80 FR 13226 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 49 (March 13, 2015)

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2014. 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 sponsorship of eight NADAs and nine ANADAs, and to make correcting amendments for a drug labeler code.

[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Rules and Regulations]
[Pages 13226-13232]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05644]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 556, and 558

[Docket No. FDA-2014-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval actions for new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during November and December 2014. 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 sponsorship 
of eight NADAs and nine ANADAs, and to make correcting amendments for a 
drug labeler code.

DATES: This rule is effective March 13, 2015.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during November and 
December 2014, 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.
    In addition, Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 
68144, has transferred ownership of, and all rights and interest in, 
the following approved applications to Pharmgate LLC, 161 North 
Franklin Turnpike, Suite 2C, Ramsey, NJ 07446:

------------------------------------------------------------------------
      File No.                 Product name               21 CFR Cite
------------------------------------------------------------------------
065-480............  Chlortetracycline Soluble Powder  520.441.
138-934............  PENNCHLOR SP (chlortetracycline,  558.145.
                      sulfamethazine, penicillin)
                      Type A medicated articles.
138-935............  PENNCHLOR (chlortetracycline)     558.128.
                      Type A medicated articles.
138-938............  PENNOX (oxytetracycline) Type A   558.450.
                      medicated articles.
138-939............  NEO-OXY (neomycin sulfate and     558.455.
                      oxytetracycline) Type A
                      medicated articles.
140-680............  TYLAN (tylosin phosphate) Type A  558.625.
                      medicated articles.
140-681............  TYLAN Sulfa-G (tylosin phosphate  558.630.
                      and sulfamethazine) Type A
                      medicated articles.
141-137............  PENITRACIN (bacitracin            Not codified.
                      methylenedisalicylate) 50 Type
                      A medicated article.
200-026............  PENNOX 343 (oxytetracycline)....  520.1660d.
200-154............  PENNOX 200 (oxytetracycline)....  558.450.
200-295............  PENNCHLOR 64 (chlortetracycline)  558.128.
200-314............  PENNCHLOR S (chlortetracycline).  558.140.
200-354............  PENNCHLOR (chlortetracycline)/    558.355.
                      COBAN (monensin).
200-356............  PENNCHLOR (chlortetracycline)/    558.600.
                      DENAGARD (tiamulin).

[[Page 13227]]

 
200-357............  PENNCHLOR (chlortetracycline)/    558.550.
                      BIO-COX (salinomycin).
200-358............  PENNCHLOR (chlortetracycline)/    558.76.
                      BMD (bacitracin MD).
200-359............  PENNCHLOR (chlortetracycline)/    558.195.
                      DECCOX (decoquinate).
------------------------------------------------------------------------

    At this time, the regulations are being amended to reflect these 
changes of sponsorship. Following these changes of sponsorship, 
Pharmgate LLC will now be the sponsor of an approved application while 
Pennfield Oil Co. will no longer be the sponsor of an approved 
application. Also, Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader 
Wadi Seer, Amman, Jordan 11118, has informed FDA that it has changed 
its name to Hikma International Pharmaceuticals LLC. Accordingly, Sec.  
510.600 (21 CFR 510.600) is being amended to reflect these changes. In 
addition, FDA is amending Sec.  510.600 and several sections of part 
520 to reflect a correct drug labeler code for Akorn Animal Health, 
Inc. FDA is also amending the regulations in 21 CFR parts 520, 522, 
556, and 558 to redesignate several sections to reflect alphabetical 
order and to make minor technical amendments. These corrections and 
technical amendments are being made to improve the accuracy of the 
animal drug regulations.

                             Table 1--Original and Supplemental NADAs and ANADAs Approved During November and December 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      New animal drug  product                                        21 CFR        FOIA         NEPA
      NADA/  ANADA                 Sponsor                      name                          Action                 Sections     Summary       Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-575................  Putney, Inc., One Monument  Carprofen Chewable         Original approval as a generic         520.309          yes   CE \1\ \2\
                          Sq., suite 400, Portland,   Tablets.                   copy of NADA 141-111.
                          ME 04101.
141-232................  Zoetis Inc., 333 Portage    SIMPLICEF (cefpodoxime     Supplemental approval of chewable      520.370          yes   CE \1\ \3\
                          St., Kalamazoo, MI 49007.   proxetil) Chewable         tablet dosage form for dogs.
                                                      Tablets.
200-512................  Zoetis Inc., 333 Portage    TRIAMULOX (tiamulin        Original approval as a generic        520.2455          yes   CE \1\ \2\
                          St., Kalamazoo, MI 49007.   hydrogen fumarate)         copy of NADA 140-916.
                                                      Liquid Concentrate.
200-573................  Putney, Inc., One Monument  Dexmedetomidine HCl......  Original approval as a generic         522.558          yes   CE \1\ \2\
                          Sq., suite 400, Portland,  (dexmedetomidine            copy of NADA 141-267.
                          ME 04101.                   hydrochloride).
                                                     Injectable Solution......
141-068................  Bayer HealthCare LLC,       BAYTRIL 100                Supplemental approval adding           522.812          yes    CE\1\ \4\
                          Animal Health Division,     (enrofloxacin).            administration by intramuscular
                          P.O. Box 390, Shawnee      Injectable Solution......   injection in swine and an
                          Mission, KS 66201.                                     indication for control of
                                                                                 colibacillosis in groups or pens
                                                                                 of weaned pigs.
141-349................  Zoetis Inc., 333 Portage    DRAXXIN 25...............  Supplemental approval for             522.2630          yes   CE \1\ \4\
                          St., Kalamazoo, MI 49007.  (tulathromycin)..........   treatment of bovine respiratory
                                                     Injectable Solution......   disease (BRD) in suckling
                                                                                 calves, dairy calves, and veal
                                                                                 calves.
141-437................  Novartis Animal Health US,  OSURNIA..................  Original approval for the              524.955          yes   CE \1\ \3\
                          Inc., 3200 Northline       (florfenicol,               treatment of otitis externa in
                          Ave., suite 300,            terbinafine,               dogs.
                          Greensboro, NC 27408.       betamethasone acetate)
                                                      Otic Gel.
034-267................  Intervet, Inc., 556 Morris  GENTOCIN DURAFILM........  Supplemental approval of             524.1044i          yes   CE \1\ \3\
                          Ave., Summit, NJ 07901.    (gentamicin sulfate and     additional safety information.
                                                      betamethasone).
                                                     Ophthalmic Solution......
141-034................  Huvepharma AD, 5th Floor,   GAINPRO..................  Supplemental approval of a free-        558.95          yes   CE \1\ \2\
                          3A Nikolay Haytov Str.,    (bambermycins)...........   choice Type C medicated loose
                          1113 Sophia, Bulgaria.     Type A medicated article.   mineral feed without selenium
                                                                                 for pasture cattle.
200-510 \5\............  Pharmgate LLC, 161 North    DERACIN..................  Original approval as a generic         558.128          yes   CE \1\ \2\
                          Franklin Turnpike, suite   (chlortetracycline)......   copy of NADA 048-761.
                          2C, Ramsey, NJ 07446.      Type A medicated articles
141-258................  Intervet, Inc., 556 Morris  ZILMAX (zilpaterol         Supplemental approval to provide       558.665          yes   CE \1\ \2\
                          Ave., Summit, NJ 07901.     hydrochloride) Type A      for component feeding of Type C
                                                      medicated article.         medicated feeds.

[[Page 13228]]

 
141-276 \5\............  Intervet, Inc., 556 Morris  ZILMAX (zilpaterol         Supplemental approval to provide       558.665          yes   CE \1\ \6\
                          Ave., Summit, NJ 07901.     hydrochloride) plus        for component feeding of
                                                      RUMENSIN (monensin) plus   combination drug Type C
                                                      TYLAN (tylosin             medicated feeds.
                                                      phosphate) Type C
                                                      medicated feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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(a)(1).
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(d)(5).
\5\ This application is 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.
\6\ CE granted under 21 CFR 25.33(a)(2).

    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 21 CFR part 510 continues to read as 
follows:

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


0
2. Amend Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1), in the entry for ``Akorn Animal 
Health, Inc.'', in the ''Drug labeler code'' column, remove ``053599'', 
and in its place add ``059399'';
0
b. In the table in paragraph (c)(1), in the entry for ``Hikma 
Pharmaceuticals LLC'', in the ``Firm name and address'' column, remove 
``Hikma Pharmaceuticals LLC'', and in its place add ``Hikma 
International Pharmaceuticals LLC'';
0
c. In the table in paragraph (c)(1), remove the entry for ``Pennfield 
Oil Co.'' and add an entry, in alphabetical order, for ``Pharmgate 
LLC'';
0
d. In the table in paragraph (c)(2), remove the entries for ``000008'', 
``048164'', and ``053599'' and add entries, in numerical order, for 
``059399'' and ``069254''; and
0
e. In the table in paragraph (c)(2), in the entry for ``059115'', in 
the ``Firm name and address'' column, remove ``Hikma Pharmaceuticals 
LLC'', and in its place add ``Hikma International Pharmaceuticals 
LLC''.
    The additions and revisions 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
------------------------------------------------------------------------
 
                              * * * * * * *
Pharmgate LLC, 161 North Franklin Turnpike, suite 2C,             069254
 Ramsey, NJ 07446.......................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
059399......................  Akorn Animal Health, Inc., 1925 West Field
                               Ct., suite 300, Lake Forest, IL 60045
 
                              * * * * * * *
069254......................  Pharmgate LLC, 161 North Franklin
                               Turnpike, suite 2C, Ramsey, NJ 07446
 

[[Page 13229]]

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

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec. Sec.  520.310 and 520.312   [Redesignated as Sec. Sec.  520.301 
and 520.302]

0
4. Redesignate Sec. Sec.  520.310 and 520.312 as Sec. Sec.  520.301 and 
520.302, respectively.


Sec.  520.309  [Redesignated as Sec.  520.304 and Amended]

0
5. Redesignate Sec.  520.309 as Sec.  520.304 and revise newly 
redesignated Sec.  520.304 by adding paragraph (b)(3) to read as 
follows:


Sec.  520.304  Carprofen.

* * * * *
    (b) * * *
    (3) No. 026637 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d) of this section.
* * * * *

0
6. In Sec.  520.370, revise paragraphs (a) and (b) and in paragraph 
(c)(2), remove ``intermedius'' and in its place add 
``pseudintermedius'' to read as follows:


Sec.  520.370  Cefpodoxime tablets.

    (a) Specifications. (1) Each tablet contains cefpodoxime proxetil 
equivalent to 100 or 200 milligrams (mg) cefpodoxime.
    (2) Each chewable tablet contains cefpodoxime proxetil equivalent 
to 100 or 200 mg cefpodoxime.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as follows:
    (1) No. 026637 for use of product in paragraph (a)(1) of this 
section as in paragraph (c) of this section.
    (2) No. 054771 for use of products in paragraph (a) of this section 
as in paragraph (c) of this section.
* * * * *


Sec.  520.441  [Amended]

0
7. In Sec.  520.441, in paragraph (b)(1), remove ``048164'' and in its 
place add ``069254''.

0
8. Amend Sec.  520.1660d as follows:
0
a. In paragraph (b)(6), remove ``048164'' and in its place add 
``069254''.
0
b. In paragraphs (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and 
(d)(1)(ii)(C)(3), revise the last sentence.
    The revisions read as follows:


Sec.  520.1660d  Oxytetracycline powder.

* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (A) * * *
    (3) * * * Zero-day withdrawal for those products sponsored by Nos. 
054771, 057561, 061133, and 069254.
    (B) * * *
    (3) * * * Zero-day withdrawal for those products sponsored by Nos. 
054771, 057561, 061133, and 069254.
    (C) * * *
    (3) * * * Zero-day withdrawal for those products sponsored by Nos. 
054771, 057561, 061133, and 069254.
* * * * *

0
9. In Sec.  520.2455, revise paragraphs (b)(3) and (c) to read as 
follows:


Sec.  520.2455  Tiamulin.

* * * * *
    (b) * * *
    (3) No. 054771 for the product described in paragraph (a)(3) of 
this section.
    (c) Related tolerances. See Sec.  556.732 of this chapter.
* * * * *

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

0
10. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec.  522.246  [Amended]

0
11. In Sec.  522.246, in paragraph (b)(3), remove ``053599'' and in its 
place add ``059399''.

0
12. In Sec.  522.558, revise paragraphs (a) and (b) to read as follows:


Sec.  522.558  Dexmedetomidine.

    (a) Specifications. Each milliliter of solution contains:
    (1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or
    (2) 0.5 mg dexmedetomidine hydrochloride.
    (b) Sponsors. See sponsors in in Sec.  510.600(c) of this chapter 
for use as in paragraph (c) of this section:
    (1) No. 026637 for use of product described in paragraph (a)(2) of 
this section;
    (2) No. 052483 for use of products described in paragraph (a) of 
this section.
* * * * *

0
13. Amend Sec.  522.812 as follows:
0
a. Revise paragraph (b)(2);
0
b. Remove paragraph (e)(3)(i);
0
c. Redesignate paragraphs (e)(3)(ii) and (e)(3)(iii) as paragraphs 
(e)(3)(i) and (e)(3)(ii), respectively; and
0
d. Revise newly redesignated paragraph (e)(3)(i).
    The revisions 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) of this section as in paragraphs 
(e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i)(B), and (e)(3)(ii) 
of this section.
* * * * *
    (e) * * *
    (3) * * *
    (i) Amounts and indications for use. (A) Administer, either by 
intramuscular or subcutaneous (behind the ear) injection, a single dose 
of 7.5 mg/kg of body weight for the treatment and control of swine 
respiratory disease (SRD) associated with Actinobacillus 
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, 
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma 
hyopneumoniae.
    (B) Administer, by subcutaneous (behind the ear) injection, a 
single dose of 7.5 mg/kg of body weight for the treatment and control 
of swine respiratory disease (SRD) associated with Actinobacillus 
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and 
Streptococcus suis.
    (C) Administer, either by intramuscular or subcutaneous (behind the 
ear) injection, a single dose of 7.5 mg/kg of body weight for the 
control of colibacillosis in groups or pens of weaned pigs where 
colibacillosis associated with Escherichia coli has been diagnosed.
* * * * *

0
14. In Sec.  522.1222, revise paragraph (b) to read as follows:


Sec.  522.1222  Ketamine.

* * * * *

[[Page 13230]]

    (b) Sponsors. See Nos. 000859, 026637, 054628, 054771, 059399, and 
063286 in Sec.  510.600(c) of this chapter.
* * * * *


Sec.  522.2474  [Amended]

0
15. In Sec.  522.2474, in paragraph (b), remove ``053599'' and in its 
place add ``059399''.

0
16. In Sec.  522.2630, revise paragraphs (b)(1), (b)(2), (d)(1)(ii)(A), 
(d)(1)(ii)(B), and (d)(1)(iii) to read as follows:


Sec.  522.2630  Tulathromycin.

* * * * *
    (b) * * *
    (1) Product described as in paragraph (a)(1) of this section for 
use as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) 
of this section.
    (2) Product described as in paragraph (a)(2) of this section for 
use as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and 
(d)(2) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (A) Beef and non-lactating dairy cattle. For the treatment of 
bovine respiratory disease (BRD) associated with Mannheimia 
haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma 
bovis. For the control of respiratory disease in cattle at high risk of 
developing BRD associated with M. haemolytica, P. multocida, H. somni, 
and M. bovis. For the treatment of infectious bovine 
keratoconjunctivitis (IBK) associated with Moraxella bovis. For the 
treatment of bovine foot rot (interdigital necrobacillosis) associated 
with Fusobacterium necrophorum and Porphyromonas levii.
    (B) Suckling calves, dairy calves, and veal calves. For the 
treatment of bovine respiratory disease (BRD) associated with 
Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and 
Mycoplasma bovis.
    (iii) Limitations. (A) Cattle intended for human consumption must 
not be slaughtered within 18 days from the last treatment. Do not use 
in female dairy cattle 20 months of age or older. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (B) Calves intended for human consumption must not be slaughtered 
within 22 days from the last treatment. Not for use in ruminating 
cattle. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
* * * * *


Sec.  522.2662  [Amended]

0
17. In Sec.  522.2662, in paragraph (b)(4), remove ``053599'' and in 
its place add ``059399''.


Sec.  522.2670  [Amended]

0
18. In Sec.  522.2670, in paragraph (b)(1), remove ``053599'' and in 
its place add ``059399''.

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

0
19. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


0
20. Add Sec.  524.955 to read as follows:


Sec.  524.955  Florfenicol, terbinafine, and betamethasone acetate otic 
gel.

    (a) Specifications. Each milliliter of gel contains 10 milligrams 
(mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer one dose (1 
tube) per affected ear(s) and repeat administration in 7 days.
    (2) Indications for use. For the treatment of otitis externa in 
dogs associated with susceptible strains of bacteria (Staphylococcus 
pseudintermedius) and yeast (Malassezia pachydermatis).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
21. In Sec.  524.1044i, revise paragraph (c)(2) to read as follows:


Sec.  524.1044i  Gentamicin and betamethasone ophthalmic solution.

* * * * *
    (c) * * *
    (2) Indications for use. For treatment of external eye infections 
and inflammation.
* * * * *

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

0
22. The authority citation for 21 CFR part 556 continues to read as 
follows:

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

Sec.  556.738  [Redesignated as Sec.  556.732]

0
23. Redesignate Sec.  556.738 as Sec.  556.732.

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

0
24. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

Sec.  558.76  [Amended]

0
25. In Sec.  558.76, in paragraph (d)(1)(iv), in the ``Limitations'' 
and ``Sponsor'' columns, remove ``048164'' and in its place add 
``069254''.

0
26. In Sec.  558.95, add paragraph (d)(4)(v) to read as follows:


Sec.  558.95  Bambermycins.

* * * * *
    (d) * * *
    (4) * * *
    (v) Used as a free-choice Type C medicated loose mineral feed for 
pasture cattle (slaughter, stocker, and feeder cattle; and dairy and 
beef replacement heifers) as follows:
    (A) Specifications.

------------------------------------------------------------------------
                                        International
             Ingredient                   feed No.           Percent
------------------------------------------------------------------------
Deflorinated phosphate (20.5%                 6-01-080             42.50
 calcium, 18.5% phosphorus).........
Sodium chloride (salt)..............          6-04-152             20.10
Calcium carbonate (38% calcium).....          6-01-069             15.45
Corn distillers dried grains w/               5-28-236              9.57
 solubles...........................
Magnesium oxide.....................          6-02-756              5.15
Vitamin and trace mineral premix *..  ................              3.72
Mineral oil.........................  ................              1.00
Yeast (primary dehydrated yeast)....          7-05-533              0.75
Bambermycins Type A article (10 g/    ................              0.60
 lb)................................
Iron oxide..........................          6-02-431              0.50
Magnesium sulfate (67%).............          6-02-758              0.32
Copper sulfate......................          6-01-720              0.18

[[Page 13231]]

 
Potassium sulfate (0.33%)...........          6-06-098              0.16
------------------------------------------------------------------------
* Content of vitamin/trace mineral premix may be varied. However, they
  should be comparable to those used for other free-choice feeds.
  Formulation modifications require FDA approval prior to marketing.
  Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
  Policy Guides Sec. 651.100 (CPG 7125.18).

    (B) Amount per ton. 120 grams.
    (C) Indications for use. For increased rate of weight gain.
    (D) Limitations. For free-choice feeding to pasture cattle 
(slaughter, stocker, and feeder cattle; and dairy and beef replacement 
heifers). Feed a non-medicated commercial mineral product for 6 weeks 
to stabilize consumption between 2.66 and 10.66 ounces per head per 
day. Feed continuously to provide 10 to 40 milligrams bambermycins per 
head per day. Daily bambermycins intakes in excess of 20 mg/head/day 
have not been shown to be more effective than 20 mg/head/day.
* * * * *

0
27. Amend Sec.  558.128 as follows:
0
a. In paragraph (b)(1), remove ``Nos. 054771, 048164, and 066104'' and 
in its place add ``Nos. 054771, 066104, and 069254'';
0
b. In paragraphs (e)(4)(ii) and (iv), in the ``Limitations'' column, 
remove ``048164'' wherever it occurs and in its place add ``069254'';
0
c. In paragraphs (e)(1)(i), (ii), and (iii), (e)(2)(i), (ii), (iii), 
and (iv), (e)(3)(i), (ii), (iii), and (iv), (e)(4)(i), (ii), (iv), 
(vii), and (viii), and (e)(5)(i) and (ii), in the ``Sponsor'' column, 
remove ``048164'' wherever it occurs and in its place in numerical 
order add ``069254''; and
0
d. Revise paragraphs (e)(1)(iv), (e)(4)(v), and (e)(4)(ix).
    The revisions read as follows:


Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
        Chlortetracycline amount             Indications for use               Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 500 g/ton.........................  Chickens: For the           1. Feed for 5 d. To sponsor         054771,
                                          reduction of mortality      No. 054771 under NADA 048-761      069254.
                                          due to E. coli infections   and No. 069254 under ANADA
                                          susceptible to              200-510: zero withdrawal time.
                                          chlortetracycline.
                                                                     2. Feed for 5 d; withdraw 24 h      012286,
                                                                      prior to slaughter; do not         054771,
                                                                      feed to chickens producing         066104,
                                                                      eggs for human consumption.        069254.
----------------------------------------------------------------------------------------------------------------

* * * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
        Chlortetracycline amount             Indications for use               Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(v) 500 to 4,000 g/ton.................  Calves, beef and            Feed continuously for not more       054771
                                          nonlactating dairy          than 5 days to provide 10 mg/       069254
                                          cattle; treatment of        lb body weight per day. To
                                          bacterial enteritis         sponsor No. 054771 under NADA
                                          caused by E. coli and       046-699: 24-h withdrawal time.
                                          bacterial pneumonia        To sponsor No. 054771 under
                                          caused by P. multocida      NADA 048-761 and No. 069254
                                          susceptible to              under ANADA 200-510: Zero
                                          chlortetracycline.          withdrawal time.
 
                                                  * * * * * * *
(ix) 350 mg/head/day...................  1. Beef cattle: For         Withdraw 48 h prior to              012286,
                                          control of bacterial        slaughter. To sponsor No.          054771,
                                          pneumonia associated with   054771 under NADA 046-699: 48-     066104,
                                          shipping fever complex      h withdrawal time. To sponsor      069254.
                                          caused by Pasteurella       No. 054771 under NADA 048-761
                                          spp. susceptible to         and No. 069254 under ANADA
                                          chlortetracycline.          200-510: Zero withdrawal time.
                                         2. Beef cattle (under 700   Withdraw 48 h prior to              012286,
                                          lb): For control of         slaughter. To sponsor No.          054771,
                                          active infection of         054771 under NADA 046-699: 48-     066104,
                                          anaplasmosis caused by A.   h withdrawal time. To sponsor      069254.
                                          marginale susceptible to    No. 054771 under NADA 048-761
                                          chlortetracycline.          and No. 069254 under ANADA
                                                                      200-510: zero withdrawal time.
----------------------------------------------------------------------------------------------------------------

* * * * *


Sec.  558.140  [Amended]

0
28. In Sec.  558.140, in paragraph (b)(1), remove ``048164'' and in its 
place add ``069254''.


Sec.  558.145  [Amended]

0
29. In Sec.  558.145, in paragraph (a)(2), remove ``048164'' and in its 
place add ``069254''.


Sec.  558.195  [Amended]

0
30. In Sec.  558.195, in paragraph (e)(2)(iv), in the ``Limitations'' 
and ``Sponsor'' columns, remove ``048164'' and in its place add 
``069254''.


Sec.  558.355  [Amended]

0
31. In Sec.  558.355, in paragraph (f)(1)(xiv)(b), remove ``048164'' 
and in its place add ``069254''.

[[Page 13232]]

Sec.  558.450  [Amended]

0
32. Amend Sec.  558.450 as follows:
0
a. In paragraph (a)(2), remove ``048164'' and in its place add 
``069254'';
0
b. In paragraphs (d)(2)(iii), (d)(2)(iv), and (d)(4)(ii), in the 
``Limitations'' column, remove ``048164'' wherever it occurs and in its 
place add ``069254''; and
0
c. In paragraphs (d)(1)(i), (ii), (iii), and (iv), (d)(2)(i), (ii), 
(iii), and (iv), (d)(3)(i) and (ii), (d)(4)(i), (ii), (iii), (iv), and 
(v), and (d)(5)(i), (ii), and (iii), in the ``Sponsor'' column, remove 
``048164'' and in its place add ``069254''.


Sec.  558.455  [Amended]

0
33. Amend Sec.  558.455 as follows:
0
a. In paragraph (b), remove ``Nos. 048164 and 066104'' and in its place 
add ``Nos. 066104 and 069254''; and
0
b. In paragraphs (e)(1)(i), (ii), (iii), and (iv), (e)(2)(i), (ii), 
(iii), and (iv), (e)(3)(i) and (ii), and (e)(4)(i), (ii), (iii), (iv), 
(v), and (vi), in the ``Sponsor'' column, remove ``048164'' and in its 
place in numerical order add ``069254''.


Sec.  558.550  [Amended]

0
34. In Sec.  558.550, in paragraphs (b)(3) and (d)(1)(xvi)(c), remove 
``048164'' and in its place add ``069254''.


Sec.  558.600  [Redesignated as Sec.  558.612 and Amended]

0
35. Redesignate Sec.  558.600 as Sec.  558.612 and amend newly 
redesignated Sec.  558.612 as follows:
0
a. In paragraph (c), remove ``Sec.  556.738'' and in its place add 
``Sec.  556.732''; and
0
b. In paragraph (e)(1)(iii), in the ``Limitations'' and ``Sponsor'' 
columns, remove ``048164'' and in its place in numerical order add 
``069254''.


Sec.  558.615  [Redesignated as Sec.  558.600]

0
36. Redesignate Sec.  558.615 as Sec.  558.600.


Sec.  558.625  [Amended]

0
37. In Sec.  558.625, in paragraph (b)(5), remove ``048164'' and in its 
place add ``069254''.


Sec.  558.630  [Amended]

0
38. In Sec.  558.630, in paragraph (b)(2), remove ``No. 054771'' and in 
its place add ``Nos. 054771 and 069254''.

0
39. Amend Sec.  558.665 as follows:
0
a. Revise paragraphs (d)(1) and (e)(1);
0
b. Redesignate paragraph (d)(2) as paragraph (d)(4); and
0
c. Add paragraphs (d)(2), (d)(3), (e)(7), and (e)(8).
    The revisions and additions read as follows:


Sec.  558.665  Zilpaterol.

* * * * *
    (d) * * *
    (1) Labeling shall bear the following caution statements: 
``Zilpaterol hydrochloride is not for use in animals intended for 
breeding. Do not allow horses or other equines access to feed 
containing zilpaterol. Do not use in veal calves.''
    (2) Labeling of Type A medicated articles and Type B medicated 
feeds used to manufacture complete Type C medicated feeds shall bear 
the caution statements in paragraph (d)(3) of this section.
    (3) Labeling of complete Type C medicated feeds shall bear the 
following caution statements: ``Not to be fed to cattle in excess of 90 
mg zilpaterol/head/day in complete feed. If pen consumption of complete 
feed exceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol 
should not be fed in complete feed.''
* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination grams/
     Zilpaterol in grams/ton              ton            Indications for use        Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 6.8.........................  ...................  Cattle fed in            Feed continuously         000061
                                                        confinement for          as the sole ration
                                                        slaughter: For           during the last 20
                                                        increased rate of        to 40 days on feed
                                                        weight gain, improved    to provide 60 to
                                                        feed efficiency, and     90 mg/head/day.
                                                        increased carcass        Withdrawal period:
                                                        leanness in cattle fed   3 days.
                                                        in confinement for
                                                        slaughter during the
                                                        last 20 to 40 days on
                                                        feed.
 
                                                  * * * * * * *
(7) 6.8 to 24...................  ...................  Cattle fed in            Feed continuously         000061
                                                        confinement for          to cattle during
                                                        slaughter: For           the last 20 to 40
                                                        increased rate of        days on feed to
                                                        weight gain, improved    provide 60 mg
                                                        feed efficiency, and     zilpaterol
                                                        increased carcass        hydrochloride per
                                                        leanness in cattle fed   head per day.
                                                        in confinement for       Withdrawal period:
                                                        slaughter during the     3 days.
                                                        last 20 to 40 days on
                                                        feed.
(8) 6.8 to 24...................  Monensin 10 to 40,   Cattle fed in            Feed continuously         000061
                                   plus tylosin 8 to    confinement for          to cattle during
                                   10.                  slaughter: For           the last 20 to 40
                                                        increased rate of        days on feed to
                                                        weight gain, improved    provide 60 mg
                                                        feed efficiency, and     zilpaterol
                                                        increased carcass        hydrochloride per
                                                        leanness in cattle fed   head per day. See
                                                        in confinement for       paragraphs Sec.
                                                        slaughter during the     Sec.   558.355(d)
                                                        last 20 to 40 days on    and 558.625(c).
                                                        feed; for prevention     Monensin and
                                                        and control of           tylosin as
                                                        coccidiosis due to       provided by No.
                                                        Eimeria bovis and E.     000986 in Sec.
                                                        zuernii; and for         510.600(c) of this
                                                        reduction of incidence   chapter.
                                                        of liver abscesses       Withdrawal period:
                                                        caused by                3 days.
                                                        Fusobacterium
                                                        necrophorum and
                                                        Arcanobacterium
                                                        (Actinomyces) pyogenes.
----------------------------------------------------------------------------------------------------------------


    Dated: March 9, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-05644 Filed 3-12-15; 8:45 am]
 BILLING CODE 4164-01-P