New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor, 13181-13191 [2021-04453]
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13181
Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations
Entity
License
requirement
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review policy
Federal Register
Citation
Myanmar Economic Corporation, a.k.a.,
the following one alias:
—MEC.
Corner of Ahlone Road and Strand
Road, Ahlone Township, Yangon,
Myanmar.
Myanmar Economic Holdings Limited,
a.k.a., the following eight aliases:
—MEHL;
—Myanma Economic Holdings Limited;
—Myanma Economic Holdings Public
Company Limited;
—Myanmar Business Holdings Public
Company Limited;
—Myanmar Economic Holdings Public
Company Limited;
—UMEH;
—Union of Myanmar Economic Holdings Company Limited; and
—Union of Myanmar Economic Holdings Limited.
189–191
Maha
Bandoola
Road,
Botahtaung
Township,
Yangon,
Burma.
For all items subject to
the EAR. (See § 744.11
of the EAR).
Presumption of denial ......
86 FR [INSERT FR PAGE
NUMBER], 3/8/2021.
For all items subject to
the EAR. (See § 744.11
of the EAR).
Presumption of denial ......
86 FR [INSERT FR PAGE
NUMBER], 3/8/2021.
Country
*
*
*
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
*
*
*
21 CFR Parts 510, 516, 520, 522, 524,
526, 529, 556, and 558
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during April,
May, and June 2020. FDA is informing
the public of the availability of
summaries of the basis of approval and
of environmental review documents,
where applicable. The animal drug
regulations are also being amended to
improve the accuracy and readability of
the regulations.
DATES: This rule is effective March 8,
2021.
[Docket No. FDA–2020–N–0002]
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2021–04794 Filed 3–4–21; 4:15 pm]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
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:
ACTION:
I. Approval Actions
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during April,
May, and June 2020, as listed in table 1.
SUMMARY:
*
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.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2020
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Approval date
File No.
April 2, 2020 .....
141–527
April 10, 2020 ...
141–533
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Product name
Species
Bayer HealthCare LLC,
Animal Health Division,
P.O. Box 390, Shawnee
Mission, KS 66201.
Boehringer Ingelheim Animal Health USA, Inc.,
3239 Satellite Blvd., Duluth, GA 30096.
BAYTRIL 100–CA1
(enrofloxacin) Injectable
Solution.
Cattle ..............
Conditional approval for the treatment
of clinical anaplasmosis in certain
classes of cattle.
FOI Summary.
ASERVO EQUIHALER
(ciclesonide inhalation
spray).
Horses ............
Original approval for the management
of clinical signs associated with severe equine asthma in horses.
FOI Summary.
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Effect of the action
Public
documents
Sponsor
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2020—
Continued
Approval date
File No.
April 22, 2020 ...
200–673
April 27, 2020 ...
200–674
May 14, 2020 ....
200–679
May 21, 2020 ....
200–680
May 27, 2020 ....
200–638
May 28, 2020 ....
200–510
June 1, 2020 .....
200–134
June 2, 2020 .....
200–682
June 4, 2020 .....
200–399
June 15, 2020 ...
141–534
June 18, 2020 ...
141–535
Sponsor
Product name
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Effect of the action
Public
documents
Aurora Pharmaceutical,
Inc., 1196 Highway 3
South, Northfield, MN
55057–3009.
Modern Veterinary Therapeutics, LLC, 14343 SW
119th Ave., Miami, FL
33186.
Huvepharma EOOD, 5th
Floor, 3A Nikolay
Haytov Str., 1113 Sophia, Bulgaria.
Felix Pharmaceuticals Pvt.
Ltd., 25–28 North Wall
Quay, Dublin 1, Ireland.
Ve´toquinol USA, Inc.,
4250 N Sylvania Ave.,
Fort Worth, TX 76137.
Pharmgate, Inc., 1800 Sir
Tyler Dr., Wilmington,
NC 28405.
REVOLT (selamectin)
Topical Solution.
Dogs and cats
Original approval as a generic copy of
NADA 141–152.
FOI Summary.
Detomidine Hydrochloride
(detomidine hydrochloride) Injectable Solution.
OPTIGRID (ractopamine
HCl) Type A Medicated
Article.
Horses ............
Original approval as a generic copy of
NADA 140–862.
FOI Summary.
Cattle ..............
Original approval as a generic copy of
NADA 141–221.
FOI Summary.
Enrofloxacin flavored tablets.
Dogs ...............
Original approval as a generic copy of
NADA 140–441.
FOI Summary.
IMOXI Topical Solution for
Cats (imidacloprid and
moxidectin).
Chlortetracycline Type B
and Type C medicated
feeds.
Cats ................
Original approval as a generic copy of
NADA 141–254.
FOI Summary.
Cattle ..............
N/A.
Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
Huvepharma EOOD, 5th
Floor, 3A Nikolay
Haytov Str., 1113 Sophia, Bulgaria.
Huvepharma EOOD, 5th
Floor, 3A Nikolay
Haytov Str., 1113 Sophia, Bulgaria.
Orion Corp., Orionintie 1,
02200 Espoo, Finland.
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
FERTAGYL (gonadorelin)
Injectable Solution.
Cattle ..............
Supplemental approval for use of
DERACIN (chlortetracycline) Type A
medicated articles in the manufacture
of Type B and Type C medicated
feeds for control of bacterial pneumonia in beef cattle and replacement
dairy heifers.
Supplemental approval for fixed-time artificial insemination in beef cows.
VETMULIN 12.5%
(tiamulin hydrogen fumarate) Liquid concentrate.
CYCLEGUARD
(melengestrol acetate
Type A liquid medicated
article).
CLEVOR (ropinirole ophthalmic solution).
Chlortetracycline,
sulfamethazine, and
lasalocid Type B and
Type C medicated feeds.
Swine .............
Original approval as a generic copy of
NADA 140–916.
FOI Summary.
Cattle ..............
Original approval as a generic copy of
NADA 039–402.
FOI Summary.
Dogs ...............
Original approval for the induction of
vomiting in dogs.
Original approval for use of AUREO S
700 (chlortetracycline and
sulfamethazine) and BOVATEC
(lasalocid) in the manufacture of Type
B and Type C medicated feeds for
beef steers and heifers fed in confinement for slaughter.
FOI Summary.
II. Changes of Sponsor
Virbac AH, Inc., P.O. Box 162059,
Fort Worth, TX 76161 has informed
FDA that it has transferred ownership
of, and all rights and interest in, NADA
141–084 for SENTINEL (lufenuron and
milbemycin oxime) Flavor Tabs, NADA
141–204 for the SENTINEL Flavor Tabs
and CAPSTAR (nitenpyram) Flea
Management System, and NADA 141–
333 for SENTINEL SPECTRUM
(lufenuron, milbemycin oxime, and
praziquantel) Chews to Intervet, Inc., 2
Giralda Farms, Madison, NJ 07940.
Also, Sparhawk Laboratories, Inc.,
12340 Santa Fe Trail Dr., Lenexa, KS
66215 has informed FDA that it has
transferred ownership of, and all rights
and interest in, A 200–348 for
ECOMECTIN (ivermectin) Cattle PourOn to Huvepharma EOOD, 5th Floor, 3A
Nikolay Haytov Str., 1113 Sofia,
Bulgaria. The animal drug regulations
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Species
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Cattle ..............
will be amended to reflect these changes
of sponsor.
III. Technical Amendments
FDA is making the following
amendments to improve the accuracy
and readability of the animal drug
regulations:
• The entries in 21 CFR 510.600(c),
520.304, and 520.812 for Dechra
Veterinary Products LLC are being
amended to reflect the firm′s current
drug labeler code.
• The entries in 21 CFR 510.600(c) for
Cronus Pharma Specialities India
Private Ltd. are being amended to reflect
the firm’s current address.
• Conditions for use in 21 CFR
520.100 for use of amprolium crumbles
in calves are being removed because no
approved NADA exists for this dosage
form product.
• The regulations in part 526 (21 CFR
part 526) for intramammary dosage form
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FOI Summary.
FOI Summary.
drugs are being amended to reflect a
current format and improve readability.
• The section in part 529 (21 CFR part
529) for sevofluorane anesthetic gas is
being redesignated to reflect a current
organizational scheme for dosage form
new animal drugs.
• Cross references in part 556 (21 CFR
part 556) to related approved uses of
new animal drugs are being amended as
conforming changes to improve the
accuracy of the regulations.
• The table in 21 CFR 558.4 is being
amended to reflect the correct format for
displaying assay limits for component
drugs in fixed-ratio, combination drug
Type A medicated articles and Type B
and Type C medicated feeds.
• Three tabular entries in 21 CFR
558.68 are being amended to reflect the
approved conditions of use of certain
feed use combinations, which had been
removed in error.
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• Typographical errors are being
corrected wherever they have been
found.
IV. Legal Authority
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. This 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 the
conditions of use of an approved or
conditionally approved new animal
drug and the name and address of the
drug’s sponsor in a ‘‘notice, which upon
publication shall be effective as a
regulation.’’ A notice published
pursuant to section 512(i) is not subject
to the notice-and-comment rulemaking
requirements of the Administrative
Procedure Act, 5 U.S.C. 551 et seq. See
section 512(i) of the FD&C Act (21
U.S.C. 360b(i)); 21 CFR 10.40(e)(3); S.
Rep. 90–1308, at 5 (1968).
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
516, 520, 522, 524, 526, 529, 556, and
558 are amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600—
a. In the table in paragraph (c)(1):
i. Revise the entries for ‘‘Cronus
Pharma Specialities India Private Ltd.’’
and ‘‘Dechra Veterinary Products LLC’’;
■ ii. Add an entry in alphabetical order
for ‘‘Felix Pharmaceuticals Pvt. Ltd.’’;
and
■ iii. Revise the entry for ‘‘Pharmgate,
Inc.’’; and
■ b. In the table in paragraph (c)(2):
■ i. Add an entry in numerical order for
‘‘017033’’;
■ ii. Remove the entry for ‘‘026637’’;
■ iii. Revise the entries for ‘‘069043’’
and ‘‘069254’’; and
■ iv. Add an entry in numerical order
for ‘‘086101’’.
The additions and revisions read as
follows:
■
■
■
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 516
Administrative practice and
procedure, Animal drugs, Confidential
business information, Reporting and
recordkeeping requirements.
21 CFR Parts 520, 522, 524, 526, and
529
Animal drugs.
21 CFR Part 556
Animal drugs, 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 510,
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Cronus Pharma Specialities India Private Ltd., Sy No-99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village,
Shamshabad Mandal, Ranga Reddy, Hyderabad Telangana 501218, India ..................................................................................
*
*
*
*
*
*
*
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 ...........................................................
*
*
*
*
*
*
*
Felix Pharmaceuticals Pvt. Ltd., 25–28 North Wall Quay, Dublin 1, Ireland ......................................................................................
*
*
*
*
*
*
*
Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405 ...............................................................................................................
*
*
*
*
*
*
069043
017033
086101
069254
*
*
*
*
(2) * * *
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Drug labeler
code
Firm name and address
*
017033 ............
*
*
*
*
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211.
*
069043 ............
*
*
*
*
*
*
Cronus Pharma Specialities India Private Ltd., Sy No-99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village,
Shamshabad Mandal, Ranga Reddy, Hyderabad Telangana 501218, India.
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Drug labeler
code
Firm name and address
*
069254 ............
*
*
*
Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.
*
*
*
*
086101 ............
*
*
*
*
Felix Pharmaceuticals Pvt. Ltd., 25–28 North Wall Quay, Dublin 1, Ireland.
*
*
*
*
*
*
*
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 § 516.812 to subpart E to read
as follows:
■
§ 516.812
Enrofloxacin.
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5. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
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*
6. In § 520.100, remove paragraph
(a)(3), revise paragraph (b)(2), add
paragraph (b)(3), and revise paragraph
(d)(2) introductory text.
The revisions and addition read as
follows:
■
§ 520.100
Amprolium.
*
(a) Specifications. Each milliliter (mL)
of solution contains 100 milligrams (mg)
enrofloxacin.
(b) Sponsor. See No. 000859 in
§ 510.600(c) of this chapter.
(c) Conditions of use in cattle—(1)
Amount. Administer, by subcutaneous
injection, a single dose of 12.5 mg/
kilogram of body weight (5.7 mL/100
pounds of body weight). Administered
dose volume should not exceed 20 mL
per injection site.
(2) Indications for use. For the
treatment of clinical anaplasmosis
associated with Anaplasma marginale
in replacement dairy heifers under 20
months of age and all classes of beef
cattle except beef calves less than 2
months of age and beef bulls intended
for breeding (any age). Not for use in
any other class of dairy cattle or in veal
calves.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Federal law
prohibits the extra-label use of this drug
in food-producing animals. Cattle
intended for human consumption must
not be slaughtered within 28 days from
the last 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 for this
product in pre-ruminating calves. Do
not use in calves to be processed for
veal.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
*
*
*
*
*
(b) * * *
(2) No. 066104 for use of product
described in paragraph (a)(1) of this
section as in paragraph (d) of this
section.
(3) No. 051072 for use of product
described in paragraph (a)(1) of this
section as in paragraph (d)(1) of this
section.
*
*
*
*
*
(d) * * *
(2) Calves. Administer concentrate
solution or soluble powder as a drench
or in drinking water as follows:
*
*
*
*
*
■ 7. In § 520.304, revise paragraph (b),
remove reserved paragraph (c), and
redesignate paragraph (d) as paragraph
(c).
The revision reads as follows:
§ 520.304
Carprofen.
*
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (c) of this section.
(1) Nos. 017033, 054771, 055529, and
062250 for use of products described in
paragraph (a) as in paragraph (c) of this
section.
(2) No. 000859 for use of product
described in paragraph (a)(2) as in
paragraph (c) of this section.
*
*
*
*
*
■ 8. In § 520.812, revise paragraphs (a)
and (b) to read as follows:
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter for use as in
paragraph (c) of this section.
(1) No. 000859 for use of products
described in paragraphs (a)(1)(i), (a)(2),
and (a)(3) of this section.
(2) No. 017033 for use of product
described in paragraph (a)(1)(i) of this
section.
(3) No. 058198 for use of product
described in paragraph (a)(1)(ii) of this
section.
(4) No. 086101 for use of product
described in paragraph (a)(2) of this
section.
*
*
*
*
*
§ 520.1443
[Amended]
9. In § 520.1443, in paragraph (b),
remove ‘‘051311’’ and in its place add
‘‘000061’’.
■
§ 520.1447
[Amended]
10. In § 520.1447, in paragraph (b),
remove ‘‘051311’’ and in its place add
‘‘000061’’.
■
§ 520.1510
[Amended]
11. In § 520.1510, in paragraph (b)(2),
remove ‘‘051311’’ and in its place add
‘‘000061’’.
■
§ 520.2455
[Amended]
12. In § 520.2455, in paragraph (b)(4),
remove ‘‘No. 061133’’ and in its place
add ‘‘Nos. 016592 and 061133’’.
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
13. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 522.536
[Amended]
14. In § 522.536, in paragraph (b),
remove ‘‘No. 052483’’ and in its place
add ‘‘Nos. 015914 and 052483’’.
■ 15. In § 522.1077:
■ a. Revise paragraphs (a)(3), (b), (d),
and (e)(1)(i);
■ b. Remove paragraph (e)(1)(ii);
■ c. Redesignate paragraphs (e)(1)(iii)
through (e)(1)(vii) as paragraphs
(e)(1)(ii) through (e)(1)(vi);
■ d. Revise newly redesignated
paragraphs (e)(1)(ii) and (iii); and
■
§ 520.812
Enrofloxacin.
(a) Specifications—(1) Each tablet
contains:
(i) 22.7, 68.0, or 136.0 milligrams (mg)
enrofloxacin; or
(ii) 22.7, 68.0, 136.0, or 272 mg
enrofloxacin.
(2) Each chewable tablet contains
22.7, 68.0, or 136.0 mg enrofloxacin.
(3) Each soft chewable tablet contains
22.7, 68.0, or 136.0 mg enrofloxacin.
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e. Remove and reserve paragraph
(e)(2).
The revisions read as follows:
■
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§ 522.1077
Gonadorelin.
(a) * * *
(3) 50 mg of gonadorelin as
gonadorelin diacetate tetrahydrate
(equivalent to 43 mg gonadorelin); or
*
*
*
*
*
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter.
(1) No. 000061 for use of the 43-mg/
mL product described in paragraph
(a)(1) as in paragraphs (e)(1)(i) and (iii)
of this section.
(2) No. 068504 for use of the 100-mg/
mL product described in paragraph
(a)(2) as in paragraph (e)(1)(iv) of this
section.
(3) No. 061133 for use of the 50-mg/
mL product described in paragraph
(a)(3) as in paragraphs (e)(1)(i) of this
section.
(4) No. 000010 for use of the 43-mg/
mL product described in paragraph
(a)(3) as in paragraphs (e)(1)(i) and (v) of
this section.
(5) No. 054771 for use of the 50-mg/
mL product described in paragraph
(a)(4) as in paragraphs (e)(1)(ii) and (vi)
of this section.
*
*
*
*
*
(d) Special considerations—(1)
Concurrent luteolytic drug use is
approved as follows:
(i) Cloprostenol injection for use as in
paragraph (e)(1)(iii) of this section as
provided by No. 000061 in § 510.600(c)
of this chapter.
(ii) Cloprostenol injection for use as in
paragraph (e)(1)(iv) of this section as
provided by No. 068504 in § 510.600(c)
of this chapter.
(iii) Cloprostenol injection for use as
in paragraph (e)(1)(v) of this section as
provided by Nos. 000010 in § 510.600(c)
of this chapter.
(iv) Dinoprost injection for use as in
paragraphs (e)(1)(vi) of this section as
provided by No. 054771 in § 510.600(c)
of this chapter.
(2) Federal law restricts this drug to
use by or on the order of a licensed
veterinarian.
(e) * * *
(1) Indications for use and amounts—
(i) For the treatment of ovarian follicular
cysts in dairy cattle: Administer 86 mg
gonadorelin (No. 000061) or 100 mg
gonadorelin diacetate tetrahydrate (Nos.
000010 and 061133) by intramuscular or
intravenous injection.
(ii) For the treatment of ovarian
follicular cysts in cattle: Administer 100
mg gonadorelin hydrochloride by
intramuscular injection.
(iii) For use with cloprostenol sodium
to synchronize estrous cycles to allow
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for fixed-time artificial insemination
(FTAI) in beef cows and lactating dairy
cows: Administer to each cow 86 mg
gonadorelin by intramuscular injection,
followed 6 to 8 days later by 500 mg
cloprostenol by intramuscular injection,
followed 30 to 72 hours later by 86 mg
gonadorelin by intramuscular injection.
*
*
*
*
*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
16. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
17. In § 524.1146, revise paragraph
(b)(2) and add paragraph (b)(3) to read
as follows:
■
§ 524.1146
Imidacloprid and moxidectin.
*
*
*
*
*
(b) * * *
(2) Nos. 000859 and 017030 for use of
product described in paragraph (a)(2) of
this section as in paragraph (d)(2) of this
section.
(3) No. 000859 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d)(3) of this
section.
*
*
*
*
*
§ 524.1193
[Amended]
18. In § 524.1193, in paragraph (b)(2),
remove ‘‘016592, 054925, and 058005’’
and in its place add ‘‘016592 and
054925’’.
■ 19. Add § 524.2080 to read as follows:
■
§ 524.2080
Ropinirole.
(a) Specifications. Each milliliter of
solution contains 30 milligrams (mg)
ropinirole (equivalent to 34.2 mg
ropinirole hydrochloride).
(b) Sponsor. See No. 052483 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Using the table provided in labeling,
administer the number of eye drops
topically, corresponding to body weight,
that results in a target dose of 3.75 mg
per square meter (mg/m2) (dose band 2.7
to 5.4 mg/m2). If the dog does not vomit
within 20 minutes of the first dose, then
a second dose may be administered.
(2) Indications for use. For the
induction of vomiting in dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 524.2098
[Amended]
20. In § 524.2098, in paragraph (b),
remove ‘‘Nos. 054771, 055529, and
061651’’ and in its place add ‘‘Nos.
051072, 054771, 055529, and 061651’’.
■
PO 00000
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13185
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
21. The authority citation for part 526
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
22. In § 526.88, revise the section
heading, paragraph (a), the paragraph
(d) subject heading, and paragraphs
(d)(1) and (3) to read as follows:
■
§ 526.88
Amoxicillin.
(a) Specifications. Each single-dose,
10-milliliter syringe contains
amoxicillin trihydrate equivalent to 62.5
milligrams (mg) amoxicillin.
*
*
*
*
*
(d) Conditions of use in lactating
cows—(1) Amount. Infuse the contents
of one syringe (equivalent to 62.5 mg
amoxicillin) into each infected quarter
every 12 hours for a maximum of 3
doses.
*
*
*
*
*
(3) Limitations. Milk taken from
animals during treatment and for 60
hours (5 milkings) after the last
treatment must not be used for food.
Treated animals must not be slaughtered
for food purposes within 12 days after
the last treatment. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 23. In § 526.313, revise paragraphs (a)
and (d) and add paragraph (e) to read as
follows:
§ 526. 313
Ceftiofur.
(a) Specifications. Each single-dose,
10-milliliter syringe contains:
(1) 125 milligrams (mg) ceftiofur
equivalents as the hydrochloride salt; or
(2) 500 mg ceftiofur equivalents as the
hydrochloride salt.
*
*
*
*
*
(d) Conditions of use for syringe
described in paragraph (a)(1) of this
section in lactating cows—(1) Amount.
Infuse the contents of one syringe (125
mg ceftiofur equivalents) into each
affected quarter. Repeat treatment in 24
hours. Once daily treatment may be
repeated for up to 8 consecutive days.
(2) Indications for use. For the
treatment of clinical mastitis associated
with coagulase-negative staphylococci,
Streptococcus dysgalactiae, and
Escherichia coli; and the treatment of
diagnosed subclinical mastitis
associated with coagulase-negative
staphylococci and S. dysgalactiae.
(3) Limitations. Milk taken from cows
during treatment (a maximum of 8 daily
infusions) and for 72 hours after the last
treatment must not be used for human
consumption. Following label use for up
to 8 consecutive days, a 2-day
preslaughter withdrawal period is
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required. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
(4) Special considerations. Federal
law prohibits extralabel use of this drug
in lactating dairy cattle for disease
prevention purposes; at unapproved
doses; frequencies, durations, or routes
of administration; and in unapproved
major food-producing species/
production classes.
(e) Conditions of use for syringe
described in paragraph (a)(2) of this
section in dry cows—(1) Amount. Infuse
the contents of one syringe (500 mg
ceftiofur equivalents) into each affected
quarter at the time of dry off.
(2) Indications for use. For the
treatment of subclinical mastitis in dairy
cattle at the time of dry off associated
with Staphylococcus aureus,
Streptococcus dysgalactiae, and
Streptococcus uberis.
(3) Limitations. Milk taken from cows
completing a 30-day dry-off period may
be used for food with no milk discard
due to ceftiofur residues. Following
intramammary infusion, a 16-day
preslaughter withdrawal period is
required for treated cows. No
preslaughter withdrawal period is
required for neonatal calves from treated
cows regardless of colostrum
consumption. Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
(4) Special considerations. Federal
law prohibits extralabel use of this drug
in dry dairy cattle for disease prevention
purposes; at unapproved doses;
frequencies, durations, or routes of
administration; and in unapproved
major food-producing species/
production classes.
■ 24. In § 526.363, revise paragraphs (a)
and (d) to read as follows:
jbell on DSKJLSW7X2PROD with RULES
§ 526. 363
Cephapirin benzathine.
(a) Specifications. Each single-dose,
10-milliliter syringe contains 300
milligrams cephapirin activity (as
cephapirin benzathine).
*
*
*
*
*
(d) Conditions of use in dry cows—(1)
Amount. Infuse the contents of one
syringe (300 mg cephapirin activity)
into each quarter following last milking,
but no later than 30 days before calving.
(2) Indications for use. For the
treatment of mastitis caused by
susceptible strains of Streptococcus
agalactiae and Staphylococcus aureus,
including penicillin-resistant strains.
(3) Limitations. For use in dry cows
only. Milk from treated cows must not
be used for food during the first 72
hours after calving. Animals infused
with this product must not be
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slaughtered for food until 42 days after
the latest infusion.
■ 25. In § 526.365, revise paragraphs (a)
and (d)(1) to read as follows:
§ 526.365
Cephapirin sodium.
(a) Specifications. Each single-dose,
10-milliliter syringe contains 200
milligrams (mg) cephapirin sodium
activity.
*
*
*
*
*
(d) * * *
(1) Amount. Infuse the contents of one
syringe (200 mg cephapirin activity)
into each infected quarter immediately
after the quarter has been completely
milked out. Do not milk out for 12
hours. Repeat once only in 12 hours.
*
*
*
*
*
■ 26. Revise § 526.464 to read as
follows:
§ 526.464
Cloxacillin benzathine.
(a) Specifications. Each single-dose,
7.5- or 10-milliliter syringe contains
cloxacillin benzathine equivalent to 500
milligrams (mg) cloxacillin.
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.165
of this chapter.
(d) Conditions of use in dry cows—(1)
Amount. Infuse the contents of one
syringe (equivalent to 500 mg
cloxacillin) into each quarter
immediately after last milking, but no
later than 30 days before calving.
(2) Indications for use. For the
treatment of mastitis caused by
Staphylococcus aureus and
Streptococcus agalactiae including
penicillin resistant strains in dairy cows
during the dry period.
(3) Limitations. Animals infused with
this product must not be slaughtered for
food until 30 days after the latest
infusion. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
§ 526.464a
■
[Removed]
27. Remove § 526.464a.
§ 525.464b
[Redesignated as § 526.464]
28. Redesignate § 526.464b as
§ 526.465 and revise the section heading
and paragraphs (a) and (d) to read as
follows:
■
§ 526.465
Cloxacillin sodium.
(a) Specifications. Each single-dose,
10-milliliter syringe contains cloxacillin
sodium equivalent to 200 milligrams
(mg) cloxacillin.
*
*
*
*
*
(d) Conditions of use in lactating
cows—(1) Amount. Infuse the contents
of one syringe (equivalent to 200 mg
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
cloxacillin) into each infected quarter.
Treatment should be repeated at 12hour intervals for a total of 3 doses.
(2) Indications for use. For the
treatment of mastitis in lactating cows
due to Streptococcus agalactiae and
Staphylococcus aureus,
nonpenicillinase-producing strains.
(3) Limitations. Milk taken from
treated animals within 48 hours (4
milkings) after the latest treatment
should not be used for food. Treated
animals should not be slaughtered for
food within 10 days after the latest
treatment. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
■ 29. Revise § 526.820 to read as
follows:
§ 526.820
Erythromycin.
(a) Specifications—(1) Each singledose, 6-milliliter (mL) syringe contains
300 milligrams (mg) erythromycin (as
the base).
(2) Each single-dose, 12-mL syringe
contains 600 mg erythromycin (as the
base).
(b) Sponsors. See Nos. 054771 and
061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.230
of this chapter.
(d) Conditions of use for syringe
described in paragraph (a)(1) of this
section in lactating cows—(1) Amount.
Infuse the contents of one 6-mL syringe
(300 mg erythromycin base) into each
infected quarter. Repeat infusion at 12hour intervals for a maximum of 3
infusions.
(2) Indications for use. For the
treatment of mastitis due to
Staphylococcus aureus, Streptococcus
agalactiae, Streptococcus dysgalactiae,
and Streptococcus uberis in lactating
cows.
(3) Limitations. Milk taken from
animals during treatment and for 36
hours (3 milkings) after the latest
treatment must not be used for food.
(e) Conditions of use for syringe
described in paragraph (a)(2) of this
section in dry cows—(1) Amount. Infuse
the contents of one 12-mL syringe (600
mg erythromycin base) into each
infected quarter at the time of drying off.
(2) Indications for use. For the
treatment of mastitis due to
Staphylococcus aureus, Streptococcus
agalactiae, Streptococcus dysgalactiae,
and Streptococcus uberis in dry cows.
(3) Limitations. For use in dry cows
only.
■ 30. In § 526.1130, revise paragraph (a),
the paragraph (d) subject heading, and
paragraphs (d)(1) and (2) to read as
follows:
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§ 526.1130
Hetacillin.
(a) Specifications. Each single-dose,
10-milliliter syringe contains hetacillin
potassium equivalent of 62.5 milligrams
(mg) ampicillin.
*
*
*
*
*
(d) Conditions of use in lactating
cows—(1) Amount. Infuse the contents
of one syringe (equivalent to 62.5 mg
ampicillin) into each infected quarter.
Repeat at 24-hour intervals for a
maximum of 3 treatments.
(2) Indications for use. For the
treatment of acute, chronic, or
subclinical mastitis in lactating cows
caused by susceptible strains of
Streptococcus agalactiae, Streptococcus
dysgalactiae, Staphylococcus aureus,
and Escherichia coli.
*
*
*
*
*
■ 31. Revise § 526.1590 to read as
follows:
jbell on DSKJLSW7X2PROD with RULES
§ 526.1590
Novobiocin.
(a) Specifications. Each single-dose,
10-milliliter syringe contains:
(1) 150 milligrams (mg) of novobiocin
equivalents as sodium novobiocin, or
(2) 400 mg of novobiocin equivalents
as sodium novobiocin.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.460
of this chapter.
(d) Conditions of use for syringe
described in paragraph (a)(1) of this
section in lactating cows—(1) Amount.
Infuse the contents of one syringe
(equivalent to 150 mg novobiocin) into
each infected quarter after milking.
Repeat treatment once after 24 hours. Do
not milk for at least 6 hours after
treatment.
(2) Indications for use. For the
treatment of mastitis caused by
susceptible strains of Staphylococcus
aureus in lactating cows.
(3) Limitations. Milk taken from
treated animals within 72 hours (6
milkings) after latest treatment should
not be used for food. Do not slaughter
treated animals for food for 15 days
following latest treatment. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(e) Conditions of use for syringe
described in paragraph (a)(2) of this
section in dry cows—(1) Amount. Infuse
the contents of one syringe (equivalent
to 400 mg novobiocin) into each quarter
at the time of drying off.
(2) Indications for use. For the
treatment of mastitis caused by
susceptible strains of Staphylococcus
aureus and Streptococcus agalactiae in
dry cows.
(3) Limitations. For udder installation
for the treatment of mastitis in dry cows
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only. Infuse each quarter at the time of
drying off, but not less than 30 days
prior to calving. Do not slaughter treated
animals for food for 30 days following
udder infusion.
■ 32. Revise § 526.1696 to read as
follows:
§ 526.1696
Penicillin G procaine.
(a) Specifications. Each single-dose,
10-milliliter syringe contains penicillin
G procaine equivalent to 100,000 units
of penicillin G.
(b) Sponsors. See Nos. 010515 and
061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.510
of this chapter.
(d) Conditions of use in lactating
cows—(1) Amount. Infuse the contents
of one 10-milliliter syringe (equivalent
to 100,000 units penicillin G) into each
infected quarter. Treatment may be
repeated at 12-hour intervals for not
more than 3 doses, as indicated by
clinical response.
(2) Indications for use. For the
treatment of mastitis caused by
Streptococcus agalactiae, S.
dysgalactiae, and S. uberus in lactating
cows.
(3) Limitations. For intramammary
infusion in lactating cows only. Discard
all milk for 60 hours (5 milkings) after
the latest treatment. Animals intended
for human consumption must not be
slaughtered within 3 days of latest
treatment.
(e) Conditions of use in dry cows—(1)
Amount. Infuse the contents of one 10milliliter syringe (equivalent to 100,000
units penicillin G) into each infected
quarter at time of drying-off.
(2) Indications for use. For the
treatment of mastitis caused by
Streptococcus agalactiae in dry cows.
(3) Limitations. For intramammary
infusion in dry cows only. Animals
intended for human consumption must
not be slaughtered within 14 days of last
treatment. Discard all milk for 72 hours
(6 milkings) following calving, or later
as indicated by the marketable quality of
the milk.
§ 526.1696a
■
[Removed]
33. Remove § 526.1696a.
§ 526.1696b
[Redesignated as § 526.1697]
34. Redesignate § 526.1696b as
§ 526.1697 and revise the section
heading and paragraphs (a) and (d) and
add paragraph (e).
The revisions and addition read as
follows:
■
§ 526.1697 Penicillin G procaine and
dihydrostreptomycin.
(a) Specifications. Each single-use, 10milliliter syringe contains a suspension
of:
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
13187
(1) Penicillin G procaine equivalent to
200,000 units penicillin G and
dihydrostreptomycin sulfate equivalent
to 300 milligrams dihydrostreptomycin;
or
(2) Penicillin G procaine equivalent to
1 million units penicillin G and
dihydrostreptomycin sulfate equivalent
to 1 gram dihydrostreptomycin.
*
*
*
*
*
(d) Conditions of use for syringe
described in paragraph (a)(1) of this
section in dry cows—(1) Amount. Infuse
the contents of one syringe (equivalent
to 200,000 units penicillin G and 300
milligrams dihydrostreptomycin) into
each quarter at the last milking prior to
drying off.
(2) Indications for use. For the
treatment of subclinical mastitis in dairy
cows at the time of drying off,
specifically against infections caused by
Staphylococcus aureus and
Streptococcus agalactiae.
(3) Limitations. For use in dry cows
only. Not to be used within 6 weeks of
calving. Milk taken from cows within 24
hours (2 milkings) after calving must not
be used for food. Animals infused with
this drug must not be slaughtered for
food within 60 days of treatment or
within 24 hours after calving.
(e) Conditions of use for syringe
described in paragraph (a)(2) of this
section in dry cows—(1) Amount. Infuse
the contents of one syringe (equivalent
to 1 million units penicillin G and 1
gram dihydrostreptomycin) into each
quarter at the last milking prior to
drying off.
(2) Indications for use. To reduce the
frequency of existing infection and to
prevent new infections with
Staphylococcus aureus in dry cows.
(3) Limitations. Not for use in
lactating cows. Not to be used within 6
weeks of calving. Milk taken from cows
within 96 hours (8 milkings) after
calving must not be used for food.
Animals infused with this drug must
not be slaughtered for food within 60
days from the time of infusion or within
96 hours after calving. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
§ 526.1696c
■
[Removed]
35. Remove § 526.1696c.
§ 526.1696d
[Redesignated as § 526.1698]
36. Redesignate § 526.1696d as
§ 526.1698 and revise the section
heading and paragraphs (a) and (d) and
add paragraph (e).
The revisions and addition read as
follows:
■
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jbell on DSKJLSW7X2PROD with RULES
§ 526.1698 Penicillin G procaine and
novobiocin.
§ 526.1810
(a) Specifications. Each single-use, 10milliliter syringe contains a suspension
of:
(1) Penicillin G procaine equivalent to
100,000 units penicillin G and 150
milligrams (mg) novobiocin as
novobiocin sodium; or
(2) Penicillin G procaine equivalent to
200,000 units penicillin G and 400 mg
novobiocin as novobiocin sodium.
*
*
*
*
*
(d) Conditions of use for syringe
described in paragraph (a)(1) of this
section in lactating cows—(1) Amount.
Infuse the contents of one syringe
(equivalent to 100,000 units penicillin G
and 150 mg novobiocin) into each
infected quarter after milking. Repeat
once after 24 hours.
(2) Indications for use. For the
treatment of mastitis caused by
susceptible strains of Staphylococcus
aureus, Streptococcus agalactiae,
Streptococcus dysgalactiae, and
Streptococcus uberis in lactating cows.
(3) Limitations. For udder instillation
in lactating cows only. Do not milk for
at least 6 hours after treatment;
thereafter, milk at regular intervals. Milk
taken from treated animals within 72
hours (6 milkings) after the latest
treatment must not be used for food.
Treated animals must not be slaughtered
for food for 15 days following the latest
treatment. If redness, swelling, or
abnormal milk persists, discontinue use
and consult a veterinarian.
(e) Conditions of use for syringe
described in paragraph (a)(2) of this
section in lactating cows—(1) Amount.
Infuse the contents of one syringe
(equivalent to 200,000 units penicillin G
and 400 mg novobiocin) into each
quarter at dry off.
(2) Indications for use. For the
treatment of subclinical mastitis caused
by susceptible strains of Staphylococcus
aureus and Streptococcus agalactiae in
dry cows.
(3) Limitations. For udder instillation
in dry cows only. Do not use less than
30 days prior to calving. Milk from
treated cows must not be used for food
during the first 72 hours after calving.
Treated animals must not be slaughtered
for food for 30 days following udder
infusion.
■ 37. In § 526.1810, revise paragraph (a),
the paragraph (d) subject heading, and
the first sentence of paragraph (d)(1) to
read as follows:
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Jkt 253001
Pirlimycin.
(a) Specifications. Each single-dose,
10-milliliter syringe contains 50
milligrams (mg) of pirlimycin (as
pirlimycin hydrochloride).
*
*
*
*
*
(d) Conditions of use in lactating
cows—(1) Amount. Infuse the contents
of one syringe (50 mg pirlimycin) into
each infected quarter. * * *
*
*
*
*
*
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
38. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
39. Add § 529.443 to read as follows:
§ 529.443
§ 556.170
[Amended]
44. In § 556.170, in paragraph (c),
remove ‘‘520.543’’ and in its place add
‘‘520.534’’.
■
§ 556.180
[Amended]
45. In § 556.180, in paragraph (c),
remove ‘‘558.205’’ and in its place add
‘‘558.198’’.
■
§ 556.185
[Amended]
46. In § 556.185, in paragraph (c),
remove ‘‘§ 558.198’’ and in its place add
‘‘§ 558.205’’.
■
§ 556.226
[Amended]
47. In § 556.226, in paragraph (c),
remove ‘‘§ 522.812’’ and in its place add
‘‘§§ 516.812 and 522.812’’.
■
Ciclesonide.
(a) Specifications. A non-pressurized
metered dose inhaler and drug cartridge
combination containing a solution of 30
milligrams/milliliter of the prodrug
ciclesonide. Each actuation releases 343
micrograms (mcg) of ciclesonide.
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer an initial dose of 8
actuations (2,744 mcg ciclesonide) twice
daily for 5 days, followed by 12
actuations (4,116 mcg ciclesonide) once
daily for 5 days.
(2) Indications for use. For the
management of clinical signs associated
with severe equine asthma.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
§ 529.2150
in its place add ‘‘§§ 526.464 and
526.465’’.
[Redesignated as § 529.2110]
§ 556.300
[Amended]
48. In § 556.300, in paragraph (c),
remove ‘‘§§ 522.1044a, 520.1044b,
520.1044c, and 524.1044e’’ and in its
place add ‘‘§§ 520.1044a, 520.1044b,
520.1044c, 522.1044, 524.1044e, and
529.1044b’’.
■
§ 556.360
[Amended]
49. In § 556.360, in paragraph (c), add
‘‘520.1265,’’ after ‘‘520.1260,’’.
■
§ 556.510
[Amended]
50. In § 556.510, in paragraph (c),
remove ‘‘526.1696a, 526.1696b,
526.1696c, and 526.1696d’’ and in its
place add ‘‘526.1696, 526.1697, and
526.1698’’.
■
§ 556.670
[Amended]
■
40. Redesignate § 529.2150 as
§ 529.2110.
51. In § 556.670, in paragraph (c),
remove ‘‘§§ 520.2218’’ and add
‘‘§§ 520.445, 520.2218’’ in its place.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
41. The authority citation for part 556
continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
§ 556.38
[Amended]
43. In § 556.165, in paragraph (c),
remove ‘‘§§ 526.464a and 526.464b’’ and
Frm 00040
Fmt 4700
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
53. In § 558.68, revise paragraphs
(e)(1)(ii), (iii), and (v) to read as follows:
§ 558.68
*
[Amended]
■
PO 00000
52. The authority citation for part 558
continues to read as follows:
■
■
42. In § 556.38, in paragraph (c), add
‘‘520.88e,’’ after ‘‘520.88d,’’.
■
§ 556.165
■
Sfmt 4700
Avilamycin.
*
*
(e) * * *
(1) * * *
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*
13189
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Avilamycin in
grams/ton
Combination in
grams/ton
*
*
(ii) 13.6 to 40.9 .....
Monensin, 90 to
110.
(iii) 13.6 to 40.9 ....
Narasin, 54 to 90
*
(v) 13.6 to 40.9 .....
*
Salinomycin sodium, 40 to 60.
Indications for use
Limitations
*
Broiler chickens: For the prevention
of mortality caused by necrotic
enteritis associated with Clostridium perfringens; and as an
aid in the prevention of coccidiosis caused by Eimeria necatrix,
E. tenella, E. acervulina, E.
brunetti, E. mivati, and E. maxima.
Broiler chickens: For the prevention
of mortality caused by necrotic
enteritis associated with Clostridium perfringens; and for the
prevention of coccidiosis caused
by Eimeria necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati,
and E. maxima.
*
*
*
*
Feed as the sole ration for 21 consecutive days. To assure responsible
antimicrobial drug use in broiler chickens, treatment administration
must begin on or before 18 days of age. See § 558.355(d) of this
chapter. Monensin as provided by No. 058198 in § 510.600(c) of this
chapter.
*
Broiler chickens: For the prevention
of mortality caused by necrotic
enteritis associated with Clostridium perfringens; and for the
prevention of coccidiosis caused
by Eimeria tenella, E. necatrix, E.
acervulina,
E.
maxima,
E.
brunetti, and E. mivati.
*
*
*
*
Feed as the sole ration for 21 consecutive days. Feed to chickens that
are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. Not approved
for use with pellet binders. To assure responsible antimicrobial drug
use in broiler chickens, treatment administration must begin on or
before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has
not been demonstrated to be effective in broiler chickens showing
clinical signs of necrotic enteritis prior to the start of medication. Do
not feed to laying hens producing eggs for human consumption. May
be fatal if fed to adult turkeys or to horses. Salinomycin as provided
by No. 016592 in § 510.600(c) of this chapter.
*
§ 558.128
■
*
*
*
*
*
54. In § 558.128, revise paragraphs
(e)(4)(xv) and (xvi) to read as follows:
Chlortetracycline
amount
Combination in
grams/ton
*
(xv) 350 mg/head/
day.
*
............................
............................
(xvi) 20 to 350 g/
ton.
............................
*
*
*
*
*
To sponsor No. 054771 under NADAs 046–699 and 049–287, No.
066104 under NADA 092–286, and No. 069254 under NADA 048–
480: withdraw 48 hours prior to slaughter. To sponsor No. 069254
under NADA 138–935 and ANADA 200–510: zero withdrawal period.
*
*
*
*
*
55. In § 558.140, revise paragraph
(b)(1), redesignate paragraph (b)(2) as
paragraph (b)(3), add new paragraph
(b)(2), and revise paragraph (e)(1).
The revisions and addition read as
follows:
jbell on DSKJLSW7X2PROD with RULES
Jkt 253001
*
*
§ 558.140 Chlortetracycline and
sulfamethazine.
*
*
*
*
*
(b) * * *
(1) No. 054771 for use of product
described in paragraph (a)(1) as in
paragraph (e)(1) of this section.
Frm 00041
058198
Sponsor
Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under
NADAs 046–699 and 049–287, No. 066104 under NADA 092–286,
and No. 069254 under NADA 048–480: withdraw 48 hours prior to
slaughter. To sponsor No. 054771 under NADA 048–761 and No.
069254 under NADA 138–935 and ANADA 200–510: zero withdrawal time.
Feed to provide chlortetracycline at the rate of 350 mg per head per
day. This drug is not approved for use in female dairy cattle 20
months of age or older, including dry dairy cows. Use in these cattle
may cause drug residues in milk and/or in calves born to these
cows. A withdrawal period has not been established for this product
in pre-ruminating calves. Do not use in calves to be processed for
veal. To sponsor No. 054771 under NADA 048–761 and No. 069254
under ANADA 200–510: zero withdrawal period.
*
PO 00000
058198
(4) * * *
*
1. Beef cattle: For control of bacterial pneumonia associated with
shipping fever complex caused
by Pasteurella spp. susceptible
to chlortetracycline.
2. Beef cattle (under 700 lb): For
control of active infection of
anaplasmosis caused by A.
marginale susceptible to chlortetracycline.
Beef cattle and replacement dairy
heifers: For control of bacterial
pneumonia associated with shipping fever complex caused by
Pasteurella spp. susceptible to
chlortetracycline.
058198
*
Limitations
■
16:10 Mar 05, 2021
*
Indications for use
*
VerDate Sep<11>2014
Feed as the sole ration for 21 consecutive days to chickens that are at
risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. To assure responsible
antimicrobial drug use in broiler chickens, treatment administration
must begin on or before 18 days of age. Do not allow adult turkeys,
horses, or other equines access to narasin formulations. Ingestion of
narasin by these species has been fatal. Narasin as provided by No.
058198 in § 510.600(c) of this chapter.
Chlortetracycline.
*
*
(e) * * *
Sponsor
Fmt 4700
Sfmt 4700
*
054771
069254
054771
069254
054771
069254
*
(2) No. 069254 for use of product
described in paragraph (a)(1) as in
paragraph (e)(1)(i) of this section.
*
*
*
*
*
(e) * * *
(1) Cattle—
E:\FR\FM\08MRR1.SGM
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Chlortetracycline
and sulfamethazine
amount each
Combination in
grams/ton
Indications for use
Limitations
(i) To provide 350
milligrams per
head per day.
............................
Feed for 28 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating
calves. Do not use in calves to be processed for veal.
054771
069254
(ii) 35 to 105 g/ton,
each.
Lasalocid, 10 to
30.
Beef cattle: As an aid in the maintenance of weight gains in the
presence of respiratory disease
such as shipping fever.
Beef steers and heifers fed in confinement for slaughter: As an aid
in the maintenance of weight
gains in the presence of respiratory disease such as shipping
fever, and for improved feed efficiency.
054771
(iii) 35 to 42.2 g/
ton, each.
Lasalocid, 25 to
30.
Beef steers and heifers fed in confinement for slaughter: As an aid
in the maintenance of weight
gains in the presence of respiratory disease such as shipping
fever, and for improved feed efficiency and increased rate of
weight gain.
(iv) 35 to 700 g/
ton, each.
Lasalocid, 30 to
181.8.
Beef cattle up to 800 lb: As an aid
in the maintenance of weight
gains in the presence of respiratory disease such as shipping
fever, and for control of coccidiosis caused by Eimeria bovis
and E. zuernii.
Feed continuously for 28 days to provide 350 mg chlortetracycline, 350
mg sulfamethazine, and 100 to 300 mg lasalocid per head per day.
Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for
use in unapproved species has not been established. Withdraw 7
days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves
to be processed for veal. Lasalocid as provided by No. 054771 in
§ 510.600(c) of this chapter.
Feed continuously for 28 days to provide 350 mg chlortetracycline, 350
mg sulfamethazine, and 250 to 300 mg lasalocid per head per day.
Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for
use in unapproved species has not been established. Withdraw 7
days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves
to be processed for veal. Lasalocid as provided by No. 054771 in
§ 510.600(c) of this chapter.
Hand feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg sulfamethazine, and 1 mg lasalocid per 2.2 lb body
weight per day up to a maximum of 360 mg lasalocid per head per
day. Do not allow horses or other equines access to Type C feeds
containing lasalocid as ingestion may be fatal. Safety of lasalocid for
use in unapproved species has not been established. Withdraw 7
days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves
to be processed for veal. Lasalocid as provided by No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
56. In § 558.311, redesignate
paragraphs (e)(5)(ii) through (vi) as
paragraphs (e)(5)(iii) through (vii) and
add new paragraph (e)(5)(ii) to read as
follows:
(e) * * *
(5) * * *
(ii) Chlortetracycline and
sulfamethazine as in § 558.140.
*
*
*
*
*
§ 558.311
■
■
*
*
*
*
*
*
*
*
Indications for use
Limitations
(i) 0.25 to 0.5 ........
............................
Heifers fed in confinement for
slaughter: For increased rate of
weight gain, improved feed efficiency, and suppression of
estrus (heat).
Administer 0.5 to 2.0 pounds (lb)/head/day of medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to provide 0.25 to
0.5 mg melengestrol acetate/head/day.
*
*
*
*
*
*
58. In § 558.500, in paragraph (b),
remove ‘‘Nos. 054771 and 058198’’ and
in its place add ‘‘Nos. 016592, 054771,
■
*
Sponsor
*
and 058198’’ and revise paragraphs
(e)(2)(i), (iii), and (vi).
The revisions read as follows:
*
§ 558.500
*
Ractopamine.
*
*
(e) * * *
(2) * * *
*
*
Combination in
grams/ton
Indications for use
Limitations
(i) 8.2 to 24.6 ........
............................
Cattle fed in confinement for
slaughter: For increased rate of
weight gain and improved feed
efficiency during the last 28 to 42
days on feed
Feed continuously as sole ration during the last 28 to 42 days on feed
16:10 Mar 05, 2021
Jkt 253001
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
E:\FR\FM\08MRR1.SGM
016592
054771
058198
*
Ractopamine in
grams/ton
VerDate Sep<11>2014
054771
Melengestrol.
*
*
(e) * * *
(1) * * *
Combination in
grams/ton
*
jbell on DSKJLSW7X2PROD with RULES
§ 558.342
Melengestrol
acetate in
mg/head/day
*
054771
add ‘‘Nos. 016592 and 058198’’ and
revise paragraph (e)(1)(i).
The revision reads as follows:
57. In § 558.342, in paragraph (b)(2),
remove ‘‘No. 058198’’ and in its place
Lasalocid.
Sponsors
Sponsor
08MRR1
016592
054771
058198
13191
Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations
Ractopamine in
grams/ton
Combination in
grams/ton
*
(iii) 9.8 to 24.6 ......
*
............................
*
(vi) Not to exceed
800; to provide
70 to 400 mg/
head/day.
*
............................
*
*
*
*
Indications for use
Limitations
*
Cattle fed in confinement for
slaughter: For increased rate of
weight gain, improved feed efficiency, and increased carcass
leanness during the last 28 to 42
days on feed
*
*
*
*
Feed continuously as sole ration during the last 28 to 42 days on feed
*
Cattle fed in confinement for
slaughter: For increased rate of
weight gain and improved feed
efficiency during the last 28 to 42
days on feed
*
*
*
*
Top dress in a minimum of 1 lb of medicated feed .................................
*
*
*
*
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04453 Filed 3–5–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
26 CFR Part 1
Background
The final regulations (TD 9926) that
are the subject of this correction are
issued under section 1446 of the Code.
Need for Correction
As published, November 30, 2020 (85
FR 76910), the final regulations (TD
9926) contain an error that needs to be
corrected.
Correction of Publication
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendments:
[TD 9926]
RIN 1545–BO60
Title: Withholding of Tax and
Information Reporting With Respect to
Interests in Partnerships Engaged in a
U.S. Trade or Business; Correcting
Amendment
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
■
Authority: 26 U.S.C. 7805 * * *
AGENCY:
This document contains a
correction to final regulations (Treasury
Decision 9926) that were published in
the Federal Register on Monday,
November 30, 2020. The final
regulations provide guidance related to
the withholding of tax and information
reporting with respect to certain
dispositions of interests in partnerships
engaged in a trade or business within
the United States.
DATES: This correction is effective on
March 8, 2021 and applies to
partnership taxable years beginning on
or after November 30, 2020. See
§ 1.1446–7.
FOR FURTHER INFORMATION CONTACT:
Chadwick Rowland or Ronald M.
Gootzeit (202) 317–6937 (not toll-free
numbers).
jbell on DSKJLSW7X2PROD with RULES
SUMMARY:
SUPPLEMENTARY INFORMATION:
16:10 Mar 05, 2021
*
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Internal Revenue Service
VerDate Sep<11>2014
*
Jkt 253001
Par. 2. Amend § 1.1446–4, by revising
the last seven sentences of paragraph
(f)(1).’’
■
§ 1.1446–4
Publicly traded partnerships.
*
*
*
*
*
(f)* * * (1) * * * LTP makes a
distribution subject to section 1446 of
$100 to UTP during its taxable year
beginning January 1, 2020, and
withholds 37 percent (the highest rate in
section 1) ($37) of that distribution
under section 1446. UTP receives a net
distribution of $63 which it
immediately redistributes to its
partners. UTP has a liability to pay 37
percent of the total actual and deemed
distribution it makes to its foreign
partners as a section 1446 withholding
tax. UTP may credit the $37 withheld by
LTP against this liability as if it were
paid by UTP. See §§ 1.1462–1(b) and
1.1446–5(b)(1). When UTP distributes
the $63 it actually receives from LTP to
its partners, UTP is treated for purposes
PO 00000
Frm 00043
Fmt 4700
Sponsor
Sfmt 4700
*
016592
054771
058198
016592
054771
058198
*
of section 1446 as if it made a
distribution of $100 to its partners ($63
actual distribution and $37 deemed
distribution). UTP’s partners (U.S. and
foreign) may claim a credit against their
U.S. income tax liability for their
allocable share of the $37 of 1446 tax
paid on their behalf.
*
*
*
*
*
Crystal Pemberton,
Senior Federal Register Liaison, Legal
Processing Division, Associate Chief Counsel,
(Procedure and Administration).
[FR Doc. 2021–00504 Filed 3–5–21; 8:45 am]
BILLING CODE 4830–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2019–0661; FRL–10019–
92–Region 4]
Air Plan Approval; GA: NonInterference Demonstration and
Maintenance Plan Revision for the
Removal of Transportation Control
Measures in the Atlanta Area
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is approving a State
Implementation Plan (SIP) revision
submitted by Georgia, through the
Georgia Environmental Protection
Division (GA EPD), on September 16,
2019, for the purpose of removing
certain transportation control measures
(TCMs) from the SIP for the thirteen
counties in the Atlanta, Georgia, area.
EPA is also approving Georgia’s update
to the 2008 8-hour ozone maintenance
plan that was submitted in the
September 16, 2019, SIP revision.
Specifically, EPA is approving the
updated mobile emissions inventory,
SUMMARY:
E:\FR\FM\08MRR1.SGM
08MRR1
]]>Agencies
[Federal Register Volume 86, Number 43 (Monday, March 8, 2021)]
[Rules and Regulations]
[Pages 13181-13191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04453]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 524, 526, 529, 556, and 558
[Docket No. FDA-2020-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during April, May, and June 2020. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to improve the accuracy
and readability of the regulations.
DATES: This rule is effective March 8, 2021.
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. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during April, May, and June 2020, 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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During April, May, and June 2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 2, 2020.......... 141-527 Bayer HealthCare LLC, BAYTRIL 100-CA1 Cattle................ Conditional approval FOI Summary.
Animal Health (enrofloxacin) for the treatment of
Division, P.O. Box Injectable Solution. clinical
390, Shawnee Mission, anaplasmosis in
KS 66201. certain classes of
cattle.
April 10, 2020......... 141-533 Boehringer Ingelheim ASERVO EQUIHALER Horses................ Original approval for FOI Summary.
Animal Health USA, (ciclesonide the management of
Inc., 3239 Satellite inhalation spray). clinical signs
Blvd., Duluth, GA associated with
30096. severe equine asthma
in horses.
[[Page 13182]]
April 22, 2020......... 200-673 Aurora Pharmaceutical, REVOLT (selamectin) Dogs and cats......... Original approval as FOI Summary.
Inc., 1196 Highway 3 Topical Solution. a generic copy of
South, Northfield, MN NADA 141-152.
55057-3009.
April 27, 2020......... 200-674 Modern Veterinary Detomidine Horses................ Original approval as FOI Summary.
Therapeutics, LLC, Hydrochloride a generic copy of
14343 SW 119th Ave., (detomidine NADA 140-862.
Miami, FL 33186. hydrochloride)
Injectable Solution.
May 14, 2020........... 200-679 Huvepharma EOOD, 5th OPTIGRID (ractopamine Cattle................ Original approval as FOI Summary.
Floor, 3A Nikolay HCl) Type A a generic copy of
Haytov Str., 1113 Medicated Article. NADA 141-221.
Sophia, Bulgaria.
May 21, 2020........... 200-680 Felix Pharmaceuticals Enrofloxacin flavored Dogs.................. Original approval as FOI Summary.
Pvt. Ltd., 25-28 tablets. a generic copy of
North Wall Quay, NADA 140-441.
Dublin 1, Ireland.
May 27, 2020........... 200-638 V[eacute]toquinol USA, IMOXI Topical Cats.................. Original approval as FOI Summary.
Inc., 4250 N Sylvania Solution for Cats a generic copy of
Ave., Fort Worth, TX (imidacloprid and NADA 141-254.
76137. moxidectin).
May 28, 2020........... 200-510 Pharmgate, Inc., 1800 Chlortetracycline Cattle................ Supplemental approval N/A.
Sir Tyler Dr., Type B and Type C for use of DERACIN
Wilmington, NC 28405. medicated feeds. (chlortetracycline)
Type A medicated
articles in the
manufacture of Type
B and Type C
medicated feeds for
control of bacterial
pneumonia in beef
cattle and
replacement dairy
heifers.
June 1, 2020........... 200-134 Intervet, Inc., 2 FERTAGYL Cattle................ Supplemental approval FOI Summary.
Giralda Farms, (gonadorelin) for fixed-time
Madison, NJ 07940. Injectable Solution. artificial
insemination in beef
cows.
June 2, 2020........... 200-682 Huvepharma EOOD, 5th VETMULIN 12.5% Swine................. Original approval as FOI Summary.
Floor, 3A Nikolay (tiamulin hydrogen a generic copy of
Haytov Str., 1113 fumarate) Liquid NADA 140-916.
Sophia, Bulgaria. concentrate.
June 4, 2020........... 200-399 Huvepharma EOOD, 5th CYCLEGUARD Cattle................ Original approval as FOI Summary.
Floor, 3A Nikolay (melengestrol a generic copy of
Haytov Str., 1113 acetate Type A NADA 039-402.
Sophia, Bulgaria. liquid medicated
article).
June 15, 2020.......... 141-534 Orion Corp., CLEVOR (ropinirole Dogs.................. Original approval for FOI Summary.
Orionintie 1, 02200 ophthalmic solution). the induction of
Espoo, Finland. vomiting in dogs.
June 18, 2020.......... 141-535 Zoetis Inc., 333 Chlortetracycline, Cattle................ Original approval for FOI Summary.
Portage St., sulfamethazine, and use of AUREO S 700
Kalamazoo, MI 49007. lasalocid Type B and (chlortetracycline
Type C medicated and sulfamethazine)
feeds. and BOVATEC
(lasalocid) in the
manufacture of Type
B and Type C
medicated feeds for
beef steers and
heifers fed in
confinement for
slaughter.
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Changes of Sponsor
Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161 has informed
FDA that it has transferred ownership of, and all rights and interest
in, NADA 141-084 for SENTINEL (lufenuron and milbemycin oxime) Flavor
Tabs, NADA 141-204 for the SENTINEL Flavor Tabs and CAPSTAR
(nitenpyram) Flea Management System, and NADA 141-333 for SENTINEL
SPECTRUM (lufenuron, milbemycin oxime, and praziquantel) Chews to
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. Also, Sparhawk
Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 has
informed FDA that it has transferred ownership of, and all rights and
interest in, A 200-348 for ECOMECTIN (ivermectin) Cattle Pour-On to
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia,
Bulgaria. The animal drug regulations will be amended to reflect these
changes of sponsor.
III. Technical Amendments
FDA is making the following amendments to improve the accuracy and
readability of the animal drug regulations:
The entries in 21 CFR 510.600(c), 520.304, and 520.812 for
Dechra Veterinary Products LLC are being amended to reflect the firm's
current drug labeler code.
The entries in 21 CFR 510.600(c) for Cronus Pharma
Specialities India Private Ltd. are being amended to reflect the firm's
current address.
Conditions for use in 21 CFR 520.100 for use of amprolium
crumbles in calves are being removed because no approved NADA exists
for this dosage form product.
The regulations in part 526 (21 CFR part 526) for
intramammary dosage form drugs are being amended to reflect a current
format and improve readability.
The section in part 529 (21 CFR part 529) for sevofluorane
anesthetic gas is being redesignated to reflect a current
organizational scheme for dosage form new animal drugs.
Cross references in part 556 (21 CFR part 556) to related
approved uses of new animal drugs are being amended as conforming
changes to improve the accuracy of the regulations.
The table in 21 CFR 558.4 is being amended to reflect the
correct format for displaying assay limits for component drugs in
fixed-ratio, combination drug Type A medicated articles and Type B and
Type C medicated feeds.
Three tabular entries in 21 CFR 558.68 are being amended
to reflect the approved conditions of use of certain feed use
combinations, which had been removed in error.
[[Page 13183]]
Typographical errors are being corrected wherever they
have been found.
IV. Legal Authority
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. This 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 the conditions of use of an approved or conditionally approved new
animal drug and the name and address of the drug's sponsor in a
``notice, which upon publication shall be effective as a regulation.''
A notice published pursuant to section 512(i) is not subject to the
notice-and-comment rulemaking requirements of the Administrative
Procedure Act, 5 U.S.C. 551 et seq. See section 512(i) of the FD&C Act
(21 U.S.C. 360b(i)); 21 CFR 10.40(e)(3); S. Rep. 90-1308, at 5 (1968).
This document does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a ``rule of particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive
Order 12866, which defines a rule as ``an agency statement of general
applicability and future effect, which the agency intends to have the
force and effect of law, that is designed to implement, interpret, or
prescribe law or policy or to describe the procedure or practice
requirements of an agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, 526, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, 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
510, 516, 520, 522, 524, 526, 529, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600--
0
a. In the table in paragraph (c)(1):
0
i. Revise the entries for ``Cronus Pharma Specialities India Private
Ltd.'' and ``Dechra Veterinary Products LLC'';
0
ii. Add an entry in alphabetical order for ``Felix Pharmaceuticals Pvt.
Ltd.''; and
0
iii. Revise the entry for ``Pharmgate, Inc.''; and
0
b. In the table in paragraph (c)(2):
0
i. Add an entry in numerical order for ``017033'';
0
ii. Remove the entry for ``026637'';
0
iii. Revise the entries for ``069043'' and ``069254''; and
0
iv. Add an entry in numerical order for ``086101''.
The additions and revisions 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
------------------------------------------------------------------------
* * * * * * *
Cronus Pharma Specialities India Private Ltd., Sy No-99/ 069043
1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalli
Village, Shamshabad Mandal, Ranga Reddy, Hyderabad
Telangana 501218, India................................
* * * * * * *
Dechra Veterinary Products LLC, 7015 College Blvd., 017033
Suite 525, Overland Park, KS 66211.....................
* * * * * * *
Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay, 086101
Dublin 1, Ireland......................................
* * * * * * *
Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405 069254
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
017033.................. Dechra Veterinary Products LLC, 7015 College
Blvd., Suite 525, Overland Park, KS 66211.
* * * * * * *
069043.................. Cronus Pharma Specialities India Private Ltd.,
Sy No-99/1, GMR Hyderabad Aviation SEZ Ltd.,
Mamidipalli Village, Shamshabad Mandal, Ranga
Reddy, Hyderabad Telangana 501218, India.
[[Page 13184]]
* * * * * * *
069254.................. Pharmgate Inc., 1800 Sir Tyler Dr.,
Wilmington, NC 28405.
* * * * * * *
086101.................. Felix Pharmaceuticals Pvt. Ltd., 25-28 North
Wall Quay, Dublin 1, Ireland.
* * * * * * *
------------------------------------------------------------------------
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. 516.812 to subpart E to read as follows:
Sec. 516.812 Enrofloxacin.
(a) Specifications. Each milliliter (mL) of solution contains 100
milligrams (mg) enrofloxacin.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cattle--(1) Amount. Administer, by
subcutaneous injection, a single dose of 12.5 mg/kilogram of body
weight (5.7 mL/100 pounds of body weight). Administered dose volume
should not exceed 20 mL per injection site.
(2) Indications for use. For the treatment of clinical anaplasmosis
associated with Anaplasma marginale in replacement dairy heifers under
20 months of age and all classes of beef cattle except beef calves less
than 2 months of age and beef bulls intended for breeding (any age).
Not for use in any other class of dairy cattle or in veal calves.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Federal law prohibits the extra-
label use of this drug in food-producing animals. Cattle intended for
human consumption must not be slaughtered within 28 days from the last
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 for this product in pre-
ruminating calves. Do not use in calves to be processed for veal.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
6. In Sec. 520.100, remove paragraph (a)(3), revise paragraph (b)(2),
add paragraph (b)(3), and revise paragraph (d)(2) introductory text.
The revisions and addition read as follows:
Sec. 520.100 Amprolium.
* * * * *
(b) * * *
(2) No. 066104 for use of product described in paragraph (a)(1) of
this section as in paragraph (d) of this section.
(3) No. 051072 for use of product described in paragraph (a)(1) of
this section as in paragraph (d)(1) of this section.
* * * * *
(d) * * *
(2) Calves. Administer concentrate solution or soluble powder as a
drench or in drinking water as follows:
* * * * *
0
7. In Sec. 520.304, revise paragraph (b), remove reserved paragraph
(c), and redesignate paragraph (d) as paragraph (c).
The revision reads as follows:
Sec. 520.304 Carprofen.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (c) of this section.
(1) Nos. 017033, 054771, 055529, and 062250 for use of products
described in paragraph (a) as in paragraph (c) of this section.
(2) No. 000859 for use of product described in paragraph (a)(2) as
in paragraph (c) of this section.
* * * * *
0
8. In Sec. 520.812, revise paragraphs (a) and (b) to read as follows:
Sec. 520.812 Enrofloxacin.
(a) Specifications--(1) Each tablet contains:
(i) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
(ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
(2) Each chewable tablet contains 22.7, 68.0, or 136.0 mg
enrofloxacin.
(3) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg
enrofloxacin.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for use as in paragraph (c) of this section.
(1) No. 000859 for use of products described in paragraphs
(a)(1)(i), (a)(2), and (a)(3) of this section.
(2) No. 017033 for use of product described in paragraph (a)(1)(i)
of this section.
(3) No. 058198 for use of product described in paragraph (a)(1)(ii)
of this section.
(4) No. 086101 for use of product described in paragraph (a)(2) of
this section.
* * * * *
Sec. 520.1443 [Amended]
0
9. In Sec. 520.1443, in paragraph (b), remove ``051311'' and in its
place add ``000061''.
Sec. 520.1447 [Amended]
0
10. In Sec. 520.1447, in paragraph (b), remove ``051311'' and in its
place add ``000061''.
Sec. 520.1510 [Amended]
0
11. In Sec. 520.1510, in paragraph (b)(2), remove ``051311'' and in
its place add ``000061''.
Sec. 520.2455 [Amended]
0
12. In Sec. 520.2455, in paragraph (b)(4), remove ``No. 061133'' and
in its place add ``Nos. 016592 and 061133''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
13. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.536 [Amended]
0
14. In Sec. 522.536, in paragraph (b), remove ``No. 052483'' and in
its place add ``Nos. 015914 and 052483''.
0
15. In Sec. 522.1077:
0
a. Revise paragraphs (a)(3), (b), (d), and (e)(1)(i);
0
b. Remove paragraph (e)(1)(ii);
0
c. Redesignate paragraphs (e)(1)(iii) through (e)(1)(vii) as paragraphs
(e)(1)(ii) through (e)(1)(vi);
0
d. Revise newly redesignated paragraphs (e)(1)(ii) and (iii); and
[[Page 13185]]
0
e. Remove and reserve paragraph (e)(2).
The revisions read as follows:
Sec. 522.1077 Gonadorelin.
(a) * * *
(3) 50 [mu]g of gonadorelin as gonadorelin diacetate tetrahydrate
(equivalent to 43 [mu]g gonadorelin); or
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 000061 for use of the 43-[mu]g/mL product described in
paragraph (a)(1) as in paragraphs (e)(1)(i) and (iii) of this section.
(2) No. 068504 for use of the 100-[mu]g/mL product described in
paragraph (a)(2) as in paragraph (e)(1)(iv) of this section.
(3) No. 061133 for use of the 50-[mu]g/mL product described in
paragraph (a)(3) as in paragraphs (e)(1)(i) of this section.
(4) No. 000010 for use of the 43-[mu]g/mL product described in
paragraph (a)(3) as in paragraphs (e)(1)(i) and (v) of this section.
(5) No. 054771 for use of the 50-[mu]g/mL product described in
paragraph (a)(4) as in paragraphs (e)(1)(ii) and (vi) of this section.
* * * * *
(d) Special considerations--(1) Concurrent luteolytic drug use is
approved as follows:
(i) Cloprostenol injection for use as in paragraph (e)(1)(iii) of
this section as provided by No. 000061 in Sec. 510.600(c) of this
chapter.
(ii) Cloprostenol injection for use as in paragraph (e)(1)(iv) of
this section as provided by No. 068504 in Sec. 510.600(c) of this
chapter.
(iii) Cloprostenol injection for use as in paragraph (e)(1)(v) of
this section as provided by Nos. 000010 in Sec. 510.600(c) of this
chapter.
(iv) Dinoprost injection for use as in paragraphs (e)(1)(vi) of
this section as provided by No. 054771 in Sec. 510.600(c) of this
chapter.
(2) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(e) * * *
(1) Indications for use and amounts--(i) For the treatment of
ovarian follicular cysts in dairy cattle: Administer 86 [mu]g
gonadorelin (No. 000061) or 100 [mu]g gonadorelin diacetate
tetrahydrate (Nos. 000010 and 061133) by intramuscular or intravenous
injection.
(ii) For the treatment of ovarian follicular cysts in cattle:
Administer 100 [mu]g gonadorelin hydrochloride by intramuscular
injection.
(iii) For use with cloprostenol sodium to synchronize estrous
cycles to allow for fixed-time artificial insemination (FTAI) in beef
cows and lactating dairy cows: Administer to each cow 86 [mu]g
gonadorelin by intramuscular injection, followed 6 to 8 days later by
500 [mu]g cloprostenol by intramuscular injection, followed 30 to 72
hours later by 86 [mu]g gonadorelin by intramuscular injection.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
16. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
17. In Sec. 524.1146, revise paragraph (b)(2) and add paragraph (b)(3)
to read as follows:
Sec. 524.1146 Imidacloprid and moxidectin.
* * * * *
(b) * * *
(2) Nos. 000859 and 017030 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(2) of this
section.
(3) No. 000859 for use of product described in paragraph (a)(2) of
this section as in paragraph (d)(3) of this section.
* * * * *
Sec. 524.1193 [Amended]
0
18. In Sec. 524.1193, in paragraph (b)(2), remove ``016592, 054925,
and 058005'' and in its place add ``016592 and 054925''.
0
19. Add Sec. 524.2080 to read as follows:
Sec. 524.2080 Ropinirole.
(a) Specifications. Each milliliter of solution contains 30
milligrams (mg) ropinirole (equivalent to 34.2 mg ropinirole
hydrochloride).
(b) Sponsor. See No. 052483 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Using the table provided in
labeling, administer the number of eye drops topically, corresponding
to body weight, that results in a target dose of 3.75 mg per square
meter (mg/m\2\) (dose band 2.7 to 5.4 mg/m\2\). If the dog does not
vomit within 20 minutes of the first dose, then a second dose may be
administered.
(2) Indications for use. For the induction of vomiting in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 524.2098 [Amended]
0
20. In Sec. 524.2098, in paragraph (b), remove ``Nos. 054771, 055529,
and 061651'' and in its place add ``Nos. 051072, 054771, 055529, and
061651''.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
21. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
22. In Sec. 526.88, revise the section heading, paragraph (a), the
paragraph (d) subject heading, and paragraphs (d)(1) and (3) to read as
follows:
Sec. 526.88 Amoxicillin.
(a) Specifications. Each single-dose, 10-milliliter syringe
contains amoxicillin trihydrate equivalent to 62.5 milligrams (mg)
amoxicillin.
* * * * *
(d) Conditions of use in lactating cows--(1) Amount. Infuse the
contents of one syringe (equivalent to 62.5 mg amoxicillin) into each
infected quarter every 12 hours for a maximum of 3 doses.
* * * * *
(3) Limitations. Milk taken from animals during treatment and for
60 hours (5 milkings) after the last treatment must not be used for
food. Treated animals must not be slaughtered for food purposes within
12 days after the last treatment. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
0
23. In Sec. 526.313, revise paragraphs (a) and (d) and add paragraph
(e) to read as follows:
Sec. 526. 313 Ceftiofur.
(a) Specifications. Each single-dose, 10-milliliter syringe
contains:
(1) 125 milligrams (mg) ceftiofur equivalents as the hydrochloride
salt; or
(2) 500 mg ceftiofur equivalents as the hydrochloride salt.
* * * * *
(d) Conditions of use for syringe described in paragraph (a)(1) of
this section in lactating cows--(1) Amount. Infuse the contents of one
syringe (125 mg ceftiofur equivalents) into each affected quarter.
Repeat treatment in 24 hours. Once daily treatment may be repeated for
up to 8 consecutive days.
(2) Indications for use. For the treatment of clinical mastitis
associated with coagulase-negative staphylococci, Streptococcus
dysgalactiae, and Escherichia coli; and the treatment of diagnosed
subclinical mastitis associated with coagulase-negative staphylococci
and S. dysgalactiae.
(3) Limitations. Milk taken from cows during treatment (a maximum
of 8 daily infusions) and for 72 hours after the last treatment must
not be used for human consumption. Following label use for up to 8
consecutive days, a 2-day preslaughter withdrawal period is
[[Page 13186]]
required. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
(4) Special considerations. Federal law prohibits extralabel use of
this drug in lactating dairy cattle for disease prevention purposes; at
unapproved doses; frequencies, durations, or routes of administration;
and in unapproved major food-producing species/production classes.
(e) Conditions of use for syringe described in paragraph (a)(2) of
this section in dry cows--(1) Amount. Infuse the contents of one
syringe (500 mg ceftiofur equivalents) into each affected quarter at
the time of dry off.
(2) Indications for use. For the treatment of subclinical mastitis
in dairy cattle at the time of dry off associated with Staphylococcus
aureus, Streptococcus dysgalactiae, and Streptococcus uberis.
(3) Limitations. Milk taken from cows completing a 30-day dry-off
period may be used for food with no milk discard due to ceftiofur
residues. Following intramammary infusion, a 16-day preslaughter
withdrawal period is required for treated cows. No preslaughter
withdrawal period is required for neonatal calves from treated cows
regardless of colostrum consumption. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
(4) Special considerations. Federal law prohibits extralabel use of
this drug in dry dairy cattle for disease prevention purposes; at
unapproved doses; frequencies, durations, or routes of administration;
and in unapproved major food-producing species/production classes.
0
24. In Sec. 526.363, revise paragraphs (a) and (d) to read as follows:
Sec. 526. 363 Cephapirin benzathine.
(a) Specifications. Each single-dose, 10-milliliter syringe
contains 300 milligrams cephapirin activity (as cephapirin benzathine).
* * * * *
(d) Conditions of use in dry cows--(1) Amount. Infuse the contents
of one syringe (300 mg cephapirin activity) into each quarter following
last milking, but no later than 30 days before calving.
(2) Indications for use. For the treatment of mastitis caused by
susceptible strains of Streptococcus agalactiae and Staphylococcus
aureus, including penicillin-resistant strains.
(3) Limitations. For use in dry cows only. Milk from treated cows
must not be used for food during the first 72 hours after calving.
Animals infused with this product must not be slaughtered for food
until 42 days after the latest infusion.
0
25. In Sec. 526.365, revise paragraphs (a) and (d)(1) to read as
follows:
Sec. 526.365 Cephapirin sodium.
(a) Specifications. Each single-dose, 10-milliliter syringe
contains 200 milligrams (mg) cephapirin sodium activity.
* * * * *
(d) * * *
(1) Amount. Infuse the contents of one syringe (200 mg cephapirin
activity) into each infected quarter immediately after the quarter has
been completely milked out. Do not milk out for 12 hours. Repeat once
only in 12 hours.
* * * * *
0
26. Revise Sec. 526.464 to read as follows:
Sec. 526.464 Cloxacillin benzathine.
(a) Specifications. Each single-dose, 7.5- or 10-milliliter syringe
contains cloxacillin benzathine equivalent to 500 milligrams (mg)
cloxacillin.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.165 of this chapter.
(d) Conditions of use in dry cows--(1) Amount. Infuse the contents
of one syringe (equivalent to 500 mg cloxacillin) into each quarter
immediately after last milking, but no later than 30 days before
calving.
(2) Indications for use. For the treatment of mastitis caused by
Staphylococcus aureus and Streptococcus agalactiae including penicillin
resistant strains in dairy cows during the dry period.
(3) Limitations. Animals infused with this product must not be
slaughtered for food until 30 days after the latest infusion. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
Sec. 526.464a [Removed]
0
27. Remove Sec. 526.464a.
Sec. 525.464b [Redesignated as Sec. 526.464]
0
28. Redesignate Sec. 526.464b as Sec. 526.465 and revise the section
heading and paragraphs (a) and (d) to read as follows:
Sec. 526.465 Cloxacillin sodium.
(a) Specifications. Each single-dose, 10-milliliter syringe
contains cloxacillin sodium equivalent to 200 milligrams (mg)
cloxacillin.
* * * * *
(d) Conditions of use in lactating cows--(1) Amount. Infuse the
contents of one syringe (equivalent to 200 mg cloxacillin) into each
infected quarter. Treatment should be repeated at 12-hour intervals for
a total of 3 doses.
(2) Indications for use. For the treatment of mastitis in lactating
cows due to Streptococcus agalactiae and Staphylococcus aureus,
nonpenicillinase-producing strains.
(3) Limitations. Milk taken from treated animals within 48 hours (4
milkings) after the latest treatment should not be used for food.
Treated animals should not be slaughtered for food within 10 days after
the latest treatment. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
29. Revise Sec. 526.820 to read as follows:
Sec. 526.820 Erythromycin.
(a) Specifications--(1) Each single-dose, 6-milliliter (mL) syringe
contains 300 milligrams (mg) erythromycin (as the base).
(2) Each single-dose, 12-mL syringe contains 600 mg erythromycin
(as the base).
(b) Sponsors. See Nos. 054771 and 061133 in Sec. 510.600(c) of
this chapter.
(c) Related tolerances. See Sec. 556.230 of this chapter.
(d) Conditions of use for syringe described in paragraph (a)(1) of
this section in lactating cows--(1) Amount. Infuse the contents of one
6-mL syringe (300 mg erythromycin base) into each infected quarter.
Repeat infusion at 12-hour intervals for a maximum of 3 infusions.
(2) Indications for use. For the treatment of mastitis due to
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus
dysgalactiae, and Streptococcus uberis in lactating cows.
(3) Limitations. Milk taken from animals during treatment and for
36 hours (3 milkings) after the latest treatment must not be used for
food.
(e) Conditions of use for syringe described in paragraph (a)(2) of
this section in dry cows--(1) Amount. Infuse the contents of one 12-mL
syringe (600 mg erythromycin base) into each infected quarter at the
time of drying off.
(2) Indications for use. For the treatment of mastitis due to
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus
dysgalactiae, and Streptococcus uberis in dry cows.
(3) Limitations. For use in dry cows only.
0
30. In Sec. 526.1130, revise paragraph (a), the paragraph (d) subject
heading, and paragraphs (d)(1) and (2) to read as follows:
[[Page 13187]]
Sec. 526.1130 Hetacillin.
(a) Specifications. Each single-dose, 10-milliliter syringe
contains hetacillin potassium equivalent of 62.5 milligrams (mg)
ampicillin.
* * * * *
(d) Conditions of use in lactating cows--(1) Amount. Infuse the
contents of one syringe (equivalent to 62.5 mg ampicillin) into each
infected quarter. Repeat at 24-hour intervals for a maximum of 3
treatments.
(2) Indications for use. For the treatment of acute, chronic, or
subclinical mastitis in lactating cows caused by susceptible strains of
Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus
aureus, and Escherichia coli.
* * * * *
0
31. Revise Sec. 526.1590 to read as follows:
Sec. 526.1590 Novobiocin.
(a) Specifications. Each single-dose, 10-milliliter syringe
contains:
(1) 150 milligrams (mg) of novobiocin equivalents as sodium
novobiocin, or
(2) 400 mg of novobiocin equivalents as sodium novobiocin.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.460 of this chapter.
(d) Conditions of use for syringe described in paragraph (a)(1) of
this section in lactating cows--(1) Amount. Infuse the contents of one
syringe (equivalent to 150 mg novobiocin) into each infected quarter
after milking. Repeat treatment once after 24 hours. Do not milk for at
least 6 hours after treatment.
(2) Indications for use. For the treatment of mastitis caused by
susceptible strains of Staphylococcus aureus in lactating cows.
(3) Limitations. Milk taken from treated animals within 72 hours (6
milkings) after latest treatment should not be used for food. Do not
slaughter treated animals for food for 15 days following latest
treatment. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
(e) Conditions of use for syringe described in paragraph (a)(2) of
this section in dry cows--(1) Amount. Infuse the contents of one
syringe (equivalent to 400 mg novobiocin) into each quarter at the time
of drying off.
(2) Indications for use. For the treatment of mastitis caused by
susceptible strains of Staphylococcus aureus and Streptococcus
agalactiae in dry cows.
(3) Limitations. For udder installation for the treatment of
mastitis in dry cows only. Infuse each quarter at the time of drying
off, but not less than 30 days prior to calving. Do not slaughter
treated animals for food for 30 days following udder infusion.
0
32. Revise Sec. 526.1696 to read as follows:
Sec. 526.1696 Penicillin G procaine.
(a) Specifications. Each single-dose, 10-milliliter syringe
contains penicillin G procaine equivalent to 100,000 units of
penicillin G.
(b) Sponsors. See Nos. 010515 and 061133 in Sec. 510.600(c) of
this chapter.
(c) Related tolerances. See Sec. 556.510 of this chapter.
(d) Conditions of use in lactating cows--(1) Amount. Infuse the
contents of one 10-milliliter syringe (equivalent to 100,000 units
penicillin G) into each infected quarter. Treatment may be repeated at
12-hour intervals for not more than 3 doses, as indicated by clinical
response.
(2) Indications for use. For the treatment of mastitis caused by
Streptococcus agalactiae, S. dysgalactiae, and S. uberus in lactating
cows.
(3) Limitations. For intramammary infusion in lactating cows only.
Discard all milk for 60 hours (5 milkings) after the latest treatment.
Animals intended for human consumption must not be slaughtered within 3
days of latest treatment.
(e) Conditions of use in dry cows--(1) Amount. Infuse the contents
of one 10-milliliter syringe (equivalent to 100,000 units penicillin G)
into each infected quarter at time of drying-off.
(2) Indications for use. For the treatment of mastitis caused by
Streptococcus agalactiae in dry cows.
(3) Limitations. For intramammary infusion in dry cows only.
Animals intended for human consumption must not be slaughtered within
14 days of last treatment. Discard all milk for 72 hours (6 milkings)
following calving, or later as indicated by the marketable quality of
the milk.
Sec. 526.1696a [Removed]
0
33. Remove Sec. 526.1696a.
Sec. 526.1696b [Redesignated as Sec. 526.1697]
0
34. Redesignate Sec. 526.1696b as Sec. 526.1697 and revise the
section heading and paragraphs (a) and (d) and add paragraph (e).
The revisions and addition read as follows:
Sec. 526.1697 Penicillin G procaine and dihydrostreptomycin.
(a) Specifications. Each single-use, 10-milliliter syringe contains
a suspension of:
(1) Penicillin G procaine equivalent to 200,000 units penicillin G
and dihydrostreptomycin sulfate equivalent to 300 milligrams
dihydrostreptomycin; or
(2) Penicillin G procaine equivalent to 1 million units penicillin
G and dihydrostreptomycin sulfate equivalent to 1 gram
dihydrostreptomycin.
* * * * *
(d) Conditions of use for syringe described in paragraph (a)(1) of
this section in dry cows--(1) Amount. Infuse the contents of one
syringe (equivalent to 200,000 units penicillin G and 300 milligrams
dihydrostreptomycin) into each quarter at the last milking prior to
drying off.
(2) Indications for use. For the treatment of subclinical mastitis
in dairy cows at the time of drying off, specifically against
infections caused by Staphylococcus aureus and Streptococcus
agalactiae.
(3) Limitations. For use in dry cows only. Not to be used within 6
weeks of calving. Milk taken from cows within 24 hours (2 milkings)
after calving must not be used for food. Animals infused with this drug
must not be slaughtered for food within 60 days of treatment or within
24 hours after calving.
(e) Conditions of use for syringe described in paragraph (a)(2) of
this section in dry cows--(1) Amount. Infuse the contents of one
syringe (equivalent to 1 million units penicillin G and 1 gram
dihydrostreptomycin) into each quarter at the last milking prior to
drying off.
(2) Indications for use. To reduce the frequency of existing
infection and to prevent new infections with Staphylococcus aureus in
dry cows.
(3) Limitations. Not for use in lactating cows. Not to be used
within 6 weeks of calving. Milk taken from cows within 96 hours (8
milkings) after calving must not be used for food. Animals infused with
this drug must not be slaughtered for food within 60 days from the time
of infusion or within 96 hours after calving. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
Sec. 526.1696c [Removed]
0
35. Remove Sec. 526.1696c.
Sec. 526.1696d [Redesignated as Sec. 526.1698]
0
36. Redesignate Sec. 526.1696d as Sec. 526.1698 and revise the
section heading and paragraphs (a) and (d) and add paragraph (e).
The revisions and addition read as follows:
[[Page 13188]]
Sec. 526.1698 Penicillin G procaine and novobiocin.
(a) Specifications. Each single-use, 10-milliliter syringe contains
a suspension of:
(1) Penicillin G procaine equivalent to 100,000 units penicillin G
and 150 milligrams (mg) novobiocin as novobiocin sodium; or
(2) Penicillin G procaine equivalent to 200,000 units penicillin G
and 400 mg novobiocin as novobiocin sodium.
* * * * *
(d) Conditions of use for syringe described in paragraph (a)(1) of
this section in lactating cows--(1) Amount. Infuse the contents of one
syringe (equivalent to 100,000 units penicillin G and 150 mg
novobiocin) into each infected quarter after milking. Repeat once after
24 hours.
(2) Indications for use. For the treatment of mastitis caused by
susceptible strains of Staphylococcus aureus, Streptococcus agalactiae,
Streptococcus dysgalactiae, and Streptococcus uberis in lactating cows.
(3) Limitations. For udder instillation in lactating cows only. Do
not milk for at least 6 hours after treatment; thereafter, milk at
regular intervals. Milk taken from treated animals within 72 hours (6
milkings) after the latest treatment must not be used for food. Treated
animals must not be slaughtered for food for 15 days following the
latest treatment. If redness, swelling, or abnormal milk persists,
discontinue use and consult a veterinarian.
(e) Conditions of use for syringe described in paragraph (a)(2) of
this section in lactating cows--(1) Amount. Infuse the contents of one
syringe (equivalent to 200,000 units penicillin G and 400 mg
novobiocin) into each quarter at dry off.
(2) Indications for use. For the treatment of subclinical mastitis
caused by susceptible strains of Staphylococcus aureus and
Streptococcus agalactiae in dry cows.
(3) Limitations. For udder instillation in dry cows only. Do not
use less than 30 days prior to calving. Milk from treated cows must not
be used for food during the first 72 hours after calving. Treated
animals must not be slaughtered for food for 30 days following udder
infusion.
0
37. In Sec. 526.1810, revise paragraph (a), the paragraph (d) subject
heading, and the first sentence of paragraph (d)(1) to read as follows:
Sec. 526.1810 Pirlimycin.
(a) Specifications. Each single-dose, 10-milliliter syringe
contains 50 milligrams (mg) of pirlimycin (as pirlimycin
hydrochloride).
* * * * *
(d) Conditions of use in lactating cows--(1) Amount. Infuse the
contents of one syringe (50 mg pirlimycin) into each infected quarter.
* * *
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
38. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
39. Add Sec. 529.443 to read as follows:
Sec. 529.443 Ciclesonide.
(a) Specifications. A non-pressurized metered dose inhaler and drug
cartridge combination containing a solution of 30 milligrams/milliliter
of the prodrug ciclesonide. Each actuation releases 343 micrograms
(mcg) of ciclesonide.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer an initial dose of 8
actuations (2,744 mcg ciclesonide) twice daily for 5 days, followed by
12 actuations (4,116 mcg ciclesonide) once daily for 5 days.
(2) Indications for use. For the management of clinical signs
associated with severe equine asthma.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Sec. 529.2150 [Redesignated as Sec. 529.2110]
0
40. Redesignate Sec. 529.2150 as Sec. 529.2110.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
41. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.38 [Amended]
0
42. In Sec. 556.38, in paragraph (c), add ``520.88e,'' after
``520.88d,''.
Sec. 556.165 [Amended]
0
43. In Sec. 556.165, in paragraph (c), remove ``Sec. Sec. 526.464a
and 526.464b'' and in its place add ``Sec. Sec. 526.464 and 526.465''.
Sec. 556.170 [Amended]
0
44. In Sec. 556.170, in paragraph (c), remove ``520.543'' and in its
place add ``520.534''.
Sec. 556.180 [Amended]
0
45. In Sec. 556.180, in paragraph (c), remove ``558.205'' and in its
place add ``558.198''.
Sec. 556.185 [Amended]
0
46. In Sec. 556.185, in paragraph (c), remove ``Sec. 558.198'' and in
its place add ``Sec. 558.205''.
Sec. 556.226 [Amended]
0
47. In Sec. 556.226, in paragraph (c), remove ``Sec. 522.812'' and in
its place add ``Sec. Sec. 516.812 and 522.812''.
Sec. 556.300 [Amended]
0
48. In Sec. 556.300, in paragraph (c), remove ``Sec. Sec. 522.1044a,
520.1044b, 520.1044c, and 524.1044e'' and in its place add ``Sec. Sec.
520.1044a, 520.1044b, 520.1044c, 522.1044, 524.1044e, and 529.1044b''.
Sec. 556.360 [Amended]
0
49. In Sec. 556.360, in paragraph (c), add ``520.1265,'' after
``520.1260,''.
Sec. 556.510 [Amended]
0
50. In Sec. 556.510, in paragraph (c), remove ``526.1696a, 526.1696b,
526.1696c, and 526.1696d'' and in its place add ``526.1696, 526.1697,
and 526.1698''.
Sec. 556.670 [Amended]
0
51. In Sec. 556.670, in paragraph (c), remove ``Sec. Sec. 520.2218''
and add ``Sec. Sec. 520.445, 520.2218'' in its place.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
52. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
53. In Sec. 558.68, revise paragraphs (e)(1)(ii), (iii), and (v) to
read as follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
[[Page 13189]]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avilamycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 13.6 to 40.9............. Monensin, 90 to 110...... Broiler chickens: For the prevention of Feed as the sole ration for 21 consecutive days. To assure responsible 058198
mortality caused by necrotic enteritis antimicrobial drug use in broiler chickens, treatment administration must
associated with Clostridium perfringens; begin on or before 18 days of age. See Sec. 558.355(d) of this chapter.
and as an aid in the prevention of Monensin as provided by No. 058198 in Sec. 510.600(c) of this chapter.
coccidiosis caused by Eimeria necatrix, E.
tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima.
(iii) 13.6 to 40.9............ Narasin, 54 to 90........ Broiler chickens: For the prevention of Feed as the sole ration for 21 consecutive days to chickens that are at 058198
mortality caused by necrotic enteritis risk of developing, but not yet showing clinical signs of, necrotic
associated with Clostridium perfringens; enteritis associated with Clostridium perfringens. To assure responsible
and for the prevention of coccidiosis antimicrobial drug use in broiler chickens, treatment administration must
caused by Eimeria necatrix, E. tenella, E. begin on or before 18 days of age. Do not allow adult turkeys, horses, or
acervulina, E. brunetti, E. mivati, and E. other equines access to narasin formulations. Ingestion of narasin by
maxima. these species has been fatal. Narasin as provided by No. 058198 in Sec.
510.600(c) of this chapter.
* * * * * * *
(v) 13.6 to 40.9.............. Salinomycin sodium, 40 to Broiler chickens: For the prevention of Feed as the sole ration for 21 consecutive days. Feed to chickens that are 058198
60. mortality caused by necrotic enteritis at risk of developing, but not yet showing clinical signs of, necrotic
associated with Clostridium perfringens; enteritis associated with Clostridium perfringens. Not approved for use
and for the prevention of coccidiosis with pellet binders. To assure responsible antimicrobial drug use in
caused by Eimeria tenella, E. necatrix, E. broiler chickens, treatment administration must begin on or before 18 days
acervulina, E. maxima, E. brunetti, and E. of age. The safety of avilamycin has not been established in chickens
mivati. intended for breeding purposes. Avilamycin has not been demonstrated to be
effective in broiler chickens showing clinical signs of necrotic enteritis
prior to the start of medication. Do not feed to laying hens producing
eggs for human consumption. May be fatal if fed to adult turkeys or to
horses. Salinomycin as provided by No. 016592 in Sec. 510.600(c) of this
chapter.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
54. In Sec. 558.128, revise paragraphs (e)(4)(xv) and (xvi) to read as
follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(xv) 350 mg/head/day.......... ......................... 1. Beef cattle: For control of bacterial To sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under 054771
pneumonia associated with shipping fever NADA 092-286, and No. 069254 under NADA 048-480: withdraw 48 hours prior 069254
complex caused by Pasteurella spp. to slaughter. To sponsor No. 069254 under NADA 138-935 and ANADA 200-510:
susceptible to chlortetracycline. zero withdrawal period.
......................... 2. Beef cattle (under 700 lb): For control Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADAs 046- 054771
of active infection of anaplasmosis caused 699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 069254
by A. marginale susceptible to 048-480: withdraw 48 hours prior to slaughter. To sponsor No. 054771 under
chlortetracycline. NADA 048-761 and No. 069254 under NADA 138-935 and ANADA 200-510: zero
withdrawal time.
(xvi) 20 to 350 g/ton......... ......................... Beef cattle and replacement dairy heifers: Feed to provide chlortetracycline at the rate of 350 mg per head per day. 054771
For control of bacterial pneumonia This drug is not approved for use in female dairy cattle 20 months of age 069254
associated with shipping fever complex or older, including dry dairy cows. Use in these cattle may cause drug
caused by Pasteurella spp. susceptible to residues in milk and/or in calves born to these cows. A withdrawal period
chlortetracycline. has not been established for this product in pre-ruminating calves. Do not
use in calves to be processed for veal. To sponsor No. 054771 under NADA
048-761 and No. 069254 under ANADA 200-510: zero withdrawal period.
* * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
55. In Sec. 558.140, revise paragraph (b)(1), redesignate paragraph
(b)(2) as paragraph (b)(3), add new paragraph (b)(2), and revise
paragraph (e)(1).
The revisions and addition read as follows:
Sec. 558.140 Chlortetracycline and sulfamethazine.
* * * * *
(b) * * *
(1) No. 054771 for use of product described in paragraph (a)(1) as
in paragraph (e)(1) of this section.
(2) No. 069254 for use of product described in paragraph (a)(1) as
in paragraph (e)(1)(i) of this section.
* * * * *
(e) * * *
(1) Cattle--
[[Page 13190]]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Chlortetracycline and
sulfamethazine amount each Combination in grams/ton Indications for use Limitations Sponsors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(i) To provide 350 milligrams ......................... Beef cattle: As an aid in the maintenance Feed for 28 days. Withdraw 7 days prior to slaughter. A withdrawal period 054771
per head per day. of weight gains in the presence of has not been established for this product in pre-ruminating calves. Do not 069254
respiratory disease such as shipping use in calves to be processed for veal.
fever.
(ii) 35 to 105 g/ton, each.... Lasalocid, 10 to 30...... Beef steers and heifers fed in confinement Feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg 054771
for slaughter: As an aid in the sulfamethazine, and 100 to 300 mg lasalocid per head per day. Do not allow
maintenance of weight gains in the horses or other equines access to Type C feeds containing lasalocid as
presence of respiratory disease such as ingestion may be fatal. Safety of lasalocid for use in unapproved species
shipping fever, and for improved feed has not been established. Withdraw 7 days prior to slaughter. A withdrawal
efficiency. period has not been established for this product in pre-ruminating calves.
Do not use in calves to be processed for veal. Lasalocid as provided by
No. 054771 in Sec. 510.600(c) of this chapter.
(iii) 35 to 42.2 g/ton, each.. Lasalocid, 25 to 30...... Beef steers and heifers fed in confinement Feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg 054771
for slaughter: As an aid in the sulfamethazine, and 250 to 300 mg lasalocid per head per day. Do not allow
maintenance of weight gains in the horses or other equines access to Type C feeds containing lasalocid as
presence of respiratory disease such as ingestion may be fatal. Safety of lasalocid for use in unapproved species
shipping fever, and for improved feed has not been established. Withdraw 7 days prior to slaughter. A withdrawal
efficiency and increased rate of weight period has not been established for this product in pre-ruminating calves.
gain. Do not use in calves to be processed for veal. Lasalocid as provided by
No. 054771 in Sec. 510.600(c) of this chapter.
(iv) 35 to 700 g/ton, each.... Lasalocid, 30 to 181.8... Beef cattle up to 800 lb: As an aid in the Hand feed continuously for 28 days to provide 350 mg chlortetracycline, 350 054771
maintenance of weight gains in the mg sulfamethazine, and 1 mg lasalocid per 2.2 lb body weight per day up to
presence of respiratory disease such as a maximum of 360 mg lasalocid per head per day. Do not allow horses or
shipping fever, and for control of other equines access to Type C feeds containing lasalocid as ingestion may
coccidiosis caused by Eimeria bovis and E. be fatal. Safety of lasalocid for use in unapproved species has not been
zuernii. established. Withdraw 7 days prior to slaughter. A withdrawal period has
not been established for this product in pre-ruminating calves. Do not use
in calves to be processed for veal. Lasalocid as provided by No. 054771 in
Sec. 510.600(c) of this chapter.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
56. In Sec. 558.311, redesignate paragraphs (e)(5)(ii) through (vi) as
paragraphs (e)(5)(iii) through (vii) and add new paragraph (e)(5)(ii)
to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(5) * * *
(ii) Chlortetracycline and sulfamethazine as in Sec. 558.140.
* * * * *
0
57. In Sec. 558.342, in paragraph (b)(2), remove ``No. 058198'' and in
its place add ``Nos. 016592 and 058198'' and revise paragraph
(e)(1)(i).
The revision reads as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Melengestrol acetate in mg/
head/day Combination in grams/ton Indications for use Limitations Sponsor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 0.25 to 0.5............... ......................... Heifers fed in confinement for slaughter: Administer 0.5 to 2.0 pounds (lb)/head/day of medicated feed containing 016592
For increased rate of weight gain, 0.125 to 1.0 mg melengestrol acetate/lb to provide 0.25 to 0.5 mg 054771
improved feed efficiency, and suppression melengestrol acetate/head/day. 058198
of estrus (heat).
* * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
58. In Sec. 558.500, in paragraph (b), remove ``Nos. 054771 and
058198'' and in its place add ``Nos. 016592, 054771, and 058198'' and
revise paragraphs (e)(2)(i), (iii), and (vi).
The revisions read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Ractopamine in grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 8.2 to 24.6............ ..................... Cattle fed in confinement for Feed continuously as sole ration during the 016592
slaughter: For increased rate of last 28 to 42 days on feed. 054771
weight gain and improved feed 058198
efficiency during the last 28 to 42
days on feed
[[Page 13191]]
* * * * * * *
(iii) 9.8 to 24.6.......... ..................... Cattle fed in confinement for Feed continuously as sole ration during the 016592
slaughter: For increased rate of last 28 to 42 days on feed. 054771
weight gain, improved feed efficiency, 058198
and increased carcass leanness during
the last 28 to 42 days on feed
* * * * * * *
(vi) Not to exceed 800; to ..................... Cattle fed in confinement for Top dress in a minimum of 1 lb of medicated 016592
provide 70 to 400 mg/head/ slaughter: For increased rate of feed. 054771
day. weight gain and improved feed 058198
efficiency during the last 28 to 42
days on feed
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04453 Filed 3-5-21; 8:45 am]
BILLING CODE 4164-01-P
