New Animal Drugs; Approval of New Animal Drug Applications, 58554-58557 [2017-26753]
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
Drugs and other appropriate officials on
emerging food and cosmetic safety, food
science, nutrition, and other foodrelated health issues that FDA considers
of primary importance for its food and
cosmetics programs. The Committee
may also be asked to provide advice and
make recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
The Committee is no longer needed
and will be terminated on December 12,
2017. Over the past several years, the
Committee has met very infrequently,
and the effort and expense of
maintaining the Committee are no
longer justified. Any relevant food
issues in the future could be addressed
by FDA’s Science Board and/or FDA’s
Risk Communication Advisory
Committee, with additional
augmentation of expertise by
appropriate subject matter experts
serving as temporary members on either
of those committees. In addition,
CFSAN will continue to hold
workshops, meetings, conferences, and
webinars to engage with its
stakeholders.
Under 5 U.S.C. 553(b)(3)(B) and (d)
and 21 CFR 10.40(d) and (e), the Agency
finds good cause to dispense with notice
and public comment procedures and to
proceed to an immediate effective date
on this rule. Notice and public comment
and a delayed effective date are
unnecessary because the Committee is
not being adequately used, and the final
rule merely removes the name of the
Food Advisory Committee from the list
of standing advisory committees in
§ 14.100 (21 CFR 14.100).
Therefore, the Agency is amending
§ 14.100(f) as set forth in the regulatory
text of the document.
List of Subjects in 21 CFR Part 14
Administrative practice and
procedure, Advisory committee, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 14 is
amended as follows:
PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE
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 make technical
amendments to improve the accuracy of
the regulations.
This rule is effective December
13, 2017.
DATES:
1. The authority citation for part 14
continues to read as follows:
FOR FURTHER INFORMATION CONTACT:
Authority: 5 U.S.C. App. 2; 15 U.S.C 1451–
1461, 21 U.S.C. 41–50, 141–149, 321–394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107–109;
Pub. L. 108–155; Pub. L. 113–54.
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
■
§ 14.100
[Amended]
SUPPLEMENTARY INFORMATION:
2. Section 14.100 is amended by
removing paragraph (f).
■
I. Approval Actions
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26829 Filed 12–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529,
and 558
[Docket No. FDA–2017–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for a
new animal drug application (NADA)
and abbreviated new animal drug
applications (ANADAs) during May and
June 2017. FDA is informing the public
SUMMARY:
FDA is amending the animal drug
regulations to reflect approval actions
for a NADA and ANADAs during May
and June 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 (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 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/ApprovedAnimalDrug
Products/default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2017
Approval date
File No.
055–099
June 21, 2017 ...........
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May 23, 2017 ............
141–338
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Sponsor
Product name
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Jkt 244001
PO 00000
Species
CLAVAMOX (amoxicillin
Dogs and cats ......
and clavulanate potassium tablets) Chewables.
INTERCEPTOR SPECDogs .....................
TRUM (milbemycin
oxime/ praziquantel)
Chewable Tablets.
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Effect of the action
Supplemental approval of
a chewable tablet form
of the approved tablet.
Supplemental approval for
the treatment and control of adult tapeworm
(Dipylidium caninum) infections in dogs and
puppies 2 pounds of
body weight or greater
and 6 weeks of age and
older.
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Public
documents
FOI Summary.
FOI Summary.
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2017—Continued
Approval date
File No.
May 25, 2017 ............
200–610
June 23, 2017 ...........
200–618
Public
documents
Sponsor
Product name
Species
Effect of the action
Modern Veterinary Therapeutics, LLC, 14343 SW
119th Ave., Miami, FL
33186.
Virbac AH, Inc., 3200
Meacham Blvd., Ft.
Worth, TX 76137.
Medetomidine HCl
(medetomidine hydrochloride) Injectable Solution.
ZOLETIL (tiletamine HCl
and zolazepam HCl) for
Injection.
Dogs .....................
Original approval as a generic copy of NADA
140–999.
FOI Summary.
Dogs and cats ......
Original approval as a generic copy of NADA
106–111.
FOI Summary.
Following the approval of ANADA
200–610, Modern Veterinary
Therapeutics, LLC, will now be
included in the lists of sponsors of
approved applications in § 510.600(c)
(21 CFR 510.600(c)).
II. Technical Amendments
We are making several technical
amendments in 21 CFR part 558, which
was amended on December 27, 2016 (81
FR 94991), and February 24, 2017 (82
FR 11510), as part of the FDA Center for
Veterinary Medicine’s (CVM’s)
Judicious Use Initiative. We are also
making several technical amendments
to the regulations for dosage form drugs
to reflect revised labeling. These actions
are being taken to improve the accuracy
of the regulations.
III. Legal Authority
This final rule is issued under section
512(i) of the Federal Food, Drug, and
Cosmetic Act (the 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 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, 524, 529, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
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.
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘Modern Veterinary
Therapeutics, LLC’’; and in the table in
paragraph (c)(2), numerically add an
entry for ‘‘015914.’’ The additions read
as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
Drug
labeler code
*
*
*
*
*
*
Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186 .............................................................................
*
015914
*
*
*
*
*
*
*
*
*
*
*
(2) * * *
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Drug labeler
code
Firm name and address
*
015914 ............
*
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*
*
*
*
Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186.
*
15:49 Dec 12, 2017
*
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§ 522.2470
injection.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
Tiletamine and zolazepam for
*
*
*
*
*
(b) Sponsors. See Nos. 026637,
051311, and 054771 in § 510.600(c) of
Authority: 21 U.S.C. 360b.
this chapter.
■ 4. In § 520.88g, revise the section
(c) * * *
heading and paragraphs (a) and (b) to
(1) * * *
read as follows:
(i) Healthy dogs. An initial
§ 520.88g Amoxicillin trihydrate and
intramuscular dosage of 3 to 4.5
clavulanate potassium tablets.
milligrams per pound (mg/lb) of body
(a) Specifications. Each tablet or
weight for diagnostic purposes; 4.5 to 6
chewable tablet contains amoxicillin
mg/lb of body weight for minor
trihydrate and clavulanate potassium
procedures of short duration such as
equivalent to 50 milligrams (mg) of
repair of lacerations and wounds,
amoxicillin and 12.5 mg clavulanic
castrations, and other procedures
acid, 100 mg of amoxicillin and 25 mg
requiring mild to moderate analgesia.
clavulanic acid, 200 mg amoxicillin and Supplemental doses when required
50 mg clavulanic acid, or 300 mg
should be less than the initial dose and
amoxicillin and 75 mg clavulanic acid.
the total dose given should not exceed
(b) Sponsors. See sponsors in
12 mg/lb of body weight. The maximum
§ 510.600(c) of this chapter:
total safe dose is 13.6 mg/lb of body
(1) No. 054771 for use of tablets and
weight.
chewable tablets as in paragraph (c) of
(ii) Healthy cats. An initial
this section.
intramuscular dosage of 4.4 to 5.4 mg/
(2) No. 026637 for use of tablets as in
lb of body weight is recommended for
paragraph (c) of this section.
such procedures as dentistry, treatment
*
*
*
*
*
of abscesses, foreign body removal, and
■ 5. In § 520.1445, revise paragraph
related types of surgery; 4.8 to 5.7 mg/
(c)(1)(ii) to read as follows:
lb of body weight for minor procedures
requiring mild to moderate analgesia,
§ 520.1445 Milbemycin oxime and
such as repair of lacerations, castrations,
praziquantel.
and other procedures of short duration.
*
*
*
*
*
Initial dosages of 6.5 to 7.2 mg/lb of
(c) * * *
body weight are recommended for
(1) * * *
ovariohysterectomy and onychectomy.
(ii) Indications for use. For the
When supplemental doses are required,
prevention of heartworm disease caused
such individual supplemental doses
by Dirofilaria immitis and for the
should be given in increments that are
treatment and control of adult
less than the initial dose, and the total
roundworm (Toxocara canis, Toxascaris
leonina), adult hookworm (Ancylostoma dose given (initial dose plus
supplemental doses) should not exceed
caninum), adult whipworm (Trichuris
the maximum allowable safe dose of
vulpis), and adult tapeworm (Taenia
pisiformis, Echinococcus multilocularis, 32.7 mg/lb of body weight.
(2) Indications for use. For restraint or
E. granulosus, and Dipylidium caninum)
for anesthesia combined with muscle
infections in dogs and puppies 2
relaxation in cats and in dogs for
pounds of body weight or greater and 6
restraint and minor procedures of short
weeks of age and older.
duration (30 minutes average) requiring
*
*
*
*
*
mild to moderate analgesia.
PART 522—IMPLANTATION OR
*
*
*
*
*
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
■ 6. The authority citation for part 522
ANIMAL DRUGS
continues to read as follows:
3. The authority citation for part 520
continues to read as follows:
■
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Authority: 21 U.S.C. 360b.
§ 522.1335
9. The authority citation for part 524
continues to read as follows:
■
[Amended]
7. In § 522.1335, in paragraph (b),
remove ‘‘052483’’ and in its place add
‘‘Nos. 015914 and 052483’’.
■ 8. In § 522.2470, revise paragraphs (b),
(c)(1)(i) and (ii), and (c)(2) to read as
follows:
Authority: 21 U.S.C. 360b.
■
VerDate Sep<11>2014
15:49 Dec 12, 2017
Jkt 244001
§ 524.1580a
[Amended]
10. In § 524.1580a, in paragraph (d)(3),
in the second sentence, remove ‘‘in’’
and in its place add ‘‘on’’.
■
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PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
11. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
12. Amend 529.1030 as follows:
a. Revise paragraph (d)(1)(ii);
b. In the table in paragraph (d)(2)(i),
revise footnote 1;
■ c. In paragraph (d)(2)(ii), in the table,
in the heading of the ‘‘Administer in
earthen ponds indefinitely (mL/L or
ppm)’’ column, remove ‘‘indefinitely’’
and in its place add ‘‘single treatment’’;
and
■ d. Revise paragraphs (d)(2)(iii) and
(d)(3).
The revisions read as follows:
■
■
■
§ 529.1030
Formalin.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) All finfish. For control of external
protozoa Ichthyophthirius spp.,
Chilodonella spp., Ichthyobodo spp.,
Ambiphrya spp., Epistylis spp., and
Trichodina spp., and the monogeneans
Cleidodiscus spp., Gyrodactylus spp.,
and Dactylogyrus spp.
*
*
*
*
*
(2) * * *
(i) * * *
1 Treat for up to 4 hours daily.
Treatment may be repeated daily until
parasite control is achieved. Use the
lower concentration when tanks or
raceways are heavily loaded with
phytoplankton or shrimp, to avoid
oxygen depletion due to the biological
oxygen demand created by decay of
dead phytoplankton. Alternatively, a
higher concentration might be used if
dissolved oxygen is strictly monitored.
*
*
*
*
*
(iii) For control of fungi of the family
Saprolegniaceae on finfish eggs: Eggs of
all finfish except Acipenseriformes,
1,000 to 2,000 mL/L (ppm) for 15
minutes; eggs of Acipenseriformes, up
to 1,500 mL/L (ppm) for 15 minutes. A
preliminary bioassay should be
conducted on a small subsample of fish
eggs to determine sensitivity before
treating an entire group. This is
necessary for all species because egg
sensitivity can vary with species or
strain and the unique conditions at each
facility.
(3) Limitations. Fish tanks and
raceways may be treated daily until
parasite control is achieved. Pond
treatment may be repeated in 5 to 10
days if needed. However, pond
treatments for Ichthyophthirius spp.
should be made at 2-day intervals until
control is achieved. Egg tanks may be
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
treated as often as necessary to prevent
growth of fungi. Do not use formalin
which has been subjected to
temperatures below 40 °F, or allowed to
freeze. Treatments in tanks and
raceways should never exceed 1 hour
for fish or 4 hours for penaeid shrimp
(even if they show no sign of distress),
nor should it exceed 15 minutes for fish
eggs. Do not apply formalin to ponds
with water warmer than 27 °C (80 °F),
when a heavy bloom of phytoplankton
is present, or when the concentration of
dissolved oxygen is less than 5
milligrams per liter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
13. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
§ 558.58
[Amended]
14. In § 558.58, remove paragraphs
(f)(4) and (5).
■
§ 558.366
[Amended]
15. In § 558.366, remove paragraph
(e).
■
Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26753 Filed 12–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–451]
Schedules of Controlled Substances:
Placement of MT–45 Into Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
With the issuance of this final
order, the Administrator of the Drug
Enforcement Administration places the
substance MT–45 (Systematic IUPAC
Name: 1-cyclohexyl-4-(1,2diphenylethyl)piperazine), including its
salts, isomers, and salts of isomers into
schedule I of the Controlled Substances
Act. This scheduling action is pursuant
to the Controlled Substances Act and is
required in order for the United States
to discharge its obligations under the
Single Convention on Narcotic Drugs,
1961. This action imposes the regulatory
controls and administrative, civil, and
criminal sanctions applicable to
schedule I controlled substances on
persons who handle (manufacture,
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SUMMARY:
VerDate Sep<11>2014
16:39 Dec 12, 2017
Jkt 244001
distribute, import, export, engage in
research or conduct instructional
activities with, or possess), or propose
to handle, MT–45.
DATES: Effective January 12, 2018.
FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Diversion Control
Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
Section 201(d)(1) of the Controlled
Substances Act (CSA) (21 U.S.C.
811(d)(1)) states that, if control of a
substance is required ‘‘by United States
obligations under international treaties,
conventions, or protocols in effect on
October 27, 1970, the Attorney General
shall issue an order controlling such
drug under the schedule he deems most
appropriate to carry out such
obligations, without regard to the
findings required by subsection (a) of
this section [811(a)] or section 812(b)
. . . and without regard to the
procedures prescribed by subsections (a)
and (b) of this section [21 U.S.C. 811(a)
and (b)] . . . .’’ If a substance is added
to one of the schedules of the Single
Convention on Narcotic Drugs, 1961
(‘‘Single Convention’’), then, in
accordance with article 3, paragraph 7
of the Convention, as a signatory
Member State, the United States is
obligated to control the substance under
its national drug control legislation, the
CSA. The Attorney General has
delegated scheduling authority under 21
U.S.C. 811 to the Administrator of the
DEA. 28 CFR 0.100.
Background
On May 17, 2016, the SecretaryGeneral of the United Nations advised
the Secretary of State of the United
States, by letter, that during the 59th
session of the Commission on Narcotic
Drugs, MT–45 was added to schedule I
of the Single Convention. This letter
was prompted by a decision at the 59th
session of the Commission on Narcotic
Drugs in March 2016 to schedule
MT–45 under schedule I of the Single
Convention. As a signatory Member
State to the Single Convention, the
United States is obligated to control
MT–45 under its national drug control
legislation, the CSA, in the schedule
deemed most appropriate to carry out its
international obligations. 21 U.S.C.
811(d)(1).
MT–45
MT–45 is an opioid analgesic drug
with pharmacological effects similar to
morphine. MT–45 was demonstrated to
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58557
produce physical dependence in mice.
This compound is a piperazine
derivative and is structurally unrelated
to most other opioids. There are two
enantiomers of MT–45 (R and S). Both
enantiomers bind to opioid receptors,
however (S)-(+)-MT–45 binds with a
greater affinity than that of (R)-(¥)-MT–
45. In functional studies, (S)-(+)-MT–45
has an analgesic effect similar to
morphine. In comparison, the analgesic
effect of (R)-(¥)-MT–45 is low.
Starting in 2013, MT–45 began
appearing on the internet for sale as a
‘legal’ opioid. Recent reports from Japan
have indicated that MT–45 is present in
herbal and chemical mixtures
containing synthetic cannabinoids and/
or synthetic cathinones. Deaths
associated with MT–45 abuse have
occurred in the United States and in
Europe. In addition, there have been at
least 13 non-fatal overdoses associated
with abuse of MT–45. There are no
published studies as to the safety of
MT–45 for human use. The DEA is not
aware of any claims or any medical or
scientific literature suggesting that
MT–45 has a currently accepted medical
use in treatment in the United States.
Accordingly, the DEA has not requested
that the Department of Health and
Human Services (HHS) conduct a
scientific and medical evaluation of the
substance’s medical utility.
Furthermore, the DEA is not required
under 21 U.S.C. 811(d)(1) to make any
findings required by 21 U.S.C. 811(a) or
812(b), and is not required to follow the
procedures prescribed by 21 U.S.C.
811(a) and (b). Therefore, consistent
with the framework of 21 U.S.C. 811(d),
the DEA concludes that MT–45 has no
currently accepted medical use in
treatment in the United States and is
most appropriately placed in schedule I
of the CSA.
Conclusion
In order to meet the obligations of the
United States under the Single
Convention on Narcotic Drugs, 1961,
and because MT–45 has no currently
accepted medical use in treatment in the
United States, the Administrator of the
Drug Enforcement Administration has
determined that this substance should
be placed in schedule I of the Controlled
Substances Act.
Requirements for Handling
Upon the effective date of this final
order, MT–45 will become subject to the
regulatory controls and administrative,
civil, and criminal sanctions applicable
to the manufacture, distribution,
importation, exportation, engagement in
research, and conduct of instructional
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]]>Agencies
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Rules and Regulations]
[Pages 58554-58557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26753]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, and 558
[Docket No. FDA-2017-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for a
new animal drug application (NADA) and abbreviated new animal drug
applications (ANADAs) during May and June 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 make technical amendments to
improve the accuracy of the regulations.
DATES: This rule is effective December 13, 2017.
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:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for a NADA and ANADAs during May and June 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 (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 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 May and June 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effect of the
Approval date File No. Sponsor Product name Species action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
May 23, 2017.............. 055-099 Zoetis Inc., 333 CLAVAMOX Dogs and cats........... Supplemental FOI Summary.
Portage St., (amoxicillin and approval of a
Kalamazoo, MI clavulanate chewable tablet
49007. potassium tablets) form of the
Chewables. approved tablet.
June 21, 2017............. 141-338 Elanco US Inc., INTERCEPTOR Dogs.................... Supplemental FOI Summary.
2500 Innovation SPECTRUM approval for the
Way, Greenfield, (milbemycin oxime/ treatment and
IN 46140. praziquantel) control of adult
Chewable Tablets. tapeworm
(Dipylidium
caninum)
infections in dogs
and puppies 2
pounds of body
weight or greater
and 6 weeks of age
and older.
[[Page 58555]]
May 25, 2017.............. 200-610 Modern Veterinary Medetomidine HCl Dogs.................... Original approval FOI Summary.
Therapeutics, LLC, (medetomidine as a generic copy
14343 SW 119th hydrochloride) of NADA 140-999.
Ave., Miami, FL Injectable
33186. Solution.
June 23, 2017............. 200-618 Virbac AH, Inc., ZOLETIL (tiletamine Dogs and cats........... Original approval FOI Summary.
3200 Meacham HCl and zolazepam as a generic copy
Blvd., Ft. Worth, HCl) for Injection. of NADA 106-111.
TX 76137.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Following the approval of ANADA 200-610, Modern Veterinary
Therapeutics, LLC, will now be included in the lists of sponsors of
approved applications in Sec. 510.600(c) (21 CFR 510.600(c)).
II. Technical Amendments
We are making several technical amendments in 21 CFR part 558,
which was amended on December 27, 2016 (81 FR 94991), and February 24,
2017 (82 FR 11510), as part of the FDA Center for Veterinary Medicine's
(CVM's) Judicious Use Initiative. We are also making several technical
amendments to the regulations for dosage form drugs to reflect revised
labeling. These actions are being taken to improve the accuracy of the
regulations.
III. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (the 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, 524, and 529
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, 524, 529, 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 ``Modern Veterinary Therapeutics, LLC''; and in the
table in paragraph (c)(2), numerically add an entry for ``015914.'' The
additions 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
------------------------------------------------------------------------
* * * * * * *
Modern Veterinary Therapeutics, LLC, 14343 SW 119th 015914
Ave., Miami, FL 33186.................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
015914.................. Modern Veterinary Therapeutics, LLC, 14343 SW
119th Ave., Miami, FL 33186.
* * * * * * *
------------------------------------------------------------------------
[[Page 58556]]
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. In Sec. 520.88g, revise the section heading and paragraphs (a) and
(b) to read as follows:
Sec. 520.88g Amoxicillin trihydrate and clavulanate potassium
tablets.
(a) Specifications. Each tablet or chewable tablet contains
amoxicillin trihydrate and clavulanate potassium equivalent to 50
milligrams (mg) of amoxicillin and 12.5 mg clavulanic acid, 100 mg of
amoxicillin and 25 mg clavulanic acid, 200 mg amoxicillin and 50 mg
clavulanic acid, or 300 mg amoxicillin and 75 mg clavulanic acid.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
(1) No. 054771 for use of tablets and chewable tablets as in
paragraph (c) of this section.
(2) No. 026637 for use of tablets as in paragraph (c) of this
section.
* * * * *
0
5. In Sec. 520.1445, revise paragraph (c)(1)(ii) to read as follows:
Sec. 520.1445 Milbemycin oxime and praziquantel.
* * * * *
(c) * * *
(1) * * *
(ii) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis and for the treatment and control of
adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm
(Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult
tapeworm (Taenia pisiformis, Echinococcus multilocularis, E.
granulosus, and Dipylidium caninum) infections in dogs and puppies 2
pounds of body weight or greater and 6 weeks of age and older.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1335 [Amended]
0
7. In Sec. 522.1335, in paragraph (b), remove ``052483'' and in its
place add ``Nos. 015914 and 052483''.
0
8. In Sec. 522.2470, revise paragraphs (b), (c)(1)(i) and (ii), and
(c)(2) to read as follows:
Sec. 522.2470 Tiletamine and zolazepam for injection.
* * * * *
(b) Sponsors. See Nos. 026637, 051311, and 054771 in Sec.
510.600(c) of this chapter.
(c) * * *
(1) * * *
(i) Healthy dogs. 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.
(ii) Healthy cats. 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.
(2) Indications for use. For restraint or for anesthesia combined
with muscle relaxation in cats and in dogs for restraint and minor
procedures of short duration (30 minutes average) requiring mild to
moderate analgesia.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1580a [Amended]
0
10. In Sec. 524.1580a, in paragraph (d)(3), in the second sentence,
remove ``in'' and in its place add ``on''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
11. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
12. Amend 529.1030 as follows:
0
a. Revise paragraph (d)(1)(ii);
0
b. In the table in paragraph (d)(2)(i), revise footnote 1;
0
c. In paragraph (d)(2)(ii), in the table, in the heading of the
``Administer in earthen ponds indefinitely ([mu]L/L or ppm)'' column,
remove ``indefinitely'' and in its place add ``single treatment''; and
0
d. Revise paragraphs (d)(2)(iii) and (d)(3).
The revisions read as follows:
Sec. 529.1030 Formalin.
* * * * *
(d) * * *
(1) * * *
(ii) All finfish. For control of external protozoa Ichthyophthirius
spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis
spp., and Trichodina spp., and the monogeneans Cleidodiscus spp.,
Gyrodactylus spp., and Dactylogyrus spp.
* * * * *
(2) * * *
(i) * * *
\1\ Treat for up to 4 hours daily. Treatment may be repeated daily
until parasite control is achieved. Use the lower concentration when
tanks or raceways are heavily loaded with phytoplankton or shrimp, to
avoid oxygen depletion due to the biological oxygen demand created by
decay of dead phytoplankton. Alternatively, a higher concentration
might be used if dissolved oxygen is strictly monitored.
* * * * *
(iii) For control of fungi of the family Saprolegniaceae on finfish
eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000
[mu]L/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500
[mu]L/L (ppm) for 15 minutes. A preliminary bioassay should be
conducted on a small subsample of fish eggs to determine sensitivity
before treating an entire group. This is necessary for all species
because egg sensitivity can vary with species or strain and the unique
conditions at each facility.
(3) Limitations. Fish tanks and raceways may be treated daily until
parasite control is achieved. Pond treatment may be repeated in 5 to 10
days if needed. However, pond treatments for Ichthyophthirius spp.
should be made at 2-day intervals until control is achieved. Egg tanks
may be
[[Page 58557]]
treated as often as necessary to prevent growth of fungi. Do not use
formalin which has been subjected to temperatures below 40 [deg]F, or
allowed to freeze. Treatments in tanks and raceways should never exceed
1 hour for fish or 4 hours for penaeid shrimp (even if they show no
sign of distress), nor should it exceed 15 minutes for fish eggs. Do
not apply formalin to ponds with water warmer than 27 [deg]C (80
[deg]F), when a heavy bloom of phytoplankton is present, or when the
concentration of dissolved oxygen is less than 5 milligrams per liter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
13. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.58 [Amended]
0
14. In Sec. 558.58, remove paragraphs (f)(4) and (5).
Sec. 558.366 [Amended]
0
15. In Sec. 558.366, remove paragraph (e).
Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26753 Filed 12-12-17; 8:45 am]
BILLING CODE 4164-01-P
