Department of Health and Human Services May 16, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is correcting notices concerning FDA's determination of the regulatory review period for PRISTIQ that appeared in the Federal Registers of August 31, 2010 (75 FR 53314) and September 2, 2010 (75 FR 53969). The documents omitted docket number FDA-2009-E-0086. This document corrects those omissions. Because the comment period for the notices closed on February 28, 2011, FDA is reopening the comment period to allow interested parties to submit comments or petitions to docket number FDA-2009-E-0086.

This document is a request for comments on opportunities to more effectively align benefits and incentives to prevent cost-shifting and improve access to care under the Medicare and Medicaid programs for individuals with both Medicare and Medicaid (``dual eligibles''). The document also reflects CMS' commitment to the general principles of the President's Executive Order released January 18, 2011, entitled ``Improving Regulation and Regulatory Review.''