Determination of Regulatory Review Period for Purposes of Patent Extension; ENHERTU; Correction
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Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 8 (Wednesday, January 12, 2022)</title>
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[Federal Register Volume 87, Number 8 (Wednesday, January 12, 2022)]
[Notices]
[Page 1762]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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