New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
Federal Register, Volume 80 Issue 236 (Wednesday, December 9, 2015)
Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)
Rules and Regulations
Pages 76384-76387
From the Federal Register Online via the Government Publishing Office www.gpo.gov
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, george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Page 76385
-
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).
-
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.
-
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.
-
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
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
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
-
In the table in paragraph (c)(1), remove the entries for ``Orkeo USA, Inc.'' and ``Teva Canada Ltd.''; and
0
-
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
-
Revise paragraphs (a) and (e)(4)(i);
0
-
In paragraph (e)(4)(iii), remove the first sentence; and
0
-
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
-
