PAR-00-126: SBIR ADVANCED TECHNOLOGY

Department of Health
and Human Services (HHS)

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SBIR ADVANCED TECHNOLOGY - NIAID (SBIR-AT-NIAID) Release Date: July 26, 2000 PA NUMBER: PAR-00-126 National Institute of Allergy and Infectious Diseases Application Receipt Dates: December 1, 2000 April 1, August 1, December 1, 2001 April 1, August 1, December 1, 2002 April 1, August 1, 2003 PURPOSE This Program Announcement, SBIR-AT-NIAID, invites grant applications for Small Business Innovation Research (SBIR) projects with award duration and amounts greater than those routinely allowed under the SBIR program. This program announcement replaces PAR-98-073 that appeared in the May 22, 1998 issue of the NIH Guide and was updated in the August 16, 1999 issue of the NIH Guide. August 1, 2000 is final receipt date for application in response to PAR-98-073. This new program announcement includes changed receipt dates (see above), new URL links, modified instructions (consistent with current SBIR application instructions), and a modified Research Objectives and Scope. SBIR-AT-NIAID applications are a parallel option for advanced technology related SBIR proposals and are not intended as an alternative for other SBIR proposals. Advanced technology projects are defined as those that include high-cost advanced technology or high-cost long-term clinical studies in human or non- human primates. NIAID invites applications for SBIR-AT-NIAID awards in the research areas identified in Research Objectives and Scope below. This PA must be read in conjunction with the Omnibus Solicitation of the Public Health Service for Phase I SBIR Grant Applications found at http://grants.nih.gov/grants/funding/sbirsttr1/index.htm and the instructions for Phase II Grant Applications found at http://grants.nih.gov/grants/funding/sbir2/index.htm. Except as noted below, all instructions and information in these documents also apply to SBIR-AT- NIAID applications. This PA provides examples of advanced technology areas in which NIAID will entertain SBIR applications and provides NIAID"s interpretation and clarification of instructions relating to total cost, dates of project period, and page limitations for these applications. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This PA, SBIR-AT-NIAID, is related to the priority areas of immunization and infectious diseases, HIV infection, sexually transmitted diseases, clinical preventive services, maternal and infant health, diabetes and chronic disabling conditions, and surveillance and data systems. Potential applicants can find "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY Eligibility requirements for Phase I and Phase II grants are found at http://grants.nih.gov/grants/funding/sbirsttr1/index.htm and http://grants.nih.gov/grants/funding/sbir2/index.htm respectively. MECHANISM OF SUPPORT - PHASE I Phase I applications in response to this PA will be funded as Phase I SBIR Grants (R43) with modifications as described below. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Applications for Phase I grants should be prepared following the instructions at http://grants.nih.gov/grants/funding/sbirsttr1/11instructions.htm. o Project Period and Amount of Award. Because the length of time and cost of research involving advanced technology projects often exceeds that routinely awarded for SBIR grants, NIAID will entertain well justified Phase I applications for an SBIR-AT-NIAID award with a project period up to two years and a budget not to exceed a total cost of $300,000 per year. See section, BUDGET REQUESTS GREATER THAN $100,000 TOTAL COSTS, in http://grants.nih.gov/grants/funding/sbirsttr1/11instructions.htm o Consultant and contractual costs. The total amount of all consultant costs and contractual costs normally may not exceed 33% of the total costs requested for Phase I SBIR applications. However, NIAID will entertain well-justified Phase I applications for an SBIR-AT-NIAID award with greater than 33% contractual costs when those costs are necessary to support clinical studies and trials. o Page Limitations. The 25-page limitation for Phase I applications apply. Supplementary or corrective material pertinent to the review of an application after the receipt date may be submitted only if it is specifically solicited by or agreed to through prior discussion with the Scientific Review Administrator of the scientific peer review group. MECHANISM OF SUPPORT - PHASE II Phase II applications in response to this PA will be awarded as Phase II SBIR grants (R44) with modifications as described below. Phase II applications in response to this PA will only be accepted as competing continuations of previously funded NIH Phase I SBIR awards. The previously funded Phase I award need not be an SBIR-AT-NIAID award, but the Phase II proposal must be a logical extension of the Phase I research. Phase II applications should be prepared using instructions at http://grants.nih.gov/grants/funding/sbir2/index.htm. o Project Period and Amount of Award. Because the length of time and cost of research involving advanced technology projects often exceeds that routinely awarded for SBIR grants, NIAID will entertain well-justified Phase II applications for an SBIR-AT-NIAID award with a project period up to three years and a budget not to exceed $1 million per year total cost. o Consultant and contractual costs. The total amount of all consultant costs and contractual costs normally may not exceed 50% of the total costs requested for Phase II SBIR applications. However, NIAID will entertain well-justified Phase II applications for an SBIR-AT-NIAID award with greater than 50% contractual costs when those costs are necessary to support clinical studies and trials. RESEARCH OBJECTIVES The SBIR program consists of the following three phases: o Phase I. The objective of Phase I is to establish the technical merit and feasibility of proposed research or R&D efforts and to determine the quality of performance of the small business grantee organization prior to providing further federal support in Phase II. o Phase II. The objective of this phase is to continue the research or R&D efforts initiated in Phase I. o Phase III. The objective of this phase, where appropriate, is for the small business concern to pursue the commercialization of the results of the research or R&D funded in Phases I and II. Normally, Phase III occurs without additional Federal funding. However, NIAID may support some Phase III studies, with non-SBIR funds, through resources such as NIAID clinical trial networks. Research Objectives and Scope. SBIR applications often do not request support for the length of time or the funding required for advanced technology projects. Advanced technology projects are defined as those that include high-cost advanced technology or high-cost long-term clinical studies in human or non-human primates. NIAID invites applications for SBIR-AT-NIAID awards in four areas: A. Development of vaccines, biologics, drugs and prevention strategies for infectious and immunologic diseases, allergy, and transplantation. B. Development of vaccine, biologic and drug delivery systems. C. Development of assays and therapeutic monitoring systems for clinical and vaccine trials and for improved diagnosis of infectious, allergic, and immunologic diseases. Examples include, but are not limited to, the following: o Kits, reagents and/or out-source services that provide reproducible measurements of human immune responses in preclinical and clinical trials of vaccines for HIV and other infections such as those caused by cytomegalovirus, hepatitis C virus, enteroviruses, B. burgdorferii (Lyme agent), aspergillus, candida, P. falciparum, STD agents, C. pneumoniae, N. meningitidis, respiratory syncytial virus, Group A streptococcus and drug- resistant microbes. o Detection and quantitative measurement of neutralizing antibodies, cytotoxic T lymphocytes, chemokine receptor assays, CD4+ helper cell activity, CD8+ suppressor cell activity, and in vitro infectivity of virus. Currently, many of these assays are not standardized among laboratories and results are difficult to compare. o Development and clinical evaluation of targeted therapies, novel vaccine constructs, diagnostic tests and tests for the monitoring of clinical response to an intervention for infectious diseases caused by pathogens such as those listed above. o Drug and therapeutic delivery systems directed towards special populations, special targets or special problems. Special populations include patient groups such as newborns, young children, pregnant women and others needing other than oral delivery. Special targets include specific physiological sites such as the genital, pulmonary, gastrointestinal tract, red blood cells, brain, etc. Special problems include prolonged release, and timed or sequential delivery of one or more components, and delivery with improved pharmokinetic factors such as oral bioavailability or protein binding. o Application of rapid and highly sensitive DNA chip technology to any of the following: kinetics of specific gene expression in different cell types under different stimulatory conditions, comparison of immune response gene expression during allograft or xenograft acceptance and rejection in humans, non-human primates, and rodents, comparison of pathogenic and non-pathogenic strains or different organisms which share the same mechanisms of pathogenesis, and correlation of gene expression with disease progression. o Protein-protein interaction chips to extend such genetic analyses to the more relevant level of functional protein expression. o Bioinformatics programs and centralized databases for analysis of data generated from new technologies, in particular gene and protein chips. These databases should also provide the means to model and understand entire systems both at the level of the cell and the whole organism. o High resolution magnetic resonance imaging (MRI) and other imaging techniques to localize and monitor in vivo any of the following: immune cells, pathogens, disease progression or remission. o New reagents that identify antigen-specific T cells to follow the course of a specific immune response, identify the responding T cell subset and cytokine profile at different times during the response, and predict the outcome of the response. o Development and clinical evaluation of topical microbicides o Development and field evaluation of methods for controlling vector-borne infections NIAID Policy on Monitoring Clinical Trials and Studies. On February 24, 2000, NIAID published its policy requiring that all clinical trials and studies supported by NIAID be monitored commensurate with the degree of potential risk to study subjects. When SBIR-AT-NIAID applications are for clinical trials or studies, applicants must meet the requirements of this policy available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear, compelling rationale, and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", published in the Federal Register of March 28, 1994 (FR 59 14508- 14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 which is available at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and which is available at the following URL address:http://grants.nih.gov/grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES Applicants should follow the instructions for SBIR Phase I or Phase II submission with the modifications as noted in this PA. Advice on Submitting Applications. Potential applicants are strongly encouraged to contact program staff for pre-application guidance and/or for more specific information on the research topics described in this PA. URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. Mailing Instructions The original application and two single-sided copies must be mailed to the NIH Center for Scientific Review. For purposes of identification and processing, the title and number of this PA must be shown in item 2 on the face page of the SBIR Phase I applications and in item 1A of the face page of Phase II grant applications (i.e., "SBIR-AT-NIAID,"). Follow the mailing instructions in the Omnibus Solicitation for Phase I applications. Follow the mailing instructions in the Phase II application package for Phase II applications. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by study sections of the Center for Scientific Review, NIH, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria Review criteria are described in Phase I and Phase SBIR websites listed above. The Phase I application should specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II. Failure to provide clear, measurable goals may be sufficient reason for the study section to judge the application non-competitive. AWARD CRITERIA The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, and the availability of funds. Applications will compete for available funds with all other favorably recommended SBIR applications. Note that applicants may achieve all Phase I goals and milestones and still not receive Phase II funding. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Allan Czarra Deputy Director Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Room 2144 - MSC 7610 Bethesda, MD 20892-7610 Bethesda, MD 20817-7610 (for express/courier service) Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: aczarra@niaid.nih.gov Direct inquiries regarding fiscal matters to: Ms. Pam Fleming Grants Management Specialist Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive Rm. 2119, MSC 7614 Bethesda, MD 20892-7614 Telephone: (301) 402-6580 FAX: (301) 480-3780 Email: pf49e@nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citations are No. 93.855, Immunology, Allergy, and Transplantation Research, and No. 93.856, Microbiology and Infectious Disease Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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