New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Federal Register, Volume 81 Issue 61 (Wednesday, March 30, 2016)
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
=======================================================================
-----------------------------------------------------------------------
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:
-
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).
-
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).
-
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.
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
