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, 39179-39187 [2019-16884]
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39179
Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Rules and Regulations
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.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during January,
February, and March 2019. FDA is
SUMMARY:
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,
george.haibel@fda.hhs.gov.
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/ApprovedAnimal
DrugProducts/default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2019
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Approval date
File No.
January 27, 2019 ........................
009–476
January 28, 2019 ........................
200–616
January 31, 2019 ........................
200–450
February 4, 2019 ........................
200–637
February 8, 2019 ........................
141–297
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Sponsor
Product name
Species
Effect of the action
Phibro Animal
Health Corp.,
GlenPointe
Centre East,
3d Floor, 300
Frank W. Burr
Blvd., Suite
21, Teaneck,
NJ 07666.
Norbrook Laboratories, Ltd.,
Station Works,
Newry BT35
6JP, Northern
Ireland.
Bimeda Animal
Health Ltd.,
1B The Herbert Building,
The Park,
Carrickmines,
Dublin, 18,
Ireland.
Provetica AH
LLC, 455 Sovereign Ct.,
Baldwin, MO
63011.
Boehringer
Ingelheim
Vetmedica,
Inc., 2621
North Belt
Highway, St.
Joseph, MO
64506–2002.
NICARB 25%
(nicarbazin)
Type A medicated article.
Chickens ...............
Supplemental approval of revised
assay limits for nicarbazin
(powder) Type A medicated article.
N/A.
CEFENIL RTU
(ceftiofur hydrochloride
sterile suspension).
Swine and cattle ...
Original approval as a generic
copy of NADA 140–890.
FOI Summary.
BIMECTIN
PLUS
(ivermectin/
clorsulon) Injection for Cattle.
Cattle ....................
Original approval as a generic
copy of NADA 140–833.
FOI Summary.
DOXIDYL
(deracoxib)
Chewable
Tablet.
Dogs .....................
Original approval as a generic
copy of NADA 141–203.
FOI Summary.
PROZINC (protamine zinc recombinant
human insulin)
Injectable
Suspension.
Dogs .....................
Supplemental approval for the reduction of hyperglycemia and
hyperglycemia-associated clinical signs in dogs with diabetes
mellitus.
FOI Summary.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2019—Continued
Approval date
File No.
Sponsor
Product name
Effect of the action
Supplemental approval adding replacement dairy heifers to the
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.
Original approval for the control
of urinary incontinence due to
urethral sphincter hypotonus.
March 29, 2019 ..........................
048–761
Zoetis Inc., 333
Portage St.,
Kalamazoo,
MI 49007.
AUREOMYCIN
(chlortetracycline) Type
C medicated
feeds.
Cattle ....................
March 29, 2019 ..........................
141–517
Pegasus Laboratories, Inc.,
8809 Ely Rd.,
Pensacola, FL
32514.
PROIN ER
(phenylpropanolamine
hydrochloride
extended-release tablets)
Tablets.
Dogs .....................
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
§ 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
File No.
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Species
006–623
008–422
010–424
011–080
011–437
011–532
011–678
012–734
013–022
013–407
013–674
013–954
014–350
015–123
015–875
030–103
034–114
035–631
037–410
042–633
043–141
044–654
047–333
048–487
042–633
043–141
044–654
047–333
048–487
049–461
065–275
065–276
094–642
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CAPARSOLATE (arsenamide sodium) Injection.
SELEEN (selenium disulfide) Suspension.
NALLINE (nalorphine hydrochloride) Injection.
HYDELTRONE-TBA (prednisolone and tertiary butylacetate) Suspension.
HYDELTRONE (prednisolone sodium phosphate and neomycin sulfate) Ointment.
SULFABROM (sulfabromomethazine sodium) Bolus.
DIURIL (chlorothiazide) Tablets.
DIURIL (chlorothiazide) Bolus.
THIBENZOLE (thiabendazole) Sheep & Goat Wormer.
EQUIZOLE (thiabendazole) Horse Wormer.
HYDROZIDE (hydrochlorothiazide) Injection.
THIBENZOLE (thiabendazole) 20% Swine Premix.
OMNIZOLE (thiabendazole).
TBZ® (thiabendazole) Cattle Wormer (Drench).
TBZ 200 (thiabendazole) Medicated Premix.
THIBENZOLE (thiabendazole) Suspension.
EQUIZOLE (thiabendazole).
THIBENZOLE (thiabendazole) Pig Wormer.
EQUIZOLE A (thiabendazole and piperazine phosphate).
TRESADERM (thiabendazole, dexamethasone, neomycin sulfate solution) Dermatologic Solution.
THIBENZOLE 300 (thiabendazole) Medicated.
EQUIZOLE (thiabendazole) Horse Wormer Pellets.
EQUIZOLE A (thiabendazole and piperazine citrate) Liquid.
TBZ (thiabendazole) Wormer Paste 50%.
TRESADERM (thiabendazole, dexamethasone, neomycin sulfate solution) Dermatologic Solution.
THIBENZOLE 300 (thiabendazole) Medicated.
EQUIZOLE (thiabendazole) Horse Wormer Pellets.
EQUIZOLE A (thiabendazole and piperazine citrate) Liquid.
TBZ (thiabendazole) Wormer Paste 50%.
TBZ (thiabendazole) Wormer Paste 43%.
Penicillin VK Filmtab (penicillin V potassium) 250 mg.
VEESYN (penicillin V potassium) Granules for Oral Solution.
CAMVET (cambendazole) Suspension Horse Wormer.
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N/A.
FOI Summary.
to Ceva Sante Animale, 10 Avenue de la
Ballastie`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 § 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:
Proprietary name
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File No.
096–506
096–731
098–379
098–689
127–443
128–409
131–392
134–314
134–930
136–742
137–006
138–412
140–439
140–818
140–833
140–841
140–883
140–886
140–971
140–974
140–988
141–015
141–042
141–054
141–078
141–079
141–097
141–123
141–188
141–214
141–227
141–230
141–253
141–313
141–327
141–328
141–406
141–421
141–458
141–492
200–564
Proprietary name
CAMVET (cambendazole) Horse Wormer Pellets.
CAMVET (cambendazole) Horse Wormer Paste 45%.
CYSTORELIN.
EQUIZOLE (thiabendazole) 50% Wormer Paste; EQUIZOLE 50% Wormer Paste for Horses.
EQVALAN (ivermectin) Injection.
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.
IVOMEC (ivermectin) Liquid for Sheep.
EQVALAN (ivermectin).
SYNCRO-MATE-B (norgestomet and estradiol valerate) Implant.
CURATREM (clorsulon) Drench for Cattle.
IVOMEC (ivermectin) Cattle Paste 0.153%.
HEARTGARD (ivermectin) Tablets.
EQVALAN (ivermectin) Oral Liquid for Horses.
PRODUCIL (efrotomycin) Type A Medicated Article for Swine.
IVOMEC Plus (ivermectin and clorsulon) Injection For Cattle.
IVOMEC (ivermectin) Pour-On.
LEGEND (hyaluronate sodium) Injectable Solution.
HEARTGARD (ivermectin) Chewables for Dogs.
HEARTGARD Plus (ivermectin and pyrantel pamoate).
IVOMEC (ivermectin) Premix for Swine.
IVOMEC (ivermectin) Sustained-Release Bolus for Cattle.
ENACARD (enalapril maleate) Tablets for Dogs.
IMMITICIDE (melarsomine dihydrochloride) Sterile Powder.
IVOMEC (ivermectin) plus LINCOMIX (lincomycin).
HEARTGARD (ivermectin) for Cats.
EPRINEX (eprinomectin) Pour-On for Beef and Dairy Cattle.
BMD (bacitracin methylendisalicylate)/IVOMEC (ivermectin) Premix for Swine.
GASTROGARD (omeprazole).
MARQUIS (ponazuril) Antiprotozoal Oral Paste.
ZIMECTERIN Gold (ivermectin and praziquantel) Paste.
ULCERGARD (omeprazole).
PREVICOX (firocoxib) Chewable Tablets.
EQUIOXX (firocoxib) Oral Paste.
EQUIOXX (firocoxib) Injection.
LONGRANGE (eprinomectin) Injection.
ZACTRAN (gamithromycin) Injectable Solution.
NEXGARD (afoxolaner) Chewable Tablet.
DUOCARE (ivermectin and praziquantel) Paste.
EQUIOXX (firocoxib) Tablets.
CENTRAGARD (eprinomectin and praziquantel) Solution.
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
§ 510.600(c). As provided in the
regulatory text, the animal drug
regulations are amended to reflect these
changes of sponsorship.
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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
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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
§ 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
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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
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Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Rules and Regulations
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.’’
21 CFR Part 558
List of Subjects
■
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
1. The authority citation for part 510
continues to read as follows:
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
iii. Remove the entries for ‘‘IDEXX
Pharmaceuticals, Inc.’’, ‘‘Luitpold
Pharmaceuticals, Inc.’’, and ‘‘Merial,
Inc.’’; and
■ iv. Revise the entry for ‘‘Pharmgate,
LLC’’; and
■ b. In the table in paragraph (c)(2):
■ i. Revise the entries for ‘‘000010’’ and
‘‘010797’’;
■ ii. Remove the entry for ‘‘050604’’;
■ iii. Revise the entry for ‘‘051072’’;
■ iv. Remove the entry for ‘‘065274’’;
and
■ v. Revise the entry for ‘‘069254’’.
The additions and revisions read as
follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600:
a. In the table in paragraph (c)(1):
i. Add an entry in alphabetical order
for ‘‘American Regent, Inc.’’;
■ ii. Revise the entries for ‘‘Aurora
Pharmaceutical, LLC’’, ‘‘Boehringer
Ingelheim Vetmedica, Inc.’’;
■
■
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
American Regent, Inc., Animal Health Division, Shirley, NY 11967 ...................................................................................................
*
*
*
*
*
*
*
Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057–3009 ...........................................................................
*
*
*
*
*
*
*
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 ..................................................................
*
*
*
*
*
*
*
Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405 ..............................................................................................................
*
*
*
*
*
*
010797
051072
000010
069254
*
*
*
*
(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.
*
*
*
*
*
*
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*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
*
§ 520.43
§ 520.284b
[Amended]
4. In § 520.43, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
§ 520.284a
§ 520.284c
■
[Amended]
5. In § 520.284a, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
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[Amended]
6. In § 520.284b, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
■
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*
[Amended]
7. In § 520.284c, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
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■
8. Revise § 520.420 to read as follows:
§ 520.420
[Amended]
10. In § 520.538, in paragraph (b),
remove ‘‘No. 058198’’ and in its place
add ‘‘Nos. 013744 and 058198’’.
■
§ 520.1196
[Amended]
17. In § 520.1196, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
[Amended]
18. In § 520.1197, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 520.1198
[Amended]
12. In § 520.928, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 520.930
[Amended]
■
[Amended]
[Amended]
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[Amended]
29. In § 520.2380d, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
30. Redesignate §§ 520.2380e and
520.2380f as §§ 520.2380f and
520.2380e, respectively.
§ 520.1696c
■
[Amended]
21. In § 520.1696c, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
[Amended]
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
■
§ 520.1760
§ 522.144
Phenylpropanolamine.
[Amended]
24. In § 520.1855, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
[Amended]
25. In § 520.2170, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
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[Amended]
31. In newly redesignated
§ 520.2380e, in paragraph (b), remove
‘‘050604’’ and in its place add
‘‘000010’’.
22. In § 520.1696d, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■ 23. In § 520.1760, revise paragraphs
(a) and (c)(1) to read as follows:
§ 520.2170
[Amended]
§ 520.2380d
§ 520.2380e
§ 520.1193
15. In § 520.1193, in paragraph (b)(1),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
28. In § 520.2380c, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
20. In § 520.1615, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
■
■
[Amended]
■
14. In § 520.1192, in paragraph (b)(1),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 520.2380c
§ 520.1615
§ 520.1855
[Amended]
[Amended]
27. In § 520.2380b, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
§§ 520.2380e and 520.2380f [Redesignated
as §§ 520.2380f and 520.2380e]
§ 520.1192
§ 520.928
§ 520.2380b
19. In § 520.1198, in paragraphs (b)(1)
and (3), remove ‘‘050604’’ and in its
place add ‘‘000010’’.
■
13. In § 520.930, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
[Amended]
11. In § 520.804, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
26. In § 520.2380a, in paragraph (b)(2),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
■
§ 520.1197
(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.
*
*
*
*
*
§ 520.804
[Amended]
■
■
9. In § 520.462, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
khammond on DSKBBV9HB2PROD with RULES
§ 520.2380a
16. In § 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’’.
§ 520.1696d
[Amended]
■
§ 520.538
[Amended]
■
Chlorothiazide.
(a) Specifications—(1) Each tablet
contains 0.25 grams chlorothiazide.
(2) Each bolus contains 2 grams
chlorothiazide.
(b) Sponsor. See No. 000010 in
§ 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.
§ 520.462
§ 520.1195
39183
32. The authority citation for part 522
continues to read as follows:
Authority: 21 U.S.C. 360b.
[Amended]
33. In § 522.144, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■ 34. In § 522.313b, revise paragraphs
(a), (b), and (e)(2)(iii) to read as follows:
■
§ 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
§ 510.600(c) of this chapter as follows:
(1) No. 054771 for products described
in paragraphs (a)(1) and (2) of this
section; and
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(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.
§ 522.814
[Amended]
35. In § 522.814, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 522.850
[Amended]
36. In § 522.850, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 522.930
[Amended]
37. In § 522.930, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 522.1014
[Amended]
38. In § 522.1014, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 522.1077
§ 522.1192
[Amended]
39. In § 522.1077, in paragraph (b)(4),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
[Amended]
41. In § 522.1150, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■ 42. In § 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:
khammond on DSKBBV9HB2PROD with RULES
■
Insulin.
*
*
*
*
*
(b) * * *
(1) No. 000061 for use of product
described in paragraph (a)(1) as in
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Ivermectin and clorsulon.
*
40. In § 522.1145, in paragraph
(e)(2)(i), remove ‘‘050604’’ and in its
place add ‘‘000010’’.
§ 522.1160
43. In § 522.1192, in paragraph (b)(1),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■ 44. In § 522.1193, revise paragraphs
(b) and (e)(3) to read as follows:
§ 522.1193
[Amended]
■
§ 522.1150
[Amended]
■
■
§ 522.1145
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 twicedaily treatment is initiated, the two
doses should be 25 percent less than the
once daily dose required to attain an
acceptable nadir.
*
*
*
*
*
*
*
*
*
(b) Sponsors. See Nos. 000010,
055529, 058005, and 061133 in
§ 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.
§ 522.1362
45. In § 522.1362, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
Frm 00010
Fmt 4700
[Amended]
46. In § 522.1452, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 522.1885
[Amended]
47. In § 522.1885, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
48. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.814
[Amended]
49. In § 524.814, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 524.815
[Amended]
50. In § 524.815, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 524.916
[Removed]
51. Effective August 19, 2019, remove
§ 524.916.
■
§ 524.1193
[Amended]
52. In § 524.1193, in paragraph (b)(1),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 524.1484g
[Amended]
53. In § 524.1484g, in paragraph (b),
remove ‘‘026637 and 050604’’ and in its
place add ‘‘000010 and 026637’’.
■
§ 524.1484j
[Amended]
54. In § 524.1484j, in paragraph (b),
remove ‘‘050604’’ and in its place add
‘‘000010’’.
■
§ 524.2101
[Amended]
55. In § 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
56. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
§ 558.58
[Amended]
57. In § 558.58, redesignate
paragraphs (e)(3) through (6) as
paragraphs (e)(2) through (5), and
redesignate paragraph (e)(9) as new
paragraph (e)(6).
■
[Amended]
■
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§ 558.76
[Amended]
58. In § 558.76, redesignate
paragraphs (e)(1)(ix) through (xvi) as
paragraphs (e)(1)(vii) through (xiv).
■ 59. In § 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:
§ 558.128
*
Chlortetracycline.
*
*
*
*
Chlortetracycline
amount
Combination in
grams/ton
Indications for use
Limitations
*
(xv) 350 mg/
head/day.
*
...........................
*
*
1. Beef cattle: For control of bacterial pneumonia associated
with shipping fever complex
caused by Pasteurella spp. susceptible to chlortetracycline.
*
*
To sponsor No. 054771 under NADAs 046–699
and 049–287, No. 066104 under NADA 092–286,
and No. 069254 under NADA 048–480: Withdraw
48 hours prior to slaughter. To sponsor No.
069254 under NADA 138–935 and ANADA 200–
510: Zero withdrawal period.
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 h prior to slaughter. To sponsor No. 054771
under NADA 048–761 and No. 069254 under
NADA 138–935 and ANADA 200–510: Zero withdrawal time.
Feed to provide chlortetracycline at the rate of 350
mg per head per day. This drug is not approved
for use in female dairy cattle 20 months of age or
older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. A withdrawal period
has not been established for this product in preruminating calves. Do not use in calves to be
processed for veal. To sponsor No. 054771
under NADA 048–761: Zero withdrawal period.
2. Beef cattle (under 700 lb): For
control of active infection of
anaplasmosis caused by A.
marginale susceptible to chlortetracycline.
(xvi) 20 to 350 g/
ton.
...........................
*
*
*
§ 558.235
Beef cattle and replacement dairy
heifers: For control of bacterial
pneumonia
associated
with
shipping fever complex caused
by Pasteurella spp. susceptible
to chlortetracycline.
*
*
*
*
[Amended]
Famphur in grams/ton
§ 558.300
Famphur.
Indications for use
62. In § 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).
§ 558.325
■
[Amended]
63. Effective August 19, 2019, in
§ 558.325, remove paragraphs (e)(2)(iii),
■
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64. Revise § 558.360 to read as
follows:
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*
*
*
054771
*
(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:
Sponsor
Feed for 30 days. Withdraw from dry dairy
and heifers 21 days prior to freshening.
draw 4 days prior to slaughter.
Feed for 10 days. Withdraw from dry dairy
and heifers 21 days prior to freshening.
draw 4 days prior to slaughter.
(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).
■
*
Limitations
Beef cattle and nonlactating dairy cows: For control of grubs and as an aid in control of sucking lice.
Beef cattle and nonlactating dairy cows: For control of grubs.
[Amended]
Sponsor
*
(a) Specifications. Type A medicated
articles containing 13.2 or 33.3 percent
famphur.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.273
of this chapter.
60. Effective September 9, 2019, in
§ 558.235, in paragraph (b), remove
‘‘050604’’ and in its place add
‘‘000010’’.
■ 61. Revise § 558.254 to read as
follows:
(i) 1.1 milligrams per
pound (mg/lb) body
weight per day.
(ii) 2.3 mg/lb body
weight per day.
*
§ 558.254
*
■
khammond on DSKBBV9HB2PROD with RULES
(b) * * *
(1) No. 054771: 50, 70, 80, 90, or 100
grams per pound (g/lb) Type A
medicated article.
*
*
*
*
*
(e) * * *
(4) * * *
§ 558.360
cows
With-
000061
cows
With-
000061
Morantel.
(a) Specifications. Each pound of
Type A medicated article contains 88
grams morantel tartrate.
(b) Sponsor. See No. 066104 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.425
of this chapter.
(d) Special considerations—(1) Do not
use in Type B or Type C medicated
feeds containing bentonite.
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(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
(1) 0.44 to 4.4 grams of
morantel tartrate per
pound of feed.
Cattle: For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms (Haemonchus spp.,
Ostertagia spp., Trichostrongylus spp.), worms
of the small intestine (Cooperia spp.,
Trichostrongylus spp., Nematodirus spp.), and
worms
of
the
large
intestine
(Oesophagostomum radiatum).
Goats: For removal and control of mature gastrointestinal nematode infections of goats including
Haemonchus
contortus,
Ostertagia
(Teladorsagia)
circumcincta,
and
Trichostrongylus axei.
Feed as a single therapeutic treatment at 0.44
gram of morantel tartrate per 100 pounds of
body weight. Fresh water should be available
at all times. When medicated feed is consumed, resume normal feeding. Conditions of
constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat cattle within
14 days of slaughter.
Feed as a single therapeutic treatment at 0.44
gram of morantel tartrate per 100 pounds of
body weight. Fresh water should be available
at all times. When medicated feed is consumed, resume normal feeding. Conditions of
constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat goats within
30 days of slaughter.
(2) 0.44 to 4.4 grams of
morantel tartrate per
pound of feed.
65. Revise § 558.600 to read as
follows:
■
§ 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
Thiabendazole in grams/
ton
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
§ 510.600(c) of this chapter.
066104
066104
(c) Related tolerances. See § 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—
Indications for use
Limitations
Swine: As an aid in the prevention of infections
of large roundworms (genus Ascaris).
Administer continuously in feed containing 0.05
to 0.1 percent thiabendazole per 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.
Indications for use
Limitations
(i) 3 grams per 100 lb.
body weight.
For control of infections of gastrointestinal
roundworms
(Trichostrongylus
spp.,
Haemonchus
spp.,
Ostertagia
spp.,
Nematodirus
spp.,
Oesophagostomum
radiatum).
(ii) 5 grams per 100 lb.
body weight.
For control of severe infections of gastrointestinal roundworms (Trichostrongylus spp.,
Haemonchus
spp.,
Ostertagia
spp.,
Nematodirus
spp.,
Oesophagostomum
radiatum); control of infections of Cooperia
spp.
Use 3 grams per 100 lb. body weight at a single
dose; may repeat once in 2 to 3 weeks. Do
not treat animals within 3 days of slaughter.
Milk taken from treated animals within 96
hours (8 milkings) after the latest treatment
must not be used for food.
Use 5 grams per 100 lb. body weight at a single
dose or divided into 3 equal doses, administered 1 dose each day, on succeeding days.
May repeat once in 2 to 3 weeks. Do not treat
animals within 3 days of slaughter. Milk taken
from treated animals within 96 hours (8
milkings) after the latest treatment must not
be used for food.
(i) 45.4 to 908 (0.005 to
0.1 percent).
Sponsor
Sponsor
000010
(ii) [Reserved]
(2) Cattle—
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Thiabendazole amount
(3) Minor species—
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000010
000010
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Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Rules and Regulations
Thiabendazole amount
(i) 2 grams per 100 lb.
body weight.
(ii) 3 grams per 100 lb.
body weight.
(iii) 454 grams per ton of
feed.
Indications for use
Limitations
Sheep and goats: For control of infections of
gastrointestinal roundworms (Trichostrongylus
spp., Haemonchus spp., Ostertagia spp.,
Cooperia
spp.;
Nematodirus
spp.,
Bunostomum
spp.,
Strongyloides
spp.,
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.).
Goats: For control of severe infections of gastrointestinal roundworms (Trichostrongylus spp.,
Haemonchus spp., Ostertagia spp., Cooperia
spp., Nematodirus spp., Bunostomum spp.,
Strongyloides spp., Chabertia spp., and
Oesophagostomum spp.).
Pheasants: For the treatment of gapeworms
(Syngamus trachea).
Use 2 grams per 100 lb. body weight at a single
dose. Do not treat animals within 30 days of
slaughter. Milk taken from treated animals
within 96 hours (8 milkings) after the latest
treatment must not be used for food.
050604
Use 3 grams per 100 lb. body weight at a single
dose. Do not treat animals within 30 days of
slaughter. Milk taken from treated animals
within 96 hours (8 milkings) after the latest
treatment must not be used for food.
050604
Feed continuously for 2 weeks (14 days). Do
not use 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.
050604
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 524 and 558
[Docket No. FDA–2019–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of two new animal drug
applications (NADAs) at the sponsors’
request because these products are no
longer manufactured or marketed.
DATES: Withdrawal of approval is
effective August 19, 2019.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Boehringer Ingelheim Animal Health
USA Inc., 3239 Satellite Blvd., Duluth,
GA 30096, has requested that FDA
withdraw approval of NADA 141–054
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SUMMARY:
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Jkt 247001
for use of LINCOMIX (lincomycin
hydrochloride) and IVOMEC
(ivermectin) Type A medicated articles
in the manufacture of 2-way,
combination drug Type C medicated
swine feeds 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.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and in accordance with § 514.116 Notice
of withdrawal of approval of application
(21 CFR 514.116), notice is given that
approval of NADAs 141–054 and NADA
141–337, and all supplements and
amendments thereto, is hereby
withdrawn, effective August 19, 2019.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16885 Filed 8–8–19; 8:45 am]
BILLING CODE 4164–01–P
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Sponsor
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2019–0673]
Special Local Regulations; Annual Les
Cheneaux Islands Antique Wooden
Boat Show; Hessel, MI.
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
a special local regulation for the Annual
Les Cheneaux Islands Antique Wooden
Boat Show on August 10, 2019, from 7
a.m. to 6:30 p.m. to provide for the
safety of life on navigable waterways
during this event. During the
enforcement period, all vessels will
operate at a no wake speed and follow
the directions of the on-scene Patrol
Commander.
SUMMARY:
The regulations in 33 CFR
100.922 will be enforced on August 10,
2019, from 7 a.m. to 6:30 p.m.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice of
enforcement, call or email LT Sean
Murphy, Coast Guard Sector Sault
Sainte Marie Waterways Management,
U.S. Coast Guard; telephone 906–635–
3223, email Sean.V.Murphy@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the special local
regulation in 33 CFR 100.922 for the
Annual Les Cheneaux Islands Antique
Wooden Boat Show on August 10, 2019
DATES:
E:\FR\FM\09AUR1.SGM
09AUR1
]]>Agencies
[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]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
