Department of Health and Human Services October 1, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics.'' This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance describes the basic principles for designing, conducting, and reporting the results from an adaptive clinical trial. The draft guidance will replace the 2010 draft guidance for industry entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.''

In October 2017, the Department of Transportation (DOT) issued a special permit to the Digital Wave Corporation, allowing the company to extend the service life of certain carbon-fiber reinforced aluminum- lined cylinders. Some stakeholders, including respirator and cylinder manufacturers, have expressed concern to the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention, about the safety of cylinders extended beyond the manufacturers' stated service life. NIOSH is seeking information about the potential effect of the special permit, as it may relate to the safety of self-contained breathing apparatus respirators approved by NIOSH for use in U.S. workplaces.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of our reporting and recordkeeping requirements for antimicrobial animal drug sales and distribution.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.