Document ID: FDA-2020-E-1817-0008
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ENHERTU; Correction
Posted Date: 2022-01-12T05:00Z

[Federal Register Volume 87, Number 8 (Wednesday, January 12, 2022)]
[Notices]
[Page 1762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00404]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-1817, FDA-2020-E-1818, and FDA-2020-E-1820]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; ENHERTU; 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 November 1, 2021, for the 
determination of a regulatory review period for purposes of patent 
extension for the human biological product, ENHERTU. This document 
corrects that notice by adjusting the applicable regulatory review 
period for the testing phase and approval phase of the product, 
ENHERTU.

DATES: All due dates for submission of comments, redetermination 
requests, and submission of petitions for due diligence as well as the 
dates used to determine the regulatory review periods for the products 
noted above remain the same as originally published.

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: On November 1, 2021, the Food and Drug 
Administration (FDA or the Agency) published a notice in the Federal 
Register determining the regulatory review period for the human 
biological product ENHERTU. This correction to the notice adjusts the 
applicable regulatory review period of the product with the number of 
days occurring during the testing phase and the approval phase of the 
product ENHERTU.

Correction

    In the Federal Register of November 1, 2021 (86 FR 60252), in FR 
Doc. 2021-23725, appearing on page 60253, in the third column, in 
section II., ``Determination of Regulatory Review Period,'' in the 
first two sentences, the following correction is made:
    FDA has determined that the applicable regulatory review period for 
ENHERTU is 1,395 days. Of this time, 114 days occurred during the 
testing phase of the regulatory review period, while 1,281 days 
occurred during the approval phase.

    Dated: January 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00404 Filed 1-11-22; 8:45 am]
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