DEFENSE THREAT REDUCTION AGENCY
BROAD AGENCY ANNOUNCEMENT
HDTRA1-15-EBOLA-BAA
CHEMICAL / BIOLOGICAL TECHNOLOGIES DEPARTMENT
FY2015 – FY2016 Program Build
24 OCTOBER 2014
https://www.fbo.gov/index?s=opportunity&mode=form&id=4644486179fe1388a4c395d0d0527b5e&tab=core&_cview=0
1. INTRODUCTION AND BACKGROUND
1.1. Introduction.
1.1.1. The Defense Threat Reduction Agency’s (DTRA) mission is to safeguard the United States and its allies from Weapons of Mass Destruction (WMD) (chemical, biological, radiological, nuclear, and high yield explosives) by providing capabilities to reduce, eliminate, and counter the threat, and mitigate its effects.
1.1.2. The DTRA Chemical and Biological Defense Program (CBDP) was established by the Department of Defense (DoD) to provide state-of-the-art defense capabilities to allow military forces of the United States to operate and to successfully complete their missions in chemical and biological warfare environments. The scope of mission efforts and the priorities assigned to specific projects are influenced by changes in military and civilian Chemical and Biological Defense (CBD) science and technology, advanced developments, operational requirements, military threat assessments, and national defense strategies. To keep pace with defense capability requirements, the CBDP as part of its mission, routinely promulgates chemical and biological research. The comprehensive research program encompasses both intramural and extramural sources, and the role of each is vital to the fulfillment of the Program objectives.
2. PURPOSE
2.1. The purpose of this Broad Agency Announcement (BAA) is to solicit research proposals for Chemical and Biological Defense Program, DTRA requirements for the CBDP Ebola BAA for the FY2015-2016 program.
DTRA, with industry and government partners, has been working aggressively for the past decade to understand and counter Zaire ebolavirus (EBOV). DTRA’s program is currently supporting the accelerated development of a therapeutic through preclinical Investigational New Drug (IND) enabling activities as well as the clinical evaluation for one EBOV vaccine. The program co-developed the rapid field deployable diagnostic systems currently in use in West Africa. The program has also been adapting and improving upon North Atlantic Treaty Organization (NATO) approved and high performance computing methods of modeling EBOV to perform analysis of the current EBOV outbreak. Recognizing that industry may have solutions applicable to the current EBOV outbreak in West Africa, this BAA has been released to ensure that all potential near-term solutions are considered
The World Health Organization (WHO) currently reports an ongoing outbreak of Ebola Virus Disease (EVD) in West Africa. The West African countries currently affected include Liberia, Sierra Leone, and Guinea, with past cases occurring in Nigeria and Senegal. There are no U.S. Food and Drug Administration (FDA) approved medical countermeasures for EBOV, the causative strain of the ongoing EVD epidemic in West Africa. Although diagnostic capabilities are available and are being utilized in West Africa, limitations with these current capabilities must be addressed. Similarly, improved modeling data, methods, and/or tools are required to better understand and predict the course of the current outbreak.
The primary objective of this BAA is to support development of near-term solutions such as therapeutic and vaccine candidates; diagnostic capabilities; modeling capabilities; and data gaps. For Medical Countermeasures (MCMs), only late stage development products for EBOV that can be completed and implemented in the near-term; defined as in time to assist with the current EBOV outbreak will be considered under this solicitation.
[snip]
2.2.4. Ebola Characterization
The means by which Ebola virus is maintained in nature remains unclear. One reservoir of this zoonotic pathogen is believed to be in bats, but it is unknown what other natural reservoirs exist. Distinct Ebola viral sequences have been identified in infected but healthy mice and shrews. (Pourrut et al., 2005) indicating there may be other unknown reservoirs. A better understanding of Ebola persistence under a variety of environmental conditions may help us identify other possible reservoirs and hosts to research reservoirs and other modes of transmission. While current science indicates the disease can only be transmitted by contact with contaminated body fluids, it remains unclear if other transmission modes are feasible. Filoviruses are able to infect via the respiratory route and are lethal at very low doses in experimental animal models, however the infectious dose is unknown. There is minimal information on how well filoviruses survive within aerosolized particles, and in certain media like the biofilm of sewage systems. Preliminary studies indicate that Ebola is aerostable in an enclosed controlled system in the dark and can survive for long periods in different liquid media and can also be recovered from plastic and glass surfaces at low temperatures for over 3 weeks (Piercy, et al., 2010).
2.2.4.1. Topic: CBS-01, Determination and Understanding of Quantitative Infectious Dose
This topic explores the physical, biological and molecular interactions of Ebola and related filoviruses to determine which of these interactions play a key role in the determination and understanding of quantitative infectious dose. The focus is on proposed efforts that aid in determining how many viable virions are required to cause human illness. Efforts that combine both experimental and computational techniques to explore molecular and physiological interactions and biochemical pathways
2.2.4.2. Topic: CBS-02, Persistence and decay or survival rates in the Environment
The research should generate knowledge on Ebola persistence in the environment and knowledge to help predict potential mutations or changes to the viron. Studies should determine persistence and decay or survival rates of Ebola virus and other filoviruses in the environment. Research areas may include (but are not limited to):
Assessment under a range of controlled environmental conditions, including, but not limited to the dark, simulated solar radiation, and ranges of temperature and humidity.
Identification of environmental factors that contribute to persistence
Assessing persistence of Ebola on fomites/ surfaces after aerosolization
Assessing persistence in other media such as water, sewage biofilm, and other priority surfaces
2.2.4.3. Topic: CBS-03, Molecular Determinants for Persistence
This topic focuses on understanding the molecular determinants that govern the ecology and environmental persistence of filoviruses. The research should focus on the molecular identities and mechanisms that promote environmental persistence of filoviruses. Research areas may include (but are not limited to):
Genomic and proteomic analyses to investigate the regulation of genes and proteins upon exposure to varying environmental conditions
Use of phylogenetics to identify potential genes involved in environmental persistence
Elucidation of mechanisms that contribute to environmental persistence
Metagenomic analysis of potential reservoir environments
Elucidation of mechanisms and environmental conditions that promote mutations in animal reservoirs
References:
Pourrut, X. et al. (2005). The natural history of Ebola virus in Africa. Microbes and Infection. (7: 7–8), 1005–1014. DOI: 10.1016/j.micinf.2005.04.006
Piercy, T., et al. (2010).The survival of filoviruses in liquids on solid substrates and in a dynamic aerosol. Journal of Applied Microbiology. (109), 1531–1539. doi:10.1111/j.1365-2672.2010.04778.x
2.2.5. Topic: CBT-01, Biohazard Personal Protective Equipment (PPE)
DTRA is seeking innovative technologies that protect warfighters who are engaged in bio-hazardous epidemic response operations. Technologies are being sought that extend wear-time in hot and humid environments by reducing thermal and cognitive burden and reduce hazards especially during the doffing process. Proposed solutions must be both innovative, technically mature, and provide a significant advantage over ensembles that are commercially available. Technical maturity must be demonstrated through statistically valid testing using applicable standard test methods. Material solutions must be cost-effective and logistically sustainable within the context of applicable military operations including security, construction, medical care, non-combatant or casualty evacuation and mortuary operations. Proposals must clearly show and justify a development and testing program to qualify the technology and validate the advantage claimed. The proposal must also consider scale-up and manufacturability as part of the overall life-cycle analysis.
2.2.6. Topic: CBT-02, Rapid Disinfection Processes
DTRA is seeking innovative technologies for rapid disinfection of interior surfaces with viral contamination. The technology must prove effective against viral contamination either deposited as an aerosol or heavy contaminated combined with body fluids (e.g. blood, vomit, feces). Responses must address the entire process, a response that only develops a disinfectant/sterilant is not sufficient. Disinfectants/sterilants must be compatible with sensitive equipment. Existing compatibility qualifications, such as registered compatibility with aircraft, is desired. The proposal must show data that demonstrates performance of the disinfectant/sterilant against pathogens similar to the Ebola virus or pathogens that are more difficult to disinfect. Material solutions must be cost-effective and logistically sustainable within the context of applicable military operations. Proposals must clearly show and justify a development and testing program to qualify the technology and validate the advantage claimed. The proposal must also consider scale-up and manufacturability as part of the overall life-cycle analysis.
[snip]
==============
Comment:by Pixie
So the Defense Threat Reduction Agency's Chemical and Biological Defense Program is soliciting research/solutions for the following problems which it does not completely understand about Ebola Zaire including:
• how well do filoviruses survive within aerosolized particles?
• is an aerosol mode of transmission is feasible? (Filoviruses are able to infect via the respiratory tract)
• what is an effective infectious dose? how many viable virons are needed to cause human illness?
• what is the persistence of Ebola on fomites/ surfaces after aerosolization?
• what is the persistence of Ebola in water and sewage?
• is there a disinfecting technology that will prove effective against viral contamination either deposited as an aerosol or heavy contaminated combined with body fluids (e.g. blood, vomit, feces)?
So we don't know much about the virus' natural reservoirs, we don't know much about its aerosolization, we don't know much about how easily it infects or what level of infection causes illness in humans, we don't know how long its fomites or aerosolized particles persist, we don't know how long it survives in water and sewage, and we don't have complete knowledge of the best ways to disinfect either Ebola aerosols or areas heavily contaminated with bodily fluids.
We don't know much, and yet tomorrow President Obama, flanked by Frieden, Fauci, and Klain, will no doubt assure the country in dulcet tones that the Science is Sound and that anyone who does not believe that is a rube, purely a rube. If they as citizens do not have faith that Frieden and Fauci and the rest of the talking heads have it all in hand, have it ALL under control, through SCIENCE!!!, they are just unwashed ignoramuses. There will be a lot of noses in the air. (Wonder if nurse Kaci Hickox will make an appearance as Exhibit A?).
This will be unfurling even as DTRA, just days before, requested research and proposals meant to answer some pretty significant Ebola questions. And it wants those questions answered and those solutions found in time to be able to implement them during this unprecedented outbreak.
So DTRA says they don't know, but they're asking a lot of questions so that they will know, eventually.
The ideologues who are pushing social philosophy over science say they Know Science, they take its name in vain, and laugh at anyone who looks at them skeptically, like the bunch of medieval conjurers they are.
I'll throw in with DTRA. I prefer it when someone says they don't know if they don't know. That means they'll be careful and cautious. And I like careful and cautious when we're talking about Ebola.
CDC admits droplets from a sneeze could spread Ebola
By Bob FredericksOctober 29, 2014 | 4:48am
http://nypost.com/2014/10/29/cdc-admits-droplets-from-a-sneeze-could-spread-ebola/
Ebola is a lot easier to catch than health officials have admitted — and can be contracted by contact with a doorknob contaminated by a sneeze from an infected person an hour or more before, experts told The Post Tuesday.
“If you are sniffling and sneezing, you produce microorganisms that can get on stuff in a room. If people touch them, they could be” infected, said Dr. Meryl Nass, of the Institute for Public Accuracy in Washington, DC.
Nass pointed to a poster the Centers for Disease Control and Prevention quietly released on its Web site saying the deadly virus can be spread through “droplets.”
“Droplet spread happens when germs traveling inside droplets that are coughed or sneezed from a sick person enter the eyes, nose or mouth of another person,” the poster states.
Nass slammed the contradiction.
“The CDC said it doesn’t spread at all by air, then Friday they came out with this poster,” she said. “They admit that these particles or droplets may land on objects such as doorknobs and that Ebola can be transmitted that way.”
Dr. Rossi Hassad, a professor of epidemiology at Mercy College, said droplets could remain active for up to a day.
“A shorter duration for dry surfaces like a table or doorknob, and longer durations in a moist, damp environment,” Hassad said.
BROAD AGENCY ANNOUNCEMENT
HDTRA1-15-EBOLA-BAA
CHEMICAL / BIOLOGICAL TECHNOLOGIES DEPARTMENT
FY2015 – FY2016 Program Build
24 OCTOBER 2014
https://www.fbo.gov/index?s=opportunity&mode=form&id=4644486179fe1388a4c395d0d0527b5e&tab=core&_cview=0
1. INTRODUCTION AND BACKGROUND
1.1. Introduction.
1.1.1. The Defense Threat Reduction Agency’s (DTRA) mission is to safeguard the United States and its allies from Weapons of Mass Destruction (WMD) (chemical, biological, radiological, nuclear, and high yield explosives) by providing capabilities to reduce, eliminate, and counter the threat, and mitigate its effects.
1.1.2. The DTRA Chemical and Biological Defense Program (CBDP) was established by the Department of Defense (DoD) to provide state-of-the-art defense capabilities to allow military forces of the United States to operate and to successfully complete their missions in chemical and biological warfare environments. The scope of mission efforts and the priorities assigned to specific projects are influenced by changes in military and civilian Chemical and Biological Defense (CBD) science and technology, advanced developments, operational requirements, military threat assessments, and national defense strategies. To keep pace with defense capability requirements, the CBDP as part of its mission, routinely promulgates chemical and biological research. The comprehensive research program encompasses both intramural and extramural sources, and the role of each is vital to the fulfillment of the Program objectives.
2. PURPOSE
2.1. The purpose of this Broad Agency Announcement (BAA) is to solicit research proposals for Chemical and Biological Defense Program, DTRA requirements for the CBDP Ebola BAA for the FY2015-2016 program.
DTRA, with industry and government partners, has been working aggressively for the past decade to understand and counter Zaire ebolavirus (EBOV). DTRA’s program is currently supporting the accelerated development of a therapeutic through preclinical Investigational New Drug (IND) enabling activities as well as the clinical evaluation for one EBOV vaccine. The program co-developed the rapid field deployable diagnostic systems currently in use in West Africa. The program has also been adapting and improving upon North Atlantic Treaty Organization (NATO) approved and high performance computing methods of modeling EBOV to perform analysis of the current EBOV outbreak. Recognizing that industry may have solutions applicable to the current EBOV outbreak in West Africa, this BAA has been released to ensure that all potential near-term solutions are considered
The World Health Organization (WHO) currently reports an ongoing outbreak of Ebola Virus Disease (EVD) in West Africa. The West African countries currently affected include Liberia, Sierra Leone, and Guinea, with past cases occurring in Nigeria and Senegal. There are no U.S. Food and Drug Administration (FDA) approved medical countermeasures for EBOV, the causative strain of the ongoing EVD epidemic in West Africa. Although diagnostic capabilities are available and are being utilized in West Africa, limitations with these current capabilities must be addressed. Similarly, improved modeling data, methods, and/or tools are required to better understand and predict the course of the current outbreak.
The primary objective of this BAA is to support development of near-term solutions such as therapeutic and vaccine candidates; diagnostic capabilities; modeling capabilities; and data gaps. For Medical Countermeasures (MCMs), only late stage development products for EBOV that can be completed and implemented in the near-term; defined as in time to assist with the current EBOV outbreak will be considered under this solicitation.
[snip]
2.2.4. Ebola Characterization
The means by which Ebola virus is maintained in nature remains unclear. One reservoir of this zoonotic pathogen is believed to be in bats, but it is unknown what other natural reservoirs exist. Distinct Ebola viral sequences have been identified in infected but healthy mice and shrews. (Pourrut et al., 2005) indicating there may be other unknown reservoirs. A better understanding of Ebola persistence under a variety of environmental conditions may help us identify other possible reservoirs and hosts to research reservoirs and other modes of transmission. While current science indicates the disease can only be transmitted by contact with contaminated body fluids, it remains unclear if other transmission modes are feasible. Filoviruses are able to infect via the respiratory route and are lethal at very low doses in experimental animal models, however the infectious dose is unknown. There is minimal information on how well filoviruses survive within aerosolized particles, and in certain media like the biofilm of sewage systems. Preliminary studies indicate that Ebola is aerostable in an enclosed controlled system in the dark and can survive for long periods in different liquid media and can also be recovered from plastic and glass surfaces at low temperatures for over 3 weeks (Piercy, et al., 2010).
2.2.4.1. Topic: CBS-01, Determination and Understanding of Quantitative Infectious Dose
This topic explores the physical, biological and molecular interactions of Ebola and related filoviruses to determine which of these interactions play a key role in the determination and understanding of quantitative infectious dose. The focus is on proposed efforts that aid in determining how many viable virions are required to cause human illness. Efforts that combine both experimental and computational techniques to explore molecular and physiological interactions and biochemical pathways
2.2.4.2. Topic: CBS-02, Persistence and decay or survival rates in the Environment
The research should generate knowledge on Ebola persistence in the environment and knowledge to help predict potential mutations or changes to the viron. Studies should determine persistence and decay or survival rates of Ebola virus and other filoviruses in the environment. Research areas may include (but are not limited to):
Assessment under a range of controlled environmental conditions, including, but not limited to the dark, simulated solar radiation, and ranges of temperature and humidity.
Identification of environmental factors that contribute to persistence
Assessing persistence of Ebola on fomites/ surfaces after aerosolization
Assessing persistence in other media such as water, sewage biofilm, and other priority surfaces
2.2.4.3. Topic: CBS-03, Molecular Determinants for Persistence
This topic focuses on understanding the molecular determinants that govern the ecology and environmental persistence of filoviruses. The research should focus on the molecular identities and mechanisms that promote environmental persistence of filoviruses. Research areas may include (but are not limited to):
Genomic and proteomic analyses to investigate the regulation of genes and proteins upon exposure to varying environmental conditions
Use of phylogenetics to identify potential genes involved in environmental persistence
Elucidation of mechanisms that contribute to environmental persistence
Metagenomic analysis of potential reservoir environments
Elucidation of mechanisms and environmental conditions that promote mutations in animal reservoirs
References:
Pourrut, X. et al. (2005). The natural history of Ebola virus in Africa. Microbes and Infection. (7: 7–8), 1005–1014. DOI: 10.1016/j.micinf.2005.04.006
Piercy, T., et al. (2010).The survival of filoviruses in liquids on solid substrates and in a dynamic aerosol. Journal of Applied Microbiology. (109), 1531–1539. doi:10.1111/j.1365-2672.2010.04778.x
2.2.5. Topic: CBT-01, Biohazard Personal Protective Equipment (PPE)
DTRA is seeking innovative technologies that protect warfighters who are engaged in bio-hazardous epidemic response operations. Technologies are being sought that extend wear-time in hot and humid environments by reducing thermal and cognitive burden and reduce hazards especially during the doffing process. Proposed solutions must be both innovative, technically mature, and provide a significant advantage over ensembles that are commercially available. Technical maturity must be demonstrated through statistically valid testing using applicable standard test methods. Material solutions must be cost-effective and logistically sustainable within the context of applicable military operations including security, construction, medical care, non-combatant or casualty evacuation and mortuary operations. Proposals must clearly show and justify a development and testing program to qualify the technology and validate the advantage claimed. The proposal must also consider scale-up and manufacturability as part of the overall life-cycle analysis.
2.2.6. Topic: CBT-02, Rapid Disinfection Processes
DTRA is seeking innovative technologies for rapid disinfection of interior surfaces with viral contamination. The technology must prove effective against viral contamination either deposited as an aerosol or heavy contaminated combined with body fluids (e.g. blood, vomit, feces). Responses must address the entire process, a response that only develops a disinfectant/sterilant is not sufficient. Disinfectants/sterilants must be compatible with sensitive equipment. Existing compatibility qualifications, such as registered compatibility with aircraft, is desired. The proposal must show data that demonstrates performance of the disinfectant/sterilant against pathogens similar to the Ebola virus or pathogens that are more difficult to disinfect. Material solutions must be cost-effective and logistically sustainable within the context of applicable military operations. Proposals must clearly show and justify a development and testing program to qualify the technology and validate the advantage claimed. The proposal must also consider scale-up and manufacturability as part of the overall life-cycle analysis.
[snip]
==============
Comment:by Pixie
So the Defense Threat Reduction Agency's Chemical and Biological Defense Program is soliciting research/solutions for the following problems which it does not completely understand about Ebola Zaire including:
• how well do filoviruses survive within aerosolized particles?
• is an aerosol mode of transmission is feasible? (Filoviruses are able to infect via the respiratory tract)
• what is an effective infectious dose? how many viable virons are needed to cause human illness?
• what is the persistence of Ebola on fomites/ surfaces after aerosolization?
• what is the persistence of Ebola in water and sewage?
• is there a disinfecting technology that will prove effective against viral contamination either deposited as an aerosol or heavy contaminated combined with body fluids (e.g. blood, vomit, feces)?
So we don't know much about the virus' natural reservoirs, we don't know much about its aerosolization, we don't know much about how easily it infects or what level of infection causes illness in humans, we don't know how long its fomites or aerosolized particles persist, we don't know how long it survives in water and sewage, and we don't have complete knowledge of the best ways to disinfect either Ebola aerosols or areas heavily contaminated with bodily fluids.
We don't know much, and yet tomorrow President Obama, flanked by Frieden, Fauci, and Klain, will no doubt assure the country in dulcet tones that the Science is Sound and that anyone who does not believe that is a rube, purely a rube. If they as citizens do not have faith that Frieden and Fauci and the rest of the talking heads have it all in hand, have it ALL under control, through SCIENCE!!!, they are just unwashed ignoramuses. There will be a lot of noses in the air. (Wonder if nurse Kaci Hickox will make an appearance as Exhibit A?).
This will be unfurling even as DTRA, just days before, requested research and proposals meant to answer some pretty significant Ebola questions. And it wants those questions answered and those solutions found in time to be able to implement them during this unprecedented outbreak.
So DTRA says they don't know, but they're asking a lot of questions so that they will know, eventually.
The ideologues who are pushing social philosophy over science say they Know Science, they take its name in vain, and laugh at anyone who looks at them skeptically, like the bunch of medieval conjurers they are.
I'll throw in with DTRA. I prefer it when someone says they don't know if they don't know. That means they'll be careful and cautious. And I like careful and cautious when we're talking about Ebola.
CDC admits droplets from a sneeze could spread Ebola
By Bob FredericksOctober 29, 2014 | 4:48am
http://nypost.com/2014/10/29/cdc-admits-droplets-from-a-sneeze-could-spread-ebola/
Ebola is a lot easier to catch than health officials have admitted — and can be contracted by contact with a doorknob contaminated by a sneeze from an infected person an hour or more before, experts told The Post Tuesday.
“If you are sniffling and sneezing, you produce microorganisms that can get on stuff in a room. If people touch them, they could be” infected, said Dr. Meryl Nass, of the Institute for Public Accuracy in Washington, DC.
Nass pointed to a poster the Centers for Disease Control and Prevention quietly released on its Web site saying the deadly virus can be spread through “droplets.”
“Droplet spread happens when germs traveling inside droplets that are coughed or sneezed from a sick person enter the eyes, nose or mouth of another person,” the poster states.
Nass slammed the contradiction.
“The CDC said it doesn’t spread at all by air, then Friday they came out with this poster,” she said. “They admit that these particles or droplets may land on objects such as doorknobs and that Ebola can be transmitted that way.”
Dr. Rossi Hassad, a professor of epidemiology at Mercy College, said droplets could remain active for up to a day.
“A shorter duration for dry surfaces like a table or doorknob, and longer durations in a moist, damp environment,” Hassad said.
