[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-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.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during 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
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Approval date File No. Sponsor Product name Species Effect of the action Public documents
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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.
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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 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]]
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Combination in
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
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* * * * * * *
(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.
* * * * * * *
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* * * * *
0
18. In Sec. 558.235, revise paragraph (d) to read as follows:
Sec. 558.235 Efrotomycin.
* * * * *
(d) Conditions of use in swine--
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Efrotomycin in grams/ton Indications for use Limitations Sponsor
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(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.
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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--
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Amount in grams/ton Indications for use Limitations Sponsor
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(i) 100 to 200..................... Growing ducks: For increased .............................. 017762
rate of weight gain.
(ii) [Reserved]
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[[Page 45310]]
(2) Dairy cows--
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Amount in grams/pound Indications for use Limitations Sponsor
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(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]
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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--
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Amount in grams/ton Indications for use Limitations Sponsor
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(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]
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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--
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Amount in grams/ton Indications for use Limitations Sponsor
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(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).
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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]]
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Poloxalene in grams/ton Indications for use Limitations Sponsor
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(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]
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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