Department of Health and Human Services June 21, 2017 – Federal Register Recent Federal Regulation Documents

On March 15, 2017 the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [82 FR 13809] announcing the availability of a draft Current Intelligence Bulletin entitled The Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards for public comment. NIOSH convened a public meeting in Cincinnati, Ohio on Tuesday, May 23, 2017 to discuss the document. The draft document can be found at www.regulations.gov. by entering CDC-2017-0028 in the search field and clicking ``Search.'' Written comments were to be received by June 13, 2017. In response to a request from an interested party, NIOSH is announcing the reopening of the comment period.

The Food and Drug Administration (FDA) is withdrawing approval of 121 new drug applications (NDAs) and 161 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulationsQuestions and Answers.'' The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products. The draft guidance expands upon recommendations in the guidance for industry entitled ``Part 11, Electronic Records; Electronic SignaturesScope and Application'' issued in August 2003 (referred to as the 2003 part 11 guidance) for recommendations that pertain to FDA-regulated clinical investigations conducted under our regulations.