New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor, 17942-17949 [2022-06395]
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Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 524,
529, 556, and 558
[Docket No. FDA–2021–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final rule; technical
amendments.
AGENCY:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during October,
November, and December 2021. FDA is
informing the public of the availability
SUMMARY:
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to improve the accuracy of the
regulations.
DATES: This rule is effective March 29,
2022.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
George.Haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
October, November, and December
2021, as listed in table 1. In addition,
FDA is informing the public of the
availability, where applicable, of
documentation of environmental review
required under the National
Environmental Policy Act (NEPA) and,
for actions requiring review of safety or
effectiveness data, summaries of the
basis of approval (FOI Summaries)
under the Freedom of Information Act
(FOIA). These public documents may be
seen in the office of the Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500. Persons
with access to the internet may obtain
these documents at the CVM FOIA
Electronic Reading Room: https://
www.fda.gov/about-fda/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.
FDA has verified the website
addresses as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND
DECEMBER 2021
Approval date
File No.
Sponsor
Product name
Species
Effect of the action
Public
documents
October 1, 2021 .....
200–691
Virbac AH, Inc., P.O. Box
162059, Fort Worth, TX
76161.
Cattle ..............
Original approval as a generic copy of
NADA 141–221.
FOI Summary.
October 20, 2021 ...
200–604
Dogs and cats
Original approval as a generic copy of
NADA 055–101.
FOI Summary.
October 28, 2021 ...
200–588
Florfenicol Injection
(florfenicol) Injectable
Solution.
Cattle ..............
Original approval as a generic copy of
NADA 141–063.
FOI Summary.
October 29, 2021 ...
200–628
Enrofloxacin 100
(enrofloxacin) Injectable
Solution.
Cattle and
swine.
Original approval as a generic copy of
NADA 141–068.
FOI Summary.
October 29, 2021 ...
141–348
Dechra Veterinary Products LLC, 7015 College
Blvd., Suite 525, Overland Park, KS 66211.
Sparhawk Laboratories,
Inc., 12340 Santa Fe
Trail Dr., Lenexa, KS
66215.
Sparhawk Laboratories,
Inc., 12340 Santa Fe
Trail Dr., Lenexa, KS
66215.
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
RAC 45 CATTLE
(ractopamine hydrochloride Type A medicated article).
Amoxicillin and
Clavulanate Potassium
for Oral Suspension.
Cattle ..............
Supplemental approval adding cattle
fed in confinement for slaughter.
FOI Summary.
November 1, 2021 ..
200–711
SYNOVEX ONE Grower
(trenbolone acetate and
estradiol benzoate extended-release implants).
TULAVEN 100
(tulathromycin injection)
Injectable Solution.
Cattle and
swine.
Original approval as a generic copy of
NADA 141–244.
FOI Summary.
November 3, 2021 ..
200–712
TULAVEN 25
(tulathromycin injection)
Injectable Solution.
Cattle and
swine.
Original approval as a generic copy of
NADA 141–349.
FOI Summary.
November 3, 2021 ..
141–508
Cattle ..............
200–668
Supplemental approval adding tolerances for residues in edible tissues
of cattle.
Original approval as a generic copy of
NADA 141–349.
FOI Summary.
November 12, 2021
November 15, 2021
200–253
EXPERIOR (lubabegron)
Type A medicated article.
TULISSIN 25
(tulathromycin injection)
Injectable Solution.
PROSTAMATE (dinoprost
tromethamine injection)
Injectable Solution.
Cattle ..............
Supplemental approval for use with
gonadorelin or with progesterone
intravaginal inserts.
FOI Summary.
November 15, 2021
200–669
TULISSIN 100
(tulathromycin injection)
Injectable Solution.
Cattle and
swine.
Original approval as a generic copy of
NADA 141–244.
FOI Summary.
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Ceva Sante Animale, 10
Avenue de la
Ballastie`re, 33500
Libourne, France.
Ceva Sante Animale, 10
Avenue de la
Ballastie`re, 33500
Libourne, France.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Virbac AH, Inc., P.O. Box
162059, Fort Worth, TX
76161.
Bimeda Animal Health
Ltd., 1B The Herbert
Building, The Park,
Carrickmines, Dublin
18, Ireland.
Virbac AH, Inc., P.O. Box
162059, Fort Worth, TX
76161.
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Cattle and
swine.
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FOI Summary.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND
DECEMBER 2021—Continued
Approval date
File No.
Sponsor
Product name
Species
Effect of the action
Public
documents
November 22, 2021
200–695
Original approval as a generic copy of
NADA 140–916.
FOI Summary.
200–714
Cats ................
Original approval as a generic copy of
NADA 141–254.
FOI Summary.
December 10, 2021
200–705
Chickens and
turkeys.
Original approval as a generic copy of
NADA 141–085.
FOI Summary.
December 21, 2021
141–552
TIA 12.5% (tiamulin hydrogen fumarate) Liquid
Concentrate.
BARRIER for Cats
(imidacloprid and
moxidectin) Topical Solution.
ZOASHIELD (zoalene)
Type A medicated article and BMD (bacitracin
methylenedisalicylate)
Type A medicated article.
CANALEVIA–CA1
(crofelemer delayed-release tablets).
Swine .............
November 24, 2021
Virbac AH, Inc., P.O. Box
162059, Fort Worth, TX
76161.
Aurora Pharmaceutical,
Inc, 1196 Highway 3
South, Northfield, MN
55057–3009.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Dogs ...............
Conditional approval for treatment of
chemotherapy-induced diarrhea.
FOI Summary.
December 23, 2021
141–521
SIMPARICA TRIO
(sarolaner, moxidectin,
and pyrantel chewable
tablets) Chewable Tablet.
Dogs ...............
Supplemental approval for the prevention of Borrelia burgdorferi infection
as a direct result of killing Ixodes
scapularis vector ticks and for the
treatment and control of L4 and immature adult Ancylostoma caninum.
FOI Summary.
Jaguar Animal Health,
200 Pine St., suite 600,
San Francisco, CA
94104.
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
II. Change of Sponsor
Elanco US Inc., 2500 Innovation Way,
Greenfield, IN 46140 has informed FDA
that it has transferred ownership of, and
all rights and interest in, the NADAs
and ANADAs listed below to Dechra,
File No.
047–955
047–956
200–322
200–408
Product name
..........................................
..........................................
..........................................
..........................................
ROMPUN (xylazine hydrochloride) Injectable (20 mg).
ROMPUN (xylazine hydrochloride) Injectable (100 mg).
Butorphanol Tartrate Injection.
Butorphanol Tartrate Injection.
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Thorn Bioscience LLC, 1044 East
Chestnut St., Louisville, KY 40204 has
informed FDA that it has transferred
ownership of, and all rights and interest
in, NADA 141–319 for SUCROMATE
Equine (deslorelin acetate injection) to
Dechra, Ltd., Snaygill Industrial Estate,
Keighley Rd., Skipton, North Yorkshire,
BD23 2RW, United Kingdom.
As provided in the regulatory text, the
animal drug regulations are amended to
reflect these changes of sponsorship.
III. Technical Amendments
FDA is making the following
amendments to improve the accuracy of
the animal drug regulations:
• 21 CFR 510.600 is amended to add
Jaguar Animal Health and remove Thorn
Bioscience LLC from the list of sponsors
of approved applications.
• 21 CFR 520.88h is amended to
correct indications for use in cats of an
oral suspension containing amoxicillin
and clavulanate.
• 21 CFR 520.2455 is amended to
correct a spelling error in the limitations
for use of tiamulin in drinking water of
swine.
• 21 CFR 522.230 is amended to add
the caution that buprenorphine
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Ltd., Snaygill Industrial Estate, Keighley
Rd., Skipton, North Yorkshire, BD23
2RW, United Kingdom:
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injectable solution is a Schedule III
opioid under the Controlled Substances
Act.
• 21 CFR 522.690 is amended to
reflect revised indications for use of
dinoprost tromethamine injectable
solution in mares.
• 21 CFR 522.1940 is amended to
reflect the approved classes of cattle and
limitations for use of progesterone and
estradiol benzoate ear implants.
• 21 CFR 522.2343 is amended to
reflect the approved classes of cattle and
limitations for use of testosterone
propionate and estradiol benzoate ear
implants.
• 21 CFR 556.240 is amended to
reflect the use of revised food
consumption values in establishing
permitted concentrations of residues of
estradiol and related esters in edible
tissues of cattle. The basis for this action
is explained in the FOI Summary for
supplemental NADA 141–348, approved
October 29, 2021. The section is also
amended to reflect a cross reference for
testosterone propionate and estradiol
benzoate implants, recently
redesignated as 21 CFR 522.2343.
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• 21 CFR 558.254 is amended to
reflect the approved conditions of use
for famphur in feed.
• 21 CFR 558.355 is amended to
reflect use of medicated feeds
containing monensin alone or in
combination with bacitracin
methylenedisalicylate in revised classes
of chickens.
• 21 CFR 558.555 is amended to
correct a spelling error in the permitted
combination use of semduramicin in
medicated feed.
• 21 CFR 558.633 is amended to
revise expiration dates for use of
pelleted or crumbled tylvalosin
medicated swine feeds.
• 21 CFR 558.680 is amended to
reflect the correct sponsor of an
application for use of Type C medicated
turkey feeds containing zoalene.
IV. 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
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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
516, 520, 522, 524, 529, 556, and 558 are
amended as follows:
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
■
21 CFR Part 516
Administrative practice and
procedure, Animal drugs, Confidential
business information, Reporting and
recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Dairy products, Foods,
Meat and meat products.
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,
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), add
in alphabetical order an entry for
‘‘Jaguar Animal Health’’ and remove the
entry for ‘‘Thorn Bioscience LLC’’; and
■ b. In the table in paragraph (c)(2),
remove the entry for ‘‘051330’’ and add
in numerical order an entry for
‘‘086149’’.
The 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
*
*
*
*
*
*
Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104 .......................................................................................
*
*
*
*
*
*
086149
*
*
(2) * * *
Drug labeler
code
Firm name and address
*
086149 ..............
*
*
Jaguar Animal Health, 200 Pine St., Suite 600,
San Francisco, CA 94104.
*
*
*
PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
3. The authority citation for part 516
continues to read as follows:
■
Authority 21 U.S.C. 360ccc, 360ccc–2,
371.
4. Add § 516.498 to subpart C to read
as follows:
■
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§ 516.498
Crofelemer.
(a) Specifications. Each delayedrelease tablet contains 125 milligrams
(mg) crofelemer.
(b) Sponsor. See No. 086149 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer 1 tablet orally twice daily
for 3 days for dogs weighing ≤140
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pounds. Administer 2 tablets orally
twice daily for 3 days for dogs weighing
>140 pounds.
(2) Indications for use. For the
treatment of chemotherapy-induced
diarrhea in dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. It is a violation
of Federal law to use this product other
than as directed in the labeling.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
5. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
6. Revise § 520.88h to read as follows:
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§ 520.88h Amoxicillin trihydrate and
clavulanate potassium for oral suspension.
(a) Specifications. When constituted,
each milliliter (mL) of suspension
contains amoxicillin trihydrate
equivalent to 50 milligrams (mg)
amoxicillin and clavulanate potassium
equivalent to 12.5 mg clavulanic acid.
(b) Sponsors. See Nos. 017033,
054771, and 069043 in § 510.600(c) of
this chapter.
(c) Conditions of use—(1) Dogs—(i)
Amount. 6.25 mg/lb (1 mL/10 lb of body
weight) twice a day. Skin and soft tissue
infections such as abscesses, cellulitis,
wounds, superficial/juvenile pyoderma,
and periodontal infections should be
treated for 5 to 7 days or for 48 hours
after all signs have subsided. If no
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response is seen after 5 days of
treatment, therapy should be
discontinued and the case reevaluated.
Deep pyoderma may require treatment
for 21 days; the maximum duration of
treatment should not exceed 30 days.
(ii) Indications for use. Treatment of
skin and soft tissue infections such as
wounds, abscesses, cellulitis,
superficial/juvenile and deep pyoderma
due to susceptible strains of the
following organisms: Beta-lactamaseproducing Staphylococcus aureus, nonbeta-lactamase-producing
Staphylococcus aureus, Staphylococcus
spp., Streptococcus spp., and
Escherichia coli. Treatment of
periodontal infections due to
susceptible strains of both aerobic and
anaerobic bacteria.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats—(i) Amount. 62.5 mg (1 mL)
twice daily. Skin and soft tissue
infections such as abscesses and
cellulitis/dermatitis should be treated
for 5 to 7 days or 48 hours after all
symptoms have subsided, not to exceed
30 days. If no response is seen after 3
days of treatment, therapy should be
discontinued and the case reevaluated.
Urinary tract infections may require
treatment for 10 to 14 days or longer.
The maximum duration of treatment
should not exceed 30 days.
(ii) Indications for use. Treatment of
skin and soft tissue infections, such as
wounds, abscesses, and cellulitis/
dermatitis due to susceptible strains of
the following organisms: Betalactamase-producing Staphylococcus
aureus, non-beta-lactamase-producing
Staphylococcus aureus, Staphylococcus
spp., Streptococcus spp., Escherichia
coli, Pasteurella multocida, and
Pasteurella spp. Urinary tract infections
(cystitis) due to susceptible strains of E.
coli.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 7. In § 520.2090, revise paragraph
(c)(2) to read as follows:
§ 520.2090
pyrantel.
Sarolaner, moxidectin, and
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*
*
*
*
(c) * * *
(2) Indications for use. For the
prevention of heartworm disease caused
by Dirofilaria immitis and for the
treatment and control of roundworm
(immature adult and adult Toxocara
canis and adult Toxascaris leonina) and
hookworm (L4, immature adult, and
adult Ancylostoma caninum and adult
Uncinaria stenocephala) infections.
Kills adult fleas (Ctenocephalides felis)
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and is indicated for the treatment and
prevention of flea infestations, and 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) for 1
month in dogs and puppies 8 weeks of
age and older, and weighing 2.8 pounds
or greater. For the prevention of Borrelia
burgdorferi infections as a direct result
of killing Ixodes scapularis vector ticks.
*
*
*
*
*
■ 8. In § 520.2455:
■ a. Revise paragraphs (b)(1) through
(4); and
■ b. In paragraph (d)(2), remove
‘‘semduramycin’’ and in its place add
‘‘semduramicin.’’
The revisions read as follows:
§ 520.2455
Tiamulin.
*
*
*
*
*
(b) * * *
(1) No. 058198 for products described
in paragraph (a) of this section.
(2) No. 066104 for product described
in paragraph (a)(1) of this section.
(3) Nos. 016592, 051311, and 061133
for product described in paragraph (a)(2)
of this section.
(4) No. 054771 for product described
in paragraph (a)(3) of this section.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
9. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
10. In § 522.246, revise paragraphs
(b)(2) and (3) to read as follows:
■
§ 522.246
Butorphanol.
*
*
*
*
*
(b) * * *
(2) No. 043264 for use of the product
described in paragraph (a)(2) of this
section as in paragraph (d)(2) of this
section.
(3) Nos. 000061, 043264, and 059399
for use of the product described in
paragraph (a)(3) of this section as in
paragraph (d)(3) of this section.
*
*
*
*
*
§ 522.533
[Amended]
11. In § 522.533, in paragraph (b)(2),
remove ‘‘051330’’ and in its place add
‘‘043264’’.
■ 12. In § 522.690:
■ a. Revise paragraphs (a) and (b);
■
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b. Revise paragraph (d)(1)
introductory text and paragraph
(d)(1)(i);
■ c. Add paragraph (d)(2) introductory
text;
■ d. Revise paragraph (d)(2)(ii);
■ e. Add paragraph (d)(3) introductory
text;
■ f. Revise paragraph (d)(3)(ii); and
■ g. Remove paragraph (d)(4).
The revisions and additions read as
follows:
■
§ 522.690
Dinoprost.
(a) Specifications. Each milliliter (mL)
of solution contains dinoprost
tromethamine equivalent to:
(1) 5 milligrams (mg) dinoprost; or
(2) 12.5 mg dinoprost.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
(1) Nos. 054771 and 061133 for use of
product described in paragraph (a)(1) as
in paragraph (d) of this section.
(2) No. 054771 for use of product
described in paragraph (a)(2) as in
paragraph (d)(1) of this section.
*
*
*
*
*
(d) * * *
(1) Cattle. Administer products
described in paragraph (a) of this
section as follows:
(i) Amount. 25 mg as an intramuscular
injection of the 5 mg/mL product or as
an intramuscular or subcutaneous
injection of the 12.5 mg/mL product.
*
*
*
*
*
(2) * * * Administer product
described in paragraph (a)(1) of this
section as follows:
*
*
*
*
*
(ii) Indications for use. (A) For
controlling the timing of estrus in
estrous cycling mares.
(B) For difficult-to-breed mares
(clinically anestrous mares that have a
corpus luteum).
*
*
*
*
*
(3) * * * Administer product
described in paragraph (a)(1) of this
section as follows:
*
*
*
*
*
(ii) Indications for use. For parturition
induction in swine.
■ 13. In § 522.812, revise paragraph
(b)(2) to read as follows:
§ 522.812
Enrofloxacin.
*
*
*
*
*
(b) * * *
(2) Nos. 055529, 058005, 058198, and
061133 for use of product described in
paragraph (a)(2) of this section as in
paragraphs (e)(2) and (3) of this section.
*
*
*
*
*
§ 522.955
[Amended]
14. In § 522.955, in paragraph (b)(3),
remove ‘‘No. 086050’’ and in its place
■
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add ‘‘Nos. 058005 and 086050’’; and in
paragraph (d)(1)(ii)(C), remove ‘‘No.
000061’’ and in its place add ‘‘Nos.
000061, 058005, and 086050’’.
■ 15. In § 522.1077, revise paragraph
(d)(1)(iv) to read as follows:
§ 522.1077
Gonadorelin.
*
*
*
*
*
(d) * * *
(1) * * *
(iv) Dinoprost injection for use as in
paragraph (e)(1)(vi) of this section as
provided by Nos. 054771 and 061133 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 16. In § 522.1940, revise the paragraph
(c)(1) heading, paragraph (c)(1)(iii), the
paragraph (c)(2) heading, and paragraph
(c)(2)(iii) to read as follows:
§ 522.1940
benzoate.
Progesterone and estradiol
*
*
*
*
(c) * * *
(1) Suckling beef calves at least 45
days old and up to 400 lb of body
weight—* * *
*
*
*
*
*
(iii) Limitations. For subcutaneous ear
implantation, one dose per animal. Do
not use in beef calves less than 45 days
of age, dairy calves, and veal calves
because effectiveness and safety have
not been established. Do not use in
animals intended for subsequent
breeding, or in dairy cows. A
withdrawal period has not been
established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
(2) Growing beef steers weighing 400
lb or more—* * *
*
*
*
*
*
(iii) Limitations. For subcutaneous ear
implantation, one dose per animal. Do
not use in beef calves less than 45 days
of age, dairy calves, and veal calves
because effectiveness and safety have
not been established. Do not use in
animals intended for subsequent
breeding, or in dairy cows. A
withdrawal period has not been
established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
*
*
*
*
*
■ 17. In § 522.2343, revise paragraph (c)
introductory text and paragraph (c)(3) to
read as follows:
lotter on DSK11XQN23PROD with RULES1
*
§ 522.2343 Testosterone propionate and
estradiol benzoate.
*
*
*
*
*
(c) Conditions of use. For
implantation in growing beef heifers
weighing 400 lb or more as follows:
*
*
*
*
*
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16:11 Mar 28, 2022
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(3) Limitations. For subcutaneous ear
implantation, one dose per animal. Not
for use in dairy or beef replacement
heifers. Do not use in beef calves less
than 2 months of age, dairy calves, and
veal calves because safety and
effectiveness have not been established.
A withdrawal period has not been
established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
■ 18. In § 522.2478, redesignate
paragraph (d)(3) as paragraph (d)(4); add
new paragraph (d)(3); and revise newly
redesignated paragraph (d)(4) heading
and paragraph (d)(4)(i)(C) to read as
follows:
§ 522.2478 Trenbolone acetate and
estradiol benzoate.
*
*
*
*
*
(d) * * *
(3) Growing beef steers and heifers fed
in confinement for slaughter. (i) For an
implant as described in paragraph
(a)(2)(ii) of this section:
(A) Amount. 150 mg trenbolone
acetate and 21 mg estradiol benzoate in
an extended-release implant.
(B) Indications for use. For increased
rate of weight gain for up to 200 days.
(C) Limitations. Implant pellets
subcutaneously in ear only. Not
approved for repeated implantation
(reimplantation) with this or any other
cattle ear implant within each separate
production phase. Safety and
effectiveness following reimplantation
have not been evaluated. Do not use in
beef calves less than 2 months of age,
dairy calves, and veal calves because
effectiveness and safety have not been
established. Do not use in beef calves
less than 2 months of age, dairy calves,
and veal calves. A withdrawal period
has not been established for this product
in pre-ruminating calves. Do not use in
dairy cows or in animals intended for
subsequent breeding. Use in these cattle
may cause drug residues in milk and/or
in calves born to these cows.
(ii) [Reserved]
(4) Growing beef steers and heifers on
pasture (stocker, feeder, and slaughter).
(i) * * *
(C) Limitations. Implant pellets
subcutaneously in ear only. Not
approved for repeated implantation
(reimplantation) with this or any other
cattle ear implant within each separate
production phase. Safety and
effectiveness following reimplantation
have not been evaluated. Do not use in
beef calves less than 2 months of age,
dairy calves, and veal calves because
effectiveness and safety have not been
established. Do not use in beef calves
less than 2 months of age, dairy calves,
and veal calves. A withdrawal period
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
has not been established for this product
in preruminating calves. Do not use in
dairy cows or in animals intended for
subsequent breeding. Use in these cattle
may cause drug residues in milk and/or
in calves born to these cows.
*
*
*
*
*
■ 19. In 522.2630, revise paragraphs
(b)(1) and (2) to read as follows:
§ 522.2630
Tulathromycin.
*
*
*
*
*
(b) * * *
(1) Nos. 013744, 051311, 054771,
058198, and 061133 for use of product
described in paragraph (a)(1) as in
paragraphs (d)(1)(i) and (ii),
(d)(1)(iii)(A), and (d)(2) of this section.
(2) Nos. 013744, 051311, and 054771
for use of product described in
paragraph (a)(2) as in paragraphs
(d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and
(d)(2) of this section.
*
*
*
*
*
■ 20. In § 522.2662, revise paragraph
(b)(3) to read as follows:
§ 522.2662
Xylazine.
*
*
*
*
*
(b) * * *
(3) Nos. 043264 and 061651 for use of
product described in paragraph (a)(1) of
this section as in paragraph (d)(1) of this
section; and product described in
paragraph (a)(2) of this section as in
paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A),
and (d)(3)(iii) of this section.
*
*
*
*
*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
21. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
22. In § 524.1146, revise paragraphs
(b)(2) and (3) to read as follows:
■
§ 524.1146
Imidacloprid and moxidectin.
*
*
*
*
*
(b) * * *
(2) Nos. 051072, 017030, 058198, and
061651 for use of product described in
paragraph (a)(2) of this section as in
paragraph (d)(2) of this section.
(3) Nos. 051072 and 058198 for use of
product described in paragraph (a)(2) of
this section as in paragraph (d)(3) of this
section.
*
*
*
*
*
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
23. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
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Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations
24. In § 529.1940, revise the last
sentence in paragraph (e)(1)(iii) to read
as follows:
■
§ 529.1940
inserts.
*
■
Progesterone intravaginal
*
*
*
*
*
(e) * * *
(1) * * *
(iii) * * * Dinoprost injection for use
as in paragraphs (e)(1)(ii)(A) and (B) of
this section as in § 522.690 of this
chapter, provided by Nos. 054771 and
061133 in § 510.600(c) of this chapter.
*
*
*
*
*
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
26. In 556.240, revise paragraphs
(b)(1) and (c) to read as follows:
§ 556.240
§ 556.370
25. The authority citation for part 556
continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
Famphur amount
*
Monensin in grams/
ton
*
Combination in grams/
ton
*
(ii) 90 to 110 ...........
29. In § 558.254, revise paragraph (e)
to read as follows:
■
*
Famphur.
Limitations
Sponsor
Feed for 30 days. Withdraw from dry dairy cows and heifers
21 days prior to freshening. Withdraw 4 days prior to
slaughter.
Feed for 10 days. Withdraw from dry dairy cows and heifers
21 days prior to freshening. Withdraw 4 days prior to
slaughter.
Indications for use
Limitations
*
*
Layer replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E.
tenella, E. acervulina, E. brunetti, E. mivati, and
E. maxima.
*
*
*
Feed continuously as the sole ration. Do not feed
to chickens over 16 weeks of age. Do not feed
to laying chickens.
*
*
(vi) 90 to 110 .......... Bacitracin
methylenedisalicylate,
50.
*
*
*
*
*
Broiler and layer replacement chickens: As an aid
Feed continuously as sole ration. Do not feed to
in the prevention of coccidiosis caused by E.
chickens over 16 weeks of age. Do not feed to
necatrix, E. tenella, E. acervulina, E. brunetti, E.
laying chickens. Monensin sodium provided by
mivati, and E. maxima, and for improved feed
No. 058198, bacitracin methylenedisalicylate
efficiency, and as an aid in the prevention of neprovided by No. 054771 in § 510.600(c) of this
crotic enteritis caused or complicated by Closchapter.
tridium spp. or other organisms susceptible to
bacitracin.
*
*
§ 558.500
■
*
*
*
*
*
31. In § 558.500, revise paragraphs (b)
and (e)(2)(i), (iii), and (vi) to read as
follows:
VerDate Sep<11>2014
16:11 Mar 28, 2022
Jkt 256001
*
*
Ractopamine.
*
*
*
*
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter.
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
000061
Sponsor
*
*
*
*
*
Layer replacement chickens: As an aid in the preFeed continuously as sole ration. Do not feed to
vention of coccidiosis caused by E. necatrix, E.
chickens over 16 weeks of age. Do not feed to
tenella, E. acervulina, E. brunetti, E. mivati, and
laying chickens. Monensin sodium provided by
E. maxima, and for increased rate of weight gain
No. 058198, bacitracin methylenedisalicylate
and improved feed efficiency.
provided by No. 054771 in § 510.600(c) of this
chapter.
*
000061
(f) * * *
(1) * * *
*
*
(iv) 90 to 110 .......... Bacitracin
methylenedisalicylate,
4 to 50.
*
lotter on DSK11XQN23PROD with RULES1
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
*
*
*
*
(e) Conditions of use. It is used in
cattle feed as follows:
(d) * * *
(8) * * *
(vi) Not for replacement chickens
intended to become broiler breeding
chickens.
*
*
*
*
*
Monensin.
*
28. The authority citation for part 558
continues to read as follows:
■
*
*
*
*
*
(b) Tolerances. The tolerances for
lubabegron (marker residue) are:
Beef cattle and nonlactating dairy cattle: For control of
grubs.
30. In § 558.355, revise paragraphs
(d)(8)(vi) and (f)(1)(ii), (iv), and (vi) to
read as follows:
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
§ 558.254
Lubabegron.
*
Beef cattle and nonlactating dairy cattle: For control of
grubs and as an aid in control of sucking lice.
■
*
(1) Cattle. (i) Liver (target tissue): 10
ppb.
(ii) Muscle: 3 ppb.
(iii) Kidney: 20 ppb.
(2) [Reserved]
*
*
*
*
*
Indications for use
(1) To provide 1.1 milligrams
per pound (mg/lb) body
weight per day.
(2) To provide 2.3 mg/lb body
weight per day.
§ 558.355
Estradiol and related esters.
*
*
*
*
(b) * * *
(1) Cattle. (i) Muscle: 0.2 ppb.
(ii) Liver: 0.6 ppb.
(iii) Kidney: 1.2 ppb.
(iv) Fat: 1.2 ppb.
*
*
*
*
*
(c) Related conditions of use. See
§§ 522.840, 522.850, 522.1940,
522.2343, 522.2477, and 522.2478 of
this chapter.
■ 27. In § 556.370, revise paragraph (b)
to read as follows:
17947
*
058198
054771
054771
*
(1) No. 058198: Type A medicated
articles containing 9 or 45.4 grams per
pound (g/lb) ractopamine
hydrochloride.
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Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations
(e) * * *
(2) * * *
(2) Nos. 016592, 051311, and 054771:
Type A medicated articles containing
45.4 g/lb ractopamine hydrochloride.
*
*
*
*
*
Combination
in grams/ton
Ractopamine in grams/ton
(i) 8.2 to 24.6 ...................
*
(iii) 9.8 to 24.6 .................
*
(vi) Not to exceed 800; to
provide 70 to 400 mg/
head/day.
*
*
...........................
*
*
*
§ 558.555
*
*
*
*
Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during
the last 28 to 42 days on feed.
*
*
*
Feed continuously as sole ration during the last 28
to 42 days on feed. Not for animals intended for
breeding.
*
*
Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed.
*
*
*
Top dress ractopamine at a minimum of 1.0 lb/
head/day of medicated feed continuously during
the last 28 to 42 days on feed. Not for animals intended for breeding..
*
*
*
Tylvalosin.
32. In § 558.555, in paragraph (f),
remove ‘‘Semduramycin’’ and in its
place add ‘‘Semduramicin’’.
33. In § 558.633, revise paragraph
(d)(3) to read as follows:
■
*
*
*
*
*
(d) * * *
(3) Pelleted Type C medicated feeds
must bear an expiration date of 30 days
after the date of manufacture. Crumbled
Type C medicated feeds must bear an
expiration date of 7 days after the date
of manufacture.
*
*
*
*
*
§ 558.680
*
Zoalene.
*
*
(d) * * *
(1) * * *
*
*
Indications for use
Limitations
*
(iii) 36.3 to 113.5 .............
*
Bacitracin
methylenedisalicylate, 50.
(iv) 36.3 to 113.5 .............
Bacitracin
methylenedisalicylate, 100
to 200.
*
*
Replacement chickens: For development of active
immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by
Clostridium spp. or other organisms susceptible
to bacitracin.
Replacement chickens: For development of active
immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by
Clostridium spp. or other organisms susceptible
to bacitracin.
*
*
*
Feed continuously as the sole ration as in the
subtable in item (i). Grower ration not to be fed to
birds over 14 weeks of age. Bacitracin
methylenedisalicylate as provided by No. 054771
in § 510.600(c) of this chapter.
Feed continuously as sole ration as in the subtable
in item (i). To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection;
administer continuously for 5 to 7 days or as long
as clinical signs persist, then reduce bacitracin to
prevention level (50 g/ton). Bacitracin
methylenedisalicylate as provided by No. 054771
in § 510.600(c) of this chapter.
*
(vii) 113.5 .........................
*
Bacitracin
methylenedisalicylate, 50.
*
*
*
Feed continuously as the sole ration. Bacitracin
methylenedisalicylate as provided by No. 054771
in § 510.600(c) of this chapter.
(viii) 113.5 ........................
Bacitracin
methylenedisalicylate,.
100 to 200 .........
*
*
Broiler chickens: For prevention and control of coccidiosis; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to
bacitracin.
Broiler chickens: For prevention and control of coccidiosis; and as an aid in the control of necrotic
enteritis caused or complicated by Clostridium
spp. or other organisms susceptible to bacitracin.
*
*
16:11 Mar 28, 2022
Jkt 256001
PO 00000
Frm 00010
Fmt 4700
*
Sfmt 4700
Sponsor
Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs
of disease; vary bacitracin dosage based on the
severity of infection; administer continuously for 5
to 7 days or as long as clinical signs persist, then
reduce bacitracin to prevention level (50 g/ton).
Bacitracin methylenedisalicylate as provided by
No. 054771 in § 510.600(c) of this chapter.
*
(2) Turkeys—
VerDate Sep<11>2014
016592
051311
054771
058198
34. In § 558.680, revise paragraphs
(d)(1)(iii), (iv), (vii), and (viii) and (d)(2)
to read as follows:
Combination in
grams/ton
*
016592
051311
054771
058198
*
Zoalene in
grams/ton
*
016592
051311
054771
058198
■
*
[Amended]
Sponsor
Feed continuously as sole ration during the last 28
to 42 days on feed. Not for animals intended for
breeding.
§ 558.633
*
Limitations
Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed.
*
■
lotter on DSK11XQN23PROD with RULES1
Indications for use
E:\FR\FM\29MRR1.SGM
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054771
058198
054771
058198
054771
058198
054771
058198
Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations
Zoalene in grams/ton
Combination in grams/
ton
Indications for use
(i) 113.5 to 170.3 ........
(ii) 113.5 to 170.3 .......
*
*
*
*
Growing turkeys: For prevention and control of
coccidiosis.
Bacitracin
methylenedisalicylate,
4 to 50.
Growing turkeys: For prevention and control of
coccidiosis; and for increased rate of weight
gain and improved feed efficiency.
*
Dated: March 21, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation,
and International Affairs, U.S. Food and Drug
Administration.
[FR Doc. 2022–06395 Filed 3–28–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 822
[Docket No. FDA–2021–N–0246]
Medical Devices; Technical
Amendments
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is amending its medical device
regulations to update mailing address
information and to reduce (from three to
one) the number of copies of certain
documents that need to be submitted to
FDA. The rule does not impose any new
regulatory requirements on affected
parties. This action is editorial in nature
and is intended to improve the accuracy
of the Agency’s regulations, and to
remove a submission requirement that is
no longer necessary.
DATES: This rule is effective March 29,
2022.
FOR FURTHER INFORMATION CONTACT:
Madhusoodana Nambiar, Office of
Policy, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5519,
Silver Spring, MD 20993–0002, 301–
796–5837.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with RULES1
SUMMARY:
I. Background
The FDA Center for Devices and
Radiological Health (CDRH) has
reorganized to create an agile
infrastructure that can adapt to future
organizational, regulatory, and scientific
needs (84 FR 22854, May 20, 2019; 85
FR 18439, April 2, 2020). The newly
VerDate Sep<11>2014
Limitations
16:11 Mar 28, 2022
Jkt 256001
II. Description of the Technical
Amendments
One regulation specified in this notice
is being revised to make a nonsubstantive editorial change to update
particular mailing address information.
For the other two regulations specified
in this notice, we are removing the
requirements for submission of multiple
copies of certain postmarket
surveillance-related documents, to
instead require submission of only one
copy, because the requirement for
multiple copies is no longer necessary.
The rule does not impose any new
regulatory requirements on affected
parties. The amendments are editorial in
nature and should not be construed as
modifying any substantive standards or
requirements.
III. Notice and Public Comment
Publication of this document
constitutes final action under the
Administrative Procedure Act (APA).
The APA generally exempts ‘‘rules of
agency organization, procedure, or
practice’’ from the requirements of
notice and comment rulemaking. (5
U.S.C. 553(b)(A)). Rules are also
Frm 00011
Fmt 4700
Sfmt 4700
Sponsor
Feed continuously as sole ration. For turkeys
grown for meat purposes only. Not to be fed to
laying birds.
Feed continuously as sole ration until 14 to 16
weeks of age. For turkeys grown for meat purposes only. Not to be fed to laying birds.
formed Office of Product Evaluation and
Quality (OPEQ) combined the former
Office of Compliance, the Office of
Device Evaluation, the Office of
Surveillance and Biometrics, and the
Office of In Vitro Diagnostics and
Radiological Health, with a focus on a
Total Product Lifecycle (TPLC)
approach to medical device oversight.
Within OPEQ there are Offices of Health
Technology that focus on the TPLC
review of specific types of medical
devices as well as cross-cutting offices
focusing on specific policy and
programmatic needs including the
Office of Regulatory Programs and the
Office of Clinical Evidence and
Analysis. As part of this technical
amendment, we are making a change to
correctly identify the address for
obtaining particular information. We are
also amending the requirement for the
submission of multiple copies of certain
documents to a single copy, as FDA’s
receipt of multiple copies is no longer
necessary. The changes published in
this notice are non-substantive and
editorial in nature.
PO 00000
17949
054771
058198
054771
058198
generally exempt from such
requirements when an Agency ‘‘for good
cause finds (and incorporates the
finding and a brief statement of reasons
therefor in the rules issued) that notice
and public procedure thereon are
impracticable, unnecessary, or contrary
to the public interest’’ (5 U.S.C.
553(b)(B)).
FDA has determined that this
rulemaking meets the APA’s notice and
comment exemption requirements. All
the revisions FDA publishes through
this notice make technical or nonsubstantive changes. Some of these
revisions pertain solely to the CDRH
reorganization, and constitute ‘‘rules of
agency organization, procedure, or
practice’’ not subject to the
requirements of notice and comment
under 5 U.S.C. 553(b)(A). The balance of
these revisions reduces (from three to
one) the number of copies of certain
documents that need to be submitted to
FDA. Such technical, non-substantive
change is ‘‘a routine determination,
insignificant in nature and impact, and
inconsequential to the industry and to
the public.’’ (Mack Trucks, Inc. v. EPA,
682 F.3d 87, 94 (D.C. Cir. 2012))
(quotation marks and citation omitted).
FDA accordingly for good cause finds
that notice and public procedure
thereon are unnecessary for this
reduction in the number of copies of
certain documents that must be
submitted.
The APA allows an effective date less
than 30 days after publication as
‘‘provided by the agency for good cause
found and published with the rule’’ (5
U.S.C. 553(d)(3)). An effective date 30 or
more days from the date of publication
is unnecessary in this case because the
amendments do not impose any new
regulatory requirements on affected
parties, and affected parties do not need
time to ‘‘adjust to the new regulation’’
before the rule takes effect (Am.
Federation of Government Emp., AFL–
CIO v. Block, 655 F.2d 1153, 1156 (D.C.
Cir. 1981)). Therefore, FDA finds good
cause for the amendments to become
effective on the date of publication of
this action.
List of Subjects in 21 CFR Part 822
Medical devices, Reporting and
recordkeeping requirements.
E:\FR\FM\29MRR1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 60 (Tuesday, March 29, 2022)]
[Rules and Regulations]
[Pages 17942-17949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06395]
[[Page 17942]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 524, 529, 556, and 558
[Docket No. FDA-2021-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor
AGENCY: Food and Drug Administration, Department of Health and Human
Services (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 October, November, and December 2021. FDA
is informing the public of the availability of summaries of the basis
of approval and of environmental review documents, where applicable.
The animal drug regulations are also being amended to improve the
accuracy of the regulations.
DATES: This rule is effective March 29, 2022.
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 October, November, and December
2021, as listed in table 1. In addition, FDA is informing the public of
the availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons
with access to the internet may obtain these documents at the CVM FOIA
Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 1, 2021........... 200-691 Virbac AH, Inc., P.O. RAC 45 CATTLE Cattle................ Original approval as FOI Summary.
Box 162059, Fort (ractopamine a generic copy of
Worth, TX 76161. hydrochloride Type A NADA 141-221.
medicated article).
October 20, 2021.......... 200-604 Dechra Veterinary Amoxicillin and Dogs and cats......... Original approval as FOI Summary.
Products LLC, 7015 Clavulanate a generic copy of
College Blvd., Suite Potassium for Oral NADA 055-101.
525, Overland Park, Suspension.
KS 66211.
October 28, 2021.......... 200-588 Sparhawk Florfenicol Injection Cattle................ Original approval as FOI Summary.
Laboratories, Inc., (florfenicol) a generic copy of
12340 Santa Fe Trail Injectable Solution. NADA 141-063.
Dr., Lenexa, KS
66215.
October 29, 2021.......... 200-628 Sparhawk Enrofloxacin 100 Cattle and swine...... Original approval as FOI Summary.
Laboratories, Inc., (enrofloxacin) a generic copy of
12340 Santa Fe Trail Injectable Solution. NADA 141-068.
Dr., Lenexa, KS
66215.
October 29, 2021.......... 141-348 Zoetis Inc., 333 SYNOVEX ONE Grower Cattle................ Supplemental approval FOI Summary.
Portage St., (trenbolone acetate adding cattle fed in
Kalamazoo, MI 49007. and estradiol confinement for
benzoate extended- slaughter.
release implants).
November 1, 2021.......... 200-711 Ceva Sante Animale, TULAVEN 100 Cattle and swine...... Original approval as FOI Summary.
10 Avenue de la (tulathromycin a generic copy of
Ballasti[egrave]re, injection) NADA 141-244.
33500 Libourne, Injectable Solution.
France.
November 3, 2021.......... 200-712 Ceva Sante Animale, TULAVEN 25 Cattle and swine...... Original approval as FOI Summary.
10 Avenue de la (tulathromycin a generic copy of
Ballasti[egrave]re, injection) NADA 141-349.
33500 Libourne, Injectable Solution.
France.
November 3, 2021.......... 141-508 Elanco US Inc., 2500 EXPERIOR (lubabegron) Cattle................ Supplemental approval FOI Summary.
Innovation Way, Type A medicated adding tolerances
Greenfield, IN 46140. article. for residues in
edible tissues of
cattle.
November 12, 2021......... 200-668 Virbac AH, Inc., P.O. TULISSIN 25 Cattle and swine...... Original approval as FOI Summary.
Box 162059, Fort (tulathromycin a generic copy of
Worth, TX 76161. injection) NADA 141-349.
Injectable Solution.
November 15, 2021......... 200-253 Bimeda Animal Health PROSTAMATE (dinoprost Cattle................ Supplemental approval FOI Summary.
Ltd., 1B The Herbert tromethamine for use with
Building, The Park, injection) gonadorelin or with
Carrickmines, Dublin Injectable Solution. progesterone
18, Ireland. intravaginal inserts.
November 15, 2021......... 200-669 Virbac AH, Inc., P.O. TULISSIN 100 Cattle and swine...... Original approval as FOI Summary.
Box 162059, Fort (tulathromycin a generic copy of
Worth, TX 76161. injection) NADA 141-244.
Injectable Solution.
[[Page 17943]]
November 22, 2021......... 200-695 Virbac AH, Inc., P.O. TIA 12.5% (tiamulin Swine................. Original approval as FOI Summary.
Box 162059, Fort hydrogen fumarate) a generic copy of
Worth, TX 76161. Liquid Concentrate. NADA 140-916.
November 24, 2021......... 200-714 Aurora BARRIER for Cats Cats.................. Original approval as FOI Summary.
Pharmaceutical, Inc, (imidacloprid and a generic copy of
1196 Highway 3 moxidectin) Topical NADA 141-254.
South, Northfield, Solution.
MN 55057-3009.
December 10, 2021......... 200-705 Elanco US Inc., 2500 ZOASHIELD (zoalene) Chickens and turkeys.. Original approval as FOI Summary.
Innovation Way, Type A medicated a generic copy of
Greenfield, IN 46140. article and BMD NADA 141-085.
(bacitracin
methylenedisalicylat
e) Type A medicated
article.
December 21, 2021......... 141-552 Jaguar Animal Health, CANALEVIA-CA1 Dogs.................. Conditional approval FOI Summary.
200 Pine St., suite (crofelemer delayed- for treatment of
600, San Francisco, release tablets). chemotherapy-induced
CA 94104. diarrhea.
December 23, 2021......... 141-521 Zoetis Inc., 333 SIMPARICA TRIO Dogs.................. Supplemental approval FOI Summary.
Portage St., (sarolaner, for the prevention
Kalamazoo, MI 49007. moxidectin, and of Borrelia
pyrantel chewable burgdorferi
tablets) Chewable infection as a
Tablet. direct result of
killing Ixodes
scapularis vector
ticks and for the
treatment and
control of L4 and
immature adult
Ancylostoma caninum.
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Change of Sponsor
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has
informed FDA that it has transferred ownership of, and all rights and
interest in, the NADAs and ANADAs listed below to Dechra, Ltd.,
Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire,
BD23 2RW, United Kingdom:
------------------------------------------------------------------------
File No. Product name
------------------------------------------------------------------------
047-955........................... ROMPUN (xylazine hydrochloride)
Injectable (20 mg).
047-956........................... ROMPUN (xylazine hydrochloride)
Injectable (100 mg).
200-322........................... Butorphanol Tartrate Injection.
200-408........................... Butorphanol Tartrate Injection.
------------------------------------------------------------------------
Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204
has informed FDA that it has transferred ownership of, and all rights
and interest in, NADA 141-319 for SUCROMATE Equine (deslorelin acetate
injection) to Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd.,
Skipton, North Yorkshire, BD23 2RW, United Kingdom.
As provided in the regulatory text, the animal drug regulations are
amended to reflect these changes of sponsorship.
III. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
21 CFR 510.600 is amended to add Jaguar Animal Health and
remove Thorn Bioscience LLC from the list of sponsors of approved
applications.
21 CFR 520.88h is amended to correct indications for use
in cats of an oral suspension containing amoxicillin and clavulanate.
21 CFR 520.2455 is amended to correct a spelling error in
the limitations for use of tiamulin in drinking water of swine.
21 CFR 522.230 is amended to add the caution that
buprenorphine injectable solution is a Schedule III opioid under the
Controlled Substances Act.
21 CFR 522.690 is amended to reflect revised indications
for use of dinoprost tromethamine injectable solution in mares.
21 CFR 522.1940 is amended to reflect the approved classes
of cattle and limitations for use of progesterone and estradiol
benzoate ear implants.
21 CFR 522.2343 is amended to reflect the approved classes
of cattle and limitations for use of testosterone propionate and
estradiol benzoate ear implants.
21 CFR 556.240 is amended to reflect the use of revised
food consumption values in establishing permitted concentrations of
residues of estradiol and related esters in edible tissues of cattle.
The basis for this action is explained in the FOI Summary for
supplemental NADA 141-348, approved October 29, 2021. The section is
also amended to reflect a cross reference for testosterone propionate
and estradiol benzoate implants, recently redesignated as 21 CFR
522.2343.
21 CFR 558.254 is amended to reflect the approved
conditions of use for famphur in feed.
21 CFR 558.355 is amended to reflect use of medicated
feeds containing monensin alone or in combination with bacitracin
methylenedisalicylate in revised classes of chickens.
21 CFR 558.555 is amended to correct a spelling error in
the permitted combination use of semduramicin in medicated feed.
21 CFR 558.633 is amended to revise expiration dates for
use of pelleted or crumbled tylvalosin medicated swine feeds.
21 CFR 558.680 is amended to reflect the correct sponsor
of an application for use of Type C medicated turkey feeds containing
zoalene.
IV. 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
[[Page 17944]]
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 Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Dairy products, Foods, Meat and meat products.
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, 516, 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), add in alphabetical order an entry
for ``Jaguar Animal Health'' and remove the entry for ``Thorn
Bioscience LLC''; and
0
b. In the table in paragraph (c)(2), remove the entry for ``051330''
and add in numerical order an entry for ``086149''.
The additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Jaguar Animal Health, 200 Pine St., Suite 600, San 086149
Francisco, CA 94104....................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
086149................... Jaguar Animal Health, 200 Pine St., Suite
600,
San Francisco, CA 94104.
* * * * * * *
------------------------------------------------------------------------
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
3. The authority citation for part 516 continues to read as follows:
Authority 21 U.S.C. 360ccc, 360ccc-2, 371.
0
4. Add Sec. 516.498 to subpart C to read as follows:
Sec. 516.498 Crofelemer.
(a) Specifications. Each delayed-release tablet contains 125
milligrams (mg) crofelemer.
(b) Sponsor. See No. 086149 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer 1 tablet orally twice
daily for 3 days for dogs weighing <=140 pounds. Administer 2 tablets
orally twice daily for 3 days for dogs weighing >140 pounds.
(2) Indications for use. For the treatment of chemotherapy-induced
diarrhea in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
6. Revise Sec. 520.88h to read as follows:
Sec. 520.88h Amoxicillin trihydrate and clavulanate potassium for
oral suspension.
(a) Specifications. When constituted, each milliliter (mL) of
suspension contains amoxicillin trihydrate equivalent to 50 milligrams
(mg) amoxicillin and clavulanate potassium equivalent to 12.5 mg
clavulanic acid.
(b) Sponsors. See Nos. 017033, 054771, and 069043 in Sec.
510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 6.25 mg/lb (1 mL/10 lb
of body weight) twice a day. Skin and soft tissue infections such as
abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and
periodontal infections should be treated for 5 to 7 days or for 48
hours after all signs have subsided. If no
[[Page 17945]]
response is seen after 5 days of treatment, therapy should be
discontinued and the case reevaluated. Deep pyoderma may require
treatment for 21 days; the maximum duration of treatment should not
exceed 30 days.
(ii) Indications for use. Treatment of skin and soft tissue
infections such as wounds, abscesses, cellulitis, superficial/juvenile
and deep pyoderma due to susceptible strains of the following
organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-
lactamase-producing Staphylococcus aureus, Staphylococcus spp.,
Streptococcus spp., and Escherichia coli. Treatment of periodontal
infections due to susceptible strains of both aerobic and anaerobic
bacteria.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. 62.5 mg (1 mL) twice daily. Skin and soft
tissue infections such as abscesses and cellulitis/dermatitis should be
treated for 5 to 7 days or 48 hours after all symptoms have subsided,
not to exceed 30 days. If no response is seen after 3 days of
treatment, therapy should be discontinued and the case reevaluated.
Urinary tract infections may require treatment for 10 to 14 days or
longer. The maximum duration of treatment should not exceed 30 days.
(ii) Indications for use. Treatment of skin and soft tissue
infections, such as wounds, abscesses, and cellulitis/dermatitis due to
susceptible strains of the following organisms: Beta-lactamase-
producing Staphylococcus aureus, non-beta-lactamase-producing
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp.,
Escherichia coli, Pasteurella multocida, and Pasteurella spp. Urinary
tract infections (cystitis) due to susceptible strains of E. coli.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
7. In Sec. 520.2090, revise paragraph (c)(2) to read as follows:
Sec. 520.2090 Sarolaner, moxidectin, and pyrantel.
* * * * *
(c) * * *
(2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis and for the treatment and control of
roundworm (immature adult and adult Toxocara canis and adult Toxascaris
leonina) and hookworm (L4, immature adult, and adult Ancylostoma
caninum and adult Uncinaria stenocephala) infections. Kills adult fleas
(Ctenocephalides felis) and is indicated for the treatment and
prevention of flea infestations, and 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) for 1 month in dogs and puppies 8 weeks of
age and older, and weighing 2.8 pounds or greater. For the prevention
of Borrelia burgdorferi infections as a direct result of killing Ixodes
scapularis vector ticks.
* * * * *
0
8. In Sec. 520.2455:
0
a. Revise paragraphs (b)(1) through (4); and
0
b. In paragraph (d)(2), remove ``semduramycin'' and in its place add
``semduramicin.''
The revisions read as follows:
Sec. 520.2455 Tiamulin.
* * * * *
(b) * * *
(1) No. 058198 for products described in paragraph (a) of this
section.
(2) No. 066104 for product described in paragraph (a)(1) of this
section.
(3) Nos. 016592, 051311, and 061133 for product described in
paragraph (a)(2) of this section.
(4) No. 054771 for product described in paragraph (a)(3) of this
section.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
10. In Sec. 522.246, revise paragraphs (b)(2) and (3) to read as
follows:
Sec. 522.246 Butorphanol.
* * * * *
(b) * * *
(2) No. 043264 for use of the product described in paragraph (a)(2)
of this section as in paragraph (d)(2) of this section.
(3) Nos. 000061, 043264, and 059399 for use of the product
described in paragraph (a)(3) of this section as in paragraph (d)(3) of
this section.
* * * * *
Sec. 522.533 [Amended]
0
11. In Sec. 522.533, in paragraph (b)(2), remove ``051330'' and in its
place add ``043264''.
0
12. In Sec. 522.690:
0
a. Revise paragraphs (a) and (b);
0
b. Revise paragraph (d)(1) introductory text and paragraph (d)(1)(i);
0
c. Add paragraph (d)(2) introductory text;
0
d. Revise paragraph (d)(2)(ii);
0
e. Add paragraph (d)(3) introductory text;
0
f. Revise paragraph (d)(3)(ii); and
0
g. Remove paragraph (d)(4).
The revisions and additions read as follows:
Sec. 522.690 Dinoprost.
(a) Specifications. Each milliliter (mL) of solution contains
dinoprost tromethamine equivalent to:
(1) 5 milligrams (mg) dinoprost; or
(2) 12.5 mg dinoprost.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
(1) Nos. 054771 and 061133 for use of product described in
paragraph (a)(1) as in paragraph (d) of this section.
(2) No. 054771 for use of product described in paragraph (a)(2) as
in paragraph (d)(1) of this section.
* * * * *
(d) * * *
(1) Cattle. Administer products described in paragraph (a) of this
section as follows:
(i) Amount. 25 mg as an intramuscular injection of the 5 mg/mL
product or as an intramuscular or subcutaneous injection of the 12.5
mg/mL product.
* * * * *
(2) * * * Administer product described in paragraph (a)(1) of this
section as follows:
* * * * *
(ii) Indications for use. (A) For controlling the timing of estrus
in estrous cycling mares.
(B) For difficult-to-breed mares (clinically anestrous mares that
have a corpus luteum).
* * * * *
(3) * * * Administer product described in paragraph (a)(1) of this
section as follows:
* * * * *
(ii) Indications for use. For parturition induction in swine.
0
13. In Sec. 522.812, revise paragraph (b)(2) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(2) Nos. 055529, 058005, 058198, and 061133 for use of product
described in paragraph (a)(2) of this section as in paragraphs (e)(2)
and (3) of this section.
* * * * *
Sec. 522.955 [Amended]
0
14. In Sec. 522.955, in paragraph (b)(3), remove ``No. 086050'' and in
its place
[[Page 17946]]
add ``Nos. 058005 and 086050''; and in paragraph (d)(1)(ii)(C), remove
``No. 000061'' and in its place add ``Nos. 000061, 058005, and
086050''.
0
15. In Sec. 522.1077, revise paragraph (d)(1)(iv) to read as follows:
Sec. 522.1077 Gonadorelin.
* * * * *
(d) * * *
(1) * * *
(iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this
section as provided by Nos. 054771 and 061133 in Sec. 510.600(c) of
this chapter.
* * * * *
0
16. In Sec. 522.1940, revise the paragraph (c)(1) heading, paragraph
(c)(1)(iii), the paragraph (c)(2) heading, and paragraph (c)(2)(iii) to
read as follows:
Sec. 522.1940 Progesterone and estradiol benzoate.
* * * * *
(c) * * *
(1) Suckling beef calves at least 45 days old and up to 400 lb of
body weight--* * *
* * * * *
(iii) Limitations. For subcutaneous ear implantation, one dose per
animal. Do not use in beef calves less than 45 days of age, dairy
calves, and veal calves because effectiveness and safety have not been
established. Do not use in animals intended for subsequent breeding, or
in dairy cows. A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.
(2) Growing beef steers weighing 400 lb or more--* * *
* * * * *
(iii) Limitations. For subcutaneous ear implantation, one dose per
animal. Do not use in beef calves less than 45 days of age, dairy
calves, and veal calves because effectiveness and safety have not been
established. Do not use in animals intended for subsequent breeding, or
in dairy cows. A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.
* * * * *
0
17. In Sec. 522.2343, revise paragraph (c) introductory text and
paragraph (c)(3) to read as follows:
Sec. 522.2343 Testosterone propionate and estradiol benzoate.
* * * * *
(c) Conditions of use. For implantation in growing beef heifers
weighing 400 lb or more as follows:
* * * * *
(3) Limitations. For subcutaneous ear implantation, one dose per
animal. Not for use in dairy or beef replacement heifers. Do not use in
beef calves less than 2 months of age, dairy calves, and veal calves
because safety and effectiveness have not been established. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
0
18. In Sec. 522.2478, redesignate paragraph (d)(3) as paragraph
(d)(4); add new paragraph (d)(3); and revise newly redesignated
paragraph (d)(4) heading and paragraph (d)(4)(i)(C) to read as follows:
Sec. 522.2478 Trenbolone acetate and estradiol benzoate.
* * * * *
(d) * * *
(3) Growing beef steers and heifers fed in confinement for
slaughter. (i) For an implant as described in paragraph (a)(2)(ii) of
this section:
(A) Amount. 150 mg trenbolone acetate and 21 mg estradiol benzoate
in an extended-release implant.
(B) Indications for use. For increased rate of weight gain for up
to 200 days.
(C) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant within each separate production phase. Safety
and effectiveness following reimplantation have not been evaluated. Do
not use in beef calves less than 2 months of age, dairy calves, and
veal calves because effectiveness and safety have not been established.
Do not use in beef calves less than 2 months of age, dairy calves, and
veal calves. A withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in dairy cows or in
animals intended for subsequent breeding. Use in these cattle may cause
drug residues in milk and/or in calves born to these cows.
(ii) [Reserved]
(4) Growing beef steers and heifers on pasture (stocker, feeder,
and slaughter). (i) * * *
(C) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant within each separate production phase. Safety
and effectiveness following reimplantation have not been evaluated. Do
not use in beef calves less than 2 months of age, dairy calves, and
veal calves because effectiveness and safety have not been established.
Do not use in beef calves less than 2 months of age, dairy calves, and
veal calves. A withdrawal period has not been established for this
product in preruminating calves. Do not use in dairy cows or in animals
intended for subsequent breeding. Use in these cattle may cause drug
residues in milk and/or in calves born to these cows.
* * * * *
0
19. In 522.2630, revise paragraphs (b)(1) and (2) to read as follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(b) * * *
(1) Nos. 013744, 051311, 054771, 058198, and 061133 for use of
product described in paragraph (a)(1) as in paragraphs (d)(1)(i) and
(ii), (d)(1)(iii)(A), and (d)(2) of this section.
(2) Nos. 013744, 051311, and 054771 for use of product described in
paragraph (a)(2) as in paragraphs (d)(1)(i), (d)(1)(ii)(B),
(d)(1)(iii)(B), and (d)(2) of this section.
* * * * *
0
20. In Sec. 522.2662, revise paragraph (b)(3) to read as follows:
Sec. 522.2662 Xylazine.
* * * * *
(b) * * *
(3) Nos. 043264 and 061651 for use of product described in
paragraph (a)(1) of this section as in paragraph (d)(1) of this
section; and product described in paragraph (a)(2) of this section as
in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this
section.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
21. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
22. In Sec. 524.1146, revise paragraphs (b)(2) and (3) to read as
follows:
Sec. 524.1146 Imidacloprid and moxidectin.
* * * * *
(b) * * *
(2) Nos. 051072, 017030, 058198, and 061651 for use of product
described in paragraph (a)(2) of this section as in paragraph (d)(2) of
this section.
(3) Nos. 051072 and 058198 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(3) of this
section.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
23. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
[[Page 17947]]
0
24. In Sec. 529.1940, revise the last sentence in paragraph
(e)(1)(iii) to read as follows:
Sec. 529.1940 Progesterone intravaginal inserts.
* * * * *
(e) * * *
(1) * * *
(iii) * * * Dinoprost injection for use as in paragraphs
(e)(1)(ii)(A) and (B) of this section as in Sec. 522.690 of this
chapter, provided by Nos. 054771 and 061133 in Sec. 510.600(c) of this
chapter.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
25. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
26. In 556.240, revise paragraphs (b)(1) and (c) to read as follows:
Sec. 556.240 Estradiol and related esters.
* * * * *
(b) * * *
(1) Cattle. (i) Muscle: 0.2 ppb.
(ii) Liver: 0.6 ppb.
(iii) Kidney: 1.2 ppb.
(iv) Fat: 1.2 ppb.
* * * * *
(c) Related conditions of use. See Sec. Sec. 522.840, 522.850,
522.1940, 522.2343, 522.2477, and 522.2478 of this chapter.
0
27. In Sec. 556.370, revise paragraph (b) to read as follows:
Sec. 556.370 Lubabegron.
* * * * *
(b) Tolerances. The tolerances for lubabegron (marker residue) are:
(1) Cattle. (i) Liver (target tissue): 10 ppb.
(ii) Muscle: 3 ppb.
(iii) Kidney: 20 ppb.
(2) [Reserved]
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
28. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
29. In Sec. 558.254, revise paragraph (e) to read as follows:
Sec. 558.254 Famphur.
* * * * *
(e) Conditions of use. It is used in cattle feed as follows:
----------------------------------------------------------------------------------------------------------------
Famphur amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) To provide 1.1 milligrams per Beef cattle and nonlactating Feed for 30 days. Withdraw 000061
pound (mg/lb) body weight per day. dairy cattle: For control of from dry dairy cows and
grubs and as an aid in heifers 21 days prior to
control of sucking lice. freshening. Withdraw 4 days
prior to slaughter.
(2) To provide 2.3 mg/lb body weight Beef cattle and nonlactating Feed for 10 days. Withdraw 000061
per day. dairy cattle: For control of from dry dairy cows and
grubs. heifers 21 days prior to
freshening. Withdraw 4 days
prior to slaughter.
----------------------------------------------------------------------------------------------------------------
0
30. In Sec. 558.355, revise paragraphs (d)(8)(vi) and (f)(1)(ii),
(iv), and (vi) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(d) * * *
(8) * * *
(vi) Not for replacement chickens intended to become broiler
breeding chickens.
* * * * *
(f) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Monensin in grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 90 to 110............ Layer replacement Feed continuously as the 058198
chickens: As an aid in sole ration. Do not feed
the prevention of to chickens over 16
coccidiosis caused by E. weeks of age. Do not
necatrix, E. tenella, E. feed to laying chickens.
acervulina, E. brunetti,
E. mivati, and E. maxima.
* * * * * * *
(iv) 90 to 110............ Bacitracin Layer replacement Feed continuously as sole 054771
methylenedisalicyla chickens: As an aid in ration. Do not feed to
te, 4 to 50. the prevention of chickens over 16 weeks
coccidiosis caused by E. of age. Do not feed to
necatrix, E. tenella, E. laying chickens.
acervulina, E. brunetti, Monensin sodium provided
E. mivati, and E. by No. 058198,
maxima, and for bacitracin
increased rate of weight methylenedisalicylate
gain and improved feed provided by No. 054771
efficiency. in Sec. 510.600(c) of
this chapter.
* * * * * * *
(vi) 90 to 110............ Bacitracin Broiler and layer Feed continuously as sole 054771
methylenedisalicyla replacement chickens: As ration. Do not feed to
te, 50. an aid in the prevention chickens over 16 weeks
of coccidiosis caused by of age. Do not feed to
E. necatrix, E. tenella, laying chickens.
E. acervulina, E. Monensin sodium provided
brunetti, E. mivati, and by No. 058198,
E. maxima, and for bacitracin
improved feed methylenedisalicylate
efficiency, and as an provided by No. 054771
aid in the prevention of in Sec. 510.600(c) of
necrotic enteritis this chapter.
caused or complicated by
Clostridium spp. or
other organisms
susceptible to
bacitracin.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
31. In Sec. 558.500, revise paragraphs (b) and (e)(2)(i), (iii), and
(vi) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 058198: Type A medicated articles containing 9 or 45.4
grams per pound (g/lb) ractopamine hydrochloride.
[[Page 17948]]
(2) Nos. 016592, 051311, and 054771: Type A medicated articles
containing 45.4 g/lb ractopamine hydrochloride.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Ractopamine in grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8.2 to 24.6................ Cattle fed in Feed continuously as 016592
confinement for sole ration during 051311
slaughter: For the last 28 to 42 054771
increased rate of days on feed. Not for 058198
weight gain and animals intended for
improved feed breeding.
efficiency during the
last 28 to 42 days on
feed.
* * * * * * *
(iii) 9.8 to 24.6.............. Cattle fed in Feed continuously as 016592
confinement for sole ration during 051311
slaughter: For the last 28 to 42 054771
increased rate of days on feed. Not for 058198
weight gain, improved animals intended for
feed efficiency, and breeding.
increased carcass
leanness during the
last 28 to 42 days on
feed.
* * * * * * *
(vi) Not to exceed 800; to ..................... Cattle fed in Top dress ractopamine 016592
provide 70 to 400 mg/head/day. confinement for at a minimum of 1.0 051311
slaughter: For lb/head/day of 054771
increased rate of medicated feed 058198
weight gain and continuously during
improved feed the last 28 to 42
efficiency during the days on feed. Not for
last 28 to 42 days on animals intended for
feed. breeding..
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.555 [Amended]
0
32. In Sec. 558.555, in paragraph (f), remove ``Semduramycin'' and in
its place add ``Semduramicin''.
0
33. In Sec. 558.633, revise paragraph (d)(3) to read as follows:
Sec. 558.633 Tylvalosin.
* * * * *
(d) * * *
(3) Pelleted Type C medicated feeds must bear an expiration date of
30 days after the date of manufacture. Crumbled Type C medicated feeds
must bear an expiration date of 7 days after the date of manufacture.
* * * * *
0
34. In Sec. 558.680, revise paragraphs (d)(1)(iii), (iv), (vii), and
(viii) and (d)(2) to read as follows:
Sec. 558.680 Zoalene.
* * * * *
(d) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Zoalene in grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) 36.3 to 113.5............ Bacitracin Replacement chickens: Feed continuously as 054771
methylenedisalicylat For development of the sole ration as in 058198
e, 50. active immunity to the subtable in item
coccidiosis; and as (i). Grower ration
an aid in the control not to be fed to
of necrotic enteritis birds over 14 weeks
caused or complicated of age. Bacitracin
by Clostridium spp. methylenedisalicylate
or other organisms as provided by No.
susceptible to 054771 in Sec.
bacitracin. 510.600(c) of this
chapter.
(iv) 36.3 to 113.5............. Bacitracin Replacement chickens: Feed continuously as 054771
methylenedisalicylat For development of sole ration as in the 058198
e, 100 to 200. active immunity to subtable in item (i).
coccidiosis; and as To control necrotic
an aid in the control enteritis, start
of necrotic enteritis medication at first
caused or complicated clinical signs of
by Clostridium spp. disease; vary
or other organisms bacitracin dosage
susceptible to based on the severity
bacitracin. of infection;
administer
continuously for 5 to
7 days or as long as
clinical signs
persist, then reduce
bacitracin to
prevention level (50
g/ton). Bacitracin
methylenedisalicylate
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
* * * * * * *
(vii) 113.5.................... Bacitracin Broiler chickens: For Feed continuously as 054771
methylenedisalicylat prevention and the sole ration. 058198
e, 50. control of Bacitracin
coccidiosis; and as methylenedisalicylate
an aid in the as provided by No.
prevention of 054771 in Sec.
necrotic enteritis 510.600(c) of this
caused or complicated chapter.
by Clostridium spp.
or other organisms
susceptible to
bacitracin.
(viii) 113.5................... Bacitracin Broiler chickens: For Feed continuously as 054771
methylenedisalicylat prevention and sole ration. To 058198
e,. control of control necrotic
100 to 200........... coccidiosis; and as enteritis, start
an aid in the control medication at first
of necrotic enteritis clinical signs of
caused or complicated disease; vary
by Clostridium spp. bacitracin dosage
or other organisms based on the severity
susceptible to of infection;
bacitracin. administer
continuously for 5 to
7 days or as long as
clinical signs
persist, then reduce
bacitracin to
prevention level (50
g/ton). Bacitracin
methylenedisalicylate
as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(2) Turkeys--
[[Page 17949]]
----------------------------------------------------------------------------------------------------------------
Combination in
Zoalene in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5 to 170.3........... Growing turkeys: For Feed continuously as 054771
prevention and control sole ration. For 058198
of coccidiosis. turkeys grown for meat
purposes only. Not to
be fed to laying birds.
(ii) 113.5 to 170.3.......... Bacitracin Growing turkeys: For Feed continuously as 054771
methylenedisalicyl prevention and control sole ration until 14 to 058198
ate, 4 to 50. of coccidiosis; and for 16 weeks of age. For
increased rate of turkeys grown for meat
weight gain and purposes only. Not to
improved feed be fed to laying birds.
efficiency.
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: March 21, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs,
U.S. Food and Drug Administration.
[FR Doc. 2022-06395 Filed 3-28-22; 8:45 am]
BILLING CODE 4164-01-P
