Department of Health and Human Services April 28, 2005 – Federal Register Recent Federal Regulation Documents

An influenza pandemic has greater potential than any other naturally occurring infectious disease event to cause large and rapid global and domestic increases in deaths and serious illnesses. Preparedness is the key to substantially reducing the health, social, and economic impacts of an influenza pandemic and other public health emergencies. One component of preparedness involves understanding the impact that annual epidemics of influenza have on the population. These data regarding impact are critical to the development of prevention and control measures such as vaccination policies. Vaccination efforts are the cornerstone of influenza prevention and will be the primary means of mitigating the impact of an influenza pandemic. The systematic collection of influenza surveillance data over time is necessary to monitor and track influenza virus and disease activity and is essential to understanding the impact influenza has on a country's population. Improving surveillance systems by developing influenza surveillance networks is critical for the rapid detection of new variants, including those with pandemic potential, to contribute to the global surveillance system. Global collaboration, under the coordination of the World Health Organization (WHO), is a key feature of influenza surveillance. WHO established an international laboratory- based surveillance network for influenza in 1948. The network currently consists of 112 National Influenza Center (NIC) laboratories in 83 countries, and four WHO Collaborating Centers for Reference and Research of Influenza (including one located at the Centers for Disease Control and Prevention). The primary purposes of the WHO network are to detect the emergence and spread of new antigenic variants of influenza, to use this information to update the formulation of influenza vaccine, and to provide as much warning as possible about the next pandemic. This system provides the foundation of worldwide influenza prevention and control. Monitoring of influenza viruses and providing contributions to the global surveillance system will assure that data used in annual WHO vaccine recommendations are relevant to each country that participates. Increased participation in the global surveillance system for influenza viruses will enhance each country's ability to monitor severe respiratory illness, to develop vaccine policy, and to help build global and regional strategies for the prevention and control of influenza. Monitoring influenza disease activity is important to facilitate resource planning, communication, intervention, and investigation. This announcement seeks to support foreign governments through their Ministries of Health or other responsible Ministries for human health in the development or improvement of epidemiologic and virologic influenza surveillance networks. These networks will focus on the systematic collection of virological and epidemiological information for influenza. This support is meant to enhance, and not to supplant, current influenza surveillance activities. Proposals should build upon infrastructure already in place. Preference will be given to countries where resources are currently limited and influenza surveillance is not well established due to lack of resources.

The Indian Health Service published a document in the Federal Register on April 14, 2005. The document contained one error.

The Food and Drug Administration (FDA) is reissuing the notice announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of 13 new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications. In the Federal Register of January 28, 2005 (70 FR 4134), FDA published a notice announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 13 NDAs from multiple sponsors. That notice published with an inadvertent error; in a document published elsewhere in this issue of the Federal Register, the agency is withdrawing that notice.

The Food and Drug Administration (FDA) is reclassifying tricalcium phosphate (TCP) granules for dental bone repair from class III to class II (special controls), classifying into class II (special controls) other bone grafting material for dental indications, and revising the classification name and identification of the device type. Bone grafting materials that contain a drug that is a therapeutic biologic will remain in class III and continue to require a premarket approval application. The classification identification includes materials such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the class II devices.