Morris K. Udall Centers of Excellence for Parkinson's Disease Research Program (P20 - Clinical Trial Optional)

Morris K. Udall Centers of Excellence for Parkinson's Disease Research Program (P20 - Clinical Trial Optional) is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH). This program establishes a network of Centers that work collaboratively and independently to define the causes of and discover improved treatments for Parkinson's disease.

Expired RFA-NS-21-002: NINDS Morris K. Udall Parkinson's Disease Research Center Without Walls (P20 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices.

Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of Neurological Disorders and Stroke ( NINDS ) Funding Opportunity Title NINDS Exploratory Grant Program in Parkinson's Disease Research (P20- Clinical Trial Optional August 11, 2020 - Notice of Change: Late Application Policy for September 28, 2020, Application Due Date for RFA-NS-21-002 "NINDS Exploratory Grant Program in Parkinson's Disease Research (P20- Clinical Trial Optional)".

See Notice NOT-NS-20-098 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-NS-21-001 , P50 Research Program Projects and Centers Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) invites Exploratory Grant (P20) applications for the planning and initiation of collaborative efforts to advance Parkinson's Disease (PD) research.

The goal of this program is to formalize new collaborative directions and/or novel interdisciplinary teams to address critical gaps in PD research and to establish a rigorous foundation of research discovery leading directly to an NINDS Morris K. Udall Center of Excellence (P50) application.

Through this mechanism, the NINDS seeks to develop synergistic, proof-of-concept research efforts around investigator-defined gaps in PD research and support collaborative teams to develop a research plan, construct an effective administrative organization, create standardized policies/procedures, and gather rigorous preliminary data in support of novel ideas to address urgent needs and emergent issues in PD research.

The Exploratory Grant theme and proposed research feasibility projects will inform the etiology, pathogenesis, or treatment of PD; investigations on related synucleinopathies may be included if such directly address the identified PD research gap.

Required components of this FOA include an Overall section, an Administrative Core, and three or more research feasibility projects, at least one of which must be led by an early career researcher poised to become an expert in PD research. Synergy among proposed research projects must be evident as well as required for successful completion of the overall aims.

To foster the development of innovative research consortia, this solicitation will provide support to formalize new collaborative directions and/or novel interdisciplinary teams only.

NINDS funding decisions will focus primarily on scientific merit, i.e., on those applications that are most likely to make innovative contributions to PD research and that demonstrate potential to submit a P50 application at the end of the Exploratory Grant project period.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (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 tall 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 I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description Parkinson's disease (PD) is a chronic, progressive movement disorder that affects the lives of at least half a million people in the United States, as well as having significant impact on the relatives and friends who care for them. The average age of onset of characteristic motor symptoms is during the sixth decade, although earlier onset is also possible.

Persons with PD also experience significant non-motor symptoms including changes in cognition and mood, sleep disturbances, and autonomic dysfunction. Currently available pharmacological and surgical treatments provide relief from some motor symptoms but fail to attenuate the ultimate progression of the disease. As our population ages, the number of persons with PD is projected to increase significantly.

While considerable research advances continue, the full complexity of PD etiology is not yet evident. Moreover, currently available treatments are primarily symptomatic, and neither slow nor halt disease progression. Challenges posed by the inherent complexity of PD are often best addressed by interdisciplinary research teams working in tandem to surmount obstacles and seize opportunities to advance knowledge and improve treatment.

However, development of an effective research consortium, identification of an optimal strategy and collection of rigorous preliminary data to address existing gaps in PD research require dedicated time and resources. With this initiative, the NINDS is now soliciting Exploratory Grant (P20) applications proposing planning and initiation of synergistic research activities to advance PD research and treatment.

The goal of this program is to formalize collaborative structures and establish a rigorous foundation of research discovery necessary to address urgent gaps and emergent issues in PD research. Synergy among proposed research projects must be evident as well as required for successful completion of the overall Exploratory Grant aims.

To foster the development of innovative research consortia, this solicitation will provide support to formalize new collaborative directions and/or novel interdisciplinary teams. Successful exploratory studies should lead to a subsequent application for support of a collaborative, interdisciplinary NINDS Morris K. Udall Center of Excellence (P50).

The purpose of this Exploratory Grant (P20) initiative is to support the formation of new collaborative directions and/or novel interdisciplinary research teams to address immediate challenges in PD. Through this mechanism, the NINDS seeks to develop synergistic, proof-of-concept research efforts around investigator-defined gaps in PD research.

This mechanism encourages collaborative teams to develop a research plan, construct an effective administrative organization, create standardized policies/procedures, and gather rigorous preliminary data in support of novel ideas to address urgent needs and emergent issues in PD research.

The Exploratory Grant theme and proposed research projects will inform the etiology, pathogenesis, or treatment of PD; investigations on related synucleinopathies may be included if such directly address the identified PD research gap. Successful Exploratory Grant activities should lead directly to the submission of an NINDS Morris K. Udall Center of Excellence (P50) application.

The Exploratory Grant provides each individual team with flexibility in project design. For example, some existing teams may have preliminary data for novel projects requiring further proof-of-concept, whereas emergent teams may have identified a key area of need and require time to convene, establish collaborative approaches, and obtain preliminary data.

The collective expertise required to form effective partnerships and develop a rigorous evidence base may involve multiple sites and institutions. Programmatic requirements of this FOA include an Overall section, an Administrative Core, and three or more research feasibility Projects, at least one of which must be led by an early career researcher poised to make contributions to PD research.

In this context, "early career researcher" includes those who are about to transition, or have recently moved, to fully independent positions as investigators, faculty members or clinician scientists, and who focus on establishing themselves as experts in their chosen research area.

For this initiative, "early career" is inclusive of Early Stage Investigators (ESI), as well junior faculty without current NIH R01-equivalent, independent support; New Investigators are eligible only if the criteria for "early career" are met. Leadership of a research feasibility project will allow ESI to retain ESI status according to NIH ESI policy .

Inclusion of an early career researcher is intended to provide a timely leadership development opportunity within the supportive and collaborative structure of the Exploratory Grant consortium. Because a goal of this initiative is to establish productive and innovative collaborations, extensive preliminary data is not required for proposed research feasibility projects.

This FOA is not intended for support of clinical trials, but does permit mechanistic clinical research, as described below. Applicants may also request support for establishment of administrative structures to form the foundation for future basic, translational, and clinical research efforts.

Applicants are encouraged to link their proposed theme and activities to critical gaps in PD research, including but not limited to research priorities from the NINDS conference, "Parkinson's Disease 2014: Advancing Research, Improving Lives" . Proposed studies must be feasible within the two-year project period and justified within the budget limits described elsewhere in this announcement.

Due to the project timeframe and focus on research feasibility projects, research Cores are not within scope of the Exploratory Grant; applications proposing research Cores will be considered non-responsive to this Clinical research is within scope of this initiative but is not required: completion of proposed clinical studies should be feasible within the timeline of the Exploratory Grant.

For this solicitation, NINDS will accept hypothesis-driven mechanistic clinical trials in basic and/or translational discovery research in healthy human subjects and in the pathobiology, pathophysiology, and neuropathology of PD. The goal of such studies is to address basic questions and to interrogate concepts in biology, behavior, and pathophysiology that will provide insight into understanding neurological disorders.

Such studies may seek to understand a biological or behavioral process, or the mechanism of action of an intervention.

Designs that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions must be submitted to an NINDS clinical trial-specific funding announcement (see NINDS Clinical Research ).

For related information on NINDS policy for submission of clinical trials, see NOT-NS-18-054 . Collection of biospecimens and clinical data will follow policies and procedures of the NINDS Parkinson's Disease Biomarker Program (PDBP) . the NIH expects applicants to apply rigor in designing and performing scientific research according to the NIH Principles and Guidelines for Reporting Preclinical Research .

This initiative is intended to provide flexibility for new applicant teams to design, establish, and strengthen collaborative efforts, and for existing applicant teams to explore novel research directions. Full-scale multicomponent research projects from established investigative teams, with requirements for supportive research Cores, are best suited to the NINDS Udall Centers of Excellence (P50) program itself.

NINDS funding decisions will focus primarily on scientific merit, i.e., on those applications that are most likely to make innovative contributions to PD research and that demonstrate potential to submit a P50 application at the end of the Exploratory Grant project period.

The NINDS will also consider the full scope of Udall Center programmatic activities when making funding decisions; applications proposing goals identical to or largely overlapping Udall Centers will receive lower program priority. In addition, the NINDS may also consider whether proposed research addresses recommendations from the NINDS conference "Parkinson's Disease 2014: Advancing Research, Improving Lives."

Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Optional: Accepting applications that either propose or do not propose clinical trial(s) help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The NINDS intends to fund up to 4 awards in FY2021, corresponding to a total of $1. 2 million in direct costs. Only one Exploratory Grant will be awarded per applicant institution.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are limited to $300,000 direct costs per year (exclusive of facilities and administrative costs of subcontracts with collaborating institutions). Budget requests should reflect the actual needs of the proposed project.

The maximum project period is 2 years. NIH grants policies as described Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government - Including the NIH Intramural U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 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 SF424 (R&R) Application Director (PD/PI) must demonstrate significant potential or proven capacity to provide effective leadership, oversight of administrative activities and coordination of scientific efforts of the Exploratory Grant consortium.

Other important considerations include current research productivity and funding, as well as capacity or potential to drive innovative advances as the head of an interdisciplinary team. The PD/PI is responsible for ensuring that consortium goals are met, for developing and managing a decision-making structure, and for allocation of resources to achieve stated goals.

The PD/PI must have sufficient research and grant administration experience, including as the PI of R01-equivalent NIH grants or clinical trials, to effectively coordinate this exploratory project. Finally, combined qualifications, expertise and productivity of the PD/PI should support potential for future, successful leadership of an NINDS Udall Center.

commensurate with the time required for effective leadership of the Exploratory Current Udall Center Directors, Senior/Key Personnel and/or Other Significant Contributors are not eligible to apply or to participate in P20 applications as Senior/Key Personnel and/or Other Significant Contributors. This FOA does not require cost sharing as defined in the NIH Grants 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Only one Exploratory Grant (P20) will be awarded per applicant organization. Section IV.

Application and Submission Information 1. Requesting an Application The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.

gov downloadable forms currently used with most NIH opportunities. 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.

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 By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: National Institute of Neurological Disorders and Strategy/Program Plan Page Limits Additional page limits described in the SF424 Application Guide of Page Limits must be followed.

Instructions for the Submission of Multi-Component The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component The application should consist of the following components: Administrative (Admin) Core: required; will include all planning Projects: required; will include minimum of three research feasibility studies, one of which must be led by an early career researcher When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall Project Information (Overall) Follow standard instructions.

Foreign Justification: If foreign components are included, describe how those present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and are not readily available in the United States (U.S.) or that augment existing U.S. resources. Attachments: The following information must be uploaded as individual attachments.

The filename for each required attachment is indicated below; filenames will be used to bookmark the attachments in the application image. Structure: provide a diagram of Exploratory Grant components and related interconnections. Resources: Include a description of extant institutional programs, infrastructure, and resources available to advance the Aims of the proposed Exploratory Grant.

If applicable, provide a summary of current institutional efforts in PD (or other neurodegeneration or neuroscience) research available to support or complement proposed research efforts. If applicable, describe existing large-scale research projects at the institution, and define the envisioned contributions of the Exploratory Grant within this context.

Examples include, but are not limited to: Parkinson's Disease Biomarkers Program (PDBP); NIH Accelerating Medicines Partnership for PD (AMP PD); NIA Alzheimer's Disease Centers or other significant NINDS/NIA programs in Alzheimer's Disease-Related Dementias (ADRD); Department of Defense Congressionally Directed Medical Research Programs- Parkinson's Research Program (DoD CDMRP-PRP); NCATS Clinical and Translational Science Awards (CTSA).

Non-Federal programs: Aligning Science Across Parkinson's (ASAP) Research Collaborative Network; Chan-Zuckerberg Initiative (CZI) Neurodegeneration Challenge; Parkinson's Foundation (PF) Research or Clinical Centers of Excellence; large-scale Michael J.

Fox Foundation (MJFF) projects and/or consortia; American Parkinson's Disease Association (APDA) Centers for Advanced Research, and similar programs A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon Research & Related Senior/Key Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the The Exploratory Grant Director (PD/PI) must be a recognized leader in scientific research with considerable potential or proven capacity for expert leadership of an interdisciplinary team.

An Associate Director may be named. The PD/PI is responsible for ensuring Exploratory Grant goals are met, for developing and managing a decision-making structure, and for allocation of resources to achieve stated goals.

If named, the Associate Director will partner with the PD/PI to facilitate and advance the goals of the The Director and Associate Director (if applicable) will demonstrate current research productivity, active research funding (NIH R01-equivalent or greater) and/or stewardship of clinical studies at time of application submission.

The PD/PI and Associate Director (if applicable) effort must be commensurate with the time required for effective leadership of the Current Udall Center Directors, Senior/Key Personnel and/or Other Significant Contributors are not eligible to apply or to participate in P20 applications, and therefore may not be named as Senior/Key Personnel and/or Other Significant Contributors.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon PHS 398 Research Plan (Overall) Specific Aims: All proposed activities will be directed toward the subsequent preparation of a full-scale NINDS Udall Center application.

Describe the goals of the collaborative project and outline how the proposed activities will contribute to advancement of these goals and result in the submission of a Udall Center (P50) application. Overall section provides an overview, rationale and timeline for activities leading to the subsequent NINDS Udall Center application.

Applicants must identify an over-arching theme that addresses a PD research gap, present a compelling vision and propose a spectrum of activities best suited to their collaborative goals, such as planning meetings, research feasibility studies, and generation Organize the Research Strategy into sections on Significance, Innovation and Approach.

Significance: Provide a vision statement for the Exploratory Grant, including expected contributions to the advancement of PD research and treatment.

Describe (i) the importance of the PD research challenge or gap to be addressed; (ii) how establishment and/or advancement of the proposed collaboration will improve scientific knowledge, treatment and/or clinical practice; and (iii) the strategy by which the proposed studies will be advanced into an NINDS Udall Center.

Innovation: Provide evidence that the proposed activities will address the stated challenge and advance PD research through use of novel concepts, collaborations, and state-of-the-art Approach: Describe the general research framework of the Exploratory Grant. Detail how proposed activities will synergistically address a defined PD research challenge and describe the strategy by which the goals of the collaboration will be met.

Clearly state the overarching theme and objectives of the proposed project. For each objective, include a brief statement describing the contributions of individual team members toward completion of common goals. Describe and justify the specific research need to be addressed; when possible, directly relate the theme and objectives to the NINDS PD2014 recommendations .

Describe the collaborative planning process, and any related research project(s). Include a narrative timeline or table outlining specific yearly objectives, including transition from planning to implementation phase (i.e. submission of an NINDS Udall Center application).

Describe the leadership structure, the research team, and the role of its members in addressing the stated research challenge and meeting collaborative goals within the two-year timeframe of the Exploratory Grant.

To optimize novel team approaches while building upon available knowledge, it is recommended that teams include at least one individual with expertise outside of the PD field and at least one individual with PD expertise, as well as an early career researcher.

For members with expertise beyond the PD field, describe how their expertise can be brought to bear to advance project goals and how expected contributions will be integral to consortium activities. Describe the novel contributions of the team to PD research. Provide confirmation of the commitment of team members to partner around common long-term goals to advance PD research.

Provide summary justification for the formation of an Exploratory Grant consortium, including a focus on new collaborative directions and/or novel interdisciplinary teams. Present compelling evidence that the assembled research team will work together effectively to accomplish the goals of the proposed exploratory effort.

Detail institutional support for a strong research base on PD and/or other neurodegenerative disorders as well as infrastructure and resources that may be leveraged to support consortium Outline envisioned contributions of the proposed activities to the NINDS Udall Centers of Excellence program , including how these contributions will complement (not overlap with) ongoing Udall Center projects.

Commitment (required): Provide endorsement of the planning effort from high-level institutional officials (e.g. Dean, Vice President, Provost; letters from Department Chairs are not sufficient). The letter should include allocation of available resources to PD research and collaborative opportunities with extant institutional programs.

Applicant institutions receiving funding from other large-scale, PD-related research projects should detail how interactions with the Exploratory Grant effort will advance PD research and provide a foundational environment for a future NINDS Udall Center application. Outline the role of the institutional official in conflict arbitration and resolution, should such arise among Exploratory Grant investigators.

with NIH Intramural Researchers (if applicable): Include a letter from the Scientific Director of the collaborating NIH Institute. The letter must describe the role of intramural staff and specify the nature and amount (funding) of NIH intramural resources to be allocated to the proposed project.

In addition, the letter should state that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research (if with Nongovernmental Organizations (if applicable): PD researchers and nongovernmental patient advocacy and funding organizations have common goals for improving treatment and understanding causes of PD.

Letters should detail ongoing or planned partnerships between the collaborative team and these organizations. Letters of support from current Udall Center Directors and investigators are not required.

Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The overall Resource Sharing Plan should address plans for sharing data beyond the immediate collaborative Exploratory Grant team.

Information in the Overall component should complement but not duplicate that provided in Research Project "Resource Sharing Plan." Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components.

To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application