Microbiology and Infectious Diseases Research

Tribal Self-Governance Study
Description of Program, Service, Function or Activity (PSFA)

INVENTORY

1. Agency Name: National Institute of Allergy and Infectious Diseases (NIAID), NIH, HHS

2. Program Name: Microbiology and Infectious Diseases Research

3. CFDA #: 93.856

4. Program Objectives: To support research related to Microbiology and Infectious Diseases with the broad aim of improving health by controlling disease caused by infectious or parasitic agents. Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines. Also supported are studies on the mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations. The objectives of the program are to assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to assist public, private and commercial institutions to conduct developmental research; to produce and test research materials; and to provide research services as required by the agency for programs in infectious diseases. Small Business Innovation Research (SBIR) program expands and improves private sector participation in biomedical research. The SBIR Program intends to increase and facilitate 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. The Small Business Technology Transfer (STTR) program stimulates and fosters 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. Research Career Development Awards support the development of scientists during the formative stages of their careers. Individual National Research Service Awards (NRSAs) are made directly to approved applicants for research training in specified biomedical shortage areas. In addition, Institutional National Research Service Awards are made to enable institutions to select and make awards to individuals to receive training under the aegis of their institutional program.

5. Titles and Descriptions of at least Three Funded Grantees: Examples of Funded Projects:

Areas of molecular microbiology include: basic research, biochemistry, physiology, and genetics of bacteria and fungi; the synthesis of new antimicrobial agents through organic chemistry; and the discovery of new antibiotics from natural sources. Areas of high relevance are: mechanisms of resistance to microbial agents, either of plasmid or chromosomal origin; and the manipulation of recombinant DNA molecules to better ascertain the molecular basis of pathogenicity and to create new substances of biological and medicinal utility.
In the area of bacteriology and mycology, research is conducted on a wide variety of problems involved directly or indirectly with diseases of man caused by bacteria and related agents. Studies to further the knowledge of the organisms involved include: investigations on the biology and physiology of bacteria; their morphology; and on antigenic structure and composition, toxins and endotoxins. More specific disease-related research includes studies on pathogenesis, immunopathology, host defense mechanisms, diagnostic procedures, therapeutic measures, animal models and the epidemiology of disease. Support is also provided for several specific disease program areas such as sexually transmitted diseases, hospital associated infections, and streptococcal diseases and sequelae. Research is also conducted in the area of mycobacteriology which includes two major diseases: tuberculosis and leprosy. This program also supports studies or bacterial diarrhea, bacterial vaccines, and antimicrobial agents.
Studies on viruses and diseases of importance to human health are also supported. Research in general virology encompasses the biology of viruses and the immunopathogenesis of viral diseases. Studies that will significantly advance the knowledge of viral structure, replication, genetics, immunology, and interaction between virus and host are encouraged, as well as research on mechanisms of viral persistence and latency that underlie problems of chronic and recurring viral diseases and studies of viral pathogenesis and host's responses to viral infections or to vaccines. Several areas of particular interest include: viral hepatitis, influenza, viral diarrhea, antiviral substances, viral vaccines and Reye's Syndrome.
Research in parasitology includes projects designed to obtain a clearer understanding of host-parasite and vector-parasite relationships, with the ultimate goal of applying this basic information to the control of parasitic diseases through such procedures as chemoprophylaxis, chemotherapy, and vector control. Research projects cover the entire field of parasitology and medical entomology. Emphasis has been directed toward studies on the immunology of parasitic infections and the biological regulation of vectors.
Studies are also being conducted on Acquired Immune Deficiency Syndrome, and include basic, applied, preclinical and clinical research on HTLV-III/LAV and related retroviruses for eventual control of HTLV-III/LAV infections. This includes research on the epidemiological, clinical, immunological, and urological aspects of this disease as well as the prevention and treatment of the major opportunistic infections associated with AIDS.

AUTHORITY

6. Authorizing Statute(s): Public Health Service Act, Title IV, Section 301, as amended, Public Law 78- 410; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564, 42 U.S.C. 241.

7. Regulatory/Administrative Requirements: 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.

8. Mandatory Statutory Changes Needed to Operate PSFA as a Demonstration: Amendment of authorizing statutes that permit NIAID to administer this program as now defined.

APPLICANTS, BENEFICIARIES and FORMULAS

9. Type of Funding: Project Grants

10. Eligible Applicants: Universities, colleges, hospitals, laboratories, and other public or private nonprofit domestic institutions, including State and local units of government, and individuals are eligible to make application for grant support of research by a named principal investigator or a research career development candidate. For-profit organizations are also eligible, with the exception of NRSA. Individual NRSA awardees must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All NRSA awardees must be citizens or have been admitted to the United States for permanent residence. To be eligible, predoctoral candidates must have completed the baccalaureate degree, and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). 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. 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 researches proposed and have no more than 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.

11. Allotment Formulas, Etc.: This program has no statutory formula or matching requirements.

12. Applicant Provisions/Allotments in Law for Indians: None. By law NIAID must fund all successful, eligible applicants within the confines of its appropriation authorization level.

13. Eligible Beneficiaries: Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

14. Beneficiary Provisions/Allotments in Law for Indians: None. By law NIAID must recognize any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

15. Amount and Percent of Total that is Mandatory for Indians: No mandatory set asides for any minority group.

FINANCIAL

16. Total FY 2000 Funding: (Grants) FY 00 est $961.063 million; (SBIR) FY 00 est $30.771 million; and (STTR) FY 00 est $1.218 million.

17. Amount and Percent of Total Funding Awarded to Indians: Unknown. Ethnicity of the applicant is requested but disclosure is not mandatory.

18. For Awards to Tribes: Number, Range and Average Amounts: N/A

19. Total FY 2001 Funding and Amount for Indians, if Known: (Grants) FY 01 est $1,069 million; (SBIR) FY 01 est $35.550 million; (STTR) FY 01 est $1.407 million. See number 17 regarding awards to Indians.

OTHER

20. How long assistance is funded: Research grant project periods average 4 years; they may not be extended beyond 7 years. (Project periods are generally composed of 1-year budget periods.) 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.

--Fund use restrictions: Beginning with fiscal year 1998, the direct costs awarded in the first year to a research project grant resulting from a competing renewal application will be limited to no more than a 20 percent increase over the direct costs awarded in the last non-competing year of that grant. Research grants provide funds for salaries, equipment, supplies, and travel. They also afford the collateral benefits of enriching the training experience of research workers. Grantees are expected to be judicious in using these funds. The application for a research grant sets forth specific terms and conditions and requires the signatures of the principal investigator and an official authorized to sign for the institution. Scientists and institutions are under an obligation to expend grant funds prudently for the purposes stated in the application and award document. For Research Career Development Awards (RCDAs) the scientists must demonstrate an outstanding research potential for independent research in the sciences related to transplantation, immunology, allergies, and immunological diseases. For National Research Service Awards (NRSAs), each individual who receives NRSA support is obligated upon termination of the award to comply with certain service and payback provisions. SBIR Phase I grants (of about 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 receive Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of 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 the Phase II application.

--Reporting requirements: Annual progress reports and financial status reports are required.

--Audit requirements: "In accordance with the provisions of OMB Circular No. A-133 (Revised, June 24, 1997), Audits of States, Local Governments, and Non-Profit Organizations, nonfederal entities that receive 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.

CONTACTS

21. DHHS Workgroup Contact: John Ruffin, Ph.D., Director
National Center on Minority Health and Health Disparities
(301) 402-1366

22. HHS Agency/Program Contact: Dr. John J. McGowan, Director
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Public Health Service
Department of Health and Human Services
Bethesda, MD 20892
(301) 496-7291

Grants Management Contact: Ms. Mary Kirker, Grants Management Officer
Grants Management Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Public Health Service
Department of Health and Human Services
Bethesda, MD 20892
(301) 496-7075

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