Department of Health and Human Services September 15, 2021 – Federal Register Recent Federal Regulation Documents

This proposed rule would repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of ``Reasonable and Necessary'' final rule, which was published on January 14, 2021, and would be effective on December 15, 2021. We are providing a public comment period to allow interested parties to provide comments about the proposed repeal, our intent to conduct future rulemaking to explore an expedited coverage pathway that provides access to innovative beneficial technologies and the reasonable and necessary definition.

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 associated with the Food Contact Substance Notification Program.