2024-21841. Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction

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Department of Health and Human Services

Food and Drug Administration

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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; correction.

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.