80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 236 (December 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 236 (December 9, 2015)
| Page Range | 76384-76387 | |
| FR Document | 2015-31042 |
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)] [Rules and Regulations] [Pages 76384-76387] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31042] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, and 558 [Docket No. FDA-2015-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship 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 September and October 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 and the voluntary withdrawals of approval of applications that occurred in September and October 2015. DATES: This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]. SUPPLEMENTARY INFORMATION: [[Page 76385]] I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during September and October 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 Center for Veterinary Medicine 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 September and October 2015 -------------------------------------------------------------------------------------------------------------------------------------------------------- 21 CFR File No. Sponsor Product name Action section FOIA summary NEPA review -------------------------------------------------------------------------------------------------------------------------------------------------------- 141-440......................... Piedmont Animal CLARO (florfenicol, Original approval for 524.957 yes............... CE.1 2 Health, 204 Muirs terbinafine, the treatment of Chapel Rd., suite mometasone furoate) otitis externa in dogs. 200, Greensboro, NC Otic Solution. 27410. 141-449......................... Intervet, Inc., 2 SAFE-GUARD AquaSol Original approval for 520.905a yes............... EA/ Giralda Farms, (fenbendazole oral the treatment and FONSI.\3\ Madison, NJ 07940. suspension) control of certain Suspension nematode worms in Concentrate. broiler chickens, replacement chickens intended to become breeding chickens, and breeding chickens. 141-442......................... Zoetis Inc., 333 LUTALYSE HighCon Supplemental approval 522.690 yes............... CE.1 4 Portage St., (dinoprost of subcutaneous route Kalamazoo, MI 49007. tromethamine of administration. injection) Injection. 108-901......................... Zoetis Inc. 333 LUTALYSE (dinoprost Supplemental approval 522.690 no................ CE.1 4 Portage St., tromethamine of revised indications Kalamazoo, MI 49007. injection) for uses in cattle. Injection. -------------------------------------------------------------------------------------------------------------------------------------------------------- \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\ 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). \4\ CE granted under 21 CFR 25.33(a)(1). II. Changes of Sponsorship During September and October 2015, ownership of, and all rights and interest in, the following approved applications have been transferred as follows: ---------------------------------------------------------------------------------------------------------------- 21 CFR File No. Previous sponsor Product name New sponsor section ---------------------------------------------------------------------------------------------------------------- 141-440...................... Piedmont Animal CLARO (florfenicol, Bayer HealthCare 524.957 Health, 204 Muirs terbinafine, LLC, Animal Health Chapel Rd., suite mometasone furoate) Division, P.O. Box 200, Greensboro, NC Otic Solution. 390, Shawnee 27410. Mission, KS 66201. 200-582...................... Orkeo USA, Inc., 77 LONCOR 300 Bayer HealthCare 522.955 Water St., New York, (florfenicol) LLC, Animal Health NY 10005. Injectable Solution. Division, P.O. Box 390, Shawnee Mission, KS 66201. ---------------------------------------------------------------------------------------------------------------- As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship. Following the change of sponsorship of ANADA 200-582, Orkeo USA, Inc., is no longer the sponsor of an approved application. III. Withdrawals of Approval In addition, during September and October 2015, 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: ---------------------------------------------------------------------------------------------------------------- 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. [[Page 76386]] 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. ---------------------------------------------------------------------------------------------------------------- \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. Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 140-680, NADA 140-681, ANADA 200-028, and ANADA 200-383, and all supplements and amendments thereto, is withdrawn, effective December 21, 2015. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval. IV. Technical Amendments FDA has noticed that a previous sponsor of ANADA 200-383, Teva Canada Ltd., was no longer the sponsor of an approved application following a prior change of sponsorship. At this time, FDA is amending the regulation to remove the firm from the listings of sponsors of approved applications in 21 CFR 510.600. This action is being taken to improve the accuracy of the regulations. FDA is also revising the special considerations for medicated feeds containing veterinary feed directive drugs to align with 21 CFR 558.6(a)(6), which was recently amended (80 FR 31708, June 3, 2015). This action is being taken to improve the consistency 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, and 524 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, 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: 0 a. In the table in paragraph (c)(1), remove the entries for ``Orkeo USA, Inc.'' and ``Teva Canada Ltd.''; and 0 b. In the table in paragraph (c)(2), remove the entries for ``043806'' and ``086050''. 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. 520.446 [Amended] 0 4. Effective December 21, 2015, in Sec. 520.446, in paragraph (b)(1), remove ``Nos. 000859 and 054771'' and in its place add ``No. 054771''. 0 5. In Sec. 520.905a: 0 a. Revise paragraphs (a) and (e)(4)(i); 0 b. In paragraph (e)(4)(iii), remove the first sentence; and 0 c. Add paragraph (e)(5). The revisions and addition read as follows: Sec. 520.905a Fenbendazole suspension. (a) Specifications. Each milliliter of suspension contains 100 milligrams (mg) fenbendazole for use as in paragraphs (e)(1), (2), (3), and (4) of this section; or 200 mg fenbendazole for use as in paragraph (e)(5) of this section. * * * * * (e) * * * (4) * * * (i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb). Retreatment may be needed after 4 to 6 weeks. * * * * * (5) Chickens--(i) Amount. Administer orally via drinking water at a daily dose of 1 mg/kg body weight (0.454 mg/lb) for 5 consecutive days. (ii) Indications for use. For the treatment and control of adult Ascaridia galli in broiler chickens and replacement chickens intended to become breeding chickens, and for the treatment and control of adult A. galli and Heterakis gallinarum in breeding chickens. (iii) Limitations. Not for use in laying hens and replacement chickens intended to become laying hens. Sec. 520.2043 [Amended] 0 6. Effective December 21, 2015, in Sec. 520.2043, in paragraph (b)(2), remove ``Nos. 054771, 055246, 058829, and 059130'' and in its place add ``Nos. 000859, 054771, and 058829''. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 7. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 8. In Sec. 522.690, revise paragraphs (b)(2) and (d)(1)(i) and add paragraph (b)(3) to read as follows: Sec. 522.690 Dinoprost. * * * * * (b) * * * (2) No. 054771 for use of the 5 mg/mL product as in paragraphs (d)(1), (2), and (3) of this section. (3) No. 000859 for use of the 5 mg/mL product as in paragraphs (d)(2), (3), and (4) of this section. * * * * * (d) * * * (1) * * * (i) Amount. 25 mg as a single intramuscular or subcutaneous injection. * * * * * Sec. 522.955 [Amended] 0 9. In Sec. 522.955(b)(2), remove ``086050'' and in its place add ``000859''. [[Page 76387]] PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 10. The authority citation for 21 CFR part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 11. Add Sec. 524.957 to read as follows: Sec. 524.957 Florfenicol, terbinafine, and mometasone otic solution. (a) Specifications. Each single-dose, prefilled dropperette contains 1 milliliter (mL) of a solution containing 15 milligrams (mg) florfenicol, 13.3 mg terbinafine, and 2 mg mometasone furoate. (b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter. (c) Conditions of use in dogs--(1) Amount. Administer one dropperette (1 mL) per affected ear(s). (2) Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 12. The authority citation for 21 CFR part 558 continues to read as follows: Authority: (P>21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 13. In Sec. 558.68, revise paragraph (c)(1) to read as follows: Sec. 558.68 Avilamycin. * * * * * (c) * * * (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements. * * * * * 0 14. In Sec. 558.261, revise paragraphs (c)(1) and (2) introductory text to read as follows: Sec. 558.261 Florfenicol. * * * * * (c) * * * (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements. (2) The expiration date of VFDs for florfenicol medicated feeds: * * * * * 0 15. In Sec. 558.618, revise paragraph (c)(1) to read as follows: Sec. 558.618 Tilmicosin. * * * * * (c) * * * (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements. * * * * * Sec. 558.625 [Amended] 0 16. Effective December 21, 2015, in Sec. 558.625, remove paragraph (b)(5) and redesignate paragraph (b)(6) as paragraph (b)(5). Sec. 558.630 [Amended] 0 17. Effective December 21, 2015, in Sec. 558.630, in paragraph (b)(2), remove ``Nos. 054771 and 069254'' and in its place add ``No. 054771''. Dated: December 4, 2015. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2015-31042 Filed 12-8-15; 8:45 am] BILLING CODE 4164-01-P
![76384 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations
15 CFR Part 734 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 PART 745—[AMENDED]
FR 54079, 3 CFR, 1996 Comp., p. 219; E.O.
Administrative practice and 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. ■ 6. The authority citation for 15 CFR
procedure, Exports, Inventions and 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 part 745 is revised to read as follows:
patents, Research, Science and Comp., p. 783; E.O. 13637, 78 FR 16129, 3
technology. CFR, 2014 Comp., p. 223; Notice of August Authority: 50 U.S.C. 1701 et seq.; E.O.
12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
15 CFR Part 736 7, 2015, 80 FR 48233 (August 11, 2015);
950; Notice of November 12, 2015, 80 FR
Notice of November 12, 2015, 80 FR 70667
Exports. 70667 (November 13, 2015).
(November 13, 2015).
Dated: November 30, 2015.
15 CFR Part 742
PART 736—[AMENDED] Kevin J. Wolf,
Exports, Terrorism. Assistant Secretary for Export
15 CFR Part 744 ■ 3. The authority citation for 15 CFR Administration.
part 736 is revised to read as follows: [FR Doc. 2015–30753 Filed 12–8–15; 8:45 am]
Exports, Reporting and recordkeeping
Authority: 50 U.S.C. app. 2401 et seq.; 50 BILLING CODE 3510–33–P
requirements, Terrorism.
U.S.C. 1701 et seq.; 22 U.S.C. 2151 note; E.O.
15 CFR Part 745 12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
Administrative practice and 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996
Comp., p. 219; E.O. 13026, 61 FR 58767, 3 DEPARTMENT OF HEALTH AND
procedure, Chemicals, Exports, Foreign HUMAN SERVICES
CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR
trade, Reporting and recordkeeping 44025, 3 CFR, 2001 Comp., p. 783; E.O.
requirements. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p. Food and Drug Administration
Accordingly, parts 730, 734, 736, 742, 168; Notice of May 6, 2015, 80 FR 26815
744, and 745 of the EAR (15 CFR parts (May 8, 2015); Notice of August 7, 2015, 80 21 CFR Parts 510, 520, 522, 524, and
730–774) are amended as follows: FR 48233 (August 11, 2015); Notice of 558
November 12, 2015, 80 FR 70667 (November
PART 730—[AMENDED] 13, 2015). [Docket No. FDA–2015–N–0002]
■ 1. The authority citation for 15 CFR PART 742—[AMENDED] New Animal Drugs; Approval of New
part 730 is revised to read as follows: Animal Drug Applications;
Authority: 50 U.S.C. app. 2401 et seq.; 50 ■ 4. The authority citation for 15 CFR Withdrawals of Approval of New
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. part 742 is revised to read as follows: Animal Drug Applications; Changes of
7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 note; Sponsorship
Authority: 50 U.S.C. app. 2401 et seq.; 50
22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; AGENCY: Food and Drug Administration,
U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; HHS.
50 U.S.C. app. 5; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108–11, 117
Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, Final rule; technical
ACTION:
U.S.C. 7210; E.O. 11912, 41 FR 15825, 3 CFR,
1978 Comp., p. 179; E.O. 12851, 58 FR 33181, amendments.
1976 Comp., p. 114; E.O. 12002, 42 FR 35623,
3 CFR, 1977 Comp., p. 133; E.O. 12058, 43 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. SUMMARY: The Food and Drug
FR 20947, 3 CFR, 1978 Comp., p. 179; E.O.
12214, 45 FR 29783, 3 CFR, 1980 Comp., p. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. Administration (FDA) is amending the
256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 animal drug regulations to reflect
Comp., p. 608; E.O. 12854, 58 FR 36587, 3 Comp., p. 783; Presidential Determination application-related actions for new
CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 2003–23, 68 FR 26459, 3 CFR, 2004 Comp., animal drug applications (NADAs) and
28205, 3 CFR, 1994 Comp., p. 899; E.O. p. 320; Notice of August 7, 2015, 80 FR 48233 abbreviated new animal drug
12938, 59 FR 59099, 3 CFR, 1994 Comp., p. (August 11, 2015); Notice of November 12, applications (ANADAs) during
950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 2015, 80 FR 70667 (November 13, 2015). September and October 2015. FDA is
Comp., p. 356; E.O. 12981, 60 FR 62981, 3 also informing the public of the
CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR PART 744—[AMENDED] availability of summaries of the basis of
54079, 3 CFR, 1996 Comp., p. 219; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
approval and of environmental review
■ 5. The authority citation for 15 CFR documents, where applicable. The
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998
part 744 is revised to read as follows: animal drug regulations are also being
Comp., p. 208; E.O. 13222, 66 FR 44025, 3
CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR Authority: 50 U.S.C. app. 2401 et seq.; 50 amended to reflect changes of
49079, 3 CFR, 2001 Comp., p. 786; E.O. U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; sponsorship of applications and the
13338, 69 FR 26751, 3 CFR, 2004 Comp., p 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 voluntary withdrawals of approval of
168; E.O. 13637, 78 FR 16129, 3 CFR, 2014 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, applications that occurred in September
Comp., p. 223; Notice of January 21, 2015, 80 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, and October 2015.
FR 3461 (January 22, 2015); Notice of May 6, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
2015, 80 FR 26815 (May 8, 2015); Notice of DATES: This rule is effective December 9,
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O.
August 7, 2015, 80 FR 48233 (August 11, 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 2015, except for the amendments to 21
2015); Notice of September 18, 2015, 80 FR 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 CFR 520.446, 520.2043, 558.625, and
57281 (September 22, 2015); Notice of Comp., p. 228; E.O. 13099, 63 FR 45167, 3 558.630, which are effective December
November 12, 2015, 80 FR 70667 (November CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 21, 2015.
13, 2015). 44025, 3 CFR, 2001 Comp., p. 783; E.O. FOR FURTHER INFORMATION CONTACT:
wgreen on DSK2VPTVN1PROD with RULES
13224, 66 FR 49079, 3 CFR, 2001 Comp., p. George K. Haibel, Center for Veterinary
PART 734—[AMENDED] 786; Notice of January 21, 2015, 80 FR 3461 Medicine (HFV–6), Food and Drug
(January 22, 2015); Notice of August 7, 2015, Administration, 7519 Standish Pl.,
■ 2. The authority citation for 15 CFR 80 FR 48233 (August 11, 2015); Notice of
part 734 is revised to read as follows: Rockville, MD 20855, 240–402–5689,
September 18, 2015, 80 FR 57281 (September
george.haibel@fda.hhs.gov.
Authority: 50 U.S.C. app. 2401 et seq.; 50 22, 2015); Notice of November 12, 2015, 80
U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, FR 70667 (November 13, 2015). SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014 15:17 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\09DER1.SGM 09DER1](https://thefederalregister.org/doc/80_FR_76620/page/1.svg)
![76386 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations
21 CFR
File No. Sponsor Product name section
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., Pensa- EVICT 300 (pyrantel pamoate) Suspension ........... 520.2043
cola, 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.
Elsewhere in this issue of the Federal CFR parts 510, 520, 522, 524, and 558 of 1 mg/kg body weight (0.454 mg/lb)
Register, FDA gave notice that approval are amended as follows: for 5 consecutive days.
of NADA 140–680, NADA 140–681, (ii) Indications for use. For the
ANADA 200–028, and ANADA 200– PART 510—NEW ANIMAL DRUGS treatment and control of adult Ascaridia
383, and all supplements and galli in broiler chickens and
amendments thereto, is withdrawn, ■ 1. The authority citation for 21 CFR
part 510 continues to read as follows: replacement chickens intended to
effective December 21, 2015. As become breeding chickens, and for the
provided in the regulatory text of this Authority: 21 U.S.C. 321, 331, 351, 352, treatment and control of adult A. galli
document, the animal drug regulations 353, 360b, 371, 379e.
and Heterakis gallinarum in breeding
are amended to reflect these voluntary § 510.600 [Amended] chickens.
withdrawals of approval.
■ 2. In § 510.600: (iii) Limitations. Not for use in laying
IV. Technical Amendments ■ a. In the table in paragraph (c)(1), hens and replacement chickens
FDA has noticed that a previous remove the entries for ‘‘Orkeo USA, intended to become laying hens.
sponsor of ANADA 200–383, Teva Inc.’’ and ‘‘Teva Canada Ltd.’’; and § 520.2043 [Amended]
Canada Ltd., was no longer the sponsor ■ b. In the table in paragraph (c)(2),
of an approved application following a remove the entries for ‘‘043806’’ and ■ 6. Effective December 21, 2015, in
prior change of sponsorship. At this ‘‘086050’’. § 520.2043, in paragraph (b)(2), remove
time, FDA is amending the regulation to ‘‘Nos. 054771, 055246, 058829, and
remove the firm from the listings of PART 520—ORAL DOSAGE FORM 059130’’ and in its place add ‘‘Nos.
sponsors of approved applications in 21 NEW ANIMAL DRUGS 000859, 054771, and 058829’’.
CFR 510.600. This action is being taken
■ 3. The authority citation for 21 CFR PART 522—IMPLANTATION OR
to improve the accuracy of the
part 520 continues to read as follows: INJECTABLE DOSAGE FORM NEW
regulations.
FDA is also revising the special Authority: 21 U.S.C. 360b. ANIMAL DRUGS
considerations for medicated feeds
containing veterinary feed directive § 520.446 [Amended] ■ 7. The authority citation for 21 CFR
drugs to align with 21 CFR 558.6(a)(6), ■ 4. Effective December 21, 2015, in part 522 continues to read as follows:
which was recently amended (80 FR § 520.446, in paragraph (b)(1), remove Authority: 21 U.S.C. 360b.
31708, June 3, 2015). This action is ‘‘Nos. 000859 and 054771’’ and in its
place add ‘‘No. 054771’’. ■ 8. In § 522.690, revise paragraphs
being taken to improve the consistency
■ 5. In § 520.905a:
(b)(2) and (d)(1)(i) and add paragraph
of the regulations.
This rule does not meet the definition ■ a. Revise paragraphs (a) and (e)(4)(i); (b)(3) to read as follows:
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because ■ b. In paragraph (e)(4)(iii), remove the § 522.690 Dinoprost.
it is a rule of ‘‘particular applicability’’. first sentence; and
■ c. Add paragraph (e)(5).
* * * * *
Therefore, it is not subject to the
congressional review requirements in 5 The revisions and addition read as (b) * * *
U.S.C. 801–808. follows: (2) No. 054771 for use of the 5 mg/mL
product as in paragraphs (d)(1), (2), and
List of Subjects § 520.905a Fenbendazole suspension. (3) of this section.
21 CFR Part 510 (a) Specifications. Each milliliter of (3) No. 000859 for use of the 5 mg/mL
suspension contains 100 milligrams product as in paragraphs (d)(2), (3), and
Administrative practice and (mg) fenbendazole for use as in
procedure, Animal drugs, Labeling, (4) of this section.
paragraphs (e)(1), (2), (3), and (4) of this
Reporting and recordkeeping section; or 200 mg fenbendazole for use * * * * *
requirements. as in paragraph (e)(5) of this section. (d) * * *
21 CFR Parts 520, 522, and 524 * * * * * (1) * * *
Animal drugs. (e) * * * (i) Amount. 25 mg as a single
(4) * * * intramuscular or subcutaneous
21 CFR Part 558 (i) Amount. Administer orally 5 mg/ injection.
wgreen on DSK2VPTVN1PROD with RULES
Animal drugs, Animal feeds. kg of body weight (2.3 mg/lb). * * * * *
Therefore, under the Federal Food, Retreatment may be needed after 4 to 6
Drug, and Cosmetic Act and under weeks. § 522.955 [Amended]
authority delegated to the Commissioner * * * * * ■ 9. In § 522.955(b)(2), remove
of Food and Drugs and redelegated to (5) Chickens—(i) Amount. Administer ‘‘086050’’ and in its place add
the Center for Veterinary Medicine, 21 orally via drinking water at a daily dose ‘‘000859’’.
VerDate Sep<11>2014 15:17 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\09DER1.SGM 09DER1](https://thefederalregister.org/doc/80_FR_76620/page/3.svg)
![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](https://thefederalregister.org/doc/80_FR_76620/page/4.svg)
Document Created: 2015-12-14 13:32:50
Document Modified: 2015-12-14 13:32:50
| 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 December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015. | |
| 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 | 80 FR 76384 | |
| CFR Citation | 21
CFR
510 21 CFR 520 21 CFR 522 21 CFR 524 21 CFR 558 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Animal Feeds |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR