80_FR_76623 80 FR 76387 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

80 FR 76387 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 236 (December 9, 2015)

Page Range76387-76388
FR Document2015-31040

The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) and two abbreviated new animal drug applications (ANADAs). This action is being taken at the sponsors' requests because these products are no longer manufactured or marketed.

Federal Register, Volume 80 Issue 236 (Wednesday, December 9, 2015) 
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Rules and Regulations]
[Pages 76387-76388]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558

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


New Animal Drugs; Withdrawal of Approval of New Animal Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of two new animal drug applications (NADAs) and two abbreviated new 
animal drug applications (ANADAs). This action is being taken at the 
sponsors' requests because these products are no longer manufactured or 
marketed.

DATES: Withdrawal of approval is effective December 21, 2015.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, [email protected].

SUPPLEMENTARY INFORMATION: The following three sponsors have requested 
that FDA withdraw approval of the NADAs and ANADAs listed in the 
following table because the products are no longer manufactured or 
marketed:

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                                                                                                      21 CFR
              File No.                           Sponsor                    Product name              section
----------------------------------------------------------------------------------------------------------------
140-680 \1\.........................  Pharmgate LLC, 1015 Ashes     TYLAN (tylosin phosphate)            558.625
                                       Dr., suite 102, Wilmington,   Premix.
                                       NC 28405.
140-681 \1\.........................  Pharmgate LLC, 1015 Ashes     TYLAN SULFA G (tylosin               558.630
                                       Dr., suite 102, Wilmington,   phosphate and
                                       NC 28405.                     sulfamethazine) Premix.
200-028.............................  Pegasus Laboratories, Inc.,   EVICT 300 (pyrantel pamoate)        520.2043
                                       8809 Ely Rd., Pensacola, FL   Suspension.
                                       32514.
200-383.............................  Bayer HealthCare LLC, Animal  CLINDAROBE (clindamycin)             520.446
                                       Health Division, P.O. Box     Capsules.
                                       390, Shawnee Mission, KS
                                       66201.
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\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.

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with 21 CFR 514.116 Notice of withdrawal of approval of 
application, notice is given that approval of NADA 140-680, NADA 140-
681, ANADA 200-028, and ANADA 200-383, and all supplements and 
amendments thereto, is hereby withdrawn, effective December 21, 2015.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary

[[Page 76388]]

withdrawal of approval of these applications.

    Dated: December 4, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31040 Filed 12-8-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations 76387 PART 524—OPHTHALMIC AND directive (VFD) drug to use by or on the Dated: December 4, 2015. TOPICAL DOSAGE FORM NEW order of a licensed veterinarian. See Bernadette Dunham, ANIMAL DRUGS § 558.6 for additional requirements. Director, Center for Veterinary Medicine. * * * * * [FR Doc. 2015–31042 Filed 12–8–15; 8:45 am] ■ 10. The authority citation for 21 CFR BILLING CODE 4164–01–P part 524 continues to read as follows: ■ 14. In § 558.261, revise paragraphs (c)(1) and (2) introductory text to read Authority: 21 U.S.C. 360b. as follows: ■ 11. Add § 524.957 to read as follows: DEPARTMENT OF HEALTH AND § 558.261 Florfenicol. HUMAN SERVICES § 524.957 Florfenicol, terbinafine, and mometasone otic solution. * * * * * Food and Drug Administration (a) Specifications. Each single-dose, (c) * * * prefilled dropperette contains 1 (1) Federal law restricts medicated 21 CFR Parts 520 and 558 milliliter (mL) of a solution containing feed containing this veterinary feed [Docket No. FDA–2015–N–0002] 15 milligrams (mg) florfenicol, 13.3 mg directive (VFD) drug to use by or on the terbinafine, and 2 mg mometasone order of a licensed veterinarian. See New Animal Drugs; Withdrawal of furoate. § 558.6 for additional requirements. Approval of New Animal Drug (b) Sponsor. See No. 000859 in (2) The expiration date of VFDs for Applications § 510.600(c) of this chapter. florfenicol medicated feeds: (c) Conditions of use in dogs—(1) AGENCY: Food and Drug Administration, Amount. Administer one dropperette (1 * * * * * HHS. mL) per affected ear(s). ■ 15. In § 558.618, revise paragraph ACTION: Notification of withdrawal. (2) Indications for use. For the (c)(1) to read as follows: treatment of otitis externa in dogs SUMMARY: The Food and Drug associated with susceptible strains of § 558.618 Tilmicosin. Administration (FDA) is withdrawing yeast (Malassezia pachydermatis) and * * * * * approval of two new animal drug bacteria (Staphylococcus applications (NADAs) and two pseudintermedius). (c) * * * abbreviated new animal drug (3) Limitations. Federal law restricts (1) Federal law restricts medicated applications (ANADAs). This action is this drug to use by or on the order of feed containing this veterinary feed being taken at the sponsors’ requests a licensed veterinarian. directive (VFD) drug to use by or on the because these products are no longer order of a licensed veterinarian. See manufactured or marketed. PART 558—NEW ANIMAL DRUGS FOR § 558.6 for additional requirements. DATES: Withdrawal of approval is USE IN ANIMAL FEEDS * * * * * effective December 21, 2015. ■ 12. The authority citation for 21 CFR FOR FURTHER INFORMATION CONTACT: § 558.625 [Amended] part 558 continues to read as follows: Sujaya Dessai, Center for Veterinary ■ 16. Effective December 21, 2015, in Medicine (HFV–212), Food and Drug Authority: (P≤21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. § 558.625, remove paragraph (b)(5) and Administration, 7519 Standish Pl., redesignate paragraph (b)(6) as Rockville, MD 20855, 240–402–5761, ■ 13. In § 558.68, revise paragraph (c)(1) sujaya.dessai@fda.hhs.gov. paragraph (b)(5). to read as follows: SUPPLEMENTARY INFORMATION: The § 558.630 [Amended] § 558.68 Avilamycin. following three sponsors have requested * * * * * ■ 17. Effective December 21, 2015, in that FDA withdraw approval of the (c) * * * § 558.630, in paragraph (b)(2), remove NADAs and ANADAs listed in the (1) Federal law restricts medicated ‘‘Nos. 054771 and 069254’’ and in its following table because the products are feed containing this veterinary feed place add ‘‘No. 054771’’. no longer manufactured or marketed: 21 CFR File No. Sponsor Product name section 140–680 1 ....................... Pharmgate LLC, 1015 Ashes Dr., suite 102, Wil- TYLAN (tylosin phosphate) Premix ...................... 558.625 mington, NC 28405. 140–681 1 ....................... Pharmgate LLC, 1015 Ashes Dr., suite 102, Wil- TYLAN SULFA G (tylosin phosphate and 558.630 mington, NC 28405. sulfamethazine) Premix. 200–028 ......................... Pegasus Laboratories, Inc., 8809 Ely Rd., Pen- EVICT 300 (pyrantel pamoate) Suspension ........ 520.2043 sacola, FL 32514. 200–383 ......................... Bayer HealthCare LLC, Animal Health Division, CLINDAROBE (clindamycin) Capsules ................ 520.446 P.O. Box 390, Shawnee Mission, KS 66201. 1 These NADAs were identified as being affected by guidance for industry #213, ‘‘New Animal Drugs and New Animal Drug Combination Prod- ucts 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. wgreen on DSK2VPTVN1PROD with RULES Therefore, under authority delegated withdrawal of approval of application, is hereby withdrawn, effective to the Commissioner of Food and Drugs notice is given that approval of NADA December 21, 2015. and redelegated to the Center for 140–680, NADA 140–681, ANADA 200– Elsewhere in this issue of the Federal Veterinary Medicine, and in accordance 028, and ANADA 200–383, and all Register, FDA is amending the animal with 21 CFR 514.116 Notice of supplements and amendments thereto, drug regulations to reflect the voluntary VerDate Sep<11>2014 15:17 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\09DER1.SGM 09DER1

76388 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations withdrawal of approval of these number: (703) 305–7090; email address: 2014–0822, by one of the following applications. RDFRNotices@epa.gov. methods: Dated: December 4, 2015. SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online Bernadette Dunham, I. General Information instructions for submitting comments. Director, Center for Veterinary Medicine. Do not submit electronically any [FR Doc. 2015–31040 Filed 12–8–15; 8:45 am] A. Does this action apply to me? information you consider to be CBI or BILLING CODE 4164–01–P You may be potentially affected by other information whose disclosure is this action if you are an agricultural restricted by statute. producer, food manufacturer, or • Mail: OPP Docket, Environmental ENVIRONMENTAL PROTECTION pesticide manufacturer. The following Protection Agency Docket Center (EPA/ AGENCY list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. Classification System (NAICS) codes is NW., Washington, DC 20460–0001. 40 CFR Part 180 not intended to be exhaustive, but rather • Hand Delivery: To make special provides a guide to help readers arrangements for hand delivery or [EPA–HQ–OPP–2014–0822; FRL–9939–52] determine whether this document delivery of boxed information, please Azoxystrobin; Pesticide Tolerances applies to them. Potentially affected follow the instructions at http:// entities may include: www.epa.gov/dockets/contacts.html. AGENCY: Environmental Protection • Crop production (NAICS code 111). Additional instructions on commenting Agency (EPA). • Animal production (NAICS code or visiting the docket, along with more ACTION: Final rule. 112). information about dockets generally, is • Food manufacturing (NAICS code available at http://www.epa.gov/ SUMMARY: This regulation establishes 311). dockets. tolerances for residues of azoxystrobin • Pesticide manufacturing (NAICS in or on quinoa grain, ti leaves, ti roots, code 32532). II. Summary of Petitioned-For and modifies the existing tolerances for Tolerance the stone fruit group 12 and tree nut B. How can I get electronic access to In the Federal Register of March 4, group 14 to read ‘‘stone fruit group 12– other related information? 2015 (80 FR 11611) (FRL–9922–68), 12’’ and ‘‘tree nut group 14–12, except You may access a frequently updated EPA issued a document pursuant to pistachio’’ respectively. Interregional electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C. Research Project Number 4 (IR–4) regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a requested these tolerances under the the Government Printing Office’s e-CFR pesticide petition (PP 4E8319) by IR–4, Federal Food, Drug, and Cosmetic Act site at http://www.ecfr.gov/cgi-bin/text- 500 College Road East, Suite 201 W, (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Princeton, NJ 08540. The petition 40tab_02.tpl. requested that 40 CFR part 180 be DATES: This regulation is effective amended by establishing tolerances for December 9, 2015. Objections and C. How can I file an objection or hearing residues of azoxystrobin (methyl (E)-2- requests for hearings must be received request? {2-[6-(2-cyanophenoxy) pyrimidin-4- on or before February 8, 2016, and must Under FFDCA section 408(g), 21 yloxy]phenyl}-3-methoxyacrylate) and be filed in accordance with the U.S.C. 346a, any person may file an the Z isomer of azoxystrobin (methyl instructions provided in 40 CFR part objection to any aspect of this regulation (Z)-2-{2-[6-(2-cyanophenoxy)pyrimidin- 178 (see also Unit I.C. of the and may also request a hearing on those 4-yloxy]phenyl}-3-methoxyacrylate) in SUPPLEMENTARY INFORMATION). objections. You must file your objection or on the raw agricultural commodities ADDRESSES: The docket for this action, or request a hearing on this regulation ti palm, leaves at 50 parts per million identified by docket identification (ID) in accordance with the instructions (ppm); ti palm, roots at 0.5 ppm; fruit, number EPA–HQ–OPP–2014–0822, is provided in 40 CFR part 178. To ensure stone, group 12–12 at 2.0 ppm; and nut, available at http://www.regulations.gov proper receipt by EPA, you must tree, group 14–12 at 0.02 ppm. Upon the or at the Office of Pesticide Programs identify docket ID number EPA–HQ– approval of the aforementioned Regulatory Public Docket (OPP Docket) OPP–2014–0822 in the subject line on tolerances, the petitioner requested to in the Environmental Protection Agency the first page of your submission. All remove the established tolerances for Docket Center (EPA/DC), West William objections and requests for a hearing azoxystrobin in or on the raw Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be agricultural commodities fruit, stone, Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or group 12 at 1.5 ppm; and nut, tree, 20460–0001. The Public Reading Room before February 8, 2016. Addresses for group 14 at 0.02 ppm. That document is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections referenced a summary of the petition Monday through Friday, excluding legal and hearing requests are provided in 40 prepared by Syngenta Crop Protection, holidays. The telephone number for the CFR 178.25(b). the registrant, which is available in the Public Reading Room is (202) 566–1744, In addition to filing an objection or docket, http://www.regulations.gov. EPA and the telephone number for the OPP hearing request with the Hearing Clerk received two comments in response to Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please the March 4, 2015 Notice of Filing that the visitor instructions and additional submit a copy of the filing (excluding simply said ‘‘Good.’’ information about the docket available any Confidential Business Information In the Federal Register of October 21, at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. 2015 (80 FR 63731) (FRL–9935–29), wgreen on DSK2VPTVN1PROD with RULES FOR FURTHER INFORMATION CONTACT: Information not marked confidential EPA amended the initial notice of filing Susan Lewis, Registration Division pursuant to 40 CFR part 2 may be for pesticide petition (PP 4E8319), (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior including the commodity quinoa grain Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your at 3.0 ppm in addition to the Pennsylvania Ave. NW., Washington, objection or hearing request, identified commodities originally requested and DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP– listed above. Comments were received VerDate Sep<11>2014 15:17 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\09DER1.SGM 09DER1


Document Created: 2015-12-14 13:33:05
Document Modified: 2015-12-14 13:33:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionNotification of withdrawal.
DatesWithdrawal of approval is effective December 21, 2015.
ContactSujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, [email protected]
FR Citation80 FR 76387 
CFR Citation21 CFR 520
21 CFR 558
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