Rule2021-22604
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Primary source
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Published
October 20, 2021
Effective
October 20, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditional new animal drug applications (cNADAs) during January, February, and March 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
Full Text
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<title>Federal Register, Volume 86 Issue 200 (Wednesday, October 20, 2021)</title>
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[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Rules and Regulations]
[Pages 57992-58016]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22604]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 526, 556 and 558
[Docket No. FDA-2021-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and conditional new animal drug applications
(cNADAs) during January, February, and March 2021. FDA is informing the
public of the availability of summaries of the basis of approval and of
environmental review documents, where applicable. The animal drug
regulations are also being amended to improve the accuracy and
readability of the regulations.
DATES: This rule is effective October 20, 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,
<a href="/cdn-cgi/l/email-protection#6106040e1306044f09000803040d210705004f0909124f060e17"><span class="__cf_email__" data-cfemail="a5c2c0cad7c2c08bcdc4ccc7c0c9e5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs, ANADAs, and conditional approval actions for cNADAs
during January, February, and March 2021, as listed in table 1. In
addition, FDA is informing the public of the availability, where
applicable, of documentation of environmental review required under the
National Environmental Policy Act (NEPA) and, for actions requiring
review of safety or effectiveness data, summaries of the basis of
approval (FOI Summaries) under the Freedom of Information Act (FOIA).
These public documents may be seen in the office of the Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500. Persons with access to the internet may
obtain these documents at the CVM FOIA Electronic Reading Room: <a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room">https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room</a>. Marketing exclusivity and patent information may be
accessed in FDA's publication, Approved Animal Drug Products Online
(Green Book) at: <a href="https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book">https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book</a>.
FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 8, 2021.............. 141-336 ECO LLC, 344 Nassau AIVLOSIN (62.5% w/w Swine.............. Supplemental FOI Summary.
St., Princeton, NJ tylvalosin as approval for the
08540. tylvalosin tartrate) addition of
Water Soluble Mycoplasma
Granules. hyopneumoniae to
the list of
pathogens for the
control of swine
respiratory disease
indication.
January 11, 2021............. 141-526 Anivive Lifesciences, LAVERDIA-CA1 Dogs............... Conditional approval FOI Summary.
Inc., 3250 Airflite (verdinexor tablets). for the treatment
Way, Suite 400, Long of lymphoma in dogs.
Beach, CA 90807.
January 12, 2021............. 200-675 Huvepharma EOOD, 5th Ractopamine Cattle............. Original approval as FOI Summary.
Floor, 3A Nikolay hydrochloride and a generic copy of
Haytov Str., 1113 monensin Type B and NADA 141-225.
Sofia, Bulgaria. Type C medicated
feeds.
January 12, 2021............. 200-676 Do................... Ractopamine Cattle............. Original approval as FOI Summary.
hydrochloride, a generic copy of
monensin, and NADA 141-224.
tylosin phosphate
Type B and Type C
medicated feeds.
[[Page 57993]]
January 12, 2021............. 200-677 Do................... Ractopamine Cattle............. Original approval as FOI Summary.
hydrochloride, a generic copy of
monensin, and NADA 141-234.
melengestrol acetate
Type C medicated
feeds.
January 12, 2021............. 200-678 Do................... Ractopamine Cattle............. Original approval as FOI Summary.
hydrochloride, a generic copy of
monensin, tylosin NADA 141-233.
phosphate, and
melengestrol acetate
Type C medicated
feeds.
January 14, 2021............. 141-544 Pegasus Laboratories, KBROVET-CA1 Dogs............... Conditional approval FOI Summary.
Inc., 8809 Ely Rd., (potassium bromide for the control of
Pensacola, FL 32514. chewable tablets) seizures associated
Chewable Tablet. with idiopathic
epilepsy in dogs.
January 15, 2021............. 141-539 Neogen Corp., 944 THYROKARE Dogs............... Original approval FOI Summary.
Nandino Blvd., (levothyroxine for replacement
Lexington, KY 40511. sodium tablets). therapy for
diminished thyroid
function in dogs.
February 1, 2021............. 200-683 Huvepharma EOOD, 5th Melengestrol acetate Cattle............. Original approval as FOI Summary.
Floor, 3A Nikolay and monensin Type C a generic copy of
Haytov Str., 1113 medicated feeds. NADA 125-476.
Sofia, Bulgaria.
February 1, 2021............. 200-684 Do................... Ractopamine Cattle............. Original approval as FOI Summary.
hydrochloride, a generic copy of
monensin, and NADA 141-234.
melengestrol acetate
Type C medicated
feeds.
February 1, 2021............. 200-685 Do................... Melengestrol acetate, Cattle............. Original approval as FOI Summary.
monensin, and a generic copy of
tylosin phosphate NADA 138-870.
Type C medicated
feeds.
February 1, 2021............. 200-686 Do................... Monensin, ractopamine Cattle............. Original approval as FOI Summary.
hydrochloride, a generic copy of
tylosin phosphate, NADA 141-233.
and melengestrol
acetate Type C
medicated feeds.
February 8, 2021............. 200-466 Sparhawk SPARMECTIN Plus Cattle............. Supplemental FOI Summary.
Laboratories, Inc., Clorsulon approval reducing
12340 Santa Fe Trail (ivermectin and preslaughter
Dr., Lenexa, KS clorsulon) Injection. withdrawal period
66215. to 21 days.
February 16, 2021............ 200-506 Chanelle ANIMEC PLUS Cattle............. Original approval as FOI Summary.
Pharmaceuticals (ivermectin and a generic copy of
Manufacturing Ltd., clorsulon) Injection. NADA 140-833.
Loughrea, County
Galway, Ireland.
February 18, 2021............ 200-657 Bimeda Animal Health MACROSYN Cattle............. Original approval as FOI Summary.
Ltd., 1B The Herbert (tulathromycin a generic copy of
Building, The Park, injection) NADA 141-244.
Carrickmines, Dublin Injectable Solution.
18, Ireland.
February 18, 2021............ 200-666 Elanco US Inc., 2500 INCREXXA Cattle............. Original approval as FOI Summary.
Innovation Way, (tulathromycin a generic copy of
Greenfield, IN 46140. injection) NADA 141-244.
Injectable Solution.
February 26, 2021............ 141-540 Pharmgate, Inc., 1800 PENNITRACIN MD Turkeys............ Original approval FOI Summary.
Sir Tyler Dr., (bacitracin Type A for the prevention
Wilmington, NC 28405. medicated article) of coccidiosis
and COBAN (monensin caused by Eimeria
Type A medicated adenoeides, E.
article) to be used meleagrimitis and
in the manufacture E. gallopavonis,
of Type C medicated and for increased
feeds. rate of weight gain
and improved feed
efficiency in
growing turkeys.
March 11, 2021............... 200-699 Akorn Animal Health, Dexmedetomidine Dogs and cats...... Original approval as FOI Summary.
Inc., 1925 West Hydrochloride a generic copy of
Field Ct., Suite Injection NADA 141-267.
300, Lake Forest, IL (dexmedetomidine
60045. hydrochloride).
[[Page 57994]]
March 15, 2021............... 141-530 Zoetis Inc., 333 MGA (melengestrol Cattle............. Original approval FOI Summary.
Portage St., acetate Type A for increased rate
Kalamazoo, MI 49007. medicated article) of weight gain,
and AUREOMYCIN improved feed
(chlortetracycline efficiency, and
Type A medicated suppression of
article) to be used estrus (heat) in
in the manufacture replacement dairy
of Type C medicated and beef heifers,
feeds. or growing beef
heifers fed in
confinement for
slaughter receiving
medicated feed
containing
chlortetracycline
for the treatment
of bacterial
enteritis or
pneumonia, control
of bacterial
pneumonia
associated with
shipping fever
complex, reduction
of incidence of
liver abscesses,
and control of
active infection of
anaplasmosis.
March 19, 2021............... 141-531 Do................... MGA (melengestrol Cattle............. Original approval FOI Summary.
acetate Type A for suppression of
medicated article), estrus (heat) in
AUREOMYCIN replacement dairy
(chlortetracycline and beef heifers,
Type A medicated or growing beef
article), and heifers fed in
BOVATEC (lasalocid confinement for
Type A medicated slaughter receiving
article) to be used medicated feed
in the manufacture containing
of Type C medicated chlortetracycline
feeds. for the treatment
of bacterial
enteritis or
pneumonia, control
of bacterial
pneumonia
associated with
shipping fever
complex, or control
of active infection
of anaplasmosis;
and lasalocid for
control of
coccidiosis,
increased rate of
weight gain, and
improved feed
efficiency.
March 22, 2021............... 200-625 Bimeda Animal Health KETOMED (ketoprofen) Horses............. Original approval as FOI Summary.
Ltd., 1B The Herbert Sterile Solution. a generic copy of
Building, The Park, NADA 140-269.
Carrickmines, Dublin
18, Ireland.
March 24, 2021............... 132-872 Intervet, Inc., 2 SAFE-GUARD Cattle............. Supplemental FOI Summary.
Giralda Farms, (fenbendazole) Paste approval providing
Madison, NJ 07940. 10%. for tolerances, a
tissue withdrawal
period, and a milk
discard time in
accordance with a
repartitioning of
the acceptable
daily intake; and
the addition of
indications for
fourth[dash]stage
larvae of certain
endoparasites.
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Changes of Sponsor
The sponsors of the following approved applications have informed
FDA that they have transferred ownership of, and all rights and
interest in, these applications to another sponsor:
----------------------------------------------------------------------------------------------------------------
File No. Product name Transferring sponsor New sponsor 21 CFR section
----------------------------------------------------------------------------------------------------------------
141-175.................. CAPSTAR (nitenpyram) Elanco US Inc., 2500 Sergeant's Pet Care 520.1510.
Tablets. Innovation Way, Products, Inc.,
Greenfield, IN 10077 S 134th St.,
46140. Omaha, NE 68138.
141-120.................. CLOMICALM Do.................. Virbac AH, Inc., 520.455.
(clomipramine P.O. Box 162059,
hydrochloride) Fort Worth, TX
Tablets. 76161.
141-474.................. ITRAFUNGOL Do.................. Do.................. 520.1189.
(itraconazole oral
solution).
065-081.................. GO-DRY (penicillin G G. C. Hanford Mfg. HQ Specialty Pharma 526.1696.
procaine) Co., P.O. Box 1017, Corp., 120 Rte. 17
Intramammary Syracuse, NY 13201. North, Suite 130,
Infusion. Paramus, NJ 07652.
200-335.................. Ampicillin Sodium Do.................. Do.................. 522.90c.
Powder for
Injection.
200-372.................. HAN-PEN (penicillin Do.................. Do.................. 520.1696a.
G potassium)
Soluble Powder.
065-071.................. Chlortetracycline Huvepharma EOOD, 5th Pharmgate Inc., 1800 520.441.
(chlortetracycline Floor, 3A Nikolay Sir Tyler Dr.,
hydrochloride) Haytov Str., 1113 Wilmington, NC
Soluble Powder. Sofia, Bulgaria. 28405.
065-440.................. CHLORONEX Do.................. Do.................. Do.
(chlortetracycline
hydrochloride)
Soluble Powder.
200-441.................. A[dash]MYCIN Do.................. Do.................. Do.
(chlortetracycline
hydrochloride)
Soluble Powder.
200-528.................. SAVALAN 60 Pharmgate Inc., 1800 Huvepharma EOOD, 5th 558.550.
(salinomycin Sir Tyler Dr., Floor, 3A Nikolay
sodium) Type A Wilmington, NC Haytov Str., 1113
medicated article. 28405. Sofia, Bulgaria.
[[Page 57995]]
200-237.................. Isoflurane, U.S.P... Piramal Enterprises Piramal Pharma Ltd., N/A.
Ltd., Ananta, Ground Floor,
Agastya Corporate Piramal Ananta,
Park, Opp Fire Agastya Corporate
Brigade, Kamani Park, Mumbai,
Junction, LBS Mag Maharashtra,
Kurla (West), 400070, India.
Mumbai, 400070,
India.
----------------------------------------------------------------------------------------------------------------
Following these changes of sponsorship, G. C. Hanford Manufacturing
Co. and Piramal Enterprises Ltd. are no longer the sponsor of an
approved application. Accordingly, the regulations in 21 CFR 510.600(c)
are being amended to reflect these changes.
III. Technical Amendments
FDA is making the following amendments to improve the accuracy,
consistency, and readability of the animal drug regulations:
<bullet> 21 CFR 510.600 is amended by revising the entries for
Cronus Pharma Specialities India Private Ltd. to reflect the correct
address for the firm.
<bullet> 21 CFR 520.2090 is amended to reflect the current approved
indications for use for sarolaner, moxidectin, and pyrantel tablets.
<bullet> 21 CFR 522.970 is amended to reflect the approved species
for a flunixin injectable solution.
<bullet> 21 CFR 558.76 for use of bacitracin methylenedisalicylate
in medicated feed is amended to reflect a current tabular format
organized by species.
<bullet> 21 CFR 558.128 is amended to reflect sponsors of
combination medicated feeds containing chlortetracycline for which
there is no preslaughter withdrawal period.
<bullet> 21 CFR 558.355 for use of monensin in medicated feeds is
amended to reflect the sponsor of an approved generic product and to
remove a redundant condition of use.
IV. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 526
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, 21 CFR
parts 510, 516, 520, 522, 526, 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. Add in alphabetical order an entry for ``Anivive Lifesciences,
Inc.'';
0
ii. Revise the entry for ``Cronus Pharma Specialities India Private
Ltd.'';
0
iii. Remove the entries for ``G. C. Hanford Manufacturing Co.'' and
``Piramal Enterprises Ltd.''; and
0
iv. Add in alphabetical order an entry for ``Piramal Pharma Ltd.''; and
0
b. In the table in paragraph (c)(2):
0
i. Remove the entry for ``010515'';
0
ii. Revise the entries for ``065085'' and ``069043''; and
0
iii. Add in numerical order an entry for ``086121''.
The revisions and additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
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* * * * * * *
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 086121
400, Long Beach, CA 90807..............................
* * * * * * *
Cronus Pharma Specialities India Private Ltd., Sy No-99/ 069043
1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli
Village, Shamshabad Mandal, Ranga Reddy, Hyderabad,
Telangana, 501218, India...............................
* * * * * * *
Piramal Pharma Ltd., Ground Floor, Piramal Ananta, 065085
Agastya Corporate Park, Mumbai, Maharashtra, 400070,
India..................................................
[[Page 57996]]
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
065085.................. Piramal Pharma Ltd., Ground Floor, Piramal
Ananta, Agastya Corporate Park, Mumbai,
Maharashtra, 400070, India
* * * * * * *
069043.................. Cronus Pharma Specialities India Private Ltd.,
Sy No-99/1, M/s GMR Hyderabad Aviation SEZ
Ltd., Mamidipalli Village, Shamshabad Mandal,
Ranga Reddy, Hyderabad, Telangana, 501218,
India
* * * * * * *
086121.................. Anivive Lifesciences, Inc., 3250 Airflite Way,
Suite 400, Long Beach, CA 90807
* * * * * * *
------------------------------------------------------------------------
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, 360ccc-2, 371.
0
4. Add Sec. 516.1858 to subpart E to read as follows:
Sec. 516.1858 Potassium bromide.
(a) Specifications. Each chewable tablet contains 250 or 500
milligrams (mg) potassium bromide.
(b) Sponsor. See No. 055246 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer 25 to 68 mg per
kilogram (11 to 31 mg per pound) of body weight once daily. The dosage
can be divided and should be adjusted to clinical response.
(2) Indications for use. For the control of seizures associated
with idiopathic epilepsy in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
0
5. Add Sec. 516.2980 to subpart E to read as follows:
Sec. 516.2980 Verdinexor.
(a) Specifications. Each tablet contains 2.5, 10, or 50 milligrams
(mg) verdinexor.
(b) Sponsor. See No. 086121 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer verdinexor tablets
orally at an initial dose of 1.25 mg per kilogram (mg/kg) of body
weight twice per week with at least 72 hours between doses. If
tolerated after 2 weeks, increase the dose to 1.5 mg/kg twice per week
with at least 72 hours between doses.
(2) Indications for use. For the treatment of lymphoma in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
7. In Sec. 520.441, revise paragraph (b)(1) to read as follows:
Sec. 520.441 Chlortetracycline powder.
* * * * *
(b) * * *
(1) Nos. 000010, 054771, and 069254 for use as in paragraph (d) of
this section.
* * * * *
0
8. In Sec. 520.455, revise the section heading and paragraph (b) to
read as follows:
Sec. 520. 455 Clomipramine.
* * * * *
(b) Sponsors. See Nos. 051311 and 086039 in Sec. 510.600(c) of
this chapter.
* * * * *
0
9. In Sec. 520.905c, revise paragraph (e)(2) to read as follows:
Sec. 520.905c Fenbendazole paste.
* * * * *
(e) * * *
(2) Beef and dairy cattle--(i) Amount. Administer orally 2.3 mg/lb
(5 mg/kg) body weight.
(ii) Indications for use. For the treatment and control of:
Lungworms: Adult (Dictyocaulus viviparus); Stomach worms: Adult brown
stomach worms (Ostertagia ostertagi), adult and fourth-stage larvae
barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole
worms (H. placei), and adult and fourth-stage larvae small stomach
worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage
larvae): Hookworms (Bunostomum phlebotomum), thread-necked intestinal
worms (Nematodirus helvetianus), small intestinal worms (Cooperia
punctata and C. oncophora), bankrupt worms (Trichostrongylus
colubriformis), and nodular worms (Oesophagostomum radiatum).
(iii) Limitations. Milk taken during treatment and for 96 hours
after the last treatment must not be used for human consumption. Cattle
must not be slaughtered for human consumption within 8 days following
last treatment with this drug product. Not for use in beef calves less
than 2 months of age, dairy calves, and veal calves. A withdrawal
period has not been established for this product in preruminating
calves.
0
10. In Sec. 520.1189, revise paragraph (b) to read as follows:
Sec. 520.1189 Itraconazole.
* * * * *
(b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
* * * * *
0
11. In Sec. 520.1248, revise paragraphs (b) and (c)(1) to read as
follows:
Sec. 520.1248 Levothyroxine.
* * * * *
[[Page 57997]]
(b) Sponsors. See Nos. 059051 and 061690 in Sec. 510.600(c) of
this chapter.
(c) * * *
(1) Amount. Administer by mouth as follows:
(i) No. 061690: 0.1 mg/10 pounds (lb) body weight (0.022 mg/
kilogram (kg)) as a single dose every 24 hours or as a divided dose
every 12 hours.
(ii) No. 059051: 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight
twice daily.
* * * * *
0
12. In Sec. 520.1510, revise paragraph (b)(1) to read as follows:
Sec. 520. 1510 Nitenpyram.
* * * * *
(b) * * *
(1) No. 021091 for use as in paragraphs (d)(1)(i)(A),
(d)(1)(ii)(A), and (d)(2) of this section.
* * * * *
0
13. In Sec. 520.1696a, revise paragraph (b) to read as follows:
Sec. 520.1696a Penicillin G powder.
* * * * *
(b) Sponsors. See Nos. 016592, 042791, 054771, 061133, and 076475
in Sec. 510.600(c) of this chapter.
* * * * *
0
14. In Sec. 520.2090, revise paragraph (c)(2) to read as follows:
Sec. 520.2090 Sarolaner, moxidectin, and pyrantel.
* * * * *
(c) * * *
(2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis and for the treatment and control of
roundworm (immature adult and adult Toxocara canis and adult Toxascaris
leonina) and adult hookworm (Ancylostoma caninum and Uncinaria
stenocephala) infections. Kills adult fleas (Ctenocephalides felis) and
is indicated for the treatment and prevention of flea infestations, and
the treatment and control of tick infestations with Amblyomma
americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick),
Dermacentor variabilis (American dog tick), Ixodes scapularis (black-
legged tick), and Rhipicephalus sanguineus (brown dog tick) for 1 month
in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds
or greater.
* * * * *
0
15. In Sec. 520.2645, revise paragraph (d)(2) to read as follows:
Sec. 520.2645 Tylvalosin.
* * * * *
(d) * * *
(2) Indications for use. For control of porcine proliferative
enteropathy (PPE) associated with Lawsonia intracellularis infection in
groups of swine intended for slaughter in buildings experiencing an
outbreak of PPE; and for control of swine respiratory disease (SRD)
associated with Bordetella bronchiseptica, Haemophilus parasuis,
Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae
in groups of swine intended for slaughter in buildings experiencing an
outbreak of SRD.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
16. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
17. In Sec. 522.90c, revise paragraph (b) to read as follows:
Sec. 522.90c Ampicillin sodium.
* * * * *
(b) See Nos. 042791 and 054771 in Sec. 510.600(c) of this chapter.
* * * * *
0
18. In Sec. 522.558, revise paragraphs (b)(1) and to read as follows:
Sec. 522.558 Dexmedetomidine.
* * * * *
(b) * * *
(1) Nos. 026637 and 059399 for use of product described in
paragraph (a)(2) of this section.
* * * * *
0
19. In Sec. 522.970, revise paragraph (b)(1) and add paragraph (b)(3)
to read as follows:
Sec. 522.970 Flunixin.
* * * * *
(b) * * *
(1) See Nos. 000061, 055529, 058198, and 061133 for use as in
paragraph (e) of this section.
* * * * *
(3) See No. 016592 for use as in paragraphs (e)(1) and (e)(2) of
this section.
* * * * *
0
20. In Sec. 522.1193, revise paragraphs (b) and (e)(2) and (3) to read
as follows:
Sec. 522.1193 Ivermectin and clorsulon.
* * * * *
(b) Sponsors. See Nos. 000010, 055529, 058005, 061133, and 061651
in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(2) Indications for use. For the treatment and control of
gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus
placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata,
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C.
punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus
helvetianus (adults only), N. spathiger (adults only), Bunostomum
phlebotomum; lungworms (adults and fourth-stage larvae) (Dictyocaulus
viviparus); liver flukes (adults only) (Fasciola hepatica); cattle
grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice
(Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus);
mange mites (cattle scab) (Psoroptes ovis (syn. P. communis var.
bovis), Sarcoptes scabiei var. bovis); and for control of infections of
D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi,
T. axei, and C. punctata for 21 days after treatment; and H. placei and
C. oncophora for 14 days after treatment.
(3) Limitations. Do not treat cattle within 21 days of slaughter.
Because a withdrawal time in milk has not been established, do not use
in female dairy cattle of breeding age. A withdrawal period has not
been established for this product in preruminating calves. Do not use
in calves to be processed for veal.
0
21. In Sec. 522.1225, revise paragraph (b) to read as follows:
Sec. 522.1225 Ketoprofen.
* * * * *
(b) Sponsors. See Nos. 054771 and 061133 in Sec. 510.600(c) of
this chapter.
* * * * *
0
22. In Sec. 522.1696a, revise paragraph (d)(2)(iii) to read as
follows:
Sec. 522.1696a Penicillin G benzathine and penicillin G procaine
suspension.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Not for use within 30 days of slaughter. For No.
016592: A withdrawal period has not been established for this product
in pre-ruminating calves. Do not use in calves to be processed for
veal.
0
23. In Sec. 522.2630, revise paragraphs (b) and (d)(1)(iii)(A) to read
as follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) Nos. 054771, 058198, and 061133 for use of product described in
paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(ii),
(d)(1)(iii)(A), and (d)(2) of this section.
(2) No. 054771 for use of product described in paragraph (a)(2) as
in
[[Page 57998]]
paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this
section.
* * * * *
(d) * * *
(1) * * *
(iii) * * *
(A) Cattle intended for human consumption must not be slaughtered
within 18 days from the last treatment. 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. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
* * * * *
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
24. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
25. In Sec. 526.1696, revise paragraph (b) to read as follows:
Sec. 526.1696 Penicillin G procaine.
* * * * *
(b) See Nos. 042791 and 061133 in Sec. 510.600(c) of this chapter.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
26. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
27. In Sec. 556.275:
0
a. Revise paragraph (b)(1)(ii);
0
b. Remove paragraph (b)(1)(iii); and
0
c. Remove and reserve paragraphs (b)(3)(ii), (b)(4)(ii), and
(b)(5)(ii).
The revision reads as follows:
Sec. 556.275 Fenbendazole.
* * * * *
(b) * * *
(1) * * *
(ii) Milk: 0.22 ppm fenbendazole sulfoxide (marker residue).
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
28. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
29. In Sec. 558.76:
0
a. Revise paragraphs (a)(1) and (2) and (d)(1);
0
b. Redesignate paragraph (d)(2) as paragraph (d)(6); and
0
c. Add new paragraph (d)(2) and paragraphs (d)(3) through (5).
The revisions and additions read as follows:
Sec. 558.76 Bacitracin methylenedisalicylate.
(a) * * *
(1) Type A medicated articles containing feed grade bacitracin
methylenedisalicylate equivalent to 10, 25, 30, 40, 50, 60, or 75 grams
bacitracin per pound.
(2) Type A medicated article containing feed grade bacitracin
methylenedisalicylate equivalent to 50 grams bacitracin per pound.
* * * * *
(d) * * *
(1) Chickens--
------------------------------------------------------------------------
Bacitracin in grams per Indications for
ton use Limitations Sponsor
------------------------------------------------------------------------
(i) 4 to 50............ Broiler and Feed 054771
replacement continuously as 069254
chickens: For sole ration.
increased rate
of weight gain
and improved
feed efficiency.
(ii) 10 to 25.......... Laying hens: For Feed 054771
increased egg continuously as
production and sole ration for
improved feed the first 7
efficiency. months of egg
production.
(iii) 50............... Broiler and Feed 054771
replacement continuously as
chickens: As an sole ration.
aid in the
prevention of
necrotic
enteritis
caused or
complicated by
Clostridium
spp. or other
organisms
susceptible to
bacitracin.
(iv) 100 to 200........ Broiler and Feed 054771
replacement continuously as
chickens: As an sole ration.
aid in the Start at first
control of clinical signs
necrotic of disease.
enteritis Vary dosage
caused or based on
complicated by severity of
Clostridium infection.
spp. or other Administer
organisms continuously
susceptible to for 5 to 7 days
bacitracin. or as long as
clinical signs
persist, then
reduce
medication to
prevention
level (50 grams/
ton).
------------------------------------------------------------------------
(2) Turkeys--
------------------------------------------------------------------------
Bacitracin in grams per Indications for
ton use Limitations Sponsor
------------------------------------------------------------------------
(i) 4 to 50............ Growing turkeys: Feed 054771
For increased continuously as 069254
rate of weight sole ration.
gain and
improved feed
efficiency.
(ii) 200............... Growing turkeys: Feed 054771
As an aid in continuously as
the control of the sole ration.
transmissible
enteritis
complicated by
organisms
susceptible to
bacitracin
methylenedisali
cylate.
------------------------------------------------------------------------
(3) Swine--
------------------------------------------------------------------------
Bacitracin in grams per Indications for
ton use Limitations Sponsor
------------------------------------------------------------------------
(i) 10 to 30........... Growing and ................ 054771
finishing
swine: For
increased rate
of weight gain
and improved
feed efficiency.
[[Page 57999]]
(ii) 250............... Growing and Feed as the sole 054771
finishing ration. Feed
swine: For 250 grams per
control of ton of complete
swine dysentery feed on
(bloody scours) premises with a
associated with history of
Brachyspira swine
hyodysenteriae dysentery, but
in pigs up to where signs of
250 lbs body the disease
weight. have not yet
occurred or
following an
approved
treatment of
the disease
condition.
Diagnosis
should be
confirmed by a
veterinarian a
when results
are not
satisfactory.
(iii) 250.............. Pregnant sows: As the sole 054771
For control of ration. Feed to
clostridial sows from 14
enteritis days before
caused by through 21 days
Clostridium after farrowing
perfringens in on premises
suckling with a history
piglets. of clostridial
scours.
Diagnosis
should be
confirmed by a
veterinarian
when results
are not
satisfactory.
------------------------------------------------------------------------
(4) Cattle--
------------------------------------------------------------------------
Indications for
Bacitracin amount use Limitations Sponsor
------------------------------------------------------------------------
(i) 70 mg per head per Beef steers and Administer 054771
day. heifers fed in continuously 069254
confinement for throughout the
slaughter: For feeding period.
reduction in
the number of
liver
condemnations
due to
abscesses.
(ii) 250 mg per head Beef steers and Administer 054771
per day. heifers fed in continuously 069254
confinement for for 5 days then
slaughter: For discontinue for
reduction in subsequent 25
the number of days, repeat
liver the pattern
condemnations during the
due to feeding period.
abscesses.
------------------------------------------------------------------------
(5) Game birds--
------------------------------------------------------------------------
Bacitracin in grams per Indications for
ton use Limitations Sponsor
------------------------------------------------------------------------
(i) 4 to 50............ Growing Feed 054771
pheasants: For continuously as 069254
increased rate sole ration.
of weight gain
and improved
feed efficiency.
(ii) 5 to 20........... Growing quail: Feed 054771
For increased continuously as 069254
rate of weight sole ration to
gain and quail not over
improved feed 5 weeks of age.
efficiency in
quail not over
5 weeks of age.
(iii) 200.............. Growing quail: Feed 054771
For the continuously as
prevention of the sole ration.
ulcerative
enteritis in
growing quail
due to
Clostridium
colinum
susceptible to
bacitracin
methylenedisali
cylate.
------------------------------------------------------------------------
* * * * *
0
30. In Sec. 558.128, revise paragraphs (d)(4) and (e)(4) to read as
follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(d) * * *
(4) Manufacture for use in free-choice feeds as in paragraph
(e)(4)(vi) of this section must conform to Sec. 510.455 of this
chapter.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Indications for
Chlortetracycline amount Combination in grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) to provide 70 mg/head/day... ............................... Growing cattle Feed to provide 054771
(over 400 lb): chlortetracycli 066104
For reduction ne at the rate 069254
of liver of 70 mg per
condemnation animal daily. A
due to liver withdrawal
abscesses. period has not
been
established in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal.
(ii) 5.83 to 14 g/ton to provide Melengestrol acetate, 0.25 to 2 Growing beef Melengestrol 054771
70 mg/head/day. g/ton to provide 0.25 to 0.5 heifers fed in acetate Type C
mg melengestrol acetate per confinement for top-dress
head per day. slaughter (over medicated feed
400 lb): For must be top
reduction of dressed onto or
the incidence mixed at
of liver feeding with
abscesses, the Type C
increased rate medicated feed
of weight gain, containing 5.83
improved feed to 14 g/ton
efficiency, and chlortetracycli
suppression of ne.
estrus (heat). Chlortetracycli
ne and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
[[Page 58000]]
(iii) to provide 0.5 mg/lb of ............................... Beef cattle Feed to provide 054771
body weight daily. (over 700 lb): chlortetracycli 066104
For control of ne at the rate 069254
active of 0.5 mg per
infection of pound of body
anaplasmosis weight daily in
caused by beef cattle
Anaplasma under 700
marginale pounds.
susceptible to Withdraw 48
chlortetracycli hours prior to
ne. slaughter. To
sponsor Nos.
054771 and
069254: Zero
withdrawal time.
(iv) 33.33 to 50 g/ton to Melengestrol acetate, 0.5 to 2 Replacement beef Melengestrol 054771
provide 0.5 mg/lb of body g/ton to provide 0.5 mg heifers over acetate Type C
weight per day. melengestrol acetate per head 700 lb: For top-dress
per day. control of medicated feed
active must be top
infection of dressed onto or
anaplasmosis mixed at
caused by feeding with a
Anaplasma Type C
marginale medicated feed
susceptible to containing
chlortetracycli 33.33 to 50 g/
ne and for ton
suppression of chlortetracycli
estrus (heat). ne. Feeding a
Type C top-
dress medicated
feed containing
melengestrol
acetate shall
not exceed 24
days.
Chlortetracycli
ne and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(v) 25 to 1,100 g/ton to provide Lasalocid, 30 to 600........... Pasture cattle Feed 054771
0.5 mg/lb of body weight daily. (slaughter, continuously on 069254
stocker, feeder a hand-fed
cattle, beef basis 0.5 mg
replacement chlortetracycli
heifers) over ne per lb. body
700 pounds: For weight per day
control of and not less
active than 60 mg or
infection of more than 300
anaplasmosis mg lasalocid
caused by per head daily
Anaplasma in at least 1
marginale pound of feed.
susceptible to Daily lasalocid
chlortetracycli intakes in
ne; and for excess of 200
increased rate mg/head/day in
of weight gain. pasture cattle
have not been
shown to be
more effective
than 200 mg
lasalocid/head/
day. Do not
allow horses or
other equines
access to feeds
containing
lasalocid. No
withdrawal
period is
required. A
withdrawal
period has not
been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. See
Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(vi) 25 to 1,100 g/ton to Lasalocid, 30 to 600; Replacement beef The melengestrol 054771
provide 0.5 mg/lb of body melengestrol acetate, 0.5 to 2 heifers on acetate Type C
weight daily. g/ton to provide 0.5 mg/head/ pasture over top-dress
day melengestrol acetate. 700 pounds: For medicated feed
control of must be top
active dressed onto or
infection of mixed at
anaplasmosis feeding with a
caused by Type C
Anaplasma medicated feed
marginale containing 25
susceptible to to 1,100 g/ton
chlortetracycli of
ne, increased chlortetracycli
rate of weight ne and 30 to
gain, and 600 g/ton
suppression of lasalocid to
estrus (heat). provide 0.5 mg
chlortetracycli
ne per lb body
weight per day
and not less
than 60 mg or
more than 300
mg lasalocid
per head per
day in at least
1 pound of
feed. Do not
exceed 24 days
of feeding. See
Sec.
558.311(d) of
this chapter.
Chlortetracycli
ne, lasalocid,
and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(vii) to provide 0.5 to 2.0 mg/ ............................... Beef cattle and In free-choice 054771
lb of body weight daily. nonlactating cattle feeds 069254
dairy cattle: such as feed
As an aid in blocks or salt-
the control of mineral mixes
active manufactured
infection of from approved
anaplasmosis Type A
caused by articles. See
Anaplasma paragraph
marginale (d)(4) of this
susceptible to section.
chlortetracycli
ne.
[[Page 58001]]
(viii) to provide 10 mg/lb of ............................... Calves, beef and Feed 054771
body weight daily. nonlactating approximately 066104
dairy cattle: 400 g/ton, 069254
For treatment varying with
of bacterial body weight and
enteritis feed
caused by consumption to
Escherichia provide 10 mg/
coli and lb per day.
bacterial Treat for not
pneumonia more than 5
caused by days. To
Pasteurella sponsor No.
multocida 054771 (NADAs
organisms 048-761 and 046-
susceptible to 699) and to
chlortetracycli sponsor No.
ne. 069254 (ANADA
200-510): May
be mixed in the
cattle's daily
ration or
administered as
a top-dress. In
feed including
milk replacers
withdraw 10
days prior to
slaughter. To
sponsor Nos.
054771 and
069254: Zero
withdrawal
time. See
paragraph
(d)(3) of this
section.
(ix) to provide 10 mg/lb of body ............................... Calves (up to A withdrawal 054771
weight daily. 250 lb): For period has not 066104
the treatment been 069254
of bacterial established for
enteritis this product in
caused by pre-ruminating
Escherichia calves. Do not
coli use in calves
susceptible to to be processed
chlortetracycli for veal.
ne.
(x) to provide 10 mg/lb of body Laidlomycin, 5................. Cattle fed in Feed 054771
weight daily. confinement for continuously at
slaughter: For a rate of 30 to
treatment of 75 mg
bacterial laidlomycin
enteritis propionate
caused by potassium per
Escherichia head per day
coli and for not more
bacterial than 5 days. A
pneumonia withdrawal
caused by period has not
Pasteurella been
multocida established for
organisms this product in
susceptible to pre-ruminating
chlortetracycli calves. Do not
ne; and for use in calves
increased rate to be processed
of weight and for veal. See
improved feed Sec.
efficiency. 558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xi) to provide 10 mg/lb of body Laidlomycin, 5 to 10........... Cattle fed in Feed 054771
weight daily. confinement for continuously at
slaughter: For a rate of 30 to
treatment of 75 mg
bacterial laidlomycin
enteritis propionate
caused by potassium per
Escherichia head per day
coli and for not more
bacterial than 5 days. A
pneumonia withdrawal
caused by period has not
Pasteurella been
multocida established for
organisms this product in
susceptible to pre-ruminating
chlortetracycli calves. Do not
ne; and for use in calves
improved feed to be processed
efficiency. for veal. See
Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xii) 500 to 2,000 to provide 10 Lasalocid, 10 to 30............ Cattle fed in Feed 054771
mg/lb of body weight daily. confinement for continuously in 069254
slaughter: For complete feed
treatment of for not more
bacterial than 5 days to
enteritis provide 10 mg
caused by chlortetracycli
Escherichia ne per lb. body
coli and weight per day
bacterial and not less
pneumonia than 100 mg or
caused by more than 360
Pasteurella mg lasalocid
multocida per head per
organisms day. Do not
susceptible to allow horses or
chlortetracycli other equines
ne; and for access to feeds
improved feed containing
efficiency. lasalocid. No
withdrawal
period is
required. A
withdrawal
period has not
been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. See
Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
[[Page 58002]]
(xiii) to provide 10 mg/lb of Lasalocid, 25 to 30............ Cattle fed in Feed 054771
body weight daily. confinement for continuously in 069254
slaughter: For complete feed
treatment of for not more
bacterial than 5 days to
enteritis provide 10 mg
caused by chlortetracycli
Escherichia ne per lb. body
coli and weight per day
bacterial and not less
pneumonia than 250 mg or
caused by more than 360
Pasteurella mg lasalocid
multocida per head per
organisms day. Do not
susceptible to allow horses or
chlortetracycli other equines
ne; and for access to feeds
increased rate containing
of weight gain lasalocid. No
and improved withdrawal
feed efficiency. period is
required. A
withdrawal
period has not
been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. See
Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xiv) 500 to 4,000 to provide 10 Lasalocid, 30 to 600........... Pasture cattle Feed 054771
mg/lb of body weight daily. (slaughter, continuously on 069254
stocker, feeder a hand-fed
cattle, dairy basis for not
and beef more than 5
replacement days to provide
heifers): For 10 mg
treatment of chlortetracycli
bacterial ne per lb. body
enteritis weight per day
caused by and not less
Escherichia than 60 mg or
coli and more than 300
bacterial mg lasalocid
pneumonia per head per
caused by day in at least
Pasteurella 1 pound of
multocida feed. Daily
organisms lasalocid
susceptible to intakes in
chlortetracycli excess of 200
ne; and for mg/head/day in
increased rate pasture cattle
of weight gain. have not been
shown to be
more effective
than 200 mg
lasalocid/head/
day. Do not
allow horses or
other equines
access to feeds
containing
lasalocid. No
withdrawal
period is
required. A
withdrawal
period has not
been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. See
Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xv) 500 to 4,000 g/ton to Lasalocid, 30 to 600: Replacement The melengestrol 054771
provide 10 mg/lb of body weight Melengestrol acetate, 0.5 to 2 dairy heifers acetate Type C
daily. g/ton to provide 0.5 mg/head/ on pasture less top-dress
day melengestrol acetate. than 20 months medicated feed
of age and must be top
replacement dressed onto or
beef heifers on mixed at
pasture: For feeding with a
treatment of Type C
bacterial medicated feed
enteritis containing 500
caused by to 4,000 g/ton
Escherichia of
coli and chlortetracycli
bacterial ne and 30 to
pneumonia 600 g/ton
caused by lasalocid to
Pasteurella provide 10 mg
multocida chlortetracycli
organisms ne per lb body
susceptible to weight per day
chlortetracycli and not less
ne, increased than 60 mg or
rate of weight more than 300
gain, and mg lasalocid
suppression of per head per
estrus (heat). day in at least
1 pound of feed
for not more
than 5 days.
After
completing
feeding of this
combination,
continue
feeding a Type
C top-dress
medicated feed
containing
melengestrol
acetate alone
for a total
time not
exceeding 24
days of
feeding. See
Sec.
558.311(d) of
this chapter.
Chlortetracycli
ne, lasalocid,
and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
[[Page 58003]]
(xvi) 500 to 4,000 g/ton........ ............................... Calves, beef and Hand feed 054771
nonlactating continuously 069254
dairy cattle: for not more
For the than 5 days to
treatment of provide 10 mg/
bacterial lb body weight
enteritis per day. A
caused by withdrawal
Escherichia period has not
coli and been
bacterial established for
pneumonia this product in
caused by pre-ruminating
Pasteurella calves. Do not
multocida use in calves
susceptible to to be processed
chlortetracycli for veal. To
ne. sponsor No.
054771 under
NADA 046-699:
24-hour
withdrawal
period. To
sponsor No.
054771 under
NADA 048-761
and No. 069254
under ANADA 200-
510: Zero
withdrawal
period.
(xvii) 500 to 4,000 g/ton....... Decoquinate, 12.9 to 90.8...... Calves, beef and Feed at a rate 054771
non-lactating of 1g 069254
dairy cattle: chlortetracycli
For the ne per 100 lb
treatment of body weight/day
bacterial and 22.7 mg
enteritis decoquinate per
caused by 100 lb of body
Escherichia weight/day for
coli and not more than 5
bacterial days. When it
pneumonia is fully
caused by consumed,
Pasteurella resume feeding
multocida 22.7 mg
organisms decoquinate per
susceptible to 100 lb of body
chlortetracycli weight/day for
ne; and for the a total of 28
prevention of days to prevent
coccidiosis coccidiosis. A
caused by withdrawal
Eimeria bovis period has not
and E. zuernii. been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. Do
not feed to
animals
producing milk
for food.
Decoquinate as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xviii) 500 to 4,000 to provide Melengestrol acetate, 0.25 to 2 Growing beef Melengestrol 054771
10 mg per pound of body weight. g/ton to provide 0.25 to 0.5 heifers fed in acetate Type C
mg melengestrol acetate per confinement for top-dress
head per day. slaughter: For medicated feed
the treatment must be top
of bacterial dressed onto or
enteritis mixed at
caused by feeding with a
Escherichia Type C
coli and medicated feed
bacterial containing 500
pneumonia to 4,000 g/ton
caused by chlortetracycli
Pasteurella ne for not more
multocida than 5 days.
organisms After
susceptible to completing
chlortetracycli feeding of this
ne, increased combination,
rate of weight continue
gain, improved feeding a Type
feed C top-dress
efficiency, and medicated feed
suppression of containing
estrus (heat). melengestrol
acetate alone.
Chlortetracycli
ne and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xix) 500 to 4,000 to provide 10 Melengestrol acetate, 0.5 to 2 Replacement Melengestrol 054771
mg per pound of body weight. g/ton to provide 0.5 mg dairy heifers acetate Type C
melengestrol acetate per head less than 20 top-dress
per day. months of age medicated feed
and replacement must be top
beef heifers: dressed onto or
For the mixed at
treatment of feeding with a
bacterial Type C
enteritis medicated feed
caused by containing 500
Escherichia to 4,000 g/ton
coli and chlortetracycli
bacterial ne for not more
pneumonia than 5 days.
caused by After
Pasteurella completing
multocida feeding of this
organisms combination,
susceptible to continue
chlortetracycli feeding a Type
ne, and for C top-dress
suppression of medicated feed
estrus (heat). containing
melengestrol
acetate alone
for a total
time not
exceeding 24
days. Use in
dairy heifers
less than 20
months of age
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.
Chlortetracycli
ne and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
[[Page 58004]]
(xx) 4,000 to 20,000 g/ton...... ............................... Calves, beef and Administer as a 054771
nonlactating top dress, 069254
dairy cattle: varying with
For the body weight and
treatment of feed
bacterial consumption, to
enteritis provide 10 mg/
caused by lb per day.
Escherichia Treat for not
coli and more than 5
bacterial days. A
pneumonia withdrawal
caused by period has not
Pasteurella been
multocida established for
organisms this product in
susceptible to pre-ruminating
chlortetracycli calves. Do not
ne. use in calves
to be processed
for veal.
(xxi) 4,000 to 20,000 g/ton..... Decoquinate, 90.8 to 535.7..... Calves, beef and Feed at a rate 054771
non-lactating of 1g 069254
dairy cattle: chlortetracycli
For the ne per 100 lb
treatment of body weight/day
bacterial and 22.7 mg
enteritis decoquinate per
caused by 100 lb of body
Escherichia weight/day for
coli and not more than 5
bacterial days. When it
pneumonia is fully
caused by consumed,
Pasteurella resume feeding
multocida 22.7 mg
organisms decoquinate per
susceptible to 100 lb of body
chlortetracycli weight/day for
ne; and for the a total of 28
prevention of days to prevent
coccidiosis coccidiosis. A
caused by withdrawal
Eimeria bovis period has not
and E. zuernii. been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. Do
not feed to
animals
producing milk
for food.
Decoquinate as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxii) 4,000 to 20,000 g/ton to Melengestrol acetate, 0.25 to 2 Growing beef Top dress 0.5 to 054771
provide 10 mg/lb of body weight g/ton to provide 0.25 to 0.5 heifers fed in 2 pounds of
per day. mg melengestrol acetate per confinement for this medicated
head per day. slaughter: For feed containing
the treatment both drugs onto
of bacterial or mix at
enteritis feeding with a
caused by non-medicated
Escherichia feed for not
coli and more than 5
bacterial days. After
pneumonia completing
caused by feeding of this
Pasteurella combination,
multocida continue
organisms feeding a Type
susceptible to C top-dress
chlortetracycli medicated feed
ne, and for containing
increased rate melengestrol
of weight gain, acetate alone.
improved feed A withdrawal
efficiency, and period has not
suppression of been
estrus (heat). established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal.
Chlortetracycli
ne and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxiii) 4,000 to 20,000 g/ton to Melengestrol acetate, 0.5 to 2 Replacement Top dress 0.5 to 054771
provide 10 mg/lb of body weight g/ton to provide 0.5 mg dairy heifers 2 pounds of
per day. melengestrol acetate per head less than 20 this medicated
per day. months of age feed containing
and replacement both drugs onto
beef heifers: or mix at
For the feeding with a
treatment of non-medicated
bacterial feed for not
enteritis more than 5
caused by days. After
Escherichia completing
coli and feeding of this
bacterial combination,
pneumonia continue
caused by feeding a Type
Pasteurella C top-dress
multocida medicated feed
organisms containing
susceptible to melengestrol
chlortetracycli acetate alone
ne, and for for a total
suppression of time not
estrus (heat). exceeding 24
days. Use in
dairy heifers
less than 20
months of age
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.
Chlortetracycli
ne and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
[[Page 58005]]
(xxiv) to provide 350 mg/head/ ............................... Beef cattle: For Feed to provide 054771
day. control of chlortetracycli 066104
bacterial ne at the rate 069254
pneumonia of 350 mg per
associated with animal daily. A
shipping fever withdrawal
complex caused period has not
by Pasteurella been
spp. established for
susceptible to this product in
chlortetracycli pre-ruminating
ne. calves. Do not
use in calves
to be processed
for veal.
Withdrawal
periods: 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
period.
(xxv) to provide 350 mg/head/day ............................... Beef cattle Feed to provide 054771
(under 700 lb): chlortetracycli 066104
For control of ne at the rate 069254
active of 350 mg per
infection of animal daily. A
anaplasmosis withdrawal
caused by period has not
Anaplasma been
marginale established for
susceptible to this product in
chlortetracycli pre-ruminating
ne. calves. Do not
use in calves
to be processed
for veal.
Withdrawal
periods: 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
period.
(xxvi) 50 to 350 g/ton to Melengestrol acetate, 0.5 to 2 Replacement beef Melengestrol 054771
provide 350 mg/head/day. g/ton to provide 0.5 mg heifers under acetate Type C
melengestrol acetate per head 700 lb: For top-dress
per day. control of medicated feed
active must be top
infection of dressed or
anaplasmosis mixed at
caused by feeding with
Anaplasma the Type C
marginale medicated feed
susceptible to containing 50
chlortetracycli to 350 g/ton
ne and for chlortetracycli
suppression of ne for up to 24
estrus (heat). days of
feeding. Do not
exceed 24 days
of feeding.
Chlortetracycli
ne and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxvii) 20 to 350 g/ton......... ............................... Beef cattle and Feed to provide 054771
replacement chlortetracycli 069254
dairy heifers: ne at the rate
For control of of 350 mg per
bacterial head per day.
pneumonia This drug is
associated with not approved
shipping fever for use in
complex caused female dairy
by Pasteurella cattle 20
spp. months of age
susceptible to or older,
chlortetracycli including dry
ne. 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.
(xxviii) 20 to 350 g/ton to Melengestrol acetate, 0.25 to 2 Growing beef Melengestrol 054771
provide 350 mg/head/day. g/ton to provide 0.25 to 0.5 heifers fed in acetate Type C
mg melengestrol acetate per confinement for top-dress
head per day. slaughter: For medicated feed
control of must be top
bacterial dressed onto or
pneumonia mixed at
associated with feeding with
shipping fever the Type C
complex caused medicated feed
by Pasteurella containing 20
spp. to 350 g/ton
susceptible to chlortetracycli
chlortetracycli ne.
ne, increased Chlortetracycli
rate of weight ne and
gain, improved melengestrol as
feed provided by No.
efficiency, and 054771 in Sec.
suppression of 510.600(c) of
estrus (heat). this chapter.
[[Page 58006]]
(xxix) 20 to 350 g/ton to Melengestrol acetate, 0.5 to 2 Replacement Melengestrol 054771
provide 350 mg/head/day. g/ton to provide 0.5 mg dairy heifers acetate Type C
melengestrol acetate per head less than 20 top-dress
per day. months of age medicated feed
and replacement must be top
beef heifers: dressed or
For control of mixed at
bacterial feeding with
pneumonia the Type C
associated with medicated feed
shipping fever containing 20
complex caused to 350 g/ton
by Pasteurella chlortetracycli
spp. ne. Use in
susceptible to dairy heifers
chlortetracycli less than 20
ne and months of age
suppression of may cause drug
estrus (heat). 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.
Chlortetracycli
ne and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxx) to provide 350 mg/head/day Laidlomycin, 5................. Cattle fed in Feed 054771
confinement for continuously at
slaughter: For a rate of 30 to
control of 75 mg
bacterial laidlomycin
pneumonia propionate
associated with potassium per
shipping fever head per day. A
complex caused withdrawal
by Pasteurella period has not
spp. been
susceptible to established for
chlortetracycli this product in
ne; and for pre-ruminating
increased rate calves. Do not
of weight and use in calves
improved feed to be processed
efficiency. for veal. See
Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxxi) to provide 350 mg/head/ Laidlomycin, 5 to 10........... Cattle fed in Feed 054771
day. confinement for continuously at
slaughter: For a rate of 30 to
control of 75 mg
bacterial laidlomycin
pneumonia propionate
associated with potassium per
shipping fever head per day. A
complex caused withdrawal
by Pasteurella period has not
spp. been
susceptible to established for
chlortetracycli this product in
ne; and for pre-ruminating
improved feed calves. Do not
efficiency. use in calves
to be processed
for veal. See
Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxxii) 25 to 42.2 g/ton to Lasalocid, 25 to 30............ Cattle under 700 Feed 054771
provide 350 mg/head/day. pounds fed in continuously in 069254
confinement for complete feed
slaughter: For at a rate of
control of 350 mg
active chlortetracycli
infection of ne and not less
anaplasmosis than 250 mg nor
caused by more than 360
Anaplasma mg lasalocid
marginale per head daily.
susceptible to Do not allow
chlortetracycli horses or other
ne; and for equines access
increased rate to feeds
of weight gain containing
and improved lasalocid. No
feed efficiency. withdrawal
period is
required. A
withdrawal
period has not
been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. See
Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxxiii) 25 to 42.2 g/ton to Lasalocid, 25 to 30............ Cattle fed in Feed 054771
provide 350 mg/head/day. confinement for continuously in 069254
slaughter: For complete feed
control of at a rate of
bacterial 350 mg
pneumonia chlortetracycli
associated with ne and not less
shipping fever than 250 mg nor
complex caused more than 360
by Pasteurella mg lasalocid
multocida per head daily.
organisms Do not allow
susceptible to horses or other
chlortetracycli equines access
ne; and for to feeds
increased rate containing
of weight gain lasalocid. No
and improved withdrawal
feed efficiency. period is
required. A
withdrawal
period has not
been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. See
Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
[[Page 58007]]
(xxxiv) 25 to 100 g/ton to Lasalocid, 10 to 30............ Cattle under 700 Feed 054771
provide 350 mg/head/day. pounds fed in continuously in 069254
confinement for complete feed
slaughter: For at a rate of
control of 350 mg
active chlortetracycli
infection of ne and not less
anaplasmosis than 100 mg nor
caused by more than 360
Anaplasma mg lasalocid
marginale per head daily.
susceptible to Do not allow
chlortetracycli horses or other
ne; and for equines access
improved feed to feeds
efficiency. containing
lasalocid. No
withdrawal
period is
required. A
withdrawal
period has not
been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. See
Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxxv) 25 to 100 g/ton to Lasalocid, 10 to 30............ Cattle fed in Feed 054771
provide 350 mg/head/day. confinement for continuously in 069254
slaughter: For complete feed
control of at a rate of
bacterial 350 mg
pneumonia chlortetracycli
associated with ne and not less
shipping fever than 100 mg nor
complex caused more than 360
by Pasteurella mg lasalocid
multocida per head daily.
organisms Do not allow
susceptible to horses or other
chlortetracycli equines access
ne; and for to feeds
improved feed containing
efficiency. lasalocid. No
withdrawal
period is
required. A
withdrawal
period has not
been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. See
Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxxvi) 25 to 700 to provide 350 Lasalocid, 30 to 600........... Pasture cattle Feed 054771
g/head/day. (slaughter, continuously on 069254
stocker, feeder a hand-fed
cattle, dairy basis at a rate
and beef of 350 mg
replacement chlortetracycli
heifers): For ne and not less
control of than 60 mg nor
bacterial more than 300
pneumonia mg lasalocid
associated with per head per
shipping fever day in at least
complex caused 1 pound of
by Pasteurella feed. Daily
multocida lasalocid
organisms intakes in
susceptible to excess of 200
chlortetracycli mg/head/day in
ne; and for pasture cattle
increased rate have not been
of weight gain. shown to be
more effective
than 200 mg
lasalocid/head/
day. Do not
allow horses or
other equines
access to feeds
containing
lasalocid. No
withdrawal
period is
required. A
withdrawal
period has not
been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. See
Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxxvii) 25 to 700 g/ton to Lasalocid, 30 to 600; Replacement beef The melengestrol 054771
provide 350 mg/head/day. melengestrol acetate, 0.5 to 2 heifers on acetate Type C
g/ton to provide 0.5 mg/head/ pasture: For top-dress
day melengestrol acetate. control of medicated feed
bacterial must be top
pneumonia dressed onto or
associated with mixed at
shipping fever feeding with a
complex caused Type C
by Pasteurella medicated feed
spp. containing 25
susceptible to to 700 g/ton of
chlortetracycli chlortetracycli
ne, increased ne and 30 to
rate of weight 600 g/ton
gain, and lasalocid to
suppression of provide 350 mg
estrus (heat). chlortetracycli
ne per head
daily and not
less than 60 mg
or more than
300 mg
lasalocid per
head daily in
at least 1
pound of feed.
Do not exceed
24 days of
feeding. See
Sec.
558.311(d) of
this chapter.
Chlortetracycli
ne, lasalocid,
and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
[[Page 58008]]
(xxxviii) 25 to 700 to provide Lasalocid, 30 to 600........... Pasture cattle Feed 054771
350 mg/head/day. (slaughter, continuously on 069254
stocker, feeder a hand-fed
cattle, beef basis at a rate
replacement of 350 mg
heifers) under chlortetracycli
700 pounds: For ne and not less
control of than 60 mg nor
active more than 300
infection of mg lasalocid
anaplasmosis per head per
caused by day in at least
Anaplasma 1 pound of
marginale feed. Daily
susceptible to lasalocid
chlortetracycli intakes in
ne; and for excess of 200
increased rate mg/head/day in
of weight gain. pasture cattle
have not been
shown to be
more effective
than 200 mg
lasalocid/head/
day. Do not
allow horses or
other equines
access to feeds
containing
lasalocid. No
withdrawal
period is
required. A
withdrawal
period has not
been
established for
this product in
pre-ruminating
calves. Do not
use in calves
to be processed
for veal. See
Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xxxix) 25 to 700 g/ton to Lasalocid, 30 to 600; Replacement beef The melengestrol 054771
provide 350 mg/head/day. melengestrol acetate, 0.5 to 2 heifers on acetate Type C
g/ton to provide 0.5 mg/head/ pasture under top-dress
day melengestrol acetate. 700 pounds: For medicated feed
control of must be top
active dressed onto or
infection of mixed at
anaplasmosis feeding with a
caused by Type C
Anaplasma medicated feed
marginale containing 25
susceptible to to 700 g/ton of
chlortetracycli chlortetracycli
ne, increased ne and 30 to
rate of weight 600 g/ton
gain, and lasalocid to
suppression of provide 350 mg
estrus (heat). chlortetracycli
ne per head
daily and not
less than 60 mg
or more than
300 mg
lasalocid per
head daily in
at least 1
pound of feed.
Do not exceed
24 days of
feeding. See
Sec.
558.311(d) of
this chapter.
Chlortetracycli
ne, lasalocid,
and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xl) 25 to 2,800 to provide 350 Lasalocid, 30 to 181.8......... Beef cattle Hand feed 054771
mg/head/day. weighing under continuously at 069254
700 pounds: For a rate of 350
control of mg
active chlortetracycli
infection of ne and 1 mg
anaplasmosis lasalocid per
caused by 2.2 lb. body
Anaplasma weight daily to
marginale cattle with a
susceptible to maximum of 360
chlortetracycli mg of lasalocid
ne; and for the per head per
[…truncated; see source link]Indexed from Federal Register on October 20, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.