
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Rules and Regulations]
[Pages 61293-61298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25918]


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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-2015-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of a New Animal Drug Application; Change of 
Sponsor; Change of Sponsor's Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) 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 July and August 2015. FDA is also informing the public 
of the availability of summaries of the basis of approval and of 
environmental review documents, where applicable. The animal drug 
regulations are also being amended to reflect a change of sponsor, a 
change of sponsor's address, a revised food safety warning, the 
voluntary withdrawal of approval of an NADA, and a technical amendment. 
This technical amendment is being made to improve the accuracy of the 
regulations.

DATES: This rule is effective October 13, 2015, except for the 
amendment to 21 CFR 558.460, which is effective October 23, 2015.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during July and August 
2015, 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.

[[Page 61294]]



                                Table 1--Original and Supplemental NADAs and ANADAs Approved During July and August 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             New animal drug                                 21 CFR
           NADA/ANADA                    Sponsor              product name               Action             sections     FOIA summary     NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-438........................  Elanco Animal Health,   KAVAULT (avilamycin)    Original approval for           556.68  yes.........  EA/FONSI.\1\
                                  A Division of Eli       Type A medicated        the reduction in                558.4
                                  Lilly & Co., Lilly      article.                incidence and overall          558.68
                                  Corporate Center,                               severity of diarrhea
                                  Indianapolis, IN                                in the presence of
                                  46285.                                          pathogenic
                                                                                  Escherichia coli in
                                                                                  groups of weaned pigs.
141-442........................  Zoetis Inc., 333        LUTALYSE HighCon        Original approval of a         522.690  yes.........  CE.2 4
                                  Portage St.,            (dinoprost              higher concentration
                                  Kalamazoo, MI 49007.    tromethamine            formulation.
                                                          injection) Injection.
141-443........................  Novartis Animal Health  ONSIOR (robenacoxib)    Original approval for         522.2075  yes.........  CE.2 3
                                  US, Inc., 3200          Injection.              the control of
                                  Northline Ave., Suite                           postoperative pain
                                  300, Greensboro, NC                             and inflammation
                                  27408.                                          associated with
                                                                                  orthopedic surgery,
                                                                                  ovariohysterectomy,
                                                                                  and castration in
                                                                                  cats.
065-252 \5\....................  Huvepharma AD, 5th      STREP-SOL               Supplemental approval         520.2158  no..........  CE.2 3
                                  Floor, 3A Nikolay       (streptomycin           to change marketing
                                  Haytov Str.,1113        sulfate) Solution 25%.  status from over-the-
                                  Sophia, Bulgaria.                               counter to by
                                                                                  veterinary
                                                                                  prescription.
200-553........................  Akorn Animal Health,    Neomycin and Polymyxin  Original approval as a         524.154  yes.........  CE.2 4
                                  Inc., 1925 West Field   B Sulfates,             generic copy of NADA
                                  Ct., Suite 300, Lake    Bacitracin Zinc         065-485.
                                  Forest, IL 60045.       Ophthalmic Ointment,
                                                          USP.
200-565........................  Putney, Inc., One       Thiabendazole,          Original approval as a       524.1484g  yes.........  CE.2 4
                                  Monument Sq., Suite     Dexamethasone,          generic copy of NADA
                                  400, Portland, ME       Neomycin Sulfate        042-633.
                                  04101.                  Solution.
200-582........................  Orkeo USA, Inc., 77     LONCOR 300              Original approval as a         522.955  yes.........  CE.2 4
                                  Water St., New York,    (florfenicol)           generic copy of NADA
                                  NY 10005.               Injectable Solution.    141-063.
200-583........................  Zoetis Inc., 333        ACTOGAIN 45             Original approval as a         558.500  yes.........  CE.2 4
                                  Portage St.,            (ractopamine            generic copy of NADA
                                  Kalamazoo, MI 49007.    hydrochloride) plus     141-233.
                                                          RUMENSIN (monensin
                                                          USP) plus TYLOVET 100
                                                          (tylosin phosphate)
                                                          plus MGA
                                                          (melengestrol
                                                          acetate) Type C
                                                          medicated feeds.
200-584........................  Zoetis Inc., 333        ENGAIN 9 or 45          Original approval as a         558.500  yes.........  CE.2 4
                                  Portage St.,            (ractopamine            generic copy of NADA
                                  Kalamazoo, MI 49007.    hydrochloride) plus     141-172.
                                                          TYLOVET 100 (tylosin
                                                          phosphate) Type B and
                                                          Type C medicated
                                                          feeds.
200-585........................  Zoetis Inc., 333        ACTOGAIN 45             Original approval as a         558.500  yes.........  CE.2 4
                                  Portage St.,            (ractopamine            generic copy of NADA
                                  Kalamazoo, MI 49007.    hydrochloride) plus     141-224.
                                                          RUMENSIN (monensin
                                                          USP) plus TYLOVET 100
                                                          (tylosin phosphate)
                                                          Type B and Type C
                                                          medicated feeds.
200-591........................  Norbrook Laboratories,  NORFENICOL              Original approval as a         522.955  yes.........  CE.2 4
                                  Ltd., Station Works,    (florfenicol)           generic copy of NADA
                                  Newry BT35 6JP,         Injectable Solution.    141-063.
                                  Northern Ireland.
141-216........................  Zoetis Inc., 333        QUEST PLUS Gel          Supplemental approval     520.1453 \6\  yes.........  CE.2 3
                                  Portage St.,            (moxidectin/            for use in breeding,
                                  Kalamazoo, MI 49007.    praziquantel).          pregnant, and
                                                                                  lactating mares.
200-495........................  Norbrook Laboratories,  ENROFLOX 100            Supplemental approval          522.812  yes.........  CE.2 4
                                  Ltd., Station Works,    (enrofloxacin)          of single-dose
                                  Newry BT35 6JP,         Injectable Solution.    indications in cattle.
                                  Northern Ireland.
200-509........................  Huvepharma AD, 5th      TILMOVET 90             Supplemental approval          558.618  yes.........  CE.2 4
                                  Floor, 3A Nikolay       (tilmicosin             for use of Type C
                                  Haytov Str., 1113       phosphate) Type A       medicated feeds for
                                  Sofia, Bulgaria.        medicated article.      control of bovine
                                                                                  respiratory disease
                                                                                  (BRD) in groups of
                                                                                  beef and non-
                                                                                  lactating dairy
                                                                                  cattle.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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).
\2\ 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.
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(a)(1).
\5\ This NADA was listed as being affected by GFI #213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed
  or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,''
  December 2013.
\6\ This supplemental approval required no change to the regulation.


[[Page 61295]]

    In addition, IMPAX Laboratories, Inc., 30831 Huntwood Ave., 
Hayward, CA 94544 has informed FDA that it has transferred ownership 
of, and all rights and interest in, ANADA 200-366 for NOVOCOX 
(carprofen sodium) Caplets to Putney, Inc., One Monument Square, suite 
400, Portland, ME 04101.

------------------------------------------------------------------------
             File No.                  Product name      21 CFR  section
------------------------------------------------------------------------
200-366..........................  NOVOCOX (carprofen           520.304
                                    sodium) Caplets.
------------------------------------------------------------------------

    Also, Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey, 
NJ 07446, has informed FDA that it has changed its address to 1015 
Ashes Dr., suite 102, Wilmington, NC 28405. Accordingly, 21 CFR 510.600 
is being amended to reflect this change.
    In addition, FDA is revising a human food safety warning for use of 
sulfamethazine soluble powder in pre-ruminating calves. FDA is also 
changing the drug labeler code for a generic dinoprost injection 
product in 21 CFR 522.690, which in error was omitted from a final rule 
changing sponsorship of an application (78 FR 17595, March 22, 2013). 
Also, the strength of lufenuron injectable suspension is also being 
amended to conform to the approved application. These technical 
amendments are being made to improve the accuracy of the regulations.
    In addition, Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has 
requested that FDA withdraw approval of NADA 046-666 that provides for 
use of Type A medicated articles containing penicillin G procaine to 
manufacture medicated feeds administered to poultry and swine. This 
action is being taken at the sponsor's request because this product is 
no longer manufactured or marketed. Note this NADA was identified as 
being affected by Guidance for Industry (GFI) #213, ``New Animal Drugs 
and New Animal Drug Combination Products Administered in or on 
Medicated Feed or Drinking Water of Food-Producing Animals: 
Recommendations for Drug Sponsors for Voluntarily Aligning Product Use 
Conditions with GFI #209,'' December 2013. Elsewhere in this issue of 
the Federal Register, FDA gave notice that approval of NADA 046-666, 
and all supplements and amendments thereto, is withdrawn, effective 
October 23, 2015. As provided in the regulatory text of this document, 
the animal drug regulations are amended to reflect this voluntary 
withdrawal of approval.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 
520, 522, 524, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 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), add an entry for 
``Orkeo USA, Inc.'' in alphabetical order and revise the entry for 
``Pharmgate LLC''; and in the table in paragraph (c)(2), revise the 
entry for ``069254'' and add in numerical order an entry for ``086050'' 
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
------------------------------------------------------------------------
 
                              * * * * * * *
Orkeo USA, Inc., 77 Water St., New York, NY 10005.......          086050
 
                              * * * * * * *
Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC          069254
 28405..................................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
069254...............................  Pharmgate LLC, 1015 Ashes Dr.,
                                        Suite 102, Wilmington, NC 28405.
 
                              * * * * * * *
086050...............................  Orkeo USA, Inc., 77 Water St.,
                                        New York, NY 10005.
 

[[Page 61296]]

 
                              * * * * * * *
------------------------------------------------------------------------

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.  520.304  [Amended]

0
4. In Sec.  520.304, in paragraph (b)(2), remove ``000115'' and in 
numerical sequence add ``026637''.

0
5. In Sec.  520.2158, revise paragraphs (d)(1) and (2) and add 
paragraph (d)(3) to read as follows:


Sec.  520.2158  Streptomycin.

* * * * *
    (d) * * *
    (1) Calves--(i) Amount. 10 to 15 milligrams per pound (mg/pound) of 
body weight (1.0 to 1.5 grams per gallon) for up to 5 days.
    (ii) Indications for use. For the treatment of bacterial enteritis 
caused by Escherichia coli and Salmonella spp. susceptible to 
streptomycin.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Swine--(i) Amount. 10 to 15 mg/pound of body weight (1.0 to 1.5 
grams per gallon) for up to 4 days.
    (ii) Indications for use. For the treatment of bacterial enteritis 
caused by Escherichia coli and Salmonella spp. susceptible to 
streptomycin.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Chickens--(i) Amount. 10 to 15 mg/pound of body weight (0.6 to 
0.9 grams per gallon) for up to 5 days.
    (ii) Indications for use. For the treatment of nonspecific 
infectious enteritis caused by organisms susceptible to streptomycin.
    (iii) Limitations. Withdraw 4 days before slaughter. Do not 
administer to chickens producing eggs for human consumption. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

0
6. In Sec.  520.2261b, in paragraph (d)(4)(iii), revise the last two 
sentences to read as follows:


Sec.  520.2261b  Sulfamethazine powder.

* * * * *
    (d) * * *
    (4) * * *
    (iii) * * * Do not use in calves under one (1) month of age or 
calves being fed an all-milk diet. Use in these classes of calves may 
cause violative residues to remain beyond the withdrawal time.

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. Amend Sec.  522.690 as follows:
0
a. Revise paragraphs (a), (b), and (c);
0
b. Redesignate paragraphs (d)(1) and (2) as paragraphs (d)(2) and (4), 
respectively, and add new paragraph (d)(1);
0
c. In newly redesignated paragraph (d)(2)(ii) and in paragraph 
(d)(3)(ii), revise the paragraph heading ``Indications'', to read 
``Indications for use''; and
0
d. Revise newly redesignated paragraph (d)(4) introductory text.
    The revisions and addition read as follows:


Sec.  522.690  Dinoprost.

    (a) Specifications. Each milliliter (mL) of solution contains 
dinoprost tromethamine equivalent to 5 milligrams (mg) or 12.5 mg 
dinoprost.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter.
    (1) No. 054771 for use of the 12.5 mg/mL product as in paragraph 
(d)(1) of this section.
    (2) Nos. 000859 and 054771 for use of the 5 mg/mL product as in 
paragraphs (d)(2), (d)(3), and (d)(4) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) * * *
    (1) Cattle. Administer product described in paragraph (b)(1) of 
this section as follows:
    (i) Amount. 25 mg as a single intramuscular injection.
    (ii) Indications for use. As a luteolytic agent; effective only in 
those cattle having a corpus luteum, i.e., those which ovulated at 
least 5 days prior to treatment.
    (A) For estrus synchronization in beef cows, beef heifers and 
replacement dairy heifers.
    (B) For unobserved (silent) estrus in lactating dairy cows with a 
corpus luteum.
    (C) For treatment of pyometra (chronic endometritis) in cattle.
    (D) For abortion in beef cows, beef heifers and replacement dairy 
heifers.
    (E) For use with gonadorelin injection as in Sec.  522.1077 of this 
chapter to synchronize estrous cycles to allow fixed-time artificial 
insemination (FTAI) in lactating dairy cows.
    (F) For use with progesterone intravaginal inserts as in Sec.  
529.1940 of this chapter for synchronization of estrus in lactating 
dairy cows.
    (G) For use with progesterone intravaginal inserts as in Sec.  
529.1940 of this chapter for synchronization of estrus in suckled beef 
cows and replacement beef and dairy heifers, advancement of first 
postpartum estrus in suckled beef cows, and advancement of first 
pubertal estrus in beef heifers.
* * * * *
    (4) Cattle. Administer product described in paragraph (b)(2) of 
this section as follows:
* * * * *

0
9. In Sec.  522.812, revise paragraph (b)(2) to read as follows:


Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (2) No. 055529 for use of product described in paragraph (a)(1) of 
this section as in paragraph (e)(1) of this section, and use of product 
described in paragraph (a)(2) in this section as in paragraphs (e)(2), 
(e)(3)(i)(B), and (e)(3)(ii) of this section.
* * * * *

0
10. In Sec.  522.955, revise paragraphs (a), (b), (d)(1) subject 
heading, (d)(1)(i) introductory text, (d)(1)(i)(C), (d)(1)(ii) 
introductory text, and (d)(1)(ii)(C) to read as follows:


Sec.  522.955  Florfenicol.

    (a) Specifications. Each milliliter of solution contains:
    (1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-
pyrrolidone and triacetin.
    (2) 300 mg florfenicol in the inactive vehicles n-methyl-2-
pyrrolidone, propylene glycol, and polyethylene glycol.
    (3) 300 mg florfenicol in the inactive vehicles 2-pyrrolidone and 
glycerol formal.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter:
    (1) No. 000061 for use of product described in paragraph (a)(1) as 
in paragraph (d)(1)(i); and
    (2) Nos. 000061 and 086050 for use of product described in 
paragraph (a)(2) as in paragraph (d)(1)(ii).

[[Page 61297]]

    (3) No. 055529 for use of product described in paragraph (a)(3) as 
in paragraph (d)(1)(ii).
* * * * *
    (d) * * *
    (1) Beef and non-lactating dairy cattle--(i) 300 mg per milliliter 
(mL) florfenicol in the inactive vehicles 2-pyrrolidone and triacetin:
* * * * *
    (C) Limitations. Animals intended for human consumption must not be 
slaughtered within 44 days of treatment. Do not use in female dairy 
cattle 20 months of age or older. Use of florfenicol in this class of 
cattle may cause milk residues. A withdrawal period has not been 
established in pre-ruminating calves. Do not use in calves to be 
processed for veal. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (ii) 300 mg/mL florfenicol in the inactive vehicles n-methyl-2- 
pyrrolidone, propylene glycol, and polyethylene glycol, or in 2-
pyrrolidone and glycerol formal:
    (C) Limitations. Animals intended for human consumption must not be 
slaughtered within 28 days of the last intramuscular treatment. Animals 
intended for human consumption must not be slaughtered within 33 days 
of subcutaneous treatment. This product is not approved for use in 
female dairy cattle 20 months of age or older, including dry dairy 
cows. Use in these cattle may cause drug residues in milk and/or in 
calves born to these cows. A withdrawal period has not been established 
in pre-ruminating calves. Do not use in calves to be processed for 
veal. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
* * * * *


Sec.  522.1289  [Amended]

0
11. In Sec.  522.1289, in paragraph (a),, remove ``10 milligrams'' and 
in its place add ``100 milligrams''.

0
12. Add Sec.  522.2075 to read as follows:


Sec.  522.2075  Robenacoxib.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) robenacoxib.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Administer 0.91 mg per 
pound (2 mg/kilogram) by subcutaneous injection, once daily, for a 
maximum of 3 days.
    (2) Indications for use. For the control of postoperative pain and 
inflammation associated with orthopedic surgery, ovariohysterectomy, 
and castration in cats at least 4 months of age for a maximum of 3 
days.
    (3) 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
13. The authority citation for part 524 continues to read as follows:

    Authority: 21 U.S.C. 360b.


0
14. In Sec.  524.154, revise paragraphs (a)(1) and (2) and (b)(2) to 
read as follows:


Sec.  524.154  Bacitracin, neomycin, and polymyxin B ophthalmic 
ointment.

    (a) * * *
    (1) 500 units bacitracin, 3.5 milligrams (mg) neomycin sulfate 
(equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B 
sulfate; or
    (2) 400 units bacitracin zinc, 5 mg neomycin sulfate (equivalent to 
3.5 mg neomycin base), and 10,000 units polymyxin B sulfate.
    (b) * * *
    (2) Nos. 000061, 043264, and 059399 for use of product described in 
paragraph (a)(2) as in paragraph (c) of this section.
* * * * *

0
15. In Sec.  524.1484g, revise paragraphs (a) and (b) to read as 
follows:


Sec.  524.1484g  Neomycin, thiabendazole, and dexamethasone solution.

    (a) Specifications. Each milliliter of solution contains 40 
milligrams (mg) thiabendazole, 3.2 mg neomycin (from neomycin sulfate), 
and 1 mg dexamethasone.
    (b) Sponsors. See Nos. 026637 and 050604 in Sec.  510.600(c) of 
this chapter.
* * * * *

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
16. The authority citation for part 556 continues to read as follows:

    Authority: 21 U.S.C. 342, 360b, 371.


0
17. Add Sec.  556.68 to read as follows:


Sec.  556.68  Avilamycin.

    (a) Acceptable Daily Intake (ADI). The ADI for total residues of 
avilamycin is 1.1 milligram per kilogram of body weight per day.
    (b) Tolerances. A tolerance for avilamycin is not required.
    (c) Related conditions of use. See Sec.  558.68 of this chapter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
18. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.


0
19. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, add 
an entry in alphabetical order for ``Avilamycin'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category I
----------------------------------------------------------------------------------------------------------------
                                                 Assay limits                                      Assay limits
                     Drug                        percent \1\         Type B maximum (200x)       percent  Type B/
                                                    Type A                                              C
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Avilamycin...................................          90-110   3.65 g/lb (0.8%)...............          80-110
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
20. Add Sec.  558.68 to read as follows:


Sec.  558.68  Avilamycin.

    (a) Specifications. Each pound of Type A medicated article contains 
90.7 grams of avilamycin.
    (b) Sponsor. See No. 000986 in Sec.  510.600(c) of this chapter.
    (c) Special considerations--(1) Federal law restricts avilamycin

[[Page 61298]]

medicated feeds to use under a veterinary feed directive (VFD) and the 
professional supervision of a licensed veterinarian. See Sec.  558.6 of 
this chapter for additional requirements.
    (2) The expiration date of VFDs for avilamycin medicated feeds must 
not exceed 90 days from the date of issuance. VFDs for avilamycin shall 
not be refilled.
    (d) Related tolerances. See Sec.  556.68 of this chapter.
    (e) Conditions of use in swine--(1) Amount. Feed at 73 grams 
avilamycin per ton of Type C medicated feed (80 ppm) as the sole ration 
for 21 consecutive days. The veterinarian may direct feeding for up to 
a total of 42 consecutive days, based on the clinical assessment.
    (2) Indications for use. Weaned pigs less than 14 weeks of age: For 
the reduction in incidence and overall severity of diarrhea in the 
presence of pathogenic Escherichia coli in groups of weaned pigs.
    (3) Limitations. Feed continuously as the sole ration.


Sec.  558.460  [Amended]

0
21. In Sec.  558.460, revise paragraphs (a) and (b) to read as follows:


Sec.  558.460  Penicillin.

    (a) Specifications. Type A medicated articles containing 100 or 227 
grams penicillin procaine G or feed grade penicillin procaine per 
pound.
    (b) Sponsor: See No. 066104 in Sec.  510.600(c) of this chapter.
* * * * *


Sec.  558.500  [Amended]

0
22. Amend Sec.  558.500 as follows:
0
a. In paragraphs (e)(1)(ii), (iii), and (iv), in the ``Limitations'' 
column, remove the last sentence and in its place add ``Ractopamine as 
provided by Nos. 000986 or 054771; tylosin as provided by Nos. 000986 
or 016592 in Sec.  510.600(c) of this chapter.''.
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b. In paragraphs (e)(2)(iv), (ix), and (xiii), in the ``Limitations'' 
column, remove the last sentence and in its place add ``Ractopamine as 
provided by Nos. 000986 or 054771 with monensin as provided by No. 
000986, and tylosin as provided by Nos. 000986 or 016592 in Sec.  
510.600(c) of this chapter.''.
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c. In paragraph (e)(2)(x), in the ``Limitations'' column, to the last 
sentence add ``; or ractopamine as provided by No. 054771 with monensin 
as provided by No. 000986, tylosin provided by No. 016592, and 
melengestrol acetate provided by No. 054771 in Sec.  510.600(c) of this 
chapter.''


Sec.  558.618  [Amended]

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23. In Sec.  558.618, in paragraph (e)(2)(i), in the ``Sponsor'' 
column, add ``016592'' after ``000986''.

    Dated: October 6, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-25918 Filed 10-9-15; 8:45 am]
 BILLING CODE 4164-01-P


