Blood Diseases and Resources Research

Published on AidPage by IDILOGIC on Jun 24, 2005

Purpose of this program:

To foster research and research training on the pathophysiology, diagnosis, treatment, and prevention of non-malignant blood diseases, including anemias, sickle cell disease, thalassemia; leukocyte biology, pre-malignant processes such as myelodysplasia and myeloproliferative disorders; hemophilia and other abnormalities of hemostasis and thrombosis; and immune dysfunction. Funding encompasses a broad spectrum of hematologic inquiry, ranging from stem cell biology to medical management of blood diseases and to assuring the adequacy and safety of the nation?s blood supply. Programs also support the development of novel cell-based therapies to bring the expertise of transfusion medicine and stem cell technology to the repair and regeneration of human tissues and organs. 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 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 the research initiated in Phase I and which are 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. These awards are made to small businesses working in collaboration with academic institutions. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential on Phase II application.

Who is eligible to apply...

Any nonprofit organization engaged in biomedical research and institutions (or companies) organized for profit may apply for grants, with the exception of NRSAs. An individual may apply for a NRSA or, in some cases, may qualify for a research grant if adequate facilities in which 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 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. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. 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 that 500 employees which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.

Eligible Applicant Categories:
Eligible Functional Categories:
Credentials/Documentation

Applicants for individual National Research Service Awards 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 designate 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 organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulations 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present a research plan the idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. SBIR and STTR applicants must use the Public Health Service Grant Application (PHS 398)forms for new/revised applications and the Progress Report for Public Health Service Grant (PHS 2590) for non-competing continuations (e.g., second year of Phase II).

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/sbir.htm on the World Wide Web. 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. For questions about forms submission or policy, please call the GRANTSINFO office at 301-435-0714 or send an e-mail to grantsinfo@nih.gov.

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. Fellowship applications have a secondary review by the staff of the Institute. Staff informs applicants of the results of the review. If support is contemplated, staff initiates preparations 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 7-1/2 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 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

Renewals require application and review 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...

Any nonprofit or for-profit organization, company or institution engaged in biomedical research.

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

$160,200 to $2,012,399; $443,047. Small Business Innovation Research/Small Business Technology Awards: 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 $385,009,000; FY 04 est $371,719,000; and FY 05 est $384,201,000.

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...

(1) An individual research grant to define the latent therapeutic value of epsilon-globin gene reactivation in adults with disorders in beta-globin expression. The research comprises a crucial step in evaluating the promise of developmentally silenced globin genes for individuals with beta-thalassemia and sickle cell anemia. (2) A multi-project grant dealing with abnormalities in the regulation of coagulation and thrombosis which play a major role in the pathogenesis of many heart, lung, and blood diseases. This project integrates the research efforts of a number of independent investigators to explore the molecular basis for selected disorders of coagulation and thrombosis and the role of hemostatic balance in vascular disease pathogenesis. (3) A grant for a Specialized Center of Research (SCOR) in Hematopoietic Stem Cell Biology. The focus is to increase our understanding of hematopoietic differentiation with the ultimate goal of improving the therapy of patients with hematological, immunological, and genetic diseases. (4) A Comprehensive Sickle Cell Center Grant that integrates clinical, translational and basic research, thereby fostering multidisciplinary collaborations directed toward the goal of finding effective therapy and ultimately a cure for sickle cell disease. (5) An Individual National Research Service Award to use in utero gene delivery to target highly proliferative hematopoietic stem cells in the fetal liver of a murine model of beta thalassemia. The fellow will train under the guidance of an accomplished mentor and will develop research skills in the important area of in utero gene transfer strategies for transduction of hematopoiet stem cells and treatment of genetic disorders of the hematopoietic system that cause ongoing morbidity and mortality in children. (6) A Small Business Innovative Research Grant to develop a rapid, accurate, cost-effective screening test to detect a broad array of bacterial contaminants in stored human red blood cells. The successful development of this technology will improve the availability and safety of the human blood supply and will have broad potential for bacterial detection applications in human diagnostic, food testing, environmental testing and other research uses.

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, 848 research grants and 65 National Research Service Awards were made. The estimates for fiscal year 2004 are 858 research grants and 50 National Research Service Awards. The estimates for fiscal year 2005 are 879 research grants and 71 National Research Service Awards. In fiscal year 2003, for new and competing renewal awards 2375 grant applications were received, and of these, 667 were awarded; 42 National Research Service Award applications were received and of these 15 were awarded. Small Business Innovation Research Awards: In fiscal year 2003, 35 Phase I and 14 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 Advisory Council may recommend funding for periods ranging from 1 to 5 years. Funding commitments are made annually. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years.

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 are required 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.

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, "Audits of States, Local Governments, and Nonprofit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 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 U.S.C 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 Contacts: Director, Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435- 0080. Small Business Innovation Research Program: Deputy Director, Division of Extramural Affairs, National Heart, Lung, and Blood Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0266. Grants Management Contact: Ms. Suzanne White, Grants Management Officer, Grants Operations Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0144. 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: