and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
NIH Blueprint for Neuroscience Research (http://neuroscienceblueprint.nih.gov) |
|
Funding Opportunity Title |
NIH Blueprint for Neuroscience Research Grand Challenge on the Transition from Acute to Chronic Neuropathic Pain (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
Reissue of RFA-DE-11-002 |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-DE-12-008 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.213, 93.389, 93.867, 93.866, 93.273, 93.286, 93.865, 93.173, 93.121, 93.279, 93.121, 93.859, 93.242, 93.853, 93.361 |
FOA Purpose |
This FOA is issued as an initiative of the NIH Blueprint for Neuroscience Research. The Neuroscience Blueprint is a collaborative framework through which 16 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/). The goal of this FOA is to facilitate research collaborations between pain scientists and neuroscientists with expertise in neuroplasticity who have not previously studied the pain system in order to expand the understanding of biological mechanisms underlying the transition from acute to chronic pain. These collaborations should capture insights and expertise from neurobiological approaches. The purpose of this FOA is to encourage submission of multi-PI grant applications that propose highly collaborative, multidisciplinary research projects addressing the development of neuropathic pain conditions. The expected outcome of this FOA will be the formation of partnerships between pain researchers and non-pain neuroscientists with expertise in neuroplasticity to elucidate the maladaptive neuroplastic changes that occur during the transition from acute to chronic neuropathic pain. |
Posted Date |
June 30, 2011 |
Open Date (Earliest Submission Date) |
September 4, 2011 |
Letter of Intent Due Date |
September 4, 2011 |
Application Due Date(s) |
October 4, 2011, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not applicable |
Scientific Merit Review |
February/March 2012 |
Advisory Council Review |
May 2012 |
Earliest Start Date(s) |
July 2012 |
Expiration Date |
October 5, 2011 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The goal of this FOA is to facilitate research collaborations between pain scientists and non-pain neuroscientists with expertise in neuroplasticity in order to study biological mechanisms underlying the transition from acute to chronic pain. The purpose of this FOA is to encourage submission of multi-PD/PI grant applications that propose highly collaborative, multidisciplinary research projects addressing the development of neuropathic pain conditions. An expected outcome of this FOA will be the formation of partnerships between pain researchers and non-pain neuroscientists with expertise in neuroplasticity to develop new collaborations focused on understanding the maladaptive neuroplastic changes that occur during the transition from acute to chronic neuropathic pain. Chronic neuropathic pain conditions are difficult to treat and researchers currently lack an understanding of the mechanisms underlying the transition to a chronic pain state after acute nerve injury. It is hypothesized that those individuals transitioning to a chronic pain state after acute injury undergo a maladaptive neuroplastic process in contrast to those who recover from injury without chronic pain. The application of expertise, tools, and knowledge from the field of neural plasticity will bring new insights and approaches to elucidate the changes associated with onset and maintenance of pain chronicity. New knowledge garnered from these studies will enable improved diagnosis, prevention, and treatment of chronic neuropathic pain conditions.
Pain conditions are a major health problem in the US and their economic burden approaches $100 billion per year in lost productivity and medical expenses. These conditions lead to medical morbidity and a reduced quality of life for millions of Americans. Chronic neuropathic pain conditions are especially difficult to treat. Researchers currently have a relatively incomplete understanding of the etiology and pathology of chronic neuropathic pain conditions. A largely unaddressed challenge is the lack of knowledge in determining who will transition to a chronic pain state and how to treat patients to prevent this transition. A mechanistic understanding is needed of how pain changes from an acute, high threshold response to a chronic, low threshold, and spontaneous dysfunctional condition. While most researchers believe that the transition from acute to chronic neuropathic pain is the result of maladaptive plasticity in the nervous system, it is not fully understand how acute pain progresses to chronic pain at any level, from the molecular to systems. In contrast, other neuroscience researchers have made extraordinary strides in delineating the neuroplastic changes that occur in cognitive decline, in developmental disorders, and in addiction. The understanding of molecular and cellular mechanisms surrounding normal adaptive responses and maladaptive changes in cognition, neurodevelopment, aging, neurodegeneration, and the stress response has increased. For example, neuroscientists have a detailed knowledge of synaptic plasticity in the hippocampus that leads to long- term memory formation. There is a real opportunity for neuroscientists in this and related fields to apply their expertise, techniques, and extensive knowledge of neuroplasticity to pain research. The understanding of neuroplastic changes that occur in the central nervous system and in the brain when patients transition to a chronic pain state will be enhanced by the participation of these researchers in pain research.
Research supported by this program will lead to the development of a detailed molecular, cellular, and systems level understanding of the neurobiological basis of the transition from acute to chronic pain. In this regard it is critical to understand the mechanisms underlying the neuroplasticity mediating the increased sensitivity to noxious and innocuous stimuli and the amplification of pain signaling in chronic pain patients. In addition, a detailed picture of the changes in the nociceptive circuits in the peripheral and central nervous systems and the chemical, functional, and structural alterations that occur during the transition to chronic pain will need to be delineated. Identification and manipulation of the neuroanatomical hubs of integration of pain signaling and altered activity are critical steps in moving towards prevention and treatment of chronic pain. The identification of crucial steps in altered pain signaling will provide opportunities to prevent or reverse changes that lead to persistent pain.
The overall objectives of this FOA are to 1) develop multi-PD/PI research projects that will apply advances in understanding of neural plasticity to basic, translational and clinical pain research endeavors and 2) expand the pool of investigators in pain research in order to bring additional expertise and cutting edge technologies in neural plasticity into the pain field.
The programmatic focus for these applications is maladaptive neuroplasticity in pain pathways and the transition from acute to chronic pain. A broad array of research and experimental approaches are being sought that will center on nervous system plasticity. The research may be hypothesis driven or discovery science. Research approaches may include, but are not limited to molecular, cell biological, animal, behavioral, or systems approaches. Experimental approaches may include, but are not limited to biochemical, immunocytochemical, morphometric, and electrophysiological analyses; molecular, cellular, and functional imaging; neuronal circuit mapping and manipulation; development of new animal models of neuropathic pain; development of new behavioral and functional assays of pain, and identification of biobehavioral mechanisms including mediating and moderating variables that may influence the transition from acute to chronic pain.
Principal Investigators should clearly describe how the expertise or technology provided by the collaboration between the pain and non-pain scientist will provide a novel scientific approach.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The Blueprint Institutes intend to commit $ 2.5 million in FY 2012. |
Award Budget |
Application budgets are not limited, but need to reflect actual needs of the proposed project. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum period is 5 years |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
Principal Investigators/Program Directors who submitted applications under RFA-DE-11-002 but were not funded must prepare a New application in response to this FOA.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Lynn Mertens King, PhD
Chief, Scientific Review
Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd. Rm 662
Bethesda, MD 20892-4878 (20817 for express deliveries)
Telephone: (301) 594-5006
Fax: (301) 480-8303
Email: [email protected]
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide.
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by National Institute of Dental and Craniofacial Research (NIDCR), NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
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 following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not applicable
Renewals
Not applicable
Revisions
Not applicable
As applicable for the project proposed, reviewers will consider 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.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s)convened by the Center for Scientific Review , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Dental and Craniofacial Research Advisory Council. The following will be considered in making funding decisions:
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 eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
John W. Kusiak, PhD
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Democracy I, Room 616
6701 Democracy Blvd.
Bethesda, MD 20892-4878
Telephone: (301) 594-7984
Fax: (301) 480-8319
Email: [email protected]
Christine Melchior, PhD
Center for Scientific Review
Two Rockledge Center, Room 5176
6701 Rockledge Dr.
Bethesda, MD 20892-7844
Telephone: (301) 435-1713
Fax: (301) 480-4184
Email: [email protected]
Kenneth Frushour
Financial Management Branch
National Institute of Neurological Disorders and
Stroke
Building 31, Room 8A34
31 Center Dr.
Bethesda, MD 20892-2540
Telephone: (301) 496-4927
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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