[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Rules and Regulations]
[Pages 21688-21694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09364]
[[Page 21688]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2017-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correcting 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 and February 2017. 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 several
changes of sponsorship of applications and to make correcting
amendments to improve the accuracy of the regulations.
DATES: This rule is effective May 10, 2017, except for amendatory
instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21
CFR 522.1002, which are effective May 22, 2017.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
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 an ANADA during January and February 2017, 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: http://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: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January and February 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 13, 2017............ 141-468 Phibro Animal Health STAFAC Chickens............. Original approval FOI Summary.
Corp., GlenPointe (virginiamycin) for prevention of
Centre East, 3d plus BIO-COX necrotic enteritis
Floor, 300 Frank W. (salinomycin) and coccidiosis in
Burr Blvd., Suite combination drug broiler chickens.
21, Teaneck, NJ Type C medicated
07666. feeds.
January 13, 2017............ 141-469 Phibro Animal Health STAFAC Chickens............. Original approval FOI Summary.
Corp., GlenPointe (virginiamycin) for prevention of
Centre East, 3d plus AMPROL necrotic enteritis
Floor, 300 Frank W. (amprolium) and coccidiosis in
Burr Blvd., Suite combination drug broiler chickens.
21, Teaneck, NJ Type C medicated
07666. feeds.
January 13, 2017............ 141-470 Phibro Animal Health STAFAC Chickens............. Original approval FOI Summary.
Corp., GlenPointe (virginiamycin) for prevention of
Centre East, 3d plus AVATEC necrotic enteritis
Floor, 300 Frank W. (lasalocid) and coccidiosis in
Burr Blvd., Suite combination drug broiler chickens.
21, Teaneck, NJ Type C medicated
07666. feeds.
January 13, 2017............ 141-472 Huvepharma AD, 5th STAFAC Chickens............. Original approval FOI Summary.
Floor, 3A Nikolay (virginiamycin) for prevention of
Haytov Str.,1113 plus CLINACOX necrotic enteritis
Sophia, Bulgaria. (diclazuril) and coccidiosis in
combination drug broiler chickens.
Type C medicated
feeds.
February 13, 2017........... 141-445 Intervet, Inc., 2 REVALOR-XR Cattle............... Original approval FOI Summary; EA/
Giralda (trenbolone acetate for increased rate FONSI.\1\
Farms,Madison, NJ and estradiol) of weight gain and
07940. Extended-Release improved feed
Implant. efficiency during
70 to 200 days
after implantation
in beef steers and
heifers fed in
confinement for
slaughter.
February 17, 2017........... 200-609 Anzac Animal Health, DIROBAN (melarsomine Dogs................. Original approval as FOI Summary.
LLC, 218 Millwell dihydrochloride) a generic copy of
Dr., Suite B, Powder for NADA 141-042.
Maryland Heights, Injection.
MO 63043.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
no significant impact (FONSI).
Following the approval of ANADA 200-609, Anzac Animal Health, LLC
will now be included in the lists of sponsors of approved applications
in Sec. 510.600(c) (21 CFR 510.600(c)).
II. Changes of Sponsorship
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St.
Joseph, MO 64506-2002 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following
applications to Bayer HealthCare LLC, Animal Health Division, P.O. Box
390, Shawnee Mission, KS 66201:
[[Page 21689]]
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File No. Product name 21 CFR section
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141-099............................. CYDECTIN (moxidectin) Pour-On for Beef and Dairy Cattle. 524.1450
141-220............................. CYDECTIN (moxidectin) Injectable Solution for Beef and 522.1450
Nonlactating Dairy Cattle.
141-247............................. CYDECTIN (moxidectin) Oral Drench for Sheep............. 520.1454
----------------------------------------------------------------------------------------------------------------
Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re, 33500
Libourne, France has informed FDA that it has transferred ownership of,
and all rights and interest in, the following applications to Cross
Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:
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File No. Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
141-420............................. TILDREN (tiludronate disodium) Powder for Infusion...... 522.2473
200-481............................. ALTRESYN (altrenogest) Solution 0.22%................... 520.48
----------------------------------------------------------------------------------------------------------------
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24,
Ireland has informed FDA that it has transferred ownership of, and all
rights and interest in, the following application to Ceva Sante
Animale, 10 Avenue de la Ballasti[egrave]re, 33500 Libourne, France:
----------------------------------------------------------------------------------------------------------------
File No. Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
200-587............................. FERROFORTE (gleptoferron) Solution, 200 mg/mL........... 522.1055
----------------------------------------------------------------------------------------------------------------
Nexcyon Pharmaceuticals, Inc., P.O. Box 259158, Madison, WI 53725
has informed FDA that it has transferred ownership of, and all rights
and interest in, the following applications to Pegasus Laboratories,
Inc., 8809 Ely Rd., Pensacola, FL 32514:
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File No. Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
141-272............................. RECONCILE (fluoxetine hydrochloride) Chewable Tablets... 520.980
----------------------------------------------------------------------------------------------------------------
Accordingly, the animal drug regulations are being amended to
reflect these changes of sponsorship. Following this withdrawal of
approval, Nexcyon Pharmaceuticals, 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).
III. Withdrawals of Approval
In addition, during January and February 2017, the following
sponsor requested that FDA withdraw approval of the NADAs listed in the
following table because the products are no longer manufactured or
marketed:
------------------------------------------------------------------------
File No. Sponsor Product name 21 CFR section
------------------------------------------------------------------------
009-505............. Sioux F.S.H.-P 522.1002
Biochemical, (follicle
Inc., 204 stimulating
Third St. NW., hormone)
Sioux Center, Powder for
IA 51250. Injection.
------------------------------------------------------------------------
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 009-505, and all supplements and amendments
thereto, is withdrawn, effective May 22, 2017. Following this
withdrawal of approval, Sioux Biochemical, Inc., is no longer the
sponsor of an approved application. As provided in the regulatory text
of this document, the animal drug regulations are amended to reflect
this voluntary withdrawal of approval.
IV. Technical Amendments
We are also making several technical amendments in part 558, which
was amended on December 27, 2016 (81 FR 94991), and February 24, 2017
(82 FR 11510), as part of the FDA Center for Veterinary Medicine's
(CVM's) Judicious Use Initiative. These actions are being taken to
improve the accuracy of the regulations.
This final rule is issued under Section 512(i) of the Federal Food,
Drug, and Cosmetic 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 Federal Food, Drug, and
Cosmetic Act, this document does not meet the definition of ``rule'' in
5 U.S.C. 804(3)(A) because it is a ``rule of particular
applicability.'' Therefore, it is not subject to the congressional
review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule
subject to Executive Order 12866 which defines a rule as ``an agency
statement of general applicability and future effect, which the agency
intends to have the force and effect of law, that is designed to
implement, interpret, or prescribe law or policy or to describe the
procedure or practice requirements of an agency.'' As such, this
document is also not subject to Executive Order 12866.
[[Page 21690]]
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 and
redelegated to the Center for Veterinary Medicine, 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. Effective May 10, 2017, in Sec. 510.600, in the table in paragraph
(c)(1), alphabetically add an entry for ``Anzac Animal Health, LLC'',
and remove the entry for ``Nexcyon Pharmaceuticals, Inc.''; and in the
table in paragraph (c)(2), remove the entry for ``050929'', and
numerically add an entry for ``086073.'' The additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, 086073
Maryland Heights, MO 63043.............................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
086073....................... Anzac Animal Health, LLC, 218 Millwell
Dr., Suite B, Maryland Heights, MO
63043.
* * * * * * *
------------------------------------------------------------------------
Sec. 510.600 [Amended]
0
3. Effective May 22, 2017, in Sec. 510.600, in the table in paragraph
(c)(1), remove the entry for ``Sioux Biochemical, Inc.'' .''; and in
the table in paragraph (c)(2), remove the entry for ``063112''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
4. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.48 [Amended]
0
5. In Sec. 520.48, in paragraph (b), remove ``013744'' and in its
place add ``061623''.
Sec. 520.980 [Amended]
0
6. In Sec. 520.980, in paragraph (b), remove ``050929'' and in its
place add ``055246''.
Sec. 520.1454 [Amended]
0
7. In Sec. 520.1454, in paragraph (b), remove ``000010'' and in its
place add ``000859''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.90b [Amended]
0
9. In Sec. 522.90b, in paragraph (a), remove ``50, 100, or 250'' and
in its place add ``200, 250, or 400''.
Sec. 522.1002 [Amended]
0
10. Effective May 22, 2017, in Sec. 522.1002, remove paragraph (b);
and redesignate paragraph (c) as paragraph (b).
Sec. 522.1055 [Amended]
0
11. In Sec. 522.1055, in paragraph (b), remove ``Nos. 013744 and
061623'' and in its place add ``No. 013744''.
Sec. 522.1362 [Amended]
0
12. In Sec. 522.1362, in paragraph (b), remove ``No. 050604'' and in
its place add ``Nos. 050604 and 086073''.
Sec. 522.1450 [Amended]
0
13. In Sec. 522.1450, in paragraph (b), remove ``000010'' and in its
place add ``000859''.
0
14. In Sec. 522.1662a, revise paragraph (e)(1); and in paragraph
(e)(3)(i)(c), revise the fifth sentence to read as follows:
Sec. 522.1662a Oxytetracycline hydrochloride injection.
* * * * *
(e) * * *
(1) Specifications. Each milliliter of solution contains 100
milligrams of oxytetracycline hydrochloride.
* * * * *
(3) * * *
(i) * * *
(c) * * * Exceeding the highest recommended dose of 5 milligrams
per pound of body weight per day, administering more than the
recommended number of treatments, and/or exceeding 10 milliliters
intramuscularly or subcutaneously per injection site in adult beef and
dairy cattle may result in antibiotic residues beyond the withdrawal
period. * * *
* * * * *
[[Page 21691]]
Sec. 522.2473 [Amended]
0
15. In Sec. 522.2473, in paragraph (b), remove ``013744'' and in its
place add ``061623''.
0
16. In Sec. 522.2477, revise paragraph (b)(2) and add paragraph (d)(4)
to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(b) * * *
(2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C),
(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A),
(d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A),
(d)(3)(ii), (d)(3)(iii), and (d)(4) of this section.
* * * * *
(d) * * *
(4) Beef steers and heifers fed in confinement for slaughter--(i)
Amount. Each extended- and delayed-release implant contains 200 mg
trenbolone acetate and 20 mg estradiol (one implant consisting of 10
pellets, each pellet containing 20 mg trenbolone acetate and 2 mg
estradiol) per implant dose.
(ii) Indications for use. For increased rate of weight gain and
improved feed efficiency during 70 to 200 days after implantation.
(iii) Limitations. Implant subcutaneously in the ear only. Do not
use in lactating dairy cows or in animals intended for subsequent
breeding. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Do not use in calves to be processed for
veal. A withdrawal period has not been established for this product in
pre-ruminating calves. Effectiveness and animal safety in veal calves
have not been established. Not approved for repeated implantation
(reimplantation) with this or any other cattle ear implant during the
production phase(s) identified on labeling (beef steers and heifers fed
in confinement for slaughter) unless otherwise indicated on labeling
because safety and effectiveness have not been evaluated.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
17. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1450 [Amended]
0
18. In Sec. 524.1450, in paragraph (b)(1), remove ``000010'' and in
its place add ``000859''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
19. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.4 [Amended]
0
20. In Sec. 558.4, in paragraph (d), in the Category I table, remove
the row entry for ``Penicillin''; and in the Category II table, remove
the row entry for ``Sulfamethazine'' the first time it appears only
along with the subsequent entries for ``Chlortetracycline'' and
``Penicillin''.
Sec. 558.76 [Amended]
0
21. In Sec. 558.76, remove and reserve paragraph (e)(1)(vii).
0
22. In Sec. 558.115, revise paragraph (d)(4) to read as follows:
Sec. 558.115 Carbadox.
* * * * *
(d) * * *
(4) Carbadox may also be used in combination with oxytetracycline
as in Sec. 558.450.
0
23. Amend Sec. 558.128 as follows:
0
a. In paragraph (b)(1), remove ``50, 65, or 100'' and in its place add
``50, 90, or 100'';
0
b. In paragraphs (e)(1)(i) and (v), in the ``Limitations'' column,
remove ``Do not feed to chickens producing eggs for human
consumption.'' and in its place add ``For No. 066104: Do not feed to
chickens producing eggs for human consumption.'';
0
c. In paragraph (e)(3)(v), in the ``Sponsor'' column, add ``054771''
before ``069254'';
0
d. In paragraph (e)(4)(iii), in the ``Indications for use'' column,
remove ``anaplsmosis'' and in its place add ``anaplasmosis''; and
0
e. Redesignate paragraphs (e)(4)(xxiv) and (xxv) as paragraphs
(e)(4)(xxv) and (xxvi), respectively, and add new paragraph
(e)(4)(xxiv).
The addition reads as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Chlortetracycline amount grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(xxiv) 25 to 2,800 to provide Lasalocid, 30 to Beef cattle Hand feed continuously 054771
350 mg/head/day. 181.8. weighing under at a rate of 350 mg
700 pounds: For chlortetracycline and
control of active 1 mg lasalocid per 2.2
infection of lb. body weight daily
anaplasmosis to cattle with a
caused by maximum of 360 mg of
Anaplasma lasalocid per head per
marginale day. Do not allow
susceptible to horses or other
chlortetracycline equines access to
; and for the feeds containing
control of lasalocid. No
coccidiosis withdrawal period is
caused by Eimeria required. A withdrawal
bovis and E. period has not been
zuernii. established for this
product in pre-
ruminating calves. Do
not use in calves to
be processed for veal.
See Sec. 558.311(d)
of this chapter.
Chlortetracycline and
lasalocid as provided
by No. 054771 in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.140 [Amended]
0
24. In Sec. 558.140, in paragraph (b)(1), remove ``(d)(1)'' and in its
place add ``(e)(1)''; and in paragraph (b)(2), remove ``(d)(2)'' and in
its place add ``(e)(2)''.
0
25. In Sec. 558.325, redesignate paragraphs (e)(2)(vii) to (xvi) as
[[Page 21692]]
paragraphs (e)(2)(viii) to (xvii), respectively, and add new paragraph
(e)(2)(vii) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Lincomycin grams/ton grams/ton use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(vii) 40....................... Pyrantel, 800..... For the treatment Feed as a single 066104
and/or control of therapeutic treatment
swine dysentery; at a rate of 1 lb of
for removal and feed per 40 lb of body
control of large weight for animals up
roundworm to 200 lb and 5 lb of
(Ascaris suum) feed per head for
and nodular worm animals over 200 lb.
(Oesophagostomum Not to be fed to swine
spp.) infections. that weigh more than
250 pounds. Withdraw
24 hours prior to
slaughter. See
paragraph (d) of this
section. Lincomycin as
provided by No.
054771; pyrantel as
provided by No. 066104
in Sec. 510.600(c)
of this chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
0
26. In Sec. 558.366, revise paragraph (e) to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(e) Nicarbazin may also be used in combination with:
(1)-(3) [Reserved]
(4) Lincomycin as in Sec. 558.325.
Sec. 558.485 [Amended]
0
27. In Sec. 558.485, remove paragraph (e)(1)(iv).
0
28. In Sec. 558.550, add paragraph (d)(5) to read as follows:
Sec. 558.550 Salinomycin.
* * * * *
(d) * * *
(5) Salinomycin may also be used in combination with:
(i)-(ii) [Reserved]
(iii) Chlortetracycline as in Sec. 558.128.
(iv) Lincomycin as in Sec. 558.325.
0
29. Amend Sec. 558.625 as follows:
0
a. Revise paragraph (d)(2);
0
b. Add paragraphs (d)(4) and (5);
0
c. In paragraphs (e)(2)(iv), (v), (viii), (x), (xii), and (xiii), in
the ``Limitations'' column, add a new sentence ``See Sec. 558.355(d)
in this chapter.'' between the fourth and fifth sentences;
0
d. In paragraph (e)(2)(vi), in the ``Limitations'' column, add a new
sentence ``See Sec. 558.355(d) in this chapter.'' between the seventh
and eighth sentences; and
0
e. In paragraphs (e)(2)(vii), (ix), (xi), (xiv), and (xv), in the
``Limitations'' column, add a new sentence ``See Sec. 558.355(d) in
this chapter.'' between the fifth and sixth sentences.
The revisions and additions read as follows:
Sec. 558.625 Tylosin.
* * * * *
(d) * * *
(2) The expiration date of VFDs for tylosin medicated feeds must
not exceed 6 months from the date of issuance. VFDs for tylosin shall
not be refilled.
* * * * *
(4) Tylosin liquid Type B medicated feeds must bear an expiration
date of 31 days after the date of manufacture.
(5) Do not use tylosin liquid Type B medicated feeds in any liquid
feed containing sodium metabisulfite or in any finished feed
(supplement, concentrate, or complete feed) containing in excess of 2
percent bentonite.
* * * * *
0
30. In Sec. 558.635, revise paragraph (e)(1) to read as follows:
Sec. 558.635 Virginiamycin.
* * * * *
(e) Conditions of use--(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Virginiamycin grams/ton grams/ton use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 20......................... .................. Broiler chickens: Not for use in layers.. 066104
For prevention of
necrotic
enteritis caused
by Clostridium
perfringens
susceptible to
virginiamycin.
(ii) 20........................ Amprolium 72.6 to Broiler chickens: For field conditions 066104
113.5. For prevention of where only E. tenella
necrotic is the major problem,
enteritis caused feed continuously as
by Clostridium the sole ration. Use
perfringens as the sole source of
susceptible to amprolium. Do not use
virginiamycin; in feeds containing
and for the bentonite. Not for use
prevention of in laying chickens.
coccidiosis Amprolium as provided
caused by Eimeria by No. 016592 in Sec.
tenella. 510.600(c) of this
chapter.
(iii) 20....................... Amprolium 113.5 to Broiler chickens: For most field 066104
227. For prevention of conditions as they
necrotic exist under modern
enteritis caused management practices,
by Clostridium feed 113.5 g/ton
perfringens amprolium
susceptible to continuously. Where
virginiamycin; severe coccidiosis
and for the conditions exist, feed
prevention of 227 g/ton. Use as the
coccidiosis where sole source of
immunity to amprolium. Do not use
coccidiosis is in feeds containing
not desired. bentonite. Not for use
in laying chickens.
Amprolium as provided
by No. 016592 in Sec.
510.600(c) of this
chapter.
[[Page 21693]]
(iv) 20........................ Diclazuril 0.91... Broiler chickens: Feed continuously as 016592
For prevention of the sole ration. Do
necrotic not use in hens
enteritis caused producing eggs for
by Clostridium human food. Diclazuril
perfringens as provided by No.
susceptible to 016592 in Sec.
virginiamycin; 510.600(c) of this
and for the chapter.
prevention of
coccidiosis
caused by Eimeria
tenella, E.
necatrix, E.
acervulina, E.
brunetti, E.
mitis (mivati),
and E. maxima.
Because
diclazuril is
effective against
E. maxima late in
its life cycle,
subclinical
intestinal
lesions may be
present for a
short time after
infection.
Diclazuril was
shown in studies
to reduce lesions
scores and
improve
performance and
health of birds
challenged with
E. maxima.
(v) 20......................... Lasalocid 68 to Broiler chickens: Feed continuously as 066104
113. For prevention of the sole ration. Do
necrotic not feed to laying
enteritis caused chickens. For broiler
by Clostridium or fryer chickens
perfringens only. Lasalocid as
susceptible to provided by No. 054771
virginiamycin; in Sec. 510.600(c)
and for the of this chapter.
prevention of
coccidiosis
caused by Eimeria
tenella, E.
necatrix, E.
acervulina, E.
brunetti, E.
mivati, and E.
maxima.
(vi) 20........................ Monensin 90 to 110 Broiler chickens: Feed continuously as 066104
For prevention of the sole ration. Do
necrotic not feed to laying
enteritis caused chickens. See Sec.
by Clostridium 558.355(d) in this
perfringens chapter. Monensin as
susceptible to provided by No. 058198
virginiamycin; in Sec. 510.600(c)
and as an aid in of this chapter.
the prevention of
coccidiosis
caused by Eimeria
necatrix, E.
tenella, E.
acervulina, E.
brunetti, E.
maxima, and E.
mivati.
(vii) 20....................... Salinomycin 40 to Broiler chickens: Feed continuously as ..............
60. For prevention of the sole ration. Do
necrotic not feed to chickens
enteritis caused over 16 weeks of age.
by Clostridium Do not feed to laying
perfringens chickens. Not approved
susceptible to for use with pellet
virginiamycin; binders. May be fatal
and for the if accidentally fed to
prevention of adult turkeys or
coccidiosis horses. Salinomycin as
caused by Eimeria provided by No. 016592
tenella, E. in Sec. 510.600(c)
necatrix, E. of this chapter.
acervulina, E.
maxima, E.
brunetti, and E.
mivati.
(viii) 20...................... Semduramicin 22.7. Broiler chickens: Feed continuously as 066104
For prevention of the sole ration. Do
necrotic not feed to laying
enteritis caused hens. Semduramicin as
by Clostridium provided by No. 066104
perfringens in Sec. 510.600(c)
susceptible to of this chapter.
virginiamycin;
and for the
prevention of
coccidiosis
caused by Eimeria
acervulina, E.
brunetti, E.
maxima, E mivati/
mitis, E.
necatrix, and E.
tenella.
(ix) 20........................ Semduramicin Broiler chickens: Feed continuously as 066104
(biomass) 22.7. For prevention of the sole ration.
necrotic Withdraw 1 day before
enteritis caused slaughter. Do not feed
by Clostridium to laying hens.
perfringens Semduramicin as
susceptible to provided by No. 066104
virginiamycin; in Sec. 510.600(c)
and for the of this chapter.
prevention of
coccidiosis
caused by Eimeria
acervulina, E.
brunetti, E.
maxima, E mivati/
mitis, E.
necatrix, and E.
tenella.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
31. In Sec. 558.680, remove paragraph (e) and add paragraph (d)(3) to
read as follows:
Sec. 558.680 Zoalene.
* * * * *
(d) * * *
(3) Zoalene may also be used in combination with:
(i)-(ii) [Reserved]
(iii) Lincomycin as in Sec. 558.325.
[[Page 21694]]
Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09364 Filed 5-9-17; 8:45 am]
BILLING CODE 4164-01-P