Document ID: FDA-2019-N-0002-0002
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsors’ Names and Addresses
Posted Date: 2019-08-09T04:00Z

[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Rules and Regulations]
[Pages 39179-39187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16884]

[[Page 39179]]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 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 
Sponsorship; Change of Sponsors' Names and Addresses

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

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 January, February, and March 2019. FDA is 
informing the public of the availability of summaries of the basis of 
approval and of environmental review documents, where applicable. 
Technical amendments are also being made to improve the accuracy, 
consistency, and readability of the regulations.

DATES: This rule is effective August 9, 2019, except for amendatory 
instructions 51 to 21 CFR 524.916 and 63 to 21 CFR 558.325, which are 
effective August 19, 2019, and instruction 60 to 21 CFR 558.235, which 
is effective September 9, 2019.

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 January, February, and March 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 January, February, and March 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
           Approval date              File No.        Sponsor        Product name           Species          Effect of the action     Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 27, 2019..................      009-476  Phibro Animal     NICARB 25%        Chickens.............  Supplemental approval  N/A.
                                                  Health Corp.,     (nicarbazin)                             of revised assay
                                                  GlenPointe        Type A                                   limits for
                                                  Centre East, 3d   medicated                                nicarbazin (powder)
                                                  Floor, 300        article.                                 Type A medicated
                                                  Frank W. Burr                                              article.
                                                  Blvd., Suite
                                                  21, Teaneck, NJ
                                                  07666.
January 28, 2019..................      200-616  Norbrook          CEFENIL RTU       Swine and cattle.....  Original approval as   FOI Summary.
                                                  Laboratories,     (ceftiofur                               a generic copy of
                                                  Ltd., Station     hydrochloride                            NADA 140-890.
                                                  Works, Newry      sterile
                                                  BT35 6JP,         suspension).
                                                  Northern
                                                  Ireland.
January 31, 2019..................      200-450  Bimeda Animal     BIMECTIN PLUS     Cattle...............  Original approval as   FOI Summary.
                                                  Health Ltd., 1B   (ivermectin/                             a generic copy of
                                                  The Herbert       clorsulon)                               NADA 140-833.
                                                  Building, The     Injection for
                                                  Park,             Cattle.
                                                  Carrickmines,
                                                  Dublin, 18,
                                                  Ireland.
February 4, 2019..................      200-637  Provetica AH      DOXIDYL           Dogs.................  Original approval as   FOI Summary.
                                                  LLC, 455          (deracoxib)                              a generic copy of
                                                  Sovereign Ct.,    Chewable Tablet.                         NADA 141-203.
                                                  Baldwin, MO
                                                  63011.
February 8, 2019..................      141-297  Boehringer        PROZINC           Dogs.................  Supplemental approval  FOI Summary.
                                                  Ingelheim         (protamine zinc                          for the reduction of
                                                  Vetmedica,        recombinant                              hyperglycemia and
                                                  Inc., 2621        human insulin)                           hyperglycemia-
                                                  North Belt        Injectable                               associated clinical
                                                  Highway, St.      Suspension.                              signs in dogs with
                                                  Joseph, MO                                                 diabetes mellitus.
                                                  64506-2002.

[[Page 39180]]

 
March 29, 2019....................      048-761  Zoetis Inc., 333  AUREOMYCIN        Cattle...............  Supplemental approval  N/A.
                                                  Portage St.,      (chlortetracycl                          adding replacement
                                                  Kalamazoo, MI     ine) Type C                              dairy heifers to the
                                                  49007.            medicated feeds.                         indications for use
                                                                                                             of chlortetracycline
                                                                                                             Type C medicated
                                                                                                             cattle feeds for
                                                                                                             control of bacterial
                                                                                                             pneumonia associated
                                                                                                             with shipping fever
                                                                                                             complex caused by
                                                                                                             Pasteurella spp.
                                                                                                             susceptible to
                                                                                                             chlortetracycline.
March 29, 2019....................      141-517  Pegasus           PROIN ER          Dogs.................  Original approval for  FOI Summary.
                                                  Laboratories,     (phenylpropanol                          the control of
                                                  Inc., 8809 Ely    amine                                    urinary incontinence
                                                  Rd., Pensacola,   hydrochloride                            due to urethral
                                                  FL 32514.         extended-                                sphincter hypotonus.
                                                                    release
                                                                    tablets)
                                                                    Tablets.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Changes of Sponsors' Names and Addresses

    Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 
55057-3009 has informed FDA that it has changed its name to Aurora 
Pharmaceutical, Inc.
    Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. 
Joseph, MO 64506-2002 has informed FDA that it has changed its name and 
address to Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite 
Blvd., Duluth, GA 30096.
    Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 
11967 has informed FDA that it has changed its name to American Regent, 
Inc.
    Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 has 
informed FDA that it has changed its name to Pharmgate, Inc.
    Accordingly, we are amending Sec.  510.600(c) to reflect these 
changes.

III. Changes of Sponsorship

    Provetica AH LLC, 455 Sovereign Ct., Baldwin, MO 63011 has informed 
FDA that it has transferred ownership of, and all rights and interest 
in, newly approved ANADA 200-637 for DOXIDYL (deracoxib) Chewable 
Tablets to Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re, 
33500 Libourne, France. Following this change of sponsorship, Provetica 
AH LLC is no longer the sponsor of an approved application. 
Accordingly, it will not be added to the list of sponsors of approved 
applications in Sec.  510.600(c) (21 CFR 510.600(c)).
    Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-
4640 has informed FDA that it has transferred ownership of, and all 
rights and interest in, the following applications to Boehringer 
Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 
30096:

------------------------------------------------------------------------
        File No.                         Proprietary name
------------------------------------------------------------------------
006-623                   CAPARSOLATE (arsenamide sodium) Injection.
008-422                   SELEEN (selenium disulfide) Suspension.
010-424                   NALLINE (nalorphine hydrochloride) Injection.
011-080                   HYDELTRONE-TBA (prednisolone and tertiary
                           butylacetate) Suspension.
011-437                   HYDELTRONE (prednisolone sodium phosphate and
                           neomycin sulfate) Ointment.
011-532                   SULFABROM (sulfabromomethazine sodium) Bolus.
011-678                   DIURIL (chlorothiazide) Tablets.
012-734                   DIURIL (chlorothiazide) Bolus.
013-022                   THIBENZOLE (thiabendazole) Sheep & Goat
                           Wormer.
013-407                   EQUIZOLE (thiabendazole) Horse Wormer.
013-674                   HYDROZIDE (hydrochlorothiazide) Injection.
013-954                   THIBENZOLE (thiabendazole) 20% Swine Premix.
014-350                   OMNIZOLE (thiabendazole).
015-123                   TBZ[supreg] (thiabendazole) Cattle Wormer
                           (Drench).
015-875                   TBZ 200 (thiabendazole) Medicated Premix.
030-103                   THIBENZOLE (thiabendazole) Suspension.
034-114                   EQUIZOLE (thiabendazole).
035-631                   THIBENZOLE (thiabendazole) Pig Wormer.
037-410                   EQUIZOLE A (thiabendazole and piperazine
                           phosphate).
042-633                   TRESADERM (thiabendazole, dexamethasone,
                           neomycin sulfate solution) Dermatologic
                           Solution.
043-141                   THIBENZOLE 300 (thiabendazole) Medicated.
044-654                   EQUIZOLE (thiabendazole) Horse Wormer Pellets.
047-333                   EQUIZOLE A (thiabendazole and piperazine
                           citrate) Liquid.
048-487                   TBZ (thiabendazole) Wormer Paste 50%.
042-633                   TRESADERM (thiabendazole, dexamethasone,
                           neomycin sulfate solution) Dermatologic
                           Solution.
043-141                   THIBENZOLE 300 (thiabendazole) Medicated.
044-654                   EQUIZOLE (thiabendazole) Horse Wormer Pellets.
047-333                   EQUIZOLE A (thiabendazole and piperazine
                           citrate) Liquid.
048-487                   TBZ (thiabendazole) Wormer Paste 50%.
049-461                   TBZ (thiabendazole) Wormer Paste 43%.
065-275                   Penicillin VK Filmtab (penicillin V potassium)
                           250 mg.
065-276                   VEESYN (penicillin V potassium) Granules for
                           Oral Solution.
094-642                   CAMVET (cambendazole) Suspension Horse Wormer.

[[Page 39181]]

 
096-506                   CAMVET (cambendazole) Horse Wormer Pellets.
096-731                   CAMVET (cambendazole) Horse Wormer Paste 45%.
098-379                   CYSTORELIN.
098-689                   EQUIZOLE (thiabendazole) 50% Wormer Paste;
                           EQUIZOLE 50% Wormer Paste for Horses.
127-443                   EQVALAN (ivermectin) Injection.
128-409                   IVOMEC (ivermectin) .27% Injection Grower and
                           Feeder Pigs; IVOMEC (ivermectin) 1%
                           Injection; IVOMEC (ivermectin) 1% Injection
                           for Cattle and Swine; IVOMEC (ivermectin)
                           Injection for Cattle.
131-392                   IVOMEC (ivermectin) Liquid for Sheep.
134-314                   EQVALAN (ivermectin).
134-930                   SYNCRO-MATE-B (norgestomet and estradiol
                           valerate) Implant.
136-742                   CURATREM (clorsulon) Drench for Cattle.
137-006                   IVOMEC (ivermectin) Cattle Paste 0.153%.
138-412                   HEARTGARD (ivermectin) Tablets.
140-439                   EQVALAN (ivermectin) Oral Liquid for Horses.
140-818                   PRODUCIL (efrotomycin) Type A Medicated
                           Article for Swine.
140-833                   IVOMEC Plus (ivermectin and clorsulon)
                           Injection For Cattle.
140-841                   IVOMEC (ivermectin) Pour-On.
140-883                   LEGEND (hyaluronate sodium) Injectable
                           Solution.
140-886                   HEARTGARD (ivermectin) Chewables for Dogs.
140-971                   HEARTGARD Plus (ivermectin and pyrantel
                           pamoate).
140-974                   IVOMEC (ivermectin) Premix for Swine.
140-988                   IVOMEC (ivermectin) Sustained-Release Bolus
                           for Cattle.
141-015                   ENACARD (enalapril maleate) Tablets for Dogs.
141-042                   IMMITICIDE (melarsomine dihydrochloride)
                           Sterile Powder.
141-054                   IVOMEC (ivermectin) plus LINCOMIX
                           (lincomycin).
141-078                   HEARTGARD (ivermectin) for Cats.
141-079                   EPRINEX (eprinomectin) Pour-On for Beef and
                           Dairy Cattle.
141-097                   BMD (bacitracin methylendisalicylate)/IVOMEC
                           (ivermectin) Premix for Swine.
141-123                   GASTROGARD (omeprazole).
141-188                   MARQUIS (ponazuril) Antiprotozoal Oral Paste.
141-214                   ZIMECTERIN Gold (ivermectin and praziquantel)
                           Paste.
141-227                   ULCERGARD (omeprazole).
141-230                   PREVICOX (firocoxib) Chewable Tablets.
141-253                   EQUIOXX (firocoxib) Oral Paste.
141-313                   EQUIOXX (firocoxib) Injection.
141-327                   LONGRANGE (eprinomectin) Injection.
141-328                   ZACTRAN (gamithromycin) Injectable Solution.
141-406                   NEXGARD (afoxolaner) Chewable Tablet.
141-421                   DUOCARE (ivermectin and praziquantel) Paste.
141-458                   EQUIOXX (firocoxib) Tablets.
141-492                   CENTRAGARD (eprinomectin and praziquantel)
                           Solution.
200-564                   Ivermectin Paste 1.87%.
------------------------------------------------------------------------

    Following this change of sponsorship, Merial, 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). 
As provided in the regulatory text, the animal drug regulations are 
amended to reflect these changes of sponsorship.

IV. Withdrawals of Approval

    Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., 
Duluth, GA 30096, has requested that FDA withdraw approval of newly 
transferred NADA 141-054 for use of LINCOMIX (lincomycin hydrochloride) 
plus IVOMEC (ivermectin) Type A medicated articles to manufacture 2-
way, combination drug Type C medicated feed for swine because the 
product is no longer manufactured or marketed.
    Also, Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, 
has requested that FDA withdraw approval of NADA 141-337 for use of 
RECOVYRA (fentanyl) Transdermal Solution for Dogs because the product 
is no longer manufactured or marketed.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 141-054 and 141-337, and all supplements and 
amendments thereto, is withdrawn effective August 19, 2019. As provided 
in the regulatory text of this document, the animal drug regulations 
are amended to reflect these actions.

V. Technical Amendments

    FDA is removing ``IDEXX Pharmaceuticals, Inc.'' from the list of 
sponsors of approved applications in Sec.  510.600(c). This action is 
being taken to improve the accuracy of the regulations.
    In addition, we are reformatting the regulations to present the 
approved conditions of use of famphur, morantel, and thiabendazole in 
tabular format in the respective named sections of subpart B of part 
558. This action is being taken to improve the readability and 
consistency of the regulations.

VI. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (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

[[Page 39182]]

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, and 524

    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, 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. Add an entry in alphabetical order for ``American Regent, Inc.'';
0
ii. Revise the entries for ``Aurora Pharmaceutical, LLC'', ``Boehringer 
Ingelheim Vetmedica, Inc.'';
0
iii. Remove the entries for ``IDEXX Pharmaceuticals, Inc.'', ``Luitpold 
Pharmaceuticals, Inc.'', and ``Merial, Inc.''; and
0
iv. Revise the entry for ``Pharmgate, LLC''; and
0
b. In the table in paragraph (c)(2):
0
i. Revise the entries for ``000010'' and ``010797'';
0
ii. Remove the entry for ``050604'';
0
iii. Revise the entry for ``051072'';
0
iv. Remove the entry for ``065274''; and
0
v. Revise the entry for ``069254''.
    The additions and revisions 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
------------------------------------------------------------------------
 
                              * * * * * * *
American Regent, Inc., Animal Health Division, Shirley,           010797
 NY 11967...............................................
 
                              * * * * * * *
Aurora Pharmaceutical, Inc., 1196 Highway 3 South,                051072
 Northfield, MN 55057-3009..............................
 
                              * * * * * * *
Boehringer Ingelheim Animal Health USA, Inc., 3239                000010
 Satellite Blvd., Duluth, GA 30096......................
 
                              * * * * * * *
Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC               069254
 28405..................................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
000010..................  Boehringer Ingelheim Animal Health USA, Inc.,
                           3239 Satellite Blvd., Duluth, GA 30096.
 
                              * * * * * * *
010797..................  American Regent, Inc., Animal Health Division,
                           Shirley, NY 11967.
 
                              * * * * * * *
051072..................  Aurora Pharmaceutical, Inc., 1196 Highway 3
                           South, Northfield, MN 55057-3009.
 
                              * * * * * * *
069254..................  Pharmgate, Inc., 1800 Sir Tyler Dr.,
                           Wilmington, NC 28405.
 
                              * * * * * * *
------------------------------------------------------------------------

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.

Sec.  520.43   [Amended]

0
4. In Sec.  520.43, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.284a   [Amended]

0
5. In Sec.  520.284a, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.284b   [Amended]

0
6. In Sec.  520.284b, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.284c   [Amended]

0
7. In Sec.  520.284c, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

[[Page 39183]]

0
8. Revise Sec.  520.420 to read as follows:

Sec.  520.420   Chlorothiazide.

    (a) Specifications--(1) Each tablet contains 0.25 grams 
chlorothiazide.
    (2) Each bolus contains 2 grams chlorothiazide.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i)--Amount. Administer 5 to 10 
milligrams per pound of body weight two or three times daily.
    (ii) Indications for use. For treatment of congestive heart failure 
and renal edema.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cows--(i)--Amount. Administer 2 grams once or twice daily for 3 
or 4 days.
    (ii) Indications for use. As an aid in reduction of postparturient 
udder edema.
    (iii) Limitations. Milk taken from dairy animals during treatment 
and for 72 hours (six milkings) after latest treatment must not be used 
for food. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

Sec.  520.462   [Amended]

0
9. In Sec.  520.462, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.538   [Amended]

0
10. In Sec.  520.538, in paragraph (b), remove ``No. 058198'' and in 
its place add ``Nos. 013744 and 058198''.

Sec.  520.804   [Amended]

0
11. In Sec.  520.804, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.928   [Amended]

0
12. In Sec.  520.928, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.930   [Amended]

0
13. In Sec.  520.930, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.1192   [Amended]

0
14. In Sec.  520.1192, in paragraph (b)(1), remove ``050604'' and in 
its place add ``000010''.

Sec.  520.1193   [Amended]

0
15. In Sec.  520.1193, in paragraph (b)(1), remove ``050604'' and in 
its place add ``000010''.

Sec.  520.1195   [Amended]

0
16. In Sec.  520.1195, in paragraph (b)(1), remove ``000859, 050604,'' 
and in its place add ``000010, 000859,''; and in paragraph (b)(3), 
remove ``050604'' and in its place add ``000010''.

Sec.  520.1196   [Amended]

0
17. In Sec.  520.1196, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.1197   [Amended]

0
18. In Sec.  520.1197, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.1198   [Amended]

0
19. In Sec.  520.1198, in paragraphs (b)(1) and (3), remove ``050604'' 
and in its place add ``000010''.

Sec.  520.1615   [Amended]

0
20. In Sec.  520.1615, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.1696c   [Amended]

0
21. In Sec.  520.1696c, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.1696d   [Amended]

0
22. In Sec.  520.1696d, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

0
23. In Sec.  520.1760, revise paragraphs (a) and (c)(1) to read as 
follows:

Sec.  520.1760   Phenylpropanolamine.

    (a) Specifications--(1) Each chewable tablet contains 25, 50, or 75 
milligram (mg) phenylpropanolamine hydrochloride.
    (2) Each extended-release tablet contains 18, 38, 74, or 145 mg 
phenylpropanolamine hydrochloride.
* * * * *
    (c) * * *
    (1) Amount--Administer orally as follows:
    (i) Chewable tablet: 2 mg/kg of body weight twice daily.
    (ii) Extended-release tablet: 2 to 4 mg/kg of body weight once 
daily with food.
* * * * *

Sec.  520.1855   [Amended]

0
24. In Sec.  520.1855, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.2170   [Amended]

0
25. In Sec.  520.2170, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.2380a   [Amended]

0
26. In Sec.  520.2380a, in paragraph (b)(2), remove ``050604'' and in 
its place add ``000010''.

Sec.  520.2380b   [Amended]

0
27. In Sec.  520.2380b, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.2380c   [Amended]

0
28. In Sec.  520.2380c, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  520.2380d   [Amended]

0
29. In Sec.  520.2380d, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec. Sec.  520.2380e and 520.2380f   [Redesignated as Sec. Sec.  
520.2380f and 520.2380e]

0
30. Redesignate Sec. Sec.  520.2380e and 520.2380f as Sec. Sec.  
520.2380f and 520.2380e, respectively.

Sec.  520.2380e   [Amended]

0
31. In newly redesignated Sec.  520.2380e, in paragraph (b), remove 
``050604'' and in its place add ``000010''.

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

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

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

Sec.  522.144   [Amended]

0
33. In Sec.  522.144, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

0
34. In Sec.  522.313b, revise paragraphs (a), (b), and (e)(2)(iii) to 
read as follows:

Sec.  522.313b   Ceftiofur hydrochloride.

    (a) Specifications. Each milliliter of suspension contains:
    (1) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of 
ceftiofur equivalents in the inactive vehicles phospholipan 90H, 
sorbitan monooleate, and cottonseed oil;
    (2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur 
equivalents in the inactive vehicle miglyol oil 812; or
    (3) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur 
equivalents in the inactive vehicles aluminum monostearate, sorbitan 
monooleate, and medium chain triglycerides.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as 
follows:
    (1) No. 054771 for products described in paragraphs (a)(1) and (2) 
of this section; and

[[Page 39184]]

    (2) No. 055529 for the product described in paragraph (a)(3) of 
this section.
* * * * *
    (e) * * *
    (2) * * *
    (iii) Limitations--(A) For products described in paragraphs (a)(2) 
and (3) of this section: Treated cattle must not be slaughtered for 3 
days following the last treatment. For products described in paragraph 
(a)(2) of this section: Treated cattle must not be slaughtered for 4 
days following the last treatment.
    (B) A withdrawal period has not been established in preruminating 
calves. Do not use in calves to be processed for veal.

Sec.  522.814   [Amended]

0
35. In Sec.  522.814, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  522.850   [Amended]

0
36. In Sec.  522.850, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  522.930   [Amended]

0
37. In Sec.  522.930, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  522.1014   [Amended]

0
38. In Sec.  522.1014, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  522.1077   [Amended]

0
39. In Sec.  522.1077, in paragraph (b)(4), remove ``050604'' and in 
its place add ``000010''.

Sec.  522.1145   [Amended]

0
40. In Sec.  522.1145, in paragraph (e)(2)(i), remove ``050604'' and in 
its place add ``000010''.

Sec.  522.1150   [Amended]

0
41. In Sec.  522.1150, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

0
42. In Sec.  522.1160, revise paragraphs (b)(1) and (2); redesignate 
the text of paragraph (c)(1)(i) as paragraph (c)(1)(i)(A); add a 
paragraph heading to newly redesignated paragraph (c)(1)(i)(A); and add 
paragraph (c)(1)(i)(B).
    The revision and addition read as follows:

Sec.  522.1160   Insulin.

* * * * *
    (b) * * *
    (1) No. 000061 for use of product described in paragraph (a)(1) as 
in paragraphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(A), 
(c)(2)(ii), and (c)(2)(iii) of this section.
    (2) No. 000010 for use of product described in paragraph (a)(2) as 
in paragraphs (c)(1)(i)(B), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(B), 
(c)(2)(ii), and (c)(2)(iii) of this section.
    (c) * * *
    (1) * * *
    (i) * * *
    (A) Porcine zinc insulin zinc. * * *
    (B) Protamine zinc recombinant human insulin. Administer a starting 
dose of 0.2 to 0.5 IU/pound of body weight (0.5 to 1.0 IU/kg) once 
daily. When transitioning from another insulin product, this form of 
insulin should be started once daily, regardless of the frequency of 
prior insulin use. The dose should be given concurrently with or right 
after a meal. Reevaluate the dog at appropriate intervals and adjust 
the dose based on both clinical signs and laboratory test results until 
adequate glycemic control has been attained. Twice-daily therapy should 
be initiated if the duration of insulin action is determined to be 
inadequate. If twice-daily treatment is initiated, the two doses should 
be 25 percent less than the once daily dose required to attain an 
acceptable nadir.
* * * * *

Sec.  522.1192   [Amended]

0
43. In Sec.  522.1192, in paragraph (b)(1), remove ``050604'' and in 
its place add ``000010''.

0
44. In Sec.  522.1193, revise paragraphs (b) and (e)(3) to read as 
follows:

Sec.  522.1193   Ivermectin and clorsulon.

* * * * *
    (b) Sponsors. See Nos. 000010, 055529, 058005, and 061133 in Sec.  
510.600(c) of this chapter.
* * * * *
    (e) * * *
    (3) Limitations--(i) Nos. 000010 and 061133: Do not treat cattle 
within 21 days of slaughter. Nos. 055529 and 058005: Do not treat 
cattle within 49 days of slaughter.
    (ii) Because a withdrawal time in milk has not been established, do 
not use in female dairy cattle of breeding age. A withdrawal period has 
not been established for this product in preruminating calves. Do not 
use in calves to be processed for veal.

Sec.  522.1362   [Amended]

0
45. In Sec.  522.1362, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  522.1452   [Amended]

0
46. In Sec.  522.1452, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  522.1885   [Amended]

0
47. In Sec.  522.1885, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

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

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

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

Sec.  524.814   [Amended]

0
49. In Sec.  524.814, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  524.815   [Amended]

0
50. In Sec.  524.815, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  524.916   [Removed]

0
51. Effective August 19, 2019, remove Sec.  524.916.

Sec.  524.1193   [Amended]

0
52. In Sec.  524.1193, in paragraph (b)(1), remove ``050604'' and in 
its place add ``000010''.

Sec.  524.1484g   [Amended]

0
53. In Sec.  524.1484g, in paragraph (b), remove ``026637 and 050604'' 
and in its place add ``000010 and 026637''.

Sec.  524.1484j   [Amended]

0
54. In Sec.  524.1484j, in paragraph (b), remove ``050604'' and in its 
place add ``000010''.

Sec.  524.2101   [Amended]

0
55. In Sec.  524.2101, in paragraph (b), remove ``000061, 017135, and 
050604'' and in its place add ``000010, 000061, and 017135''.

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

0
56. 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
57. In Sec.  558.58, redesignate paragraphs (e)(3) through (6) as 
paragraphs (e)(2) through (5), and redesignate paragraph (e)(9) as new 
paragraph (e)(6).

[[Page 39185]]

Sec.  558.76  [Amended]

0
58. In Sec.  558.76, redesignate paragraphs (e)(1)(ix) through (xvi) as 
paragraphs (e)(1)(vii) through (xiv).

0
59. In Sec.  558.128, revise paragraphs (b)(1) and (e)(4)(xv), 
redesignate paragraphs (e)(4)(xvi) through (xxvi) as paragraphs 
(e)(4)(xvii) through (xxvii), and add new paragraph (e)(4)(xvi).
    The revisions and addition read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (b) * * *
    (1) No. 054771: 50, 70, 80, 90, or 100 grams per pound (g/lb) Type 
A medicated article.
* * * * *
    (e) * * *
    (4) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
       Chlortetracycline amount         Combination in grams/ton       Indications for use                     Limitations                    Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(xv) 350 mg/head/day..................  ........................  1. Beef cattle: For control    To sponsor No. 054771 under NADAs 046-                *
                                                                   of bacterial pneumonia         699 and 049-287, No. 066104 under NADA
                                                                   associated with shipping       092-286, and No. 069254 under NADA 048-
                                                                   fever complex caused by        480: Withdraw 48 hours prior to
                                                                   Pasteurella spp. susceptible   slaughter. To sponsor No. 069254 under
                                                                   to chlortetracycline.          NADA 138-935 and ANADA 200-510: Zero
                                                                                                  withdrawal period.
                                                                  2. Beef cattle (under 700      To sponsor No. 054771 under NADAs 046-                *
                                                                   lb): For control of active     699 and 049-287, No. 066104 under NADA
                                                                   infection of anaplasmosis      092-286, and No. 069254 under NADA 048-
                                                                   caused by A. marginale         480: Withdraw 48 h prior to slaughter.
                                                                   susceptible to                 To sponsor No. 054771 under NADA 048-
                                                                   chlortetracycline.             761 and No. 069254 under NADA 138-935
                                                                                                  and ANADA 200-510: Zero withdrawal
                                                                                                  time.
(xvi) 20 to 350 g/ton.................  ........................  Beef cattle and replacement    Feed to provide chlortetracycline at             054771
                                                                   dairy heifers: For control     the rate of 350 mg per head per day.
                                                                   of bacterial pneumonia         This drug is not approved for use in
                                                                   associated with shipping       female dairy cattle 20 months of age
                                                                   fever complex caused by        or older, including dry dairy cows.
                                                                   Pasteurella spp. susceptible   Use in these cattle may cause drug
                                                                   to chlortetracycline.          residues in milk and/or in calves born
                                                                                                  to these cows. A withdrawal period has
                                                                                                  not been established for this product
                                                                                                  in pre-ruminating calves. Do not use
                                                                                                  in calves to be processed for veal. To
                                                                                                  sponsor No. 054771 under NADA 048-761:
                                                                                                  Zero withdrawal period.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

Sec.  558.235  [Amended]

0
60. Effective September 9, 2019, in Sec.  558.235, in paragraph (b), 
remove ``050604'' and in its place add ``000010''.

0
61. Revise Sec.  558.254 to read as follows:

Sec.  558.254  Famphur.

    (a) Specifications. Type A medicated articles containing 13.2 or 
33.3 percent famphur.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.273 of this chapter.
    (d) Special considerations. Famphur is a cholinesterase inhibitor. 
Do not use this product in animals simultaneously or within a few days 
before or after treatment with or exposure to cholinesterase-inhibiting 
drugs, pesticides, or chemicals.
    (e) Conditions of use. It is used in cattle feed as follows:

----------------------------------------------------------------------------------------------------------------
        Famphur in grams/ton               Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1.1 milligrams per pound (mg/lb)  Beef cattle and nonlactating  Feed for 30 days. Withdraw            000061
 body weight per day.                  dairy cows: For control of    from dry dairy cows and
                                       grubs and as an aid in        heifers 21 days prior to
                                       control of sucking lice.      freshening. Withdraw 4 days
                                                                     prior to slaughter.
(ii) 2.3 mg/lb body weight per day..  Beef cattle and nonlactating  Feed for 10 days. Withdraw            000061
                                       dairy cows: For control of    from dry dairy cows and
                                       grubs.                        heifers 21 days prior to
                                                                     freshening. Withdraw 4 days
                                                                     prior to slaughter.
----------------------------------------------------------------------------------------------------------------

Sec.  558.300  [Amended]

0
62. In Sec.  558.300, in paragraph (b), remove ``050604'' and in its 
place add ``No. 000010''; in paragraphs (e)(1) through (6), in the 
``Sponsor'' column, remove ``050604'' and in its place add ``000010''; 
and remove paragraph (f).

Sec.  558.325  [Amended]

0
63. Effective August 19, 2019, in Sec.  558.325, remove paragraphs 
(e)(2)(iii), (x), and (xvi); and redesignate paragraphs (e)(2)(iv) 
through (ix) as paragraphs (e)(2)(iii) through (viii), paragraphs 
(e)(2)(xi) through (xv) as paragraphs (e)(2)(ix) through (xiii), and 
paragraph (e)(2)(xvii) as paragraph (e)(2)(xiv).

0
64. Revise Sec.  558.360 to read as follows:

Sec.  558.360  Morantel.

    (a) Specifications. Each pound of Type A medicated article contains 
88 grams morantel tartrate.
    (b) Sponsor. See No. 066104 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.425 of this chapter.
    (d) Special considerations--(1) Do not use in Type B or Type C 
medicated feeds containing bentonite.

[[Page 39186]]

    (2) Consult your veterinarian before using in severely debilitated 
animals and for assistance in the diagnosis, treatment, and control of 
parasitism.
    (e) Conditions of use. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
   Morantel tartrate in grams/ton          Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 0.44 to 4.4 grams of morantel     Cattle: For removal and       Feed as a single therapeutic          066104
 tartrate per pound of feed.           control of mature             treatment at 0.44 gram of
                                       gastrointestinal nematode     morantel tartrate per 100
                                       infections of cattle          pounds of body weight.
                                       including stomach worms       Fresh water should be
                                       (Haemonchus spp.,             available at all times.
                                       Ostertagia spp.,              When medicated feed is
                                       Trichostrongylus spp.),       consumed, resume normal
                                       worms of the small            feeding. Conditions of
                                       intestine (Cooperia spp.,     constant worm exposure may
                                       Trichostrongylus spp.,        require retreatment in 2 to
                                       Nematodirus spp.), and        4 weeks. Do not treat
                                       worms of the large            cattle within 14 days of
                                       intestine (Oesophagostomum    slaughter.
                                       radiatum).
(2) 0.44 to 4.4 grams of morantel     Goats: For removal and        Feed as a single therapeutic          066104
 tartrate per pound of feed.           control of mature             treatment at 0.44 gram of
                                       gastrointestinal nematode     morantel tartrate per 100
                                       infections of goats           pounds of body weight.
                                       including Haemonchus          Fresh water should be
                                       contortus, Ostertagia         available at all times.
                                       (Teladorsagia)                When medicated feed is
                                       circumcincta, and             consumed, resume normal
                                       Trichostrongylus axei.        feeding. Conditions of
                                                                     constant worm exposure may
                                                                     require retreatment in 2 to
                                                                     4 weeks. Do not treat goats
                                                                     within 30 days of slaughter.
----------------------------------------------------------------------------------------------------------------

0
65. Revise Sec.  558.600 to read as follows:

Sec.  558.600  Thiabendazole.

    (a) Specifications. Dry Type A medicated articles containing 22, 
44.1, 66.1, or 88.2 percent thiabendazole. The 66.1 percent Type A 
medicated article is solely for the manufacture of cane molasses liquid 
Type B feed, which is mixed in dry feeds. The 88.2 percent Type A 
medicated article is used solely for the manufacture of an aqueous 
slurry for adding to a Type C dry cattle feed.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.730 of this chapter.
    (d) Special considerations. Do not use in Type B or Type C 
medicated feed containing bentonite.
    (e) Conditions of use. It is used in feed for animals as follows:
    (1) Swine--

----------------------------------------------------------------------------------------------------------------
     Thiabendazole in grams/ton            Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 45.4 to 908 (0.005 to 0.1         Swine: As an aid in the       Administer continuously in            000010
 percent).                             prevention of infections of   feed containing 0.05 to 0.1
                                       large roundworms (genus       percent thiabendazole per
                                       Ascaris).                     ton for 2 weeks followed by
                                                                     feed containing 0.005 to
                                                                     0.02 percent thiabendazole
                                                                     per ton for 8 to 14 weeks.
                                                                     Do not treat animals within
                                                                     30 days of slaughter.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (2) Cattle--

----------------------------------------------------------------------------------------------------------------
        Thiabendazole amount               Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 3 grams per 100 lb. body weight.  For control of infections of  Use 3 grams per 100 lb. body          000010
                                       gastrointestinal roundworms   weight at a single dose;
                                       (Trichostrongylus spp.,       may repeat once in 2 to 3
                                       Haemonchus spp., Ostertagia   weeks. Do not treat animals
                                       spp., Nematodirus spp.,       within 3 days of slaughter.
                                       Oesophagostomum radiatum).    Milk taken from treated
                                                                     animals within 96 hours (8
                                                                     milkings) after the latest
                                                                     treatment must not be used
                                                                     for food.
(ii) 5 grams per 100 lb. body weight  For control of severe         Use 5 grams per 100 lb. body          000010
                                       infections of                 weight at a single dose or
                                       gastrointestinal roundworms   divided into 3 equal doses,
                                       (Trichostrongylus spp.,       administered 1 dose each
                                       Haemonchus spp., Ostertagia   day, on succeeding days.
                                       spp., Nematodirus spp.,       May repeat once in 2 to 3
                                       Oesophagostomum radiatum);    weeks. Do not treat animals
                                       control of infections of      within 3 days of slaughter.
                                       Cooperia spp.                 Milk taken from treated
                                                                     animals within 96 hours (8
                                                                     milkings) after the latest
                                                                     treatment must not be used
                                                                     for food.
----------------------------------------------------------------------------------------------------------------

    (3) Minor species--

[[Page 39187]]

----------------------------------------------------------------------------------------------------------------
        Thiabendazole amount               Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2 grams per 100 lb. body weight.  Sheep and goats: For control  Use 2 grams per 100 lb. body          050604
                                       of infections of              weight at a single dose. Do
                                       gastrointestinal roundworms   not treat animals within 30
                                       (Trichostrongylus spp.,       days of slaughter. Milk
                                       Haemonchus spp., Ostertagia   taken from treated animals
                                       spp., Cooperia spp.;          within 96 hours (8
                                       Nematodirus spp.,             milkings) after the latest
                                       Bunostomum spp.,              treatment must not be used
                                       Strongyloides spp.,           for food.
                                       Chabertia spp., and
                                       Oesophagostomum spp.); also
                                       active against ova and
                                       larvae passed by sheep from
                                       3 hours to 3 days after the
                                       feed is consumed (good
                                       activity against ova and
                                       larvae of T. colubriformis
                                       and axei, Ostertagia spp.,
                                       Nematodirus spp.,
                                       Strongyloides spp.; less
                                       effective against those of
                                       Haemonchus contortus and
                                       Oesophagostomum spp.).
(ii) 3 grams per 100 lb. body weight  Goats: For control of severe  Use 3 grams per 100 lb. body          050604
                                       infections of                 weight at a single dose. Do
                                       gastrointestinal roundworms   not treat animals within 30
                                       (Trichostrongylus spp.,       days of slaughter. Milk
                                       Haemonchus spp., Ostertagia   taken from treated animals
                                       spp., Cooperia spp.,          within 96 hours (8
                                       Nematodirus spp.,             milkings) after the latest
                                       Bunostomum spp.,              treatment must not be used
                                       Strongyloides spp.,           for food.
                                       Chabertia spp., and
                                       Oesophagostomum spp.).
(iii) 454 grams per ton of feed.....  Pheasants: For the treatment  Feed continuously for 2               050604
                                       of gapeworms (Syngamus        weeks (14 days). Do not use
                                       trachea).                     treated pheasants for food
                                                                     for 21 days after last day
                                                                     of treatment. Fertility,
                                                                     hatchability, and other
                                                                     reproductive data are not
                                                                     available on use in
                                                                     breeding animals.
----------------------------------------------------------------------------------------------------------------

    Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16884 Filed 8-8-19; 8:45 am]
BILLING CODE 4164-01-P