[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,
[email protected].
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
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Approval date File No. Sponsor Product name Species Effect of the action Public documents
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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.
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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:
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21 CFR
File No. Product name Transferring sponsor New sponsor section
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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.
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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
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* * * * * * *
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
* * * * * * *
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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