SOURCES SOUGHT
A -- Medical Countermeasures to address Chemical, Biological, Radiological and Nuclear Threats
- Notice Date
- 9/14/2006
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Office of Public Health Emergency Preparedness, Office of Public Health Emergency Medical Countermeasures 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-RFI-OPHEMC-06-03
- Response Due
- 10/31/2006
- Archive Date
- 11/15/2006
- Description
- Background In March of 2006 the Secretary of Health and Human Services (HHS) announced his intention to establish a dedicated strategic planning function in HHS that more efficiently integrates biodefense requirements, across the full range of threat agents, with the execution of advanced development and procurement of medical countermeasures. HHS will work to make the current BioShield interagency governance process more transparent and work to educate industry about HHS priorities and opportunities. To meet this objective, HHS created the Public Health Emergency Medical Countermeasures Enterprise (PHEMC Enterprise), (published in the Federal Register in July 2006), which under the coordination of OPHEMC, will: 1) define and prioritize requirements for public health emergency medical countermeasures; 2) coordinate research, early- and late-stage product development and procurement activities to address these requirements; and 3) set deployment and use strategies for medical countermeasures held in the Strategic National Stockpile. The PHEMC Enterprise incorporates a broad approach to preparedness from effective surveillance/detection of threats to the research, development, acquisition, storage/maintenance, deployment and effective utilization of medical countermeasures. Additionally, HHS is undertaking a two-staged approach to develop a STRATEGY that will lead to an IMPLEMENTATION PLAN for medical countermeasures to address chemical, biological, radiological or nuclear (CBRN) threats. The HHS Strategy details the principles, priority policy issues, and strategic objectives for developing and acquiring the most appropriate medical countermeasures for the highest priority CBRN threats facing our nation. On September 8, 2006, the draft ?Public Health Emergency Medical Countermeasures Enterprise Strategy for Chemical, Biological, Radiological and Nuclear Threats? was published in the Federal Register (Vol 71 No. 174) for public comment. The HHS Implementation Plan will be a prioritized plan with near-, mid- and long-term goals for research, development and acquisition of medical countermeasures that is consistent with the guiding principles and priority-setting criteria, as defined in the final HHS Strategy. Description This is a Request for Information (RFI) only. It is not a request for proposals and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned. Data obtained from this RFI will provide critical inputs to the HHS Implementation Plan, with the ultimate goal to acquire the most appropriate medical countermeasures for mitigating the health effects from the highest priority CBRN threats facing the nation. OPHEMC is responsible for coordinating, supporting and providing leadership and expert advice with respect to public health medical countermeasure late stage advanced development and procurement. To this end, the Federal Government is interested in identifying and characterizing the current and projected status of the research and development programs related to CBRN medical countermeasures. Within this class of public health emergency medical countermeasures, the Federal Government is especially interested in medical countermeasures or diagnostic devices that could be readily deployed and used in preparation for, or response to, a CBRN event. Product attributes that facilitate this objective include, but are not limited to products that are single dose, self-administered, have demonstrated efficacy within a window of opportunity consistent with public health emergency response, limited or no cold chain requirements for storage, and a long shelf life. Diagnostic devices that are point of care and able to be rapidly deployed are of special interest. Medical countermeasures that address the following threats are of particular interest: Biological Category A, as defined by the Center for Disease Control and Prevention (CDC), (http://www.bt.cdc.gov/agent/agentlist-category.asp) o Anthrax (Bacillus anthracis) o Botulism (Clostridium botulinum toxin) o Plague (Yersinia pestis) o Smallpox (variola major) o Tularemia (Francisella tularensis) o Viral hemorrhagic fevers (filoviruses [e.g., Ebola, Marburg] and arenaviruses [e.g., Lassa, Machupo]) Category B - (http://www.bt.cdc.gov/agent/agentlist-category.asp) o Brucellosis (Brucella species) o Epsilon toxin of Clostridium perfringens o Food safety threats (e.g., Salmonella species, Escherichia coli O157:H7, Shigella) o Glanders (Burkholderia mallei) o Meliodosis(Burkholderia pseudomallei) o Psittacosis (Chlamydia psittaci) o Q fever (Coxiella burnetii) o Ricin toxin from Ricinus communis (castor beans) o Staphylococcal enterotoxin B o Typhus fever (Rickettsia prowazekii) o Viral encephalitis (alphaviruses [e.g., Venezuelan equine encephalitis, eastern equine encephalitis, western equine encephalitis]) o Water safety threats (e.g., Vibrio cholerae, Cryptosporidium parvum) Category C (http://www.bt.cdc.gov/agent/agentlist-category.asp) o Emerging infectious diseases such as Nipah virus and hantavirus Chemical Nerve agents, chemicals that affect the respiratory tract, and cellular/metabolic poisons. Radiological/Nuclear Radiological or nuclear agents that cause acute radiation syndrome and/or the delayed effects of radiation exposure. In order to assess the maturity of each medical countermeasure program or medical diagnostic device, Technology Readiness Levels (TRLs), Appendices 1-4 are to be used as a reference to gauge the stage of development of each medical countermeasure program, which will aid in comparisons among different projects and across different companies. Please refer to the TRL level of your program(s) in the cover letter of the submission. Appendices included are: Appendix 1- Technology Readiness Levels For Biological Medical Countermeasures Appendix 2 - Technology Readiness Levels For Chemical Medical Countermeasures Appendix 3 - Technology Readiness Levels For Radiological and Nuclear Medical Countermeasures Appendix 4 - Technology Readiness Levels For Medical Diagnostics Devices Countermeasures Interested organizations that have candidate products are invited to submit capability statements to HHS. Submitted information should include: a) a description of the candidate product including relevant chemical, physical chemical or immunological characteristics; b) a description of the mechanism of action; c) a description of the proposed formulation, dosage and route of administration; d) information regarding the stage of product development, including, but not limited to: preclinical and clinical safety and efficacy studies, e) nature and status of assay and animal model development; f) an estimate of production capacity complying with applicable regulations on Current Good Manufacturing Practices (GMP); and g) integrated project plans and timelines that incorporate manufacturing, regulatory, clinical and non-clinical tasks/actions to move the candidate product from development to approval, licensure, or clearance by the Food and Drug Administration (including studies to meet Animal Rule requirements, if product approval or licensure will be sought under 21 CFR Part 314, Subpart I or 21 CFR Part 601, Subpart H, respectively). All information submitted to HHS will be kept confidential as allowed by relevant Federal law. Information must be submitted by 3pm, October 31, 2006. Responses should be limited to 25 pages. Data sets (e.g., tables, charts, graphs) and documents which are pertinent to the response can be submitted as appendices to the primary submission. Electronic format is required and can be e-mailed to the attention of the primary contact person: Contracting Officer Darrick (Andre) Early, email:darrick.early@hhs.gov.
- Record
- SN01143370-W 20060916/060914220421 (fbodaily.com)
- Source
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