[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Rules and Regulations]
[Pages 12167-12170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03930]
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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
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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:
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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.
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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