, as listed applicability and legal effect, most of which amending the animal drug regulations to in table 1. In addition, FDA is informing are keyed to and codified in the Code of reflect application-related actions for the public of the availability, where Federal Regulations, which is published under new animal drug applications (NADAs) 50 titles pursuant to 44 U.S.C. 1510. applicable, of documentation of and abbreviated new animal drug environmental review required under The Code of Federal Regulations is sold by applications (ANADAs) during the National Environmental Policy Act the Superintendent of Documents. Prices of November and December 2016. FDA is and, for actions requiring review of new books are listed in the first FEDERAL also informing the public of the safety or effectiveness data, summaries REGISTER issue of each week. availability of summaries of the basis of of the basis of approval (FOI approval and of environmental review Summaries) under the Freedom of documents, where applicable. The Information Act (FOIA). These public DEPARTMENT OF HEALTH AND animal drug regulations are also being HUMAN SERVICES documents may be seen in the Division amended to reflect the change of of Dockets Management (HFA–305), sponsorship of an application and a Food and Drug Administration change of a sponsor’s name. Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD DATES: This rule is effective March 1, 21 CFR Parts 510, 516, 520, 522, 529, 20852, between 9 a.m. and 4 p.m., 2017, except for amendments 2.a and and 558 2.c to 21 CFR 510.600, and the Monday through Friday. Persons with amendments to 21 CFR 522.313c and access to the Internet may obtain these [Docket No. FDA–2016–N–0002] 529.1186, which are effective March 13, documents at the CVM FOIA Electronic 2017. Reading Room: http://www.fda.gov/ New Animal Drugs; Approval of New FOR FURTHER INFORMATION CONTACT: AboutFDA/CentersOffices/ Animal Drug Applications; Withdrawal George K. Haibel, Center for Veterinary OfficeofFoods/CVM/ of Approval of a New Animal Drug Medicine (HFV–6), Food and Drug CVMFOIAElectronicReadingRoom/ Application; Change of Sponsor; Administration, 7519 Standish Pl., default.htm. Marketing exclusivity and Change of Sponsor’s Name Rockville, MD 20855, 240–402–5689, patent information may be accessed in george.haibel@fda.hhs.gov. FDA’s publication, Approved Animal AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: Drug Products Online (Green Book) at: HHS. http://www.fda.gov/AnimalVeterinary/ I. Approval Actions Products/ Final rule; technical ACTION: amendment. FDA is amending the animal drug ApprovedAnimalDrugProducts/ regulations to reflect approval actions default.htm. TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING NOVEMBER AND DECEMBER 2016 Public Approval date File No. Sponsor Product name Species Effect of the action documents November 10, 2016 ... 141–474 Elanco US, Inc., ITRAFUNGOL Cats ......... Original approval for the FOI Sum- 2500 Innovation (itraconazole oral treatment of mary. Way, Greenfield, solution). dermatophytosis caused IN 46140. by Microsporum canis in cats. November 16, 2016 ... 141–443 Elanco US Inc., ONSIOR Dogs ........ Supplemental approval for FOI Sum- 2500 Innovation (robenacoxib) In- the control of post- mary. Way, Greenfield, jection. operative pain and inflam- IN 46140. mation associated with soft tissue surgery in dogs by subcutaneous injection; and for the use of oral tab- lets to complete the dosing regimen of a maximum of 3 days. December 12, 2016 ... 141–452 Zoetis Inc., 333 SIMPARICA Dogs ........ Supplemental approval for FOI Sum- Portage St., (sarolaner) the treatment and control mary. Kalamazoo, MI Chewables. of infestations of Ixodes jstallworth on DSK7TPTVN1PROD with RULES 49007. scapularis (black-legged tick) in dogs. VerDate Sep<11>2014 14:27 Feb 28, 2017 Jkt 241001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\01MRR1.SGM 01MRR1

12168 Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules and Regulations TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING NOVEMBER AND DECEMBER 2016— Continued Public Approval date File No. Sponsor Product name Species Effect of the action documents December 16, 2016 ... 141–473 Huvepharma AD, LINCOMIX (linco- Chickens .. Original approval for use in FOI Sum- 5th Floor, 3A mycin phos- two-way, combination drug mary. Nikolay Haytov phate) plus Type C medicated broiler Str., 1113 So- STENOROL feeds for control of necrot- phia, Bulgaria. (halofuginone ic enteritis and prevention hydrobromide) of coccidiosis in broiler Type C medi- chickens. cated feeds. December 21, 2016 ... 200–589 Med-Pharmex, Inc., FLORCON Swine ....... Original approval of a ge- FOI Sum- 2727 Thompson (florfenicol) 2.3% neric copy of NADA 141– mary. Creek Rd., Po- Concentrate So- 206. mona, CA lution. 91767–1861. December 29, 2016 ... 141–475 VetDC, Inc., 320 E. TANOVEA–CA1 Dogs ........ Conditional approval for the FOI Sum- Vine Dr., Suite (rabacfosadine treatment of lymphoma in mary. 218, Fort Collins, for injection). dogs. CO 80524. Following the conditional approval of transferred ownership of, and all rights III. Withdrawals of Approval NADA 141–175, VetDC, Inc. will now and interest in, ANADA 200–600 for be included in the list of sponsors of WORMX (pyrantel pamoate) Flavored During November and December approved applications in § 510.600(c) Tablets to Sergeant’s Pet Care Products, 2016, the following sponsors requested (21 CFR 510.600(c)). Inc., 10077 S. 134th St., Omaha, NE that FDA withdraw approval of the 68138. The regulations will be amended NADAs listed in the following table II. Change of Sponsorship because the products are no longer to reflect this change of sponsorship. ECO LLC, 344 Nassau St., Princeton, manufactured or marketed: NJ 08540 has informed FDA that it has 21 CFR File No. Sponsor Product name section 135–773 ......................................... Baxter Healthcare Corp., One Baxter Pkwy., Deer- AERRANE (isoflurane USP) .......... 529.1186 field, IL 60015. 200–421 ......................................... Hospira, Inc., 275 North Field Dr., Lake Forest, IL Ceftiofur (ceftiofur sodium) for In- 522.313c 60045. jection. Elsewhere in this issue of the Federal congressional review requirements in 5 CFR parts 510, 516, 520, 522, 529, and Register, FDA gave notice that approval U.S.C. 801–808. 558 are amended as follows: of NADA 135–773 and ANADA 200– List of Subjects PART 510—NEW ANIMAL DRUGS 524, and all supplements and amendments thereto, is withdrawn, 21 CFR Part 510 effective March 13, 2017. As provided ■ 1. The authority citation for part 510 Administrative practice and continues to read as follows: in the regulatory text of this document, procedure, Animal drugs, Labeling, the animal drug regulations are Authority: 21 U.S.C. 321, 331, 351, 352, amended to reflect this voluntary Reporting and recordkeeping 353, 360b, 371, 379e. withdrawal of approval. Following this requirements. ■ 2. Amend § 510.600 as follows: withdrawal of approval, neither Baxter 21 CFR Part 516 ■ a. Effective March 13, 2017, in the Healthcare Corp. nor Hospira, Inc. is the Administrative practice and table in paragraph (c)(1), remove the sponsor of an approved application. IV. Technical Amendments procedure, Animal drugs, Confidential entries for ‘‘Baxter Healthcare Corp.’’ iVaoes Animal Health, 4300 SW 73rd business information, Reporting and and ‘‘Hospira, Inc.’’; Ave., Suite 110, Miami, FL 33155 has recordkeeping requirements. ■ b. Effective March 1, 2017, in the table informed FDA that it has changed its 21 CFR Parts 520, 522, and 529 in paragraph (c)(1), revise the entry for name to Ivaoes Animal Health. ‘‘iVaoes Animal Health’’ and Accordingly, we are amending § 510.600 Animal drugs. alphabetically add an entry for ‘‘VetDC, (c) to reflect this change of sponsor 21 CFR Part 558 Inc.’’; jstallworth on DSK7TPTVN1PROD with RULES name. We are also making several ■ c. Effective March 13, 2017, in the technical amendments to improve the Animal drugs, Animal feeds. table in paragraph (c)(2), remove the accuracy of the regulations. Therefore, under the Federal Food, entries for ‘‘000409’’ and ‘‘010019’’; and This rule does not meet the definition Drug, and Cosmetic Act and under ■ d. Effective March 1, 2017, in the table of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because authority delegated to the Commissioner in paragraph (c)(2), revise the entry for it is a rule of ‘‘particular applicability.’’ of Food and Drugs and redelegated to ‘‘086064’’ and numerically add an entry Therefore, it is not subject to the the Center for Veterinary Medicine, 21 for ‘‘086072’’. VerDate Sep<11>2014 14:27 Feb 28, 2017 Jkt 241001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 E:\FR\FM\01MRR1.SGM 01MRR1

Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules and Regulations 12169 The revisions and additions read as § 510.600 Names, addresses, and drug (c) * * * follows: labeler codes of sponsors of approved applications. (1) * * * * * * * * Drug labeler Firm name and address code * * * * * * * Ivaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155 .......................................................................................... 086064 * * * * * * * VetDC, Inc., 320 E. Vine Dr., Suite 218, Fort Collins, CO 80524 ...................................................................................................... 086072 * * * * * * * (2) * * * Drug labeler Firm name and address code * * * * * * * 086064 ........ Ivaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155. * * * * * * * 086072 ........ VetDC, Inc., 320 E Vine Dr., Suite 218, Fort Collins, CO 80524. * * * * * * * PART 516—NEW ANIMAL DRUGS FOR § 520.370 [Amended] ■ 10. In § 520.2086, revise paragraph MINOR USE AND MINOR SPECIES ■ 6. In § 520.370, in paragraph (c)(2), (c)(2) to read as follows: remove ‘‘(group G, -hemolytic)’’ and in § 520.2086 Sarolaner. ■ 3. The authority citation for part 516 its place add ‘‘(group G, beta- continues to read as follows: hemolytic)’’. * * * * * ■ 7. In § 520.955, revise paragraph (b) to (c) * * * Authority: 360ccc, 360ccc–2, 371. read as follows: (2) Indications for use. Kills adult ■ 4. Add § 516.2065 to read as follows: fleas, and for the treatment and § 520.955 Florfenicol. prevention of flea infestations § 516.2065 Rabacfosadine. * * * * * (Ctenocephalides felis), and the (a) Specifications. Each vial of powder (b) Sponsors. See Nos. 000061, treatment and control of tick contains 16.4 milligrams (mg) 054925, and 058198 in § 510.600(c) of infestations [Amblyomma americanum rabacfosadine. Each milliliter of this chapter. (lone star tick), Amblyomma maculatum constituted solution contains 8.2 mg * * * * * (Gulf Coast tick), Dermacentor variabilis rabacfosadine. ■ 8. Add § 520.1189 to read as follows: (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus (b) Sponsor. See No. 086072 in § 520.1189 Itraconazole. sanguineus (brown dog tick)] for 1 § 510.600(c) of this chapter. (a) Specifications. Each milliliter (mL) month in dogs 6 months of age or older (c) Conditions of use in dogs—(1) of solution contains 10 milligrams (mg) and weighing 2.8 pounds or greater. Amount. Administer rabacfosadine at 1 of itraconazole. * * * * * mg/kilogram body weight as a 30- (b) Sponsor. See No. 058198 in minute intravenous infusion, once every § 510.600(c) of this chapter. § 520.2325b [Amended] 3 weeks, for up to 5 doses. (c) Conditions of use—(1) Amount. ■ 11. In § 520.2325b, in paragraph (b), (2) Indications for use. For the Administer 5 mg/kilogram (kg) (0.5 mL/ remove ‘‘050749’’ and in its place add treatment of lymphoma in dogs. kg) of body weight once daily on ‘‘016592’’. (3) Limitations. Federal law restricts alternating weeks for 3 treatment cycles. (2) Indications for use. For the PART 522—IMPLANTATION OR this drug to use by or on the order of treatment of dermatophytosis caused by INJECTABLE DOSAGE FORM NEW a licensed veterinarian. It is a violation Microsporum canis in cats. ANIMAL DRUGS of Federal law to use this product other (3) Limitations. Federal law restricts than as directed in the labeling. this drug to use by or on the order of jstallworth on DSK7TPTVN1PROD with RULES ■ 12. The authority citation for part 522 PART 520—ORAL DOSAGE FORM a licensed veterinarian. continues to read as follows: NEW ANIMAL DRUGS § 520.2041 [Amended] Authority: 21 U.S.C. 360b. ■ 9. In § 520.2041, in paragraph (b), ■ 5. The authority citation for part 520 § 522.313c [Amended] remove ‘‘017135, 051311, and 066916’’ continues to read as follows: and in its place add ‘‘066916, 017135, ■ 13. Effective March 13, 2017, in Authority: 21 U.S.C. 360b. and 051311’’. § 522.313c, in paragraph (b), remove VerDate Sep<11>2014 14:27 Feb 28, 2017 Jkt 241001 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 E:\FR\FM\01MRR1.SGM 01MRR1

12170 Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules and Regulations ‘‘000409, 054771, and 068330’’ and in dogs at least 4 months of age for a Authority: 21 U.S.C. 360b. its place add ‘‘054771 and 068330’’. maximum of 3 days. (iii) Limitations. Federal law restricts § 529.1186 [Amended] ■ 14. In § 522.2075, revise paragraph (c) this drug to use by or on the order of to read as follows: ■ 16. Effective March 13, 2017, in a licensed veterinarian. § 529.1186, in paragraph (b), remove § 522.2075 Robenacoxib. (2) Cats—(i) Amount. Administer 0.91 ‘‘010019,’’. mg per pound (2 mg/kg) by * * * * * subcutaneous injection, once daily, for a PART 558—NEW ANIMAL DRUGS FOR (c) Conditions of use—(1) Dogs—(i) maximum of 3 days. USE IN ANIMAL FEEDS Amount. Administer 0.91 mg per pound (ii) Indications for use. For the control (2 mg/kilogram (kg)) by subcutaneous of postoperative pain and inflammation injection, once daily, for a maximum of associated with orthopedic surgery, ■ 17. The authority citation for part 558 3 days. After the initial subcutaneous ovariohysterectomy, and castration in continues to read as follows: dose, subsequent doses can be given by cats at least 4 months of age for a Authority: 21 U.S.C. 354, 360b, 360ccc, subcutaneous injection or as the oral maximum of 3 days. 360ccc–1, 371. tablet in dogs weighing at least 5.5 (iii) Limitations. Federal law restricts pounds (2.5 kg) and at least 4 months of this drug to use by or on the order of ■ 18. In § 558.325, revise paragraph age, for a maximum of 3 total doses over a licensed veterinarian. (e)(1)(ii) to read as follows: 3 days, not to exceed 1 dose per day. § 558.325 Lincomycin. See § 520.2075(c)(1) of this chapter. PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS * * * * * (ii) Indications for use. For the control of postoperative pain and inflammation ■ 15. The authority citation for part 529 (e) * * * associated with soft tissue surgery in continues to read as follows: (1) * * * Lincomycin Combination Indications for use Limitations Sponsor grams/ton in grams/ton * * * * * * * (ii) 2 ......................... Halofuginone 2.72 Broiler chickens: For the control of ne- Feed continuously as sole ration. With- 016592 crotic enteritis caused or complicated draw 4 days before slaughter. Do not by Clostridium spp. or other orga- feed to laying chickens or waterfowl. nisms susceptible to lincomycin; and Halofuginone hydrobromide as pro- the prevention of coccidiosis caused vided by No. 016592 in § 510.600 of by Eimeria tenella, E. necatrix, E. this chapter. acervulina, E. brunetti, E. mivati, and E. maxima. * * * * * DEPARTMENT OF HEALTH AND new animal drug application (ANADA) Dated: February 23, 2017. HUMAN SERVICES at the sponsors’ requests because the products are no longer manufactured or Leslie Kux, Food and Drug Administration marketed. Associate Commissioner for Policy. DATES: Withdrawal of approval is [FR Doc. 2017–03930 Filed 2–28–17; 8:45 am] 21 CFR Parts 510, 522, and 529 effective March 13, 2017. BILLING CODE 4164–01–P [Docket No. FDA–2017–N–0002] FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary New Animal Drugs; Withdrawal of Medicine (HFV–212), Food and Drug Approval of a New Animal Drug Administration, 7519 Standish Pl., Application Rockville, MD 20855, 240–402– AGENCY: Food and Drug Administration, 5761,sujaya.dessai@fda.hhs.gov. HHS. SUPPLEMENTARY INFORMATION: The ACTION: Notification of withdrawal. sponsors of the following applications have requested that FDA withdraw SUMMARY: The Food and Drug approval of the NADA and ANADA Administration (FDA) is withdrawing listed in the following table because the approval of a new animal drug products are no longer manufactured or application (NADA) and an abbreviated marketed: 21 CFR File No. Sponsor Product name section jstallworth on DSK7TPTVN1PROD with RULES 135–773 ......................................... Baxter Healthcare Corp., One Baxter Pkwy., Deer- AERRANE (isoflurane USP) .......... 529.1186 field, IL 60015. 200–421 ......................................... Hospira, Inc., 275 North Field Dr., Lake Forest, IL Ceftiofur (ceftiofur Na) for Injection 522.313c 60045. VerDate Sep<11>2014 14:27 Feb 28, 2017 Jkt 241001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\01MRR1.SGM 01MRR1


Document Created: 2017-03-01 03:39:08
Document Modified: 2017-03-01 03:39:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; technical amendment.
DatesThis rule is effective March 1, 2017, except for amendments 2.a and 2.c to 21 CFR 510.600, and the amendments to 21 CFR 522.313c and 529.1186, which are effective March 13, 2017.
ContactGeorge K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]
FR Citation82 FR 12167 
CFR Citation21 CFR 510
21 CFR 516
21 CFR 520
21 CFR 522
21 CFR 529
21 CFR 558
CFR AssociatedAdministrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements; Confidential Business Information and Animal Feeds
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