New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor, 10964-10973 [2022-03538]
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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations
identified in paragraphs (h)(1) through (3) of
this AD may be installed on any airplane
unless the requirements of paragraph (i) of
this AD have been accomplished on that
affected assembly.
(l) Credit for Previous Actions
This paragraph provides credit for the
actions specified in paragraphs (h) or (i) of
this AD, if those actions were performed
before the effective date of this AD using the
service information specified in paragraphs
(l)(1) through (5) of this AD.
(1) AVOX Systems Inc. Service Bulletin
10015804–35–01, dated March 6, 2019.
(2) AVOX Systems Inc. Alert Service
Bulletin 10015804–35–01, Revision 01, dated
July 9, 2019.
(3) AVOX Systems Inc. Alert Service
Bulletin 10015804–35–02, Revision 1, dated
September 4, 2019.
(4) AVOX Systems Inc. Service Bulletin
10015804–35–03, dated April 11, 2019.
(5) AVOX Systems Inc. Alert Service
Bulletin 10015804–35–03, Revision 01, dated
May 21, 2019.
(m) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, New York ACO Branch,
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with
14 CFR 39.19, send your request to your
principal inspector or local Flight Standards
District Office, as appropriate. If sending
information directly to the manager of the
certification office, send it to ATTN: Program
Manager, Continuing Operational Safety,
FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590;
telephone 516–228–7300; fax 516–794–5531.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
Issued on February 11, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
(n) Related Information
[Docket No. FDA–2021–N–0002]
(1) For more information about this AD,
contact Elizabeth Dowling, Aerospace
Engineer, Mechanical Systems and
Administrative Services Section, FAA, New
York ACO Branch, 1600 Stewart Avenue,
Suite 410, Westbury, NY 11590; telephone
516–228–7300; email 9-avs-nyaco-cos@
faa.gov.
(2) Service information identified in this
AD that is not incorporated by reference is
available at the addresses specified in
paragraphs (o)(3) and (4) of this AD.
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of a New Animal Drug
Application; Change of Sponsor
(o) Material Incorporated by Reference
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(i) AVOX Systems Inc. Alert Service
Bulletin 10015804–35–01, Revision 02, dated
October 16, 2019.
(ii) AVOX Systems Inc. Alert Service
Bulletin 10015804–35–02, Revision 2, dated
October 31, 2019.
(iii) AVOX Systems Inc. Alert Service
Bulletin 10015804–35–03, Revision 02, dated
October 15, 2019.
(3) For service information identified in
this AD, contact AVOX Systems Inc., 225
Erie Street, Lancaster, NY 14086; telephone
716–683–5100; internet https://
www.safranaerosystems.com.
(4) You may view this service information
at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th
St., Des Moines, WA. For information on the
availability of this material at the FAA, call
206–231–3195.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA,
fr.inspection@nara.gov, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
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[FR Doc. 2022–04146 Filed 2–25–22; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 500, 510, 516, 520, 522,
524, 529, 556, and 558
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
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 a
conditionally approved new animal
drug application (cNADA) during July,
August, and September 2021. FDA is
SUMMARY:
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informing the public of the availability
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to improve the accuracy of the
regulations.
This rule is effective February
28, 2022. The incorporation by reference
of certain material listed in this rule is
approved by the Director of the Federal
Register as February 28, 2022. The
incorporation by reference of other
material listed in this rule was approved
by the Director of the Federal Register
as of November 25, 2011.
DATES:
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during July,
August, and September 2021, as listed
in table 1. In addition, FDA is informing
the public of the availability, where
applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the office of
the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Persons with access to the internet may
obtain these documents at the CVM
FOIA Electronic Reading Room: https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing
exclusivity and patent information may
be accessed in FDA’s publication,
‘‘Approved Animal Drug Products
Online (Green Book)’’ at: https://
www.fda.gov/animal-veterinary/
products/approved-animal-drugproducts-green-book.
FDA has verified the website
addresses as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
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10965
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND SEPTEMBER
2021
Approval date
File No.
July 7, 2021 ..........
200–703
July 15, 2021 ........
141–545
August 2, 2021 .....
200–708
August 16, 2021 ...
200–618
August 18, 2021 ...
200–709
August 19, 2021 ...
141–063
Product name
Species
Dechra Veterinary
Products LLC,
7015 College Blvd.,
Suite 525, Overland Park, KS
66211.
VetDC, Inc., 320 E
Vine Dr., Suite
218, Fort Collins,
CO 80524.
Carprofen Tablets .....
Dogs ................
Original approval as
a generic copy of
NADA 141–053.
FOI Summary.
TANOVEA
(rabacfosadine for
injection) Powder
for Injection.
Dogs ................
FOI Summary.
Felix Pharmaceuticals PVT Ltd.,
25–288 North Wall
Quay, Dublin, 1,
Ireland.
Virbac AH, Inc., PO
Box 162059, Fort
Worth, TX 76161.
Cronus Pharma Specialties India Private Ltd., Sy No99/1, M/s GMR
Hyderabad Aviation
SEZ Ltd.,
Mamidipalli Village,
Shamshabad
Mandal, Ranga
Reddy, Hyderabad,
Telangana,
501218, India.
Intervet, Inc., 2
Giralda Farms,
Madison, NJ 07940.
Enrofloxacin Antibacterial Injectable
Solution 2.27%.
Dogs ................
Full approval of conditionally approved
cNADA 141–475
for the treatment of
lymphoma.
Original approval as
a generic copy of
NADA 140–913.
ZOLETIL (tiletamine
and zolazepam for
Injection).
Amoxicillin and
Clavulanate Potassium for Oral Suspension.
Dogs and cats
Original approval as
a generic copy of
NADA 106–111.
Original approval as
a generic copy of
NADA 055–101.
FOI Summary.
NUFLOR–S
(florfenicol)
Injectable Solution.
Swine ...............
Supplemental approval for the treatment of swine respiratory disease.
FOI Summary.
II. Withdrawal of Approval
Elanco US Inc., 2500 Innovation Way,
Greenfield, IN 46140, has requested that
FDA withdraw approval of NADA 093–
329 for use of a sustained-release bolus
containing sulfamethazine in cattle
because the product is no longer
manufactured or marketed. As provided
in the regulatory text of this document,
the animal drug regulations are
amended to reflect this action.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADA 093–329, and all supplements
and amendments thereto, is withdrawn.
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III. Change of Sponsor
VetDC, Inc., 320 E Vine Dr., Suite 218,
Fort Collins, CO 80524, has informed
FDA that it has transferred ownership
of, and all rights and interest in, newly
approved NADA 141–545 for
TANOVEA (rabacfosadine) for Injection
to Elanco US Inc., 2500 Innovation Way,
Greenfield, IN 46140. The codification
of this application in new 21 CFR
522.2065 will reflect this change of
sponsorship.
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Dogs and cats
IV. Technical Amendments
FDA is making the following
amendments to improve the accuracy of
the animal drug regulations:
• 21 CFR 500.1410 is amended to add
uncooked edible tissues of swine to the
standard for residues of n-methyl-2pyrrolidone.
• 21 CFR 510.600 is amended to have
sponsor addresses conform to the
current style.
• 21 CFR 520.905c is amended to
reflect the current label indications for
use of fenbendazole paste in horses.
• 21 CFR 520.1044c is amended to
reflect a current swine pathogen name
for gentamicin soluble powder.
• 21 CFR 520.1660d is amended to
revise conditions of use of
oxytetracycline in drinking water of
swine to reflect approved applications.
• 21 CFR 520.1780 is amended to
revise the indications for use of
pimobendan tablets in dogs.
• 21 CFR 520.2130 is amended to
remove the 90-milligram strength for
spinosad chewable tablets.
• 21 CFR 520.2220a is amended to
add human food safety warnings for use
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Effect of the action
Public
documents
Sponsor
FOI Summary.
FOI Summary.
of sulfadimethoxine concentrate
solution and soluble powder.
• 21 CFR 520.2260b is amended to
reflect the voluntary withdrawal of
approval of an application for sustainedrelease boluses containing
sulfamethazine and to correct the
spelling of a disease condition.
• 21 CFR 520.2604 is amended to
revise indications for use of tablets in
dogs containing trimeprazine with
prednisolone.
• 21 CFR 522.558 is amended to
reflect the drug labeler code for the
current sponsor of a dexmedetomidine
injectable solution.
• 21 CFR 522.840 is amended to
reflect the current classes of cattle
approved for use of estradiol ear
implants.
• 21 CFR 522.842 for testosterone
propionate and estradiol benzoate
implants is renamed to list the drug
with the higher concentration first and
redesignated to be listed in alphabetical
order.
• 21 CFR 522.955 is amended to
reflect the current scientific name of a
bovine pathogen and the withdrawal
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periods for different formulations of
florfenicol injectable solution.
• 21 CFR 522.1156 is amended to add
subcutaneous administration to the
approved conditions of use of imidocarb
dipropionate solution in dogs.
• 21 CFR 522.2477 is amended to
reorganize an approved use of
trenbolone acetate and estradiol
implants in steers.
• 21 CFR 524.770 is amended to
reflect current label dosage information
and human food safety warnings.
• 21 CFR 529.1030 is redesignated as
§ 529.1004 in conformity with an
announced FDA numbering system (40
FR 13802, March 27, 1975).
• 21 CFR 529.1940 is amended to add
limitations to the use of progesterone
intravaginal inserts in cows.
• 21 CFR 558.59 is amended to
reference apramycin’s status as a
veterinary feed directive (VFD) drug and
to add current limitations on VFD refills
for apramycin medicated feeds.
• 21 CFR 558.205 is amended to
reflect a current egg food safety warning
for broiler chickens and growing turkeys
fed Type C medicated feeds containing
diclazuril.
• 21 CFR 558.254 is amended to
remove an erroneous table title.
• 21 CFR 558.261 is amended to
correct the upper inclusion rate for
florfenicol in Type C medicated feed for
freshwater-reared salmonids.
• 21 CFR 558.311 is being amended
to codify free-choice Type C medicated
cattle feeds containing lasalocid.
• 21 CFR 558.450 is amended to add
conditions of use in honey bees for a
Type C extender patty containing
oxytetracycline.
• 21 CFR 558.633 is amended to add
manufacturing limitations for use of
Type C medicated swine feeds
containing tylvalosin.
• 21 CFR 558.635 is amended to
reflect a current egg food safety warning
for broiler chickens fed Type C
medicated feeds containing
virginiamycin and diclazuril.
This standard adds a method of
detection for total for residues of the
carcinogenic excipient n-methyl-2pyrrolidone in uncooked edible swine
tissues to a section established for a
method for residues of n-methyl-2pyrrolidone in uncooked edible cattle
tissues.
V. Incorporation by Reference
FDA is incorporating by reference an
analytical method approved by the
Office of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. To obtain a copy of the
analytical method, go to: https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. You may
inspect a copy at the office of the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, 240–402–7500, between 9 a.m.
and 4 p.m., Monday through Friday.
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
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VI. 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 500
Animal drugs, Animal feeds, Cancer,
Incorporation by reference, Labeling,
Packaging and containers,
Polychlorinated biphenyls (PCBs).
21 CFR Part 510
21 CFR Part 516
Administrative practice and
procedure, Animal drugs, Confidential
business information, Reporting and
recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
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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 500,
510, 516, 520, 522, 524, 529, 556, and
558 are amended as follows:
PART 500—GENERAL
1. The authority citation for part 500
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 342, 343,
348, 351, 352, 353, 360b, 371, 379e.
2. Revise § 500.1410 to read as
follows:
■
§ 500.1410
N-methyl-2-pyrrolidone.
(a) Standard for residues. No residues
of n-methyl-2-pyrrolidone may be found
in the uncooked edible tissues of cattle
and swine as determined by methods in
paragraph (b) of this section.
(b) Incorporation by reference. The
standards required in this section are
incorporated by reference into this
section with the approval of the Director
of the Federal Register under 5 U.S.C.
552(a) and 1 CFR part 51. All approved
material is available for inspection at
the Food and Drug Administration’s
Dockets Management Staff (HFA–305),
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240–402–7500, between 9
a.m. and 4 p.m., Monday through
Friday. It may be obtained from the
sources indicated elsewhere in
paragraph (b) of this section and at:
https://www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. It is also
available for inspection at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
email fr.inspection@nara.gov, or go to:
www.archives.gov/federal-register/cfr/
ibr-locations.html.
(1) Food and Drug Administration,
Center for Veterinary Medicine, 7500
Standish Pl., Rockville, MD 20855, 240–
402–7002.
(i) ‘‘Method of Analysis: N-methyl-2pyrrolidone,’’ September 26, 2011; the
method of analysis for uncooked edible
tissues of cattle.
(ii) [Reserved]
(2) Merck Animal Health, 29160
Intervet Lane, Millsboro, DE 19966, 1–
800–211–3573.
(i) ‘‘Determinative and Confirmatory
Procedures for the Analysis of NMethyl-2-pyrrolidone (NMP) in Swine
Liver Tissue using LC–MS/MS,’’ July 20,
2017; the method of analysis for
uncooked edible tissues of swine.
(ii) [Reserved]
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(c) Related conditions of use. See
§§ 522.814 and 522.955 of this chapter.
PART 510—NEW ANIMAL DRUGS
3. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
§ 510.600
[Amended]
4. In § 510.600:
■ a. In the table in paragraph (c)(1),
revise the entries for ‘‘Anzac Animal
Health, LLC’’, ‘‘AquaBounty
Technologies, Inc.’’, ‘‘Dechra Veterinary
Products LLC’’, ‘‘Halocarbon Products
Corp.’’, ‘‘Kindred Biosciences, Inc.’’,
‘‘Mizner Bioscience LLC’’, ‘‘QBiotics
■
Group Ltd.’’, ‘‘Revivicor, Inc.’’, and
‘‘Ridley USA, Inc.’’, remove ‘‘Suite’’ and
in its place add ‘‘suite’’; and
■ b. In the table in paragraph (c)(2),
revise the entries for ‘‘012164’’,
‘‘017033’’, ‘‘067949’’, ‘‘086039’’,
‘‘086053’’, ‘‘086073’’, ‘‘086078’’,
‘‘086132’’, and ‘‘086134’’.
The revisions read as follows:
(c) * * *
(1) ALPHABETICAL LISTING OF SPONSORS
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807 .............................................................................
Anzac Animal Health, LLC, 218 Millwell Dr., suite B, Maryland Heights, MO 63043 .........................................................................
AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754 ......................................................................
*
*
*
*
*
*
*
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 ...........................................................
*
*
*
*
*
*
*
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092 ..................................................
*
*
*
*
*
*
*
Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010 ........................................................................
*
*
*
*
*
*
*
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432 ............................................................................
*
*
*
*
*
*
*
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia ......................................................
*
*
*
*
*
*
*
Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060 .......
Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001 ................................................................................................
*
*
*
*
*
*
086121
086073
086053
017033
012164
086078
086039
086132
086134
067949
*
*
*
012164 ............
*
*
*
*
*
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092.
*
*
017033 ............
*
*
*
*
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211.
*
*
*
067949 ............
*
*
*
Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001.
*
*
*
086039 ............
*
*
*
*
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432.
*
*
*
086053 ............
*
*
*
*
AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754.
*
*
*
086073 ............
086078 ............
*
*
*
*
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043.
Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010.
*
*
*
086121 ............
086132 ............
086134 ............
*
*
*
*
*
*
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807.
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia.
Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060
(2) NUMERICAL LISTING OF SPONSORS
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code
*
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PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
5. The authority citation for part 516
continues to read as follows:
■
Authority: 21 U.S.C. 360ccc, 360ccc–2,
371.
§ 516.2065
■
[Removed]
6. Remove § 516.2065.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
7. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
8. Revise § 520.88h to read as follows:
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§ 520.88h Amoxicillin trihydrate and
clavulanate potassium for oral suspension.
(a) Specifications. When constituted,
each milliliter (mL) of suspension
contains amoxicillin trihydrate
equivalent to 50 milligrams (mg)
amoxicillin and clavulanate potassium
equivalent to 12.5 mg clavulanic acid.
(b) Sponsors. See Nos. 054771 and
069043 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Dogs—(i)
Amount. 6.25 mg/lb (1 mL/10 lb of body
weight) twice a day. Skin and soft tissue
infections such as abscesses, cellulitis,
wounds, superficial/juvenile pyoderma,
and periodontal infections should be
treated for 5 to 7 days or for 48 hours
after all signs have subsided. If no
response is seen after 5 days of
treatment, therapy should be
discontinued and the case reevaluated.
Deep pyoderma may require treatment
for 21 days; the maximum duration of
treatment should not exceed 30 days.
(ii) Indications for use. Treatment of
skin and soft tissue infections such as
wounds, abscesses, cellulitis,
superficial/juvenile and deep pyoderma
due to susceptible strains of the
following organisms: beta-lactamaseproducing Staphylococcus aureus, nonbeta-lactamase-producing
Staphylococcus aureus, Staphylococcus
spp., Streptococcus spp., and
Escherichia coli. Treatment of
periodontal infections due to
susceptible strains of both aerobic and
anaerobic bacteria.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats—(i) Amount. 62.5 mg (1 mL)
twice daily. Skin and soft tissue
infections such as abscesses and
cellulitis/dermatitis should be treated
for 5 to 7 days or 48 hours after all
symptoms have subsided, not to exceed
30 days. If no response is seen after 3
days of treatment, therapy should be
discontinued and the case reevaluated.
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Urinary tract infections may require
treatment for 10 to 14 days or longer.
The maximum duration of treatment
should not exceed 30 days.
(ii) Indications for use. Treatment of
skin and soft tissue infections, such as
wounds, abscesses, and cellulitis/
dermatitis due to susceptible strains of
the following organisms: beta-lactamaseproducing Staphylococcus aureus, nonbeta-lactamase-producing
Staphylococcus aureus, Staphylococcus
spp., Streptococcus spp., Escherichia
coli, Pasteurella multocida, and
Pasteurella spp. Urinary tract infections
(cystitis) due to susceptible strains of E.
coli.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 9. In § 520.905c, revise paragraphs
(e)(1)(i) to read as follows:
§ 520.905c
Fenbendazole paste.
*
*
*
*
*
(e) * * *
(1) * * *
(i) Indications for use and amounts.
(A) For the treatment and control of
large strongyles (Strongylus edentatus,
S. equinus, S. vulgaris), small
strongyles, and pinworms (Oxyuris
equi). For large strongyles, small
strongyles, and pinworms, the
recommended dose is 5 mg/kg (2.3 mg/
lb).
(B) For treatment and control of
ascarids (Parascaris equorum). For
ascarids, the recommended dose is 10
mg/kg (4.6 mg/lb).
(C) For treatment and control of
hypobiotic (encysted early third-stage),
late third-stage, and fourth-stage
cyathostome larvae, as well as fourthstage Strongylus vulgaris larvae, the
recommended dose is 10 mg/kg (4.6 mg/
lb) daily for 5 consecutive days.
(D) For the control of arteritis caused
by fourth-stage larvae of Strongylus
vulgaris in horses.
(E) Fenbendazole paste 10 percent
may be used concomitantly with
approved forms of trichlorfon for the
indications provided in paragraph
(e)(1)(i)(A) of this section and for
treating infections of stomach bots as
provided in § 520.2520.
*
*
*
*
*
■ 10. In § 520.1044c, revise paragraph
(d)(2) to read as follows:
§ 520.1044c
Gentamicin sulfate powder.
*
*
*
*
*
(d) * * *
(2) Indications for use. For control
and treatment of colibacillosis in
weanling swine caused by strains of
Escherichia coli sensitive to gentamicin,
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
and for control and treatment of swine
dysentery associated with Brachyspira
hyodysenteriae.
*
*
*
*
*
■ 11. In § 520.1660d, revise paragraphs
(d)(1)(iii)(A) and (C) to read as follows:
§ 520.1660d
Oxytetracycline powder.
*
*
*
*
*
(d) * * *
(1) * * *
(iii) * * *
(A) Amount. Administer 10
milligrams per pound of body weight
daily in drinking water. Administer up
to 14 days; do not use for more than 14
consecutive days those products
sponsored by Nos. 054771, 061133, and
069254. Administer up to 5 days; do not
use for more than 5 consecutive days
those products sponsored by Nos.
016592 and 061133.
*
*
*
*
*
(C) Limitations. Withdraw zero days
prior to slaughter. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
*
*
*
*
*
■ 12. In § 520.1780, revise paragraph
(c)(2) to read as follows:
§ 520.1780
Pimobendan.
*
*
*
*
*
(c) * * *
(2) Indications for use. For the
management of the signs of mild,
moderate, or severe congestive heart
failure in dogs due to clinical
myxomatous mitral valve disease
(MMVD) or dilated cardiomyopathy
(DCM); for use with concurrent therapy
for congestive heart failure (e.g.,
furosemide, etc.) as appropriate on a
case-by-case basis.
*
*
*
*
*
■ 13. In § 520.2130, revise paragraph (a)
to read as follows:
§ 520.2130
Spinosad.
(a) Specifications. Each chewable
tablet contains 140, 270, 560, 810, or
1620 milligrams (mg) spinosad.
*
*
*
*
*
■ 14. In § 520.2220a, revise paragraphs
(d)(1)(iii) and (d)(2)(iii) to read as
follows:
§ 520.2220a Sulfadimethoxine oral
solution and soluble powder.
*
*
*
*
*
(d) * * *
(1) * * *
(iii) Limitations. Withdraw 5 days
before slaughter. Do not administer to
chickens over 16 weeks (112 days) of
age. Federal law restricts this drug to
use by or on the order of a licensed
veterinarian.
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(2) * * *
(iii) Limitations. Withdraw 5 days
before slaughter. Do not administer to
turkeys over 24 weeks (168 days) of age.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
*
*
*
*
*
§ 520.2260b
[Amended]
15. In § 520.2260b, remove and
reserve paragraphs (b) and (e); and in
paragraph (f)(2)(ii) remove ‘‘diptheria’’
and in its place add ‘‘diphtheria’’.
■
16. In § 520.2604, revise paragraph
(c)(2) to read as follows:
■
§ 520.2604
tablets.
Trimeprazine with prednisolone
*
*
*
*
*
(c) * * *
(2) Indications for use. For the relief
of itching regardless of cause; and for
reduction of inflammation commonly
associated with most skin disorders of
dogs such as eczema, caused by internal
disorders, otitis, and dermatitis, allergic,
parasitic, pustular, and nonspecific
origins. As adjunctive therapy in
various cough conditions including
treatment of ‘‘kennel cough’’ or
tracheobronchitis, bronchitis including
allergic bronchitis, infections, and
coughs of nonspecific origin.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
17. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 522.558
[Amended]
18. In § 522.558, in paragraph (b)(1),
remove ‘‘026637’’ and in its place add
‘‘017033’’.
■
19. In § 522.812, revise paragraph
(b)(1) to read as follows:
■
§ 522.812
Enrofloxacin.
khammond on DSKJM1Z7X2PROD with RULES
*
*
*
*
*
(b) * * *
(1) Nos. 016729, 017033, 055529,
058198, and 086101 for use of product
described in paragraph (a)(1) as in
paragraph (e)(1) of this section; and
*
*
*
*
*
§ 522.840
[Amended]
20. In § 522.840, in paragraph (d)(2),
in the first sentence, remove ‘‘confined
steers and heifers’’ and in its place add
‘‘steers and heifers fed in confinement
for slaughter’’.
■
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§ 522.842
[Redesignated as § 522.2343]
21. Redesignate § 522.842 as
§ 522.2343.
■ 22. In § 522.955:
■ a. Revise paragraph (b)(2);
■ b. Redesignate paragraph (b)(3) as
paragraph (b)(4) and add new paragraph
(b)(3);
■ c. In paragraphs (d)(1)(ii)(A)(2) and
(d)(1)(ii)(B)(2), remove ‘‘Haemophilus
somnus’’ and in its place add
‘‘Histophilus somni’’;
■ d. Revise paragraph (d)(1)(ii)(C); and
■ e. Add paragraph (d)(2).
The revisions and additions read as
follows:
■
§ 522.955
Florfenicol.
*
*
*
*
*
(b) * * *
(2) No. 000061 for use of product
described in paragraph (a)(2) of this
section as in paragraphs (d)(1)(ii) and
(d)(2) of this section.
(3) No. 086050 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d)(1)(ii) of this
section.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) * * *
(C) Limitations. Animals intended for
human consumption must not be
slaughtered within 28 days of the last
intramuscular treatment. No. 000061:
Animals intended for human
consumption must not be slaughtered
within 38 days of subcutaneous
treatment. No. 055529: Animals
intended for human consumption must
not be slaughtered within 33 days of
subcutaneous treatment. This 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 in pre-ruminating calves. Do
not use in calves to be processed for
veal. Federal law restricts this drug to
use by or on the order of a licensed
veterinarian.
(2) Swine—(i) 300 mg/mL florfenicol
in the inactive vehicles n-methyl-2pyrrolidone, propylene glycol, and
polyethylene glycol:
(A) Amount. 15 mg/kg of body weight
as an intramuscular injection. A second
dose should be administered 48 hours
later.
(B) Indications for use. For the
treatment of swine respiratory disease
associated with Actinobacillus
pleuropneumoniae, Pasteurella
multocida, Salmonella Choleraesuis,
Streptococcus suis, Bordetella
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10969
bronchiseptica, and Glaesserella
(Haemophilus) parasuis in swine except
for nursing piglets and swine of
reproductive age intended for breeding.
(C) Limitations. Swine intended for
human consumption must not be
slaughtered within 11 days of the last
intramuscular treatment. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(ii) [Reserved]
■ 23. In § 522.1156, revise paragraph
(c)(1) to read as follows:
§ 522.1156
Imidocarb solution.
*
*
*
*
*
(c) * * *
(1) Amount. Administer 6.6 mg per
kilogram (3 mg per pound) of body
weight by intramuscular or
subcutaneous injection. Repeat the dose
after 2 weeks for a total of two
treatments.
*
*
*
*
*
■ 24. Add § 522.2065 to read as follows:
§ 522.2065
Rabacfosadine.
(a) Specifications. Each vial of powder
contains 16.4 milligrams (mg)
rabacfosadine. Each milliliter of
constituted solution contains 8.2 mg
rabacfosadine.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer rabacfosadine at 1
mg/kilogram body weight as a 30minute intravenous infusion, once every
3 weeks, for up to 5 doses.
(2) Indications for use. For the
treatment of lymphoma in dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 25. Revise the section heading of
newly designated § 522.2343 to read as
follows:
§ 522.2343 Testosterone propionate and
estradiol benzoate.
26. In § 522.2470, revise paragraph (b)
introductory text to read as follows:
■
§ 522.2470
injection.
Tiletamine and zolazepam for
*
*
*
*
*
(b) Sponsors. See Nos. 026637,
051311, and 054771 in § 510.600(c) of
this chapter.
*
*
*
*
*
■ 27. In § 522.2477, revise paragraph
(b)(2), remove paragraph (d)(1)(i)(G),
and add paragraph (d)(6) to read as
follows:
§ 522.2477
estradiol.
*
Trenbolone acetate and
*
*
(b) * * *
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*
*
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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations
(2) No. 000061 for use as in
paragraphs (d)(1)(i)(A), (d)(1)(i)(C),
(d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii),
(d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(D),
(d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A),
(d)(3)(ii), (d)(3)(iii), (d)(4), (d)(5), and
(d)(6) of this section.
*
*
*
*
*
(d) * * *
(6) Steers fed in confinement for
slaughter—(i) Amount. Each extendedrelease implant contains 200 mg
trenbolone acetate and 40 mg estradiol
(one implant consisting of 6 coated and
4 uncoated pellets, each containing 20
mg trenbolone acetate and 4 mg
estradiol).
(ii) Indications for use. For increased
rate of weight gain and improved feed
efficiency for up to 200 days after
implantation.
(iii) Limitations. Administer implant
subcutaneously in the ear only. Do not
use in lactating dairy cows or in animals
intended for subsequent breeding. Use
in these cattle may cause drug residues
in milk and/or in calves born to these
cows. A withdrawal period has not been
established for this product in preruminating calves. Do not use in calves
to be processed for veal. Effectiveness
and animal safety in veal calves have
not been established. Not approved for
repeated implantation (reimplantation)
with this or any other cattle ear implant
during the production phase(s)
identified on labeling (steers fed in
confinement for slaughter) unless
otherwise indicated on labeling because
safety and effectiveness have not been
evaluated.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
28. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
29. In § 524.770, revise paragraphs
(e)(1) and (e)(3) to read as follows:
■
§ 524.770
khammond on DSKJM1Z7X2PROD with RULES
*
Doramectin.
*
*
*
*
(e) * * *
(1) Amount. Administer topically 1
mL (5 mg doramectin) per 22 lb (10 kg)
of body weight.
*
*
*
*
*
(3) Limitations. Cattle must not be
slaughtered for human consumption
within 45 days of treatment. Not for use
in female dairy cattle 20 months of age
or older. A withdrawal period has not
been established for this product in preruminating calves. Do not use in calves
to be processed for veal.
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
30. The authority citation for part 529
continues to read as follows:
■
33. The authority citation for part 556
continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
34. In § 556.710, revise paragraph (c)
to read as follows:
■
§ 556.710
Testosterone.
*
*
*
*
*
(c) Related conditions of use. See
§ 522.2343 of this chapter.
[Redesignated as § 529.1004]
35. The authority citation for part 558
continues to read as follows:
■
31. Redesignate § 529.1030 as
§ 529.1004.
■ 32. In § 529.1940, revise paragraph
(e)(1)(iii) to read as follows:
■
§ 529.1940
inserts.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
Authority: 21 U.S.C. 360b.
§ 529.1030
as provided by No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
36. In § 558.59, redesignate paragraph
(d) as paragraph (e) and add new
paragraph (d) to read as follows:
■
Progesterone intravaginal
*
*
*
*
*
(e) * * *
(1) * * *
(iii) Limitations. Do not use in beef or
dairy heifers of insufficient size or age
for breeding or in animals with
abnormal, immature, or infected genital
tracts. Do not use in anestrous lactating
dairy cows less than 42 days or greater
than 78 days postpartum. Do not use in
lactating dairy cows less than 40 days
postpartum. Do not use in beef cows
that are less than 20 days postpartum.
Do not use an insert more than once. To
prevent the potential transmission of
venereal and bloodborne diseases, the
inserts should be disposed after a single
use. Administration of vaginal inserts
for periods greater than 7 days may
result in reduced fertility. Dinoprost
injection for use in paragraphs
(e)(1)(ii)(A) and (e)(1)(ii)(B) of this
section as in § 522.690 of this chapter,
§ 558.59
Apramycin.
*
*
*
*
*
(d) Special considerations. (1) Federal
law restricts medicated feed containing
this veterinary feed directive (VFD) drug
to use by or on the order of a licensed
veterinarian. See § 558.6 for additional
requirements.
(2) The expiration date of VFDs for
apramycin medicated feeds must not
exceed 6 months from the date of
issuance. VFDs for apramycin shall not
be refilled.
*
*
*
*
*
■ 37. In § 558.205, revise paragraphs
(d)(1) and (2) to read as follows:
§ 558.205
Diclazuril.
*
*
*
*
*
(d) * * *
(1) Chickens. For chickens it is used
as follows:
Diclazuril
grams/ton
Combination
grams/ton
Indications for use
Limitations
(i) 0.91 ............
......................................
Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix,
E. acervulina, E. brunetti, E. mitis (mivati),
and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle,
subclinical intestinal lesions may be present
for a short time after infection. Diclazuril was
shown in studies to reduce lesion scores and
improve performance and health of birds
challenged with E. maxima.
Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption.
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058198
Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations
10971
Diclazuril
grams/ton
Combination
grams/ton
Indications for use
Limitations
(ii) 0.91 ...........
Bacitracin
methylenedisalicylate,
4 to 50.
Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption.
Bacitracin
methylenedisalicylate provided by
No. 054771 in § 510.600(c) of
this chapter.
058198
(iii) 0.91 ..........
Bambermycins, 1 to 2 ..
Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix,
E. acervulina, E. brunetti, E. mitis (mivati),
and E. maxima, and for increased rate of
weight gain and improved feed efficiency. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal
lesions may be present for a short time after
infection. Diclazuril was shown in studies to
reduce lesion scores and improve performance and health of birds challenged with E.
maxima.
Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix,
E. acervulina, E. brunetti, E. mitis (mivati),
and E. maxima, and for increased rate of
weight gain and improved feed efficiency. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal
lesions may be present for a short time after
infection. Diclazuril was shown in studies to
reduce lesion scores and improve performance and health of birds challenged with E.
maxima.
Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bambermycins provided by
No. 016592 in § 510.600(c) of
this chapter.
058198
Sponsor
(2) Turkeys. For turkeys it is used as
follows:
Diclazuril
grams/ton
Combination
grams/ton
Indications for use
Limitations
(i) 0.91 ............
......................................
Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E.
gallopavonis, and E. meleagrimitis.
(ii) 0.91 ...........
Bacitracin
methylenedisalicylate,
4 to 50.
Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E.
gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved
feed efficiency.
(iii) 0.91 ..........
Bambermycins 1 to 2 ...
Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E.
gallopavonis, and E. meleagrimitis, and for
improved feed efficiency.
(iv) 0.91 ..........
Bambermycins 2 ..........
Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E.
gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved
feed efficiency.
Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption.
Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption.
Bacitracin
methylenedisalicylate as provided
by No. 054771 in § 510.600(c) of
this chapter.
Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bambermycins as provided
by No. 016592 in § 510.600(c) of
this chapter.
Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bambermycins as provided
by No. 016592 in § 510.600(c) of
this chapter.
khammond on DSKJM1Z7X2PROD with RULES
§ 558.254
[Amended]
VerDate Sep<11>2014
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39. In § 558.261, revise paragraph
(e)(2)(ii) to read as follows:
■
38. In § 558.254, in paragraph (e)
introductory text, remove ‘‘Table 2—
Size Proxies for SRCs in 2016’’.
■
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§ 558.261
*
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*
(e) * * *
(2) * * *
Florfenicol.
*
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*
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*
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Florfenicol in
grams/ton of feed
*
(ii) 182 to 1,816 .........
*
Indications for use
*
*
*
*
*
*
Freshwater-reared salmonids: For the control Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg
of mortality due to coldwater disease associflorfenicol per kg of fish. Feed containing florfenicol shall not be fed
ated with Flavobacterium psychrophilum and
for more than 10 days. Following administration, fish should be refurunculosis associated with Aeromonas
evaluated by a licensed veterinarian before initiating a further course
salmonicida.
of therapy. The effects of florfenicol on reproductive performance
have not been determined. Feeds containing florfenicol must be
withdrawn 15 days prior to slaughter.
*
*
*
*
§ 558.311
■
*
*
*
*
*
39. In § 558.311, add paragraph
(e)(3)(ix) to read as follows:
*
*
Lasalocid.
*
*
(e) * * *
*
(3) * * *
*
*
Lasalocid
amount
Indications for use
Limitations
*
(ix) 60 to 300
mg of
lasalocid per
head per day.
*
*
Growing beef steers and heifers on pasture (stocker, feeder, and slaughter)
and replacement beef and dairy heifers on pasture: For increased rate of
weight gain.
*
*
*
Feed continuously as a Type C free-choice medicated feed at a
rate of 60 to 300 mg of lasalocid per head per day. Daily intakes
of lasalocid in excess of 200 mg/head/day have not been shown
to be more effective than 200 mg/head/day.
*
*
*
*
*
40. In § 558.450, revise paragraph
(e)(5)(ii), redesignate paragraphs
(e)(5)(iii) through (vii) as paragraphs
■
(e)(5)(iv) through (viii), and add new
paragraph (e)(5)(iii) to read as follows:
Sponsor
§ 558.450
*
*
Limitations
*
(ii) 200 mg/colony as
a dust (200 mg/oz)
or syrup (200 mg/5
lb).
(iii) 800 mg/colony as
an extender patty
(800 mg/patty).
*
*
*
Honey bees: For control of American foulbrood caused by
Paenibacillus larvae and European foulbrood caused by
Melissococcus plutonius susceptible to oxytetracycline.
*
*
Apply every 4 to 5 days for a total of
three applications. Remove at least 6
weeks prior to main honey flow.
Honey bees: For control of American foulbrood caused by
Paenibacillus larvae and European foulbrood caused by
Melissococcus plutonius susceptible to oxytetracycline.
Use as a single application. Remove at
least 6 weeks prior to main honey flow.
*
*
*
*
*
*
41. In § 558.633, revise paragraph
(d)(3) to read as follows:
■
§ 558.633
Tylvalosin.
*
*
*
*
*
(d) * * *
(3) An expiration date of 1 week is
required for tylvalosin Type C
VerDate Sep<11>2014
18:16 Feb 25, 2022
Jkt 256001
*
*
medicated swine feeds in pelleted or
crumbled form. Pelleted Type C
medicated feeds must bear an expiration
date of 30 days after the date of
manufacture. Crumbled Type C
medicated feeds must bear an expiration
date of 7 days after the date of
manufacture.
*
*
*
*
*
PO 00000
Frm 00048
Fmt 4700
Sfmt 4700
054771
*
Indications for use
*
*
Oxytetracycline.
*
*
(e) * * *
(5) * * *
Oxytetracycline
amount
*
khammond on DSKJM1Z7X2PROD with RULES
Limitations
Sponsor
*
*
066104
069254
066104
069254
*
42. In § 558.635, revise paragraph
(e)(1)(iv) to read as follows:
■
§ 558.635
*
*
Virginiamycin.
*
(e) * * *
(1) * * *
E:\FR\FM\28FER1.SGM
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*
*
10973
Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations
Virginiamycin
in grams/ton
Combination
in grams/ton
*
(iv) 20 ..............
*
Diclazuril, 0.91
*
*
*
Indications for use
*
*
*
*
Broiler chickens: For prevention of necrotic enteritis Feed continuously as the sole racaused by Clostridium perfringens susceptible to
tion. Do not feed to birds provirginiamycin; and for the prevention of coccidiosis
ducing eggs for human concaused by Eimeria tenella, E. necatrix, E. acervulina,
sumption. Diclazuril as provided
E. brunetti, E. mitis (mivati), and E. maxima. Because
by No. 058198 in § 510.600(c)
diclazuril is effective against E. maxima later in its life
of this chapter.
cycle, subclinical intestinal lesions may be present for a
short time after infection. Diclazuril was shown in studies to reduce lesions scores and improve performance
and health of birds challenged with E. maxima.
*
*
*
*
*
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
DEPARTMENT OF HOMELAND
SECURITY
CFR Code of Federal Regulations
COTP Captain of the Port Sector New
Orleans
DHS Department of Homeland Security
FR Federal Register
TFR Temporary Final Rule
§ Section
U.S.C. United States Code
Coast Guard
33 CFR Part 165
[Docket Number USCG–2022–0084]
RIN 1625–AA87
II. Background Information and
Regulatory History
Security Zone; Lower Mississippi
River, New Orleans, LA
Coast Guard, DHS.
ACTION: Temporary final rule.
AGENCY:
The Coast Guard is
establishing a temporary security zone
for all navigable waters within 400
yards of the Left Descending Bank (LDB)
of the Lower Mississippi River (LMR)
MM 94.4 and MM 95.1, Above Head of
Passes (AHP), New Orleans, LA. This
security zone is necessary to provide
security and protection for visiting
personnel during the events related to
the Mardi Gras Celebrations. Entry of
vessels or persons into this zone is
prohibited unless specifically
authorized by the Captain of the Port
New Orleans (COTP) or a designated
representative.
DATES: This rule is effective from 6 p.m.
on February 25, 2022, through 11:59
p.m. on March 1, 2022.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2022–
0084 in the search box and click
‘‘Search.’’ Next, in the Document Type
column, select ‘‘Supporting & Related
Material.’’
SUMMARY:
khammond on DSKJM1Z7X2PROD with RULES
*
If
you have questions on this rule, call or
email Lieutenant Commander, William
A. Stewart, Sector New Orleans, U.S.
Coast Guard; telephone 504–365–2246,
email William.A.Stewart@uscg.mil.
[FR Doc. 2022–03538 Filed 2–25–22; 8:45 am]
16:12 Feb 25, 2022
*
FOR FURTHER INFORMATION CONTACT:
Dated: February 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
VerDate Sep<11>2014
Limitations
Jkt 256001
The Coast Guard is issuing this
temporary rule without prior notice and
opportunity to comment pursuant to
authority under section 4(a) of the
Administrative Procedure Act (APA) (5
U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because it
would be impracticable. We must
establish this security zone by February
25, 2022 in order to provide proper
security for these visiting personnel,
and we do not have sufficient time to
request and respond to comments.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. Delaying the effective date of
this rule would be contrary to the public
interest because immediate action is
needed to provide adequate security to
protect the public.
PO 00000
Frm 00049
Fmt 4700
Sfmt 4700
*
Sponsor
*
058198
*
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 46 U.S.C. 70034
(previously 33 U.S.C. 1231). The
Captain of the Port New Orleans (COTP)
has determined that the increased
number of personnel anticipated to be
visiting the city during the Mardi Gras
Celebration requires certain security
measures to ensure that the persons and
property are kept secure during the
events. The Coast Guard determined
that a temporary security zone is needed
for this and related events that will be
taking place adjacent to a portion of
Lower Mississippi River (LMR).
IV. Discussion of the Rule
This rule establishes a security zone
from 6 p.m. on February 25, 2022
through 11:59 p.m. on March 1, 2022.
The security zone will cover all
navigable waters within 400 yards of the
Left Descending Bank (LDB) of the LMR
from MM 94.4 and MM 95.1, Above
Head of Passes (AHP), New Orleans, LA.
This zone is necessary in order to
provide to provide waterside security
for the protection of visitors attending
the events related to the Mardi Gras
Celebrations. No vessel or person will
be permitted to enter the security zone
without obtaining permission from the
COTP or a designated representative. A
designated representative is a
commissioned, warrant, or petty officer
of the U.S. Coast Guard assigned to
units under the operational control of
USCG Sector New Orleans. They may be
contacted on VHF–FM Channel 16 or 67
or by telephone at 504–365–2545.
Persons and vessels permitted to enter
this security zone must transit at their
slowest safe speed and comply with all
lawful directions issued by the COTP or
the designated representative.
The COTP or a designated
representative will inform the public of
the enforcement times and date for this
regulated area through Broadcast
Notices to Mariners (BNMs), Local
E:\FR\FM\28FER1.SGM
28FER1
]]>Agencies
[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Rules and Regulations]
[Pages 10964-10973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03538]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 500, 510, 516, 520, 522, 524, 529, 556, and 558
[Docket No. FDA-2021-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of a New Animal Drug Application; Change of
Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and a conditionally approved new animal drug
application (cNADA) during July, August, and September 2021. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to improve the accuracy
of the regulations.
DATES: This rule is effective February 28, 2022. The incorporation by
reference of certain material listed in this rule is approved by the
Director of the Federal Register as February 28, 2022. The
incorporation by reference of other material listed in this rule was
approved by the Director of the Federal Register as of November 25,
2011.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July, August, and September 2021,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons
with access to the internet may obtain these documents at the CVM FOIA
Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing
exclusivity and patent information may be accessed in FDA's
publication, ``Approved Animal Drug Products Online (Green Book)'' at:
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
[[Page 10965]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effect of the
Approval date File No. Sponsor Product name Species action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 7, 2021.............. 200-703 Dechra Veterinary Carprofen Tablets.. Dogs................... Original approval FOI Summary.
Products LLC, 7015 as a generic copy
College Blvd., of NADA 141-053.
Suite 525,
Overland Park, KS
66211.
July 15, 2021............. 141-545 VetDC, Inc., 320 E TANOVEA Dogs................... Full approval of FOI Summary.
Vine Dr., Suite (rabacfosadine for conditionally
218, Fort Collins, injection) Powder approved cNADA
CO 80524. for Injection. 141-475 for the
treatment of
lymphoma.
August 2, 2021............ 200-708 Felix Enrofloxacin Dogs................... Original approval FOI Summary.
Pharmaceuticals Antibacterial as a generic copy
PVT Ltd., 25-288 Injectable of NADA 140-913.
North Wall Quay, Solution 2.27%.
Dublin, 1, Ireland.
August 16, 2021........... 200-618 Virbac AH, Inc., PO ZOLETIL (tiletamine Dogs and cats.......... Original approval FOI Summary.
Box 162059, Fort and zolazepam for as a generic copy
Worth, TX 76161. Injection). of NADA 106-111.
August 18, 2021........... 200-709 Cronus Pharma Amoxicillin and Dogs and cats.......... Original approval FOI Summary.
Specialties India Clavulanate as a generic copy
Private Ltd., Sy Potassium for Oral of NADA 055-101.
No-99/1, M/s GMR Suspension.
Hyderabad Aviation
SEZ Ltd.,
Mamidipalli
Village,
Shamshabad Mandal,
Ranga Reddy,
Hyderabad,
Telangana, 501218,
India.
August 19, 2021........... 141-063 Intervet, Inc., 2 NUFLOR-S Swine.................. Supplemental FOI Summary.
Giralda Farms, (florfenicol) approval for the
Madison, NJ 07940. Injectable treatment of
Solution. swine respiratory
disease.
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Withdrawal of Approval
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has
requested that FDA withdraw approval of NADA 093-329 for use of a
sustained-release bolus containing sulfamethazine in cattle because the
product is no longer manufactured or marketed. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect this action. Elsewhere in this issue of the Federal
Register, FDA gave notice that approval of NADA 093-329, and all
supplements and amendments thereto, is withdrawn.
III. Change of Sponsor
VetDC, Inc., 320 E Vine Dr., Suite 218, Fort Collins, CO 80524, has
informed FDA that it has transferred ownership of, and all rights and
interest in, newly approved NADA 141-545 for TANOVEA (rabacfosadine)
for Injection to Elanco US Inc., 2500 Innovation Way, Greenfield, IN
46140. The codification of this application in new 21 CFR 522.2065 will
reflect this change of sponsorship.
IV. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
21 CFR 500.1410 is amended to add uncooked edible tissues
of swine to the standard for residues of n-methyl-2-pyrrolidone.
21 CFR 510.600 is amended to have sponsor addresses
conform to the current style.
21 CFR 520.905c is amended to reflect the current label
indications for use of fenbendazole paste in horses.
21 CFR 520.1044c is amended to reflect a current swine
pathogen name for gentamicin soluble powder.
21 CFR 520.1660d is amended to revise conditions of use of
oxytetracycline in drinking water of swine to reflect approved
applications.
21 CFR 520.1780 is amended to revise the indications for
use of pimobendan tablets in dogs.
21 CFR 520.2130 is amended to remove the 90-milligram
strength for spinosad chewable tablets.
21 CFR 520.2220a is amended to add human food safety
warnings for use of sulfadimethoxine concentrate solution and soluble
powder.
21 CFR 520.2260b is amended to reflect the voluntary
withdrawal of approval of an application for sustained-release boluses
containing sulfamethazine and to correct the spelling of a disease
condition.
21 CFR 520.2604 is amended to revise indications for use
of tablets in dogs containing trimeprazine with prednisolone.
21 CFR 522.558 is amended to reflect the drug labeler code
for the current sponsor of a dexmedetomidine injectable solution.
21 CFR 522.840 is amended to reflect the current classes
of cattle approved for use of estradiol ear implants.
21 CFR 522.842 for testosterone propionate and estradiol
benzoate implants is renamed to list the drug with the higher
concentration first and redesignated to be listed in alphabetical
order.
21 CFR 522.955 is amended to reflect the current
scientific name of a bovine pathogen and the withdrawal
[[Page 10966]]
periods for different formulations of florfenicol injectable solution.
21 CFR 522.1156 is amended to add subcutaneous
administration to the approved conditions of use of imidocarb
dipropionate solution in dogs.
21 CFR 522.2477 is amended to reorganize an approved use
of trenbolone acetate and estradiol implants in steers.
21 CFR 524.770 is amended to reflect current label dosage
information and human food safety warnings.
21 CFR 529.1030 is redesignated as Sec. 529.1004 in
conformity with an announced FDA numbering system (40 FR 13802, March
27, 1975).
21 CFR 529.1940 is amended to add limitations to the use
of progesterone intravaginal inserts in cows.
21 CFR 558.59 is amended to reference apramycin's status
as a veterinary feed directive (VFD) drug and to add current
limitations on VFD refills for apramycin medicated feeds.
21 CFR 558.205 is amended to reflect a current egg food
safety warning for broiler chickens and growing turkeys fed Type C
medicated feeds containing diclazuril.
21 CFR 558.254 is amended to remove an erroneous table
title.
21 CFR 558.261 is amended to correct the upper inclusion
rate for florfenicol in Type C medicated feed for freshwater-reared
salmonids.
21 CFR 558.311 is being amended to codify free-choice Type
C medicated cattle feeds containing lasalocid.
21 CFR 558.450 is amended to add conditions of use in
honey bees for a Type C extender patty containing oxytetracycline.
21 CFR 558.633 is amended to add manufacturing limitations
for use of Type C medicated swine feeds containing tylvalosin.
21 CFR 558.635 is amended to reflect a current egg food
safety warning for broiler chickens fed Type C medicated feeds
containing virginiamycin and diclazuril.
V. Incorporation by Reference
FDA is incorporating by reference an analytical method approved by
the Office of the Federal Register in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. To obtain a copy of the analytical method, go to:
https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. You may inspect a copy at the office of the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9
a.m. and 4 p.m., Monday through Friday.
This standard adds a method of detection for total for residues of
the carcinogenic excipient n-methyl-2-pyrrolidone in uncooked edible
swine tissues to a section established for a method for residues of n-
methyl-2-pyrrolidone in uncooked edible cattle tissues.
VI. 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 500
Animal drugs, Animal feeds, Cancer, Incorporation by reference,
Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs).
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
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
500, 510, 516, 520, 522, 524, 529, 556, and 558 are amended as follows:
PART 500--GENERAL
0
1. The authority citation for part 500 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371, 379e.
0
2. Revise Sec. 500.1410 to read as follows:
Sec. 500.1410 N-methyl-2-pyrrolidone.
(a) Standard for residues. No residues of n-methyl-2-pyrrolidone
may be found in the uncooked edible tissues of cattle and swine as
determined by methods in paragraph (b) of this section.
(b) Incorporation by reference. The standards required in this
section are incorporated by reference into this section with the
approval of the Director of the Federal Register under 5 U.S.C. 552(a)
and 1 CFR part 51. All approved material is available for inspection at
the Food and Drug Administration's Dockets Management Staff (HFA-305),
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between
9 a.m. and 4 p.m., Monday through Friday. It may be obtained from the
sources indicated elsewhere in paragraph (b) of this section and at:
https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. It is also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) Food and Drug Administration, Center for Veterinary Medicine,
7500 Standish Pl., Rockville, MD 20855, 240-402-7002.
(i) ``Method of Analysis: N-methyl-2-pyrrolidone,'' September 26,
2011; the method of analysis for uncooked edible tissues of cattle.
(ii) [Reserved]
(2) Merck Animal Health, 29160 Intervet Lane, Millsboro, DE 19966,
1-800-211-3573.
(i) ``Determinative and Confirmatory Procedures for the Analysis of
N-Methyl-2-pyrrolidone (NMP) in Swine Liver Tissue using LC-MS/MS,''
July 20, 2017; the method of analysis for uncooked edible tissues of
swine.
(ii) [Reserved]
[[Page 10967]]
(c) Related conditions of use. See Sec. Sec. 522.814 and 522.955
of this chapter.
PART 510--NEW ANIMAL DRUGS
0
3. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
0
4. In Sec. 510.600:
0
a. In the table in paragraph (c)(1), revise the entries for ``Anzac
Animal Health, LLC'', ``AquaBounty Technologies, Inc.'', ``Dechra
Veterinary Products LLC'', ``Halocarbon Products Corp.'', ``Kindred
Biosciences, Inc.'', ``Mizner Bioscience LLC'', ``QBiotics Group
Ltd.'', ``Revivicor, Inc.'', and ``Ridley USA, Inc.'', remove ``Suite''
and in its place add ``suite''; and
0
b. In the table in paragraph (c)(2), revise the entries for ``012164'',
``017033'', ``067949'', ``086039'', ``086053'', ``086073'', ``086078'',
``086132'', and ``086134''.
The revisions read as follows:
(c) * * *
(1) Alphabetical Listing of Sponsors
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 086121
400, Long Beach, CA 90807..............................
Anzac Animal Health, LLC, 218 Millwell Dr., suite B, 086073
Maryland Heights, MO 63043.............................
AquaBounty Technologies, Inc., 2 Mill and Main Pl., 086053
Suite 395, Maynard, MA 01754...........................
* * * * * * *
Dechra Veterinary Products LLC, 7015 College Blvd., 017033
Suite 525, Overland Park, KS 66211.....................
* * * * * * *
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 012164
200, Peachtree Corners, GA 30092.......................
* * * * * * *
Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 086078
200, Burlingame, CA 94010..............................
* * * * * * *
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, 086039
Boca Raton, FL 33432...................................
* * * * * * *
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., 086132
Taringa, Queensland 4068, Australia....................
* * * * * * *
Revivicor, Inc., a wholly owned subsidiary of United 086134
Therapeutics Corp., 1700 Kraft Dr., Suite 2400,
Blacksburg, VA 24060...................................
Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, 067949
MN 56001...............................................
* * * * * * *
------------------------------------------------------------------------
(2) Numerical Listing of Sponsors
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
012164.................. Halocarbon Products Corp., 6525 The Corners
Pkwy., Suite 200, Peachtree Corners, GA
30092.
* * * * * * *
017033.................. Dechra Veterinary Products LLC, 7015 College
Blvd., Suite 525, Overland Park, KS 66211.
* * * * * * *
067949.................. Ridley USA, Inc., 111 W Cherry St., Suite 500,
Mankato, MN 56001.
* * * * * * *
086039.................. Mizner Bioscience LLC, 225 NE Mizner Blvd.,
Suite 760, Boca Raton, FL 33432.
* * * * * * *
086053.................. AquaBounty Technologies, Inc., 2 Mill and Main
Pl., Suite 395, Maynard, MA 01754.
* * * * * * *
086073.................. Anzac Animal Health, LLC, 218 Millwell Dr.,
Suite B, Maryland Heights, MO 63043.
086078.................. Kindred Biosciences, Inc., 1555 Bayshore Hwy.,
Suite 200, Burlingame, CA 94010.
* * * * * * *
086121.................. Anivive Lifesciences, Inc., 3250 Airflite Way,
Suite 400, Long Beach, CA 90807.
086132.................. QBiotics Group Ltd., Suite 3A, Level 1, 165
Moggill Rd., Taringa, Queensland 4068,
Australia.
086134.................. Revivicor, Inc., a wholly owned subsidiary of
United Therapeutics Corp., 1700 Kraft Dr.,
Suite 2400, Blacksburg, VA 24060
* * * * * * *
------------------------------------------------------------------------
[[Page 10968]]
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
5. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc, 360ccc-2, 371.
Sec. 516.2065 [Removed]
0
6. Remove Sec. 516.2065.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
8. Revise Sec. 520.88h to read as follows:
Sec. 520.88h Amoxicillin trihydrate and clavulanate potassium for
oral suspension.
(a) Specifications. When constituted, each milliliter (mL) of
suspension contains amoxicillin trihydrate equivalent to 50 milligrams
(mg) amoxicillin and clavulanate potassium equivalent to 12.5 mg
clavulanic acid.
(b) Sponsors. See Nos. 054771 and 069043 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. 6.25 mg/lb (1 mL/10 lb
of body weight) twice a day. Skin and soft tissue infections such as
abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and
periodontal infections should be treated for 5 to 7 days or for 48
hours after all signs have subsided. If no response is seen after 5
days of treatment, therapy should be discontinued and the case
reevaluated. Deep pyoderma may require treatment for 21 days; the
maximum duration of treatment should not exceed 30 days.
(ii) Indications for use. Treatment of skin and soft tissue
infections such as wounds, abscesses, cellulitis, superficial/juvenile
and deep pyoderma due to susceptible strains of the following
organisms: beta-lactamase-producing Staphylococcus aureus, non-beta-
lactamase-producing Staphylococcus aureus, Staphylococcus spp.,
Streptococcus spp., and Escherichia coli. Treatment of periodontal
infections due to susceptible strains of both aerobic and anaerobic
bacteria.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. 62.5 mg (1 mL) twice daily. Skin and soft
tissue infections such as abscesses and cellulitis/dermatitis should be
treated for 5 to 7 days or 48 hours after all symptoms have subsided,
not to exceed 30 days. If no response is seen after 3 days of
treatment, therapy should be discontinued and the case reevaluated.
Urinary tract infections may require treatment for 10 to 14 days or
longer. The maximum duration of treatment should not exceed 30 days.
(ii) Indications for use. Treatment of skin and soft tissue
infections, such as wounds, abscesses, and cellulitis/dermatitis due to
susceptible strains of the following organisms: beta-lactamase-
producing Staphylococcus aureus, non-beta-lactamase-producing
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp.,
Escherichia coli, Pasteurella multocida, and Pasteurella spp. Urinary
tract infections (cystitis) due to susceptible strains of E. coli.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
9. In Sec. 520.905c, revise paragraphs (e)(1)(i) to read as follows:
Sec. 520.905c Fenbendazole paste.
* * * * *
(e) * * *
(1) * * *
(i) Indications for use and amounts. (A) For the treatment and
control of large strongyles (Strongylus edentatus, S. equinus, S.
vulgaris), small strongyles, and pinworms (Oxyuris equi). For large
strongyles, small strongyles, and pinworms, the recommended dose is 5
mg/kg (2.3 mg/lb).
(B) For treatment and control of ascarids (Parascaris equorum). For
ascarids, the recommended dose is 10 mg/kg (4.6 mg/lb).
(C) For treatment and control of hypobiotic (encysted early third-
stage), late third-stage, and fourth-stage cyathostome larvae, as well
as fourth-stage Strongylus vulgaris larvae, the recommended dose is 10
mg/kg (4.6 mg/lb) daily for 5 consecutive days.
(D) For the control of arteritis caused by fourth-stage larvae of
Strongylus vulgaris in horses.
(E) Fenbendazole paste 10 percent may be used concomitantly with
approved forms of trichlorfon for the indications provided in paragraph
(e)(1)(i)(A) of this section and for treating infections of stomach
bots as provided in Sec. 520.2520.
* * * * *
0
10. In Sec. 520.1044c, revise paragraph (d)(2) to read as follows:
Sec. 520.1044c Gentamicin sulfate powder.
* * * * *
(d) * * *
(2) Indications for use. For control and treatment of
colibacillosis in weanling swine caused by strains of Escherichia coli
sensitive to gentamicin, and for control and treatment of swine
dysentery associated with Brachyspira hyodysenteriae.
* * * * *
0
11. In Sec. 520.1660d, revise paragraphs (d)(1)(iii)(A) and (C) to
read as follows:
Sec. 520.1660d Oxytetracycline powder.
* * * * *
(d) * * *
(1) * * *
(iii) * * *
(A) Amount. Administer 10 milligrams per pound of body weight daily
in drinking water. Administer up to 14 days; do not use for more than
14 consecutive days those products sponsored by Nos. 054771, 061133,
and 069254. Administer up to 5 days; do not use for more than 5
consecutive days those products sponsored by Nos. 016592 and 061133.
* * * * *
(C) Limitations. Withdraw zero days prior to slaughter. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
* * * * *
0
12. In Sec. 520.1780, revise paragraph (c)(2) to read as follows:
Sec. 520.1780 Pimobendan.
* * * * *
(c) * * *
(2) Indications for use. For the management of the signs of mild,
moderate, or severe congestive heart failure in dogs due to clinical
myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM);
for use with concurrent therapy for congestive heart failure (e.g.,
furosemide, etc.) as appropriate on a case-by-case basis.
* * * * *
0
13. In Sec. 520.2130, revise paragraph (a) to read as follows:
Sec. 520.2130 Spinosad.
(a) Specifications. Each chewable tablet contains 140, 270, 560,
810, or 1620 milligrams (mg) spinosad.
* * * * *
0
14. In Sec. 520.2220a, revise paragraphs (d)(1)(iii) and (d)(2)(iii)
to read as follows:
Sec. 520.2220a Sulfadimethoxine oral solution and soluble powder.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Withdraw 5 days before slaughter. Do not
administer to chickens over 16 weeks (112 days) of age. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
[[Page 10969]]
(2) * * *
(iii) Limitations. Withdraw 5 days before slaughter. Do not
administer to turkeys over 24 weeks (168 days) of age. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
* * * * *
Sec. 520.2260b [Amended]
0
15. In Sec. 520.2260b, remove and reserve paragraphs (b) and (e); and
in paragraph (f)(2)(ii) remove ``diptheria'' and in its place add
``diphtheria''.
0
16. In Sec. 520.2604, revise paragraph (c)(2) to read as follows:
Sec. 520.2604 Trimeprazine with prednisolone tablets.
* * * * *
(c) * * *
(2) Indications for use. For the relief of itching regardless of
cause; and for reduction of inflammation commonly associated with most
skin disorders of dogs such as eczema, caused by internal disorders,
otitis, and dermatitis, allergic, parasitic, pustular, and nonspecific
origins. As adjunctive therapy in various cough conditions including
treatment of ``kennel cough'' or tracheobronchitis, bronchitis
including allergic bronchitis, infections, and coughs of nonspecific
origin.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
17. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.558 [Amended]
0
18. In Sec. 522.558, in paragraph (b)(1), remove ``026637'' and in its
place add ``017033''.
0
19. In Sec. 522.812, revise paragraph (b)(1) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(1) Nos. 016729, 017033, 055529, 058198, and 086101 for use of
product described in paragraph (a)(1) as in paragraph (e)(1) of this
section; and
* * * * *
Sec. 522.840 [Amended]
0
20. In Sec. 522.840, in paragraph (d)(2), in the first sentence,
remove ``confined steers and heifers'' and in its place add ``steers
and heifers fed in confinement for slaughter''.
Sec. 522.842 [Redesignated as Sec. 522.2343]
0
21. Redesignate Sec. 522.842 as Sec. 522.2343.
0
22. In Sec. 522.955:
0
a. Revise paragraph (b)(2);
0
b. Redesignate paragraph (b)(3) as paragraph (b)(4) and add new
paragraph (b)(3);
0
c. In paragraphs (d)(1)(ii)(A)(2) and (d)(1)(ii)(B)(2), remove
``Haemophilus somnus'' and in its place add ``Histophilus somni'';
0
d. Revise paragraph (d)(1)(ii)(C); and
0
e. Add paragraph (d)(2).
The revisions and additions read as follows:
Sec. 522.955 Florfenicol.
* * * * *
(b) * * *
(2) No. 000061 for use of product described in paragraph (a)(2) of
this section as in paragraphs (d)(1)(ii) and (d)(2) of this section.
(3) No. 086050 for use of product described in paragraph (a)(2) of
this section as in paragraph (d)(1)(ii) of this section.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(C) Limitations. Animals intended for human consumption must not be
slaughtered within 28 days of the last intramuscular treatment. No.
000061: Animals intended for human consumption must not be slaughtered
within 38 days of subcutaneous treatment. No. 055529: Animals intended
for human consumption must not be slaughtered within 33 days of
subcutaneous treatment. This 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 in pre-
ruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Swine--(i) 300 mg/mL florfenicol in the inactive vehicles n-
methyl-2-pyrrolidone, propylene glycol, and polyethylene glycol:
(A) Amount. 15 mg/kg of body weight as an intramuscular injection.
A second dose should be administered 48 hours later.
(B) Indications for use. For the treatment of swine respiratory
disease associated with Actinobacillus pleuropneumoniae, Pasteurella
multocida, Salmonella Choleraesuis, Streptococcus suis, Bordetella
bronchiseptica, and Glaesserella (Haemophilus) parasuis in swine except
for nursing piglets and swine of reproductive age intended for
breeding.
(C) Limitations. Swine intended for human consumption must not be
slaughtered within 11 days of the last intramuscular treatment. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(ii) [Reserved]
0
23. In Sec. 522.1156, revise paragraph (c)(1) to read as follows:
Sec. 522.1156 Imidocarb solution.
* * * * *
(c) * * *
(1) Amount. Administer 6.6 mg per kilogram (3 mg per pound) of body
weight by intramuscular or subcutaneous injection. Repeat the dose
after 2 weeks for a total of two treatments.
* * * * *
0
24. Add Sec. 522.2065 to read as follows:
Sec. 522.2065 Rabacfosadine.
(a) Specifications. Each vial of powder contains 16.4 milligrams
(mg) rabacfosadine. Each milliliter of constituted solution contains
8.2 mg rabacfosadine.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer rabacfosadine
at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once
every 3 weeks, for up to 5 doses.
(2) Indications for use. For the treatment of lymphoma in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
25. Revise the section heading of newly designated Sec. 522.2343 to
read as follows:
Sec. 522.2343 Testosterone propionate and estradiol benzoate.
0
26. In Sec. 522.2470, revise paragraph (b) introductory text to read
as follows:
Sec. 522.2470 Tiletamine and zolazepam for injection.
* * * * *
(b) Sponsors. See Nos. 026637, 051311, and 054771 in Sec.
510.600(c) of this chapter.
* * * * *
0
27. In Sec. 522.2477, revise paragraph (b)(2), remove paragraph
(d)(1)(i)(G), and add paragraph (d)(6) to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(b) * * *
[[Page 10970]]
(2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C),
(d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(C),
(d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), (d)(3)(ii),
(d)(3)(iii), (d)(4), (d)(5), and (d)(6) of this section.
* * * * *
(d) * * *
(6) Steers fed in confinement for slaughter--(i) Amount. Each
extended-release implant contains 200 mg trenbolone acetate and 40 mg
estradiol (one implant consisting of 6 coated and 4 uncoated pellets,
each containing 20 mg trenbolone acetate and 4 mg estradiol).
(ii) Indications for use. For increased rate of weight gain and
improved feed efficiency for up to 200 days after implantation.
(iii) Limitations. Administer implant subcutaneously in the ear
only. Do not use in lactating dairy cows or in animals intended for
subsequent breeding. Use in these cattle may cause drug residues in
milk and/or in calves born to these cows. A withdrawal period has not
been established for this product in pre-ruminating calves. Do not use
in calves to be processed for veal. Effectiveness and animal safety in
veal calves have not been established. Not approved for repeated
implantation (reimplantation) with this or any other cattle ear implant
during the production phase(s) identified on labeling (steers fed in
confinement for slaughter) unless otherwise indicated on labeling
because safety and effectiveness have not been evaluated.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
28. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
29. In Sec. 524.770, revise paragraphs (e)(1) and (e)(3) to read as
follows:
Sec. 524.770 Doramectin.
* * * * *
(e) * * *
(1) Amount. Administer topically 1 mL (5 mg doramectin) per 22 lb
(10 kg) of body weight.
* * * * *
(3) Limitations. Cattle must not be slaughtered for human
consumption within 45 days of treatment. Not for use in female dairy
cattle 20 months of age or older. A withdrawal period has not been
established for this product in pre-ruminating calves. Do not use in
calves to be processed for veal.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
30. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1030 [Redesignated as Sec. 529.1004]
0
31. Redesignate Sec. 529.1030 as Sec. 529.1004.
0
32. In Sec. 529.1940, revise paragraph (e)(1)(iii) to read as follows:
Sec. 529.1940 Progesterone intravaginal inserts.
* * * * *
(e) * * *
(1) * * *
(iii) Limitations. Do not use in beef or dairy heifers of
insufficient size or age for breeding or in animals with abnormal,
immature, or infected genital tracts. Do not use in anestrous lactating
dairy cows less than 42 days or greater than 78 days postpartum. Do not
use in lactating dairy cows less than 40 days postpartum. Do not use in
beef cows that are less than 20 days postpartum. Do not use an insert
more than once. To prevent the potential transmission of venereal and
bloodborne diseases, the inserts should be disposed after a single use.
Administration of vaginal inserts for periods greater than 7 days may
result in reduced fertility. Dinoprost injection for use in paragraphs
(e)(1)(ii)(A) and (e)(1)(ii)(B) of this section as in Sec. 522.690 of
this chapter, as provided by No. 054771 in Sec. 510.600(c) of this
chapter.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
33. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
34. In Sec. 556.710, revise paragraph (c) to read as follows:
Sec. 556.710 Testosterone.
* * * * *
(c) Related conditions of use. See Sec. 522.2343 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
35. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
36. In Sec. 558.59, redesignate paragraph (d) as paragraph (e) and add
new paragraph (d) to read as follows:
Sec. 558.59 Apramycin.
* * * * *
(d) Special considerations. (1) Federal law restricts medicated
feed containing this veterinary feed directive (VFD) drug to use by or
on the order of a licensed veterinarian. See Sec. 558.6 for additional
requirements.
(2) The expiration date of VFDs for apramycin medicated feeds must
not exceed 6 months from the date of issuance. VFDs for apramycin shall
not be refilled.
* * * * *
0
37. In Sec. 558.205, revise paragraphs (d)(1) and (2) to read as
follows:
Sec. 558.205 Diclazuril.
* * * * *
(d) * * *
(1) Chickens. For chickens it is used as follows:
----------------------------------------------------------------------------------------------------------------
Diclazuril grams/ton Combination grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.91................. ..................... Broiler chickens: For the Feed continuously as 058198
prevention of coccidiosis the sole ration. Do
caused by Eimeria not feed to birds
tenella, E. necatrix, E. producing eggs for
acervulina, E. brunetti, human consumption.
E. mitis (mivati), and E.
maxima. Because
diclazuril is effective
against E. maxima later
in its life cycle,
subclinical intestinal
lesions may be present
for a short time after
infection. Diclazuril was
shown in studies to
reduce lesion scores and
improve performance and
health of birds
challenged with E. maxima.
[[Page 10971]]
(ii) 0.91................ Bacitracin Broiler chickens: For the Feed continuously as 058198
methylenedisalicylat prevention of coccidiosis the sole ration. Do
e, 4 to 50. caused by Eimeria not feed to birds
tenella, E. necatrix, E. producing eggs for
acervulina, E. brunetti, human consumption.
E. mitis (mivati), and E. Bacitracin
maxima, and for increased methylenedisalicylat
rate of weight gain and e provided by No.
improved feed efficiency. 054771 in Sec.
Because diclazuril is 510.600(c) of this
effective against E. chapter.
maxima later in its life
cycle, subclinical
intestinal lesions may be
present for a short time
after infection.
Diclazuril was shown in
studies to reduce lesion
scores and improve
performance and health of
birds challenged with E.
maxima.
(iii) 0.91............... Bambermycins, 1 to 2. Broiler chickens: For the Feed continuously as 058198
prevention of coccidiosis the sole ration. Do
caused by Eimeria not feed to birds
tenella, E. necatrix, E. producing eggs for
acervulina, E. brunetti, human consumption.
E. mitis (mivati), and E. Bambermycins
maxima, and for increased provided by No.
rate of weight gain and 016592 in Sec.
improved feed efficiency. 510.600(c) of this
Because diclazuril is chapter.
effective against E.
maxima later in its life
cycle, subclinical
intestinal lesions may be
present for a short time
after infection.
Diclazuril was shown in
studies to reduce lesion
scores and improve
performance and health of
birds challenged with E.
maxima.
----------------------------------------------------------------------------------------------------------------
(2) Turkeys. For turkeys it is used as follows:
----------------------------------------------------------------------------------------------------------------
Diclazuril grams/ton Combination grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.91................. ..................... Growing turkeys: For the Feed continuously as 058198
prevention of coccidiosis the sole ration. Do
caused by Eimeria not feed to breeding
adenoeides, E. turkeys. Do not feed
gallopavonis, and E. to birds producing
meleagrimitis. eggs for human
consumption.
(ii) 0.91................ Bacitracin Growing turkeys: For the Feed continuously as 058198
methylenedisalicylat prevention of coccidiosis the sole ration. Do
e, 4 to 50. caused by Eimeria not feed to breeding
adenoeides, E. turkeys. Do not feed
gallopavonis, and E. to birds producing
meleagrimitis, and for eggs for human
increased rate of weight consumption.
gain and improved feed Bacitracin
efficiency. methylenedisalicylat
e as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(iii) 0.91............... Bambermycins 1 to 2.. Growing turkeys: For the Feed continuously as 058198
prevention of coccidiosis the sole ration. Do
caused by Eimeria not feed to breeding
adenoeides, E. turkeys. Do not feed
gallopavonis, and E. to birds producing
meleagrimitis, and for eggs for human
improved feed efficiency. consumption.
Bambermycins as
provided by No.
016592 in Sec.
510.600(c) of this
chapter.
(iv) 0.91................ Bambermycins 2....... Growing turkeys: For the Feed continuously as 058198
prevention of coccidiosis the sole ration. Do
caused by Eimeria not feed to breeding
adenoeides, E. turkeys. Do not feed
gallopavonis, and E. to birds producing
meleagrimitis, and for eggs for human
increased rate of weight consumption.
gain and improved feed Bambermycins as
efficiency. provided by No.
016592 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
Sec. 558.254 [Amended]
0
38. In Sec. 558.254, in paragraph (e) introductory text, remove
``Table 2--Size Proxies for SRCs in 2016''.
0
39. In Sec. 558.261, revise paragraph (e)(2)(ii) to read as follows:
Sec. 558.261 Florfenicol.
* * * * *
(e) * * *
(2) * * *
[[Page 10972]]
----------------------------------------------------------------------------------------------------------------
Florfenicol in grams/ton of feed Indications for use Limitations
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 182 to 1,816................... Freshwater-reared salmonids: Feed as a sole ration for 10 consecutive
For the control of mortality days to deliver 10 to 15 mg florfenicol
due to coldwater disease per kg of fish. Feed containing
associated with Flavobacterium florfenicol shall not be fed for more
psychrophilum and furunculosis than 10 days. Following administration,
associated with Aeromonas fish should be reevaluated by a licensed
salmonicida. veterinarian before initiating a further
course of therapy. The effects of
florfenicol on reproductive performance
have not been determined. Feeds
containing florfenicol must be withdrawn
15 days prior to slaughter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
39. In Sec. 558.311, add paragraph (e)(3)(ix) to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(3) * * *
----------------------------------------------------------------------------------------------------------------
Lasalocid amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ix) 60 to 300 mg of lasalocid per Growing beef steers and Feed continuously as a Type C free- 054771
head per day. heifers on pasture choice medicated feed at a rate
(stocker, feeder, and of 60 to 300 mg of lasalocid per
slaughter) and head per day. Daily intakes of
replacement beef and lasalocid in excess of 200 mg/
dairy heifers on head/day have not been shown to
pasture: For increased be more effective than 200 mg/
rate of weight gain. head/day.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
40. In Sec. 558.450, revise paragraph (e)(5)(ii), redesignate
paragraphs (e)(5)(iii) through (vii) as paragraphs (e)(5)(iv) through
(viii), and add new paragraph (e)(5)(iii) to read as follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(e) * * *
(5) * * *
----------------------------------------------------------------------------------------------------------------
Oxytetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 200 mg/colony as a dust (200 mg/oz) Honey bees: For control of Apply every 4 to 5 days for 066104
or syrup (200 mg/5 lb). American foulbrood caused a total of three 069254
by Paenibacillus larvae applications. Remove at
and European foulbrood least 6 weeks prior to
caused by Melissococcus main honey flow.
plutonius susceptible to
oxytetracycline.
(iii) 800 mg/colony as an extender patty Honey bees: For control of Use as a single 066104
(800 mg/patty). American foulbrood caused application. Remove at 069254
by Paenibacillus larvae least 6 weeks prior to
and European foulbrood main honey flow.
caused by Melissococcus
plutonius susceptible to
oxytetracycline.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
41. In Sec. 558.633, revise paragraph (d)(3) to read as follows:
Sec. 558.633 Tylvalosin.
* * * * *
(d) * * *
(3) An expiration date of 1 week is required for tylvalosin Type C
medicated swine feeds in pelleted or crumbled form. Pelleted Type C
medicated feeds must bear an expiration date of 30 days after the date
of manufacture. Crumbled Type C medicated feeds must bear an expiration
date of 7 days after the date of manufacture.
* * * * *
0
42. In Sec. 558.635, revise paragraph (e)(1)(iv) to read as follows:
Sec. 558.635 Virginiamycin.
* * * * *
(e) * * *
(1) * * *
[[Page 10973]]
----------------------------------------------------------------------------------------------------------------
Virginiamycin in grams/ Combination in grams/
ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 20................ Diclazuril, 0.91...... Broiler chickens: For Feed continuously 058198
prevention of necrotic as the sole
enteritis caused by ration. Do not
Clostridium perfringens feed to birds
susceptible to producing eggs for
virginiamycin; and for the human consumption.
prevention of coccidiosis Diclazuril as
caused by Eimeria tenella, provided by No.
E. necatrix, E. acervulina, 058198 in Sec.
E. brunetti, E. mitis 510.600(c) of this
(mivati), and E. maxima. chapter.
Because diclazuril is
effective against E. maxima
later in its life cycle,
subclinical intestinal
lesions may be present for a
short time after infection.
Diclazuril was shown in
studies to reduce lesions
scores and improve
performance and health of
birds challenged with E.
maxima.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: February 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03538 Filed 2-25-22; 8:45 am]
BILLING CODE 4164-01-P
