NIDDK EXPANDED AWARDS FOR SBIR-AT-NIDDK Release Date: May 10, 2001 PA NUMBER: PA-01-093 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The NIDDK encourages the small business community to participate in the research and development of cutting-edge approaches, technologies, tools, methods, devices, cells, biomolecules and biomaterials that can be used in the study and/or treatment of diseases in the mission of the NIDDK. The NIDDK supports research pertaining to diabetes, endocrine and metabolic diseases, nutritional disorders, obesity, and digestive diseases, and kidney, urologic and hematologic diseases. Because the length of time and cost of research involving the development of advanced technologies may exceed those normally awarded for SBIR grants, this announcement serves to expand the allowable time and funding level requested for SBIR grants assigned to NIDDK (SBIR-AT- NIDDK). SBIR-AT-NIDDK applications are not appropriate for all SBIR applications, but are an option for projects proposing the development of advanced technologies as defined below. Advanced technology projects, for the purpose of the SBIR-AT-NIDDK program are defined as those that are aimed at developing cutting-edge therapeutic or diagnostic devices, tests, and reagents, as well as projects that involve testing of diagnostics, drugs or therapeutic devices in humans and non-human primates. NIDDK invites applications for SBIR-AT-NIDDK 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-NIDDK applications. This PA provides examples of advanced technology areas in which NIDDK will entertain SBIR applications and provides NIDDK"s interpretation and clarification of instructions relating to total cost, and dates of project period. 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-NIDDK), is related to one or more the priority areas including Diabetes and other Chronic Disabling Conditions. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS 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 http://grants.nih.gov/grants/funding/phs398/phs398.html o Project Period and Amount of Award. Because the length of time and cost of research involving advanced technology projects often exceed those routinely awarded for SBIR grants, NIDDK will entertain well justified Phase I applications for an SBIR-AT-NIDDK award with a project period up to two years and a budget not to exceed a total cost of $250,000 per year (direct costs, indirect costs and fixed fee). See section, BUDGET REQUESTS GREATER THAN $100,000 TOTAL COSTS, in http://grants.nih.gov/grants/funding/phs398/phs398.html 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, NIDDK will entertain well-justified Phase I applications for an SBIR-AT-NIDDK award with greater than 33% contractual costs when those costs are necessary to support clinical studies and trials. 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/STTR awards. The previously funded Phase I award need not be an SBIR-AT-NIDDK 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, NIDDK will entertain well-justified Phase II applications for an SBIR-AT-NIDDK award with a project period up to three years and a budget not to exceed total costs of $650,000 per year (direct costs, indirect costs and fixed fee). 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, NIDDK will entertain well-justified Phase II applications for an SBIR-AT-NIDDK award with greater than 50% contractual costs when those costs are necessary to support clinical studies and trials. MECHANISM OF SUPPORT-FAST TRACK Applications for fast track SBIR grants should be prepared following the instructions for Phase I applications at http://grants.nih.gov/grants/funding/phs398/phs398.html, Phase II applications at http://grants.nih.gov/grants/funding/phs398/phs398.html, and the additional instructions at http://grants.nih.gov/grants/funding/sbirsttr1/sbirsttrft-rs.pdf The total duration of Phase I and Phase II cannot exceed 5 years for fast track applications, and the budget levels described above for Phase I and Phase II applications apply. RESEARCH OBJECTIVES AND SCOPE Background The SBIR program consists of the following three phases. Only the first two phases will be considered for support: 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. Phase III occurs without additional Federal funding. Objective and Scope The time and budget guidelines for SBIR applications can be prohibitive for projects where advanced technologies are developed and/or applied to treatment and research on diseases in NIDDK’s mission. Advanced technology projects are defined as those that develop or employ high- cost new technologies or carry out high-cost, long-term toxicity or efficacy studies in animals, or clinical studies in human. NIDDK invites applications for SBIR-AT-NIDDK awards in the following areas: o Identification, isolation, characterization and propagation of adult human stem/progenitor cells of the endocrine and exocrine pancreas, liver, gut, kidney, bladder, prostate, and hematopoietic lineages. o Development of resources for progenitor cell research, including reliable and convenient clonegenic assays for stem cell populations in pancreas, liver, stomach/intestine, kidney, bladder, bone, and hematopoietic tissues. Development of broadly applicable methods for amplifying mRNAs from single or small numbers of recovered progenitor cells so that gene expression profiling can be performed, as well as protein profiling. Development of methods for manipulating gene expression in progenitor cells and their immediate descendents. o Development of surrogate markers for identification of disease states and disease progression, hepatotoxicity, or for use as endpoints in clinical studies of diseases within NIDDK’s mission. o Identification, generation and characterization of new receptor ligands and/or partial receptor agonists or antagonists with therapeutic potential for treatment of the diseases within NIDDK’s mission. For example, use of rational drug design or high throughput screening methods to develop agents that interact with L-type calcium channels and can be used to treat diseases of the bowel. o Development or application of imaging techniques to assess physiologic or functional changes in liver, kidney, gut, prostate, bladder or pancreas during disease progression or acute environmental insult to these organs. For example, the NIDDK encourages development of methods to measure pancreatic beta cell mass, inflammation or perfusion, to measure iron content of the liver and to allow non- invasive detection of fibrotic, necrotic and fatty tissue in this organ, to measure progression of kidney disease, and to develop methods to differentiate between benign and malignant parenchymal diseases. o Initiation and/or enhancement of research in tissue engineering for the development of pancreas or pancreatic islets, liver, gut and kidney. The NIDDK encourages research to ascertain angiogenic, adhesion or other factors necessary to promote the development of these organs or tissues in vitro and in vivo. In addition, the requirements of other types of cells must be examined. For example, endothelial cells or exocrine cells may synergize with the protein factors or endocrine cells to establish a pancreas or islet organ independent of or contained within the pancreas of a person with diabetes. o Development of devices to aid in the diagnosis and treatment of diabetes, endocrine and metabolic diseases, nutritional disorders, liver and digestive diseases, motility disorders, and kidney, urologic and hematologic diseases. The NIDDK encourages development and testing of the following: non-invasive or minimally invasive methods of monitoring blood glucose, improved and miniaturized insulin delivery systems, integration of sensor and delivery systems to create an artificial pancreas (closed-loop system), devices to accurately assess energy intake and/or energy expenditure, and non-invasive measures of hepatotoxicity. o Development of rapid and sensitive DNA chip technology and protein- protein interaction chip technology to help understand the physiology of disease conditions, and for ultimate use in the diagnosis and treatment of diabetes and other endocrine disorders, and diseases of the blood, kidney, genitourinary and digestive tract, and their complications. For example, the NIDDK encourages the development of methods to do the following: measure the kinetics and levels of gene transciption and protein in beta cells, hepatocytes and cell populations present in the kidney, urinary bladder and prostate under different stimulatory condition, or in disease states, correlation of gene and protein expression with disease progression in humans and non- human primates and rodent models of diabetes and obesity or during differentiation of stem/progenitor cells into differentiated cell types such as a beta cell, hepatocyte, hematopoietic cells, prostate urinary bladder and kidney. Development, propagation and distribution of novel genes promoters and transgenic knock-out animals targeting processes involved in the development and/or function of pancreas, liver, intestine, urinary bladder, prostate, blood, and kidney. Other advanced technology topics may be of interest to the NIDDK and may be appropriate for SBIR-AT-NIDDK. 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 is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applicants should follow the instructions for SBIR Phase I, Phase II or fast-track submissions with the modifications as noted in this PA. 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. 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 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, SBIR-AT-NIDDK, PA 01- 072, 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. 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 Scientific Review Groups (SRG) 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 II 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. Applications for the SBIR-AT-NIDDK must justify why the project requires longer duration and a larger budget than 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 the research areas of the announcement, and the availability of funds. Applications will compete for available funds with all other favorably recommended SBIR applications assigned to the NIDDK. 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: Dr. Carol Renfrew Haft National Institute of Diabetes and Digestive and Kidney Diseases Division of Diabetes, Endocrinology and Metabolic Diseases 6707 Democracy Blvd., Room 605 MSC-5460 Bethesda, MD 20892-5460 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 594-7689 FAX: (301) 480-3503 Email: haftC@extra.niddk.nih.gov Dr. Judith Podskalny National Institute of Diabetes and Digestive and Kidney Diseases Division of Digestive Diseases and Nutrition 6707 Democracy Blvd., Room 667 MSC-5460 Bethesda, MD 20892-5460 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 594-8876 FAX: (301) 480-8300 Email: jp53s@nih.gov Dr. M. James Scherbenske National Institute of Diabetes and Digestive and Kidney Diseases Division of Kidney, Urologic and Hematologic Diseases 6707 Democracy Blvd., Room 613 MSC-5460 Bethesda, MD 20892-5460 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 594-7719 FAX: (301) 480-3510 Email: js255f@nih.gov Direct inquiries regarding fiscal matters to: Mr. David Mineo Chief, Grants Management Officer Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 731 MSC-5460 Bethesda, MD 20892-5460 Telephone: (301) 594-8854 FAX: (301) 480-3504 Email: mineod@extra.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847, 93.848 and 93.849. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency 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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