Document ID: FDA-2017-N-0002-0002
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications;  Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
Posted Date: 2017-05-10T04:00Z

[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Rules and Regulations]
[Pages 21688-21694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09364]

[[Page 21688]]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Applications; Changes of 
Sponsorship

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during January and February 2017. FDA is also 
informing the public of the availability of summaries of the basis of 
approval and of environmental review documents, where applicable. The 
animal drug regulations are also being amended to reflect several 
changes of sponsorship of applications and to make correcting 
amendments to improve the accuracy of the regulations.

DATES: This rule is effective May 10, 2017, except for amendatory 
instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21 
CFR 522.1002, which are effective May 22, 2017.

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

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and an ANADA during January and February 2017, as 
listed in table 1. In addition, FDA is informing the public of the 
availability, where applicable, of documentation of environmental 
review required under the National Environmental Policy Act (NEPA) and, 
for actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA). These public documents may be seen in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 
p.m., Monday through Friday. Persons with access to the Internet may 
obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and 
patent information may be accessed in FDA's publication, Approved 
Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                              Table 1--Original and Supplemental NADAs and ANADAs Approved During January and February 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
        Approval date           File No.          Sponsor            Product name             Species         Effect of the action    Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 13, 2017............      141-468  Phibro Animal Health  STAFAC                Chickens.............  Original approval     FOI Summary.
                                            Corp., GlenPointe     (virginiamycin)                              for prevention of
                                            Centre East, 3d       plus BIO-COX                                 necrotic enteritis
                                            Floor, 300 Frank W.   (salinomycin)                                and coccidiosis in
                                            Burr Blvd., Suite     combination drug                             broiler chickens.
                                            21, Teaneck, NJ       Type C medicated
                                            07666.                feeds.
January 13, 2017............      141-469  Phibro Animal Health  STAFAC                Chickens.............  Original approval     FOI Summary.
                                            Corp., GlenPointe     (virginiamycin)                              for prevention of
                                            Centre East, 3d       plus AMPROL                                  necrotic enteritis
                                            Floor, 300 Frank W.   (amprolium)                                  and coccidiosis in
                                            Burr Blvd., Suite     combination drug                             broiler chickens.
                                            21, Teaneck, NJ       Type C medicated
                                            07666.                feeds.
January 13, 2017............      141-470  Phibro Animal Health  STAFAC                Chickens.............  Original approval     FOI Summary.
                                            Corp., GlenPointe     (virginiamycin)                              for prevention of
                                            Centre East, 3d       plus AVATEC                                  necrotic enteritis
                                            Floor, 300 Frank W.   (lasalocid)                                  and coccidiosis in
                                            Burr Blvd., Suite     combination drug                             broiler chickens.
                                            21, Teaneck, NJ       Type C medicated
                                            07666.                feeds.
January 13, 2017............      141-472  Huvepharma AD, 5th    STAFAC                Chickens.............  Original approval     FOI Summary.
                                            Floor, 3A Nikolay     (virginiamycin)                              for prevention of
                                            Haytov Str.,1113      plus CLINACOX                                necrotic enteritis
                                            Sophia, Bulgaria.     (diclazuril)                                 and coccidiosis in
                                                                  combination drug                             broiler chickens.
                                                                  Type C medicated
                                                                  feeds.
February 13, 2017...........      141-445  Intervet, Inc., 2     REVALOR-XR            Cattle...............  Original approval     FOI Summary; EA/
                                            Giralda               (trenbolone acetate                          for increased rate    FONSI.\1\
                                            Farms,Madison, NJ     and estradiol)                               of weight gain and
                                            07940.                Extended-Release                             improved feed
                                                                  Implant.                                     efficiency during
                                                                                                               70 to 200 days
                                                                                                               after implantation
                                                                                                               in beef steers and
                                                                                                               heifers fed in
                                                                                                               confinement for
                                                                                                               slaughter.
February 17, 2017...........      200-609  Anzac Animal Health,  DIROBAN (melarsomine  Dogs.................  Original approval as  FOI Summary.
                                            LLC, 218 Millwell     dihydrochloride)                             a generic copy of
                                            Dr., Suite B,         Powder for                                   NADA 141-042.
                                            Maryland Heights,     Injection.
                                            MO 63043.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

    Following the approval of ANADA 200-609, Anzac Animal Health, LLC 
will now be included in the lists of sponsors of approved applications 
in Sec.  510.600(c) (21 CFR 510.600(c)).

II. Changes of Sponsorship

    Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. 
Joseph, MO 64506-2002 has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following 
applications to Bayer HealthCare LLC, Animal Health Division, P.O. Box 
390, Shawnee Mission, KS 66201:

[[Page 21689]]

----------------------------------------------------------------------------------------------------------------
              File No.                                      Product name                         21 CFR section
----------------------------------------------------------------------------------------------------------------
141-099.............................  CYDECTIN (moxidectin) Pour-On for Beef and Dairy Cattle.          524.1450
141-220.............................  CYDECTIN (moxidectin) Injectable Solution for Beef and            522.1450
                                       Nonlactating Dairy Cattle.
141-247.............................  CYDECTIN (moxidectin) Oral Drench for Sheep.............          520.1454
----------------------------------------------------------------------------------------------------------------

    Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re, 33500 
Libourne, France has informed FDA that it has transferred ownership of, 
and all rights and interest in, the following applications to Cross 
Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:

----------------------------------------------------------------------------------------------------------------
              File No.                                      Product name                         21 CFR section
----------------------------------------------------------------------------------------------------------------
141-420.............................  TILDREN (tiludronate disodium) Powder for Infusion......          522.2473
200-481.............................  ALTRESYN (altrenogest) Solution 0.22%...................            520.48
----------------------------------------------------------------------------------------------------------------

    Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, 
Ireland has informed FDA that it has transferred ownership of, and all 
rights and interest in, the following application to Ceva Sante 
Animale, 10 Avenue de la Ballasti[egrave]re, 33500 Libourne, France:

----------------------------------------------------------------------------------------------------------------
              File No.                                      Product name                         21 CFR section
----------------------------------------------------------------------------------------------------------------
200-587.............................  FERROFORTE (gleptoferron) Solution, 200 mg/mL...........          522.1055
----------------------------------------------------------------------------------------------------------------

    Nexcyon Pharmaceuticals, Inc., P.O. Box 259158, Madison, WI 53725 
has informed FDA that it has transferred ownership of, and all rights 
and interest in, the following applications to Pegasus Laboratories, 
Inc., 8809 Ely Rd., Pensacola, FL 32514:

----------------------------------------------------------------------------------------------------------------
              File No.                                      Product name                         21 CFR section
----------------------------------------------------------------------------------------------------------------
141-272.............................  RECONCILE (fluoxetine hydrochloride) Chewable Tablets...           520.980
----------------------------------------------------------------------------------------------------------------

    Accordingly, the animal drug regulations are being amended to 
reflect these changes of sponsorship. Following this withdrawal of 
approval, Nexcyon Pharmaceuticals, Inc. is no longer the sponsor of an 
approved application. Accordingly, it will be removed from the list of 
sponsors of approved applications in Sec.  510.600(c).

III. Withdrawals of Approval

    In addition, during January and February 2017, the following 
sponsor requested that FDA withdraw approval of the NADAs listed in the 
following table because the products are no longer manufactured or 
marketed:

------------------------------------------------------------------------
      File No.            Sponsor        Product name    21 CFR section
------------------------------------------------------------------------
009-505.............  Sioux            F.S.H.-P                 522.1002
                       Biochemical,     (follicle
                       Inc., 204        stimulating
                       Third St. NW.,   hormone)
                       Sioux Center,    Powder for
                       IA 51250.        Injection.
------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 009-505, and all supplements and amendments 
thereto, is withdrawn, effective May 22, 2017. Following this 
withdrawal of approval, Sioux Biochemical, Inc., is no longer the 
sponsor of an approved application. As provided in the regulatory text 
of this document, the animal drug regulations are amended to reflect 
this voluntary withdrawal of approval.

IV. Technical Amendments

    We are also making several technical amendments in part 558, which 
was amended on December 27, 2016 (81 FR 94991), and February 24, 2017 
(82 FR 11510), as part of the FDA Center for Veterinary Medicine's 
(CVM's) Judicious Use Initiative. These actions are being taken to 
improve the accuracy of the regulations.
    This final rule is issued under Section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C.360b(i)), which requires Federal 
Register publication of ``notice[s]. . . effective as a regulation,'' 
of the conditions of use of approved new animal drugs. This rule sets 
forth technical amendments to the regulations to codify recent actions 
on approved new animal drug applications and corrections to improve the 
accuracy of the regulations, and as such does not impose any burden on 
regulated entities.
    Although denominated a rule pursuant to the Federal Food, Drug, and 
Cosmetic Act, this document does not meet the definition of ``rule'' in 
5 U.S.C. 804(3)(A) because it is a ``rule of particular 
applicability.'' Therefore, it is not subject to the congressional 
review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule 
subject to Executive Order 12866 which defines a rule as ``an agency 
statement of general applicability and future effect, which the agency 
intends to have the force and effect of law, that is designed to 
implement, interpret, or prescribe law or policy or to describe the 
procedure or practice requirements of an agency.'' As such, this 
document is also not subject to Executive Order 12866.

[[Page 21690]]

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 558

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

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. Effective May 10, 2017, in Sec.  510.600, in the table in paragraph 
(c)(1), alphabetically add an entry for ``Anzac Animal Health, LLC'', 
and remove the entry for ``Nexcyon Pharmaceuticals, Inc.''; and in the 
table in paragraph (c)(2), remove the entry for ``050929'', and 
numerically add an entry for ``086073.'' The additions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B,              086073
 Maryland Heights, MO 63043.............................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
086073.......................  Anzac Animal Health, LLC, 218 Millwell
                                Dr., Suite B, Maryland Heights, MO
                                63043.
 
                              * * * * * * *
------------------------------------------------------------------------

Sec.  510.600  [Amended]

0
3. Effective May 22, 2017, in Sec.  510.600, in the table in paragraph 
(c)(1), remove the entry for ``Sioux Biochemical, Inc.'' .''; and in 
the table in paragraph (c)(2), remove the entry for ``063112''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
4. The authority citation for part 520 continues to read as follows:

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

Sec.  520.48   [Amended]

0
5. In Sec.  520.48, in paragraph (b), remove ``013744'' and in its 
place add ``061623''.

Sec.  520.980   [Amended]

0
6. In Sec.  520.980, in paragraph (b), remove ``050929'' and in its 
place add ``055246''.

Sec.  520.1454   [Amended]

0
7. In Sec.  520.1454, in paragraph (b), remove ``000010'' and in its 
place add ``000859''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
8. The authority citation for part 522 continues to read as follows:

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

Sec.  522.90b   [Amended]

0
9. In Sec.  522.90b, in paragraph (a), remove ``50, 100, or 250'' and 
in its place add ``200, 250, or 400''.

Sec.  522.1002   [Amended]

0
10. Effective May 22, 2017, in Sec.  522.1002, remove paragraph (b); 
and redesignate paragraph (c) as paragraph (b).

Sec.  522.1055   [Amended]

0
11. In Sec.  522.1055, in paragraph (b), remove ``Nos. 013744 and 
061623'' and in its place add ``No. 013744''.

Sec.  522.1362   [Amended]

0
12. In Sec.  522.1362, in paragraph (b), remove ``No. 050604'' and in 
its place add ``Nos. 050604 and 086073''.

Sec.  522.1450   [Amended]

0
13. In Sec.  522.1450, in paragraph (b), remove ``000010'' and in its 
place add ``000859''.

0
14. In Sec.  522.1662a, revise paragraph (e)(1); and in paragraph 
(e)(3)(i)(c), revise the fifth sentence to read as follows:

Sec.  522.1662a   Oxytetracycline hydrochloride injection.

* * * * *
    (e) * * *
    (1) Specifications. Each milliliter of solution contains 100 
milligrams of oxytetracycline hydrochloride.
* * * * *
    (3) * * *
    (i) * * *
    (c) * * * Exceeding the highest recommended dose of 5 milligrams 
per pound of body weight per day, administering more than the 
recommended number of treatments, and/or exceeding 10 milliliters 
intramuscularly or subcutaneously per injection site in adult beef and 
dairy cattle may result in antibiotic residues beyond the withdrawal 
period. * * *
* * * * *

[[Page 21691]]

Sec.  522.2473   [Amended]

0
15. In Sec.  522.2473, in paragraph (b), remove ``013744'' and in its 
place add ``061623''.

0
16. In Sec.  522.2477, revise paragraph (b)(2) and add paragraph (d)(4) 
to read as follows:

Sec.  522.2477   Trenbolone acetate and estradiol.

* * * * *
    (b) * * *
    (2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), 
(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), 
(d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), 
(d)(3)(ii), (d)(3)(iii), and (d)(4) of this section.
* * * * *
    (d) * * *
    (4) Beef steers and heifers fed in confinement for slaughter--(i) 
Amount. Each extended- and delayed-release implant contains 200 mg 
trenbolone acetate and 20 mg estradiol (one implant consisting of 10 
pellets, each pellet containing 20 mg trenbolone acetate and 2 mg 
estradiol) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency during 70 to 200 days after implantation.
    (iii) Limitations. Implant subcutaneously in the ear only. Do not 
use in lactating dairy cows or in animals intended for subsequent 
breeding. Use in these cattle may cause drug residues in milk and/or in 
calves born to these cows. Do not use in calves to be processed for 
veal. A withdrawal period has not been established for this product in 
pre-ruminating calves. Effectiveness and animal safety in veal calves 
have not been established. Not approved for repeated implantation 
(reimplantation) with this or any other cattle ear implant during the 
production phase(s) identified on labeling (beef steers and heifers fed 
in confinement for slaughter) unless otherwise indicated on labeling 
because safety and effectiveness have not been evaluated.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
17. The authority citation for part 524 continues to read as follows:

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

Sec.  524.1450   [Amended]

0
18. In Sec.  524.1450, in paragraph (b)(1), remove ``000010'' and in 
its place add ``000859''.

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

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

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

Sec.  558.4   [Amended]

0
20. In Sec.  558.4, in paragraph (d), in the Category I table, remove 
the row entry for ``Penicillin''; and in the Category II table, remove 
the row entry for ``Sulfamethazine'' the first time it appears only 
along with the subsequent entries for ``Chlortetracycline'' and 
``Penicillin''.

Sec.  558.76   [Amended]

0
21. In Sec.  558.76, remove and reserve paragraph (e)(1)(vii).

0
22. In Sec.  558.115, revise paragraph (d)(4) to read as follows:

Sec.  558.115   Carbadox.

* * * * *
    (d) * * *
    (4) Carbadox may also be used in combination with oxytetracycline 
as in Sec.  558.450.

0
23. Amend Sec.  558.128 as follows:
0
a. In paragraph (b)(1), remove ``50, 65, or 100'' and in its place add 
``50, 90, or 100'';
0
b. In paragraphs (e)(1)(i) and (v), in the ``Limitations'' column, 
remove ``Do not feed to chickens producing eggs for human 
consumption.'' and in its place add ``For No. 066104: Do not feed to 
chickens producing eggs for human consumption.'';
0
c. In paragraph (e)(3)(v), in the ``Sponsor'' column, add ``054771'' 
before ``069254'';
0
d. In paragraph (e)(4)(iii), in the ``Indications for use'' column, 
remove ``anaplsmosis'' and in its place add ``anaplasmosis''; and
0
e. Redesignate paragraphs (e)(4)(xxiv) and (xxv) as paragraphs 
(e)(4)(xxv) and (xxvi), respectively, and add new paragraph 
(e)(4)(xxiv).
    The addition reads as follows:

Sec.  558.128   Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
    Chlortetracycline amount          grams/ton              use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(xxiv) 25 to 2,800 to provide    Lasalocid, 30 to    Beef cattle         Hand feed continuously           054771
 350 mg/head/day.                 181.8.              weighing under      at a rate of 350 mg
                                                      700 pounds: For     chlortetracycline and
                                                      control of active   1 mg lasalocid per 2.2
                                                      infection of        lb. body weight daily
                                                      anaplasmosis        to cattle with a
                                                      caused by           maximum of 360 mg of
                                                      Anaplasma           lasalocid per head per
                                                      marginale           day. Do not allow
                                                      susceptible to      horses or other
                                                      chlortetracycline   equines access to
                                                      ; and for the       feeds containing
                                                      control of          lasalocid. No
                                                      coccidiosis         withdrawal period is
                                                      caused by Eimeria   required. A withdrawal
                                                      bovis and E.        period has not been
                                                      zuernii.            established for this
                                                                          product in pre-
                                                                          ruminating calves. Do
                                                                          not use in calves to
                                                                          be processed for veal.
                                                                          See Sec.   558.311(d)
                                                                          of this chapter.
                                                                          Chlortetracycline and
                                                                          lasalocid as provided
                                                                          by No. 054771 in Sec.
                                                                           510.600(c) of this
                                                                          chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec.  558.140   [Amended]

0
24. In Sec.  558.140, in paragraph (b)(1), remove ``(d)(1)'' and in its 
place add ``(e)(1)''; and in paragraph (b)(2), remove ``(d)(2)'' and in 
its place add ``(e)(2)''.

0
25. In Sec.  558.325, redesignate paragraphs (e)(2)(vii) to (xvi) as

[[Page 21692]]

paragraphs (e)(2)(viii) to (xvii), respectively, and add new paragraph 
(e)(2)(vii) to read as follows:

Sec.  558.325  Lincomycin.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
      Lincomycin grams/ton            grams/ton              use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(vii) 40.......................  Pyrantel, 800.....  For the treatment   Feed as a single                 066104
                                                      and/or control of   therapeutic treatment
                                                      swine dysentery;    at a rate of 1 lb of
                                                      for removal and     feed per 40 lb of body
                                                      control of large    weight for animals up
                                                      roundworm           to 200 lb and 5 lb of
                                                      (Ascaris suum)      feed per head for
                                                      and nodular worm    animals over 200 lb.
                                                      (Oesophagostomum    Not to be fed to swine
                                                      spp.) infections.   that weigh more than
                                                                          250 pounds. Withdraw
                                                                          24 hours prior to
                                                                          slaughter. See
                                                                          paragraph (d) of this
                                                                          section. Lincomycin as
                                                                          provided by No.
                                                                          054771; pyrantel as
                                                                          provided by No. 066104
                                                                          in Sec.   510.600(c)
                                                                          of this chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
26. In Sec.  558.366, revise paragraph (e) to read as follows:

Sec.  558.366   Nicarbazin.

* * * * *
    (e) Nicarbazin may also be used in combination with:
    (1)-(3) [Reserved]
    (4) Lincomycin as in Sec.  558.325.

Sec.  558.485   [Amended]

0
27. In Sec.  558.485, remove paragraph (e)(1)(iv).

0
28. In Sec.  558.550, add paragraph (d)(5) to read as follows:

Sec.  558.550   Salinomycin.

* * * * *
    (d) * * *
    (5) Salinomycin may also be used in combination with:
    (i)-(ii) [Reserved]
    (iii) Chlortetracycline as in Sec.  558.128.
    (iv) Lincomycin as in Sec.  558.325.

0
29. Amend Sec.  558.625 as follows:
0
a. Revise paragraph (d)(2);
0
b. Add paragraphs (d)(4) and (5);
0
c. In paragraphs (e)(2)(iv), (v), (viii), (x), (xii), and (xiii), in 
the ``Limitations'' column, add a new sentence ``See Sec.  558.355(d) 
in this chapter.'' between the fourth and fifth sentences;
0
d. In paragraph (e)(2)(vi), in the ``Limitations'' column, add a new 
sentence ``See Sec.  558.355(d) in this chapter.'' between the seventh 
and eighth sentences; and
0
e. In paragraphs (e)(2)(vii), (ix), (xi), (xiv), and (xv), in the 
``Limitations'' column, add a new sentence ``See Sec.  558.355(d) in 
this chapter.'' between the fifth and sixth sentences.
    The revisions and additions read as follows:

Sec.  558.625   Tylosin.

* * * * *
    (d) * * *
    (2) The expiration date of VFDs for tylosin medicated feeds must 
not exceed 6 months from the date of issuance. VFDs for tylosin shall 
not be refilled.
* * * * *
    (4) Tylosin liquid Type B medicated feeds must bear an expiration 
date of 31 days after the date of manufacture.
    (5) Do not use tylosin liquid Type B medicated feeds in any liquid 
feed containing sodium metabisulfite or in any finished feed 
(supplement, concentrate, or complete feed) containing in excess of 2 
percent bentonite.
* * * * *

0
30. In Sec.  558.635, revise paragraph (e)(1) to read as follows:

Sec.  558.635   Virginiamycin.

* * * * *
    (e) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
    Virginiamycin grams/ton           grams/ton              use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 20.........................  ..................  Broiler chickens:   Not for use in layers..          066104
                                                      For prevention of
                                                      necrotic
                                                      enteritis caused
                                                      by Clostridium
                                                      perfringens
                                                      susceptible to
                                                      virginiamycin.
(ii) 20........................  Amprolium 72.6 to   Broiler chickens:   For field conditions             066104
                                  113.5.              For prevention of   where only E. tenella
                                                      necrotic            is the major problem,
                                                      enteritis caused    feed continuously as
                                                      by Clostridium      the sole ration. Use
                                                      perfringens         as the sole source of
                                                      susceptible to      amprolium. Do not use
                                                      virginiamycin;      in feeds containing
                                                      and for the         bentonite. Not for use
                                                      prevention of       in laying chickens.
                                                      coccidiosis         Amprolium as provided
                                                      caused by Eimeria   by No. 016592 in Sec.
                                                      tenella.             510.600(c) of this
                                                                          chapter.
(iii) 20.......................  Amprolium 113.5 to  Broiler chickens:   For most field                   066104
                                  227.                For prevention of   conditions as they
                                                      necrotic            exist under modern
                                                      enteritis caused    management practices,
                                                      by Clostridium      feed 113.5 g/ton
                                                      perfringens         amprolium
                                                      susceptible to      continuously. Where
                                                      virginiamycin;      severe coccidiosis
                                                      and for the         conditions exist, feed
                                                      prevention of       227 g/ton. Use as the
                                                      coccidiosis where   sole source of
                                                      immunity to         amprolium. Do not use
                                                      coccidiosis is      in feeds containing
                                                      not desired.        bentonite. Not for use
                                                                          in laying chickens.
                                                                          Amprolium as provided
                                                                          by No. 016592 in Sec.
                                                                           510.600(c) of this
                                                                          chapter.

[[Page 21693]]

 
(iv) 20........................  Diclazuril 0.91...  Broiler chickens:   Feed continuously as             016592
                                                      For prevention of   the sole ration. Do
                                                      necrotic            not use in hens
                                                      enteritis caused    producing eggs for
                                                      by Clostridium      human food. Diclazuril
                                                      perfringens         as provided by No.
                                                      susceptible to      016592 in Sec.
                                                      virginiamycin;      510.600(c) of this
                                                      and for the         chapter.
                                                      prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      tenella, E.
                                                      necatrix, E.
                                                      acervulina, E.
                                                      brunetti, E.
                                                      mitis (mivati),
                                                      and E. maxima.
                                                      Because
                                                      diclazuril is
                                                      effective against
                                                      E. maxima late in
                                                      its life cycle,
                                                      subclinical
                                                      intestinal
                                                      lesions may be
                                                      present for a
                                                      short time after
                                                      infection.
                                                      Diclazuril was
                                                      shown in studies
                                                      to reduce lesions
                                                      scores and
                                                      improve
                                                      performance and
                                                      health of birds
                                                      challenged with
                                                      E. maxima.
(v) 20.........................  Lasalocid 68 to     Broiler chickens:   Feed continuously as             066104
                                  113.                For prevention of   the sole ration. Do
                                                      necrotic            not feed to laying
                                                      enteritis caused    chickens. For broiler
                                                      by Clostridium      or fryer chickens
                                                      perfringens         only. Lasalocid as
                                                      susceptible to      provided by No. 054771
                                                      virginiamycin;      in Sec.   510.600(c)
                                                      and for the         of this chapter.
                                                      prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      tenella, E.
                                                      necatrix, E.
                                                      acervulina, E.
                                                      brunetti, E.
                                                      mivati, and E.
                                                      maxima.
(vi) 20........................  Monensin 90 to 110  Broiler chickens:   Feed continuously as             066104
                                                      For prevention of   the sole ration. Do
                                                      necrotic            not feed to laying
                                                      enteritis caused    chickens. See Sec.
                                                      by Clostridium      558.355(d) in this
                                                      perfringens         chapter. Monensin as
                                                      susceptible to      provided by No. 058198
                                                      virginiamycin;      in Sec.   510.600(c)
                                                      and as an aid in    of this chapter.
                                                      the prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      necatrix, E.
                                                      tenella, E.
                                                      acervulina, E.
                                                      brunetti, E.
                                                      maxima, and E.
                                                      mivati.
(vii) 20.......................  Salinomycin 40 to   Broiler chickens:   Feed continuously as     ..............
                                  60.                 For prevention of   the sole ration. Do
                                                      necrotic            not feed to chickens
                                                      enteritis caused    over 16 weeks of age.
                                                      by Clostridium      Do not feed to laying
                                                      perfringens         chickens. Not approved
                                                      susceptible to      for use with pellet
                                                      virginiamycin;      binders. May be fatal
                                                      and for the         if accidentally fed to
                                                      prevention of       adult turkeys or
                                                      coccidiosis         horses. Salinomycin as
                                                      caused by Eimeria   provided by No. 016592
                                                      tenella, E.         in Sec.   510.600(c)
                                                      necatrix, E.        of this chapter.
                                                      acervulina, E.
                                                      maxima, E.
                                                      brunetti, and E.
                                                      mivati.
(viii) 20......................  Semduramicin 22.7.  Broiler chickens:   Feed continuously as             066104
                                                      For prevention of   the sole ration. Do
                                                      necrotic            not feed to laying
                                                      enteritis caused    hens. Semduramicin as
                                                      by Clostridium      provided by No. 066104
                                                      perfringens         in Sec.   510.600(c)
                                                      susceptible to      of this chapter.
                                                      virginiamycin;
                                                      and for the
                                                      prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      acervulina, E.
                                                      brunetti, E.
                                                      maxima, E mivati/
                                                      mitis, E.
                                                      necatrix, and E.
                                                      tenella.
(ix) 20........................  Semduramicin        Broiler chickens:   Feed continuously as             066104
                                  (biomass) 22.7.     For prevention of   the sole ration.
                                                      necrotic            Withdraw 1 day before
                                                      enteritis caused    slaughter. Do not feed
                                                      by Clostridium      to laying hens.
                                                      perfringens         Semduramicin as
                                                      susceptible to      provided by No. 066104
                                                      virginiamycin;      in Sec.   510.600(c)
                                                      and for the         of this chapter.
                                                      prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      acervulina, E.
                                                      brunetti, E.
                                                      maxima, E mivati/
                                                      mitis, E.
                                                      necatrix, and E.
                                                      tenella.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
31. In Sec.  558.680, remove paragraph (e) and add paragraph (d)(3) to 
read as follows:

Sec.  558.680  Zoalene.

* * * * *
    (d) * * *
    (3) Zoalene may also be used in combination with:
    (i)-(ii) [Reserved]
    (iii) Lincomycin as in Sec.  558.325.

[[Page 21694]]

    Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09364 Filed 5-9-17; 8:45 am]
 BILLING CODE 4164-01-P