This Program Announcement (PA) has been superceded by the PA dated July 26, 2000. SMALL BUSINESS INNOVATION RESEARCH ADVANCED TECHNOLOGY: NIAID (SBIR-AT-NIAID) Release Date: May 21, 1998 PA NUMBER: PAR-98-073 P.T. National Institute of Allergy and Infectious Diseases Application Receipt Dates: April 15, August 15, and December 15 PURPOSE This Program Announcement (PA), 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. 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. This PA must be read in conjunction with the Omnibus Solicitation of the Public Health Service (Omnibus Solicitation) for Phase I SBIR Grant Applications (PHS 98-2) and the instructions for Phase II Grant Applications revised March 1998. 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 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," 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 may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017- 001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone 202-512-1800). ELIGIBILITY Eligibility requirements are described in the Omnibus Solicitation. 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 directions for Phase I SBIR applications as described in the Omnibus Solicitation. The Omnibus Solicitation is available on the Internet at: http://www.nih.gov/grants/funding/sbir1/sbir.htm A limited number of hard copies of the Omnibus Solicitation are available from: PHS SBIR/STTR Solicitation Office 13685 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX: (301) 206-9722 Email: a2y@cu.nih.gov 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. 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 in academic institutions. o Page Limitations. The 25-page limitation for Phase I applications apply (see Omnibus Solicitation). If the allowed number of pages is not sufficient for an SBIR- AT-NIAID application, applicants should contact the Scientific Review Administrator (SRA) after receipt and assignment of the application to request approval for submission of supplementary information for review. MECHANISM OF SUPPORT - PHASE II Phase II applications in response to this PA will be awarded as Phase II SBIR grants (R44) or contracts (N44) 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. Applications for Phase II awards should be prepared following the instructions for NIH Phase II SBIR applications. The Phase II SBIR instructions and application may be found on the Internet at: http://www.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 in academic institutions. o Applications over $500,000. Applicants who plan to submit a Phase II SBIR application requesting $500,000 or more in total cost for any one year are advised that they must contact NIAID program staff as they begin to develop plans. Furthermore, applicants must obtain agreement from NIAID that the application will be accepted for consideration for award. Finally, the applicant must identify in a cover letter that is sent with the application, the staff member who agreed to accept assignment of the application. Applications received without prior staff contact may be delayed in the review process or returned to the applicant without review (see NIH GUIDE, March 20, 1998). RESEARCH OBJECTIVES o Background. 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. o 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 three 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. 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 cytomeaglovirus, 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 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 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 and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of 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", which have been 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. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE 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 is scientific or ethical reasons not to include them. This 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 is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES o Applicants should follow the instructions for SBIR Phase I or Phase II submission with the modifications as noted in this PA. o 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. They are also encouraged to read the advice and information on SBIR and STTR programs located on the Internet at: http://www.nih.gov/grants/funding/sbirsttradvice.htm o Mailing Instructions. The original application and two single-sided copies must be mailed both to the NIH Center for Scientific Review and to the NIAID Division of Extramural activities. 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," PAR-98-073). 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 o 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. o Review Criteria. Review criteria are described in the Omnibus Solicitation. 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. o Release of Grant Application Review Information. Following evaluation of grant applications by the study section but prior to National Advisory Council or Board action, summary statements will be sent automatically to principal investigators. A "summary statement" documents the evaluation of an application by the study section and conveys the group's recommendations to the awarding component and its Council or Board. No one other than the Principal Investigator may receive the summary statement and evaluation rating. 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, the availability of funds, and the commercialization status where the small business concern has received more than 15 Phase II awards in the prior five (5) fiscal years, if applicable (see this application requirement under "Prior SBIR Phase II Awards" found in the "Introduction and Application Instructions" portion of the Omnibus Solicitation). 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: Gregory Milman, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2C06 Bethesda, MD 20892 Telephone: (301) 496-8666 FAX: (301) 402-3211 Email: gm16s@nih.gov Mr. Allan Czarra Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C23 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: ac20a@nih.gov Direct inquiries regarding fiscal matters to: Ms. Pam Fleming Grants Management Specialist National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C25 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 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 Citation is (No. 93.855 - Immunology, Allergy, and Transplantation Research and No. 93.856 - Microbiology and Infectious Disease Research [or] both of the preceding. 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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