New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address, 11506-11509 [2017-03677]
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Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations
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Powers Act. BIS continues to carry out
the provisions of the Export
Administration Act, as appropriate and
to the extent permitted by law, pursuant
to Executive Order 13222, as amended
by Executive Order 13637.
Rulemaking Requirements
1. Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
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emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
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expected to increase as a result of this
rule. You may send comments regarding
the collection of information associated
with this rule, including suggestions for
reducing the burden, to Jasmeet K.
Seehra, Office of Management and
Budget (OMB), by email to Jasmeet_K._
Seehra@omb.eop.gov, or by fax to (202)
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3. This rule does not contain policies
with Federalism implications as that
term is defined in Executive Order
13132.
4. The provisions of the
Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed
rulemaking, the opportunity for public
comment, and a delay in effective date
are inapplicable because this regulation
involves a military or foreign affairs
function of the United States. (See 5
U.S.C. 553(a)(1)). If this rule were
delayed to allow for notice and
VerDate Sep<11>2014
14:13 Feb 23, 2017
Jkt 241001
comment and a delay in effective date,
then the national security and foreign
policy objectives of this rule would be
harmed. Because a notice of proposed
rulemaking and an opportunity for
public comment are not required to be
given for this rule by 5 U.S.C. 553, or
by any other law, the analytical
requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq., are
not applicable. Accordingly, no
regulatory flexibility analysis is required
and none has been prepared.
List of Subject in 15 CFR Part 744
Exports, Reporting and recordkeeping
requirements, Terrorism.
Accordingly, part 744 of the Export
Administration Regulations (15 CFR
parts 730 through 774) is amended as
follows:
PART 744—[AMENDED]
1. The authority citation for 15 CFR
part 744 continues to read as follows:
■
Authority: 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;
42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR,
1978 Comp., p. 179; E.O. 12851, 58 FR 33181,
3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O.
12947, 60 FR 5079, 3 CFR, 1995 Comp., p.
356; E.O. 13026, 61 FR 58767, 3 CFR, 1996
Comp., p. 228; E.O. 13099, 63 FR 45167, 3
CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR
44025, 3 CFR, 2001 Comp., p. 783; E.O.
13224, 66 FR 49079, 3 CFR, 2001 Comp., p.
786; Notice of January 20, 2016, 81 FR 3937
(January 22, 2016); Notice of August 4, 2016,
81 FR 52587 (August 8, 2016); Notice of
September 15, 2016, 81 FR 64343 (September
19, 2016); Notice of November 8, 2016, 81 FR
79379 (November 10, 2016).
Supplement No. 7 to Part 744—
[AMENDED]
2. In Supplement No. 7 to part 744,
remove ‘‘February 27, 2017’’ and add in
its place ‘‘March 29, 2017’’.
■
Dated: February 21, 2017.
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
[FR Doc. 2017–03664 Filed 2–23–17; 8:45 am]
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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 a New Animal Drug
Application; Change of Sponsor;
Change of Sponsor’s Address
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
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
September and October 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 several applications and
a change of a sponsor’s address.
DATES: This rule is effective February
24, 2017, except for the amendment to
21 CFR 524.1465, which is effective
March 6, 2017.
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:
SUMMARY:
I. Approval Actions
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
September and October 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.,
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Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations
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 SEPTEMBER AND OCTOBER 2016
Approval date
File No.
Sponsor
Product name
Species
Effect of the action/indications for use
Original approval for the prevention of
mortality caused by necrotic enteritis associated with Clostridium
perfringens in broiler chickens; and
as an aid in the prevention of coccidiosis caused by Eimeria necatrix,
E. tenella, E. acervulina, E. brunetti,
E. mivati, and E. maxima.
Original approval of a generic copy of
NADA 055–099.
October 26, 2016 ....
141–465
Elanco US Inc,
2500 Innovation
Way, Greenfield,
IN 46140.
INTEPRITY
(avilamycin) and
COBAN
(monensin) Type
C medicated
feeds.
Chickens
September 8, 2016
200–592
Putney, Inc., One
Monument Sq.,
Suite 400, Portland, ME 04101.
Amoxicillin Trihydrate and
Clavulanate Potassium Tablets.
Dogs ......
II. Change of Sponsorship
informed FDA that it has transferred
ownership of, and all rights and interest
in, the following applications to Ceva
Sogeval S. A., 200 Avenue de
Mayenne, 53000 Laval, France has
FOI Summary.
FOI Summary.
Sante Animale, 10 Avenue de la
`
Ballastiere, 33500 Libourne, France:
File No.
Product name
099–667 ...................................................
110–399 ...................................................
IMPOSIL (iron heptomer) Injection ..........................................................................
GLEPTOSIL (gleptoferron) Injection ........................................................................
Following these changes of
sponsorship, Sogeval S. A. is no longer
the sponsor of an approved NADA.
Accordingly, the firm’s name, address,
and drug labeler code are being removed
from § 510.600(c) (21 CFR 510.600(c)).
In addition, Zoetis, Inc., 333 Portage
St., Kalamazoo, MI 49007 has informed
FDA that it has transferred ownership
File No.
006–417
032–319
038–838
108–687
111–369
...................................................
...................................................
...................................................
...................................................
...................................................
III. Withdrawals of Approval
Wildlife Laboratories, Inc., 1401 Duff
Dr., Suite 600, Fort Collins, CO 80524
has informed FDA that it has changed
its address to 1230 W. Ash St., Suite D,
Windsor, CO 80550. In addition, FDA
has noticed that a sponsor name in
§ 510.600 does not reflect the particular
punctuation used in this sponsor’s
applications and other correspondence.
At this time, we are amending the list
of sponsors of approved applications in
§ 510.600(c) to reflect this change of
sponsor address and sponsor’s
punctuation.
In addition, Putney, Inc., One
Monument Square, Suite 400, Portland,
ME 04101 has requested that FDA
withdraw approval of ANADA 200–524
for Mupirocin Ointment 2% because the
product is no longer manufactured or
marketed.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of ANADA 200–524, and all
supplements and amendments thereto,
is withdrawn, effective March 6, 2017.
14:13 Feb 23, 2017
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522.1182
522.1055
of, and all rights and interest in, the
following applications to Kinetic
Technologies, LLC, 961 Beasley St.,
Suite 270, Lexington, KY 40509:
21 CFR section
RECOVR (tripelennamine hydrochloride) Injection .................................................
FUROX (furazolidone) Aerosol Powder ..................................................................
ROBAXIN–V (methocarbamol) Injection .................................................................
PET DERM III (dexamethasone) Tablets ................................................................
Dexamethasone Sterile Solution .............................................................................
As provided in the regulatory text of
this document, the animal drug
regulations are amended to reflect this
voluntary withdrawal of approval.
VerDate Sep<11>2014
21 CFR section
Product name
Following these changes of
sponsorship, Kinetic Technologies, LLC
is now the sponsor of an approved
NADA. Accordingly, the firm’s name,
address, and drug labeler code are being
added to § 510.600(c).
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Public
documents
IV. Technical Amendments
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522.2615
524.1005
522.1380
520.540c
522.540
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.
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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
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.
§ 510.600
[Amended]
ii. Revise the entry for ‘‘053923’’
iii. In the entry for ‘‘058198’’, remove
‘‘Elanco US, Inc.’’ and in its place add
‘‘Elanco US Inc.’’; and
■ iv. Remove the entry for ‘‘059120’’.
The additions and revisions read as
follows:
■
2. Revise § 510.600 as follows:
a. In the table in paragraph (c)(1):
i. In the entry for ‘‘Elanco US, Inc.’’,
remove ‘‘Elanco US, Inc.’’ and in its
place add ‘‘Elanco US Inc.’’;
■ ii. Alphabetically add an entry for
‘‘Kinetic Technologies, LLC’’;
■ iii. Remove the entry for ‘‘Sogeval S.
A.’’; and
■ iv. Revise the entry for ‘‘Wildlife
Laboratories, Inc.’’
■ b. In the table in paragraph (c)(2):
■ i. Numerically add an entry for
‘‘051031’’;
■
■
■
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509 ..................................................................................
*
*
*
*
*
*
*
Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, Windsor, CO 80550 .......................................................................................
*
*
*
*
*
*
*
051031
053923
*
(2) * * *
Drug labeler
code
Firm name and address
*
*
*
051031 ...........................................................................................
*
*
*
*
Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509.
*
*
*
053923 ...........................................................................................
*
*
*
*
Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, Windsor, CO 80550.
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
4. In § 520.88g, in paragraph (b),
remove ‘‘No. 054771’’ and in its place
add ‘‘Nos. 026637 and 054771’’.
■
5. In § 520.540c, in paragraph (b),
remove ‘‘054771’’ and in its place add
‘‘051031’’.
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PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
7. In § 522.540, in paragraph (d)(2)(i),
remove ‘‘054771’’ and in its place add
‘‘051031’’.
■
[Amended]
8. In § 522.1055, in paragraph (b),
remove ‘‘059120’’ and in its place add
‘‘013744’’.
§ 522.1182
[Amended]
9. In § 522.1182, in paragraph (b)(3),
remove ‘‘059120’’ and in its place add
‘‘013744’’.
§ 522.1380
Authority: 21 U.S.C. 360b.
Jkt 241001
[Amended]
10. In § 522.1380, in paragraph (b),
remove ‘‘054771’’ and in its place add
‘‘051031’’.
■
§ 522.2615
6. The authority citation for part 522
continues to read as follows:
■
14:13 Feb 23, 2017
[Amended]
■
[Amended]
■
VerDate Sep<11>2014
*
*
[Amended]
12. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
Frm 00008
Fmt 4700
§ 524.1005
[Amended]
13. In § 524.1005, in paragraph (b)(1),
remove ‘‘054771’’ and in its place add
‘‘051031’’.
■
§ 524.1465
[Amended]
14. Effective March 6, 2017, in
§ 524.1465, in paragraph (b), remove
‘‘026637’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
15. The authority citation for part 558
continues to read as follows:
■
11. In § 522.2615, in paragraph (b),
remove ‘‘054771’’ and in its place add
‘‘051031’’.
■
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*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
■
[Amended]
§ 520.540c
§ 522.540
§ 522.1055
Authority: 21 U.S.C. 360b.
§ 520.88g
*
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Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
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Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations
§ 558.68
16. In § 558.68, revise paragraph
(e)(1)(ii) to read as follows:
■
*
Avilamycin.
*
*
*
(e) * * *
(1) * * *
*
Avilamycin in
grams/ton
Combination in
grams/ton
Indications for use
*
(ii) 13.6 to 40.9 ........
*
Monensin 90 to 110;
as provided by
No. 058198 in
§ 510.600(c) of
this chapter.
*
*
Broiler chickens: For the prevention of
mortality caused by necrotic enteritis
associated with Clostridium perfringens
in broiler chickens; and as an aid in the
prevention of coccidiosis caused by
Eimeria necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati, and
E. maxima.
Limitations
[Docket No. FDA–2016–N–0002]
New Animal Drugs; Withdrawal of
Approval of a New Animal Drug
Application
Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
*
*
*
*
Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03677 Filed 2–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
AGENCY:
Food and Drug Administration,
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of an abbreviated new animal
drug application (ANADA) at the
sponsor’s request because the product is
no longer manufactured or marketed.
DATES: Withdrawal of approval is
effective March 6, 2017.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Putney,
Inc., One Monument Square, Suite 400,
Portland, ME 04101 has requested that
FDA withdraw approval of ANADA
200–524 for Mupirocin Ointment 2%
because the product is no longer
manufactured or marketed.
SUMMARY:
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[FR Doc. 2017–03678 Filed 2–23–17; 8:45 am]
BILLING CODE 4164–01–P
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2016–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of 18 new animal drug
applications (NADAs) and 2 abbreviated
new animal drug applications
(ANADAs). These withdrawals of
SUMMARY:
File No.
LINCOMIX (lincomycin)/AMPROL PLUS (amprolium
and ethopabate).
approval of NADAs and ANADAs for
antimicrobial drugs of importance to
human medicine that are administered
to food-producing animals in medicated
feed are being made because the
products are no longer manufactured or
marketed. These actions are consistent
with the FDA Center for Veterinary
Medicine’s initiative for the Judicious
Use of Antimicrobials.
Withdrawal of approval is
effective February 24, 2017.
DATES:
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
withdrawing approval of 18 NADAs and
2 ANADAs. These applications were
identified as being affected by guidance
for industry (GFI) #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 (https://www.fda.gov/downloads/
AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/UCM299624.pdf).
Their withdrawal of approval is
consistent with the FDA Center for
Veterinary Medicine’s initiative for the
Judicious Use of Antimicrobials.
Approval of the following
applications for new animal drugs
administered in medicated feed is being
voluntarily withdrawn at the sponsors’
requests because these products are no
longer manufactured or marketed:
Product name
044–820 ......................................
VerDate Sep<11>2014
14:13 Feb 23, 2017
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Sponsor
Sfmt 4700
Sponsor
*
*
*
Feed as the sole ration for 21 consecu058198
tive days. To assure responsible antimicrobial drug use in broiler chickens,
treatment administration must begin on
or before 10 days of age. See
§ 558.355(d) of this chapter for additional required labeling.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of ANADA 200–524, and all
supplements and amendments thereto,
is hereby withdrawn, effective March 6,
2017.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of this
application.
*
11509
Zoetis Inc.
333 Portage St.
Kalamazoo, MI 49007 (Zoetis Inc.).
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]]>Agencies
[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Pages 11506-11509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03677]
=======================================================================
-----------------------------------------------------------------------
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 a New Animal Drug Application; Change of
Sponsor; 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 September and October 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 several applications and a change of a sponsor's
address.
DATES: This rule is effective February 24, 2017, except for the
amendment to 21 CFR 524.1465, which is effective March 6, 2017.
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 September and October 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.,
[[Page 11507]]
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 September and October 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effect of the action/
Approval date File No. Sponsor Product name Species indications for use Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 26, 2016................ 141-465 Elanco US Inc, 2500 INTEPRITY Chickens........... Original approval for FOI Summary.
Innovation Way, (avilamycin) and the prevention of
Greenfield, IN COBAN (monensin) mortality caused by
46140. Type C medicated necrotic enteritis
feeds. associated with
Clostridium
perfringens in broiler
chickens; and as an
aid in the prevention
of coccidiosis caused
by Eimeria necatrix,
E. tenella, E.
acervulina, E.
brunetti, E. mivati,
and E. maxima.
September 8, 2016............... 200-592 Putney, Inc., One Amoxicillin Dogs............... Original approval of a FOI Summary.
Monument Sq., Trihydrate and generic copy of NADA
Suite 400, Clavulanate 055-099.
Portland, ME 04101. Potassium Tablets.
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Change of Sponsorship
Sogeval S. A., 200 Avenue de Mayenne, 53000 Laval, France has
informed FDA that it has transferred ownership of, and all rights and
interest in, the following applications to Ceva Sante Animale, 10
Avenue de la Ballasti[egrave]re, 33500 Libourne, France:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
099-667....................... IMPOSIL (iron 522.1182
heptomer) Injection.
110-399....................... GLEPTOSIL 522.1055
(gleptoferron)
Injection.
------------------------------------------------------------------------
Following these changes of sponsorship, Sogeval S. A. is no longer
the sponsor of an approved NADA. Accordingly, the firm's name, address,
and drug labeler code are being removed from Sec. 510.600(c) (21 CFR
510.600(c)).
In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has
informed FDA that it has transferred ownership of, and all rights and
interest in, the following applications to Kinetic Technologies, LLC,
961 Beasley St., Suite 270, Lexington, KY 40509:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
006-417....................... RECOVR 522.2615
(tripelennamine
hydrochloride)
Injection.
032-319....................... FUROX (furazolidone) 524.1005
Aerosol Powder.
038-838....................... ROBAXIN-V 522.1380
(methocarbamol)
Injection.
108-687....................... PET DERM III 520.540c
(dexamethasone)
Tablets.
111-369....................... Dexamethasone Sterile 522.540
Solution.
------------------------------------------------------------------------
Following these changes of sponsorship, Kinetic Technologies, LLC
is now the sponsor of an approved NADA. Accordingly, the firm's name,
address, and drug labeler code are being added to Sec. 510.600(c).
III. Withdrawals of Approval
In addition, Putney, Inc., One Monument Square, Suite 400,
Portland, ME 04101 has requested that FDA withdraw approval of ANADA
200-524 for Mupirocin Ointment 2% because the product is no longer
manufactured or marketed.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of ANADA 200-524, and all supplements and amendments
thereto, is withdrawn, effective March 6, 2017. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect this voluntary withdrawal of approval.
IV. Technical Amendments
Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort
Collins, CO 80524 has informed FDA that it has changed its address to
1230 W. Ash St., Suite D, Windsor, CO 80550. In addition, FDA has
noticed that a sponsor name in Sec. 510.600 does not reflect the
particular punctuation used in this sponsor's applications and other
correspondence. At this time, we are amending the list of sponsors of
approved applications in Sec. 510.600(c) to reflect this change of
sponsor address and sponsor's punctuation.
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.
[[Page 11508]]
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.
Sec. 510.600 [Amended]
0
2. Revise Sec. 510.600 as follows:
0
a. In the table in paragraph (c)(1):
0
i. In the entry for ``Elanco US, Inc.'', remove ``Elanco US, Inc.'' and
in its place add ``Elanco US Inc.'';
0
ii. Alphabetically add an entry for ``Kinetic Technologies, LLC'';
0
iii. Remove the entry for ``Sogeval S. A.''; and
0
iv. Revise the entry for ``Wildlife Laboratories, Inc.''
0
b. In the table in paragraph (c)(2):
0
i. Numerically add an entry for ``051031'';
0
ii. Revise the entry for ``053923''
0
iii. In the entry for ``058198'', remove ``Elanco US, Inc.'' and in its
place add ``Elanco US Inc.''; and
0
iv. Remove the entry for ``059120''.
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
------------------------------------------------------------------------
* * * * * * *
Kinetic Technologies, LLC, 961 Beasley St., Suite 270, 051031
Lexington, KY 40509....................................
* * * * * * *
Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, 053923
Windsor, CO 80550......................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug labeler code Firm name and address
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
051031..................................... Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509.
* * * * * * *
053923..................................... Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, Windsor, CO 80550.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
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. 520.88g [Amended]
0
4. In Sec. 520.88g, in paragraph (b), remove ``No. 054771'' and in its
place add ``Nos. 026637 and 054771''.
Sec. 520.540c [Amended]
0
5. In Sec. 520.540c, in paragraph (b), remove ``054771'' and in its
place add ``051031''.
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. 522.540 [Amended]
0
7. In Sec. 522.540, in paragraph (d)(2)(i), remove ``054771'' and in
its place add ``051031''.
Sec. 522.1055 [Amended]
0
8. In Sec. 522.1055, in paragraph (b), remove ``059120'' and in its
place add ``013744''.
Sec. 522.1182 [Amended]
0
9. In Sec. 522.1182, in paragraph (b)(3), remove ``059120'' and in its
place add ``013744''.
Sec. 522.1380 [Amended]
0
10. In Sec. 522.1380, in paragraph (b), remove ``054771'' and in its
place add ``051031''.
Sec. 522.2615 [Amended]
0
11. In Sec. 522.2615, in paragraph (b), remove ``054771'' and in its
place add ``051031''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
12. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1005 [Amended]
0
13. In Sec. 524.1005, in paragraph (b)(1), remove ``054771'' and in
its place add ``051031''.
Sec. 524.1465 [Amended]
0
14. Effective March 6, 2017, in Sec. 524.1465, in paragraph (b),
remove ``026637''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
15. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
[[Page 11509]]
0
16. In Sec. 558.68, revise paragraph (e)(1)(ii) to read as follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 13.6 to 40.9.............. Monensin 90 to Broiler chickens: For Feed as the sole ration 058198
110; as provided the prevention of for 21 consecutive
by No. 058198 in mortality caused by days. To assure
Sec. 510.600(c) necrotic enteritis responsible
of this chapter. associated with antimicrobial drug use
Clostridium in broiler chickens,
perfringens in broiler treatment
chickens; and as an administration must
aid in the prevention begin on or before 10
of coccidiosis caused days of age. See Sec.
by Eimeria necatrix, 558.355(d) of this
E. tenella, E. chapter for additional
acervulina, E. required labeling.
brunetti, E. mivati,
and E. maxima.
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03677 Filed 2-23-17; 8:45 am]
BILLING CODE 4164-01-P
