Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction
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Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 111 (Friday, June 11, 2021)</title>
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[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Page 31318]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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]
BILLING CODE 4164-01-P
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