81_FR_59298 81 FR 59131 - 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

81 FR 59131 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 167 (August 29, 2016)

Page Range59131-59135
FR Document2016-19914

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.

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  [www.thefederalregister.org]
[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: 

I. 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).

II. 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.

III. 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]]

IV. 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

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 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
a. 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
b. 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

Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations 59131 PART 1—GENERAL ENFORCEMENT § 101.2 [Amended] SUMMARY: The Food and Drug REGULATIONS ■ 8. Amend § 101.2 in paragraph (c) Administration (FDA or we) is introductory text by removing amending the animal drug regulations to ■ 1. The authority citation for part 1 ‘‘§ 101.105(h)(1)’’ and adding in its reflect application-related actions for continues to read as follows: place ‘‘§ 101.7(h)(1)’’. new animal drug applications (NADAs) Authority: 15 U.S.C. 1333, 1453, 1454, and abbreviated new animal drug § 101.105 [Redesignated as § 101.7] applications (ANADAs) during May and 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342i, 343, ■ 9. Redesignate § 101.105 as § 101.7. June 2016. FDA is also informing the 350c, 350d, 350e, 352, 355, 360b, 360ccc, ■ 10. Revise newly designated § 101.7 public of the availability of summaries 360ccc–1, 360ccc–2, 362, 371, 373, 374, 381, section heading to read as follows: of the basis of approval and of 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, environmental review documents, 243, 262, 264. § 101.7 Declaration of net quantity of contents. where applicable. The animal drug § 1.1 [Amended] * * * * * regulations are also being amended to reflect changes of sponsorship of ■ 2. Amend § 1.1(c) as follows: § 101.13 [Amended] applications, changes of sponsors’ ■ a. Remove ‘‘101.105(f)’’ and add in its names and addresses, and the voluntary ■ 11. Amend paragraphs (d)(2), (h)(4)(i), place ‘‘101.7(f)’’. withdrawals of approval of applications. and (i)(2) by removing ‘‘§ 101.105(i)’’ ■ b. Remove ‘‘101.105(i)’’ and add in its and adding in its place ‘‘§ 101.7(i)’’. DATES: This rule is effective August 29, place ‘‘101.7(i)’’. 2016, except for the amendments to 21 ■ c. Remove ‘‘101.105(j)’’ and add in its § 101.30 [Amended] CFR 558.274, 58.355, 58.363, 58.550, place ‘‘101.7(j)’’. ■ 12. Amend § 101.30(g) by removing 558.625, and 558.630, which are ■ d. Remove ‘‘101.105(o)’’ and add in its ‘‘§ 101.105(i)’’ and adding in its place effective September 8, 2016. place ‘‘101.7(o)’’. ‘‘§ 101.7(i)’’. FOR FURTHER INFORMATION CONTACT: § 1.20 [Amended] PART 104—NUTRITIONAL QUALITY George K. Haibel, Center for Veterinary ■ 3. In § 1.20, by removing GUIDELINES FOR FOODS Medicine (HFV–6), Food and Drug ‘‘§ 101.105(f)’’ and adding in its place Administration, 7519 Standish Pl., ■ 13. The authority citation for part 104 Rockville, MD 20855, 240–402–5689, ‘‘§ 101.7(f)’’. continues to read as follows: george.haibel@fda.hhs.gov. § 1.24 [Amended] Authority: 21 U.S.C. 321, 343, 371(a). SUPPLEMENTARY INFORMATION: ■ 4. Amend § 1.24 as follows: § 104.5 [Amended] ■ a. Remove ‘‘§ 101.105’’ in paragraph I. Approval Actions ■ 14. Amend § 104.5(b) by removing (a)(2) and add in its place ‘‘§ 101.7’’. ‘‘§ 101.105’’ and adding in its place FDA is amending the animal drug ■ b. Remove ‘‘§ 101.105(b)(2)’’ wherever regulations to reflect approval actions ‘‘§ 101.7’’. it appears and add in its place for NADAs and ANADAs during May ‘‘§ 101.7(b)(2)’’. Dated: August 16, 2016. and June 2016, as listed in table 1. In ■ c. Remove ‘‘§ 101.105(f)’’ wherever it Jeremy Sharp, addition, FDA is informing the public of appears and add in its place Deputy Commissioner for Policy, Planning, the availability, where applicable, of ‘‘§ 101.7(f)’’. Legislation, and Analysis. documentation of environmental review ■ d. Remove ‘‘§ 101.105(j)’’ wherever it [FR Doc. 2016–19925 Filed 8–26–16; 8:45 am] required under the National appears and add in its place BILLING CODE 4164–01–P Environmental Policy Act (NEPA) and, ‘‘§ 101.7(j)’’. for actions requiring review of safety or ■ e. Remove ‘‘§ 101.105(j)(1)’’ wherever effectiveness data, summaries of the it appears and add in its place DEPARTMENT OF HEALTH AND basis of approval (FOI Summaries) ‘‘§ 101.7(j)(1)’’. HUMAN SERVICES under the Freedom of Information Act (FOIA). These public documents may be PART 100—GENERAL Food and Drug Administration seen in the Division of Dockets ■ 5. The authority citation for part 100 Management (HFA–305), Food and Drug 21 CFR Parts 510, 520, 522, 524, and continues to read as follows: Administration, 5630 Fishers Lane, Rm. 558 1061, Rockville, MD 20852, between 9 Authority: 21 U.S.C. 321, 331, 337, 342, [Docket No. FDA–2016–N–0002] a.m. and 4 p.m., Monday through 343, 348, 371. Friday. Persons with access to the New Animal Drugs; Approval of New Internet may obtain these documents at § 100.155 [Amended] Animal Drug Applications; Withdrawal the CVM FOIA Electronic Reading ■ 6. Amend § 100.155 in paragraphs (a) of Approval of New Animal Drug Room: http://www.fda.gov/AboutFDA/ and (b) by removing ‘‘§ 101.105’’ and Applications; Changes of CentersOffices/OfficeofFoods/CVM/ adding in its place ‘‘§ 101.7’’. Sponsorship; Change of Sponsor’s CVMFOIAElectronicReadingRoom/ Name and Address; Change of default.htm. Marketing exclusivity and PART 101—FOOD LABELING Sponsor’s Address patent information may be accessed in ■ 7. The authority citation for part 101 AGENCY: Food and Drug Administration, FDA’s publication, Approved Animal continues to read as follows: HHS. Drug Products Online (Green Book) at: jstallworth on DSK7TPTVN1PROD with RULES Authority: 15 U.S.C. 1453, 1454, 1455; 21 http://www.fda.gov/AnimalVeterinary/ Final rule; technical ACTION: U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. Products/ApprovedAnimalDrug amendment. 243, 264, 271. Products/default.htm. 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59132 Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2016 Indications for use/effect Public Approval date File No. Sponsor Product name Species of the action documents May 2, 2016 .......... 141–439 Elanco Animal Health, A Divi- INTEPRITY (avilamycin) Type Chickens .... Original approval for the pre- FOI Summary, sion of Eli Lilly & Co., Lilly A medicated article. vention of mortality caused EA/FONSI.1 Corporate Center, Indianap- by necrotic enteritis associ- olis, IN 46285. ated with Clostridium perfringens in broiler chick- ens. May 16, 2016 ........ 141–457 Aratana Therapeutics, Inc., ENTYCE (capromorelin oral Dogs ........... Original approval for appetite FOI Summary. 11400 Tomahawk Creek solution). stimulation in dogs. Pkwy., Leawood, KS 66211. May 17, 2016 ........ 141–463 Elanco US, Inc., 2500 Innova- ONSIOR (robenacoxib) Tablets Dogs ........... Original approval for the con- FOI Summary. tion Way, Greenfield, IN for Dogs. trol of postoperative pain 46140. and inflammation associated with soft tissue surgery in dogs. May 17, 2016 ........ 200–536 Med-Pharmex, Inc., 2727 MOMETAVET (gentamicin sul- Dogs ........... Original approval of a generic FOI Summary. Thompson Creek Rd., Po- fate, USP; mometasone copy of NADA 141–177. mona, CA 91767–1861. furoate anhydrous, USP; and clotrimazole, USP) Otic Sus- pension. May 24, 2016 ........ 200–596 Huvepharma EOOD, 5th Floor, TILMOVET 90 (tilmicosin phos- Cattle .......... Original approval for use in FOI Summary. 3A Nikolay Haytov Str., 1113 phate) and RUMENSIN 90 two-way, combination drug Sophia, Bulgaria. (monensin) Type A medi- Type B and Type C medi- cated articles. cated feeds for cattle fed in confinement for slaughter. June 20, 2016 ....... 200–587 Cross Vetpharm Group Ltd. FERROFORTE (gleptoferron Piglets ........ Original approval as a generic FOI Summary. Broomhill Rd., Tallaght, Dub- injection). copy of NADA 110–399. lin 24, 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 signifi- cant impact (FONSI). II. Changes of Sponsorship Mission, KS 66201 has informed FDA approved applications to Huvepharma Bayer HealthCare LLC, Animal Health that it has transferred ownership of, and EOOD, 5th Floor, 3A Nikolay Haitov Division, P.O. Box 390, Shawnee, all rights and interest in, the following Str., 1113 Sofia, Bulgaria: 21 CFR File No. Product name section 200–228 PHOENECTIN (ivermectin) Injectable Solution .............................................................................................................. 522.1192 200–254 Iron Dextran Injection, 100 mg/mL .................................................................................................................................. 522.1182 200–256 Iron Dextran Injection, 200 mg/mL .................................................................................................................................. 522.1182 200–351 Lincomycin Injectable, USP ............................................................................................................................................ 522.1260 200–389 Amprolium 9.6% Oral Solution ........................................................................................................................................ 520.100 As provided in the regulatory text of III. Withdrawals of Approval that FDA withdraw approval of the this document, the animal drug In addition, during May and June NADAs listed in the following table regulations are amended to reflect these 2016, Elanco US, Inc., 2500 Innovation because the products are no longer changes of sponsorship. Way, Greenfield, IN 46140 requested manufactured or marketed: 21 CFR File No. Product name section 012–548 1 TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) ........................................................................................... 558.274 013–162 1 TYLAN TM (tylosin phosphate) Type A medicated article .............................................................................................. 558.625 013–388 1 TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) Premix ................................................................................... 558.274 015–166 1 TYLAN TM (tylosin phosphate) Type A medicated article .............................................................................................. 558.625 127–507 1 TYLAN 5, 10, 20, or 40 SULFA-G (tylosin phosphate and sulfamethazine) .................................................................. 558.630 141–164 1 TYLAN (tylosin phosphate)/COBAN (monensin) ............................................................................................................ 558.355 141–170 1 TYLAN (tylosin phosphate)/MONTEBAN (narasin) ......................................................................................................... 558.363 141–198 1 TYLAN TM (tylosin phosphate)/BIO-COX (salinomycin) ................................................................................................ 558.550 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. jstallworth on DSK7TPTVN1PROD with RULES Elsewhere in this issue of the Federal amendments thereto, is withdrawn, are amended to reflect these voluntary Register, FDA gave notice that approval effective September 8, 2016. As withdrawals of approval. of NADAs 012–548, 013–162, 013–388, provided in the regulatory text of this 015–166, 127–507, 141–640, 141–170, document, the animal drug regulations and 141–198, and all supplements and VerDate Sep<11>2014 14:52 Aug 26, 2016 Jkt 238001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\29AUR1.SGM 29AUR1

Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations 59133 IV. Technical Amendments section to provide for appropriate CFR parts 510, 520, 522, 524, and 558 FDA has noticed that a drug labeler concentrations in Type B medicated are amended as follows: code in 21 CFR 520.2325a does not feeds for salmonids and catfish. This action is being taken to improve the PART 510—NEW ANIMAL DRUGS accurately reflect the sponsorship of a new animal drug application. At this accuracy of the regulations. This rule does not meet the definition ■ 1. The authority citation for part 510 time, we are amending this section. This of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because continues to read as follows: action is being taken to improve the accuracy of the regulations. it is a rule of ‘‘particular applicability.’’ Authority: 21 U.S.C. 321, 331, 351, 352, Also, ConAgra Pet Products Co., 3902 Therefore, it is not subject to the 353, 360b, 371, 379e. Leavenworth St., Omaha, NE 68105 has congressional review requirements in 5 U.S.C. 801–808. ■ 2. In § 510.600, in the table in informed FDA that it is changing its paragraph (c)(1), alphabetically add an name and address to Sergeant’s Pet Care List of Subjects entry for ‘‘Alexion Pharmaceuticals, Products, Inc., 10077 S. 134th St., 21 CFR Part 510 Inc.’’, remove the entry for ‘‘ConAgra Omaha, NE 68138. Alexion Pharmaceuticals, Inc., 33 Pet Products Co.’’, and alphabetically Administrative practice and Hayden Ave., Lexington, MA 02421 has add an entry for ‘‘Sergeant’s Pet Care procedure, Animal drugs, Labeling, informed FDA that it has changed its Products, Inc.’’; and in the table in Reporting and recordkeeping address to 100 College St., New Haven, paragraph (c)(2), revise the entry for requirements. CT 06510. At this time, this firm is ‘‘021091’’ and numerically add an entry being added to the list of sponsors of 21 CFR Parts 520, 522, and 524 for ‘‘069334’’. approved application in 21 CFR Animal drugs. The additions and revisions read as 510.600(c) which we had not done follows: 21 CFR Part 558 previously. Animal drugs, Animal feeds. § 510.600 Names, addresses, and drug FDA has noticed that the maximum labeler codes of sponsors of approved concentration of sulfadimethoxine with Therefore, under the Federal Food, applications. ormetoprim in 2-way, fixed-ratio Drug, and Cosmetic Act and under combination drug Type B medicated authority delegated to the Commissioner * * * * * feeds in 21 CFR 558.4 was amended in of Food and Drugs and redelegated to (c) * * * error. At this time, we are revising this the Center for Veterinary Medicine, 21 (1) * * * Drug labeler Firm name and address code * * * * * * * Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510 ........................................................................................... 069334 * * * * * * * Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138 .................................................................................... 021091 * * * * * * * (2) * * * Drug labeler Firm name and address code * * * * * * * 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 §§ 520.300, 520.300a, 520.300b, and (b) Sponsor. See No. 086026 in NEW ANIMAL DRUGS 520.300c [Redesignated as §§ 520.284, § 510.600(c) of this chapter. 520.284a, 520.284b, and 520.284c.] (c) Conditions of use in dogs—(1) ■ 3. The authority citation for part 520 ■ 5. Redesignate §§ 520.300, 520.300a, Amount. Administer 3 mg/kg once daily continues to read as follows: 520.300b, and 520.300c as §§ 520.284, by mouth. jstallworth on DSK7TPTVN1PROD with RULES 520.284a, 520.284b, and 520.284c. (2) Indications for use. For appetite Authority: 21 U.S.C. 360b. stimulation in dogs. ■ 6. Add § 520.292 to read as follows: § 520.100 [Amended] (3) Limitations. Federal law restricts § 520.292 Capromorelin. this drug to use by or on the order of ■ 4. In § 520.100, remove paragraphs (a) Specifications. Each milliliter of a licensed veterinarian. (b)(3) and (4). solution contains 30 milligrams (mg) ■ 7. In § 520.2075, revise paragraphs (a) capromorelin. and (c) to read as follows: VerDate Sep<11>2014 14:52 Aug 26, 2016 Jkt 238001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\29AUR1.SGM 29AUR1

59134 Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations § 520.2075 Robenacoxib. § 522.1055 Gleptoferron. ■ 15. In § 524.1044h, revise paragraphs (a) Specifications. Each tablet (a) Specifications. Each milliliter (mL) (a) and (b) to read as follows: contains 10, 20, or 40 milligrams (mg) contains the equivalent of 200 robenacoxib for use in dogs, or 6 mg milligrams of elemental iron as § 524.1044h Gentamicin, mometasone, and robenacoxib for use in cats. clotrimazole otic suspension. gleptoferron, a complex of ferric * * * * * hydroxide and dextran glucoheptonic (a) Specifications. Each gram of (c) Conditions of use—(1) Dogs—(i) acid. suspension contains gentamicin sulfate, Amount. Administer 0.91 mg/lb (2 mg/ (b) Sponsors. See Nos. 059120 and United States Pharmacopeia (USP) kg) orally, once daily, for a maximum of 061623 in § 510.600(c) of this chapter. equivalent to 3 milligram (mg) 3 days. (c) Conditions of use in swine—(1) gentamicin base, mometasone furoate (ii) Indications for use. For the control Indications for use and amounts—(i) monohydrate or mometasone furoate of postoperative pain and inflammation Prevention of anemia due to iron anhydrous, USP, equivalent to 1 mg associated with soft tissue surgery in deficiency: Administer 1 mL (200 mg mometasone, and 10 mg clotrimazole, dogs weighing at least 5.5 lb (2.5 kg) and iron) per pig by intramuscular injection at least 4 months of age for a maximum USP. on or before 3 days of age. of 3 days. (ii) Treatment of anemia due to iron (b) Sponsors. See Nos. 000061 and (iii) Limitations. Federal law restricts deficiency: Administer 1 mL (200 mg 054925 in § 510.600(c) of this chapter. this drug to use by or on the order of iron) per pig by intramuscular injection * * * * * a licensed veterinarian. as soon as signs of deficiency appear. (2) Cats—(i) Amount. Administer 0.45 (2) [Reserved] PART 558—NEW ANIMAL DRUGS FOR mg/lb (1 mg/kg) orally, once daily, for USE IN ANIMAL FEEDS a maximum of 3 days. § 522.1182 [Amended] (ii) Indications for use. For the control ■ 16. The authority citation for part 558 ■ 11. In § 522.1182, in paragraph (b) of postoperative pain and inflammation continues to read as follows: introductory text, remove ‘‘baby pigs’’ associated with orthopedic surgery, and in its place add ‘‘young piglets’’; in Authority: 21 U.S.C. 354, 360b, 360ccc, ovariohysterectomy, and castration in cats weighing at least 5.5 lb (2.5 kg) and paragraph (b)(7) introductory text, 360ccc–1, 371. at least 4 months of age for a maximum remove ‘‘000859’’ and in its place add ‘‘016592’’; and in paragraphs (b)(7)(i) § 558.4 [Amended] of 3 days. (iii) Limitations. Federal law restricts and (ii), remove ‘‘baby pig’’. ■ 17. In § 558.4, in paragraph (d), in the this drug to use by or on the order of § 522.1192 [Amended] ‘‘Category I’’ table, in the ‘‘Type B a licensed veterinarian. ■ 12. In § 522.1192, in paragraph (b)(2), maximum (200 ×)’’ column, in the row § 520.2325a [Amended] remove ‘‘000859’’ and in its place add entry for ‘‘Avilamycin’’, remove ‘‘3.65 g/ ‘‘016592,’’. lb (0.8%)’’ and in its place add ‘‘7.3 g/ ■ 8. In § 520.2325a, in paragraph (a)(3), lb (1.6%)’’; and in the ‘‘Category II’’ remove ‘‘053501’’ and in its place add § 522.1260 [Amended] table, remove the row entry for ‘‘054771’’. 13. In § 522.1260, in paragraph (b)(2), ■ ‘‘Sulfadimethoxine’’ and two following PART 522—IMPLANTATION OR remove ‘‘000859’’ and in its place add row entries for ‘‘Ormetoprim’’, and in INJECTABLE DOSAGE FORM NEW ‘‘016592’’. their place add row entries for ANIMAL DRUGS ‘‘Sulfadimethoxine’’ and ‘‘Ormetoprim’’. PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW The additions read as follows: ■ 9. The authority citation for part 522 continues to read as follows: ANIMAL DRUGS § 558.4 Requirement of a medicated feed Authority: 21 U.S.C. 360b. ■ 14. The authority citation for part 524 mill license. ■ 10. Revise § 522.1055 to read as continues to read as follows: * * * * * follows: Authority: 21 U.S.C. 360b. (d) * * * CATEGORY II Assay limits Assay limits Type B maximum Drug percent 1 percent (100 ×) Type A 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 ......................................................... * * * * * * * jstallworth on DSK7TPTVN1PROD with RULES * * * * * § 558.68 Avilamycin. (e) Conditions of use. Administer in ■ 18. In § 558.68, revise paragraphs (a) (a) Each pound of Type A medicated feed as follows: and (e) to read as follows: article contains 45.4 or 90.7 grams of (1) Chickens— avilamycin. * * * * * VerDate Sep<11>2014 14:52 Aug 26, 2016 Jkt 238001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\29AUR1.SGM 29AUR1

Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations 59135 Avilamycin in Combination in Indications for use Limitations Sponsor grams/ton grams/ton (i) 13.6 to 40.9 .............. ........................ Broiler chickens: For the prevention of Feed as the sole ration for 21 consecu- 000986 mortality caused by necrotic enteritis tive days. To assure responsible anti- associated with Clostridium microbial drug use in broiler chickens, perfringens in broiler chickens. treatment administration must begin on or before 10 days of age. (ii) [Reserved]. (2) Swine— Avilamycin in Combinationin Indications for use Limitations Sponsor grams/ton grams/ton (i) 73 ............................. ........................ Weaned pigs less than 14 weeks of Feed as the sole ration for 21 consecu- 000986 age: For the reduction in incidence tive days. To assure responsible anti- and overall severity of diarrhea in the microbial drug use in pigs, do not ad- presence of pathogenic Escherichia minister to pigs 14 weeks of age or coli in groups of weaned pigs. older. (ii) [Reserved]. § 558.274 [Amended] ■ 24. Effective September 8, 2016, in DEPARTMENT OF HEALTH AND ■ 19. Effective September 8, 2016, in § 558.625, revise paragraphs (b)(1), HUMAN SERVICES § 558.274, remove and reserve (f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and paragraphs (c)(1)(ii) and (c)(2)(ii). remove paragraphs (f)(2)(viii) and (ix). Food and Drug Administration ■ 20. Effective September 8, 2016, in The revisions read as follows: § 558.355, remove and reserve 21 CFR Part 558 § 558.625 Tylosin. paragraph (f)(1)(xxviii) and revise * * * * * paragraphs (f)(8)(i) and (ii). (b) * * * [Docket No. FDA–2016–N–0002] The revisions read as follows: (1) No. 000986: 40 and 100 grams per New Animal Drugs for Use in Animal § 558.355 Monensin. pound for use as in paragraph (f) of this Feed; Withdrawal of Approval of a New section. * * * * * Animal Drug Application (f) * * * * * * * * (f) * * * AGENCY: Food and Drug Administration, (8) * * * (2) * * * (i) Decoquinate alone and in HHS. (i) Decoquinate alone and in combination as in § 558.195. combination as in § 558.195. ACTION: Notification of withdrawal. (ii) Melengestrol acetate alone and in * * * * * SUMMARY: The Food and Drug combination as in § 558.342. (iii) Melengestrol acetate alone and in Administration (FDA) is withdrawing * * * * * combination as in § 558.342. approval of eight new animal drug § 558.363 [Amended] * * * * * applications (NADAs) at the sponsor’s (vii) Zilpaterol alone and in request because these products are no ■ 21. Effective September 8, 2016, in combination as in § 558.665. longer manufactured or marketed. § 558.363, remove and reserve ■ 25. Effective September 8, 2016, in paragraph (d)(1)(vi). § 558.630, revise paragraph (b)(1) to read DATES: Withdrawal of approval is as follows: effective September 8, 2016. § 558.550 [Amended] FOR FURTHER INFORMATION CONTACT: ■ 22. Effective September 8, 2016, in § 558.630 Tylosin and sulfamethazine. Sujaya Dessai, Center for Veterinary § 558.550, remove and reserve * * * * * Medicine (HFV–212), Food and Drug paragraph (d)(1)(xxii). (b) * * * Administration, 7519 Standish Pl., § 558.618 [Amended] (1) No. 000986: 40 and 100 grams per Rockville, MD 20855, 240–402–5761, pound for use as in paragraph (e) of this sujaya.dessai@fda.hhs.gov. ■ 23. In § 558.618, in paragraphs section. (e)(2)(ii) and (iii): SUPPLEMENTARY INFORMATION: Elanco * * * * * ■ a. In the ‘‘Limitations’’ column, add Animal Health, A Division of Eli Lilly ‘‘Tilmicosin as provided by Nos. 000986 Dated: August 8, 2016. & Co., Lilly Corporate Center, or 016952; monensin as provided by No. Tracey H. Forfa, Indianapolis, IN 46285 has requested 000986 in § 510.600(c) of this chapter.’’ Deputy Director, Center for Veterinary that FDA withdraw approval of the to the end of the existing entries; and Medicine. NADAs listed in the following table ■ b. In the ‘‘Sponsor’’ column, [FR Doc. 2016–19914 Filed 8–26–16; 8:45 am] because the products are no longer jstallworth on DSK7TPTVN1PROD with RULES numerically add ‘‘016952’’. BILLING CODE 4164–01–P manufactured or marketed: 21 CFR File No. Product name section 012–548 1 TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) ........................................................................................... 558.274 013–162 1 TYLAN TM (tylosin phosphate) Type A medicated article .............................................................................................. 558.625 VerDate Sep<11>2014 14:52 Aug 26, 2016 Jkt 238001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\29AUR1.SGM 29AUR1


Document Created: 2016-08-26 23:50:19
Document Modified: 2016-08-26 23:50:19
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
ActionFinal rule; technical amendment.
DatesThis 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.
ContactGeorge K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]
FR Citation81 FR 59131 
CFR Citation21 CFR 510
21 CFR 520
21 CFR 522
21 CFR 524
21 CFR 558
CFR AssociatedAdministrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Animal Feeds
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