Document ID: FDA-2020-N-0002-0025
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications
Posted Date: 2021-04-01T04:00Z

[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Rules and Regulations]
[Pages 17061-17065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06704]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 528, and 558

[Docket No. FDA-2020-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications

AGENCY: Food and Drug Administration, Department of Health and Human 
Services.

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 October, November, and December 2020. 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 improve the 
accuracy and readability of the regulations.

DATES: This rule is effective April 1, 2021.

[[Page 17062]]

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. Approvals

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during October, November, and December 
2020, 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, 240-402-7500. Persons 
with access to the internet may obtain these documents at the CVM FOIA 
Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing 
exclusivity and patent information may be accessed in FDA's 
publication, Approved Animal Drug Products Online (Green Book) at: 
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.

                        Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                   Effect of the
          Approval date             File No.        Sponsor          Product name              Species                 action         Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 16, 2020.................    141-536  Elanco US Inc.,     ELURA              Dogs and cats.............  Original approval  FOI Summary.
                                               2500 Innovation     (capromorelin                                  for management
                                               Way, Greenfield,    oral solution).                                of weight loss
                                               IN 46140.                                                          in cats with
                                                                                                                  chronic kidney
                                                                                                                  disease.
October 29, 2020.................    200-692  Virbac AH, Inc.,    CYCLAVANCE         Dogs......................  Original approval  FOI Summary.
                                               P.O. Box 162059,    (cyclosporine                                  as a generic
                                               Fort Worth, TX      oral solution)                                 copy of NADA 141-
                                               76161.              USP MODIFIED.                                  218.
November 16, 2020................    141-541  QBiotics Group      STELFONTA          Dogs......................  Original approval  FOI Summary.
                                               Ltd., Suite 3A,     (tigilanol                                     for the
                                               Level 1, 165        tiglate                                        treatment of non-
                                               Moggill Rd.,        injection).                                    metastatic
                                               Taringa,                                                           cutaneous mast
                                               Queensland 4068,                                                   cell tumors and
                                               Australia.                                                         non-metastatic
                                                                                                                  subcutaneous
                                                                                                                  mast cell tumors
                                                                                                                  located at or
                                                                                                                  distal to the
                                                                                                                  elbow or the
                                                                                                                  hock in dogs.
November 25, 2020................    200-557  Dechra Veterinary   TZED (tiletamine   Dogs......................  Supplemental       FOI Summary.
                                               Products LLC,       and zolazepam                                  approval for an
                                               7015 College        for injection).                                intravenous
                                               Blvd., Suite 525,                                                  route.
                                               Overland Park, KS
                                               66211.
December 14, 2020................    141-542  Revivicor, Inc., a  pPL657 rDNA        Swine.....................  Original approval  FOI Summary.
                                               wholly owned        construct in                                   for an
                                               subsidiary of       domestic pigs.                                 intentional
                                               United                                                             genomic
                                               Therapeutics                                                       alteration in
                                               Corp., 1700 Kraft                                                  domestic pigs.
                                               Dr., Suite 2400,
                                               Blacksburg, VA
                                               24060.
December 16, 2020................    200-696  Bimeda Animal       SELASPOT           Dogs and cats.............  Original approval  FOI Summary.
                                               Health Ltd., 1B     (selamectin)                                   as a generic
                                               The Herbert         Topical Solution.                              copy of NADA 141-
                                               Building, The                                                      152.
                                               Park,
                                               Carrickmines,
                                               Dublin 18,
                                               Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    As provided in the regulatory text, the animal drug regulations are 
amended to reflect these approval actions. As they are now the sponsor 
of an approved application, QBiotics Group Ltd. and Revivicor, Inc. 
will be added to the list of sponsors of approved applications in 21 
CFR 510.600(c).

II. Technical Amendments

    FDA is making the following amendments to improve the accuracy, 
consistency, and readability of the animal drug regulations:
     21 CFR 558.128 is amended to reflect the sponsors of 
approved conditions of use for chlortetracycline in beef cattle.
     21 CFR 558.342 is amended to reformat special 
considerations for labeling and manufacture of melengestrol medicated 
feeds.
     Typographical errors are being corrected wherever they 
have been found.

[[Page 17063]]

III. Legal Authority

    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. This 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 the conditions of use of an approved or conditionally approved new 
animal drug and the name and address of the drug's sponsor in a 
``notice, which upon publication shall be effective as a regulation.'' 
A notice published pursuant to section 512(i) is not subject to the 
notice-and-comment rulemaking requirements of the Administrative 
Procedure Act, 5 U.S.C. 551 et seq. See section 512(i) of the FD&C Act; 
21 CFR 10.40(e)(3); S. Rep. 90-1308, at 5 (1968).
    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 528

    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, 528, 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), add entries for ``QBiotics Group 
Ltd.'' and ``Revivicor, Inc.'' in alphabetical order; and
0
b. In the table in paragraph (c)(2), add entries for ``086132'' and 
``086134'' in numerical order.
    The additions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd.,          086132
 Taringa, Queensland 4068, Australia....................
 
                              * * * * * * *
Revivicor, Inc., a wholly owned subsidiary of United              086134
 Therapeutics Corp., 1700 Kraft Dr., Suite 2400,
 Blacksburg, VA 24060...................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
086132.......................  QBiotics Group Ltd., Suite 3A, Level 1,
                                165 Moggill Rd., Taringa, Queensland
                                4068, Australia
086134.......................  Revivicor, Inc., a wholly owned
                                subsidiary of United Therapeutics Corp.,
                                1700 Kraft Dr., Suite 2400, Blacksburg,
                                VA 24060
 
                              * * * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
4. In Sec.  520.292, revise paragraphs (a) and (c) to read as follows:

Sec.  520.292  Capromorelin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 30 milligrams (mg) capromorelin; or
    (2) 20 mg capromorelin.
* * * * *
    (c) Conditions of use--(1) Dogs. Use product described in paragraph 
(a)(1) of this section as follows:
    (i) Amount. Administer 3 mg/kg once daily by mouth.
    (ii) Indications for use. For appetite stimulation in dogs.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats. Use product described in paragraph (a)(2) of this section 
as follows:
    (i) Amount. Administer 2 mg/kg once daily by mouth.
    (ii) Indications for use. For management of weight loss in cats 
with chronic kidney disease.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
5. In Sec.  520.522, add paragraph (b)(3) to read as follows:

Sec.  520.522  Cyclosporine.

* * * * *
    (b) * * *

[[Page 17064]]

    (3) No. 051311 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d)(1) of this section.
* * * * *

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

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

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

0
7. Add Sec.  522.2450 to read as follows:

Sec.  522.2450  Tigilanol.

    (a) Specifications. Each milliliter (mL) of solution contains 1 
milligram tigilanol tiglate.
    (b) Sponsor. See No. 086132 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer as an 
intratumoral injection at a dose of 0.5 mL per cubic centimeter of 
tumor volume.
    (2) Indications for use. For the treatment of non-metastatic 
cutaneous mast cell tumors and non-metastatic subcutaneous mast cell 
tumors located at or distal to the elbow or the hock in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

Sec.  522.2470  Tiletamine and zolazepam for injection.

* * * * *
    (b) * * *
    (1) Nos. 026637 and 054771 for use as in paragraph (c) of this 
section.
    (2) No. 051311 for use as in paragraphs (c)(1)(i)(A), 
(c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section.
* * * * *

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

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

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

0
10. In Sec.  524.2098:
0
a. Revise paragraphs (a) and (b);
0
b. Remove paragraph (c) and redesignate paragraph (d) as paragraph (c); 
and
0
c. Revise newly redesignated paragraph (c)(1).
    The revisions read as follows:

Sec.  524.2098  Selamectin.

    (a) Specifications. Each milliliter contains 60 or 120 milligrams 
(mg) of selamectin.
    (b) Sponsors. See Nos. 054771, 055529, 061133, and 061651 in Sec.  
510.600(c) of this chapter.
    (c) * * *
    (1) Amount. Administer topically 2.7 mg of selamectin per pound (6 
mg per kilogram) of body weight.
* * * * *

PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

0
11. The authority citation for part 528 continues to read as follows:

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

0
12 Add Sec.  528.2001 to read as follows:

Sec.  528.2001  pPL657 recombinant deoxyribonucleic acid construct.

    (a) Specifications. pPL657 in the glycoprotein 
galactosyltransferase alpha-1,3 (GGTA1) gene in domestic pigs.
    (b) Sponsor. See No. 086134 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Intended use. pPL657 rDNA construct in 
the glycoprotein galactosyltransferase alpha-1,3 gene (GGTA1) in the 
lineage of domestic pigs (Sus scrofa domesticus) hemizygous and 
homozygous for the intentional genomic alteration resulting in 
undetectable endogenous galactose alpha-1,3-galactose sugar residues on 
biological derivatives of domestic pigs homozygous for the intentional 
genomic alteration lineage that are intended to be used as sources of 
food or human therapeutics including excipients, devices, drugs, or 
biological products.
    (2) Limitations. Pigs of this lineage (possessing the intentional 
genomic alteration (pPL657 rDNA construct)) should not be treated with 
aminoglycoside drugs and must only be housed in physically contained 
facilities specified in the approved application.

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

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

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

0
14. In Sec.  558.128, revise paragraph (e)(4)(xv) to read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Combination in grams/
      Chlortetracycline amount                  ton                Indications for use                        Limitations                      Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(xv) 350 mg/head/day................                           1. Beef cattle: For control  Withdrawal periods: To sponsor No. 054771 under       054771
                                                                of bacterial pneumonia       NADAs 046-699 and 049-287, No. 066104 under          066104
                                                                associated with shipping     NADA 092-286, and No. 069254 under NADA 048-         069254
                                                                fever complex caused by      480: Withdraw 48 hours prior to slaughter. To
                                                                Pasteurella spp.             sponsor No. 069254 under NADA 138-935 and
                                                                susceptible to               ANADA 200-510: Zero withdrawal period.
                                                                chlortetracycline.
                                                               2. Beef cattle (under 700    Withdrawal periods: To sponsor No. 054771 under       054771
                                                                lb): For control of active   NADAs 046-699 and 049-287, No. 066104 under          066104
                                                                infection of anaplasmosis    NADA 092-286, and No. 069254 under NADA 048-         069254
                                                                caused by A. marginale       480: Withdraw 48 hours prior to slaughter. To
                                                                susceptible to               sponsor No. 054771 under NADA 048-761 and No.
                                                                chlortetracycline.           069254 under NADA 138-935 and ANADA 200-510:
                                                                                             Zero withdrawal period.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
15. In Sec.  558.342:
0
a. Revise paragraphs (d)(3) through (6); and
0
b. Remove paragraphs (d)(7) and (8).
    The revisions read as follows:

[[Page 17065]]

Sec.  558.342  Melengestrol.

* * * * *
    (d) * * *
    (3) Liquid or dry combination Type B or C medicated feeds 
containing melengestrol acetate and lasalocid must be labeled in 
accordance with Sec.  558.311(d).
    (4) Liquid or dry combination Type B or C medicated feeds 
containing melengestrol acetate and monensin must be labeled in 
accordance with Sec.  558.355(d).
    (5) Liquid combination Type B or C medicated feeds containing 
melengestrol acetate and tylosin must be manufactured in accordance 
with Sec.  558.625(d).
    (6) Liquid melengestrol acetate may not be mixed with 
oxytetracycline in a common liquid feed supplement.
* * * * *

    Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06704 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P