New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor, 13226-13232 [2015-05644]
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[FR Doc. 2015–05590 Filed 3–12–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556,
and 558
[Docket No. FDA–2014–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor
AGENCY:
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during November and
December 2014. FDA is also informing
the public of the availability of
summaries of the basis of approval and
of environmental review documents,
where applicable. The animal drug
regulations are also being amended to
reflect a change of sponsorship of eight
NADAs and nine ANADAs, and to make
SUMMARY:
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065–480
138–934
138–935
138–938
138–939
140–680
140–681
141–137
200–026
200–154
200–295
200–314
200–354
200–356
........
........
........
........
........
........
........
........
........
........
........
........
........
........
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Food and Drug Administration,
HHS.
This rule is effective March 13,
2015.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
george.haibel@fda.hhs.gov.
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during November and
December 2014, 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 Division of Dockets
Management (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.
In addition, Pennfield Oil Co., 14040
Industrial Rd., Omaha, NE 68144, has
transferred ownership of, and all rights
and interest in, the following approved
applications to Pharmgate LLC, 161
North Franklin Turnpike, Suite 2C,
Ramsey, NJ 07446:
SUPPLEMENTARY INFORMATION:
Product name
21 CFR Cite
Chlortetracycline Soluble Powder ..................................................................................................
PENNCHLOR SP (chlortetracycline, sulfamethazine, penicillin) Type A medicated articles .......
PENNCHLOR (chlortetracycline) Type A medicated articles ........................................................
PENNOX (oxytetracycline) Type A medicated articles .................................................................
NEO–OXY (neomycin sulfate and oxytetracycline) Type A medicated articles ...........................
TYLAN (tylosin phosphate) Type A medicated articles ................................................................
TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) Type A medicated articles ..................
PENITRACIN (bacitracin methylenedisalicylate) 50 Type A medicated article ............................
PENNOX 343 (oxytetracycline) .....................................................................................................
PENNOX 200 (oxytetracycline) .....................................................................................................
PENNCHLOR 64 (chlortetracycline) ..............................................................................................
PENNCHLOR S (chlortetracycline) ...............................................................................................
PENNCHLOR (chlortetracycline)/COBAN (monensin) ..................................................................
PENNCHLOR (chlortetracycline)/DENAGARD (tiamulin) .............................................................
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520.441.
558.145.
558.128.
558.450.
558.455.
558.625.
558.630.
Not codified.
520.1660d.
558.450.
558.128.
558.140.
558.355.
558.600.
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File No.
Product name
200–357 ........
200–358 ........
200–359 ........
PENNCHLOR (chlortetracycline)/BIO–COX (salinomycin) ...........................................................
PENNCHLOR (chlortetracycline)/BMD (bacitracin MD) ................................................................
PENNCHLOR (chlortetracycline)/DECCOX (decoquinate) ...........................................................
At this time, the regulations are being
amended to reflect these changes of
sponsorship. Following these changes of
sponsorship, Pharmgate LLC will now
be the sponsor of an approved
application while Pennfield Oil Co. will
no longer be the sponsor of an approved
application. Also, Hikma
Pharmaceuticals LLC, P.O. Box 182400,
Bayader Wadi Seer, Amman, Jordan
21 CFR Cite
11118, has informed FDA that it has
changed its name to Hikma
International Pharmaceuticals LLC.
Accordingly, § 510.600 (21 CFR
510.600) is being amended to reflect
these changes. In addition, FDA is
amending § 510.600 and several sections
of part 520 to reflect a correct drug
labeler code for Akorn Animal Health,
Inc. FDA is also amending the
558.550.
558.76.
558.195.
regulations in 21 CFR parts 520, 522,
556, and 558 to redesignate several
sections to reflect alphabetical order and
to make minor technical amendments.
These corrections and technical
amendments are being made to improve
the accuracy of the animal drug
regulations.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING NOVEMBER AND DECEMBER 2014
NADA/
ANADA
Sponsor
200–575 ....
Putney, Inc., One
Monument Sq., suite
400, Portland, ME
04101.
Zoetis Inc., 333 Portage St., Kalamazoo,
MI 49007.
141–232 ....
200–512 ....
200–573 ....
141–068 ....
141–349 ....
141–437 ....
034–267 ....
141–034 ....
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200–510 5 ..
141–258 ....
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New animal drug
product name
Zoetis Inc., 333 Portage St., Kalamazoo,
MI 49007.
Putney, Inc., One
Monument Sq., suite
400, Portland, ME
04101.
Bayer HealthCare LLC,
Animal Health Division, P.O. Box 390,
Shawnee Mission,
KS 66201.
Zoetis Inc., 333 Portage St., Kalamazoo,
MI 49007.
Novartis Animal Health
US, Inc., 3200
Northline Ave., suite
300, Greensboro,
NC 27408.
Intervet, Inc., 556 Morris Ave., Summit, NJ
07901.
Huvepharma AD, 5th
Floor, 3A Nikolay
Haytov Str., 1113
Sophia, Bulgaria.
Pharmgate LLC, 161
North Franklin Turnpike, suite 2C,
Ramsey, NJ 07446.
Intervet, Inc., 556 Morris Ave., Summit, NJ
07901.
16:34 Mar 12, 2015
Action
21 CFR
Sections
FOIA
Summary
NEPA
Review
Carprofen Chewable
Tablets.
Original approval as a generic
copy of NADA 141–111.
520.309
yes
CE 1 2
SIMPLICEF
(cefpodoxime
proxetil) Chewable
Tablets.
TRIAMULOX (tiamulin
hydrogen fumarate)
Liquid Concentrate.
Dexmedetomidine HCl
(dexmedetomidine hydrochloride).
Injectable Solution ......
BAYTRIL 100
(enrofloxacin).
Injectable Solution ......
Supplemental
approval
of
chewable tablet dosage form for
dogs.
520.370
yes
CE 1 3
Original approval as a generic
copy of NADA 140–916.
520.2455
yes
CE 1 2
Original approval as a generic
copy of NADA 141–267.
522.558
yes
CE 1 2
Supplemental approval adding administration by intramuscular injection in swine and an indication for control of colibacillosis in
groups or pens of weaned pigs.
Supplemental approval for treatment of bovine respiratory disease (BRD) in suckling calves,
dairy calves, and veal calves.
Original approval for the treatment
of otitis externa in dogs.
522.812
yes
CE1 4
522.2630
yes
CE 1 4
524.955
yes
CE 1 3
Supplemental approval of additional safety information.
524.1044i
yes
CE 1 3
Supplemental approval of a freechoice Type C medicated loose
mineral feed without selenium
for pasture cattle.
Original approval as a generic
copy of NADA 048–761.
558.95
yes
CE 1 2
558.128
yes
CE 1 2
558.665
yes
CE 1 2
DRAXXIN 25 ...............
(tulathromycin) ............
Injectable Solution ......
OSURNIA ....................
(florfenicol, terbinafine,
betamethasone acetate) Otic Gel.
GENTOCIN
DURAFILM.
(gentamicin sulfate and
betamethasone).
Ophthalmic Solution ....
GAINPRO ...................
(bambermycins) ..........
Type A medicated article.
DERACIN ....................
(chlortetracycline) ........
Type A medicated articles.
ZILMAX (zilpaterol hydrochloride) Type A
medicated article.
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Supplemental approval to provide
for component feeding of Type
C medicated feeds.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING NOVEMBER AND DECEMBER 2014—
Continued
NADA/
ANADA
Sponsor
New animal drug
product name
Action
21 CFR
Sections
141–276 5 ..
Intervet, Inc., 556 Morris Ave., Summit, NJ
07901.
ZILMAX (zilpaterol hydrochloride) plus
RUMENSIN
(monensin) plus
TYLAN (tylosin
phosphate) Type C
medicated feeds.
Supplemental approval to provide
for component feeding of combination drug Type C medicated
feeds.
FOIA
Summary
558.665
NEPA
Review
CE 1 6
yes
1 The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or
an environmental impact statement because it is of a type that does not have a significant effect on the human environment.
2 CE granted under 21 CFR 25.33(a)(1).
3 CE granted under 21 CFR 25.33(d)(1).
4 CE granted under 21 CFR 25.33(d)(5).
5 This application is affected by guidance for industry (GFI) #213, ‘‘New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,’’ December 2013.
6 CE granted under 21 CFR 25.33(a)(2).
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510, 520, 522, 524, 556, and
558 are amended as follows:
List of Subjects
■
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. Amend § 510.600 as follows:
a. In the table in paragraph (c)(1), in
the entry for ‘‘Akorn Animal Health,
Inc.’’, in the ’’Drug labeler code’’
column, remove ‘‘053599’’, and in its
place add ‘‘059399’’;
■ b. In the table in paragraph (c)(1), in
the entry for ‘‘Hikma Pharmaceuticals
LLC’’, in the ‘‘Firm name and address’’
column, remove ‘‘Hikma
Pharmaceuticals LLC’’, and in its place
add ‘‘Hikma International
Pharmaceuticals LLC’’;
■
■
21 CFR Parts 520, 522, and 524
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
c. In the table in paragraph (c)(1),
remove the entry for ‘‘Pennfield Oil Co.’’
and add an entry, in alphabetical order,
for ‘‘Pharmgate LLC’’;
■ d. In the table in paragraph (c)(2),
remove the entries for ‘‘000008’’,
‘‘048164’’, and ‘‘053599’’ and add
entries, in numerical order, for
‘‘059399’’ and ‘‘069254’’; and
■ e. In the table in paragraph (c)(2), in
the entry for ‘‘059115’’, in the ‘‘Firm
name and address’’ column, remove
‘‘Hikma Pharmaceuticals LLC’’, and in
its place add ‘‘Hikma International
Pharmaceuticals LLC’’.
The additions and revisions read as
follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey, NJ 07446 ....................................................................................
*
*
*
*
*
*
069254
*
*
(2) * * *
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Drug labeler
code
Firm name and address
*
059399 .........
*
*
*
*
Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045
*
*
*
069254 .........
*
*
*
*
Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey, NJ 07446
*
*
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Drug labeler
code
Firm name and address
*
*
*
§ 520.1660d
Authority: 21 U.S.C. 360b.
§§ 520.310 and 520.312 [Redesignated as
§§ 520.301 and 520.302]
4. Redesignate §§ 520.310 and 520.312
as §§ 520.301 and 520.302, respectively.
■
§ 520.309 [Redesignated as § 520.304 and
Amended]
5. Redesignate § 520.309 as § 520.304
and revise newly redesignated § 520.304
by adding paragraph (b)(3) to read as
follows:
■
Carprofen.
*
*
*
*
*
(b) * * *
(3) No. 026637 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d) of this
section.
*
*
*
*
*
■ 6. In § 520.370, revise paragraphs (a)
and (b) and in paragraph (c)(2), remove
‘‘intermedius’’ and in its place add
‘‘pseudintermedius’’ to read as follows:
Cefpodoxime tablets.
(a) Specifications. (1) Each tablet
contains cefpodoxime proxetil
equivalent to 100 or 200 milligrams (mg)
cefpodoxime.
(2) Each chewable tablet contains
cefpodoxime proxetil equivalent to 100
or 200 mg cefpodoxime.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for uses as
follows:
(1) No. 026637 for use of product in
paragraph (a)(1) of this section as in
paragraph (c) of this section.
(2) No. 054771 for use of products in
paragraph (a) of this section as in
paragraph (c) of this section.
*
*
*
*
*
§ 520.441
[Amended]
7. In § 520.441, in paragraph (b)(1),
remove ‘‘048164’’ and in its place add
‘‘069254’’.
■ 8. Amend § 520.1660d as follows:
■ a. In paragraph (b)(6), remove
‘‘048164’’ and in its place add
‘‘069254’’.
■ b. In paragraphs (d)(1)(ii)(A)(3),
(d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3), revise
the last sentence.
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■
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Oxytetracycline powder.
*
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
§ 520.370
*
The revisions read as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
§ 520.304
*
*
*
*
*
(d) * * *
(1) * * *
(ii) * * *
(A) * * *
(3) * * * Zero-day withdrawal for
those products sponsored by Nos.
054771, 057561, 061133, and 069254.
(B) * * *
(3) * * * Zero-day withdrawal for
those products sponsored by Nos.
054771, 057561, 061133, and 069254.
(C) * * *
(3) * * * Zero-day withdrawal for
those products sponsored by Nos.
054771, 057561, 061133, and 069254.
*
*
*
*
*
■ 9. In § 520.2455, revise paragraphs
(b)(3) and (c) to read as follows:
§ 520.2455
Tiamulin.
*
*
*
*
*
(b) * * *
(3) No. 054771 for the product
described in paragraph (a)(3) of this
section.
(c) Related tolerances. See § 556.732
of this chapter.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
10. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 522.246
[Amended]
11. In § 522.246, in paragraph (b)(3),
remove ‘‘053599’’ and in its place add
‘‘059399’’.
■ 12. In § 522.558, revise paragraphs (a)
and (b) to read as follows:
■
§ 522.558
Dexmedetomidine.
(a) Specifications. Each milliliter of
solution contains:
(1) 0.1 milligrams (mg)
dexmedetomidine hydrochloride; or
(2) 0.5 mg dexmedetomidine
hydrochloride.
(b) Sponsors. See sponsors in in
§ 510.600(c) of this chapter for use as in
paragraph (c) of this section:
(1) No. 026637 for use of product
described in paragraph (a)(2) of this
section;
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*
*
(2) No. 052483 for use of products
described in paragraph (a) of this
section.
*
*
*
*
*
■ 13. Amend § 522.812 as follows:
■ a. Revise paragraph (b)(2);
■ b. Remove paragraph (e)(3)(i);
■ c. Redesignate paragraphs (e)(3)(ii)
and (e)(3)(iii) as paragraphs (e)(3)(i) and
(e)(3)(ii), respectively; and
■ d. Revise newly redesignated
paragraph (e)(3)(i).
The revisions read as follows:
§ 522.812
Enrofloxacin.
*
*
*
*
*
(b) * * *
(2) No. 055529 for use of product
described in paragraph (a)(1) of this
section as in paragraph (e)(1) of this
section, and use of product described in
paragraph (a)(2) of this section as in
paragraphs (e)(2)(i)(B), (e)(2)(ii)(B),
(e)(2)(iii), (e)(3)(i)(B), and (e)(3)(ii) of
this section.
*
*
*
*
*
(e) * * *
(3) * * *
(i) Amounts and indications for use.
(A) Administer, either by intramuscular
or subcutaneous (behind the ear)
injection, a single dose of 7.5 mg/kg of
body weight for the treatment and
control of swine respiratory disease
(SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella
multocida, Haemophilus parasuis,
Streptococcus suis, Bordetella
bronchiseptica, and Mycoplasma
hyopneumoniae.
(B) Administer, by subcutaneous
(behind the ear) injection, a single dose
of 7.5 mg/kg of body weight for the
treatment and control of swine
respiratory disease (SRD) associated
with Actinobacillus pleuropneumoniae,
Pasteurella multocida, Haemophilus
parasuis, and Streptococcus suis.
(C) Administer, either by
intramuscular or subcutaneous (behind
the ear) injection, a single dose of 7.5
mg/kg of body weight for the control of
colibacillosis in groups or pens of
weaned pigs where colibacillosis
associated with Escherichia coli has
been diagnosed.
*
*
*
*
*
■ 14. In § 522.1222, revise paragraph (b)
to read as follows:
§ 522.1222
Ketamine.
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*
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15. In § 522.2474, in paragraph (b),
remove ‘‘053599’’ and in its place add
‘‘059399’’.
■ 16. In § 522.2630, revise paragraphs
(b)(1), (b)(2), (d)(1)(ii)(A), (d)(1)(ii)(B),
and (d)(1)(iii) to read as follows:
slaughtered within 18 days from the last
treatment. Do not use in female dairy
cattle 20 months of age or older. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
(B) Calves intended for human
consumption must not be slaughtered
within 22 days from the last treatment.
Not for use in ruminating cattle. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
*
*
*
*
*
§ 522.2630
§ 522.2662
(b) Sponsors. See Nos. 000859,
026637, 054628, 054771, 059399, and
063286 in § 510.600(c) of this chapter.
*
*
*
*
*
§ 522.2474
[Amended]
■
Tulathromycin.
*
*
*
*
*
(b) * * *
(1) Product described as in paragraph
(a)(1) of this section for use as in
paragraphs (d)(1)(i), (d)(1)(ii),
(d)(1)(iii)(A), and (d)(2) of this section.
(2) Product described as in paragraph
(a)(2) of this section for use as in
paragraphs (d)(1)(i), (d)(1)(ii)(B),
(d)(1)(iii)(B), and (d)(2) of this section.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) * * *
(A) Beef and non-lactating dairy
cattle. For the treatment of bovine
respiratory disease (BRD) associated
with Mannheimia haemolytica,
Pasteurella multocida, Histophilus
somni, and Mycoplasma bovis. For the
control of respiratory disease in cattle at
high risk of developing BRD associated
with M. haemolytica, P. multocida, H.
somni, and M. bovis. For the treatment
of infectious bovine keratoconjunctivitis
(IBK) associated with Moraxella bovis.
For the treatment of bovine foot rot
(interdigital necrobacillosis) associated
with Fusobacterium necrophorum and
Porphyromonas levii.
(B) Suckling calves, dairy calves, and
veal calves. For the treatment of bovine
respiratory disease (BRD) associated
with Mannheimia haemolytica,
Pasteurella multocida, Histophilus
somni, and Mycoplasma bovis.
(iii) Limitations. (A) Cattle intended
for human consumption must not be
[Amended]
17. In § 522.2662, in paragraph (b)(4),
remove ‘‘053599’’ and in its place add
‘‘059399’’.
■
§ 522.2670
[Amended]
18. In § 522.2670, in paragraph (b)(1),
remove ‘‘053599’’ and in its place add
‘‘059399’’.
21. In § 524.1044i, revise paragraph
(c)(2) to read as follows:
■
§ 524.1044i Gentamicin and
betamethasone ophthalmic solution.
*
*
*
*
*
(c) * * *
(2) Indications for use. For treatment
of external eye infections and
inflammation.
*
*
*
*
*
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
22. The authority citation for 21 CFR
part 556 continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
19. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
§ 556.738
23. Redesignate § 556.738 as
§ 556.732.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
24. The authority citation for 21 CFR
part 558 continues to read as follows:
■
20. Add § 524.955 to read as follows:
§ 524.955 Florfenicol, terbinafine, and
betamethasone acetate otic gel.
(a) Specifications. Each milliliter of
gel contains 10 milligrams (mg)
florfenicol, 10 mg terbinafine, and 1 mg
betamethasone acetate.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer one dose (1 tube)
per affected ear(s) and repeat
administration in 7 days.
(2) Indications for use. For the
treatment of otitis externa in dogs
associated with susceptible strains of
bacteria (Staphylococcus
pseudintermedius) and yeast
(Malassezia pachydermatis).
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
[Redesignated as § 556.732]
Authority: 21 U.S.C. 360b, 371.
§ 558.76
[Amended]
25. In § 558.76, in paragraph (d)(1)(iv),
in the ‘‘Limitations’’ and ‘‘Sponsor’’
columns, remove ‘‘048164’’ and in its
place add ‘‘069254’’.
■
26. In § 558.95, add paragraph
(d)(4)(v) to read as follows:
■
§ 558.95
Bambermycins.
*
*
*
*
*
(d) * * *
(4) * * *
(v) Used as a free-choice Type C
medicated loose mineral feed for
pasture cattle (slaughter, stocker, and
feeder cattle; and dairy and beef
replacement heifers) as follows:
(A) Specifications.
tkelley on DSK3SPTVN1PROD with RULES
Ingredient
International feed
No.
Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) ........................................................................
Sodium chloride (salt) ......................................................................................................................................
Calcium carbonate (38% calcium) ...................................................................................................................
Corn distillers dried grains w/solubles .............................................................................................................
Magnesium oxide .............................................................................................................................................
Vitamin and trace mineral premix * ..................................................................................................................
Mineral oil ........................................................................................................................................................
Yeast (primary dehydrated yeast) ...................................................................................................................
Bambermycins Type A article (10 g/lb) ...........................................................................................................
Iron oxide .........................................................................................................................................................
Magnesium sulfate (67%) ................................................................................................................................
Copper sulfate .................................................................................................................................................
6–01–080
6–04–152
6–01–069
5–28–236
6–02–756
............................
............................
7–05–533
............................
6–02–431
6–02–758
6–01–720
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Percent
42.50
20.10
15.45
9.57
5.15
3.72
1.00
0.75
0.60
0.50
0.32
0.18
13231
Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations
International feed
No.
Ingredient
Potassium sulfate (0.33%) ...............................................................................................................................
Percent
6–06–098
0.16
* Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
(B) Amount per ton. 120 grams.
(C) Indications for use. For increased
rate of weight gain.
(D) Limitations. For free-choice
feeding to pasture cattle (slaughter,
stocker, and feeder cattle; and dairy and
beef replacement heifers). Feed a nonmedicated commercial mineral product
for 6 weeks to stabilize consumption
between 2.66 and 10.66 ounces per head
per day. Feed continuously to provide
10 to 40 milligrams bambermycins per
head per day. Daily bambermycins
intakes in excess of 20 mg/head/day
have not been shown to be more
effective than 20 mg/head/day.
*
*
*
*
*
■ 27. Amend § 558.128 as follows:
■ a. In paragraph (b)(1), remove ‘‘Nos.
054771, 048164, and 066104’’ and in its
place add ‘‘Nos. 054771, 066104, and
069254’’;
■ b. In paragraphs (e)(4)(ii) and (iv), in
the ‘‘Limitations’’ column, remove
‘‘048164’’ wherever it occurs and in its
place add ‘‘069254’’;
■ c. In paragraphs (e)(1)(i), (ii), and (iii),
(e)(2)(i), (ii), (iii), and (iv), (e)(3)(i), (ii),
(iii), and (iv), (e)(4)(i), (ii), (iv), (vii), and
(viii), and (e)(5)(i) and (ii), in the
‘‘Sponsor’’ column, remove ‘‘048164’’
wherever it occurs and in its place in
numerical order add ‘‘069254’’; and
■ d. Revise paragraphs (e)(1)(iv),
(e)(4)(v), and (e)(4)(ix).
The revisions read as follows:
§ 558.128
*
Chlortetracycline.
*
*
(e) * * *
(1) * * *
*
*
Chlortetracycline amount
Indications for use
Limitations
*
(iv) 500 g/ton .....................
*
*
*
Chickens: For the reduction of mortality
due to E. coli infections susceptible to
chlortetracycline.
*
*
1. Feed for 5 d. To sponsor No. 054771 under NADA
048–761 and No. 069254 under ANADA 200–510:
zero withdrawal time.
2. Feed for 5 d; withdraw 24 h prior to slaughter; do
not feed to chickens producing eggs for human consumption.
*
*
*
*
*
Sponsor
*
054771,
069254.
012286,
054771,
066104,
069254.
(4) * * *
Chlortetracycline amount
Indications for use
Limitations
*
(v) 500 to 4,000 g/ton ........
*
*
*
Calves, beef and nonlactating dairy cattle;
treatment of bacterial enteritis caused by
E. coli and bacterial pneumonia caused
by P. multocida susceptible to chlortetracycline.
*
*
Feed continuously for not more than 5 days to provide
10 mg/lb body weight per day. To sponsor No.
054771 under NADA 046–699: 24-h withdrawal time.
To sponsor No. 054771 under NADA 048–761 and
No. 069254 under ANADA 200–510: Zero withdrawal time.
*
*
(ix) 350 mg/head/day .........
*
*
*
1. Beef cattle: For control of bacterial pneumonia associated with shipping fever
complex caused by Pasteurella spp. susceptible to chlortetracycline.
*
*
Withdraw 48 h prior to slaughter. To sponsor No.
054771 under NADA 046–699: 48-h withdrawal
time. To sponsor No. 054771 under NADA 048–761
and No. 069254 under ANADA 200–510: Zero withdrawal time.
Withdraw 48 h prior to slaughter. To sponsor No.
054771 under NADA 046–699: 48-h withdrawal
time. To sponsor No. 054771 under NADA 048–761
and No. 069254 under ANADA 200–510: zero withdrawal time.
*
2. Beef cattle (under 700 lb): For control of
active infection of anaplasmosis caused
by A. marginale susceptible to chlortetracycline.
tkelley on DSK3SPTVN1PROD with RULES
*
*
§ 558.140
*
*
§ 558.145
*
[Amended]
29. In § 558.145, in paragraph (a)(2),
remove ‘‘048164’’ and in its place add
‘‘069254’’.
■
[Amended]
28. In § 558.140, in paragraph (b)(1),
remove ‘‘048164’’ and in its place add
‘‘069254’’.
■
§ 558.195
30. In § 558.195, in paragraph
(e)(2)(iv), in the ‘‘Limitations’’ and
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054771
069254
012286,
054771,
066104,
069254.
012286,
054771,
066104,
069254.
‘‘Sponsor’’ columns, remove ‘‘048164’’
and in its place add ‘‘069254’’.
§ 558.355
[Amended]
31. In § 558.355, in paragraph
(f)(1)(xiv)(b), remove ‘‘048164’’ and in
its place add ‘‘069254’’.
■
[Amended]
■
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E:\FR\FM\13MRR1.SGM
13MRR1
13232
§ 558.450
Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations
[Amended]
32. Amend § 558.450 as follows:
a. In paragraph (a)(2), remove
‘‘048164’’ and in its place add
‘‘069254’’;
■ b. In paragraphs (d)(2)(iii), (d)(2)(iv),
and (d)(4)(ii), in the ‘‘Limitations’’
column, remove ‘‘048164’’ wherever it
occurs and in its place add ‘‘069254’’;
and
■ c. In paragraphs (d)(1)(i), (ii), (iii), and
(iv), (d)(2)(i), (ii), (iii), and (iv), (d)(3)(i)
and (ii), (d)(4)(i), (ii), (iii), (iv), and (v),
and (d)(5)(i), (ii), and (iii), in the
‘‘Sponsor’’ column, remove ‘‘048164’’
and in its place add ‘‘069254’’.
■
■
§ 558.455
[Amended]
35. Redesignate § 558.600 as § 558.612
and amend newly redesignated
§ 558.612 as follows:
■ a. In paragraph (c), remove
‘‘§ 556.738’’ and in its place add
‘‘§ 556.732’’; and
■ b. In paragraph (e)(1)(iii), in the
‘‘Limitations’’ and ‘‘Sponsor’’ columns,
remove ‘‘048164’’ and in its place in
numerical order add ‘‘069254’’.
■
§ 558.615
[Amended]
34. In § 558.550, in paragraphs (b)(3)
and (d)(1)(xvi)(c), remove ‘‘048164’’ and
in its place add ‘‘069254’’.
■
[Redesignated as § 558.600]
36. Redesignate § 558.615 as
§ 558.600.
■
§ 558.625
33. Amend § 558.455 as follows:
a. In paragraph (b), remove ‘‘Nos.
048164 and 066104’’ and in its place
add ‘‘Nos. 066104 and 069254’’; and
■ b. In paragraphs (e)(1)(i), (ii), (iii), and
(iv), (e)(2)(i), (ii), (iii), and (iv), (e)(3)(i)
and (ii), and (e)(4)(i), (ii), (iii), (iv), (v),
and (vi), in the ‘‘Sponsor’’ column,
remove ‘‘048164’’ and in its place in
numerical order add ‘‘069254’’.
■
■
§ 558.550
§ 558.600 [Redesignated as § 558.612 and
Amended]
[Amended]
37. In § 558.625, in paragraph (b)(5),
remove ‘‘048164’’ and in its place add
‘‘069254’’.
■
§ 558.630
[Amended]
38. In § 558.630, in paragraph (b)(2),
remove ‘‘No. 054771’’ and in its place
add ‘‘Nos. 054771 and 069254’’.
■ 39. Amend § 558.665 as follows:
■ a. Revise paragraphs (d)(1) and (e)(1);
■ b. Redesignate paragraph (d)(2) as
paragraph (d)(4); and
■ c. Add paragraphs (d)(2), (d)(3), (e)(7),
and (e)(8).
■
The revisions and additions read as
follows:
§ 558.665
Zilpaterol.
*
*
*
*
*
(d) * * *
(1) Labeling shall bear the following
caution statements: ‘‘Zilpaterol
hydrochloride is not for use in animals
intended for breeding. Do not allow
horses or other equines access to feed
containing zilpaterol. Do not use in veal
calves.’’
(2) Labeling of Type A medicated
articles and Type B medicated feeds
used to manufacture complete Type C
medicated feeds shall bear the caution
statements in paragraph (d)(3) of this
section.
(3) Labeling of complete Type C
medicated feeds shall bear the following
caution statements: ‘‘Not to be fed to
cattle in excess of 90 mg zilpaterol/
head/day in complete feed. If pen
consumption of complete feed exceeds
26.5 lb/head/day (90 percent dry matter
basis), zilpaterol should not be fed in
complete feed.’’
*
*
*
*
*
(e) * * *
Combination grams/
ton
Indications for use
Limitations
(1) 6.8 ........................
...................................
Cattle fed in confinement for slaughter: For
increased rate of weight gain, improved
feed efficiency, and increased carcass
leanness in cattle fed in confinement for
slaughter during the last 20 to 40 days on
feed.
Feed continuously as the sole ration during the last 20 to 40 days
on feed to provide 60 to 90 mg/
head/day. Withdrawal period: 3
days.
*
(7) 6.8 to 24 ..............
*
...................................
(8) 6.8 to 24 ..............
tkelley on DSK3SPTVN1PROD with RULES
Zilpaterol in grams/ton
Monensin 10 to 40,
plus tylosin 8 to 10.
*
*
*
*
Cattle fed in confinement for slaughter: For Feed continuously to cattle during
increased rate of weight gain, improved
the last 20 to 40 days on feed to
feed efficiency, and increased carcass
provide 60 mg zilpaterol hydroleanness in cattle fed in confinement for
chloride per head per day. Withslaughter during the last 20 to 40 days on
drawal period: 3 days.
feed.
Cattle fed in confinement for slaughter: For Feed continuously to cattle during
increased rate of weight gain, improved
the last 20 to 40 days on feed to
feed efficiency, and increased carcass
provide 60 mg zilpaterol hydroleanness in cattle fed in confinement for
chloride per head per day. See
slaughter during the last 20 to 40 days on
paragraphs §§ 558.355(d) and
feed; for prevention and control of coc558.625(c).
Monensin
and
cidiosis due to Eimeria bovis and E.
tylosin as provided by No.
zuernii; and for reduction of incidence of
000986 in § 510.600(c) of this
liver abscesses caused by Fusobacterium
chapter. Withdrawal period: 3
necrophorum
and
Arcanobacterium
days.
(Actinomyces) pyogenes.
Dated: March 9, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015–05644 Filed 3–12–15; 8:45 am]
BILLING CODE 4164–01–P
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000061
*
000061
000061
]]>Agencies
[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Rules and Regulations]
[Pages 13226-13232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05644]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556, and 558
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during November and December 2014. FDA is also informing the
public of the availability of summaries of the basis of approval and of
environmental review documents, where applicable. The animal drug
regulations are also being amended to reflect a change of sponsorship
of eight NADAs and nine ANADAs, and to make correcting amendments for a
drug labeler code.
DATES: This rule is effective March 13, 2015.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during November and
December 2014, 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 Division of Dockets Management (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.
In addition, Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE
68144, has transferred ownership of, and all rights and interest in,
the following approved applications to Pharmgate LLC, 161 North
Franklin Turnpike, Suite 2C, Ramsey, NJ 07446:
------------------------------------------------------------------------
File No. Product name 21 CFR Cite
------------------------------------------------------------------------
065-480............ Chlortetracycline Soluble Powder 520.441.
138-934............ PENNCHLOR SP (chlortetracycline, 558.145.
sulfamethazine, penicillin)
Type A medicated articles.
138-935............ PENNCHLOR (chlortetracycline) 558.128.
Type A medicated articles.
138-938............ PENNOX (oxytetracycline) Type A 558.450.
medicated articles.
138-939............ NEO-OXY (neomycin sulfate and 558.455.
oxytetracycline) Type A
medicated articles.
140-680............ TYLAN (tylosin phosphate) Type A 558.625.
medicated articles.
140-681............ TYLAN Sulfa-G (tylosin phosphate 558.630.
and sulfamethazine) Type A
medicated articles.
141-137............ PENITRACIN (bacitracin Not codified.
methylenedisalicylate) 50 Type
A medicated article.
200-026............ PENNOX 343 (oxytetracycline).... 520.1660d.
200-154............ PENNOX 200 (oxytetracycline).... 558.450.
200-295............ PENNCHLOR 64 (chlortetracycline) 558.128.
200-314............ PENNCHLOR S (chlortetracycline). 558.140.
200-354............ PENNCHLOR (chlortetracycline)/ 558.355.
COBAN (monensin).
200-356............ PENNCHLOR (chlortetracycline)/ 558.600.
DENAGARD (tiamulin).
[[Page 13227]]
200-357............ PENNCHLOR (chlortetracycline)/ 558.550.
BIO-COX (salinomycin).
200-358............ PENNCHLOR (chlortetracycline)/ 558.76.
BMD (bacitracin MD).
200-359............ PENNCHLOR (chlortetracycline)/ 558.195.
DECCOX (decoquinate).
------------------------------------------------------------------------
At this time, the regulations are being amended to reflect these
changes of sponsorship. Following these changes of sponsorship,
Pharmgate LLC will now be the sponsor of an approved application while
Pennfield Oil Co. will no longer be the sponsor of an approved
application. Also, Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader
Wadi Seer, Amman, Jordan 11118, has informed FDA that it has changed
its name to Hikma International Pharmaceuticals LLC. Accordingly, Sec.
510.600 (21 CFR 510.600) is being amended to reflect these changes. In
addition, FDA is amending Sec. 510.600 and several sections of part
520 to reflect a correct drug labeler code for Akorn Animal Health,
Inc. FDA is also amending the regulations in 21 CFR parts 520, 522,
556, and 558 to redesignate several sections to reflect alphabetical
order and to make minor technical amendments. These corrections and
technical amendments are being made to improve the accuracy of the
animal drug regulations.
Table 1--Original and Supplemental NADAs and ANADAs Approved During November and December 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug product 21 CFR FOIA NEPA
NADA/ ANADA Sponsor name Action Sections Summary Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-575................ Putney, Inc., One Monument Carprofen Chewable Original approval as a generic 520.309 yes CE \1\ \2\
Sq., suite 400, Portland, Tablets. copy of NADA 141-111.
ME 04101.
141-232................ Zoetis Inc., 333 Portage SIMPLICEF (cefpodoxime Supplemental approval of chewable 520.370 yes CE \1\ \3\
St., Kalamazoo, MI 49007. proxetil) Chewable tablet dosage form for dogs.
Tablets.
200-512................ Zoetis Inc., 333 Portage TRIAMULOX (tiamulin Original approval as a generic 520.2455 yes CE \1\ \2\
St., Kalamazoo, MI 49007. hydrogen fumarate) copy of NADA 140-916.
Liquid Concentrate.
200-573................ Putney, Inc., One Monument Dexmedetomidine HCl...... Original approval as a generic 522.558 yes CE \1\ \2\
Sq., suite 400, Portland, (dexmedetomidine copy of NADA 141-267.
ME 04101. hydrochloride).
Injectable Solution......
141-068................ Bayer HealthCare LLC, BAYTRIL 100 Supplemental approval adding 522.812 yes CE\1\ \4\
Animal Health Division, (enrofloxacin). administration by intramuscular
P.O. Box 390, Shawnee Injectable Solution...... injection in swine and an
Mission, KS 66201. indication for control of
colibacillosis in groups or pens
of weaned pigs.
141-349................ Zoetis Inc., 333 Portage DRAXXIN 25............... Supplemental approval for 522.2630 yes CE \1\ \4\
St., Kalamazoo, MI 49007. (tulathromycin).......... treatment of bovine respiratory
Injectable Solution...... disease (BRD) in suckling
calves, dairy calves, and veal
calves.
141-437................ Novartis Animal Health US, OSURNIA.................. Original approval for the 524.955 yes CE \1\ \3\
Inc., 3200 Northline (florfenicol, treatment of otitis externa in
Ave., suite 300, terbinafine, dogs.
Greensboro, NC 27408. betamethasone acetate)
Otic Gel.
034-267................ Intervet, Inc., 556 Morris GENTOCIN DURAFILM........ Supplemental approval of 524.1044i yes CE \1\ \3\
Ave., Summit, NJ 07901. (gentamicin sulfate and additional safety information.
betamethasone).
Ophthalmic Solution......
141-034................ Huvepharma AD, 5th Floor, GAINPRO.................. Supplemental approval of a free- 558.95 yes CE \1\ \2\
3A Nikolay Haytov Str., (bambermycins)........... choice Type C medicated loose
1113 Sophia, Bulgaria. Type A medicated article. mineral feed without selenium
for pasture cattle.
200-510 \5\............ Pharmgate LLC, 161 North DERACIN.................. Original approval as a generic 558.128 yes CE \1\ \2\
Franklin Turnpike, suite (chlortetracycline)...... copy of NADA 048-761.
2C, Ramsey, NJ 07446. Type A medicated articles
141-258................ Intervet, Inc., 556 Morris ZILMAX (zilpaterol Supplemental approval to provide 558.665 yes CE \1\ \2\
Ave., Summit, NJ 07901. hydrochloride) Type A for component feeding of Type C
medicated article. medicated feeds.
[[Page 13228]]
141-276 \5\............ Intervet, Inc., 556 Morris ZILMAX (zilpaterol Supplemental approval to provide 558.665 yes CE \1\ \6\
Ave., Summit, NJ 07901. hydrochloride) plus for component feeding of
RUMENSIN (monensin) plus combination drug Type C
TYLAN (tylosin medicated feeds.
phosphate) Type C
medicated feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an
environmental impact statement because it is of a type that does not have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(d)(5).
\5\ This application is affected by guidance for industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on
Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI
#209,'' December 2013.
\6\ CE granted under 21 CFR 25.33(a)(2).
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
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 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. Amend Sec. 510.600 as follows:
0
a. In the table in paragraph (c)(1), in the entry for ``Akorn Animal
Health, Inc.'', in the ''Drug labeler code'' column, remove ``053599'',
and in its place add ``059399'';
0
b. In the table in paragraph (c)(1), in the entry for ``Hikma
Pharmaceuticals LLC'', in the ``Firm name and address'' column, remove
``Hikma Pharmaceuticals LLC'', and in its place add ``Hikma
International Pharmaceuticals LLC'';
0
c. In the table in paragraph (c)(1), remove the entry for ``Pennfield
Oil Co.'' and add an entry, in alphabetical order, for ``Pharmgate
LLC'';
0
d. In the table in paragraph (c)(2), remove the entries for ``000008'',
``048164'', and ``053599'' and add entries, in numerical order, for
``059399'' and ``069254''; and
0
e. In the table in paragraph (c)(2), in the entry for ``059115'', in
the ``Firm name and address'' column, remove ``Hikma Pharmaceuticals
LLC'', and in its place add ``Hikma International Pharmaceuticals
LLC''.
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
------------------------------------------------------------------------
* * * * * * *
Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, 069254
Ramsey, NJ 07446.......................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
059399...................... Akorn Animal Health, Inc., 1925 West Field
Ct., suite 300, Lake Forest, IL 60045
* * * * * * *
069254...................... Pharmgate LLC, 161 North Franklin
Turnpike, suite 2C, Ramsey, NJ 07446
[[Page 13229]]
* * * * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. Sec. 520.310 and 520.312 [Redesignated as Sec. Sec. 520.301
and 520.302]
0
4. Redesignate Sec. Sec. 520.310 and 520.312 as Sec. Sec. 520.301 and
520.302, respectively.
Sec. 520.309 [Redesignated as Sec. 520.304 and Amended]
0
5. Redesignate Sec. 520.309 as Sec. 520.304 and revise newly
redesignated Sec. 520.304 by adding paragraph (b)(3) to read as
follows:
Sec. 520.304 Carprofen.
* * * * *
(b) * * *
(3) No. 026637 for use of product described in paragraph (a)(2) of
this section as in paragraph (d) of this section.
* * * * *
0
6. In Sec. 520.370, revise paragraphs (a) and (b) and in paragraph
(c)(2), remove ``intermedius'' and in its place add
``pseudintermedius'' to read as follows:
Sec. 520.370 Cefpodoxime tablets.
(a) Specifications. (1) Each tablet contains cefpodoxime proxetil
equivalent to 100 or 200 milligrams (mg) cefpodoxime.
(2) Each chewable tablet contains cefpodoxime proxetil equivalent
to 100 or 200 mg cefpodoxime.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
uses as follows:
(1) No. 026637 for use of product in paragraph (a)(1) of this
section as in paragraph (c) of this section.
(2) No. 054771 for use of products in paragraph (a) of this section
as in paragraph (c) of this section.
* * * * *
Sec. 520.441 [Amended]
0
7. In Sec. 520.441, in paragraph (b)(1), remove ``048164'' and in its
place add ``069254''.
0
8. Amend Sec. 520.1660d as follows:
0
a. In paragraph (b)(6), remove ``048164'' and in its place add
``069254''.
0
b. In paragraphs (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and
(d)(1)(ii)(C)(3), revise the last sentence.
The revisions read as follows:
Sec. 520.1660d Oxytetracycline powder.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(A) * * *
(3) * * * Zero-day withdrawal for those products sponsored by Nos.
054771, 057561, 061133, and 069254.
(B) * * *
(3) * * * Zero-day withdrawal for those products sponsored by Nos.
054771, 057561, 061133, and 069254.
(C) * * *
(3) * * * Zero-day withdrawal for those products sponsored by Nos.
054771, 057561, 061133, and 069254.
* * * * *
0
9. In Sec. 520.2455, revise paragraphs (b)(3) and (c) to read as
follows:
Sec. 520.2455 Tiamulin.
* * * * *
(b) * * *
(3) No. 054771 for the product described in paragraph (a)(3) of
this section.
(c) Related tolerances. See Sec. 556.732 of this chapter.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
10. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.246 [Amended]
0
11. In Sec. 522.246, in paragraph (b)(3), remove ``053599'' and in its
place add ``059399''.
0
12. In Sec. 522.558, revise paragraphs (a) and (b) to read as follows:
Sec. 522.558 Dexmedetomidine.
(a) Specifications. Each milliliter of solution contains:
(1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or
(2) 0.5 mg dexmedetomidine hydrochloride.
(b) Sponsors. See sponsors in in Sec. 510.600(c) of this chapter
for use as in paragraph (c) of this section:
(1) No. 026637 for use of product described in paragraph (a)(2) of
this section;
(2) No. 052483 for use of products described in paragraph (a) of
this section.
* * * * *
0
13. Amend Sec. 522.812 as follows:
0
a. Revise paragraph (b)(2);
0
b. Remove paragraph (e)(3)(i);
0
c. Redesignate paragraphs (e)(3)(ii) and (e)(3)(iii) as paragraphs
(e)(3)(i) and (e)(3)(ii), respectively; and
0
d. Revise newly redesignated paragraph (e)(3)(i).
The revisions read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(2) No. 055529 for use of product described in paragraph (a)(1) of
this section as in paragraph (e)(1) of this section, and use of product
described in paragraph (a)(2) of this section as in paragraphs
(e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i)(B), and (e)(3)(ii)
of this section.
* * * * *
(e) * * *
(3) * * *
(i) Amounts and indications for use. (A) Administer, either by
intramuscular or subcutaneous (behind the ear) injection, a single dose
of 7.5 mg/kg of body weight for the treatment and control of swine
respiratory disease (SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis,
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma
hyopneumoniae.
(B) Administer, by subcutaneous (behind the ear) injection, a
single dose of 7.5 mg/kg of body weight for the treatment and control
of swine respiratory disease (SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and
Streptococcus suis.
(C) Administer, either by intramuscular or subcutaneous (behind the
ear) injection, a single dose of 7.5 mg/kg of body weight for the
control of colibacillosis in groups or pens of weaned pigs where
colibacillosis associated with Escherichia coli has been diagnosed.
* * * * *
0
14. In Sec. 522.1222, revise paragraph (b) to read as follows:
Sec. 522.1222 Ketamine.
* * * * *
[[Page 13230]]
(b) Sponsors. See Nos. 000859, 026637, 054628, 054771, 059399, and
063286 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 522.2474 [Amended]
0
15. In Sec. 522.2474, in paragraph (b), remove ``053599'' and in its
place add ``059399''.
0
16. In Sec. 522.2630, revise paragraphs (b)(1), (b)(2), (d)(1)(ii)(A),
(d)(1)(ii)(B), and (d)(1)(iii) to read as follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(b) * * *
(1) Product described as in paragraph (a)(1) of this section for
use as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2)
of this section.
(2) Product described as in paragraph (a)(2) of this section for
use as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and
(d)(2) of this section.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(A) Beef and non-lactating dairy cattle. For the treatment of
bovine respiratory disease (BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma
bovis. For the control of respiratory disease in cattle at high risk of
developing BRD associated with M. haemolytica, P. multocida, H. somni,
and M. bovis. For the treatment of infectious bovine
keratoconjunctivitis (IBK) associated with Moraxella bovis. For the
treatment of bovine foot rot (interdigital necrobacillosis) associated
with Fusobacterium necrophorum and Porphyromonas levii.
(B) Suckling calves, dairy calves, and veal calves. For the
treatment of bovine respiratory disease (BRD) associated with
Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and
Mycoplasma bovis.
(iii) Limitations. (A) Cattle intended for human consumption must
not be slaughtered within 18 days from the last treatment. Do not use
in female dairy cattle 20 months of age or older. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(B) Calves intended for human consumption must not be slaughtered
within 22 days from the last treatment. Not for use in ruminating
cattle. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
* * * * *
Sec. 522.2662 [Amended]
0
17. In Sec. 522.2662, in paragraph (b)(4), remove ``053599'' and in
its place add ``059399''.
Sec. 522.2670 [Amended]
0
18. In Sec. 522.2670, in paragraph (b)(1), remove ``053599'' and in
its place add ``059399''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
19. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
20. Add Sec. 524.955 to read as follows:
Sec. 524.955 Florfenicol, terbinafine, and betamethasone acetate otic
gel.
(a) Specifications. Each milliliter of gel contains 10 milligrams
(mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer one dose (1
tube) per affected ear(s) and repeat administration in 7 days.
(2) Indications for use. For the treatment of otitis externa in
dogs associated with susceptible strains of bacteria (Staphylococcus
pseudintermedius) and yeast (Malassezia pachydermatis).
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
21. In Sec. 524.1044i, revise paragraph (c)(2) to read as follows:
Sec. 524.1044i Gentamicin and betamethasone ophthalmic solution.
* * * * *
(c) * * *
(2) Indications for use. For treatment of external eye infections
and inflammation.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
22. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.738 [Redesignated as Sec. 556.732]
0
23. Redesignate Sec. 556.738 as Sec. 556.732.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
24. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.76 [Amended]
0
25. In Sec. 558.76, in paragraph (d)(1)(iv), in the ``Limitations''
and ``Sponsor'' columns, remove ``048164'' and in its place add
``069254''.
0
26. In Sec. 558.95, add paragraph (d)(4)(v) to read as follows:
Sec. 558.95 Bambermycins.
* * * * *
(d) * * *
(4) * * *
(v) Used as a free-choice Type C medicated loose mineral feed for
pasture cattle (slaughter, stocker, and feeder cattle; and dairy and
beef replacement heifers) as follows:
(A) Specifications.
------------------------------------------------------------------------
International
Ingredient feed No. Percent
------------------------------------------------------------------------
Deflorinated phosphate (20.5% 6-01-080 42.50
calcium, 18.5% phosphorus).........
Sodium chloride (salt).............. 6-04-152 20.10
Calcium carbonate (38% calcium)..... 6-01-069 15.45
Corn distillers dried grains w/ 5-28-236 9.57
solubles...........................
Magnesium oxide..................... 6-02-756 5.15
Vitamin and trace mineral premix *.. ................ 3.72
Mineral oil......................... ................ 1.00
Yeast (primary dehydrated yeast).... 7-05-533 0.75
Bambermycins Type A article (10 g/ ................ 0.60
lb)................................
Iron oxide.......................... 6-02-431 0.50
Magnesium sulfate (67%)............. 6-02-758 0.32
Copper sulfate...................... 6-01-720 0.18
[[Page 13231]]
Potassium sulfate (0.33%)........... 6-06-098 0.16
------------------------------------------------------------------------
* Content of vitamin/trace mineral premix may be varied. However, they
should be comparable to those used for other free-choice feeds.
Formulation modifications require FDA approval prior to marketing.
Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
Policy Guides Sec. 651.100 (CPG 7125.18).
(B) Amount per ton. 120 grams.
(C) Indications for use. For increased rate of weight gain.
(D) Limitations. For free-choice feeding to pasture cattle
(slaughter, stocker, and feeder cattle; and dairy and beef replacement
heifers). Feed a non-medicated commercial mineral product for 6 weeks
to stabilize consumption between 2.66 and 10.66 ounces per head per
day. Feed continuously to provide 10 to 40 milligrams bambermycins per
head per day. Daily bambermycins intakes in excess of 20 mg/head/day
have not been shown to be more effective than 20 mg/head/day.
* * * * *
0
27. Amend Sec. 558.128 as follows:
0
a. In paragraph (b)(1), remove ``Nos. 054771, 048164, and 066104'' and
in its place add ``Nos. 054771, 066104, and 069254'';
0
b. In paragraphs (e)(4)(ii) and (iv), in the ``Limitations'' column,
remove ``048164'' wherever it occurs and in its place add ``069254'';
0
c. In paragraphs (e)(1)(i), (ii), and (iii), (e)(2)(i), (ii), (iii),
and (iv), (e)(3)(i), (ii), (iii), and (iv), (e)(4)(i), (ii), (iv),
(vii), and (viii), and (e)(5)(i) and (ii), in the ``Sponsor'' column,
remove ``048164'' wherever it occurs and in its place in numerical
order add ``069254''; and
0
d. Revise paragraphs (e)(1)(iv), (e)(4)(v), and (e)(4)(ix).
The revisions read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 500 g/ton......................... Chickens: For the 1. Feed for 5 d. To sponsor 054771,
reduction of mortality No. 054771 under NADA 048-761 069254.
due to E. coli infections and No. 069254 under ANADA
susceptible to 200-510: zero withdrawal time.
chlortetracycline.
2. Feed for 5 d; withdraw 24 h 012286,
prior to slaughter; do not 054771,
feed to chickens producing 066104,
eggs for human consumption. 069254.
----------------------------------------------------------------------------------------------------------------
* * * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(v) 500 to 4,000 g/ton................. Calves, beef and Feed continuously for not more 054771
nonlactating dairy than 5 days to provide 10 mg/ 069254
cattle; treatment of lb body weight per day. To
bacterial enteritis sponsor No. 054771 under NADA
caused by E. coli and 046-699: 24-h withdrawal time.
bacterial pneumonia To sponsor No. 054771 under
caused by P. multocida NADA 048-761 and No. 069254
susceptible to under ANADA 200-510: Zero
chlortetracycline. withdrawal time.
* * * * * * *
(ix) 350 mg/head/day................... 1. Beef cattle: For Withdraw 48 h prior to 012286,
control of bacterial slaughter. To sponsor No. 054771,
pneumonia associated with 054771 under NADA 046-699: 48- 066104,
shipping fever complex h withdrawal time. To sponsor 069254.
caused by Pasteurella No. 054771 under NADA 048-761
spp. susceptible to and No. 069254 under ANADA
chlortetracycline. 200-510: Zero withdrawal time.
2. Beef cattle (under 700 Withdraw 48 h prior to 012286,
lb): For control of slaughter. To sponsor No. 054771,
active infection of 054771 under NADA 046-699: 48- 066104,
anaplasmosis caused by A. h withdrawal time. To sponsor 069254.
marginale susceptible to No. 054771 under NADA 048-761
chlortetracycline. and No. 069254 under ANADA
200-510: zero withdrawal time.
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.140 [Amended]
0
28. In Sec. 558.140, in paragraph (b)(1), remove ``048164'' and in its
place add ``069254''.
Sec. 558.145 [Amended]
0
29. In Sec. 558.145, in paragraph (a)(2), remove ``048164'' and in its
place add ``069254''.
Sec. 558.195 [Amended]
0
30. In Sec. 558.195, in paragraph (e)(2)(iv), in the ``Limitations''
and ``Sponsor'' columns, remove ``048164'' and in its place add
``069254''.
Sec. 558.355 [Amended]
0
31. In Sec. 558.355, in paragraph (f)(1)(xiv)(b), remove ``048164''
and in its place add ``069254''.
[[Page 13232]]
Sec. 558.450 [Amended]
0
32. Amend Sec. 558.450 as follows:
0
a. In paragraph (a)(2), remove ``048164'' and in its place add
``069254'';
0
b. In paragraphs (d)(2)(iii), (d)(2)(iv), and (d)(4)(ii), in the
``Limitations'' column, remove ``048164'' wherever it occurs and in its
place add ``069254''; and
0
c. In paragraphs (d)(1)(i), (ii), (iii), and (iv), (d)(2)(i), (ii),
(iii), and (iv), (d)(3)(i) and (ii), (d)(4)(i), (ii), (iii), (iv), and
(v), and (d)(5)(i), (ii), and (iii), in the ``Sponsor'' column, remove
``048164'' and in its place add ``069254''.
Sec. 558.455 [Amended]
0
33. Amend Sec. 558.455 as follows:
0
a. In paragraph (b), remove ``Nos. 048164 and 066104'' and in its place
add ``Nos. 066104 and 069254''; and
0
b. In paragraphs (e)(1)(i), (ii), (iii), and (iv), (e)(2)(i), (ii),
(iii), and (iv), (e)(3)(i) and (ii), and (e)(4)(i), (ii), (iii), (iv),
(v), and (vi), in the ``Sponsor'' column, remove ``048164'' and in its
place in numerical order add ``069254''.
Sec. 558.550 [Amended]
0
34. In Sec. 558.550, in paragraphs (b)(3) and (d)(1)(xvi)(c), remove
``048164'' and in its place add ``069254''.
Sec. 558.600 [Redesignated as Sec. 558.612 and Amended]
0
35. Redesignate Sec. 558.600 as Sec. 558.612 and amend newly
redesignated Sec. 558.612 as follows:
0
a. In paragraph (c), remove ``Sec. 556.738'' and in its place add
``Sec. 556.732''; and
0
b. In paragraph (e)(1)(iii), in the ``Limitations'' and ``Sponsor''
columns, remove ``048164'' and in its place in numerical order add
``069254''.
Sec. 558.615 [Redesignated as Sec. 558.600]
0
36. Redesignate Sec. 558.615 as Sec. 558.600.
Sec. 558.625 [Amended]
0
37. In Sec. 558.625, in paragraph (b)(5), remove ``048164'' and in its
place add ``069254''.
Sec. 558.630 [Amended]
0
38. In Sec. 558.630, in paragraph (b)(2), remove ``No. 054771'' and in
its place add ``Nos. 054771 and 069254''.
0
39. Amend Sec. 558.665 as follows:
0
a. Revise paragraphs (d)(1) and (e)(1);
0
b. Redesignate paragraph (d)(2) as paragraph (d)(4); and
0
c. Add paragraphs (d)(2), (d)(3), (e)(7), and (e)(8).
The revisions and additions read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(d) * * *
(1) Labeling shall bear the following caution statements:
``Zilpaterol hydrochloride is not for use in animals intended for
breeding. Do not allow horses or other equines access to feed
containing zilpaterol. Do not use in veal calves.''
(2) Labeling of Type A medicated articles and Type B medicated
feeds used to manufacture complete Type C medicated feeds shall bear
the caution statements in paragraph (d)(3) of this section.
(3) Labeling of complete Type C medicated feeds shall bear the
following caution statements: ``Not to be fed to cattle in excess of 90
mg zilpaterol/head/day in complete feed. If pen consumption of complete
feed exceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol
should not be fed in complete feed.''
* * * * *
(e) * * *
----------------------------------------------------------------------------------------------------------------
Combination grams/
Zilpaterol in grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 6.8......................... ................... Cattle fed in Feed continuously 000061
confinement for as the sole ration
slaughter: For during the last 20
increased rate of to 40 days on feed
weight gain, improved to provide 60 to
feed efficiency, and 90 mg/head/day.
increased carcass Withdrawal period:
leanness in cattle fed 3 days.
in confinement for
slaughter during the
last 20 to 40 days on
feed.
* * * * * * *
(7) 6.8 to 24................... ................... Cattle fed in Feed continuously 000061
confinement for to cattle during
slaughter: For the last 20 to 40
increased rate of days on feed to
weight gain, improved provide 60 mg
feed efficiency, and zilpaterol
increased carcass hydrochloride per
leanness in cattle fed head per day.
in confinement for Withdrawal period:
slaughter during the 3 days.
last 20 to 40 days on
feed.
(8) 6.8 to 24................... Monensin 10 to 40, Cattle fed in Feed continuously 000061
plus tylosin 8 to confinement for to cattle during
10. slaughter: For the last 20 to 40
increased rate of days on feed to
weight gain, improved provide 60 mg
feed efficiency, and zilpaterol
increased carcass hydrochloride per
leanness in cattle fed head per day. See
in confinement for paragraphs Sec.
slaughter during the Sec. 558.355(d)
last 20 to 40 days on and 558.625(c).
feed; for prevention Monensin and
and control of tylosin as
coccidiosis due to provided by No.
Eimeria bovis and E. 000986 in Sec.
zuernii; and for 510.600(c) of this
reduction of incidence chapter.
of liver abscesses Withdrawal period:
caused by 3 days.
Fusobacterium
necrophorum and
Arcanobacterium
(Actinomyces) pyogenes.
----------------------------------------------------------------------------------------------------------------
Dated: March 9, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-05644 Filed 3-12-15; 8:45 am]
BILLING CODE 4164-01-P
