[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Rules and Regulations]
[Pages 36787-36790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13517]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Rules
and Regulations
[[Page 36787]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 556, 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
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 March and April 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 and the voluntary withdrawals of approval
of applications that occurred in January and February.
DATES: This rule is effective June 8, 2016 except for the amendments to
21 CFR 520.1696b, 520.2325a, 520.2261a, 558.248, and 558.625, which are
effective June 20, 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,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during March and April 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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During March and April 2016
----------------------------------------------------------------------------------------------------------------
21 CFR
File No. Sponsor Product name Action section FOIA summary NEPA review
----------------------------------------------------------------------------------------------------------------
141-392.......... Elanco Animal IMRESTOR Original 522.1684 yes.......... EA/FONSI \1\
Health, a (pegbovigrastim approval for
Division of Eli injection). the reduction
Lilly & Co., in the
Lilly Corporate incidence of
Center, clinical
Indianapolis, mastitis in the
IN 46285. first 30 days
of lactation in
periparturient
dairy cows and
periparturient
replacement
dairy heifers.
141-455.......... Aratana GALLIPRANT Original 510.600 yes.......... CE \2\ \3\
Therapeutics, (grapiprant approval for 520.1084
Inc., 11400 tablets). the control of
Tomahawk Creek pain and
Pkwy., Leawood, inflammation
KS 66211. associated with
osteoarthritis
in dogs.
141-460.......... ECO LLC, 344 AIVLOSIN 17% Original 558.633 yes.......... CE \2\ \4\
Nassau St., (tylvalosin approval for
Princeton, NJ tartrate) Type control of
08540. A Medicated porcine
Article. proliferative
enteropathy
(PPE)
associated with
Lawsonia
intracellularis
infection in
groups of swine
in buildings
experiencing an
outbreak of PPE.
----------------------------------------------------------------------------------------------------------------
\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).
\2\ 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.
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(d)(5).
[[Page 36788]]
II. Changes of Sponsorship
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee
Mission, KS 66201 (Bayer) has informed FDA that it has transferred
ownership of, and all rights and interest in, the following approved
applications to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght,
Dublin 24, Ireland:
----------------------------------------------------------------------------------------------------------------
File No. Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
099-169....................................... Oxytocin Injection.............................. 522.1680
124-241....................................... PVL Oxytocin Injectable Solution................ 522.1680
200-069....................................... OvaCyst (gonadorelin diacetate tetrahydrate) 522.1077
Injection.
200-253....................................... ProstaMate (dinoprost tromethamine) Injectable 522.690
Solution.
----------------------------------------------------------------------------------------------------------------
Bayer has also transferred sponsorship of NADA 141-070 for
RAPINOVET (propofol) Injectable Emulsion to iVaoes Animal Health, 4300
SW 73rd Ave., suite 110, Miami, FL 33155. 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 March and April 2016, the following two
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:
----------------------------------------------------------------------------------------------------------------
File No. Sponsor Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
007-076 \1\.................. Cross Vetpharm Group Ltd., SULFA-NOX Liquid 520.2325a
Broomhill Rd., Tallaght, (sulfaquinoxaline) 3.44%
Dublin 24, Ireland. Solution.
008-244 \1\.................. Cross Vetpharm Group Ltd., SULFA-NOX Concentrate 520.2325a
Broomhill Rd., Tallaght, (sulfaquinoxaline) 12.85%
Dublin 24, Ireland. Solution.
041-955 \1\.................. Cross Vetpharm Group Ltd., Erythromycin Medicated 558.248
Broomhill Rd., Tallaght, Premix.
Dublin 24, Ireland.
049-729 \1\.................. Cross Vetpharm Group Ltd., PURINA Sulfa 520.2261a
Broomhill Rd., Tallaght, (sulfamethazine) 12.5%
Dublin 24, Ireland. Solution.
100-128 \1\.................. Cross Vetpharm Group Ltd., Supersweet Medipak TYLAN 10. 558.625
Broomhill Rd., Tallaght,
Dublin 24, Ireland.
200-307 \1\.................. Vetoquinol N.-A., Inc., 2000 Penicillin G Potassium 520.1696b
chemin Georges, Lavaltrie Soluble Powder.
(PQ), Canada J5T 3S5.
----------------------------------------------------------------------------------------------------------------
\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 007-076, 008-244, 041-955, 049-729, 100-128, and
ANADA 200-307, and all supplements and amendments thereto, is
withdrawn, effective June 20, 2016. As provided in the regulatory text
of this document, the animal drug regulations are amended to reflect
these voluntary withdrawals of approval.
IV. Technical Amendments
FDA has noticed that the section heading for 21 CFR 520.1430 does
not accurately reflect the new animal drug for which approved
conditions of use are codified. At this time, we are amending the
section heading to read ``Mibolerone'' rather than ``Megestrol acetate
tablets.'' 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 and 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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, parts 510, 520, 522,
556, 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. In Sec. 510.600:
0
a. In the table in paragraph (c)(1), alphabetically add entries for
``Aratana Therapeutics, Inc.'' and ``iVaoes Animal Health'' and revise
entry for ``Huvepharma AD;'' and
0
b. In the table in paragraph (c)(2), revise the entry for ``016592''
and numerically add entries for ``086026'' and ``086064.''
The additions and revisions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 36789]]
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., 086026
Leawood, KS 66211......................................
* * * * * * *
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 016592
Sofia, Bulgaria........................................
* * * * * * *
iVaoes Animal Health, 4300 SW 73rd Ave., suite 110, 086064
Miami, FL 33155........................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
016592...................... Huvepharma EOOD, 5th Floor, 3A Nikolay
Haytov Str., 1113 Sofia, Bulgaria
* * * * * * *
086026...................... Aratana Therapeutics, Inc., 11400 Tomahawk
Creek Pkwy., Leawood, KS 66211
* * * * * * *
086064...................... iVaoes Animal Health, 4300 SW 73rd Ave.,
suite 110, Miami, FL 33155
* * * * * * *
------------------------------------------------------------------------
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.
0
4. Add Sec. 520.1084 to read as follows:
Sec. 520.1084 Grapiprant.
(a) Specifications. Each tablet contains 20, 60, or 100 milligrams
(mg) grapiprant.
(b) Sponsor. See No. 086026 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 0.9 mg/lb (2
mg/kg) once daily by mouth.
(2) Indications for use. For the control of pain and inflammation
associated with osteoarthritis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
5. Revise the heading of Sec. 520.1430 to read as follows:
Sec. 520.1430 Mibolerone.
* * * * *
Sec. 520.1696b [Amended]
0
6. Effective June 20, 2016, in Sec. 520.1696b, in paragraph (b),
remove ``059320,''.
Sec. 520.2261a [Amended]
0
7. Effective June 20, 2016, in Sec. 520.2261a, in paragraph (b),
remove ``Nos. 016592 and 061623'' and in its place add ``No. 016592''.
Sec. 520.2325a [Amended]
0
8. Effective June 20, 2016, in Sec. 520.2325a, remove paragraph (a)(2)
and redesignate paragraphs (a)(3) and (4) as paragraphs (a)(2) and (3).
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.
Sec. 522.690 [Amended]
0
10. In Sec. 522.690, in paragraph (b)(3), remove ``000859'' and in its
place add ``061623''.
Sec. 522.1077 [Amended]
0
11. In Sec. 522.1077, in paragraph (b)(3), remove ``000859 and
050604'' and in its place add ``050604 and 061623''.
Sec. 522.1680 [Amended]
0
12. In Sec. 522.1680, in paragraph (b), remove ``000859''.
0
13. Add Sec. 522.1684 to read as follows:
Sec. 522.1684 Pegbovigrastim.
(a) Specifications. Each pre-filled, single-dose syringe contains
15 milligrams of pegbovigrastim.
(b) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cattle--(1) Amount. Administer the first
dose (syringe) by subcutaneous injection 7 days prior to the cow's or
heifer's anticipated calving date. If necessary, the first dose may be
administered within a range of 4 to 10 days prior to the anticipated
calving date to accommodate management schedules. Administer the second
dose (syringe) by subcutaneous injection within 24 hours after calving.
(2) Indications for use. For the reduction in the incidence of
clinical mastitis in the first 30 days of lactation in periparturient
dairy cows and periparturient replacement dairy heifers.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.2005 [Amended]
0
14. In Sec. 522.2005, in paragraph (b)(1), remove ``000859'' and in
its place add ``086064''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
15. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
16. In Sec. 556.748, revise paragraph (c) to read as follows:
[[Page 36790]]
Sec. 556.748 Tylvalosin.
* * * * *
(c) Related conditions of use. See Sec. Sec. 520.2645 and 558.633
of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
17. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
18. In Sec. 558.4, in paragraph (d), in the ``Category I'' table, add
an entry in alphabetical order for ``Tylvalosin'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category I
----------------------------------------------------------------------------------------------------------------
Assay limits percent Type Assay limits
Drug A Type B maximum (200x) percent Type B/C
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Tylvalosin............................ 90-110................... 3.86 g/lb................ 85-115
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.248 [Amended]
0
19. Effective June 20, 2016, in Sec. 558.248, revise paragraphs (a)
and (b) and remove and reserve paragraph (d)(1)(iii).
The revisions read as follows:
Sec. 558.248 Erythromycin.
(a) Specifications. Type A medicated articles containing 5 or 10
percent erythromycin thiocyanate.
(b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 558.625 [Amended]
0
20. Effective June 20, 2016, in Sec. 558.625, remove paragraph (b)(3)
and redesignate paragraphs (b)(4) and (5) as paragraphs (b)(3) and (4).
0
21. Add Sec. 558.633 to read as follows:
Sec. 558.633 Tylvalosin.
(a) Specifications. Type A medicated articles containing 77.12
grams tylvalosin per pound as tylvalosin tartrate.
(b) Sponsor. See No. 066916 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.748 of this chapter.
(d) Special considerations--(1) Federal law restricts tylvalosin
medicated feeds to use under a veterinary feed directive (VFD) and the
professional supervision of a licensed veterinarian. See Sec. 558.6 of
this chapter for additional requirements.
(2) VFDs for tylvalosin shall not be refilled.
(3) An expiration date of 1 week is required for tylvalosin Type C
medicated swine feeds in pelleted or crumbled form.
(e) Conditions of use in swine--(1) Amount. Administer 38.6 grams
tylvalosin per ton of Type C medicated feed (42.5 ppm) as the sole
ration for 14 consecutive days.
(2) Indications for use. For the control of porcine proliferative
enteropathy (PPE) associated with Lawsonia intracellularis infection in
groups of swine in buildings experiencing an outbreak of PPE.
Dated: May 31, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-13517 Filed 6-7-16; 8:45 am]
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