Government Bioscience Grant (GBG) Report September 2016 BROAD AGENCY ANNOUNCEMENTS

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1 Government Bioscience Grant (GBG) Report September 2016 Title () Opp. Number Description Deadline Level Eligibility Link BROAD AGENCY ANNOUNCEMENTS 1. Safe Genes (DoD) DARPA- BAA DARPA is soliciting innovative research proposals to generate and evaluate novel biological tools and countermeasures that facilitate the safe pursuit of advanced genome editing applications, while reducing the risk of, and providing new protections against, potential engineered genetic threats. Research should investigate radically different approaches to integrate biosafety and biosecurity features into new genome editing biotechnologies and their derivative applications at their inception. 11/17/16 bo.gov/index?s=opportunit y&mode=for m&id=1f54e6 9797b94552e 7a951551d16 a91f&tab=cor e&_cview=0 2. Reconfigurable Imaging (ReImagine) (DoD) DARPA- BAA The objectives of the ReImagine program are to demonstrate that a software-reconfigurable imaging system can enable revolutionary capabilities, present a new approach to application development that is more similar to field programmable gate array (FPGA) based design than to ASIC design, and to develop the underlying theory and algorithms that learn to collect the most valuable information when the sensor can be configured for a variety of measurements. The ReImagine program aims to demonstrate that a single ROIC architecture can be configured to accommodate multiple modes of imaging operations that may be defined after the chip has been designed. 11/10/16 $20M for Multiple s bo.gov/index?s=opportunit y&mode=for m&id=4f92ee 6b62df0cc7e0 21a06a1372c 258&tab=cor e&_cview=0 1

2 BIOMEDICAL 3. Facile Methods and Technologies for Synthesis of Biomedically Relevant Carbohydrates (U01) (NIH) RFA-RM This FOA is focused on development of new methods and technologies for 1) synthesis of biomedically relevant mammalian glycomes; and 2) synthesis of biomedically relevant microbial glycans that can inform on disease processes. New robust, stereo-selective catalytic methods; approaches that open up new chemical space; approaches for the rapid and cost effective synthesis of microbial glycans; approaches for the rapid and cost effective synthesis of glycopeptides are examples sought Intent Due: 10/28/16 11/28/16 $4M in FY 17 for 6 s RM html#_Se ction_i._fund ing CANCER 4. Integrating Biospecimen Science Approaches into Clinical Assay Development (U01) (HHS, NIH and National Cancer Institute) 166 Results from this research program will improve the understanding of how biopsy collection, processing, and storage procedures may affect all aspects of analytical performance for current and emerging clinical biomarkers, as well as expedite clinical biomarker assay development through the evidence-based standardization of biopsy handling practices. Critical information gained through these research awards may increase the reliability of clinical biomarker assays, reduce time requirements for assay development, and decrease assay failure during late-stage testing. 1/13/17 Full : 2/13/17 $250,000 per year 166.html CELLS 5. Changes in Cellular Architecture During Aging (R01) (NIH) PA This FOA seeks applications that propose innovative research strategies aimed at increasing the understanding of the changes in cellular architecture that occur during the aging process. Studies on cytoskeleton structure and function, the impact of the cytoskeleton on intracellular organelle interactions, signaling or regulatory molecules controlling cellular architecture, or the role of the cytoskeleton in nuclear-cytoplasmic communications, and in spatio-temporal relationships during the aging process and in diseases. 2/5/17 files/pa html#_se ction_iii._eli gibility 2

3 CLINICAL TRIALS 6. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Clinical Trial Planning Grant (R34) (NIH, NIAMS) 446 This FOA supports planning grants for investigator-initiated clinical intervention trails. This planning grant is expected to precede the submission of a clinical trial cooperative agreement (U01). This grant will provide support to complete the administrative and planning activities that are required prior to subject recruitment such as, but not limited to: establishing the research team, identifying collaborators and clinical sites, developing the protocol and clinical investigators brochure, writing of the manual of operating procedures, developing a data and safety monitoring plan, developing tools for data collection and data management, and initiating the IRB approval process. 30 days before application due date Full : 3/1/ html 7. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Clinical Trial Implementation Cooperative Agreement (U01) (NIH, NIAMS) 447 This NIAMS is committed to identifying effective approaches to address arthritis and musculoskeletal and skin diseases and disorders through the support of clinical studies that test promising new interventions with the potential to improve health practices and clinical care. Investigators may also apply for a NIAMS Clinical Trial Planning Grant prior to submitting this application in order to accomplish necessary planning with NIAMS support. 30 days before application due date Full : 3/1/ html#_Se ction_i._fund ing GENOMICS 8. Genomics of HIV/AIDS Drug Response and Co- Morbidities (R01) (HHS, NIH) PA This FOA will expand the use of high-throughput genotyping, genomic sequencing, and related genomic technologies, and will generate widely available data resources for research use, to improve the efficacy and the safety and ease of use of HIV/AIDS therapies and of non- HIV drugs used to treat HIV/AIDS patients, and to reduce HIV/AIDS-related comorbidities, co-infections, and complications. It will also support analysis of existing genomic data for these purposes and deposition of analysis results into appropriate data resources to enhance their value. 1/7/16 files/pa html#_se ction_i._fund ing 3

4 IMAGING 9. BRAIN Imitative: Non-Invasive Neuromodulation- New Tools and Techniques for Spatiotemporal Precision (HHS, NIH) 10. Foundations of Non-Invasive Functional Human Brain Imaging and Recording-Bridging Scales and Modalities (HHS, NIH) RFA-MH RFA-MH This FOA seeks grant applications in two areas. The first area is in the development and testing of novel tools and methods of neuromodulation that go beyond existing variations on magnetic or electrical stimulation. The second area is in the optimization of existing electrical and magnetic stimulation methods. This grant opportunity seeks to support efforts that will revolutionize our understanding of the biological activity underlying, and bioinformatics content of, data collected using contemporary non-invasive functional brain imaging techniques. 10/23/16 11/23/16 10/23/16 11/23/16 Estimated Total Program : $3,000,000 $700,000 MH html MH html KIDNEY 11. Kidney Precision Medicine Project- Technology Development and Validation (R34/R44) (HHS, NIH) PA This cooperative agreement encourages small businesses to address the technological needs of the Kidney Precision Medicine Project (KPMP) which will obtain and evaluate kidney biopsies from participants with acute kidney injury (AKI) and chronic kidney disease (CKD), create a kidney tissue atlas, define diseases subgroups, and indentify critical cells, pathways and targets for novel therapies. 2/16/17 Small Businesses files/pa html MUSCULOSKELETAL 12. Core Centers for Clinical Research (CCR) (P30) (NIH) RFA-AR The goal of this FOA is to address existing and future clinical research needs at the institutional. Local, and national level for musculoskeletal, rheumatologic, and skin diseases by fostering the development, implementation, and inclusion of novel data, analytical methods, metrics, and outcomes measures into clinical research at the institutional, local, and national levels. 12/17/16 1/17/17 $4,000,000 AR html#_ 4

5 NANOTECHNOLOGY 13. Nanomanufacturing (NSF) PD This program supports basic research in nanostructure and process design principles, integration across length-scales, and system-level integration. Research on the processes and production systems based on computation, modeling and simulation, use of process metrology, sensing, monitoring, and control, and assessment of product quality and performance are encouraged. Includes fabrication of nonmaterial by design, three-dimensional nanostructures, multi-layer nanodevices, and multi-material nanosystems. Full Proposal Window: 12/30/16-1/13/17 $300,000 sf.gov/fundin g/pgm_summ.jsp?pims_id= NEURAL SYSTEMS 14. New Concepts and Early-Stage Research for Large- Scale Recording and Modulation in the (HHS, NIH) 15. New Technologies and Novel Approaches for Large-Scale Recording and (U01) (HHS, NIH) RFA-EY This opportunity seeks invasive or non-invasive approaches that will ultimately enable or reduce the current barriers to large-scale recording or manipulation of neural activity, and will ultimately be compatible with experiments in human or behaving animals. This FOA has the goal to produce a dynamic picture of function brain by developing and applying improved methods for large-scale monitoring of neural activity, as outlined in section III of the BRAIN 2025 report. Applicants are sought to conduct proof-of-concept development and testing of new technologies and novel approaches for large-scale recording and manipulation of neural activity, to enable transformative understanding of dynamic signaling in the nervous system. 12/7/16 11/21/16 12/21/16 $200,000 for a single year; $300,000 for two year budgets $9M per year to fund 15 to 20 projects EY html 003.html 16. Optimization of Transformative Technologies for Large Scale Recording and This opportunity seeks applications for the optimization of existing and emerging technologies and approaches that have potential to address major challenges associated with recording and manipulating neural activity, at or near cellular resolution, at multiple spatial and temporal scales, in any region and throughout the entire depth of the brain. $9M per year to fund 15 to 20 projects 004.html 5

6 (U01) (HHS, NIH) 17. Next-Generation Invasive Devices for Recording and Human Central (U44) (HHS, NIH) This FOA encourages small business concerns to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain. Activities supported by this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical study. $6.5M expected for 5 awards Small Businesses 007.html 18. Clinical Studies to Advance Next- Generation Invasive Devices for Recording and Human Central (UH3) (HHS, NIH) This FOA seeks to address the goal of developing innovative technologies to understand the human brain and treat its disorders. Small clinical studies that answer key questions about the function or final design of an implantable devices with recording and/or stimulation capabilities that both advance clinical diagnostic or therapeutic applications and maximize their scientific research vale, as outlined in Section III of the BRAIN 2025 report. $10M per year to support 5-7 awards 006.html 19. Next-Generation Invasive Devices for Recording and Human Central (UG3/UH3) (HHS, NIH) The purpose of this FOA is to encourage investigators to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical study (e.g., Early Feasibility Study). $10M per year to support 5-7 awards 005.html 6

7 SBIR/STTR 20. Kidney Precision Medicine Project- Technological Development and Validation (R41/R42) (NIH) PA This small business technology transfer grant calls for businesses to address the technological needs of the Kidney Precision Medicine Project (KPMP). Proposed technologies are expected to improve the safety of the human kidney biopsy or enhance interrogation of human kidney tissue, thus ensuring that the kidney biopsy yields useful research or clinical information. Applicants must be United States small business concerns. 9/5/17 Small Businesses files/pa html 21. SBIR Direct to Phase II Next- Generation Invasive Devices for Recording and Human Central The purpose of this Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue a small clinical study to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and thereby better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical study should provide data to answer key questions about the function or final design of a device. 12/21/16 $6.5M to support 5 awards Small Businesses 008.html SENSORS 22. DoD Joint Program Committee 1/Medical Simulation and Information Sciences Developing Models for Military and/or Civilian Medical Training from Field Data Collected from Sensors W81XWH- 16- DMRDP- MSIS- MAT The FY 18 JPC-1/MSIS MATADOR provides programmatic funding recommendations for OASD(HA) medical DHP RDT&E dollars related to medical training and education efforts to advance the development and integration of simulation-based medical training system. The supported research will be for the development and preliminary validation of a conceptual predictive model with the ability to rapidly collect, analyze, and weigh sensor and/or biosurveillance data collected directly from the field via a variety of sensors and/or biosurveillance systems. Pre- Submission Deadline: 11/14/16 Submission Deadline: 3/6/17 Estimated total program funding: $2,200,000 rmy.mil/fundi ng/pa/17dmrd pmatador_intr a_pa.pdf 7

8 TRANSFUSIONS MEDICINE 23. Selected Topics in Transfusion Medicine (R01) (NIH) 24. Select Topics in Transfusion Medicine (R21) (NIH) This Opportunity Announcement (FOA) encourages research grant applications from investigators who propose to study research topics in blood banking and transfusion medicine aimed at improving the safety and availability of the blood supply and the practice of transfusion medicine. Research focused on improving blood donor health, the safety and availability of blood products, and improving the practice of transfusion medicine is critical to public health. This FOA encourages research grant applications from investigators who propose to study research topics in blood banking and transfusion medicine aimed at improving the safety and availability of the blood supply and the practice of transfusion medicine. Research priorities are outlined in the full program announcement. 30 days before application due date 2/5/17 30 days before application due date 2/16/ html 441.html 8