Department of Health and Human Services May 30, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for PROGENSA PCA3 ASSAY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Expedited Programs for Serious ConditionsDrugs and Biologics.'' The purpose of this guidance is to provide a single resource for information on FDA's policies and procedures related to expedited drug development and review programs. The following programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition (expedited programs): Fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. This guidance finalizes the draft guidance issued in June 2013.

This Supplemental Bulletin updates the OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees that published in the Federal Register on November 22, 2005 (70 FR 70623).