Research on the Cognitive Sequelae of Parkinson's Disease (R21)

Research on the Cognitive Sequelae of Parkinson's Disease (R21) is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), National Institute of Mental Health (NIMH), National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PA-09-034: Research on the Cognitive Sequelae of Parkinsons Disease (R21) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services National Institutes of Health (NIH), ( http://www.

nih. gov ) Components of Participating Organizations National Institute of Neurological Disorders and Stroke (NINDS), ( http://www. ninds.

nih. gov ) Institute on Aging (NIA), ( http://www. nia.

nih. gov ) Title : Research on the Cognitive Sequelae of Parkinsons Disease (R21) This Funding Opportunity Announcement (FOA) is a reissue of PA-06-195 . Update: The following updates relating to this announcement have been issued: 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. This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond.

If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

November 27, 2009 - See Notice NOT-MH-10-006 NIMH Announces Changes in NIMH Participation, As of January 8, 2010, NIMH will terminate or withdraw its participation from this FOA. Announcement (PA) Number: PA-09-034 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 MAY NOT BE SUBMITTED IN PAPER FORMAT. FOA must be read in conjunction with the application guidelines included with this announcement in Grants.

gov/Apply for Grants (hereafter called Grants. gov/Apply). registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission Domestic Assistance Number(s) Opening Date: January 16, 2009 (Earliest date an application may be submitted to Grants.

gov) Letters of Intent Receipt Date(s): Not applicable NOTE: On-time submission 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 Dates: Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm AIDS Application Due Dates: Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#AIDS . Peer Review Dates: Standard dates apply, please see http://grants1.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward Dates: Standard dates apply, please see http://grants1.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward Anticipated Start Dates: Standard dates apply, please see http://grants1.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward Information To Be Available Date (URL Activation Date): Not Applicable Expiration Date: January 8, 2012 Purpose .

Under this Funding Opportunity Announcement (FOA), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Aging (NIA), and the National Institute of Mental Health (NIMH) invite research grant applications to develop new, or improve existing, animal models which address the underlying neurobiological mechanisms associated with cognitive impairment and mood disturbance in Parkinson's disease (PD), that assist in the development of clinical interventions and therapeutics for cognitive impairment and affective symptoms in PD, or that promote improved treatment of cognitive and affective impairment in PD.

A goal of this FOA is to begin a process where basic and clinical scientists from various disciplines can overcome barriers to cross-disciplinary and biobehavioral research and examine all aspects of cognition and affective regulation in the context of the diagnosis and treatment of Parkinson's disease. Mechanism of Support.

This FOA will use the NIH Exploratory/Developmental (R21) grant mechanism and runs in parallel with a FOA of identical scientific scope, PA-09-033 , that encourages applications under the R01 mechanism. Funds Available and Anticipated Number of Awards. Because 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.

The total amount awarded and the number of awards will depend upon the mechanism, numbers, quality, duration, and costs of the applications and Project Period. The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.

The R21 is not Application Research Strategy Length: Item 3 of the R21 application Research Plan component of the PHS398 may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. See http://grants. nih.

gov/grants/funding/funding_program. htm . Eligible Institutions/Organizations.

Institutions/organizations liste d in Section III, 1. A. are eligible to apply.

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 of PDs/PIs.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct. 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 will be permitted only a single amendment (A1). See http://grants.

nih. gov/grants/guide/notice-files/NOT-OD-09-003. html and NOT-OD-09-016 Original new and competing renewal applications that were submitted prior to January 25, 2009 will be 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. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted.

Materials. See Section IV. 1 for application materials.

All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the current forms and instructions. 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/ Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY 301-451-5936. Part I Overview Information 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 Other Submission Requirements and Information Section V.

Application Review Information 2. Review and Selection Process A. Additional Review Criteria B.

Additional Review Considerations C. Resource Sharing Plan(s) 3. Anticipated Announcement and Award Dates 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 Parkinson's disease (PD) is commonly viewed as an extrapyramidal motor disorder. Hence, a substantial body of research has focused on understanding the neural mechanisms underlying the most apparent symptoms (tremors, slowness, initiation of movements) and on treatment of these debilitating clinical manifestations.

However, PD is more than a motor disease; it also affects thinking, reasoning, learning, processing speed, and other cognitive abilities as well as regulation of mood and affect. In addition, medications commonly used to treat Parkinsons disease can provoke or enhance cognitive dysfunction.

Consequently, Parkinson's patients exhibiting both motor and non-motor symptoms present unique challenges for the assessment and treatment of psychopathology in their disease process. In such patients, both quality of life and treatment outcome are severely compromised. The cognitive and affective changes seen in PD patients are less understood and studied than parkinsonian motor symptoms.

2005, NINDS organized the second Parkinsons Disease focused on the advancement of therapeutics in PD. For reasons listed above, a special breakout session on the non-motor complications of PD was convened. The group discussed a wide range of non-motor aspects of PD, identifying behavioral and cognitive impairment as particularly important for future research studies.

The participants made a number of high priority recommendations in this area: the scientific knowledge base for non-motor manifestations such as cognitive and neuropsychiatric impairment in PD towards the goal of enhancing therapeutic and intervention development.

animal models that reproduce non-motor features of PD for research, drug non-motor manifestations of PD, such as cognitive and affective impairment, into clinical trials to facilitate testing of both pharmacological and non-pharmacological interventions for improved methods for characterizing the non-motor com plications, including standardized methods for addition to these priority recommendations, the group also suggested a number of other strategies to move this field forward, including studies of how the cellular changes in PD lead to non-motor symptoms; the incorporation of studies of non-motor manifestations into the development of risk factor criteria; and further studies of the impact of these aspects of the disease on disability.

order to address these recommendations, this FOA encourages research on the development of new, or improvement of existing, animal models that reproduce aspects of cognitive or affective dysfunction as seen in the context of the diagnosis, progression, and treatment of PD.

purpose of this initiative is to: foster multidisciplinary approaches to the study of cognitive dysfunction in PD by encouraging collaborations between basic neuroscientists, cognitive and affective neuroscientists, and clinical scientists; promote the development of relevant animal models that will 1) lead to improved understanding of the neurophysiology underlying cognitive and affective changes in PD, and/or 2) prove useful as screening tools for potential therapeutic agents designed to reverse or forestall cognitive impairments and/or mood dysregulation in encourage the development of biomarkers for cognitive and affective impairment or risk for cognitive and affective impairment in PD; promote research on the development of new therapeutics, or the improvement of current therapeutics, for cognitive impairment and that demonstrate the establishment of collaborative research programs with researchers at existing Udall Centers of Excellence for Parkinson's disease research are particularly encouraged.

topics appropriate for this FOA include, but are not limited, to the following: molecular or cellular studies in animals of potential drugs or other treatments which could address cognitive impairments or mood dys regulation in PD. and physiological characterization of models based on the molecular understanding of synuclein, parkin and other proteins involved in the pathogenic processes of neurodegenerative disorders.

on the neurobiological basis of common cognitive and affective impairments in PD using animal models.

of new cognitive tests and paradigms in animal models of PD that could successfully be used in human patients (parallel assessments), particularly those that do not rely on motor of neuroprotective or other agents in animal models of PD with induced to identify risk factors for drug-induced cognitive or affective impairment in animal models of PD that examine the association between motor symptom onset, PD neuropathology and the development and severity of cognitive and affective impairments.

of pathological markers in the basal ganglia that better define PD with motor changes alone as compared to PD with both motor and non-motor impairments. of neuroanatomical circuits and neurochemical processes mediating cognitive or affective states and cognition- or affect-based individual differences in animal models of PD.

of the specific consequences of deep brain stimulation (DBS) or other surgical interventions, on the cognitive aspects of Parkinson's disease. respect to the above objectives, NIMH priorities relate particularly to research pertaining to affective regulation, mood disturbance, depression or other neuropsychiatric symptoms in PD.

addition to the above objectives and suggested topics, the NIA priorities include promotion of research that would explore, using animal models, the characteristic cognitive and affective impairments seen in PD that may be instigated or enhanced by the aging process itself.

The NIA encourages longitudinal studies using animal models of PD that explore the mechanisms contributing to the progression from motor only impairments to cognitive and affective impairments and that inform us about the role of the aging process in the progression.

Development of pharmacological or non-pharmacological intervention strategies to block the progression from motor to cognitive and affective impairments during the course of the disease also is encouraged.

Novel, exploratory research that simultaneously investigates the common pathologies, genetic mechanisms, and regional and cellular selective vulnerabilities of PD and Alzheimers disease (AD) that would inform us about the cognitive and affective sequelae of PD is another priority of the NIA.

Of particular interest is research on people with co-occurring PD and other dementias, e.g., AD, diffuse Lewy Body disease (DLB), or Frontotemporal dementia (FTD), especially with respect to the cognitive and affective components. Projects that employ neuroimaging and other biomarker approaches for these studies are encouraged.

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data.

By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research. The R21 mechanism is intended to encourage new exploratory and developmental research projects.

For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area.

These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism.

For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. Information on the R03 program can be found at http://grants. nih.

gov/grants/funding/r03. htm . See Section VIII, Other Information - Required Federal Citations , for policies related This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism .

The Project Director/Principal Investigator (PD/PI) will be solely responsible 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 the Modular Applications and Awards section of the NIH Grants Policy Statement .

Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3. 4, Modular Budget Component, of the Application Guide).

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 .

seeking to carry out pilot studies of therapies in preparation for a clinical trial that are specifically relevant to the mission of the NINDS should apply under the auspices of the Preliminary Investigations Leading To Optimal Trials In Neurology program announcement PAR-07-294. This announcement can be found at http://grants. nih.

gov/grants/guide/pa-files/PAR-07-294. html .

seeking to develop milestone-driven translational therapeutics programs for Cognitive Impairment in PD that are specifically relevant to the mission of the NINDS should apply under the auspices of either 1) the NINDS Exploratory/Developmental Projects in Translational Research Program Announcement (for translational R21 applications); or 2) NINDS Cooperative Program in Translational Research Program Announcement (for U01 or U54 applications).

These announcements can be found at http://grants. nih. gov/grants/guide/pa-files/PAR-08-232.

html or http://grants. nih. gov/grants/guide/pa-files/PAR-08-233.

html and http://grants. nih. gov/grants/guide/pa-files/PAR-08-234.

html , respectively. Because 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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total project period for an application submitted in response to this funding opportunity may not exceed 2 years.

Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.

Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made consortium participants are not included in the direct cost limitation. See NOT-OD-05-004 , November 2, III.

Eligibility Information organizations/institutions are eligible to apply: Controlled Institutions of Higher Education Institutions of Higher Education Historically Black C olleges and Universities (HBCUs) 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 Organizations (Other than Small Businesses) American Tribal Governments (Federally Recognized) American Tribally Designated Organizations Housing Authorities/Indian Housing Authorities U.S. Territory or Possession American Tribal Governments (Other than Federally (non-U.S.) Entities (Foreign Organizations) Eligible Agencies of the Federal Government Faith-based or Community-based Organizations.

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 for NIH support.

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://era. nih.

gov/ElectronicReceipt/preparing. htm for instructions). decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant 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 . does not require cost sharing as defined in the current NIH Grants Policy Statement .

of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct. 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 will be permitted only a single amendment (A1). See http://grants.

nih. gov/grants/guide/notice-files/NOT-OD-09-003. html and NOT-OD-09-016 Original new and competing renewal applications that were submitted prior to January 25, 2009 will be 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. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation) applications will not be accepted.

Section IV. Application and Submission Information Appropriate 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, applications 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 but the submission deadline for the application to be considered on-time (see 3. C. 1 for more information about on-time submission).

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.

A one-time registration 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: 1) 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: Grants. gov Customer Support 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) 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. PD/PI must 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. 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. registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons. the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: If a PD/PI is also an NIH peer-reviewer the DUNS number obtained and used in the reviewer role may NOT be used and is not applicable to any Grant Application to the Federal Government. This DUNS number is different from the DUNS number used by the applicant organization. The individual DUNS number should be used only for the purposes of personal reimbursement.

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 in both Grants. gov and the Commons .

The NIH will accept electronic applications only from organizations that have completed all 1. Request Application Information download the SF424 (R&R) application forms and 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. For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected] .

Telecommunications for the hearing impaired: TTY Content and Form of Application Submission using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide ( MS (R&R) Application Guide is critical to submitting a complete and accurate application to NIH.

There are fields within the SF424 (R&R) application components that, 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/PIs 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 Guide, Electronic Submission of Grant Applications . application is comprised of data arranged in separate components. Some components are required, others are optional.

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

A completed application in response to this FOA will include the following components: Research & Related Project/Performance Site Research & Related Other Project Information Research & Related Senior/Key Person PHS398 Cover Page Supplement Modular Budget or Research & Related Budget , as appropriate (See Section IV. 6 . , Special Instructions , regarding appropriate required budget component.)

Research & Related Subaward Budget Attachment(s) Organizations (Non-domestic [non-U.S.] Entities) 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, 2001); 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.

Applications with Multiple PDs/PIs When multiple PDs/PIs 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 Information for the Contact PD/PI should be entered in Item 13 of 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 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 to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new 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).

Applications Involving a Single Institution When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Applications Involving Multiple Institutions When multiple 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 budget When submitting a 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