Centers for Medicare and Medicaid Services 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are correcting a notice that appeared in the Federal Register of October 11, 2011 (76 FR 62808). The document announced a pilot program for sponsors of innovative device technologies to participate in a program of parallel FDA-CMS review. The document was published with an incorrect Web page address and an incorrect email address. This document corrects those errors.

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) (the Agencies) are soliciting nominations from sponsors of innovative device technologies to participate in a pilot program for concurrent review of certain FDA premarket review submissions and CMS national coverage determinations. The Agencies announced the intention to initiate a pilot program in the Federal Register of September 17, 2010. The Agencies are now providing notice of the procedures for voluntary participation in the pilot program, as well as the guiding principles the Agencies intend to follow.

This proposed notice with comment period acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.