[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Rules and Regulations]
[Pages 64738-64744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27238]
[[Page 64738]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556, and 558
[Docket No. FDA-2018-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship; Change of a Sponsor's Name and Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during April, May, and June 2018. FDA is
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 make technical
amendments to improve the accuracy and readability of the regulations.
DATES: This rule is effective December 18, 2018.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during April, May, and June 2018, as
listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday. Persons with access
to the internet may obtain these documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During April, May, and June 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
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May 4, 2018............. 141-481 Kindred Biosciences, MIRATAZ (mirtazapine Cats............. Original approval for the FOI Summary.
Inc., 1555 Bayshore transdermal management of weight
Hwy., Suite 200, ointment). loss in cats.
Burlingame, CA
94010.
May 15, 2018............ 141-501 Boehringer Ingelheim SEMINTRA Cats............. Original approval for the FOI Summary.
Vetmedica, Inc., (telmisartan oral control of systemic
2621 North Belt solution). hypertension in cats.
Hwy., St. Joseph,
MO 64506-2002.
May 25, 2018............ 141-063 Intervet, Inc., 2 NUFLOR Cattle........... Supplemental approval to FOI Summary.
Giralda Farms, (florfenicol), provide human food
Madison, NJ 07940. Injectable Solution. safety information for
the use of the inactive
ingredient n[dash]methyl-
2-pyrrolidone (NMP).
May 31, 2018............ 141-495 Elanco US Inc., 2500 INTEPRITY Chickens......... Original approval for the FOI Summary.
Innovation Way, (avilamycin) and prevention of mortality
Greenfield, IN BIO-COX caused by necrotic
46140. (salinomycin enteritis and for the
sodium) Type C prevention of
medicated feeds. coccidiosis in broiler
chickens.
June 6, 2018............ 141-342 Jurox Pty. Ltd., 85 ALFAXAN Dogs and cats.... Supplemental approval FOI Summary.
Gardiner Rd., (alfaxalone), providing for addition
Rutherford, NSW Injectable Solution. of preservatives and use
2320, Australia. of a multidose vial.
June 14, 2018........... 098-379 Merial, Inc., 3239 CYSTORELIN Cattle........... Supplemental approval for FOI Summary, EA/FONSI.\1\
Satellite Blvd., (gonadorelin), use with cloprostenol
Bldg. 500, Duluth, Injectable Solution. sodium to synchronize
GA 30096-4640. estrous cycles to allow
for fixed-time
artificial insemination
(FTAI) in lactating
dairy cows and beef cows.
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\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
no significant impact (FONSI).
II. Technical Amendments
With the approval of NADA 141-481, Kindred Biosciences, Inc. is now
the sponsor of an approved application. Accordingly, we are amending
Sec. 510.600(c) to add the name, address, and drug labeler code of
this sponsor.
Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam Marg, Lower
Parel, Mumbai-400 013, India, has informed FDA that it has changed its
name and address to Piramal Enterprises Ltd., Ananta, Agastya Corporate
Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai,
400070, India. We are amending Sec. 510.600(c) to reflect this change.
We are also making technical amendments to update the scientific
name of a pathogenic bacterium and to accurately list the
concentrations of active ingredients in an otic dosage form new animal
drug. We are also making a technical amendment to correct the sponsor
of epsiprantel tablets. These actions are being taken to improve the
accuracy of the regulations.
In addition, we are reformatting the regulations to create a
tabular display of
[[Page 64739]]
the approved uses of narasin and a separate section for uses of a
fixed-ratio, combination drug Type A medicated article containing
narasin and nicarbazin. These actions are being taken to improve the
readability, consistency, and accuracy of the regulations.
III. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 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, 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 part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``Kindred Biosciences, Inc.'' and remove the entry for
``Piramal Healthcare Ltd.'' and add an entry for ``Piramal Enterprises
Ltd.'' in its place; and in the table in paragraph (c)(2), revise the
entry for ``065085'' and numerically add an entry for ``086078'' to
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
------------------------------------------------------------------------
* * * * * * *
Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 086078
200, Burlingame, CA 94010..............................
* * * * * * *
Piramal Enterprises Ltd., Ananta, Agastya Corporate 065085
Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla
(West), Mumbai, 400070, India..........................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
065085.................. Piramal Enterprises Ltd., Ananta, Agastya
Corporate Park, Opp Fire Brigade, Kamani
Junction, LBS Mag Kurla (West), Mumbai,
400070, India.
* * * * * * *
086078.................. Kindred Biosciences, Inc., 1555 Bayshore Hwy.,
Suite 200, Burlingame, CA 94010.
* * * * * * *
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[[Page 64740]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.88f [Amended]
0
4. In Sec. 520.88f, in paragraph (c)(2), remove ``lacerations) due to
S. aureus, Streptococcus spp., E. coli'' and in its place add
``lacerations) due to S. aureus, Enterococcus faecalis, E. coli''.
Sec. 520.816 [Amended]
0
5. In Sec. 520.816, in paragraph (b), remove ``050604'' and in its
place add ``054771''.
0
6. Add Sec. 520.2335 to read as follows:
Sec. 520.2335 Telmisartan.
(a) Specifications. Each milliliter of solution contains 10
milligrams (mg) telmisartan.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer 1.5 mg/kilogram (kg)
(0.68 mg/pound (lb)) orally twice daily for 14 days, followed by 2 mg/
kg (0.91 mg/lb) orally once daily.
(2) Indications for use. For the control of systemic hypertension
in cats.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
8. Revise Sec. 522.1077 to read as follows:
Sec. 522.1077 Gonadorelin.
(a) Specifications. Each milliliter (mL) of solution contains:
(1) 43 micrograms ([mu]g) of gonadorelin as gonadorelin acetate;
(2) 100 [mu]g of gonadorelin as gonadorelin acetate;
(3) 43 [mu]g of gonadorelin as gonadorelin diacetate tetrahydrate;
or
(4) 50 [mu]g of gonadorelin as gonadorelin hydrochloride.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 000061 for use of the 43-[mu]g/mL product described in
paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of
this section.
(2) No. 068504 for use of the 100-[mu]g/mL product described in
paragraph (a)(2) as in paragraphs (d)(1)(ii), (d)(1)(v), and (d)(2) of
this section.
(3) No. 061623 for use of the 43-[mu]g/mL product described in
paragraph (a)(3) as in paragraphs (d)(1)(i) and (d)(2) of this section.
(4) No. 050604 for use of the 43-[mu]g/mL product described in
paragraph (a)(3) as in paragraphs (d)(1)(i), (d)(1)(vi), and (d)(2) of
this section.
(5) No. 054771 for use of the 50-[mu]g/mL product described in
paragraph (a)(4) as in paragraphs (d)(1)(iii), (d)(1)(vii), and (d)(2)
of this section.
(c) Special considerations. Concurrent luteolytic drug use is
approved as follows:
(1) Cloprostenol injection for use as in paragraph (d)(1)(iv) of
this section as provided by No. 000061 in Sec. 510.600(c) of this
chapter.
(2) Cloprostenol injection for use as in paragraph (d)(1)(v) and
(d)(1)(vi) of this section as provided by No. 000061 or No. 068504 in
Sec. 510.600(c) of this chapter.
(3) Dinoprost injection for use as in paragraph (d)(1)(vii) of this
section as provided by No. 054771 in Sec. 510.600(c) of this chapter.
(d) Conditions of use in cattle--(1) Indications for use and
amounts--(i) For the treatment of ovarian follicular cysts in dairy
cattle: Administer 86 [mu]g gonadorelin (No. 000061) or 100 [mu]g
gonadorelin diacetate tetrahydrate (Nos. 061623 and 050604) by
intramuscular or intravenous injection.
(ii) For the treatment of ovarian follicular cysts in dairy cattle:
Administer 100 [mu]g gonadorelin by intramuscular or intravenous
injection.
(iii) For the treatment of ovarian follicular cysts in cattle:
Administer 100 [mu]g gonadorelin by intramuscular injection.
(iv) For use with cloprostenol injection to synchronize estrous
cycles to allow for fixed-time artificial insemination (FTAI) in
lactating dairy cows: Administer to each cow 86 [mu]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 500 [mu]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by 86 [mu]g gonadorelin by intramuscular injection.
(v) For use with cloprostenol sodium to synchronize estrous cycles
to allow for fixed-time artificial insemination (FTAI) in lactating
dairy cows and beef cows: Administer to each cow 100 [mu]g gonadorelin
by intramuscular injection, followed 6 to 8 days later by 500 [mu]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by 100 [mu]g gonadorelin by intramuscular injection.
(vi) For use with cloprostenol sodium to synchronize estrous cycles
to allow for fixed-time artificial insemination (FTAI) in lactating
dairy cows and beef cows: Administer to each cow 100 [mu]g gonadorelin
diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days
later by 500 [mu]g cloprostenol by intramuscular injection, followed 30
to 72 hours later by 100 [mu]g gonadorelin diacetate tetrahydrate by
intramuscular injection.
(vii) For use with dinoprost injection to synchronize estrous
cycles to allow fixed-time artificial insemination (FTAI) in lactating
dairy cows: Administer to each cow 100 to 200 [mu]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost
by intramuscular injection, followed 30 to 72 hours later by 100 to 200
[mu]g gonadorelin by intramuscular injection.
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
10. In Sec. 524.957, revise paragraph (a) to read as follows:
Sec. 524.957 Florfenicol, terbinafine, and mometasone otic solution.
(a) Specifications. Each single-dose, prefilled dropperette
contains 1 milliliter (mL) of a solution containing 16.6 milligrams
(mg) florfenicol, 14.8 mg terbinafine (equivalent to 16.6 mg
terbinafine hydrochloride), and 2.2 mg mometasone furoate.
* * * * *
0
11. Add Sec. 524.1448 to read as follows:
Sec. 524.1448 Mirtazapine transdermal ointment.
(a) Specifications. Each gram of ointment contains 20 milligrams
(mg) mirtazapine.
(b) Sponsor. See No. 086078 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer topically by applying
a 1.5 inch ribbon of ointment (approximately 2 mg) on the inner pinna
of the cat's ear once daily for 14 days. Alternate the daily
application of ointment between the left and right inner pinna of the
ears.
(2) Indications for use. For the management of weight loss in cats.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
12. The authority citation for part 556 continues to read as follows:
[[Page 64741]]
Authority: 21 U.S.C. 342, 360b, 371.
0
13. In Sec. 556.428, add paragraph (c) to read as follows:
Sec. 556.428 Narasin.
* * * * *
(c) Related conditions of use. See Sec. Sec. 558.363 and 558.364
of this chapter.
0
14. Revise Sec. 556.445 to read as follows:
Sec. 556.445 Nicarbazin.
(a) [Reserved]
(b) Tolerances. A tolerance of 4 parts per million is established
for residues of nicarbazin in uncooked chicken muscle, liver, skin, and
kidney.
(c) Related conditions of use. See Sec. Sec. 558.364 and 558.366
of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
15. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
16. In Sec. 558.68, revise paragraph (e)(1)(ii) and add paragraph
(e)(1)(v) to read as follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Avilamycin in grams/ton grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 13.6 to 40.9....... Monensin, 90 to Broiler chickens: Feed as the sole ration for 21 058198
110. For the consecutive days. To assure
prevention of responsible antimicrobial drug
mortality caused use in broiler chickens,
by necrotic treatment administration must
enteritis begin on or before 10 days of
associated with age. See Sec. 558.355(d) of
Clostridium this chapter. Monensin as
perfringens; and provided by No. 058198 in Sec.
as an aid in the 510.600(c) of this chapter.
prevention of
coccidiosis
caused by Eimeria
necatrix, E.
tenella, E.
acervulina, E.
brunetti, E.
mivati, and E.
maxima.
* * * * * * *
(v) 13.6 to 40.9........ Salinomycin Broiler chickens: Feed as the sole ration for 21 058198
sodium, 40 to 60. For the consecutive days. Feed to
prevention of chickens that are at risk of
mortality caused developing, but not yet showing
by necrotic clinical signs of, necrotic
enteritis enteritis associated with
associated with Clostridium perfringens. Not
Clostridium approved for use with pellet
perfringens; and binders. To assure responsible
for the antimicrobial drug use in
prevention of broiler chickens, treatment
coccidiosis administration must begin on or
caused by Eimeria before 10 days of age. The
tenella, E. safety of avilamycin has not
necatrix, E. been established in chickens
acervulina, E. intended for breeding purposes.
maxima, E. Avilamycin has not been
brunetti, and E. demonstrated to be effective in
mivati. broiler chickens showing
clinical signs of necrotic
enteritis prior to the start of
medication. Do not feed to
laying hens producing eggs for
human consumption. May be fatal
if fed to adult turkeys or to
horses. Salinomycin as provided
by No. 016592 in Sec.
510.600(c) of this chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
17. In Sec. 558.76, remove and reserve paragraph (e)(1)(viii);
redesignate paragraphs (e)(2)(xiii) through (xvii) as paragraphs
(e)(2)(xiv) through (xviii); add new paragraph (e)(2)(xiii); and revise
newly redesignated paragraph (e)(2)(xiv).
The addition and revision read as follows:
Sec. 558.76 Bacitracin methylendisalicylate.
* * * * *
(e) * * *
(2) * * *
(xiii) Narasin and nicarbazin as in Sec. 558.364.
(xiv) Nicarbazin as in Sec. 558.366.
* * * * *
0
18. In Sec. 558.78, add paragraph (d)(3)(vii) to read as follows:
Sec. 558.78 Bacitracin zinc.
* * * * *
(d) * * *
(3) * * *
(vii) Nicarbazin as in Sec. 558.366.
* * * * *
0
19. In Sec. 558.95, revise paragraph (d)(5)(viii); redesignate
paragraphs (d)(5)(ix) through (xi) as paragraphs (d)(5)(x) through
(xii); and add new paragraph (d)(5)(ix).
The revision and addition read as follows:
Sec. 558.95 Bambermycins.
* * * * *
(d) * * *
(5) * * *
(viii) Narasin as in Sec. 558.363.
(ix) Narasin and nicarbazin as in Sec. 558.364.
* * * * *
Sec. 558.128 [Amended]
0
20. In Sec. 558.128, in paragraph (e)(3)(iv), in the ``Limitations''
column, at the end of the second sentence, add ``Chlortetracycline and
bacitracin methylenedisalicylate as provided by No. 054771 in Sec.
510.600(c) of this chapter.''
Sec. 558.325 [Amended]
0
21. In Sec. 558.325, in paragraph (e)(1)(iv), in the ``Combination in
grams/ton'' column, remove ``Decoquinate, 2.72'' and in its place add
``Decoquinate, 27.2''.
0
22. Revise Sec. 558.363 to read as follows:
Sec. 558.363 Narasin.
(a) Specifications. Type A medicated articles containing 36, 45,
54, 72, and 90 grams narasin per pound.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Tolerances. See Sec. 556.428 of this chapter.
(d) Special considerations. An expiration date of 2 months (8
weeks) is required for narasin Type C medicated swine feeds.
(e) Conditions of use. It is used as follows:
(1) Chickens--
[[Page 64742]]
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Narasin grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 54 to 90.............. ..................... Broiler chickens: For For broiler chickens 058198
prevention of only. Feed continuously
coccidiosis caused as sole ration. Do not
by Eimeria necatrix, allow adult turkeys,
E. tenella, E. horses, or other equines
acervulina, E. access to narasin
brunetti, E. mivati, formulations. Ingestion
and E. maxima. of narasin by these
species has been fatal.
(ii) 54 to 72............. Bacitracin Broiler chickens: For For broiler chickens 054771
methylenedisalicylat prevention of only. Feed continuously
e, 10 to 50. coccidiosis caused as sole ration. Do not
by Eimeria necatrix, feed to laying hens. Do
E. tenella, E. not allow adult turkeys,
acervulina, E. horses, or other equines
brunetti, E. mivati, access to narasin
and E. maxima, and formulations. Ingestion
for increased rate of narasin by these
of weight gain and species has been fatal.
improved feed Bacitracin
efficiency. methylenedisalicylate as
provided by No. 054771
in Sec. 510.600(c) of
this chapter.
(iii) 54 to 72............ Bacitracin zinc, 4 to Broiler chickens: For For broiler chickens 054771
50. prevention of only. Feed continuously
coccidiosis caused as sole ration. Do not
by Eimeria necatrix, allow adult turkeys,
E. tenella, E. horses, or other equines
acervulina, E. access to narasin
brunetti, E. mivati, formulations. Ingestion
and E. maxima, and of narasin by these
for increased rate species has been fatal.
of weight gain and Bacitracin zinc as
improved feed provided by No. 054771
efficiency. in Sec. 510.600(c) of
this chapter.
(iv) 54 to 72............. Bambermycins, 1 to 2. Broiler chickens: For For broiler chickens 016592
prevention of only. Feed continuously
coccidiosis caused as sole ration. Do not
by Eimeria necatrix, allow adult turkeys,
E. tenella, E. horses, or other equines
acervulina, E. access to narasin
brunetti, E. mivati, formulations. Ingestion
and E. maxima, and of narasin by these
for increased rate species has been fatal.
of weight gain and Bambermycins as provided
improved feed by No. 016592 in Sec.
efficiency. 510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
(2) Swine--
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Narasin grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.6 to 27.2.......... ..................... Growing-finishing Feed continuously for at 058198
swine: For increased least 4 weeks to swine
rate of weight gain during the growing-
when fed for at finishing period as the
least 4 weeks. sole ration. No
increased benefit in
rate of weight gain has
been shown when narasin
concentrations in the
diet are greater than
13.6 g/ton.
Effectiveness has not
been demonstrated when
fed for durations less
than 4 weeks. Do not
allow adult turkeys,
horses, or other equines
access to narasin
formulations. Ingestion
of narasin by these
species has been fatal.
Not approved for use in
breeding animals because
safety and effectiveness
have not been evaluated
in these animals. Swine
being fed with narasin
should not have access
to feeds containing
pleuromutilins (e.g.,
tiamulin) as adverse
reactions may occur. If
signs of toxicity occur,
discontinue use.
(ii) 18.1 to 27.2......... ..................... Growing-finishing Feed continuously for at 058198
swine: For increased least 4 weeks to swine
rate of weight gain during the growing-
and improved feed finishing period as the
efficiency when fed sole ration. No
for at least 4 weeks. increased benefit in
rate of weight gain has
been shown when narasin
concentrations in the
diet are greater than
13.6 g/ton.
Effectiveness has not
been demonstrated when
fed for durations less
than 4 weeks. Do not
allow adult turkeys,
horses, or other equines
access to narasin
formulations. Ingestion
of narasin by these
species has been fatal.
Not approved for use in
breeding animals because
safety and effectiveness
have not been evaluated
in these animals. Swine
being fed with narasin
should not have access
to feeds containing
pleuromutilins (e.g.,
tiamulin) as adverse
reactions may occur. If
signs of toxicity occur,
discontinue use.
----------------------------------------------------------------------------------------------------------------
(3) Narasin single-ingredient Type A medicated articles may also be
used in combination with:
(i) Avilamycin as in Sec. 558.68.
(ii) [Reserved]
Sec. 558.364 [Redesignated as Sec. 558.365]
0
23. Redesignate Sec. 558.364 as Sec. 558.365.
0
24. Add new Sec. 558.364 to read as follows:
Sec. 558.364 Narasin and nicarbazin.
(a) Specifications. A fixed-ratio, combination drug Type A
medicated article containing 36 grams narasin and 36 grams nicarbazin
per pound.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Tolerances. See Sec. Sec. 556.428 and 556.445 of this chapter.
(d) Conditions of use. It is used as follows:
(1) Chickens--
[[Page 64743]]
----------------------------------------------------------------------------------------------------------------
Narasin and nicarbazin Combination in grams/
grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 27 to 45 of each drug. ..................... Broiler chickens: For Feed continuously as sole 058198
prevention of ration. Do not feed to
coccidiosis caused laying hens. Withdraw 5
by Eimeria tenella, days before slaughter.
E. necatrix, E. Do not allow adult
acervulina, E. turkeys, horses, or
maxima, E. brunetti, other equines access to
and E. mivati. narasin formulations.
Ingestion of narasin by
these species has been
fatal.
(ii) 27 to 45 of each drug Bacitracin Broiler chickens: For Feed continuously as sole 058198
methylenedisalicylat prevention of ration. Do not feed to
e, 4 to 50. coccidiosis caused laying hens. Withdraw 5
by Eimeria tenella, days before slaughter.
E. necatrix, E. Do not allow turkeys,
acervulina, E. horses, or other equines
maxima, E. brunetti, access to formulations
and E. mivati, and containing narasin.
for increased rate Ingestion of narasin by
of weight gain and these species has been
improved feed fatal. Bacitracin
efficiency. methylenedisalicylate as
provided by No. 054771
in Sec. 510.600(c) of
this chapter.
(iii) 27 to 45 of each Bacitracin Broiler chickens: For Feed continuously as sole 054771
drug. methylenedisalicylat prevention of ration. Withdraw 5 days
e, 50. coccidiosis caused before slaughter. Do not
by Eimeria tenella, feed to laying hens. Do
E. necatrix, E. not allow turkeys,
acervulina, E. horses, or other equines
maxima, E. brunetti, access to formulations
and E. mivati, and containing narasin.
as an aid in the Ingestion of narasin by
prevention of these species has been
necrotic enteritis fatal. Bacitracin
caused or methylenedisalicylate as
complicated by provided by No. 054771
Clostridium spp. or in Sec. 510.600(c) of
other organisms this chapter.
susceptible to
bacitracin.
(iv) 27 to 45 of each drug Bacitracin Broiler chickens: For To control necrotic 054771
methylenedisalicylat prevention of enteritis, start
e, 100 to 200. coccidiosis caused medication at first
by Eimeria tenella, clinical signs of
E. necatrix, E. disease; vary dosage
acervulina, E. based on the severity of
maxima, E. brunetti, infection; administer
and E. mivati, and continuously for 5 to 7
as an aid in the days or as long as
control of necrotic clinical signs persist,
enteritis caused or then reduce bacitracin
complicated by to prevention level (50
Clostridium spp. or g/ton). Do not feed to
other organisms laying hens. Withdraw 5
susceptible to days before slaughter.
bacitracin. Do not allow turkeys,
horses, or other equines
access to formulations
containing narasin.
Ingestion of narasin by
these species has been
fatal. Bacitracin
methylenedisalicylate as
provided by No. 054771
in Sec. 510.600(c) of
this chapter.
(v) 27 to 45 of each drug. Bambermycins, 1 to 2. Broiler chickens: As Feed continuously as sole 058198
an aid in preventing ration from time chicks
outbreaks of cecal are placed on litter
(Eimeria tenella) until past the time when
and intestinal (E. coccidiosis is
acervulina, E. ordinarily a hazard. Do
maxima, E. necatrix, not use as a treatment
and E. brunetti) for coccidiosis. Do not
coccidiosis, and for feed to laying hens.
increased rate of Withdraw 5 days before
weight gain and slaughter. Do not allow
improved feed turkeys, horses, or
efficiency. other equines access to
formulations containing
narasin. Ingestion of
narasin by these species
has been fatal.
Bambermycins as provided
by No. 016592 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
(2) Narasin and nicarbazin fixed-ratio, combination drug Type A
medicated articles may also be used in combination with:
(i) Avilamycin as in Sec. 558.68.
(ii) [Reserved]
0
25. Revise Sec. 558.366 to read as follows:
Sec. 558.366 Nicarbazin.
(a) Specifications. Type A medicated articles containing 25 percent
nicarbazin.
(b) Sponsors. See Nos. 058198, 060728, and 066104 in Sec.
510.600(c) of this chapter for use as in paragraph (d) of this section.
(c) Related tolerances. See Sec. 556.445 of this chapter.
(d) Conditions of use. It is used as follows:
(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in grams
Nicarbazin in grams per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 90.8 to 181.6.......... ...................... Broiler chickens: As Feed continuously as sole 066104
an aid in preventing ration from time chicks
outbreaks of cecal are placed on litter
(Eimeria tenella) and until past the time when
intestinal (E. coccidiosis is ordinarily
acervulina, E. a hazard. Do not use as a
maxima, E. necatrix, treatment for outbreaks
and E. brunetti) of coccidiosis. Do not
coccidiosis. use in flushing mashes.
Do not feed to laying
hens. Withdraw 4 days
before slaughter for use
levels at or below 113.5
g/ton. Withdraw 5 days
before slaughter for use
levels above 113.5 g/ton.
(ii) 90.8 to 181.6......... Bacitracin Broiler chickens: As Feed continuously as sole 054771
methylenedisalicylate an aid in preventing ration from time chicks
, 4 to 50. outbreaks of cecal are placed on litter
(Eimeria tenella) and until past the time when
intestinal (E. coccidiosis is ordinarily
acervulina, E. a hazard. Do not use as a
maxima, E. necatrix, treatment for outbreaks
and E. brunetti) of coccidiosis. Do not
coccidiosis, and for use in flushing mashes.
increased rate of Do not feed to laying
weight gain and hens. Withdraw 4 days
improved feed before slaughter for use
efficiency. levels at or below 113.5
g/ton. Withdraw 5 days
before slaughter for use
levels above 113.5 g/ton.
Nicarbazin as provided by
No. 066104; bacitracin
methylenedisalicylate as
provided by No. 054771 in
Sec. 510.600(c) of this
chapter.
[[Page 64744]]
(iii) 90.8 to 181.6........ Bacitracin Broiler chickens; As Feed continuously as sole 066104
methylenedisalicylate an aid in preventing ration from time chicks
, 30. outbreaks of cecal are placed on litter
(Eimeria tenella) and until past the time when
intestinal (E. coccidiosis is ordinarily
acervulina, E. a hazard. Do not use as a
maxima, E. necatrix, treatment for
and E. brunetti) coccidiosis. Do not use
coccidiosis, and for in flushing mashes. Do
increased rate of not feed to laying hens.
weight gain and Withdraw 4 days before
improved feed slaughter for use levels
efficiency. at or below 113.5 g/ton.
Withdraw 5 days before
slaughter for use levels
above 113.5 g/ton.
Nicarbazin as provided by
No. 066104; bacitracin
methylenedisalicylate as
provided by No. 054771 in
Sec. 510.600(c) of this
chapter.
(iv) 90.8 to 181.6......... Bacitracin Broiler chickens: As Feed continuously as sole 054771
methylenedisalicylate an aid in preventing ration from time chicks
50. outbreaks of cecal are placed on litter
(Eimeria tenella) and until past the time when
intestinal (E. coccidiosis is ordinarily
acervulina, E. a hazard. Do not use as a
maxima, E. necatrix, treatment for outbreaks
and E. brunetti) of coccidiosis. Do not
coccidiosis, and as use in flushing mashes.
an aid in the Do not feed to laying
prevention of hens. Withdraw 4 days
necrotic enteritis before slaughter for use
caused or complicated levels at or below 113.5
by Clostridium spp. g/ton. Withdraw 5 days
or other organisms before slaughter for use
susceptible to levels above 113.5 g/ton.
bacitracin. Nicarbazin as provided by
No. 066104; bacitracin
methylenedisalicylate as
provided by No. 054771 in
Sec. 510.600(c) of this
chapter.
(v) 113.5.................. ...................... Chickens: As an aid in Feed continuously as sole 058198
preventing outbreaks ration from time chicks 060728
of cecal (Eimeria are placed on litter
tenella) and until past the time when
intestinal (E. coccidiosis is ordinarily
acervulina, E. a hazard. Do not use as a
maxima, E. necatrix, treatment for
and E. brunetti) coccidiosis. Do not use
coccidiosis. in flushing mashes. Do
not feed to laying hens.
Withdraw 4 days before
slaughter.
(vi) 113.5................. Bacitracin Broiler chickens; aid Feed continuously as sole 060728
methylenedisalicylate in preventing ration from time chicks
, 30. outbreaks of cecal are placed on litter
(Eimeria tenella) and until past the time when
intestinal (E. coccidiosis is ordinarily
acervulina, E. a hazard. Do not use as a
maxima, E. necatrix, treatment for
and E. brunetti) coccidiosis. Do not use
coccidiosis, and for in flushing mashes. Do
increased rate of not feed to laying hens.
weight gain and Withdraw 4 days before
improved feed slaughter. Nicarbazin as
efficiency. provided by No. 066104;
bacitracin
methylenedisalicylate as
provided by No. 054771 in
Sec. 510.600(c) of this
chapter.
(vii) 113.5................ Bacitracin zinc, 4 to Broiler chickens; aid For broiler chickens only. 054771
50. in preventing Feed continuously as sole 066104
outbreaks of cecal ration from time chicks
(Eimeria tenella) and are placed on litter
intestinal (E. until past the time when
acervulina, E. coccidiosis is ordinarily
maxima, E. necatrix, a hazard. Do not use in
and E. brunetti) flushing mashes. Do not
coccidiosis, and for feed to laying hens.
increased rate of Withdraw 4 days before
weight gain and slaughter. Nicarbazin as
improved feed provided by No. 066104,
efficiency. bacitracin zinc as
provided by No. 054771 in
Sec. 510.600(c) of this
chapter.
(viii) 113.5............... Bambermycins, 1 to 2.. Broiler chickens: As Feed continuously as sole 016592
an aid in preventing ration from time chicks
outbreaks of cecal are placed on litter
(Eimeria tenella) and until past the time when
intestinal (E. coccidiosis is ordinarily
acervulina, E. a hazard; do not use as a
maxima, E. necatrix, treatment for
and E. brunetti) coccidiosis. Do not use
coccidiosis, and for in flushing mashes. Do
increased rate of not feed to laying hens.
weight gain and Withdraw 4 days before
improved feed slaughter. Nicarbazin as
efficiency. provided by No. 066104;
bambermycins as provided
by No. 016592 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
(2) [Reserved]
Sec. 558.485 [Amended]
0
26. In Sec. 558.485, in paragraph (e)(2), in the ``Limitations''
column, remove ``Not for use in horses intended for food.'' and in its
place add ``Do not use in horses intended for human consumption.''
Dated: December 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27238 Filed 12-17-18; 8:45 am]
BILLING CODE 4164-01-P