EXPIRED
KNOWLEDGE INTEGRATION ACROSS DISTRIBUTED HETEROGENEOUS DATA SOURCES (SBIR/STTR) RELEASE DATE: October 1, 2002 (see reissue PA-05-003) PA NUMBER: PA-03-001 EXPIRATION DATE: December 2004, unless reissued. National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The purpose of this PA is to encourage small businesses to develop innovative software for addressing the integration of distributed cross-disciplinary data sources into coherent knowledge bases for biomedical research. Federating such data sources requires solving a large number of technical, scientific, financial, social and legal issues, and new tools are needed for aiding in almost every aspect of this problem. Applications are expected to describe at least one biomedical research problem that will benefit from the proposed tool or tool set, as well as to describe how the approach will scale when applied to additional data sources and/or to other biomedical problems. A clear description should be provided of how the impact of these tools on biomedical research will be measured. Finally, a reasonable mechanism for maintenance and expansion of the software as well as integration with existing solutions should be carefully outlined. RESEARCH OBJECTIVES Industry has over the past five years shown increased interest in information technology's (IT) promise to aid in the assembling of a corporation's knowledge that is typically distributed across individuals and vast numbers of unconnected documents and databases into a coherent, accessible entity known as a knowledge base. Although much of the promise remains unfulfilled, some technologies resulting from initial efforts appear to be moving from the research stage to mainstream production (e.g. IBM's Discovery Link). Like a corporation, the biomedical research community is greatly hindered by its inability to easily access knowledge that may have already been painstakingly acquired. Existing approaches and tools from corporate knowledge base efforts should be employed wherever they can to improve this situation. However, the biomedical research community is more diverse than a typical corporation in almost every aspect, from document and data types to philosophies of data sharing. Accordingly, new tools and processes for knowledge integration must be developed that facilitate cooperative approaches to solving biomedical research problems that span a broad array of subdisciplines. These tools and processes must be designed with openness, flexibility and extreme scalability if they are to address the diverse needs of this community with regard to knowledge integration, and if they are to be able to grow and adapt with the rapidly changing developments in this field that are expected to come. Awards made under this PA will support software and system development that address one or more aspects of the components necessary for integrating knowledge across data sources that reside at multiple laboratories and institutions and that encompass disparate data types from multiple subdisciplines. Tools for visualization and summarization of results from such systems may also be supported, as well as tools for managing data security, data integrity, query efficiency, and data ownership. MECHANISM(S) OF SUPPORT This PA will use the National Institutes of Health (NIH) SBIR award and Fast Track SBIR award mechanisms with award duration and amounts greater than those routinely allowed under the SBIR program. This PA must be read in conjunction with the current calendar year Omnibus Solicitation at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. 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 using the PHS 398 instructions and forms: http://grants.nih.gov/grants/funding/phs398/phs398.html. Please refer to Chapter VI of the PHS 398 instructions prior to preparing an SBIR application. PHS 398 forms specific to SBIR applications are available. See http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc. Because the duration and cost of research to develop knowledge integration tools are likely to exceed that routinely awarded for SBIR grants, well-justified Phase I applications under this PA will be considered. These applications can request a project period up to two years and a budget not to exceed a total cost of $400,000 (i.e., an average of $200,000 per year). Phase II applications in response to this PA will be awarded as Phase II SBIR grants (R44) with modifications as described below. Individual 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 have been awarded under this PA but the Phase II proposal must be a logical extension of the Phase I research. Applications for Phase II awards should be prepared using the PHS 398 instructions and forms: http://grants.nih.gov/grants/funding/phs398/phs398.html . Please refer to Chapter VI of the PHS 398 instructions prior to preparing an SBIR application. PHS 398 forms specific to SBIR applications are available. See http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc. Because the duration and cost of research to develop knowledge integration tools are likely to exceed that routinely awarded for SBIR grants, well-justified Phase II applications under this PA will be considered. These applications can request a project period up to three years and a budget not to exceed a total cost of $1.2 million (i.e., an average of $400,000 for each of three years). Applications may be submitted for the FAST-TRACK review option. Information on the FAST-TRACK process may be found in Section VI-B of the PHS 398 at: http://grants.nih.gov/grants/funding/phs398/phs398.html. To be eligible for the FAST-TRACK option, the Phase I SBIR application must include well defined quantifiable milestones that will be used to judge the success of the proposed research, as well as a credible plan to apply the selected technology in a pilot study of interest to test the feasibility for site remediation or monitoring technology for the Phase II R44 application. The FAST-TRACK must have a section labeled Milestones at the end of the Research Plan Phase I. This section must include well-defined quantifiable milestones for completion of Phase I, a discussion of the suitability of the proposed milestones for assessing the success in Phase I, and a discussion of the implications of successful completion of these milestones on the proposed Phase II. In addition, Fast-Track applications must include a concise Product Development Plan (limited to ten pages). Label this section clearly and include it in Section J of the Phase II Research Plan. Applications submitted through the FAST-TRACK option are subject to the same total cost limits per year as when submitted outside of the FAST- TRACK option. The total duration (Phase I plus Phase II applications) cannot exceed five years. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $100,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. ELIGIBLE INSTITUTIONS Eligibility requirements for SBIR are described in the NIH Omnibus Solicitation for SBIR/STTR Grant Applications, which is available on the internet at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The primary employment of the Principal Investigator must be with the small business concern at the time of award and during the conduct of the proposed project. Primary employment means that more than one half of the Principal Investigator's time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Bret Peterson, Ph.D. National Center for Research Resources (NCRR) Building RKL1, Room 6158 Bethesda, MD 20892 Telephone: (301) 435-0758 FAX: (301) 480-3659 Email: bretp@ncrr.nih.gov Margaret Grabb, Ph.D. National Institute of Mental Health (NIMH) 6001 Executive Blvd, Rm 7201 (MSC 9645) Bethesda, MD 20892 Telephone: (301) 443-3563 FAX:(301) 443-1731 Email: mgrabb@mail.nih.gov Anne Heath, Ph.D. National Cancer Institute (NCI) SBMAB, DCB Bethesda, MD 20892 Telephone: (301) 435-5225 FAX: (301) 480-2854 Email: ah43v@nih.gov Susan E. Old, Ph.D. National Heart, Lung, and Blood Institute (NHLBI) 6701 Rockledge Drive, MSC 7940 Bethesda, MD 20892 Telephone: (301) 435-1802 FAX: (301) 480-3659 Email: Olds@nhlbi.nih.gov Mary S Pastel, ScD National Institute of Biomedical Imaging and Bioengineering (NIBIB) 6707 Democracy Blvd, Suite 920 Bethesda, MD 20892-5469 Telephone: (301) 451-4781 FAX:(301) 480-4973 Email: pastelm@mail.nih.gov o Direct your questions about financial or grants management matters to: Kimberly Pendleton Office of Grants Management National Center for Research Resources Rockledge 1, Room 6216 Bethesda, MD 20892 Telephone: (301) 435-0845 FAX: (301) 480-3777 Email: pendletonk@ncrr.nih.gov Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6001 Executive Blvd, Rm 8A17M Bethesda, MD 20892 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: hancockk@mail.nih.gov Shane Woodward Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-8649 FAX: (301) 496-8601 Email: Shane_Woodward@nih.gov Edward (Gene) McGeehan Grants Management National Heart, Lung, and Blood Institute (NHLBI) 6701 Rockledge Drive, Room 7044 Bethesda, MD 20892 Telephone: (301) 435-0148 FAX: (301) 480-3659 Email: McGeehaE@nhlbi.nih.gov Lisa Moeller Office of Grants Management National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Blvd, Suite 900 Bethesda, MD 20892-5469 Telephone: (301) 451-4793 FAX: (301) 480-4974 Email: moellerl@mail.nih.gov SUBMITTING AN APPLICATION You may submit your application as a Phase I or Phase II application or as a Fast Track pair of Phase I and Phase II applications. See "Specific Instructions" below. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines (April 1, August 1, December 1). See http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR PHASE I APPLICATIONS: Application forms, requirements, and procedures are the same as listed in the Omnibus Solicitation for Phase I SBIR/STTR Grant applications (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf), except for the following: o Type the title and number of this PA on line 2 on the face page of the application. SPECIFIC INSTRUCTIONS FOR Phase II Applications: We will only accept Phase II applications as competing continuations of previously funded NIH Phase I SBIR awards. The Phase II application must be for developmental work that is a logical extension of the feasibility research conducted during Phase I. When preparing an application for a Phase II award, you should follow the instructions for NIH Phase II SBIR applications. The instructions and forms for a Phase II SBIR award are available at http://grants.nih.gov/grants/funding/phs398/phs398.html. SPECIFIC INSTRUCTIONS FOR Fast Track Applications: For Fast Track applications, the NIH expedites evaluation of progress following the Phase I feasibility study, for transition to the Phase II funding for expanded developmental work. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. In considering the scientific and technical merit of each application, the following criteria will be used: ALL SBIR/STTR APPLICATIONS o SIGNIFICANCE: Does the proposed project have commercial potential to lead to a marketable product or process? Does this study address an important problem? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of the application are achieved, how will scientific knowledge be advanced? Does the application lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? o APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate? o INNOVATION: Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and innovative? o INVESTIGATORS: Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed? o ENVIRONMENT: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technological environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. PHASE II APPLICATION REVIEW CRITERIA In addition to the above criteria: 1. How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity? 2. Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in the Research Plan item J? 3. Does the project carry a high degree of commercial potential, as described in the Product Development Plan? PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA For Phase I/Phase II Fast Track applications, the following criteria also will be applied: 1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? 2. Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in the Research Plan, item J? 3. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/ STTR funding sources that would enhance the likelihood for commercialization? 4. Does the project carry a high degree of commercial potential, as described in the Product Development Plan? Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating. Failure to provide clear, measurable goals may be sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review. AWARD CRITERIA: Applications submitted in response to this PA will compete for available funds with all other recommended SBIR applications. The following will be considered in making funding decisions for Phase I or Phase II applications: o Quality of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities Phase II applications will be selected for funding based on the following: o Quality of the proposed project as determined by peer review o Assessment of Phase I progress o Determination that the Phase I goals were achieved o The project's potential for commercial success o Availability of funds Fast-Track Phase II applications that are recommended for approval may be funded following submission of the Phase I progress report and other documents necessary for continuation. Phase II applications will be selected for funding based on the project's scientific and technical merit, the awarding component's assessment of the Phase I progress report and determination that the Phase I goals were achieved, an update and verification of the Product Development Plan and any commitment(s) for funds and/or resources from an investor or partner organization, as described below, the project's potential for meeting the mission of the awarding component and for commercial success, and the availability of funds. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Nos. 93.371, 93.242, 93.396, 93.839 and 93.286 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the 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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