PA-01-052: SBIR ADVANCED TECHNOLOGY - NIAID (SBIR-AT-NIAID)

Department of Health
and Human Services (HHS)

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SBIR ADVANCED TECHNOLOGY - NIAID (SBIR-AT-NIAID) Release Date: February 13, 2001 (replaced by PA-04-127) (see addendum NOT-AI-03-049) PA NUMBER: PA-01-052 National Institute of Allergy and Infectious Diseases Application Receipt Dates: 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-00-126 that appeared in the July 26, 2000 issue of the NIH Guide. This program announcement includes instructions for applications for funds in excess of $500,000 annual total cost and new contact listings for inquiries. 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.pdf 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 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.pdf 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 (Appendix A) http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf 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/index.pdf 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. SBIR-AT-NIAID Phase I applications may not exceed 25 single-spaced standard size (8 " x 11") pages, excluding Cover letters; One-page "Introduction" required when submitting a revised (amended) application; Biographical sketches (no more than 3 pages per person); Letters of commitment from collaborators and consultants; "Checklist" (Form Page 5);"Personal Data on Principal Investigator" Form Page; and, if applicable, Second Year Budget Page (see below) and Page(s) furnishing information required under "Prior SBIR/STTR Phase II Awards. " Items A-D of the Phase I Research Plan are limited to 15 pages. The 25-page limit includes all other Form Pages and "continuation" pages. 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. o Page limitations. Items 1-4 of the Phase II RESEARCH PLAN are limited to 25 pages. There is no further limitation on the total number of pages for the entire Phase II application http://grants.nih.gov/grants/funding/sbir2/index.htm. 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 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 and for improved diagnosis of infectious, allergic, and immunologic diseases. POLICY ON HUMAN SUBJECTS AND 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. On October 1, 2000, NIH required education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects. Information about this policy may be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. Frequently asked questions regarding this policy may be found at (http://grants.nih.gov/grants/policy/hs_educ_faq.htm). 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 indicating 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 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. APPLICATION PROCEDURES Applicants should follow the instructions for SBIR Phase I or Phase II submission with the modifications as noted in this PA. SBIR-AT-NIAID are NOT modular grant applications or awards. Complete budget information must be submitted on the SBIR application forms. Phase I SBIR Applicants requesting a budget period of more than 1 year should follow the following procedures: o Photocopy Form Page 3 "Budget for Phase I-Direct Costs Only", number it Form Page "3a" o Use Form Page 3 for the first year budget and title Form Page 3a "Phase I - 2nd year budget." This page will not be counted against the "25-page" total. o Provide the appropriate/requested information in the narrative justification (Form Page 4) for years 1 and 2 o Indicate on the Phase I Face page in Field 6, Dates of Project Period, the dates for the entire project period (e.g., Nov, 15, 2000- Nov. 15, 2002) o Indicate on the Phase I Face Page in Field 7, the requested Direct Costs for the entire project period and the Total Costs for the entire project period (e.g. 2 years) o The summary statement will reflect the recommended budget for the -01 year and -02 year. Advice on Submitting Applications--Potential applicants are encouraged to contact program staff for pre-application guidance and/or for more specific information on the research topics described in this PA. MAILING INSTRUCTIONS The original application and five 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 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 the 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 unscore the application. AN APPLICANT FOR SBIR-AT-NIAID FUNDING MUST JUSTIFY WHY THE PROPOSED PROJECT REQUIRES FUNDS IN EXCESS OF THOSE NORMALLY PROVIDED FOR SBIR PROJECTS. 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: Gregory Milman, Ph.D. Director Office of Innovation and Special Programs Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Room 2140 - MSC 7610 Bethesda, MD 20892-7610 Bethesda, MD 20817-7610 (for express/courier service) Telephone: (301) 496-8666 FAX: (301) 402-0369 Email: gmilman@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 Bethesda, MD 20817-7614 (for express/courier service) 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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