New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, 27693-27701 [2023-09212]
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Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 / Rules and Regulations
Matthew.McConnell@nrc.gov. Both are
staff of the U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001.
SUPPLEMENTARY INFORMATION:
I. Discussion
The NRC is issuing a revision in the
NRC’s ‘‘Regulatory Guide’’ series. This
series was developed to describe
methods that are acceptable to the NRC
staff for implementing specific parts of
the agency’s regulations, to explain
techniques that the staff uses in
evaluating specific issues or postulated
events, and to describe information that
the staff needs in its review of
applications for permits and licenses.
Revision 2 to RG 1.89 was issued with
a temporary identification of Draft
Regulatory Guide, DG–1361 (ADAMS
Accession No. ML20183A423).
The staff revised RG 1.89 to endorse,
with clarifications, exceptions, and
supplements, International
Electrotechnical Commission/Institute
of Electrical and Electronic Engineers
Standard 60780–323, ‘‘Nuclear
Facilities—Electrical Equipment
Important to Safety—Qualification,’’
Edition 1, 2016–02, as this standard
reflects almost 40 years of experience
gained in implementing regulatory
requirements and industry research and
testing related to environmental
qualification (EQ). Nuclear plant license
renewal provides additional motivation
for continuing attention to equipment
qualification. This revised guide
contains information specific for EQ for
both older plants and newer reactors
licensed under parts 50 and 52 of title
10 of the Code of Federal Regulations
(10 CFR).
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II. Additional Information
16:29 May 02, 2023
This RG is a rule as defined in the
Congressional Review Act (5 U.S.C.
801–808). However, the Office of
Management and Budget has not found
it to be a major rule as defined in the
Congressional Review Act.
IV. Backfitting, Forward Fitting, and
Issue Finality
Issuance of RG 1.89, Revision 2, does
not constitute backfitting as defined in
10 CFR 50.109, ‘‘Backfitting,’’ and as
described in NRC Management Directive
(MD) 8.4, ‘‘Management of Backfitting,
Forward Fitting, Issue Finality, and
Information Requests’’; affect the issue
finality of an approval issued under 10
CFR part 52; or constitute forward
fitting as defined in MD 8.4 because, as
explained in this RG, licensees are not
required to comply with the positions
set forth in this RG.
V. Submitting Suggestions for
Improvement of Regulatory Guides
A member of the public may, at any
time, submit suggestions to the NRC for
improvement of existing RGs or for the
development of new RGs. Suggestions
can be submitted on the NRC’s public
website at https://www.nrc.gov/readingrm/doc-collections/reg-guides/
contactus.html. Suggestions will be
considered in future updates and
enhancements to the ‘‘Regulatory
Guide’’ series.
Dated: April 28, 2023.
For the Nuclear Regulatory Commission.
Meraj Rahimi,
Chief, Regulatory Guide and Programs
Management Branch, Division of Engineering,
Office of Nuclear Regulatory Research.
[FR Doc. 2023–09389 Filed 5–2–23; 8:45 am]
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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–2023–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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Final rule; technical
amendments.
ACTION:
BILLING CODE 7590–01–P
The NRC published notices of the
availability of DG–1361 in the Federal
Register on December 17, 2020 (85 FR
81958) and February 18, 2021 (86 FR
10133) for 60-day public comment
periods. The public comment periods
closed on February 16, 2021, and April
19, 2021, respectively. Public comments
on DG–1361 and the staff responses to
the public comments are available
under ADAMS under Accession No.
ML22272A601.
As noted in the Federal Register on
December 9, 2022 (87 FR 75671), this
document is being published in the
‘‘Rules’’ section of the Federal Register
to comply with publication
requirements under 1 CFR chapter I.
VerDate Sep<11>2014
III. Congressional Review Act
27693
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
January, February, and March 2023.
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 their accuracy and
readability.
DATES: This rule is effective May 3,
2023.
SUMMARY:
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, ANADAs, and cNADAs
during January, February, and March
2023, 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.
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Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING JANUARY, FEBRUARY,
AND MARCH 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS
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Approval date
File No.
Sponsor
Product name
Effect of the action
Public
documents
Original approval for the relief
of pain and inflammation
associated with osteoarthritis and for the control
of postoperative pain associated with soft tissue and
orthopedic surgeries in
dogs as a generic copy of
NADA 141–053.
Original approval as a sedative and analgesic to facilitate minor surgical and diagnostic procedures in
horses as a generic copy of
NADA 140–862.
Original approval for treatment and control of internal
and external parasites of
cattle as a generic copy of
NADA 141–095.
Supplemental approval for the
treatment and control of
Asian long horned tick infestations for 12 weeks in
dogs and puppies.
Supplemental approval for
prevention of heartworm
disease and treatment of
flea infestations in ferrets
as a generic copy of NADA
141–254.
Original approval for treatment of infections in dogs
and cats associated with
bacteria susceptible to
marbofloxacin as a generic
copy of NADA 141–151.
Original approval for removal
or removal and control of
certain canine tapeworms
as a generic copy of NADA
111–798.
Original approval for use as a
sedative, analgesic, and
preanesthetic in dogs and
cats as a generic copy of
NADA 141–267.
Original approval for treatment of infections in dogs
and cats associated with
bacteria susceptible to
marbofloxacin as a generic
copy of NADA 141–151.
Original approval for the management of diseases associated with bacteria susceptible to enrofloxacin in dogs
and cats as a generic copy
of NADA 140–441.
Original approval for the relief
of pain and inflammation
associated with osteoarthritis and for the control
of postoperative pain associated with soft tissue and
orthopedic surgeries in
dogs as a generic copy of
NADA 141–111.
Supplemental approval for
prevention of heartworm
disease and treatment of
flea infestations in ferrets
as a generic copy of NADA
141–254.
FOI Summary .....
520.304
FOI Summary .....
522.536
FOI Summary .....
524.770
FOI Summary .....
520.998
FOI Summary .....
524.1146
FOI Summary .....
520.1310
FOI Summary .....
520.1870
FOI Summary .....
522.558
FOI Summary .....
520.1310
FOI Summary .....
520.812
FOI Summary .....
520.304
FOI Summary .....
524.1146
January 5, 2023 ..........
200–732
Felix Pharmaceuticals Pvt.
Ltd., 25–28 North Wall
Quay, Dublin 1, Ireland.
Carprofen Tablets (carprofen
tablets) Caplets.
January 11, 2023 ........
200–611
Akorn Operating Company
LLC, 5605 Centerpoint Ct.,
Suite A, Gurnee, IL 60031.
DETOMISED (detomidine hydrochloride) Injectable Solution.
January 11, 2023 ........
200–738
Aurora Pharmaceutical, Inc.,
DECTOGARD (doramectin
1196 Highway 3 South,
topical solution) Topical SoNorthfield, MN 55057–3009.
lution.
January 12, 2023 ........
141–426
Intervet, Inc., 2 Giralda
Farms, Madison, NJ 07940.
BRAVECTO (fluralaner)
Chewable tablets.
January 12, 2023 ........
200–721
Norbrook Laboratories Ltd.,
Carnbane Industrial Estate,
Newry, County Down, BT35
6QQ, United Kingdom.
MIDAMOX for Cats
(imidacloprid and
moxidectin) Topical Solution.
January 12, 2023 ........
200–733
Felix Pharmaceuticals Pvt.
Ltd., 25–28 North Wall
Quay, Dublin 1, Ireland.
Marbofloxacin Chewable Tablets (marbofloxacin).
January 12, 2023 ........
200–734
Do ..........................................
Praziquantel Tablets
(praziquantel).
January 13, 2023 ........
200–735
ZyVet Animal Health, Inc., 73
Route 31N, Pennington, NJ
08534.
Dexmedetomidine Hydrochloride (dexmedetomidine
hydrochloride) Injectable
Solution.
January 13, 2023 ........
200–736
Do ..........................................
Marbofloxacin Tablets
(marbofloxacin).
February 2, 2023 .........
200–737
Do ..........................................
Enrofloxacin (enrofloxacin)
Flavored Antimicrobial Tablets.
February 2, 2023 .........
200–739
Do ..........................................
Carprofen (carprofen)
Chewable Tablets.
February 9, 2023 .........
200–701
Chanelle Pharmaceuticals
Manufacturing Ltd.,
Loughrea, County Galway,
Ireland.
PARASEDGE Multi for Cats
(imidacloprid and
moxidectin) Topical Solution.
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21 CFR
section
Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 / Rules and Regulations
27695
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING JANUARY, FEBRUARY,
AND MARCH 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS—Continued
Approval date
File No.
Sponsor
February 24, 2023 .......
200–741
Aurora Pharmaceutical, Inc.,
EPRIGARD (eprinomectin)
1196 Highway 3 South,
Topical Solution.
Northfield, MN 55057–3009.
March 21, 2023 ...........
200–743
Provetica LLC, 8735 Rosehill
Rd., Suite 300, Lenexa, KS
66215.
MODULIS for Dogs
(cyclosporine oral solution)
USP MODIFIED.
March 21, 2023 ...........
200–745
Parnell Technologies Pty.
Ltd., Unit 4, 476 Gardeners
Rd., Alexandria, New South
Wales 2015, Australia.
RESPIRMYCIN 25
(tulathromycin injection)
Injectable Solution.
March 29, 2023 ...........
200–744
Provetica LLC, 8735 Rosehill
Rd., Suite 300, Lenexa, KS
66215.
MODULIS for Cats
(cyclosporine oral solution)
USP MODIFIED.
March 30, 2023 ...........
200–746
Norbrook Laboratories Ltd.,
Carnbane Industrial Estate,
Newry, County Down, BT35
6QQ, United Kingdom.
TAURAMOX (moxidectin)
Injectable Solution.
March 31, 2023 ...........
200–747
ZyVet Animal Health, Inc., 73
Route 31N, Pennington, NJ
08534.
Maropitant Citrate (maropitant
citrate) Tablets.
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).
Effect of the action
Public
documents
Original approval for treatment and control of internal
and external parasites in
cattle as a generic copy of
NADA 141–079.
Original approval for the control of atopic dermatitis in
dogs as a generic copy of
NADA 141–218.
Original approval for the treatment of respiratory disease
in swine and calves as a
generic copy of NADA
141–349.
Original approval for the control of feline allergic dermatitis in cats as a generic
copy of NADA 141–329.
Original approval for treatment and control of internal
and external parasites in
beef and nonlactating dairy
cattle as a generic copy of
NADA 141–220.
Original approval for the prevention of acute vomiting
and the prevention of vomiting due to motion sickness
in dogs as a generic copy
of NADA 141–262.
FOI Summary .....
524.814
FOI Summary .....
520.522
FOI Summary .....
522.2630
FOI Summary .....
520.522
FOI Summary .....
522.1450
FOI Summary .....
520.1315
Product name
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
21 CFR
section
Antimicrobial Drugs Approved for Use
in Animals to Voluntarily Bring Under
Veterinary Oversight All Products That
Continue to be Available Over-theCounter,’’ June 11, 2021 (https://
www.fda.gov/media/130610/download).
TABLE 2—SUPPLEMENTAL APPLICATIONS APPROVED DURING JANUARY, FEBRUARY, AND MARCH 2023 TO CHANGE THE
MARKETING STATUS OF ANTIMICROBIAL ANIMAL DRUG PRODUCTS FROM OTC TO Rx
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Approval date
File No.
Product name
LINCOMIX (lincomycin hydrochloride)
Injectable Solution.
GALLIMYCIN 100 Injection (erythromycin)
Injectable Solution.
522.1260
GENTOCIN Pinkeye Spray (gentamicin)
Topical Spray.
SULMET (sodium sulfamethazine)
Injectable Solution.
COMBI–PEN–48 (penicillin G benzathine
and penicillin G procaine) Injectable
Suspension.
Chlortetracycline (chlortetracycline hydrochloride) Tablets, 25 mg.
SPECTAM Scour-Halt (spectinomycin)
Oral Solution.
SPECTAM (spectinomycin) Injectable Solution.
NOROCILLIN (penicillin G procaine)
Injectable Suspension.
Lincomycin Injectable, USP .......................
Lincomycin Injectable, USP .......................
GARACIN Pig Pump (gentamicin) Oral
Solution.
524.1044e
January 3, 2022 .............
200–274
January 12, 2022 ...........
012–123
January 12, 2022 ...........
130–952
January 13, 2022 ...........
008–774
February 10, 2023 ..........
065–506
February 14, 2023 ..........
055–018
February 15, 2023 ..........
033–157
Zoetis Inc., 333 Portage St., Kalamazoo,
MI 49007.
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines,
Dublin 18, Ireland.
Intervet, Inc., 2 Giralda Farms, Madison,
NJ 07940.
Huvepharma EEOD, 5th Floor, 3A Nikolay
Haytov Str., 1113 Sofia, Bulgaria.
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines,
Dublin 18, Ireland.
Huvepharma EOOD, 5th Floor, 3A Nikolay
Haytov Str., 1113 Sofia, Bulgaria.
Do ...............................................................
February 15, 2023 ..........
040–040
Do ...............................................................
February 24, 2023 ..........
065–010
Do ...............................................................
March 1, 2023 ................
March 1, 2023 ................
March 1, 2023 ................
200–351
200–368
130–464
Do ...............................................................
Do ...............................................................
Intervet, Inc., 2 Giralda Farms, Madison,
NJ 07940.
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section
Sponsor
Frm 00011
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522.820
522.2260
522.1696a
520.443
520.2123c
522.2120
522.1696b
522.1260
522.1260
520.1044b
27696
Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 / Rules and Regulations
TABLE 2—SUPPLEMENTAL APPLICATIONS APPROVED DURING JANUARY, FEBRUARY, AND MARCH 2023 TO CHANGE THE
MARKETING STATUS OF ANTIMICROBIAL ANIMAL DRUG PRODUCTS FROM OTC TO Rx—Continued
Approval date
File No.
March 9, 2023 ................
035–456
March 13, 2023 ..............
200–315
March 16, 2023 ..............
065–505
March 20, 2023 ..............
200–127
March 25, 2023 ..............
040–181
March 28, 2023 ..............
065–081
Sponsor
Product name
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines,
Dublin 18, Ireland.
Sparhawk Laboratories, Inc., 12340 Santa
Fe Trail Dr., Lenexa, KS 66215.
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines,
Dublin 18, Ireland.
Zoetis Inc., 333 Portage St., Kalamazoo,
MI 49007.
Huvepharma EOOD, 5th Floor, 3A Nikolay
Haytov Str., 1113 Sofia, Bulgaria.
HQ Specialty Pharma Corp., 120 Rte. 17
North, Suite 130, Paramus, NJ 07652.
II. Withdrawals of Approval
Elanco US Inc. (Elanco), 2500
Innovation Way, Greenfield, IN 46140
has requested that FDA withdraw
approval of conditionally approved
NADA 141–527 for BAYTRIL 100–CA1
(enrofloxacin) Injectable Solution.
Pursuant to Elanco’s request, approval
GALLIMYCIN–36 (erythromycin)
Intramammary Solution.
LINCOMYCIN 300 (lincomycin hydrochloride) Injectable Solution.
PRO–PEN–G (penicillin G procaine)
Injectable Suspension.
PROSPEC (spectinomycin hydrochloride)
Injectable Solution.
VETSULID (sulfachlorpyridazine) Oral
Suspension.
MASTI–CLEAR (penicillin G procaine)
Suspension and GO–DRY (penicillin G
procaine) Suspension.
of their application was withdrawn on
March 31, 2023. As provided in the
regulatory text of this document, the
animal drug regulations in 21 CFR
516.812 are removed to reflect this
action.
Boehringer Ingelheim Animal Health
USA, Inc., 3239 Satellite Blvd., Duluth,
21 CFR
section
526.820
522.1260
522.1696b
522.2120
520.2200
526.1696
GA 30096 has requested that FDA
withdraw approval of the 49
applications listed in table 3 because the
products are no longer manufactured or
marketed. As provided in the regulatory
text of this document, the animal drug
regulations are amended where
appropriate to reflect this action.
TABLE 3—APPLICATIONS FOR WHICH APPROVAL WAS VOLUNTARILY WITHDRAWN BY FDA
Product name
21 CFR
cite
CAPARSOLATE (arsenamide sodium) Injectable Solution .............................................................................
SELEEN (selenium disulfide) Topical Suspension ..........................................................................................
NALLINE (nalorphine hydrochloride) Injectable Solution .................................................................................
HYDELTRONE-TBA (prednisolone tertiary butylacetate) Injectable Suspension ...........................................
HYDELTRONE (neomycin sulfate and prednisolone sodium phosphate) Ointment .......................................
SULFABROM (sulfabromomethazine sodium) Bolus ......................................................................................
DIURIL (chlorothiazide) Tablets .......................................................................................................................
DIURIL (chlorothiazide) Bolus ..........................................................................................................................
THIBENZOLE (thiabendazole) Sheep & Goat Wormer ...................................................................................
EQUIZOLE (thiabendazole) Horse Wormer Top Dress ...................................................................................
Triamcinolone Acetonide Tablets .....................................................................................................................
HYDROZIDE (hydrochlorothiazide) Injectable Solution ...................................................................................
THIBENZOLE (thiabendazole) 20% Swine Premix .........................................................................................
OMNIZOLE (thiabendazole) Oral Liquid ..........................................................................................................
TBZ (thiabendazole) Cattle Wormer Oral Liquid ..............................................................................................
TBZ 200 (thiabendazole) Medicated Feed Premix ..........................................................................................
THIBENZOLE (thiabendazole) Oral Liquid ......................................................................................................
PROM ACE (acepromazine maleate) Tablets .................................................................................................
VETISULID (sulfachlorpyridazine) Bolus ..........................................................................................................
VETISULID (sulfachlorpyridazine) Injectable Solution .....................................................................................
VETISULID (sulfachlorpyridazine) Tablets .......................................................................................................
EQUIZOLE (thiabendazole) Oral Liquid ...........................................................................................................
DOPRAM-V (doxapram hydrochloride) Injectable Solution .............................................................................
THIBENZOLE (thiabendazole) Pig Wormer .....................................................................................................
EQUIZOLE A (thiabendazole and piperazine phosphate) Oral Liquid ............................................................
THIBENZOLE 300 (thiabendazole) Medicated ................................................................................................
EQUIZOLE (thiabendazole) Horse Wormer Pellets .........................................................................................
VETALOG (triamcinolone acetonide) Cream ...................................................................................................
EQUIZOLE A (thiabendazole and piperazine citrate) Oral Liquid ...................................................................
TBZ (thiabendazole) Wormer Paste 50% ........................................................................................................
TBZ (thiabendazole) Wormer Paste 43% ........................................................................................................
HETACIN K (hetacillin potassium) Capsules Vet ............................................................................................
HETACIN K (hetacillin potassium) Tablets ......................................................................................................
HETACIN K (hetacillin potassium) Oral Liquid ................................................................................................
Penicillin VK (penicillin V potassium) Filmtab Tablets 250 mg ........................................................................
VEESYN (penicillin V potassium) Granules for Oral Solution .........................................................................
VOREN (dexamethasone-21-isonicotinate) Suspension .................................................................................
Not codified
524.2101
522.1452
522.1885
524.1484j
520.2170
520.420
520.420
520.2380c
520.2380a
520.2483
522.1150
558.600
520.2380b
520.2380b
558.600
520.2380b
520.23
520.2200
520.2200
520.2200
520.2380b
522.775
520.2380b
520.2380e
558.600
520.2380a
524.2483
520.2380d
520.2380b
520.2380b
520.1130
520.1130
520.1130
520.1696c
520.1696b
522.542
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File No.
006–623
008–422
010–424
011–080
011–437
011–532
011–678
012–734
013–022
013–407
013–624
013–674
013–954
014–350
015–123
015–875
030–103
032–702
033–127
033–318
033–319
034–114
034–879
035–631
037–410
043–141
044–654
046–146
047–333
048–487
049–461
055–021
055–022
055–048
065–275
065–276
093–600
....................
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27697
TABLE 3—APPLICATIONS FOR WHICH APPROVAL WAS VOLUNTARILY WITHDRAWN BY FDA—Continued
File No.
094–642
095–642
096–506
096–731
098–689
099–388
117–531
127–443
140–439
141–180
200–361
200–564
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
CAMVET (cambendazole) Suspension Horse Wormer ...................................................................................
OXY-TET (oxytetracycline hydrochloride) Injectable Solution .........................................................................
CAMVET (cambendazole) Horse Wormer Pellets ...........................................................................................
CAMVET (cambendazole) Horse Wormer Paste 45% ....................................................................................
EQUIZOLE (thiabendazole) 50% Wormer Paste .............................................................................................
VETALOG (triamcinolone acetonide) Oral Powder ..........................................................................................
Acepromazine Maleate Injection ......................................................................................................................
EQVALAN (ivermectin) Injectable Solution ......................................................................................................
EQVALAN (ivermectin) Oral Liquid For Horses ...............................................................................................
TORPEX (albuterol sulfate) ..............................................................................................................................
Acepromazine Maleate Injection ......................................................................................................................
Ivermectin Paste 1.87% ...................................................................................................................................
III. Technical Amendments
FDA is making the following
amendments to improve the accuracy of
the animal drug regulations.
• 21 CFR 520.48 is amended to reflect
the sponsors of products containing
altrenogest for use in horses and swine.
• 21 CFR 520.2380 is removed and 21
CFR 558.600 revised to characterize a
free-choice block containing
thiabendazole as a new animal drug for
use in cattle feed.
• 21 CFR 522.1077 is amended to
reflect indications for use of gonadorelin
in cattle.
• 21 CFR 522.1222 is amended to
reflect sponsors of approved
applications for use of ketamine in cats
and subhuman primates.
• 21 CFR 556.620 is removed because
there are no longer any approved
products containing
sulfabromomethazine for use in foodproducing animals.
• 21 CFR 556.730 is revised to reflect
the removal of products containing
thiabendazole for use in food-producing
animals other than cattle.
• 21 CFR 558.311 is amended to
reflect approved classes of pasture cattle
for use of lasalocid medicated feeds.
• 21 CFR 558.455 is amended to
reflect the approved conditions of use of
medicated feeds containing
oxytetracycline and neomycin in sheep.
lotter on DSK11XQN23PROD with RULES1
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.
VerDate Sep<11>2014
21 CFR
cite
Product name
16:29 May 02, 2023
Jkt 259001
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
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
520.284a
522.1662a
520.284b
520.284c
520.2380b
520.2483
522.23
522.1192
522.1195
529.40
522.23
520.1192
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
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.
2. In § 510.600:
a. In paragraph (c)(1), amend the table
by adding an entry for ‘‘Provetica LLC’’;
and
■ b. In paragraph (c)(2), amend the table
by adding add an entry for ‘‘086097’’.
The additions read as follows:
■
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
E:\FR\FM\03MYR1.SGM
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*
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Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 / Rules and Regulations
Firm name and address
Drug labeler code
*
*
*
*
*
*
Provetica LLC, 8735 Rosehill Rd., Suite 300, Lenexa, KS 66215 .........................................................................................
*
*
*
*
*
*
086097
*
*
*
*
*
*
*
*
(2) * * *
Drug labeler code
*
086097 .......................
Firm name and address
*
*
*
Provetica LLC, 8735 Rosehill Rd., Suite 300, Lenexa, KS 66215.
*
*
*
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–1, 360ccc–2,
371.
§ 516.812
■
[Removed]
4. Remove § 516.812.
*
(2) Nos. 058198 and 086117 for use of
product described in paragraph (a)(2) as
in paragraph (c) of this section.
*
*
*
*
*
§§ 520.420
§ 520.443
boluses.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
[Removed]
9. Remove § 520.420.
■ 10. In § 520.443, amend paragraph
(d)(2)(ii) by adding a sentence at the end
of the paragraph to read as follows:
■
Chlortetracycline tablets and
*
5. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
6. In § 520.48, revise paragraph (b) to
read as follows:
■
§ 520.48
Altrenogest.
*
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter:
(1) Nos. 000061 and 051072 for use as
in paragraph (d) of this section.
(2) No. 061133 for use as in paragraph
(d)(1) of this section.
(3) No. 013744 for use as in paragraph
(d)(2) of this section.
*
*
*
*
*
§§ 520.284, 520.284a, 520.284b, and
520.284c [Removed]
7. Remove §§ 520.284, 520.284a,
520.284b, and 520.284c.
■ 8. In § 520.304, revise paragraphs
(b)(1) and (2) to read as follows:
■
lotter on DSK11XQN23PROD with RULES1
§ 520.304
Carprofen.
*
*
*
*
*
(b) * * *
(1) Nos. 017033, 054771, 055529,
062250, and 086101 for use of products
described in paragraph (a)(1) and (2) of
this section as in paragraph (c) of this
section.
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*
*
*
*
(d) * * *
(2) * * *
(ii) * * * Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
*
*
*
*
*
■ 11. In § 520.522, add paragraph (b)(4)
and revise (d)(2)(ii) to read as follows:
§ 520.522
Cyclosporine.
*
*
*
*
*
(b) * * *
(4) No. 086097 for use of product
described in paragraph (a)(2) as in
paragraph (d) of this section.
*
*
*
*
*
(d) * * *
(2) * * *
(ii) Indications for use. For the control
of feline allergic dermatitis as
manifested by excoriations (including
facial and neck), miliary dermatitis,
eosinophilic plaques, and self-induced
alopecia in cats at least 6 months of age
and at least 3 lbs (1.4 kg) in body
weight.
*
*
*
*
*
§ 520.812
[Amended]
Frm 00014
Fmt 4700
§ 520.998
Sfmt 4700
Fluralaner.
*
*
*
*
*
(c) * * *
(2) * * *
(i) Chewable tablets described in
paragraph (a)(1) of this section. Kills
adult fleas; for the treatment and
prevention of flea infestations
(Ctenocephalides felis), and the
treatment and control of tick
infestations (Ixodes scapularis (blacklegged tick), Dermacentor variabilis
(American dog tick), Rhipicephalus
sanguineus (brown dog tick), and
Haemaphysalis longicornis (Asian
longhorned tick)) for 12 weeks in dogs
and puppies 6 months of age and older,
and weighing 4.4 lbs or greater; and for
the treatment and control of
Amblyomma americanum (lone star
tick) infestations for 8 weeks in dogs
and puppies 6 months of age and older,
and weighing 4.4 lbs or greater.
*
*
*
*
*
14. Amend § 520.1044b by adding a
sentence at the end of paragraph (d)(3)
to read as follows:
■
§ 520.1044b
[Amended]
*
*
*
*
*
(d) * * *
(3) * * * Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
§ 520.1130
■
[Removed]
15. Remove §§ 520.1130.
§ 520.1195
12. Amend § 520.812 by:
a. In paragraph (b)(2), removing ‘‘No.
017033’’ and in its place adding ‘‘Nos.
017033 and 086117’’; and
■ b. Removing paragraph (b)(4).
■
■
PO 00000
13. In § 520.998, revise paragraph
(c)(2)(i) to read as follows:
■
[Amended]
16. In § 520.1195, in paragraph (b)(1),
remove ‘‘000010,’’.
■
17. In § 520.1310, revise paragraphs
(a) and (b) to read as follows:
■
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Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 / Rules and Regulations
§ 520.1310
Marbofloxacin.
§ 520.2380f
(a) Specifications. Each tablet or
chewable tablet contains 25, 50, 100, or
200 milligrams (mg) marbofloxacin.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section:
(1) Nos. 017033, 054771, and 086117
for use of tablets.
(2) No. 086101 for use of chewable
tablets.
*
*
*
*
*
■ 18. In § 520.1315, revise paragraph (b)
to read as follows:
§ 520.1315
Maropitant.
*
*
*
*
(b) Sponsors. See Nos. 054771 and
086117 in § 510.600(c) of this chapter.
*
*
*
*
*
§ 520.1696b
[Removed]
26. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
§ 522.775
§ 520.1870
■
[Amended]
21. In § 520.1870, in paragraph (b)(2),
remove ‘‘No. 069043’’ and in its place
add ‘‘Nos. 069043 and 086101’’.
■ 22. In § 520.2200, revise paragraph
(a)(2), remove paragraph (a)(3), revise
paragraphs (d)(1)(i) and (d)(2)(i), and
remove (d)(3) to read as follows:
■
Sulfachlorpyridazine.
(a) * * *
(2) Each milliliter (mL) of suspension
contains 50 milligrams (mg) of sodium
sulfachlorpyridazine.
*
*
*
*
*
(d) * * *
(1) * * *
(i) Amount. Administer 30 to 45 mg
sulfachlorpyridazine powder per pound
(/lb) of body weight per day in milk or
milk replacer in divided doses twice
daily for 1 to 5 days.
*
*
*
*
*
(2) * * *
(i) Amount. Administer 20 to 35 mg/
lb body weight per day in divided doses
twice daily for 1 to 5 days in drinking
water or an oral suspension containing
50 mg per mL.
*
*
*
*
*
§ § 520.1696b, 520.2170, 520.2380,
520.2380a, 520.2380b, 520.2380c, 520.2380d
and 520.2380e [Removed]
23. Remove §§ 520.1696b, 520.2170,
520.2380, 520.2380a, 520.2380b,
520.2380c, 520.2380d and 520.2380e.
■
VerDate Sep<11>2014
16:29 May 02, 2023
Jkt 259001
[Removed]
[Amended]
29. In § 522.558, in paragraph (b)(1),
remove ‘‘Nos. 017033 and 059399’’ and
in its place add ‘‘Nos. 017033, 059399,
and 086117’’.
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
[Removed]
30. Remove § 522.775.
31. Amend § 522.820 by adding a
sentence at the end of paragraph
(d)(3)(iii) to read as follows:
■
§ 522.820
Erythromycin.
*
*
*
*
(d) * * *
(3) * * *
(iii) * * * Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
■ 32. In § 522.1077, revise paragraphs
(b)(2), (d)(1)(iv), and (e)(1)(i) to read as
follows:
Gonadorelin.
*
*
*
*
*
(b) * * *
(2) No. 068504 for use of the 100-mg/
mL product described in paragraph
(a)(2) as in paragraphs (d)(1)(i) and (iv)
of this section.
*
*
*
*
*
(d) * * *
(1) * * *
(iv) Dinoprost injection for use as in
paragraph (e)(1)(vi) of this section as
provided by No. 054771 in § 510.600(c)
of this chapter.
*
*
*
*
*
(e) * * *
(1) * * *
(i) For the treatment of ovarian
follicular cysts in dairy cattle:
Administer 86 mg gonadorelin (No.
000061), or 100 mg gonadorelin diacetate
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
*
*
*
*
(b) * * *
(1) Nos. 000010, 016592, 055529,
058005, and 061133 for use of the
product described in paragraph (a)(2) of
this section as in paragraphs (e)(2)
through (e)(5) of this section; and
(2) No. 000010 for use of the product
described in paragraph (a)(3) of this
section as in paragraphs (e)(3) and (e)(6)
of this section.
*
*
*
*
*
(e) * * *
(2) * * *
(i) Amount. 200 micrograms per
kilogram (mg/kg) of body weight by
subcutaneous injection.
*
*
*
*
*
§ 522.1222
[Amended]
35. In § 522.1222, revise paragraph (b)
by adding, in numeric sequence,
‘‘00010,’’.
■ 36. In § 522.1450, revise paragraphs
(a), (b), and (e) to read as follows:
■
*
§ 522.1077
Ivermectin.
*
■
Penicillin V tablets.
[Removed]
33. Remove § 522.1150.
■ 34. In § 522.1192, remove and reserve
paragraph (a)(1), and revise paragraphs
(b)(1) and (2), remove and reserve
paragraph (e)(1), and revise paragraph
(e)(2)(i) to read as follows:
■
§ 522.1192
[Amended]
28. Remove § 522.542.
§ 522.558
tetrahydrate (Nos. 000010 and 061133),
or 100 mg gonadorelin (as gonadorelin
acetate; No. 068504) by intramuscular or
intravenous injection.
*
*
*
*
*
§ 522.1150
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
§ 522.542
*
§ 520.2200
[Removed]
25. Remove § 520.2483.
27. In § 522.536, in paragraph (b),
remove ‘‘Nos. 015914 and 052483’’ and
in its place add ‘‘Nos. 015914, 052483,
and 059399’’.
19. Remove § 520.1696b.
■ 20. In § 520.1696c, revise paragraph
(b) to read as follows:
lotter on DSK11XQN23PROD with RULES1
■
■
■
§ 520.1696c
§ 520.2483
§ 522.536
*
[Redesignated]
24. Redesignate § 520.2380f as
§ 520.2382.
■
27699
§ 522.1450
Moxidectin solution.
(a) Specifications. Each milliliter (mL)
of solution contains 10 milligrams (mg)
moxidectin.
(b) Sponsors. See Nos. 055529 and
058198 in § 510.600(c) of this chapter.
*
*
*
*
*
(e) Conditions of use in cattle—(1)
Amount. Administer by subcutaneous
injection 1 mL for each 110 pounds (lb)
(50 kilograms (kg)) body weight to
provide 0.2 mg moxidectin/2.2 lb (0.2
mg/kg) body weight.
(2) Indications for use. Beef and
nonlactating dairy cattle: For treatment
and control of Gastrointestinal
roundworms: Ostertagia ostertagi
(adults, fourth-stage larvae, and
inhibited larvae), Haemonchus placei
(adults), Trichostrongylus axei (adults
and fourth-stage larvae),
Trichostrongylus colubriformis (adults
and fourth-stage larvae), Cooperia
oncophora (adults), Cooperia pectinata
(adults), Cooperia punctata (adults and
fourth-stage larvae), Cooperia spatulata
(adults), Cooperia surnabada (adults
E:\FR\FM\03MYR1.SGM
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and fourth-stage larvae), Nematodirus
helvetianus (adults), Oesophagostomum
radiatum (adults and fourth-stage
larvae), Trichuris spp. (adults);
Lungworms: Dictyocaulus viviparus
(adults and fourth-stage larvae); Cattle
grubs: Hypoderma bovis and
Hypoderma lineatum; Mites: Psoroptes
ovis (Psoroptes communis var. bovis);
Lice: Linognathus vituli and
Solenopotes capillatus. For protection
from reinfection with Dictyocaulus
viviparus and Oesophagostomum
radiatum for 42 days after treatment,
with Haemonchus placei for 35 days
after treatment, and with Ostertagia
ostertagi and Trichostrongylus axei for
14 days after treatment.
(3) Limitations. Cattle must not be
slaughtered for human consumption
within 21 days of treatment. This drug
product is not approved for use in
female dairy cattle 20 months of age or
older, including dry dairy cows. Use in
these cattle may cause drug residues in
milk and/or in calves born to these
cows. A withdrawal period has not been
established for preruminating calves. Do
not use in calves to be processed for
veal.
§ 522.1696b
[Amended]
42. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
43. In § 524.770, revise paragraph (b)
to read as follows:
§ 524.770
Doramectin.
*
*
*
*
*
(b) Sponsors. See Nos. 051072 and
054771 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 44. In § 524.814, revise paragraphs (b)
and (e)(1) to read as follows:
§ 524.814
Authority: 21 U.S.C. 360b.
51. Amend § 526.1696 by adding a
sentence at the end of paragraph (d)(3)
and paragraph (e)(3) to read as follows:
■
§ 526.1696
Eprinomectin.
*
*
*
*
*
(b) Sponsors. See Nos. 000010,
051072, and 055529 in § 510.600(c) of
this chapter.
*
*
*
*
*
(e) * * *
(1) Amount. Apply 5 mg (1 mL) per
10 kilograms (kg) of body weight (500
micrograms/kg) topically along
backbone from withers to tailhead.
*
*
*
*
*
*
*
*
*
(d) * * *
(3) * * * For No. 042791: Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(e)
(3) * * * For No. 042791: 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
52. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 529.40
■
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
54. The authority citation for part 556
continues to read as follows:
■
[Amended]
■
45. Amend § 524.1044e by adding a
sentence at the end of paragraph (d)(3)
to read as follows:
§ 556.620
§ 522.1885
§ 524.1044e
■
38. Remove § 522.1885.
■ 39. Amend § 522.2120 by adding a
sentence at the end of paragraph
(d)(1)(ii) to read follows:
*
§ 522.2120
§ 524.1146
Spectinomycin hydrochloride.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) * * * Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
*
*
*
*
*
§ 522.2200
§ 524.1484j
■
[Removed]
§ 524.2483
Tulathromycin.
16:29 May 02, 2023
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[Amended]
48. In § 524.2101, in paragraph (b),
remove ‘‘000010, 000061,’’ and in its
place add ‘‘000061’’.
■
*
*
*
*
(b) * * *
(2) Nos. 013744, 051311, 054771,
058198, and 068504 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.
*
*
*
*
*
VerDate Sep<11>2014
[Removed]
47. Remove § 524.1484j.
§ 524.2101
40. Remove § 522.2200.
■ 41. In 522.2630, revise paragraph
(b)(2) to read as follows:
*
[Amended]
46. In § 524.1146, in paragraph (b)(3),
remove ‘‘Nos. 051072 and 058198’’ and
in its place add ‘‘Nos. 051072, 055529,
058198, and 061651’’.
■
■
§ 522.2630
Gentamicin spray.
*
*
*
*
(d) * * *
(3) * * * Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
■
[Amended]
49. In § 524.2483, in paragraph (b),
remove ‘‘Nos. 000010 and 054925’’ and
in its place add ‘‘No. 054925’’.
■
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
50. The authority citation for part 526
continues to read as follows:
■
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
[Removed]
53. Remove § 529.40.
37. In § 522.1696b, amend paragraph
(d)(2)(iii)(C), by removing ‘‘For Nos.
054771 and 055529:’’.
[Removed]
Penicillin G procaine.
*
■
§ 524.1044e
■
lotter on DSK11XQN23PROD with RULES1
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
Authority: 21 U.S.C. 342, 360b, 371.
[Removed]
55. Remove § 556.620.
56. Revise § 556.730 to read as
follows:
■
§ 556.730
Thiabendazole.
(a) [Reserved]
(b) Tolerances. The tolerances for
thiabendazole are:
(1) Cattle—(i) Edible tissues
(excluding milk): 0.1 ppm.
(ii) Milk: 0.05 ppm.
(2) [Reserved]
(c) Related conditions of use. See
§ 558.600.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
57. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
58. In § 558.311, revise paragraph
(e)(3)(iii) to read as follows:
■
§ 558.311
*
Lasalocid.
*
*
(e) * * *
(3) * * *
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*
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Lasalocid amount
Indications for use
*
*
(iii) Not less than 60 mg or
more than 300 mg of
lasalocid per head per day.
*
*
*
Pasture cattle (slaughter, stocker, feeder cattle, and beef replacement heifers): For increased rate of weight gain.
*
*
§ 558.455
■
*
*
Oxytetracycline and neomycin.
*
*
(e) * * *
*
Sponsor
*
*
Feed continuously at a rate of not less than 60
mg or more than 300 mg of lasalocid per
head per day when on pasture. The drug
must be contained in at least 1 pound of
feed. Daily intakes of lasalocid in excess of
200 mg/head/day have not been shown to
be more effective than 200 mg/head/day.
*
*
*
*
*
*
50. In § 558.455, revise paragraph
(e)(5) to read as follows:
*
Limitations
(i) To provide 10 mg/lb of body
weight daily.
Sheep: For treatment of bacterial enteritis
caused by Escherichia coli and bacterial
pneumonia caused by Pasteurella multocida
susceptible to oxytetracycline; treatment and
control of colibacillosis (bacterial enteritis)
caused by E. coli susceptible to neomycin.
Feed continuously for 7 to 14 days. Treatment
should continue 24 to 48 hours beyond remission of clinical signs of disease. Withdraw 5 days before slaughter.
§ 558.600
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
Thiabendazole.
(a) Specifications. Mineral protein
block containing 3.3 percent
thiabendazole.
(b) Sponsor. See No. 012286 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.730
of this chapter.
(d) Special considerations. See
§ 500.25 of this chapter.
(e) Conditions of use in cattle—(1)
Amount. Provide free-choice to cattle on
pasture or range accustomed to mineral
protein block feeding for 3 days. Cattle
should consume at a recommended
level of 0.11 pound per 100 pounds of
body weight per day. Animals
maintained under conditions of
constant worm exposure may require retreatment within 2 to 3 weeks.
(2) Indications for use. For control of
infections of gastrointestinal
roundworms (Trichostrongylus,
Haemonchus, Ostertagia, and Cooperia).
(3) Limitations. Milk taken from
animals during treatment and within 96
hours (8 milkings) after the latest
treatment must not be used for food. Do
not treat cattle within 3 days of
slaughter.
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09212 Filed 5–2–23; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:29 May 02, 2023
Jkt 259001
50 CFR Part 622
[Docket No. 230427–0115]
RIN 0648–BL89
Fisheries of the Caribbean, Gulf of
Mexico, and South Atlantic; Reef Fish
Resources of the Gulf of Mexico;
Temporary Measures To Reduce
Overfishing of Gag
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
AGENCY:
ACTION:
Final temporary rule.
This final temporary rule
implements interim measures to reduce
overfishing of gag in Federal waters of
the Gulf of Mexico (Gulf). This final
temporary rule reduces the 2023
commercial and recreational sector
harvest levels for gag and changes the
2023 recreational fishing season for gag
in Federal waters of the Gulf. This
temporary rule is effective for 180 days,
but NMFS may extend the interim
measures for a maximum of an
additional 186 days. The purpose of this
temporary rule is to reduce overfishing
of gag while the long-term management
measures are developed.
SUMMARY:
PO 00000
Frm 00017
Fmt 4700
054771
*
(5) Sheep. It is used in feed as follows:
Indications for use
(ii) [Reserved]
59. Revise § 558.600 to read as
follows:
*
*
Oxytetracycline and neomycin
sulfate amount
■
lotter on DSK11XQN23PROD with RULES1
Limitations
Sfmt 4700
Sponsors
066104
069254
This final temporary rule is
effective from May 3, 2023, until
October 30, 2023.
ADDRESSES: An electronic copy of the
environmental assessment (EA)
supporting these interim measures may
be obtained from the Southeast Regional
Office website at https://www.fisheries.
noaa.gov/action/interim-action-reduceoverfishing-gag-gulf-mexico. The EA
includes a regulatory impact review and
a Regulatory Flexibility Act (RFA)
analysis.
DATES:
Dan
Luers, NMFS Southeast Regional Office,
telephone: 727–824–5305, or email:
daniel.luers@noaa.gov.
SUPPLEMENTARY INFORMATION: The reef
fish fishery in the Gulf is managed
under the Fishery Management Plan for
the Reef Fish Resources of the Gulf of
Mexico (FMP) and includes gag and 30
other managed reef fish species. The
FMP was prepared by the Gulf of
Mexico Fishery Management Council
(Council) and is implemented by NMFS
through regulations at 50 CFR part 622
under authority of the MagnusonStevens Fishery Conservation and
Management Act (Magnuson-Stevens
Act).
On February 3, 2023, NMFS
published a proposed temporary rule in
the Federal Register and requested
public comment (88 FR 7388). The
proposed temporary rule and EA outline
the rationale for the actions contained in
this final temporary rule, and the EA is
available from NMFS (see ADDRESSES
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\03MYR1.SGM
03MYR1
]]>Agencies
[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Rules and Regulations]
[Pages 27693-27701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09212]
=======================================================================
-----------------------------------------------------------------------
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-2023-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications
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 January, February, and March 2023. 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 their
accuracy and readability.
DATES: This rule is effective May 3, 2023.
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, ANADAs, and cNADAs during January, February, and
March 2023, 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.
[[Page 27694]]
Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During January, February, and March 2023 Requiring Evidence of Safety and/or
Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name Effect of the action Public documents section
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 5, 2023................ 200-732 Felix Pharmaceuticals Carprofen Tablets Original approval for FOI Summary.............. 520.304
Pvt. Ltd., 25-28 (carprofen tablets) the relief of pain
North Wall Quay, Caplets. and inflammation
Dublin 1, Ireland. associated with
osteoarthritis and
for the control of
postoperative pain
associated with soft
tissue and orthopedic
surgeries in dogs as
a generic copy of
NADA 141-053.
January 11, 2023............... 200-611 Akorn Operating DETOMISED (detomidine Original approval as a FOI Summary.............. 522.536
Company LLC, 5605 hydrochloride) sedative and
Centerpoint Ct., Injectable Solution. analgesic to
Suite A, Gurnee, IL facilitate minor
60031. surgical and
diagnostic procedures
in horses as a
generic copy of NADA
140-862.
January 11, 2023............... 200-738 Aurora Pharmaceutical, DECTOGARD (doramectin Original approval for FOI Summary.............. 524.770
Inc., 1196 Highway 3 topical solution) treatment and control
South, Northfield, MN Topical Solution. of internal and
55057-3009. external parasites of
cattle as a generic
copy of NADA 141-095.
January 12, 2023............... 141-426 Intervet, Inc., 2 BRAVECTO (fluralaner) Supplemental approval FOI Summary.............. 520.998
Giralda Farms, Chewable tablets. for the treatment and
Madison, NJ 07940. control of Asian long
horned tick
infestations for 12
weeks in dogs and
puppies.
January 12, 2023............... 200-721 Norbrook Laboratories MIDAMOX for Cats Supplemental approval FOI Summary.............. 524.1146
Ltd., Carnbane (imidacloprid and for prevention of
Industrial Estate, moxidectin) Topical heartworm disease and
Newry, County Down, Solution. treatment of flea
BT35 6QQ, United infestations in
Kingdom. ferrets as a generic
copy of NADA 141-254.
January 12, 2023............... 200-733 Felix Pharmaceuticals Marbofloxacin Chewable Original approval for FOI Summary.............. 520.1310
Pvt. Ltd., 25-28 Tablets treatment of
North Wall Quay, (marbofloxacin). infections in dogs
Dublin 1, Ireland. and cats associated
with bacteria
susceptible to
marbofloxacin as a
generic copy of NADA
141-151.
January 12, 2023............... 200-734 Do.................... Praziquantel Tablets Original approval for FOI Summary.............. 520.1870
(praziquantel). removal or removal
and control of
certain canine
tapeworms as a
generic copy of NADA
111-798.
January 13, 2023............... 200-735 ZyVet Animal Health, Dexmedetomidine Original approval for FOI Summary.............. 522.558
Inc., 73 Route 31N, Hydrochloride use as a sedative,
Pennington, NJ 08534. (dexmedetomidine analgesic, and
hydrochloride) preanesthetic in dogs
Injectable Solution. and cats as a generic
copy of NADA 141-267.
January 13, 2023............... 200-736 Do.................... Marbofloxacin Tablets Original approval for FOI Summary.............. 520.1310
(marbofloxacin). treatment of
infections in dogs
and cats associated
with bacteria
susceptible to
marbofloxacin as a
generic copy of NADA
141-151.
February 2, 2023............... 200-737 Do.................... Enrofloxacin Original approval for FOI Summary.............. 520.812
(enrofloxacin) the management of
Flavored diseases associated
Antimicrobial Tablets. with bacteria
susceptible to
enrofloxacin in dogs
and cats as a generic
copy of NADA 140-441.
February 2, 2023............... 200-739 Do.................... Carprofen (carprofen) Original approval for FOI Summary.............. 520.304
Chewable Tablets. the relief of pain
and inflammation
associated with
osteoarthritis and
for the control of
postoperative pain
associated with soft
tissue and orthopedic
surgeries in dogs as
a generic copy of
NADA 141-111.
February 9, 2023............... 200-701 Chanelle PARASEDGE Multi for Supplemental approval FOI Summary.............. 524.1146
Pharmaceuticals Cats (imidacloprid for prevention of
Manufacturing Ltd., and moxidectin) heartworm disease and
Loughrea, County Topical Solution. treatment of flea
Galway, Ireland. infestations in
ferrets as a generic
copy of NADA 141-254.
[[Page 27695]]
February 24, 2023.............. 200-741 Aurora Pharmaceutical, EPRIGARD Original approval for FOI Summary.............. 524.814
Inc., 1196 Highway 3 (eprinomectin) treatment and control
South, Northfield, MN Topical Solution. of internal and
55057-3009. external parasites in
cattle as a generic
copy of NADA 141-079.
March 21, 2023................. 200-743 Provetica LLC, 8735 MODULIS for Dogs Original approval for FOI Summary.............. 520.522
Rosehill Rd., Suite (cyclosporine oral the control of atopic
300, Lenexa, KS 66215. solution) USP dermatitis in dogs as
MODIFIED. a generic copy of
NADA 141-218.
March 21, 2023................. 200-745 Parnell Technologies RESPIRMYCIN 25 Original approval for FOI Summary.............. 522.2630
Pty. Ltd., Unit 4, (tulathromycin the treatment of
476 Gardeners Rd., injection) Injectable respiratory disease
Alexandria, New South Solution. in swine and calves
Wales 2015, Australia. as a generic copy of
NADA 141-349.
March 29, 2023................. 200-744 Provetica LLC, 8735 MODULIS for Cats Original approval for FOI Summary.............. 520.522
Rosehill Rd., Suite (cyclosporine oral the control of feline
300, Lenexa, KS 66215. solution) USP allergic dermatitis
MODIFIED. in cats as a generic
copy of NADA 141-329.
March 30, 2023................. 200-746 Norbrook Laboratories TAURAMOX (moxidectin) Original approval for FOI Summary.............. 522.1450
Ltd., Carnbane Injectable Solution. treatment and control
Industrial Estate, of internal and
Newry, County Down, external parasites in
BT35 6QQ, United beef and nonlactating
Kingdom. dairy cattle as a
generic copy of NADA
141-220.
March 31, 2023................. 200-747 ZyVet Animal Health, Maropitant Citrate Original approval for FOI Summary.............. 520.1315
Inc., 73 Route 31N, (maropitant citrate) the prevention of
Pennington, NJ 08534. Tablets. acute vomiting and
the prevention of
vomiting due to
motion sickness in
dogs as a generic
copy of NADA 141-262.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 (https://www.fda.gov/media/130610/download).
Table 2--Supplemental Applications Approved During January, February, and March 2023 To Change the Marketing
Status of Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name section
----------------------------------------------------------------------------------------------------------------
January 3, 2022....................... 200-274 Zoetis Inc., 333 LINCOMIX (lincomycin 522.1260
Portage St., hydrochloride)
Kalamazoo, MI 49007. Injectable Solution.
January 12, 2022...................... 012-123 Bimeda Animal Health GALLIMYCIN 100 522.820
Ltd., 1B The Herbert Injection
Building, The Park, (erythromycin)
Carrickmines, Dublin Injectable Solution.
18, Ireland.
January 12, 2022...................... 130-952 Intervet, Inc., 2 GENTOCIN Pinkeye Spray 524.1044e
Giralda Farms, (gentamicin) Topical
Madison, NJ 07940. Spray.
January 13, 2022...................... 008-774 Huvepharma EEOD, 5th SULMET (sodium 522.2260
Floor, 3A Nikolay sulfamethazine)
Haytov Str., 1113 Injectable Solution.
Sofia, Bulgaria.
February 10, 2023..................... 065-506 Bimeda Animal Health COMBI-PEN-48 522.1696a
Ltd., 1B The Herbert (penicillin G
Building, The Park, benzathine and
Carrickmines, Dublin penicillin G
18, Ireland. procaine) Injectable
Suspension.
February 14, 2023..................... 055-018 Huvepharma EOOD, 5th Chlortetracycline 520.443
Floor, 3A Nikolay (chlortetracycline
Haytov Str., 1113 hydrochloride)
Sofia, Bulgaria. Tablets, 25 mg.
February 15, 2023..................... 033-157 Do.................... SPECTAM Scour-Halt 520.2123c
(spectinomycin) Oral
Solution.
February 15, 2023..................... 040-040 Do.................... SPECTAM 522.2120
(spectinomycin)
Injectable Solution.
February 24, 2023..................... 065-010 Do.................... NOROCILLIN (penicillin 522.1696b
G procaine)
Injectable Suspension.
March 1, 2023......................... 200-351 Do.................... Lincomycin Injectable, 522.1260
USP.
March 1, 2023......................... 200-368 Do.................... Lincomycin Injectable, 522.1260
USP.
March 1, 2023......................... 130-464 Intervet, Inc., 2 GARACIN Pig Pump 520.1044b
Giralda Farms, (gentamicin) Oral
Madison, NJ 07940. Solution.
[[Page 27696]]
March 9, 2023......................... 035-456 Bimeda Animal Health GALLIMYCIN-36 526.820
Ltd., 1B The Herbert (erythromycin)
Building, The Park, Intramammary Solution.
Carrickmines, Dublin
18, Ireland.
March 13, 2023........................ 200-315 Sparhawk Laboratories, LINCOMYCIN 300 522.1260
Inc., 12340 Santa Fe (lincomycin
Trail Dr., Lenexa, KS hydrochloride)
66215. Injectable Solution.
March 16, 2023........................ 065-505 Bimeda Animal Health PRO-PEN-G (penicillin 522.1696b
Ltd., 1B The Herbert G procaine)
Building, The Park, Injectable Suspension.
Carrickmines, Dublin
18, Ireland.
March 20, 2023........................ 200-127 Zoetis Inc., 333 PROSPEC (spectinomycin 522.2120
Portage St., hydrochloride)
Kalamazoo, MI 49007. Injectable Solution.
March 25, 2023........................ 040-181 Huvepharma EOOD, 5th VETSULID 520.2200
Floor, 3A Nikolay (sulfachlorpyridazine
Haytov Str., 1113 ) Oral Suspension.
Sofia, Bulgaria.
March 28, 2023........................ 065-081 HQ Specialty Pharma MASTI-CLEAR 526.1696
Corp., 120 Rte. 17 (penicillin G
North, Suite 130, procaine) Suspension
Paramus, NJ 07652. and GO-DRY
(penicillin G
procaine) Suspension.
----------------------------------------------------------------------------------------------------------------
II. Withdrawals of Approval
Elanco US Inc. (Elanco), 2500 Innovation Way, Greenfield, IN 46140
has requested that FDA withdraw approval of conditionally approved NADA
141-527 for BAYTRIL 100-CA1 (enrofloxacin) Injectable Solution.
Pursuant to Elanco's request, approval of their application was
withdrawn on March 31, 2023. As provided in the regulatory text of this
document, the animal drug regulations in 21 CFR 516.812 are removed to
reflect this action.
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd.,
Duluth, GA 30096 has requested that FDA withdraw approval of the 49
applications listed in table 3 because the products are no longer
manufactured or marketed. As provided in the regulatory text of this
document, the animal drug regulations are amended where appropriate to
reflect this action.
Table 3--Applications for Which Approval Was Voluntarily Withdrawn by FDA
----------------------------------------------------------------------------------------------------------------
File No. Product name 21 CFR cite
----------------------------------------------------------------------------------------------------------------
006-623......................................... CAPARSOLATE (arsenamide sodium) Injectable Not
Solution. codified
008-422......................................... SELEEN (selenium disulfide) Topical Suspension... 524.2101
010-424......................................... NALLINE (nalorphine hydrochloride) Injectable 522.1452
Solution.
011-080......................................... HYDELTRONE-TBA (prednisolone tertiary 522.1885
butylacetate) Injectable Suspension.
011-437......................................... HYDELTRONE (neomycin sulfate and prednisolone 524.1484j
sodium phosphate) Ointment.
011-532......................................... SULFABROM (sulfabromomethazine sodium) Bolus..... 520.2170
011-678......................................... DIURIL (chlorothiazide) Tablets.................. 520.420
012-734......................................... DIURIL (chlorothiazide) Bolus.................... 520.420
013-022......................................... THIBENZOLE (thiabendazole) Sheep & Goat Wormer... 520.2380c
013-407......................................... EQUIZOLE (thiabendazole) Horse Wormer Top Dress.. 520.2380a
013-624......................................... Triamcinolone Acetonide Tablets.................. 520.2483
013-674......................................... HYDROZIDE (hydrochlorothiazide) Injectable 522.1150
Solution.
013-954......................................... THIBENZOLE (thiabendazole) 20% Swine Premix...... 558.600
014-350......................................... OMNIZOLE (thiabendazole) Oral Liquid............. 520.2380b
015-123......................................... TBZ (thiabendazole) Cattle Wormer Oral Liquid.... 520.2380b
015-875......................................... TBZ 200 (thiabendazole) Medicated Feed Premix.... 558.600
030-103......................................... THIBENZOLE (thiabendazole) Oral Liquid........... 520.2380b
032-702......................................... PROM ACE (acepromazine maleate) Tablets.......... 520.23
033-127......................................... VETISULID (sulfachlorpyridazine) Bolus........... 520.2200
033-318......................................... VETISULID (sulfachlorpyridazine) Injectable 520.2200
Solution.
033-319......................................... VETISULID (sulfachlorpyridazine) Tablets......... 520.2200
034-114......................................... EQUIZOLE (thiabendazole) Oral Liquid............. 520.2380b
034-879......................................... DOPRAM-V (doxapram hydrochloride) Injectable 522.775
Solution.
035-631......................................... THIBENZOLE (thiabendazole) Pig Wormer............ 520.2380b
037-410......................................... EQUIZOLE A (thiabendazole and piperazine 520.2380e
phosphate) Oral Liquid.
043-141......................................... THIBENZOLE 300 (thiabendazole) Medicated......... 558.600
044-654......................................... EQUIZOLE (thiabendazole) Horse Wormer Pellets.... 520.2380a
046-146......................................... VETALOG (triamcinolone acetonide) Cream.......... 524.2483
047-333......................................... EQUIZOLE A (thiabendazole and piperazine citrate) 520.2380d
Oral Liquid.
048-487......................................... TBZ (thiabendazole) Wormer Paste 50%............. 520.2380b
049-461......................................... TBZ (thiabendazole) Wormer Paste 43%............. 520.2380b
055-021......................................... HETACIN K (hetacillin potassium) Capsules Vet.... 520.1130
055-022......................................... HETACIN K (hetacillin potassium) Tablets......... 520.1130
055-048......................................... HETACIN K (hetacillin potassium) Oral Liquid..... 520.1130
065-275......................................... Penicillin VK (penicillin V potassium) Filmtab 520.1696c
Tablets 250 mg.
065-276......................................... VEESYN (penicillin V potassium) Granules for Oral 520.1696b
Solution.
093-600......................................... VOREN (dexamethasone-21-isonicotinate) Suspension 522.542
[[Page 27697]]
094-642......................................... CAMVET (cambendazole) Suspension Horse Wormer.... 520.284a
095-642......................................... OXY-TET (oxytetracycline hydrochloride) 522.1662a
Injectable Solution.
096-506......................................... CAMVET (cambendazole) Horse Wormer Pellets....... 520.284b
096-731......................................... CAMVET (cambendazole) Horse Wormer Paste 45%..... 520.284c
098-689......................................... EQUIZOLE (thiabendazole) 50% Wormer Paste........ 520.2380b
099-388......................................... VETALOG (triamcinolone acetonide) Oral Powder.... 520.2483
117-531......................................... Acepromazine Maleate Injection................... 522.23
127-443......................................... EQVALAN (ivermectin) Injectable Solution......... 522.1192
140-439......................................... EQVALAN (ivermectin) Oral Liquid For Horses...... 522.1195
141-180......................................... TORPEX (albuterol sulfate)....................... 529.40
200-361......................................... Acepromazine Maleate Injection................... 522.23
200-564......................................... Ivermectin Paste 1.87%........................... 520.1192
----------------------------------------------------------------------------------------------------------------
III. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations.
21 CFR 520.48 is amended to reflect the sponsors of
products containing altrenogest for use in horses and swine.
21 CFR 520.2380 is removed and 21 CFR 558.600 revised to
characterize a free-choice block containing thiabendazole as a new
animal drug for use in cattle feed.
21 CFR 522.1077 is amended to reflect indications for use
of gonadorelin in cattle.
21 CFR 522.1222 is amended to reflect sponsors of approved
applications for use of ketamine in cats and subhuman primates.
21 CFR 556.620 is removed because there are no longer any
approved products containing sulfabromomethazine for use in food-
producing animals.
21 CFR 556.730 is revised to reflect the removal of
products containing thiabendazole for use in food-producing animals
other than cattle.
21 CFR 558.311 is amended to reflect approved classes of
pasture cattle for use of lasalocid medicated feeds.
21 CFR 558.455 is amended to reflect the approved
conditions of use of medicated feeds containing oxytetracycline and
neomycin in sheep.
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:
0
a. In paragraph (c)(1), amend the table by adding an entry for
``Provetica LLC''; and
0
b. In paragraph (c)(2), amend the table by adding add an entry for
``086097''.
The additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 27698]]
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * * * *
Provetica LLC, 8735 Rosehill Rd., Suite 300, 086097
Lenexa, KS 66215.................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
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Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
086097...................... Provetica LLC, 8735 Rosehill Rd., Suite
300, Lenexa, KS 66215.
* * * * * * *
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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. 516.812 [Removed]
0
4. Remove Sec. 516.812.
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. In Sec. 520.48, revise paragraph (b) to read as follows:
Sec. 520.48 Altrenogest.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
(1) Nos. 000061 and 051072 for use as in paragraph (d) of this
section.
(2) No. 061133 for use as in paragraph (d)(1) of this section.
(3) No. 013744 for use as in paragraph (d)(2) of this section.
* * * * *
Sec. Sec. 520.284, 520.284a, 520.284b, and 520.284c [Removed]
0
7. Remove Sec. Sec. 520.284, 520.284a, 520.284b, and 520.284c.
0
8. In Sec. 520.304, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 520.304 Carprofen.
* * * * *
(b) * * *
(1) Nos. 017033, 054771, 055529, 062250, and 086101 for use of
products described in paragraph (a)(1) and (2) of this section as in
paragraph (c) of this section.
(2) Nos. 058198 and 086117 for use of product described in
paragraph (a)(2) as in paragraph (c) of this section.
* * * * *
Sec. Sec. 520.420 [Removed]
0
9. Remove Sec. 520.420.
0
10. In Sec. 520.443, amend paragraph (d)(2)(ii) by adding a sentence
at the end of the paragraph to read as follows:
Sec. 520.443 Chlortetracycline tablets and boluses.
* * * * *
(d) * * *
(2) * * *
(ii) * * * Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *
0
11. In Sec. 520.522, add paragraph (b)(4) and revise (d)(2)(ii) to
read as follows:
Sec. 520.522 Cyclosporine.
* * * * *
(b) * * *
(4) No. 086097 for use of product described in paragraph (a)(2) as
in paragraph (d) of this section.
* * * * *
(d) * * *
(2) * * *
(ii) Indications for use. For the control of feline allergic
dermatitis as manifested by excoriations (including facial and neck),
miliary dermatitis, eosinophilic plaques, and self-induced alopecia in
cats at least 6 months of age and at least 3 lbs (1.4 kg) in body
weight.
* * * * *
Sec. 520.812 [Amended]
0
12. Amend Sec. 520.812 by:
0
a. In paragraph (b)(2), removing ``No. 017033'' and in its place adding
``Nos. 017033 and 086117''; and
0
b. Removing paragraph (b)(4).
0
13. In Sec. 520.998, revise paragraph (c)(2)(i) to read as follows:
Sec. 520.998 Fluralaner.
* * * * *
(c) * * *
(2) * * *
(i) Chewable tablets described in paragraph (a)(1) of this section.
Kills adult fleas; for the treatment and prevention of flea
infestations (Ctenocephalides felis), and the treatment and control of
tick infestations (Ixodes scapularis (black-legged tick), Dermacentor
variabilis (American dog tick), Rhipicephalus sanguineus (brown dog
tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 12
weeks in dogs and puppies 6 months of age and older, and weighing 4.4
lbs or greater; and for the treatment and control of Amblyomma
americanum (lone star tick) infestations for 8 weeks in dogs and
puppies 6 months of age and older, and weighing 4.4 lbs or greater.
* * * * *
0
14. Amend Sec. 520.1044b by adding a sentence at the end of paragraph
(d)(3) to read as follows:
Sec. 520.1044b [Amended]
* * * * *
(d) * * *
(3) * * * Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Sec. 520.1130 [Removed]
0
15. Remove Sec. Sec. 520.1130.
Sec. 520.1195 [Amended]
0
16. In Sec. 520.1195, in paragraph (b)(1), remove ``000010,''.
0
17. In Sec. 520.1310, revise paragraphs (a) and (b) to read as
follows:
[[Page 27699]]
Sec. 520.1310 Marbofloxacin.
(a) Specifications. Each tablet or chewable tablet contains 25, 50,
100, or 200 milligrams (mg) marbofloxacin.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section:
(1) Nos. 017033, 054771, and 086117 for use of tablets.
(2) No. 086101 for use of chewable tablets.
* * * * *
0
18. In Sec. 520.1315, revise paragraph (b) to read as follows:
Sec. 520.1315 Maropitant.
* * * * *
(b) Sponsors. See Nos. 054771 and 086117 in Sec. 510.600(c) of
this chapter.
* * * * *
Sec. 520.1696b [Removed]
0
19. Remove Sec. 520.1696b.
0
20. In Sec. 520.1696c, revise paragraph (b) to read as follows:
Sec. 520.1696c Penicillin V tablets.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 520.1870 [Amended]
0
21. In Sec. 520.1870, in paragraph (b)(2), remove ``No. 069043'' and
in its place add ``Nos. 069043 and 086101''.
0
22. In Sec. 520.2200, revise paragraph (a)(2), remove paragraph
(a)(3), revise paragraphs (d)(1)(i) and (d)(2)(i), and remove (d)(3) to
read as follows:
Sec. 520.2200 Sulfachlorpyridazine.
(a) * * *
(2) Each milliliter (mL) of suspension contains 50 milligrams (mg)
of sodium sulfachlorpyridazine.
* * * * *
(d) * * *
(1) * * *
(i) Amount. Administer 30 to 45 mg sulfachlorpyridazine powder per
pound (/lb) of body weight per day in milk or milk replacer in divided
doses twice daily for 1 to 5 days.
* * * * *
(2) * * *
(i) Amount. Administer 20 to 35 mg/lb body weight per day in
divided doses twice daily for 1 to 5 days in drinking water or an oral
suspension containing 50 mg per mL.
* * * * *
Sec. Sec. 520.1696b, 520.2170, 520.2380, 520.2380a, 520.2380b,
520.2380c, 520.2380d and 520.2380e [Removed]
0
23. Remove Sec. Sec. 520.1696b, 520.2170, 520.2380, 520.2380a,
520.2380b, 520.2380c, 520.2380d and 520.2380e.
Sec. 520.2380f [Redesignated]
0
24. Redesignate Sec. 520.2380f as Sec. 520.2382.
Sec. 520.2483 [Removed]
0
25. Remove Sec. 520.2483.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
26. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.536 [Amended]
0
27. In Sec. 522.536, in paragraph (b), remove ``Nos. 015914 and
052483'' and in its place add ``Nos. 015914, 052483, and 059399''.
Sec. 522.542 [Removed]
0
28. Remove Sec. 522.542.
Sec. 522.558 [Amended]
0
29. In Sec. 522.558, in paragraph (b)(1), remove ``Nos. 017033 and
059399'' and in its place add ``Nos. 017033, 059399, and 086117''.
Sec. 522.775 [Removed]
0
30. Remove Sec. 522.775.
0
31. Amend Sec. 522.820 by adding a sentence at the end of paragraph
(d)(3)(iii) to read as follows:
Sec. 522.820 Erythromycin.
* * * * *
(d) * * *
(3) * * *
(iii) * * * Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
0
32. In Sec. 522.1077, revise paragraphs (b)(2), (d)(1)(iv), and
(e)(1)(i) to read as follows:
Sec. 522.1077 Gonadorelin.
* * * * *
(b) * * *
(2) No. 068504 for use of the 100-[micro]g/mL product described in
paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section.
* * * * *
(d) * * *
(1) * * *
(iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this
section as provided by No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(1) * * *
(i) For the treatment of ovarian follicular cysts in dairy cattle:
Administer 86 [micro]g gonadorelin (No. 000061), or 100 [micro]g
gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100
[micro]g gonadorelin (as gonadorelin acetate; No. 068504) by
intramuscular or intravenous injection.
* * * * *
Sec. 522.1150 [Removed]
0
33. Remove Sec. 522.1150.
0
34. In Sec. 522.1192, remove and reserve paragraph (a)(1), and revise
paragraphs (b)(1) and (2), remove and reserve paragraph (e)(1), and
revise paragraph (e)(2)(i) to read as follows:
Sec. 522.1192 Ivermectin.
* * * * *
(b) * * *
(1) Nos. 000010, 016592, 055529, 058005, and 061133 for use of the
product described in paragraph (a)(2) of this section as in paragraphs
(e)(2) through (e)(5) of this section; and
(2) No. 000010 for use of the product described in paragraph (a)(3)
of this section as in paragraphs (e)(3) and (e)(6) of this section.
* * * * *
(e) * * *
(2) * * *
(i) Amount. 200 micrograms per kilogram ([micro]g/kg) of body
weight by subcutaneous injection.
* * * * *
Sec. 522.1222 [Amended]
0
35. In Sec. 522.1222, revise paragraph (b) by adding, in numeric
sequence, ``00010,''.
0
36. In Sec. 522.1450, revise paragraphs (a), (b), and (e) to read as
follows:
Sec. 522.1450 Moxidectin solution.
(a) Specifications. Each milliliter (mL) of solution contains 10
milligrams (mg) moxidectin.
(b) Sponsors. See Nos. 055529 and 058198 in Sec. 510.600(c) of
this chapter.
* * * * *
(e) Conditions of use in cattle--(1) Amount. Administer by
subcutaneous injection 1 mL for each 110 pounds (lb) (50 kilograms
(kg)) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body
weight.
(2) Indications for use. Beef and nonlactating dairy cattle: For
treatment and control of Gastrointestinal roundworms: Ostertagia
ostertagi (adults, fourth-stage larvae, and inhibited larvae),
Haemonchus placei (adults), Trichostrongylus axei (adults and fourth-
stage larvae), Trichostrongylus colubriformis (adults and fourth-stage
larvae), Cooperia oncophora (adults), Cooperia pectinata (adults),
Cooperia punctata (adults and fourth-stage larvae), Cooperia spatulata
(adults), Cooperia surnabada (adults
[[Page 27700]]
and fourth-stage larvae), Nematodirus helvetianus (adults),
Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris
spp. (adults); Lungworms: Dictyocaulus viviparus (adults and fourth-
stage larvae); Cattle grubs: Hypoderma bovis and Hypoderma lineatum;
Mites: Psoroptes ovis (Psoroptes communis var. bovis); Lice:
Linognathus vituli and Solenopotes capillatus. For protection from
reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum
for 42 days after treatment, with Haemonchus placei for 35 days after
treatment, and with Ostertagia ostertagi and Trichostrongylus axei for
14 days after treatment.
(3) Limitations. Cattle must not be slaughtered for human
consumption within 21 days of treatment. This drug product is not
approved for use in female dairy cattle 20 months of age or older,
including dry dairy cows. Use in these cattle may cause drug residues
in milk and/or in calves born to these cows. A withdrawal period has
not been established for preruminating calves. Do not use in calves to
be processed for veal.
Sec. 522.1696b [Amended]
0
37. In Sec. 522.1696b, amend paragraph (d)(2)(iii)(C), by removing
``For Nos. 054771 and 055529:''.
Sec. 522.1885 [Removed]
0
38. Remove Sec. 522.1885.
0
39. Amend Sec. 522.2120 by adding a sentence at the end of paragraph
(d)(1)(ii) to read follows:
Sec. 522.2120 Spectinomycin hydrochloride.
* * * * *
(d) * * *
(1) * * *
(ii) * * * Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *
Sec. 522.2200 [Removed]
0
40. Remove Sec. 522.2200.
0
41. In 522.2630, revise paragraph (b)(2) to read as follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(b) * * *
(2) Nos. 013744, 051311, 054771, 058198, and 068504 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.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
42. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
43. In Sec. 524.770, revise paragraph (b) to read as follows:
Sec. 524.770 Doramectin.
* * * * *
(b) Sponsors. See Nos. 051072 and 054771 in Sec. 510.600(c) of
this chapter.
* * * * *
0
44. In Sec. 524.814, revise paragraphs (b) and (e)(1) to read as
follows:
Sec. 524.814 Eprinomectin.
* * * * *
(b) Sponsors. See Nos. 000010, 051072, and 055529 in Sec.
510.600(c) of this chapter.
* * * * *
(e) * * *
(1) Amount. Apply 5 mg (1 mL) per 10 kilograms (kg) of body weight
(500 micrograms/kg) topically along backbone from withers to tailhead.
* * * * *
Sec. 524.1044e [Amended]
0
45. Amend Sec. 524.1044e by adding a sentence at the end of paragraph
(d)(3) to read as follows:
Sec. 524.1044e Gentamicin spray.
* * * * *
(d) * * *
(3) * * * Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Sec. 524.1146 [Amended]
0
46. In Sec. 524.1146, in paragraph (b)(3), remove ``Nos. 051072 and
058198'' and in its place add ``Nos. 051072, 055529, 058198, and
061651''.
Sec. 524.1484j [Removed]
0
47. Remove Sec. 524.1484j.
Sec. 524.2101 [Amended]
0
48. In Sec. 524.2101, in paragraph (b), remove ``000010, 000061,'' and
in its place add ``000061''.
Sec. 524.2483 [Amended]
0
49. In Sec. 524.2483, in paragraph (b), remove ``Nos. 000010 and
054925'' and in its place add ``No. 054925''.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
50. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
51. Amend Sec. 526.1696 by adding a sentence at the end of paragraph
(d)(3) and paragraph (e)(3) to read as follows:
Sec. 526.1696 Penicillin G procaine.
* * * * *
(d) * * *
(3) * * * For No. 042791: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
(e)
(3) * * * For No. 042791: 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
52. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.40 [Removed]
0
53. Remove Sec. 529.40.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
54. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.620 [Removed]
0
55. Remove Sec. 556.620.
0
56. Revise Sec. 556.730 to read as follows:
Sec. 556.730 Thiabendazole.
(a) [Reserved]
(b) Tolerances. The tolerances for thiabendazole are:
(1) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm.
(ii) Milk: 0.05 ppm.
(2) [Reserved]
(c) Related conditions of use. See Sec. 558.600.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
57. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
58. In Sec. 558.311, revise paragraph (e)(3)(iii) to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(3) * * *
[[Page 27701]]
----------------------------------------------------------------------------------------------------------------
Lasalocid amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) Not less than 60 mg or more than Pasture cattle (slaughter, Feed continuously at a rate 054771
300 mg of lasalocid per head per day. stocker, feeder cattle, of not less than 60 mg or
and beef replacement more than 300 mg of
heifers): For increased lasalocid per head per day
rate of weight gain. when on pasture. The drug
must be contained in at
least 1 pound of feed.
Daily intakes of lasalocid
in excess of 200 mg/head/
day have not been shown to
be more effective than 200
mg/head/day.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
50. In Sec. 558.455, revise paragraph (e)(5) to read as follows:
Sec. 558.455 Oxytetracycline and neomycin.
* * * * *
(e) * * *
(5) Sheep. It is used in feed as follows:
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin sulfate
amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight Sheep: For treatment of Feed continuously for 7 to 066104
daily. bacterial enteritis caused 14 days. Treatment should 069254
by Escherichia coli and continue 24 to 48 hours
bacterial pneumonia caused beyond remission of
by Pasteurella multocida clinical signs of disease.
susceptible to Withdraw 5 days before
oxytetracycline; treatment slaughter.
and control of
colibacillosis (bacterial
enteritis) caused by E.
coli susceptible to
neomycin.
----------------------------------------------------------------------------------------------------------------
(ii) [Reserved]
0
59. Revise Sec. 558.600 to read as follows:
Sec. 558.600 Thiabendazole.
(a) Specifications. Mineral protein block containing 3.3 percent
thiabendazole.
(b) Sponsor. See No. 012286 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.730 of this chapter.
(d) Special considerations. See Sec. 500.25 of this chapter.
(e) Conditions of use in cattle--(1) Amount. Provide free-choice to
cattle on pasture or range accustomed to mineral protein block feeding
for 3 days. Cattle should consume at a recommended level of 0.11 pound
per 100 pounds of body weight per day. Animals maintained under
conditions of constant worm exposure may require re-treatment within 2
to 3 weeks.
(2) Indications for use. For control of infections of
gastrointestinal roundworms (Trichostrongylus, Haemonchus, Ostertagia,
and Cooperia).
(3) Limitations. Milk taken from animals during treatment and
within 96 hours (8 milkings) after the latest treatment must not be
used for food. Do not treat cattle within 3 days of slaughter.
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09212 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P
