Document ID: FDA-2017-N-0002-0008
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Approval of New Animal Drug Applications
Posted Date: 2017-12-13T05:00Z

[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Rules and Regulations]
[Pages 58554-58557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26753]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, and 558

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for a 
new animal drug application (NADA) and abbreviated new animal drug 
applications (ANADAs) during May and June 2017. FDA is 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 make technical amendments to 
improve the accuracy of the regulations.

DATES: This rule is effective December 13, 2017.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
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 a NADA and ANADAs during May and June 2017, 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 Dockets Management 
Staff (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: https://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: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                                  Table 1--Original and Supplemental NADAs and ANADAs Approved During May and June 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Effect of the
       Approval date          File No.         Sponsor            Product name              Species                 action           Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
May 23, 2017..............      055-099  Zoetis Inc., 333     CLAVAMOX             Dogs and cats...........  Supplemental         FOI Summary.
                                          Portage St.,         (amoxicillin and                               approval of a
                                          Kalamazoo, MI        clavulanate                                    chewable tablet
                                          49007.               potassium tablets)                             form of the
                                                               Chewables.                                     approved tablet.
June 21, 2017.............      141-338  Elanco US Inc.,      INTERCEPTOR          Dogs....................  Supplemental         FOI Summary.
                                          2500 Innovation      SPECTRUM                                       approval for the
                                          Way, Greenfield,     (milbemycin oxime/                             treatment and
                                          IN 46140.            praziquantel)                                  control of adult
                                                               Chewable Tablets.                              tapeworm
                                                                                                              (Dipylidium
                                                                                                              caninum)
                                                                                                              infections in dogs
                                                                                                              and puppies 2
                                                                                                              pounds of body
                                                                                                              weight or greater
                                                                                                              and 6 weeks of age
                                                                                                              and older.

[[Page 58555]]

 
May 25, 2017..............      200-610  Modern Veterinary    Medetomidine HCl     Dogs....................  Original approval    FOI Summary.
                                          Therapeutics, LLC,   (medetomidine                                  as a generic copy
                                          14343 SW 119th       hydrochloride)                                 of NADA 140-999.
                                          Ave., Miami, FL      Injectable
                                          33186.               Solution.
June 23, 2017.............      200-618  Virbac AH, Inc.,     ZOLETIL (tiletamine  Dogs and cats...........  Original approval    FOI Summary.
                                          3200 Meacham         HCl and zolazepam                              as a generic copy
                                          Blvd., Ft. Worth,    HCl) for Injection.                            of NADA 106-111.
                                          TX 76137.
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    Following the approval of ANADA 200-610, Modern Veterinary 
Therapeutics, LLC, will now be included in the lists of sponsors of 
approved applications in Sec.  510.600(c) (21 CFR 510.600(c)).

II. Technical Amendments

    We are making several technical amendments in 21 CFR part 558, 
which was amended on December 27, 2016 (81 FR 94991), and February 24, 
2017 (82 FR 11510), as part of the FDA Center for Veterinary Medicine's 
(CVM's) Judicious Use Initiative. We are also making several technical 
amendments to the regulations for dosage form drugs to reflect revised 
labeling. These actions are being taken to improve the accuracy of the 
regulations.

III. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(i)), which 
requires Federal Register publication of ``notice[s] . . . effective as 
a regulation,'' of the conditions of use of approved new animal drugs. 
This rule sets forth technical amendments to the regulations to codify 
recent actions on approved new animal drug applications and corrections 
to improve the accuracy of the regulations, and as such does not impose 
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document 
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. 
Likewise, this is not a rule subject to Executive Order 12866, which 
defines a rule as ``an agency statement of general applicability and 
future effect, which the agency intends to have the force and effect of 
law, that is designed to implement, interpret, or prescribe law or 
policy or to describe the procedure or practice requirements of an 
agency.''

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, 524, 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, 21 CFR parts 
510, 520, 522, 524, 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. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically 
add an entry for ``Modern Veterinary Therapeutics, LLC''; and in the 
table in paragraph (c)(2), numerically add an entry for ``015914.'' The 
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
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                              * * * * * * *
Modern Veterinary Therapeutics, LLC, 14343 SW 119th              015914
 Ave., Miami, FL 33186.................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
015914..................  Modern Veterinary Therapeutics, LLC, 14343 SW
                           119th Ave., Miami, FL 33186.
 
                              * * * * * * *
------------------------------------------------------------------------

[[Page 58556]]

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
4. In Sec.  520.88g, revise the section heading and paragraphs (a) and 
(b) to read as follows:

Sec.  520.88g  Amoxicillin trihydrate and clavulanate potassium 
tablets.

    (a) Specifications. Each tablet or chewable tablet contains 
amoxicillin trihydrate and clavulanate potassium equivalent to 50 
milligrams (mg) of amoxicillin and 12.5 mg clavulanic acid, 100 mg of 
amoxicillin and 25 mg clavulanic acid, 200 mg amoxicillin and 50 mg 
clavulanic acid, or 300 mg amoxicillin and 75 mg clavulanic acid.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) No. 054771 for use of tablets and chewable tablets as in 
paragraph (c) of this section.
    (2) No. 026637 for use of tablets as in paragraph (c) of this 
section.
* * * * *

0
5. In Sec.  520.1445, revise paragraph (c)(1)(ii) to read as follows:

Sec.  520.1445  Milbemycin oxime and praziquantel.

* * * * *
    (c) * * *
    (1) * * *
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis and for the treatment and control of 
adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm 
(Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult 
tapeworm (Taenia pisiformis, Echinococcus multilocularis, E. 
granulosus, and Dipylidium caninum) infections in dogs and puppies 2 
pounds of body weight or greater and 6 weeks of age and older.
* * * * *

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

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

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

Sec.  522.1335  [Amended]

0
7. In Sec.  522.1335, in paragraph (b), remove ``052483'' and in its 
place add ``Nos. 015914 and 052483''.

0
8. In Sec.  522.2470, revise paragraphs (b), (c)(1)(i) and (ii), and 
(c)(2) to read as follows:

Sec.  522.2470  Tiletamine and zolazepam for injection.

* * * * *
    (b) Sponsors. See Nos. 026637, 051311, and 054771 in Sec.  
510.600(c) of this chapter.
    (c) * * *
    (1) * * *
    (i) Healthy dogs. An initial intramuscular dosage of 3 to 4.5 
milligrams per pound (mg/lb) of body weight for diagnostic purposes; 
4.5 to 6 mg/lb of body weight for minor procedures of short duration 
such as repair of lacerations and wounds, castrations, and other 
procedures requiring mild to moderate analgesia. Supplemental doses 
when required should be less than the initial dose and the total dose 
given should not exceed 12 mg/lb of body weight. The maximum total safe 
dose is 13.6 mg/lb of body weight.
    (ii) Healthy cats. An initial intramuscular dosage of 4.4 to 5.4 
mg/lb of body weight is recommended for such procedures as dentistry, 
treatment of abscesses, foreign body removal, and related types of 
surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring 
mild to moderate analgesia, such as repair of lacerations, castrations, 
and other procedures of short duration. Initial dosages of 6.5 to 7.2 
mg/lb of body weight are recommended for ovariohysterectomy and 
onychectomy. When supplemental doses are required, such individual 
supplemental doses should be given in increments that are less than the 
initial dose, and the total dose given (initial dose plus supplemental 
doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb 
of body weight.
    (2) Indications for use. For restraint or for anesthesia combined 
with muscle relaxation in cats and in dogs for restraint and minor 
procedures of short duration (30 minutes average) requiring mild to 
moderate analgesia.
* * * * *

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

0
9. The authority citation for part 524 continues to read as follows:

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

Sec.  524.1580a  [Amended]

0
10. In Sec.  524.1580a, in paragraph (d)(3), in the second sentence, 
remove ``in'' and in its place add ``on''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
12. Amend 529.1030 as follows:
0
a. Revise paragraph (d)(1)(ii);
0
b. In the table in paragraph (d)(2)(i), revise footnote 1;
0
c. In paragraph (d)(2)(ii), in the table, in the heading of the 
``Administer in earthen ponds indefinitely ([mu]L/L or ppm)'' column, 
remove ``indefinitely'' and in its place add ``single treatment''; and
0
d. Revise paragraphs (d)(2)(iii) and (d)(3).
    The revisions read as follows:

Sec.  529.1030  Formalin.

* * * * *
    (d) * * *
    (1) * * *
    (ii) All finfish. For control of external protozoa Ichthyophthirius 
spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis 
spp., and Trichodina spp., and the monogeneans Cleidodiscus spp., 
Gyrodactylus spp., and Dactylogyrus spp.
* * * * *
    (2) * * *
    (i) * * *
    \1\ Treat for up to 4 hours daily. Treatment may be repeated daily 
until parasite control is achieved. Use the lower concentration when 
tanks or raceways are heavily loaded with phytoplankton or shrimp, to 
avoid oxygen depletion due to the biological oxygen demand created by 
decay of dead phytoplankton. Alternatively, a higher concentration 
might be used if dissolved oxygen is strictly monitored.
* * * * *
    (iii) For control of fungi of the family Saprolegniaceae on finfish 
eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000 
[mu]L/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 
[mu]L/L (ppm) for 15 minutes. A preliminary bioassay should be 
conducted on a small subsample of fish eggs to determine sensitivity 
before treating an entire group. This is necessary for all species 
because egg sensitivity can vary with species or strain and the unique 
conditions at each facility.
    (3) Limitations. Fish tanks and raceways may be treated daily until 
parasite control is achieved. Pond treatment may be repeated in 5 to 10 
days if needed. However, pond treatments for Ichthyophthirius spp. 
should be made at 2-day intervals until control is achieved. Egg tanks 
may be

[[Page 58557]]

treated as often as necessary to prevent growth of fungi. Do not use 
formalin which has been subjected to temperatures below 40 [deg]F, or 
allowed to freeze. Treatments in tanks and raceways should never exceed 
1 hour for fish or 4 hours for penaeid shrimp (even if they show no 
sign of distress), nor should it exceed 15 minutes for fish eggs. Do 
not apply formalin to ponds with water warmer than 27 [deg]C (80 
[deg]F), when a heavy bloom of phytoplankton is present, or when the 
concentration of dissolved oxygen is less than 5 milligrams per liter.

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

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

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

Sec.  558.58  [Amended]

0
14. In Sec.  558.58, remove paragraphs (f)(4) and (5).

Sec.  558.366  [Amended]

0
15. In Sec.  558.366, remove paragraph (e).

    Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26753 Filed 12-12-17; 8:45 am]
BILLING CODE 4164-01-P