Submit either electronic or written comments on or before June 6, 2012. The companion proposed rule and this direct final rule are substantively identical. We are publishing a companion proposed rule under our usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event we receive any significant adverse comments and withdraw this direct final rule. We are proceeding in accordance with our direct final rule procedures. We are making these technical changes to conserve Agency time and resources, reduce government paperwork, and eliminate unnecessary Federal Register printing costs while continuing to afford public access to these documents. This direct final rule, accordingly, eliminates it. Because we already post and will continue to post our ongoing agreements and MOUs with other departments, Agencies, and organizations on our Web site upon their completion, this requirement is no longer necessary. This direct final rule makes technical changes that will update a requirement that many of our written agreements and memoranda of understanding (MOUs) with other departments, Agencies, and organizations be published in the Federal Register. 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 False negatives and false positives of favored ‘expedient’ procedures allow drugs to reach the market with misleading and inaccurate information about the total drug effect.This site displays a prototype of a “Web 2.0” version of the dailyįederal Register. Conflicting results reveal astounding deficiencies of current ADME approaches. Such efforts are not new, but a renewed urgency has come from comparing results obtained with methods of different resolution and sensitivity, namely high-resolution receptor microscopic autoradiography compared and viewed in parallel to conventional low-resolution ‘cut-and-count’ radioassays and whole body autoradiography. Similar demands have been made repeatedly in the literature. Experience from academic research and ADME experiments during drug development has prompted this appeal for improved drug target recognition. Pharmacokineticists and toxicologists may consider this proposal, weigh its merits, and provide input for implementation. This memorandum is addressed to members of regulatory agencies, as well as managers of pharmaceutical companies.
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