81 FR 17604 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 61 (March 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 61 (March 30, 2016)
| Page Range | 17604-17610 | |
| FR Document | 2016-07135 |
[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)] [Rules and Regulations] [Pages 17604-17610] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. 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
![17604 Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
(Lat. 37°19′31″ N., long. 79°12′04″ W.) That airspace extending upward from 700 amended to reflect changes of
Falwell Airport, VA feet above the surface within a 6.5-mile sponsorship of applications that
(Lat. 37°22′41″ N., long. 79°07′20″ W.) radius of Lynchburg Regional-Preston Glenn occurred in November and December
That airspace extending upward from the Field, and within 2.7 miles each side of the
Lynchburg VORTAC 200° radial extending
2015.
surface to and including 3,400 feet MSL
from the 6.5-mile radius to 7.4 miles south DATES: This rule is effective March 30,
within a 4.5-mile radius of Lynchburg
of the VORTAC, and within 3.1 miles each 2016.
Municipal-Preston Glenn Field Airport,
side of the Lynchburg VORTAC 022° radial
excluding the portion within a .5-mile radius extending from the 6.5-mile radius to 21.3 FOR FURTHER INFORMATION CONTACT:
of Falwell Airport. This Class D airspace area miles northeast of the VORTAC, and within George K. Haibel, Center for Veterinary
is effective during the specific dates and a 6.5-mile radius of Falwell Airport.
times established in advance by a Notice to Medicine (HFV–6), Food and Drug
Airmen. The effective date and time will Issued in College Park, Georgia, on March Administration, 7519 Standish Pl.,
thereafter be published continuously in the 23, 2016. Rockville, MD 20855, 240–402–5689,
Airport/Facility Directory. Jim Dickinson, george.haibel@fda.hhs.gov.
Acting Manager, Operations Support Group, SUPPLEMENTARY INFORMATION:
Paragraph 6004 Class E Airspace
Eastern Service Center, Air Traffic
Designated as an Extension to a Class D I. Approval Actions
Organization.
Surface Area.
[FR Doc. 2016–07079 Filed 3–29–16; 8:45 am]
* * * * * FDA is amending the animal drug
BILLING CODE 4910–13–P
regulations to reflect approval actions
AEA VA E4 Lynchburg, VA [Corrected] for NADAs and ANADAs during
Lynchburg Regional-Preston Glenn Field November and December 2015, as listed
Airport, Lynchburg, VA DEPARTMENT OF HEALTH AND in table 1. In addition, FDA is informing
(Lat. 37°19′31″ N., long. 79°12′04″ W.) HUMAN SERVICES the public of the availability, where
Lynchburg VORTAC
applicable, of documentation of
(Lat. 37°15′17″ N., long. 79°14′11″ W.) Food and Drug Administration
environmental review required under
That airspace extending upward from the the National Environmental Policy Act
surface within 2.7 miles each side of the 21 CFR Parts 510, 520, 522, 524, 528,
(NEPA) and, for actions requiring
Lynchburg VORTAC 020° and 200° radials 529, 556, and 558
extending from the 4.5-mile radius of review of safety or effectiveness data,
Lynchburg Municipal-Preston Glenn Field [Docket No. FDA–2015–N–0002] summaries of the basis of approval (FOI
Airport to 1 mile south of the VORTAC, and Summaries) under the Freedom of
within 1.8 miles each side of the Lynchburg
New Animal Drugs; Approval of New Information Act (FOIA). These public
VORTAC 022° radial extending from the 4.5- Animal Drug Applications; Changes of documents may be seen in the Division
mile radius of the airport to 11.3 miles Sponsorship of Dockets Management (HFA–305),
northeast of the VORTAC. This Class E AGENCY: Food and Drug Administration, Food and Drug Administration, 5630
airspace area is effective during the specific Fishers Lane, Rm. 1061, Rockville, MD
HHS.
dates and times established in advance by a 20852, between 9 a.m. and 4 p.m.,
Notice to Airmen. The effective date and time Final rule; technical
ACTION:
amendment. Monday through Friday. Persons with
will thereafter be published continuously in
access to the Internet may obtain these
the Airport/Facility Directory.
SUMMARY: The Food and Drug documents at the CVM FOIA Electronic
Paragraph 6005 Class E Airspace Areas Administration (FDA) is amending the Reading Room: http://www.fda.gov/
Extending Upward From 700 Feet or More animal drug regulations to reflect AboutFDA/CentersOffices/
Above the Surface of the Earth. application-related actions for new OfficeofFoods/CVM/
* * * * * animal drug applications (NADAs) and CVMFOIAElectronicReadingRoom/
AEA VA E5 Lynchburg, VA [Corrected] abbreviated new animal drug default.htm. Marketing exclusivity and
applications (ANADAs) during patent information may be accessed in
Lynchburg Regional-Preston Glenn Field
November and December 2015. FDA is FDA’s publication, Approved Animal
Airport, Lynchburg, VA
(Lat. 37°19′31″ N., long. 79°12′04″ W.) also informing the public of the Drug Products Online (Green Book) at:
Lynchburg VORTAC availability of summaries of the basis of http://www.fda.gov/AnimalVeterinary/
(Lat. 37°15′17″ N., long. 79°14′11″ W.) approval and of environmental review Products/
Falwell Airport, VA documents, where applicable. The ApprovedAnimalDrugProducts/
(Lat. 37°22′41″ N., long. 79°07′20″ W.) animal drug regulations are also being default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING NOVEMBER AND DECEMBER 2015
21 CFR FOIA NEPA
File No. Sponsor Product name Action Section Summary Review
141–453 ................ Alexion Pharmaceuticals, Inc., hLAL rDNA construct in SBC Original approval for expression 528.2010 yes ........ EA/
33 Hayden Ave., Lexington, LAL–C chickens. of a human gene for recom- FONSI 1
MA 02421. binant human lysosomal acid
lipase (rhLAL) protein in
chicken egg whites.
141–456 ................ Orion Corp., Orionintie 1, 02200 SILEO (dexmedetomidine Original approval for the treat- 529.539 yes ........ CE 2 3
asabaliauskas on DSK3SPTVN1PROD with RULES
Espoo, Finland. oromucosal gel). ment of noise aversion in
dogs.
141–246 ................ Intervet, Inc., 556 Morris Ave., AQUAFLOR (florfenicol) Type A Supplemental approval of re- 556.283, no .......... CE 2 4
Summit, NJ 07901. medicated article. vised representative labeling 558.261
for Type C medicated feeds;
technical amendments revis-
ing the expiration of veterinary
feed directives (VFDs) and
the description of tolerances
for fish.
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In addition, Novartis Animal Health informed FDA that it has transferred to Elanco US, Inc., 2500 Innovation
US, Inc., 3200 Northline Ave., suite 300, ownership of, and all rights and interest Way, Greenfield, IN 46140.
Greensboro, NC 27408 (Novartis) has in, the following approved applications
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 medicated feed for both drugs. These Therefore, under the Federal Food,
this document, the animal drug actions are being taken to improve the Drug, and Cosmetic Act and under
regulations are amended to reflect these accuracy of the regulations. authority delegated to the Commissioner
changes of sponsorship. Elanco US, Inc., In addition, FDA is taking this of Food and Drugs and redelegated to
is retaining Novartis’ drug labeler code opportunity to revise the spelling of a the Center for Veterinary Medicine, 21
(058198). Accordingly, the animal drug bacitracin salt to a preferred form, CFR parts 510, 520, 522, 524, 528, 529,
regulations need only be amended in bacitracin methylenedisalicylate, and to 556, and 558 are amended as follows:
§ 510.600(c) to add Elanco US, Inc., who correct the spelling of a genus of
previously was not the sponsor of an pathogenic bacteria, Haemophilus. PART 510—NEW ANIMAL DRUGS
approved application. Cronus Pharma These actions are being taken to
LLC will also be added as a new listing. improve the accuracy of the regulations. ■ 1. The authority citation for 21 CFR
Following these changes of sponsorship, This rule does not meet the definition part 510 continues to read as follows:
Novartis is no longer the sponsor of an of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’ Authority: 21 U.S.C. 321, 331, 351, 352,
approved application and will be 353, 360b, 371, 379e.
removed from § 510.600(c). Therefore, it is not subject to the
congressional review requirements in 5
§ 510.600 [Amended]
III. Technical Amendments U.S.C. 801–808.
List of Subjects ■ 2. In § 510.600, in the table in
FDA has noticed the animal drug
paragraph (c)(1), remove the entry for
regulations in 21 CFR part 556 contain 21 CFR Part 510 ‘‘Novartis Animal Health US, Inc.’’ and
tolerances for residues in edible tissues
Administrative practice and add entries for ‘‘Cronus Pharma LLC’’
for sulfathiazole, which is no longer the
procedure, Animal drugs, Labeling, and ‘‘Elanco US, Inc.’’ in alphabetical
subject of an approved application (79
FR 15540, March 20, 2014). Reporting and recordkeeping order; and in the table in paragraph
Accordingly, § 556.690 is being requirements. (c)(2), revise the entry for ‘‘058198’’ and
removed. FDA has also noticed that the add an entry for ‘‘069043’’ in numerical
21 CFR Parts 520, 522, 524, 528, and
animal drug regulations in 21 CFR 558.4 order to read as follows:
529
(§ 558.4) contain assay limits for ronnel Animal drugs. § 510.600 Names, addresses, and drug
and sulfaethoxypyridazine in medicated labeler codes of sponsors of approved
feed. As there is no longer an approved 21 CFR Part 556
asabaliauskas on DSK3SPTVN1PROD with RULES
applications.
application for use of either of these Animal drugs, Foods. * * * * *
drugs in medicated feed, the table for
Category II drugs in § 558.4 is being 21 CFR Part 558 (c) * * *
amended to remove assay limits in Animal drugs, Animal feeds. (1) * * *
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![Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations 17607
Drug labeler
Firm name and address code
* * * * * * *
Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816 ........................................................................ 069043
* * * * * * *
Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 ............................................................................................................. 058198
* * * * * * *
(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 § 520.446 [Amended] described in paragraph (a)(2) of this
NEW ANIMAL DRUGS ■ 9. In § 520.446, in paragraph (b)(1), section as in paragraph (c)(2) of this
remove ‘‘No. 054771’’ and in its place section.
■ 3. The authority citation for 21 CFR add ‘‘Nos. 054771 and 069043’’. * * * * *
part 520 continues to read as follows:
§ 520.447 [Amended] § 520.2043 [Amended]
Authority: 21 U.S.C. 360b.
■ 10. In § 520.447, in paragraph (b), ■ 16. In § 520.2043, in paragraph (b)(1),
§ 520.88b [Amended] remove ‘‘Nos. 000859, 051311, 054771, remove ‘‘Nos. 000859, 054771, and
■ 4. In § 520.88b, in paragraph 058829, and 061623’’ and in its place 058829’’ and in its place add ‘‘Nos.
(b)(1)(ii)(B), remove ‘‘Hemophilus’’ and add ‘‘Nos. 051311, 054771, 058829, 054771, 058829, and 069043’’.
in its place add ‘‘Haemophilus’’. 061623, and 069043’’.
■ 5. In § 520.154b: § 520.2044 [Amended]
§ 520.823 [Amended]
■ a. Revise the section heading. ■ 17. In § 520.2044, in paragraph (b)(2),
■ b. In paragraph (a), remove ■ 11. In § 520.823, in paragraph remove ‘‘000859’’ and in its place add
‘‘methylene disalicylate’’ and in its (d)(2)(ii), remove ‘‘Hemophilus’’ and in ‘‘017135’’.
place add ‘‘methylenedisalicylate’’. its place add ‘‘Haemophilus’’.
The revision reads as follows: § 520.2200 [Amended]
§ 520.1010 [Amended]
■ 12. In § 520.1010, in paragraph (b)(3), ■ 18. In § 520.2200, in paragraph (b),
§ 520.154b Bacitracin
methylenedisalicylate and streptomycin remove ‘‘Nos. 000859 and 058829’’ and remove ‘‘000010’’ and in its place add
sulfate powder. in its place add ‘‘Nos. 058829 and ‘‘016592’’.
* * * * * 069043’’. § 520.2260a [Amended]
§ 520.441 [Amended] § 520.1193 [Amended] ■ 19. In § 520.2260a, in paragraph (a)(1),
■ 6. In § 520.441, in paragraphs (b)(2) ■ 13. In § 520.1193, in paragraph (b)(2), remove ‘‘000010’’ and in its place add
and (d)(4)(iii)(C), remove ‘‘000010’’ and remove ‘‘Nos. 000859 and 051311’’ and ‘‘016592’’.
in its place add ‘‘016592’’; and in in in its place add ‘‘Nos. 051311 and § 520.2261a [Amended]
paragraphs (d)(1)(i)(A)(1), (d)(2)(i)(A)(1), 069043’’.
(d)(4)(iii)(B), and (d)(4)(iv)(B), remove ■ 20. In § 520.2261a, in paragraph (b),
‘‘Hemophilus’’ and in its place add § 520.1720a [Amended] remove ‘‘000010’’ and in its place add
‘‘Haemophilus’’. ■ 14. In § 520.1720a, in paragraph (b)(2), ‘‘016592’’.
remove ‘‘Nos. 000859 and 054628’’ and
§ 520.443 [Amended] § 520.2261b [Amended]
in its place add ‘‘Nos. 054628 and
■ 7. In § 520.443, in paragraph (b), 069043’’. ■ 21. In § 520.2261b, in paragraph (b),
remove ‘‘No. 054628’’ and in its place ■ 15. In § 520.1870, revise paragraph (b) remove ‘‘000010’’ and in its place add
add ‘‘Nos. 016592 and 054628’’; and in to read as follows: ‘‘016592’’.
asabaliauskas on DSK3SPTVN1PROD with RULES
paragraphs (d)(1)(i), (d)(2)(i), and § 520.2345d [Amended]
§ 520.1870 Praziquantel tablets.
(d)(3)(i), remove ‘‘Hemophilus’’ and in
its place add ‘‘Haemophilus’’. * * * * * ■ 22. In § 520.2345d, in paragraphs
(b) Sponsor. See No. 069043 in (b)(5), (d)(1)(iii), and (d)(2)(iii), remove
§ 520.445 [Amended] § 510.600(c) of this chapter for use of the ‘‘000010’’ and in its place add
■ 8. In § 520.445, in paragraph (b), product described in paragraph (a)(1) of ‘‘016592’’; and in paragraphs (d)(1)(ii)
remove ‘‘000010’’ and in its place add this section as in paragraph (c)(1) of this and (d)(2)(ii), remove ‘‘Hemophilus’’
‘‘016592’’. section; and for use of the product and in its place add ‘‘Haemophilus’’.
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■ 23. In § 520.2471, revise paragraph PART 524—OPHTHALMIC AND (2) Indications for use. For the
(d)(2) to read as follows: TOPICAL DOSAGE FORM NEW treatment of noise aversion in dogs.
ANIMAL DRUGS (3) Limitations. Federal law restricts
§ 520.2471 Tilmicosin. this drug to use by or on the order of
* * * * * ■ 32. The authority citation for 21 CFR a licensed veterinarian.
(d) * * * part 524 continues to read as follows:
(2) Indications for use—(i) For the PART 556—TOLERANCES FOR
Authority: 21 U.S.C. 360b.
control of swine respiratory disease RESIDUES OF NEW ANIMAL DRUGS
associated with Pasteurella multocida § 524.1044g [Amended] IN FOOD
and Haemophilus parasuis in groups of ■ 33. In § 522.1044g, in paragraph (b)(3),
■ 38. The authority citation for 21 CFR
swine in buildings where a respiratory remove ‘‘000859’’ and in its place add
part 556 continues to read as follows:
disease outbreak is diagnosed. ‘‘069043’’.
Authority: 21 U.S.C. 342, 360b, 371.
(ii) For the control of swine
PART 528—NEW ANIMAL DRUGS IN
respiratory disease associated with ■ 39. In § 556.70, in paragraph (b),
GENETICALLY ENGINEERED
Mycoplasma hyopneumoniae in the remove ‘‘methylene disalicylate’’ and in
ANIMALS
presence of Porcine Reproductive and its place add ‘‘methylenedisalicylate’’;
Respiratory Syndrome Virus (PRRSV) in ■ 34. The authority citation for 21 CFR and add paragraph (c) to read as follows:
groups of swine in buildings where a part 528 continues to read as follows:
respiratory disease outbreak is § 556.70 Bacitracin.
diagnosed. Authority: 21 U.S.C. 360b. * * * * *
(c) Related conditions of use. See
* * * * * ■ 35. Add § 528.2010 to read as follows:
§§ 520.154a, 520.154c, 558.76, and
PART 522—IMPLANTATION OR § 528.2010 Human lysosomal acid lipase 558.78 of this chapter.
recombinant deoxyribonucleic acid ■ 40. In § 556.283, revise paragraphs
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS construct. (b)(3) and (4) to read as follows:
(a) Specifications. A single copy of a
§ 556.283 Florfenicol.
■ 24. The authority citation for 21 CFR human lysosomal acid lipase (hLAL)
recombinant deoxyribonucleic acid * * * * *
part 522 continues to read as follows: (b) * * *
(rDNA) gene construct located at the
Authority: 21 U.S.C. 360b. (3) Freshwater-reared finfish (other
SYN LAL–C site in chromosome 6 in a
than catfish) and salmonids. The
§ 522.56 [Amended] specific, diploid line (SBC LAL–C) of
tolerance for florfenicol amine (the
hemizygous and homozygous domestic
■ 25. In § 522.56, in paragraph (b), marker residue) in muscle/skin (the
chickens (Gallus gallus), derived from
remove ‘‘000859’’ and in its place add target tissues) is 1 ppm.
the lineage progenitor XLL 109. (4) Catfish. The tolerance for
‘‘069043’’. (b) Sponsor. See No. 069334 in florfenicol amine (the marker residue) in
§ 522.390 [Amended] § 510.600 of this chapter. muscle (the target tissues) is 1 ppm.
(c) Conditions of use—(1) Intended
■ 26. In § 522.390, in paragraph (b), use. The gene construct directs the * * * * *
remove ‘‘Nos. 000859 and 054771’’ and expression of that encoding gene such
in its place add ‘‘Nos. 054771 and § 556.690 [Removed]
that recombinant, human lysosomal ■ 41. Remove § 556.690.
069043’’. acid lipase (rhLAL) protein intended for ■ 42. In § 556.765, revise paragraph
§ 522.540 [Amended] the treatment of human disease is (b)(1)(i) and add paragraphs (b)(1)(ii)
present in SBC LAL–C chicken egg and (c) to read as follows:
■ 27. In § 522.540, in paragraph (e)(2),
whites.
remove ‘‘000859’’ and in its place add § 556.765 Zilpaterol.
(2) Limitations. Food or feed from
‘‘069043’’.
XLL 109 chickens is not permitted in * * * * *
§ 522.810 [Amended] the food or feed supply. (b) * * *
(1) * * *
■ 28. In § 522.810, in paragraph (b), PART 529—CERTAIN OTHER DOSAGE (i) Liver (the target tissue). The
remove ‘‘000859’’ and in its place add FORM NEW ANIMAL DRUGS tolerance for zilpaterol (the marker
‘‘069043’’. residue) is 12 parts per billion (ppb).
■ 36. The authority citation for 21 CFR (ii) Muscle. The tolerance for
§ 522.1066 [Amended]
part 529 continues to read as follows: zilpaterol (the marker residue) is 10
■ 29. In § 522.1066, in paragraph (b), ppb.
Authority: 21 U.S.C. 360b.
remove ‘‘Nos. 000859 and 054771’’ and
* * * * *
in its place add ‘‘Nos. 054771 and ■ 37. Add § 529.539 to read as follows: (c) Related conditions of use. See
069043’’. § 558.665 of this chapter.
§ 529.539 Dexmedetomidine.
§ 522.1662a [Amended] (a) Specifications. Each milliliter of PART 558—NEW ANIMAL DRUGS FOR
■ 30. In § 520.1662a, in paragraphs gel contains 0.09 milligrams (mg) USE IN ANIMAL FEEDS
(b)(3)(i)(b), (c)(3)(i), (d)(3)(i)(a), dexmedetomidine (equivalent to 0.1 mg
asabaliauskas on DSK3SPTVN1PROD with RULES
(e)(3)(i)(b), (g)(3)(i)(b), and (k)(3)(ii), dexmedetomidine hydrochloride). ■ 43. The authority citation for 21 CFR
remove ‘‘Hemophilus’’ and in its place (b) Sponsor. See No. 052483 in part 558 continues to read as follows:
add ‘‘Haemophilus’’. § 510.600(c) of this chapter. Authority: 21 U.S.C. 354, 360b, 360ccc,
(c) Conditions of use—(1) Amount. 360ccc–1, 371.
§ 522.2260 [Amended] Administer onto the oral mucosa
■ 31. In § 522.2260, in paragraph (b), between the dog’s cheek and gum at a § 558.4 [Amended]
remove ‘‘000010’’ and in its place add dose of 125 micrograms per square ■ 44. In § 558.4, in paragraph (d), in the
‘‘016592’’. meter. ‘‘Category I’’ table, in the ‘‘Drug’’
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![Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations 17609
column, remove ‘‘Bacitracin methylene remove ‘‘methylene disalicylate’’ and in ‘‘Combination in grams per ton’’ and
disalicylate’’ and in its place add ’’ its place add ‘‘methylenedisalicylate’’. ‘‘Limitations’’ columns, remove
Bacitracin methylenedisalicylate’’; and ‘‘methylene disalicylate’’ and in its
in the ‘‘Category II’’ table, remove the § 558.198 [Amended] place add ‘‘methylenedisalicylate’’.
entries for ‘‘Ronnel’’ and ■ 52. In § 558.198, in paragraphs
‘‘Sulfaethoxypyridazine’’. (d)(1)(ii) and (d)(2)(ii), in the § 558.355 [Amended]
‘‘Combination grams/ton’’ and ■ 58. In § 558.355, in paragraphs
§ 558.55 [Amended] ‘‘Limitations’’ columns, remove (f)(1)(iii)(b), (f)(1)(xxiv), (f)(1)(xxix)
■ 45. In § 558.55, in paragraph (d)(2)(ii), ‘‘methylene disalicylate’’ and in its introductory text, (f)(1)(xxix)(b),
in the ‘‘Combination in grams per ton’’ place add ‘‘methylenedisalicylate’’. (f)(1)(xxx) introductory text,
and ‘‘Limitations’’ columns, remove (f)(1)(xxx)(b), (f)(2)(ii) introductory text,
‘‘methylene disalicylate’’ and in its § 558.258 [Amended]
(f)(2)(ii)(b), (f)(2)(iii) introductory text,
place add ‘‘methylenedisalicylate’’. ■ 53. In § 588.258, in paragraphs (f)(2)(iii)(a), (f)(2)(iii)(b), (f)(4)(ii)
(e)(2)(vi) and (vii), in the ‘‘Combination introductory text, (f)(4)(ii)(b), (f)(4)(iii)
§ 558.58 [Amended] in grams per ton’’ and ‘‘Limitations’’ introductory text, (f)(4)(iii)(b), (f)(4)(v)
■ 46. In § 558.58, in paragraph (e)(4), in columns, remove ‘‘methylene introductory text, and (f)(4)(v)(b),
the ‘‘Limitations’’ column, remove disalicylate’’ and in its place add remove ‘‘methylene disalicylate’’ and in
‘‘methylene disalicylate’’ and in its ‘‘methylenedisalicylate’’. its place add ‘‘methylenedisalicylate’’.
place add ‘‘methylenedisalicylate’’. ■ 54. In § 558.261, redesignate
paragraphs (c)(2)(i) and (ii) as § 558.363 [Amended]
§ 558.68 [Amended]
paragraphs (c)(2)(ii) and (i),
■ 47. In § 558.68, remove paragraph ■ 59. In § 558.363, in paragraphs
respectively, revise redesignated
(e)(3). (d)(1)(iv) introductory text, (d)(1)(iv)(B),
paragraph (c)(2)(ii), and add paragraph
■ 48. In § 558.76, remove paragraph and (d)(3)(ii), remove ‘‘methylene
(c)(4) to read as follows:
(e)(2), redesignate paragraph (e)(3) as disalicylate’’ and in its place add
paragraph (e)(2), and revise redesignated § 558.261 Florfenicol. ‘‘methylenedisalicylate’’.
paragraph (e)(2) to read as follows: * * * * * § 558.366 [Amended]
(c) * * *
§ 558.76 Bacitracin methylenedisalicylate. ■ 60. In § 558.366, in paragraph (d), in
(2) * * *
* * * * * (ii) For fish must not exceed 6 months the ‘‘Combination in grams per ton’’ and
(e) * * * from the date of issuance. ‘‘Limitations’’ columns, remove
(2) Bacitracin methylenedisalicylate ‘‘methylene disalicylate’’ wherever it
* * * * *
may also be used in combination with: occurs and in its place add
(4) Type A medicated articles and
(i) Amprolium as in § 558.55. ‘‘methylenedisalicylate’’.
(ii) Amprolium and ethopabate as in medicated feeds intended for use in fish
§ 558.58. shall bear the following: ‘‘Not for use in § 558.450 [Amended]
(iii) Clopidol as in § 558.175. animals intended for breeding purposes.
■ 61. In § 558.450, in paragraph
(iv) Decoquinate as in § 558.195. The effects of florfenicol on
(d)(5)(v), in the ‘‘Indications for Use’’
(v) Diclazuril as in § 558.198. reproductive performance have not been
column, remove ‘‘Hemophilus’’ and in
(vi) Fenbendazole as in § 588.258. determined. Toxicity studies in dogs,
its place add ‘‘Haemophilus’’.
(vii) Halofuginone hydrobromide as in rats, and mice have associated the use
§ 558.265. of florfenicol with testicular § 558.515 [Amended]
(viii) Ivermectin as in § 558.300. degeneration and atrophy.’’
■ 62. In § 558.515, in paragraph (d), in
(ix) Lasalocid as in § 558.311. * * * * * the ‘‘Combination in grams per ton’’ and
(x) Monensin as in § 588.355. ‘‘Limitations’’ columns, remove
§ 558.265 [Amended]
(xi) Narasin as in § 558.363. ‘‘methylene disalicylate’’ wherever it
(xii) Nicarbazin alone and with ■ 55. In § 558.265, in paragraphs
occurs and in its place add
narasin as in § 558.366. (d)(1)(vi) and (d)(2)(ii), remove
‘‘methylenedisalicylate’’.
(xiii) Robenidine as in § 558.515. ‘‘methylene disalicylate’’ and in its
(xiv) Salinomycin as in § 558.550. place add ‘‘methylenedisalicylate’’. § 558.550 [Amended]
(xv) Semduramicin as in § 558.555. § 558.300 [Amended] ■ 63. In § 558.550, in paragraphs
(xvi) Zoalene as in § 558.680. (d)(1)(iii)(a), (d)(1)(iii)(c), (d)(1)(vi)(a),
■ 56. In § 558.300, in paragraphs (e)(2)
§ 558.128 [Amended] and (3), in the ‘‘Combination in g/ton of (d)(1)(xx)(A), (d)(1)(xx)(C),
■ 49. In § 558.128, in paragraph feed’’ column, remove ‘‘methylene (d)(1)(xxi)(A), (d)(1)(xxi)(C), (d)(3)(ii)
(e)(7)(ii), remove ‘‘methylene disalicylate’’ and in its place add introductory text, (d)(3)(ii)(B), (d)(3)(iii)
disalicylate’’ and in its place add ‘‘methylenedisalicylate’’; and in introductory text, (d)(3)(iii)(B), (d)(3)(v)
‘‘methylenedisalicylate’’. paragraph (e)(9), in the ‘‘Combination in introductory text, and (d)(3)(v)(B),
g/ton of feed ’’ and ‘‘Limitations’’ remove ‘‘methylene disalicylate’’ and in
§ 558.175 [Amended] columns, remove ‘‘methylene its place add ‘‘methylenedisalicylate’’;
■ 50. In § 558.175, in paragraph (d)(2), disalicylate’’ and in its place add and in paragraph (d)(1)(vi)(c), remove
in the ‘‘Combination in grams per ton’’ ‘‘methylenedisalicylate’’. ‘‘Bacitracin MD’’ and in its place add
asabaliauskas on DSK3SPTVN1PROD with RULES
and ‘‘Limitations’’ columns, remove ‘‘Bacitracin methylenedisalicylate’’.
§ 558.311 [Amended]
‘‘methylene disalicylate’’ and in its § 558.555 [Amended]
place add ‘‘methylenedisalicylate’’. ■ 57. In § 558.311, in paragraphs
(e)(1)(iv) and (x), in the ‘‘Limitations’’ ■ 64. In § 558.555, in paragraph (d)(2),
§ 558.195 [Amended] column, remove ‘‘methylene in the ‘‘Combination in grams per ton’’
■ 51. In § 558.195, in paragraph disalicylate’’ and in its place add and ‘‘Limitations’’ columns, remove
(e)(1)(ii), in the ‘‘Combination in grams/ ‘‘methylenedisalicylate’’; and in ‘‘methylene disalicylate’’ and in its
ton’’ and ‘‘Limitations’’ columns, paragraph (e)(1)(xv), in the place add ‘‘methylenedisalicylate’’.
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![17610 Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations
§ 558.680 [Amended] • Hand delivery or courier: Deliver years after the customer received the
■ 65. In § 558.680, in paragraphs comments to front desk at the address reproduction not only is not reasonable,
(d)(1)(ii), (iii), (iv), (vi), (vii), and (viii) above. but occurs four years after we destroyed
in the ‘‘Combination in grams per ton’’ Instructions: All submissions must records of the order, making it
and ‘‘Limitations’’ columns, remove include NARA’s name and the impossible for us to determine if the
‘‘methylene disalicylate’’ and in its regulatory information number for this customer was notified and approved the
place add ‘‘methylenedisalicylate’’; and rulemaking (RIN 3095–AB90). We may reproduction, whether there really was
in paragraph (d)(2)(ii), in the publish any comments we receive an error or something incorrect about
‘‘Combination in grams per ton’’ without changes, including any the order, and similar issues.
column, remove ‘‘methylene personal information you include. As a result of these difficulties with
disalicylate’’ and in its place add FOR FURTHER INFORMATION CONTACT: refund requests on old orders, we are
‘‘methylenedisalicylate’’. Kimberly Keravuori, by email at now revising 36 CFR 1258.16 to set a
Dated: March 25, 2016. regulation_comments@nara.gov, or by refund time limit. Customers will have
Tracey H. Forfa, telephone at 301–837–3151. four months from the order date in
Deputy Director, Center for Veterinary SUPPLEMENTARY INFORMATION: which to request a refund.
Medicine.
Background Regulatory Analysis
[FR Doc. 2016–07135 Filed 3–29–16; 8:45 am]
BILLING CODE 4161–01–P NARA is authorized by 44 U.S.C. Review Under Executive Orders 12866
2116(c) to charge reproduction fees and 13563
when it reproduces documents for non-
NATIONAL ARCHIVES AND RECORDS Federal individuals or entities. This Executive Order 12866, Regulatory
ADMINISTRATION includes official reproductions with the Planning and Review, 58 FR 51735
Archives seal, reproductions of archival (September 30, 1993), and Executive
36 CFR Part 1258 holdings, and reproductions of Order 13563, Improving Regulation and
operational records. The statute Regulation Review, 76 FR 23821
[FDMS No. NARA–16–0003; NARA–2016–
018] authorizes NARA to recoup its costs, (January 18, 2011), direct agencies to
equipment fees, and similar expenses, assess all costs and benefits of available
RIN 3095–AB90 and to retain the fees as part of the regulatory alternatives and, if regulation
National Archives Trust Fund. NARA is necessary, to select regulatory
Fees promulgated regulations at 36 CFR 1258 approaches that maximize net benefits
AGENCY: National Archives and Records to notify users of the fee structure and (including potential economic,
Administration (NARA). processes. Among these regulations is a environmental, public health and safety
ACTION: Direct final rule. section addressing refunds of these fees effects, distributive impacts, and
(36 CFR 1258.16). It is this provision equity). This proposed rule is not
SUMMARY: The National Archives and that we are revising with this ‘‘significant’’ under section 3(f) of
Records Administration (NARA) is rulemaking. Executive Order 12866 because it
making a minor administrative revision Due to various factors, it is merely modifies the window of
to its fees regulation to set a time limit occasionally difficult for us to make a opportunity in which customers may
for requesting refunds of reproduction legible reproduction, particularly of old request refunds of reproduction fees.
fees. documents. We notify customers if we The Office of Management and Budget
DATES: This rule is effective April 29, anticipate the reproduction will have (OMB) has reviewed this regulation.
2016, without further action, unless questionable legibility, and request the
NARA receives adverse comments by customer’s approval to proceed with the Review Under the Regulatory
April 19, 2016. If NARA receives an reproduction—and the fee charges. As a Flexibility Act (5 U.S.C. 601, et seq.)
adverse comment, it will publish a result, we do not provide refunds except
This review requires an agency to
timely withdrawal of the rule in the in special cases; primarily if we have
somehow processed an order incorrectly prepare an initial regulatory flexibility
Federal Register. analysis and publish it when the agency
ADDRESSES: You may submit comments, or it contains errors. However, the
regulation’s refund provision did not publishes the proposed rule. This
identified by RIN 3095–AB90, by any of requirement does not apply if the
the following methods: include a refund cut-off period after
which a person who ordered a agency certifies that the rule will not, if
• Federal eRulemaking Portal: http:// promulgated, have a significant
www.regulations.gov. Follow the reproduction could no longer request a
refund. Customers could request economic impact on a substantial
instructions for submitting comments. number of small entities (5 U.S.C. 603).
• Email: Regulation_comments@ refunds for orders that were years old,
which has occurred in several instances. NARA certifies, after review and
nara.gov. Include RIN 3095–AB90 in the
We had no recourse but to process the analysis, that this proposed rule will not
subject line of the message.
• Fax: 301–837–0319. Include RIN refunds, which is not a reasonable have a significant adverse economic
3095–AB90 in the subject line of the fax business practice for orders that are impact on small entities because it
cover sheet. multiple years old. This also caused a merely modifies the window of
• Mail (for paper, disk, or CD–ROM significant administrative burden, as opportunity in which customers may
asabaliauskas on DSK3SPTVN1PROD with RULES
submissions. Include RIN 3095–AB90 NARA had discarded records for some request refunds of reproduction fees.
on the submission): Regulations of these orders at the end of their Review Under the Paperwork
Comment Desk (External Policy routine business life, in accord with our Reduction Act of 1995 (44 U.S.C. 3501
Program, Strategy & Performance agency’s official records schedule. For et seq.)
Division (SP)); Suite 4100; National example, under records schedule 1807–
Archives and Records Administration; 2, orders made on our online ordering This proposed rule does not contain
8601 Adelphi Road; College Park, MD system (SOFA) are destroyed once they any information collection requirements
20740–6001 are one year old. A refund request five subject to the Paperwork Reduction Act.
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Document Created: 2016-03-30 09:28:57
Document Modified: 2016-03-30 09:28:57
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; technical amendment. | |
| Dates | This rule is effective March 30, 2016. | |
| Contact | George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected] | |
| FR Citation | 81 FR 17604 | |
| CFR Citation | 21
CFR
510 21 CFR 520 21 CFR 522 21 CFR 524 21 CFR 528 21 CFR 529 21 CFR 556 21 CFR 558 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements; Foods and Animal Feeds |
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