[Federal Register Volume 89, Number 185 (Tuesday, September 24, 2024)]
[Notices]
[Page 77866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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