New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address, 76418-76425 [2022-24106]
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Federal Register / Vol. 87, No. 239 / Wednesday, December 14, 2022 / Rules and Regulations
(2) Where EASA AD 2022–0096 refers to its
effective date, this AD requires using the
effective date of this AD.
(3) Where paragraph (1) of EASA AD 2022–
0096 specifies to ‘‘inform all flight crews,
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CFR 91.9, 14 CFR 91.505, and 14 CFR
121.137).
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(j) Additional Information
For more information about this AD,
contact Hye Yoon Jang, Aerospace Engineer,
Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des
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Moines, WA 98198; telephone 817–222–
5584; email Hye.Yoon.Jang@faa.gov.
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Issued on November 16, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022–27018 Filed 12–13–22; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 528,
and 558
[Docket No. FDA–2022–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor; Change of Sponsor Address
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
SUMMARY:
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Fmt 4700
Sfmt 4700
new animal drug applications (NADAs),
abbreviated new animal drug
applications (ANADAs), and
conditionally approved new animal
drug applications (cNADAs) during
April, May, and June 2022. FDA is
informing the public of the availability
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to improve the accuracy and
readability of the regulations.
This rule is effective December
14, 2022.
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, ANADAs, and cNADAs
during April, May, and June 2022, as
listed in table 1. In addition, FDA is
informing the public of the availability,
where applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the office of
the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Persons with access to the internet may
obtain these documents at the CVM
FOIA Electronic Reading Room: https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing
exclusivity and patent information may
be accessed in FDA’s publication,
Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/
animal-veterinary/products/approvedanimal-drug-products-green-book.
FDA has verified the website
addresses as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING APRIL, MAY, AND JUNE
2022 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS
Approval date
File No.
Sponsor
Product name
Effect of the action
Public
documents
Supplemental approval for the prevention
of mortality caused by necrotic enteritis
associated with Clostridium perfringens
in broiler and replacement chickens.
Conditional approval for the delay of
onset of congestive heart failure in
dogs with Stage B2 preclinical
myxomatous mitral valve disease.
FOI Summary ....
558.76
FOI Summary ....
516.1780
April 28, 2022
141–137
Pharmgate, Inc., 1800 Sir
Tyler Dr., Wilmington, NC
28405.
PENNITRACIN MD (bacitracin Type A medicated
article).
June 16, 2022
141–556
Boehringer Ingelheim Animal Health USA, Inc.,
3239 Satellite Blvd., Duluth, GA 30096.
VETMEDIN-CA1
(pimobendan) Chewable
Tablets.
Antimicrobial Drugs Approved for Use
in Animals to Voluntarily Bring Under
Veterinary Oversight All Products That
Continue to be Available Over-theCounter,’’ June 11, 2021 (https://
www.fda.gov/media/130610/download).
These applications were submitted in
voluntary compliance with the goals of
the FDA Center for Veterinary
Medicine’s (CVM’s) Judicious Use
Initiative as identified by guidance for
industry #263, ‘‘Recommendations for
Sponsors of Medically Important
Also, FDA is amending the animal
drug regulations to reflect approval of
supplemental applications, as listed in
table 2, to change the marketing status
of dosage form antimicrobial animal
drug products from over-the-counter
(OTC) to veterinary prescription (Rx).
21 CFR
section
TABLE 2—SUPPLEMENTAL APPLICATIONS APPROVED DURING APRIL, MAY, AND JUNE 2022 TO CHANGE THE MARKETING
STATUS OF ANTIMICROBIAL ANIMAL DRUG PRODUCTS FROM OTC TO RX
Approval date
Sponsor
Product name
21 CFR
section
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
Do .......................................................
TERRAMYCIN (oxytetracycline hydrochloride) Injectable Solution;
LIQUAMYCIN (oxytetracycline hydrochloride) Injectable Solution.
SOXISOL (sulfisoxazole) Tablets ....................................................................
522.1662a
File No.
May 31, 2022 .........
008–769
June 7, 2022 ..........
007–981
II. Changes of Sponsorship
FDA that they have transferred
ownership of, and all rights and interest
The sponsors of the following
approved applications have informed
520.2330
in, the applications to another sponsor,
as listed in table 3.
TABLE 3—CHANGES OF SPONSORSHIP DURING APRIL, MAY, AND JUNE 2022
File No.
Product name
Transferring sponsor
119–688 ..........
CEFA–TABS (cefadroxil) Tablets ...............
140–684 ..........
CEFA–DROPS (cefadroxil) Powder for
Suspension.
ZEUTERIN (zinc gluconate) Injectable Solution.
ZENALPHA (medetomidine hydrochloride
and vatinoxan hydrochloride) Injectable
Solution.
Boehringer Ingelheim Animal Health USA,
Inc., 3239 Satellite Blvd., Duluth, GA
30096.
Do ...............................................................
141–217 ..........
141–551 ..........
Following these changes of
sponsorship, Ark Sciences, Inc. and
Vetcare Oy are no longer the sponsor of
an approved application. Accordingly,
the drug labeler codes for these firms
will be removed from § 510.600 (21 CFR
510.600).
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III. Change of Sponsor Address
Anivive Lifesciences, Inc., 3250
Airflite Way, Suite 400, Long Beach, CA
90807 has informed FDA that it has
changed its address to 3777 Worsham
Ave. Long Beach, CA 90808. As
provided in the regulatory text,
§ 510.600 is amended to reflect this
change.
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New sponsor
Ark Sciences, Inc., 1101 East 33rd St.,
Suite B304, Baltimore, MD 21218.
Vetcare Oy, P.O. Box 26 (Liedontie 45),
Ma¨ntsa¨la¨, Uusimaa, 04601, Finland.
HQ Specialty Pharma Corp., 120 Rte. 17
North, Suite 130, Paramus, NJ 07652.
520.314
Do ...............................................................
520.314
Aiping Pharmaceutical, Inc., 350 W Wireless Blvd., Hauppauge, NY 11788.
Dechra, Ltd., Snaygill Industrial Estate,
Keighley Rd., Skipton, North Yorkshire,
BD23 2RW, United Kingdom.
IV. Technical Amendments
FDA is making the following
amendments to improve the accuracy of
the animal drug regulations:
• 21 CFR 510.600 is amended to
remove Ark Sciences, Inc., and Vetcare
Oy from the list of sponsors of approved
applications and to revise the address
for Anivive Lifesciences, Inc. A
punctuation change is made in the
codified name for Vea´toquinol USA,
Inc.
• 21 CFR 520.563 is amended to
reflect the correct section title for
diatrizoate oral solution.
• 21 CFR 520.2640 is amended to
reflect sponsors’ container contents and
the dosage in parts per million of tylosin
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21 CFR
section
522.2690
522.1338
tartrate soluble powder for use in
drinking water of turkeys and swine.
• 21 CFR 522.955 is amended to
reflect drug labeler codes of application
sponsors and to revise a pathogen name
for florfenicol injectable solution in
cattle.
• 21 CFR 522.2471 is amended to
reflect a revised withdrawal period and
human food safety warnings for
tilmicosin injectable solution in sheep.
• The heading for Part 528 is revised
to reflect a more accurate title.
• 21 CFR 558.95 is amended to reflect
revised classes of cattle for use of
bambermycins medicated feeds.
• 21 CFR 558.128 is amended to
reflect approved incorporation rates for
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chlortetracycline medicated feeds for
cattle.
• 21 CFR 558.342 is amended to
reflect all sponsors of approved
applications for use of melengestrol
medicated feeds in heifers.
• 21 CFR 558.450 is amended to
reflect revised residue warnings for use
of oxytetracycline medicated feeds in
cattle.
• 21 CFR 558.455 is amended to
reflect a revised indication for use of
oxytetracycline with neomycin in
medicated cattle feeds and an updated
format.
• 21 CFR 558.575 is amended to
reflect approved incorporations rates for
use of sulfadimethoxine and
ormetoprim in medicated feeds for
salmonids and catfish.
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.’’
V. 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.
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
List of Subjects
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, and 528
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510,
516, 520, 522, 528, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600:
a. In the table in paragraph (c)(1),
remove the entries for ‘‘Ark Sciences,
Inc.’’ and ‘‘Vetcare Oy’’; revise the
entries for ‘‘Anivive Lifesciences, Inc.’’;
and ‘‘Vea´toquinol USA, Inc.’’; and add
in alphabetical order an entry for
‘‘Aiping Pharmaceutical, Inc.’’; and
■ b. In the table in paragraph (c)(2), add
an entry for ‘‘011788’’; revise the entries
for ‘‘017030’’ and ‘‘086121’’; and remove
the entries for ‘‘076175’’ and ‘‘086155’’.
The revisions and additions read as
follows:
■
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
21 CFR Part 558
Animal drugs, Animal feeds.
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788 ......................................................................................
*
*
*
*
*
*
*
Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808 .........................................................................................
*
*
*
*
*
*
*
Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, TX 76137 .................................................................................................
*
*
*
*
*
*
011788
086121
017030
*
*
(2) * * *
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Drug labeler
code
Firm name and address
*
011788 ............
*
*
*
*
Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788.
*
*
*
017030 ............
*
*
*
Vetoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137.
*
*
*
*
086121 ............
*
*
*
Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808.
*
*
*
*
*
*
*
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*
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*
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PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
3. The authority citation for part 516
continues to read as follows:
■
Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371.
4. Add § 516.1780 to subpart E to read
as follows:
■
§ 516.1780
Pimobendan.
(a) Specifications. Each chewable
tablet contains 1.25, 2.5, 5, or 10
milligrams (mg) pimobendan.
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer orally at a total daily dose
of 0.23 mg per pound (0.5 mg per
kilogram) body weight, using a suitable
combination of whole or half tablets.
The total daily dose should be divided
into two portions administered
approximately 12 hours apart.
(2) Indications for use in dogs. For the
delay of onset of congestive heart failure
in dogs with Stage B2 preclinical
myxomatous mitral valve disease (2019
ACVIM Consensus Statement). Stage B2
preclinical myxomatous mitral valve
disease (MMVD) refers to dogs with
asymptomatic MMVD that have a
moderate or loud mitral murmur due to
mitral regurgitation and cardiomegaly.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. It is a violation
of Federal law to use this product other
than as directed in the labeling.
§ 520.2640
Tylosin.
(a) Specifications. Each container of
soluble powder contains tylosin tartrate
equivalent to:
(1) 100 grams (g) tylosin base, or
(2) 256 g tylosin base.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (e) of this section:
(1) Nos. 016592 and 058198 for use of
the 100-g container as in paragraph (e)
of this section
(2) No. 061133 for use of the 100-or
256-g container as in paragraphs
(e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and
(e)(4) of this section.
*
*
*
*
*
(e) * * *
(2) * * *
(i) Amount. 2 grams per gallon (528
ppm) for 2 to 5 days as the sole source
of drinking water. Treated turkeys
should consume enough medicated
drinking water to provide 60 mg tylosin
per pound of body weight per day.
*
*
*
*
*
(3) * * *
(i) Amount. 250 mg per gallon (66
ppm) as the only source of drinking
water for 3 to 10 days, depending on the
severity of the condition being treated.
*
*
*
*
*
§ 522.1662a
injection.
§ 522.955
Authority: 21 U.S.C. 360b.
§ 520.314
[Amended]
6. In § 520.314, in paragraph (b),
remove ‘‘000010’’ and in its place add
‘‘042791’’.
■ 7. In § 520.563, revise the section
heading to read as follows:
§ 520.563
Diatrizoate.
*
*
*
*
*
■ 8. In § 520.2330, amend paragraph
(c)(3) by adding a sentence to the end of
the paragraph.
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§ 520.2330
Sulfisoxazole tablets.
*
*
*
*
*
(c) * * *
(3) * * * Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
■ 9. In § 520.2640, revise paragraphs (a),
(b), (e)(2)(i), and (3)(i) to read as follows:
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*
*
*
*
(b) * * *
(3) Nos. 058005 and 058198 for use of
product described in paragraph (a)(2) of
this section as in paragraph (d)(1)(ii) of
this section.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) * * *
(A) * * *
(2) Indications for use. For treatment
of BRD associated with Mannheimia
haemolytica, Pasteurella multocida, and
Histophilus somni. For treatment of
bovine interdigital phlegmon (foot rot,
acute interdigital necrobacillosis,
infectious pododermatitis) associated
with Fusobacterium necrophorum and
Bacteroides melaninogenicus.
(B) * * *
(2) Indications for use. For control of
respiratory disease in cattle at high risk
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■
Oxytetracycline hydrochloride
*
Florfenicol.
*
■
[Amended]
10. The authority citation for part 522
continues to read as follows:
■
11. In § 522.955, revise paragraphs
(b)(3), (d)(1)(ii)(A)(2), (d)(1)(ii)(B)(2),
and (d)(1)(ii)(C) to read as follows:
5. The authority citation for part 520
continues to read as follows:
§ 522.1338
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
■
■
of developing BRD associated with
Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni.
(C) Limitations. Animals intended for
human consumption must not be
slaughtered within 28 days of the last
intramuscular treatment. Nos. 000061,
058005, and 058198: 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 preruminating calves. Do not use in calves
to be processed for veal. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
*
*
*
*
*
12. In 522.1338, in paragraph (b),
remove ‘‘086155’’ and in its place add
‘‘043264’’.
■ 13. In § 522.1662a, revise paragraph
(e)(1); add paragraphs (e)(3)(i)(D),
(e)(3)(ii)(C), and (e)(3)(iii)(D); and
remove paragraphs (e)(3)(iv) through
(vii) to read as follows:
Authority: 21 U.S.C. 360b.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
76421
*
*
*
*
(e) * * *
(1) Specifications. Each milliliter of
solution contains 50 milligrams (mg)
oxytetracycline hydrochloride.
*
*
*
*
*
(3) * * *
(i) * * *
(D) Treatment must be discontinued
at least 22 days prior to slaughter. Not
for use in lactating dairy animals.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
(ii) * * *
(C) Treatment must be discontinued at
least 22 days prior to slaughter. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
(iii) * * *
(D) Do not administer to laying hens
unless the eggs are used for hatching
only. Treatment must be discontinued at
least 5 days prior to slaughter. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
*
*
*
*
*
■ 14. In § 522.2471, revise paragraph
(e)(2)(iii) to read as follows:
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§ 522.2471
Tilmicosin.
§ 522.2690
*
*
*
*
*
(e) * * *
(2) * * *
(iii) Limitations. Animals intended for
human consumption must not be
slaughtered within 42 days of the last
treatment. Not for use in lactating ewes
producing milk for human
consumption.
[Amended]
15. In 522.2690, in paragraph (b),
remove ‘‘076175’’ and in its place add
‘‘011788’’.
■
PART 528—INTENTIONAL GENOMIC
ALTERATIONS IN ANIMALS
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
■
18. The authority citation for part 558
continues to read as follows:
19. In § 558.95, revise paragraphs
(e)(4)(i) and (ii) to read as follows:
■
16. The authority citation for part 528
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 558.95
*
17. Revise the heading for part 528 to
read as set forth above.
■
Bambermycins.
*
*
(e) * * *
(4) * * *
*
*
Bambermycins
in grams/ton
Indications for use
Limitations
(i) 1 to 4 .............................
Growing beef steers and heifers fed in confinement for
slaughter: For increased rate of weight gain and improved
feed efficiency.
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 at a rate of 10 to 20 milligrams per head
per day.
016592
Feed continuously on a hand-fed basis at a rate of 10 to 40
milligrams per head per day in 1 to 10 pounds of supplemental Type C medicated feed.
016592
(ii) 2 to 80 ..........................
*
§ 558.128
■
*
*
*
*
*
20. In § 558.128, revise paragraphs
(e)(4)(x), (xi), (xiii), (xxx), and (xxxi) to
read as follows:
Chlortetracycline
amount
lotter on DSK11XQN23PROD with RULES1
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
*
(x) 500 to 2,000 g/
ton to provide
10 mg/lb of
body weight
daily.
Laidlomycin, 5 .........
(xi) 500 to 4,000
g/ton to provide
10 mg/lb of
body weight
daily.
Laidlomycin, 5 to 10
*
*
(xiii) 500 to 1,200
g/ton to provide
10 mg/lb of
body weight
daily.
Lasalocid, 25 to 30 ..
*
*
(xxx) 23.3 to 58.3
g/ton to provide
350 mg/head/
day.
Laidlomycin, 5 .........
16:00 Dec 13, 2022
*
*
Indications for use
*
VerDate Sep<11>2014
Chlortetracycline.
*
*
(e) * * *
(4) * * *
Combination
in grams/ton
*
Limitations
*
*
*
Cattle fed in confinement for slaughter: For treatment
of bacterial enteritis caused by Escherichia coli
and bacterial pneumonia caused by Pasteurella
multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and
improved feed efficiency.
Cattle fed in confinement for slaughter: For treatment
of bacterial enteritis caused by Escherichia coli
and bacterial pneumonia caused by Pasteurella
multocida organisms susceptible to chlortetracycline; and for improved feed efficiency.
*
*
*
*
*
Cattle fed in confinement for slaughter: For treatment
of bacterial enteritis caused by Escherichia coli
and bacterial pneumonia caused by Pasteurella
multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and
improved feed efficiency.
*
*
Cattle fed in confinement for slaughter: For control of
bacterial pneumonia associated with shipping fever
complex caused by Pasteurella spp. susceptible to
chlortetracycline; and for increased rate of weight
gain and improved feed efficiency.
Jkt 259001
*
PO 00000
Sponsors
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Fmt 4700
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*
*
Sponsor
*
Feed continuously at a rate of 30 to 75 mg
laidlomycin propionate potassium per head per day
for not more than 5 days. A withdrawal period has
not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter.
Laidlomycin as provided by No. 054771 in
§ 510.600(c) of this chapter.
Feed continuously at a rate of 30 to 75 mg
laidlomycin propionate potassium per head per day
for not more than 5 days. A withdrawal period has
not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter.
Laidlomycin as provided by No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
14DER1
054771
*
Feed continuously at a rate of 30 to 75 mg
laidlomycin propionate potassium per head per
day. A withdrawal period has not been established
for this product in pre-ruminating calves. Do not
use in calves to be processed for veal. See
§ 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter.
E:\FR\FM\14DER1.SGM
054771
*
Feed continuously in complete feed to provide 10 mg
chlortetracycline per lb body weight and not less
than 250 mg or more than 360 mg lasalocid per
head per day. Do not allow horses or other
equines access to feeds containing lasalocid. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. See § 558.311(d)
of this chapter. Lasalocid as provided by No.
054771 in § 510.600(c) of this chapter.
*
054771
054771
Federal Register / Vol. 87, No. 239 / Wednesday, December 14, 2022 / Rules and Regulations
Chlortetracycline
amount
Combination
in grams/ton
Indications for use
Limitations
(xxxi) 14.6 to
116.7 g/ton to
provide 350 mg/
head/day.
Laidlomycin, 5 to 10
Cattle fed in confinement for slaughter: For control of
bacterial pneumonia associated with shipping fever
complex caused by Pasteurella spp. susceptible to
chlortetracycline; and for improved feed efficiency.
Feed continuously at a rate of 30 to 75 mg
laidlomycin propionate potassium per head per
day. A withdrawal period has not been established
for this product in pre-ruminating calves. Do not
use in calves to be processed for veal. See
§ 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter.
*
*
*
*
§ 558.342
■
*
*
*
*
*
21. In § 558.342, revise paragraph
(e)(1)(ii) to read as follows:
Melengestrol
acetate in
mg/head/day
*
(ii) 0.5 ........................
*
*
Limitations
*
*
*
*
■
§ 558.450
■
*
c. Add new paragraph (e)(4)(ii); and
d. Revise newly redesignated
paragraphs (e)(4)(iii) and (vi).
The addition and revisions read as
follows:
Combination
in grams/ton
..................................
Calves and beef and nonlactating dairy cattle: For
treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping
fever complex) caused by Pasteurella multocida
susceptible to oxytetracycline.
(ii) 10 mg/lb of
body weight
daily.
..................................
Calves: For treatment of bacterial enteritis caused by
E. coli susceptible to oxytetracycline.
(iii) 75 mg/head/
day.
..................................
Growing cattle (over 400 lb): For reduction of incidence of liver abscesses.
*
*
(vi) 0.5 to 2.0 g/
head/day.
..................................
*
*
*
Cattle: For prevention and treatment of the early
stages of shipping fever complex.
*
*
*
*
*
■ 23. In § 558.455:
■ a. Redesignate paragraphs (e)(1)(ii)
through (iv) as paragraphs (e)(1)(i)
through (iii);
VerDate Sep<11>2014
16:00 Dec 13, 2022
Jkt 259001
*
Fmt 4700
*
Sfmt 4700
Sponsor
*
066104
069254
066104
069254
066104
069254
*
Feed 3 to 5 days before and after arrival in feedlots.
This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause
drug residues in milk and/or in calves born to
these cows.
b. Redesignate paragraphs (e)(2)(ii)
through (iv) as paragraphs (e)(2)(i)
through (iii);
■ c. Revise paragraphs (e)(3) and (4);
and
■
Frm 00019
*
Feed continuously for 7 to 14 days. This drug product is not approved for use in female dairy cattle
20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues
in milk and/or in calves born to these cows. For
No. 069254, withdraw 5 days before slaughter. For
No. 066104, zero-day withdrawal period.
Feed continuously for 7 to 14 days in milk replacer or
starter feed. This drug product is not approved for
use in female dairy cattle 20 months of age or
older, including dry dairy cows. Use in these cattle
may cause drug residues in milk and/or in calves
born to these cows. For No. 069254, withdraw 5
days before slaughter. For No. 066104, zero-day
withdrawal period.
Feed continuously. This drug product is not approved
for use in female dairy cattle 20 months of age or
older, including dry dairy cows. Use in these cattle
may cause drug residues in milk and/or in calves
born to these cows.
*
PO 00000
Oxytetracycline.
Limitations
(i) 10 mg/lb of
body weight
daily.
016592
054771
058198
*
*
*
(e) * * *
(4) * * *
Indications for use
*
*
Administer 0.5 to 2.0 lb/head/day of Type C feed
containing 0.25 to 1.0 mg melengestrol acetate/lb
to provide 0.5 mg melengestrol acetate/head/
day. Do not exceed 24 days of feeding.
■
■
■
Oxytetracycline
amount
Sponsor
*
*
*
*
*
*
22. In § 558.450:
a. Revise paragraph (e)(4)(i);
b. Redesignate paragraphs (e)(4)(ii)
through (v) as paragraphs (e)(4)(iii)
through (vi);
*
(1) * * *
*
*
Heifers intended for breeding: For suppression of
estrus (heat).
*
054771
*
*
..................................
Sponsor
*
Indications for use
*
*
*
Melengestrol.
*
*
(e) * * *
Combination
in grams/ton
*
lotter on DSK11XQN23PROD with RULES1
*
76423
066104
069254
d. Add paragraph (e)(5).
The revisions and addition read as
follows:
■
E:\FR\FM\14DER1.SGM
14DER1
76424
§ 558.455
*
*
Federal Register / Vol. 87, No. 239 / Wednesday, December 14, 2022 / Rules and Regulations
Oxytetracycline and neomycin.
*
*
(e) * * *
(3) Swine. It is used in feed as follows:
*
Oxytetracycline and neomycin
sulfate amount
(i) To provide 10 mg/lb of
body weight daily.
(ii) To provide 10 mg/lb of
body weight daily.
Limitations
Swine: For treatment of bacterial enteritis caused by E. coli
and Salmonella choleraesuis and treatment of bacterial
pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial
enteritis) caused by E. coli susceptible to neomycin.
Breeding swine: For control and treatment of leptospirosis
(reducing the incidence of abortion and shedding of
leptospirae) caused by Leptospira pomona susceptible to
oxytetracycline.
Sponsors
Feed continuously for 7 to 14 d; withdraw 5 d before
slaughter.
066104
069254
Feed continuously for not more than 14 d; withdraw 5 d
before slaughter.
066104
069254
(4) Cattle. It is used in feed as follows:
Oxytetracycline and neomycin
sulfate amount
Indications for use
Limitations
(i) To provide 10 mg/lb of
body weight daily.
Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by E. coli and bacterial
pneumonia (shipping fever complex) caused by P.
multocida susceptible to oxytetracycline; treatment and
control of colibacillosis (bacterial enteritis) caused by E.
coli susceptible to neomycin.
(ii) To provide 10 mg/lb of
body weight daily.
Calves (up to 250 lb): For treatment of bacterial enteritis
caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis)
caused by E. coli susceptible to neomycin.
(iii) To provide 75 mg/head/
day.
(iv) To provide 0.5 to 2.0 g/
head/ day.
Growing cattle (over 400 lb): For the reduction of the incidence of liver abscesses.
Cattle: For prevention and treatment of the early stages of
shipping fever complex.
Feed continuously for 7 to 14 d; in feed or milk replacers.
Treatment should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not
been established for use in preruminating calves. Do not
use in calves to be processed for veal. A milk discard
time has not been established for use in lactating dairy
cattle. Do not use in female dairy cattle 20 months of
age or older. Withdraw 5 d before slaughter.
Feed continuously for 7 to 14 d; in milk replacers or starter
feed. Treatment should continue 24 to 48 hours beyond
remission of disease symptoms. A withdrawal period has
not been established for use in preruminating calves. Do
not use in calves to be processed for veal. A milk discard time has not been established for use in lactating
dairy cattle. Do not use in female dairy cattle 20 months
of age or older. Withdraw 5 d before slaughter.
Feed continuously .................................................................
Feed 3 to 5 d before and after arrival in feedlots. A withdrawal period has not been established for use in
preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older.
Sponsors
066104
069254
066104
069254
066104
069254
066104
069254
(5) S. It is used in feed as follows:
Oxytetracycline and neomycin
sulfate amount
(i) To provide 10 mg/lb of
body weight daily.
Indications for use
Limitations
Sheep: For treatment of bacterial enteritis caused by E.
coli and bacterial pneumonia caused by P. multocida
susceptible to oxytetracycline; treatment and control of
colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin.
Feed continuously for 7 to 14 d. If symptoms persist after
using for 2 or 3 days, consult a veterinarian. Treatment
should continue 24 to 48 hours beyond remission of disease symptoms. Withdraw 5 d before slaughter.
Sponsors
66104,
069254
(ii) [Reserved].
§ 558.575 Sulfadimethoxine and
ormetoprim.
24. In § 558.575, revise paragraphs
(e)(3)(iv) and (v) to read as follows:
■
*
lotter on DSK11XQN23PROD with RULES1
Sulfadimethoxine and ormetoprim amount
16:00 Dec 13, 2022
Jkt 259001
*
*
*
Indications for use
*
*
(iv) 630 to 3780 g/ton sulfadimethoxine and 126 to
756 g/ton ormetoprim to provide 50 milligrams
(mg) of active ingredients per kilogram of body
per day.
(v) 630 to 3780 g/ton sulfadimethoxine and 126 to
756 g/ton ormetoprim to provide 50 mg of active
ingredients per kilogram of body per day.
VerDate Sep<11>2014
*
(e) * * *
(3) * * *
Limitations
*
*
*
*
*
Salmonids: For the control of furunculosis in Administer for 5 consecutive days. Withdraw 42
salmonids (trout and salmon) caused by
days before release as stocker fish or slaughAeromonas salmonicida strains susceptible to
ter.
sulfadimethoxine and ormetoprim combination.
Catfish: For control of enteric septicemia of cat- Administer for 5 consecutive days. Withdraw 3
fish caused by Edwardsiella ictaluri strains
days before slaughter or release as stocker
susceptible
to
sulfadimethoxine
and
fish.
ormetoprim combination.
PO 00000
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E:\FR\FM\14DER1.SGM
14DER1
Sponsors
015331
015331
Federal Register / Vol. 87, No. 239 / Wednesday, December 14, 2022 / Rules and Regulations
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[FR Doc. 2022–24106 Filed 12–13–22; 8:45 am]
BILLING CODE 4164–01–P
33 CFR Part 165
[Docket No. USCG–2022–0899]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Safety Zones; Fireworks Displays in
the Fifth Coast Guard District
Food and Drug Administration
Coast Guard, DHS.
Notification of enforcement of
regulation.
AGENCY:
ACTION:
21 CFR Part 516
[Docket No. FDA–2022–N–1128]
Defining Small Number of Animals for
Minor Use Determination; Periodic
Reassessment; Confirmation of
Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA) is confirming the
effective date of December 14, 2022, for
the final rule that appeared in the
Federal Register of September 15, 2022.
The direct final rule revises the ‘‘small
number of animals’’ definition for dogs
and cats in our existing regulation for
new animal drugs for minor use or
minor species. This document confirms
the effective date of the direct final rule.
DATES: The effective date of December
14, 2022, for the direct final rule
published September 15, 2022 (87 FR
56583) is confirmed.
FOR FURTHER INFORMATION CONTACT:
Janah Maresca, Center for Veterinary
Medicine (HVF–50), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–796–5079,
email: janah.maresca@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 15, 2022
(87 FR 56583), FDA solicited comments
concerning the direct final rule for a 60day period ending November 14, 2022.
FDA stated that the effective date of the
direct final rule would be on December
14, 2022, 30 days after the end of the
comment period, unless any significant
adverse comment was submitted to FDA
during the comment period. FDA did
not receive any significant adverse
comments.
lotter on DSK11XQN23PROD with RULES1
SUMMARY:
Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371. Accordingly, the amendments issued
thereby are effective.
Dated: December 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27147 Filed 12–13–22; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:00 Dec 13, 2022
Jkt 259001
The Coast Guard will enforce
the Delaware River, Philadelphia, PA;
Safety Zone from 5:45 p.m. through 6:30
p.m. on December 31, 2022, and from
11:45 p.m. on December 31, 2022,
through 12:30 a.m. on January 1, 2023,
to provide for the safety of life on
navigable waterways during two bargebased fireworks displays. Our regulation
for marine events within the Fifth Coast
Guard District identifies the regulated
area for this event in Philadelphia, PA.
During the enforcement period, the
operator of any vessel in the regulated
area must comply with directions from
the Patrol Commander or any Official
Patrol displaying a Coast Guard ensign.
DATES: The regulation 33 CFR 165.506
will be enforced for the location
identified in entry 10 of table 1 to
paragraph (h)(1) from 5:45 p.m. through
6:30 p.m. on December 31, 2022, and
from 11:45 p.m. on December 31, 2022,
through 12:30 a.m. on January 1, 2023.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice of
enforcement, you may call or email
Petty Officer Dylan Caikowski, U.S.
Coast Guard, Sector Delaware Bay,
Waterways Management Division,
telephone 215–271–4814, email
SecDelBayWWM@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the safety zone in
table 1 to paragraph (h)(1) to 33 CFR
165.506, entry No. 10 for two bargebased fireworks displays from 5:45 p.m.
through 6:30 p.m. on December 31,
2022, and from 11:45 p.m. on December
31, 2022, through 12:30 a.m. on January
1, 2023. This action is necessary to
ensure safety of life on the navigable
waters of the United States immediately
prior to, during, and immediately after
fireworks displays. Our regulation for
safety zones of fireworks displays
within the Fifth Coast Guard District,
table 1 to paragraph (h)(1) to 33 CFR
165.506, entry 10 specifies the location
of the regulated area as all waters of the
Delaware River, adjacent to Penn’s
Landing, Philadelphia, PA, within a
500-yard radius of the fireworks barge
SUMMARY:
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
76425
position. The approximate position for
the display is latitude 39°56′52″ N,
longitude 075°8′9.28″ W. During the
enforcement period, as reflected in
§ 165.506(d), vessels may not enter,
remain in, or transit through the safety
zone unless authorized by the Captain
of the Port or designated Coast Guard
patrol personnel on-scene.
In addition to this notice of
enforcement in the Federal Register, the
Coast Guard will provide notification of
this enforcement period via broadcast
notice to mariners.
Dated: December 7, 2022.
Jonathan D. Theel,
Captain, U.S. Coast Guard, Captain of the
Port Delaware Bay.
[FR Doc. 2022–27042 Filed 12–13–22; 8:45 am]
BILLING CODE 9110–04–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 64
[CG Docket No. 02–278; FCC 22–85; FRID
116788]
Telephone Consumer Protection Act of
1991; Petition for Declaratory Ruling of
All About the Message, LLC
Federal Communications
Commission.
ACTION: Declaratory ruling and order.
AGENCY:
In this document, the Federal
Communications Commission
(Commission) finds that ‘‘ringless
voicemail’’ to wireless phones requires
consumer consent because it is a ‘‘call’’
made using an artificial or prerecorded
voice and thus is covered by of the 1991
Telephone Consumer Protection Act
(TCPA). The Commission denies a
request from All About the Message,
LLC (AATM) to declare that ringless
voicemail is not subject to of the TCPA
and the Commission’s implementing
rules. The Commission also denies
AATM’s alternative request for a
retroactive waiver of the Commission’s
rules.
DATES: The Declaratory Ruling and
Order was effective November 21, 2022.
FOR FURTHER INFORMATION CONTACT:
Mika Savir of the Consumer Policy
Division, Consumer and Governmental
Affairs Bureau, at mika.savir@fcc.gov or
(202) 418–0384.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s
Declaratory Ruling and Order, FCC 22–
85, CG Docket No. 02–278, adopted on
November 14, 2022, and released on
November 21, 2022. The full text of this
document is available online at https://
SUMMARY:
E:\FR\FM\14DER1.SGM
14DER1
]]>Agencies
[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Rules and Regulations]
[Pages 76418-76425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24106]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 528, and 558
[Docket No. FDA-2022-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor; Change of Sponsor Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (cNADAs) during April, May, and June 2022. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to improve the accuracy
and readability of the regulations.
DATES: This rule is effective December 14, 2022.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs, ANADAs, and cNADAs during April, May, and June 2022,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons
with access to the internet may obtain these documents at the CVM FOIA
Electronic Reading Room: 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 76419]]
Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During April, May, and June 2022 Requiring Evidence of Safety and/or Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name Effect of the action Public documents section
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 28, 2022.................... 141-137 Pharmgate, Inc., 1800 PENNITRACIN MD Supplemental approval FOI Summary............ 558.76
Sir Tyler Dr., (bacitracin Type A for the prevention
Wilmington, NC 28405. medicated article). of mortality caused
by necrotic
enteritis associated
with Clostridium
perfringens in
broiler and
replacement chickens.
June 16, 2022..................... 141-556 Boehringer Ingelheim VETMEDIN-CA1 Conditional approval FOI Summary............ 516.1780
Animal Health USA, (pimobendan) for the delay of
Inc., 3239 Satellite Chewable Tablets. onset of congestive
Blvd., Duluth, GA heart failure in
30096. dogs with Stage B2
preclinical
myxomatous mitral
valve disease.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Also, FDA is amending the animal drug regulations to reflect
approval of supplemental applications, as listed in table 2, to change
the marketing status of dosage form antimicrobial animal drug products
from over-the-counter (OTC) to veterinary prescription (Rx). These
applications were submitted in voluntary compliance with the goals of
the FDA Center for Veterinary Medicine's (CVM's) Judicious Use
Initiative as identified by guidance for industry #263,
``Recommendations for Sponsors of Medically Important Antimicrobial
Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary
Oversight All Products That Continue to be Available Over-the-
Counter,'' June 11, 2021 (https://www.fda.gov/media/130610/download).
Table 2--Supplemental Applications Approved During April, May, and June 2022 To Change the Marketing Status of
Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name section
----------------------------------------------------------------------------------------------------------------
May 31, 2022....................... 008-769 Zoetis Inc., 333 TERRAMYCIN (oxytetracycline 522.1662a
Portage St., hydrochloride) Injectable
Kalamazoo, MI 49007. Solution; LIQUAMYCIN
(oxytetracycline
hydrochloride) Injectable
Solution.
June 7, 2022....................... 007-981 Do.................... SOXISOL (sulfisoxazole) 520.2330
Tablets.
----------------------------------------------------------------------------------------------------------------
II. Changes of Sponsorship
The sponsors of the following approved applications have informed
FDA that they have transferred ownership of, and all rights and
interest in, the applications to another sponsor, as listed in table 3.
Table 3--Changes of Sponsorship During April, May, and June 2022
----------------------------------------------------------------------------------------------------------------
21 CFR
File No. Product name Transferring sponsor New sponsor section
----------------------------------------------------------------------------------------------------------------
119-688........................... CEFA-TABS Boehringer Ingelheim HQ Specialty Pharma 520.314
(cefadroxil) Animal Health USA, Corp., 120 Rte. 17
Tablets. Inc., 3239 North, Suite 130,
Satellite Blvd., Paramus, NJ 07652.
Duluth, GA 30096.
140-684........................... CEFA-DROPS Do.................. Do.................. 520.314
(cefadroxil) Powder
for Suspension.
141-217........................... ZEUTERIN (zinc Ark Sciences, Inc., Aiping 522.2690
gluconate) 1101 East 33rd St., Pharmaceutical,
Injectable Solution. Suite B304, Inc., 350 W
Baltimore, MD 21218. Wireless Blvd.,
Hauppauge, NY 11788.
141-551........................... ZENALPHA Vetcare Oy, P.O. Box Dechra, Ltd., 522.1338
(medetomidine 26 (Liedontie 45), Snaygill Industrial
hydrochloride and M[auml]nts[auml]l[a Estate, Keighley
vatinoxan uml], Uusimaa, Rd., Skipton, North
hydrochloride) 04601, Finland. Yorkshire, BD23
Injectable Solution. 2RW, United Kingdom.
----------------------------------------------------------------------------------------------------------------
Following these changes of sponsorship, Ark Sciences, Inc. and
Vetcare Oy are no longer the sponsor of an approved application.
Accordingly, the drug labeler codes for these firms will be removed
from Sec. 510.600 (21 CFR 510.600).
III. Change of Sponsor Address
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long
Beach, CA 90807 has informed FDA that it has changed its address to
3777 Worsham Ave. Long Beach, CA 90808. As provided in the regulatory
text, Sec. 510.600 is amended to reflect this change.
IV. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
21 CFR 510.600 is amended to remove Ark Sciences, Inc.,
and Vetcare Oy from the list of sponsors of approved applications and
to revise the address for Anivive Lifesciences, Inc. A punctuation
change is made in the codified name for Ve[aacute]toquinol USA, Inc.
21 CFR 520.563 is amended to reflect the correct section
title for diatrizoate oral solution.
21 CFR 520.2640 is amended to reflect sponsors' container
contents and the dosage in parts per million of tylosin tartrate
soluble powder for use in drinking water of turkeys and swine.
21 CFR 522.955 is amended to reflect drug labeler codes of
application sponsors and to revise a pathogen name for florfenicol
injectable solution in cattle.
21 CFR 522.2471 is amended to reflect a revised withdrawal
period and human food safety warnings for tilmicosin injectable
solution in sheep.
The heading for Part 528 is revised to reflect a more
accurate title.
21 CFR 558.95 is amended to reflect revised classes of
cattle for use of bambermycins medicated feeds.
21 CFR 558.128 is amended to reflect approved
incorporation rates for
[[Page 76420]]
chlortetracycline medicated feeds for cattle.
21 CFR 558.342 is amended to reflect all sponsors of
approved applications for use of melengestrol medicated feeds in
heifers.
21 CFR 558.450 is amended to reflect revised residue
warnings for use of oxytetracycline medicated feeds in cattle.
21 CFR 558.455 is amended to reflect a revised indication
for use of oxytetracycline with neomycin in medicated cattle feeds and
an updated format.
21 CFR 558.575 is amended to reflect approved
incorporations rates for use of sulfadimethoxine and ormetoprim in
medicated feeds for salmonids and catfish.
V. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 528
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 516, 520, 522, 528, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600:
0
a. In the table in paragraph (c)(1), remove the entries for ``Ark
Sciences, Inc.'' and ``Vetcare Oy''; revise the entries for ``Anivive
Lifesciences, Inc.''; and ``Ve[aacute]toquinol USA, Inc.''; and add in
alphabetical order an entry for ``Aiping Pharmaceutical, Inc.''; and
0
b. In the table in paragraph (c)(2), add an entry for ``011788'';
revise the entries for ``017030'' and ``086121''; and remove the
entries for ``076175'' and ``086155''.
The revisions and additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Aiping Pharmaceutical, Inc., 350W Wireless Blvd., 011788
Hauppauge, NY 11788....................................
* * * * * * *
Anivive Lifesciences, Inc., 3777 Worsham Ave., Long 086121
Beach, CA 90808........................................
* * * * * * *
Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, 017030
TX 76137...............................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
011788.................. Aiping Pharmaceutical, Inc., 350W Wireless
Blvd., Hauppauge, NY 11788.
* * * * * * *
017030.................. Vetoquinol USA, Inc., 4250 N. Sylvania Ave.,
Fort Worth, TX 76137.
* * * * * * *
086121.................. Anivive Lifesciences, Inc., 3777 Worsham Ave.,
Long Beach, CA 90808.
* * * * * * *
------------------------------------------------------------------------
[[Page 76421]]
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
3. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
0
4. Add Sec. 516.1780 to subpart E to read as follows:
Sec. 516.1780 Pimobendan.
(a) Specifications. Each chewable tablet contains 1.25, 2.5, 5, or
10 milligrams (mg) pimobendan.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally at a total
daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight,
using a suitable combination of whole or half tablets. The total daily
dose should be divided into two portions administered approximately 12
hours apart.
(2) Indications for use in dogs. For the delay of onset of
congestive heart failure in dogs with Stage B2 preclinical myxomatous
mitral valve disease (2019 ACVIM Consensus Statement). Stage B2
preclinical myxomatous mitral valve disease (MMVD) refers to dogs with
asymptomatic MMVD that have a moderate or loud mitral murmur due to
mitral regurgitation and cardiomegaly.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.314 [Amended]
0
6. In Sec. 520.314, in paragraph (b), remove ``000010'' and in its
place add ``042791''.
0
7. In Sec. 520.563, revise the section heading to read as follows:
Sec. 520.563 Diatrizoate.
* * * * *
0
8. In Sec. 520.2330, amend paragraph (c)(3) by adding a sentence to
the end of the paragraph.
Sec. 520.2330 Sulfisoxazole tablets.
* * * * *
(c) * * *
(3) * * * Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
0
9. In Sec. 520.2640, revise paragraphs (a), (b), (e)(2)(i), and (3)(i)
to read as follows:
Sec. 520.2640 Tylosin.
(a) Specifications. Each container of soluble powder contains
tylosin tartrate equivalent to:
(1) 100 grams (g) tylosin base, or
(2) 256 g tylosin base.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (e) of this section:
(1) Nos. 016592 and 058198 for use of the 100-g container as in
paragraph (e) of this section
(2) No. 061133 for use of the 100-or 256-g container as in
paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this
section.
* * * * *
(e) * * *
(2) * * *
(i) Amount. 2 grams per gallon (528 ppm) for 2 to 5 days as the
sole source of drinking water. Treated turkeys should consume enough
medicated drinking water to provide 60 mg tylosin per pound of body
weight per day.
* * * * *
(3) * * *
(i) Amount. 250 mg per gallon (66 ppm) as the only source of
drinking water for 3 to 10 days, depending on the severity of the
condition being treated.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
10. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
11. In Sec. 522.955, revise paragraphs (b)(3), (d)(1)(ii)(A)(2),
(d)(1)(ii)(B)(2), and (d)(1)(ii)(C) to read as follows:
Sec. 522.955 Florfenicol.
* * * * *
(b) * * *
(3) Nos. 058005 and 058198 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this
section.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(A) * * *
(2) Indications for use. For treatment of BRD associated with
Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.
For treatment of bovine interdigital phlegmon (foot rot, acute
interdigital necrobacillosis, infectious pododermatitis) associated
with Fusobacterium necrophorum and Bacteroides melaninogenicus.
(B) * * *
(2) Indications for use. For control of respiratory disease in
cattle at high risk of developing BRD associated with Mannheimia
haemolytica, Pasteurella multocida, and Histophilus somni.
(C) Limitations. Animals intended for human consumption must not be
slaughtered within 28 days of the last intramuscular treatment. Nos.
000061, 058005, and 058198: 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.
* * * * *
Sec. 522.1338 [Amended]
0
12. In 522.1338, in paragraph (b), remove ``086155'' and in its place
add ``043264''.
0
13. In Sec. 522.1662a, revise paragraph (e)(1); add paragraphs
(e)(3)(i)(D), (e)(3)(ii)(C), and (e)(3)(iii)(D); and remove paragraphs
(e)(3)(iv) through (vii) to read as follows:
Sec. 522.1662a Oxytetracycline hydrochloride injection.
* * * * *
(e) * * *
(1) Specifications. Each milliliter of solution contains 50
milligrams (mg) oxytetracycline hydrochloride.
* * * * *
(3) * * *
(i) * * *
(D) Treatment must be discontinued at least 22 days prior to
slaughter. Not for use in lactating dairy animals. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(ii) * * *
(C) Treatment must be discontinued at least 22 days prior to
slaughter. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
(iii) * * *
(D) Do not administer to laying hens unless the eggs are used for
hatching only. Treatment must be discontinued at least 5 days prior to
slaughter. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
* * * * *
0
14. In Sec. 522.2471, revise paragraph (e)(2)(iii) to read as follows:
[[Page 76422]]
Sec. 522.2471 Tilmicosin.
* * * * *
(e) * * *
(2) * * *
(iii) Limitations. Animals intended for human consumption must not
be slaughtered within 42 days of the last treatment. Not for use in
lactating ewes producing milk for human consumption.
Sec. 522.2690 [Amended]
0
15. In 522.2690, in paragraph (b), remove ``076175'' and in its place
add ``011788''.
PART 528--INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS
0
16. The authority citation for part 528 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
17. Revise the heading for part 528 to read as set forth above.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
18. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
19. In Sec. 558.95, revise paragraphs (e)(4)(i) and (ii) to read as
follows:
Sec. 558.95 Bambermycins.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Bambermycins in grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 1 to 4............................... Growing beef steers and Feed continuously at a rate 016592
heifers fed in confinement of 10 to 20 milligrams per
for slaughter: For head per day.
increased rate of weight
gain and improved feed
efficiency.
(ii) 2 to 80............................. Growing beef steers and Feed continuously on a hand- 016592
heifers on pasture fed basis at a rate of 10
(stocker, feeder, and to 40 milligrams per head
slaughter), and replacement per day in 1 to 10 pounds
beef and dairy heifers on of supplemental Type C
pasture: For increased rate medicated feed.
of weight gain.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
20. In Sec. 558.128, revise paragraphs (e)(4)(x), (xi), (xiii), (xxx),
and (xxxi) to read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * * * *
(x) 500 to 2,000 g/ton to Laidlomycin, 5............ Cattle fed in Feed continuously 054771
provide 10 mg/lb of body weight confinement for at a rate of 30
daily. slaughter: For to 75 mg
treatment of laidlomycin
bacterial propionate
enteritis caused potassium per
by Escherichia head per day for
coli and bacterial not more than 5
pneumonia caused days. A
by Pasteurella withdrawal period
multocida has not been
organisms established for
susceptible to this product in
chlortetracycline; pre-ruminating
and for increased calves. Do not
rate of weight use in calves to
gain and improved be processed for
feed efficiency. veal. See Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xi) 500 to 4,000 g/ton to Laidlomycin, 5 to 10...... Cattle fed in Feed continuously 054771
provide 10 mg/lb of body weight confinement for at a rate of 30
daily. slaughter: For to 75 mg
treatment of laidlomycin
bacterial propionate
enteritis caused potassium per
by Escherichia head per day for
coli and bacterial not more than 5
pneumonia caused days. A
by Pasteurella withdrawal period
multocida has not been
organisms established for
susceptible to this product in
chlortetracycline; pre-ruminating
and for improved calves. Do not
feed efficiency. use in calves to
be processed for
veal. See Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
* * * * * * * * *
(xiii) 500 to 1,200 g/ton to Lasalocid, 25 to 30....... Cattle fed in Feed continuously 054771
provide 10 mg/lb of body weight confinement for in complete feed
daily. slaughter: For to provide 10 mg
treatment of chlortetracycline
bacterial per lb body
enteritis caused weight and not
by Escherichia less than 250 mg
coli and bacterial or more than 360
pneumonia caused mg lasalocid per
by Pasteurella head per day. Do
multocida not allow horses
organisms or other equines
susceptible to access to feeds
chlortetracycline; containing
and for increased lasalocid. A
rate of weight withdrawal period
gain and improved has not been
feed efficiency. established for
this product in
pre-ruminating
calves. Do not
use in calves to
be processed for
veal. See Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
* * * * * * * * *
(xxx) 23.3 to 58.3 g/ton to Laidlomycin, 5............ Cattle fed in Feed continuously 054771
provide 350 mg/head/day. confinement for at a rate of 30
slaughter: For to 75 mg
control of laidlomycin
bacterial propionate
pneumonia potassium per
associated with head per day. A
shipping fever withdrawal period
complex caused by has not been
Pasteurella spp. established for
susceptible to this product in
chlortetracycline; pre-ruminating
and for increased calves. Do not
rate of weight use in calves to
gain and improved be processed for
feed efficiency. veal. See Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
[[Page 76423]]
(xxxi) 14.6 to 116.7 g/ton to Laidlomycin, 5 to 10...... Cattle fed in Feed continuously 054771
provide 350 mg/head/day. confinement for at a rate of 30
slaughter: For to 75 mg
control of laidlomycin
bacterial propionate
pneumonia potassium per
associated with head per day. A
shipping fever withdrawal period
complex caused by has not been
Pasteurella spp. established for
susceptible to this product in
chlortetracycline; pre-ruminating
and for improved calves. Do not
feed efficiency. use in calves to
be processed for
veal. See Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
21. In Sec. 558.342, revise paragraph (e)(1)(ii) to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Melengestrol acetate in mg/
head/day Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * * * *
(ii) 0.5........................ .......................... Heifers intended Administer 0.5 to 016592
for breeding: For 2.0 lb/head/day 054771
suppression of of Type C feed 058198
estrus (heat). containing 0.25
to 1.0 mg
melengestrol
acetate/lb to
provide 0.5 mg
melengestrol
acetate/head/day.
Do not exceed 24
days of feeding.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
22. In Sec. 558.450:
0
a. Revise paragraph (e)(4)(i);
0
b. Redesignate paragraphs (e)(4)(ii) through (v) as paragraphs
(e)(4)(iii) through (vi);
0
c. Add new paragraph (e)(4)(ii); and
0
d. Revise newly redesignated paragraphs (e)(4)(iii) and (vi).
The addition and revisions read as follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight .......................... Calves and beef and Feed continuously 066104
daily. nonlactating dairy for 7 to 14 days. 069254
cattle: For This drug product
treatment of is not approved
bacterial for use in female
enteritis caused dairy cattle 20
by Escherichia months of age or
coli and bacterial older, including
pneumonia dry dairy cows.
(shipping fever Use in these
complex) caused by cattle may cause
Pasteurella drug residues in
multocida milk and/or in
susceptible to calves born to
oxytetracycline. these cows. For
No. 069254,
withdraw 5 days
before slaughter.
For No. 066104,
zero-day
withdrawal period.
(ii) 10 mg/lb of body weight .......................... Calves: For Feed continuously 066104
daily. treatment of for 7 to 14 days 069254
bacterial in milk replacer
enteritis caused or starter feed.
by E. coli This drug product
susceptible to is not approved
oxytetracycline. 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. For
No. 069254,
withdraw 5 days
before slaughter.
For No. 066104,
zero-day
withdrawal period.
(iii) 75 mg/head/day............ .......................... Growing cattle Feed continuously. 066104
(over 400 lb): For This drug product 069254
reduction of is not approved
incidence of liver for use in female
abscesses. 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.
* * * * * * * * * *
(vi) 0.5 to 2.0 g/head/day...... .......................... Cattle: For Feed 3 to 5 days 066104
prevention and before and after 069254
treatment of the arrival in
early stages of feedlots. This
shipping fever drug product is
complex. 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.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
23. In Sec. 558.455:
0
a. Redesignate paragraphs (e)(1)(ii) through (iv) as paragraphs
(e)(1)(i) through (iii);
0
b. Redesignate paragraphs (e)(2)(ii) through (iv) as paragraphs
(e)(2)(i) through (iii);
0
c. Revise paragraphs (e)(3) and (4); and
0
d. Add paragraph (e)(5).
The revisions and addition read as follows:
[[Page 76424]]
Sec. 558.455 Oxytetracycline and neomycin.
* * * * *
(e) * * *
(3) Swine. It is used in feed as follows:
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin sulfate
amount Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight Swine: For treatment of Feed continuously for 7 to 14 066104
daily. bacterial enteritis caused by d; withdraw 5 d before 069254
E. coli and Salmonella slaughter.
choleraesuis and treatment of
bacterial pneumonia caused by
P. multocida susceptible to
oxytetracycline; treatment
and control of colibacillosis
(bacterial enteritis) caused
by E. coli susceptible to
neomycin.
(ii) To provide 10 mg/lb of body Breeding swine: For control Feed continuously for not 066104
weight daily. and treatment of more than 14 d; withdraw 5 d 069254
leptospirosis (reducing the before slaughter.
incidence of abortion and
shedding of leptospirae)
caused by Leptospira pomona
susceptible to
oxytetracycline.
----------------------------------------------------------------------------------------------------------------
(4) Cattle. It is used in feed as follows:
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin sulfate
amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight Calves and beef and Feed continuously for 7 to 14 066104
daily. nonlactating dairy cattle: d; in feed or milk 069254
For treatment of bacterial replacers. Treatment should
enteritis caused by E. coli continue 24 to 48 hours
and bacterial pneumonia beyond remission of disease
(shipping fever complex) symptoms. A withdrawal
caused by P. multocida period has not been
susceptible to established for use in
oxytetracycline; treatment preruminating calves. Do not
and control of colibacillosis use in calves to be
(bacterial enteritis) caused processed for veal. A milk
by E. coli susceptible to discard time has not been
neomycin. established for use in
lactating dairy cattle. Do
not use in female dairy
cattle 20 months of age or
older. Withdraw 5 d before
slaughter.
(ii) To provide 10 mg/lb of body Calves (up to 250 lb): For Feed continuously for 7 to 14 066104
weight daily. treatment of bacterial d; in milk replacers or 069254
enteritis caused by E. coli starter feed. Treatment
susceptible to should continue 24 to 48
oxytetracycline; treatment hours beyond remission of
and control of colibacillosis disease symptoms. A
(bacterial enteritis) caused withdrawal period has not
by E. coli susceptible to been established for use in
neomycin. preruminating calves. Do not
use in calves to be
processed for veal. A milk
discard time has not been
established for use in
lactating dairy cattle. Do
not use in female dairy
cattle 20 months of age or
older. Withdraw 5 d before
slaughter.
(iii) To provide 75 mg/head/day....... Growing cattle (over 400 lb): Feed continuously............ 066104
For the reduction of the 069254
incidence of liver abscesses.
(iv) To provide 0.5 to 2.0 g/head/ day Cattle: For prevention and Feed 3 to 5 d before and 066104
treatment of the early stages after arrival in feedlots. A 069254
of shipping fever complex. withdrawal period has not
been established for use in
preruminating calves. Do not
use in calves to be
processed for veal. A milk
discard time has not been
established for use in
lactating dairy cattle. Do
not use in female dairy
cattle 20 months of age or
older.
----------------------------------------------------------------------------------------------------------------
(5) S. It is used in feed as follows:
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin sulfate
amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight Sheep: For treatment of Feed continuously for 7 to 14 66104,
daily. bacterial enteritis caused by d. If symptoms persist after 069254
E. coli and bacterial using for 2 or 3 days,
pneumonia caused by P. consult a veterinarian.
multocida susceptible to Treatment should continue 24
oxytetracycline; treatment to 48 hours beyond remission
and control of colibacillosis of disease symptoms.
(bacterial enteritis) caused Withdraw 5 d before
by E. coli susceptible to slaughter.
neomycin.
(ii) [Reserved].......................
----------------------------------------------------------------------------------------------------------------
0
24. In Sec. 558.575, revise paragraphs (e)(3)(iv) and (v) to read as
follows:
Sec. 558.575 Sulfadimethoxine and ormetoprim.
* * * * *
(e) * * *
(3) * * *
----------------------------------------------------------------------------------------------------------------
Sulfadimethoxine and ormetoprim amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 630 to 3780 g/ton sulfadimethoxine Salmonids: For the control Administer for 5 consecutive 015331
and 126 to 756 g/ton ormetoprim to of furunculosis in days. Withdraw 42 days
provide 50 milligrams (mg) of active salmonids (trout and before release as stocker
ingredients per kilogram of body per day. salmon) caused by Aeromonas fish or slaughter.
salmonicida strains
susceptible to
sulfadimethoxine and
ormetoprim combination.
(v) 630 to 3780 g/ton sulfadimethoxine Catfish: For control of Administer for 5 consecutive 015331
and 126 to 756 g/ton ormetoprim to enteric septicemia of days. Withdraw 3 days
provide 50 mg of active ingredients per catfish caused by before slaughter or release
kilogram of body per day. Edwardsiella ictaluri as stocker fish.
strains susceptible to
sulfadimethoxine and
ormetoprim combination.
----------------------------------------------------------------------------------------------------------------
[[Page 76425]]
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24106 Filed 12-13-22; 8:45 am]
BILLING CODE 4164-01-P
