[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Rules and Regulations]
[Pages 48940-48950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21146]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, 556, and 558
[Docket No. FDA-2018-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship; Change of a Sponsor's Name
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) and abbreviated new animal drug
applications (ANADAs) during January, February, and March 2018. FDA is
informing the public of the availability
[[Page 48941]]
of summaries of the basis of approval and of environmental review
documents, where applicable. The animal drug regulations are also being
amended to reflect the withdrawal of approval of applications, changes
of sponsorship of applications, and a change of a sponsor's name, and
to make technical amendments to improve the accuracy of the
regulations.
DATES: This rule is effective September 28, 2018, except for amendatory
instructions 7 to 21 CFR 520.580, 18 to 21 CFR 520.905d, 20 to 21 CFR
520.1182, 29 to 21 CFR 520.1840, 33 to 21 CFR 520.2380a, 37 to 21 CFR
522.1182, 51 to 21 CFR 524.900, 62 to 21 CFR 558.185, 68 to 21 CFR
558.365, and 70 to 21 CFR 558.485, which are effective October 9, 2018.
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 January, February, and March 2018,
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. Persons with access
to the internet may obtain these documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2018
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Effect of the
Approval date File No. Sponsor Product name Species action Public documents
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January 5, 2018.................. 141-449 Intervet, Inc., 2 SAFE-GUARD AquaSol Chickens............ Supplemental FOI Summary; EA/
Giralda Farms, (fenbendazole oral approval for the FONSI \1\.
Madison, NJ 07940. suspension), treatment and
Suspension control of certain
Concentrate. nematode worms in
laying hens; and
of a tolerance in
chicken eggs.
January 16, 2018................. 200-563 Norbrook EPRIZERO Cattle.............. Original approval FOI Summary.
Laboratories, (eprinomectin), as a generic copy
Ltd., Station Pour-On for Beef of NADA 141-079.
Works, Newry BT35 and Dairy Cattle.
6JP, Northern
Ireland.
January 19, 2018................. 141-494 Elanco US Inc., CREDELIO Dogs................ Original approval FOI Summary.
2500 Innovation (lotilaner), for killing adult
Way, Greenfield, Chewable Tablet. fleas, and for the
IN 46140. treatment of flea
infestations and
the treatment and
control of tick
infestations in
dogs.
January 29, 2018................. 200-622 Pharmgate LLC, 1800 Chlortetracycline Cattle.............. Original approval FOI Summary.
Sir Tyler Dr., and decoquinate, as a generic copy
Wilmington, NC Type C medicated of NADA 141-185.
28405. feeds.
February 28, 2018................ 141-482 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary.
Portage St., (lincomycin) and for the control of
Kalamazoo, MI ROBENZ (robenidine necrotic enteritis
49007. hydrochloride), and for the
Type C medicated prevention of
feeds. coccidiosis in
broiler chickens.
February 28, 2018................ 141-483 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary.
Portage St., (lincomycin) and for the control of
Kalamazoo, MI DECCOX necrotic enteritis
49007. (decoquinate), and for the
Type C medicated prevention of
feeds. coccidiosis in
broiler chickens.
March 2, 2018.................... 141-484 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary.
Portage St., (lincomycin) and for the control of
Kalamazoo, MI BIO-COX necrotic enteritis
49007. (salinomycin and for the
sodium), Type C prevention of
medicated feeds. coccidiosis in
broiler chickens.
March 5, 2018.................... 141-489 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary.
Portage St., (lincomycin) and for the control of
Kalamazoo, MI ZOAMIX (zoalene), necrotic enteritis
49007. Type C medicated and for the
feeds. prevention and
control of
coccidiosis in
broiler chickens.
March 8, 2018.................... 141-492 Merial, Inc., 3239 CENTRAGARD Cats................ Original approval FOI Summary.
Satellite Blvd., (eprinomectin and for the prevention
Bldg. 500, Duluth, praziquantel of heartworm
GA 30096-4640. transdermal disease, and for
solution). the treatment and
control of
roundworms,
hookworms, and
tapeworms in cats
and kittens.
March 26, 2018................... 141-491 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary.
Portage St., (lincomycin) and for the control of
Kalamazoo, MI COBAN (monensin), necrotic enteritis
49007. Type C medicated and as an aid in
feeds. the prevention of
coccidiosis in
broiler chickens.
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\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
no significant impact (FONSI).
[[Page 48942]]
II. Change of Sponsorship
Agri Laboratories Ltd., P.O. Box 3103, St. Joseph, MO 64503 has
informed FDA that it has transferred ownership of, and all rights and
interest in, the following applications to Huvepharma EOOD, 5th Floor,
3A Nikolay Haytov Str., 1113 Sofia, Bulgaria:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
200-030...................... DI-METHOX 520.2220a
(sulfadimethoxine) 12.5%
Solution.
200-031...................... DI-METHOX 520.2220a
(sulfadimethoxine)
Soluble Powder.
200-037...................... LEGACY (gentamicin 529.1044a
sulfate) Solution.
200-038...................... DI-METHOX 522.2220
(sulfadimethoxine)
Injection 40%.
200-049...................... TETRA-BAC 324 520.2345d
(tetracycline
hydrochloride) Soluble
Powder.
200-061...................... FLU-NIX (flunixin 522.970
meglumine) Injection.
200-066...................... AGRIMYCIN-343 520.1660d
(oxytetracycline
hydrochloride) Soluble
Powder.
200-128...................... AGRIMYCIN-200 522.1660a
(oxytetracycline
dihydrate) Injection.
200-185...................... GEN-GARD (gentamicin 520.1044c
sulfate) Soluble Powder.
200-225...................... PROHIBIT (levamisole 520.1242a
hydrochloride) Soluble
Drench Powder.
200-271...................... Levamisole Phosphate 522.1242
Injection.
200-407...................... Lincomycin-Spectinomycin 520.1265
(lincomycin
hydrochloride/
spectinomycin
dihydrochloride
pentahydrate) Water
Soluble Powder.
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Following this withdrawal of approval, Agri Laboratories Ltd. is no
longer the sponsor of an approved application. Accordingly, it will be
removed from the list of sponsors of approved applications in Sec.
510.600(c) (21 CFR 510.600(c)).
Strategic Veterinary Pharmaceuticals, Inc., 100 NW Airport Rd., St.
Joseph, MO 64503 has informed FDA that it has transferred ownership of,
and all rights and interest in, the following applications to Cronus
Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816:
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File No. Product name 21 CFR section
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011-531...................... DIZAN (dithiazanine 520.763a
iodide) Tablets.
011-674...................... DIZAN (dithiazanine 520.763b
iodide) Powder.
012-469...................... DIZAN (dithiazanine 520.763c
iodide) Suspension with
Piperazine Citrate.
031-512...................... ATGARD (dichlorvos) Swine 558.205
Wormer.
033-803...................... TASK (dichlorvos) Dog 520.600
Anthelmintic.
035-918...................... EQUIGARD; VERDISOL 520.596
(dichlorvos).
039-483...................... BIO-TAL (thiamylal 522.2424
sodium) Injection.
040-848...................... ATGARD C (dichlorvos) 558.205
Swine Wormer.
043-606...................... ATGARD V (dichlorvos) 558.205
Swine Wormer.
045-143...................... OXYJECT (oxytetracycline 522.1662a
hydrochloride) Injection.
047-278...................... BIO-MYCIN OXY-TET 50 522.1662a
(oxytetracycline
hydrochloride) Injection.
047-712...................... BIZOLIN-100; BIZOLIN-200 522.1720
(phenylbutazone)
Injection.
048-010...................... ANAPLEX (dichlorophene 520.580
and toluene) Canine and
Feline Wormer Caps.
048-237...................... EQUIGEL (dichlorvos)..... 520.602
048-271...................... TASK (dichlorvos) Tablets 520.598
049-032...................... ATGARD C (dichlorvos) 558.205
Premix 9.6%.
065-461...................... ANACETIN 520.390a
(chloramphenicol)
Tablets.
065-481...................... Calf Scour Boluses 520.443
(chlortetracycline
hydrochloride).
065-486...................... CTC Bisulfate 520.441
(chlortetracycline
bisulfate) Soluble
Powder.
065-491...................... MEDICHOL 520.390a
(chloramphenicol)
Tablets.
092-837...................... NEMACIDE 520.622b
(diethylcarbamazine
citrate) Oral Syrup.
093-516...................... BIZOLIN (phenylbutazone) 522.1720
Injection 20%.
097-452...................... OXYJECT 100 522.1662a
(oxytetracycline
hydrochloride) Injection.
098-569...................... MEDACIDE-SDM 522.2220
(sulfadimethoxine)
Injection 10%.
099-618...................... BIZOLIN (phenylbutazone) 520.1720a
1-G Bolus.
108-963...................... MEDAMYCIN 522.1662a
(oxytetracycline
hydrochloride)
Injectable Solution.
117-689...................... NEUROSYN (primidone) 520.1900
Tablets.
125-797...................... Nitrofurazone Dressing... 524.1580a
126-236...................... Nitrofurazone Soluble 524.1580b
Powder.
126-676...................... D & T (dichlorophene and 520.580
toluene) Worm Capsules.
127-627...................... NEMACIDE; NEMACIDE-C 520.622a
(diethylcarbamazine
citrate) Tablets.
128-069...................... NEMACIDE 520.622c
(diethylcarbamazine
citrate) Chewable
Tablets.
132-028...................... ANESTATAL (thiamylal 522.2424
sodium) Injectable
Solution.
135-771...................... Methylprednisolene 520.1408
Tablets.
136-212...................... Methylprednisolone 522.1410
Acetate Injection.
137-310...................... Gentamicin Sulfate 522.1044
Injectable Solution.
138-869...................... Triamcinolone Acetonide 522.2483
Suspension.
140-442...................... Xylazine HCl Injection... 522.2662
200-023...................... Gentamicin Sulfate 522.1044
Solution 100 mg/mL.
200-029...................... Ketamine Hydrochloride 522.1222
Injection.
200-165...................... SDM (sulfadimethoxine) 520.2220a
Concentrated Solution
12.5%.
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[[Page 48943]]
The animal drug regulations are being amended to reflect these
changes of sponsorship.
III. Withdrawals of Approval
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 has
requested that FDA withdraw approval of the NADAs listed in the
following table because the products are no longer manufactured or
marketed:
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File No. Product name 21 CFR section
------------------------------------------------------------------------
011-779...................... PURINA PIGEMIA 100 522.1182
(colloidal ferric oxide).
040-205...................... PURINA Horse Wormer 520.2380a
Medicated
(thiabendazole).
042-116...................... PURINA 6 DAY WORM-KILL 558.185
Feed Premix (coumaphos).
043-215...................... PURINA GRUB-KILL Pour-on 524.900
Cattle Insecticide
(famphur).
046-700...................... STATYL (nequinate) 558.365
Medicated Premix.
091-260...................... PULVEX WORM CAPS 520.1804
(piperazine phosphate
monohydrate).
097-258...................... PURINA BAN-WORM for Pigs 558.485
(pyrantel tartrate).
102-942...................... PULVEX Multipurpose Worm 520.580
Caps (dichlorophene,
toluene).
113-748...................... PURINA PIGEMIA Oral (iron 520.1182
dextran complex).
135-941...................... CHECK-R-TON BM (pyrantel 558.485
tartrate).
136-116...................... PURINA WORM-A-RESTTM 520.905d
Litter Pack Premix
(fenbendazole).
140-869...................... PURINA SAF-T-BLOC BG 520.1840
Medicated Feed Block
(poloxalene, 6.6%).
------------------------------------------------------------------------
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 011-779, 040-205, 042-116, 043-215, 046-700,
091-260, 097-258, 102-942, 113-748, 135-941, 136-116, and 140-869, and
all supplements and amendments thereto, is withdrawn, effective October
9, 2018. As provided in the regulatory text of this document, the
animal drug regulations are amended to reflect these actions.
IV. Technical Amendments
JBS United Animal Health II LLC, 322 S Main St., Sheridan, IN 46069
has informed FDA that it has changed its name to United-AH II LLC.
Accordingly, we are amending Sec. 510.600(c) to reflect this change.
We are also making technical amendments to update the scientific
name of a pathogenic bacterium and to accurately list the
concentrations of new animal drug ingredients in combination drug
medicated feeds. These actions are being taken to improve the accuracy
of the regulations.
V. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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, 520, 522, 524, 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, in the table in paragraph (c)(1), remove the entry
for ``JBS United Animal Health II LLC'', and alphabetically add an
entry for ``United-AH II LLC''; and in the table in paragraph (c)(2),
revise the entry for ``051233'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 48944]]
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
United-AH II LLC, 322 S Main St., Sheridan, IN 46069.... 051233
* * * * * * *
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
051233.................. United-AH II LLC, 322 S Main St., Sheridan, IN
46069
* * * * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.390a [Amended]
0
4. In Sec. 520.390a, in paragraph (b)(1)(i), remove ``054628'' and in
its place add ``069043''.
Sec. 520.441 [Amended]
0
5. In Sec. 520.441, in paragraph (b)(3), remove ``069254 and 076475''
and in its place add ``069043, 069254, and 076475''.
Sec. 520.443 [Amended]
0
6. In Sec. 520.443, in paragraph (b), remove ``054628'' and in its
place add ``069043''.
Sec. 520.580 [Amended]
0
7. In Sec. 520.580, in paragraph (b)(1), remove ``051311''; and in
paragraph (b)(2), remove ``000061 and 054771'', and in its place add
``000061, 054771, and 069043''.
Sec. 520.600 [Redesignated as Sec. 520.596]
0
8. Redesignate Sec. 520.600 as Sec. 520.596 and revise newly
redesignated Sec. 520.596 to read as follows:
Sec. 520.596 Dichlorvos powder.
(a) Specifications--(1) Each 2-ounce packet contains 2.27 grams (4
percent) dichlorvos.
(2) Each milligram of powder contains 2.27 milligrams (mg)
dichlorvos.
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter for
use of the product described in paragraph (a)(1) of this section as in
paragraph (d)(1) of this section and the product described in paragraph
(a)(2) of this section as in paragraph (d)(2) of this section.
(c) Related tolerances. See Sec. 556.180 of this chapter.
(d) Conditions of use--(1) Swine (adult gilts, sows, and boars)--
(i) Amount. Add powder to the indicated amount of feed and administered
shortly after mixing, as follows:
----------------------------------------------------------------------------------------------------------------
Pounds of mixed
Pounds of feed to feed to be Number of pigs to
Weight of animal in pounds be mixed with administered to be treated per
each 0.08 ounce each pig as a 0.08 ounce of
of dichlorvos single treatment dichlorvos
----------------------------------------------------------------------------------------------------------------
20-30.................................................. 4 0.33 12
31-40.................................................. 5 0.56 9
41-60.................................................. 6 1.00 6
61-80.................................................. 5 1.00 5
81-100................................................. 4 1.00 4
16 4.00 4
----------------------------------------------------------------------------------------------------------------
(ii) Indications for use. For the removal and control of sexually
mature (adult), sexually immature and/or 4th stage larvae of the
whipworm (Trichuris suis), nodular worms (Oesophagostomum spp.), large
round-worm (Ascaris suum), and the mature thick stomach worm (Ascarops
strongylina) occurring in the lumen of the gastrointestinal tract of
pigs, boars, and open or bred gilts and sows.
(iii) Limitations. Do not use this product on animals either
simultaneously or within a few days before or after treatment with or
exposure to cholinesterase inhibiting drugs, pesticides, or chemicals.
The preparation should be mixed thoroughly with the feed on a clean,
impervious surface. Do not allow swine access to feed other than that
containing the preparation until treatment is complete. Do not treat
pigs with signs of scours until these signs subside or are alleviated
by proper medication. Resume normal feeding schedule afterwards. Swine
may be retreated in 4 to 5 weeks.
(2) Horses--(i) Amount. Administer in the grain portion of the
ration at a dosage of 14.2 to 18.5 mg per pound of body weight as a
single dose. Administered at one-half of the single
[[Page 48945]]
recommended dosage and repeated 8 to 12 hours later in the treatment of
very aged, emaciated, or debilitated subjects or those reluctant to
consume medicated feed. In suspected cases of severe ascarid infection
sufficient to cause concern over mechanical blockage of the intestinal
tract, the split dosage should be used.
(ii) Indications for use. For the removal and control of bots
(Gastrophilus intestinalis, G. nasalis), large strongyles (Strongylus
vulgaris, S. equinus, S. edentatus), small strongyles (of the genera
Cyathostomum, Cylicocercus, Cylicocyclus, Cylicodontophorus,
Triodontophorus, Poteriostomum, Gyalocephalus), pinworms (Oxyuris
equi), and large roundworm (Parascaris equorum) in horses including
ponies and mules. Not for use in foals (sucklings and young weanlings).
(iii) Limitations. Do not use in horses which are severely
debilitated, suffering from diarrhea or severe constipation, infectious
disease, toxemia, or colic. Do not administer in conjunction with or
within 1 week of administration of muscle relaxant drugs, phenothiazine
derived tranquilizers or central nervous system depressant drugs.
Horses should not be subjected to insecticide treatment for 5 days
prior to or after treating with the drug. Do not administer to horses
afflicted with chronic alveolar emphysema (heaves) or related
respiratory conditions. The product is a cholinesterase inhibitor and
should not be used simultaneously or within a few days before or after
treatment with or exposure to cholinesterase inhibiting drugs,
pesticides or chemicals. Do not use in animals other than horses,
ponies, and mules. Do not use in horses, ponies, and mules intended for
food purposes. Do not allow fowl access to feed containing this
preparation or to fecal excrement from treated animals.
0
9. Add Sec. 520.598 to read as follows:
Sec. 520.598 Dichlorvos tablets.
(a) Specifications. Each tablet contains 2, 5, 10, or 20 milligrams
(mg) dichlorvos.
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs, puppies, cats, and kittens--(1)
Amount. Administer orally at 5 mg dichlorvos per pound of body weight.
(2) Indications for use--(i) Dogs and puppies: Removal and control
of intestinal roundworms (Toxocara canis and Toxascaris leonina) and
hookworms (Ancylostoma caninum and Uncinaria stenocephala).
(ii) Cats and kittens: Removal and control of intestinal roundworms
(Toxocara cati and Toxascaris leonina) and hookworms (Ancylostoma
tubaeforme and Uncinaria stenocephala).
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
10. Add Sec. 520.600 to read as follows:
Sec. 520.600 Dichlorvos capsules and pellets.
(a) Specifications. Each capsule contains 2.27 milligrams (mg) (4
percent) dichlorvos.
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer any
combination of capsules and/or pellets so that the animal receives a
single dose equaling 12 to 15 mg of dichlorvos per pound of body
weight.
(2) Indications for use. For removal of Toxocara canis and
Toxascaris leonina (roundworms), Ancylostoma caninum and Uncinaria
stenocephala (hookworms), and Trichuris vulpis (whipworm) residing in
the lumen of the gastrointestinal tract.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
11. Add Sec. 520.602 to read as follows:
Sec. 520.602 Dichlorvos gel.
(a) Specifications. Each milligram (mg) of gel contains 2.27
milligrams (mg) dichlorvos.
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 20 mg per
kilogram of body weight for the removal of bots and ascarids. Repeat
administration every 21 to 28 days for the control of bots and
ascarids. For the control of bots only, the repeat dosage is 10
milligrams per kilogram of body weight every 21 to 28 days during bot
fly season.
(2) Indications for use. For the removal and control of first,
second, and third instar bots (Gastrophilus intestinalis and G.
nasalis), sexually mature and sexually immature (4th stage) ascarids
(Parascaris equorum) in horses and foals.
(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. 520.622a [Amended]
0
12. In Sec. 520.622a, in paragraph (a)(6), remove ``054628'' and in
its place add ``069043''.
Sec. 520.622b [Amended]
0
13. In Sec. 520.622b, in paragraph (c)(2), remove ``054628'' and in
its place add ``069043''.
Sec. 520.622c [Amended]
0
14. In Sec. 520.622c, in paragraph (b)(6), remove ``054628'' and in
its place add ``069043''.
Sec. 520.763a [Amended]
0
15. In Sec. 520.763a, in paragraph (b), remove ``054628'' and in its
place add ``069043''.
Sec. 520.763b [Amended]
0
16. In Sec. 520.763b, in paragraph (b), remove ``000010'' and in its
place add ``069043''.
Sec. 520.763c [Amended]
0
17. In Sec. 520.763c, in paragraph (b), remove ``054628'' and in its
place add ``069043''.
0
18. In Sec. 520.905d, revise paragraphs (a) and (b) to read as
follows:
Sec. 520.905d Fenbendazole powder.
(a) Specifications. Each 2-ounce packet contains 2.27 grams (4
percent) fenbendazole.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 520.1044c [Amended]
0
19. In Sec. 520.1044c, in paragraph (b)(2), remove ``057561'' and in
its place add ``016592''.
Sec. 520.1182 [Removed]
0
20. Remove Sec. 520.1182.
Sec. 520.1242a [Amended]
0
21. In Sec. 520.1242a, in paragraph (b)(3), remove ``057561'' and in
its place add ``016592''.
Sec. 520.1263c [Amended]
0
22. In Sec. 520.1263c, in paragraph (b)(1), remove ``Nos. 016592 and
054771'' and in its place add ``No. 054771''; and in paragraph (b)(2),
remove ``Nos. 054925, 061623, and 076475'' and in its place add ``Nos.
016592, 054925, 061623, and 076475''.
Sec. 520.1265 [Amended]
0
23. In Sec. 520.1265, in paragraph (b)(2), remove ``057561'' and in
its place add ``016592''.
0
24. Add Sec. 520.1286 to read as follows:
Sec. 520.1286 Lotilaner.
(a) Specifications. Each chewable tablet contains 56.25, 112.5,
225, 450, or 900 milligrams (mg) lotilaner.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
[[Page 48946]]
(c) Conditions of use in dogs--(1) Amount. Administer orally once a
month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).
(2) Indications for use. Kills adult fleas, and for the treatment
of flea infestations (Ctenocephalides felis), and the treatment and
control of tick infestations (Amblyomma americanum (lone star 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 or older and weighing 4.4
pounds or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.1408 [Amended]
0
25. In Sec. 520.1408, in paragraph (b)(1), remove ``054628'' and in
its place add ``069043''.
Sec. 520.1660d [Amended]
0
26. In Sec. 520.1660d, in paragraph (b)(4), remove ``No. 057561'' and
in its place add ``No. 016592''.
Sec. 20.1720a [Amended]
0
27. In Sec. 520.1720a, in paragraph (b)(2), remove ``Nos. 054628 and
069043'' and in its place add ``No. 069043''.
Sec. 520.1804 [Removed]
0
28. Remove Sec. 520.1804.
Sec. 520.1840 [Amended]
0
29. In Sec. 520.1840, remove paragraph (b)(2), redesignate paragraphs
(b)(3) and (4) as paragraphs (b)(2) and (3), and remove paragraph
(d)(4).
Sec. 520.1900 [Amended]
0
30. In Sec. 520.1900, in paragraph (b)(1), remove ``054628'' and in
its place add ``069043''.
Sec. 520.2220a [Amended]
0
31. In Sec. 520.2220a, in paragraph (b)(1), remove ``Nos. 016592,
054628, 054771, 054925, and 057561'' and in its place add ``Nos.
016592, 054771, 054925, and 069043''; and in paragraph (b)(2), remove
``Nos. 054771, 054925, 057561, 058829, 061623, and 066104'' and in its
place add ``Nos. 016592, 054771, 054925, 058829, 061623, and 066104''.
Sec. 520.2345d [Amended]
0
32. In Sec. 520.2345d, in paragraph (b)(4), remove ``Nos. 054925,
057561, 061623, and 076475'' and in its place add ``Nos. 016592,
054925, 061623, and 076475''.
Sec. 520.2380a [Amended]
0
33. In Sec. 520.2380a, remove and reserve paragraphs (b)(1) and
(d)(1)(i).
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
34. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.970 [Amended]
0
35. In Sec. 522.970, in paragraph (b)(1), remove ``Nos. 000061,
000859, 055529, 057561, and 061623'' and in its place add ``Nos.
000061, 000859, 016592, 055529, and 061623''.
Sec. 522.1044 [Amended]
0
36. In Sec. 522.1044, in paragraph (b)(3), remove ``054628'' and in
its place add ``069043''.
Sec. 522.1182 [Amended]
0
37. In Sec. 522.1182, in paragraph (b)(4), remove ``Nos. 051311 and
054771'' and in its place add ``No. 054771''.
Sec. 522.1222 [Amended]
0
38. In Sec. 522.1222, in paragraph (b), remove ``Nos. 000859, 026637,
054628, 054771, 059399, and 063286'' and in its place add ``Nos.
000859, 026637, 054771, 059399, 063286, and 069043''.
Sec. 522.1242 [Amended]
0
39. In Sec. 522.1242, in paragraph (b), remove ``057561'' and in its
place add ``016592''.
Sec. 522.1410 [Amended]
0
40. In Sec. 522.1410, in paragraph (b), remove ``054628 and 054771''
and in its place add ``054771 and 069043''.
Sec. 522.1660a [Amended]
0
41. In Sec. 522.1660a, in paragraph (b), remove ``057561,''.
Sec. 522.1662a [Amended]
0
42. In Sec. 522.1662a, in paragraphs (a)(2), (b)(2), (g)(2), and
(h)(2), remove ``054628'' and in its place add ``069043''.
Sec. 522.1720 [Amended]
0
43. In Sec. 522.1720, in paragraph (b)(3), remove ``054628 and
058005'' and in its place add ``058005 and 069043''.
Sec. 522.2220 [Amended]
0
44. In Sec. 522.2220, in paragraph (b)(1), remove ``054628'' and in
its place add ``069043''; and in paragraph (b)(3), remove ``Nos.
016592, 057561, and 061623'' and in its place add ``Nos. 016592 and
061623''.
Sec. 522.2424 [Amended]
0
45. In Sec. 522.2424, in paragraph (b), remove ``054628 and 054771''
and in its place add ``054771 and 069043''.
Sec. 522.2483 [Amended]
0
46. In Sec. 522.2483, in paragraph (b), remove ``054628'' and in its
place add ``069043''.
Sec. 522.2662 [Amended]
0
47. In Sec. 522.2662, in paragraph (b)(1), remove ``054628'' and in
its place add ``069043''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
48. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
49. In Sec. 524.814, revise paragraph (b) to read as follows:
Sec. 524.814 Eprinomectin.
* * * * *
(b) Sponsors. See Nos. 050604 and 055529 in Sec. 510.600(c) of
this chapter.
* * * * *
0
50. Add Sec. 524.815 to read as follows:
Sec. 524.815 Eprinomectin and praziquantel.
(a) Specifications. Each milliliter (mL) of solution contains 4
milligrams (mg) eprinomectin and 83 mg praziquantel.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. Using the 0.3 mL and 0.9
mL unit applicators, administer a minimum dose of 0.23 mg eprinomectin
per pound body weight and 4.55 mg praziquantel per pound body weight by
topical application on the dorsal midline between the base of the skull
and the shoulder blades.
(2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis, and for the treatment and control of
roundworms (adult and fourth stage larval Toxocara cati), hookworms
(adult and fourth stage larval Ancylostoma tubaeforme; adult
Ancylostoma braziliense), and tapeworms (adult Dipylidium caninum and
Echinococcus multilocularis), in cats and kittens 7 weeks of age and
older and 1.8 lbs or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 524.900 [Amended]
0
51. In Sec. 524.900, in paragraph (b), remove ``Nos. 000061 and
051311'' and in its place add ``No. 000061''.
[[Page 48947]]
Sec. 524.1580a [Amended]
0
52. In Sec. 524.1580a, in paragraph (b)(1), remove ``Nos. 054628,
054925, 058005, 059051, and 061623'' and in its place add ``Nos.
054925, 058005, 059051, 061623, and 069043''.
Sec. 524.1580b [Amended]
0
53. In Sec. 524.1580b, in paragraph (b), remove ``054628 and 059051''
and in its place add ``059051 and 069043''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
54. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1044a [Amended]
0
55. In Sec. 529.1044a, in paragraph (b), remove ``Nos. 000061, 000859,
054628, 054771, 057561, 058005, and 061623'' and in its place add
``Nos. 000061, 000859, 016592, 054628, 054771, 058005, and 061623''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
56. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
57. In Sec. 556.275, add paragraph (b)(3)(ii) to read as follows:
Sec. 556.275 Fenbendazole.
* * * * *
(b) * * *
(3) * * *
(ii) Eggs. The tolerance for fenbendazole sulfone (the marker
residue) is 1.8 ppm.
* * * * *
Sec. 556.440 [Removed]
0
58. Remove Sec. 556.440.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
59. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.4 [Amended]
0
60. In Sec. 558.4, in paragraph (d), in the ``Category I'' table,
remove the row entry for ``Nequinate''.
Sec. 558.128 [Amended]
0
61. In Sec. 558.128, in paragraphs (e)(4)(xi) and (xiii), in the
``Indications for use'' column, remove ``P. multocida'' and in its
place add ``P. multocida organisms''.
0
62. In Sec. 558.185, revise paragraph (b), remove paragraph (e)(1),
and redesignate paragraphs (e)(2) and (3) as paragraphs (e)(1) and (2).
The revision reads as follows:
Sec. 558.185 Coumaphos.
* * * * *
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 558.195 [Amended]
0
63. In Sec. 558.195, remove and reserve paragraph (e)(2)(v).
0
64. In Sec. 558.205, revise paragraph (a); redesignate paragraphs (b)
through (d) as paragraphs (c) through (e); and add new paragraph (b).
The revision and addtion read as follows:
Sec. 558.205 Dichlorvos.
(a) Specifications. Type A medicated articles containing 3.1 or 9.6
percent dichlorvos.
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
* * * * *
0
65. In Sec. 558.311, revise paragraph (e)(5) to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(5) Lasalocid may also be used in combination with:
(i) Chlortetracycline as in Sec. 558.128.
(ii) Melengestrol as in Sec. 558.342.
(iii) Oxytetracycline as in Sec. 558.450.
(iv) Tylosin alone or in combination with melengestrol acetate as
in Sec. 558.625.
(v) Virginiamycin as in Sec. 558.635.
0
66. In Sec. 558.325, redesignate paragraph (e)(1)(ii) as paragraph
(e)(1)(v); add reserved paragraphs (e)(1)(ii), (iii), and (vi); and add
paragraphs (e)(1)(iv), (vii), (viii), (ix), and (x) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Lincomycin grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) [Reserved]
(iii) [Reserved]
(iv) 2........................ Decoquinate, Broiler chickens: For Feed as the sole ration. 054771
2.72. the control of Do not use in feeds
necrotic enteritis containing bentonite. Not
caused or for use in laying hens,
complicated by breeding chickens, or
Clostridium spp. or turkeys. Do not allow
other organisms rabbits, hamsters, guinea
susceptible to pigs, horses, or
lincomycin; and for ruminants access to feeds
the prevention of containing lincomycin.
coccidiosis caused Ingestion by these
by Eimeria tenella, species may result in
E. necatrix, E. severe gastrointestinal
acervulina, E. effects. Decoquinate as
brunetti, E. mivati, provided by No. 054771 in
and E. maxima. Sec. 510.600 of this
chapter.
* * * * * * *
(vi) [Reserved]
(vii) 2....................... Monensin, 90 to Broiler chickens: For Feed as the sole ration. 054771
110. the control of Must be thoroughly mixed
necrotic enteritis in feeds before use. Do
caused or not feed undiluted. Not
complicated by for use in laying hens,
Clostridium spp. or breeding chickens, or
other organisms turkeys. Do not allow
susceptible to horses, or other equines,
lincomycin, and as mature turkeys, or guinea
an aid the fowl access to feed
prevention of containing monensin.
coccidiosis caused Ingestion of monensin by
by Eimeria necatrix, horses and guinea fowl
E. tenella, E. has been fatal. Do not
acervulina, E. allow rabbits, hamsters,
brunetti, E. mivati, guinea pigs, horses, or
and E. maxima. ruminants access to feeds
containing lincomycin.
Ingestion by these
species may result in
severe gastrointestinal
effects. Monensin as
provided by No. 058198 in
Sec. 510.600 of this
chapter.
[[Page 48948]]
(viii) 2...................... Robenidine Broiler chickens: For Feed as the sole ration. 054771
hydrochloride, the control of Do not use in feeds
30. necrotic enteritis containing bentonite. Do
caused or not feed to laying hens
complicated by producing eggs for human
Clostridium spp. or consumption. Not for use
other organisms in laying hens, breeding
susceptible to chickens, or turkeys. Do
lincomycin, and as not allow rabbits,
an aid in the hamsters, guinea pigs,
prevention of horses, or ruminants
coccidiosis caused access to feeds
by Eimeria mivati, containing lincomycin.
E. brunetti, E. Ingestion by these
tenella, E. species may result in
acervulina, E. severe gastrointestinal
maxima, and E. effects. Withdraw 5 days
necatrix. prior to slaughter. Type
C feed containing
robenidine hydrochloride
must be fed within 50
days from the date of
manufacture. Robenidine
hydrochloride as provided
by No. 054771 in Sec.
510.600 of this chapter.
(ix) 2........................ Salinomycin Broiler chickens: For Feed as the sole ration to 054771
sodium, 40 to the control of broiler chickens. Do not
60. necrotic enteritis feed to laying hens
caused or producing eggs for human
complicated by consumption. Not approved
Clostridium spp. or for use with pellet
other organisms binders. May be fatal if
susceptible to accidentally fed to adult
lincomycin, and for turkeys or horses. Not
the prevention of for use in laying hens,
coccidiosis caused breeding chickens, or
by Eimeria tenella, turkeys. Do not allow
E. necatrix, E. rabbits, hamsters, guinea
acervulina, E pigs, horses, or
maxima, E. brunetti, ruminants access to feeds
and E. mivati. containing lincomycin.
Ingestion by these
species may result in
severe gastrointestinal
effects. Salinomycin
sodium as provided by No.
054771 in Sec. 510.600
of this chapter.
(x) 2......................... Zoalene, 113.5.. Broiler chickens: For Feed as the sole ration 054771
the control of from the time chicks are
necrotic enteritis placed in floor pens
caused or until slaughtered for
complicated by meat. Not for use in
Clostridium spp. or laying hens, breeding
other organisms chickens, or turkeys. Do
susceptible to not allow rabbits,
lincomycin; and for hamsters, guinea pigs,
the prevention and horses, or ruminants
control of access to feeds
coccidiosis. containing lincomycin.
Ingestion by these
species may result in
severe gastrointestinal
effects. Zoalene as
provided by No. 054771 in
Sec. 510.600 of this
chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
67. In Sec. 558.342, in paragraph (e)(1), revise the table headings,
add paragraphs (e)(1)(iii) and (iv), and remove paragraphs (e)(1)(v)
through (xi); and in paragraph (e)(2), redesignate paragraphs (e)(2)(i)
through (iii) as paragraphs (e)(2)(ii) through (iv) and add new
paragraph (e)(2)(i).
The revisions and additions read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Melengestrol acetate in mg/ Combination in
head/day grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) 0.25 to 0.5............. Lasalocid, 10 to Heifers fed in Add at the rate of 0.5 to 054771
30. confinement for 2.0 lb/head/day a 058198
slaughter: For medicated feed (liquid or
increased rate of dry) containing 0.125 to
weight gain, 1.0 mg melengestrol
improved feed acetate/lb to a feed
efficiency, and containing 10 to 30 g of
suppression of lasalocid per ton to
estrus (heat); and provide 0.25 to 0.5 mg
for control of melengestrol acetate and
coccidiosis caused 100 to 360 milligrams of
by Eimeria bovis and lasalocid per head/day.
Eimeria zuernii. See Sec. 558.311(d) of
this chapter. Lasalocid
as provided by No. 054771
in Sec. 510.600(c) of
this chapter.
(iv) 0.25 to 0.5.............. Monensin, 10 to Heifers fed in Add at the rate of 0.5 to 054771
40. confinement for 2.0 lb/head/day a 058198
slaughter: For medicated feed (liquid or
increased rate of dry) containing 0.125 to
weight gain, 1.0 mg melengestrol
improved feed acetate/lb to a feed
efficiency, and containing 10 to 40 g of
suppression of monensin per ton to
estrus (heat); and provide 0.25 to 0.5 mg
for the prevention melengestrol acetate/head/
and control of day and 0.14 to 0.42 mg
coccidiosis due to monensin/lb body weight,
Eimeria bovis and E. depending on severity of
zuernii. coccidiosis challenge, up
to 480 mg monensin/head/
day. See Sec.
558.355(d) of this
chapter. Monensin as
provided by No. 058198 in
Sec. 510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
(2) * * *
(i) Oxytetracycline as in Sec. 558.450.
* * * * *
Sec. 558.365 [Removed]
0
68. Remove Sec. 558.365.
Sec. 558.450 [Amended]
0
69. In Sec. 558.450, in paragraph (e)(5)(iv) entries 1 and 2, remove
``A. liquefaciens'' and in its place add ``A. hydrophila''.
0
70. Revise Sec. 558.485 to read as follows:
Sec. 558.485 Pyrantel.
(a) Specifications. Type A medicated articles containing 48 or 80
grams per pound pyrantel tartrate.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
uses as in paragraph (e) of this section.
(1) No. 066104: 48 and 80 grams per pound for use as in paragraph
(e)(1) of this section.
(2) Nos. 017135 and 054771: 48 grams per pound for use as in
paragraph (e)(2) of this section.
(c) Related tolerances. See Sec. 556.560 of this chapter.
[[Page 48949]]
(d) Special considerations--(1) See Sec. 500.25 of this chapter.
Consult a veterinarian before using in severely debilitated animals.
(2) Do not mix in Type B or Type C medicated feeds containing
bentonite.
(e) Conditions of use--(1) Swine--
----------------------------------------------------------------------------------------------------------------
Pyrantel grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 96.............................. Swine: As an aid in the Feed continuously as the sole 066104
prevention of migration ration in a Type C feed.
and establishment of large Withdraw 24 hours prior to
roundworm (Ascaris suum) slaughter.
infections; aid in the
prevention of
establishment of nodular
worm (Oesophagostomum)
infections.
(ii) 96............................. Swine: For the removal and Feed for 3 days as the sole 066104
control of large roundworm ration in a Type C feed.
(Ascaris suum) infections. Withdraw 24 hours prior to
slaughter.
(iii) 800........................... Swine: For the removal and Feed as the sole ration for a 066104
control of large roundworm single therapeutic treatment in
(Ascaris suum) and nodular Type C feed at a rate of 1 lb
worm (Oesophagostomum) of feed per 40 lb of body
infections. weight for animals up to 200
lb, and 5 lb of feed per head
for animals 200 lb or over.
Withdraw 24 hours prior to
slaughter.
----------------------------------------------------------------------------------------------------------------
(2) Horses--
----------------------------------------------------------------------------------------------------------------
Pyrantel grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
To provide 1.2 mg/lb body weight.... Prevention of Strongylus Feed continuously. Administer 017135
vulgaris larval either as a top-dress (not to 054771
infections; control of exceed 20,000 g/ton) or mixed
adult large strongyles (S. in the horse's daily grain
vulgaris, and S. ration (not to exceed 1,200 g/
edentatus), adult and 4th ton) during the time that the
stage larvae small animal is at risk of exposure
strongyles (Cyathostomum to internal parasites. Not for
spp., Cylicocyclus spp., use in horses intended for
Cylicostephanus spp., food. Consult your veterinarian
Cylicodontophorus spp., before using in severely
Poteriostomum spp., and debilitated animals and for
Triodontophorus spp.), assistance in the diagnosis,
adult and 4th stage larvae treatment, and control of
pinworms (Oxyuris equi), parasitism.
and adult and 4th stage
larvae ascarids
(Parascaris equorum).
----------------------------------------------------------------------------------------------------------------
(3) Pyrantel may also be used in combination with:
(i) Carbadox as in Sec. 558.115.
(ii) Lincomycin as in Sec. 558.325.
(iii) Tylosin as in Sec. 558.625.
0
71. In Sec. 558.625, revise paragraphs (e)(2)(ii) and (iii) to read as
follows:
Sec. 558.625 Tylosin.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Tylosin grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 8 to 10.................. Lasalocid, 100 Heifers fed in Feed continuously as sole 016592
to 1440; plus confinement for ration. Feed to heifers 054771
melengestrol, slaughter: For at the rate of 0.5 to 2.0 058198
0.25 to 2.0. reduction of pound(s) per head per day
incidence of liver (specify one level) to
abscesses caused by provide 0.25 to 0.5 mg
Fusobacterium melengestrol acetate per
necrophorum and head per day (specify one
Arcanobacterium level), 100 to 360 mg
pyogenes; and for lasalocid per head per
increased rate of day (specify one level),
weight gain, and 90 mg tylosin per
improved feed head per day. This Type C
efficiency, and product may be top
suppression of dressed onto or mixed
estrus (heat). into a complete feed
prior to feeding. Tylosin
as provided by Nos.
016592 and 058198;
lasalocid as provided by
No. 054771; melengestrol
as provided by Nos.
054771 and 058198 in Sec.
510.600(c) of this
chapter. See Sec. Sec.
558.311(d) and 558.342(d)
in this chapter.
(iii) 8 to 10................. Melengestrol, Heifers fed in Feed continuously as sole 016592
0.25 to 2.0. confinement for ration. Each pound 054771
slaughter: For contains 0.125 to 1.0 mg 058198
reduction of melengestrol acetate and
incidence of liver 45 to 180 mg of tylosin.
abscesses caused by Feed to heifers at a rate
Fusobacterium of 0.5 to 2.0 pounds per
necrophorum and head per day to provide
Arcanobacterium 0.25 to 0.5 mg
pyogenes; and for melengestrol acetate and
increased rate of 60 to 90 mg tylosin per
weight gain, head per day. Prior to
improved feed feeding, this Type C
efficiency, and product must be top-
suppression of dressed onto a complete
estrus (heat). feed or mixed into the
amount of complete feed
consumed by an animal per
day. Tylosin provided by
Nos. 016592 and 058198;
melengestrol provided by
Nos. 054771 and 058198 in
Sec. 510.600(c) of this
chapter. See Sec.
558.342(d) in this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[[Page 48950]]
Dated: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21146 Filed 9-27-18; 8:45 am]
BILLING CODE 4164-01-P