Notice Number: NOT-NS-10-013
Update: The following update relating to this announcement has been issued:
Release Date: March 12, 2010
Application Due Date: May 12, 2010
Earliest Anticipated Start Date: September 30, 2010
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
The purpose of this notice is to encourage requests for competitive revisions to research projects currently funded by NIH R01 and R37 grant mechanisms, appropriate for support on research and development for a Grand Challenge on achieving optimal electrocorticography (ECoG) based cortical control of the Revolutionizing Upper-limb Prosthetics 2009 developed by the U.S. Defense Advanced Research Projects Agency (DARPA). The Grand Challenge will be to achieve reaching and grasping of objects by the DARPA Arms in a subject’s natural work space, by obtaining maximum cortical control that can be realized on the highly anthropomorphic prosthetic arm and hand.
Device-based therapeutic approaches offer opportunities for restoring neurological function through mechanical, electronic, and neural interfacing technologies, and complement other cellular and molecular strategies under development, in their roles of reducing the burden of disease or injuries. The DARPA Revolutionizing Upper-limb Prosthetics (DARPA Arms) have been developed in response to the urgent needs in providing clinical care to and improving life quality for the recently injured war veterans. Launched in 2005 and funded at over $100 million, the four-year component of the program has a 2009 deadline to demonstrate a modular upper-limb prosthetic where all associated hardware and software will become available as open-source, so that the specifications will replace the current confusion of scattered prosthetic-arm designs with a standard platform that could incorporate the current as well as the future 21st century technologies. All the desired functions will be anthropomorphically designed to fit inside a package that has the look, weight, strength, dexterity, natural movement, and toughness of an intact arm. Led by DEKA Inc., and by the Applied Physics Laboratory (APL) at the Johns Hopkins University, over 30 universities and research institutions, with more than 300 investigators, have participated in the DARPA project. It is a multidisciplinary collaboration in areas of mechatronics, neuroscience, neurology/neurosurgery, electrical engineering; signal processing, battery design, nanotechnology, robotics, cognitive and behavioral sciences. All of the participating labs are considered leading groups in their respective fields.
One of the goals for the DARPA Arm program is to allow investigators to explore neural sensorimotor integration and feedback paradigms that could be incorporated in the control of the prosthetic arm by upper-limb amputees, or by patients with paralysis-related disorders, such as spinal cord injury (SCI) and stroke, to regain purposeful movements and functions. The DARPA Arms are designed to be capable of being controlled by decoded neural signals. It is expected that rigorous and comprehensive experimental tests on optimal neural control in animals or humans can be conducted, once the electromechanic components are completed. It is also recognized that investigators who have the scientific knowledge and interests and who also have the appropriate experimental resources to provide a test platform for identifying optimal neural control of the DARPA arm are mostly NIH-funded investigators. This funding initiative intends to capture a unique opportunity for providing NIH-supported expertise in sensorimotor neurophysiology and neural interface technology to a scientific challenge of developing and demonstrating optimal cortical control paradigms for these highly advanced anthropomorphically designed prosthetic arms.
Scope and Objectives of the Grand Challenge
A competitive revision of up to a maximum 2 years duration (the project period of the competitive revision may not extend beyond that of the “parent” award) will be limited to currently active NIH projects that focus on studying cortical sensorimotor control and functions in awake humans or non-human primates using defined motor behavioral paradigms of the upper arm, and/or projects that involve electrocorticographic (ECoG) or local field potential (LFP) recordings in awake humans. These parent projects should already have the capability of generating brain signals from cortical areas, to be decoded for establishing interface for neutral control of an external device. The goal is to foster collaborative team efforts by NIH-funded cortical neurophysiologists, and neurosurgeons who have significant experience in ECoG or LFP data collection in awake humans. To receive competitive revision funding, the proposed revision projects should have established IRB approval for all the invasive procedures in humans. The collaborative team should have the capability of recording and decoding broadband low to high frequency cortical signals, capable of interfacing with the DARPA Arms for optimal ECoG based cortical control. Of particular interest are signals recorded from multiple cortical sites and in combination with multiple modalities. We intend to seek the most robust approach for recording signals (in terms of recording scale, duration, and signal quality), the most robust decoding algorithm, and the smoothest, volitionally-controlled kinematic trajectories of the full functional degrees of freedom of the arm and hand. Of additional programmatic interest is the potential role that brain plasticity plays in adaptive control of dexterity using visual (or other sensory) feedback, once the neural interfacing is established. We expect this Grand Challenge will not only be able to identify and implement the best ECoG-based cortical control for the DARPA Arms, but will also be reverse-translational in generating important scientific questions for further basic science research in this program area.
Progress will be monitored by NIH and DARPA program staff through semi-annual reporting and site-visiting, and will be evaluated administratively for sufficient progress to merit release of funds for the second year. Funded projects will be required to present results for evaluation by NIH and DARPA program staff and a selected steering committee at a dedicated workshop or symposium, using video demo and kinematic analysis of cortical controlled DARPA arm and hand movement. A resource sharing plan will be a required element of the application.
This notice calls for competitive revision applications to active NIH Research Grants funded under R01 and R37 grant mechanisms.
To be eligible, the “parent” award on which the revision application is based must be active at the time the revision application is submitted. The project period of the competitive revision may not extend beyond that of the “parent” award. If a no-cost extension is needed to complete the work to be proposed in the revision, the no-cost extension must be in place before the application is submitted.
The proposed studies must be within the scope described in the “Scope and Objectives of the Grand Challenge” section above, i.e. the peer-reviewed activities specified within the active NIH parent award(s) would include recording of brain signals in human or non-human primates performing upper-limb motor tasks, and/or projects that involve electrocorticographic (ECoG) or local field potential (LFP) recordings in awake humans.
For all revision applications, the Project Director/Principal Investigator (PD/PI) must be the same as the PD/PI on the parent award. For revision applications to multiple PD/PI parent awards, the Contact PD/PI must be the PD/PI listed on the parent application. A competitive revision does not allow a change in the Multiple PD/PI team nor a conversion from a single PD/PI to multiple PD/PIs.
All revision applications must be submitted by the sponsoring institution of the PD/PI (or Contact PD/PI for multi-PD/PI grants) listed on the parent grant. Only one revision request may be submitted per PD/PI of an NIH-funded parent project.
NIH encourages the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities and individuals from disadvantaged backgrounds.
Budget and Funding Information
The NINDS intends to commit up to $3 million in total costs per year in FY 2010 and FY 2011 to fund up to 4 competitive revisions in response to this announcement. Funding for competitive revisions to existing “parent” awards will be available in FY2010 and FY 2011. Due to the limited, two-year nature of these funds, competitive revision applications may be requested for no more than two years; therefore the scope and budget of the requested revision must reflect aims and goals that can be accomplished within that limited timeframe.
Applicants must submit a budget using the same budget format as was used for the parent award.
An applicant may request a budget of up to $400,000 per year for direct costs associated with the proposed new work, in addition to the funds allowed for purchasing the DARPA Arms. Applicants should budget $250,000 for either the DEKA arm (www.dekaresearch.com) or the APL arm (www.jhuapl.edu/ourwork/biomed). Device specifications and interface details of the DARPA Arms can be obtained by directly contacting DEKA and APL, or by contacting with the NIH Program Director listed below. DARPA is currently negotiating prices of these arms. If lower prices are achieved, awards will be reduced commensurately. The maximum duration of each award will be limited to two years. Facilities and Administrative (F&A) costs will be paid at the full, negotiated rate. Applicants should provide a detailed budget justification for personnel costs, supplies, and other expenses.
The revision award period cannot extend beyond the original project end date of the parent grant. Any no-cost extension must be in place before submission of the revision application. Although the budget plans of the NINDS provide support for this program, awards pursuant to this solicitation are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Application Review Process
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For funding considerations, revision applications will be assigned to the IC through which the “parent” grant was funded. Applications that are complete will be evaluated for scientific and technical merit by appropriate scientific review group(s) convened by the Center for Scientific Review in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below. Applicants will be notified regarding the review outcome.
As part of the scientific peer review, all applications will:
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the standard review criteria, and additional review criteria (as applicable for the project proposed). The review committee will consider the overall scientific merit of the new work proposed, the appropriateness of the match between the parent project and the proposed work, and the likelihood for the project to achieve the goal of the Grand Challenge.
When reviewing a revision application, the committee will consider the scientific merit of the new work proposed and the appropriateness of the proposed expansion of the scope of the project. If the revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident. Additionally, the committee will consider the feasibility of accomplishing the specific aims of the revision application within the requested project period.
Scored Review Criteria. The standard review criteria for research grant applications and cooperative agreements will be used by reviewers for evaluating the scientific and technical merit of all applications as outlined in this Notice: NOT-OD-09-025.
Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items: Protections for Human Subjects; Inclusion of Women, Children, and Minorities; Vertebrate Animals; and Biohazards.
Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score: Budget and Period Support; Select Agent Research; and Resource Sharing Plans.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
If the application is considered for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General. A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.
Terms of Award
All awards will be subject to the standard NIH terms of award. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”
The resource sharing plan will become part of the terms and conditions of the award.
A Program Official from one or more of the participating NIH Institutes and Centers will be assigned to each funded application and will assume responsibility for normal stewardship of the awards.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.
How to Apply
The receipt date for revision applications is May 12, 2010.
Applicants interested in applying for revision support must submit the application through Grants.gov, using the Funding Opportunity Announcement (FOA) that was used for the parent grant. Or, if this FOA is no longer active, use the Parent FOA that matches the program (activity code) of the award.
NOTE: Applicants submitting an R37 revision in response to the R01 Parent FOA will receive the following warning from eSubmission: “The mechanism of the prior submission (referenced by the Federal Identifier on the SF 424 RR Cover page) does not match the mechanism of the Funding Opportunity Announcement (FOA). Please check the Federal Identifier provided for your application to ensure you are including the correct prior information and the FOA to ensure you are submitting to the correct opportunity. This application will be processed but there may be a delay in referral.” Please ignore this warning.
For ALL applications:
Follow the instructions as noted below. Note: Font size restrictions apply as designated within the applicable SF424 (R&R) Application or the PHS398 application instructions. The current NIH guideline on page limitations should be followed.
a) Specific Aims. Summarize the activities that were included in the “parent” grant that encompass those proposed in the revision request. This section should include a description of the revision’s specific aims, including research design and methods and data analysis. Describe the relationship of the revision request to the “parent” grant and the impact that the proposed work will have on the research field(s) involved.
b) Research Strategy. The research strategy section, limited to 12 pages, should discuss how the cortical neurophysiology expertise and the existing research resource from the current parent grant can be leveraged and synergized with the expertise of the collaborating neurosurgical team, to address scientific and technical issues of the Grand Challenge.
c) Budget. The budget format must be the same as that of the parent grant. Budget for the revision with a justification that details the items requested, including Facilities and Administrative costs and a justification for all personnel and their role in this project. The budget provided for the revision application must match the budget provided in the “parent” application. For instance, if the “parent” application was submitted using the Modular budget component, then the revision application must also use the Modular budget component.
d) Biographical Sketch for PD/PI and all new Senior/Key Personnel (those who are additions on the revision project). You will need to include an updated biographical Sketch for the PD/PI and new Senior/Key Personnel, using the forms, which are available as MS Word (http://grants.nih.gov/grants/funding/phs398/biosketch.doc) or PDF (http://grants.nih.gov/grants/funding/phs398/biosketch.pdf). There is no need to repeat information previously provided for other Senior/Key Personnel.
e) Human Subjects/Vertebrate Animal documentation (if applicable). Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a revision award being made. Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative revision activity and the parent grant should be noted. When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions (http://grants1.nih.gov/grants/funding/phs398/phs398.html).
For electronic applications (R01, R37): Use the SF424 (R&R) Application Guide available at: ttp://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.doc (MS Word [3.5 MB]) or http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf (PDF [4.5 MB]).
Applicants are encouraged to discuss their plans for responding to this Notice by phone or e-mail to NINDS Program Directors listed below. Scientific inquiries can also be directed to the NIH Program Directors who oversee the parent grant associated with the competitive revision request.
Dr. Daofen Chen
Dr. James Gnadt
Systems and Cognitive Neuroscience
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd
Rockville, MD 20892
Email: email@example.com; firstname.lastname@example.org
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