Rule2023-05465
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 20, 2023
Effective
March 20, 2023
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), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during October, November, and December 2022. 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 and readability of the regulations.
Full Text
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<title>Federal Register, Volume 88 Issue 53 (Monday, March 20, 2023)</title>
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[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Rules and Regulations]
[Pages 16543-16550]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05465]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 524, 526, 529, 556, and 558
[Docket No. FDA-2022-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (cNADAs) during October, November, and December 2022. 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 and readability of the regulations.
DATES: This rule is effective March 20, 2023.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl.,
[[Page 16544]]
Rockville, MD 20855, 240-402-5689, <a href="/cdn-cgi/l/email-protection#86c1e3e9f4e1e3a8cee7efe4e3eac6e0e2e7a8eeeef5a8e1e9f0"><span class="__cf_email__" data-cfemail="5a1d3f35283d3f74123b33383f361a3c3e3b74323229743d352c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs, ANADAs, and cNADAs during October, November, and
December 2022, 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, ANADAs, and cNADAs Approved During October, November, and December 2022 Requiring Evidence of Safety and/or
Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name Effect of the action Public documents section
--------------------------------------------------------------------------------------------------------------------------------------------------------
November 4, 2022................... 200-730 Parnell Technologies RESPIRMYCIN Original approval for FOI Summary 522.2630
Pty. Ltd., Unit 4, (tulathromycin the treatment of
476 Gardeners Rd., injection) Injectable bovine respiratory
Alexandria, New South Solution. disease, infectious
Wales 2015, Australia. bovine
keratoconjunctivitis,
and bovine foot rot
as a generic copy of
NADA 141-244.
November 14, 2022.................. 141-567 Ishihara Sangyo PANOQUELL-CA1 Conditional approval FOI Summary 516.1012
Kaisha, Ltd., 3-15, (fuzapladib sodium for management of
Edobori 1-chome, for injection) Powder clinical signs
Nishi-ku, Osaka 550- for injection. associated with acute
0002, Japan. onset of pancreatitis
in dogs.
December 2, 2022................... 200-377 Bimeda Animal Health LINXMED (lincomycin Supplemental approval FOI Summary 520.1263b
Ltd., 1B The Herbert hydrochloride) for control of
Building, The Park, Soluble Powder. American foulbrood in
Carrickmines, Dublin honey bees as a
18, Ireland. generic copy of NADA
111-636.
December 2, 2022................... 141-529 Pharmgate, Inc., 1800 PENNITRACIN Original approval for FOI Summary 558.364
Sir Tyler Dr., (bacitracin the prevention of
Wilmington, NC 28405. methylenedisalicylate mortality caused by
) and MAXIBAN necrotic enteritis
(narasin and and coccidiosis in
nicarbazin). broiler chickens.
December 8, 2022................... 141-566 Increvet, Inc., 200 BEXACAT (bexagliflozin Original approval to FOI Summary 520.170
Portland St., Floor tablets) Tablets. improve glycemic
3, Boston, MA 02114. control in otherwise
healthy cats with
diabetes mellitus not
previously treated
with insulin.
December 15, 2022.................. 200-455 Bimeda Animal Health BILOVET (tylosin Original approval for FOI Summary 520.2640
Ltd., 1B The Herbert tartrate) Soluble the control of
Building, The Park, Powder. mortality caused by
Carrickmines, Dublin necrotic enteritis
18, Ireland. associated with
Clostridium
perfringens in
broiler chickens as a
generic copy of NADA
013-076.
December 20, 2022.................. 141-559 Anzac Animal Health, ZYCOSAN (pentosan Original approval for FOI Summary 522.1704
LLC, 218 Millwell polysulfate sodium the control of
Dr., Suite B, injection) Injectable clinical signs
Maryland Heights, MO Solution. associated with
63043. osteoarthritis in
horses.
December 23, 2022.................. 141-450 Intervet, Inc., 2 BANAMINE Transdermal Supplemental approval FOI Summary 524.970
Giralda Farms, (flunixin transdermal for control of
Maison, NJ 07940. solution) Transdermal pyrexia associated
Solution. with acute bovine
mastitis, for
addition of lactating
dairy cows for all
approved indications,
and of a milk discard
time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Also, FDA is amending the animal drug regulations to reflect
approval of supplemental applications, as listed in table 2, to change
the marketing status of dosage form antimicrobial animal drug products
from over-the-counter (OTC) to by veterinary prescription (Rx). These
applications were submitted in voluntary compliance with the goals of
the FDA Center for Veterinary Medicine's (CVM's) Judicious Use
Initiative as identified by guidance for industry #263,
``Recommendations for Sponsors of Medically Important Antimicrobial
Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary
Oversight All Products That Continue to be Available Over-the-
Counter,'' June 11, 2021 (<a href="https://www.fda.gov/media/130610/download">https://www.fda.gov/media/130610/download</a>).
Table 2--Supplemental Applications Approved During October, November, and December 2022 To Change the Marketing
Status of Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
October 11, 2022.................. 097-222 Boehringer Ingelheim TODAY (cephapirin 526.365
Animal Health USA, Inc., sodium)
3239 Satellite Blvd., Intramammary
Duluth, GA 30096. Infusion.
[[Page 16545]]
October 18, 2022.................. 055-039 Huvepharma EOOD, 5th Chlortetracycline 520.443
Floor, 3A Nikolay Haytov Calf Oblets, 500 mg.
Str., 1113 Sofia,
Bulgaria.
October 31, 2022.................. 034-025 Zoetis Inc., 333 Portage LINCOMIX (lincomycin 522.1260
St., Kalamazoo, MI 49007. hydrochloride)
Injectable Solution.
November 2, 2022.................. 065-498 Huvepharma EOOD, 5th PEN BP-48 522.1696a
Floor, 3A Nikolay Haytov (penicillin G
Str., 1113 Sofia, benzathine and
Bulgaria. penicillin G
procaine)
Injectable
Suspension.
November 9, 2022.................. 108-114 Boehringer Ingelheim TOMORROW (cephapirin 526.363
Animal Health USA, Inc., benzathine)
3239 Satellite Blvd., Intramammary
Duluth, GA 30096. Infusion.
November 15, 2022................. 065-010 Norbrook Laboratories NOROCILLIN 522.1696b
Ltd., Carnbane (penicillin G
Industrial Estate, procaine)
Newry, County Down, BT35 Injectable
6QQ, United Kingdom. Suspension.
November 16, 2022................. 140-582 Bimeda Animal Health BIOCYL-50 522.1662
Ltd., 1B The Herbert (oxytetracycline
Building, The Park, hydrochloride)
Carrickmines, Dublin 18, Injectable
Ireland. Solution; BIOCYL-
100
(oxytetracycline
hydrochloride)
Injectable Solution.
November 18, 2022................. 141-143 Norbrook Laboratories NOROMYCIN 300 LA 522.1660b
Ltd., Carnbane (oxytetracycline)
Industrial Estate, Injectable Solution.
Newry, County Down, BT35
6QQ, United Kingdom.
November 30, 2022................. 031-715 Zoetis Inc., 333 Portage ALBON 520.2220d
St., Kalamazoo, MI 49007. (sulfadimethoxine)
Boluses.
November 30, 2022................. 122-271 Huvepharma EOOD, 5th SULMET 520.2260a
Floor, 3A Nikolay Haytov (sulfamethazine)
Str., 1113 Sofia, Oblets.
Bulgaria.
November 30, 2022................. 200-038 Do....................... DI-METHOX 522.2220
(sulfadimethoxine)
Injectable Solution.
December 2, 2022.................. 101-862 Intervet, Inc., 2 Giralda GARASOL (gentamicin 522.1044
Farms, Madison, NJ 07940. sulfate) Injection.
December 7, 2022.................. 065-174 Zoetis Inc., 333 Portage CRYSTICILLIN 300 522.1696b
St., Kalamazoo, MI 49007. A.S. (penicillin G
procaine)
Injectable
Suspension.
December 9, 2022.................. 113-232 Do....................... LIQUAMYCIN 522.1660a
LA[dash]200
(oxytetracycline)
Injectable Solution.
December 9, 2022.................. 200-523 Bimeda Animal Health SULFAMED 522.2220
Ltd., 1B The Herbert (sulfadimethoxine)
Building, The Park, Injectable Solution.
Carrickmines, Dublin 18,
Ireland.
December 12, 2022................. 103-037 Intervet, Inc., 2 Giralda GARACIN (gentamicin) 522.1044
Farms, Madison, NJ 07940. Injectable Solution.
December 15, 2022................. 200-508 Bimeda Animal Health BILOVET (tylosin) 522.2640
Ltd., 1B The Herbert Injectable Solution.
Building, The Park,
Carrickmines, Dublin 18,
Ireland.
December 16, 2022................. 138-955 Huvepharma EOOD, 5th TYLOVET (tylosin) 522.2640
Floor, 3A Nikolay Haytov Injectable Solution.
Str., 1113 Sofia,
Bulgaria.
December 22, 2022................. 092-523 Intervet, Inc., 2 Giralda GARASOL (gentamicin 529.1044b
Farms, Madison, NJ 07940. sulfate) Solution.
----------------------------------------------------------------------------------------------------------------
II. Changes of Sponsorship
Increvet, Inc., 200 Portland St., Floor 3, Boston, MA 02114 has
informed FDA that it has transferred ownership of, and all rights and
interest in, NADA 141-566 for BEXACAT (bexagliflozin tablets) Tablets,
approved December 8, 2022, to Elanco US Inc., 2500 Innovation Way,
Greenfield, IN 46140. The regulatory text for the original approval of
this application reflects this change of sponsorship.
III. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
<bullet> 21 CFR 516.498 is removed from subpart C of part 516 and
is added to subpart E.
<bullet> 21 CFR 520.370, 520.522, 522.246, 522.304, 522.2470,
524.1044c, 524.1044f, and 524.1484g are amended to reflect a sponsor's
current drug labeler code.
<bullet> 21 CFR 520.441 is amended to revise the sponsor listings
for uses of chlortetracycline in drinking water of various food-
producing animals.
<bullet> 21 CFR 520.443 is amended to revise the sponsor listings
for uses of chlortetracycline tablets and boluses in calves.
<bullet> 21 CFR 520.1196 is amended to revise the indication for
uses of ivermectin and pyrantel tablets in dogs.
<bullet> 21 CFR 522. 1660a is amended to reflect the correct drug
labeler code for a sponsor of an oxytetracycline injectable solution.
<bullet> 21 CFR 522.2471 is amended to add human food safety
warnings for use of tilmicosin injectable solution in cattle and sheep.
<bullet> 21 CFR 524.1448 is amended to revise the indication for
use of mirtazapine transdermal ointment in cats.
<bullet> 21 CFR 556.222 is amended to reflect a revised tolerance
for residues of doramectin in liver of cattle.
<bullet> 21 CFR 556.500 is amended to reflect revised numbering of
sections for oxytetracycline uses in food-producing animals.
<bullet> 21 CFR 558.76 is amended to add conditions of use
previously approved under NADA 141-137 for use of bacitracin
methylenedisalicylate in the manufacture of Type C medicated feeds for
broiler and replacement chickens (87 FR 76418, December 14, 2022).
<bullet> 21 CFR 558.355 is amended to revise a caution statement on
labeling of monensin Type A medicated articles for use in broiler
breeder replacement chickens.
[[Page 16546]]
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 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, 526, 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, 526, 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, in the table in paragraph (c)(1), add entries in
alphabetical order for ``Ishihara Sangyo Kaisha, Ltd.'' and ``ZyVet
Animal Health, Inc.'' and in the table in paragraph (c)(2), add entries
in numerical order for ``064642'' and ``086117'' to 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
------------------------------------------------------------------------
* * * * * * *
Ishihara Sangyo Kaisha, Ltd., 3-15, Edobori 1-chome, 064642
Nishi-ku, Osaka 550-0002, Japan........................
* * * * * * *
ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 086117
08534..................................................
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
064642....................... Ishihara Sangyo Kaisha, Ltd., 3-15,
Edobori 1-chome, Nishi-ku, Osaka 550-
0002, Japan.
* * * * * * *
086117....................... ZyVet Animal Health, Inc., 73 Route 31N,
Pennington, NJ 08534.
* * * * * * *
------------------------------------------------------------------------
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-1, 360ccc-2, 371.
Sec. 516.498 [Transferred to Subpart E]
0
4. Transfer Sec. 516.498 from subpart C to subpart E.
0
5. Add Sec. 516.1012 to read as follows:
Sec. 516.1012 Fuzapladib.
(a) Specifications. The drug is provided as a powder for injection
that is reconstituted with 3.5 milliliter (mL) of provided diluent to a
final concentration of 4 milligrams (mg) fuzapladib sodium per mL.
(b) Sponsor. See No. 064642 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer at a dosage of 0.4 mg
(0.1 mL) per kilogram of body weight once daily for 3 consecutive days
by intravenous (IV) injection over 15 seconds to 1 minute.
(2) Indications for use in dogs. For the management of clinical
signs associated with acute onset of pancreatitis 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.
[[Page 16547]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
7. Add Sec. 520.170 to read as follows:
Sec. 520.170 Bexagliflozin.
(a) Specifications. Each tablet contains 15 milligrams
bexagliflozin.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer one tablet by mouth
to cats 6.6 lb (3.0 kg) or greater once daily, at approximately the
same time each day, with or without food, and regardless of blood
glucose level.
(2) Indications for use. To improve glycemic control in otherwise
healthy cats with diabetes mellitus not previously treated with
insulin.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.370 [Amended]
0
8. In Sec. 520.370, in paragraph (b)(1), remove ``026637'' and add in
its place ``017033''.
0
9. In Sec. 520.441, revise paragraphs (b)(1) and (3) and
(d)(4)(iii)(C) to read as follows:
Sec. 520.441 Chlortetracycline powder.
* * * * *
(b) * * *
(1) No. 069254 for use as in paragraph (d) of this section.
* * * * *
(3) Nos. 069043 and 076475 for use as in paragraphs (d)(4)(i)(A),
(d)(4)(i)(B), and (d)(4)(ii) and (iii) of this section.
* * * * *
(d) * * *
(4) * * *
(iii) * * *.
(C) Limitations. Prepare fresh solution daily as the sole source of
chlortetracycline. Do not use for more than 5 days. For Nos. 066104,
069043, 069254, and 076475: Do not slaughter animals for food within 5
days of treatment. For No. 069254: Do not slaughter animals for food
within 24 hours of treatment. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
* * * * *
0
10. In Sec. 520.443, revise paragraphs (a), (b), and (d)(3)(ii) to
read as follows:
Sec. 520.443 Chlortetracycline hydrochloride tablets and boluses.
(a) Specifications. Each tablet contains 25 milligrams (mg)
chlortetracycline hydrochloride; each bolus contains 250 or 500 mg
chlortetracycline hydrochloride.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(1) No. 069043 for use of a 250-mg bolus as in paragraph (d)(1) of
this section.
(2) No. 016592 for use of a 25-mg tablet as in paragraph (d)(2) of
this section.
(3) No. 016592 for use of a 500-mg bolus as in paragraph (d)(3) of
this section.
* * * * *
(d) * * *
(3) * * *
(ii) Limitations. Do not use for more than 5 days. Do not
administer within 24 hours of slaughter. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
Sec. 520.522 [Amended]
0
11. In Sec. 520.522, in paragraph (b)(2), remove ``026637'' and add in
its place ``017033''.
Sec. 520.1196 [Amended]
0
12. In Sec. 520.1196, in paragraph (c)(1)(ii), remove ``ascarids'' and
add in its place ``roundworms''.
0
13. In Sec. 520.1263b, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 520.1263b Lincomycin powder.
* * * * *
(b) * * *
(1) Nos. 054771 and 061133 for use as in paragraph (d) of this
section.
(2) Nos. 016592, 054925, and 076475 for use as in paragraphs (d)(1)
and (d)(2) of this section.
* * * * *
0
14. In Sec. 520.2220d, revise paragraph (d)(3) to read as follows:
Sec. 520.2220d Sulfadimethoxine bolus.
* * * * *
(d) * * *
(3) Limitations. Do not administer within 7 days of slaughter. Milk
that has been taken from animals during treatment and 60 hours (five
milkings) after the latest treatment must not be used for food. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
0
15. In Sec. 520.2260a, revise paragraph (d)(1)(iii) to read as
follows:
Sec. 520.2260a Sulfamethazine oblets and boluses.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Do not administer for more than 5 consecutive
days. Do not treat cattle within 10 days of slaughter. Do not use in
female dairy cattle 20 months of age or older. Use of sulfamethazine in
this class of cattle may cause milk residues. A withdrawal period has
not been established for this product in preruminating calves. Do not
use in calves to be processed for veal. Do not use in horses intended
for human consumption. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
* * * * *
0
16. In Sec. 520.2640, add paragraph (b)(3) to read as follows:
Sec. 520.2640 Tylosin.
* * * * *
(b) * * *
(3) No. 061133 for use of a 100-g container as in paragraphs
(e)(1)(i)(B) and (e)(1)(ii) of this section.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
17. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
18. In Sec. 522.246, revise paragraph (b)(3) to read as follows:
Sec. 522.246 Butorphanol.
* * * * *
(b) * * *
(3) Nos. 000061, 017033, 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. 522.304 [Amended]
0
19. In Sec. 522.304, in paragraph (b), remove ``026637'' and add in
its place ``017033''.
0
20. In Sec. 522.1044, revise paragraphs (d)(2)(i) through (iii),
(d)(3)(i) though (iii), and (d)(4)(i) through (iii) to read as follows:
Sec. 522.1044 Gentamicin.
* * * * *
(d) * * *
(2) * * *
(i) Amount. Administer subcutaneously in the neck 1 mg of
gentamicin per 0.2 mL dose, using the 50- or 100-mg/mL product diluted
with sterile saline to a concentration of 5 mg/mL.
(ii) Indications for use. As an aid in the prevention of early
mortality in 1- to 3-day old turkey poults due to Arizona
[[Page 16548]]
paracolon infections susceptible to gentamicin.
(iii) Limitations. Injected poults must not be slaughtered for food
for at least 9 weeks after treatment. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(3) * * *
(i) Amount. Administer subcutaneously in the neck 0.2 mg of
gentamicin per 0.2 mL dose, using the 50- or 100-mg/mL product diluted
with sterile saline to a concentration of 1.0 mg/mL.
(ii) Indications for use. For prevention of early mortality in day-
old chickens caused by Escherichia coli, Salmonella typhimurium, and
Pseudomonas aeruginosa susceptible to gentamicin.
(iii) Limitations. Injected chicks must not be slaughtered for food
for at least 5 weeks after treatment. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(4) * * *
(i) Amount. Administer 5 mg of gentamicin as a single intramuscular
dose using the 5 mg/mL solution.
(ii) Indications for use. For treatment of porcine colibacillosis
in piglets up to 3 days old caused by strains of Escherichia coli
sensitive to gentamicin.
(iii) Limitations. For single intramuscular dose in pigs up to 3
days of age only. Do not slaughter treated animals for food for at
least 40 days following treatment. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
* * * * *
0
21. In Sec. 522.1260, revise paragraph (e)(2)(iii) to read as follows:
Sec. 522.1260 Lincomycin.
* * * * *
(e) * * *
(2) * * *
(iii) Limitations. Do not treat within 48 hours of slaughter. For
No 054771: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
0
22. In Sec. 522.1660a, revise paragraph (b) and add a sentence to the
end of paragraphs (e)(1)(ii) and (e)(2)(ii) to read as follows:
Sec. 522.1660a Oxytetracycline solution, 200 milligrams/milliliter.
* * * * *
(b) Sponsors. See Nos. 000010, 016592, 054771, 055529, 061133, and
069254 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(1) * * *
(ii) * * * For No. 054771: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(2) * * *
(ii) * * * For No. 054771: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
0
23. In Sec. 522.1660b, add a sentence to the end of paragraphs
(e)(1)(ii) and (e)(2)(ii) to read as follows:
Sec. 522.1660b Oxytetracycline solution, 300 milligrams/milliliter.
* * * * *
(e) * * *
(1) * * *
(ii) * * * For No. 055529: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(2) * * *
(ii) * * * For No. 055529: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
0
24. In Sec. 522.1662, revise paragraphs (j)(3)(i) and (iii) to read as
follows:
Sec. 522.1662 Oxytetracycline.
* * * * *
(j) * * *
(3) * * *
(i) Amount. Administer by intravenous injection 3 to 5 milligrams
per pound of body weight daily. Administer 5 milligrams per pound for
anaplasmosis, severe foot rot, and severe forms of other diseases.
Treatment should be continued 24 to 48 hours following remission of
disease symptoms, but not to exceed a total of 4 consecutive days.
* * * * *
(iii) Limitations. Not for use in lactating dairy cattle.
Discontinue use at least 19 days prior to slaughter. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
0
25. In Sec. 522.1696a, revise paragraph (d)(2)(iii) to read as
follows:
Sec. 522.1696a Penicillin G benzathine and penicillin G procaine
suspension.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Not for use within 30 days of slaughter. For No.
016592: A withdrawal period has not been established for this product
in pre-ruminating calves. Do not use in calves to be processed for
veal. For No. 016592: Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
26. In Sec. 522.1696b, revise paragraph (d)(2)(iii)(C) to read as
follows:
Sec. 522.1696b Penicillin G procaine aqueous suspension.
* * * * *
(d) * * *
(2) * * *
(iii) * * *
(C) For Nos. 054771 and 055529: Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
0
27. Add Sec. 522.1704 to read as follows:
Sec. 522.1704 Pentosan polysulfate sodium.
(a) Specifications. Each milliliter of solution contains 250
milligrams (mg) of pentosan polysulfate sodium.
(b) Sponsor. See No. 086073 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer 3 mg per kilogram of
body weight (1.4 mg per pound) by intramuscular injection once weekly
for 4 weeks for a total of four doses.
(2) Indications for use. For the control of clinical signs
associated with osteoarthritis in horses.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
28. In Sec. 522.2470, revise paragraphs (b) introductory text and
(b)(1) to read as follows:
Sec. 522.2470 Tiletamine and zolazepam for injection.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) Nos. 017033 and 054771 for use as in paragraph (c) of this
section.
* * * * *
0
29. In Sec. 522.2471, remove paragraph (d), redesignate paragraph (e)
as paragraph (d), and revise newly redesignated paragraphs (d)(1)(iii)
and (d)(2)(iii).
The revisions read as follows:
Sec. 522.2471 Tilmicosin.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Animals intended for human consumption must not
be slaughtered within 42 days of last treatment. Do not use in
lactating dairy cattle 20 months of age or older. Use of tilmicosin in
this class of cattle may cause milk residues. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(2) * * *
(iii) Limitations. Not for use in lactating ewes producing milk for
human consumption. Animals intended for human consumption must not be
slaughtered within 42 days of last treatment. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
0
30. In 522.2630, revise paragraph (b)(1) to read as follows:
[[Page 16549]]
Sec. 522.2630 Tulathromycin.
* * * * *
(b) * * *
(1) Nos. 000061, 013744, 051311, 054771, 055529, 058198, 061133,
and 068504 for use of product described in paragraph (a)(1) as in
paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this
section.
* * * * *
Sec. 522.2640 [Amended]
0
31. In Sec. 522.2640, in paragraph (b)(2), remove ``000010'' and add
in its place ``016592'' and in paragraphs (e)(1)(iii) and (e)(2)(iii),
in the last sentence of each paragraph, remove ``For No. 058198:''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
32. The authority citation for part 524 continues to read as follows:
Authority 21 U.S.C. 360b.
0
33. In Sec. 524.970, revise paragraphs (d)(2) and (3) to read as
follows:
Sec. 524.970 Flunixin.
* * * * *
(d) * * *
(2) Indications for use. For the control of pyrexia associated with
bovine respiratory disease and acute bovine mastitis, and the control
of pain associated with foot rot in beef cattle 2 months of age and
older and dairy cattle.
(3) Limitations. Not for use in beef and dairy bulls intended for
breeding over 1 year of age. Milk that has been taken during treatment
and for 48 hours after treatment must not be used for human
consumption. Cattle must not be slaughtered for human consumption
within 8 days of treatment. Not for use in replacement dairy heifers 20
months of age or older or dry dairy cows; use in these cattle may cause
drug residues in calves born to these cows or heifers. Not for 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. Approved only as a single topical dose in cattle.
Repeated treatments may result in violative residues in milk or in
edible tissues. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
Sec. 524.1044c [Amended]
0
34. In Sec. 524.1044c, in paragraph (b), remove ``026637'' and add in
its place ``017033''.
0
35. In Sec. 524.1044f, revise paragraph (b) to read as follows:
Sec. 524.1044f Gentamicin and betamethasone spray.
* * * * *
(b) Sponsors. See Nos. 000061, 017033, 054925, 058005, and 058829
in Sec. 510.600(c) of this chapter.
* * * * *
0
36. In Sec. 524.1448, revise paragraph (c)(2) to read as follows:
Sec. 524.1448 Mirtazapine transdermal ointment.
* * * * *
(c) * * *
(2) Indications for use. For body weight gain in cats with a
history of weight loss.
* * * * *
Sec. 524.1484g [Amended]
0
37. In Sec. 524.1484g, in paragraph (b), remove ``026637'' and add in
its place ``017033''.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
38. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
39. In Sec. 526.363, revise paragraph (d)(3) to read as follows:
Sec. 526.363 Cephapirin benzathine.
* * * * *
(d) * * *
(3) Limitations. For use in dry cows only. Not to be used within 30
days of calving. Milk from treated cows must not be used for food
during the first 72 hours after calving. Animals infused with this
product must not be slaughtered for food until 42 days after the latest
infusion. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
0
40. In Sec. 526.365, revise paragraph (d)(3) to read as follows:
Sec. 526.365 Cephapirin sodium.
* * * * *
(d) * * *
(3) Limitations. Milk that has been taken from animals during
treatment and for 96 hours after the last treatment must not be used
for food. Treated animals must not be slaughtered for food until 4 days
after the last treatment. Federal law restricts this drug to use by or
on the order of a licensed veterinarian.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
41. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
42. In Sec. 529.1044b, add a sentence to the end of paragraph (c)(3)
to read as follows:
Sec. 529.1044b Gentamicin solution for dipping eggs.
* * * * *
(c) * * *
(3) * * * For No. 000061: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
43. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
44. In Sec. 556.222, revise paragraphs (b)(1)(i) and (c) to read as
follows:
Sec. 556.222 Doramectin.
* * * * *
(b) * * *
(1) * * *
(i) Liver (target tissue): 300 ppb.
* * * * *
(c) Related conditions of use. See Sec. Sec. 522.770, 522.772, and
524.770 of this chapter.
0
45. In Sec. 556.500, revise paragraph (c) to read as follows:
Sec. 556.500 Oxytetracycline.
* * * * *
(c) Related conditions of use. See Sec. Sec. 520.1660a, 520.1660c,
520.1660d, 522.1660a, 522.1660b, 522.1662, 522.1664, 529.1660, 558.450,
and 558.455 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
46. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
47. In Sec. 558.76, redesignate paragraph (d)(1)(iv) as paragraph
(d)(1)(v) and add new paragraph (d)(1)(iv) to read as follows:
Sec. 558.76 Bacitracin methylenedisalicylate.
* * * * *
(d) * * *
(1) * * *
[[Page 16550]]
----------------------------------------------------------------------------------------------------------------
Bacitracin in grams per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 50........................ Broiler and replacement Feed as the sole ration for 28 069254
chickens: For the prevention to 35 days, starting from the
of mortality caused by time chicks are placed for
necrotic enteritis associated brooding.
with Clostridium perfringens.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
48. In Sec. 558.355, revise paragraph (d)(8)(vi) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(d) * * *
(8) * * *
(vi) Not for broiler breeder replacement chickens.
* * * * *
0
49. In Sec. 558.364:
0
a. Revise paragraphs (d)(1)(ii) and (iii);
0
b. Redesignate paragraphs (d)(1)(iv) and (v) as paragraphs (d)(1)(vi)
and (vii); and
0
c. Add new paragraphs (d)(1)(iv) and (v).
The revisions and additions read as follows:
Sec. 558.364 Narasin and nicarbazin.
* * * * *
(d) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Narasin and nicarbazin grams/ Combination in
ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 27 to 45 of each drug.... Bacitracin Broiler chickens: For Feed continuously as 058198
methylenedisalic the prevention of the sole ration. Do
ylate, 4 to 50. coccidiosis caused by not feed to laying
Eimeria necatrix, E. hens. Do not allow
tenella, E. adult turkeys,
acervulina, E. horses, or other
brunetti, E. mivati, equines access to
and E. maxima, and formulations
for increased rate of containing narasin.
weight gain and Ingestion of narasin
improved feed by these species has
efficiency. been fatal. Withdraw
5 days before
slaughter.
Bacitracin
methylenedisalicylat
e as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(iii) 27 to 45 of each drug... Bacitracin Broiler chickens: For Feed as the sole 069254
methylenedisalic the prevention of ration throughout
ylate, 4 to 50. coccidiosis caused by the feeding period.
Eimeria necatrix, E. For broiler chickens
tenella, E. only. Do not feed to
acervulina, E. laying hens. Do not
brunetti, E. mivati, allow adult turkeys,
and E. maxima, and horses, or other
for increased rate of equines access to
weight gain and formulations
improved feed containing narasin.
efficiency. Ingestion of narasin
by these species has
been fatal.
Bacitracin
methylenedisalicylat
e as provided by No.
069254 in Sec.
510.600(c) of this
chapter.
(iv) 27 to 45 of each drug.... Bacitracin Broiler chickens: For Feed continuously as 054771
methylenedisalic the prevention of the sole ration. Do
ylate, 50. coccidiosis caused by not feed to laying
Eimeria tenella, E. hens. Do not allow
necatrix, E. adult turkeys,
acervulina, E. horses, or other
maxima, E. brunetti, equines access to
and E. mivati, and as formulations
an aid in the containing narasin.
prevention of Ingestion of narasin
necrotic enteritis by these species has
caused or complicated been fatal. Withdraw
by Clostridium spp. 5 days before
or other organisms slaughter.
susceptible to Bacitracin
bacitracin. methylenedisalicylat
e as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(v) 27 to 45 of each drug..... Bacitracin Broiler chickens: For Feed as the sole 069254
methylenedisalic the prevention of ration for 28 to 35
ylate, 50. coccidiosis caused by days, starting from
Eimeria necatrix, E. the time chicks are
tenella, E. placed for brooding.
acervulina, E. For broiler chickens
brunetti, E. mivati, only. Do not feed to
and E. maxima, and laying hens. Do not
for the prevention of allow adult turkeys,
mortality caused by horses, or other
necrotic enteritis equines access to
associated with formulations
Clostridium containing narasin.
perfringens. Ingestion of narasin
by these species has
been fatal.
Bacitracin
methylenedisalicylat
e as provided by No.
069254 in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05465 Filed 3-17-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on March 20, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.