Cardiovascular Diseases Research (CFDA 93.837)

Cardiovascular Diseases Research (CFDA 93.837) is sponsored by National Heart, Lung, and Blood Institute (NHLBI) - NIH. This opportunity supports mission-aligned projects and measurable outcomes.

HEALTH AND HUMAN SERVICES, DEPARTMENT OF The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives.

To foster heart and vascular research in the basic, translational, clinical and population sciences, and to foster training to build talented young investigators in these areas, funded through competitive research training grants.

Small Business Innovation Research (SBIR) program: To stimulate technological innovation; use small business to meet Federal research and development needs; foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons; and increase private-sector commercialization of innovations derived from Federal research and development funding.

Small Business Technology Transfer (STTR) program: To stimulate technological innovation; foster technology transfer through cooperative R&D between small businesses and research institutions, and increase private sector commercialization of innovations derived from federal R&D.

Fosters heart and vascular research in the basic, translational, clinical and population sciences, and to foster training to build talented young investigators in these areas, funded through competitive research training grants.

Small Business Innovation Research (SBIR) program: To stimulate technological innovation; use small business to meet Federal research and development needs; foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons; and increase private-sector commercialization of innovations derived from Federal research and development funding.

Small Business Technology Transfer (STTR) program: To stimulate technological innovation; foster technology transfer through cooperative R&D between small businesses and research institutions, and increase private sector commercialization of innovations derived from federal R&D.

HEALTH - LR Prevention and Control (includes Suicide Prevention) Title Public Health Service Act, Part 422 and 487, Section 301 Title Public Health Service Act, Part Subpart 2, Part C, Title IV, Section 503, 424 _These funding amounts do not reflect the award amounts that are displayed on USASpending. gov_ **This listing is funded for the current fiscal year.

** F001 - Grant, F002 - Cooperative Agreement Individual NRSA awardees and Institutional NRSA trainees must be citizens or noncitizen nationals of the United States or have been admitted for permanent residency. Two levels of training are available: graduate level predoctoral training and postdoctoral training.

All potential trainees must possess a desire for training in one of the health or health-related areas specified by the National Institutes of Health. Each applicant must be sponsored by an accredited public or private nonprofit institution engaged in such training. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments.

For-profit organization costs are determined in accordance with Subpart 31. 2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with DHHS Regulations 45 CFR, Part 74, Subpart Q.

For SBIR and STTR grants, the applicant organization (small business concern) must present a research plan 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. SBIR and STTR applicants must use the SF424 Research and Related (R&R) application for electronic submission through grants.

gov. Electronic submission of NIH Research Performance Progress Reports (RPPR) applies to non-competing continuations (e.g., second year of Phase II). OMB Circular No. A-87 applies to this program. 2 CFR 200, Subpart E - Cost Principles applies to this program.

2 CFR 200, Subpart E - Cost Principles applies to this program. 2 CFR 200, Subpart E - Cost Principles applies to this program.

Unrestricted by Individual Type, Not-for-Profit Organization Local (includes State-designated Indian Tribes; excludes institutions of higher education and hospitals), Public nonprofit institution/organization (includes institutions of higher education and hospitals), Individual/Family, Small business (less than 500 employees), Private nonprofit institution/organization (includes institutions of higher education and hospitals) .

Any nonprofit organization engaged in biomedical research and institutions or companies organized for profit may apply for almost any kind of grant. Only domestic, non-profit, private or public institutions may apply for NRSA Institutional Research Training Grants. An individual may apply for an NRSA or, in some cases, for a research grant if adequate facilities to perform the research are available.

SBIR grants can be awarded only to United States small business concerns (entities that are independently owned and operated for profit or owned by another small business that itself is independently owned and operated for profit, or owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these and have no more than 500 employees including affiliates).

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 research must be performed in the U.S. or its possessions except under rare and unique circumstances where foreign components are thoroughly justified and necessary to the overall completion of the project.

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. Normally, SBIR projects must be performed at least 67% by the applicant small business in Phase I and at least 50% of the Project in Phase II.

STTR grants can be awarded only to United States small business concerns (entities that are independently owned and operated for profit and have no more than 500 employees) that formally collaborate with a university or other non-profit research institution in cooperative research and development.

The principal investigator of an STTR award may be employed with either the small business concern or collaborating non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant small business concern and is willing to devote at least 10% effort (1. 2 calendar months) to the project.

At least 40% of the project is to be performed by the small business concern and at least 30% by the non-profit research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions except under rare and unique circumstances where foreign components are thoroughly justified and necessary to the overall completion of the project.

Unrestricted by Individual Type, Any nonprofit or for-profit organization, company or institution engaged in biomedical research. Only domestic for-profit small business firms may apply for SBIR and STTR programs.

Laboratory Directed Research and Development, Research Patient Care Costs, Travel – Research Patients, Materials and Supplies Costs, Including Costs of Computing Devices, Program Related Supplies, Personal Services Compensation (e.g., Salary, Stipend), Scholarships, Student Aid, and Tuition Grants may support stipends, research expenses, supplies, travel, childcare costs, and research training tuition as required to perform the research effort.

Restrictions or limitations are imposed against the use of funds for entertainment, foreign travel, general-purpose equipment, alterations and renovations, and other items not regularly required for the performance of research. Individual predoctoral and postdoctoral national research service awards (NRSAs) are made directly to individuals through their universities for research training in heart and vascular diseases.

NRSA awards may be made to eligible institutions to enable them to appoint individuals selected by the institution for research training. Certain service and payback provisions may apply to postdoctoral individuals upon termination of the award or termination of the appointment.

SBIR Phase I awards (of approximately 6 to 24 months in duration) are to establish the scientific and technical merit of the proposed research effort, and feasibility of ideas that appear to have commercial potential. Direct to Phase II SBIR awards are for projects that have been developed beyond the feasibility phase using resources other than NIH Phase I awards that meet program needs and exhibit potential for commercial application.

SBIR Phase IIB awards are for promising projects that require additional time and funding to advance to commercialization as well as ultimate approval or clearance by a Federal regulatory agency. The Phase IIB program promotes partnerships between previously funded SBIR or STTR Phase II awardees and third-party investors and/or strategic partners by encouraging matching contributions.

STTR Phase I awards (normally of 6 to 24 months in duration) are to establish the scientific and technical merit of the proposed cooperative research effort between a small business and non-profit research institution, and feasibility of ideas that appear to have commercial potential.

Phase II awards are for the continuation of research initiated in Phase I that meets particular program needs and exhibits potential for commercial application. Fast-Track is an option whereby Phase I and Phase II SBIR or STTR projects are submitted and reviewed concurrently with the aim of reducing or eliminating the funding gap between Phase I and Phase II.

The SBIR/STTR Commercialization Readiness Pilot Program awards facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization phase by providing additional support for technical assistance and later stage research and development activities not typically supported through Phase II or Phase IIB grants or contracts including replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance or a combination of services.

While the intent of the SBIR/STTR programs is commercialization (Phase III), only SBIR/STTR technical and business assistance (TABA) funds are allowed to be used for commercialization activities such as intellectual property protections; market and sales; market research; business development/product development/market plans; legal fees, travel and other costs including labor relating to license agreements and partnerships.

The remaining SBIR/STTR funds are for research and development purposes only and exclude these commercialization activities. General Purpose Equipment, Alteration and Renovations Restrictions or limitations are imposed against the use of funds for entertainment, foreign travel, general-purpose equipment, alterations and renovations, and other items not regularly required for the performance of research.

Contact the headquarters or regional location, as appropriate for application deadlines Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.

O. 12372. 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program.

Opportunity Posted Location: Grants.

gov Application Procedures Location: NOFO 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 importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; and (8) the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research.

Plans for the recruitment and retention of subjects will be evaluated; and (9) 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) The adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research.

Plans for the recruitment and retention of subjects will be evaluated; and (9) 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. All accepted applications are evaluated by an appropriate initial review group (study section).

All grant applications receive a final secondary review by the National Heart, Lung, and Blood Advisory Council. Staff inform applicants of the results of the review. If support is contemplated, staff initiate preparation of awards for grants.

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.

> 180 Days. Regular Grants: From 7 to 9 months. SBIR/STTR Grants: About 7-1/2 to 9 months.

> 180 Days. Renewal applications are reviewed in the same manner as new applications. 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. A description of the NIH Peer Review Appeal procedures is available in the NIH Guide at the following URL http://grants.

nih. gov/grants/guide/notice-files/NOT-OD-11-064. html.

The following 2CFR policy requirements apply to this assistance listing: Subpart B, General provisions Subpart C, Pre-Federal Award Requirements and Contents of Federal Awards Subpart D, Post Federal; Award Requirements Subpart E, Cost Principles Subpart F, Audit Requirements The following 2CFR policy requirements are excluded from coverage under this assistance listing: **Financial Reports:**Annual reports on progress and expenditures.

Final reports are required within 120 days of termination. Reports are required after termination of National Research Service Awards to ascertain compliance with the service and payback provisions. , Frequency: Annually **Progress/Performance Reports :**Annual reports on progress and expenditures are required.

Final reports are required within 120 days of termination. Reports are required after termination of NRSAs to ascertain compliance with the service and payback provisions.

, Frequency: Annually Additional audit requirements: In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, nonfederal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year.

Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200. 503, Frequency: Determined at Time of Award Retention Period: 3 Years **Additional Compliance Requirements:** Domestic Assistance Program that uses Core-Based Statistical Area (CBSA): National Heart, Lung, and Blood Institute (NHLBI), christine. cullinane@nih.

gov National Heart, Lung, and Blood Institute (NHLBI), Cardiovascular Diseases Research Cardiovascular Diseases Research Cardiovascular Diseases Research Cardiovascular Diseases Research Cardiovascular Diseases Research Cardiovascular Diseases Research Cardiovascular Diseases Research Cardiovascular Diseases Research Cardiovascular Diseases Research Cardiovascular Diseases Research Number changed from 13.

837 Heart and Vascular Diseases Research