New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address
Federal Register, Volume 81 Issue 167 (Monday, August 29, 2016)
Federal Register Volume 81, Number 167 (Monday, August 29, 2016)
Rules and Regulations
Pages 59131-59135
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-19914
-----------------------------------------------------------------------
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 New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
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 May and June 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 applications, changes of sponsors' names and addresses, and the voluntary withdrawals of approval of applications.
DATES: This rule is effective August 29, 2016, except for the amendments to 21 CFR 558.274, 58.355, 58.363, 58.550, 558.625, and 558.630, which are effective September 8, 2016.
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:
-
Approval Actions
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during May and June 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., 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.
Page 59132
Table 1--Original and Supplemental NADAs and ANADAs Approved During May and June 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for use/
Approval date File No. Sponsor Product name Species effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
May 2, 2016................ 141-439 Elanco Animal Health, INTEPRITY Chickens........... Original approval for FOI Summary, EA/
A Division of Eli (avilamycin) Type A the prevention of FONSI.\1\
Lilly & Co., Lilly medicated article. mortality caused by
Corporate Center, necrotic enteritis
Indianapolis, IN associated with
46285. Clostridium
perfringens in
broiler chickens.
May 16, 2016............... 141-457 Aratana Therapeutics, ENTYCE (capromorelin Dogs............... Original approval for FOI Summary.
Inc., 11400 Tomahawk oral solution). appetite stimulation
Creek Pkwy., in dogs.
Leawood, KS 66211.
May 17, 2016............... 141-463 Elanco US, Inc., 2500 ONSIOR (robenacoxib) Dogs............... Original approval for FOI Summary.
Innovation Way, Tablets for Dogs. the control of
Greenfield, IN 46140. postoperative pain
and inflammation
associated with soft
tissue surgery in
dogs.
May 17, 2016............... 200-536 Med-Pharmex, Inc., MOMETAVET (gentamicin Dogs............... Original approval of FOI Summary.
2727 Thompson Creek sulfate, USP; a generic copy of
Rd., Pomona, CA mometasone furoate NADA 141-177.
91767-1861. anhydrous, USP; and
clotrimazole, USP)
Otic Suspension.
May 24, 2016............... 200-596 Huvepharma EOOD, 5th TILMOVET 90 Cattle............. Original approval for FOI Summary.
Floor, 3A Nikolay (tilmicosin use in two-way,
Haytov Str., 1113 phosphate) and combination drug
Sophia, Bulgaria. RUMENSIN 90 Type B and Type C
(monensin) Type A medicated feeds for
medicated articles. cattle fed in
confinement for
slaughter.
June 20, 2016.............. 200-587 Cross Vetpharm Group FERROFORTE Piglets............ Original approval as FOI Summary.
Ltd. Broomhill Rd., (gleptoferron a generic copy of
Tallaght, Dublin 24, injection). NADA 110-399.
Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ 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).
-
Changes of Sponsorship
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee, Mission, KS 66201 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma EOOD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
200-228................ PHOENECTIN (ivermectin) 522.1192
Injectable Solution.
200-254................ Iron Dextran Injection, 100 mg/ 522.1182
mL.
200-256................ Iron Dextran Injection, 200 mg/ 522.1182
mL.
200-351................ Lincomycin Injectable, USP..... 522.1260
200-389................ Amprolium 9.6% Oral Solution... 520.100
------------------------------------------------------------------------
As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship.
-
Withdrawals of Approval
In addition, during May and June 2016, Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
012-548 \1\............ TYLOSIN (tylosin phosphate)/ 558.274
HYGROMIX (hygromycin B).
013-162 \1\............ TYLAN TM (tylosin phosphate) 558.625
Type A medicated article.
013-388 \1\............ TYLAN (tylosin phosphate)/ 558.274
HYGROMIX (hygromycin B) Premix.
015-166 \1\............ TYLAN TM (tylosin phosphate) 558.625
Type A medicated article.
127-507 \1\............ TYLAN 5, 10, 20, or 40 SULFA-G 558.630
(tylosin phosphate and
sulfamethazine).
141-164 \1\............ TYLAN (tylosin phosphate)/COBAN 558.355
(monensin).
141-170 \1\............ TYLAN (tylosin phosphate)/ 558.363
MONTEBAN (narasin).
141-198 \1\............ TYLAN TM (tylosin phosphate)/ 558.550
BIO-COX (salinomycin).
------------------------------------------------------------------------
\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 NADAs 012-548, 013-162, 013-388, 015-166, 127-507, 141-640, 141-170, and 141-198, and all supplements and amendments thereto, is withdrawn, effective September 8, 2016. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval.
Page 59133
-
Technical Amendments
FDA has noticed that a drug labeler code in 21 CFR 520.2325a does not accurately reflect the sponsorship of a new animal drug application. At this time, we are amending this section. This action is being taken to improve the accuracy of the regulations.
Also, ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105 has informed FDA that it is changing its name and address to Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138.
Alexion Pharmaceuticals, Inc., 33 Hayden Ave., Lexington, MA 02421 has informed FDA that it has changed its address to 100 College St., New Haven, CT 06510. At this time, this firm is being added to the list of sponsors of approved application in 21 CFR 510.600(c) which we had not done previously.
FDA has noticed that the maximum concentration of sulfadimethoxine with ormetoprim in 2-way, fixed-ratio combination drug Type B medicated feeds in 21 CFR 558.4 was amended in error. At this time, we are revising this section to provide for appropriate concentrations in Type B medicated feeds for salmonids and catfish. This action is being taken 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
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 part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically add an entry for ``Alexion Pharmaceuticals, Inc.'', remove the entry for ``ConAgra Pet Products Co.'', and alphabetically add an entry for ``Sergeant's Pet Care Products, Inc.''; and in the table in paragraph (c)(2), revise the entry for ``021091'' and numerically add an entry for ``069334''.
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
------------------------------------------------------------------------
* * * * * * *
Alexion Pharmaceuticals, Inc., 100 College St., New 069334
Haven, CT 06510........................................
* * * * * * *
Sergeant's Pet Care Products, Inc., 10077 S. 134th St., 021091
Omaha, NE 68138........................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
021091.......................... Sergeant's Pet Care Products, Inc.,
10077 S. 134th St., Omaha, NE 68138.
* * * * * * *
069334.......................... Alexion Pharmaceuticals, Inc., 100
College St., New Haven, CT 06510.
* * * * * * *
------------------------------------------------------------------------
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. 520.100 Amended
0
4. In Sec. 520.100, remove paragraphs (b)(3) and (4).
Sec. Sec. 520.300, 520.300a, 520.300b, and 520.300c Redesignated as Sec. Sec. 520.284, 520.284a, 520.284b, and 520.284c.
0
5. Redesignate Sec. Sec. 520.300, 520.300a, 520.300b, and 520.300c as Sec. Sec. 520.284, 520.284a, 520.284b, and 520.284c.
0
6. Add Sec. 520.292 to read as follows:
Sec. 520.292 Capromorelin.
(a) Specifications. Each milliliter of solution contains 30 milligrams (mg) capromorelin.
(b) Sponsor. See No. 086026 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 3 mg/kg once daily by mouth.
(2) Indications for use. For appetite stimulation in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
0
7. In Sec. 520.2075, revise paragraphs (a) and (c) to read as follows:
Page 59134
Sec. 520.2075 Robenacoxib.
(a) Specifications. Each tablet contains 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs, or 6 mg robenacoxib for use in cats.
* * * * *
(c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.91 mg/lb (2 mg/kg) orally, once daily, for a maximum of 3 days.
(ii) Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats--(i) Amount. Administer 0.45 mg/lb (1 mg/kg) orally, once daily, for a maximum of 3 days.
(ii) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Sec. 520.2325a Amended
0
8. In Sec. 520.2325a, in paragraph (a)(3), remove ``053501'' and in its place add ``054771''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
10. Revise Sec. 522.1055 to read as follows:
Sec. 522.1055 Gleptoferron.
(a) Specifications. Each milliliter (mL) contains the equivalent of 200 milligrams of elemental iron as gleptoferron, a complex of ferric hydroxide and dextran glucoheptonic acid.
(b) Sponsors. See Nos. 059120 and 061623 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in swine--(1) Indications for use and amounts--(i) Prevention of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection on or before 3 days of age.
(ii) Treatment of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection as soon as signs of deficiency appear.
(2) Reserved
Sec. 522.1182 Amended
0
11. In Sec. 522.1182, in paragraph (b) introductory text, remove ``baby pigs'' and in its place add ``young piglets''; in paragraph (b)(7) introductory text, remove ``000859'' and in its place add ``016592''; and in paragraphs (b)(7)(i) and (ii), remove ``baby pig''.
Sec. 522.1192 Amended
0
12. In Sec. 522.1192, in paragraph (b)(2), remove ``000859'' and in its place add ``016592,''.
Sec. 522.1260 Amended
0
13. In Sec. 522.1260, in paragraph (b)(2), remove ``000859'' and in its place add ``016592''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
14. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
15. In Sec. 524.1044h, revise paragraphs (a) and (b) to read as follows:
Sec. 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension.
(a) Specifications. Each gram of suspension contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram (mg) gentamicin base, mometasone furoate monohydrate or mometasone furoate anhydrous, USP, equivalent to 1 mg mometasone, and 10 mg clotrimazole, USP.
(b) Sponsors. See Nos. 000061 and 054925 in Sec. 510.600(c) of this chapter.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
16. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.4 Amended
0
17. In Sec. 558.4, in paragraph (d), in the ``Category I'' table, in the ``Type B maximum (200 x)'' column, in the row entry for ``Avilamycin'', remove ``3.65 g/lb (0.8%)'' and in its place add ``7.3 g/lb (1.6%)''; and in the ``Category II'' table, remove the row entry for ``Sulfadimethoxine'' and two following row entries for ``Ormetoprim'', and in their place add row entries for ``Sulfadimethoxine'' and ``Ormetoprim''.
The additions read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
----------------------------------------------------------------------------------------------------------------
Assay limits
Drug percent \1\ Type Type B maximum (100 x) Assay limits
A percent Type B/C
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Sulfadimethoxine........................... 90-110 Poultry: 5.675 g/lb.......... 80-115/75-125
Fish: 85.1 g/lb..............
Ormetoprim................................. 90-110 Poultry: 3.405 g/lb.......... 80-115
Fish: 17.0 g/lb..............
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
18. In Sec. 558.68, revise paragraphs (a) and (e) to read as follows:
Sec. 558.68 Avilamycin.
(a) Each pound of Type A medicated article contains 45.4 or 90.7 grams of avilamycin.
* * * * *
(e) Conditions of use. Administer in feed as follows:
(1) Chickens--
Page 59135
----------------------------------------------------------------------------------------------------------------
Combination in
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.6 to 40.9.................. .............. Broiler chickens: For Feed as the sole 000986
the prevention of ration for 21
mortality caused by consecutive days. To
necrotic enteritis assure responsible
associated with antimicrobial drug
Clostridium use in broiler
perfringens in chickens, treatment
broiler chickens. administration must
begin on or before
10 days of age.
(ii) Reserved...................
----------------------------------------------------------------------------------------------------------------
(2) Swine--
----------------------------------------------------------------------------------------------------------------
Combinationin
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73............................ .............. Weaned pigs less than Feed as the sole 000986
14 weeks of age: For ration for 21
the reduction in consecutive days. To
incidence and assure responsible
overall severity of antimicrobial drug
diarrhea in the use in pigs, do not
presence of administer to pigs
pathogenic 14 weeks of age or
Escherichia coli in older.
groups of weaned
pigs.
(ii) Reserved...................
----------------------------------------------------------------------------------------------------------------
Sec. 558.274 Amended
0
19. Effective September 8, 2016, in Sec. 558.274, remove and reserve paragraphs (c)(1)(ii) and (c)(2)(ii).
0
20. Effective September 8, 2016, in Sec. 558.355, remove and reserve paragraph (f)(1)(xxviii) and revise paragraphs (f)(8)(i) and (ii).
The revisions read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(8) * * *
(i) Decoquinate alone and in combination as in Sec. 558.195.
(ii) Melengestrol acetate alone and in combination as in Sec. 558.342.
* * * * *
Sec. 558.363 Amended
0
21. Effective September 8, 2016, in Sec. 558.363, remove and reserve paragraph (d)(1)(vi).
Sec. 558.550 Amended
0
22. Effective September 8, 2016, in Sec. 558.550, remove and reserve paragraph (d)(1)(xxii).
Sec. 558.618 Amended
0
23. In Sec. 558.618, in paragraphs (e)(2)(ii) and (iii):
0
-
In the ``Limitations'' column, add ``Tilmicosin as provided by Nos. 000986 or 016952; monensin as provided by No. 000986 in Sec. 510.600(c) of this chapter.'' to the end of the existing entries; and
0
-
In the ``Sponsor'' column, numerically add ``016952''.
0
24. Effective September 8, 2016, in Sec. 558.625, revise paragraphs (b)(1), (f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and remove paragraphs (f)(2)(viii) and (ix).
The revisions read as follows:
Sec. 558.625 Tylosin.
* * * * *
(b) * * *
(1) No. 000986: 40 and 100 grams per pound for use as in paragraph (f) of this section.
* * * * *
(f) * * *
(2) * * *
(i) Decoquinate alone and in combination as in Sec. 558.195.
* * * * *
(iii) Melengestrol acetate alone and in combination as in Sec. 558.342.
* * * * *
(vii) Zilpaterol alone and in combination as in Sec. 558.665.
0
25. Effective September 8, 2016, in Sec. 558.630, revise paragraph (b)(1) to read as follows:
Sec. 558.630 Tylosin and sulfamethazine.
* * * * *
(b) * * *
(1) No. 000986: 40 and 100 grams per pound for use as in paragraph (e) of this section.
* * * * *
Dated: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
FR Doc. 2016-19914 Filed 8-26-16; 8:45 am
BILLING CODE 4164-01-P
-
