Department of Health and Human Services September 2, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Dr. Maria Anne Kirkman Campbell (Dr. Campbell) from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Campbell was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and conduct otherwise relating to the regulation of a drug product under the act. Dr. Campbell failed to request a hearing and, therefore, has waived her opportunity for a hearing concerning this action. Even assuming that any statement in Dr. Campbell's correspondence with FDA were to be construed as requesting a hearing, Dr. Campbell has failed to file with the agency information and analyses sufficient to create a basis for a hearing concerning this action. Therefore, we are, in the alternative, issuing an order denying any such assumed request for a hearing because we find that there is no genuine and substantial issue of fact to grant a hearing on the debarment, if a hearing were requested.

Under section 6021 of Public Law 109-171, the Deficit Reduction Act of 2005 (DRA), States may provide asset disregards (and related estate recovery offsets) for Medicaid applicants who receive benefits under qualified long term care insurance policies (Partnership policies) that were purchased in the same State. This notice sets forth standards for states that choose to enter into a reciprocity agreement under section 6021(b) of the DRA, under which they agree to provide the same disregards and offsets for qualified Partnership policies that a Medicaid applicant purchased in another State that participates in the reciprocity agreement.