Department of Health and Human Services June 1, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for GEM 21S GROWTH-FACTOR ENHANCED MATRIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA) has determined the regulatory review period for PHAKIC INTRAOCULAR LENSES and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration is announcing that a collection of information entitled ``Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines,'' dated May 2007. The guidance document provides to sponsors of pandemic influenza vaccines guidance on clinical development approaches to facilitate and expedite the licensure of influenza vaccines for the prevention of disease caused by pandemic influenza viruses. The guidance provides recommendations concerning clinical data to support traditional license approval of a biologics license application (BLA), or a BLA using the accelerated approval pathway. The guidance announced in this notice finalizes the draft guidance of the same title dated March 2006.

The U.S. Department of Health and Human Services (HHS) announces the first in a series of three federal advisory committee meetings on the Physical Activity Guidelines for Americans, to be held in Washington, DC. These meeting will be open to the public. The Physical Activity Guidelines Advisory Committee will review existing scientific literature to identify where there is sufficient evidence to develop a comprehensive set of specific physical activity recommendations. The Committee will prepare a report to the Secretary of HHS that documents the scientific background and rationale for the issuance of Physical Activity Guidelines for Americans. The report will also identify areas where further scientific research is needed. HHS will use the Final Report of the Committee to develop Physical Activity Guidelines. The intent is to issue physical activity recommendations for all Americans that will be tailored as necessary for specific subgroups of the population.