Department of Health and Human Services January 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is denying Jason Vale's request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. Vale 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 Mr. Vale was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. Mr. Vale has failed to file with the agency information and analyses sufficient to create a basis for a hearing concerning this action.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for veterinary prescription use of a combination injectable solution containing florfenicol and flunixin meglumine in cattle.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Anika Therapeutics, Inc. The supplemental NADA provides for a revised human food safety warning for use of hyaluronate sodium injectable solution in horses.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.'' The draft guidance encourages manufacturers of medically necessary drug products (MNPs) and components to develop contingency production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the draft guidance is to provide to industry considerations for developing such emergency plans, as well as to discuss the Center for Drug Evaluation and Research's (CDER's) intended approach to assist in avoiding drug product shortages that may have a negative impact on the national public health during such emergencies.

The DHHS Agency for Healthcare Research and Quality (AHRQ) invites nominations from interested organizations and knowledgeable individuals for members of the Stakeholder Group to support the work of the Effective Health Care Program, established [for consultation] pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. The goals of this program are to develop evidence on the effectiveness and comparative effectiveness of different treatments and health care interventions of importance to the Medicare, Medicaid, and State Child Health Insurance programs. To achieve these goals, AHRQ supports projects to review, synthesize, generate, and translate scientific evidence, as well as identify important issues for which existing scientific evidence is insufficient to inform decisions about health care. The Effective Health Care Program makes the evidence information it develops readily available to health care decision makers. The Stakeholder Group is critical to the success of the Effective Health Care Program by providing input to improve the applicability and relevance of research products to health care decision makers. The Effective Health Care Program Stakeholder Group will be a part of the Citizen's Forum initiative, funded by the American Recovery and Reinvestment Act, to formally and broadly engage stakeholders, and to enhance and expand public involvement in the entire Effective Health Care enterprise.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products,'' dated December 2009. As part of the Medical Device User Fee Amendments of 2007 (MDUFA) Commitment for the Performance Goals and Procedures commitment letter, FDA agreed to publish guidance for medical imaging devices for use with imaging contrast agents or radiopharmaceuticals. FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products that provide image contrast enhancement. The final guidance announced in this document fulfills FDA's commitment to issue guidance called for by the commitment letter. The guidance supercedes the draft guidance of the same title dated September 30, 2008.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.