Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib, 3324 [2016-01100]

Download as PDF 3324 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Rules and Regulations body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. Environmental Review List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (Air) Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: ■ Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389. [Amended] 2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015, is amended as follows: jstallworth on DSK7TPTVN1PROD with RULES ■ Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. * * * VerDate Sep<11>2014 * * 15:08 Jan 20, 2016 operation of law, was no longer in effect as of December 15, 2015.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. Issued in Fort Worth, TX, on January 7, 2016. Robert W. Beck, Manager, Operations Support Group, ATO Central Service Center. 21 CFR Part 516 [FR Doc. 2016–00879 Filed 1–20–16; 8:45 am] The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, ‘‘Environmental Impacts: Policies and Procedures’’ paragraph 5–6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment. § 71.1 ASW TX E5 El Paso, TX [Amended] Biggs AAF, (Fort Bliss) (Lat. 31°50′58″ N., long. 106°22′48″ W.). El Paso International Airport, TX (Lat. 31°48′26″ N., long. 106°22′35″ W.) El Paso VORTAC (Lat. 31°48′57″ N., long. 106°16′55″ W.). Class E airspace extending upward from 700 feet above the surface within a 9.1-mile radius of Biggs AAF, and within a 8.4-mile radius of El Paso International Airport, and within 2 miles each side of the 050° bearing from El Paso International Airport extending from the 8.4-mile radius to 13 miles northeast of the airport, and within 1.6 miles each side of the 093° radial of the El Paso VORTAC extending from the 8.4-mile radius to 7.3 miles east of the VORTAC. Jkt 238001 BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 516 List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 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 [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: 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, george.haibel@fda.hhs.gov. 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 Frm 00036 Fmt 4700 Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. § 510.600 Final rule. SUMMARY: PO 00000 1. The authority citation for 21 CFR part 510 continues to read as follows: ■ Sfmt 9990 [Amended] 2. In § 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 3. The authority citation for 21 CFR part 516 continues to read as follows: ■ Authority: 21 U.S.C. 360ccc–1, 360ccc–2, 371. § 516.1318 ■ [Removed] 4. Remove § 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 E:\FR\FM\21JAR1.SGM 21JAR1

Agencies

[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Rules and Regulations]
[Page 3324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 
george.haibel@fda.hhs.gov.

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