Summary: The Office of Research and Development Coordination (ORDC), Office of Public Health Emergency Preparedness, Department of Health and Human Services, is seeking comments from any interested parties to assist in planning a public meeting that will provide a forum for constructive dialogue on the opportunities and challenges of Project BioShield implementation. Responses to this notice will be used to develop a meeting agenda that addresses the major areas of concern and enhances the productivity of the meeting. Dates: Written comments must be postmarked, and electronic comments submitted by, November 24, 2004. Page Limit: Responses should be limited to three pages. Address: Electronic responses are preferred and may be submitted to
[email protected]. Written comments may be sent to the attention of Darrick A. Early, Office of Public Health Emergency Preparedness, Office of Research and Development Coordination, U.S. Department of Health and Human Services, 200 Independence Avenue, SW, Room 624D, Washington, DC 20201. Background: To inform effective implementation of the Project BioShield Act of 2004 (P.L. 108-276), ORDC is organizing a public meeting (to take place on or about January 11-12, 2005). The Project BioShield Act sets forth requirements for the acquisition of medical countermeasures for the Strategic National Stockpile (SNS) through use of Project BioShield funds of up to $5,593,000,000 for fiscal years 2004 through 2013. ORDC has the primary responsibility within HHS to enter into contracts with manufacturers for the acquisition of licensable medical countermeasures for the Strategic National Stockpile. Additional information can be located at the following website http://www.hhs.gov/asphep/ordc/. Medical countermeasures acquired under Project BioShield will be a critical component of the Nation’s biodefense preparedness efforts. The January 2005 public meeting will inform the biotechnology and biopharmaceutical industries, medical and public health care sectors, university-based product development researchers, Congress and concerned citizens about the procurement and deployment processes under Project BioShield. ORDC is soliciting questions and comments from these parties during the planning stage to assist in developing a productive meeting agenda. Areas of special interest or concern will be targeted for discussion in either general or break-out sessions. Response Comments are sought from the perspectives of both potential future suppliers and future consumers of medical countermeasures. Please note that the Government will not provide individual responses to such comments. However, a dialogue may be established with any individual or business entity concerning a given issue raised by this notice. The HHS Contracting Officer will determine the extent of such a dialogue, for the purposes of fairness and compliance with Agency regulations. This request for information is for meeting planning only and shall not be construed as a solicitation for proposals or as an obligation on the part of the Government. The Government will not pay for the preparation of any information submitted or the Government’s use of that information. All respondents are asked to indicate the type and size of your business or organization where applicable; e.g., large business, small business, county or state public health office, professional organization, educational institution, or profit/nonprofit organization. Electronic responses are preferred and can be submitted by November 24, 2004 to
[email protected]. Written responses postmarked by November 24, 2004 may also be submitted to the attention of Darrick A. Early, Office of Public Health Emergency Preparedness, U.S. Department of Health and Human Services, 200 Independence Avenue, SW, Room 624D, Washington, DC 20201. Responses should be no longer than three pages and should include the name, position/title, telephone/extension, facsimile number(s), and e-mail address (es) of the contact individual. The response should also identify the institution, organization, company, etc. and the complete street address (including, where applicable, location identifiers, e.g., office stop and room number) including zip code.