Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Comments submitted electronically, including attachments, to Follow the instructions for submitting comments. Submit electronic comments in the following way:įederal eRulemaking Portal. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Eastern Time at the end of February 9, 2024. TheĮlectronic filing system will accept comments until 11:59 p.m. Please note that late, untimely filed comments will not be considered. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 10, 2024. ) are incorrect may submit either electronic or written comments and ask for a redetermination by February 9, 2024. DATES:Īnyone with knowledge that any of the dates as published (see Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human drug product. FDA has made the determination because of the submission of applications to the Director of the U.S. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for WELIREG and is publishing this notice of that determination as required by law. Provide legal notice to the public or judicial notice to the courts.įood and Drug Administration, HHS. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of The official SGML-based PDF version on, those relying on it for The material on is accurately displayed, consistent with While every effort has been made to ensure that Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal The following is the output of the above example, with two consoles sinks configured.This site displays a prototype of a “Web 2.0” version of the dailyįederal Register. Console (outputTemplate : "[ ", exampleUser, DateTime.
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