Required Application Instructions

It is critical that applicants follow the 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 to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Parkinson's disease (PD) is a chronic, progressive movement disorder that affects 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 is during the sixth decade, although earlier onset is also possible, and the incidence of PD is expected to increase as the population ages. Moreover, currently available treatments are primarily symptomatic, and neither slow nor halt disease progression. While significant research advances continue, improved treatments require greater understanding of the complex etiology underlying disease onset and progression. The most critical challenges posed by the inherent complexity of PD are best addressed by transdisciplinary research teams pursuing synergistic approaches to surmount obstacles and seize opportunities for research advancement. However, development of an effective research consortium, identification of an optimal strategy and planning of comprehensive efforts to address fundamental challenges in PD research require dedicated time and resources.

As the primary Federal funder of PD research, the National Institute of Neurological Disorders and Stroke (NINDS) supports a significant investigator-initiated PD research portfolio as well as several targeted programs. The NINDS Udall Centers of Excellence for Parkinson’s Disease Research were established in tandem with passage of the Morris K. Udall Parkinson’s Disease Research Act of 1997 (PL 105-78). The objective of the NINDS Udall Centers (P50) program is to establish a network of Centers that work independently as well as collaboratively to define the causes of and discover improved treatments for PD while serving as local resources for and national leaders in PD research. Current Udall Centers focus on investigator-initiated research themes, most often hypothesis-driven approaches to understand disease mechanism, and build upon the strengths of the Udall Director and his/her collaborators at a single US academic institution. While this model represents one effective means to advance knowledge of underlying causes of neurological disease, surmounting major obstacles to understanding and treatment requires transformative efforts of large, specialized (and often international) research consortia using a unique combination of knowledge, skills and resources in a goal-driven approach to meet an essential research priority.

Therefore, this Funding Opportunity Announcement (FOA) solicits Planning Grant applications to convene novel, unique research consortia and optimize comprehensive strategies necessary to resolve key questions in PD research. In 2014, the NINDS hosted a PD conference "Advancing Research, Improving Lives (PD2014)," which resulted in a series of prioritized research recommendations. The scope and resolution of several PD2014 recommendations, as well as of additional, recently emergent issues in PD research, are beyond the reach of a single laboratory or institution and require uniquely skilled transdisciplinary teams to address; such complex issues are best addressed by a "Center without Walls (CWOW)" approach in which a specialized consortium works across institutional and geographic boundaries using a milestone-driven approach to resolve an essential question or controversy in PD. To facilitate such an approach, this NINDS Planning Grant initiative will provide dedicated support for novel consortia to establish organizational structure and plan milestone-driven research approaches for a subsequent NINDS Morris K. Udall Center without Walls for PD Research (Udall PD-CWOW) application. Udall PD-CWOW applications are expected to transform PD research and treatment through transdisciplinary, synergistic and timely resolution of an identified critical challenge. The anticipated scope of ensuing Udall PD-CWOW applications (described below) will include the optimal combination of preclinical and clinical research necessary to address the stated problem and to meet associated milestones within a five year project period.

To foster the rapid development of dynamic research consortia tailored to meet critical challenges, this FOA will only support new collaborations; continuation of established projects and teams will not be supported. Responsive applications will demonstrate the ability to meet timelines for planning activities, as well as considerable potential to: rapidly convene a new, highly skilled, and facile research consortium; contribute unique knowledge and scientific advances; provide broad sharing of data and resources consistent with achieving the goals of the program; and develop milestones for a subsequent Udall PD-CWOW application that will resolve a defined, essential challenge in PD research within a five year period using a goal-driven approach. The PD research priority must be defined and justified within the application; statement of related research milestones is neither expected nor required, as these should be developed during the planning process itself.

The following activities are within the scope of this FOA:

• Selection and justification of an essential PD research priority.
• Research consortium identification, development and coordination.
• Establishment of administrative and governance structure, including an internal Executive Committee.
• Planning meetings to:
• Convene the consortium, review related research and develop a strategic plan for an NINDS Udall PD-CWOW application, including an initial milestone draft.
• Finalize milestones and a transdisciplinary, thematically integrated, synergistic strategy to meet the identified research challenge.
• Prepare the Udall PD-CWOW application.
• Periodic web meetings and teleconferences.
• Organization of existing tools for research management and broad sharing of data consistent with achieving the goals of the program.
• Coordination of standardized procedures for collection and storage of data and biospecimens.

The following activities are beyond the scope of this FOA:

• Research activities.
• Clinical trials.
• Establishment of institutional research infrastructure and/or research resources (e.g. cell repositories, brain/tissue/biospecimen banks, data bases/repositories, etc).
• Career development/training activities.
• Planning for continuation of ongoing, or recapitulation of prior, collaborative research efforts.

Applicants should provide justification for larger-scale, milestone-driven efforts required to resolve the identified challenge within a subsequent five-year U54 period. Activities of established teams pursuing collaborative aims-driven approaches to reach an overall research goal, including integrated subprojects and cores housed mainly at the same academic institution, are more appropriate for the NINDS Research Program Project Grant (P01) mechanism or the NINDS Udall Centers of Excellence (P50) Program (the latter if clinical populations, community outreach and career enhancement activities are included, in service of status as a local resource for and national leader in PD research).

NINDS funding decisions will focus primarily on scientific merit, i.e., on those consortia that are best poised to develop a competitive Udall PD-CWOW application, and resolve a central challenge in PD research within a subsequent five year project period. Additional considerations include the transformative significance of the defined challenge, the novelty and skillset of the research consortium, and the potential for rapid, innovative solution of the proposed problem. The NINDS will also consider the full scope of ongoing activities in PD, including active Udall Centers and other existing research consortia, when making funding decisions; applications proposing goals identical to or largely overlapping with ongoing activities will receive lower program priority. In addition, the NINDS will consider the degree to which proposed activities justify and address an essential challenge in PD research, including but not limited to specific recommendations from the NINDS conference "Parkinson's Disease 2014: Advancing Research, Improving Lives."

By design, successful awardees will be positioned to submit competitive applications for an NINDS Udall PD-CWOW. The PD-CWOW FOA is anticipated in fiscal year (FY) 2018, and will utilize the NIH Specialized Center Cooperative Agreement (U54) mechanism. The U54 is a milestone-driven mechanism, the continuation of which is dependent upon the achievement of quantifiable steps within a clearly defined timeframe. Udall PD-CWOW milestones will describe the research goal as well as provide objective and quantitative outcomes by which to justify advancing the project, i.e. measures that would be recognizable as appropriate endpoints in the specific scientific area. Synergy must be evident among PD-CWOW research projects and cores, such that successful completion of proposed milestones could not be accomplished without the Center structure. Clinical trials and therapeutic development approaches will be beyond the scope of NINDS Udall PD-CWOW efforts; in addition, applications proposing incremental expansion (rather than transformative advancement) of knowledge, data, resources or technologies will not be considered responsive.

In order to facilitate the development of a planning grant application, required components for a Udall PD-CWOW application are expected to include:

• An Overall Section, including but not limited to:
• Statement of and justification for the essential PD challenge.
• Expected impact of the proposed solution.
• Description of synergistic research activities, including:
• Transdisciplinary pursuit of the defined research challenge.
• Harmonization of methodologies, technologies, and approaches.
• Standardization of data and biospecimen collection.
• Justification for the proposed consortium, including unique skills brought to bear
• Well-defined milestones.
• A timeline for key Center events.
• A minimum of three milestone-driven Research Projects.
• An Administrative Core.
• A minimum of one Scientific Core; each Core must support at least two Research Projects.
• A Clinical Core to support human subjects-focused research (if proposed).
• A Resource Sharing Core.
• Scientific Governance structure, including but not limited to:
• Internal Executive Committee.
• External Steering Committee (to be assembled only subsequent to a successful U54 application).
• Other coordinating committees required for optimal Udall PD-CWOW function, e.g.
  • Data coordination/access.
  • Resource coordination/access.
  • Clinical research oversight.
• A dedicated website to provide information to the research community.

Due to the goal-driven nature of the planned U54 FOA and inherent differences from aims-driven approach of the P50 Udall Centers, the Udall PD-CWOW will not include career development and outreach activities. Based on common goals for advancement of PD research, Udall PD-CWOW Program Directors/Principal Investigators will become part of the overall NINDS Udall Centers program, and will be required to participate in annual meetings to exchange information and ideas. As part of the Udall Centers program, a PD-CWOW will be expected to share resources, including knowledge, data and reagents, broadly with the research community, consistent with achieving the goals of the program.

An R34 Planning Grant Award is not a requirement for submission of a Udall PD-CWOW U54 application.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• 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 Higher Education:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• 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
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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. The NIH 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 late submission.

• Dun and Bradstreet 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) (formerly CCR) 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.
• NATO 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program 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.

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 NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The Planning Grant Director (PD/PI) must be an expert investigator with proven stewardship of successful research consortia, eminently qualified to provide visionary leadership of a Udall PD-CWOW as well as effective oversight of Center administrative activities. Leadership of the Udall PD-CWOW will require coordination with existing governmental and non-governmental efforts in PD research, as well as the utilization of available resources and infrastructure to advance the goals of the Center.

Other important PD/PI qualifications include current research funding (NIH R01 equivalent or greater) and outstanding productivity, as well as proven success in the effective leadership of innovative transdisciplinary team efforts. 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 meet stated goals. Expertise in other neurodegenerative diseases and disciplines is encouraged, if the Director s skills can be applied in novel ways to resolution of the chosen PD challenge. The PD/PI must be located at a US institution, and must dedicate substantial effort to Planning Grant activities. The PD/PI would be expected to commit substantive effort to a Udall PD-CWOW application.

An Associate Director with similar qualifications may be named; the primary role of the Associate Director will be to assist the PD/PI with coordination of planning efforts.

Directors of active, large-scale research efforts, including NIH multi-component grants (e.g. NINDS Udall Center, P50; NIA Alzheimer's Disease Research Center, P50, or Core Center, P30; NIH Program Project Grant, P01), are eligible to apply as PD/PI. However, the proposed planning efforts must be novel, in terms of team and science, and non-overlapping with ongoing research efforts. In addition, PD/PI effort must be commensurate with effective leadership of an intensive year of R34 planning activities. The PD/PI would be expected to prioritize Udall PD-CWOW efforts, and adjust other activities as necessary.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• 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).

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• 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:

Beth-Anne Sieber, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
6001 Executive Boulevard, Room 2223
Bethesda, MD 20892-9525
Telephone: 301-496-5680
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

The applicant institution should have the potential for effective coordination of the planning grant as well as the subsequent Udall PD-CWOW effort.

All collaborating sites must have the potential and resources to make effective contributions to the resolution of the identified research problem.

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities & Other Resources: Highlight resources or services available at proposed sites. If key personnel are housed at foreign institutions, their participation must be justified on the basis of special opportunities for contribution to consortium goals through the use of unusual talent, resources, populations, or environmental conditions that are not readily available in the United States or that augment an existing U.S. resource.

Other Attachments: The following information should be uploaded as individual attachments. The filenames are indicated below; these will be used to bookmark the attachment in the application image.

• Organizational Structure: provide a diagram that details interactions among participating investigators and sites, including available resources that may be leveraged in subsequent Udall PD-CWOW efforts.
• Timeline: provide a narrative timeline or table outlining specific objectives, including transition from planning to implementation phase (i.e. submission of an NINDS Udall PD-CWOW application).

All instructions in the SF424 (R&R) Application Guide must be followed.

Planning Grant key personnel must be established investigators who are optimally qualified to provide effective leadership of future scientific projects or research cores within the consortium. Other important considerations include current research funding (NIH R01 equivalent or greater) and excellent productivity, as well as successful participation in collaborative research efforts. In addition, key personnel must have the seniority and skills required for effective project or core leadership in the subsequent Udall PD-CWOW application. The expertise of key personnel may focus in areas other than PD research, if relevant skills can be readily applied to achievement of future Udall PD-CWOW milestones. Investigators are responsible for working closely with the PD/PI to meet consortium goals.

To optimize novel team approaches and perspectives in addressing critical challenges, key personnel must include at least one individual with expertise outside of the PD field and be anchored by at least one individual with PD expertise. Inclusion of international collaborators with critical expertise for reaching proposed goals is encouraged. All key personnel must dedicate appropriate effort to pursuit of Planning Grant activities.

Key personnel will also include a Planning Grant Coordinator. The Coordinator must be proficient in NIH grant policies and business practices, and provide consultation in matters of fiscal administration; consortium investigators should not assume this role. The Coordinator will work closely with the PD/PI on overall implementation of planning activities and communicate with consortium members. A biosketch for the Coordinator should be included.

All instructions in the SF424 (R&R) Application Guide must be followed.

Requested budget should reflect proposed planning activities, which should include, but is not limited to, the following:

• Initial planning meeting to convene the research consortium and refine approach, including:
• Travel, lodging and per diem costs for consortium participants.
• Audiovisual and technical equipment rental and related support.
• Rental costs for conference space.
• Supplies needed for conduct of the meeting.
• Periodic (frequent) teleconferences and/or web meetings.
• Conclusive Udall PD-CWOW application planning meeting.
• (Costs will be budgeted as for the initial consortium meeting)
• Salary support required to enable effective planning leadership by the PD/PI, the Coordinator, and essential key personnel at the applicant institution.

To promote efficient spending, budgeted costs for consortium travel will be within range of local per diem rates (as per General Services Administration (GSA) guidance) and follow general NIH guidelines for travel and expense reimbursement.

The following budget requests are out of scope:

• Funds for research-related activities.
• Funds for planning meetings held at non-US sites.
• Funds for transportation costs exceeding US carrier coach class fares.
• Funds for food and beverages.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

This R34 focuses solely on planning activities, and is not designed for research activities, including the collection of preliminary data (pre-clinical or clinical) or of prospective data to support rationale for future clinical studies.

Specific Aims: Identify the essential PD challenge to be addressed by the ensuing PD-CWOW application, and if relevant, the associated NINDS PD2014 research recommendation(s). Clearly state the objectives of the proposed planning effort, including the overarching theme for the Udall PD-CWOW effort. Describe planning activities directed toward the subsequent preparation of a full-scale NINDS Udall PD-CWOW application.

Research Strategy: Applicants must propose a compelling vision, strategic approach and a spectrum of planning activities best suited to their collaborative goals. Organize the Research Strategy into sections on Significance, Innovation and Approach.

Significance: Provide a vision statement for the Planning Grant. Include justification for (i) the importance of the PD research priority to be addressed, framed (if applicable) according to selected NINDS PD2014 recommendations; (ii) how convening the proposed, novel research consortium will transform scientific knowledge, treatment and/or clinical practice by surmounting roadblocks to essential questions in PD research, and/or realization of PD2014 research priorities; and (iii) the strategy by which the proposed activities will lead directly to an NINDS Udall PD-CWOW (U54) application. Describe the means by which planning efforts establish a "proof of concept" conceptual and organizational framework that will serve as the robust foundation for a full-scale Udall PD-CWOW application.

Innovation: Justify the establishment of a novel, consortium-based effort to address the identified research challenge, including unique skillsets and combined knowledge that will be brought to bear. Provide evidence that the proposed planning activities will address the stated challenge through dynamic use of collaborative approaches and resource sharing among participating sites. Detail novel means proposed to facilitate consortium communication during the planning process.

Approach: Detail how proposed activities will address a defined PD research challenge and describe the strategy by which the goals of the planning grant will be met.

• PD Challenge: Define the essential PD challenge to be addressed by the Planning Grant. Directly relate the theme and planning objectives to the NINDS PD2014 recommendations and/or the stated research challenge. Justify the significance and timeliness of the challenge using literature citations, data from other sources, or when possible, from investigator-generated data; preliminary data is not required.
• Research Consortium: Describe the research consortium, leadership structure and the role of its members in addressing the stated research challenge and meeting collaborative planning goals. Detail the administrative, technical, and scientific responsibilities for planning grant key personnel. Describe the novel contributions of the team to PD research, including any unconventional approaches that may be utilized to resolve the selected PD challenge; for members with alternate expertise, describe how their contributions will be brought to bear to advance project goals. Highlight relative contribution of resources and services to the goals of planning efforts as well as a following PD-CWOW application; include a description of how existing tools will be leveraged for research management and broad sharing of data and resources, consistent with achieving the goals of the program. Provide confirmation of investigator commitment to partner around common long-term PD research goals. Provide a plan for team continuity throughout the planning period and PD-CWOW activities. Detail how geographically separate investigators will be aligned into a cohesive planning approach. Detail relevant collaborative connections among planning sites and other entities such as nongovernmental organizations and industry.
• Planning Activities: Provide a timeline for planning meetings and teleconferences. Provide details regarding location and structure of the initial planning meeting, which should be held within 2 months of award. Provide information on frequency of teleconferences and/or web meetings to maintain consortium communication. Detail approaches, including available information technologies (e.g. web-based sharing, data portals) that will be used to facilitate communication and coordination among investigators across geographic locations. Provide a proposed date, location and structure for a meeting to conclude planning via development of final milestones and preparation of a U54 application submission.
• Administrative Structure and Governance: Describe the administrative structure for the planning grant, including lines of communication, decision-making processes, and procedures for resolving conflicts. Describe plans to convene an internal Executive Committee, consisting of the Director (PD/PI), Associate Director (if applicable), project Coordinator, and key personnel, to assist the Director with scientific and administrative decisions. Describe Executive Committee activities, including regular meetings to discuss consortium activities and direction. Describe inclusion of institutional officials in planning discussions.
• External governance structure should not be implemented for the Planning Grant. An external Steering Committee will be required for Udall PD-CWOW governance, and should be assembled only subsequent to the award of a successful U54 application, in collaboration with NINDS program staff.
• Standardized Biospecimen and Data Collection Procedures: Acknowledge and include plans to use standardized procedures for collection of biospecimens and clinical data, described in "NINDS Research Standardization Practices" in Part 2, Section IV.7.

Letters of Support:

Institutional Commitment (required): Provide endorsement from appropriate institutional officials, including a description of how a Planning Grant effort will provide a foundational environment for a subsequent NINDS Udall PD-CWOW application. Applicant institutions receiving funding for large-scale PD research projects, including NINDS Udall Centers (P50) and Parkinson's Disease Biomarkers Program (PDBP; U01) projects and Program Project Grants (P01), should detail potential interactions with the R34 program in this context. Additional examples of large-scale efforts include, but are not limited to: NIH Accelerating Medicines Partnership (AMP), National Institute on Aging (NIA) Alzheimer's Disease Research Center (ADRC, P50) or Core Center (ADCC, P30), Parkinson's Disease Foundation (PDF) Centers, National Parkinson Foundation (NPF) Centers of Excellence, Department of Defense Neurotoxin Exposure Treatment Parkinson's Research (NETPR) program funding, and large-scale Michael J. Fox Foundation (MJFF) projects/consortia.

Institutional Partnerships (if applicable): Applicants are encouraged to leverage institutional partnerships and programs to further R34 (and future Udall PD-CWOW) goals. Provide letters from institutional partners that will collaborate to advance R34 planning goals; such partners may include large-scale research efforts mentioned above (e.g. NIA ADRC, ADCC) as well as additional programs that may advance planning goals, e.g. the Clinical and Translational Science Awards Program (National Center for Advancing Translational Sciences, NCATS).

Collaboration 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 consortium. 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 applicable). Additional information is available in Part 2. Section IV.7, below.

Collaboration with Non-Federal Entities (if applicable): PD researchers share common goals (e.g. for understanding etiology and improving treatment) with nongovernmental, philanthropic and international research organizations, as well as with the biotechnology and pharmaceutical sectors. Letters should detail planned partnerships between the consortium and these groups, including the allocation of related knowledge, data or resources.

Resource 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.

Rapid, organized, and broad resource sharing consistent with achieving the goals of the program will be expected for future Udall PD-CWOW awards.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Not Applicable

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

NIH intramural researchers may serve as collaborators or consultants on Planning Grant activities.

During the application process, intramural researchers must provide their Scientific Director with copies of formal letters of collaboration, and in turn obtain written approval from the Scientific Director for inclusion within the R34 application. All requests for substantial intramural involvement in extramural research activities must also be approved by the Ethics and Grants Management Offices from the respective NIH Institute or Center (IC).

Funds for intramural support cannot be included in the R34 application. If a Planning Grant application is selected for award, appropriate funding will be provided by the NIH Intramural Program. Budget requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

According to NIH policy, successfully reviewed applications with substantial intramural involvement will be converted to a cooperative agreement mechanism, with related terms and conditions, prior to award of funds.

At an early planning stage, Planning Grant applicants intending to collaborate with NIH intramural investigators are encouraged to communicate with the NINDS Scientific/Research Contact, below.

Although research activities are not within scope of Planning Grant activities, all human subjects-focused studies in a subsequent NINDS Udall PD-CWOW will employ a common set of tools and resources that will promote the collection of standardized biospecimens and data across sites. Therefore, applicants should familiarize themselves with related policies, and relay plans for research standardization of biospecimen collection/distribution/storage, use of Common Data Elements (CDEs) for collection of clinical data, and data collection and storage through the NINDS PD Data Management Resource (PD-DMR) in future proposed PD-CWOW research efforts. The following information is provided to foster planning efforts.

Biospecimen Collection and Distribution

In future Udall PD-CWOW (U54) efforts, biospecimens must be collected using protocols of the NINDS Parkinson's Disease Biomarkers Program (PDBP) Laboratory Manual. These procedures are virtually identical to the Parkinson's Progression Markers Initiative of the Michael J. Fox Foundation. If site logistics are challenging regarding the PDBP protocols, then the Alzheimer’s Disease Neuroimaging Initiative (ADNI) protocols could be used as an alternative, pending approval of the NINDS program officer.

PD-CWOW applicants will also be expected to utilize NINDS repositories for storage of biospecimens. In 2015 the NINDS established two new repositories, for biomarkers and for human cells. The NINDS Biospecimen Exchange for Neurological Disorders (NINDS BioSEND) currently banks a variety of biospecimens including DNA, plasma, serum, RNA, CSF, and saliva using standardized procedures.

The NINDS Human Cell and Data Repository (NCHDR) supports the reprogramming, gene editing, banking and distribution of fibroblasts and induced pluripotent stem cells for neurological disorders, including PD.

Consent forms for Udall PD-CWOW clinical studies must clearly state that any biological samples and de-identified clinical data will be appropriately shared with academics or industry and must be consistent with the designated NINDS Repository and NINDS PD Data Management Resource (PD-DMR) broad consent requirements.

NINDS Common Data Elements (CDEs)

In order to maximize data standardization across studies, the NINDS strongly encourages researchers to use the NINDS Common Data Elements. The NINDS PD-DMR has developed web-based forms to assure ease of data entry and quality assurance. Some of these assessments may be self-administered in order to reduce subject and study burden. Subsequent Udall PD-CWOW research projects and cores will utilize General and PD-specific CDEs.

Data Management and Storage

Future PD-CWOW research efforts will use the NINDS Parkinson's Disease Biomarkers Project Data Management Resource (DMR) to store biospecimen-related and clinical data collected for Center projects and cores. The PD-DMR provides an essential data coordination tool for the entire PD research community through the development of a web-based data management system that provides tools to NINDS-supported projects for both the collection and quality assurance of data in a standardized format. The DMR also coordinates the assembly of de-identified data into a common database thus enabling the query and distribution of aggregate data for the acceleration of PD research. For NINDS-supported clinical projects, patient consent must allow broad sharing of de-identified data and biospecimen resources though the PD-DMR and NINDS Repositories as appropriate.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

This FOA supports only those organizational activities directed toward the ensuing submission of an application for an NINDS Udall Parkinson's Disease Center without Walls (Udall PD-CWOW; U54). The R34 application must provide substantial evidence to support the potential for a novel, highly skilled investigative team to surmount a critical obstacle in PD. Preliminary data are not required for R34 applications; while investigator-generated data may be included, justification for the proposed work may be provided through literature citations and data from other sources, together with citation of NINDS PD2014 research priorities (if applicable). Accordingly, reviewers will emphasize the significance of the problem proposed, the conceptual and organizational framework, the novelty and unique skill set of the investigative team, the strength and timeliness of the proposed planning activities, and the potential transformative impact of a prospective PD-CWOW upon the PD field.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Reviewers will also be asked to consider the following:

Does the Planning Grant application identify a critical barrier to progress in the understanding and treatment of PD, one that requires resolution by a novel, transdisciplinary research consortium using a milestone-based approach? Is the vision statement sufficiently compelling to support planning for a future Udall PD-CWOW effort? Is the PD research challenge clearly defined? If applicable, is relation to NINDS PD2014 research priorities clearly stated?

Is the proposed focus potentially transformative, rather than an incremental refinement of theoretical concepts, approaches and/or methodologies? Is there potential for subsequent Udall PD-CWOW efforts to resolve an essential challenge in PD?

Will proposed planning efforts establish a "proof of concept" conceptual and organizational framework that will serve as a robust foundation for a full-scale Udall PD-CWOW application?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Is the PD/PI a scientific leader with outstanding productivity and expertise in PD and/or other research area? Does the PD/PI have the creativity, drive, seniority and administrative experience to coordinate planning as well as to lead a future NINDS Udall PD-CWOW application? Does the PD/PI have proven success in the effective leadership of transdisciplinary team efforts? Does the PD/PI have current funding (NIH R01 or equivalent)? Is the effort commitment of the PD/PI appropriate for the intensive timeline leading to submission of a PD-CWOW?

Does the proposed consortium represent a new, rather than established, collaborative effort?

Is the investigative team comprised of creative, eminently qualified investigators who would be optimal participants in a full-scale Udall PD-CWOW to address the chosen topic? Will team members provide transdisciplinary scientific perspectives required to successfully address the stated challenge? Is compelling justification provided for selected participants, including their leadership in the proposed area of investigation, expected contributions to the significance and synergy of proposed activities, as well as their unique skillsets and combined knowledge? Are the roles of team members clearly defined? Are the investigators currently productive and funded by independent R01 (or equivalent) support? Is the effort commitment of consortium investigators appropriate to meet planning timelines?

Is the research team anchored by at least one investigator from within and informed by at least one investigator with expertise from beyond the PD research field?

How strong are the qualifications of the internal Executive Committee?

If key personnel are housed at foreign institutions, is their participation justified on the basis of special opportunities for contribution to consortium goals through the use of unusual talent, resources, populations, or environmental conditions that are not readily available in the United States or that augment an existing U.S. resource?

If investigators currently holding large multi-component grants or Centers will participate: are their efforts novel, in terms of team and science, and non-overlapping with their currently supported efforts? Is their commitment sufficient to accomplishing the goals of the planning grant?

Does the project Coordinator have the necessary skills and knowledge to capably partner with the PD/PI and communicate effectively with consortium members?

At the end of the planning period, will the proposed consortium be poised to effectively address the proposed PD research challenge?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the application justify the initiation of a novel, transformative, consortium-based effort to address the identified PD research challenge in a goal-driven manner? Is the proposed consortium novel? Is evidence provided that the proposed planning activities will address the stated challenge through dynamic use of collaborative approaches and resource sharing among participating sites? Are novel means to facilitate communication proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Is strong justification provided regarding the essential nature of the identified PD challenge? Are the overarching theme and specific objectives of the planning effort clear? Do the proposed objectives have the potential to transform PD research, rather than make incremental advances in knowledge or technology? Does the proposed strategy provide evidence that planning is to be implemented in a strategic, effective and efficient manner? Are the planning activities synergistic and aligned with stated goals of the consortium? Is the proposed consortium effort likely to provide an effective foundation for resolution of the stated challenge within a subsequent 5 year PD-CWOW project period?

Is an appropriate leadership structure provided, and are administrative, technical and scientific responsibilities clearly laid out? Are available resources at each site detailed? Are details provided regarding how existing tools will be leveraged for research management and broad sharing of data and resources? Are proposed communication and collaboration strategies sufficiently detailed and appropriate? Is sufficient attention paid to fostering collaborations over geographic distance? Is a strategy in place for team continuity during planning and future PD-CWOW activities? Are relevant collaborative relationships with non-governmental entities described?

How strong are the detailed planning objectives and goals, and are these likely to result in submission of a competitive Udall PD-CWOW application? How strong are the plans for the initial planning meeting, teleconferences and/or web meetings, as well as their timeliness and value to effective fostering of consortium wide communication during the planning process? Evaluate the plans for and timeliness of the proposed meeting to develop final milestones and prepare a U54 application submission.

Based on information provided, what is the likelihood that the administrative structure, including lines of communication, decision-making processes, coordination across geographic sites, and procedures for resolving conflicts, will support an effective planning effort? How strong is the internal Executive Committee's proposed planning responsibilities, and will this group facilitate planning efforts? What is the value to overall efforts of plans for communication with institutional officials at the applicant institution?

Does the application include a description of standardized data and biospecimen collection methods to be utilized by the consortium in a future PD-CWOW? Are related NINDS policies and procedures acknowledged?

If the aims of the Planning Grant are successfully completed, what is the likelihood that the investigative team will have an optimal strategy for a subsequent NINDS Udall PD-CWOW application?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

How strong are the features of the proposed research environments that ensure success of a future Udall PD-CWOW?

How well does the applicant institution demonstrate the potential for effective coordination of the planning grant as well as the subsequent Udall PD-CWOW effort?

How appropriate are the significant potential and specific dedicated resources at all sites that will allow effective contributions to the resolution of the identified research problem? How well will existing resources at each site be leveraged to meet the goals of a Udall PD-CWOW?

How appropriate are institutional commitments proposed to support the goals of the research consortium during the planning process, and also during a potential future CWOW project period? If other large-scale PD projects exist at participating institutions, how well will potential resources and collaborations be utilized?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not applicable.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NINDS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke (NANDS) Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Areas of complementarity to existing NINDS Udall Centers and other ongoing, large-scale PD research efforts.
• Number of applications from each institution (only one planning grant will be awarded per institution).
• Potential to directly and effectively address priorities identified in NINDS PD2014 research recommendations or a defined critical challenge in PD research.

Additional NINDS considerations during the selection of Planning Grant applications include:

• The qualifications and experience of the PD/PI and other key personnel.
• The novelty of the proposed research consortium.
• The statutory and program purposes to be accomplished.
• The potential to rapidly advance PD research using a goal-driven approach to resolve an essential challenge.

The NINDS will consider the full scope of PD programmatic activities when making funding decisions; applications proposing goals identical to or largely overlapping with active Udall Centers and/or other large-scale PD research efforts will receive lower program priority. The NINDS will prioritize innovative applications with greatest potential to develop a subsequent Udall PD-CWOW application.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Beth-Anne Sieber, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: [email protected]

Birgit Neuhuber, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-3562
Email: [email protected]

Tijuanna Decoster, PhD, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.