Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NIH Blueprint for Neuroscience Research

National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Research Resources (NCRR)
Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

NIH Blueprint for Neuroscience Research Short Courses in Neurotherapeutics Development (R25)

Activity Code

R25 Education Projects

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-NS-12-001

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestics Assistance (CFDA) Number(s)

93.113, 93.121, 93.142, 93.143, 93.172,93.173, 93.213, 93.233, 93.242, 93.273 ,93.279 ,93.286 ,93.307, 93.361, 93.389,93.393, 93.394, 93.395,93.396, 93.399, 93.837, 93.838, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879, 93.989

FOA Purpose

This FOA solicits Research Education Grant (R25) applications to develop and implement short courses on neurotherapeutics development for academic neuroscientists. The short courses should provide participants with a sufficient overview of the neurotherapeutics development process to (1) understand the steps required for therapeutics development, (2) anticipate and overcome common challenges in the process, and (3) interact effectively with collaborators who have expertise in various aspects of therapeutics development. The short courses should primarily target independent academic neuroscience researchers and senior post-doctoral fellows interested in incorporating treatment development into their research programs.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

March 11, 2011

Letter of Intent Due Date

March 11, 2011

Application Due Date(s)

April 11, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

July 2011

Advisory Council Review

October 2011

Earliest Start Date(s)

December 2011

Expiration Date

April 12, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the ). 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

This FOA solicits Research Education Grant (R25) applications to develop and implement short courses on neurotherapeutics development for academic neuroscientists. The short courses should provide participants with a sufficient overview of the neurotherapeutics development process to (1) understand the steps required for therapeutics development, (2) anticipate and overcome common challenges in the process, and (3) interact effectively with collaborators who have expertise in various aspects of therapeutics development.

This FOA is an initiative of the NIH Blueprint for Neuroscience Research, a consortium of sixteen NIH Institutes and Centers who support neuroscience research (http://neuroscienceblueprint.nih.gov/blueprint_basics/about_blueprint.htm). By pooling resources and expertise, the NIH Blueprint for Neuroscience Research takes advantage of economies of scale, confronts challenges too large for any single Institute or Center, and develops research tools and infrastructure that serve the entire neuroscience community. In 2010, the NIH Blueprint established the Grand Challenge for Neurotherapeutics in response to the paucity of effective treatments for disorders of the nervous system. This short course initiative is one of several strategies to address the Grand Challenge for Neurotherapeutics. As such, short courses developed under this initiative must have a neuroscience focus and must address the unique challenges inherent in developing treatments for nervous system disorders, such as blood-brain barrier penetration and limitations of animal and cell-based models for evaluating novel treatments for neurological and behavioral disorders. The courses also must be broadly applicable diseases of the nervous system, rather than focusing on a single disease or disease class. The NIH Blueprint for Neuroscience Research anticipates funding one R25 award under this FOA. The NINDS may fund a second award, if there is an additional application that is highly meritorious and significantly different from the Blueprint-funded application in the format, focus, or approach of the proposed short course.

The short courses should provide a general overview of the therapeutics development process and address the particular challenges (both technical and strategic) that academic neuroscientists are likely to face in planning and conducting drug discovery research. The courses should clearly identify the types of expertise and collaborations typically required to initiate a successful discovery program. The curriculum should draw upon lessons learned in academia and in the biopharmaceutical industry.

Topics to be covered in the courses may include, but are not limited to:

Short courses should include faculty with extensive experience along the therapeutic development pipeline. Faculty should be drawn from both academia and industry and include a diverse range of perspectives. Faculty may also include representatives from government agencies, such the Food and Drug Administration (FDA).

Participants in the short courses should be primarily independent academic neuroscience researchers and senior post-doctoral fellows with a strong interest in incorporating therapeutics development into their research programs. Participants should include basic researchers and clinician scientists. The NIH encourages all proposed short courses to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and women. The short courses should be broadly accessible and relevant to the U.S. neuroscience community. Host institution affiliates should not make up more than 20% of the total course enrollment.

The proposed short courses may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and cannot be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.

Applicants should consider the needs and constraints of the target participants in conceptualizing the course duration and structure. The courses should be attended in person, but applicants are encouraged to utilize internet-based technologies, such as the web and podcasts, to disseminate course materials and lectures as broadly as possible. Courses should combine lectures with discussions and interactive sessions that demonstrate approaches to specific therapeutic development steps and problems. The use of case studies is encouraged.

Support for short courses is available for up to five years. The first year may be devoted to curriculum development and planning, with courses held annually thereafter.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2012:
NIH Blueprint for Neuroscience Research, $300,000, for one award

NINDS, $240,000, for one award

Award Budget

Direct costs of up to $250,000 per year may be requested. To the extent possible, the budget should be designed to defray participant costs in the years when the courses will be held...

Award Project Period

The maximum period is 5 years.

Other Award Budget Information
Personnel Costs

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds).

While there are no caps on personnel costs beyond the standard NIH policies, applicants are strongly urged to minimize personnel expenses during the years when courses will be held so that most of the funds in those years can be used to defray participant costs.

Participant Costs

To the extent possible, the budget should be designed to defray participant costs. Course registration costs to participants should be covered under the proposed budget. Participants in the short course may receive a per diem to help cover meals and assistance with temporary housing.

Expenses for participant travel must be exceptionally well justified.

The participants in the short courses should be primarily independent researchers and senior-level post-doctoral researchers. Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the R25 mechanism, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25 mechanism is not intended as a substitute for an NRSA institutional training program (T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

Other Program-Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.  

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Preceptors/Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants

Applications must describe the intended participants, and the eligibility and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels essential for participation in the planned program.

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

.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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Rebecca Farkas, Ph.D.
Office of Translational Research
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
Neuroscience Center/Room 2109
Bethesda, MD 20892
For courier service only, use Rockville, MD 20852
Telephone: 301-496-1779
Email: farkasr@ninds.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow the instructions in the SF 424 (R&R) to determine which components are required.

Page Limitations

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

SF424 (R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

Facilities & Other Resources

Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.   

R&R Budget Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

PHS 398 Research Plan Component

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

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below: Proposed Research Education Program, Institutional Environment and Commitment, Program Director/Principal Investigator, Program Faculty/Staff, Program Participants, Diversity Recruitment and Retention Plan, Plan for Instruction in the Responsible Conduct of Research, Evaluation Plan, Dissemination Plan.

Proposed Research Education Program (Component of Research Education Program Plan)

While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly describe the distinction between the intended participants in the proposed research education program and the research training supported by the training program. The information should include a description of the education and/or career levels of the planned participants.  Applicants should identify specific challenges facing academic neuroscientists in pursuing translational research and how the proposed courses will help participants address these challenges. The applicant should provide a description of the topics to be covered in the short courses and the format for the proposed courses, including the length of the course, teaching methods to be used, and the proposed class size.

Institutional Environment and Commitment (Component of Research Education Program Plan)

Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under “Facilities & Other Resources”), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.   

Program Director/Principal Investigator (Component of Research Education Program Plan)

Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.      

Program Faculty/Staff (Component of Research Education Program Plan)

Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of NIH. Provide biosketches for key faculty members and letters from those individuals indicating their interest in teaching the short course.

Program Participants (Component of Research Education Program Plan)

Where the proposed program involves participants, provide details about the pool of expected participants, their qualifications, recruitment strategies and sources of applicant pool, etc. Indicate how participants will be selected, including the selection criteria to be used.

Recruitment and Retention Plan  to Enhance Diversity (Component of Research Education Program Plan)

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americas, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the US Pacific Islands. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.

New applications must include a description of plans to enhance recruitment of a diverse participant pool and may wish to include data in support of past accomplishments.

Applications lacking a diversity recruitment and retention plan may be delayed or not accepted for review. An award cannot be made if an application lacks this component.

Plan for Instruction in the Responsible Conduct of Research (Component of Research Education Program Plan)

Every participant supported by this Research Education grant must receive instruction in the responsible conduct of research. All applications must include a plan to provide such instruction. The plan must address five components (format; subject matter; faculty participation; duration of instruction; and frequency of instruction) as detailed in NOT-OD-10-019.

Applications lacking a plan for instruction in responsible conduct of research may be delayed or not accepted for review. An award cannot be made if an application lacks this component. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Evaluation Plan (Component of Research Education Program Plan)

A plan must be provided for program evaluation. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report short or long-term outcome measures that would determine the success of the research education program in achieving its objectives. Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program improvements.

Dissemination Plan (Component of Research Education Program Plan) A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sample curricula, web postings, presentations at scientific meetings, workshops, etc.

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.  There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

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.   

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.  

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NINDS Referral Office by email at nindsreview.nih.gov@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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

Scored Review Criteria

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.

Significance

Does the proposed research education program address an important problem or critical question in research education or other critical issues?  How will implementation of the proposed program advance the objectives of the proposed program?  Will the proposed short course provide a comprehensive overview of the neurotherapeutics development process? Does the proposed course adequately address challenges unique to neurotherapeutics development and common to many diseases of the nervous system? Does the proposed course address the key challenges of pursuing drug development an academic environment?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program?  If Early Stage Investigator or New Investigator, or in the early stages of an independent career, does the PD/PI have appropriate experience to lead the program?  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 there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives? Does the faculty for the short course include individuals representing the appropriate breadth of neurotherapeutics development expertise and a broad range of perspectives? 

Innovation

Is the proposed research education program characterized by innovation and scholarship?  Does the proposed program challenge and seek to shift current research education paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area?  Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere?  Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program?     

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  If called for, is the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program?  Is there evidence that the program is based on sound research concepts and educational principles?  Is the approach feasible and appropriate to achieve the stated research education goals?  If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? 

If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is the proposed course designed to attract and engage independent researchers and senior post-doctoral fellows who are likely to go on to initiate and/or lead new neurotherapeutics development projects?

Environment

Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success?  Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed?  Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Is there evidence of appropriate collaboration among participating programs, departments, and institutions?  If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?

Additional Review Criteria

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

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

Not applicable

Additional Review Considerations

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

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the research education program, level of participant experience, and the particular circumstances of the participants, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g. lectures and/or real-time discussion groups?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety?  Do the plans adequately describe how faculty will participate in the instruction?  Do the plans ensure participants will receive instruction (or in the case of more senior level participants, provide instruction) for an appropriate amount of time given the length of the research education experience?  If this is a renewal, is there a report describing past instruction in the five components described above?  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus rating of the review committee. Applications rated UNACCEPTABLE will not be funded until the applicant provides an acceptable, revised plan.

Applications from Foreign Organizations

Not applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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 General.

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 business official.

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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.

Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, participants are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

3. Reporting

The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements (Financial Status Report) as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and acceptedPrograms that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the PHS 2590 Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards.

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. 

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

Other Reporting Requirements

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Rebecca Farkas, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: farkasr@ninds.nih.gov

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: nindsreview.nih.gov@mail.nih.gov

Financial/Grants Management Contact(s)

Tijuanna E. DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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