The Food and Drug Administration has announced that due to scheduled maintenance, users of certain systems and their subcomponents, including the Food Facility Registration system and the Prior Notice System Interface (PNSI), may experience intermittent time outs on April 23, 2011 between 3:00 - 10:00 a.m. ET.
On April 19, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration has posted the agenda for the April 20, 2011 public meeting on the preventive controls that food facilities must develop pursuant to the Food Safety Modernization Act (FSMA), which became law on January 4, 2011.
The Environmental Protection Agency has released the 16th annual U.S. greenhouse gas inventory. The final report shows overall emissions during 2009 decreased by 6.1 percent from the previous year. This downward trend was attributed to a decrease in fuel and electricity consumption across all U.S. economic sectors. The complete report, "Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2009," is available here.
The Environmental Protection Agency announces that the Administrator of EPA has forwarded to the Secretary of Agriculture and the Secretary of Health and Human Services a draft final rule under the Federal Insecticide, Fungicide, and Rodenticide Act which would codify a separate listing of data requirements for the registration of antimicrobial pesticide products to reflect current scientific knowledge and current EPA regulatory practices.
The Food and Drug Administration's Center for Tobacco Products (CTP) is announcing a notice for participation in its Site Tours Program. This program is intended to give CTP staff an opportunity to visit facilities involved in the growing, processing, or manufacturing of tobacco or tobacco products. Interested parties should submit either an electronic or written request for participation by June 17, 2011.
On April 15, 2011, the Food and Drug Administration updated its Import Alert (IA # 99-33) on detention without physical examination of certain milk, milk products, fruit, vegetables, and baby formula from Japan due to radionuclide contamination.
On April 18, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is announcing the availability of a guidance for industry entitled "How to Write a Request for Designation (RFD)," which supersedes the previous RFD guidance document issued in August 2005. The goal of the guidance is to help a sponsor understand what information FDA needs to determine the regulatory identity or classification of a product as a drug, device, biological product, or combination product, and to assign the product to the appropriate Agency component for review and regulation.
On April 15, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of: