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, 4204-4210 [2020-00421]
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Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations
FAA, call 206–231–3195. This material may
be found in the AD docket on the internet at
https://www.regulations.gov by searching for
and locating Docket No. FAA–2019–0722.
(5) You may view this material that is
incorporated by reference at the National
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(NARA). For information on the availability
of this material at NARA, email fedreg.legal@
nara.gov, or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
Issued on January 14, 2020.
Dionne Palermo,
Acting Director, System Oversight Division,
Aircraft Certification Service.
[FR Doc. 2020–01043 Filed 1–23–20; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
SUMMARY:
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.
DATES:
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:
I. Approval Actions
Final rule; technical
amendments.
ACTION:
Food and Drug Administration,
HHS.
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:
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.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND SEPTEMBER
2019
Approval date
File No.
July 1, 2019 ...
200–639
July 2, 2019 ...
141–519
July 5, 2019 ...
113–645
July 26, 2019
141–255
August 27,
2019.
141–465
August 27,
2019.
141–467
VerDate Sep<11>2014
Product name
Huvepharma EOOD, 5th
Floor, 3A Nikolay
Haytov Str., 1113 Sophia, Bulgaria.
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
MONOVET (monensin)
Type A Medicated Article.
Cattle and
goats.
Original approval as a generic copy of NADA
095–735.
FOI Summary.
PROHEART 12
(moxidectin) for Extended-Release
Injectable Suspension.
Dogs ...........
FOI Summary.
Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
Syndel USA, 1441 W.
Smith Rd., Ferndale,
WA 98248.
ESTRUMATE .................
(cloprostenol injection) ...
Cattle ..........
35% PEROX-AID (hydrogen peroxide) Concentrated Immersion
Solution.
Finfish .........
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Do. ..................................
Avilamycin and
monensin Type C
medicated feeds.
Avilamycin and narasin
Type C medicated
feeds.
Chickens ....
Original approval 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.
Supplemental approval for synchronization of
estrous cycles to allow for fixed time artificial
insemination (FTAI) in lactating dairy cows.
Supplemental approval for the control of mortality in freshwater-reared coldwater 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.
Supplemental approval of a revised age restriction caution statement for broiler feeds.
15:58 Jan 23, 2020
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Species
Effect of the action
Public
documents
Sponsor
Chickens ....
Sfmt 4700
Supplemental approval of a revised age restriction caution statement for broiler feeds.
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FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND SEPTEMBER
2019—Continued
Approval date
File No.
August 27,
2019.
Public
documents
Sponsor
Product name
Species
Effect of the action
141–495
Do. ..................................
Chickens ....
Supplemental approval of a revised age restriction caution statement for broiler feeds.
FOI Summary.
September 3,
2019.
September 20,
2019.
141–494
Do. ..................................
Dogs ...........
Huvepharma EOOD, 5th
Floor, 3A Nikolay
Haytov Str., 1113 Sophia, Bulgaria.
September 20,
2019.
200–643
Do. ..................................
Monensin and tylosin
phosphate Type B and
Type C medicated
feeds.
Cattle ..........
September 20,
2019.
200–644
Do. ..................................
Monensin, ractopamine
hydrochloride, and
tylosin phosphate Type
B and Type C medicated feeds.
Cattle ..........
September 20,
2019.
200–645
Do. ..................................
Monensin, ractopamine
hydrochloride, and
tylosin phosphate Type
B and Type C medicated feeds.
Cattle ..........
September 20,
2019.
200–646
Do. ..................................
Monensin, ractopamine
hydrochloride, and
tylosin phosphate Type
B and Type C medicated feeds.
Cattle ..........
September 20,
2019.
200–647
Do. ..................................
Monensin, ractopamine
hydrochloride, and
tylosin phosphate Type
B and Type C medicated feeds.
Cattle ..........
September 20,
2019.
200–648
Do. ..................................
Monensin, ractopamine
hydrochloride, tylosin
phosphate, and
melengestrol acetate
Type C medicated
feeds.
Cattle ..........
September 20,
2019.
200–649
Do. ..................................
Monensin, ractopamine
hydrochloride, tylosin
phosphate, and
melengestrol acetate
Type C medicated
feeds.
Cattle ..........
September 20,
2019.
200–650
Do. ..................................
Monensin, ractopamine
hydrochloride, tylosin
phosphate, and
melengestrol acetate
Type C medicated
feeds.
Cattle ..........
Supplemental approval for prevention of flea
infestations for 1 month in dogs and puppies.
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
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.
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
TYLAN (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.
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
OPTAFLEXX (ractopamine hydrochloride
Type A 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.
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
ACTOGAIN (ractopamine hydrochloride Type
A 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.
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
OPTAFLEXX (ractopamine hydrochloride
Type A 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.
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
ACTOGAIN (ractopamine hydrochloride Type
A 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.
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
OPTAFLEXX (ractopamine hydrochloride
Type A medicated article), TYLOVET (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.
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
ACTOGAIN (ractopamine hydrochloride Type
A medicated article), TYLOVET (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.
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
OPTAFLEXX (ractopamine hydrochloride
Type A medicated article), TYLOVET (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.
FOI Summary.
200–642
Avilamycin and
salinomycin Type C
medicated feeds.
CREDELIO (lotilaner)
Chewable Tablet.
Monensin and tylosin
phosphate Type B and
Type C medicated
feeds.
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Cattle ..........
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FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
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Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND SEPTEMBER
2019—Continued
Approval date
File No.
September 20,
2019.
200–651
Sponsor
Product name
Do. ..................................
II. Changes of Sponsor
Effect of the action
Cattle ..........
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
ACTOGAIN (ractopamine hydrochloride Type
A medicated article), TYLAN (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.
FDA that they have transferred
ownership of, and all rights and interest
The sponsors of the following
approved applications have informed
Public
documents
FOI Summary.
in, these applications to another
sponsor:
21 CFR
section
File No.
Product name
Transferring sponsor
New sponsor
140–872 .........
POSILAC
(sometribove
zinc)
Injectable Suspension.
ENTYCE (capromorelin) Oral Solution.
Elanco US Inc., 2500 Innovation
Way, Greenfield, IN 46140.
Aratana Therapeutics, Inc., 11400
Tomahawk
Creek
Pkwy.,
Leawood, KS 66211.
Aratana Therapeutics, Inc., 11400
Tomahawk
Creek
Pkwy.,
Leawood, KS 66211.
G. C. Hanford Mfg. Co., P.O. Box
1017, Syracuse, NY 13201.
Union Agener, Inc., 1788 Lovers
Ln., Augusta, GA 30901.
Elanco US Inc., 2500 Innovation
Way, Greenfield, IN 46140.
522.2112
Do. ..................................................
522.224
HQ Specialty Pharma Corp., 120
Rte. 17 North, Suite 130,
Paramus, NJ 07652.
Putney, Inc., One Monument Sq.,
Suite 400, Portland, ME 04101.
522.90b
141–457 .........
141–461 .........
NOCITA (bupivacaine liposome
injectable suspension).
200–180 .........
Ampicillin Trihydrate (ampicillin trihydrate) Powder for Injection.
200–273 .........
VETRO–GEN (gentamicin sulfate)
Veterinary Ophthalmic Ointment.
200–388 .........
GB
(gentamicin
sulfate
and
betamethasone valerate) Topical
Spray.
Carprofen (carprofen) Chewable
Tablets.
200–490 .........
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
§ 510.600(c) to reflect this change.
IV. Withdrawals of Approval
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Monensin, ractopamine
hydrochloride, tylosin
phosphate, and
melengestrol acetate
Type C medicated
feeds.
Species
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
VerDate Sep<11>2014
15:58 Jan 23, 2020
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Dechra, Ltd., Snaygill Industrial
Estate, Keighley Rd., Skipton,
North Yorkshire, BD23 2RW,
United Kingdom.
American Pharmaceuticals and
Cosmetics. Inc., 1401 Joel East
Rd., Fort Worth, TX 76140.
Dragon Fire Holding Co., Inc.,
2619 Skyway Dr., Grand Prairie,
TX 75052.
Frm 00016
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524.1044c
Do. ..................................................
524.1044f
Do. ..................................................
520.490
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 § 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
PO 00000
520.292
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
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Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations
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
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.
2. In § 510.600:
a. In the table in paragraph (c)(1):
i. Remove the entries for ‘‘American
Pharmaceuticals and Cosmetics. Inc.’’,
‘‘Aratana Therapeutics, Inc.’’, and
‘‘Dragon Fire Holding Co., Inc.’’;
■ ii. Revise the entry for ‘‘Halocarbon
Products Corp.’’; and
■ iii. Add an entry in alphabetical order
for ‘‘Union Agener, Inc.’’;
■ b. In the table in paragraph (c)(2):
■ i. Revise the entry for ‘‘012164’’;
■ ii. Remove the entries for ‘‘065531’’,
‘‘076033’’, and ‘‘086026’’; and
■ iii. Add an entry in numerical order
for ‘‘086106’’.
■ The revisions and additions read as
follows:
■
■
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092 ..................................................
*
*
*
*
*
*
*
Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901 ................................................................................................................
*
*
*
*
*
*
012164
086106
*
*
*
012164 ............
*
*
*
*
*
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092
*
*
086106 ............
*
*
*
Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901
(2) * * *
Drug labeler
code
Firm name and address
*
§ 510.600
*
*
[Amended]
3. Effective February 3, 2020,
§ 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’’.
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■
VerDate Sep<11>2014
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*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
4. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
PO 00000
*
*
*
*
*
*
§ 520.292
[Amended]
5. In § 520.292, in paragraph (b),
remove ‘‘086026’’ and in its place add
‘‘058198’’.
■
§ 520.304
[Amended]
6. In § 520.304, in paragraph (b)(1),
remove ‘‘062250, and 076033’’ and in its
place add ‘‘and 062250’’.
■
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Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations
§ 520.1286
[Amended]
14. In § 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:
■
7. In § 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’’.
■
§ 520.1807
§ 522.460
[Removed]
8. Effective February 3, 2020,
§ 520.1807 is removed.
■ 9. In § 520.2520d, revise the section
heading and add paragraph (c) to read
as follows:
■
§ 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.
■ 10. In § 520.2612, revise paragraph
(c)(2)(i) to read as follows:
§ 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
11. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 522.90b
[Amended]
12. In § 522.90b, in paragraph (b),
remove ‘‘010515’’ and in its place add
‘‘042791’’.
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■
§ 522.224
[Amended]
13. In § 522.224, in paragraph (b),
remove ‘‘086026’’ and in its place add
‘‘058198’’.
■
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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 mg by
intramuscular injection for abortion of
unwanted pregnancies from mismatings
from 1 week after mating until 5 months
after conception; for unobserved (nondetected) 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 mg 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 mg
gonadorelin by intramuscular injection,
followed 6 to 8 days later by 500 mg
cloprostenol by intramuscular injection,
followed 30 to 72 hours later by 86 mg
gonadorelin by intramuscular injection.
(2) Limitations. Gonadorelin acetate
for use in paragraph (c)(1)(iv) of this
section as provided by No. 000061 in
§ 510.600(c) of this chapter.
■ 15. Revise § 522.1451 to read as
follows:
§ 522.1451
injection.
Moxidectin microspheres for
Frm 00018
§ 522.2112
[Amended]
16. In § 522.2112, in paragraph (b),
remove ‘‘058198’’ and in its place add
‘‘086106’’.
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
17. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.1044c
[Amended]
18. In § 524.1044c, in paragraph (b),
remove ‘‘043264’’ and in its place add
‘‘026637’’.
■
§ 524.1044f
(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
§ 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
PO 00000
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.
Fmt 4700
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[Amended]
19. In § 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
20. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 529.1115
[Amended]
21. Effective February 3, 2020, in
§ 529.1115, in paragraph (b), remove
‘‘Nos. 012164 and 054771’’ and in its
place add ‘‘No. 054771’’.
■ 22. In § 529.1150, revise paragraph (c)
to read as follows:
■
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§ 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 freshwaterreared 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, °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®
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
23. The authority citation for part 556
continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
§ 556.513
[Removed]
24. Effective February 3, 2020,
§ 556.513 is removed.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
25. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
26. In § 558.4, in paragraph (d), revise
the entry for ‘‘Nicarbazin (powder)’’ to
read as follows:
■
§ 558.4 Requirement of a medicated feed
mill license.
*
*
*
(d) * * *
*
*
CATEGORY II
Assay limits
percent 1
Type A
Drug
*
*
*
Nicarbazin (powder) ......................................................
*
lotter on DSKBCFDHB2PROD with RULES
*
*
*
*
VerDate Sep<11>2014
*
*
*
15:58 Jan 23, 2020
*
96–104
Type B maximum
(100x)
Assay limits
percent 1
Type B/C 2
*
*
9.08 g/lb (2.00%) ..........................................................
*
85–115/75–
125
*
*
27. In § 558.68, revise paragraphs
(e)(1)(ii), (iii), and (v) to read as follows:
■
Jkt 250001
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*
§ 558.68
*
Avilamycin.
*
*
(e) * * *
(1) * * *
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Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations
Avilamycin
in grams/ton
Indications for use
*
(ii) 13.6 to 40.9 ..........
(iii) 13.6 to 40.9 .........
*
(v) 13.6 to 40.9 ..........
*
*
*
*
*
*
*
*
*
Salinomycin sodium, 40 to 60 ......... Feed as the sole ration for 21 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
§ 510.600(c) of this chapter.
*
*
28. In § 558.355, revise paragraphs (b)
and (f)(6)(i) to read as follows:
*
*
Monensin.
*
*
*
(b) Sponsors. See sponsors in
§ 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
Indications for use
Limitations
(i) 20 ......................
For the prevention of coccidiosis caused
by Eimeria crandallis, E. christenseni,
and E. ninakohlyakimovae.
Feed only to goats being fed in confinement. Do not feed to lactating goats. See
paragraph (d)(11) of this section for provisions for monensin liquid Type C goat
feeds.
*
*
§ 558.625
*
*
*
*
*
■
[Amended]
29. Amend § 558.625:
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:
■ 1. Paragraph (e)(2)(iv),
■ 2. Paragraph (e)(2)(v),
■ 3. Paragraph (e)(2)(x),
■ 4. Paragraph (e)(2)(xi),
■ 5. Paragraph (e)(2)(xii), and
■ 6. Paragraph (e)(2)(xiii); and
■ b. By adding ‘‘016592’’ in numerical
order in the ‘‘Sponsors’’ column in:
■ 1. Paragraph (e)(2)(x),
■ 2. Paragraph (e)(2)(xi),
■ 3. Paragraph (e)(2)(xii), and
■
■
VerDate Sep<11>2014
16:19 Jan 23, 2020
Jkt 250001
*
4. Paragraph (e)(2)(xiii).
[FR Doc. 2020–00421 Filed 1–23–20; 8:45 am]
058198
058198
Sponsor
*
Dated: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
058198
monensin, USP, per pound as in
paragraphs (f)(3), (f)(4)(vi), and (f)(6) of
this section.
*
*
*
*
*
(f) * * *
(6) * * *
Monensin
in grams/ton
*
lotter on DSKBCFDHB2PROD with RULES
Sponsor
*
*
*
*
*
*
Monensin, 90 to 110 ........................ Feed as the sole ration for 21 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 § 510.600(c) of this chapter.
Narasin, 54 to 90 ............................. Feed as the sole ration for 21 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 § 510.600(c) of this chapter.
■
§ 558.355
Limitations
*
058198
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 529
BILLING CODE 4164–01–P
PO 00000
[Docket No. FDA–2019–N–0002]
New Animal Drugs; Withdrawal of
Approval of a New Animal Drug
Application; Withdrawal of Approval of
Abbreviated New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Frm 00020
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E:\FR\FM\24JAR1.SGM
Notification of withdrawal.
24JAR1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 1, 2019......... 200-639 Huvepharma EOOD, 5th MONOVET (monensin) Cattle and goats.. Original approval as a generic FOI Summary.
Floor, 3A Nikolay Type A Medicated copy of NADA 095-735.
Haytov Str., 1113 Article.
Sophia, Bulgaria.
July 2, 2019......... 141-519 Zoetis Inc., 333 PROHEART 12 Dogs.............. Original approval for FOI Summary.
Portage St., (moxidectin) for prevention of heartworm
Kalamazoo, MI 49007. Extended-Release disease caused by Dirofilaria
Injectable immitis for 12 months in dogs
Suspension. 12 months of age and older;
and for treatment of existing
larval and adult hookworm
(Ancylostoma caninum and
Uncinaria stenocephala)
infections.
July 5, 2019......... 113-645 Intervet, Inc., 2 ESTRUMATE........... Cattle............ Supplemental approval for FOI Summary.
Giralda Farms, (cloprostenol synchronization of estrous
Madison, NJ 07940. injection). cycles to allow for fixed
time artificial insemination
(FTAI) in lactating dairy
cows.
July 26, 2019........ 141-255 Syndel USA, 1441 W. 35% PEROX-AID Finfish........... Supplemental approval for the FOI Summary.
Smith Rd., Ferndale, (hydrogen peroxide) control of mortality in
WA 98248. Concentrated freshwater-reared coldwater
Immersion Solution. finfish, fingerling and adult
freshwater-reared coolwater
finfish, and fingerling and
adult freshwater-reared
warmwater finfish due to
saprolegniasis associated
with fungi in the family
Saprolegniaceae; for the
treatment and control of
Gyrodactylus spp. in
freshwater-reared salmonids;
and for the control of
mortality in freshwater-
reared warmwater finfish due
to external columnaris
associated with
Flavobacterium columnare.
August 27, 2019...... 141-465 Elanco US Inc., 2500 Avilamycin and Chickens.......... Supplemental approval of a FOI Summary.
Innovation Way, monensin Type C revised age restriction
Greenfield, IN 46140. medicated feeds. caution statement for broiler
feeds.
August 27, 2019...... 141-467 Do................... Avilamycin and Chickens.......... Supplemental approval of a FOI Summary.
narasin Type C revised age restriction
medicated feeds. caution statement for broiler
feeds.
[[Page 4205]]
August 27, 2019...... 141-495 Do................... Avilamycin and Chickens.......... Supplemental approval of a FOI Summary.
salinomycin Type C revised age restriction
medicated feeds. caution statement for broiler
feeds.
September 3, 2019.... 141-494 Do................... CREDELIO (lotilaner) Dogs.............. Supplemental approval for FOI Summary.
Chewable Tablet. prevention of flea
infestations for 1 month in
dogs and puppies.
September 20, 2019... 200-642 Huvepharma EOOD, 5th Monensin and tylosin Cattle............ Original approval for use of FOI Summary.
Floor, 3A Nikolay phosphate Type B MONOVET 90 (monensin Type A
Haytov Str., 1113 and Type C medicated article) with
Sophia, Bulgaria. medicated feeds. TYLOVET (tylosin phosphate)
Type A medicated articles in
the manufacture of Type B and
Type C medicated feeds as a
generic copy of NADA 104-646.
September 20, 2019... 200-643 Do................... Monensin and tylosin Cattle............ Original approval for use of FOI Summary.
phosphate Type B MONOVET 90 (monensin Type A
and Type C medicated article) with TYLAN
medicated feeds. (tylosin phosphate) Type A
medicated articles in the
manufacture of Type B and
Type C medicated feeds as a
generic copy of NADA 104-646.
September 20, 2019... 200-644 Do................... Monensin, Cattle............ Original approval for use of FOI Summary.
ractopamine MONOVET 90 (monensin Type A
hydrochloride, and medicated article) with
tylosin phosphate OPTAFLEXX (ractopamine
Type B and Type C hydrochloride Type A
medicated feeds. medicated article) and
TYLOVET (tylosin phosphate)
Type A medicated article in
the manufacture of Type B and
Type C medicated feeds as a
generic copy of NADA 141-224.
September 20, 2019... 200-645 Do................... Monensin, Cattle............ Original approval for use of FOI Summary.
ractopamine MONOVET 90 (monensin Type A
hydrochloride, and medicated article) with
tylosin phosphate ACTOGAIN (ractopamine
Type B and Type C hydrochloride Type A
medicated feeds. medicated article) and
TYLOVET (tylosin phosphate)
Type A medicated article in
the manufacture of Type B and
Type C medicated feeds as a
generic copy of NADA 141-224.
September 20, 2019... 200-646 Do................... Monensin, Cattle............ Original approval for use of FOI Summary.
ractopamine MONOVET 90 (monensin Type A
hydrochloride, and medicated article) with
tylosin phosphate OPTAFLEXX (ractopamine
Type B and Type C hydrochloride Type A
medicated feeds. medicated article) and TYLAN
(tylosin phosphate) Type A
medicated article in the
manufacture of Type B and
Type C medicated feeds as a
generic copy of NADA 141-224.
September 20, 2019... 200-647 Do................... Monensin, Cattle............ Original approval for use of FOI Summary.
ractopamine MONOVET 90 (monensin Type A
hydrochloride, and medicated article) with
tylosin phosphate ACTOGAIN (ractopamine
Type B and Type C hydrochloride Type A
medicated feeds. medicated article) and TYLAN
(tylosin phosphate) Type A
medicated article in the
manufacture of Type B and
Type C medicated feeds as a
generic copy of NADA 141-224.
September 20, 2019... 200-648 Do................... Monensin, Cattle............ Original approval for use of FOI Summary.
ractopamine MONOVET 90 (monensin Type A
hydrochloride, medicated article) with
tylosin phosphate, OPTAFLEXX (ractopamine
and melengestrol hydrochloride Type A
acetate Type C medicated article), TYLOVET
medicated feeds. (tylosin phosphate) Type A
medicated article, and MGA
(melengestrol acetate Type A
medicated article) in the
manufacture of Type C
medicated feeds as a generic
copy of NADA 141-233.
September 20, 2019... 200-649 Do................... Monensin, Cattle............ Original approval for use of FOI Summary.
ractopamine MONOVET 90 (monensin Type A
hydrochloride, medicated article) with
tylosin phosphate, ACTOGAIN (ractopamine
and melengestrol hydrochloride Type A
acetate Type C medicated article), TYLOVET
medicated feeds. (tylosin phosphate) Type A
medicated article, and MGA
(melengestrol acetate Type A
medicated article) in the
manufacture of Type C
medicated feeds as a generic
copy of NADA 141-233.
September 20, 2019... 200-650 Do................... Monensin, Cattle............ Original approval for use of FOI Summary.
ractopamine MONOVET 90 (monensin Type A
hydrochloride, medicated article) with
tylosin phosphate, OPTAFLEXX (ractopamine
and melengestrol hydrochloride Type A
acetate Type C medicated article), TYLOVET
medicated feeds. (tylosin phosphate) Type A
medicated article, and MGA
(melengestrol acetate Type A
medicated article) in the
manufacture of Type C
medicated feeds as a generic
copy of NADA 141-233.
[[Page 4206]]
September 20, 2019... 200-651 Do................... Monensin, Cattle............ Original approval for use of FOI Summary.
ractopamine MONOVET 90 (monensin Type A
hydrochloride, medicated article) with
tylosin phosphate, ACTOGAIN (ractopamine
and melengestrol hydrochloride Type A
acetate Type C medicated article), TYLAN
medicated feeds. (tylosin phosphate) Type A
medicated article, and MGA
(melengestrol acetate Type A
medicated article) in the
manufacture of Type C
medicated feeds as a generic
copy of NADA 141-233.
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Changes of Sponsor
The sponsors of the following approved applications have informed
FDA that they have transferred ownership of, and all rights and
interest in, these applications to another sponsor:
----------------------------------------------------------------------------------------------------------------
21 CFR
File No. Product name Transferring sponsor New sponsor section
----------------------------------------------------------------------------------------------------------------
140-872.................. POSILAC (sometribove Elanco US Inc., 2500 Union Agener, Inc., 522.2112
zinc) Injectable Innovation Way, 1788 Lovers Ln.,
Suspension. Greenfield, IN 46140. Augusta, GA 30901.
141-457.................. ENTYCE (capromorelin) Aratana Therapeutics, Elanco US Inc., 2500 520.292
Oral Solution. Inc., 11400 Tomahawk Innovation Way,
Creek Pkwy., Leawood, Greenfield, IN 46140.
KS 66211.
141-461.................. NOCITA (bupivacaine Aratana Therapeutics, Do................... 522.224
liposome injectable Inc., 11400 Tomahawk
suspension). Creek Pkwy., Leawood,
KS 66211.
200-180.................. Ampicillin Trihydrate G. C. Hanford Mfg. HQ Specialty Pharma 522.90b
(ampicillin Co., P.O. Box 1017, Corp., 120 Rte. 17
trihydrate) Powder Syracuse, NY 13201. North, Suite 130,
for Injection. Paramus, NJ 07652.
200-273.................. VETRO-GEN (gentamicin Dechra, Ltd., Snaygill Putney, Inc., One 524.1044c
sulfate) Veterinary Industrial Estate, Monument Sq., Suite
Ophthalmic Ointment. Keighley Rd., 400, Portland, ME
Skipton, North 04101.
Yorkshire, BD23 2RW,
United Kingdom.
200-388.................. GB (gentamicin sulfate American Do................... 524.1044f
and betamethasone Pharmaceuticals and
valerate) Topical Cosmetics. Inc., 1401
Spray. Joel East Rd., Fort
Worth, TX 76140.
200-490.................. Carprofen (carprofen) Dragon Fire Holding Do................... 520.490
Chewable Tablets. Co., Inc., 2619
Skyway Dr., Grand
Prairie, TX 75052.
----------------------------------------------------------------------------------------------------------------
Following these changes of sponsorship, American Pharmaceuticals and
Cosmetics, Inc.; Aratana Therapeutics, Inc.; and Dragon Fire Holding
Co., Inc. are no longer the sponsor of an approved application.
Accordingly, the regulations in parts 510, 520, 522, and 524 are being
amended to reflect these changes.
III. Change of Sponsor's Address
Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ
07661 has informed FDA that it has changed its address to 6525 The
Corners Pkwy., Suite 200, Peachtree Corners, GA 30092. Accordingly, we
are amending Sec. 510.600(c) to reflect this change.
IV. Withdrawals of Approval
Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234,
has requested that FDA withdraw approval of NADA 010-005 for use of
WAZINE (dipiperazine sulfate and piperazine hydrochloride) Soluble
Powders because the product is no longer manufactured or marketed.
Following this withdrawal of approval, Fleming Laboratories, Inc., is
no longer the sponsor of an approved application. Accordingly, it will
be removed from the list of sponsors of approved applications in Sec.
510.600(c). In addition, Fleming Laboratories, Inc.'s product was the
only piperazine product approved for use in food-producing animals.
Accordingly, tolerances for piperazine will be removed from part 556.
Also, Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200,
Peachtree Corners, GA 30092, has requested that FDA withdraw approval
of ANADA 200-200 for use of Halothane USP (halothane) because the
product is no longer manufactured or marketed.
Lastly, Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL
61103, has requested that FDA withdraw approval of ANADA 200-472 for
use of Fomepizole Injection because the product is no longer
manufactured or marketed.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 010-005 and ANADAs 200-200 and 200-472, and all
supplements and amendments thereto, is withdrawn effective February 3,
2020. As provided in the regulatory text of this document, the animal
drug regulations in parts 510, 520, 556, and 529 are amended to reflect
these actions.
V. Technical Amendments
FDA is revising the regulations at 21 CFR 520.2520d to reflect the
approved conditions of use of trichlorfon, phenothiazine, and
piperazine soluble powder for oral administration to horses as an
anthelmintic. This information was deleted in error during
redesignation (79 FR 28833, May 20, 2014). FDA is also revising the
regulations at 21 CFR 520.2612 to reflect the currently approved dosage
for trimethoprim and sulfadiazine
[[Page 4207]]
suspension for oral administration to horses as an antimicrobial.
Lastly, FDA is revising the assay limits for nicarbazin medicated feeds
at 21 CFR 558.4(d) in the ``Category II'' table. These actions are
being taken to improve the accuracy of the regulations.
VI. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.360b(i)), which
requires Federal Register publication of ``notice[s] . . . effective as
a regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, 529, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600:
0
a. In the table in paragraph (c)(1):
0
i. Remove the entries for ``American Pharmaceuticals and Cosmetics.
Inc.'', ``Aratana Therapeutics, Inc.'', and ``Dragon Fire Holding Co.,
Inc.'';
0
ii. Revise the entry for ``Halocarbon Products Corp.''; and
0
iii. Add an entry in alphabetical order for ``Union Agener, Inc.'';
0
b. In the table in paragraph (c)(2):
0
i. Revise the entry for ``012164'';
0
ii. Remove the entries for ``065531'', ``076033'', and ``086026''; and
0
iii. Add an entry in numerical order for ``086106''.
0
The revisions and additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 012164
200, Peachtree Corners, GA 30092.......................
* * * * * * *
Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901.. 086106
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
012164.................. Halocarbon Products Corp., 6525 The Corners
Pkwy., Suite 200, Peachtree Corners, GA 30092
* * * * * * *
086106.................. Union Agener, Inc., 1788 Lovers Ln., Augusta,
GA 30901
* * * * * * *
------------------------------------------------------------------------
Sec. 510.600 [Amended]
0
3. Effective February 3, 2020, Sec. 510.600 is further amended, in the
table in paragraph (c)(1), remove the entry for ``Fleming Laboratories,
Inc.''; and in the table in paragraph (c)(2), remove the entry for
``015565''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
4. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.292 [Amended]
0
5. In Sec. 520.292, in paragraph (b), remove ``086026'' and in its
place add ``058198''.
Sec. 520.304 [Amended]
0
6. In Sec. 520.304, in paragraph (b)(1), remove ``062250, and 076033''
and in its place add ``and 062250''.
[[Page 4208]]
Sec. 520.1286 [Amended]
0
7. In Sec. 520.1286, in paragraph (c)(2), remove ``for the treatment
of flea infestations'' and in its place add ``for the treatment and
prevention of flea infestations''.
Sec. 520.1807 [Removed]
0
8. Effective February 3, 2020, Sec. 520.1807 is removed.
0
9. In Sec. 520.2520d, revise the section heading and add paragraph (c)
to read as follows:
Sec. 520.2520d Trichlorfon, phenothiazine, and piperazine.
* * * * *
(c) Conditions of use in horses--(1) Amount. 18.2 milligrams (mg)
of trichlorfon, 12.5 mg of phenothiazine, and 40 mg of piperazine base
per pound of body weight.
(2) Indications for use. For removal of bots (Gastrophilus nasalis,
Gastrophilus intestinalis), large strongyles (Strongylus vulgaris),
small strongyles, large roundworms (ascarids, Parascaris equorum), and
pinworms (Oxyuris equi).
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
0
10. In Sec. 520.2612, revise paragraph (c)(2)(i) to read as follows:
Sec. 520.2612 Trimethoprim and sulfadiazine suspension.
* * * * *
(c) * * *
(2) * * *
(i) Amount. Administer orally at a dosage of 24 mg combined active
ingredients per kilogram body weight (10.9 mg/lb) twice daily for 10
days. Administered by volume at 2.7 mL per 45.4 kilograms of body
weight (2.7 mL/100 lb).
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
11. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.90b [Amended]
0
12. In Sec. 522.90b, in paragraph (b), remove ``010515'' and in its
place add ``042791''.
Sec. 522.224 [Amended]
0
13. In Sec. 522.224, in paragraph (b), remove ``086026'' and in its
place add ``058198''.
0
14. In Sec. 522.460, add paragraph (b)(3), revise paragraphs
(c)(1)(ii) and (iii), add paragraph (c)(1)(iv), and revise paragraph
(c)(2) to read as follows:
Sec. 522.460 Cloprostenol.
* * * * *
(b) * * *
(3) No. 000061 for use of product described in paragraph (a)(2) as
in paragraphs (c)(1)(iv) and (c)(2) of this section.
(c) * * *
(1) * * *
(ii) Administer 500 [micro]g by intramuscular injection for
abortion of unwanted pregnancies from mismatings from 1 week after
mating until 5 months after conception; for unobserved (non-detected)
estrus; for treatment of mummified fetus, luteal cysts, and pyometra or
chronic endometritis in beef cows, lactating dairy cows, and
replacement beef and dairy heifers.
(iii) Administer 500 [micro]g by intramuscular injection as a
single injection regimen or double injection regimen with a second
injection 11 days after the first, for estrus synchronization in beef
cows, lactating dairy cows, and replacement beef and dairy heifers.
(iv) For use with gonadorelin acetate to synchronize estrous cycles
to allow for fixed time artificial insemination (FTAI) in lactating
dairy cows: Administer to each cow 86 [micro]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 500 [micro]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by 86 [micro]g gonadorelin by intramuscular injection.
(2) Limitations. Gonadorelin acetate for use in paragraph
(c)(1)(iv) of this section as provided by No. 000061 in Sec.
510.600(c) of this chapter.
0
15. Revise Sec. 522.1451 to read as follows:
Sec. 522.1451 Moxidectin microspheres for injection.
(a) Specifications. The drug product consists of two separate
vials. One vial contains 10 percent moxidectin microspheres and the
second vial contains a vehicle for constitution of the moxidectin
microspheres.
(1) Each milliliter (mL) of constituted suspension contains 3.4
milligrams (mg) moxidectin.
(2) Each mL of constituted suspension contains 10 mg moxidectin.
(b) Sponsor. See No. 54771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. (i) Using the suspension
described in paragraph (a)(1) of this section, administer 0.05 mL of
the constituted suspension per kilogram (kg) of body weight (0.023 mL
per pound (lb)) as a single subcutaneous injection to provide 0.17 mg/
kg body weight (0.0773 mg/lb).
(ii) Using the suspension described in paragraph (a)(2) of this
section, administer 0.05 mL of the constituted suspension/kg of body
weight (0.023 mL/lb) as a single subcutaneous injection to provide 0.5
mg/kg body weight (0.23 mg/lb).
(2) Indications for use--(i) Suspension described in paragraph
(a)(1) of this section. For prevention of heartworm disease caused by
Dirofilaria immitis in dogs 6 months of age and older; and for
treatment of existing larval and adult hookworm (Ancylostoma caninum
and Uncinaria stenocephala) infections.
(ii) Suspension described in paragraph (a)(2) of this section. For
prevention of heartworm disease caused by Dirofilaria immitis for 12
months in dogs 12 months of age and older; and for treatment of
existing larval and adult hookworm (Ancylostoma caninum and Uncinaria
stenocephala) infections.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.2112 [Amended]
0
16. In Sec. 522.2112, in paragraph (b), remove ``058198'' and in its
place add ``086106''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
17. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1044c [Amended]
0
18. In Sec. 524.1044c, in paragraph (b), remove ``043264'' and in its
place add ``026637''.
Sec. 524.1044f [Amended]
0
19. In Sec. 524.1044f, in paragraph (b), remove ``058829, and 065531''
and in its place add ``and 058829''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
20. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1115 [Amended]
0
21. Effective February 3, 2020, in Sec. 529.1115, in paragraph (b),
remove ``Nos. 012164 and 054771'' and in its place add ``No. 054771''.
0
22. In Sec. 529.1150, revise paragraph (c) to read as follows:
[[Page 4209]]
Sec. 529.1150 Hydrogen peroxide.
* * * * *
(c) Conditions of use--(1) Indications and amount. (i) Freshwater-
reared finfish eggs for the control of mortality in due to
saprolegniasis associated with fungi in the family Saprolegniaceae:
(A) For all coldwater and coolwater species of freshwater-reared
finfish eggs: 500 to 1,000 mg per liter (/L) of culture water for 15
minutes in a continuous flow system once per day on consecutive or
alternate days until hatch, or
(B) For all freshwater-reared warmwater finfish eggs: 750 to 1,000
mg/L for 15 minutes in a continuous flow system once per day on
consecutive or alternate days until hatch.
(ii) Freshwater-reared finfish for the control of mortality due to
saprolegniasis associated with the fungi in the family Saprolegniaceae:
For freshwater-reared coldwater finfish including salmonids (all life
stages), freshwater-reared coolwater finfish fingerlings and adults,
and freshwater-reared warmwater finfish fingerlings and adults: 75 mg/L
for 60 minutes in continuous flow water supply or as a static bath once
per day on alternate days for three treatments.
(iii) Freshwater-reared salmonids for the control of mortality due
to bacterial gill disease associated with Flavobacterium
branchiophilum: 100 mg/L for 30 minutes, or 50 to 100 mg/L for 60
minutes, in a continuous flow water supply or as a static bath once per
day on alternate days for three treatments.
(iv) Freshwater-reared salmonids for the treatment and control of
Gyrodactylus spp: 100 mg/L for 30 minutes, or 50 to 100 mg/L for 60
minutes, in a continuous flow water supply or as a static bath once per
day on alternate days for three treatments.
(v) Freshwater-reared coolwater and warmwater finfish fingerlings
and adults for the control of mortality due to external columnaris
disease associated with Flavobacterium columnare: 50 to 75 mg/L for 60
minutes in continuous flow water supply or as a static bath once per
day on alternate days for three treatments.
(vi) Freshwater-reared coolwater finfish fry and warmwater finfish
fry for the control of mortality due to external columnaris disease
associated with Flavobacterium columnare: 50 mg/L for 60 minutes in
continuous flow water supply or as a static bath once per day on
alternate days for three treatments.
(2) Limitations. (i) Initial bioassay on a small number is
recommended before treating the entire group.
(ii) Eggs: Some strains of rainbow trout eggs are sensitive to
hydrogen peroxide treatment at a time during incubation concurrent with
blastopore formation through closure, about 70 to 140 Daily Temperature
Units, [deg]C. Consider withholding treatment or using an alternate
therapeutant during that sensitive time to reduce egg mortalities due
to drug toxicity.
(iii) Finfish: Because finfish sensitivity to 35% PEROX-AID[supreg]
increases with increasing water temperature, consider administering
initial treatments at the lower end of the treatment regimen or
reducing water temperature before treatment. Do not use this product to
treat northern pike (Esox lucius) or paddlefish (Polyodon spathula) of
any age. Do not use this product to treat pallid sturgeon fry. Use with
caution on walleye (Sander vitreus) and ornamental finfish.
(iv) Preharvest withdrawal time: Zero days.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
23. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.513 [Removed]
0
24. Effective February 3, 2020, Sec. 556.513 is removed.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
25. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
26. In Sec. 558.4, in paragraph (d), revise the entry for ``Nicarbazin
(powder)'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
----------------------------------------------------------------------------------------------------------------
Assay limits Assay limits
Drug percent \1\ Type B maximum (100x) percent \1\
Type A Type B/C \2\
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Nicarbazin (powder).......................... 96-104 9.08 g/lb (2.00%).............. 85-115/75-125
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
27. In Sec. 558.68, revise paragraphs (e)(1)(ii), (iii), and (v) to
read as follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
[[Page 4210]]
----------------------------------------------------------------------------------------------------------------
Avilamycin in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 13.6 to 40.9................... Monensin, 90 to 110......... Feed as the sole ration for 21 058198
consecutive days. Feed to
chickens that are at risk of
developing, but not yet showing
clinical signs of, necrotic
enteritis associated with
Clostridium perfringens in
broiler chickens. Avilamycin has
not been demonstrated to be
effective in broiler chickens
showing clinical signs of
necrotic enteritis prior to the
start of medication. To assure
responsible antimicrobial drug
use in broiler chickens,
treatment administration must
begin on or before 18 days of
age. Do not feed to chickens
over 16 weeks of age. The safety
of avilamycin has not been
established in chickens intended
for breeding purposes. Do not
allow horses or other equines
access to feed containing
avilamycin and monensin.
Ingestion of monensin by horses
has been fatal. Do not feed to
chickens producing eggs for
human consumption. Monensin as
provided by No. 058198 in Sec.
510.600(c) of this chapter.
(iii) 13.6 to 40.9.................. Narasin, 54 to 90........... Feed as the sole ration for 21 058198
consecutive days. Feed to
chickens that are at risk of
developing, but not yet showing
clinical signs of, necrotic
enteritis associated with
Clostridium perfringens.
Avilamycin has not been
demonstrated to be effective in
broiler chickens showing
clinical signs of necrotic
enteritis prior to the start of
medication. To assure
responsible antimicrobial drug
use in broiler chickens,
treatment administration must
begin on or before 18 days of
age. The safety of avilamycin
has not been established in
chickens intended for breeding
purposes. Do not allow adult
turkeys, horses, or other
equines access to narasin
formulations. Ingestion of
narasin by these species has
been fatal. Do not feed to
chickens producing eggs for
human consumption. Narasin as
provided by No. 058198 in Sec.
510.600(c) of this chapter.
* * * * * * *
(v) 13.6 to 40.9.................... Salinomycin sodium, 40 to 60 Feed as the sole ration for 21 058198
consecutive days. Feed to
chickens that are at risk of
developing, but not yet showing
clinical signs of, necrotic
enteritis associated with
Clostridium perfringens.
Avilamycin has not been
demonstrated to be effective in
broiler chickens showing
clinical signs of necrotic
enteritis prior to the start of
medication. To assure
responsible antimicrobial drug
use in broiler chickens,
treatment administration must
begin on or before 18 days of
age. The safety of avilamycin
has not been established in
chickens intended for breeding
purposes. May be fatal if fed to
adult turkeys or to horses. Not
approved for use with pellet
binders. Do not feed to laying
hens producing eggs for human
consumption. Salinomycin as
provided by No. 016592 in Sec.
510.600(c) of this chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
28. In Sec. 558.355, revise paragraphs (b) and (f)(6)(i) to read as
follows:
Sec. 558.355 Monensin.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (f) of this section.
(1) No. 058198 for use as in paragraph (f) of this section.
(2) No. 016592 for use of a Type A medicated article containing
90.7 grams monensin, USP, per pound as in paragraphs (f)(3),
(f)(4)(vi), and (f)(6) of this section.
* * * * *
(f) * * *
(6) * * *
------------------------------------------------------------------------
Indications for
Monensin in grams/ton use Limitations Sponsor
------------------------------------------------------------------------
(i) 20............... For the Feed only to goats 058198
prevention of being fed in
coccidiosis confinement. Do not
caused by feed to lactating
Eimeria goats. See
crandallis, E. paragraph (d)(11)
christenseni, of this section for
and E. provisions for
ninakohlyakimov monensin liquid
ae. Type C goat feeds.
* * * * * * *
------------------------------------------------------------------------
* * * * *
Sec. 558.625 [Amended]
0
29. Amend Sec. 558.625:
0
a. By removing ``monensin as provided by No. 058198'' and adding in its
place ``monensin as provided by Nos. 016592 or 058198'' in the
``Limitations'' column, in:
0
1. Paragraph (e)(2)(iv),
0
2. Paragraph (e)(2)(v),
0
3. Paragraph (e)(2)(x),
0
4. Paragraph (e)(2)(xi),
0
5. Paragraph (e)(2)(xii), and
0
6. Paragraph (e)(2)(xiii); and
0
b. By adding ``016592'' in numerical order in the ``Sponsors'' column
in:
0
1. Paragraph (e)(2)(x),
0
2. Paragraph (e)(2)(xi),
0
3. Paragraph (e)(2)(xii), and
0
4. Paragraph (e)(2)(xiii).
Dated: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00421 Filed 1-23-20; 8:45 am]
BILLING CODE 4164-01-P
