Department of Health and Human Services June 5, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices.'' The guidance sets forth the agency's recommendations for ensuring the safety of refrigerated carrot juice and other low-acid refrigerated juices. The guidance is in response to six recent cases of botulism poisoning linked to refrigerated carrot juice that occurred in the United States and Canada.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatReceipt Date.'' This draft guidance provides information on what FDA will consider to be the receipt date for certain submissions provided in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The receipt date of these submissions has a number of important regulatory implications. Under the draft guidance, FDA will not consider a submission to be received until it has passed a technical validation check to ensure that the submission can be opened, processed, and archived.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor address for Watson Laboratories, Inc.

The Department of Health and Human Services is pleased to announce the upcoming HHS Public Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop, to be held July 31- August 2, 2007, in Washington, DC. This three-day event is an open meeting that seeks to bring together representatives from the pharmaceutical and biotechnology industries, professional societies, state and local public health organizations, the academic research and development community, public interest groups, stakeholder federal agencies, and Congress. Featured topics will include the Biomedical Advanced Research and Development Authority (BARDA); Project BioShield; the HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats; the HHS Pandemic Influenza Implementation Plan; and contracting with HHS for medical countermeasure development and acquisition.

The Food and Drug Administration (FDA) is announcing that we have revised the Advisory Committee Information Hotline (the hotline). The hotline provides the public with access to the most current information available on FDA advisory committee meetings. This notice supersedes all previously published announcements of the hotline.

The Food and Drug Administration (FDA) has determined the regulatory review period for NAMENDA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of two applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.