NIH ERA SMALL BUSINESS FUNDING OPPORTUNITIES (ERA-SBIR) RELEASE DATE: January 29, 2002 (See Addendum NOT-RR-02-007) RFA: RFA-RR-02-004 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) National Institute of Alcoholism and Alcohol Abuse (NIAAA) (http://www.niaaa.nih.gov) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) National Institute of Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) PUBLIC BRIEFING DATE: March 4, 2002 LETTER OF INTENT RECEIPT DATE: March 22, 2002 APPLICATION RECEIPT DATE: April 17, 2002 AWARD DATE: September 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Public Briefing o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to become Principal Investigators o Special Requirements o Where to send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA On behalf of the National Institutes of Health, the National Center for Research Resources (NCRR) invites applications for the development of commercial products and services supporting NIH Electronic Research Administration (eRA). These products and services should be useful to the thousands of institutions, organizations, and principal investigators that apply for and are awarded NIH grants and cooperative agreements and will use the eRA component, the NIH Commons, for creation and exchange of research and administrative information with the NIH. Detailed information about the NIH eRA, its components, and the status/plans for each can be found at: http://era.nih.gov/. This RFA, eRA-SBIR, invites FAST-TRACK grant applications from organizations eligible for Small Business Innovation Research (SBIR) research and development grants. Grants awarded under this RFA will have the following special characteristics: o award amounts and durations greater than those routinely allowed under the SBIR program; o subcontracts for larger percentages of the research and development effort than is traditionally allowed in SBIR grants; o research and development performed in collaboration with NIH's development and updating of the NIH's Electronic Research Administration (eRA) system; o research and development timelines and milestones tied to the timelines and milestones for the NIH eRA development and implementation, as made available to grantee organizations on the eRA website; o applications submitted for both phase I and Phase II grants (SBIR Fast-Track applications) so that there can be continuity of R&D efforts; and, o awardee products/services that meet NIH eRA requirements and specifications certified by NIH for use by grantee organizations at the end of Phase II. PUBLIC BRIEFING. On March 4, 2002, a briefing by NIH staff developing the NIH eRA (IMPAC II and the Commons) will be held from 10:00 am to 5:00 pm at the NIH in Room 1202, 6700B Rockledge Drive, Rockville, MD. The purposes of this briefing will be to (1) provide up-to-date information on the status of and plans for the Commons and (2) answer questions that potential applicants may have. The briefing will be telecast and viewers will be able to call to have their questions answered. Further information on the briefing including how to log into the telecast will appear in the NIH Guide shortly. RESEARCH OBJECTIVES Background Each year NIH invests billions of dollars -- about $13.5 billion in FY 2000 -- in grant awards to some 50,000 grantees worldwide. In addition, applicants submit approximately 47,000 competing research and research training applications each year. The administration associated with annual reports submitted by existing awardees, and well as applications for funding sets in motion intense, multi-step processes. This massive enterprise currently generates hundreds of millions of pieces of paper each year. The paperless transfer of extramural research grant application and administrative data is NIH's vision for the 21st century. The Electronic Research Administration (eRA) at NIH is dedicated to making the research enterprise more effective and efficient through business process reengineering and the use of current technology. In responding to a congressional mandate requiring federal agencies to migrate from paper-based to electronic systems, the NIH has undertaken the eRA project to lower costs and administrative effort, expedite extramural grants processing, and provide better quality information to the NIH and the external grantee community. The eRA project is a collaborative endeavor of the full NIH community. Ultimately, all parties involved will conduct seamless, secure, interactive business in a fully electronic environment. eRA is NIH's infrastructure for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of NIH grant awards to biomedical and behavioral investigators worldwide. eRA integrates two parallel systems, the NIH Commons and IMPAC II. The Commons enables communication with NIH's partners in the research community, whereas IMPAC II is used by NIH staff. In addition, the NIH Commons is designed to exchange data and transactions with other federal agencies through a trans-government electronic grants administration system, the Federal Commons (see http://www.fedcommons.gov/Docs/data.html). In practical terms, eRA is a system comprised of modules (software applications) for each grants administration business area as well as cross- functional processes. By mid FY2002, the following modules will be available on the NIH Commons: o Registration and Accounts Administration o Profiles (Organizational and Professional) o Status o Training Activities o Invention Reports By early FY2003, the NIH Commons will also include modules for the Non- Competing Award process and for the Competitive Grant Application process. As a gateway for the grantee organization community to engage in electronic research administration activities with the NIH, the magnitude of NIH awardees predicts the required capacity of the NIH Commons. In Fiscal Year 2000, NIH provided research support to more than 2500 institutions: universities, medical schools, research institutes, and for-profit and not-for-profit organizations. More than $1,000,000 was awarded to 663 institutions; more than $10,000,000 to 200 institutions; and more than $100,000,000 to 40 institutions. To undertake the grants business processes electronically, some awardee institutions plan to independently participate fully in the NIH Commons with development of internal applications for this purpose. Other institutions may wish to develop some applications and purchase others. Finally, some institutions may wish to use outside service providers to act as their agents for most or all interactions with the Commons. Research Objectives It is predicted that a large number of NIH grantee organizations will not independently develop all of the capabilities needed to interact fully with the NIH Commons. Therefore, a potential market exists for one or more companies to provide products and services to NIH grantee organizations. The purpose of this RFA is to stimulate the development of applications and services that could be purchased by or licensed to these NIH grantee organizations so they can fully participate in the NIH Commons and to stimulate the small business community to augment the functionality of the commons to provide additional services to the NIH research applicant community. It is recognized that the funds available may not be the full amount needed for the development and testing of products and services. However, the potential market is large enough that applicant organizations should consider the use of internal resources to support this effort; further, potential applicants should see http://www.cfda.gov for information about the grant related information plans for all federal agencies. Organizations that wish to develop applications and services without NIH financial support may do so NIH will work cooperatively with these organizations and will offer certification for products/services that meet compatibility requirements (see Certification below). NIH has been a leader among federal research grant making agencies in the development of data standards for grant applications. NIH was a key participant in the approval of the EDI Transaction Set 194 as an ANSI national standard. Additionally, NIH has mapped the data requirements for a notice of grant award (NGA) to the EDI 850 Transaction Set. Since the development of these formats, these data standards have now been described in an XML DTD format for grant applications and notice of grant awards (see http://www.fedcommons.gov/Docs/data.html). NIH intends to follow these data standards and will only certify software that is also compliant with these standards. NIH expects awardees to develop software including tools that enable grantees to: o register with the Commons o create and update Organizational and Individual (Professional) Profiles in a fully secure/authenticated session o create and submit competing grant applications electronically in a fully secure/authenticated session o obtain information about pending grant applications and awards in a fully secure/authenticated session o submit applications for non-competing continuation grant awards in a fully secure/authenticated session o provide required information on inventions developed with government funds in a fully secure/authenticated session (NOTE: If the functions of the Commons expand, extension of the Phase II SBIR award with additional funds is possible.) Certification Successful completion of Phase II research and development will be NIH certification that the applications developed by the awardee, when used appropriately, will enable grantee institutions and NIH to communicate via the Commons. Certification could be given for applications that perform some, but not all, Commons functions. MECHANISM OF SUPPORT The administrative and funding mechanisms to be used to undertake this program will be the SBIR FAST TRACK. Simultaneous submission of the Phase I and Phase II grant applications is required for applications in response to this RFA; simultaneous submissions are called FAST-TRACK APPLICATIONS. FAST-TRACK APPLICATIONS. Information on the FAST-TRACK process may be found in Section VI-B of the PHS 398 at: https://grants.nih.gov/grants/funding/phs398/phs398.html. To meet FAST-TRACK requirements, the Phase I SBIR application must include well defined quantifiable milestones that will be used to judge the feasibility of the proposed approach for development of applications and services to send and receive transactions to and from the NIH eRA system through the NIH Commons, as well as a credible plan for development and testing of the products and services in the Phase II application. These milestones must be linked to the timeline for NIH eRA activities available at: http://era.nih.gov/ProjectMgmt/implementation/index.cfm. FAST-TRACK applications in response to this RFA are subject to the following cost and duration limits: o Phase I grants. Unless approved before the submission of an application by the NIH Program Officer (see INQUIRIES below), the total requested budget may not exceed $500,000 and the duration of the Phase I award may not exceed 12 months. At least 30% of the Phase I research and development effort (i.e., 30% or more of the proposed budget) must be carried out by the small business concern. o Phase II grants. Unless approved before the submission of an application by the NIH Program Office, the total annual requested budget may not exceed $1,500,000; the duration (project period) of the Phase II award may not exceed four years. At least 25% of the Phase II research and development effort (i.e., 25% or more of the proposed budget) must be carried out by the small business concern. FUNDS AVAILABLE The estimated total funds, direct and Facilities and Administrative (F&A) costs, available for the first year of support for all awards made under this RFA will be $1,500,000 in Fiscal Year 2002 and $3,000,000 annually in Fiscal Years 2003, 2004, 2005, and 2006. NIH plans to fund one to three Phase I awards in FY 2002 and one or two Phase II awards in FY 2003. The most promising of the Phase I awardees will be funded for Phase II. Although this program is provided for in the financial plans of the NIH, awards pursuant to this RFA are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of high scientific merit. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. ELIGIBILE INSTITUTIONS Applicant organizations must meet the eligibility requirements for SBIR grants are found in Section I.D, SBIR/STTR PROGRAM ELIGIBILITY, at https://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. SPECIAL REQUIREMENTS There will be a required series of meetings between the awardee(s) and the NIH eRA staff: (1) an initial two day meeting at NIH within 30 days of grant award to establish initial milestones; (2) annual two day meetings at NIH thereafter to share information, discuss progress and future directions, and revise milestones as necessary. In addition, applicants should request additional interactions as they deem necessary. Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement of each R43 and R44 grant awarded under RFA RR-02-004 and will be provided to the Principal Investigator, as well as the appropriate institutional official, at the time of award. The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Parts 74 and 92 [Part 92 are applicable when State and local Governments are eligible to apply], as are other DHHS, NIH, and NIH grant administration policies: (1) Principal Investigator (P.I.) Rights and Responsibilities: The P.I. will have the primary responsibility for developing the products and services within the guidelines of RFA RR-02-004 and for performing the research and development activities. The P.I. will agree to accept close coordination, cooperation, and participation of NIH staff and contractors in those aspects of technical management of the project as described under "NIH Responsibilities." (2) NIH Responsibilities: The NIH Program Director and others working with the NIH eRA will have substantial involvement during the conduct of the R&D through technical assistance, advice and coordination. The Program Director will: o Participate in discussing priorities, timelines and milestones with the SBIR P.I. and staff. o Serve as liaison to the NIH eRA staff to enable the SBIR P.I. and staff access to needed information about the Commons modules. o Retain the option to recommend, with the advice of the Commons Advisory Panel, the withholding or reduction of support from any grantee that substantially fails to achieve agreed to milestones. (3) Collaborative Responsibilities The awardee and Program Director will be responsible for: o Establishing project milestones. o Delineating the specific access to NIH eRA staff and computer systems/applications needed by the awardee for timely development and testing of products and services o Determining, during the Phase I award, the specific requirements for products and services to meet NIH Certification requirements o Meetings between the awardee(s) and the NIH eRA staff: (a) an initial two day meeting at NIH within 30 days of grant award to establish initial milestones; (b) annual two day meetings at NIH thereafter to share information, discuss progress and future directions, and revise milestones as necessary. (4) Commons Advisory Panel (CAP) A Commons Advisory Panel (CAP) will be responsible for reviewing and evaluating awardee progress and making recommendations to the P.I. and NIH Program Director. The CAP will be composed of 3 to 5 experts in NIH grants and information technology from NIH grantee organizations. The membership of the CAP may be enlarged permanently, or on an ad hoc basis, as needed. The CAP will review awardee progress at the end of Phase I and make recommendations to the NIH Program Director for continuation to Phase II. The CAP will review progress annually during Phase II and make recommendations and, based on the results of tests of the awardee products and services, make recommendations to the NIH Program Director concerning certification of the awardee products and services. (5) Milestones After consultation with the NIH Program Director, the awardee will define initial milestones for both Phase I and Phase II awards within 30 days of the time of the award and to update these milestones annually at the anniversary date. These will be made a condition of the award. In accord with the procedures described above, NIH may withhold or reduce funds for any project that substantially fails to meet its milestones or to maintain the state of the art. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about research and development issues to: Mr. Jerry Stuck Commons Coordinator, NIH eRA Office of Extramural Research, OD National Institutes of Health 6705 Rockledge Drive, Suite 1040 Bethesda, MD 20892-7980 Telephone: (301) 435-0690, ext. 615 Email: js706d@nih.gov (or) Amy Swain, Ph.D. Program Director Division of Biomedical Technology National Center for Research Resources Rockledge 1, Room 6154 6705 Rockledge Drive Bethesda, MD 20892 Telephone: 301-435-0755 FAX: 301-480-3659 Email: as387d@nih.gov o Direct your questions about peer review issues to: Dr. Bill Bunnag Center for Scientific Review, NIH Rockledge II Building, Room 5124 MSC 7850 6701 Rockledge Drive Bethesda, MD 20892-7850 Telephone: (301) 435-1177 Email: bb24c@nih.gov o Direct your questions about financial or grants management matters to: Bryan S. Clark, MBA 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: clarkb@ncrr.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Amy Swain, Ph.D. Program Director Division of Biomedical Technology National Center for Research Resources Rockledge 1, Room 6154 6705 Rockledge Drive Bethesda, MD 20892 Telephone: 301-435-0755 FAX: 301-480-3659 Email: as387d@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. URLS IN NIH GRANT APPLICATIONS OR APPENDICES Because of the special nature of the products and services to be developed, APPLICANTS ARE ALLOWED TO PRESENT URLS IN THEIR APPLICATIONS. The URLs should be limited to links that provide information essential for staff and peer reviewers to assess the capabilities and experience of the applicant related to this RFA. In addition, or alternatively, the applicants may as an appendix to their application a CD with comparable information on directly relevant information capabilities and experience. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/labels.pdf or https://grants.nih.gov/grants/funding/phs398/labels.doc. 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 the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCRR and OER/NIH. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Receive a second level review by the NCRR National Advisory Council. REVIEW CRITERIA The review criteria for applications in response to this RFA will be the standard SBIR criteria found in Section VI of the PHS 398 (5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html. RECEIPT AND REVIEW SCHEDULE Public Briefing Date: March 4, 2002 Letter of Intent Receipt Date: March 22, 2002 Application Receipt Date: April 17, 2002 Peer Review Date: June 2002 Council Review: August/September 2002 Earliest Anticipated Start Date: September 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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. 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 RFA 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 No. 93.371 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 https://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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