Department of Health and Human Services July 29, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA research in obtaining information from pharmacists and other management at outsourcing facilities as well as at related compounding businesses to support a comprehensive analysis of the outsourcing facility sector that will inform future FDA work in this area.

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on July 2, 2019. That Notice requires a correction in the Supplementary Information section.

The Food and Drug Administration (FDA or Agency) has determined that FORTAMET (metformin hydrochloride) extended-release tablets, 500 milligrams (mg) and 1 gram (g), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.