Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction
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Abstract
The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 12, 2018, for the determination of the regulatory review period for the animal drug BRAVECTO. In accordance with the Court's order in Nissan Chemical Corp., et al. v. FDA, et al., No. 22-01598 (D.D.C), this document revises the SUPPLEMENTARY INFORMATION section of that notice by adjusting the start date of the testing phase for BRAVECTO. This notice supersedes the June 11, 2021, Federal Register document revising the February 12, 2018, notice.
Full Text
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<title>Federal Register, Volume 89 Issue 185 (Tuesday, September 24, 2024)</title>
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[Federal Register Volume 89, Number 185 (Tuesday, September 24, 2024)]
[Notices]
[Page 77866]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21841]
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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 the Agency) published
a notice in the Federal Register of February 12, 2018, for the
determination of the regulatory review period for the animal drug
BRAVECTO. In accordance with the Court's order in Nissan Chemical
Corp., et al. v. FDA, et al., No. 22-01598 (D.D.C), this document
revises the SUPPLEMENTARY INFORMATION section of that notice by
adjusting the start date of the testing phase for BRAVECTO. This notice
supersedes the June 11, 2021, Federal Register document revising the
February 12, 2018, notice.
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: 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 revision is made on page 6034:
FDA has determined that the applicable regulatory review period for
BRAVECTO is 1,548 days. Of this time, 1,510 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 Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(j)) became effective:
February 19, 2010. Pursuant to the Court's order in Nissan Chemical
Corp., et al. v. FDA, et al., No. 22-01598 (D.D.C), the start date of
the testing phase for BRAVECTO was February 19, 2010.
Dated: September 19, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21841 Filed 9-23-24; 8:45 am]
BILLING CODE 4164-01-P
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