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Extramural Research Program - Funding Opportunities

Small Business Innovation Research (SBIR)

Funding Opportunity Announcement (FOA)

Title

PHS 2009-02 Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])

Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the Administration for Children and Families (ACF) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH, CDC, FDA and ACF awarding components identified in this FOA are encouraged to submit SBIR grant applications in response to identified topics.

Topics

Complete FOA Topic Information

PHPR-Related FOA Topics

Office of Public Health Preparedness and Response (PHPR)
The Office of Public Health Preparedness and Response (PHPR) http://www.cdc.gov/phpr/ has primary oversight and responsibility for programs that comprise the Centers for Disease Control and Prevention's (CDC) terrorism preparedness and emergency response portfolio. Through an all-hazards approach to preparedness that focuses on threats from natural, biological, chemical, nuclear, and radiological events, PHPR helps the nation prepare for and respond to urgent threats to the public's health. PHPR's mission is to "safeguard health and save lives by providing a flexible and robust platform for public health emergency response (proposed)." To carry out its mission, PHPR (1) fosters collaborations, partnerships, integration, and resource leveraging to increase CDC's health impact and achieve population health goals; (2) provides strategic direction to support CDC's terrorism preparedness and emergency response efforts; (3) manages CDC-wide preparedness and emergency response programs; (4) maintains concerted emergency response operations—including the Strategic National Stockpile and the Director's Emergency Operations Center; and (5) communicates terrorism preparedness and emergency response activities to internal and external stakeholders.

RESEARCH TOPICS:

PHPR interest in SBIR research is focused on the following research topic(s). Other research topics that are within the mission of PHPR are of interest:

A. Computer-Based Models For Evaluating Strategies and Outcomes in Pandemic Preparedness
As part of the National Strategy for Pandemic Influenza Implementation Plan, the Federal Government was tasked to "review and approve state pandemic influenza plans to supplement and support DHS State Homeland Security Strategies to ensure that Federal homeland security grants and other forms of assistance are applied to a common set of priorities in conformance with the National Preparedness Goal within 12 months". A priority area of this review was the topic of community containment and mitigation, which is the use of measures other than vaccination and drug treatment that might be useful during an influenza pandemic to reduce its harm. In February 2007, the Centers for Disease Control and Prevention released interim planning guidance on the use of non-pharmaceutical interventions to mitigate an influenza pandemic (Community Strategy for Community Mitigation, www.pandemicflu.gov); however, reviews of state pandemic influenza operational plans and feedback from state planners indicate that community mitigation is still an area where additional guidance and concrete methodology is needed. There is a need for state and local planners to better identify potential impacts and implications in each of the CDC defined pandemic severity index levels for mitigating disease spread, sustaining government and community infrastructure, and lessening the pandemic's impact on the economy and the functioning of society (schools, business, transportation, health, and other community sectors) if the federal government's pandemic interventions are implemented at the state and community level. A computerized modeling product using decision-tree algorithms is desired to help state and local planners examine possible outcomes related to the application of community containment interventions against state and local pandemic influenza plans. The model should be readily usable by staff in Federal, Tribal, State, Territorial, and Local health departments or by disaster planners and should be developed so that it can be made available at a low cost.

B. Development of an Improved Reusable Insulated [Cold-Chain] Shipping Container (ISC)
There is a need for cost-effective methodologies to ship vaccines and other drugs or biologicals while keeping the cold-chain intact. Research is needed to develop the technology for a reusable insulated cold-chain shipping container with specifications that would allow for various deployment conditions of assets in the Strategic National Stockpile.

Designs are needed for small, medium, and large Insulated Shipping Containers (ISC) to meet multi-performance ranges preferably within one ISC configuration for refrigerated and frozen specifications (not more than two separate configurations are desired). The temperature ranges for the new ISC design are: 1) Refrigerated specifications: 2° to 8° C; 2) Frozen specifications: -30° to -15° C and -30° to 8° C. Designs must meet or exceed all ISTA 7D temperature and drop tests on all 6 sides of ISC; ISC's must be ISTA certified and stamped. Designers must be capable of providing Qualification, Validation Performance testing in a licensed ISTA Lab with an ISO 9000/9001 certification for the design. In addition, the ISC must have state-of-the-art mold resistant and water/moisture retardant coating on all sides (inner/outer surface); Must contain disposable moisture absorbent padding material for the inner bottom of the ISC; Must utilize the same ISC machine tooling for the corresponding sizes between the 2°C to 8°C ISC and the -30°C to -15°C / -30C°C to 8°C. All ISC's must have a Universal Pack-out Configuration with a desirable payload capacity for small: 10.2"x 5.1"x 4.5" (LxWxH); medium: 15" x 9.9" x 6.4"; large: 14.8" x 14.8" x 11". The ISC's should be deliverable as constructed and ready for long term storage and or immediate use. Complete packout of ISC's must take no longer than 30 seconds PCM (phase change materials) must enact at temperatures -22°C or warmer; No liquid nitrogen or dry ice PCM; No special considerations for safe disposal; ISC components and materials must be innocuous, non-toxic, and remain safe for use for minimum of 15 to 20 years; ISC's are to be 100% passive; No battery AC/DC powered components, No electronic circuitry permitted; the design should be such that it is functional for a minimum of 15 years under performance specifications and conditions/stipulations. The technology should be readily usable by staff in Federal, State and Local health departments or by disaster planners that require management or re-distribution of stockpile materials. Optimally, the systems developed should have low maintenance costs; estimated costs for development should be documented. In addition, evaluation and validation of the shipping systems are required. Validation specifications and maximum tare weight requirements will be provided upon request.

C. Training in Public Health Ethics for Public Health Responders
There is a need for specific training for public health responders about the complex ethical and social values that are involved in the planning, response, and follow-up phases of public health emergencies. Research is needed to develop training modules for public health professionals and practitioners on ethical principles and to explore key ethical issues related to public health emergency preparedness and response. Where appropriate, the training should provide guidance to reconcile potential ethics issues. When developing the training, the grantee should consider all available public health ethics frameworks. The specific frameworks utilized should be articulated in the proposed project. The training should be readily usable by staff in Federal, Tribal, State, Territorial, and Local health departments or by disaster planners and should be developed so that it can be made available at a low cost. In addition, evaluation of the effectiveness of the training should be incorporated into the training modules produced (e.g., exam questions). A computer or web-based training platform is desired but not essential.

D. State, Local, Community and Faith Based Tools and Resources for Protecting Vulnerable Populations from Excess Health Burden During All-Hazards Events
The unanticipated consequences of Hurricane Katrina uncovered a host of realities that need to be addressed to systematically prevent similar circumstances in the event of future hurricanes or other disasters of catastrophic magnitude. Although substantial progress has been made to design communication materials to reach vulnerable populations, the specific preparedness, response and recovery needs of vulnerable populations and the factors that contribute to vulnerability are still inadequately understood among first responders. Concerned public health professionals and first responders have engaged in efforts to develop guidelines and resources for protecting vulnerable populations during disasters. However, there continues to be a need for a useful, validated tool that can be used across the broad spectrum of preparedness stakeholders. Input from consumers and stakeholders indicate that research is needed to develop broad-spectrum, field-tested tools and resources to address population specific and functional needs of vulnerable populations in response to all-types of public health hazards. This technology should be readily accessible to and usable by responders and staff from Federal agencies, State and Local health departments, National Volunteer Organizations Active in Disasters (VOAD), local community and faith-based organizations, and other disaster planners. Optimally, the tools and resources developed should have low maintenance costs and that can be documented. In addition, evaluation and validation of the tools and resources is required. The following is of particular interest:

Development of tools and resources to systematically identify and plan for the All-hazards Emergency and Response needs of vulnerable populations. Tools should have the ability to target specific vulnerable population groups and functional needs such as the need for sheltering, food and water, medication, or transport and should go beyond currently available resources for vulnerable populations, be easily implemented, and adaptable to varying community and vulnerable population needs.

E. Pre-Hospital Transport Vehicle for the Acutely Injured
The management of injuries and trauma related morbidity during a public health emergency is a significant aspect in preparedness planning. In many cases those at greatest risk from injuries are the young or those with limited economic and social support systems. In addition to the scarcity of resources, such as may occur in rural settings, several factors may contribute to the difficulty in managing injuries during an event including:

  • Remote locations with poor communication
  • Traffic congestion
  • Poor road infrastructure and access
  • Lack of trained personnel
  • Lack of appropriate equipment and supplies
  • Deficiencies in ability to deliver timely definitive care
In these settings, effective public health interventions that are both economically and technically feasible will become increasingly important in mitigating the severe public health impacts of injuries, especially during an emergency event.

There is a need to develop pre-hospital transport capability (ambulances) specifically designed for application in such settings. The WHO, with support from CDC, led the development of trauma and emergency care systems that are applicable for conditions in an emergency event. WHO published Pre-hospital Trauma Care Systems and Guidelines for Essential Trauma Care to support the development and use of these systems internationally. A critical component in the care of the acutely ill or injured patient is timely transport to definitive care facilities under the challenging circumstances often encountered during various emergency events.

For use in these situations, the vehicle design process needs to take into account the following desired characteristics:

  • Low manufacturing cost
  • Low maintenance and fuel costs
  • Capable of moving on paved and non-paved surfaces
  • Capable of navigating narrow passages
  • Warning devices and capability for poor weather use
  • Seats with seatbelts for a driver, care provider
  • Capable of securing a stretcher or having a padded bench with seatbelts for a patient to be able to lie flat
  • Capable of securely carrying necessary equipment and supplies for the proposed level of care to be provided (e.g. as outlined in Pre-hospital Trauma Care Systems)

Technologies for Rapid and Efficient Communication in Emergency Response
Effective communication is crucial for emergency response before, during, and after a public health emergency event. Factors in emergency response communication include effective strategies to facilitate rapid information exchange, clear communication messaging to reach target audiences, established channels of communication, and others. Research is needed to develop or enhance existing communication technologies for use in emergency response. Design factors should improve upon existing technologies, such as improved ease of use under all hazard conditions, longer signal range, extended period of operability, lower cost to operate and/or to maintain, etc. Technology should be usable by responders and staff from Federal agencies, State and Local health departments, National Volunteer Organizations Active in Disasters (VOAD), local community and faith-based organizations, and other disaster planners.



 
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