Department of Health and Human Services May 9, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002.

The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Daphne I. Panagotacos and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Panagotacos for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Panagotacos was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Panagotacos's debarment, FDA has considered the relevant factors listed in the FD&C Act. Panagotacos has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.