[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Rules and Regulations]
[Pages 22520-22525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08827]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, 524, 529, 556, and 558
[Docket No. FDA-2016-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA, 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 2016. 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
[[Page 22521]]
amended to reflect changes of sponsorship of applications that occurred
in January and February.
DATES: This rule is effective April 18, 2016.
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 ANADAs during January and February 2016, 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 2016
----------------------------------------------------------------------------------------------------------------
21 CFR FOIA
File No. Sponsor Product name Action section summary NEPA review
----------------------------------------------------------------------------------------------------------------
141-444....... Dechra, Ltd., ZYCORTAL Original 522.535 yes......... CE.\1\ \2\
Snaygill Suspension approval for
Industrial (desoxycorticos use as
Estate, terone pivalate replacement
Keighley Rd., injectable therapy for
Skipton, North suspension). mineralocortico
Yorkshire, BD23 id deficiency
2RW United in dogs with
Kingdom. primary
hypoadrenocorti
cism (Addison's
disease).
141-448....... Lloyd, Inc., 604 THYRO-TABS Original 520.1248 yes......... CE.\1\ \2\
W. Thomas Ave., CANINE approval for
Shenandoah, IA (levothyroxine replacement
51601. sodium tablets). therapy for
diminished
thyroid
function in
dogs.
141-452....... Zoetis Inc., 333 SIMPARICA Original 520.2086 yes......... CE.\1\ \2\
Portage St., (sarolaner) approval for
Kalamazoo, MI Chewables. killing adult
49007. fleas, and for
the treatment
and prevention
of flea
infestations
and the
treatment and
control of tick
infestations in
dogs.
141-263....... Zoetis Inc., 333 CERENIA Supplemental 522.1315 yes......... CE.\1\ \2\
Portage St., (maropitant approval
Kalamazoo, MI citrate) providing for
49007. Injectable intravenous
Solution. administration
in dogs and
cats.
141-449....... Intervet, Inc., SAFE-GUARD Supplemental 520.905a, yes......... EA/FONSI.\3\
2 Giralda AquaSol approval for 556.275
Farms, Madison, (fenbendazole the treatment
NJ 07940. oral and control of
suspension) certain
Suspension nematode worms
Concentrate. in swine,
except for
nursing
piglets; and of
a revised
tolerance in
swine liver.
200-600....... ECO LLC, 344 WORMX (pyrantel Original 520.2041 yes......... CE.\1\ \2\
Nassau St., pamoate) approval as a
Princeton, NJ Flavored generic copy of
08540. Tablets. NADA 139-191.
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\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(d)(1).
\3\ 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).
Also, FDA is amending the regulations to reflect the approval of
several minor supplemental applications that revised classes of food-
producing animals in indications and in food safety warnings for
decoquinate and robenidine in medicated feeds. A food safety
precautionary statement has also been revised for use of monensin in
medicated chicken feed.
II. Changes of Sponsorship
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390,
Shawnee, Mission, KS 66201 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following approved
applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113
Sofia, Bulgaria:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
006-391............... S.Q. (sulfaquinoxaline) 40% 558.586
Medicated Feed.
006-677............... S.Q. (sulfaquinoxaline) 20% 520.2325a
Solution.
007-087............... Sulfaquinoxaline Solubilized. 520.2325a
[[Page 22522]]
033-157............... SPECTAM Scour Halt 520.2123c
(spectinomycin
dihydrochloride
pentahydrate) Solution.
040-040............... SPECTAM (spectinomycin) 522.2120
Injectable Solution.
048-287............... Oxytetracycline-50 522.1662a
(oxytetracycline
hydrochloride) Injection.
065-110............... PEN-G-MAX (penicillin G 522.1696b
procaine) Injectable
Suspension.
065-498............... DUAL-CILLIN (benzathine 522.1696a
penicillin G and procaine
penicillin G) Injectable
Suspension.
119-142............... PVL Iron Dextran (iron 522.1182
hydrogenated dextran)
Injectable.
128-089............... ZONOMETH (dexamethasone) 522.540
Injectable Solution.
140-270............... SULFASURE SR (sulfamethazine) 520.2260b
Sustained-Release Cattle
Bolus.
200-068............... Oxytetracycline Hydrochloride 522.1662a
100 mg/mL Injection.
200-108............... Dexamethasone Injectable 522.540
Solution.
200-118............... Neomycin (neomycin sulfate) 520.1484
Oral Solution.
200-123............... MAXIM-200 (oxytetracycline) 522.1660a
Injection.
200-147............... GENTA-JECT (gentamicin 522.1044
sulfate) Injectable Solution.
200-153............... NEO 200 (neomycin sulfate) 520.1484
Oral Solution.
200-162............... Tripelennamine Hydrochloride 522.2615
Injection.
200-174............... Gentamicin Sulfate Pig Pump 520.1044b
Oral Solution.
200-177............... Sulfadimethoxine Injection 522.2220
40%.
200-192............... Sulfadimethoxine 12.5% Oral 520.2220a
Solution.
200-219............... Ivermectin Pour-On for Cattle 524.1193
200-463............... Amprolium-P 9.6% Oral 520.100
Solution.
------------------------------------------------------------------------
Also, Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport
Rd., St. Joseph, MO 64503 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following
applications to Phibro Animal Health Corp., GlenPointe Centre East, 3d
floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666.
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
038-200............... OXY WS (oxytetracycline) 520.1660d
Soluble Antibiotic.
065-178............... FERMYCIN (chlortetracycline) 520.441
Soluble.
065-496............... Tetracycline Soluble Powder.. 520.2345d
------------------------------------------------------------------------
In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has
informed FDA that it has transferred ownership of, and all rights and
interest in, the following approved applications to Huvepharma AD, 5th
Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
006-891............... SUL-Q-NOX (sulfaquinoxaline) 520.2325a
Soluble Powder.
065-140............... TET-SOL 324 (tetracycline 520.2345d
hydrochloride) Soluble
Powder.
100-094............... POULTRYSULFA (sulfamerazine, 520.2218
sulfamethazine, and
sulfaquinoxaline) Soluble
Powder.
128-686............... BIO-COX (salinomycin) Type A 558.550
Medicated Article.
130-435............... OXY-TET (oxytetracycline 520.1660d
hydrochloride) Soluble
Powder/Solution.
134-284............... BIO-COX/FLAVOMYCIN 558.550
(bambermycins).
200-106............... R-PEN (Penicillin G 520.1696b
potassium) Soluble Powder.
200-130............... NEO-SOL 50 (neomycin sulfate) 520.1484
Soluble Powder.
200-189............... Lincomycin Soluble Powder.... 520.1263c
200-441............... AUREOMYCIN 520.441
(chlortetracycline) Soluble
Powder.
------------------------------------------------------------------------
As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these changes of sponsorship.
III. Technical Amendments
FDA has noticed that it failed to amend all necessary regulations
to reflect the change of sponsorship of an oxytetracycline soluble
powder (80 FR 13226, March 13, 2015). At this time, we are amending 21
CFR 529.1660 to include the drug labeler code for the new sponsor. This
action is being taken to improve the accuracy of the regulations.
FDA has also noticed that in Sec. 558.355 (21 CFR 558.355) use of
bacitracin methylenedisalicylate at 100 to 200 grams/ton in combination
with monensin in broiler and replacement chicken feeds was codified in
error for NADA 141-140 (66 FR 13236, March 5, 2001). At this time,
Sec. 558.355 is amended by removing paragraphs (f)(1)(xxx) and
(f)(4)(v). In addition, paragraph (f)(4)(iv), a remnant of a previous
technical amendment (79 FR 10963, February 27, 2014), is also being
removed. We have also noticed that certain paragraphs describing
approved conditions of use were removed in error from Sec. 558.355
during codification of a supplemental application to NADA 138-456 that
increased the dose range for monensin used in combination with
bacitracin methylenedisalicylate in broiler chicken feed (57 FR 6554,
February 26, 1992). At this time, Sec. 558.355 is amended by adding
paragraphs (f)(1)(xxiv)(a) and (b). These actions are being taken to
improve the accuracy of the regulations.
FDA has noticed that in error we removed the approved conditions of
use for gleptoferron, an injectable iron used to prevent anemia in
young piglets. At this time, 21 CFR 522.1055 is being added. This
action is being taken to improve the accuracy of the regulations.
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
[[Page 22523]]
congressional review requirements in 5 U.S.C. 801-808.
List of Subjects
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
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 520,
522, 524, 529, 556, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.100 [Amended]
0
2. In Sec. 520.100, remove and reserve paragraph (b)(3).
0
3. In Sec. 520.441, revise paragraph (b)(1), remove paragraph (b)(2);
redesignate paragraphs (b)(3) and (4) as paragraphs (b)(2) and (3); and
revise newly redesignated paragraph (b)(2).
The revisions read as follows:
Sec. 520.441 Chlortetracycline powder.
* * * * *
(b) * * *
(1) Nos. 000010, 016592, 054771, and 069254 for use as in paragraph
(d) of this section.
(2) No. 066104 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B),
and (d)(4)(ii) through (d)(4)(iv) of this section.
* * * * *
0
4. In Sec. 520.905a, in paragraph (a), remove ``paragraph (e)(5)'' and
in its place add ``paragraphs (e)(5) and (6)''; and add paragraph
(e)(6) to read as follows:
Sec. 520.905a Fenbendazole suspension.
* * * * *
(e) * * *
(6) Swine, except for nursing piglets--(i) Amount. Administer
orally via the drinking water at a daily dose of 2.2 mg/kg of body
weight (1.0 mg/lb) for 3 consecutive days.
(ii) Indications for use. For the treatment and control of
lungworms: Adult Metastrongylus apri, adult M. pudendotectus;
gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung,
intestinal forms) large roundworms (Ascaris suum); nodular worms
(Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms
(Hyostrongylus rubidus): Adult and larvae (L2, L3, L4 stages--
intestinal mucosal forms) whipworms (Trichuris suis); and kidney worms:
Adult and larvae Stephanurus dentatus.
(iii) Limitations. Swine intended for human consumption must not be
slaughtered within 2 days from the last treatment.
Sec. 520.1044b [Amended]
0
5. In Sec. 520.1044b, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
0
6. Add Sec. 520.1248 to read as follows:
Sec. 520.1248 Levothyroxine.
(a) Specifications. Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5,
0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium.
(b) Sponsor. See No. 061690 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer by mouth 0.1 mg/10
pounds of body weight (0.022 mg/kilogram) as a single dose every 24
hours or as a divided dose every 12 hours.
(2) Indications for use. For replacement therapy for diminished
thyroid function in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
7. In Sec. 520.1263c, revise paragraph (b) to read as follows:
Sec. 520.1263c Lincomycin powder.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter as follows:
(1) No. 016592 for use as in paragraph (d) of this section.
(2) Nos. 054925, 061623, and 076475 for use as in paragraphs (d)(1)
and (d)(2) of this section.
* * * * *
Sec. 520.1484 [Amended]
0
8. In Sec. 520.1484, in paragraph (b)(2), remove ``054771'' and in its
place add ``016592, 054771,''; and in paragraph (b)(3), remove
``000859'' and in its place add ``016592''.
Sec. 520.1660d [Amended]
0
9. In Sec. 520.1660d, in paragraph (b)(2), remove ``054771'' and in
its place add ``016592''; and in paragraph (b)(3), remove ``054628''
and in its place add ``066104''.
Sec. 520.1696b [Amended]
0
10. In Sec. 520.1696b, in paragraph (b), in numerical order add
``016592''.
Sec. 520.1705 [Amended]
0
11. In Sec. 520.1705, in paragraph (a), remove ``pergolide mesylate''
and in its place add ``pergolide (as pergolide mesylate)''.
Sec. 520.2041 [Amended]
0
12. In Sec. 520.2041, in paragraph (b), remove ``Nos. 017135 and
051311'' and in its place add ``Nos. 017135, 051311, and 066916''.
0
13. Add Sec. 520.2086 to read as follows:
Sec. 520.2086 Sarolaner.
(a) Specifications. Each chewable tablet contains 5, 10, 20, 40,
80, or 120 milligrams (mg) sarolaner.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer orally once a
month at the recommended minimum dosage of 0.9 mg/lb (2 mg/kg).
(2) Indications for use. Kills adult fleas, and for the treatment
and prevention of flea infestations (Ctenocephalides felis), and the
treatment and control of tick infestations (Amblyomma americanum (lone
star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor
variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog
tick)) for 1 month in dogs 6 months of age or older and weighing 2.8
pounds or more.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.2123c [Amended]
0
14. In Sec. 520.2123c, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
Sec. 520.2218 [Amended]
0
15. In Sec. 520.2218, in paragraph (b), remove ``054771'' and in its
place add ``016592''.
Sec. 520.2220a [Amended]
0
16. In Sec. 520.2220a, in paragraph (b)(1), remove ``000859'' and in
its place add ``016592''.
Sec. 520.2260b [Amended]
0
17. In Sec. 520.2260b, in paragraph (f)(1), remove ``000859'' and in
its place add ``016592''.
Sec. 520.2325a [Amended]
0
18. In Sec. 520.2325a, in paragraph (a)(1), remove ``000859'' and in
its place add ``016592''; and in paragraph (a)(3), remove ``No.
054771'' and in its place add ``Nos. 016592 and 054771''.
0
19. In Sec. 520.2345d, in paragraph (b)(2), remove ``054628'' and in
its place add ``066104''; in paragraph (b)(3),
[[Page 22524]]
remove ``No. 054771'' and in its place add ``Nos. 016592 and 054771'';
and revise the first sentence in paragraph (d)(1)(iii) and paragraph
(d)(2)(iii) to read as follows:
Sec. 520.2345d Tetracycline powder.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Administer for 3 to 5 days; do not slaughter
animals for food within 4 days of treatment for No. 066104 and within 5
days of treatment for Nos. 016592, 054771, 054925, 057561, 059130, and
061623; prepare a fresh solution daily; use as the sole source of
tetracycline.* * *
(2) * * *
(iii) Limitations. Administer for 3 to 5 days; do not slaughter
animals for food within 7 days of treatment for No. 066104 and within 4
days of treatment for Nos. 016592, 054771, 054925, 057561, 059130, and
061623; prepare a fresh solution daily; use as the sole source of
tetracycline.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
20. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
21. Revise Sec. 522.535 to read as follows:
Sec. 522.535 Desoxycorticosterone.
(a) Specifications. Each milliliter of suspension contains 25
milligrams (mg) of desoxycorticosterone pivalate.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 043264 for use as in paragraphs (c)(1)(i), (c)(2)(i), and
(c)(3) of this section.
(2) No. 058198 for use as in paragraphs (c)(1)(ii), (c)(2)(ii), and
(c)(3) of this section.
(c) Conditions of use--(1) Amount. (i) Administer an initial dose
of 2.2 mg/kilogram (1 mg/lb) of body weight by subcutaneous injection.
Subsequent dosages should be individualized according to label
instructions based on patient response to therapy.
(ii) Dosage requirements are variable and must be individualized on
the basis of the response of the patient to therapy. Initial dose of 1
milligram per pound (0.45 kilogram) of body weight every 25 days,
intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body
weight every 21 to 30 days.
(2) Indications for use--(i) For use as replacement therapy for
mineralocorticoid deficiency in dogs with primary hypoadrenocorticism
(Addison's Disease).
(ii) For use as replacement therapy for the mineralocorticoid
deficit in dogs with primary adrenocortical insufficiency.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.540 [Amended]
0
22. In Sec. 522.540, in paragraphs (a)(2)(i) and (d)(2)(i), remove
``000859'' and in its place add ``016592''.
Sec. 522.1044 [Amended]
0
23. In Sec. 522.1044, in paragraph (b)(4), remove ``000859'' and in
its place add ``016592''.
0
24. Add Sec. 522.1055 to read as follows:
Sec. 522.1055 Gleptoferron.
(a) Specifications. Each milliliter contains the equivalent of 200
milligrams (mg) of elemental iron as gleptoferron (complex of ferric
hydroxide and dextran glucoheptonic acid).
(b) Sponsor. See No. 059120 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. It is used in young piglets as follows:
(1) Amounts and indications for use--(i) Administer 200 mg of
elemental iron intramuscularly on or before 3 days of age for
prevention of iron deficiency anemia.
(ii) Administer 200 mg of elemental iron intramuscularly for
treatment of iron deficiency anemia.
(2) [Reserved]
Sec. 522.1182 [Amended]
0
25. In Sec. 522.1182, in paragraph (b)(6), remove ``000859'' and in
its place add ``016592''; and remove paragraph (b)(8).
Sec. 522.1315 [Amended]
0
26. In Sec. 522.1315, in paragraphs (c)(1)(i) and (c)(2)(i), remove
``subcutaneous injection'' and in its place add ``subcutaneous or
intravenous injection''.
Sec. 522.1660a [Amended]
0
27. In Sec. 522.1660a, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
Sec. 522.1662a [Amended]
0
28. In Sec. 522.1662a, in paragraphs (h)(2) and (i)(2), remove
``000859'' and in its place add ``016592''.
Sec. 522.1696a [Amended]
0
29. In Sec. 522.1696a, in paragraph (b)(2), remove ``000859'' and in
its place add ``016592''.
Sec. 522.1696b [Amended]
0
30. In Sec. 522.1696b, in paragraph (b)(1), remove ``000859'' and in
its place add ``016592''.
Sec. 522.2120 [Amended]
0
31. In Sec. 522.2120, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
Sec. 522.2220 [Amended]
0
32. In Sec. 522.2220, in paragraph (b)(3), remove ``000859'' and in
its place add ``016592''.
Sec. 522.2615 [Amended]
0
33. In Sec. 522.2615, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
34. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1193 [Amended]
0
35. In paragraph (b)(2) of Sec. 522.1193, remove ``000859'' and in its
place add ``016592''.
Sec. 524.1484k [Amended]
0
36. In Sec. 522.1484k, revise the section heading to read: Neomycin
and prednisolone suspension.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
37. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1660 [Amended]
0
38. In Sec. 529.1660, in paragraph (b)(2), remove ``048164, 054771,
and 061623'' and in its place add ``054771, 061623, and 069254''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
39. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
40. In Sec. 556.275, in paragraph (b)(2)(i), remove ``6 ppm'' and in
its place add ``3.2 ppm''; redesignate paragraphs (b)(3) and (4) as
paragraphs (b)(4) and (5); and add new paragraph (b)(3) and paragraph
(c) to read as follows:
Sec. 556.275 Fenbendazole.
* * * * *
(b) * * *
[[Page 22525]]
(3) Chickens--(i) Liver (the target tissue). The tolerance for
fenbendazole sulfone (the marker residue) is 5.2 ppm.
(ii) [Reserved]
* * * * *
(c) Related conditions of use. See Sec. Sec. 520.905a, 520.905c,
520.905d, 520.905e, and 558.258 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
41. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.195 [Amended]
0
42. Amend Sec. 558.195 as follows:
0
a. In the table in paragraph (e)(1)(i), in the ``Limitations'' column,
remove ``Do not feed to laying chickens.'' and in its place add ``Do
not feed to laying hens producing eggs for human consumption.'';
0
b. In the table in paragraph (e)(2)(i), in the ``Limitations'' column,
remove ``Do not feed to cows producing milk for food.'' and in its
place add ``Do not feed to cows producing milk for human
consumption.'';
0
c. In the table in paragraphs (e)(3)(i)1. and (e)(3)(ii)1., in the
``Limitations'' column, remove ``Do not feed to sheep producing milk
for food.'' and in its place add ``Do not feed to sheep producing milk
for human consumption.''; and
0
d. In the table in paragraphs (e)(3)(i)2. and (e)(3)(ii)2., in the
``Limitations'' column, remove ``Do not feed to goats producing milk
for food.'' and in its place add ``Do not feed to goats producing milk
for human consumption.''
0
43. In Sec. 558.340, redesignate paragraphs (c)(1)(i) and (ii) as
paragraphs (c)(2) and (3); and revise newly redesignated paragraph
(c)(2) to read as follows:
Sec. 558.340 Maduramicin.
* * * * *
(c) * * *
(2) Indications for use. Broiler chickens: For prevention of
coccidiosis caused by Eimeria acervulina, E. tenella, E. brunetti, E.
maxima, E. necatrix, and E. mivati.
* * * * *
0
44. In Sec. 558.355, revise paragraph (f)(1)(xxiv); and revise
paragraph (f)(1)(xxv) introductory text and remove and reserve
paragraphs (f)(1)(xxx), (f)(4)(iv), and (f)(4)(v).
The revisions read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(1) * * *
(xxiv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
methylenedisalicylate, 4 to 50 grams.
(a) Indications for use. For improved feed efficiency; as an aid in
the prevention of coccidiosis caused by Eimeria necatrix, E. tenella,
E. acervulina, E. maxima, E. brunetti, and E. mivati.
(b) Limitations. Do not feed to laying chickens; feed continuously
as sole ration; in the absence of coccidiosis, the use of monensin with
no withdrawal period may limit feed intake resulting in reduced weight
gain; as bacitracin methylenedisalicylate provided by No. 054771 in
Sec. 510.600(c) of this chapter.
(xxv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
zinc, 4 to 50 grams.
* * * * *
Sec. 558.515 [Amended]
0
45. In Sec. 558.515, in the table in paragraph (d), in the entry for
``30 (0.0033 pct)'', in the first entry under the ``Indications for
use'' column, remove ``For broiler and fryer chickens:'' and in its
place add ``Broiler chickens:''; and in the first entry under the
``Limitations'' column, remove ``Do not feed to layers.'' and in its
place add ``Do not feed to chickens producing eggs for food.''
Sec. 558.550 [Amended]
0
46. Amend Sec. 558.550 as follows:
0
a. In paragraph (b)(1), remove ``054771'' and in its place add
``016592'';
0
b. Remove paragraph (b)(2) and redesignate paragraph (b)(3) as
paragraph (b)(2);
0
c. In paragraph (d)(1)(xvi)(c), remove ``Chlortetracycline as provided
by Nos. 054771 and 069254; salinomycin as provided by Nos. 054771 and
016592 in Sec. 510.600(c) of this chapter.'' and in its place add
``Chlortetracycline as provided by Nos. 054771 and 069254; salinomycin
as provided by No. 016592 in Sec. 510.600(c) of this chapter.'';
0
d. In paragraph (d)(1)(xx)(C) and (xxi)(C), remove ``Salinomycin as
provided by 054771; bacitracin methylene disalicylate as provided by
054771 in Sec. 510.600(c) in this chapter.'' and in its place add
``Salinomycin as provided by No. 016592; bacitracin
methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) in
this chapter.'';
0
e. In paragraph (d)(1)(xxii)(B), remove ``Salinomycin as provided by
Nos. 016592 and 054771; tylosin phosphate as provided by Nos. 000986
and 016592 in Sec. 510.600(c) of this chapter.'' and in its place add
``Salinomycin as provided by No. 016592; tylosin phosphate as provided
by Nos. 000986 and 016592 in Sec. 510.600(c) of this chapter.'';
0
f. In paragraph (d)(1)(xxiii)(b), remove ``Salinomycin as provided by
Nos. 054771 and 016592; bambermycins by No. 016592 in Sec. 510.600(c)
of this chapter.'' and in its place add ``Salinomycin and bambermycins
as provided by No. 016592 in Sec. 510.600(c) of this chapter.'';
0
g. In paragraphs (d)(3)(ii)(B), (iii)(B), and (v)(B), remove
``Salinomycin as provided by 054771; bacitracin methylene disalicylate
as provided by 054771 in Sec. 510.600(c) of this chapter.'' and in its
place add ``Salinomycin as provided by No. 016592; bacitracin
methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) of
this chapter.''; and
0
h. In paragraph (d)(4)(i)(b), remove ``Salinomycin as provided by Nos.
054771 and 016592; oxytetracycline as provided by No. 066104 in Sec.
510.600(c) of this chapter.'' and in its place add ``Salinomycin as
provided by No. 016592; oxytetracycline as provided by No. 066104 in
Sec. 510.600(c) of this chapter.''
Sec. 558.586 [Amended]
0
47. In Sec. 558.586, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
Dated: April 12, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-08827 Filed 4-15-16; 8:45 am]
BILLING CODE 4164-01-P