New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor, 45306-45311 [2020-15760]
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collateral posted pursuant to § 1200.204
for any expenses incurred in
development of the proposed program.
§ 1200.206
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Execution of the order.
(a) Issuance of the order. The
Administrator shall, if the
Administrator finds that it will tend to
effectuate the purposes of the Act, issue
the final order.
(b) Effective date of order. No order
shall become effective in less than 30
days after its publication in the Federal
Register, unless the Administrator,
upon good cause found and published
with the order, fixes an earlier effective
date.
(c) Notice of issuance. After the
Administrator issues the order, AMS
will publish notice of the order’s
issuance in the Federal Register.
Bruce Summers,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2020–15412 Filed 7–27–20; 8:45 am]
BILLING CODE P
21 CFR Parts 510, 520, 522, 524, and
558
I. Approvals
[Docket No. FDA–2020–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications; Change of Sponsor
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during January,
February, and March 2020. FDA is
informing the public of the availability
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to make technical
amendments to improve the accuracy of
the regulations.
DATES: This rule is effective July 28,
2020.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
January, February, and March 2020, as
listed in table 1. In addition, FDA is
informing the public of the availability,
where applicable, of documentation of
environmental review required under
the National Environmental Policy Act
and, for actions requiring review of
safety or effectiveness data, summaries
of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the office of
the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday. 240–402–7500.
Persons with access to the internet may
obtain these documents at the CVM
FOIA Electronic Reading Room: https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing
exclusivity and patent information may
be accessed in FDA’s publication,
Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/
animal-veterinary/products/approvedanimal-drug-products-green-book.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2020
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Approval date
File No.
Sponsor
Product name
Species
Effect of the action
Supplemental approval of an increased
age restriction and reduced withdrawal period in the use of
MAXIBAN (narasin and nicarbazin)
Type A medicated article) with
INTEPRITY (avilamycin) Type A
medicated articles in the manufacture of Type C medicated broiler
feeds.
Original approval as a generic copy of
NADA 119–807.
FOI Summary.
Original approval for the prevention of
heartworm disease; kills adult fleas
and is indicated for the treatment
and prevention of flea infestations,
the treatment and control of tick infestations, and the treatment and
control of roundworm and adult
hookworm infections for one month.
Original approval as a generic copy of
NADA 141–152.
FOI Summary.
January 28, 2020 ...
141–466
Elanco US Inc.,
2500 Innovation
Way, Greenfield,
IN 46140.
Narasin and
nicarbazin and
avilamycin Type
C medicated
broiler feeds.
Chickens .........
February 7, 2020 ...
200–614
Pentobarbital Sodium and Phenytoin Sodium
Injectable Solution.
Dogs ................
February 27, 2020
141–521
Akorn Animal
Health, Inc.,
1925 West Field
Ct., Suite 300,
Lake Forest, IL
60045.
Zoetis Inc., 333
Portage St.,
Kalamazoo, MI
49007.
SIMPARICA TRIO
(sarolaner,
moxidectin, and
pyrantel
chewable tablets)
Chewable Tablet.
Dogs ................
March 10, 2020 ......
200–670
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, County Galway, H62
FH90, Ireland.
SENERGY
(selamectin) Topical Solution.
Dogs and cats
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Public documents
FOI Summary.
FOI Summary.
Federal Register / Vol. 85, No. 145 / Tuesday, July 28, 2020 / Rules and Regulations
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2020—Continued
Approval date
File No.
March 23, 2020 ......
200–586
March 27, 2020 ......
141–322
Sponsor
Dechra Veterinary
Products, LLC,
7015 College
Blvd., Suite 525,
Overland Park,
KS 66211.
Zoetis Inc., 333
Portage St.,
Kalamazoo, MI
49007.
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II. Withdrawals of Approval
Hikma International Pharmaceuticals
LLC, P.O. Box 182400, Bayader Wadi
Seer, Amman, Jordan 11118 has
requested that FDA withdraw approval
of ANADA 200–323 for a 1-gram
phenylbutazone bolus because the
product is no longer manufactured or
marketed. Following this withdrawal of
approval, Hikma International
Pharmaceuticals LLC is no longer the
sponsor of an approved application. As
provided in the regulatory text of this
document, the animal drug regulations
are amended to reflect this action.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of ANADA 200–323, and all
supplements and amendments thereto,
is withdrawn.
III. Changes of Sponsor
Dechra Veterinary Products LLC, 7015
College Blvd., Suite 525, Overland Park,
KS 66211 has informed FDA that it has
transferred ownership of, and all rights
and interest in, approved NADA 008–
760 for ADRENOMONE (corticotropin)
Injection to Dechra, Ltd., Snaygill
Industrial Estate, Keighley Rd., Skipton,
North Yorkshire, BD23 2RW, United
Kingdom.
Kindred Biosciences, Inc., 1555
Bayshore Hwy., Suite 200, Burlingame,
CA 94010 has informed FDA that it has
transferred ownership of, and all rights
and interest in, approved NADA 141–
481 for MIRATAZ (mirtazapine)
Transdermal Ointment to Dechra, Ltd.,
Snaygill Industrial Estate, Keighley Rd.,
Skipton, North Yorkshire, BD23 2RW,
United Kingdom.
Accordingly, we are amending the
regulations to reflect these changes.
IV. Technical Amendments
FDA is revising sections for
efrotomycin, iodinated casein,
maduramicin, mibolerone, nystatin, and
poloxalene in 21 CFR part 558 to reflect
a tabular format. The section for
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Product name
Species
Effect of the action
MARBOQUIN
(marbofloxacin)
Tablets.
Dogs ................
Original approval as a generic copy of
NADA 141–151.
FOI Summary.
IMPROVEST
(gonadotropin release factor analog-diphtheria
toxoid conjugate)
Injectable Solution.
Swine ..............
Supplemental approval for the temporary suppression of estrus in gilts
intended for slaughter.
FOI Summary EA/FONSI.
tiamulin oral dosage forms in 21 CFR
part 520 is being revised to correct
ownership of certain products. These
amendments will improve the
readability and accuracy of the animal
drug regulations.
V. Legal Authority
This final rule is issued under section
512(i) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360b(i)), which requires Federal
Register publication of ‘‘notice[s] . . .
effective as a regulation,’’ of the
conditions of use of approved new
animal drugs. This rule sets forth
technical amendments to the regulations
to codify recent actions on approved
new animal drug applications and
corrections to improve the accuracy of
the regulations, and as such does not
impose any burden on regulated
entities.
Although denominated a rule
pursuant to the FD&C Act, this
document does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a ‘‘rule of particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
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
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520, 522, and 524
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Animal drugs.
Frm 00005
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21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510,
520, 522, 524, and 558 are amended as
follows:
PART 510—NEW ANIMAL DRUGS
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.
§ 510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Hikma International Pharmaceuticals
LLC’’; and in the table in paragraph
(c)(2), remove the entry for ‘‘059115’’.
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.1310
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[Amended]
4. In § 520.1310, in paragraph (b),
remove ‘‘No. 054771’’ and in its place
add ’’ Nos. 026637 and 054771’’.
■
§ 520.1720a
[Amended]
5. In § 520.1720a, remove paragraphs
(b)(4) and (5) and redesignate paragraph
(b)(6) as paragraph (b)(4).
■ 6. Add § 520.2090 to read as follows:
■
§ 520.2090
pyrantel.
21 CFR Part 510
Public documents
Sarolaner, moxidectin, and
(a) Specifications. Each chewable
tablet contains:
(1) 3.0 mg sarolaner, 0.06 mg
moxidectin, and 12.5 milligrams (mg)
pyrantel (as pamoate salt);
(2) 6.0 mg sarolaner, 0.12 mg
moxidectin, and 25.0 mg pyrantel (as
pamoate salt);
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(3) 12.0 mg sarolaner, 0.24 mg
moxidectin, and 50.0 mg pyrantel (as
pamoate salt);
(4) 24.0 mg sarolaner, 0.48 mg
moxidectin, and 100 mg pyrantel (as
pamoate salt);
(5) 48.0 mg sarolaner, 0.96 mg
moxidectin, and 200 mg pyrantel (as
pamoate salt); or
(6) 72.0 mg sarolaner, 1.44 mg
moxidectin, and 300 mg pyrantel (as
pamoate salt).
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer orally, once a
month, at the recommended minimum
dose of 0.54 mg/lb (1.2 mg/kg) sarolaner,
0.011 mg/lb (24 mg/kg) moxidectin, and
2.27 mg/lb (5 mg/kg) pyrantel (as
pamoate salt).
(2) Indications for use. Prevents
heartworm disease caused by Dirofilaria
immitis, kills adult fleas
(Ctenocephalides felis) and is indicated
for the treatment and prevention of flea
infestations, the treatment and control
of tick infestations with Amblyomma
americanum (lone star tick),
Amblyomma maculatum (Gulf Coast
tick), Dermacentor variabilis (American
dog tick), Ixodes scapularis (blacklegged tick), and Rhipicephalus
sanguineus (brown dog tick), and the
treatment and control of roundworm
(immature adult and adult Toxocara
canis and adult Toxascaris leonina) and
adult hookworm (Ancylostoma caninum
and Uncinaria stenocephala) infections
for 1 month in dogs and puppies 8
weeks of age and older, and weighing
2.8 pounds or greater.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 520.2455
[Amended]
7. In § 520.2455, in paragraph (b)(2),
remove ‘‘paragraph (a)(1)’’ and in its
place add ‘‘paragraphs (a)(1) and (a)(3)’’.
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PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
8. The authority citation for part 522
continues to read as follows:
■
■
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12. The authority citation for part 524
continues to read as follows:
Authority: 21 U.S.C. 360b.
§ 522.480
Authority: 21 U.S.C. 360b.
[Amended]
§ 524.1448
9. In § 522.480, in paragraph (b)(2),
remove ‘‘026637’’ and in its place add
‘‘043264’’.
■ 10. In § 522.1083, revise paragraphs
(a) and (c) to read as follows:
■
§ 522.1083 Gonadotropin releasing factor
analog-diphtheria toxoid conjugate.
(a) Specifications. Each milliliter (mL)
of solution contains 0.2 milligrams (mg)
gonadotropin releasing factor analogdiphtheria toxoid conjugate.
*
*
*
*
*
(c) Conditions of use in swine—(1)
Amount. Each intact male pig or gilt
should receive two 2-mL (0.4 mg) doses
by subcutaneous injection. Administer
the first dose no earlier than 9 weeks of
age. Administer the second dose at least
4 weeks after the first dose.
(2) Indications for use. (i) Intact male
pigs intended for slaughter: For the
temporary immunological castration
(suppression of testicular function) and
reduction of boar taint.
(ii) Gilts intended for slaughter: For
the temporary suppression of estrus.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. For reduction of
boar taint, intact male pigs should be
slaughtered no earlier than 3 weeks and
no later than 10 weeks after the second
dose.
§ 522.1697
[Amended]
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[Amended]
13. In § 524.1448, in paragraph (b),
remove ‘‘086078’’ and in its place add
‘‘043264’’.
■
14. In § 524.1484b, revise the section
heading and paragraph (a) to read as
follows:
■
§ 524.1484b Neomycin, isoflupredone, and
tetracaine powder.
(a) Specifications. Each 15-gram
insufflator bottle contains 5 milligrams
(mg) neomycin sulfate (equivalent to 3.5
mg neomycin base), 1 mg isoflupredone
acetate, and 5 mg tetracaine
hydrochloride in a powder base.
*
*
*
*
*
§ 524.2098
[Amended]
15. In § 524.2098, in paragraph (b),
remove ‘‘Nos. 054771 and 055529’’ and
in its place add ‘‘Nos. 054771, 055529,
and 061651’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
16. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
17. In § 558.68, revise paragraph
(e)(1)(iv) to read as follows:
■
§ 558.68
11. In § 522.1697, in paragraph (b),
remove ‘‘000061, 051311, and 054925’’
and in its place add ‘‘000061, 051311,
054925, and 059399’’.
■
■
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PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
*
*
Avilamycin.
*
(e) * * *
(1) * * *
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*
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Avilamycin in
grams/ton
*
(iv) 13.6 to 40.9 .....
Combination in
grams/ton
*
Narasin, 27 to 45
plus nicarbazin,
27 to 45.
*
Limitations
*
*
Broiler chickens: For the prevention of
mortality caused by necrotic enteritis
associated
with
Clostridium
perfringens; and for the prevention of
coccidiosis caused by Eimeria necatrix,
E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima.
*
*
Feed as the sole ration for 21 consecutive days 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 and nicarbazin as provided by No. 058198 in § 510.600(c) of
this chapter.
*
*
*
*
§ 558.235
■
*
*
*
*
*
18. In § 558.235, revise paragraph (d)
to read as follows:
*
*
Limitations
(1) 3.6 ......................
Swine: For improved feed efficiency ..........................
(2) 3.6 to 14.5 .........
Swine: For increased rate of weight gain ...................
Feed continuously as sole ration. Not to be used in
swine weighing more than 250 pounds.
Feed continuously as sole ration. Not to be used in
swine weighing more than 250 pounds.
§ 558.295
Iodinated casein.
(a) Type A medicated articles
containing grams iodinated casein per
pound.
Limitations
(i) 100 to 200 ..........
(ii) [Reserved]
Growing ducks: For increased rate of weight gain ....
.....................................................................................
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*
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Sponsor
000010
000010
(c) Conditions of use—(1) Ducks—
Indications for use
15:58 Jul 27, 2020
058198
(b) Sponsor. See No. 017762 in
§ 510.600(c) of this chapter.
Amount in grams/ton
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*
Efrotomycin.
Indications for use
19. Revise § 558.295 to read as
follows:
Sponsor
*
*
*
*
(d) Conditions of use in swine—
Efrotomycin
in grams/ton
■
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Indications for use
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Sponsor
017762
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(2) Dairy cows—
Amount in grams/
pound
(1) 0.5 to 1.5 per
100 lb of body
weight.
Indications for use
Limitations
Dairy cows: For increased milk production ................
This drug is effective for limited periods of time, and
the effectiveness is limited to the declining phase
of lactation. Administration must be accompanied
with increased feed intake. Administration may increase heat sensitivity of the animal.
Sponsor
017762
(2) [Reserved]
§ 558.340
20. Revise § 558.340 to read as
follows:
■
Maduramicin.
(a) Specifications. Type A medicated
articles containing 4.54 grams
maduramicin per pound.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Tolerances. See § 556.375 of this
chapter.
(d) Conditions of use in chickens—
Amount in grams/ton
Indications for use
Limitations
(1) 4.54 to 5.45 .......
Broiler chickens: For prevention of coccidiosis
caused by Eimeria acervulina, E. tenella, E.
brunetti, E. maxima, E. necatrix, and E. mivati.
Feed continuously as sole ration. For broiler chickens only. Do not feed to laying hens. Withdraw 5
days before slaughter.
Sponsor
054771
(2) [Reserved]
21. Revise § 558.348 to read as
follows:
■
§ 558.348
Mibolerone.
(a) Specifications. Each 6.5 ounce can
contains 30 or 60 micrograms (mg) of
mibolerone.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. 30 mg for animals weighing up
to 25 pounds; 60 mg for animals
weighing 26 to 50 pounds; 120 mg for
animals weighing 51 to 100 pounds; 180
estrous period or in purebred
Bedlington terriers. It is not intended for
animals being used primarily for
breeding purposes. Use orally in adult
female dogs only. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
22. Revise In § 558.430, revise
paragraph (d) to read as follows:
■
§ 558.430
*
Nystatin.
*
*
*
*
(d) Conditions of use—
Amount in grams/ton
Indications for use
Limitations
(1) 50 .......................
Growing and laying chickens and growing turkeys:
As an aid in the control of crop mycosis and
mycotic diarrhea (Candida albicans).
Growing and laying chickens and growing turkeys:
For the treatment of crop mycosis and mycotic diarrhea (Candida albicans).
.....................................................................................
054771
To be fed for 7 to 10 days ..........................................
054771
(2) 100 .....................
23. Revise § 558.465 to read as
follows:
■
§ 558.465
Poloxalene.
(a) Specifications. Dry Type A
medicated articles containing 53 percent
poloxalene or liquid Type A medicated
articles containing 99.5 percent
poloxalene.
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mg for animals weighing over 100
pounds, or German Shepherds or
German Shepherd mix weighing 30 to
80 pounds. Administer daily at least 30
days before expected initiation of heat
and continue as long as desired, but for
not more than 12 months.
(2) Indications for use. For the
prevention of estrus (heat) in adult
female dogs not intended primarily for
breeding purposes.
(3) Limitations. Mibolerone should
not be used in bitches before first
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(b) Sponsor. See No. 066104 in
§ 510.600(c) of this chapter.
(c) Tolerances. See § 556.517 of this
chapter.
(d) Special considerations. Poloxalene
dry Type A article and liquid Type A
article must be thoroughly blended and
evenly distributed in feed prior to use.
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Sponsor
This may be accomplished by adding
the Type A article to a small quantity of
feed, mixing thoroughly, then adding
this mixture to the remaining feed and
again mixing thoroughly.
(e) Conditions of use in cattle—
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Poloxalene in grams/
ton
Indications for use
Limitations
(1) To deliver 1 to 2
grams per 100
pounds of body
weight.
Cattle: For prevention of legume (alfalfa, clover) and
wheat pasture bloat in cattle.
Dosage is 1 gram of poloxalene per 100 pounds of
body weight daily and continued during exposure
to bloat producing conditions. If bloating conditions
are severe, the dose is doubled. Treatment should
be started 2 to 3 days before exposure to bloatproducing conditions. Repeat dosage if animals
are exposed to bloat-producing conditions more
than 12 hours after the last treatment. Do not exceed the higher dosage levels in any 24-hour period.
45311
Sponsor
054771
(2) [Reserved]
§ 558. 500
[Amended]
(21 CFR 514.116), notice is given that
approval of ANADA 200–323, and all
supplements and amendments thereto,
is hereby withdrawn, effective July 28,
2020.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
24. In § 558.500, remove reserved
paragraphs (e)(1)(iii) and (iv).
■
Dated: July 15, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–15760 Filed 7–27–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 15, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2020–15761 Filed 7–27–20; 8:45 am]
BILLING CODE 4164–01–P
21 CFR Part 520
[Docket No. FDA–2020–N–0002]
DEPARTMENT OF THE TREASURY
New Animal Drugs; Withdrawal of
Approval of Abbreviated New Animal
Drug Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of an abbreviated new animal
drug application (ANADA) at the
sponsor’s request because the product is
no longer manufactured or marketed.
DATES: Withdrawal of approval is
effective July 28, 2020.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Hikma
International Pharmaceuticals LLC, P.O.
Box 182400, Bayader Wadi Seer,
Amman, Jordan 11118, has requested
that FDA withdraw approval of ANADA
200–323 for use of a 1-gram bolus of
phenylbutazone in horses because the
product is no longer manufactured or
marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and in accordance with § 514.116 Notice
of withdrawal of approval of application
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:58 Jul 27, 2020
Jkt 250001
Office of Investment Security
31 CFR Parts 800 and 802
RIN 1505–AC63, 1505–AC64, 1505–AC65
Definition of ‘‘Principal Place of
Business’’; Filing Fees for Notices of
Certain Investments in the United
States by Foreign Persons and Certain
Transactions by Foreign Persons
Involving Real Estate in the United
States
Office of Investment Security,
Department of the Treasury.
ACTION: Final rule.
AGENCY:
The final rule makes a
clarifying revision to the definition of
‘‘principal place of business’’ and
adopts the interim rule establishing a
fee for parties filing a formal written
notice of a transaction for review by the
Committee on Foreign Investment in the
United States.
DATES: The final rule is effective on
August 27, 2020.
FOR FURTHER INFORMATION CONTACT: For
questions about this rule, contact: Laura
Black, Director of Investment Security
Policy and International Relations;
Meena R. Sharma, Deputy Director of
Investment Security Policy and
International Relations; David Shogren,
SUMMARY:
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
Senior Policy Advisor; or James Harris,
Senior Policy Advisor, at U.S.
Department of the Treasury, 1500
Pennsylvania Avenue NW, Washington,
DC 20220; telephone: (202) 622–3425;
email: CFIUS.FIRRMA@treasury.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Definition of ‘‘Principal Place of
Business’’
On January 17, 2020, the Department
of the Treasury (Treasury Department)
published two interim rules, each
effective February 13, 2020, that
provided a definition for the term
‘‘principal place of business’’ as
applicable to transactions subject to
review by the Committee on Foreign
Investment in the United States (CFIUS
or the Committee). 85 FR 3112 (January
17, 2020); 85 FR 3158 (January 17,
2020). The preambles to the interim
rules provide background on this
definition. While the definition took
effect on February 13, 2020, the public
was provided an opportunity to
comment. The Treasury Department
received several comments, which are
discussed further below.
B. Filing Fees for Formal Written
Notices
On March 9, 2020, the Treasury
Department published a notice of
proposed rulemaking amending 31 CFR
part 800 and 31 CFR part 802 to
establish a fee for ‘‘covered
transactions’’ and ‘‘covered real estate
transactions,’’ respectively, that are filed
with CFIUS as formal written notices.
85 FR 13586 (March 9, 2020). The
public was provided an opportunity to
comment on the proposed rule and
several comments were received.
Following consideration of the public
comments, on April 29, 2020, the
Treasury Department published an
interim rule establishing filing fees,
effective May 1, 2020. 85 FR 23736
(April 29, 2020). As explained in the
preamble to the interim rule, subpart K
on filing fees was added to the
E:\FR\FM\28JYR1.SGM
28JYR1
]]>Agencies
[Federal Register Volume 85, Number 145 (Tuesday, July 28, 2020)]
[Rules and Regulations]
[Pages 45306-45311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15760]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2020-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Change of
Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during January, February, and March 2020. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to make technical
amendments to improve the accuracy of the regulations.
DATES: This rule is effective July 28, 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. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during January, February, and March 2020,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act and, for
actions requiring review of safety or effectiveness data, summaries of
the basis of approval (FOI Summaries) under the Freedom of Information
Act (FOIA). These public documents may be seen in the office of the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday. 240-402-7500. Persons with access to the
internet may obtain these documents at the CVM FOIA Electronic Reading
Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing exclusivity and patent
information may be accessed in FDA's publication, Approved Animal Drug
Products Online (Green Book) at: https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 28, 2020....... 141-466 Elanco US Inc., Narasin and Chickens........... Supplemental approval FOI Summary.
2500 Innovation nicarbazin and of an increased age
Way, Greenfield, avilamycin Type C restriction and
IN 46140. medicated broiler reduced withdrawal
feeds. period in the use of
MAXIBAN (narasin and
nicarbazin) Type A
medicated article)
with INTEPRITY
(avilamycin) Type A
medicated articles in
the manufacture of
Type C medicated
broiler feeds.
February 7, 2020....... 200-614 Akorn Animal Pentobarbital Dogs............... Original approval as a FOI Summary.
Health, Inc., Sodium and generic copy of NADA
1925 West Field Phenytoin Sodium 119-807.
Ct., Suite 300, Injectable
Lake Forest, IL Solution.
60045.
February 27, 2020...... 141-521 Zoetis Inc., 333 SIMPARICA TRIO Dogs............... Original approval for FOI Summary.
Portage St., (sarolaner, the prevention of
Kalamazoo, MI moxidectin, and heartworm disease;
49007. pyrantel chewable kills adult fleas and
tablets) Chewable is indicated for the
Tablet. treatment and
prevention of flea
infestations, the
treatment and control
of tick infestations,
and the treatment and
control of roundworm
and adult hookworm
infections for one
month.
March 10, 2020......... 200-670 Chanelle SENERGY Dogs and cats...... Original approval as a FOI Summary.
Pharmaceuticals (selamectin) generic copy of NADA
Manufacturing Topical Solution. 141-152.
Ltd., Loughrea,
County Galway,
H62 FH90, Ireland.
[[Page 45307]]
March 23, 2020......... 200-586 Dechra Veterinary MARBOQUIN Dogs............... Original approval as a FOI Summary.
Products, LLC, (marbofloxacin) generic copy of NADA
7015 College Tablets. 141-151.
Blvd., Suite 525,
Overland Park, KS
66211.
March 27, 2020......... 141-322 Zoetis Inc., 333 IMPROVEST Swine.............. Supplemental approval FOI Summary EA/FONSI.
Portage St., (gonadotropin for the temporary
Kalamazoo, MI release factor suppression of estrus
49007. analog-diphtheria in gilts intended for
toxoid conjugate) slaughter.
Injectable
Solution.
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Withdrawals of Approval
Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader
Wadi Seer, Amman, Jordan 11118 has requested that FDA withdraw approval
of ANADA 200-323 for a 1-gram phenylbutazone bolus because the product
is no longer manufactured or marketed. Following this withdrawal of
approval, Hikma International Pharmaceuticals LLC is no longer the
sponsor of an approved application. As provided in the regulatory text
of this document, the animal drug regulations are amended to reflect
this action. Elsewhere in this issue of the Federal Register, FDA gave
notice that approval of ANADA 200-323, and all supplements and
amendments thereto, is withdrawn.
III. Changes of Sponsor
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525,
Overland Park, KS 66211 has informed FDA that it has transferred
ownership of, and all rights and interest in, approved NADA 008-760 for
ADRENOMONE (corticotropin) Injection to Dechra, Ltd., Snaygill
Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW,
United Kingdom.
Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200,
Burlingame, CA 94010 has informed FDA that it has transferred ownership
of, and all rights and interest in, approved NADA 141-481 for MIRATAZ
(mirtazapine) Transdermal Ointment to Dechra, Ltd., Snaygill Industrial
Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United
Kingdom.
Accordingly, we are amending the regulations to reflect these
changes.
IV. Technical Amendments
FDA is revising sections for efrotomycin, iodinated casein,
maduramicin, mibolerone, nystatin, and poloxalene in 21 CFR part 558 to
reflect a tabular format. The section for tiamulin oral dosage forms in
21 CFR part 520 is being revised to correct ownership of certain
products. These amendments will improve the readability and accuracy of
the animal drug regulations.
V. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``Hikma International Pharmaceuticals LLC''; and in the table in
paragraph (c)(2), remove the entry for ``059115''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1310 [Amended]
0
4. In Sec. 520.1310, in paragraph (b), remove ``No. 054771'' and in
its place add '' Nos. 026637 and 054771''.
Sec. 520.1720a [Amended]
0
5. In Sec. 520.1720a, remove paragraphs (b)(4) and (5) and redesignate
paragraph (b)(6) as paragraph (b)(4).
0
6. Add Sec. 520.2090 to read as follows:
Sec. 520.2090 Sarolaner, moxidectin, and pyrantel.
(a) Specifications. Each chewable tablet contains:
(1) 3.0 mg sarolaner, 0.06 mg moxidectin, and 12.5 milligrams (mg)
pyrantel (as pamoate salt);
(2) 6.0 mg sarolaner, 0.12 mg moxidectin, and 25.0 mg pyrantel (as
pamoate salt);
[[Page 45308]]
(3) 12.0 mg sarolaner, 0.24 mg moxidectin, and 50.0 mg pyrantel (as
pamoate salt);
(4) 24.0 mg sarolaner, 0.48 mg moxidectin, and 100 mg pyrantel (as
pamoate salt);
(5) 48.0 mg sarolaner, 0.96 mg moxidectin, and 200 mg pyrantel (as
pamoate salt); or
(6) 72.0 mg sarolaner, 1.44 mg moxidectin, and 300 mg pyrantel (as
pamoate salt).
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer orally, once
a month, at the recommended minimum dose of 0.54 mg/lb (1.2 mg/kg)
sarolaner, 0.011 mg/lb (24 [mu]g/kg) moxidectin, and 2.27 mg/lb (5 mg/
kg) pyrantel (as pamoate salt).
(2) Indications for use. Prevents heartworm disease caused by
Dirofilaria immitis, kills adult fleas (Ctenocephalides felis) and is
indicated for the treatment and prevention of flea infestations, the
treatment and control of tick infestations with Amblyomma americanum
(lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor
variabilis (American dog tick), Ixodes scapularis (black-legged tick),
and Rhipicephalus sanguineus (brown dog tick), and the treatment and
control of roundworm (immature adult and adult Toxocara canis and adult
Toxascaris leonina) and adult hookworm (Ancylostoma caninum and
Uncinaria stenocephala) infections for 1 month in dogs and puppies 8
weeks of age and older, and weighing 2.8 pounds or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.2455 [Amended]
0
7. In Sec. 520.2455, in paragraph (b)(2), remove ``paragraph (a)(1)''
and in its place add ``paragraphs (a)(1) and (a)(3)''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.480 [Amended]
0
9. In Sec. 522.480, in paragraph (b)(2), remove ``026637'' and in its
place add ``043264''.
0
10. In Sec. 522.1083, revise paragraphs (a) and (c) to read as
follows:
Sec. 522.1083 Gonadotropin releasing factor analog-diphtheria toxoid
conjugate.
(a) Specifications. Each milliliter (mL) of solution contains 0.2
milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid
conjugate.
* * * * *
(c) Conditions of use in swine--(1) Amount. Each intact male pig or
gilt should receive two 2-mL (0.4 mg) doses by subcutaneous injection.
Administer the first dose no earlier than 9 weeks of age. Administer
the second dose at least 4 weeks after the first dose.
(2) Indications for use. (i) Intact male pigs intended for
slaughter: For the temporary immunological castration (suppression of
testicular function) and reduction of boar taint.
(ii) Gilts intended for slaughter: For the temporary suppression of
estrus.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. For reduction of boar taint,
intact male pigs should be slaughtered no earlier than 3 weeks and no
later than 10 weeks after the second dose.
Sec. 522.1697 [Amended]
0
11. In Sec. 522.1697, in paragraph (b), remove ``000061, 051311, and
054925'' and in its place add ``000061, 051311, 054925, and 059399''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
12. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1448 [Amended]
0
13. In Sec. 524.1448, in paragraph (b), remove ``086078'' and in its
place add ``043264''.
0
14. In Sec. 524.1484b, revise the section heading and paragraph (a) to
read as follows:
Sec. 524.1484b Neomycin, isoflupredone, and tetracaine powder.
(a) Specifications. Each 15-gram insufflator bottle contains 5
milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base),
1 mg isoflupredone acetate, and 5 mg tetracaine hydrochloride in a
powder base.
* * * * *
Sec. 524.2098 [Amended]
0
15. In Sec. 524.2098, in paragraph (b), remove ``Nos. 054771 and
055529'' and in its place add ``Nos. 054771, 055529, and 061651''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
16. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
17. In Sec. 558.68, revise paragraph (e)(1)(iv) to read as follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
[[Page 45309]]
----------------------------------------------------------------------------------------------------------------
Combination in
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 13.6 to 40.9........... Narasin, 27 to 45 Broiler chickens: For Feed as the sole ration 058198
plus nicarbazin, the prevention of for 21 consecutive
27 to 45. mortality caused by days to chickens that
necrotic enteritis are at risk of
associated with developing, but not
Clostridium yet showing clinical
perfringens; and for signs of, necrotic
the prevention of enteritis associated
coccidiosis caused by with Clostridium
Eimeria necatrix, E. perfringens.
tenella, E. acervulina, Avilamycin has not
E. brunetti, E. mivati, been demonstrated to
and E. maxima. 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 and nicarbazin
as provided by No.
058198 in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
18. In Sec. 558.235, revise paragraph (d) to read as follows:
Sec. 558.235 Efrotomycin.
* * * * *
(d) Conditions of use in swine--
----------------------------------------------------------------------------------------------------------------
Efrotomycin in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 3.6............................ Swine: For improved feed Feed continuously as sole 000010
efficiency. ration. Not to be used in
swine weighing more than 250
pounds.
(2) 3.6 to 14.5.................... Swine: For increased rate of Feed continuously as sole 000010
weight gain. ration. Not to be used in
swine weighing more than 250
pounds.
----------------------------------------------------------------------------------------------------------------
0
19. Revise Sec. 558.295 to read as follows:
Sec. 558.295 Iodinated casein.
(a) Type A medicated articles containing grams iodinated casein per
pound.
(b) Sponsor. See No. 017762 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Ducks--
----------------------------------------------------------------------------------------------------------------
Amount in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 to 200..................... Growing ducks: For increased .............................. 017762
rate of weight gain.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------
[[Page 45310]]
(2) Dairy cows--
----------------------------------------------------------------------------------------------------------------
Amount in grams/pound Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 0.5 to 1.5 per 100 lb of body Dairy cows: For increased milk This drug is effective for 017762
weight. production. limited periods of time, and
the effectiveness is limited
to the declining phase of
lactation. Administration
must be accompanied with
increased feed intake.
Administration may increase
heat sensitivity of the
animal.
(2) [Reserved]
----------------------------------------------------------------------------------------------------------------
0
20. Revise Sec. 558.340 to read as follows:
Sec. 558.340 Maduramicin.
(a) Specifications. Type A medicated articles containing 4.54 grams
maduramicin per pound.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Tolerances. See Sec. 556.375 of this chapter.
(d) Conditions of use in chickens--
----------------------------------------------------------------------------------------------------------------
Amount in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 4.54 to 5.45................... Broiler chickens: For Feed continuously as sole 054771
prevention of coccidiosis ration. For broiler chickens
caused by Eimeria acervulina, only. Do not feed to laying
E. tenella, E. brunetti, E. hens. Withdraw 5 days before
maxima, E. necatrix, and E. slaughter.
mivati.
(2) [Reserved]
----------------------------------------------------------------------------------------------------------------
0
21. Revise Sec. 558.348 to read as follows:
Sec. 558.348 Mibolerone.
(a) Specifications. Each 6.5 ounce can contains 30 or 60 micrograms
([micro]g) of mibolerone.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. 30 [micro]g for animals
weighing up to 25 pounds; 60 [micro]g for animals weighing 26 to 50
pounds; 120 [micro]g for animals weighing 51 to 100 pounds; 180
[micro]g for animals weighing over 100 pounds, or German Shepherds or
German Shepherd mix weighing 30 to 80 pounds. Administer daily at least
30 days before expected initiation of heat and continue as long as
desired, but for not more than 12 months.
(2) Indications for use. For the prevention of estrus (heat) in
adult female dogs not intended primarily for breeding purposes.
(3) Limitations. Mibolerone should not be used in bitches before
first estrous period or in purebred Bedlington terriers. It is not
intended for animals being used primarily for breeding purposes. Use
orally in adult female dogs only. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
0
22. Revise In Sec. 558.430, revise paragraph (d) to read as follows:
Sec. 558.430 Nystatin.
* * * * *
(d) Conditions of use--
----------------------------------------------------------------------------------------------------------------
Amount in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 50............................. Growing and laying chickens and .............................. 054771
growing turkeys: As an aid in
the control of crop mycosis
and mycotic diarrhea (Candida
albicans).
(2) 100............................ Growing and laying chickens and To be fed for 7 to 10 days.... 054771
growing turkeys: For the
treatment of crop mycosis and
mycotic diarrhea (Candida
albicans).
----------------------------------------------------------------------------------------------------------------
0
23. Revise Sec. 558.465 to read as follows:
Sec. 558.465 Poloxalene.
(a) Specifications. Dry Type A medicated articles containing 53
percent poloxalene or liquid Type A medicated articles containing 99.5
percent poloxalene.
(b) Sponsor. See No. 066104 in Sec. 510.600(c) of this chapter.
(c) Tolerances. See Sec. 556.517 of this chapter.
(d) Special considerations. Poloxalene dry Type A article and
liquid Type A article must be thoroughly blended and evenly distributed
in feed prior to use. This may be accomplished by adding the Type A
article to a small quantity of feed, mixing thoroughly, then adding
this mixture to the remaining feed and again mixing thoroughly.
(e) Conditions of use in cattle--
[[Page 45311]]
----------------------------------------------------------------------------------------------------------------
Poloxalene in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) To deliver 1 to 2 grams per 100 Cattle: For prevention of Dosage is 1 gram of poloxalene 054771
pounds of body weight. legume (alfalfa, clover) and per 100 pounds of body weight
wheat pasture bloat in cattle. daily and continued during
exposure to bloat producing
conditions. If bloating
conditions are severe, the
dose is doubled. Treatment
should be started 2 to 3 days
before exposure to bloat-
producing conditions. Repeat
dosage if animals are exposed
to bloat-producing conditions
more than 12 hours after the
last treatment. Do not exceed
the higher dosage levels in
any 24-hour period.
(2) [Reserved]
----------------------------------------------------------------------------------------------------------------
Sec. 558. 500 [Amended]
0
24. In Sec. 558.500, remove reserved paragraphs (e)(1)(iii) and (iv).
Dated: July 15, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15760 Filed 7-27-20; 8:45 am]
BILLING CODE 4164-01-P
