(1) To support extramural research within the National Institute of Neurological Disorders and Stroke (NINDS) including: neurological science basic research that explores the fundamental structure and function of the brain and the nervous system; research to understand the causes and origins of pathological

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conditions of the nervous system with the goal of prevention of these disorders; research on the natural course of neurological disorders; research on mechanisms associated with stroke and other cerebrovascular disorders, effects of trauma to the nervous system, neuroplasticity and regeneration, and tumors of neural and sensory tissues; improved methods of disease prevention; new methods of diagnosis and treatment; clinical trials; drug development; development of neural prostheses for stroke and paraplegia; epidemiological research; and research training in the clinical neurosciences.

Programmatic areas within this Institute support research on such topics as stroke; traumatic injury to the brain, spinal cord and peripheral nervous system; neurodegenerative disorders, including Parkinson's disease and Alzheimer's disease; brain tumors; development of artificial prosthetic devices to restore function to the damaged nervous system; convulsive disorders, including epilepsy; infectious disorders of the brain and nervous system, including AIDS; immune disorders of the brain and nervous system, including multiple sclerosis; disorders related to sleep; and pain.

Programmatic areas also include neurodevelopment, repair and plasticity, channels synapses and circuits, neurogenetics, neurodegeneration, neural environment, and systems and cognitive neuroscience.

Extramural research is also supported by the Office of Minority Health and Research.

(2) To expand and improve the Small Business Innovation Research (SBIR) program; to increase private sector commercialization of innovations derived from Federal research and development; to increase small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.

(3) To utilize the Small Business Technology Transfer (STTR) program; to stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.

The NINDS also participates in the Academic Research Enhancement Award (AREA) Program, which is intended to provide research support to institutions currently having little National Institutes of Health (NIH) support.

In fiscal year 2007, there were 3,470 competing research applications, and of that number 648 awards were made.

Uses and Use Restrictions

Research grants may be used to provide salaries, equipment, supplies, travel and other expenses for research.

The grantee institution is obliged to expend grant funds prudently for the purposes stated in the application and award document.

National Research Service Awards (NRSAs) are made directly to individuals for research training in specified biomedical shortage areas, or to institutions, to enable them to make NRSAs to individuals selected by them.

Each individual who receives a NRSA is obligated upon termination of the award to comply with service and payback provisions.

Career Development Awards such as the Independent Scientist Awards provide support for newly independent scientists with health related degrees who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers.

Mentored Clinical Research Scientist Development Awards provide support for clinically trained health professionals who need an additional period of sponsored research experience as a way to gain expertise in a research area new to the candidate or in an area that would demonstrably enhance the candidate's scientific career.

The Mentored Research Scientist Development Award are of three types: Re-Entry into the Neurological Sciences (RENS) which are made to women and men who have been out of neuroscience research for at least 3 years to give them an opportunity to re-establish their skills as independent neuroscientists, the Career Development Award to promote diversity in neuroscience research support, an intensive, supervised research career development experience for underrepresented career neuroscientists, and Mentored Research Scientist Development Awards in Translational Research to support new investigators to build a program of translational research in neurological disorders.

The Mentored Patient-Oriented Research Career Development Award provide support for a period of supervised study and research for clinically trained professionals who have the potential to develop into productive clinical investigators.

The Mid-career Investigator Award in Patient-Oriented Research provide support for clinicians to allow them protected time to devote to patient-oriented research and to act as mentors for beginning clinical investigators.

The Collaborative Neurological Sciences Award is to develop and promote competitive neurological science research programs at predominantly minority institutions through collaborations with grantees from research intensive institutions who have NIH grant support to conduct neurological science research.

SBIR Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process.

Phase II grants are for the continuation of the research efforts initiated in Phase I that are likely to result in commercial products or processes.

Only Phase I awardees are eligible to receive Phase II support.

STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of proposed cooperative effort that has potential for commercial application.

Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of Phase II application.

Grant funds may be expended only for the purpose stated in the application and award document.

The NINDS participates in the NIH SBIR/STTR "fast track" initiative.

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Eligibility Requirements

Applicant Eligibility

Research Grants: Any public, private, nonprofit, or for-profit institution is eligible to apply.

For-profit institutions are not eligible for Institutional National Research Service Awards but are eligible for Individual NRSAs.

All proposals are reviewed for scientific merit, for evaluation of the qualifications of the investigators, for adequacy of the research environment, and for significance of the problem.

Approved proposals compete for available funds.

All Career Development Program awardees, with the exception of awardees of the Pathway to Independence Award, must be citizens or have been admitted to the United States for permanent residence.

Candidates must be nominated for the program by a nonfederal public or private nonprofit institution located in the United States, its possessions or territories.

Awardees for RENS must have been accepted by a sponsoring institution, had previous training and experience in neurological science, an interruption in their careers for a period of at least three years and not more than 8 years, and be citizens or non-citizen nationals of the United States.

Awardees for the Collaborative Neurological Sciences Award must be from a predominantly minority institution and must have a doctoral degree in a basic or clinical science area.

To be eligible, postdoctoral NRSA trainees or fellows must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.

Eng., or equivalent domestic or foreign degree).

SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees).

Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project.

In both Phase I and Phase II, the entire research must be performed in the United States.

To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.

STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development.

At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution.

In both Phase I and Phase II, the research must be performed in the U.S.

and its possessions.

To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.

Beneficiary Eligibility

Health professionals, graduate students, health professional students, scientists, and researchers.

Credentials/Documentation

Research grants are awarded to an institution in the name of an individual investigator. Persons qualified to carry out research related to the extramural programs described above may apply for funds to support their investigations. Mentored Career Program training must be conducted under the direction of a competent sponsor. National Research Service Awards: Individual NRSA Fellowships for postdoctoral training: the candidate's academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training must be included in the application. Institutional Training Grants for predoctoral and postdoctoral training: The applicant institution must show the objectives, methodology and resources for the research training program; the qualifications and experience of directing staff; the criteria to be used in selecting individuals for stipend support; and a detailed budget and justification for the amount of grant funds requested. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulations 45 CFR, Part 74 and 92, Subpart Q. For SBIR and STTR grants, the applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Grant forms PHS 6246-1 and PHS 6246-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively.

Aplication and Award Process

Preapplication Coordination

Research grant applications exceeding $500,000 direct costs in any yearly budget period will not be accepted unless the NINDS has agreed to accept the application prior to submission (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html).

This program is excluded from coverage under E.O.

12372.

Application Procedures

NIH is in the process of transitioning to the SF424 family of forms and electronic submission through Grants.govby research program or funding mechanism. See http://era.nih.gov/ElectronicReceipt/ for a list of grant mechanisms that have already transitioned to electronic submission. For applications to be submitted electronically, see http://era.nih.gov/ElectronicReceipt/. The change from paper submission to electronic applications for grant programs currently targeted to transition after May 2007, including Career Development (K), Fellowship (F), Training & Development (T&D) and complex mechanisms (P, U) will be delayed. See http://grants1.nih.gov/grants/forms.htm to determine the appropriate paper application package (PHS 398 or PHS 416) to be used.

Award Procedures

Research Grant and Training Program applications are reviewed initially by technical panels, composed of scientific authorities, and by the National Advisory Neurological Disorders and Stroke Council composed of 18 leaders in medical science, education, and public affairs. Approved applications will compete on a merit basis for available funds. Formal award notices are transmitted to the grantee or awardee. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines

All new research grant and career program applications, plus all (new, competing continuation, supplemental or revised) program project and center grant applications deadline dates can be found at http://grants1.nih.gov/grants/funding/submissionschedule.htm.

Authorization

Public Health Service Act, Sections 301, 405,408, 457, 458, 459, and 487, Public Law 78-410, as amended, 42 U.S.C. 241; 42 U.S.C. 284; 42 U.S.C. 284c; 42 U.S.C. 285j; 42 U.S.C. 285j-7; 42 U.S.C. 285L-2; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

Range of Approval/Disapproval Time

Research grants: Approximately 6 to 9 months. Career program: From 6 to 9 months. SBIR/STTR applications: About 7-1/2 months. Institutional Training Grants: From 6 to 12 months.

Appeals

A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute, and subsequently, the P.I. and applicant institution may appeal to the NINDS appeals officer. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http://grants.nih.gov/grants/guide/notice-files/not97-232.html.

Renewals

By application and review in same manner as new applications. Research Career Awards may not be renewed.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance

Research grant awards are made for a 12-month period with recommendation of up to 4 years of additional support. Career Program awards provide support for 3 to 5 years. Training Program awards are usually for a 12-month period with recommendation of additional support of up to a total of 5 years for predoctoral training and no more than 3 years for postdoctoral training. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years.

Post Assistance Requirements

Reports

Research Grants: Annual and final progress reports, including a description of results, positive and negative, and a list of any publications.

Career Program: Awardee submits annual progress report.

Termination notice, PHS 416-7, must be submitted upon completion of NRSA training.

Reports are required after termination of National Research Service Awards to ascertain compliance with the service and payback provisions.

A Financial Status Report must be submitted within 90 days after the close of each budget period for which an award has been issued.

Audits

In accordance with the provisions of OMB Circular No. A-133, (Revised, June 27, 2003), "Audits of States and Local Governments," and Nonprofit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 or more in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.

Records

Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last Financial Status Report for the report period.

Financial Information

Account Identification

75-0886-0-1-552.

Obigations

(Extramural Research) FY 07 $1,340,542,000; FY 08 est $1,345,652,000; and FY 09 est $1,344,174,000.

Range and Average of Financial Assistance

Research grants: $50,000 to $7,727,226; $372,346. National Research Service Awards: Institutional $20,674 to $512,907; $195,982. Individual: $1,251to $68,740; $37,264. SBIR: Phase 1 approximately $150,000; Phase II not to exceed $750,000. STTR: Phase I approximately $100,000; Phase II not to exceed $500,000. (The SBIR and STTR dollars are guidelines, not limits).

Regulations, Guidelines, and Literature

42 CFR 52; 42 CFR 66; 45 CFR 74; Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.

Information Contacts

Regional or Local Office

Not applicable.

Headquarters Office

National Institute of Neurological Disorders and Stroke (NINDS), Division of Extramural Research (DER), National Institutes of Health, Department of Health and Human Services, Neuroscience Center, 6001 Executive Boulevard, Bethesda, MD 20892. Director DER: Dr. Robert Finkelstein, Suite 3309, Telephone: (301) 496- 9248. The address above (include suite # below) should be used for each Program Contact: Dr. Ramona Hicks, Repair and Plasticity, Suite 2206, Telephone: (301) 496-1447; Dr. May Wong, Neural Environment, Suite 2113, Telephone: (301) 496-1431; Dr. Larry Refolo, Neurodegeneration, Suite 2223, Telephone: (301) 496-5680; Dr. Debra Babcock, Systems & Cognitive Neuroscience, Suite 2108, telephone: (301) 496-9964; Dr. Shai Silberberg, Channels, Synapses & Circuits, Suite 2142, Telephone: (301) 496-1917; Dr. Laura Mamounas, Neurogenetics, Suite 2114a, Telephone: (301) 496-5745; Dr. Yuan Liu, Office of International Activities, Suite 2187, Telephone: 301-496-0012; Dr. Deborah Hirtz, Clinical Trials, Suite 2212, Telephone: (301) 496-9135; Dr. Jill Heemskerk, Technology Development, Suite 2229, Telephone: (301) 496-1779; Grants Management Branch: Ms. Tijuanna DeCoster, Grants Management Officer, Suite 3258, Telephone: (301) 496-9231; Contracts Management Branch: Mr. Kirk Davis, Contracts Management Officer, Suite 3280, Telephone: (301) 496-1813; Dr. Alfred Gordon, Office of Minority Health and Research, Suite 2151, Telephone: (301) 496-3102; Dr. Stephen Korn, Training and Career Development Officer, Suite 2186, Telephone: (301) 496-4188.

Criteria for Selecting Proposals

The major elements in evaluating proposals include assessments of: (1) the scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) the soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) the degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and 8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.