New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address
Federal Register, Volume 82 Issue 36 (Friday, February 24, 2017)
Federal Register Volume 82, Number 36 (Friday, February 24, 2017)
Rules and Regulations
Pages 11506-11509
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2017-03677
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
Docket No. FDA-2016-N-0002
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA or we) 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 2016. 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 several applications and a change of a sponsor's address.
DATES: This rule is effective February 24, 2017, except for the amendment to 21 CFR 524.1465, which is effective March 6, 2017.
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:
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Approval Actions
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during September and October 2016, 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.,
Page 11507
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 September and October 2016
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Effect of the action/
Approval date File No. Sponsor Product name Species indications for use Public documents
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October 26, 2016................ 141-465 Elanco US Inc, 2500 INTEPRITY Chickens........... Original approval for FOI Summary.
Innovation Way, (avilamycin) and the prevention of
Greenfield, IN COBAN (monensin) mortality caused by
46140. Type C medicated necrotic enteritis
feeds. associated with
Clostridium
perfringens in broiler
chickens; and as an
aid in the prevention
of coccidiosis caused
by Eimeria necatrix,
E. tenella, E.
acervulina, E.
brunetti, E. mivati,
and E. maxima.
September 8, 2016............... 200-592 Putney, Inc., One Amoxicillin Dogs............... Original approval of a FOI Summary.
Monument Sq., Trihydrate and generic copy of NADA
Suite 400, Clavulanate 055-099.
Portland, ME 04101. Potassium Tablets.
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Change of Sponsorship
Sogeval S. A., 200 Avenue de Mayenne, 53000 Laval, France has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Ceva Sante Animale, 10 Avenue de la Ballastiegravere, 33500 Libourne, France:
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File No. Product name 21 CFR section
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099-667....................... IMPOSIL (iron 522.1182
heptomer) Injection.
110-399....................... GLEPTOSIL 522.1055
(gleptoferron)
Injection.
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Following these changes of sponsorship, Sogeval S. A. is no longer the sponsor of an approved NADA. Accordingly, the firm's name, address, and drug labeler code are being removed from Sec. 510.600(c) (21 CFR 510.600(c)).
In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509:
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File No. Product name 21 CFR section
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006-417....................... RECOVR 522.2615
(tripelennamine
hydrochloride)
Injection.
032-319....................... FUROX (furazolidone) 524.1005
Aerosol Powder.
038-838....................... ROBAXIN-V 522.1380
(methocarbamol)
Injection.
108-687....................... PET DERM III 520.540c
(dexamethasone)
Tablets.
111-369....................... Dexamethasone Sterile 522.540
Solution.
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Following these changes of sponsorship, Kinetic Technologies, LLC is now the sponsor of an approved NADA. Accordingly, the firm's name, address, and drug labeler code are being added to Sec. 510.600(c).
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Withdrawals of Approval
In addition, Putney, Inc., One Monument Square, Suite 400, Portland, ME 04101 has requested that FDA withdraw approval of ANADA 200-524 for Mupirocin Ointment 2% because the product is no longer manufactured or marketed.
Elsewhere in this issue of the Federal Register, FDA gave notice that approval of ANADA 200-524, and all supplements and amendments thereto, is withdrawn, effective March 6, 2017. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this voluntary withdrawal of approval.
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Technical Amendments
Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort Collins, CO 80524 has informed FDA that it has changed its address to 1230 W. Ash St., Suite D, Windsor, CO 80550. In addition, FDA has noticed that a sponsor name in Sec. 510.600 does not reflect the particular punctuation used in this sponsor's applications and other correspondence. At this time, we are amending the list of sponsors of approved applications in Sec. 510.600(c) to reflect this change of sponsor address and sponsor's punctuation.
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.
21 CFR Part 558
Animal drugs, Animal feeds.
Page 11508
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 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. Revise Sec. 510.600 as follows:
0
a. In the table in paragraph (c)(1):
0
i. In the entry for ``Elanco US, Inc.'', remove ``Elanco US, Inc.'' and in its place add ``Elanco US Inc.'';
0
ii. Alphabetically add an entry for ``Kinetic Technologies, LLC'';
0
iii. Remove the entry for ``Sogeval S. A.''; and
0
iv. Revise the entry for ``Wildlife Laboratories, Inc.''
0
b. In the table in paragraph (c)(2):
0
i. Numerically add an entry for ``051031'';
0
ii. Revise the entry for ``053923''
0
iii. In the entry for ``058198'', remove ``Elanco US, Inc.'' and in its place add ``Elanco US Inc.''; and
0
iv. Remove the entry for ``059120''.
The additions and revisions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug labeler
Firm name and address code
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* * * * * * *
Kinetic Technologies, LLC, 961 Beasley St., Suite 270, 051031
Lexington, KY 40509....................................
* * * * * * *
Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, 053923
Windsor, CO 80550......................................
* * * * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * * * *
051031..................................... Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509.
* * * * * * *
053923..................................... Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, Windsor, CO 80550.
* * * * * * *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.88g Amended
0
4. In Sec. 520.88g, in paragraph (b), remove ``No. 054771'' and in its place add ``Nos. 026637 and 054771''.
Sec. 520.540c Amended
0
5. In Sec. 520.540c, in paragraph (b), remove ``054771'' and in its place add ``051031''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.540 Amended
0
7. In Sec. 522.540, in paragraph (d)(2)(i), remove ``054771'' and in its place add ``051031''.
Sec. 522.1055 Amended
0
8. In Sec. 522.1055, in paragraph (b), remove ``059120'' and in its place add ``013744''.
Sec. 522.1182 Amended
0
9. In Sec. 522.1182, in paragraph (b)(3), remove ``059120'' and in its place add ``013744''.
Sec. 522.1380 Amended
0
10. In Sec. 522.1380, in paragraph (b), remove ``054771'' and in its place add ``051031''.
Sec. 522.2615 Amended
0
11. In Sec. 522.2615, in paragraph (b), remove ``054771'' and in its place add ``051031''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
12. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1005 Amended
0
13. In Sec. 524.1005, in paragraph (b)(1), remove ``054771'' and in its place add ``051031''.
Sec. 524.1465 Amended
0
14. Effective March 6, 2017, in Sec. 524.1465, in paragraph (b), remove ``026637''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
15. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
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0
16. In Sec. 558.68, revise paragraph (e)(1)(ii) to read as follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
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Combination in
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
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* * * * * * *
(ii) 13.6 to 40.9.............. Monensin 90 to Broiler chickens: For Feed as the sole ration 058198
110; as provided the prevention of for 21 consecutive
by No. 058198 in mortality caused by days. To assure
Sec. 510.600(c) necrotic enteritis responsible
of this chapter. associated with antimicrobial drug use
Clostridium in broiler chickens,
perfringens in broiler treatment
chickens; and as an administration must
aid in the prevention begin on or before 10
of coccidiosis caused days of age. See Sec.
by Eimeria necatrix, 558.355(d) of this
E. tenella, E. chapter for additional
acervulina, E. required labeling.
brunetti, E. mivati,
and E. maxima.
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* * * * *
Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
FR Doc. 2017-03677 Filed 2-23-17; 8:45 am
BILLING CODE 4164-01-P
