81 FR 3324 - Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib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

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that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.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, 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Conditional Approval of a New Animal Drug No Longer in Effect; 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minor use, is no longer in effect.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no longer in effect.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that conditional approval of this drug, by operation of law, was no 
longer in effect as of December 15, 2015.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