Department of Health and Human Services July 20, 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing its intent to establish a pilot project program under the Drug Supply Chain Security Act (the DSCSA Pilot Project Program) to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States. Under this program, FDA will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Participation in the DSCSA Pilot Project Program will be voluntary and will be open to pharmaceutical distribution supply chain members. FDA will be particularly interested in participation reflecting the diversity of the supply chain, including large and small entities from all industry sectors. This notice describes the proposed DSCSA Pilot Project Program, including proposed instructions for submitting a request to participate. FDA is soliciting comments on the proposed collection of information associated with establishment of the DSCSA Pilot Project Program before submitting the proposed collection to the Office of Management and Budget (OMB) for approval. FDA does not intend to begin the proposed DSCSA Pilot Project Program or accept requests to participate in the program until OMB has approved the proposed collection of information.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems and certain provisions under the 21st Century Cures Act (Pub. L. 114-255). In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.