Determination of Regulatory Review Period for Purposes of Patent Extension; ENHERTU; Correction

• Published date: 12 January 2022
• Record Number: 2022-00404
• Section: Notices
• Court: Food And Drug Administration

Federal Register, Volume 87 Issue 8 (Wednesday, January 12, 2022)

[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]
                BILLING CODE 4164-01-P