Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Specialized Neuroscience Research Program (SNRP) (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

  • August 1, 2012 - See Notice NOT-NS-12-020. The purpose of this notice is to inform the extramural research community that the NINDS will host a technical assistance webinar for applicants.

Funding Opportunity Announcement (FOA) Number

RFA-NS-13-004

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.853

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute of Neurological Disorders and Stroke (NINDS) encourages applications to augment and strengthen emerging research programs focused on NINDS mission related research at institutions committed to increasing diversity in the neuroscience workforce. For the purposes of this FOA, Specialized Neuroscience Research Programs (SNRPs) are defined as those institutions with NINDS funding less than $25 million total cumulative costs over the 3 years leading up to the application. The intent of the SNRP is to promote opportunities to improve the research infrastructure at academic institutions with emerging NINDS mission related research programs to engage researchers in novel, cutting edge research. It also provides early stage investigators with the opportunity for intensive research experiences to promote scholarship in discovery, integration, and the application of knowledge in basic and translational neuroscience research. Support from SNRP facilitates the planning, implementation and evaluation of meritorious exploratory research projects; stimulates effective collaboration among academic researchers to advance neuroscience knowledge; broadens participation in neuroscience research by engaging institutions, organizations and individuals in NINDS mission relevant research; and increases the academic preparedness of students from diverse backgrounds for advanced neuroscience research careers.

Key Dates
Posted Date

July 10, 2012

Letter of Intent Due Date

September 23, 2012

Application Due Date(s)

October 23, 2012  

AIDS Application Due Date(s)

November 27, 2012

Scientific Merit Review

February - March, 2013  

Advisory Council Review

May 2013

Earliest Start Date(s)

July 1, 2013

Expiration Date

November 28, 2012

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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

Purpose

This FOA issued by the National Institute of Neurological Disorders and Stroke (NINDS) encourages applications to augment and strengthen emerging research programs focused on NINDS mission related research at institutions committed to increasing diversity in the neuroscience workforce. For the purposes of this FOA, Specialized Neuroscience Research Programs (SNRPs) are defined as those institutions with NINDS funding less than $25 million total cumulative costs over the 3 years leading up to the application. The intent of the SNRP is to promote opportunities to improve the research infrastructure at academic institutions with emerging NINDS mission related research programs to engage researchers in novel, cutting edge research. It also provides early stage investigators with the opportunity for intensive research experiences to promote scholarship in discovery, integration, and the application of knowledge in basic and translational neuroscience research. Support from SNRP facilitates the planning, implementation and evaluation of meritorious exploratory research projects; stimulates effective collaboration among academic researchers to advance neuroscience knowledge; broadens participation in neuroscience research by engaging institutions, organizations and individuals in NINDS mission relevant research; and increases the academic preparedness of students from diverse backgrounds for advanced neuroscience research careers.

Background

A unique aspect of the U.S. higher education system is the extent to which fundamental research is conducted at universities with doctoral level education organized around intensive real-world research experiences. This uniqueness also is reflected in the diversity of the institution's missions, learning environment, selectivity, and student population. According to Carnegie Classifications (http://classifications.carnegiefoundation.org/), research institutions (i.e., doctorate-granting institutions) with very high research activities award the majority of the science and engineering degrees, and continue to be an indispensable and fundamental cornerstone to U.S. global competitiveness. Doctorate-granting research institutions classified with high research activity and special focus medical schools have demonstrated a commitment to educating and making substantial contributions to the pool of doctorate recipients from diverse backgrounds. Strategic efforts to insure diversity in the nation’s workforce, especially efforts to increase the academic readiness of diverse students and fellows for advanced careers in neuroscience, should focus on enhancing opportunities for research institutions with high research activity and special focus medical schools to develop their emerging neuroscience research programs.  Additionally, these opportunities should increase the pool of new and diverse research talent for the biomedical research enterprise.

The National Institutes of Health (NIH) is the nation’s lead agency supporting scientific research that advances the discovery of new knowledge to improve human health.  To fulfill its mission, the NIH must attract and retain the most talented researchers from a globally competitive marketplace.  The NIH recognizes the role(s) that academic research universities contribute to science innovation and in recruiting and preparing well-trained researchers. The NIH promotes diversity as a means to insure progress in the production of new knowledge while developing the scientific workforce. The NIH expects that its efforts to diversify the workforce will lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; and to balance and broaden the perspectives in setting research priorities. Accordingly, the NIH continues to encourage institutions to enhance diversity among their student and faculty populations and thus to increase the participation of individuals from groups currently underrepresented in the biomedical and translational sciences at the national level.

The mission of the NINDS is to reduce the burden of neurological disease - a burden borne by every age group, by every segment of society, by people all over the world. To accomplish this goal the NINDS supports and conducts basic and translational research on the normal and diseased nervous system. To continue to lead scientific innovation and discovery, the NINDS must develop and retain talented individuals able to contribute to new scientific knowledge. Support for SNRP applications with emerging neuroscience programs will expand the research and development competitiveness across a broad range of NINDS mission-related research. These applications provide a major pathway forward for committed institutions to enhance diversity by producing well-trained individuals capable of contributing new knowledge and accelerate discovery. 

The scope of SNRP applications will vary depending on the institutional setting. Each applicant must justify the need for research capacity building in areas relevant to the priorities of the NINDS mission, and all applications must comply with the definition of an eligible institution defined as an institution with NINDS funding less than $25 million total cumulative costs over the 3 years leading up to the application.  (NINDS funding support can be determined at: http://projectreporter.nih.gov/reporter.cfm).

Program Objectives

The SNRP program is designed to increase the quality of education of scientists from diverse backgrounds underrepresented in neuroscience research by promoting opportunities to improve the research infrastructure at a subset of academic institutions on a national level. The SNRP also provides early stage investigators with intensive research experiences to promote scholarship in discovery, integration, and the application of knowledge in basic and translational neuroscience research. Support from SNRP facilitates the planning, implementation and evaluation of meritorious exploratory research projects; stimulates effective collaboration among academic researchers to advance neuroscience knowledge; broadens participation in neuroscience research by engaging institutions, organizations and individuals in NINDS mission relevant research; and increases the academic preparedness of students from diverse backgrounds for advanced neuroscience research careers.

The following objectives have been identified as key elements to obtaining this goal: (1) the Research Program; (2) the Enrichment Program; and (3) Program Evaluation.  All 3 elements are required components of the application and must be addressed as described in detail later in this section. However, the applicant institution has the flexibility to determine the implementation of these elements under the budget limitations of $1 million direct costs.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this FOA 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.

Element I - Research Program

The SNRP program is designed to promote opportunities for academic research institutions with emerging NINDS mission related neuroscience research to achieve the following programmatic goals:

There are 6 required components in the Research Program that must be addressed within the application.  Although all 6 components are required, the applicant has flexibility in the design and implementation of each. The following components of the Research Program (a) Program Leadership, (b) Institutional Commitment and Neuroscience Research Infrastructure, (c) Exploratory Research Projects, (d) Supportive Research Core(s), (e) Advisory Committee, and (f) Administrative Core are described in detail below.

     (a) Program Leadership (required)

Individuals with the skills, knowledge, and resources necessary to carry out the proposed program are invited to work with their institution/organization to develop an application.  Ideally the program will be led jointly by a Scientific Director and an Administrative Director.  On occasion, one individual may be appropriate for the dual roles; however, there should be a strong rationale and justification for assigning both roles to one individual.  The dual directors will be responsible for planning, directing, implementing, executing, and administering the proposed SNRP. 

The SNRP Leadership (Administrative and Scientific Directors) will provide oversight for the entire program and monitor the overall implementation and evaluation of the research projects, supportive research cores, and the enrichment program. The roles and responsibilities of the directors should be clearly outlined.  A plan detailing the working relationship between the Administrative and Scientific Directors and the applicant institution must be included.  The plan should be jointly written by the proposed SNRP leadership and senior officials (e.g., Dean, Provost, Vice President) at the applicant institution. The application should describe the resources (e.g., release time) and support (administrative and program coordinator) that the institution will provide to assist the Scientific and Administrative Director in effectively managing the SNRP program.  

The Scientific Director should be an established and accomplished neuroscience researcher with the ability to provide outstanding scientific leadership.  Evidence of scientific leadership includes current and ongoing independent NIH R01 (or equivalent funding).  Specifically, this includes recent NIH funding (2009 – present), as well as a track record of NIH funding during the past 10 years.  Evidence must be provided that some portion of the NIH funded research was NINDS mission relevant.  In addition, funding support from similar Federal agencies such as the National Science Foundation (NSF) is applicable.  It is expected that the Scientific Director will continue to be scientifically active during the course of the program. The Scientific Director is eligible to receive pilot research funds under the SNRP program; however, he/she will be held to the same level of review as any other faculty member competing for pilot funding.

The Administrative Director should also have a recent history of scientific performance as demonstrated by grant support and publications within the 10 years leading up to the award. The Administrative Director must demonstrate the ability to work effectively with the institution administration, investigative team, and the NIH.  The administrator should have demonstrated excellent supervisory, organizational, planning and training skills. The Administrative Director may be internal or external to the institution, but clear evidence must be provided that he/she has the knowledge and understanding of the institution’s mission, authority structure, and strengths and weaknesses. In addition the Administrative Director must possess the appropriate authority to affect change within the institution.

(b) Institutional Commitment and Neuroscience Research Infrastructure (required)  

Eligible institutions must show evidence of an existing research infrastructure with a focus on neuroscience research that can be built upon to support the SNRP. For the purpose of this announcement research infrastructure is defined as the institutional resources necessary to carry out high quality research projects and programs, excluding direct costs that should be covered by research grants.  Assessments of research infrastructure should include descriptions of available resources such as sponsored research office support, curricula offerings, faculty release time, research equipment support, collaborative arrangements, consultant expertise, and data management.  The applicant institution must also provide a history (previous 3 years) of the neuroscience research conducted within the institution. 

In addition to the description of available institutional resources, the applicant organization must propose a plan outlining the future commitment to enhancing neuroscience research and diversity at the institution. Specifically, the application should describe the institution’s overall mission, including its goals for diversity, organizational structure, and specific details for how the SNRP leadership will interact with the institution’s administrative leadership.  Describe the lines of authority and the organizational procedures that will be in place to ensure the success of the SNRP Directors in achieving the goals of the program. 

A senior administrator with the responsibility and authority to make high-level decisions on behalf of the institution must be named in the application.  This official will work with the institution’s administration and the SNRP leadership to ensure progress of the program.  The plan must also describe the support needed by the institution to fulfill the goals of the SNRP.  Specific benchmarks/measurable objectives to move neuroscience forward at the institution must be described in the application.  At least once a year the senior administrator will report on the institutions progress to the Advisory Committee.

(c) Exploratory Research Projects (required)

The SNRP program will provide support for 1 to 3 exploratory research projects open to all faculty levels.  Exploratory projects are defined as those designed to assess the feasibility of novel areas of investigation or new experimental paradigms that have the potential to enhance neuroscience research.  Examples of exploratory projects include unique and innovative use of existing methodology to explore a new scientific area, studies that break new ground or extend previous discoveries toward new directions or applications, confirmation of the significance of research, feasibility of methods, and refinement of hypotheses.  The total project period for the exploratory projects may not exceed 3 years.  Although the size of the award will vary with the scope of the proposed research, it is expected that projects will stay within the budgetary guidelines of direct costs limited to $325,000 over the 3 years, with no more than $175,000 in direct costs allowed for any single year.  Applications for the exploratory project awards should describe projects that are distinct from those proposed in a traditional R01 mechanism (e.g., long-term projects).  Projects submitted for consideration should be novel and exploratory with studies that aim to break new ground or extend previous discoveries toward new directions or applications. Following the 3 year period, transitional funds to assist in preparation for independent grant funding may be available to successful PI’s who meet their a priori determined outcomes. Outcomes are to be quantifiable and measureable and will be developed by the PI of the project in collaboration with SNRP Leadership, the Advisory Committee, and NINDS. Evaluation of on-going progress of the outcomes will be evaluated by NINDS (see Program Evaluation below for additional detail).

All projects must be clearly related to the mission of NINDS - to reduce the burden of neurological disease – a burden borne by every age group, by every segment of society, by people all over the world. Research projects could include proposals for basic and/or translational research. See http://www.ninds.nih.gov/research/index.htm for details on research programs that fall within the NINDS mission.  

A research plan describing the project methodology must be included for each exploratory research project. The plan should address the following items:

Eligible Project Investigators

Exploratory research projects are open to all faculty candidates; however the following guidelines must be taken into consideration when selecting faculty to direct the projects.

For early stage investigators (those within 10 years of completion of their terminal degree)

For senior investigators (those with more than 10 years since the completion of their terminal degree)

Specific criteria for how faculty candidates were selected as research project directors must be submitted with the application.

Individual Research Development Plan:

Research project directors are responsible for the administration and implementation of their projects, with guidance from the SNRP leadership and the advisory committee.  Individual research development plans for each proposed research project director must accompany the research plan. Individualize development plans should describe resources and activities necessary for increasing the research project director abilities to conduct state-of-the-art neuroscience research.  All research project plans must include descriptions of how the completion of the proposed research project will advance the scientific career of the faculty member and add to the overall competitiveness of the applicant institution with respect to neuroscience research.  In addition, each proposed project should include milestones, benchmarks, and timelines that will be used for ongoing assessment of progress.

Mentorship Plan for Early Stage Investigators:

A mentorship plan is required for Early Stage Investigators (ESIs) who participate in an exploratory research project.  An ESI is defined as an investigator who is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). The mentorship plan must include specific directions for how the mentor will interact with the ESI on the research project.  Quantitative benchmarks and timelines for monitoring progress should be included.  Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.  The research mentor will sponsor and oversee the proposed research project and will ensure that the ESI receives proper guidance and mentoring for a future research career.  Mentors should have expertise in the proposed area of research. They should be committed to participate throughout the total period of the ESI’s research project.  Mentors must show evidence of active externally funded research projects relevant to the mission of NINDS and a track record of research training, including successful former trainees who have established productive scientific careers.  Mentors do not receive support for their salaries or fringe benefits as part of the SNRP program.

(d) Supportive Research Core (required)

The Supportive Research Core coordinates all technical related cores associated with the research projects. The Supportive Research Core, although part of the SNRP program, will be available to all neuroscience research investigators at the applicant institution.  For each core identified, at least one project used to justify the core must be a budgeted SNRP exploratory research project.  Details regarding selection of projects and individual researcher utilization of the core should be described.  In addition, all activities under this core will be managed by a senior-level internal faculty member.  The faculty member selected to direct the core must show aptitude in research through external funding and publications, both current (2009 - present) and a track record (previous 10 years).  The Director of the Supportive Research Core will report directly to the SNRP Leadership, but must also have a strong working relationship with institutional officials. 

(e) Advisory Committee (required)

An Advisory Committee comprised of individuals external to the applicant institution with the relevant expertise in neuroscience research and in the development, administration, and management of research centers is required. The Advisory Committee should consist of 5 to 7 members.  The role of the committee is to provide guidance to the Scientific and Administrative Directors of the SNRP with respect to productivity of all of the key elements of the SNRP program.  Therefore, the Advisory Committee interacts directly with the SNRP Leadership and NINDS.

The applicant institution should describe the composition and specific functions of the committee such as how the committee will interface with the SNRP, institutional officials, and NINDS, meeting frequency, and balance of scientific and administrative expertise.  It is required that the Advisory Committee meets in person at least once a year to discuss an annual evaluation of the program (see program evaluation section).  Funds may be budgeted within the SNRP to cover travel and logistic expenses for this meeting. Applications must include a biographical sketch and letter of commitment from each proposed advisory member.

     (f) Administrative Core (required)

The Administrative Director of the SNRP will oversee the management of the Administrative Core. The Administrative Core is designed to support a research environment necessary to build a cutting-edge and innovative neuroscience research program.  The Administrative Core is responsible for overseeing all SNRP program activities, projects and resources, including the research program, advisory committee, supportive research cores, program evaluation, faculty development activities, and diversity student preparedness component.

Element II - Enrichment Program  

A major goal of the SNRP program is to develop a diverse group of highly trained neuroscientists who have the knowledge, skills, and abilities to conduct NINDS mission relevant independent research.  The Enrichment Program is designed to provide the applicant institution with the necessary resources to train its faculty and students in the skills needed to establish or augment an academic environment supported by independent investigator- initiated funded neuroscience research.  The Enrichment Program should be led by a director who has a strong history of training and mentoring career development.  Specific experience of the proposed director in training and mentoring individuals from diverse backgrounds should be highlighted.  The Enrichment Program consists of two components (a) Faculty Research Development Component and (b) Diversity Student Research Preparedness Component that must be described in the application.

(a) Faculty Research Development Component (required)

The application must describe a plan for how the institution will assist its neuroscience research faculty in augmenting their professional development and career goals, especially for new and early stage SNRP research faculty.  For all faculty involved specifically with the SNRP program, an individual development plan including how they will utilize the Enrichment Program is required.

The objectives of the Faculty Research Development Component are:

The applicant institution has flexibility in how it will achieve the desired objectives stated above. However, specific activities that will be used to achieve the objectives must be provided in detail. Possible activities may include, but are not limited to:

(b)  Diversity Student Research Preparedness Component (required)

The primary aim of the Diversity Student and Fellow Research Preparedness Component is to assist in ensuring that a diverse and highly trained workforce be available to assume leadership roles in the biomedical and neuroscience research arenas.  Specifically, the component should be designed to identinfy and meet the particular needs of undergraduate through postdoctoral students from diverse backgrounds underrepresented in neuroscience research on a national level, including underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds with the knowledge, skills, and abilities necessary to compete for independent NIH training and/or career awards.  The objectives of the Diversity Student and Fellow Research Preparedness Component are:

The SNRP will support up to 4 graduate and/or postdoctoral students from diverse backgrounds for 3 years each. SNRP funds may be used for stipend support, travel costs, and research activities associated with professional development. The most recent stipend, tuition, and research related expenses are described on the Ruth L. Kirschstein National Research Service Award (NRSA) site. The SNRP will also support part time research experience, such as a summer laboratory placement, for up to an additional 4 undergraduate students from backgrounds underrepresented in biomedical research per year. An additional 2 years of funding may be made available to the institution with evidence of successful implementation of the Diversity Student Research Preparedness Component (see Program evaluation section).

Describe in general terms the pool of potential candidates including information about any prior research experience and career level required for acceptance into the SNRP program. It is not necessary to include specific information for proposed candidates. Instead, the plan should describe the characteristics of the ideal student or fellow who would benefit from the SNRP program and add to the overall research environment at the applicant institution. A detailed plan outlining student and fellow recruitment and the criteria used to select students into the program must be described in the application.  In addition, the SNRP leadership should limit appointments to candidates who are committed to a research career and who plan to remain in the SNRP program for a minimum of 2 years (not applicable to part time undergraduate students). By the time of appointment, each candidate must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Individuals on temporary or student visas are not eligible. It is required that each student selected to participate be from 1 of the 3 underrepresented groups in the biomedical sciences (see Faculty Development Component for specific definitions of the 3 groups).

In addition to a recruitment plan, development activities that will be provided to the selected students within the SNRP program should be described. Specifically, the plan should reflect the full range of research development activities that will enable the students to advance to the next level of their careers as well as to increase their competitiveness for NIH training and career awards.  Development activities could include educational enrichment opportunities such as training in responsible conduct of research, classes and seminars geared towards increasing knowledge about disorders that affect the nervous system, formalized mentoring programs to enhance career development, open houses, invitations to lecture series and workshops, laboratory sabbaticals to research intensive institutions with emphasis on increasing diversity within the biomedical workforce, formal collaborations/consortium agreements with outside institutions, attendance to relevant scientific conferences, and joint graduate student-faculty projects.

A mentorship plan is required for all students who participate in the Diversity Student Research Preparedness Component.  The mentorship plan must include specific directions for how the mentor will interact with the ESI on the research project.  Quantitative benchmarks and timelines for monitoring progress should be included. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.  The research mentor will sponsor and oversee the proposed research activities and ensure that the student receives proper guidance and mentoring for a future research career.  Mentors should have expertise in neuroscience research relevant to the student's interest(s). They should be committed to participate throughout the total period of the student's participation in the Diversity Student Research Preparedness Plan. Mentors must show evidence of active externally funded research projects relevant to the mission of NINDS and a track record of research training, including successful former trainees who have established productive scientific careers.  Mentors do not receive support for their salaries or fringe benefits as part of the SNRP program.

It is anticipated that the proposed Diversity Student Research Preparedness Component will complement other ongoing research training programs within the applicant institution and that a number of the participating faculty members will have active research laboratories in which SNRP students will gain relevant research experiences.  Institutions with existing programs must explain what distinguishes this proposed program from the others and how the SNRP Preparedness Component will synergize with other applicable programs.  The application should make clear that the pool of faculty, potential student candidates, and resources are robust enough to support additional programs.  

Once students have been selected into the SNRP program, benchmarks and planned assessments must be established for each student participant.  Examples of potential outcomes may include, but are not limited to, journal submissions, applications for NIH individual grant awards (e.g., F’s and K’s), and presentations at national science conferences. Evaluation of progress will be conducted annually.  The NINDS is interested in examining the long-term impact of the SNRP program in enhancing the neuroscience infrastructure, research environment, and professional development at its grantee institutions.  Therefore the applicant must include plans for how it will track students who have participated in the SNRP program.  How the SNRP program will obtain feedback from current and former scholars must be described.

            Recruitment and Retention Plan to Enhance Faculty Diversity (required)

As part of the Faculty Research Development Component, this FOA requires all applicants to submit a plan for potential recruitment and retention to enhance faculty diversity. All applications must include a description of plans to enhance recruitment of a diverse faculty pool and may wish to include data in support of past accomplishments.  The plan should describe steps to be taken during the proposed award period regarding the identification, recruitment, and retention of faculty from underrepresented groups in the biomedical sciences.  In describing the plan, consider the success and/or failures of recruitment strategies used in the past.  Specifically, describe the efforts to be undertaken by the SNRP program and how these might relate to the overall efforts of the institution at large. 

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 and translational sciences on a national level 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 candidates:

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 data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders.

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:

1.Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. 

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of 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.

Applications without a diversity recruitment and retention plan will be considered incomplete and will not be reviewed.

Element III - Program Evaluation

The NINDS is interested in examining the effectiveness of the SNRP program in enhancing the neuroscience infrastructure, research environment, and professional development of its grantee institutions.  Therefore, each SNRP will be engaged in a dual evaluation over the course of the award. First, all SNRP programs will be required to report annually on common evaluation metrics listed below.  Understanding that each SNRP will have additional goals and objectives that are unique to their program, the second part of the evaluation requires each institution to develop an evaluation plan with metrics to address these goals. 

Each year the Advisory Committee and the NINDS will assess the progress of the SNRP in fulfilling the mission of the overall SNRP program and its individual objectives based on the defined metrics.  NINDS will administratively monitor the success of the program on an annual basis and may suggest adjustments to the evaluation plan as needed.  In addition, progress towards the common evaluation metrics and institution-specific indicators will be reviewed in the third year and funding of years 4 -5 will be contingent on successful performance.  Successful performance will be determined by the Advisory Committee and the NINDS, with final consideration determined by NINDS. 

Common evaluation metrics

The following metrics will be assessed annually with progress determined by NINDS and the SNRP Advisory Committee.   Additional items may be added to this list based on outcome data provided in the yearly progress reports.

Element I - Research Program                                                            

Element II - Enrichment Program

For the second part of the evaluation, each application must contain a detailed plan that will be used in conjunction with the common evaluation metrics to assess the overall success of each SNRP in achieving its goals and objectives. This evaluation plan must include milestones for each key element and its associated objectives, as well as broader programmatic milestones in terms of enhancement of the institutional neuroscience infrastructure and environment necessary to facilitate neuroscience research.  In addition, the Program Evaluation must provide indicators for knowing when the SNRP program has successfully achieved its goals. The institution has flexibility in the design of the evaluation plan; however the plan must be developed in consultation with proposed Advisory Committee.

At a minimum the following items must be included in the plan:

The evaluation plan that is submitted under this FOA will be deemed acceptable or not acceptable by the NINDS. 

In addition to the annual evaluation mentioned above, an overall evaluation of the SNRP program will be conducted within 10 years after the release of this notice.  NINDS will assess the program’s overall effectiveness in fulfilling its mission to augment and strengthen emerging research programs focused on NINDS mission related research at institutions committed to increasing diversity in the neuroscience workforce. Upon the completion of the evaluation, NINDS will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.  Information from the annual evaluation assessments of each institution will be considered in the overall evaluation of the SNRP program.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

NINDS intends to commit $3 million in direct costs in FY 2013.

Award Budget

Overall Budget - An applicant may request a project period of up to five years and a budget for direct costs not to exceed $1.0 million for the first year with incremental increases for recurring costs (i.e., personnel, consultants, supplies, travel and other expenses). Increases in outyear budgets for recurring costs are subject to the availability of funds. Applications exceeding the budgetary limits specified above will be returned to the applicant without peer review. 

Element I - Research Program - a maximum of $650,000 direct costs per year can be requested. The budget for the Research Program should encompass the budget of each key component listed below.

Exploratory Research Projects - Up to $325,000 direct costs over 3  years, with no more than $175,000 in any single year may be requested to support an exploratory project.  Support will be provided for up to 3 exploratory projects for a limit of a three-year period for each.  Transition funds may be requested for years 4-5 to assist in preparation of independent grant funding.  If an exploratory project is favorably recommended for the initial three-year period, funds will be included each year for the full five years. Funds requested in Years 4-5 will be contingent upon successful completion of performance goals for years 1-3 and review and     approval by NINDS staff.     

Other key components - up to $325,000 direct costs can be requested to support SNRP program leadership, neuroscience infrastructure, supportive research cores, administrative core, and advisory committee.

Element II - Enrichment Program - a maximum of $400,000 direct costs can be requested. The budget for the Enrichment Program should encompass the budget of each key element listed below.

Faculty Development Component - up to $125,000 to support development activities

Diversity Student Research Preparedness Component - up to  $275,000 to support up to 4 graduate and/or postdoctoral students. The most recent stipend, tuition, and research related expenses are described on the Ruth L. Kirschstein National Research Service Award (NRSA). Up to $25,000 to support an additional part time research experience for up to 4 undergraduate  students.

Element III - Program Evaluation - up to $50,000 per year in direct costs may be allotted to evaluating the SNRP program.

Award Project Period

The maximum period of support is 5 years.  Evaluation of the key elements of the SNRP program, including the Research Program, the Enrichment Program, and Program Evaluation will take place at year 3. The evaluation will be based on metrics established by each institution's Program Evaluation in collaboration with the Advisory Committee and NINDS. Funding for years 4 and 5 will be contingent on successful completion of performance metrics. The size and duration of each award will vary depending on the nature and scope of the proposed research. Although the financial plans of the NINDS provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

Additional Criteria for Institutional Eligibility

In making its assessment for eligibility the NINDS will limit applications to institutions with emerging neuroscience research programs as defined as those with NINDS funding less than $25 million total cumulative costs over the 3 years leading up to the application (NINDS funding support can be determined at: http://projectreporter.nih.gov/reporter.cfm). When running the query make sure to select the "admin" button under the Agency/Institution/Center: heading to ensure that funding levels reported for your institution include all subprojects. 

In addition, NINDS will use the Carnegie Foundation for the Advancement of Teaching Classifications for eligibility consideration. This framework has been widely used in the study of higher education, both as a way to represent and control for institutional differences, and also in the design of research studies to ensure adequate representation of sampled institutions students, or faculty. Applicants should refer to: http://classifications.carnegiefoundation.org/lookup_listings/institution.php to determine your institution's Carnegie Classification.

For medical Schools, eligible institutions will be those with:

Basic classification for special focus medical schools and centers (Carnegie rating = Spec/Medical: Medical schools and medical centers). Defined as institutions awarding baccalaureate or higher-level degrees where a high concentration of degrees (above 75%) is in a single field or set of related fields.

For Research Universities, eligible institutions will be those with:

Basic classification for doctorate-granting research universities with high activity (Carnegie rating = RU/H: Research Universities (high research activity). High activity is defined as institutions that awarded at least 20 research doctoral degrees during the update year (excluding doctoral-level degrees that qualify recipients for entry into professional practice, such as J.D., M.D., Pharm. D., DPT, etc.).

AND

Undergraduate Instructional Program with Balanced Arts and Sciences with some or high graduate coexistence (Carnegie rating = Bal/SGC: Balanced arts & sciences/professions, some graduate coexistence; Bal/HGC: Balanced arts & sciences/professions, high graduate coexistence) 

OR

Undergraduate Instructional Program with Professional training with high degrees of graduate coexistence (Carnegie rating = Prof+A&S/HGC: Professions plus arts & sciences, high graduate coexistence).

AND

Graduate Instructional Program Comprehensive Doctoral (Carnegie rating = CompDoc/MedVet: Comprehensive doctoral with medical/veterinary; CompDoc/NMedVet: Comprehensive doctoral with no medical/veterinary)

OR

Graduate Instructional Program Doctoral STEM Programs (Carnegie rating= Doc/STEM: Doctoral, STEM dominant)

Foreign Institutions

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 not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

Ideally the program will be led jointly by a Scientific Director and an Administrative Director.  On occasion, one individual may be appropriate for the dual roles; however, there should be a strong rationale and justification for assigning both roles to one individual.  The dual directors will be responsible for planning, directing, implementing, executing, and administering the proposed SNRP. 

The SNRP Leadership (Administrative and Scientific Directors) will provide oversight for the entire program and monitor the overall implementation and evaluation of the research projects, associated research cores, and the enrichment program. The roles and responsibilities of the directors should be clearly outlined.  A plan detailing the working relationship between the Administrative and Scientific Directors and the applicant institution must be included.  The plan should be jointly written by the proposed SNRP leadership and senior officials (e.g., Dean, Provost, Vice President) at the applicant institution. The application should describe the resources (e.g., release time) and support (administrative and program coordinator) that the institution will provide to assist the Scientific and Administrative Director in effectively managing the SNRP program.  

The Scientific Director should be an established and accomplished neuroscience researcher with the ability to provide outstanding scientific leadership.  Evidence of scientific leadership includes current and ongoing independent NIH R01 (or equivalent funding).  Specifically, this includes recent NIH funding (2009 – present), as well as a track record of NIH funding during the past 10 years.  Evidence must be provided that some portion of the NIH funded research was NINDS mission relevant.  In addition, funding support from similar Federal agencies such as the National Science Foundation (NSF) is applicable.  It is expected that the Scientific Director will continue to be scientifically active during the course of the program. The Scientific Director is eligible to receive pilot research funds under the SNRP program; however, he/she will be held to the same level of review as any other faculty member competing for pilot funding.

The Administrative Director should also have a recent history of scientific performance as demonstrated by grant support and publications within the 10 years leading up to the award. The Administrative Director must demonstrate the ability to work effectively with the institution administration, investigative team, and the NIH.  The administrator should have demonstrated excellent supervisory, organizational, planning and training skills. The Administrative Director may be internal or external to the institution, but clear evidence must be provided that he/she has the knowledge and understanding of the institution’s mission, authority structure, and strengths and weaknesses. In addition the Administrative Director must possess the appropriate authority to affect change within the institution.  

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.

Although an organization may submit more than one application, NINDS will only support one application per organization at a time of award.    

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

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:

The letter of intent should be sent to:

Courtney Ferrell Aklin, Ph.D.
Program Director, Office of Special Programs in Diversity
National Institute of Neurological Disorders and Stroke, NIH
6001 Executive Blvd, NSC, Room 2150
Bethesda, MD 20892-9535
Rockville, MD 20852 (for Express/Courier Service)
Telephone: (301) 496-3102
Fax: (301) 594-5929
Email: cferrell@mail.nih.gov

Pre-application assistance

Technical assistance teleconference

NINDS Staff are planning to hold a technical assistance teleconference in August 2012 to address applicant questions regarding preparation of a SNRP application.  A Notice to the NIH Guide will be posted with details regarding the teleconference.

Individual consultations

In addition to the technical assistance teleconference, applicants are strongly encouraged to consult with NINDS staff as plans for an application are being developed. Early contact provides an opportunity for NINDS to discuss the program scope and goals, and to provide information and guidance on how to develop an appropriate evaluation plan.  Other aspects of an application that are unique to this program are also discussed.  Consultations may include both an introductory call and a conference call with NINDS staff. The introductory call should be completed at least 10 weeks before the receipt date and the conference call at least 8 weeks before the receipt date. 

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke, NIH
Neuroscience Center
6001 Executive Blvd 
Bethesda, MD 20892
Telephone: (301) 496-9223
Email: nindsreview@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following additional requirements:

For U54 applications, page limits are as follows:

Element I - Research Program

Exploratory Research Project Description (each Project)

Supportive Research Core Descriptions (each Core)

Administrative Core Description

Element II - Enrichment Program

Element III - Program Evaluation                                                                                 12 pages

Applicants should use the following instructions for preparing the application:

SECTION I: Preliminary Pages

Face Page (Form Page 1)

Complete all items on the application's face page. For item 2, enter the number of this FOA and the title "Specialized Neuroscience Research Programs (U54)". Number succeeding pages consecutively.

Description: SNRP Summary and Relevance, Project/Performance Site(s), Senior/Key Personnel, and Other Significant Contributors (Form Page 2 and 2-continued)

Describe briefly the proposed research program, indicate the research emphasis and theme of the Exploratory Research Projects, and identify the purpose of the proposed Supportive Research Core units.

List all Senior/Key Personnel and Other Significant Contributors engaged in the SNRP.  Use continuation pages as necessary, numbering consecutively.

Table of Contents (Form Page 3)

In lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a Table of Contents should be prepared listing all of the major sections described below and paginated to enable reviewers to find specific information easily.

Overview of entire SNRP Program

Element I - Research Program

          A.  Program Leadership (Research and Administrative Directors)

          B.  Institutional Commitment and Neuroscience Research Infrastructure

          C.  Exploratory Projects (Identify each Exploratory Research project by title and Roman Numeral (i, ii, ii…)

          D.  Supportive Research Cores (Identify each Supportive Research Core by title and lowercase letters (a, b, c…)

          E.  Advisory Committee

          F.  Administrative Core

Element II - Enrichment Program

          A.  Faculty Development Component

          B.  Diversity Student Research Preparedness Component

Element II - Program Evaluation

Budget Instructions (Form Page 4 & 5)  

Follow the current PHS 398 instructions to provide a detailed budget (direct costs) for the entire application for the first 12-month period (Form page 4) and the entire proposed project period (Form page 5).  Use additional Form Pages 4 and 5 to provide detailed separate budget information (first-year and cumulative budgets for the entire project period) for the key components of the SNRP.

Specifically provide:

Budget Justifications and Explanations: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For additional years of support requested, justify any significant increases or decreases in any category over the first 12-month budget period. Identify such changes with asterisks against the appropriate amounts. If a recurring annual increase in personnel or other costs is anticipated, give the percentage; however, the maximum allowable escalation under this FOA is 2%.

If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.

Use PHS-398 Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support. Consortium/Contractual costs on the individual component budget and a detailed sub-awardee budget is to be placed following the appropriate Research Project or Core budget.

Biographical Sketch (Biographical Sketch Format Page)

Follow the instructions on the Biographical Sketch Format Page. This section must contain the biographical sketches of all individuals listed as Senior/Key Personnel and Other Significant Contributors, following the order listed on Form Page 2.  Biographical sketches are required for all key personnel participating in the Research Project components, Core units, and Advisory Committee.   Begin with the SNRP PD(s)/PI(s) and thereafter, in alphabetical order, submit biographical sketches as described in the Instructions for Form PHS-398. Do not exceed four pages for each person.

Resources (Resources Format Page)

Complete the "Resources" page of PHS-398 for the overall SNRP. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. 

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

SECTION II: Research Plan

The Research Plan should include a general overview of the SNRP, followed by individual sections for each Exploratory Research Project and Core. Wherever possible, use the headings and subheadings specified below (12 Pages).

Overview of the Specialized Neuroscience Research Program: Include history, purpose and objectives.  Describe the overall objectives and general plans for the proposed grant period.  Describe the organizational framework and provide an organizational chart when applicable.  Include the proposed program research grant funding history with yearly funding levels.

Program Leadership (2 pages): Include information on the knowledge, skills, and abilities of the SNRP Leadership (Administrative and Scientific Directors).  Discuss the authority of the Directors and their plan for providing oversight and direction over the SNRP.  

Institutional Commitment and Neuroscience Research Infrastructure (4 pages): Include assessments of research infrastructure devoted to neuroscience research. Describe plans for future commitment to enhancing neuroscience research at the Institution. Include specific information regarding support and commitment of the applicant Institution for the SNRP.  Provide grant funding history in neuroscience research for previous 3 years leading up to the application.

Advisory Committee (2 pages): Include the names, expertise, role and responsibilities of the advisory committee. Describe the composition and specific functions of the committee.

Research Program: Include information on the support and commitment of the parent institution for the program, highlighting its central theme and mission relevance to the NINDS. List the Exploratory Research Projects and Supportive Research Cores by title and investigator's names.  Describe the relationship between the projects and Core units and their roles, responsibilities, and relationship within the SNRP.

Description of Assurances and Collaborative Agreements:  Provide an overview and rationale for any collaborative endeavors or subcontracts. Letters of agreement for these arrangements should be included in the applications.

Exploratory Research Project Descriptions

Identify each project by a Roman numeral (i, ii, iii …) and a title.  A full description of each project is to be provided following the format and instructions for Form PHS0398.  Begin the presentation of each Exploratory Research Project on a separate page (Cover Page). 

Cover Pages for Exploratory Research Project (1 page; not the PHS398 Face Page) - include the Title of Project, Project Director/Principal Investigator (PD/PI), title, affiliation and other investigator titles and affiliations on the project.

Abstract of the Research Plan (1 page; use PHS-398 Form page 2) - discuss the purpose and nature of the project and its relevance to the overall SNRP Program.

Content of the Research Plan (Begin each section with a section header) to include the following:

Start each section with the appropriate section heading—Significance, Investigator, Innovation, Approach, Environment. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section.  For new applications, include information on Preliminary Studies.  Indicate the Research Project's use of Core unit services, including why needed and the advantages and cost effectiveness of Core unit usage for the project.

           interaction and cooperation with the other components of the program should be addressed.

Supportive Research Core Descriptions

Identify each proposed Supportive Research Core by a lowercase letter (a, b, c...) and a title (e.g., Imaging Core, Molecular/Cellular Core, etc.).  

A full description of each Supportive Research Core is to be provided following the format below.   

Begin the presentation of each Core unit on a separate page (Cover Page).  

Cover Page for Cores (1 page; not the PHS398 Face Page) – Include the following information: 

Abstract (1 page;  use PHS-398 Form Page 2):   Include an Abstract that identifies and describes the purpose of the proposed Supportive Research Core.  Summarize the Core unit's overall objectives; highlight the decision-making process for use of Core services and plans for cost-effectiveness and quality control.

The information listed below should be described for each Supportive Research Core (6 pages).

Provide a summary for the first year of the SNRP showing the percentage use of each Supportive Research Core by the Exploratory Research Projects.

Administrative Core Description

The following information listed below should be used in the description of the Administrative Core.

Enrichment Program (12 pages)

Provide a separate detail description for each of the following plans:

For each component clearly describe the objectives, needs, and rationale for the approach selected in implementing the objectives laid out in the program objective section.  Discuss implementation timetable in the context of available resources, alternatives considered, and overall goals and objectives for each plan.  Indicate specific measureable outcomes and proposed timeline associated with each goal for both components. 

Program Evaluation (12 pages)

Describe an evaluation plan to review and determine the effectiveness of the SNRP in achieving the proposed goals and objectives. This should include detailed and measurable goals for each of the key elements of the program (Research Program and Enrichment Program).  Provide evidence of the expertise of the individual(s) chosen to conduct the evaluation. Provide evidence that the members of the proposed Program Advisory Committee were consulted in developing the metrics.

Multiple Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) Leadership Plan

For Center applications designating Multiple PD(s)/PI(s), a leadership plan must be included.  The multiple PD(s)/PI(s) option is allowed for the overall center and/or for individual research projects.  A rationale for choosing a multiple PD(s)/PI(s) approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD(s)/PI(s), including responsibilities for human or live vertebrate animal subject studies as appropriate. Do not submit a leadership plan if you are not submitting a Multiple PD(s)/PI(s) application.  If budget allocation is planned, the distribution of resources to specific components of the project or the individual PD/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Letters of Assurance/Agreement  

Any arrangements for collaborative and cooperative endeavors or subcontracts should be highlighted. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a PHS-398 face page or other documentation, signed by the off-site institutional officials, must be submitted with the application.

Training in Responsible Research Conduct

Applications must include a description of programs designed to provide formal and informal instruction in scientific integrity or the responsible conduct of research relevant to all SNRP activities. Applications without plans for instruction in the responsible conduct of research for each component will be returned to the applicant without review.

Every trainee, scholar, or participant supported by this SNRP 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.  The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.   See SF424, Section 8.7. Research Training Program Plan Components, Item 5, Plan for Instruction in the Responsible Conduct of Research.

Resource Sharing Plan

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 PHS398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.  

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.

For this particular announcement note the following regarding scored review criteria:

For the SNRP Center applications, peer review of scientific and technical merit will focus on 3 key elements: (I) the review of the Research Program; (II) review of the Enrichment Program containing the Faculty Development and Student Research Preparedness Components, and (III) review of the Program Evaluation.

Element I - Scored Review Criteria of the SNRP Research Program

The SNRP Research Program is composed of 6 elements [(a) Program Leadership, (b) Institutional Commitment and Neuroscience Research Infrastructure, (c) Exploratory Research Projects, (d) Supportive Research Core(s), (e) Advisory Committee, and (f) Administrative Core] and while each of the 6 elements will be considered in the overall score of the SNRP Research Program, each element will not be given a score.

Program Leadership

There will not be a separate score for this section, but reviewers will consider performance on the items below in determining the overall score for the SNRP research program.

Are the qualifications, research experience, commitment and administrative competence of the Scientific and Administrative Directors appropriate?

Is there an appropriate time and effort commitment made by the Directors of the proposed SNRP?

Is there evidence that the SNRP leadership worked in consultation with the applicant's institutional officials in developing the application?

Does the application describe an effective administration and governance structure that will promote neuroscience research at the applicant institution?

Will the leadership plan accommodate changes in direction of research and allow for the efficient use of funds?

Institutional Commitment and Neuroscience Research Infrastructure

There will not be a separate score for this section, but reviewers will consider performance on the items below in determining the overall score for the SNRP research program.

Is there institutional commitment to establishing the SNRP as an integral part of its overall neuroscience research environment?

Is there a substantial commitment from the institutional leadership to protect the time of the investigators to pursue neuroscience research?

Is the institutional leadership committed to this program and its goals in terms of providing specific assets for the program, such as financial support, faculty support, specific equipment, or dedicated space, for example?

Is there a named senior administrator from the applicant institution with the appropriate experience and position to affect change at the institution?

Is there a discussion of the Institute’s commitment to diversity?

Exploratory Research Projects

There will not be a separate score for this section, but reviewers will consider performance on the items below in determining the overall score for the SNRP research program.

Significance. Does the project address an important problem or a critical barrier to progress in the neurosciences? If the aims of the project are achieved, how will scientific knowledge and technical capability be improved? How will successful completion of the aims change the concepts, methods, technologies, or services that drive the field of neuroscience?

Investigator(s). Are the Proposed Project Investigator(s) well suited for the project? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise? Is there an individual research development plan? Does it outline how work on the project will contribute to the growth of the investigator's career?

If Early Stage Investigators (ESIs), do they have appropriate experience and training? For ESIs is there a mentor plan included? Do the mentors have strong records as researchers, including successful research funding in the area related to the proposed research project? Do the mentors have strong track records of research training appropriate to the level of student/ESI candidate?

Innovation. Does the research project seek to shift current neuroscience research by utilizing novel theoretical concepts, approaches or methodologies or instrumentation? Are the concepts, approaches, or instrumentation novel to one field of research or novel in the broad sense? Is refinement, improvement, or new application of theoretical concepts proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

Environment. 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?

Supportive Research Core

Reviewers will approve or disapprove each Supportive Research Core, based on the assessment of each Supportive Research Core independently in terms of the specified review criteria for Cores (see below).  There will not be a separate score for this section, but reviewers will consider performance on the items below in determining the overall score for the SNRP research program.

Is the Supportive Research Core necessary? Has the applicant demonstrated the need for the proposed core facilities and the effectiveness of these facilities to enhance the research effort?

Does it support at least 1 of the SNRP-budgeted projects? Is the use of core services by the budgeted SNRP projects and, if applicable, by external projects appropriate?

Has the applicant selected qualified personnel to manage and operate the core facilities? Are the qualifications, experience, and commitment of the core director (s) and other core personnel appropriate?

How good are the facilities or services provided by the core? Will the quality of services provided enable SNRP investigators to achieve their research goals? Is there cost effectiveness in the core; will there be quality control measures taken for core procedures?

Is there a decision-making process within the proposed SNRP for the evaluation of research productivity, for allocation of funds and for management of the resources?

Are plans for charge back and priority management procedures for core units offering services to external projects adequate?

What is the overall strength of the plan for Supportive Research Core evaluation, including the use of any internal and external advisory groups? 

What is the overall strength of the internal data sharing and publication plan?

Has the applicant demonstrated that each proposed core will serve the scientific needs of the individual research projects and has he/she shown how each core will impact the development of the SNRP?

Does the applicant indicate any institutional commitment to support and maintain the proposed core facilities?

Advisory Committee 

There will not be a separate score for this section, but reviewers will consider performance on the items below in determining the overall score for the SNRP research program.

Do the proposed members of the Advisory Committee have the experience and expertise to guide the SNRP Center?

Is a plan included for how the Advisory Committee will interact with the Institutional officials, SNRP Leadership, and NINDS?

Administrative Core

There will not be a separate score for this section, but reviewers will consider performance on the items below in determining the overall score for the SNRP research program.

Does the Administrative Core provide appropriate logistical support for the SNRP Center? Does the Administrative Core include services, activities, and/or programs to meet administrative needs of the research faculty and students?

Element II - Review Criteria for the Enrichment Program

Reviewers will provide an overall score for the Enrichment Program. The criteria listed below will be reflected in the score.

What is the likelihood that the proposed Enrichment Program activities will result in a more highly trained and diverse NINDS mission neuroscience research workforce?

Is the Enrichment Program well integrated with other supportive institutional programs for faculty, staff, and students that value and actively support inclusiveness and diversity?

Does the Enrichment Program provide sufficient evaluation methods and accountability for the implementation and promotion of diversity within the SNRP?

Does the Enrichment Program provide an effective diversity student research preparedness plan with high-quality research training experiences for students, postdoctoral fellows or residents?

For the Diversity Student Research Preparedness Component is a mentor plan included?

Do the mentors have strong records as researchers, including successful research funding in the area related to the proposed student research projects?

Do the mentors have strong track records of research training appropriate to the level of student/ESI candidate?

Is there a plan for the evaluation of research productivity?

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the SNRP 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 SNRP 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. For example, a component that by its nature is not innovative may be essential to advance a field.

Significance

Does the SNRP address an important problem or a critical barrier to progress in the field? If the aims of the SNRP 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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the SNRP Center? 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

Innovation

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?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the SNRP? 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? 

If the SNRP 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? 

Environment

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? 

Additional Review Criteria

As applicable for the SNRP 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.

Element III - Review Criteria for the Program Evaluation

Reviewers will provide yes or no responses to the inclusion of the following materials. While reviewer answers will not be reflected in the overall score of the SNRP, any items that are missing must be addressed before any award is made.

Is there a detailed program evaluation plan that includes information on reporting on the common evaluation metrics and program-specific indicators?

Are the qualifications and experience of the person(s) selected to conduct the evaluation expressed in the program evaluation section?

Has the applicant clearly delineated the timelines and milestones for which program achievements will be measured in determining intermediate and long-term success of the SNRP?

Are the milestones/timelines proposed for each of the required key elements (Research Program, Enrichment Program, and Program Evaluation) of the SNRP?

Do the milestones and timelines provide feasible objectives, and detailed quantitative and/or concrete criteria by which milestone achievements will be assessed?

Does the applicant provide a compelling interest statement for achieving diversity in the student readiness plan?

SNRP as an Integrated Collection of Exploratory Research Projects, Cores, and Programs

The overall SNRP will be evaluated as an integrated research effort focused on one or more research areas that are NINDS mission relevant.  The relationship and contributions of each Exploratory Research Project, Core, and Program to the overall objectives will be discussed and evaluated. Reviewers will assign an impact/priority score based on assessment of the scientific and technical merit of the overall SNRP. The assessment will take into consideration all proposed Exploratory Research Projects, Cores, and Programs including any with poor ratings. The review will assess the level of merit of the SNRP as an integrated effort, including the following criteria:

What are the advantages of conducting the proposed research as a program rather than through separate research efforts?  Will the research efforts taken together have more impact on the field than each separate project conducted in isolation?  Will the research proposed in individual projects be enhanced by the SNRP?

Are mechanisms proposed for regular communication and coordination among investigators in the SNRP?

Are administrative structures in place for the day-to-day management of the SNRP, including arrangements for internal quality control of ongoing research?

To what degree do the letters of institutional commitment support the priorities and objectives proposed for the SNRP? Is the level of authority of officials committing to the SNRP effort adequate to meet the overall program performance for the SNRP during the project period of the SNRP?

To what degree do the letters of support from the Advisory Committee support the priorities and objectives of the SNRP? How well does the Advisory Committee scientific and administrative expertise align with the overall program performance goals of the SNRP?

Do the Research Program, Enrichment Program and Program Evaluation elements tie in to the administration and coordination of the overall SNRP? Is there a specific organizational plan for how all parts of the SNRP will be coordinated?

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed SNRP Center involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable

Additional Review Considerations

As applicable for the SNRP  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.   

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, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center and 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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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.

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 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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NINDS Project Collaborator will have responsibility for:

Areas of Joint Responsibility include:

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened. It will have three members: a designee of the Advisory Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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)

Courtney Ferrell Aklin, Ph.D.
Program Director, Office of Special Programs in Diversity
National Institute of Neurological Disorders and Stroke, NIH
6001 Executive Blvd, NSC, Room 2150
Bethesda, MD 20892-9535
Rockville, MD 20852 (for Express/Courier Service)
Telephone: (301) 451-7968
Fax: (301) 594-5929
Email: cferrell@mail.nih.gov

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke, NIH
Neuroscience Center
6001 Executive Blvd 
Bethesda, MD 20892
Telephone: (301) 496-9223
Email: nindsreview@mail.nih.gov

Financial/Grants Management Contact(s)

Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke, NIH
Telephone: (301) 496-9231
Email: decostert@ninds.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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