Centers for Medicare and Medicaid Services September 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. This process will serve the public interest by reducing the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs). The agencies are establishing a docket to receive information and comment from the public on what products would be appropriate for parallel review by the two agencies, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process. The agencies are also announcing their intent to create a pilot program for parallel review of medical devices. The pilot program will begin after both agencies have reviewed the public comments on this notice. A memorandum of understanding (MOU) concerning the exchange of data and information has been completed between the two agencies. See https://www.fda.gov/AboutFDA/ PartnershipsCollaborations/MemorandaofUnderstandingMOUs/Domes ticMOUs/ ucm217585.htm.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Health Administration Center (HAC) of the Department of Veteran Affairs. We have provided background information about the proposed matching program in the ``Supplementary Information'' section below. The Privacy Act provides an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.