[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Rules and Regulations]
[Pages 4204-4210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00421]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, 556, and 558

[Docket No. FDA-2019-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Applications; Changes of 
Sponsor; Change of Sponsor's Address

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 new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during July, August, and September 2019. 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 January 24, 2020, except for amendatory 
instruction number 3 to 21 CFR 510.600, number 8 to 21 CFR 520.1807, 
number 21 to 21 CFR 529.1115, and number 24 to 21 CFR 556.513, which 
are effective February 3, 2020.

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, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during July, August, and September 2019, 
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 
office of 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 July, August, and September 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Approval date       File No.         Sponsor             Product name            Species            Effect of the action          Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 1, 2019.........    200-639  Huvepharma EOOD, 5th   MONOVET (monensin)    Cattle and goats..  Original approval as a generic  FOI Summary.
                                   Floor, 3A Nikolay      Type A Medicated                          copy of NADA 095-735.
                                   Haytov Str., 1113      Article.
                                   Sophia, Bulgaria.
July 2, 2019.........    141-519  Zoetis Inc., 333       PROHEART 12           Dogs..............  Original approval for           FOI Summary.
                                   Portage St.,           (moxidectin) for                          prevention of heartworm
                                   Kalamazoo, MI 49007.   Extended-Release                          disease caused by Dirofilaria
                                                          Injectable                                immitis for 12 months in dogs
                                                          Suspension.                               12 months of age and older;
                                                                                                    and for treatment of existing
                                                                                                    larval and adult hookworm
                                                                                                    (Ancylostoma caninum and
                                                                                                    Uncinaria stenocephala)
                                                                                                    infections.
July 5, 2019.........    113-645  Intervet, Inc., 2      ESTRUMATE...........  Cattle............  Supplemental approval for       FOI Summary.
                                   Giralda Farms,        (cloprostenol                              synchronization of estrous
                                   Madison, NJ 07940.     injection).                               cycles to allow for fixed
                                                                                                    time artificial insemination
                                                                                                    (FTAI) in lactating dairy
                                                                                                    cows.
July 26, 2019........    141-255  Syndel USA, 1441 W.    35% PEROX-AID         Finfish...........  Supplemental approval for the   FOI Summary.
                                   Smith Rd., Ferndale,   (hydrogen peroxide)                       control of mortality in
                                   WA 98248.              Concentrated                              freshwater-reared coldwater
                                                          Immersion Solution.                       finfish, fingerling and adult
                                                                                                    freshwater-reared coolwater
                                                                                                    finfish, and fingerling and
                                                                                                    adult freshwater-reared
                                                                                                    warmwater finfish due to
                                                                                                    saprolegniasis associated
                                                                                                    with fungi in the family
                                                                                                    Saprolegniaceae; for the
                                                                                                    treatment and control of
                                                                                                    Gyrodactylus spp. in
                                                                                                    freshwater-reared salmonids;
                                                                                                    and for the control of
                                                                                                    mortality in freshwater-
                                                                                                    reared warmwater finfish due
                                                                                                    to external columnaris
                                                                                                    associated with
                                                                                                    Flavobacterium columnare.
August 27, 2019......    141-465  Elanco US Inc., 2500   Avilamycin and        Chickens..........  Supplemental approval of a      FOI Summary.
                                   Innovation Way,        monensin Type C                           revised age restriction
                                   Greenfield, IN 46140.  medicated feeds.                          caution statement for broiler
                                                                                                    feeds.
August 27, 2019......    141-467  Do...................  Avilamycin and        Chickens..........  Supplemental approval of a      FOI Summary.
                                                          narasin Type C                            revised age restriction
                                                          medicated feeds.                          caution statement for broiler
                                                                                                    feeds.

[[Page 4205]]

 
August 27, 2019......    141-495  Do...................  Avilamycin and        Chickens..........  Supplemental approval of a      FOI Summary.
                                                          salinomycin Type C                        revised age restriction
                                                          medicated feeds.                          caution statement for broiler
                                                                                                    feeds.
September 3, 2019....    141-494  Do...................  CREDELIO (lotilaner)  Dogs..............  Supplemental approval for       FOI Summary.
                                                          Chewable Tablet.                          prevention of flea
                                                                                                    infestations for 1 month in
                                                                                                    dogs and puppies.
September 20, 2019...    200-642  Huvepharma EOOD, 5th   Monensin and tylosin  Cattle............  Original approval for use of    FOI Summary.
                                   Floor, 3A Nikolay      phosphate Type B                          MONOVET 90 (monensin Type A
                                   Haytov Str., 1113      and Type C                                medicated article) with
                                   Sophia, Bulgaria.      medicated feeds.                          TYLOVET (tylosin phosphate)
                                                                                                    Type A medicated articles in
                                                                                                    the manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 104-646.
September 20, 2019...    200-643  Do...................  Monensin and tylosin  Cattle............  Original approval for use of    FOI Summary.
                                                          phosphate Type B                          MONOVET 90 (monensin Type A
                                                          and Type C                                medicated article) with TYLAN
                                                          medicated feeds.                          (tylosin phosphate) Type A
                                                                                                    medicated articles in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 104-646.
September 20, 2019...    200-644  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride, and                        medicated article) with
                                                          tylosin phosphate                         OPTAFLEXX (ractopamine
                                                          Type B and Type C                         hydrochloride Type A
                                                          medicated feeds.                          medicated article) and
                                                                                                    TYLOVET (tylosin phosphate)
                                                                                                    Type A medicated article in
                                                                                                    the manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-224.
September 20, 2019...    200-645  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride, and                        medicated article) with
                                                          tylosin phosphate                         ACTOGAIN (ractopamine
                                                          Type B and Type C                         hydrochloride Type A
                                                          medicated feeds.                          medicated article) and
                                                                                                    TYLOVET (tylosin phosphate)
                                                                                                    Type A medicated article in
                                                                                                    the manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-224.
September 20, 2019...    200-646  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride, and                        medicated article) with
                                                          tylosin phosphate                         OPTAFLEXX (ractopamine
                                                          Type B and Type C                         hydrochloride Type A
                                                          medicated feeds.                          medicated article) and TYLAN
                                                                                                    (tylosin phosphate) Type A
                                                                                                    medicated article in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-224.
September 20, 2019...    200-647  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride, and                        medicated article) with
                                                          tylosin phosphate                         ACTOGAIN (ractopamine
                                                          Type B and Type C                         hydrochloride Type A
                                                          medicated feeds.                          medicated article) and TYLAN
                                                                                                    (tylosin phosphate) Type A
                                                                                                    medicated article in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-224.
September 20, 2019...    200-648  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride,                            medicated article) with
                                                          tylosin phosphate,                        OPTAFLEXX (ractopamine
                                                          and melengestrol                          hydrochloride Type A
                                                          acetate Type C                            medicated article), TYLOVET
                                                          medicated feeds.                          (tylosin phosphate) Type A
                                                                                                    medicated article, and MGA
                                                                                                    (melengestrol acetate Type A
                                                                                                    medicated article) in the
                                                                                                    manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 141-233.
September 20, 2019...    200-649  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride,                            medicated article) with
                                                          tylosin phosphate,                        ACTOGAIN (ractopamine
                                                          and melengestrol                          hydrochloride Type A
                                                          acetate Type C                            medicated article), TYLOVET
                                                          medicated feeds.                          (tylosin phosphate) Type A
                                                                                                    medicated article, and MGA
                                                                                                    (melengestrol acetate Type A
                                                                                                    medicated article) in the
                                                                                                    manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 141-233.
September 20, 2019...    200-650  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride,                            medicated article) with
                                                          tylosin phosphate,                        OPTAFLEXX (ractopamine
                                                          and melengestrol                          hydrochloride Type A
                                                          acetate Type C                            medicated article), TYLOVET
                                                          medicated feeds.                          (tylosin phosphate) Type A
                                                                                                    medicated article, and MGA
                                                                                                    (melengestrol acetate Type A
                                                                                                    medicated article) in the
                                                                                                    manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 141-233.

[[Page 4206]]

 
September 20, 2019...    200-651  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride,                            medicated article) with
                                                          tylosin phosphate,                        ACTOGAIN (ractopamine
                                                          and melengestrol                          hydrochloride Type A
                                                          acetate Type C                            medicated article), TYLAN
                                                          medicated feeds.                          (tylosin phosphate) Type A
                                                                                                    medicated article, and MGA
                                                                                                    (melengestrol acetate Type A
                                                                                                    medicated article) in the
                                                                                                    manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 141-233.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Changes of Sponsor

    The sponsors of the following approved applications have informed 
FDA that they have transferred ownership of, and all rights and 
interest in, these applications to another sponsor:

----------------------------------------------------------------------------------------------------------------
                                                                                                      21 CFR
         File No.               Product name        Transferring sponsor        New sponsor           section
----------------------------------------------------------------------------------------------------------------
140-872..................  POSILAC (sometribove    Elanco US Inc., 2500    Union Agener, Inc.,          522.2112
                            zinc) Injectable        Innovation Way,         1788 Lovers Ln.,
                            Suspension.             Greenfield, IN 46140.   Augusta, GA 30901.
141-457..................  ENTYCE (capromorelin)   Aratana Therapeutics,   Elanco US Inc., 2500          520.292
                            Oral Solution.          Inc., 11400 Tomahawk    Innovation Way,
                                                    Creek Pkwy., Leawood,   Greenfield, IN 46140.
                                                    KS 66211.
141-461..................  NOCITA (bupivacaine     Aratana Therapeutics,   Do...................         522.224
                            liposome injectable     Inc., 11400 Tomahawk
                            suspension).            Creek Pkwy., Leawood,
                                                    KS 66211.
200-180..................  Ampicillin Trihydrate   G. C. Hanford Mfg.      HQ Specialty Pharma           522.90b
                            (ampicillin             Co., P.O. Box 1017,     Corp., 120 Rte. 17
                            trihydrate) Powder      Syracuse, NY 13201.     North, Suite 130,
                            for Injection.                                  Paramus, NJ 07652.
200-273..................  VETRO-GEN (gentamicin   Dechra, Ltd., Snaygill  Putney, Inc., One           524.1044c
                            sulfate) Veterinary     Industrial Estate,      Monument Sq., Suite
                            Ophthalmic Ointment.    Keighley Rd.,           400, Portland, ME
                                                    Skipton, North          04101.
                                                    Yorkshire, BD23 2RW,
                                                    United Kingdom.
200-388..................  GB (gentamicin sulfate  American                Do...................       524.1044f
                            and betamethasone       Pharmaceuticals and
                            valerate) Topical       Cosmetics. Inc., 1401
                            Spray.                  Joel East Rd., Fort
                                                    Worth, TX 76140.
200-490..................  Carprofen (carprofen)   Dragon Fire Holding     Do...................         520.490
                            Chewable Tablets.       Co., Inc., 2619
                                                    Skyway Dr., Grand
                                                    Prairie, TX 75052.
----------------------------------------------------------------------------------------------------------------

Following these changes of sponsorship, American Pharmaceuticals and 
Cosmetics, Inc.; Aratana Therapeutics, Inc.; and Dragon Fire Holding 
Co., Inc. are no longer the sponsor of an approved application. 
Accordingly, the regulations in parts 510, 520, 522, and 524 are being 
amended to reflect these changes.

III. Change of Sponsor's Address

    Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 
07661 has informed FDA that it has changed its address to 6525 The 
Corners Pkwy., Suite 200, Peachtree Corners, GA 30092. Accordingly, we 
are amending Sec.  510.600(c) to reflect this change.

IV. Withdrawals of Approval

    Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234, 
has requested that FDA withdraw approval of NADA 010-005 for use of 
WAZINE (dipiperazine sulfate and piperazine hydrochloride) Soluble 
Powders because the product is no longer manufactured or marketed. 
Following this withdrawal of approval, Fleming Laboratories, Inc., is 
no longer the sponsor of an approved application. Accordingly, it will 
be removed from the list of sponsors of approved applications in Sec.  
510.600(c). In addition, Fleming Laboratories, Inc.'s product was the 
only piperazine product approved for use in food-producing animals. 
Accordingly, tolerances for piperazine will be removed from part 556.
    Also, Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, 
Peachtree Corners, GA 30092, has requested that FDA withdraw approval 
of ANADA 200-200 for use of Halothane USP (halothane) because the 
product is no longer manufactured or marketed.
    Lastly, Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 
61103, has requested that FDA withdraw approval of ANADA 200-472 for 
use of Fomepizole Injection because the product is no longer 
manufactured or marketed.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 010-005 and ANADAs 200-200 and 200-472, and all 
supplements and amendments thereto, is withdrawn effective February 3, 
2020. As provided in the regulatory text of this document, the animal 
drug regulations in parts 510, 520, 556, and 529 are amended to reflect 
these actions.

V. Technical Amendments

    FDA is revising the regulations at 21 CFR 520.2520d to reflect the 
approved conditions of use of trichlorfon, phenothiazine, and 
piperazine soluble powder for oral administration to horses as an 
anthelmintic. This information was deleted in error during 
redesignation (79 FR 28833, May 20, 2014). FDA is also revising the 
regulations at 21 CFR 520.2612 to reflect the currently approved dosage 
for trimethoprim and sulfadiazine

[[Page 4207]]

suspension for oral administration to horses as an antimicrobial. 
Lastly, FDA is revising the assay limits for nicarbazin medicated feeds 
at 21 CFR 558.4(d) in the ``Category II'' table. These actions are 
being taken to improve the accuracy of the regulations.

VI. 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 556

    Animal drugs, Food.

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, 556, 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:
0
a. In the table in paragraph (c)(1):
0
i. Remove the entries for ``American Pharmaceuticals and Cosmetics. 
Inc.'', ``Aratana Therapeutics, Inc.'', and ``Dragon Fire Holding Co., 
Inc.'';
0
ii. Revise the entry for ``Halocarbon Products Corp.''; and
0
iii. Add an entry in alphabetical order for ``Union Agener, Inc.'';
0
b. In the table in paragraph (c)(2):
0
i. Revise the entry for ``012164'';
0
ii. Remove the entries for ``065531'', ``076033'', and ``086026''; and
0
iii. Add an entry in numerical order for ``086106''.
0
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
------------------------------------------------------------------------
 
                              * * * * * * *
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite          012164
 200, Peachtree Corners, GA 30092.......................
 
                              * * * * * * *
Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901..          086106
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
   Drug labeler  code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
012164..................  Halocarbon Products Corp., 6525 The Corners
                           Pkwy., Suite 200, Peachtree Corners, GA 30092
 
                              * * * * * * *
086106..................  Union Agener, Inc., 1788 Lovers Ln., Augusta,
                           GA 30901
 
                              * * * * * * *
------------------------------------------------------------------------

Sec.  510.600   [Amended]

0
3. Effective February 3, 2020, Sec.  510.600 is further amended, in the 
table in paragraph (c)(1), remove the entry for ``Fleming Laboratories, 
Inc.''; and in the table in paragraph (c)(2), remove the entry for 
``015565''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  520.292   [Amended]

0
5. In Sec.  520.292, in paragraph (b), remove ``086026'' and in its 
place add ``058198''.


Sec.  520.304   [Amended]

0
6. In Sec.  520.304, in paragraph (b)(1), remove ``062250, and 076033'' 
and in its place add ``and 062250''.

[[Page 4208]]

Sec.  520.1286   [Amended]

0
7. In Sec.  520.1286, in paragraph (c)(2), remove ``for the treatment 
of flea infestations'' and in its place add ``for the treatment and 
prevention of flea infestations''.


Sec.  520.1807   [Removed]

0
8. Effective February 3, 2020, Sec.  520.1807 is removed.

0
9. In Sec.  520.2520d, revise the section heading and add paragraph (c) 
to read as follows:


Sec.  520.2520d   Trichlorfon, phenothiazine, and piperazine.

* * * * *
    (c) Conditions of use in horses--(1) Amount. 18.2 milligrams (mg) 
of trichlorfon, 12.5 mg of phenothiazine, and 40 mg of piperazine base 
per pound of body weight.
    (2) Indications for use. For removal of bots (Gastrophilus nasalis, 
Gastrophilus intestinalis), large strongyles (Strongylus vulgaris), 
small strongyles, large roundworms (ascarids, Parascaris equorum), and 
pinworms (Oxyuris equi).
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

0
10. In Sec.  520.2612, revise paragraph (c)(2)(i) to read as follows:


Sec.  520.2612   Trimethoprim and sulfadiazine suspension.

* * * * *
    (c) * * *
    (2) * * *
    (i) Amount. Administer orally at a dosage of 24 mg combined active 
ingredients per kilogram body weight (10.9 mg/lb) twice daily for 10 
days. Administered by volume at 2.7 mL per 45.4 kilograms of body 
weight (2.7 mL/100 lb).
* * * * *

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

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

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


Sec.  522.90b   [Amended]

0
12. In Sec.  522.90b, in paragraph (b), remove ``010515'' and in its 
place add ``042791''.


Sec.  522.224   [Amended]

0
13. In Sec.  522.224, in paragraph (b), remove ``086026'' and in its 
place add ``058198''.

0
14. In Sec.  522.460, add paragraph (b)(3), revise paragraphs 
(c)(1)(ii) and (iii), add paragraph (c)(1)(iv), and revise paragraph 
(c)(2) to read as follows:


Sec.  522.460   Cloprostenol.

* * * * *
    (b) * * *
    (3) No. 000061 for use of product described in paragraph (a)(2) as 
in paragraphs (c)(1)(iv) and (c)(2) of this section.
    (c) * * *
    (1) * * *
    (ii) Administer 500 [micro]g by intramuscular injection for 
abortion of unwanted pregnancies from mismatings from 1 week after 
mating until 5 months after conception; for unobserved (non-detected) 
estrus; for treatment of mummified fetus, luteal cysts, and pyometra or 
chronic endometritis in beef cows, lactating dairy cows, and 
replacement beef and dairy heifers.
    (iii) Administer 500 [micro]g by intramuscular injection as a 
single injection regimen or double injection regimen with a second 
injection 11 days after the first, for estrus synchronization in beef 
cows, lactating dairy cows, and replacement beef and dairy heifers.
    (iv) For use with gonadorelin acetate to synchronize estrous cycles 
to allow for fixed time artificial insemination (FTAI) in lactating 
dairy cows: Administer to each cow 86 [micro]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 500 [micro]g 
cloprostenol by intramuscular injection, followed 30 to 72 hours later 
by 86 [micro]g gonadorelin by intramuscular injection.
    (2) Limitations. Gonadorelin acetate for use in paragraph 
(c)(1)(iv) of this section as provided by No. 000061 in Sec.  
510.600(c) of this chapter.

0
15. Revise Sec.  522.1451 to read as follows:


Sec.  522.1451   Moxidectin microspheres for injection.

    (a) Specifications. The drug product consists of two separate 
vials. One vial contains 10 percent moxidectin microspheres and the 
second vial contains a vehicle for constitution of the moxidectin 
microspheres.
    (1) Each milliliter (mL) of constituted suspension contains 3.4 
milligrams (mg) moxidectin.
    (2) Each mL of constituted suspension contains 10 mg moxidectin.
    (b) Sponsor. See No. 54771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. (i) Using the suspension 
described in paragraph (a)(1) of this section, administer 0.05 mL of 
the constituted suspension per kilogram (kg) of body weight (0.023 mL 
per pound (lb)) as a single subcutaneous injection to provide 0.17 mg/
kg body weight (0.0773 mg/lb).
    (ii) Using the suspension described in paragraph (a)(2) of this 
section, administer 0.05 mL of the constituted suspension/kg of body 
weight (0.023 mL/lb) as a single subcutaneous injection to provide 0.5 
mg/kg body weight (0.23 mg/lb).
    (2) Indications for use--(i) Suspension described in paragraph 
(a)(1) of this section. For prevention of heartworm disease caused by 
Dirofilaria immitis in dogs 6 months of age and older; and for 
treatment of existing larval and adult hookworm (Ancylostoma caninum 
and Uncinaria stenocephala) infections.
    (ii) Suspension described in paragraph (a)(2) of this section. For 
prevention of heartworm disease caused by Dirofilaria immitis for 12 
months in dogs 12 months of age and older; and for treatment of 
existing larval and adult hookworm (Ancylostoma caninum and Uncinaria 
stenocephala) infections.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  522.2112   [Amended]

0
16. In Sec.  522.2112, in paragraph (b), remove ``058198'' and in its 
place add ``086106''.

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

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

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


Sec.  524.1044c   [Amended]

0
18. In Sec.  524.1044c, in paragraph (b), remove ``043264'' and in its 
place add ``026637''.


Sec.  524.1044f   [Amended]

0
19. In Sec.  524.1044f, in paragraph (b), remove ``058829, and 065531'' 
and in its place add ``and 058829''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  529.1115   [Amended]

0
21. Effective February 3, 2020, in Sec.  529.1115, in paragraph (b), 
remove ``Nos. 012164 and 054771'' and in its place add ``No. 054771''.

0
22. In Sec.  529.1150, revise paragraph (c) to read as follows:

[[Page 4209]]

Sec.  529.1150   Hydrogen peroxide.

* * * * *
    (c) Conditions of use--(1) Indications and amount. (i) Freshwater-
reared finfish eggs for the control of mortality in due to 
saprolegniasis associated with fungi in the family Saprolegniaceae:
    (A) For all coldwater and coolwater species of freshwater-reared 
finfish eggs: 500 to 1,000 mg per liter (/L) of culture water for 15 
minutes in a continuous flow system once per day on consecutive or 
alternate days until hatch, or
    (B) For all freshwater-reared warmwater finfish eggs: 750 to 1,000 
mg/L for 15 minutes in a continuous flow system once per day on 
consecutive or alternate days until hatch.
    (ii) Freshwater-reared finfish for the control of mortality due to 
saprolegniasis associated with the fungi in the family Saprolegniaceae: 
For freshwater-reared coldwater finfish including salmonids (all life 
stages), freshwater-reared coolwater finfish fingerlings and adults, 
and freshwater-reared warmwater finfish fingerlings and adults: 75 mg/L 
for 60 minutes in continuous flow water supply or as a static bath once 
per day on alternate days for three treatments.
    (iii) Freshwater-reared salmonids for the control of mortality due 
to bacterial gill disease associated with Flavobacterium 
branchiophilum: 100 mg/L for 30 minutes, or 50 to 100 mg/L for 60 
minutes, in a continuous flow water supply or as a static bath once per 
day on alternate days for three treatments.
    (iv) Freshwater-reared salmonids for the treatment and control of 
Gyrodactylus spp: 100 mg/L for 30 minutes, or 50 to 100 mg/L for 60 
minutes, in a continuous flow water supply or as a static bath once per 
day on alternate days for three treatments.
    (v) Freshwater-reared coolwater and warmwater finfish fingerlings 
and adults for the control of mortality due to external columnaris 
disease associated with Flavobacterium columnare: 50 to 75 mg/L for 60 
minutes in continuous flow water supply or as a static bath once per 
day on alternate days for three treatments.
    (vi) Freshwater-reared coolwater finfish fry and warmwater finfish 
fry for the control of mortality due to external columnaris disease 
associated with Flavobacterium columnare: 50 mg/L for 60 minutes in 
continuous flow water supply or as a static bath once per day on 
alternate days for three treatments.
    (2) Limitations. (i) Initial bioassay on a small number is 
recommended before treating the entire group.
    (ii) Eggs: Some strains of rainbow trout eggs are sensitive to 
hydrogen peroxide treatment at a time during incubation concurrent with 
blastopore formation through closure, about 70 to 140 Daily Temperature 
Units, [deg]C. Consider withholding treatment or using an alternate 
therapeutant during that sensitive time to reduce egg mortalities due 
to drug toxicity.
    (iii) Finfish: Because finfish sensitivity to 35% PEROX-AID[supreg] 
increases with increasing water temperature, consider administering 
initial treatments at the lower end of the treatment regimen or 
reducing water temperature before treatment. Do not use this product to 
treat northern pike (Esox lucius) or paddlefish (Polyodon spathula) of 
any age. Do not use this product to treat pallid sturgeon fry. Use with 
caution on walleye (Sander vitreus) and ornamental finfish.
    (iv) Preharvest withdrawal time: Zero days.

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

0
23. The authority citation for part 556 continues to read as follows:

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


Sec.  556.513   [Removed]

0
24. Effective February 3, 2020, Sec.  556.513 is removed.

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

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

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

0
26. In Sec.  558.4, in paragraph (d), revise the entry for ``Nicarbazin 
(powder)'' to read as follows:


Sec.  558.4   Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                 Assay limits                                      Assay limits
                     Drug                        percent \1\         Type B maximum  (100x)        percent \1\
                                                    Type A                                         Type B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Nicarbazin (powder)..........................          96-104   9.08 g/lb (2.00%)..............   85-115/75-125
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
27. In Sec.  558.68, revise paragraphs (e)(1)(ii), (iii), and (v) to 
read as follows:


Sec.  558.68   Avilamycin.

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

[[Page 4210]]



----------------------------------------------------------------------------------------------------------------
      Avilamycin  in grams/ton             Indications for use                 Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 13.6 to 40.9...................  Monensin, 90 to 110.........  Feed as the sole ration for 21        058198
                                                                     consecutive days. Feed to
                                                                     chickens that are at risk of
                                                                     developing, but not yet showing
                                                                     clinical signs of, necrotic
                                                                     enteritis associated with
                                                                     Clostridium perfringens in
                                                                     broiler chickens. Avilamycin has
                                                                     not been demonstrated to be
                                                                     effective in broiler chickens
                                                                     showing clinical signs of
                                                                     necrotic enteritis prior to the
                                                                     start of medication. To assure
                                                                     responsible antimicrobial drug
                                                                     use in broiler chickens,
                                                                     treatment administration must
                                                                     begin on or before 18 days of
                                                                     age. Do not feed to chickens
                                                                     over 16 weeks of age. The safety
                                                                     of avilamycin has not been
                                                                     established in chickens intended
                                                                     for breeding purposes. Do not
                                                                     allow horses or other equines
                                                                     access to feed containing
                                                                     avilamycin and monensin.
                                                                     Ingestion of monensin by horses
                                                                     has been fatal. Do not feed to
                                                                     chickens producing eggs for
                                                                     human consumption. Monensin as
                                                                     provided by No. 058198 in Sec.
                                                                     510.600(c) of this chapter.
(iii) 13.6 to 40.9..................  Narasin, 54 to 90...........  Feed as the sole ration for 21        058198
                                                                     consecutive days. Feed to
                                                                     chickens that are at risk of
                                                                     developing, but not yet showing
                                                                     clinical signs of, necrotic
                                                                     enteritis associated with
                                                                     Clostridium perfringens.
                                                                     Avilamycin has not been
                                                                     demonstrated to be effective in
                                                                     broiler chickens showing
                                                                     clinical signs of necrotic
                                                                     enteritis prior to the start of
                                                                     medication. To assure
                                                                     responsible antimicrobial drug
                                                                     use in broiler chickens,
                                                                     treatment administration must
                                                                     begin on or before 18 days of
                                                                     age. The safety of avilamycin
                                                                     has not been established in
                                                                     chickens intended for breeding
                                                                     purposes. Do not allow adult
                                                                     turkeys, horses, or other
                                                                     equines access to narasin
                                                                     formulations. Ingestion of
                                                                     narasin by these species has
                                                                     been fatal. Do not feed to
                                                                     chickens producing eggs for
                                                                     human consumption. Narasin as
                                                                     provided by No. 058198 in Sec.
                                                                     510.600(c) of this chapter.
 
                                                  * * * * * * *
(v) 13.6 to 40.9....................  Salinomycin sodium, 40 to 60  Feed as the sole ration for 21        058198
                                                                     consecutive days. Feed to
                                                                     chickens that are at risk of
                                                                     developing, but not yet showing
                                                                     clinical signs of, necrotic
                                                                     enteritis associated with
                                                                     Clostridium perfringens.
                                                                     Avilamycin has not been
                                                                     demonstrated to be effective in
                                                                     broiler chickens showing
                                                                     clinical signs of necrotic
                                                                     enteritis prior to the start of
                                                                     medication. To assure
                                                                     responsible antimicrobial drug
                                                                     use in broiler chickens,
                                                                     treatment administration must
                                                                     begin on or before 18 days of
                                                                     age. The safety of avilamycin
                                                                     has not been established in
                                                                     chickens intended for breeding
                                                                     purposes. May be fatal if fed to
                                                                     adult turkeys or to horses. Not
                                                                     approved for use with pellet
                                                                     binders. Do not feed to laying
                                                                     hens producing eggs for human
                                                                     consumption. Salinomycin as
                                                                     provided by No. 016592 in Sec.
                                                                     510.600(c) of this chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
28. In Sec.  558.355, revise paragraphs (b) and (f)(6)(i) to read as 
follows:


Sec.  558.355   Monensin.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (f) of this section.
    (1) No. 058198 for use as in paragraph (f) of this section.
    (2) No. 016592 for use of a Type A medicated article containing 
90.7 grams monensin, USP, per pound as in paragraphs (f)(3), 
(f)(4)(vi), and (f)(6) of this section.
* * * * *
    (f) * * *
    (6) * * *

------------------------------------------------------------------------
                        Indications for
Monensin in grams/ton         use             Limitations       Sponsor
------------------------------------------------------------------------
(i) 20...............  For the           Feed only to goats       058198
                        prevention of     being fed in
                        coccidiosis       confinement. Do not
                        caused by         feed to lactating
                        Eimeria           goats. See
                        crandallis, E.    paragraph (d)(11)
                        christenseni,     of this section for
                        and E.            provisions for
                        ninakohlyakimov   monensin liquid
                        ae.               Type C goat feeds.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *


Sec.  558.625   [Amended]

0
29. Amend Sec.  558.625:
0
a. By removing ``monensin as provided by No. 058198'' and adding in its 
place ``monensin as provided by Nos. 016592 or 058198'' in the 
``Limitations'' column, in:
0
1. Paragraph (e)(2)(iv),
0
2. Paragraph (e)(2)(v),
0
3. Paragraph (e)(2)(x),
0
4. Paragraph (e)(2)(xi),
0
5. Paragraph (e)(2)(xii), and
0
6. Paragraph (e)(2)(xiii); and
0
b. By adding ``016592'' in numerical order in the ``Sponsors'' column 
in:
0
1. Paragraph (e)(2)(x),
0
2. Paragraph (e)(2)(xi),
0
3. Paragraph (e)(2)(xii), and
0
4. Paragraph (e)(2)(xiii).

    Dated: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00421 Filed 1-23-20; 8:45 am]
BILLING CODE 4164-01-P


