Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Neurological Disorders and Stroke (NINDS)
Funding Opportunity Title	NINDS Cooperative Program in Translational Research Small Business Awards (U44)
Activity Code	U44 Small Business Innovation Research (SBIR) Cooperative Agreement Phase II or Fast-Track
Announcement Type	Reissue of PAR-08-235
Related Notices	November 19, 2012 - See Companions PAR-13-023 NINDS Exploratory/Developmental Projects in Translational Research (R21) and PAR-13-022 NINDS Cooperative Program in Translational Research (U01). April 10, 2012 - See Notice NOT-NS-12-013, Extension of Expiration Date.
Funding Opportunity Announcement (FOA) Number	PAR-11-296
Companion FOA	PAR-11-293, R21, NINDS Exploratory/Developmental Projects in Translational Research; PAR-11-294, U01, NINDS Cooperative Program in Translational Research Single-Component Projects; and PAR-11-295, U54, NINDS Cooperative Program in Translational Research Multi-Component Projects
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.853
FOA Purpose	The goal of this funding opportunity announcement (FOA) is to support preclinical development and testing of new therapies for neurological disorders. The program will facilitate encouragementation, development, and review of therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. Phase II and Fast-Track SBIR cooperative agreements are supported under the program. Phase I, as part of a Fast-Track, supports preliminary steps in the process for the preclinical development of therapeutics. To be eligible for Phase II support, either based on a previously successful Phase I or as part of a Fast-Track, projects must include therapeutic leads and in vivo proof of concept on efficacy. Phase II supports preclinical optimization and testing of the leads, and projects must be sufficiently advanced that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) can be submitted by the end of the project period. Phase II cannot support early-stage therapeutic discovery activities such as screening. The program scope excludes clinical research, basic research, and studies of disease mechanism. The scope includes only therapy development activities, so development of diagnostics, biomarkers, or rehabilitation strategies cannot be supported. This is a milestone-driven SBIR cooperative agreement program involving participation of NINDS staff in the development of the project plan and monitoring of research progress.

Posted Date	August 8, 2011
Open Date (Earliest Submission Date)	November 5, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates
Expiration Date	(New Date January 8, 2013 per NOT-NS-12-013) , Original Date September 8, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Recent discoveries across a broad range of research areas in the neurosciences offer promising opportunities for treatment of neurological disorders. As part of its mission to reduce the burden of neurological disease, NINDS is committed to encouraging the translation of these discoveries into new treatments. The goal of this FOA is to support milestone-driven projects focused on the optimization and preclinical testing of candidate therapeutics. The program will facilitate the encouragementation, development, and review of therapy-directed projects and will accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing.

This FOA is one of four coordinated programs being released by NINDS to promote translational research, including NINDS Exploratory/Developmental Projects in Translational Research (R21) (PAR-11-293), NINDS Cooperative Program in Translational Research Single-Component Projects (U01) (PAR-11-294), and NINDS Cooperative Program in Translational Research Multi-Component Projects (U54) (PAR-11-295). The extramural research community may use these translational research initiatives in whatever combinations are necessary to achieve the most rapid and effective development of investigational interventions for neurological disorders.

Definition of Translational Research:

Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease.

Background:

Opportunities for discovery and progress in the treatment of neurological diseases have never been greater. Remarkable advances have been made recently in our understanding of the molecular and genetic bases of disease, and the potential therapeutic opportunities offered by these scientific findings create an opportunity for basic, applied, and clinical scientists to combine and coordinate their efforts. The realization of the potential for translating accumulated new knowledge will depend on the cooperation and partnering of public and private funding organizations, universities, academic medical centers, research institutes, contract research organizations, biotechnology companies, and pharmaceutical companies. Collaborative arrangements between drug and device companies and academic institutions will be needed, with a spirit of sharing in the risks and rewards of the effort being inherent to the relationships.

The NINDS Cooperative Program in Translational Research is intended to catalyze the development of partnerships between basic and clinical investigators, and to stimulate agreements between the academic and industrial sectors, so that translational research in neuroscience can flourish as a cooperative, iterative process leading to new and effective interventions for neurological disorders.

Scope of the Program:

The NINDS Translational Research Program is specifically focused on the preclinical therapy development necessary to begin clinical testing of therapeutic candidates for neurological disorders. The program supports the preclinical development of drugs, biologics, and devices leading to IND or IDE applications to the FDA. All proposed studies must be directed at the most efficient route to regulatory submission, and therefore this program excludes basic research and studies of disease mechanism. Also outside the scope of the program are development of diagnostics or biomarkers, rehabilitation strategies, and non-exempt human studies. The program supports only preclinical development, so production of therapeutics for clinical trials is outside the scope.

Phase I Awards (available only as part of a Fast-Track application)

The scope of Phase I includes any research activities required to advance candidate therapeutics through IND or IDE submission, and ready them for clinical testing.

However, Phase II is used in this program to support projects that begin with in vivo proof of concept on efficacy and proceed through IND or IDE. Therefore, the primary purpose of Phase I is to support preliminary therapy development goals that are outside the scope of Phase II.

These include:

• Creation and validation of screening assays for therapy development. The assays may be intended for primary or secondary screening efforts at any level of throughput.
• Creation of animal models of neurological disorders for therapy development. Animal models that will be used for basic research are outside the scope of the program.
• Identification of candidate therapeutics, including primary or secondary screening efforts at any level of throughput. Primary screening efforts are not supported in Phase II.
• Development of preliminary in vivo efficacy data for identified candidate therapeutics. If a NINDS Phase I includes in vivo proof of concept on efficacy, the project will be eligible for transition to Phase II.

Phase II Awards

For entry to Phase II, projects must have one or more identified therapeutic leads and there must be available in vivo proof of concept data on efficacy, which is normally preliminary efficacy data in an animal model of the disease. When projects do not include an animal model of disease for efficacy testing, an acceptable alternative for entry to Phase II is in vitro efficacy data and in vivo proof of concept in normal animals that the therapeutic lead is available via the intended route of administration. Preliminary data should demonstrate rigor in the preliminary evaluation of candidate therapeutics entering Phase II, including, when possible, preliminary assessments of drug-like characteristics.

There is increasing awareness among neurological disease communities that to assess the predictive value of preclinical research, sufficient information must be available about study design, execution, analysis, and interpretation. Examples of the critical elements of a well-designed study are summarized on the NINDS website (http://www.ninds.nih.gov/funding/grant_policy.htm). NINDS urges applicants to the program to consider these elements when describing supporting data and designing the proposed studies.

Primary screens for identifying candidate therapeutics are outside Phase II scope. Screening assay and animal model development are outside the scope of Phase II, so all screening assays and animal models that will be used during preclinical development must be available and working.

Research activities explicitly within Phase II scope include preclinical efficacy testing, predictive ADME (absorption, distribution, metabolism, and excretion) and toxicology testing, optimization of candidate therapeutics, formulation and stability studies, process development and manufacturing of candidate therapeutics, IND- or IDE-enabling pharmacology and toxicology, regulatory affairs, and IND or IDE submission. An IND or IDE must be achieved during Phase II.

Applications must include proposed milestones at the end of Phase I and annually in Phase II to be within program scope. Milestones toward therapeutic intervention are goals that create go/no-go decision points in the project and include quantitative success criteria (see http://www.ninds.nih.gov/funding/research/translational/DevelopingMilestones.htm). Achievement of milestones will be evaluated by NINDS, and funding of Phase II as part of a Fast-Track and non-competing Phase II award years will depend on milestone accomplishment.

Applicants are encouraged to consult with NINDS 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 milestone plan. Other aspects of an application that are unique to the 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 a receipt date and the conference call at least 8 weeks before a receipt date.

Implementation:

The NINDS Cooperative Program in Translational Research Small Business Awards provides funding through the U44 cooperative agreement mechanism. As a cooperative agreement, implementation will involve participation of NINDS program staff in the planning and execution of the therapy-directed projects. The U44 cooperative agreements support translational research projects that are focused on a single approach to therapy development for a neurological disorder or a group of closely related neurological disorders. A U44 project plan leads to the submission of one IND or IDE and supports the planning for one clinical trial.

Collaboration among awardees will be encouraged and facilitated by NINDS. Investigators will have the opportunity to share data, materials, and expertise. It is expected that lessons learned and techniques developed within one disease community will be relevant to the efforts of other communities.

Funding Instrument	Cooperative Agreement
Application Types Allowed	New (Fast-Track, Phase II) Resubmission (Fast-Track, Phase II) Revision The OER Glossary and the SF424 (R&R) SBIR/STTR 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.
Award Budget	According to statutory guidelines, total funding support normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. Applicants are encouraged to propose a budget that is reasonable and appropriate for completion of the research project. However, statutory guidelines may be exceeded based on scientific requirements to reach IND or IDE in the project period.
Award Project Period	Durations up to 2 years for Phase I (as part of a Fast-Track) and up to 3 years for Phase II may be requested.

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.

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;

2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;

3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;

4. Has, including its affiliates, not more than 500 employees.

SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.

Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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.

Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.

The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.

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

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

NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide.

A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.

In Phase I, normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and fee).

In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).

Due to the special requirements for therapeutics development, performance site criteria may be waived based on scientific justification to permit necessary contractual/consortium arrangements to reach IND or IDE submission. Applicants may propose the necessary contractual/consortium arrangements and will be asked to provide the scientific justification prior to funding.

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.

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

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR 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.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate optional components.

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

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

Research Strategy

Overall Plan for Therapy Development:

Projects submitted to the NINDS Cooperative Program in Translational Research must include, within the 12 page Research Strategy, a description of an overall plan for therapy development to be within program scope. The plan must be based on a clearly stated project timeline that includes practical, achievable goals, project milestones, and IND or IDE submission. The plan should also include, when appropriate, a Target Product Profile. Any collaborators, consultants, or subcontractors should be identified, no matter when during the conduct of the research activity the proposed interaction occurs.

Team building is an essential step in the development of the overall plan for therapy development. Because translational research is intrinsically interdisciplinary, the plan will often involve cooperation among basic researchers, experts in preclinical development, and clinicians, and may include the participation of private-sector companies and voluntary organizations.

Resource Sharing Plans

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

Appendix

Do not use the appendix to circumvent page limits. Note that Phase I SBIR/STTR Appendix materials are not permitted, unless requested specifically by NIH SBIR/STTR The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide.

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

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

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.

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

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)

Investigator(s)

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

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 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?

If the project 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 arrangement?

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

• Is the translational research objective important to the neurological disorder under study?
• If a Fast-Track, does Phase I include in vivo proof of concept on efficacy that would allow transition to Phase II?
• Is the overall plan for therapy development through IND or IDE submission practical, achievable, and of high quality?
• Are the proposed project milestones adequate and feasible?
• Has an interdisciplinary team been assembled, and experts in preclinical development and clinical development been included in the conception, design, and proposed implementation of the project?
• Are there adequate plans for optimization of candidate therapeutics, as appropriate?

Phase II Applications

For Phase II Applications, how well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?

Phase I/Phase II Fast-Track Applications

For Phase I/Phase II Fast-Track Applications, reviewers will consider the following:

1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

2. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization?

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 project 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

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.

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:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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 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.

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.

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.

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:

• The Principal Investigator will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.
• Awardees are responsible for identifying specific milestones toward disease intervention that will be achieved during the project period.
• Awardees agree to participate in the overall coordination of NINDS research efforts in translational research. This participation may include collaboration and consultation with other translational research awardees, and the sharing of information, data, and research materials.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
• Each project will have the support of one or more Project Scientists from NINDS program staff who are assigned an administrative role for the neurological disorder being studied and have expertise in the implementation of the NINDS Cooperative Program in Translational Research.
• The NINDS Project Scientists will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants.
• NINDS Project Scientists will be responsible for assessing the progress of the projects toward the accomplishment of specified milestones, and for recommending if further funds should be released to the project.
• The NINDS Project Scientists will facilitate the establishment of contacts and collaborations between awardees of the NINDS Cooperative Program in Translational Research and other persons or organizations whose participation will assist with the accomplishment of project goals. These persons or organizations may include the FDA, disease voluntary organizations, pharmaceutical companies, or research organizations that can provide essential services on contract.
• An important part of the NINDS program in translational research is the coordination of research efforts across different funding mechanisms and research structures, and coordination among efforts aimed at different neurological disorders. NINDS Project Scientists will have the primary responsibility for this overall coordination.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

• None; all responsibilities are divided between awardees and NIH staff as described above.

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 composed of three members will be convened. It will have three members: a designee of the Steering 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. .

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.

Milestones toward therapeutic intervention are included in the project and have quantitative success criteria (see http://www.ninds.nih.gov/funding/research/translational/DevelopingMilestones.htm). Achievement of milestones will be reported in the PHS 2590 and evaluated by NINDS. Funding of non-competing award years will depend on milestone accomplishment.

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.

• Expenditure data portion of the Federal Financial Report
• Final Progress Report
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Final Cash Transaction Report (PSC 272)
• Phase II Data Collection Requirement for Government Tech-Net Database

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF424 (R&R) SBIR/STTR Application Guide.

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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

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

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

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

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

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

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) and P.L. 102-564 (Small Business Research and Development Act).The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.

The STTR Program is mandated by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorizing legislation, Small Business Technology Transfer Program Reauthorization Act of 2001 (P.L. 107-50). The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.