Document ID: FDA-2016-N-0002-0001
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Posted Date: 2016-04-18T04:00Z

[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.

-----------------------------------------------------------------------

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, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during January 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.
----------------------------------------------------------------------------------------------------------------
\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