Department of Health and Human Services June 4, 2008 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) is pleased to announce the upcoming HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop 2008, to be held September 24-26, 2008, in Arlington, VA. This third annual event will provide an open forum for pharmaceutical and biotechnology industry representatives, state and local first responders, Executive Branch officials, public health advocates, academicians, Congressional staff, and other key stakeholders to discuss critical issues surrounding the development, acquisition, and distribution of medical countermeasures against chemical, biological, radiological, nuclear, and naturally emerging threats, and to share their visions for the future of U.S. public health emergency preparedness. Featured topics will include PHEMCE progress over the past year in medical countermeasure development and acquisitions under the HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats and the HHS Pandemic Influenza Implementation Plan; Biomedical Advanced Research and Development Authority (BARDA) anticipated advanced development contracts and procurements under Project BioShield; medical countermeasure use at the point of care; Pandemic and All-Hazards Preparedness Act (PAHPA) implementation; and developing and sustaining a biodefense industry. This year's Workshop will also feature BARDA Industry Afternoons and evening poster sessions, designed to provide unique opportunities for biotechnology and pharmaceutical industry representatives to showcase cutting-edge biodefense medical countermeasure advances in the areas of vaccines, therapeutics, diagnostics, and platform technologies.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Research Resources (NCRR), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 24, 2008, Vol. 73, No. 57, page 15530, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Inventory and Evaluation of Clinical Research Networks. Type of Information Collection Request: REVISION of OMB 0925-0550 Expiration: 07/31/08. Need and Use of Information Collection: Through the original data collection, the IECRN project identified and surveyed clinical research networks to obtain data for two purposes: (1) To create a web-based inventory of clinical research networks that can be accessed by the clinical research community and the general public and (2) to prepare a detailed description of existing network practices from a sample of identified networks. The current request is to continue collecting data for the first purpose only. The instrument known as the Core Survey will be used to collect information to confirm that the respondent is truly a clinical research network, plus basic characteristics about each identified clinical research network to be included in the web-based inventory. The information for the inventory database includes the network's name, address, contact information, funding sources, age, geographic coverage, size, composition, and populations and diseases of focus. Permission to post the network's data in the web-based public inventory will be requested, and only those networks that agree will have their information posted. Currently the inventory includes ``network profiles'' for approximately 270 clinical research networks. While this number is believed to represent most of the existing networks, some networks have not yet been identified, are unaware of the existence of the inventory, or are newly formed since the original data collection occurred. In addition, each network in the inventory is requested annually to update the information posted in its ``network profile'' to ensure that the inventory is complete and accurate. Frequency of Response: Once (Core Survey), Annually (Network Updates). Affected Public: Individuals; Type of Respondents: Health Professionals (Physicians and others involved in research networks).