[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Rules and Regulations]
[Pages 14584-14588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06961]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 526, and 558
[Docket No. FDA-2017-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship; Change of a Sponsor's Name and Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 October, November, and December 2017. FDA
is 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 a change of a sponsor's name and
address.
DATES: This rule is effective April 5, 2018.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
[[Page 14585]]
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during October, November, and December
2017, 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 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 Dockets
Management Staff (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: https://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: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During
October, November, and December 2017
----------------------------------------------------------------------------------------------------------------
Effect of the
Approval date File No. Sponsor Product name Species action Public documents
----------------------------------------------------------------------------------------------------------------
October 27, 141-467 Elanco US Inc., Avilamycin and Chickens...... Original FOI Summary; EA/
2017. 2500 Innovation narasin Type C approval for FONSI. \1\
Way, medicated feeds. use of
Greenfield, IN INTREPITY
46140. (avilamycin)
and MONTEBAN
(narasin) Type
A medicated
articles to
manufacture
Type C
medicated
broiler
chicken feeds
for the
prevention of
mortality
caused by
necrotic
enteritis
associated
with
Clostridium
perfringens,
and the
prevention of
coccidiosis
caused by
Eimeria
necatrix, E.
tenella, E.
acervulina, E.
brunetti, E.
mivati, and E.
maxima.
October 27, 141-466 Elanco US Inc., Avilamycin, Chickens...... Original FOI Summary; EA/
2017. 2500 Innovation narasin, and approval for FONSI. \1\
Way, nicarbazin Type use of
Greenfield, IN C medicated INTREPITY
46140. feeds. (avilamycin)
and MAXIBAN
(narasin and
nicarbazin)
Type A
medicated
articles to
manufacture
Type C
medicated
broiler
chicken feeds
for the
prevention of
mortality
caused by
necrotic
enteritis
associated
with
Clostridium
perfringens,
and the
prevention of
coccidiosis
caused by
Eimeria
necatrix, E.
tenella, E.
acervulina, E.
brunetti, E.
mivati, and E.
maxima.
November 9, 106-111 Zoetis Inc., 333 TELAZOL Dogs.......... Supplemental FOI Summary.
2017. Portage St., (tiletamine and approval for
Kalamazoo, MI zolazepam for intravenous
49007. injection). administration
in dogs for
induction of
anesthesia
followed by
maintenance
with an
inhalant
anesthetic.
November 21, 200-473 Huvepharma EOOD, TYLOVET (tylosin Chickens...... Supplemental FOI Summary.
2017. 5th Floor, 3A tartrate) approval for
Nikolay Haytov Soluble Powder. the control of
Str., 1113 mortality
Sofia, Bulgaria. caused by
necrotic
enteritis
associated
with
Clostridium
perfringens in
broiler
chickens.
November 30, 097-505 Zoetis Inc., 333 Lincomycin Type Swine......... Supplemental ................
2017. Portage St., B and Type C approval for
Kalamazoo, MI medicated feeds. use of
49007. LINCOMIX
(lincomycin)
Type A
medicated
articles to
manufacture
Type B and
Type C
medicated
swine feeds
for reduction
in the
severity of
the effects of
respiratory
disease
associated
with
Mycoplasma
hyopneumoniae.
December 11, 141-441 Virbac AH, Inc., IVERHART MAX Dogs.......... Original FOI Summary.
2017. 3200 Meacham (ivermectin, approval of a
Blvd., Ft. pyrantel soft chewable
Worth, TX 76137. pamoate, tablet to
praziquantel) prevent canine
Soft Chew. heartworm
disease by
eliminating
the tissue
stage of
heartworm
larvae
(Dirofilaria
immitis) for a
month (30
days) after
infection and
for the
treatment and
control of
roundworm
(Toxocara
canis,
Toxascaris
leonina),
hookworm
(Ancylostoma
caninum,
Uncinaria
stenocephala,
Ancylostoma
braziliense),
and tapeworm
(Dipylidium
caninum,
Taenia
pisiformis)
infections.
December 12, 200-617 Pharmgate LLC, Chlortetracyclin Cattle........ Original ................
2017. 1800 Sir Tyler e and lasalocid approval for
Dr., Type B and Type use of DERACIN
Wilmington, NC C medicated (chlortetracyc
28405. feeds. line) and
BOVATEC
(lasalocid)
Type A
medicated
articles to
manufacture
Type B and
Type C
medicated
cattle feeds
as a generic
copy of NADA
141-250.
----------------------------------------------------------------------------------------------------------------
\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
Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS
66211 has informed FDA that it has transferred ownership of, and all
rights and interest in, the following application to Elanco US, Inc.,
2500 Innovation Way, Greenfield, IN 46140:
[[Page 14586]]
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
141-455........................ GALLIPRANT (grapiprant) 520.1084
Tablets.
------------------------------------------------------------------------
Strategic Veterinary Pharmaceuticals, Inc., 100 NW Airport Rd., St.
Joseph, MO 64503 has informed FDA that it has transferred ownership of,
and all rights and interest in, the following applications to HQ
Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ
07652:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
055-097........................ DRY-MAST (pen G 526.1696b
procaine/
dihydrostreptomycin
sulfate) Infusion.
------------------------------------------------------------------------
Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box
8500, Mankato, MN 56002-8500 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following
applications to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato,
MN 56001:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
141-187........................ CRYSTALYX IONO-LYX 558.311
(lasalocid) Type C
Medicated Protein
Block.
------------------------------------------------------------------------
Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. Box
8500, Mankato, MN 56002-8500 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following application
to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato, MN 56001:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
033-733........................ SWEETLIX BLOAT-GUARD 520.1840
(poloxalene) Pressed
Block.
------------------------------------------------------------------------
Accordingly, the animal drug regulations are being amended to
reflect these changes of sponsorship. Following these withdrawals of
approval, neither Ridley Block Operations, Inc. nor Ridley U.S.
Holdings, Inc. is the sponsor of an approved application. Accordingly,
these firms will be removed from the list of sponsors of approved
applications in Sec. 510.600(c) (21 CFR 510.600(c)).
III. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
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.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 526
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, 21 CFR parts
510, 520, 522, 526, 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), remove the entry
for ``Ridley Block Operations, Inc.'' and revise the entry for ``Ridley
U.S. Holdings, Inc.''; and in the table in paragraph (c)(2), remove the
entry for ``068287'' and revise the entry for ``067949''.
The revisions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 14587]]
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * * * *
Ridley USA, Inc., 111 W Cherry St., Suite 500, 067949
Mankato, MN 56001............................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
067949........................................ Ridley USA, Inc., 111 W
Cherry St., Suite 500,
Mankato, MN 56001.
* * * * * * *
------------------------------------------------------------------------
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. 520.1084 [Amended]
0
4. In Sec. 520.1084, in paragraph (b), remove ``086026'' and in its
place add ``058198''.
Sec. 520.1199 [Amended]
0
5. In Sec. 520.1199, in paragraph (a) introductory text, remove
``chewable tablet'' and in its place add ``chewable tablet or soft
chewable tablet''; and in paragraph (c)(2), remove ``Prevents'' and in
its place add ``To prevent''.
0
6. In Sec. 520.2640, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 520.2640 Tylosin.
* * * * *
(b) * * *
(1) Nos. 016592 and 058198 for use as in paragraph (e) of this
section.
(2) No. 061623 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii),
(e)(2), (e)(3), and (e)(4) of this section.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
8. In Sec. 522.2470, revise paragraphs (b) and (c) to read as follows:
Sec. 522.2470 Tiletamine and zolazepam for injection.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
(1) No. 054771 for use as in paragraph (c) of this section.
(2) Nos. 026637 and 051311 for use as in paragraphs (c)(1)(i)(A),
(c)(1)(ii)(A), (c)(1)(iii) and (c)(2) of this section.
(c) Conditions of use--(1) Dogs--(i) Amount. Expressed as
milligrams of the drug combination:
(A) An initial intramuscular dosage of 3 to 4.5 milligrams per
pound (mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of
body weight for minor procedures of short duration such as repair of
lacerations and wounds, castrations, and other procedures requiring
mild to moderate analgesia. Supplemental doses when required should be
less than the initial dose and the total dose given should not exceed
12 mg/lb of body weight. The maximum total safe dose is 13.6 mg/lb of
body weight.
(B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg)
body weight to effect for induction of anesthesia followed by
maintenance with an inhalant anesthetic.
(ii) Indications for use. (A) Intramuscular administration in dogs
for restraint and minor procedures of short duration (30 minutes
average) requiring mild to moderate analgesia.
(B) Intravenous administration in dogs for induction of anesthesia
followed by maintenance with an inhalant anesthetic.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. An initial intramuscular dosage of 4.4 to 5.4
mg/lb of body weight is recommended for such procedures as dentistry,
treatment of abscesses, foreign body removal, and related types of
surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring
mild to moderate analgesia, such as repair of lacerations, castrations,
and other procedures of short duration. Initial dosages of 6.5 to 7.2
mg/lb of body weight are recommended for ovariohysterectomy and
onychectomy. When supplemental doses are required, such individual
supplemental doses should be given in increments that are less than the
initial dose and the total dose given (initial dose plus supplemental
doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb
of body weight.
(ii) Indications for use. For restraint or for anesthesia combined
with muscle relaxation.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 526.1696b [Amended]
0
10. In Sec. 526.1696b, in paragraph (b), remove ``054628'' and in its
place add ``042791''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
11. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
12. In Sec. 558.68, add paragraphs (e)(1)(iii) and (iv) to read as
follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
[[Page 14588]]
----------------------------------------------------------------------------------------------------------------
Combination in
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) 13.6 to 40.9.............. Narasin,........... Broiler chickens: Feed as the sole ration 058198
54 to 90........... For the prevention for 21 consecutive
of mortality days to chickens that
caused by necrotic are at risk of
enteritis developing, but not
associated with yet showing clinical
Clostridium signs of, necrotic
perfringens; and enteritis associated
for the prevention with Clostridium
of coccidiosis perfringens. To assure
caused by Eimeria responsible
necatrix, E. antimicrobial drug use
tenella, E. in broiler chickens,
acervulina, E. treatment
brunetti, E. administration must
mivati, and E. begin on or before 10
maxima. days of age. Do not
allow adult turkeys,
horses, or other
equines access to
narasin formulations.
Ingestion of narasin
by these species has
been fatal. Narasin as
provided by No. 058198
in Sec. 510.600(c)
of this chapter.
(iv) 13.6 to 40.9............... Narasin............ Broiler chickens: Feed as the sole ration 058198
27 to 45;.......... For the prevention for 21 consecutive
nicarbazin......... of mortality days to chickens that
27 to 45........... caused by necrotic are at risk of
enteritis developing, but not
associated with yet showing clinical
Clostridium signs of, necrotic
perfringens; and enteritis associated
for the prevention with Clostridium
of coccidiosis perfringens. To assure
caused by Eimeria responsible
necatrix, E. antimicrobial drug use
tenella, E. in broiler chickens,
acervulina, E. treatment
brunetti, E. administration must
mivati, and E. begin on or before 10
maxima. days of age. Do not
allow adult turkeys,
horses, or other
equines access to
narasin formulations.
Ingestion of narasin
by these species has
been fatal. Do not
feed to laying hens.
Withdraw 5 days before
slaughter. Narasin and
nicarbazin as provided
by No. 058198 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.128 [Amended]
0
13. In Sec. 558.128, in paragraph (e)(4), in the ``Sponsor'' column,
numerically add ``069254'' to paragraphs (e)(4)(ii), (vii), (viii),
(ix), and (xviii) through (xxvi).
Sec. 558.311 [Amended]
0
14. In Sec. 558.311, in paragraph (b)(9) and in paragraph (e)(1)(xix),
in the ``Sponsor'' column, remove ``068287'' and in its place add
``067949''.
0
15. In Sec. 558.325 revise paragraph (e)(2)(xiv) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Lincomycin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(xiv) 100 to 200............... .................. For reduction in the Feed as sole 054771
severity of the ration for 21
effects of respiratory days.
disease associated
with Mycoplasma
hyopneumoniae.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: March 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06961 Filed 4-4-18; 8:45 am]
BILLING CODE 4164-01-P