Document ID: FDA-2015-E-2079-0010
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction
Posted Date: 2021-06-11T04:00Z

[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Page 31318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12284]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-2079]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; BRAVECTO; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA or Agency) published a 
notice in the Federal Register of February 12, 2018. After review of a 
timely request for reconsideration by the applicant of the 
determination of the regulatory review period of the animal drug, 
BRAVECTO, in that notice, FDA has determined that a revision of the 
SUPPLEMENTARY INFORMATION section is warranted. This document presents 
the revised regulatory review period.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of February 12, 2018 (83 FR 6033), in FR 
Doc. 2018-02761, in the first column, the first two paragraphs under 
the section ``II. Determination of Regulatory Review Period,'' the 
following correction is made on page 6034:
    FDA has determined that the applicable regulatory review period for 
BRAVECTO is 1,054 days. Of this time, 1,016 days occurred during the 
testing phase of the regulatory review period, while 38 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 512(j) of the FD&C Act (21 
U.S.C. 360b(j)) became effective: June 28, 2011. The applicant claims 
February 19, 2010, as the date the investigational new animal drug 
application (INAD) became effective. However, after consideration of 
additional information presented by the applicant in response to the 
Federal Register notice (83 FR 6033), FDA has determined that the start 
of the testing phase was June 28, 2011, which was the date the first 
major health or environmental effects test began.

    Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12284 Filed 6-10-21; 8:45 am]
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