Heart and Vascular Diseases Research
Published on AidPage by IDILOGIC on Jun 24, 2005
Purpose of this program:
To foster research and prevention, education, and control activities related to heart and vascular diseases and to develop young scientist investigators in these areas. Small Business Innovation Research (SBIR) program: To expand and improve the SBIR program; to increase private sector commercialization of innovations derived from Federal research and development; to increase small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. Small Business Technology Transfer (STTR) program: To stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.
Possible uses and use restrictions...
Grants may support salaries, equipment, supplies, travel, and patient hospitalization 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. National Research Service Awards (NRSAs) are made directly to individuals for research training in specified biomedical shortage areas. Grants may be made to institutions to enable them to make NRSAs to individuals selected by them. Certain service and payback provisions apply to individuals upon termination of the award. SBIR Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of research initiated in Phase I that is likely to result in commercial products or processes. Only Phase I awardees are eligible to apply for Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of Phase II application.
Who is eligible to apply...
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. Any nonprofit organization engaged in biomedical research and institutions or companies organized for profit may apply for almost any kind of grant( an exception being the NRSA grant). 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 domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is being proposed, and have no more than 500 employees). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) that "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions.
Credentials/Documentation
Applicants for individual NRSAs must be citizens of the United States or have been admitted for permanent residency; must hold a doctoral degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree); and 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, in a research plan, an idea that has potential for commercialization and must furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. The grant application form PHS 398 is used to apply for all SBIR and STTR grants.
Note:This is a brief description of the credentials or documentation required prior to, or along with, an application for assistance.
About this section:
This section indicates who can apply to the Federal government for assistance and the criteria the potential applicant must satisfy.
For example, individuals may be eligible for research grants, and the criteria to be satisfied may be that they have a professional or scientific degree,
3 years of research experience, and be a citizen of the United States. Universities, medical schools, hospitals, or State and local governments may also be eligible.
Where State governments are eligible, the type of State agency will be indicated (State welfare agency or State agency on aging) and the criteria that they
must satisfy.
Certain federal programs (e.g., the Pell Grant program which provides grants to students) involve intermediate levels of application processing, i.e., applications
are transmitted through colleges or universities that are neither the direct applicant nor the ultimate beneficiary. For these programs,
the criteria that the intermediaries must satisfy are also indicated, along with intermediaries who are not eligible.
How to apply...
Application Procedure:
Research grant applications are submitted on designated forms to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. Forms for individual NRSA award applications may be obtained from and submitted to: Office of Research Manpower, Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. For some special grant programs, applicants may be advised to submit directly to the Review Branch, Division of Extramural Affairs, National Heart, Lung, and Blood Institute, Bethesda, MD 20892. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92 for State and local governments, must be used for this program. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at www.nih.gov/grants/funding/sbirsttr1. The Solicitation includes submission procedures, review considerations, and grant application or contract proposal forms. SBIR and STTR grant applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710. Small Instrumentation Grants Program: Those invited to apply should prepare and submit applications on Form PHS 398. Only the face page, budget page, and checklist page are to be completed. Additional information required includes the number and dollar amount of the grant(s) that would benefit from the requested equipment, a brief description of each beneficiary project, and an explanation of how the equipment would benefit the project. This program is subject to the provisions of 45 CFR, Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations.
Note: Each program will indicate whether applications are to be submitted to the Federal headquarters, regional or local office, or to a State or local government office.
Award Procedure:
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.
Note: Grant payments may be made by a letter of credit, advance by Treasury check, or reimbursement by Treasury check.
Awards may be made by the headquarters office directly to the applicant, an agency field office, a regional office,
or by an authorized county office. The assistance may pass through the initial applicant for further distribution by
intermediate level applicants to groups or individuals in the private sector.
Deadlines and process...
Deadlines
New Research Grants: February 1, June 1, and October 1 (or as specified in Request for Applications (RFA) announcements). Renewals and Supplementals: March 1, July 1, and November 1. Institutional NRSAs: January 10 and May 10. Individual NRSA: April 5, August 5, and December 5. SBIR and STTR Grants: April 1, August 1, and December 1.
Note:
When available, this section indicates the deadlines for applications to the funding agency which will
be stated in terms of the date(s) or between what dates the application should be received.
When not available, applicants should contact the funding agency for deadline information.
Range of Approval/Disapproval Time
Regular Grants: From 7 to 9 months. SBIR/STTR Grants: About 9 months.
Preapplication Coordination
Not applicable. This program is excluded from coverage under E.O. 12372.
Note:
This section indicates whether any prior coordination or approval is required with governmental or nongovernmental units
prior to the submission of a formal application to the federal funding agency.
Appeals
A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the National Heart, Lung, and Blood Institute.
Note:
In some cases, there are no provisions for appeal. Where applicable, this section discusses appeal procedures or allowable rework time for resubmission
of applications to be processed by the funding agency. Appeal procedures vary with individual programs and are either listed in this section or
applicants are referred to appeal procedures documented in the relevant Code of Federal Regulations (CFR).
Renewals
Renewal applications are reviewed in the same manner as new applications.
Note:
In some instances, renewal procedures may be the same as for the application procedure, e.g., for projects of a non-continuing nature renewals will be treated as new, competing applications; for projects of an ongoing nature, renewals may be given annually.
Who can benefit...
Research project grants and cooperative agreements, training and career development grants, and SBIR and STTR grants.
Beneficiaries
About this section:
This section lists the ultimate beneficiaries of a program, the criteria they must satisfy and who specifically is not eligible. The applicant and beneficiary will generally be the same for programs that provide assistance directly from a Federal agency. However, financial assistance that passes through State or local governments will have different applicants and beneficiaries since the assistance is transmitted to private sector beneficiaries who are not obligated to request or apply for the assistance.
What types of assistance...
Project Grants
The funding, for fixed or known periods, of specific projects. Project grants can include fellowships, scholarships, research grants, training grants, traineeships, experimental and demonstration grants, evaluation grants, planning grants, technical assistance grants, survey grants, and construction grants.
How much financial aid...
Range and Average of Financial Assistance
Grants: $108,000 to $3,270,696; $451,486. SBIR/STTR: Phase I - $100,000; Phase II - up to $750,000.
Note:
This section lists the representative range (smallest to largest) of the amount of financial assistance available. These figures are based upon funds awarded in the past fiscal year and the current fiscal year to date. Also indicated is an approximate average amount of awards which were made in the past and current fiscal years.
Obligations
(Grants) FY 03 $1,230,551,000; FY 04 est $1,308,450,000; and FY 05 est $1,352,385,000.
Note:
The dollar amounts listed in this section represent obligations for the past fiscal year (PY), estimates for the current fiscal year (CY), and estimates for the budget fiscal year (BY) as reported by the Federal agencies. Obligations for non-financial assistance programs indicate the administrative expenses involved in the operation of a program.
Account Identification
75-0872-0-1-552.
Note:
Note: This 11-digit budget account identification code represents the account which funds a particular program.
This code should be consistent with the code given for the program area as specified in Appendix III of the Budget of the United States Government.
Examples of funded projects...
EXAMPLES OF FUNDED PROJECTS (1) Investigator-initiated research project grants on the surgical treatment of cardiac arrythmias, on growth-factor mediation of healing in vascular grafts, and on mechanisms for cardiovascular control early in diabetes. (2) Institute-initiated research project grants on stem cell research in cardiomyopathy, on using adult stem cells to repair cardiac damage, and on altered glucose and lipid metabolism in obesity and cardiovascular disease. (3) AIDS-related research project grants on cardiomyopathy, on mitochondrial nucleotide carriers, and on endothelial oxidative stress and atherosclerosis. (4) An institute-initiated program project, a center of excellence in gene therapy. (5) Investigator-initiated program project grants on genetic approaches to early cardiac development, on oxidative stress and diabetic cardiovascular disease, and on the biomechanics of the heart, vessels, and blood cells. (6) Institute-initiated Specialized Centers of Research (SCORs) on the arterial wall and atherogenesis in mice and humans, and on heart failure. (7) Cooperative agreements for a clinical trial of the surgical treatment for ischemic heart failure, for a pediatric heart disease clinical research network, and for a center on fetal monkey gene transfer for heart, lung, and blood. (8) SBIR and STTR grants on the preservation of tissue-engineered myocardial components, on cardiac output for children?s ICU, on developing ECG software to detect acute myocardial infarction, on developing a biologically active vascular graft, and on new drugs for treating atrial fibrillation. (9) Training grants on translational cardiovascular science and medicine, on developmental cardiology and pulmonary training, on short-term training for minority students, and on cardiovascular biomechanics and imaging.
About this section
This section indicates the different types of projects which have been funded in the past. Only projects funded under Project Grants or Direct Payments for Specified Use should be listed here. The examples give potential applicants an idea of the types of projects that may be accepted for funding. The agency should list at least five examples of the most recently funded projects.
Program accomplishments...
In fiscal year 2003, 2,917 research grants and 285 National Research Service Awards were made. The estimates or fiscal year 2004 are 2,937 research grants and 281 National Research Service awards. The estimates for fiscal year 2005 are 2,879 research grants and 301 National Research Service Awards. In fiscal year 2003, for new and competing renewal awards: 8,171 grant applications were received, and of these, 798 were awarded; 2,185 National Research Service Award applications were received, and of these, 258 were awarded. Small Business innovation Research Awards: In fiscal year 2003, 69 Phase I awards, and 25 Phase II awards were made.
Criteria for selecting proposals...
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2)the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.
Assistance considerations...
Length and Time Phasing of Assistance
The National Heart, Lung, and Blood Advisory Council may recommend funding for periods typically ranging from one to five years. Funding commitments are made annually. Usually, SBIR Phase I awards are for six months and Phase II for two years, and STTR Phase I awards are for one year and Phase II are for two years
Formula and Matching Requirements
This program has no statutory formula or matching requirements.
Note:
A formula may be based on population, per capita income, and other statistical factors. Applicants are informed whether there are any matching requirements to be met when participating in the cost of a project. In general, the matching share represents that portion of the project costs not borne by the Federal government. Attachment F of OMB Circular No. A-102 (Office of Management and Budget) sets forth the criteria and procedures for the evaluation of matching share requirements which may be cash or in-kind contributions made by State and local governments or other agencies, institutions, private organizations, or individuals to satisfy matching requirements of Federal grants or loans.
Cash contributions represent the grantees' cash outlay, including the outlay of money contributed to the grantee by other public agencies, institutions, private organizations, or individuals. When authorized by Federal regulation, Federal funds received from other grants may be considered as the grantees' cash contribution.
In-kind contributions represent the value of noncash contributions provided by the grantee, other public agencies and institutions, private organizations or individuals. In-kind contributions may consist of charges for real property and equipment, and value of goods and services directly benefiting and specifically identifiable to the grant program. When authorized by Federal legislation, property purchased with Federal funds may be considered as grantees' in-kind contribution.
Maintenance of effort (MOE) is a requirement contained in certain legislation, regulations, or administrative policies stating that a grantee must maintain a specified level of financial effort in a specific area in order to receive Federal grant funds, and that the Federal grant funds may be used only to supplement, not supplant, the level of grantee funds.
Post assistance requirements...
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.
Note:
This section indicates whether program reports, expenditure reports, cash reports or performance monitoring are required by the Federal funding agency, and specifies at what time intervals (monthly, annually, etc.) this must be accomplished.
Audits
In accordance with the provisions of OMB Circular No. A- 133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Nonprofit Organizations," nonfederal entities that expend financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal government officials.
Note:
This section discusses audits required by the Federal agency.
The procedures and requirements for State and local governments and nonprofit entities are set forth in OMB Circular No. A-133.
These requirements pertain to awards made within the respective State's fiscal year - not the Federal fiscal year,
as some State and local governments may use the calendar year or other variation of time span designated as the fiscal year period,
rather than that commonly known as the Federal fiscal year (from October 1st through September 30th).
Records
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last financial status report for the report period.
Note:
This section indicates the record retention requirements and the type of records the Federal agency may require.
Not included are the normally imposed requirements of the General Accounting Office.
For programs falling under the purview of OMB Circular No. A-102, record retention is set forth in Attachment C.
For other programs, record retention is governed by the funding agency's requirements.
Regulations...
Authorization
Public Health Service Act, Section 301, 422 and 487, as amended, Public Laws 78-410 and 99-158, 42 U.S.C. 241, 42 U.S.C. 285, and 42 U.S.C. 288, as amended; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
Note:
This section lists the legal authority upon which a program is based (acts, amendments to acts, Public Law numbers, titles, sections, Statute Codes, citations to the U.S. Code, Executive Orders, Presidential Reorganization Plans, and Memoranda from an agency head).
Regulations, Guidelines, And Literature
42 CFR 52; 42 CFR 66; 45 CFR 74; "NIH Guide for Grants and Contracts, and Supplements"; Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications; Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.
Contact information...
Web Sites
Regional Or Local Office
Not applicable.
Note:
This section lists the agency contact person, address and telephone number of the Federal Regional or Local Office(s)
to be contacted for detailed information regarding a program such as:
(1) current availability of funds and the likelihood of receiving assistance within a given period;
(2) pre-application and application forms required;
(3) whether a pre-application conference is recommended;
(4) assistance available in preparation of applications;
(5) whether funding decisions are made at the headquarters, regional or local level;
(6) application renewal procedures (including continuations and supplementals) or appeal procedures for rejected applications; and
(7) recently published program guidelines and material.
However, for most federal programs, this section will instruct the reader to consult the so-called
Appendix IV of the Catalog due to the large volume of Regional and Local Office Contacts for most agencies.
This information is provided in Additional Contact Information (see below).
Headquarters Office
Program Contact: Director, Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0466. SBIR Program: Deputy Director, Division of Extramural Affairs, National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0266. Grants Management Contact: Grants Management Officer, Grants Operations Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0166. Use the same numbers for FTS.
Note:
This section lists names and addresses of the office at the headquarters level with direct operational responsibility for managing a program. A telephone number is provided in cases where a Regional or Local Office is not normally able to answer detailed inquiries concerning a program. Also listed are the name(s) and telephone number(s) of the information contact person(s) who can provide additional program information to applicants.
Additional Contact Information (Appendix IV)
Due to the large volume of regional and local office contacts for most agencies, full contact information is also provided separately here in a PDF format:
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