Agency: DoD Congressionally Directed Medical Research Programs
Funding Opportunity Title: Complex Traumatic Brain Injury Rehabilitation Research Award
Funding Opportunity Number: W81XWH-16-PHTBIRP-CTRRA
Preproposal Deadline: August 17, 2016
Invited Full Proposal Deadline: November 30, 2016
Summary:
The FY16 PH/TBIRP Complex TBI Rehabilitation Research Award (CTRRA) is intended to support observational studies and clinical trials addressing rehabilitation of patients with complex TBI. TBI is defined as being caused by (1) a direct blow or impact to the head, (2) a penetrating head injury, or (3) an exposure to external forces such as blast waves that disrupt the function of the brain. Not all blows to the head or exposure to external forces result in a TBI. The severity of TBI may range from “mild” — a brief change in mental status or consciousness — to “severe,” an extended period of unconsciousness or confusion after the injury. All applications to the FY16 PH/TBIRP CTRRA must be relevant to complex TBI, defined by a diagnosed TBI in conjunction with symptoms identified in one or more of the following JPC-8/CRMRP Focus Areas:
• The Sensory Systems Traumatic Injury Focus Area involves visual, auditory, and vestibular dysfunction associated with traumatic injury.
• The Pain Management Focus Area is concerned with chronic pain, acute pain in the context of chronic pain, and establishing safety margins for prescriptions, as well as developing strategies to help patients cope with pain.
• The Neuromusculoskeletal Injury Rehabilitation Focus Area deals with amputee care, spinal cord injuries, burns and contractures, and orthopaedic injuries, as well as developing guidelines for standards of care.
In addition, research in the areas described below is very highly encouraged. Patients with complex TBI demonstrate symptoms including, but not limited to, dizziness, visual dysfunction, headaches, and cognitive deficits that are refractory to treatment (i.e., slow/non-response to current treatment regiment, relapsing symptoms following treatment). The FY16 PH/TBIRP CTRRA seeks research on the affected patient populations, mechanisms of comorbidities and potential interventions in the following three Areas of Encouragement:
• Epidemiological studies to define differences between populations of patients with complex TBI whose symptoms are non-responsive as compared to responsive to treatment. (Observational studies only; clinical trials are not supported for this Area of Encouragement. See the definition of a clinical trial and observational studies on
• Etiological studies to identify factors that contribute to differences between patients with complex TBI who respond to treatment and those who do not, with the goal of identifying mechanisms underlying refractory symptoms. (Observational studies only; clinical trials are not supported for this Area of Encouragement. See the definition of a clinical trial and observational studies on page 7 of this Program Announcement/ Funding Opportunity.)
• Interventional studies to evaluate emerging or existing rehabilitation strategies for the treatment of patients with complex TBI compared to existing standards of care. Proposed studies evaluating interventions for patients with TBI and comorbidities that may be refractory to treatment are of particular interest. (Both observational studies and clinical trials are allowed for this Area of Encouragement.)
Additionally, other studies of complex TBI may be considered if they address important issues relevant to the identified JPC-8/CRMRP Focus Areas in the context of TBI if sufficient justification is included in the appropriate sections of the pre-application and application.
Military Relevance: Relevance to the healthcare needs of military Service members, Veterans, and beneficiaries is a key feature of this award. Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate military relevance:
• Explanation of how the project addresses an aspect of the target disease/condition/ technology that has direct relevance to military Service members, Veterans, and/or other military health system beneficiaries
• Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to benefit the civilian population and also address a military need
• Use of military or Veteran populations or datasets in the proposed research
Award Information
The FY16 PH/TBIRP CTRRA is intended to support both observational studies and clinical trials addressing TBI and co-occurring clinical presentations (neuromusculoskeletal injuries, multisensory dysfunction, and pain) that are often slow/nonresponsive to treatment. The intent of the award is to advance the evidence-based practice for the treatment of TBI with JPC-8/CRMRP-relevant comorbidities by improving understanding of the composition and problems of this population and developing and evaluating treatments.
Applications for this award mechanism may propose epidemiological, etiological, and/or interventional studies (see CTRRA Areas of Encouragement on page 4).
Preclinical studies and studies using animals are not supported by this Program Announcement/Funding Opportunity.
Two different funding levels, based on the type of study proposed, are available under this Program Announcement/Funding Opportunity. It is the responsibility of the PI to select the funding level that is most appropriate for the research proposed based on the following descriptions.
The following, although not all-inclusive, are research projects that would be appropriate to propose under each funding level:
• Funding Level 1: For epidemiological and etiological studies comparing patients with complex TBI responsive versus refractory to treatments. PIs should describe a reproducible methodological approach that will identify or define factors that are associated with slow/non-response to treatment, or relapse of symptoms for patients with complex TBI. Observational studies, but not clinical trials, are permitted at this Funding Level.
• Funding Level 2: For interventional studies to evaluate emerging or existing treatment and rehabilitation strategies. PIs should explain how their work will inform the development, refinement, and/or revision of existing standards of care, clinical recommendations, or guidelines. Both observational studies and clinical trials are permitted at this Funding Level.
Both observational studies and clinical trials, but not preclinical research studies, are allowed in the FY16 PH/TBIRP CTRRA. Observational studies and clinical trials have different submission requirements and it is the responsibility of the PI to correctly identify the type of research proposed and to comply with the relevant submission requirements. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. An observational study is a type of clinical study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given). These types of studies are not considered clinical trials. All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of research.
References:
Program Solicitation
Tuesday, July 26, 2016
Thursday, June 16, 2016
ARVO Publications Grant
Agency: ARVO
Funding Opportunity Title: ARVO Publications Grant
Deadline: Applications accepted at any time.
Summary:
ARVO’s Publications Grant is available to authors who need funding assistance to publish in one of our three journals: Investigative Ophthalmology & Visual Science (IOVS); Journal of Vision (JOV); and Translational Vision Science & Technology (TVST). This grant is supported by the ARVO Foundation and aligns with ARVO’s goal to capture the full spectrum of vision science in our family of journals.
The grant will provide support to several individuals per year at a maximum of $1,500 per grant.
Application Process:
Corresponding authors must apply for a Publications Grant prior to submitting an article to an ARVO journal. To apply, the corresponding author must submit:
- An application.
- A support letter from an administrator at the author’s institution, describing the need for the grant and lack of funds. ARVO will not consider applications without a support letter. We recommend that the letter be on institution letterhead stationery. Acceptable letter formats include a PDF attachment to the application form or a hard-copy letter mailed to:
ARVO
Attn: Journals Department
1801 Rockville Pike, Suite 400
Rockville, MD 20852
References:
ARVO Solicitation
Funding Opportunity Title: ARVO Publications Grant
Deadline: Applications accepted at any time.
Summary:
ARVO’s Publications Grant is available to authors who need funding assistance to publish in one of our three journals: Investigative Ophthalmology & Visual Science (IOVS); Journal of Vision (JOV); and Translational Vision Science & Technology (TVST). This grant is supported by the ARVO Foundation and aligns with ARVO’s goal to capture the full spectrum of vision science in our family of journals.
The grant will provide support to several individuals per year at a maximum of $1,500 per grant.
Application Process:
Corresponding authors must apply for a Publications Grant prior to submitting an article to an ARVO journal. To apply, the corresponding author must submit:
- An application.
- A support letter from an administrator at the author’s institution, describing the need for the grant and lack of funds. ARVO will not consider applications without a support letter. We recommend that the letter be on institution letterhead stationery. Acceptable letter formats include a PDF attachment to the application form or a hard-copy letter mailed to:
ARVO
Attn: Journals Department
1801 Rockville Pike, Suite 400
Rockville, MD 20852
References:
ARVO Solicitation
Brain Machine Interface Prototype Development for Vision Restoration
Agency: Medical Technology Enterprise Consortium (MTEC)
Funding Opportunity Title: Brain Machine Interface Prototype Development for Vision Restoration
Solicitation Number: MTEC-16-02-Brain Machine Interface
Deadline: August 22, 2016
What is Medical Technology Enterprise Consortium?
The Medical Technology Enterprise Consortium (MTEC) is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities, in cooperation with the U.S. Army Medical Research and Materiel Command (USAMRMC) and other Government agencies in the biomedical sciences (including but not limited to drugs, biologics, vaccines, medical software and medical devices) to protect, treat and optimize the health and performance of U.S. military personnel. MTEC is a nonprofit corporation with the following principal objectives:
(a) biomedical research and prototyping;
(b) exploration of private sector technology opportunities;
(c) technology transfer; and
(d) deployment of intellectual property and follow-on production.
This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International, dba SCRA Applied R&D, represents a Request for Project Proposals (RPP) for MTEC’s support of the Clinical and Rehabilitative Medicine Research Program (CRMRP) technology objectives. Strategic oversight for the award(s) supported by this RPP will be provided by CRMRP.
The Internal Revenue Service recently approved MTC’s application for tax exempt status. MTC is a 501c3 nonprofit.
Summary of Technology Objectives for Brain Machine Interface Project
The overarching goal of this program, is to provide a prototype visual prosthesis for human testing within 5 years that (1) provides the ability to navigate for ambulation, identify faces and objects critical to daily life, and read large print, and (2) is economically feasible. Applications to MTEC should clearly state how the proposed research provides an innovative solution to a critical problem in the development of a brain machine interface prototype for vision restoration.
A critical step towards realization of the overarching goals is the development of an appropriate brain-machine interface. Applications must address the following focus area in vision restoration to be considered:
Specifically, MTEC seeks the prototype development of a device that:
1. Stimulates visual pathways in either the a)the lateral geniculate nucleus (LGN) or b) primary visual cortex.
2. Provides appropriate punctate stimuli with either a) electrical stimulation or b) optical stimulation for photolysis of caged excitatory neurotransmitters, photoswitches, or optogenetics (an optical stimulation delivery device is being sought, NOT the development of caged neurotransmitters, photoswitches or optogenetic tools).
3. Provides density of stimulation for the equivalent of at least 20/40 in the central 2° of visual field.
4. Stimulates neurons normally responsive to the peripheral field providing the equivalent of at least 70° of horizontal visual field for each eye.
5. Proposal must address specific anatomical challenges associated with implantation and communicating with the stimulation device.
6. Proposal must address biocompatibility (i.e.,the prosthesis should ideally function for the lifetime of the patient).
7. Components of the device must be demonstrated as a prototype in animal or appropriate in vitro models.
MTEC seeks applications from investigators comprising multi-disciplinary teams from a wide spectrum of disciplines including, but not limited to, basic science, engineering, translational research, and clinical research.
The current effort aims to promote highly innovative, groundbreaking research; high- impact research with near-term clinical relevance; multidisciplinary, synergistic research; and translational studies to support the fluid transfer of knowledge from basic principles to a working visual prosthesis prototype. Results of studies conducted through this effort should inform the developmental pathway for a visual prosthesis prototype.
Proposed projects must be based on logical reasoning and sound scientific rationale. Please note that awards are not to be exploratory in nature and require a foundation of preliminary data.
Research involving animal or human subjects is allowed, in accordance with the PPG.
Although seven critical specifications of the visual prosthesis prototype are outlined in the above, we encourage you to submit even if you cannot currently meet all seven specifications. However, it is expected that an Offeror’s approach to the visual prosthesis prototype will one day satisfy all seven critical specifications.
Funding Availability and Type of Funding Instrument Issued:
Total funding for awards made from this Funding Opportunity for Fiscal Year 2016 is $2.0M. Awards will be funded based on Milestone completion. The Government intends to award three - Phase 1 awards at $332K each (direct and indirect costs). The Government intends to award one Phase 2 award at $1.0M (direct and indirect costs). The Offeror must include both Phase 1 and Phase 2 study plans and define specific Milestones for the end of Phase 1 and Phase 2. The Government will make a Phase 2 award based on progress towards completion of Phase 1. The Period of Performance (POP) for Phase 1 is not to exceed 12 months. Progress Reports are due to the Government quarterly. The Final Report is due at the end of month 12 for Phase 2 selection. The POP for Phase 2 is not to exceed 24 months. Quarterly Progress Reports and a Final Progress Report are required for Phase 2. As of the release date of this RPP, future year Defense Appropriations Bills have not been passed and there is no guarantee that any additional funds will be made available to support this program. The funding estimated for this RPP is approximate and subject to realignment. Funding of proposals received in response to this RPP is contingent upon the availability of federal funds for this program. MTEC reserves the right to reduce the second year award, if the Offeror's technology after the first year excels only in a limited number of the requirements/goals/tasks listed in the announcement. MTEC reserves the right to encourage two or three of the first year awardees to collaborate in the second year award to maximize performance across the greatest number of the requirements/goals/tasks listed in the announcement, and may allocate the second year funds in accordance with participation in such a collaboration.
The Government-selected Research Project Awards will be funded under the Other Transaction Agreement Number W81XWH-15-9-0001 (or subsequent OTAs in support of MTEC) with MTEC administered by the CM, SCRA Applied R&D. The CM will negotiate and execute a Base Agreement with MTEC members. This Base Agreement will be governed by the same provisions as the OTA between the Government and MTEC. Subsequently, any proposal that is selected for award will be funded through a Research Project Award issued under the Base Agreement. A sample of the MTEC Base Agreement can be found on the Members Only portion of the MTEC website at www.mtec-sc.org. At the time of the submission, if Offerors have not yet executed a Base Agreement, then Offerors must certify on the cover page of their proposals that, if selected for award, they will abide by the terms and conditions of the latest version of the MTEC Base Agreement. If the Offeror already has executed an MTEC Base Agreement with the MTEC CM, then the Offeror must state on the cover page of its proposals that, if selected for award, it anticipates the proposed effort will be funded under its executed MTEC Base Agreement No. 20XX-XXX.
Offerors are advised to check the MTEC website periodically during the proposal preparation period for any changes to the MTEC Base Agreement terms and conditions.
References:
Full Solicitation
MTEC website
Funding Opportunity Title: Brain Machine Interface Prototype Development for Vision Restoration
Solicitation Number: MTEC-16-02-Brain Machine Interface
Deadline: August 22, 2016
What is Medical Technology Enterprise Consortium?
The Medical Technology Enterprise Consortium (MTEC) is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities, in cooperation with the U.S. Army Medical Research and Materiel Command (USAMRMC) and other Government agencies in the biomedical sciences (including but not limited to drugs, biologics, vaccines, medical software and medical devices) to protect, treat and optimize the health and performance of U.S. military personnel. MTEC is a nonprofit corporation with the following principal objectives:
(a) biomedical research and prototyping;
(b) exploration of private sector technology opportunities;
(c) technology transfer; and
(d) deployment of intellectual property and follow-on production.
This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International, dba SCRA Applied R&D, represents a Request for Project Proposals (RPP) for MTEC’s support of the Clinical and Rehabilitative Medicine Research Program (CRMRP) technology objectives. Strategic oversight for the award(s) supported by this RPP will be provided by CRMRP.
The Internal Revenue Service recently approved MTC’s application for tax exempt status. MTC is a 501c3 nonprofit.
Summary of Technology Objectives for Brain Machine Interface Project
The overarching goal of this program, is to provide a prototype visual prosthesis for human testing within 5 years that (1) provides the ability to navigate for ambulation, identify faces and objects critical to daily life, and read large print, and (2) is economically feasible. Applications to MTEC should clearly state how the proposed research provides an innovative solution to a critical problem in the development of a brain machine interface prototype for vision restoration.
A critical step towards realization of the overarching goals is the development of an appropriate brain-machine interface. Applications must address the following focus area in vision restoration to be considered:
Specifically, MTEC seeks the prototype development of a device that:
1. Stimulates visual pathways in either the a)the lateral geniculate nucleus (LGN) or b) primary visual cortex.
2. Provides appropriate punctate stimuli with either a) electrical stimulation or b) optical stimulation for photolysis of caged excitatory neurotransmitters, photoswitches, or optogenetics (an optical stimulation delivery device is being sought, NOT the development of caged neurotransmitters, photoswitches or optogenetic tools).
3. Provides density of stimulation for the equivalent of at least 20/40 in the central 2° of visual field.
4. Stimulates neurons normally responsive to the peripheral field providing the equivalent of at least 70° of horizontal visual field for each eye.
5. Proposal must address specific anatomical challenges associated with implantation and communicating with the stimulation device.
6. Proposal must address biocompatibility (i.e.,the prosthesis should ideally function for the lifetime of the patient).
7. Components of the device must be demonstrated as a prototype in animal or appropriate in vitro models.
MTEC seeks applications from investigators comprising multi-disciplinary teams from a wide spectrum of disciplines including, but not limited to, basic science, engineering, translational research, and clinical research.
The current effort aims to promote highly innovative, groundbreaking research; high- impact research with near-term clinical relevance; multidisciplinary, synergistic research; and translational studies to support the fluid transfer of knowledge from basic principles to a working visual prosthesis prototype. Results of studies conducted through this effort should inform the developmental pathway for a visual prosthesis prototype.
Proposed projects must be based on logical reasoning and sound scientific rationale. Please note that awards are not to be exploratory in nature and require a foundation of preliminary data.
Research involving animal or human subjects is allowed, in accordance with the PPG.
Although seven critical specifications of the visual prosthesis prototype are outlined in the above, we encourage you to submit even if you cannot currently meet all seven specifications. However, it is expected that an Offeror’s approach to the visual prosthesis prototype will one day satisfy all seven critical specifications.
Funding Availability and Type of Funding Instrument Issued:
Total funding for awards made from this Funding Opportunity for Fiscal Year 2016 is $2.0M. Awards will be funded based on Milestone completion. The Government intends to award three - Phase 1 awards at $332K each (direct and indirect costs). The Government intends to award one Phase 2 award at $1.0M (direct and indirect costs). The Offeror must include both Phase 1 and Phase 2 study plans and define specific Milestones for the end of Phase 1 and Phase 2. The Government will make a Phase 2 award based on progress towards completion of Phase 1. The Period of Performance (POP) for Phase 1 is not to exceed 12 months. Progress Reports are due to the Government quarterly. The Final Report is due at the end of month 12 for Phase 2 selection. The POP for Phase 2 is not to exceed 24 months. Quarterly Progress Reports and a Final Progress Report are required for Phase 2. As of the release date of this RPP, future year Defense Appropriations Bills have not been passed and there is no guarantee that any additional funds will be made available to support this program. The funding estimated for this RPP is approximate and subject to realignment. Funding of proposals received in response to this RPP is contingent upon the availability of federal funds for this program. MTEC reserves the right to reduce the second year award, if the Offeror's technology after the first year excels only in a limited number of the requirements/goals/tasks listed in the announcement. MTEC reserves the right to encourage two or three of the first year awardees to collaborate in the second year award to maximize performance across the greatest number of the requirements/goals/tasks listed in the announcement, and may allocate the second year funds in accordance with participation in such a collaboration.
The Government-selected Research Project Awards will be funded under the Other Transaction Agreement Number W81XWH-15-9-0001 (or subsequent OTAs in support of MTEC) with MTEC administered by the CM, SCRA Applied R&D. The CM will negotiate and execute a Base Agreement with MTEC members. This Base Agreement will be governed by the same provisions as the OTA between the Government and MTEC. Subsequently, any proposal that is selected for award will be funded through a Research Project Award issued under the Base Agreement. A sample of the MTEC Base Agreement can be found on the Members Only portion of the MTEC website at www.mtec-sc.org. At the time of the submission, if Offerors have not yet executed a Base Agreement, then Offerors must certify on the cover page of their proposals that, if selected for award, they will abide by the terms and conditions of the latest version of the MTEC Base Agreement. If the Offeror already has executed an MTEC Base Agreement with the MTEC CM, then the Offeror must state on the cover page of its proposals that, if selected for award, it anticipates the proposed effort will be funded under its executed MTEC Base Agreement No. 20XX-XXX.
Offerors are advised to check the MTEC website periodically during the proposal preparation period for any changes to the MTEC Base Agreement terms and conditions.
References:
Full Solicitation
MTEC website
Friday, April 8, 2016
NEI Research Grant for Vision Related Secondary Data Analysis
Agency: NEI
Funding Opportunity Title: NEI Research Grant for Vision Related Secondary Data Analysis
Funding Opportunity Number: PAR-16-168
Due Date: Standard Due Dates, June 16, October 16 and February 16
Summary:
The goal of this funding opportunity announcement (FOA) is to fund meritorious vision related research projects that involve secondary data analyses using existing database resources. The development of statistical methodology necessary for improving methods to analyze vision health data using existing vision data may also be proposed.
Research Objectives:
The NEI supports an extensive portfolio of clinical trials and large-scale epidemiologic research project wherein numerous data collection activities are required to meet each project's specific aims. The resultant wealth of data generated by these studies often provides unique, cost-effective opportunities to pursue new questions.
This FOA may be used to develop new statistical methodologies or to test new hypotheses using existing data. This FOA actively encourages the use of existing database resources to conduct additional analyses secondary to a project's originally-intended primary purpose; it will not support the collection of new data.
This FOA supports secondary data analysis on existing data sets. A typical project is expected to make substantial progress towards having vision related manuscript(s) submitted in peer reviewed journals within the first year.
Data sets are not limited to those collected under NEI support but these data sets are of the highest programmatic interest. Applicants should consider the relevance of their proposed analyses to NEI programs and priorities as described in the National Plan for Eye and Vision Research, which is available on the NEI website. http://www.nei.nih.gov.
The full program announcement can be found at the NIH Guide.
Subscribe to:
Posts (Atom)