80 FR 18773 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 67 (April 8, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 67 (April 8, 2015)
| Page Range | 18773-18777 | |
| FR Document | 2015-08025 |
[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)] [Rules and Regulations] [Pages 18773-18777] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08025] ======================================================================== Rules and Regulations Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. ======================================================================== Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations [[Page 18773]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, and 558 [Docket No. FDA-2015-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 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 several non-substantive changes. These technical amendments are being made to improve the accuracy of the regulations. DATES: This rule is effective April 8, 2015, except for the amendment to 21 CFR 522.1004, which is effective April 20, 2015. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, [email protected]. SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January and February 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 January and February 2015 -------------------------------------------------------------------------------------------------------------------------------------------------------- New animal drug 21 CFR NADA/ANADA Sponsor product name Action sections FOIA summary NEPA review -------------------------------------------------------------------------------------------------------------------------------------------------------- 141-435................ Piedmont Animal ADVANTUS Original approval for 520.1156 yes..................... CE 1 2 Health, 204 Muirs (imidacloprid) the treatment of Chapel Rd., Suite Chewable Tablets. flea infestations on 200, Greensboro, NC dogs and puppies. 27410. 141-418................ Luitpold BETAVET (betamethasone Original approval for 522.167 yes..................... CE 1 2 Pharmaceuticals, sodium phosphate and the control of pain Inc., Animal Health betamethasone and inflammation Division, Shirley, NY acetate) Injectable associated with 11967. Suspension. osteoarthritis in horses. 200-527................ Putney, Inc., One Enrofloxacin Original approval as 522.812 yes..................... CE 1 3 Monument Sq., suite Antibacterial a generic copy of 400, Portland, ME Injectable Solution. NADA 140-913. 04101. 200-576................ Akorn Animal Health, Gentamicin Sulfate Original approval as 524.1044a yes..................... CE 1 3 Inc., 1925 West Field Ophthalmic Solution. a generic copy of Ct., suite 300, Lake NADA 099-008. Forest, IL 60045. [[Page 18774]] 141-280 \4\............ Intervet, Inc., 556 ZILMAX (zilpaterol Supplemental approval 558.665 yes..................... CE 1 5 Morris Ave., Summit, hydrochloride) plus to provide for NJ 07901. RUMENSIN (monensin) component feeding of plus TYLAN (tylosin combination drug phosphate) plus MGA Type C medicated (melengestrol feeds to heifers fed acetate) Type A in confinement for medicated articles. slaughter. 141-406................ Merial, Inc., 3239 NEXGARD (afoxolaner) Supplemental approval 520.43 yes..................... CE 1 2 Satellite Blvd., Chewable Tablets. for the treatment Bldg. 500, Duluth, GA and control of an 30096-4640. additional tick species in dogs and puppies. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not have a significant effect on the human environment. \2\ CE granted under 21 CFR 25.33(d)(1). \3\ CE granted under 21 CFR 25.33(a)(1). \4\ This application is affected by guidance for industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209'', December 2013. \5\ CE granted under 21 CFR 25.33(a)(2). In addition during January and February 2015, ownership of, and all rights and interest in, the following approved applications have been transferred as follows: ---------------------------------------------------------------------------------------------------------------- New animal drug NADA/ANADA Previous sponsor product name New sponsor 21 CFR Section ---------------------------------------------------------------------------------------------------------------- 141-098................. Abbott Laboratories, PROPOFLO (propofol) Zoetis Inc., 333 522.2005 North Chicago, IL Injectable Suspension. Portage St., 60064. Kalamazoo, MI 49007. 141-103................. Abbott Laboratories, SEVOFLO (sevoflurane) Zoetis Inc., 333 529.2150 North Chicago, IL Inhalation Anesthetic. Portage St., 60064. Kalamazoo, MI 49007. 141-346................. Abbott Laboratories, OROCAM (meloxicam) Zoetis Inc., 333 529.1350 North Chicago, IL Oral Spray. Portage St., 60064. Kalamazoo, MI 49007. 141-434................. Abbott Laboratories, SIMBADOL Zoetis Inc., 333 522.230 North Chicago, IL (buprenorphine) Portage St., 60064. Injectable Solution. Kalamazoo, MI 49007. 200-070................. Abbott Laboratories, ISOFLO (isoflurane) Zoetis Inc., 333 529.1186 North Chicago, IL Inhalation Anesthetic. Portage St., 60064. Kalamazoo, MI 49007. 048-480................. ADM Alliance CHLORATET 90 and 100 Pharmgate LLC, 161 558.128 Nutrition., Inc., (chlortetracycline) North Franklin 1000 North 30th St., Type A medicated Turnpike, suite 2C, Quincy, IL 62305-3115. articles. Ramsey, NJ 07446. 065-256................. ADM Alliance CHLORTET-SOLUBLE-O Pharmgate LLC, 161 520.441 Nutrition., Inc., (chlortetracycline) North Franklin 1000 North 30th St., Powder. Turnpike, suite 2C, Quincy, IL 62305-3115. Ramsey, NJ 07446. 200-197................. Contemporary Products, Streptomycin Oral Huvepharma AD, 5th 520.2158 Inc., 3788 Elm Solution. Floor, 3A Nikolay Springs Rd., Haitov Str., 1113 Springdale, AR 72764- Sofia, Bulgaria. 6067. 141-084................. Novartis Animal Health SENTINEL (milbemycin Virbac AH, Inc., 3200 522.1143 US, Inc., 3200 oxime and lufenuron) Meacham Blvd., Ft. Northline Ave., suite FLAVOR TABS. Worth, TX 76137. 300, Greensboro, NC 27408. 141-204................. Novartis Animal Health SENTINEL (milbemycin Virbac AH, Inc., 3200 520.1510 US, Inc., 3200 oxime and lufenuron) Meacham Blvd., Ft. Northline Ave., suite FLAVOR TABS and Worth, TX 76137. 300, Greensboro, NC CAPSTAR (nitenpyram) 27408. Tablets Flea Management Program. 141-333................. Novartis Animal Health SENTINEL SPECTRUM Virbac AH, Inc., 3200 520.1447 US, Inc., 3200 (milbemycin oxime/ Meacham Blvd., Ft. Northline Ave., suite lufenuron/ Worth, TX 76137. 300, Greensboro, NC praziquantel) Tablets. 27408. 141-067................. OPK Biotech, LLC, 11 OXYGLOBIN (hemoglobin Hemoglobin Oxygen 522.1125 and 39 Hurley St., glutamer-200 Therapeutics, LLC, Cambridge, MA. (bovine)). 674 Souder Rd., Souderton, PA 18964. ---------------------------------------------------------------------------------------------------------------- [[Page 18775]] At this time, the regulations are being amended to reflect these changes of sponsorship. In addition, Paladin Labs (USA), Inc., 160 Greentree Dr., Suite 101, Dover, DE 19904 has requested that FDA withdraw approval of NADA 141-075 for ANTIZOL-VET (fomepizole) Injection. Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 141-075, and all supplements and amendments thereto, is withdrawn, effective April 20, 2015. As provided in the regulatory text of this document, the animal drug regulations are being amended to reflect this voluntary withdrawal of approval. Following these changes of sponsorship and withdrawal of approval, Hemoglobin Oxygen Therapeutics, LLC is now the sponsor of an approved application while OPK Biotech, LLC and Paladin Labs (USA), Inc., are no longer the sponsor of an approved application. Also, Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, has informed FDA that it has changed its name to Merial, Inc., and Intervet, Inc., 556 Morris Ave., Summit, NJ 07901, has informed FDA that it has changed its address to 2 Giralda Farms, Madison, NJ 07940. Accordingly, Sec. 510.600 (21 CFR 510.600) is being amended to reflect these changes. In addition, FDA is amending the tables in Sec. 510.600(c) to remove listings for International Nutrition, Inc.; NutriBasics Co.; Seeco Inc.; Southern Micro-Blenders, Inc.; and Wellmark International because these firms are no longer the sponsor of an approved application. These technical amendments are being made 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, and 529 Animal drugs. 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 520, 522, 524, 529, and 558 are amended as follows: PART 510--NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 0 2. Amend Sec. 510.600 as follows: 0 a. In the table in paragraph (c)(1), remove the entries for ``Contemporary Products, Inc.'', ``International Nutrition, Inc.'', ``NutriBasics Co.'', ``OPK Biotech, LLC'', ``Paladin Labs (USA), Inc.'', ``Seeco Inc.'', ``Southern Micro-Blenders, Inc.'', and ``Wellmark International''; 0 b. In the table in paragraph (c)(1), revise the entries for ``Intervet, Inc.'' and ``Merial Ltd.''; and add an entry, in alphabetical order, for ``Hemoglobin Oxygen Therapeutics, LLC''; 0 c. In the table in paragraph (c)(2), remove the entries for ``011536'', ``043733'', ``046129'', and ``055462''; and 0 d. In the table in paragraph (c)(2), revise the entries for ``000061'', ``050604'', and ``063075''. The additions and revisions read as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * ------------------------------------------------------------------------ Drug labeler Firm name and address code ------------------------------------------------------------------------ * * * * * Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., 063075 Souderton, PA 18964.................................... * * * * * Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940...... 000061 * * * * * Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, 050604 GA 30096-4640.......................................... * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * 000061.............................. Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. * * * * * 050604.............................. Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640. * * * * * 063075.............................. Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964. * * * * * ------------------------------------------------------------------------ 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. 0 4. In Sec. 520.43, revise paragraph (c)(2) to read as follows: Sec. 520.43 Afoxolaner. * * * * * (c) * * * (2) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis); for the treatment and control of black-legged tick (Ixodes scapularis), American dog tick (Dermacentor variabilis), lone star tick (Amblyomma americanum), and brown dog tick (Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 lb of body weight or greater, for 1 month. * * * * * Sec. 520.441 [Amended] 0 5. In Sec. 520.441, in paragraph (b)(4), remove ``012286'' and in its place add ``069254''. 0 6. Add Sec. 520.1156 to read as follows: Sec. 520.1156 Imidacloprid. (a) Specifications. Each chewable tablet contains 7.5 or 37.5 milligrams (mg) imidacloprid. (b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter. (c) Conditions of use in dogs--(1) Amount. Administer daily one 7.5-mg chewable tablet to dogs weighing 4 to 22 pounds (lb) or one 37.5-mg chewable table to dogs weighing 23 to 110 lb. (2) Indications for use. Kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 lb or greater. (3) Limitations. Do not give to puppies younger than 10 weeks of age or to dogs weighing less than 4 lb. Do not give more than one tablet a day. [[Page 18776]] Sec. 520.1443 [Amended] 0 7. In Sec. 520.1443, in paragraph (b), remove ``058198'' and in its place add ``051311''. Sec. 520.1447 [Amended] 0 8. In Sec. 520.1447, in paragraph (b), remove ``058198'' and in its place add ``051311''. 0 9. In Sec. 520.1510, in paragraph (d)(1)(ii)(B), remove ``Sec. 520.1446(d)(1) of this chapter'' and in its place add ``Sec. 520.1443(d)(1)''; and revise the section heading and paragraph (b) to read as follows: Sec. 520.1510 Nitenpyram. * * * * * (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this chapter: (1) No. 058198 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of this section. (2) No. 051311 for use as in paragraphs (d)(1)(i)(B) and (d)(1)(ii)(B) of this section. * * * * * Sec. 520.2158 [Amended] 0 10. In Sec. 520.2158, in paragraph (b), remove ``Nos. 016592 and 055462'' and in its place add ``No. 016592''. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 11. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 12. Add Sec. 522.167 to read as follows: Sec. 522.167 Betamethasone sodium phosphate and betamethasone acetate. (a) Specifications. Each milliliter (mL) of suspension contains 6 milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate and 2.85 mg betamethasone acetate). (b) Sponsor. See No. 010797 in Sec. 510.600(c) of this chapter. (c) Conditions of use in horses--(1) Amount. Administer 1.5 mL (9 mg total betamethasone) per joint by intra-articular injection. May be administered concurrently in up to two joints per horse. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in horses. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 522.230 [Amended] 0 13. In Sec. 522.230, in paragraph (b), remove ``000044'' and in its place add ``054771''. 0 14. In Sec. 522.812, add paragraph (b)(3) to read as follows: Sec. 522.812 Enrofloxacin. * * * * * (b) * * * (3) No. 026637 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section. * * * * * Sec. 522.1004 [Removed] 0 15. Remove Sec. 522.1004. 0 16. In Sec. 522.2005, remove paragraph (b)(3); and revise paragraph (b)(2) to read as follows: Sec. 522.2005 Propofol. * * * * * (b) * * * (2) No. 054771 for use as in paragraph (c) of this section. * * * * * PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 17. The authority citation for 21 CFR part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 18. Revise Sec. 524.1044a to read as follows: Sec. 524.1044a Gentamicin ophthalmic solution. (a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsors. See Nos. 000061 and 059399 in Sec. 510.600(c) of this chapter. (c) Conditions of use in dogs and cats--(1) Amount. Administer 1 or 2 drops into the conjunctival sac 2 to 4 times a day. (2) Indications for use. For the topical treatment of infections of the conjunctiva caused by susceptible bacteria. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 0 19. The authority citation for 21 CFR part 529 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 529.1186 [Amended] 0 20. In Sec. 529.1186, in paragraph (b), remove ``000044'' and add ``054771,'' after ``012164,''. Sec. 529.1350 [Amended] 0 21. In Sec. 529.1350, in paragraph (b), remove ``000074'' and in its place add ``054771''. Sec. 529.2150 [Amended] 0 22. In Sec. 529.2150, in paragraph (b), remove ``000044'' and add ``054771,'' after ``012164,''. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 23. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. Sec. 558.128 [Amended] 0 24. Amend Sec. 558.128 as follows: 0 a. In paragraph (b)(2), remove ``No. 012286'' and in its place add ``No. 069254''; 0 b. In paragraph (e)(3)(iv), in the ``Limitations'' column, remove ``012286'' and in its place add ``069254''; and 0 c. In the tables in paragraphs (e)(1), (e)(2), (e)(3), and (e)(4), in the ``Sponsor'' column, remove ``012286,'' wherever it occurs. 0 25. In Sec. 558.665, add paragraph (e)(9) to read as follows: Sec. 558.665 Zilpaterol. * * * * * (e) * * * [[Page 18777]] ---------------------------------------------------------------------------------------------------------------- Combination in Zilpaterol in grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (9) 6.8 to 24.................... Monensin 10 to 40, Heifers fed in Feed continuously 000061 plus tylosin 8 to confinement for to heifers during 10, plus slaughter: For the last 20 to 40 melengestrol increased rate of days on feed to acetate to provide weight gain, provide 60 mg 0.25 to 0.5 mg/ improved feed zilpaterol head/day. efficiency, and hydrochloride per increased carcass head per day. See leanness in cattle Sec. Sec. fed in confinement 558.342(d), for slaughter 558.355(d), and during the last 20 558.625(c). to 40 days on Monensin and feed; for tylosin as prevention and provided by No. control of 000986; coccidiosis due to melengestrol Eimeria bovis and acetate as E. zuernii; and provided by No. for reduction of 054771 in Sec. incidence of liver 510.600(c) of this abscesses caused chapter. by Fusobacterium Withdrawal period: necrophorum and 3 days. Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat). ---------------------------------------------------------------------------------------------------------------- Dated: April 3, 2015. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2015-08025 Filed 4-7-15; 8:45 am] BILLING CODE 4164-01-P
![18773
Rules and Regulations Federal Register
Vol. 80, No. 67
Wednesday, April 8, 2015
This section of the FEDERAL REGISTER SUMMARY: The Food and Drug 2015, as listed in table 1. In addition,
contains regulatory documents having general Administration (FDA) is amending the FDA is informing the public of the
applicability and legal effect, most of which animal drug regulations to reflect availability, where applicable, of
are keyed to and codified in the Code of application-related actions for new documentation of environmental review
Federal Regulations, which is published under animal drug applications (NADAs) and
50 titles pursuant to 44 U.S.C. 1510. required under the National
abbreviated new animal drug Environmental Policy Act (NEPA) and,
The Code of Federal Regulations is sold by applications (ANADAs) during January for actions requiring review of safety or
the Superintendent of Documents. Prices of and February 2015. FDA is also effectiveness data, summaries of the
new books are listed in the first FEDERAL informing the public of the availability basis of approval (FOI Summaries)
REGISTER issue of each week. of summaries of the basis of approval under the Freedom of Information Act
and of environmental review (FOIA). These public documents may be
documents, where applicable. The seen in the Division of Dockets
DEPARTMENT OF HEALTH AND animal drug regulations are also being
HUMAN SERVICES Management (HFA–305), Food and Drug
amended to reflect several non-
Administration, 5630 Fishers Lane, Rm.
substantive changes. These technical
Food and Drug Administration amendments are being made to improve 1061, Rockville, MD 20852, between 9
the accuracy of the regulations. a.m. and 4 p.m., Monday through
21 CFR Parts 510, 520, 522, 524, 529, Friday. Persons with access to the
and 558 DATES: This rule is effective April 8,
Internet may obtain these documents at
2015, except for the amendment to 21
[Docket No. FDA–2015–N–0002] the CVM FOIA Electronic Reading
CFR 522.1004, which is effective April
Room: http://www.fda.gov/AboutFDA/
20, 2015.
New Animal Drugs; Approval of New CentersOffices/OfficeofFoods/CVM/
Animal Drug Applications; Withdrawal FOR FURTHER INFORMATION CONTACT:
CVMFOIAElectronicReadingRoom/
of Approval of New Animal Drug George K. Haibel, Center for Veterinary default.htm. Marketing exclusivity and
Applications; Change of Sponsor; Medicine (HFV–6), Food and Drug
patent information may be accessed in
Change of Sponsor’s Name; Change of Administration, 7519 Standish Pl.,
FDA’s publication, Approved Animal
Sponsor’s Address Rockville, MD 20855, 240–276–9019,
Drug Products Online (Green Book) at:
george.haibel@fda.hhs.gov.
AGENCY: Food and Drug Administration, http://www.fda.gov/
HHS. SUPPLEMENTARY INFORMATION: FDA is AnimalVeterinary/Products/
amending the animal drug regulations to ApprovedAnimalDrugProducts/
Final rule; technical
ACTION:
reflect approval actions for NADAs and default.htm.
amendments.
ANADAs during January and February
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY AND FEBRUARY 2015
New animal drug 21 CFR
NADA/ANADA Sponsor Action FOIA summary NEPA review
product name sections
141–435 ........ Piedmont Animal ADVANTUS Original approval for 520.1156 yes ................. CE 1 2
Health, 204 Muirs (imidacloprid) the treatment of flea
Chapel Rd., Suite Chewable Tablets. infestations on dogs
200, Greensboro, NC and puppies.
27410.
141–418 ........ Luitpold Pharma- BETAVET Original approval for 522.167 yes ................. CE 1 2
ceuticals, Inc., Ani- (betamethasone so- the control of pain
mal Health Division, dium phosphate and and inflammation as-
Shirley, NY 11967. betamethasone ace- sociated with osteo-
tate) Injectable Sus- arthritis in horses.
pension.
200–527 ........ Putney, Inc., One Enrofloxacin Anti- Original approval as a 522.812 yes ................. CE 1 3
Monument Sq., suite bacterial Injectable generic copy of
400, Portland, ME Solution. NADA 140–913.
04101.
200–576 ........ Akorn Animal Health, Gentamicin Sulfate Original approval as a 524.1044a yes ................. CE 1 3
Inc., 1925 West Field Ophthalmic Solution. generic copy of
Ct., suite 300, Lake NADA 099–008.
asabaliauskas on DSK5VPTVN1PROD with RULES
Forest, IL 60045.
VerDate Sep<11>2014 16:24 Apr 07, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\08APR1.SGM 08APR1](https://thefederalregister.org/doc/80_FR_18840/page/1.svg)
![Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations 18775
At this time, the regulations are being the Center for Veterinary Medicine, 21 Drug labeler Firm name and address
amended to reflect these changes of CFR parts 510, 520, 522, 524, 529, and code
sponsorship. 558 are amended as follows:
In addition, Paladin Labs (USA), Inc., * * * * *
160 Greentree Dr., Suite 101, Dover, DE PART 510—NEW ANIMAL DRUGS 050604 ......... Merial, Inc., 3239 Satellite
Blvd., Bldg. 500, Duluth,
19904 has requested that FDA withdraw
■ 1. The authority citation for 21 CFR GA 30096–4640.
approval of NADA 141–075 for
ANTIZOL–VET (fomepizole) Injection. part 510 continues to read as follows:
* * * * *
Elsewhere in this issue of the Federal Authority: 21 U.S.C. 321, 331, 351, 352, 063075 ......... Hemoglobin Oxygen Thera-
Register, FDA gave notice that approval 353, 360b, 371, 379e. peutics, LLC, 674 Souder
of NADA 141–075, and all supplements ■ 2. Amend § 510.600 as follows: Rd., Souderton, PA 18964.
and amendments thereto, is withdrawn, ■ a. In the table in paragraph (c)(1),
effective April 20, 2015. As provided in * * * * *
remove the entries for ‘‘Contemporary
the regulatory text of this document, the Products, Inc.’’, ‘‘International
animal drug regulations are being Nutrition, Inc.’’, ‘‘NutriBasics Co.’’, PART 520—ORAL DOSAGE FORM
amended to reflect this voluntary ‘‘OPK Biotech, LLC’’, ‘‘Paladin Labs NEW ANIMAL DRUGS
withdrawal of approval. (USA), Inc.’’, ‘‘Seeco Inc.’’, ‘‘Southern
Following these changes of Micro-Blenders, Inc.’’, and ‘‘Wellmark ■ 3. The authority citation for 21 CFR
sponsorship and withdrawal of International’’; part 520 continues to read as follows:
approval, Hemoglobin Oxygen ■ b. In the table in paragraph (c)(1), Authority: 21 U.S.C. 360b.
Therapeutics, LLC is now the sponsor of revise the entries for ‘‘Intervet, Inc.’’ and
an approved application while OPK ■ 4. In § 520.43, revise paragraph (c)(2)
‘‘Merial Ltd.’’; and add an entry, in
Biotech, LLC and Paladin Labs (USA), to read as follows:
alphabetical order, for ‘‘Hemoglobin
Inc., are no longer the sponsor of an Oxygen Therapeutics, LLC’’; § 520.43 Afoxolaner.
approved application. Also, Merial Ltd.,
■ c. In the table in paragraph (c)(2), * * * * *
3239 Satellite Blvd., Bldg. 500, Duluth,
remove the entries for ‘‘011536’’, (c) * * *
GA 30096–4640, has informed FDA that
‘‘043733’’, ‘‘046129’’, and ‘‘055462’’;
it has changed its name to Merial, Inc., (2) Indications for use. Kills adult
and
and Intervet, Inc., 556 Morris Ave., fleas; for the treatment and prevention
■ d. In the table in paragraph (c)(2),
Summit, NJ 07901, has informed FDA of flea infestations (Ctenocephalides
revise the entries for ‘‘000061’’,
that it has changed its address to 2 felis); for the treatment and control of
‘‘050604’’, and ‘‘063075’’.
Giralda Farms, Madison, NJ 07940. black-legged tick (Ixodes scapularis),
Accordingly, § 510.600 (21 CFR The additions and revisions read as
American dog tick (Dermacentor
510.600) is being amended to reflect follows:
variabilis), lone star tick (Amblyomma
these changes. § 510.600 Names, addresses, and drug americanum), and brown dog tick
In addition, FDA is amending the labeler codes of sponsors of approved (Rhipicephalus sanguineus) infestations
tables in § 510.600(c) to remove listings applications. in dogs and puppies 8 weeks of age and
for International Nutrition, Inc.; * * * * * older, weighing 4 lb of body weight or
NutriBasics Co.; Seeco Inc.; Southern (c) * * * greater, for 1 month.
Micro-Blenders, Inc.; and Wellmark (1) * * * * * * * *
International because these firms are no
longer the sponsor of an approved Drug labeler § 520.441 [Amended]
Firm name and address
application. These technical code
■ 5. In § 520.441, in paragraph (b)(4),
amendments are being made to improve remove ‘‘012286’’ and in its place add
the accuracy of the regulations. ‘‘069254’’.
This rule does not meet the definition * * * * *
Hemoglobin Oxygen Thera- ■ 6. Add § 520.1156 to read as follows:
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because peutics, LLC, 674 Souder
it is a rule of ‘‘particular applicability.’’ Rd., Souderton, PA 18964 063075 § 520.1156 Imidacloprid.
Therefore, it is not subject to the
congressional review requirements in 5 * * * * *(a) Specifications. Each chewable
U.S.C. 801–808. Intervet, Inc., 2 Giralda tablet contains 7.5 or 37.5 milligrams
Farms, Madison, NJ 07940 000061 (mg) imidacloprid.
List of Subjects (b) Sponsor. See No. 000859 in
21 CFR Part 510 * * * * * § 510.600(c) of this chapter.
Merial, Inc., 3239 Satellite (c) Conditions of use in dogs—(1)
Administrative practice and Blvd., Bldg. 500, Duluth,
procedure, Animal drugs, Labeling, GA 30096–4640 ................ 050604
Amount. Administer daily one 7.5-mg
Reporting and recordkeeping chewable tablet to dogs weighing 4 to 22
requirements. * * * * * pounds (lb) or one 37.5-mg chewable
table to dogs weighing 23 to 110 lb.
21 CFR Parts 520, 522, 524, and 529 (2) * * * (2) Indications for use. Kills adult
asabaliauskas on DSK5VPTVN1PROD with RULES
Animal drugs. fleas and is indicated for the treatment
Drug labeler Firm name and address of flea infestations on dogs and puppies
21 CFR Part 558 code 10 weeks of age and older and weighing
Animal drugs, Animal feeds. 4 lb or greater.
Therefore, under the Federal Food, * * * * * (3) Limitations. Do not give to puppies
Drug, and Cosmetic Act and under 000061 ......... Intervet, Inc., 2 Giralda younger than 10 weeks of age or to dogs
authority delegated to the Commissioner Farms, Madison, NJ 07940. weighing less than 4 lb. Do not give
of Food and Drugs and redelegated to more than one tablet a day.
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![18776 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations
§ 520.1443 [Amended] (2) Indications for use. For the control (2) Indications for use. For the topical
■ 7. In § 520.1443, in paragraph (b), of pain and inflammation associated treatment of infections of the
remove ‘‘058198’’ and in its place add with osteoarthritis in horses. conjunctiva caused by susceptible
‘‘051311’’. (3) Limitations. Do not use in horses bacteria.
intended for human consumption. (3) Limitations. Federal law restricts
§ 520.1447 [Amended] Federal law restricts this drug to use by this drug to use by or on the order of
or on the order of a licensed a licensed veterinarian.
■ 8. In § 520.1447, in paragraph (b),
veterinarian.
remove ‘‘058198’’ and in its place add
‘‘051311’’. PART 529—CERTAIN OTHER DOSAGE
§ 522.230 [Amended]
FORM NEW ANIMAL DRUGS
■ 9. In § 520.1510, in paragraph
■ 13. In § 522.230, in paragraph (b),
(d)(1)(ii)(B), remove ‘‘§ 520.1446(d)(1) of remove ‘‘000044’’ and in its place add ■ 19. The authority citation for 21 CFR
this chapter’’ and in its place add ‘‘054771’’. part 529 continues to read as follows:
‘‘§ 520.1443(d)(1)’’; and revise the ■ 14. In § 522.812, add paragraph (b)(3)
section heading and paragraph (b) to Authority: 21 U.S.C. 360b.
to read as follows:
read as follows: § 529.1186 [Amended]
§ 522.812 Enrofloxacin.
§ 520.1510 Nitenpyram. 20. In § 529.1186, in paragraph (b),
* * * * * ■
* * * * * (b) * * * remove ‘‘000044’’ and add ‘‘054771,’’
(b) Sponsors. See sponsor numbers in (3) No. 026637 for use of product after ‘‘012164,’’.
§ 510.600(c) of this chapter: described in paragraph (a)(1) as in
(1) No. 058198 for use as in paragraph (e)(1) of this section. § 529.1350 [Amended]
paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and * * * * * ■ 21. In § 529.1350, in paragraph (b),
(d)(2) of this section. remove ‘‘000074’’ and in its place add
(2) No. 051311 for use as in § 522.1004 [Removed]
‘‘054771’’.
paragraphs (d)(1)(i)(B) and (d)(1)(ii)(B) ■ 15. Remove § 522.1004.
of this section. ■ 16. In § 522.2005, remove paragraph
§ 529.2150 [Amended]
* * * * * (b)(3); and revise paragraph (b)(2) to ■ 22. In § 529.2150, in paragraph (b),
read as follows: remove ‘‘000044’’ and add ‘‘054771,’’
§ 520.2158 [Amended]
§ 522.2005 Propofol. after ‘‘012164,’’.
■ 10. In § 520.2158, in paragraph (b),
remove ‘‘Nos. 016592 and 055462’’ and * * * * * PART 558—NEW ANIMAL DRUGS FOR
in its place add ‘‘No. 016592’’. (b) * * * USE IN ANIMAL FEEDS
(2) No. 054771 for use as in paragraph
PART 522—IMPLANTATION OR (c) of this section. ■ 23. The authority citation for 21 CFR
INJECTABLE DOSAGE FORM NEW * * * * * part 558 continues to read as follows:
ANIMAL DRUGS Authority: 21 U.S.C. 360b, 371.
PART 524—OPHTHALMIC AND
■ 11. The authority citation for 21 CFR TOPICAL DOSAGE FORM NEW
§ 558.128 [Amended]
part 522 continues to read as follows: ANIMAL DRUGS
■ 24. Amend § 558.128 as follows:
Authority: 21 U.S.C. 360b. ■ 17. The authority citation for 21 CFR ■ a. In paragraph (b)(2), remove ‘‘No.
■ 12. Add § 522.167 to read as follows: part 524 continues to read as follows:
012286’’ and in its place add ‘‘No.
Authority: 21 U.S.C. 360b. 069254’’;
§ 522.167 Betamethasone sodium
phosphate and betamethasone acetate. ■ 18. Revise § 524.1044a to read as ■ b. In paragraph (e)(3)(iv), in the
(a) Specifications. Each milliliter (mL) follows: ‘‘Limitations’’ column, remove
of suspension contains 6 milligrams ‘‘012286’’ and in its place add
§ 524.1044a Gentamicin ophthalmic
(mg) betamethasone (3.15 mg ‘‘069254’’; and
solution.
betamethasone sodium phosphate and ■ c. In the tables in paragraphs (e)(1),
(a) Specifications. Each milliliter of
2.85 mg betamethasone acetate). (e)(2), (e)(3), and (e)(4), in the ‘‘Sponsor’’
solution contains gentamicin sulfate
(b) Sponsor. See No. 010797 in equivalent to 3 milligrams of column, remove ‘‘012286,’’ wherever it
§ 510.600(c) of this chapter. gentamicin. occurs.
(c) Conditions of use in horses—(1) (b) Sponsors. See Nos. 000061 and ■ 25. In § 558.665, add paragraph (e)(9)
Amount. Administer 1.5 mL (9 mg total 059399 in § 510.600(c) of this chapter. to read as follows:
betamethasone) per joint by intra- (c) Conditions of use in dogs and
articular injection. May be administered cats—(1) Amount. Administer 1 or 2 § 558.665 Zilpaterol.
concurrently in up to two joints per drops into the conjunctival sac 2 to 4 * * * * *
horse. times a day. (e) * * *
asabaliauskas on DSK5VPTVN1PROD with RULES
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![Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations 18777
Zilpaterol in Combination in grams/ton Indications for use Limitations Sponsor
grams/ton
* * * * * * *
(9) 6.8 to 24 ....... Monensin 10 to 40, plus Heifers fed in confinement for slaughter: For Feed continuously to heifers 000061
tylosin 8 to 10, plus increased rate of weight gain, improved during the last 20 to 40
melengestrol acetate to feed efficiency, and increased carcass days on feed to provide 60
provide 0.25 to 0.5 mg/ leanness in cattle fed in confinement for mg zilpaterol hydrochloride
head/day. slaughter during the last 20 to 40 days on per head per day. See
feed; for prevention and control of coc- §§ 558.342(d), 558.355(d),
cidiosis due to Eimeria bovis and E. and 558.625(c). Monensin
zuernii; and for reduction of incidence of and tylosin as provided by
liver abscesses caused by Fusobacterium No. 000986; melengestrol
necrophorum and Arcanobacterium acetate as provided by No.
(Actinomyces) pyogenes; and for sup- 054771 in § 510.600(c) of
pression of estrus (heat). this chapter. Withdrawal
period: 3 days.
Dated: April 3, 2015. Therefore, under authority delegated ADDRESSES: EPA has established a
Bernadette Dunham, to the Commissioner of Food and Drugs docket for this action under Docket ID
Director, Center for Veterinary Medicine. and redelegated to the Center for No. EPA–HQ–RCRA–2015–0118. All
[FR Doc. 2015–08025 Filed 4–7–15; 8:45 am] Veterinary Medicine, and in accordance documents in the docket are listed in
BILLING CODE 4164–01–P
with § 514.116 Notice of withdrawal of the www.regulations.gov index.
approval of application (21 CFR Although listed in the index, some
514.116), notice is given that approval information is not publicly available,
DEPARTMENT OF HEALTH AND of NADA 141–075, and all supplements e.g., Confidential Business Information
HUMAN SERVICES and amendments thereto, is hereby (CBI) or other information whose
withdrawn. disclosure is restricted by statute.
Food and Drug Administration Elsewhere in this issue of the Federal Certain other material, such as
Register, FDA is amending the animal copyrighted material, is not placed on
21 CFR Part 522 drug regulations to reflect the voluntary the internet and will be publicly
withdrawal of approval of this available only in hard copy form.
[Docket No. FDA–2015–N–0002] application. Publicly available docket materials are
Dated: April 3, 2015. available either electronically through
Implantation or Injectable Dosage
www.regulations.gov or in hard copy at
Form New Animal Drugs; Withdrawal Bernadette Dunham,
the EPA Docket Center, EPA/DC, WJC
of Approval of New Animal Drug Director, Center for Veterinary Medicine.
West Building, Room 3334, 1301
Application; Fomepizole [FR Doc. 2015–08024 Filed 4–7–15; 8:45 am]
Constitution Ave. NW., Washington,
BILLING CODE 4164–01–P DC. The Public Reading Room is open
AGENCY: Food and Drug Administration,
HHS. from 8:30 a.m. to 4:30 p.m. Monday
ACTION: Notification of withdrawal. through Friday, excluding legal
ENVIRONMENTAL PROTECTION holidays. The telephone number for the
SUMMARY: The Food and Drug AGENCY Public Reading Room is (202) 566–1744
Administration (FDA) is withdrawing and the telephone number for the RCRA
approval of a new animal drug 40 CFR Parts 260 and 261 Docket is (202) 566–0270.
application (NADA) for a fomepizole [EPA–HQ–RCRA–2015–0118; FRL_9923–12– FOR FURTHER INFORMATION CONTACT:
injectable solution used as an antidote OSWER]
Office of Resource Conservation and
for ethylene glycol poisoning in dogs.
Response to Vacaturs of the Recovery, Materials Recovery and Waste
This action is being taken at the
Comparable Fuels Rule and the Management Division, MC 5304P,
sponsor’s request because this product
Gasification Rule Environmental Protection Agency, 1200
is no longer manufactured or marketed.
Pennsylvania Ave. NW., Washington,
DATES: Withdrawal of approval is AGENCY: Environmental Protection DC 20460, Tracy Atagi, at (703) 308–
effective April 20, 2015. Agency (EPA). 8672, (atagi.tracy@epa.gov) or Frank
FOR FURTHER INFORMATION CONTACT: ACTION: Final rule. Behan, at (703) 308–8476, behan.frank@
Sujaya Dessai, Center for Veterinary epa.gov.
Medicine (HFV–212), Food and Drug SUMMARY: The Environmental Protection
Administration, 7519 Standish Pl., Agency (EPA) is revising regulations SUPPLEMENTARY INFORMATION:
Rockville, MD 20855, 240–276–9075, associated with the comparable fuels Preamble Outline
sujaya.dessai@fda.hhs.gov. exclusion and the gasification
I. General Information
asabaliauskas on DSK5VPTVN1PROD with RULES
SUPPLEMENTARY INFORMATION: Paladin exclusion, originally issued by EPA
under the Resource Conservation and II. Statutory Authority
Labs (USA), Inc., 160 Greentree Dr., III. Which regulations is EPA removing?
suite 101, Dover, DE 19904 has Recovery Act (RCRA). These revisions
IV. Background on the Comparable Fuels
requested that FDA withdraw approval implement vacaturs ordered by the Rule and the Gasification Rule
of NADA 141–075 for ANTIZOL–VET United States Court of Appeals for the V. When will the final rule become effective?
(fomepizole) Injection because the District of Columbia Circuit (D.C. VI. State Authorization
product is no longer manufactured or Circuit), on June 27, 2014. VII. Statutory and Executive Order (EO)
marketed. DATES: Effective April 8, 2015. Reviews
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Document Created: 2018-02-21 10:07:11
Document Modified: 2018-02-21 10:07:11
| 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 amendments. | |
| Dates | This rule is effective April 8, 2015, except for the amendment to 21 CFR 522.1004, which is effective April 20, 2015. | |
| Contact | George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, [email protected] | |
| FR Citation | 80 FR 18773 | |
| CFR Citation | 21
CFR
510 21 CFR 520 21 CFR 522 21 CFR 524 21 CFR 529 21 CFR 558 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Animal Feeds |
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