Microbiology And Infectious Diseases Research
NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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; and to make grants or award contracts to public and nonprofit private entities to expand, remodel, renovate, or alter existing research facilities or construct new facilities. 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.
Types of Assistance
Uses and 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 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 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.
Universities, colleges, hospitals, laboratories and other public or private nonprofit domestic institutions, including State and local units of government. 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 candidates must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng.), or must have an 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. 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 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.
Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.
Research grant applicants must define the objectives, methodology, and facilities for the program, and must present the program director's competence and scientific interest. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an 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. Grant forms PHS 6246-1 and PHS 6246-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively. Applicants for Individual NRSAs must include their academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training in their applications. The applicant for an Institutional NRSA must specify the objectives, methodology, and resources for the research training program, the qualifications and experience of directing staff, the criteria to be used in selecting individuals for award, and a detailed budget and justification for the amount of grant funds requested. Costs will be determined in accordance with OMB Circular No. A-87 for State and local government. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations 45 CFR, Part 74, Subpart Q.
Application and Award Process
This program is excluded from coverage under E.O. 12372.
Use Form PHS-398 (Rev. May 1995), (PHS- 5161-1 for State and local government units) to apply for new, renewal, and supplemental research grants. Application forms and information concerning current areas of science being supported are available from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, MD 20892. Telephone: (301) 435- 0714. Fax (301) 480-0525. E-mail: email@example.com. 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. 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. Completed applications should be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at http://www.nih.gov/grants/funding/sbir.htm on the World Wide Web. A limited number of hard copies of these publications are produced. Subject to availability, they may be obtained by contacting the NIH support services contractor: phone: (301) 206-9385; fax: (301) 206-9722; e- mail: firstname.lastname@example.org. The Solicitations include 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.
All accepted applications are reviewed for scientific merit by an appropriate initial review group and a national advisory council. If the application is recommended for approval and a decision to make an award is made, a formal award notice will be sent to the applicant or applicant institution. 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.
New Non-AIDS research applications: February 1, June 1, and October 1. For Renewal and Supplemental Non-AIDS research grant applications: March 1, July 1, and November 1. For all AIDS research grant applications: January 2, May 1, September 1. Research Career Development Award programs: February 1, June 1, October 1. Individual NRSAs: April 5, August 5, and December 5. Institutional NRSA: September 10. SBIR/STTR: April 1, August 1, and December 1.
Range of Approval/Disapproval Time
From 8 to 9 months. SBIR/STTR: About 7-1/2 months.
A principal investigator may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. Final decisions on unresolved appeals are made with the advice of the National Advisory Allergy and Infectious Diseases Council.
Formula and Matching Requirements
Length and Time Phasing of Assistance
Research grant project periods average 4 years; these 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.
Post Assistance Requirements
Annual progress reports and financial status reports are required.
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.
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
(Grants) FY 07 $1,970,809,000; FY 08 est $1,974,287,000; and FY 09 est $1,980,998,000. (SBIR) FY 07 $77,591,000; FY 08 est $81,665,000; and FY 09 est $81,665,000. (STTR) FY 07 $10,509,000; FY 08 est $11,061,000; and FY 09 est $11,061,000.
Range and Average of Financial Assistance
(Grants) $2,500 to $46,482,429; $538,472. (NRSAs) $4,202 to $647,660; $141,463. (SBIR) Average Phase I awards are for approximately $280,384. Phase II awards may be made for amounts up to $801,192 (total for funding period). (STTR) Phase I approximately $302,167; Phase II up to $1,085,549 (total per funding period).
An estimated 4,098 and 4,159 awards will be made in fiscal years 2007 and 2008 respectively.
Regulations, Guidelines and Literature
42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; (SBIR) Small Business Administration Policy Directive No. 65 01 (47 FR 52966 et seq. (1982), as amended by Policy Directive No. 65 01.1 (48 FR 38794 et seq. (1983)); 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.
Regional or Local Office
Program Contact: Dr. John J. McGowan, Acting Director, Division of Extramural Activities, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 496-7291. Grants Management Contact: 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. Telephone: (301) 496-7075. Use the same numbers for FTS.
Web Site Address
93.855, Allergy, Immunology And Transplantation Research
Examples of Funded Projects
(1) 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. (2) 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. (3) 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. (4) 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. (5) 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.
Criteria for Selecting Proposals
The major elements in evaluating proposals include assessments of: the scientific merit and general significance of the proposed study and its objectives; the technical adequacy of the experimental design and approach; the competency of the proposed investigator or group to successfully pursue the project; the adequacy of the available and proposed facilities and resources; the necessity of the budget components requested in relation to the proposed project; and 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 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.