Rule2022-06395
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 29, 2022
Effective
March 29, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 60 (Tuesday, March 29, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06395]
[[Page 17942]]
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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,
<a href="/cdn-cgi/l/email-protection#a5e2c0cad7c2c08bedc4ccc7c0c9e5c3c1c48bcdcdd68bc2cad3"><span class="__cf_email__" data-cfemail="c384a6acb1a4a6ed8ba2aaa1a6af83a5a7a2edababb0eda4acb5">[email protected]</span></a>.
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: <a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room">https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room</a>. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
<a href="https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book">https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book</a>.
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:
<bullet> 21 CFR 510.600 is amended to add Jaguar Animal Health and
remove Thorn Bioscience LLC from the list of sponsors of approved
applications.
<bullet> 21 CFR 520.88h is amended to correct indications for use
in cats of an oral suspension containing amoxicillin and clavulanate.
<bullet> 21 CFR 520.2455 is amended to correct a spelling error in
the limitations for use of tiamulin in drinking water of swine.
<bullet> 21 CFR 522.230 is amended to add the caution that
buprenorphine injectable solution is a Schedule III opioid under the
Controlled Substances Act.
<bullet> 21 CFR 522.690 is amended to reflect revised indications
for use of dinoprost tromethamine injectable solution in mares.
<bullet> 21 CFR 522.1940 is amended to reflect the approved classes
of cattle and limitations for use of progesterone and estradiol
benzoate ear implants.
<bullet> 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.
<bullet> 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.
<bullet> 21 CFR 558.254 is amended to reflect the approved
conditions of use for famphur in feed.
<bullet> 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.
<bullet> 21 CFR 558.555 is amended to correct a spelling error in
the permitted combination use of semduramicin in medicated feed.
<bullet> 21 CFR 558.633 is amended to revise expiration dates for
use of pelleted or crumbled tylvalosin medicated swine feeds.
<bullet> 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
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