NINDS Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs

NINDS Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), NIH. This opportunity supports mission-aligned projects and measurable outcomes.

Expired PA-11-347: NINDS SBIR Technology Transfer (SBIR-TT [R43/R44]) This notice has expired. Check the NIH Guide for active opportunities and notices. Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating National Heart, Lung, and Blood Institute ( NHLBI ) National Institute of Neurological Disorders and Stroke ( NINDS ) National Eye Institute ( NEI ) Funding Opportunity Title NINDS SBIR Technology Transfer (SBIR-TT [R43/R44]) R43 / R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and September 21, 2015 - This PA has been reissued as PA-15-354 .

See Notice NOT-NS-14-038. Notice of the Change in the Expiration Date for PA-11-347 "NINDS SBIR Technology Transfer (SBIR-TT [R43/R44])" supersedes instructions in Section III. 3 regarding applications that are essentially the same.

May 12, 2014 ( NOT-OD-14-089 ) - September 26, 2013 - See Notice NOT-EY-13-004. NEI Announces its Participation November 21, 2011 - See Notice NOT-HL-11-164, NHLBI Announces Participation. Funding Opportunity Announcement (FOA) Number Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 853, 93. 233, 93.

837, 93. 838, 93. 839, 93.

867 This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for projects to transfer technology out of the NIH intramural research labs into the private sector.

If selected for SBIR funding, the SBC will be granted a royalty-free, non-exclusive internal research-use license for the term of and within the field of use of the SBIR award to technologies held by NIH with the intent that the SBC will develop the invention into a commercial product to benefit the public. Open Date (Earliest Submission Date) Letter of Intent Due Date dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s) dates apply, by 5:00 PM local time of applicant organization. Now January 8, 2015 (Originally September 8, 2014) Required Application Instructions It is critical that applicants follow the instructions in (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 Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information I.

Funding Opportunity Description The NINDS SBIR Technology Transfer (SBIR-TT) Funding Opportunity Announcement (FOA) is intended to help move commercially-viable neuroscience based technologies from the NIH Intramural Program to the marketplace. Small Business Concerns (SBCs) are encouraged to submit applications that further develop such technologies and bring them to the commercial market.

While universities can spin off companies, use incubator resources, and obtain funding from venture capital, the NIH intramural programs have no similar mechanism to develop technologies. It is frequently challenging for SBCs to develop technologies before they have obtained funding.

If selected for SBIR funding, the SBC will be granted a royalty-free, non-exclusive internal research-use license for the term of and within the field of use of the SBIR award to technologies held by NIH with the intent that the SBC will develop the invention into a commercial product to benefit the public.

This FOA encourages applications focusing on collaborations with intramural investigators on those projects that address neurological mechanisms or disorders falling under the NINDS mission, such as stroke, Parkinson's Disease, Multiple Sclerosis, and MRI imaging related to neurological disorders. Any project that fits within the NINDS mission that relies on the use of an NIH intramural technology is eligible for this award.

For more information on NIH research from intramural labs see: http://irp. nih. gov/ .

The NINDS Intramural Research Program is one of the largest neuroscience research centers in the world. Investigators in the NINDS intramural program conduct research in the basic, translational, and clinical neurosciences. Their specific interests cover a broad range of neuroscience research including molecular biophysics, synapses and circuits, neuronal development, integrative neuroscience, brain imaging and neurological disorders.

An NIH intramural investigator may provide assistance in a collaborative manner by providing technology, reagents and/or discussions during the SBIR award period. No SBIR funds are allowed to go to the NIH intramural investigator or to the NIH intramural program. For more information on NINDS research from intramural labs see: http://neuroscience.

nih. gov/ and http://intra. ninds.

nih. gov/ . Please see the NINDS Technology Transfer Office for more details on NINDS licensing opportunities: http://tto.

ninds. nih. gov/Licensing.

asp . For a complete listing of NIH intramural technologies which are available, please see NIH Office of Technology Transfer at: http://www. ott.

nih. gov/Technologies/AbsSearchBox. aspx .

A list of relevant technical, invention, and licensing-related answers can be found online at the NINDS Technology Transfer Office: http://tto. ninds. nih.

gov/ . Small business concerns should submit an SBIR application through Grants. gov using the SF424(R&R) application package.

SBCs are encouraged to submit a license application to the NIH Office of Technology Transfer (OTT) before submitting an SBIR application. The SBIR application will be reviewed by the NIH Center for Scientific Review (CSR), while license applications will be reviewed by the NIH Office of Technology Transfer.

Under the NINDS SBIR-TT program, the SBIR grant review process will be conducted in parallel with, but distinct from, the review of any application for a license. NINDS has a policy requiring authorization from the Food and Drug Administration (FDA) to use an investigational drug, biologic product or device in a clinical trial prior to submission of an application. For more details see: http://grants.

nih. gov/grants/guide/notice-files/NOT-NS-11-018. html .

Small business concerns are also encouraged to refer to the NINDS Small Business Program website for general information about the SBIR program at http://www. ninds. nih.

gov/funding/small-business/index. htm . Application Types Allowed New (Phase I, Fast-Track) Resubmission (all phases) 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 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.

Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research Durations up to 2 years for Phase I and up to 3 years for Phase II may be requested. Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. Section III.

Eligibility Information 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 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. Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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.

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 Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually 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 least four (4) 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. Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD(s)/PI(s) 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(s)/PI(s), at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements.

For institutions/organizations proposing multiple PD(s)/PI(s), see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . Additional Information on Eligibility 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 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.

Contractual/Consortium Arrangements 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).

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 Section IV.

Application and Submission 1. Requesting an Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants. gov .

Form of Application Submission It is critical that applicants follow the instructions in (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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Required and Optional Components The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate optional All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions: 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.

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) 3.

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

Organizations must submit applications via Grants. gov , the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants 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. 4. Intergovernmental Review (E.

O. 12372) This initiative is not subject to intergovernmental 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 Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Instructions. Paper applications will 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 .

All PD(s)/PI(s) 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. 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. An NIH intramural investigator may provide assistance in a collaborative manner by providing technology, reagents and/or discussions during the SBIR award period.

If the collaboration with the intramural investigator is not applicable, the SBC should address why in the SBIR application. If applicable, a letter of support from the NIH intramural investigator should be provided with the SBIR application. The letter of support from the intramural investigator should describe any potential collaboration between the small business concern and the NIH intramural investigator.

The SBIR application should include this letter of support for the SBIR review as a . pdf attachment in the Letters of Support section of the PHS 398 Research Plan. No SBIR funds are allowed to go to the NIH intramural investigator or to the NIH intramural program.

While there are multiple types of licenses available from the NIH, the license application should at a minimum request a license for non-exclusive internal research-use rights. The application can be obtained at: http://www. ott.

nih. gov/forms_model_agreements/forms_model_agreements. aspx#MLA .

This completed license application should be submitted by the SBC to the NIH Office of Technology Transfer via an email with a subject line that includes SBIR-TT to [email protected] . SBCs are encouraged to submit a license application to the NIH Office of Technology Transfer before submitting an SBIR application, although they are not required until selected for SBIR funding.

The SBC will receive a letter of confirmation for the submitted internal research-use license application. SBCs are encouraged to include this letter of confirmation as a . pdf attachment in the Letters of Support section of the PHS 398 Research Plan.

In addition to the non-exclusive internal research use license, the SBC is encouraged to apply for an exclusive or non-exclusive commercialization license to make, use, and sell products or services incorporating the NIH technology, consistent with achieving the goals of this program. Completed applications should be sent to the NIH Office of Technology Transfer (OTT) in accordance with the licensing process at http://www. ott.

nih. gov/licensing_royalties/flowchart_licproc. aspx .

The SBC will receive a letter of confirmation for any submitted licensing application. SBCs are encouraged to include this letter of confirmation for any such commercial license application(s) as a . pdf attachment in the Letters of Support section of the PHS 398 Research Plan.

Completion of the application for an exclusive or non-exclusive commercialization license and submission thereof supersedes the need for the non-exclusive internal research use license application requirement above. If a commercialization license is not applicable, the SBC should address why in the SBIR application.

More information about license applications and model license agreements can be found on the NIH Office of Technology Transfer website at http://www. ott. nih.

gov/index. aspx . This license application provides NIH with information about the potential licensee, some of the terms desired, and the potential licensee's plans for development and/or commercialization of the invention.

License applications will be treated in accordance with federal patent licensing regulations as provided in 37 CFR Part 404 . A further description of the NIH licensing process is available at http://www. ott.

nih. gov/licensing_royalties/intra_techlic. aspx .

NIH will notify SBCs who have submitted an application for an exclusive commercialization license if another application for an exclusive license to the technology for the same field of use is received at any time before such a Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 . V.

Application Review Information 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 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.

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?) Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project?

If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 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? 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 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 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 Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

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 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 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 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 .

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

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 For renewals, the committee will consider the progress made in the last funding period..

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

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

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

Review and Selection Process Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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 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. Relevance of the proposed project to program priorities. 3.

Anticipated Announcement and Award Dates After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) Information regarding the disposition of applications is available in the NIH Grants Section VI.

Award Administration Information If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as Grants Policy Statement . If selected for SBIR funding the applicant should submit a license application to the NIH Office of Technology Transfer, as appropriate.

Once the applicant receives approval for any required NIH license they should submit documentation confirming approval as part of their just-in-time. No award will be made to the applicant until they have been granted any required NIH license to the NIH intramural technology