Document ID: FDA-2015-N-0002-0062
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Changes of
Sponsorship
Posted Date: 2016-03-30T04:00Z

[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Rules and Regulations]
[Pages 17604-17610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07135]

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

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558

[Docket No. FDA-2015-N-0002]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) 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 November and December 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 changes of sponsorship of 
applications that occurred in November and December 2015.

DATES: This rule is effective March 30, 2016.

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

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during November and December 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.

                             Table 1--Original and Supplemental NADAs and ANADAs Approved During November and December 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
         File No.                   Sponsor                 Product name                 Action           21 CFR Section   FOIA Summary     NEPA Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-453..................  Alexion Pharmaceuticals,   hLAL rDNA construct in    Original approval for           528.2010  yes...........  EA/
                            Inc., 33 Hayden Ave.,      SBC LAL-C chickens.       expression of a human                                    FONSI \1\
                            Lexington, MA 02421.                                 gene for recombinant
                                                                                 human lysosomal acid
                                                                                 lipase (rhLAL) protein
                                                                                 in chicken egg whites.
141-456..................  Orion Corp., Orionintie    SILEO (dexmedetomidine    Original approval for            529.539  yes...........  CE \2\ \3\
                            1, 02200 Espoo, Finland.   oromucosal gel).          the treatment of noise
                                                                                 aversion in dogs.
141-246..................  Intervet, Inc., 556        AQUAFLOR (florfenicol)    Supplemental approval of        556.283,  no............  CE \2\ \4\
                            Morris Ave., Summit, NJ    Type A medicated          revised representative          558.261
                            07901.                     article.                  labeling for Type C
                                                                                 medicated feeds;
                                                                                 technical amendments
                                                                                 revising the expiration
                                                                                 of veterinary feed
                                                                                 directives (VFDs) and
                                                                                 the description of
                                                                                 tolerances for fish.

[[Page 17605]]

 
141-258..................  Intervet, Inc., 556        ZILMAX (zilpaterol        Supplemental approval of         556.765  yes...........  CE \2\ \4\
                            Morris Ave., Summit, NJ    hydrochloride) Type A     a cattle muscle
                            07901.                     medicated article.        tolerance and of new
                                                                                 determinative and
                                                                                 confirmatory procedures
                                                                                 for residues of
                                                                                 zilpaterol in cattle
                                                                                 liver and muscle.
141-361..................  Elanco Animal Health, A    PULMOTIL AC (tilmicosin   Supplemental approval           520.2471  yes...........  EA/
                            Division of Eli Lilly &    phosphate) Concentrate    for the control of                                       FONSI \1\
                            Co., Lilly Corporate       Solution.                 swine respiratory
                            Center, Indianapolis, IN                             disease associated with
                            46285.                                               Mycoplasma
                                                                                 hyopneumoniae in the
                                                                                 presence of Porcine
                                                                                 Reproductive and
                                                                                 Respiratory Syndrome
                                                                                 Virus (PRRSV).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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).

II. Changes of Sponsorship

    Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee 
Mission, KS 66201 (Bayer) has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following approved 
applications to Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, 
East Brunswick, NJ 08816:

------------------------------------------------------------------------
           File No.                 Product name        21 CFR section
------------------------------------------------------------------------
055-002......................  TEVCOSIN               522.390
                                (chloramphenicol)
                                Injectable Solution.
094-170......................  Phenylbutazone         520.1720a
                                Tablets, USP 100 mg
                                and 200 mg.
123-815......................  Dexamethasone Sodium   522.540
                                Phosphate Injection.
141-245......................  TRIBUTAME              522.810
                                (chloroquine
                                phosphate,
                                embutramid,
                                lidocaine)
                                Euthanasia Solution.
200-178......................  Amikacin Sulfate       522.56
                                Injection, 50 mg/mL.
200-193......................  Clindamycin            520.447
                                Hydrochloride Oral
                                Liquid.
200-248......................  Pyrantel Pamoate       520.2043
                                Suspension; 2.27 and
                                4.54 mg.
200-265......................  Praziquantel Tablets.  520.1870
200-287......................  GBC (Gentamicin        524.1044g
                                Sulfate
                                Betamethasone
                                Valerate
                                Clotrimazole)
                                Ointment.
200-297......................  Ivermectin Chewable    520.1193
                                Tablets.
200-298......................  Clindamycin            520.446
                                Hydrochloride
                                Capsules.
200-365......................  ROBINUL-V              522.1066
                                (glycopyrrolate)
                                Injectable Solution.
200-382......................  Furosemide Syrup 1%..  520.1010
------------------------------------------------------------------------

    Bayer has also informed FDA that it has transferred ownership of, 
and all rights and interest in, approved ANADA 200-342 for Pyrantel 
Pamoate Paste to Farnam Companies, Inc., 301 West Osborn Rd., Phoenix, 
AZ 85013-3928.
    Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Hwy., St. 
Joseph, MO 64506-2002 has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following approved 
applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 
Sofia, Bulgaria:

------------------------------------------------------------------------
           File No.                 Product name        21 CFR section
------------------------------------------------------------------------
006-084 \1\..................  SULMET                 520.2261a
                                (sulfamethazine)
                                Drinking Water
                                Solution.
008-774......................  SULMET                 522.2260
                                (sulfamethazine)
                                Injectable Solution.
033-373 \1\..................  VETSULID               520.2200
                                (sulfachlorpyridazin
                                e).
040-181 \1\..................  VETSULID               520.2200
                                (sulfachlorpyridazin
                                e) Oral Suspension.
055-012 \1\..................  CHLORONEX SULMET       520.445
                                (chlortetracycline
                                bisulfate/
                                sulfamethazine
                                bisulfate) Soluble
                                Powder.
055-018 \1\..................  AUREOMYCIN             520.443
                                (chlortetracycline
                                HCl) Tablets 25 mg.
055-039 \1\..................  AUREOMYCIN             520.443
                                (chlortetracycline
                                HCl) Soluble Oblets.
065-071 \1\..................  AUREOMYCIN             520.441
                                (chlortetracycline
                                HCl) Soluble Powder.
065-269 \1\..................  POLYOTIC               520.2345d
                                (tetracycline
                                hydrochloride)
                                Soluble Powder.
065-440 \1\..................  CHLORONEX              520.441
                                (chlortetracycline
                                HCl or
                                chlortetracycline
                                bisulfate) Soluble
                                Powder.
122-271 \1\..................  SULMET                 520.2260a
                                (sulfamethazine)
                                Oblets.
122-272 \1\..................  SULMET                 520.2261b
                                (sulfamethazine
                                sodium) Soluble
                                Powder.
------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for
  industry #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.

[[Page 17606]]

    In addition, Novartis Animal Health US, Inc., 3200 Northline Ave., 
suite 300, Greensboro, NC 27408 (Novartis) has informed FDA that it has 
transferred ownership of, and all rights and interest in, the following 
approved applications to Elanco US, Inc., 2500 Innovation Way, 
Greenfield, IN 46140.

------------------------------------------------------------------------
           File No.                           Product name
------------------------------------------------------------------------
134-644......................  DENAGARD (tiamulin) Soluble Powder.
139-472......................  DENAGARD (tiamulin) Type B Medicated
                                Feed.
140-915......................  INTERCEPTOR (milbemycin oxime) Tablets.
140-916......................  DENAGARD (tiamulin) Liquid Concentrate.
141-011......................  DENAGARD (tiamulin) plus CTC
                                (chlortetracycline).
141-026......................  PROGRAM (lufenuron) Suspension.
141-029......................  PERCORTEN-V (desoxycorticosterone
                                pivalate) Injectable Suspension.
141-035......................  PROGRAM (lufenuron).
141-062......................  PROGRAM (lufenuron) Cat Flavor Tabs.
141-084......................  SENTINEL (lufenuron and milbemycin oxime)
                                Flavor Tabs.
141-105......................  PROGRAM (lufenuron) 6-Month Injectable
                                for Cats.
141-120......................  CLOMICALM (clomipramine) Tablets.
141-163......................  MILBEMITE (milbemycin oxime) Otic
                                Solution.
141-175......................  CAPSTAR (nitenpyram) Tablets.
141-203......................  DERAMAXX (deracoxib) Chewable Tablets.
141-204......................  SENTINEL Flavor Tabs and CAPSTAR Flea
                                Management System.
141-205......................  PROGRAM Flavor Tabs and CAPSTAR Flea
                                Management System.
141-218......................  ATOPICA (cyclosporine) Capsules.
141-320......................  ONSIOR (robenacoxib) Tablets.
141-329......................  ATOPICA (cyclosporine) Oral Solution for
                                Cats.
141-333......................  SENTINEL SPECTRUM (milbemycin oxime,
                                lufenuron, praziquantel) Chewable
                                Tablets.
141-338......................  INTERCEPTOR SPECTRUM (milbemycin oxime
                                and praziquantel) Chewable Tablets.
141-437......................  OSURNIA (florfenicol, betamethasone
                                acetate, and terbinafine) Otic Gel.
141-443......................  ONSIOR (robenacoxib) Injection.
200-517......................  ZOBUXA (enrofloxacin) Tablets.
200-519......................  FLORVIO (florfenicol) 2.3% Concentrate
                                Solution.
------------------------------------------------------------------------

    As provided in the regulatory text of this document, the animal 
drug regulations are amended to reflect these changes of sponsorship. 
Elanco US, Inc., is retaining Novartis' drug labeler code (058198). 
Accordingly, the animal drug regulations need only be amended in Sec.  
510.600(c) to add Elanco US, Inc., who previously was not the sponsor 
of an approved application. Cronus Pharma LLC will also be added as a 
new listing. Following these changes of sponsorship, Novartis is no 
longer the sponsor of an approved application and will be removed from 
Sec.  510.600(c).

III. Technical Amendments

    FDA has noticed the animal drug regulations in 21 CFR part 556 
contain tolerances for residues in edible tissues for sulfathiazole, 
which is no longer the subject of an approved application (79 FR 15540, 
March 20, 2014). Accordingly, Sec.  556.690 is being removed. FDA has 
also noticed that the animal drug regulations in 21 CFR 558.4 (Sec.  
558.4) contain assay limits for ronnel and sulfaethoxypyridazine in 
medicated feed. As there is no longer an approved application for use 
of either of these drugs in medicated feed, the table for Category II 
drugs in Sec.  558.4 is being amended to remove assay limits in 
medicated feed for both drugs. These actions are being taken to improve 
the accuracy of the regulations.
    In addition, FDA is taking this opportunity to revise the spelling 
of a bacitracin salt to a preferred form, bacitracin 
methylenedisalicylate, and to correct the spelling of a genus of 
pathogenic bacteria, Haemophilus. These actions are being taken to 
improve the accuracy of the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the 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, 524, 528, and 529

    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, 528, 529, 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.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Novartis Animal Health US, Inc.'' and add entries for ``Cronus 
Pharma LLC'' and ``Elanco US, Inc.'' in alphabetical order; and in the 
table in paragraph (c)(2), revise the entry for ``058198'' and add an 
entry for ``069043'' in numerical order to read as follows:

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

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

[[Page 17607]]

------------------------------------------------------------------------
           Firm name and address                  Drug labeler code
------------------------------------------------------------------------
 
                              * * * * * * *
Cronus Pharma LLC, 2 Tower Center Blvd.,    069043
 Suite 1101, East Brunswick, NJ 08816.
 
                              * * * * * * *
Elanco US, Inc., 2500 Innovation Way,       058198
 Greenfield, IN 46140.
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
058198............................  Elanco US, Inc., 2500 Innovation
                                     Way, Greenfield, IN 46140
 
                              * * * * * * *
069043............................  Cronus Pharma LLC, 2 Tower Center
                                     Blvd., Suite 1101, East Brunswick,
                                     NJ 08816
 
                              * * * * * * *
------------------------------------------------------------------------

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.  520.88b  [Amended]

0
4. In Sec.  520.88b, in paragraph (b)(1)(ii)(B), remove ``Hemophilus'' 
and in its place add ``Haemophilus''.
0
5. In Sec.  520.154b:
0
a. Revise the section heading.
0
b. In paragraph (a), remove ``methylene disalicylate'' and in its place 
add ``methylenedisalicylate''.
    The revision reads as follows:

Sec.  520.154b  Bacitracin methylenedisalicylate and streptomycin 
sulfate powder.

* * * * *

Sec.  520.441  [Amended]

0
6. In Sec.  520.441, in paragraphs (b)(2) and (d)(4)(iii)(C), remove 
``000010'' and in its place add ``016592''; and in in paragraphs 
(d)(1)(i)(A)(1), (d)(2)(i)(A)(1), (d)(4)(iii)(B), and (d)(4)(iv)(B), 
remove ``Hemophilus'' and in its place add ``Haemophilus''.

Sec.  520.443  [Amended]

0
7. In Sec.  520.443, in paragraph (b), remove ``No. 054628'' and in its 
place add ``Nos. 016592 and 054628''; and in paragraphs (d)(1)(i), 
(d)(2)(i), and (d)(3)(i), remove ``Hemophilus'' and in its place add 
``Haemophilus''.

Sec.  520.445  [Amended]

0
8. In Sec.  520.445, in paragraph (b), remove ``000010'' and in its 
place add ``016592''.

Sec.  520.446  [Amended]

0
9. In Sec.  520.446, in paragraph (b)(1), remove ``No. 054771'' and in 
its place add ``Nos. 054771 and 069043''.

Sec.  520.447  [Amended]

0
10. In Sec.  520.447, in paragraph (b), remove ``Nos. 000859, 051311, 
054771, 058829, and 061623'' and in its place add ``Nos. 051311, 
054771, 058829, 061623, and 069043''.

Sec.  520.823  [Amended]

0
11. In Sec.  520.823, in paragraph (d)(2)(ii), remove ``Hemophilus'' 
and in its place add ``Haemophilus''.

Sec.  520.1010  [Amended]

0
12. In Sec.  520.1010, in paragraph (b)(3), remove ``Nos. 000859 and 
058829'' and in its place add ``Nos. 058829 and 069043''.

Sec.  520.1193  [Amended]

0
13. In Sec.  520.1193, in paragraph (b)(2), remove ``Nos. 000859 and 
051311'' and in its place add ``Nos. 051311 and 069043''.

Sec.  520.1720a  [Amended]

0
14. In Sec.  520.1720a, in paragraph (b)(2), remove ``Nos. 000859 and 
054628'' and in its place add ``Nos. 054628 and 069043''.
0
15. In Sec.  520.1870, revise paragraph (b) to read as follows:

Sec.  520.1870  Praziquantel tablets.

* * * * *
    (b) Sponsor. See No. 069043 in Sec.  510.600(c) of this chapter for 
use of the product described in paragraph (a)(1) of this section as in 
paragraph (c)(1) of this section; and for use of the product described 
in paragraph (a)(2) of this section as in paragraph (c)(2) of this 
section.
* * * * *

Sec.  520.2043  [Amended]

0
16. In Sec.  520.2043, in paragraph (b)(1), remove ``Nos. 000859, 
054771, and 058829'' and in its place add ``Nos. 054771, 058829, and 
069043''.

Sec.  520.2044  [Amended]

0
17. In Sec.  520.2044, in paragraph (b)(2), remove ``000859'' and in 
its place add ``017135''.

Sec.  520.2200  [Amended]

0
18. In Sec.  520.2200, in paragraph (b), remove ``000010'' and in its 
place add ``016592''.

Sec.  520.2260a  [Amended]

0
19. In Sec.  520.2260a, in paragraph (a)(1), remove ``000010'' and in 
its place add ``016592''.

Sec.  520.2261a  [Amended]

0
20. In Sec.  520.2261a, in paragraph (b), remove ``000010'' and in its 
place add ``016592''.

Sec.  520.2261b  [Amended]

0
21. In Sec.  520.2261b, in paragraph (b), remove ``000010'' and in its 
place add ``016592''.

Sec.  520.2345d  [Amended]

0
22. In Sec.  520.2345d, in paragraphs (b)(5), (d)(1)(iii), and 
(d)(2)(iii), remove ``000010'' and in its place add ``016592''; and in 
paragraphs (d)(1)(ii) and (d)(2)(ii), remove ``Hemophilus'' and in its 
place add ``Haemophilus''.

[[Page 17608]]

0
23. In Sec.  520.2471, revise paragraph (d)(2) to read as follows:

Sec.  520.2471  Tilmicosin.

* * * * *
    (d) * * *
    (2) Indications for use--(i) For the control of swine respiratory 
disease associated with Pasteurella multocida and Haemophilus parasuis 
in groups of swine in buildings where a respiratory disease outbreak is 
diagnosed.
    (ii) For the control of swine respiratory disease associated with 
Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and 
Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings 
where a respiratory disease outbreak is diagnosed.
* * * * *

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

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

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

Sec.  522.56  [Amended]

0
25. In Sec.  522.56, in paragraph (b), remove ``000859'' and in its 
place add ``069043''.

Sec.  522.390  [Amended]

0
26. In Sec.  522.390, in paragraph (b), remove ``Nos. 000859 and 
054771'' and in its place add ``Nos. 054771 and 069043''.

Sec.  522.540  [Amended]

0
27. In Sec.  522.540, in paragraph (e)(2), remove ``000859'' and in its 
place add ``069043''.

Sec.  522.810  [Amended]

0
28. In Sec.  522.810, in paragraph (b), remove ``000859'' and in its 
place add ``069043''.

Sec.  522.1066  [Amended]

0
29. In Sec.  522.1066, in paragraph (b), remove ``Nos. 000859 and 
054771'' and in its place add ``Nos. 054771 and 069043''.

Sec.  522.1662a  [Amended]

0
30. In Sec.  520.1662a, in paragraphs (b)(3)(i)(b), (c)(3)(i), 
(d)(3)(i)(a), (e)(3)(i)(b), (g)(3)(i)(b), and (k)(3)(ii), remove 
``Hemophilus'' and in its place add ``Haemophilus''.

Sec.  522.2260  [Amended]

0
31. In Sec.  522.2260, in paragraph (b), remove ``000010'' and in its 
place add ``016592''.

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

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

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

Sec.  524.1044g  [Amended]

0
33. In Sec.  522.1044g, in paragraph (b)(3), remove ``000859'' and in 
its place add ``069043''.

PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

0
34. The authority citation for 21 CFR part 528 continues to read as 
follows:

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

0
35. Add Sec.  528.2010 to read as follows:

Sec.  528.2010  Human lysosomal acid lipase recombinant 
deoxyribonucleic acid construct.

    (a) Specifications. A single copy of a human lysosomal acid lipase 
(hLAL) recombinant deoxyribonucleic acid (rDNA) gene construct located 
at the SYN LAL-C site in chromosome 6 in a specific, diploid line (SBC 
LAL-C) of hemizygous and homozygous domestic chickens (Gallus gallus), 
derived from the lineage progenitor XLL 109.
    (b) Sponsor. See No. 069334 in Sec.  510.600 of this chapter.
    (c) Conditions of use--(1) Intended use. The gene construct directs 
the expression of that encoding gene such that recombinant, human 
lysosomal acid lipase (rhLAL) protein intended for the treatment of 
human disease is present in SBC LAL-C chicken egg whites.
    (2) Limitations. Food or feed from XLL 109 chickens is not 
permitted in the food or feed supply.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
36. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

0
37. Add Sec.  529.539 to read as follows:

Sec.  529.539  Dexmedetomidine.

    (a) Specifications. Each milliliter of gel contains 0.09 milligrams 
(mg) dexmedetomidine (equivalent to 0.1 mg dexmedetomidine 
hydrochloride).
    (b) Sponsor. See No. 052483 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer onto the oral mucosa 
between the dog's cheek and gum at a dose of 125 micrograms per square 
meter.
    (2) Indications for use. For the treatment of noise aversion in 
dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

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

0
39. In Sec.  556.70, in paragraph (b), remove ``methylene 
disalicylate'' and in its place add ``methylenedisalicylate''; and add 
paragraph (c) to read as follows:

Sec.  556.70  Bacitracin.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  520.154a, 520.154c, 
558.76, and 558.78 of this chapter.
0
40. In Sec.  556.283, revise paragraphs (b)(3) and (4) to read as 
follows:

Sec.  556.283  Florfenicol.

* * * * *
    (b) * * *
    (3) Freshwater-reared finfish (other than catfish) and salmonids. 
The tolerance for florfenicol amine (the marker residue) in muscle/skin 
(the target tissues) is 1 ppm.
    (4) Catfish. The tolerance for florfenicol amine (the marker 
residue) in muscle (the target tissues) is 1 ppm.
* * * * *

Sec.  556.690  [Removed]

0
41. Remove Sec.  556.690.
0
42. In Sec.  556.765, revise paragraph (b)(1)(i) and add paragraphs 
(b)(1)(ii) and (c) to read as follows:

Sec.  556.765  Zilpaterol.

* * * * *
    (b) * * *
    (1) * * *
    (i) Liver (the target tissue). The tolerance for zilpaterol (the 
marker residue) is 12 parts per billion (ppb).
    (ii) Muscle. The tolerance for zilpaterol (the marker residue) is 
10 ppb.
* * * * *
    (c) Related conditions of use. See Sec.  558.665 of this chapter.

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

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

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

Sec.  558.4  [Amended]

0
44. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, in 
the ``Drug''

[[Page 17609]]

column, remove ``Bacitracin methylene disalicylate'' and in its place 
add '' Bacitracin methylenedisalicylate''; and in the ``Category II'' 
table, remove the entries for ``Ronnel'' and ``Sulfaethoxypyridazine''.

Sec.  558.55  [Amended]

0
45. In Sec.  558.55, in paragraph (d)(2)(ii), in the ``Combination in 
grams per ton'' and ``Limitations'' columns, remove ``methylene 
disalicylate'' and in its place add ``methylenedisalicylate''.

Sec.  558.58  [Amended]

0
46. In Sec.  558.58, in paragraph (e)(4), in the ``Limitations'' 
column, remove ``methylene disalicylate'' and in its place add 
``methylenedisalicylate''.

Sec.  558.68  [Amended]

0
47. In Sec.  558.68, remove paragraph (e)(3).
0
48. In Sec.  558.76, remove paragraph (e)(2), redesignate paragraph 
(e)(3) as paragraph (e)(2), and revise redesignated paragraph (e)(2) to 
read as follows:

Sec.  558.76  Bacitracin methylenedisalicylate.

* * * * *
    (e) * * *
    (2) Bacitracin methylenedisalicylate may also be used in 
combination with:
    (i) Amprolium as in Sec.  558.55.
    (ii) Amprolium and ethopabate as in Sec.  558.58.
    (iii) Clopidol as in Sec.  558.175.
    (iv) Decoquinate as in Sec.  558.195.
    (v) Diclazuril as in Sec.  558.198.
    (vi) Fenbendazole as in Sec.  588.258.
    (vii) Halofuginone hydrobromide as in Sec.  558.265.
    (viii) Ivermectin as in Sec.  558.300.
    (ix) Lasalocid as in Sec.  558.311.
    (x) Monensin as in Sec.  588.355.
    (xi) Narasin as in Sec.  558.363.
    (xii) Nicarbazin alone and with narasin as in Sec.  558.366.
    (xiii) Robenidine as in Sec.  558.515.
    (xiv) Salinomycin as in Sec.  558.550.
    (xv) Semduramicin as in Sec.  558.555.
    (xvi) Zoalene as in Sec.  558.680.

Sec.  558.128  [Amended]

0
49. In Sec.  558.128, in paragraph (e)(7)(ii), remove ``methylene 
disalicylate'' and in its place add ``methylenedisalicylate''.

Sec.  558.175  [Amended]

0
50. In Sec.  558.175, in paragraph (d)(2), in the ``Combination in 
grams per ton'' and ``Limitations'' columns, remove ``methylene 
disalicylate'' and in its place add ``methylenedisalicylate''.

Sec.  558.195  [Amended]

0
51. In Sec.  558.195, in paragraph (e)(1)(ii), in the ``Combination in 
grams/ton'' and ``Limitations'' columns, remove ``methylene 
disalicylate'' and in its place add ``methylenedisalicylate''.

Sec.  558.198  [Amended]

0
52. In Sec.  558.198, in paragraphs (d)(1)(ii) and (d)(2)(ii), in the 
``Combination grams/ton'' and ``Limitations'' columns, remove 
``methylene disalicylate'' and in its place add 
``methylenedisalicylate''.

Sec.  558.258  [Amended]

0
53. In Sec.  588.258, in paragraphs (e)(2)(vi) and (vii), in the 
``Combination in grams per ton'' and ``Limitations'' columns, remove 
``methylene disalicylate'' and in its place add 
``methylenedisalicylate''.
0
54. In Sec.  558.261, redesignate paragraphs (c)(2)(i) and (ii) as 
paragraphs (c)(2)(ii) and (i), respectively, revise redesignated 
paragraph (c)(2)(ii), and add paragraph (c)(4) to read as follows:

Sec.  558.261  Florfenicol.

* * * * *
    (c) * * *
    (2) * * *
    (ii) For fish must not exceed 6 months from the date of issuance.
* * * * *
    (4) Type A medicated articles and medicated feeds intended for use 
in fish shall bear the following: ``Not for use in animals intended for 
breeding purposes. The effects of florfenicol on reproductive 
performance have not been determined. Toxicity studies in dogs, rats, 
and mice have associated the use of florfenicol with testicular 
degeneration and atrophy.''
* * * * *

Sec.  558.265  [Amended]

0
55. In Sec.  558.265, in paragraphs (d)(1)(vi) and (d)(2)(ii), remove 
``methylene disalicylate'' and in its place add 
``methylenedisalicylate''.

Sec.  558.300  [Amended]

0
56. In Sec.  558.300, in paragraphs (e)(2) and (3), in the 
``Combination in g/ton of feed'' column, remove ``methylene 
disalicylate'' and in its place add ``methylenedisalicylate''; and in 
paragraph (e)(9), in the ``Combination in g/ton of feed '' and 
``Limitations'' columns, remove ``methylene disalicylate'' and in its 
place add ``methylenedisalicylate''.

Sec.  558.311  [Amended]

0
57. In Sec.  558.311, in paragraphs (e)(1)(iv) and (x), in the 
``Limitations'' column, remove ``methylene disalicylate'' and in its 
place add ``methylenedisalicylate''; and in paragraph (e)(1)(xv), in 
the ``Combination in grams per ton'' and ``Limitations'' columns, 
remove ``methylene disalicylate'' and in its place add 
``methylenedisalicylate''.

Sec.  558.355  [Amended]

0
58. In Sec.  558.355, in paragraphs (f)(1)(iii)(b), (f)(1)(xxiv), 
(f)(1)(xxix) introductory text, (f)(1)(xxix)(b), (f)(1)(xxx) 
introductory text, (f)(1)(xxx)(b), (f)(2)(ii) introductory text, 
(f)(2)(ii)(b), (f)(2)(iii) introductory text, (f)(2)(iii)(a), 
(f)(2)(iii)(b), (f)(4)(ii) introductory text, (f)(4)(ii)(b), 
(f)(4)(iii) introductory text, (f)(4)(iii)(b), (f)(4)(v) introductory 
text, and (f)(4)(v)(b), remove ``methylene disalicylate'' and in its 
place add ``methylenedisalicylate''.

Sec.  558.363  [Amended]

0
59. In Sec.  558.363, in paragraphs (d)(1)(iv) introductory text, 
(d)(1)(iv)(B), and (d)(3)(ii), remove ``methylene disalicylate'' and in 
its place add ``methylenedisalicylate''.

Sec.  558.366  [Amended]

0
60. In Sec.  558.366, in paragraph (d), in the ``Combination in grams 
per ton'' and ``Limitations'' columns, remove ``methylene 
disalicylate'' wherever it occurs and in its place add 
``methylenedisalicylate''.

Sec.  558.450  [Amended]

0
61. In Sec.  558.450, in paragraph (d)(5)(v), in the ``Indications for 
Use'' column, remove ``Hemophilus'' and in its place add 
``Haemophilus''.

Sec.  558.515  [Amended]

0
62. In Sec.  558.515, in paragraph (d), in the ``Combination in grams 
per ton'' and ``Limitations'' columns, remove ``methylene 
disalicylate'' wherever it occurs and in its place add 
``methylenedisalicylate''.

Sec.  558.550  [Amended]

0
63. In Sec.  558.550, in paragraphs (d)(1)(iii)(a), (d)(1)(iii)(c), 
(d)(1)(vi)(a), (d)(1)(xx)(A), (d)(1)(xx)(C), (d)(1)(xxi)(A), 
(d)(1)(xxi)(C), (d)(3)(ii) introductory text, (d)(3)(ii)(B), 
(d)(3)(iii) introductory text, (d)(3)(iii)(B), (d)(3)(v) introductory 
text, and (d)(3)(v)(B), remove ``methylene disalicylate'' and in its 
place add ``methylenedisalicylate''; and in paragraph (d)(1)(vi)(c), 
remove ``Bacitracin MD'' and in its place add ``Bacitracin 
methylenedisalicylate''.

Sec.  558.555  [Amended]

0
64. In Sec.  558.555, in paragraph (d)(2), in the ``Combination in 
grams per ton'' and ``Limitations'' columns, remove ``methylene 
disalicylate'' and in its place add ``methylenedisalicylate''.

[[Page 17610]]

Sec.  558.680  [Amended]

0
65. In Sec.  558.680, in paragraphs (d)(1)(ii), (iii), (iv), (vi), 
(vii), and (viii) in the ``Combination in grams per ton'' and 
``Limitations'' columns, remove ``methylene disalicylate'' and in its 
place add ``methylenedisalicylate''; and in paragraph (d)(2)(ii), in 
the ``Combination in grams per ton'' column, remove ``methylene 
disalicylate'' and in its place add ``methylenedisalicylate''.

    Dated: March 25, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-07135 Filed 3-29-16; 8:45 am]
 BILLING CODE 4161-01-P