[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Rules and Regulations]
[Pages 39179-39187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16884]
[[Page 39179]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2019-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship; Change of Sponsors' Names and Addresses
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 2019. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable.
Technical amendments are also being made to improve the accuracy,
consistency, and readability of the regulations.
DATES: This rule is effective August 9, 2019, except for amendatory
instructions 51 to 21 CFR 524.916 and 63 to 21 CFR 558.325, which are
effective August 19, 2019, and instruction 60 to 21 CFR 558.235, which
is effective September 9, 2019.
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 2019,
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 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 27, 2019.................. 009-476 Phibro Animal NICARB 25% Chickens............. Supplemental approval N/A.
Health Corp., (nicarbazin) of revised assay
GlenPointe Type A limits for
Centre East, 3d medicated nicarbazin (powder)
Floor, 300 article. Type A medicated
Frank W. Burr article.
Blvd., Suite
21, Teaneck, NJ
07666.
January 28, 2019.................. 200-616 Norbrook CEFENIL RTU Swine and cattle..... Original approval as FOI Summary.
Laboratories, (ceftiofur a generic copy of
Ltd., Station hydrochloride NADA 140-890.
Works, Newry sterile
BT35 6JP, suspension).
Northern
Ireland.
January 31, 2019.................. 200-450 Bimeda Animal BIMECTIN PLUS Cattle............... Original approval as FOI Summary.
Health Ltd., 1B (ivermectin/ a generic copy of
The Herbert clorsulon) NADA 140-833.
Building, The Injection for
Park, Cattle.
Carrickmines,
Dublin, 18,
Ireland.
February 4, 2019.................. 200-637 Provetica AH DOXIDYL Dogs................. Original approval as FOI Summary.
LLC, 455 (deracoxib) a generic copy of
Sovereign Ct., Chewable Tablet. NADA 141-203.
Baldwin, MO
63011.
February 8, 2019.................. 141-297 Boehringer PROZINC Dogs................. Supplemental approval FOI Summary.
Ingelheim (protamine zinc for the reduction of
Vetmedica, recombinant hyperglycemia and
Inc., 2621 human insulin) hyperglycemia-
North Belt Injectable associated clinical
Highway, St. Suspension. signs in dogs with
Joseph, MO diabetes mellitus.
64506-2002.
[[Page 39180]]
March 29, 2019.................... 048-761 Zoetis Inc., 333 AUREOMYCIN Cattle............... Supplemental approval N/A.
Portage St., (chlortetracycl adding replacement
Kalamazoo, MI ine) Type C dairy heifers to the
49007. medicated feeds. indications for use
of chlortetracycline
Type C medicated
cattle feeds for
control of bacterial
pneumonia associated
with shipping fever
complex caused by
Pasteurella spp.
susceptible to
chlortetracycline.
March 29, 2019.................... 141-517 Pegasus PROIN ER Dogs................. Original approval for FOI Summary.
Laboratories, (phenylpropanol the control of
Inc., 8809 Ely amine urinary incontinence
Rd., Pensacola, hydrochloride due to urethral
FL 32514. extended- sphincter hypotonus.
release
tablets)
Tablets.
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II. Changes of Sponsors' Names and Addresses
Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN
55057-3009 has informed FDA that it has changed its name to Aurora
Pharmaceutical, Inc.
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St.
Joseph, MO 64506-2002 has informed FDA that it has changed its name and
address to Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite
Blvd., Duluth, GA 30096.
Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY
11967 has informed FDA that it has changed its name to American Regent,
Inc.
Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 has
informed FDA that it has changed its name to Pharmgate, Inc.
Accordingly, we are amending Sec. 510.600(c) to reflect these
changes.
III. Changes of Sponsorship
Provetica AH LLC, 455 Sovereign Ct., Baldwin, MO 63011 has informed
FDA that it has transferred ownership of, and all rights and interest
in, newly approved ANADA 200-637 for DOXIDYL (deracoxib) Chewable
Tablets to Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re,
33500 Libourne, France. Following this change of sponsorship, Provetica
AH LLC is no longer the sponsor of an approved application.
Accordingly, it will not be added to the list of sponsors of approved
applications in Sec. 510.600(c) (21 CFR 510.600(c)).
Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-
4640 has informed FDA that it has transferred ownership of, and all
rights and interest in, the following applications to Boehringer
Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA
30096:
------------------------------------------------------------------------
File No. Proprietary name
------------------------------------------------------------------------
006-623 CAPARSOLATE (arsenamide sodium) Injection.
008-422 SELEEN (selenium disulfide) Suspension.
010-424 NALLINE (nalorphine hydrochloride) Injection.
011-080 HYDELTRONE-TBA (prednisolone and tertiary
butylacetate) Suspension.
011-437 HYDELTRONE (prednisolone sodium phosphate and
neomycin sulfate) Ointment.
011-532 SULFABROM (sulfabromomethazine sodium) Bolus.
011-678 DIURIL (chlorothiazide) Tablets.
012-734 DIURIL (chlorothiazide) Bolus.
013-022 THIBENZOLE (thiabendazole) Sheep & Goat
Wormer.
013-407 EQUIZOLE (thiabendazole) Horse Wormer.
013-674 HYDROZIDE (hydrochlorothiazide) Injection.
013-954 THIBENZOLE (thiabendazole) 20% Swine Premix.
014-350 OMNIZOLE (thiabendazole).
015-123 TBZ[supreg] (thiabendazole) Cattle Wormer
(Drench).
015-875 TBZ 200 (thiabendazole) Medicated Premix.
030-103 THIBENZOLE (thiabendazole) Suspension.
034-114 EQUIZOLE (thiabendazole).
035-631 THIBENZOLE (thiabendazole) Pig Wormer.
037-410 EQUIZOLE A (thiabendazole and piperazine
phosphate).
042-633 TRESADERM (thiabendazole, dexamethasone,
neomycin sulfate solution) Dermatologic
Solution.
043-141 THIBENZOLE 300 (thiabendazole) Medicated.
044-654 EQUIZOLE (thiabendazole) Horse Wormer Pellets.
047-333 EQUIZOLE A (thiabendazole and piperazine
citrate) Liquid.
048-487 TBZ (thiabendazole) Wormer Paste 50%.
042-633 TRESADERM (thiabendazole, dexamethasone,
neomycin sulfate solution) Dermatologic
Solution.
043-141 THIBENZOLE 300 (thiabendazole) Medicated.
044-654 EQUIZOLE (thiabendazole) Horse Wormer Pellets.
047-333 EQUIZOLE A (thiabendazole and piperazine
citrate) Liquid.
048-487 TBZ (thiabendazole) Wormer Paste 50%.
049-461 TBZ (thiabendazole) Wormer Paste 43%.
065-275 Penicillin VK Filmtab (penicillin V potassium)
250 mg.
065-276 VEESYN (penicillin V potassium) Granules for
Oral Solution.
094-642 CAMVET (cambendazole) Suspension Horse Wormer.
[[Page 39181]]
096-506 CAMVET (cambendazole) Horse Wormer Pellets.
096-731 CAMVET (cambendazole) Horse Wormer Paste 45%.
098-379 CYSTORELIN.
098-689 EQUIZOLE (thiabendazole) 50% Wormer Paste;
EQUIZOLE 50% Wormer Paste for Horses.
127-443 EQVALAN (ivermectin) Injection.
128-409 IVOMEC (ivermectin) .27% Injection Grower and
Feeder Pigs; IVOMEC (ivermectin) 1%
Injection; IVOMEC (ivermectin) 1% Injection
for Cattle and Swine; IVOMEC (ivermectin)
Injection for Cattle.
131-392 IVOMEC (ivermectin) Liquid for Sheep.
134-314 EQVALAN (ivermectin).
134-930 SYNCRO-MATE-B (norgestomet and estradiol
valerate) Implant.
136-742 CURATREM (clorsulon) Drench for Cattle.
137-006 IVOMEC (ivermectin) Cattle Paste 0.153%.
138-412 HEARTGARD (ivermectin) Tablets.
140-439 EQVALAN (ivermectin) Oral Liquid for Horses.
140-818 PRODUCIL (efrotomycin) Type A Medicated
Article for Swine.
140-833 IVOMEC Plus (ivermectin and clorsulon)
Injection For Cattle.
140-841 IVOMEC (ivermectin) Pour-On.
140-883 LEGEND (hyaluronate sodium) Injectable
Solution.
140-886 HEARTGARD (ivermectin) Chewables for Dogs.
140-971 HEARTGARD Plus (ivermectin and pyrantel
pamoate).
140-974 IVOMEC (ivermectin) Premix for Swine.
140-988 IVOMEC (ivermectin) Sustained-Release Bolus
for Cattle.
141-015 ENACARD (enalapril maleate) Tablets for Dogs.
141-042 IMMITICIDE (melarsomine dihydrochloride)
Sterile Powder.
141-054 IVOMEC (ivermectin) plus LINCOMIX
(lincomycin).
141-078 HEARTGARD (ivermectin) for Cats.
141-079 EPRINEX (eprinomectin) Pour-On for Beef and
Dairy Cattle.
141-097 BMD (bacitracin methylendisalicylate)/IVOMEC
(ivermectin) Premix for Swine.
141-123 GASTROGARD (omeprazole).
141-188 MARQUIS (ponazuril) Antiprotozoal Oral Paste.
141-214 ZIMECTERIN Gold (ivermectin and praziquantel)
Paste.
141-227 ULCERGARD (omeprazole).
141-230 PREVICOX (firocoxib) Chewable Tablets.
141-253 EQUIOXX (firocoxib) Oral Paste.
141-313 EQUIOXX (firocoxib) Injection.
141-327 LONGRANGE (eprinomectin) Injection.
141-328 ZACTRAN (gamithromycin) Injectable Solution.
141-406 NEXGARD (afoxolaner) Chewable Tablet.
141-421 DUOCARE (ivermectin and praziquantel) Paste.
141-458 EQUIOXX (firocoxib) Tablets.
141-492 CENTRAGARD (eprinomectin and praziquantel)
Solution.
200-564 Ivermectin Paste 1.87%.
------------------------------------------------------------------------
Following this change of sponsorship, Merial, Inc., 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).
As provided in the regulatory text, the animal drug regulations are
amended to reflect these changes of sponsorship.
IV. Withdrawals of Approval
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd.,
Duluth, GA 30096, has requested that FDA withdraw approval of newly
transferred NADA 141-054 for use of LINCOMIX (lincomycin hydrochloride)
plus IVOMEC (ivermectin) Type A medicated articles to manufacture 2-
way, combination drug Type C medicated feed for swine because the
product is no longer manufactured or marketed.
Also, Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140,
has requested that FDA withdraw approval of NADA 141-337 for use of
RECOVYRA (fentanyl) Transdermal Solution for Dogs because the product
is no longer manufactured or marketed.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 141-054 and 141-337, and all supplements and
amendments thereto, is withdrawn effective August 19, 2019. As provided
in the regulatory text of this document, the animal drug regulations
are amended to reflect these actions.
V. Technical Amendments
FDA is removing ``IDEXX Pharmaceuticals, Inc.'' from the list of
sponsors of approved applications in Sec. 510.600(c). This action is
being taken to improve the accuracy of the regulations.
In addition, we are reformatting the regulations to present the
approved conditions of use of famphur, morantel, and thiabendazole in
tabular format in the respective named sections of subpart B of part
558. This action is being taken to improve the readability and
consistency of the regulations.
VI. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5
[[Page 39182]]
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, and 524
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, 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 an entry in alphabetical order for ``American Regent, Inc.'';
0
ii. Revise the entries for ``Aurora Pharmaceutical, LLC'', ``Boehringer
Ingelheim Vetmedica, Inc.'';
0
iii. Remove the entries for ``IDEXX Pharmaceuticals, Inc.'', ``Luitpold
Pharmaceuticals, Inc.'', and ``Merial, Inc.''; and
0
iv. Revise the entry for ``Pharmgate, LLC''; and
0
b. In the table in paragraph (c)(2):
0
i. Revise the entries for ``000010'' and ``010797'';
0
ii. Remove the entry for ``050604'';
0
iii. Revise the entry for ``051072'';
0
iv. Remove the entry for ``065274''; and
0
v. Revise the entry for ``069254''.
The additions and revisions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
American Regent, Inc., Animal Health Division, Shirley, 010797
NY 11967...............................................
* * * * * * *
Aurora Pharmaceutical, Inc., 1196 Highway 3 South, 051072
Northfield, MN 55057-3009..............................
* * * * * * *
Boehringer Ingelheim Animal Health USA, Inc., 3239 000010
Satellite Blvd., Duluth, GA 30096......................
* * * * * * *
Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 069254
28405..................................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
000010.................. Boehringer Ingelheim Animal Health USA, Inc.,
3239 Satellite Blvd., Duluth, GA 30096.
* * * * * * *
010797.................. American Regent, Inc., Animal Health Division,
Shirley, NY 11967.
* * * * * * *
051072.................. Aurora Pharmaceutical, Inc., 1196 Highway 3
South, Northfield, MN 55057-3009.
* * * * * * *
069254.................. Pharmgate, Inc., 1800 Sir Tyler Dr.,
Wilmington, NC 28405.
* * * * * * *
------------------------------------------------------------------------
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. 520.43 [Amended]
0
4. In Sec. 520.43, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.284a [Amended]
0
5. In Sec. 520.284a, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.284b [Amended]
0
6. In Sec. 520.284b, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.284c [Amended]
0
7. In Sec. 520.284c, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
[[Page 39183]]
0
8. Revise Sec. 520.420 to read as follows:
Sec. 520.420 Chlorothiazide.
(a) Specifications--(1) Each tablet contains 0.25 grams
chlorothiazide.
(2) Each bolus contains 2 grams chlorothiazide.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i)--Amount. Administer 5 to 10
milligrams per pound of body weight two or three times daily.
(ii) Indications for use. For treatment of congestive heart failure
and renal edema.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cows--(i)--Amount. Administer 2 grams once or twice daily for 3
or 4 days.
(ii) Indications for use. As an aid in reduction of postparturient
udder edema.
(iii) Limitations. Milk taken from dairy animals during treatment
and for 72 hours (six milkings) after latest treatment must not be used
for food. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
Sec. 520.462 [Amended]
0
9. In Sec. 520.462, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.538 [Amended]
0
10. In Sec. 520.538, in paragraph (b), remove ``No. 058198'' and in
its place add ``Nos. 013744 and 058198''.
Sec. 520.804 [Amended]
0
11. In Sec. 520.804, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.928 [Amended]
0
12. In Sec. 520.928, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.930 [Amended]
0
13. In Sec. 520.930, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.1192 [Amended]
0
14. In Sec. 520.1192, in paragraph (b)(1), remove ``050604'' and in
its place add ``000010''.
Sec. 520.1193 [Amended]
0
15. In Sec. 520.1193, in paragraph (b)(1), remove ``050604'' and in
its place add ``000010''.
Sec. 520.1195 [Amended]
0
16. In Sec. 520.1195, in paragraph (b)(1), remove ``000859, 050604,''
and in its place add ``000010, 000859,''; and in paragraph (b)(3),
remove ``050604'' and in its place add ``000010''.
Sec. 520.1196 [Amended]
0
17. In Sec. 520.1196, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.1197 [Amended]
0
18. In Sec. 520.1197, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.1198 [Amended]
0
19. In Sec. 520.1198, in paragraphs (b)(1) and (3), remove ``050604''
and in its place add ``000010''.
Sec. 520.1615 [Amended]
0
20. In Sec. 520.1615, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.1696c [Amended]
0
21. In Sec. 520.1696c, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.1696d [Amended]
0
22. In Sec. 520.1696d, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
0
23. In Sec. 520.1760, revise paragraphs (a) and (c)(1) to read as
follows:
Sec. 520.1760 Phenylpropanolamine.
(a) Specifications--(1) Each chewable tablet contains 25, 50, or 75
milligram (mg) phenylpropanolamine hydrochloride.
(2) Each extended-release tablet contains 18, 38, 74, or 145 mg
phenylpropanolamine hydrochloride.
* * * * *
(c) * * *
(1) Amount--Administer orally as follows:
(i) Chewable tablet: 2 mg/kg of body weight twice daily.
(ii) Extended-release tablet: 2 to 4 mg/kg of body weight once
daily with food.
* * * * *
Sec. 520.1855 [Amended]
0
24. In Sec. 520.1855, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.2170 [Amended]
0
25. In Sec. 520.2170, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.2380a [Amended]
0
26. In Sec. 520.2380a, in paragraph (b)(2), remove ``050604'' and in
its place add ``000010''.
Sec. 520.2380b [Amended]
0
27. In Sec. 520.2380b, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.2380c [Amended]
0
28. In Sec. 520.2380c, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 520.2380d [Amended]
0
29. In Sec. 520.2380d, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. Sec. 520.2380e and 520.2380f [Redesignated as Sec. Sec.
520.2380f and 520.2380e]
0
30. Redesignate Sec. Sec. 520.2380e and 520.2380f as Sec. Sec.
520.2380f and 520.2380e, respectively.
Sec. 520.2380e [Amended]
0
31. In newly redesignated Sec. 520.2380e, in paragraph (b), remove
``050604'' and in its place add ``000010''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
32. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.144 [Amended]
0
33. In Sec. 522.144, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
0
34. In Sec. 522.313b, revise paragraphs (a), (b), and (e)(2)(iii) to
read as follows:
Sec. 522.313b Ceftiofur hydrochloride.
(a) Specifications. Each milliliter of suspension contains:
(1) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of
ceftiofur equivalents in the inactive vehicles phospholipan 90H,
sorbitan monooleate, and cottonseed oil;
(2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur
equivalents in the inactive vehicle miglyol oil 812; or
(3) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur
equivalents in the inactive vehicles aluminum monostearate, sorbitan
monooleate, and medium chain triglycerides.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
(1) No. 054771 for products described in paragraphs (a)(1) and (2)
of this section; and
[[Page 39184]]
(2) No. 055529 for the product described in paragraph (a)(3) of
this section.
* * * * *
(e) * * *
(2) * * *
(iii) Limitations--(A) For products described in paragraphs (a)(2)
and (3) of this section: Treated cattle must not be slaughtered for 3
days following the last treatment. For products described in paragraph
(a)(2) of this section: Treated cattle must not be slaughtered for 4
days following the last treatment.
(B) A withdrawal period has not been established in preruminating
calves. Do not use in calves to be processed for veal.
Sec. 522.814 [Amended]
0
35. In Sec. 522.814, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 522.850 [Amended]
0
36. In Sec. 522.850, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 522.930 [Amended]
0
37. In Sec. 522.930, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 522.1014 [Amended]
0
38. In Sec. 522.1014, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 522.1077 [Amended]
0
39. In Sec. 522.1077, in paragraph (b)(4), remove ``050604'' and in
its place add ``000010''.
Sec. 522.1145 [Amended]
0
40. In Sec. 522.1145, in paragraph (e)(2)(i), remove ``050604'' and in
its place add ``000010''.
Sec. 522.1150 [Amended]
0
41. In Sec. 522.1150, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
0
42. In Sec. 522.1160, revise paragraphs (b)(1) and (2); redesignate
the text of paragraph (c)(1)(i) as paragraph (c)(1)(i)(A); add a
paragraph heading to newly redesignated paragraph (c)(1)(i)(A); and add
paragraph (c)(1)(i)(B).
The revision and addition read as follows:
Sec. 522.1160 Insulin.
* * * * *
(b) * * *
(1) No. 000061 for use of product described in paragraph (a)(1) as
in paragraphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(A),
(c)(2)(ii), and (c)(2)(iii) of this section.
(2) No. 000010 for use of product described in paragraph (a)(2) as
in paragraphs (c)(1)(i)(B), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(B),
(c)(2)(ii), and (c)(2)(iii) of this section.
(c) * * *
(1) * * *
(i) * * *
(A) Porcine zinc insulin zinc. * * *
(B) Protamine zinc recombinant human insulin. Administer a starting
dose of 0.2 to 0.5 IU/pound of body weight (0.5 to 1.0 IU/kg) once
daily. When transitioning from another insulin product, this form of
insulin should be started once daily, regardless of the frequency of
prior insulin use. The dose should be given concurrently with or right
after a meal. Reevaluate the dog at appropriate intervals and adjust
the dose based on both clinical signs and laboratory test results until
adequate glycemic control has been attained. Twice-daily therapy should
be initiated if the duration of insulin action is determined to be
inadequate. If twice-daily treatment is initiated, the two doses should
be 25 percent less than the once daily dose required to attain an
acceptable nadir.
* * * * *
Sec. 522.1192 [Amended]
0
43. In Sec. 522.1192, in paragraph (b)(1), remove ``050604'' and in
its place add ``000010''.
0
44. In Sec. 522.1193, revise paragraphs (b) and (e)(3) to read as
follows:
Sec. 522.1193 Ivermectin and clorsulon.
* * * * *
(b) Sponsors. See Nos. 000010, 055529, 058005, and 061133 in Sec.
510.600(c) of this chapter.
* * * * *
(e) * * *
(3) Limitations--(i) Nos. 000010 and 061133: Do not treat cattle
within 21 days of slaughter. Nos. 055529 and 058005: Do not treat
cattle within 49 days of slaughter.
(ii) 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.
Sec. 522.1362 [Amended]
0
45. In Sec. 522.1362, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 522.1452 [Amended]
0
46. In Sec. 522.1452, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 522.1885 [Amended]
0
47. In Sec. 522.1885, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
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.
Sec. 524.814 [Amended]
0
49. In Sec. 524.814, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 524.815 [Amended]
0
50. In Sec. 524.815, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 524.916 [Removed]
0
51. Effective August 19, 2019, remove Sec. 524.916.
Sec. 524.1193 [Amended]
0
52. In Sec. 524.1193, in paragraph (b)(1), remove ``050604'' and in
its place add ``000010''.
Sec. 524.1484g [Amended]
0
53. In Sec. 524.1484g, in paragraph (b), remove ``026637 and 050604''
and in its place add ``000010 and 026637''.
Sec. 524.1484j [Amended]
0
54. In Sec. 524.1484j, in paragraph (b), remove ``050604'' and in its
place add ``000010''.
Sec. 524.2101 [Amended]
0
55. In Sec. 524.2101, in paragraph (b), remove ``000061, 017135, and
050604'' and in its place add ``000010, 000061, and 017135''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
56. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.58 [Amended]
0
57. In Sec. 558.58, redesignate paragraphs (e)(3) through (6) as
paragraphs (e)(2) through (5), and redesignate paragraph (e)(9) as new
paragraph (e)(6).
[[Page 39185]]
Sec. 558.76 [Amended]
0
58. In Sec. 558.76, redesignate paragraphs (e)(1)(ix) through (xvi) as
paragraphs (e)(1)(vii) through (xiv).
0
59. In Sec. 558.128, revise paragraphs (b)(1) and (e)(4)(xv),
redesignate paragraphs (e)(4)(xvi) through (xxvi) as paragraphs
(e)(4)(xvii) through (xxvii), and add new paragraph (e)(4)(xvi).
The revisions and addition read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(b) * * *
(1) No. 054771: 50, 70, 80, 90, or 100 grams per pound (g/lb) Type
A medicated article.
* * * * *
(e) * * *
(4) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(xv) 350 mg/head/day.................. ........................ 1. Beef cattle: For control To sponsor No. 054771 under NADAs 046- *
of bacterial pneumonia 699 and 049-287, No. 066104 under NADA
associated with shipping 092-286, and No. 069254 under NADA 048-
fever complex caused by 480: Withdraw 48 hours prior to
Pasteurella spp. susceptible slaughter. To sponsor No. 069254 under
to chlortetracycline. NADA 138-935 and ANADA 200-510: Zero
withdrawal period.
2. Beef cattle (under 700 To sponsor No. 054771 under NADAs 046- *
lb): For control of active 699 and 049-287, No. 066104 under NADA
infection of anaplasmosis 092-286, and No. 069254 under NADA 048-
caused by A. marginale 480: Withdraw 48 h prior to slaughter.
susceptible to To sponsor No. 054771 under NADA 048-
chlortetracycline. 761 and No. 069254 under NADA 138-935
and ANADA 200-510: Zero withdrawal
time.
(xvi) 20 to 350 g/ton................. ........................ Beef cattle and replacement Feed to provide chlortetracycline at 054771
dairy heifers: For control the rate of 350 mg per head per day.
of bacterial pneumonia This drug is not approved for use in
associated with shipping female dairy cattle 20 months of age
fever complex caused by or older, including dry dairy cows.
Pasteurella spp. susceptible Use in these cattle may cause drug
to chlortetracycline. 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:
Zero withdrawal period.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.235 [Amended]
0
60. Effective September 9, 2019, in Sec. 558.235, in paragraph (b),
remove ``050604'' and in its place add ``000010''.
0
61. Revise Sec. 558.254 to read as follows:
Sec. 558.254 Famphur.
(a) Specifications. Type A medicated articles containing 13.2 or
33.3 percent famphur.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.273 of this chapter.
(d) Special considerations. Famphur is a cholinesterase inhibitor.
Do not use this product in animals simultaneously or within a few days
before or after treatment with or exposure to cholinesterase-inhibiting
drugs, pesticides, or chemicals.
(e) Conditions of use. It is used in cattle feed as follows:
----------------------------------------------------------------------------------------------------------------
Famphur in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1.1 milligrams per pound (mg/lb) Beef cattle and nonlactating Feed for 30 days. Withdraw 000061
body weight per day. dairy cows: For control of from dry dairy cows and
grubs and as an aid in heifers 21 days prior to
control of sucking lice. freshening. Withdraw 4 days
prior to slaughter.
(ii) 2.3 mg/lb body weight per day.. Beef cattle and nonlactating Feed for 10 days. Withdraw 000061
dairy cows: For control of from dry dairy cows and
grubs. heifers 21 days prior to
freshening. Withdraw 4 days
prior to slaughter.
----------------------------------------------------------------------------------------------------------------
Sec. 558.300 [Amended]
0
62. In Sec. 558.300, in paragraph (b), remove ``050604'' and in its
place add ``No. 000010''; in paragraphs (e)(1) through (6), in the
``Sponsor'' column, remove ``050604'' and in its place add ``000010'';
and remove paragraph (f).
Sec. 558.325 [Amended]
0
63. Effective August 19, 2019, in Sec. 558.325, remove paragraphs
(e)(2)(iii), (x), and (xvi); and redesignate paragraphs (e)(2)(iv)
through (ix) as paragraphs (e)(2)(iii) through (viii), paragraphs
(e)(2)(xi) through (xv) as paragraphs (e)(2)(ix) through (xiii), and
paragraph (e)(2)(xvii) as paragraph (e)(2)(xiv).
0
64. Revise Sec. 558.360 to read as follows:
Sec. 558.360 Morantel.
(a) Specifications. Each pound of Type A medicated article contains
88 grams morantel tartrate.
(b) Sponsor. See No. 066104 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.425 of this chapter.
(d) Special considerations--(1) Do not use in Type B or Type C
medicated feeds containing bentonite.
[[Page 39186]]
(2) Consult your veterinarian before using in severely debilitated
animals and for assistance in the diagnosis, treatment, and control of
parasitism.
(e) Conditions of use. It is used in feed as follows:
----------------------------------------------------------------------------------------------------------------
Morantel tartrate in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 0.44 to 4.4 grams of morantel Cattle: For removal and Feed as a single therapeutic 066104
tartrate per pound of feed. control of mature treatment at 0.44 gram of
gastrointestinal nematode morantel tartrate per 100
infections of cattle pounds of body weight.
including stomach worms Fresh water should be
(Haemonchus spp., available at all times.
Ostertagia spp., When medicated feed is
Trichostrongylus spp.), consumed, resume normal
worms of the small feeding. Conditions of
intestine (Cooperia spp., constant worm exposure may
Trichostrongylus spp., require retreatment in 2 to
Nematodirus spp.), and 4 weeks. Do not treat
worms of the large cattle within 14 days of
intestine (Oesophagostomum slaughter.
radiatum).
(2) 0.44 to 4.4 grams of morantel Goats: For removal and Feed as a single therapeutic 066104
tartrate per pound of feed. control of mature treatment at 0.44 gram of
gastrointestinal nematode morantel tartrate per 100
infections of goats pounds of body weight.
including Haemonchus Fresh water should be
contortus, Ostertagia available at all times.
(Teladorsagia) When medicated feed is
circumcincta, and consumed, resume normal
Trichostrongylus axei. feeding. Conditions of
constant worm exposure may
require retreatment in 2 to
4 weeks. Do not treat goats
within 30 days of slaughter.
----------------------------------------------------------------------------------------------------------------
0
65. Revise Sec. 558.600 to read as follows:
Sec. 558.600 Thiabendazole.
(a) Specifications. Dry Type A medicated articles containing 22,
44.1, 66.1, or 88.2 percent thiabendazole. The 66.1 percent Type A
medicated article is solely for the manufacture of cane molasses liquid
Type B feed, which is mixed in dry feeds. The 88.2 percent Type A
medicated article is used solely for the manufacture of an aqueous
slurry for adding to a Type C dry cattle feed.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.730 of this chapter.
(d) Special considerations. Do not use in Type B or Type C
medicated feed containing bentonite.
(e) Conditions of use. It is used in feed for animals as follows:
(1) Swine--
----------------------------------------------------------------------------------------------------------------
Thiabendazole in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 45.4 to 908 (0.005 to 0.1 Swine: As an aid in the Administer continuously in 000010
percent). prevention of infections of feed containing 0.05 to 0.1
large roundworms (genus percent thiabendazole per
Ascaris). ton for 2 weeks followed by
feed containing 0.005 to
0.02 percent thiabendazole
per ton for 8 to 14 weeks.
Do not treat animals within
30 days of slaughter.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------
(2) Cattle--
----------------------------------------------------------------------------------------------------------------
Thiabendazole amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 3 grams per 100 lb. body weight. For control of infections of Use 3 grams per 100 lb. body 000010
gastrointestinal roundworms weight at a single dose;
(Trichostrongylus spp., may repeat once in 2 to 3
Haemonchus spp., Ostertagia weeks. Do not treat animals
spp., Nematodirus spp., within 3 days of slaughter.
Oesophagostomum radiatum). Milk taken from treated
animals within 96 hours (8
milkings) after the latest
treatment must not be used
for food.
(ii) 5 grams per 100 lb. body weight For control of severe Use 5 grams per 100 lb. body 000010
infections of weight at a single dose or
gastrointestinal roundworms divided into 3 equal doses,
(Trichostrongylus spp., administered 1 dose each
Haemonchus spp., Ostertagia day, on succeeding days.
spp., Nematodirus spp., May repeat once in 2 to 3
Oesophagostomum radiatum); weeks. Do not treat animals
control of infections of within 3 days of slaughter.
Cooperia spp. Milk taken from treated
animals within 96 hours (8
milkings) after the latest
treatment must not be used
for food.
----------------------------------------------------------------------------------------------------------------
(3) Minor species--
[[Page 39187]]
----------------------------------------------------------------------------------------------------------------
Thiabendazole amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2 grams per 100 lb. body weight. Sheep and goats: For control Use 2 grams per 100 lb. body 050604
of infections of weight at a single dose. Do
gastrointestinal roundworms not treat animals within 30
(Trichostrongylus spp., days of slaughter. Milk
Haemonchus spp., Ostertagia taken from treated animals
spp., Cooperia spp.; within 96 hours (8
Nematodirus spp., milkings) after the latest
Bunostomum spp., treatment must not be used
Strongyloides spp., for food.
Chabertia spp., and
Oesophagostomum spp.); also
active against ova and
larvae passed by sheep from
3 hours to 3 days after the
feed is consumed (good
activity against ova and
larvae of T. colubriformis
and axei, Ostertagia spp.,
Nematodirus spp.,
Strongyloides spp.; less
effective against those of
Haemonchus contortus and
Oesophagostomum spp.).
(ii) 3 grams per 100 lb. body weight Goats: For control of severe Use 3 grams per 100 lb. body 050604
infections of weight at a single dose. Do
gastrointestinal roundworms not treat animals within 30
(Trichostrongylus spp., days of slaughter. Milk
Haemonchus spp., Ostertagia taken from treated animals
spp., Cooperia spp., within 96 hours (8
Nematodirus spp., milkings) after the latest
Bunostomum spp., treatment must not be used
Strongyloides spp., for food.
Chabertia spp., and
Oesophagostomum spp.).
(iii) 454 grams per ton of feed..... Pheasants: For the treatment Feed continuously for 2 050604
of gapeworms (Syngamus weeks (14 days). Do not use
trachea). treated pheasants for food
for 21 days after last day
of treatment. Fertility,
hatchability, and other
reproductive data are not
available on use in
breeding animals.
----------------------------------------------------------------------------------------------------------------
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16884 Filed 8-8-19; 8:45 am]
BILLING CODE 4164-01-P