Department of Health and Human Services November 3, 2017 – Federal Register Recent Federal Regulation Documents

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.

This document announces that on September 1, 2017, the statewide temporary moratorium on the enrollment of new Medicare Part B non-emergency ground ambulance suppliers in Texas was lifted. This announcement also applies to the temporary moratorium on enrollment of non-emergency ground ambulance suppliers in Medicaid and the Children's Health Insurance Program in Texas.

The Food and Drug Administration (FDA or Agency) has determined that REVEX (nalmefene hydrochloride injection), 0.1 milligram (mg) base/milliliter (mL) and 1.0 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA' controlled correspondence response and the Agency's process for responding to those requests. This draft guidance revises the guidance for industry ``Controlled Correspondence Related to Generic Drug Development'' issued in September 2015.