81 FR 3432 - Conditional Approval of a New Animal Drug No Longer In Effect; Masitinib Mesylate Tablets
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 13 (January 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 13 (January 21, 2016)
| Page Range | 3432-3432 | |
| FR Document | 2016-01104 |
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)] [Notices] [Page 3432] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01104] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0002] Conditional Approval of a New Animal Drug No Longer In Effect; Masitinib Mesylate Tablets AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conditional approval no longer in effect. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is providing notice that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect. DATES: Conditional approval is no longer in effect as of December 15, 2015. FOR FURTHER INFORMATION CONTACT: Herman M. Schoenemann III, Center for Veterinary Medicine (HFV-108), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0652, [email protected]. SUPPLEMENTARY INFORMATION: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Minor Use and Minor Species Animal Health Act of 2004 (Pub. L. 108-282), permits conditional approval of new animal drugs for minor uses. Conditional approval of a new animal drug is effective for a 1-year period, and may be renewed for up to four additional 1-year periods. The holder of a conditionally approved new animal drug is required to submit all information necessary to support a complete new animal drug application (NADA) under section 512(b)(1) of the FD&C Act (21 U.S.C. 360b(b)(1) by 180 days before the termination of the fifth 1-year period of conditional approval. If FDA does not approve an NADA for the new animal drug by the termination date of the conditional approval, then pursuant to section 571(h) of the FD&C Act (21 U.S.C. 360ccc(h)) the conditional approval is no longer in effect. AB Science, 3 Avenue George V, 75008 Paris, France, filed an application for conditional approval (141-308) that provided for veterinary prescription use of KINAVET-CA1 (masitinib mesylate) Tablets for the treatment of recurrent (post-surgery) or nonresectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids. That application was conditionally approved on December 15, 2010. On December 15, 2014, application 141-308 received the fourth and final renewal of its conditional approval. That final renewal terminated on December 15, 2015. As of that date, FDA did not approve an NADA for KINAVET-CA1 under section 512 of the FD&C Act. Consequently, as of December 15, 2015, the conditional approval of application 141-308 is no longer in effect. Because the conditional approval is no longer in effect, KINAVET- CA1 Tablets is now an unapproved new animal drug product with no legal marketing status. Further marketing, sales, and distribution of the product are illegal. This notice is issued under section 571 of the FD&C Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine. Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect that the conditional approval of an application for this new animal drug is no longer in effect. Dated: January 14, 2016. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2016-01104 Filed 1-20-16; 8:45 am] BILLING CODE 4164-01-P
![3432 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
AboutAdvisoryCommittees/ U.S.C. 360ccc(h)) the conditional availability of the guidance entitled
ucm111462.htm for procedures on approval is no longer in effect. ‘‘Implanted Blood Access Devices for
public conduct during advisory AB Science, 3 Avenue George V, Hemodialysis.’’ This guidance was
committee meetings. 75008 Paris, France, filed an application developed to support the
Notice of this meeting is given under for conditional approval (141–308) that reclassification of the implanted blood
the Federal Advisory Committee Act (5 provided for veterinary prescription use access devices for hemodialysis into
U.S.C. app. 2). of KINAVET–CA1 (masitinib mesylate) class II (special controls) and to assist
Dated: January 15, 2016. Tablets for the treatment of recurrent industry in preparing premarket
Jill Hartzler Warner, (post-surgery) or nonresectable Grade II notification (510(k)) submissions for
or III cutaneous mast cell tumors in dogs implanted blood access devices for
Associate Commissioner for Special Medical
Programs. that have not previously received hemodialysis.
[FR Doc. 2016–01165 Filed 1–20–16; 8:45 am]
radiotherapy and/or chemotherapy DATES: Submit either electronic or
except corticosteroids. That application written comments on this guidance at
BILLING CODE 4164–01–P
was conditionally approved on any time. General comments on Agency
December 15, 2010. guidance documents are welcome at any
DEPARTMENT OF HEALTH AND On December 15, 2014, application time.
HUMAN SERVICES 141–308 received the fourth and final ADDRESSES: You may submit comments
renewal of its conditional approval. as follows:
Food and Drug Administration That final renewal terminated on
December 15, 2015. As of that date, FDA Electronic Submissions
[Docket No. FDA–2015–N–0002]
did not approve an NADA for Submit electronic comments in the
Conditional Approval of a New Animal KINAVET–CA1 under section 512 of the following way:
Drug No Longer In Effect; Masitinib FD&C Act. Consequently, as of • Federal eRulemaking Portal: http://
Mesylate Tablets December 15, 2015, the conditional www.regulations.gov. Follow the
approval of application 141–308 is no instructions for submitting comments.
AGENCY: Food and Drug Administration, longer in effect. Comments submitted electronically,
HHS. Because the conditional approval is including attachments, to http://
ACTION:Notice of conditional approval no longer in effect, KINAVET–CA1 www.regulations.gov will be posted to
no longer in effect. Tablets is now an unapproved new the docket unchanged. Because your
animal drug product with no legal comment will be made public, you are
SUMMARY: The Food and Drug marketing status. Further marketing, solely responsible for ensuring that your
Administration (FDA) is providing sales, and distribution of the product are comment does not include any
notice that the conditional approval of illegal. confidential information that you or a
an application for masitinib mesylate This notice is issued under section third party may not wish to be posted,
tablets, a new animal drug for a minor 571 of the FD&C Act and under such as medical information, your or
use, is no longer in effect. authority delegated to the Commissioner anyone else’s Social Security number, or
DATES: Conditional approval is no of Food and Drugs and redelegated to confidential business information, such
longer in effect as of December 15, 2015. the Center for Veterinary Medicine. as a manufacturing process. Please note
FOR FURTHER INFORMATION CONTACT: Elsewhere in this issue of the Federal that if you include your name, contact
Herman M. Schoenemann III, Center for Register, FDA is amending the animal information, or other information that
Veterinary Medicine (HFV–108), Food drug regulations to reflect that the identifies you in the body of your
and Drug Administration, 7500 Standish conditional approval of an application comments, that information will be
Pl., Rockville, MD 20855, 240–402– for this new animal drug is no longer in posted on http://www.regulations.gov.
0652, herman.schoenemann@ effect. • If you want to submit a comment
fda.hhs.gov. with confidential information that you
Dated: January 14, 2016. do not wish to be made available to the
SUPPLEMENTARY INFORMATION: The Bernadette Dunham, public, submit the comment as a
Federal Food, Drug, and Cosmetic Act Director, Center for Veterinary Medicine. written/paper submission and in the
(FD&C Act), as amended by the Minor [FR Doc. 2016–01104 Filed 1–20–16; 8:45 am] manner detailed (see ‘‘Written/Paper
Use and Minor Species Animal Health
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’).
Act of 2004 (Pub. L. 108–282), permits
conditional approval of new animal Written/Paper Submissions
drugs for minor uses. Conditional DEPARTMENT OF HEALTH AND Submit written/paper submissions as
approval of a new animal drug is HUMAN SERVICES follows:
effective for a 1-year period, and may be • Mail/Hand delivery/Courier (for
renewed for up to four additional 1-year Food and Drug Administration written/paper submissions): Division of
periods. The holder of a conditionally Dockets Management (HFA–305), Food
approved new animal drug is required [Docket No. FDA–2013–D–0749]
and Drug Administration, 5630 Fishers
to submit all information necessary to Lane, Rm. 1061, Rockville, MD 20852.
Implanted Blood Access Devices for
support a complete new animal drug
Hemodialysis; Guidance for Industry • For written/paper comments
application (NADA) under section submitted to the Division of Dockets
asabaliauskas on DSK9F6TC42PROD with NOTICES
and Food and Drug Administration
512(b)(1) of the FD&C Act (21 U.S.C. Management, FDA will post your
Staff; Availability
360b(b)(1) by 180 days before the comment, as well as any attachments,
termination of the fifth 1-year period of AGENCY: Food and Drug Administration, except for information submitted,
conditional approval. If FDA does not HHS. marked and identified, as confidential,
approve an NADA for the new animal ACTION: Notice of availability. if submitted as detailed in
drug by the termination date of the ‘‘Instructions.’’
conditional approval, then pursuant to SUMMARY: The Food and Drug Instructions: All submissions received
section 571(h) of the FD&C Act (21 Administration (FDA) is announcing the must include the Docket No. FDA–
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Document Created: 2018-02-02 12:33:41
Document Modified: 2018-02-02 12:33:41
| 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 | Notices | |
| Action | Notice of conditional approval no longer in effect. | |
| Dates | Conditional approval is no longer in effect as of December 15, 2015. | |
| Contact | Herman M. Schoenemann III, Center for Veterinary Medicine (HFV-108), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0652, [email protected] | |
| FR Citation | 81 FR 3432 |
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