81 FR 3324 - Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 13 (January 21, 2016)

Page Range		3324-3324
FR Document		2016-01100

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.

Federal Register, Volume 81 Issue 13 (Thursday, January 21, 2016)

[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Rules and Regulations]
[Page 3324]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01100]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 516

[Docket No. FDA-2015-N-0002]


Conditional Approval of a New Animal Drug No Longer in Effect; 
Masitinib

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect that the conditional approval of an 
application for masitinib mesylate tablets, a new animal drug for a 
minor use, is no longer in effect.

DATES: This rule is effective January 21, 2016.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect that application 141-308 for conditional approval of 
KINAVET-CA1 (masitinib mesylate) Tablets, a new animal drug for a minor 
use sponsored by AB Science, 3 Avenue George V, 75008 Paris, France, is 
no longer in effect.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that conditional approval of this drug, by operation of law, was no 
longer in effect as of December 15, 2015.
    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 Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

    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 and 
516 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``AB Science'' and in the table in paragraph (c)(2), remove the 
entry for ``052913''.

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for 21 CFR part 516 continues to read as 
follows:

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.


Sec.  516.1318  [Removed]

0
4. Remove Sec.  516.1318.

    Dated: January 14, 2016.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2016-01100 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P

3324 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Rules and Regulations

body of technical regulations for which ASW TX E5 El Paso, TX [Amended] operation of law, was no longer in effect
frequent and routine amendments are Biggs AAF, (Fort Bliss) as of December 15, 2015.
necessary to keep them operationally (Lat. 31°50′58″ N., long. 106°22′48″ W.). This rule does not meet the definition
current, is non-controversial and El Paso International Airport, TX
(Lat. 31°48′26″ N., long. 106°22′35″ W.)
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
unlikely to result in adverse or negative it is a rule of ‘‘particular applicability.’’
comments. It, therefore, (1) is not a El Paso VORTAC
(Lat. 31°48′57″ N., long. 106°16′55″ W.). Therefore, it is not subject to the
‘‘significant regulatory action’’ under
Class E airspace extending upward from congressional review requirements in 5
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT 700 feet above the surface within a 9.1-mile U.S.C. 801–808.
radius of Biggs AAF, and within a 8.4-mile
Regulatory Policies and Procedures (44 radius of El Paso International Airport, and List of Subjects
FR 11034; February 26, 1979); and (3) within 2 miles each side of the 050° bearing
does not warrant preparation of a 21 CFR Part 510
from El Paso International Airport extending
regulatory evaluation as the anticipated from the 8.4-mile radius to 13 miles northeast Administrative practice and
impact is so minimal. Since this is a of the airport, and within 1.6 miles each side
of the 093° radial of the El Paso VORTAC
procedure, Animal drugs, Labeling,
routine matter that only affects air traffic
extending from the 8.4-mile radius to 7.3 Reporting and recordkeeping
procedures and air navigation, it is
certified that this rule, when miles east of the VORTAC. requirements.
promulgated, does not have a significant Issued in Fort Worth, TX, on January 7, 21 CFR Part 516
economic impact on a substantial 2016.
number of small entities under the Robert W. Beck, Administrative practice and
criteria of the Regulatory Flexibility Act. Manager, Operations Support Group, ATO procedure, Animal drugs, Confidential
Central Service Center. business information, Reporting and
Environmental Review
[FR Doc. 2016–00879 Filed 1–20–16; 8:45 am] recordkeeping requirements.
The FAA has determined that this BILLING CODE 4910–13–P
Therefore, under the Federal Food,
action qualifies for categorical exclusion
Drug, and Cosmetic Act and under
under the National Environmental
Policy Act in accordance with FAA authority delegated to the Commissioner
DEPARTMENT OF HEALTH AND of Food and Drugs and redelegated to
Order 1050.1F, ‘‘Environmental HUMAN SERVICES
Impacts: Policies and Procedures’’ the Center for Veterinary Medicine, 21
paragraph 5–6.5a. This airspace action Food and Drug Administration CFR parts 510 and 516 are amended as
is not expected to cause any potentially follows:
significant environmental impacts, and 21 CFR Parts 510 and 516
no extraordinary circumstances exist PART 510—NEW ANIMAL DRUGS
[Docket No. FDA–2015–N–0002]
that warrant preparation of an
environmental assessment. ■ 1. The authority citation for 21 CFR
Conditional Approval of a New Animal
Drug No Longer in Effect; Masitinib part 510 continues to read as follows:
List of Subjects in 14 CFR Part 71
Authority: 21 U.S.C. 321, 331, 351, 352,
Airspace, Incorporation by reference, AGENCY: Food and Drug Administration, 353, 360b, 371, 379e.
Navigation (Air) HHS.
ACTION: Final rule. § 510.600 [Amended]
Adoption of the Amendment
SUMMARY: The Food and Drug ■ 2. In § 510.600, in the table in
In consideration of the foregoing, the Administration (FDA) is amending the paragraph (c)(1), remove the entry for
Federal Aviation Administration animal drug regulations to reflect that ‘‘AB Science’’ and in the table in
amends 14 CFR part 71 as follows: the conditional approval of an paragraph (c)(2), remove the entry for
PART 71—DESIGNATION OF CLASS A, application for masitinib mesylate ‘‘052913’’.
B, C, D, AND E AIRSPACE AREAS; AIR tablets, a new animal drug for a minor
TRAFFIC SERVICE ROUTES; AND use, is no longer in effect. PART 516—NEW ANIMAL DRUGS FOR
REPORTING POINTS DATES: This rule is effective January 21, MINOR USE AND MINOR SPECIES
2016.
■ 1. The authority citation for part 71 FOR FURTHER INFORMATION CONTACT: ■ 3. The authority citation for 21 CFR
continues to read as follows: George K. Haibel, Center for Veterinary part 516 continues to read as follows:
Authority: 49 U.S.C. 106(f), 106(g); 40103, Medicine (HFV–6), Food and Drug Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Administration, 7519 Standish Pl., 371.
1959–1963 Comp., p. 389. Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov. § 516.1318 [Removed]
§ 71.1 [Amended]
SUPPLEMENTARY INFORMATION: FDA is
■ 4. Remove § 516.1318.
■ 2. The incorporation by reference in amending the animal drug regulations to
14 CFR 71.1 of FAA Order 7400.9Z, reflect that application 141–308 for Dated: January 14, 2016.
Airspace Designations and Reporting conditional approval of KINAVET–CA1 Bernadette Dunham,
Points, dated August 6, 2015, and (masitinib mesylate) Tablets, a new Director, Center for Veterinary Medicine.
jstallworth on DSK7TPTVN1PROD with RULES

effective September 15, 2015, is animal drug for a minor use sponsored [FR Doc. 2016–01100 Filed 1–20–16; 8:45 am]
amended as follows: by AB Science, 3 Avenue George V, BILLING CODE 4164–01–P
75008 Paris, France, is no longer in
Paragraph 6005 Class E Airspace Areas effect.
Extending Upward From 700 Feet or More Elsewhere in this issue of the Federal
Above the Surface of the Earth. Register, FDA gave notice that
* * * * * conditional approval of this drug, by

VerDate Sep<11>2014 15:08 Jan 20, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4700 Sfmt 9990 E:\FR\FM\21JAR1.SGM 21JAR1

Document Created: 2018-02-02 12:33:26
Document Modified: 2018-02-02 12:33:26

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This rule is effective January 21, 2016.
Contact		George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]
FR Citation		81 FR 3324
CFR Citation		21 CFR 510 21 CFR 516
CFR Associated		Administrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Confidential Business Information

81 FR 3324 - Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 13 (January 21, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration