NIH Blueprint for Neuroscience Research Competitive Revisions for Studies Focused on Neuropathic Pain or Neural Plasticity to Promote Collaborative Pain Research (R01)

NIH Blueprint for Neuroscience Research Competitive Revisions for Studies Focused on Neuropathic Pain or Neural Plasticity to Promote Collaborative Pain Research (R01) is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAR-10-204: NIH Blueprint for Neuroscience Research Competitive Revisions for Studies Focused on Neuropathic Pain or Neural Plasticity to Promote Collaborative Pain Research (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Institutes of Health (NIH), ( http://www.

nih. gov ) Participating Organizations NIH Blueprint for Neuroscience Research ( http://neuroscienceblueprint. nih.

gov/ ) National Center for Complementary and Alternative Medicine (NCCAM) ( http://nccam. nih. gov/ ) National Center for Research Resources (NCRR) ( http://www.

ncrr. nih. gov/ ) (No Longer Participating per NOT-OD-12-097 ) National Eye Institute (NEI) ( http://www.

nei. nih. gov/ ) National Institute on Aging (NIA) ( http://www.

nia. nih. gov/ ) National Institute on Alcohol Abuse and Alcoholism (NIAAA) ( http://www.

niaaa. nih. gov/ ) National Institute of Biomedical Imaging and Bioengineering (NIBIB) ( http://www.

nibib. nih. gov/ ) National Institute of Child Health and Human Development (NICHD) ( http://www.

nichd. nih. gov/ ) National Institute on Deafness and Other Communication Disorders (NIDCD) ( http://www.

nidcd. nih. gov/ ) National Institute of Dental and Craniofacial Research (NIDCR) ( http://www.

nidcr. nih. gov/ ) National Institute on Drug Abuse (NIDA) ( http://www.

nida. nih. gov/ ) National Institute of Environmental Health Sciences (NIEHS) ( http://www.

niehs. nih. gov/ ) National Institute of General Medical Sciences (NIGMS) ( http://www.

nigms. nih. gov/ ) National Institute of Mental Health (NIMH) ( http://www.

nimh. nih. gov/ ) National Institute of Neurological Disorders and Stroke (NINDS) ( http://www.

ninds. nih. gov/ ) National Institute of Nursing Research (NINR) ( http://www.

ninr. nih. gov/ ) Behavioral and Social Sciences Research (OBSSR) ( http://obssr.

od. nih. gov/content ) Title: NIH Blueprint for Neuroscience Research Competitive Revisions for Studies Focused on Neuropathic Pain or Neural Plasticity to Promote Collaborative Pain Research (R01) This Funding Opportunity Announcement (FOA) is a reissue Update: The following updates relating to this announcement have been issued: April 5, 2012 - See Notice NOT-OD-12-097.

Notice of Change in Participation of NIH Institutes and Centers. September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.

August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time.

See NOT-OD-10-123 . Announcement (PA) Number: PAR-10-204 submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants. gov ( http://www.

grants. gov ) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. BE SUBMITTED IN PAPER FORMAT.

in conjunction with the application guidelines included with this announcement for Grants (hereafter called Grants. gov/Apply). is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date.

See Section IV . Domestic Assistance Number(s) 93. 213, 93.

867, 93. 866, 93. 273, 93.

286, 93. 865, 93. 173, 93.

121, 93. 279, 93. 894, 93.

859, 93. 242, 93. 853, 93.

361 Date : August 2 8 , 2010 (Earliest date an application may be submitted to Grants. gov) Letters of Intent Receipt Date(s): Not applicable requires that applications be successfully submitted to Grants. gov no later than 5:00 p.

m. local time (of the applicant institution/organization). Application Due Date(s): September 28, 2010; September 28, 2011; Due Date(s): Not applicable Date(s): March 2011, March Date(s): May 2011, May 2012, May 2013 Anticipated Start Date(s): July 2011, July Information To Be Available Date (Activation Date): Not Applicable Expiration Date: September 29, 2012 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 the partnering of pain scientists and non-pain neuroscientists from the field of neural plasticity to capture insights and expertise from disciplines where transitions from health to disease have been extensively examined.

An expected outcome of this FOA will be the formation of partnerships between pain researchers and non-pain neuroscientists to develop new collaborations focused on understanding the maladaptive neuroplastic changes that occur during the transition from acute to chronic pain.

It is anticipated that these initial collaborations will lead to new applications for highly innovative projects centered on similar studies of the transition from acute to chronic pain. The purpose of this FOA is to encourage the submission of competitive revision applications that propose a collaborative, one year pilot study or a new specific aim associated with an active NIH grant.

The parent grant may be focused on pain or on neural plasticity outside the of Support. This FOA will utilize the Competitive Revision grant mechanism for R01 applications. Funds Available and Anticipated Number of Awards.

The participating Neuroscience Blueprint Institutes intend to commit at least $375,000 in 2011 (and at least an additional $375,000 per year in 2012 and 2013 to fund approximately 5-6 Competitive Revisions in response to this FOA. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. and Project Period.

The total project period for an application submitted in response to this FOA may not exceed one year. Direct costs of up to $75,000 per year may be requested. The period of the Competitive Revision may not exceed that of the parent grant.

Application Research Strategy Length . The Competitive Revision application Research Strategy section may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. However, PIs are encouraged to submit concise revisions in order to expedite the evaluation and review of these applications.

See Table of Page Institutions/Organizations. Institutions/organizations listed in Section III, 1. A.

are Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.

The contact PD/PI must be the same as on the parent grant. of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.

Single PD/PI R01 grants may be modified into Multiple PD/PI applications in this revision by adding a Multiple PD/PI leadership plan. A new investigator added to the parent R01 as a PI with this revision will lose his or her new PI status if the application is awarded. The contact PD/PI whether in a multiple PD/PI revision or a single PI revision application must be the same as on the Number of Applications.

Applicants may submit more than one application, provided that each application is scientifically distinct. However, only one Competitive Revision may be submitted for each active R01. Resubmissions.

Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications ( NOT-OD-09-003 , NOT-OD-09-016 ). Renewals.

Renewals will not be Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates Application Materials.

See Section IV. 1 for application materials. general information on SF424 (R&R) Application and Electronic Submission, (R&R) Application and Electronic Submission Information: http://grants.

nih. gov/grants/funding/424/index. htm General information on Electronic Submission of Grant Applications: http://era.

nih. gov/ElectronicReceipt/ Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936 Part II Full Text of Announcement Section I.

Funding Opportunity Section II. Award Information Section III. Eligibility Information 2.

Cost Sharing or Matching 3. Other-Special Eligibility Criteria Section IV. Application and Submission 1.

Request Application Information 2. Content and Form of Application Submission 3. Submission Dates and Times A.

Submission, Review, and B. Submitting an Application Electronically to the NIH C. Application Processing 4.

Intergovernmental Review Section V. Application Review Information 2. Review and Selection Process 3.

Anticipated Announcement Section VI. Award Administration 2. Administrative and National Policy Requirements Section VII.

Agency Contacts 1. Scientific/Research Contact(s) 2. Peer Review Contact(s) 3.

Financial/Grants Management Contact(s) Section VIII. Other Information - Required Federal Citations Part II - Full Text of Announcement Section I. Funding Opportunity Description The goal of this FOA is to facilitate the partnering of pain scientists and non-pain neuroscientists to capture insights and expertise from disciplines where transitions from health to disease have been extensively examined.

An expected outcome of this FOA will be the formation of partnerships between pain researchers and non-pain neuroscientists to develop a new collaboration focused on understanding the maladaptive neuroplastic changes that occur during the transition from acute to chronic neuropathic pain.

It is anticipated that these initial collaborations will lead to new applications for highly innovative projects centered on similar studies of the transition from acute to chronic pain. The purpose of this FOA is to encourage the submission of competitive revision applications that propose a collaborative, one year pilot study or a new specific aim associated with an active NIH grant.

The parent grant may be focused on pain or on neural plasticity outside the area of pain. Chronic neuropathic pain conditions are difficult to treat and we 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. We currently have a relatively incomplete understanding of the etiology and pathology of chronic neuropathic pain conditions. A largely unaddressed challenge is our lack of knowledge in determining who will transition to a chronic pain state and how to treat patients to prevent this transition.

We need to understand, mechanistically, how pain changes from an acute, high threshold, protective 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, we do 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. Our understanding of the molecular and cellular mechanisms surrounding normal adaptive responses and maladaptive changes in cognition, neurodevelopment, aging, neurodegeneration, and the stress response has increased.

Neuroscientists have a detailed knowledge of synaptic plasticity in the hippocampus that leads to long-term memory formation. The close linkage between the neuroplastic changes that are induced by chronic stress and the reversal of these changes by antidepressant drug therapy has been extensively studied by neuroscientists studying mood disorders.

These discoveries have been aided by the application of novel molecular, electrophysiological, imaging, and genetic technologies. There is a real opportunity for neuroscientists in these related fields to apply their expertise, techniques, and extensive knowledge of neuroplasticity to pain research.

Our understanding of the neuroplastic changes that occur in the dorsal horn of the spinal cord and in the brain when patients transition to a chronic pain state will be enhanced by the participation of these researchers in chronic pain studies.

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 brain and dorsal horn of the spinal cord 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 The overall objectives of this FOA are to 1) expand the scope of the parent grant to apply advances in our understanding of neural plasticity in non-pain systems to pain pathways and 2) expand the pool of investigators in pain research in order to bring additional expertise and cutting edge technologies in neural plasticity The programmatic focus for these competitive revisions 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; genomic, proteomic, and metabolomic analyses; 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 to the existing project.

In addition, the PI should describe how this collaboration will provide the basis for future grant applications that expand upon one of the current projects or lead to an entirely new approach to chronic neuropathic pain research.

See Section VIII, Other Information - Required Federal Citations , for policies related to this FOA will use the Competitive Revision (formerly referred to as competitive supplement ) to the R01 award mechanism . The Project Director/Principal Investigator (PD/PI) will be for planning, directing, and executing the proposed project. Just-in-Time information concepts (see SF424 (R&R) Application Guide ) .

It also uses the modular as well as the non-modular budget formats (see http://grants. nih. gov/grants/funding/modular/modular.

htm ). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component. U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component .

Institutes intend to commit at least $375,000 in 2011 (and an additional $375,000 per year in 2012 and 2013).

number of awards: 5-6 per year direct cost amount for individual awards: up to $75,000 for one year maximum project period is one year and the maximum direct costs are $75,000 per the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004 . 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. III.

Eligibility Information 1. A.

Eligible Institutions organizations/institutions are eligible to apply: Controlled Institutions of Higher Education Institutions of Higher Education Hispani c-serving Institutions Historically Black Colleges Tribally Controlled Colleges Alaska Native and Native Hawaiian Serving with 501(c)(3) IRS Status (Other than Institutions of Higher Education) without 501(c)(3) IRS Status (Other than Institutions of Higher Education) Organizations (Other than Small Businesses) American Tribal Governments (Federally Recognized) American Tribally Designated Organizations Housing Authorities/Indian Housing Authorities U.S. Territory or Possession Indian/Native American Tribal Governments (Other than Federally (non-U.S.) Entities (Foreign Organizations) Eligible Agencies of the Federal Government Faith-based or Community-based Organizations.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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 All revision applications must be submitted by the PD/PI (or Contact PD/PI for multi-PI grants) listed on the parent grant. than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model.

Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants. nih. gov/grants/multi_pi .

All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://grants. nih. gov/grants/ElectronicReceipt/preparing.

htm for instructions). The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below.

When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.

Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants. nih.

gov/grants/multi_pi . program does not require cost sharing as defined in the current NIH Grants 3. Other-Special Eligibility Criteria applications must be for costs to support new research objectives and aims that are outside of the scope of the approved parent grant.

be eligible, the parent grant must be active at the time the revision application is submitted, and the research proposed in the revision must be accomplished within the current competitive segment. That is, the period of support requested for the revision cannot exceed the current project period end date of the parent grant, including projects on a no-cost extension.

Also, a no-cost extension must be in place before the revision application is Competitive Revision must have the same budget format as that of the parent contact PI in a multiple PI application must be the PD/PI of the parent R01. of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.

However, only one Competitive Revision may be submitted for each active R01. Resubmissions . Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).

Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications ( NOT-OD-09-003 , NOT-OD-09-016 ).

Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date. Renewals.

Renewals will not be Section IV. Application and Submission Information download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www. grants.

gov/Apply/ and follow the directions provided on that Web site. registrations with Grants. gov and eRA Commons must be completed on or before the due date in order to successfully submit an application .

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants. gov and the Commons .

All registrations must be complete by the submission deadline for the application to be considered on-time (see 3. C. 1 for more information about is required for institutions/organizations at both: Grants.

gov ( http://www. grants. gov/applicants/get_registered.

jsp ) eRA Commons ( http://era. nih. gov/ElectronicReceipt/preparing.

htm ) PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons. additional separate actions are required before an applicant can submit an electronic application, as follows: Organizational/Institutional Registration in Grants.

gov/Get Registered Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants. gov registration process. If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time.

A valid TIN or EIN is necessary for CCR registration. The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days. Direct questions regarding Grants.

gov registration to: Business Hours: M-F 7:00 a. m. - 9:00 p.

m. Eastern Time 2) Organizational/Institutional Registration in the eRA Commons To find out if an organization is already Commons-registered, see Organizations Registered in NIH eRA Commons. Direct questions regarding the Commons registration to: Phone: 301-402-7469 or 866-504-9552 (Toll Free) Business hours M-F 7:00 a.

m. 8:00 p. m.

Eastern Time Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application. hold a PD/PI account in the Commons.

Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account. When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization.

PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons. This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons. and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants. gov and eRA Commons as soon as their organization has obtained a DUNS number.

Only one DUNS number is required and the same DUNS number must be referenced when completing Grants. gov registration, eRA Commons registration and the SF424 (R&R) Request Application Information download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants. gov/Apply .

Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA. assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected] .

for the hearing impaired: TTY: (301) 451-5936 Content and Form of Application Submission applications using the SF424 (R&R) application forms for this FOA through Grants. gov/Apply and in accordance with the SF424 (R&R) Application Guide ( http://grants. nih.

gov/grants/funding/424/index. htm ). Application Guide is critical to submitting a complete and accurate application to NIH.

Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH ( e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID ). Agency-specific instructions for such fields are clearly identified in the Application Guide.

For additional information, see Frequently Asked Questions Application Submission of Grant Applications . application has several components. Some components are required, others are optional.

The forms package associated with this FOA in Grants. gov/APPLY includes all applicable components, required and optional.

A completed application in response to this FOA includes the data in the following Project/Performance Site Locations Research & Related Other Project Information Research & Related Senior/Key Person PHS398 Cover Page Supplement PHS398 Modular Budget or Research & Related Budget , Research & Related Subaward Budget Attachment(s) Organizations ( Non-domestic [non-U.S.] Entities) policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.

nih. gov/grants/policy/nihgps_2003/NIHGPS_Part12. htm#_Toc54600260 .

from Foreign organizations must: Request budgets in U.S. dollars; detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component)( see NOT-OD-06-096 ); Not include any charge-back of customs and import Comply with the format specifications, which are based upon a standard U.S. paper size of 8.

5 x 11 within each PDF; If appropriate, request funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) ( see NOT-OD-01-028 , March 29, Comply with Federal/NIH policies on human subjects, animals, and biohazards; and with Federal/NIH biosafety and biosecurity regulations (see Section VI. 2 .

, Administrative and National Policy Requirements ) Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project.

The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those Contact PD/PI should be entered on the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.

Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.

Failure to include this data field will cause the application PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled Multiple PD/PI Leadership Plan , must be included. A rationale for choosing a multiple PD/PI approach should be described.

The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Involving a Single Institution within a single institution, follow the instructions contained in the SF424 Involving Multiple Institutions institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution.

When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.

8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format.

See Section 5. 4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component. 3.

Submission Dates and Times See Section IV. 3. A.

for details. Submission, Review and Anticipated Start Dates Date : August 2 8 , 2010 (Earliest date an application may be submitted to Grants.

gov) Application Due Date(s): September 28, 2010; September 28, 2011; September 28, 2012 Peer Review Date(s): March 2011, March 2012, March 2013 Council Review Date(s): May 2011, May 2012, May 2012 Anticipated Start Date(s): July 2011, July 2012, July 2013 letter of intent is not required for the funding opportunity. 3. B.

Submitting an Application Electronically to the To submit an application in response to this FOA, applicants should access this FOA via http://www. grants. gov/applicants/apply_for_grants.

jsp and follow Steps 1-4. Note: Applications must only be submitted electronically . PAPER APPLICATIONS WILL NOT BE ACCEPTED.

All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a . pdf extension must be used. Applications may be submitted on or after the opening date and must be successfully received by Grants.

gov no later than 5:00 p. m. local time (of the applicant institution/organization) on the application due date(s).

(See Section IV. 3. A.

for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All