NIH REINVENTION ACTIVITIES: STATUS REPORT NIH Guide, Volume 25, Number 23, July 12, 1996 P.T. 34 Keywords: Grants Administration/Policy+ 1014017 National Institutes of Health This is the fourth status report on NIH reinvention activities. The previous reports were published in the NIH Guide for Grants and Contracts, Vol. 23, No. 44, December 16, 1994; Vol. 24, No. 14, April 14, 1995, and Vol. 24, No. 40, November 24, 1995. The initiatives described below represent the high priority areas for the NIH at this time. Initiatives that have been fully implemented and described in previous status report are not repeated below, nor are other initiatives that are under preliminary discussion and not yet at the pilot testing stage. As the NIH continues to undertake reinvention activities and new initiatives, we recognize the need to establish a framework to provide the necessary structure for optimal interactions and complementarity of the various reinvention activities. The framework delineates four major goals for reinvention: (1) maximize scientific opportunities through optimal use of resources; (2) enhance NIH interactions with the scientific community; (3) clarify and streamline decision-making processes; and (4) focus internal operations on outcomes and results. Each of these goals are further developed into specific reinvention objectives, and the plan is to use these goals and objectives as guide-posts as the NIH moves forward with the myriad of reinvention projects. The initiatives described in this report support the reinvention goals mentioned above. For example, the electronic research administration (ERA) initiative is developed as a set of tools and systems that enable the NIH to improve its interactions with the scientific community. Other reinvention goals are met through initiatives that streamline the application processes, focus peer review and Council or Board functions, reduce administrative burdens for the grantee institutions and the NIH staff, etc. Collectively, they are aimed to achieve the NIH mission: to improve health through science. The NIH reinvention laboratory, as designated under Vice President Gore's National Performance Review (http://www.npr.gov), is an open forum, grounded on the important principles that value its employees and their input as well as feedback from the scientific community. Reinvention is an evolving operation, which will continue to rely on the valued input of all interested parties. Comments or suggestions on the implemented changes and pilot experiments are welcome and may be sent to the following email address: DDER@nih.gov. I. ELECTRONIC REPORTING AND SUBMISSION OF GRANT AND CONTRACT MATERIALS A. ELECTRONIC RESEARCH ADMINISTRATION (ERA): (expanded pilot project under way) -- This initiative represents a commitment to improve administrative operations through information technologies and reengineering of process. A key feature of the reengineering effort is the idea of maintaining the information required for various NIH processes within a client-server common file database. This common file is envisioned as the electronic interface between the NIH and the awardee community and the repository for information generated during the life cycle of each award. The database would be accessible to authorized applicants, awardees and NIH staff, who could each review and add information as required. Proposed components of the system include the application shell, institutional profile, status system (including review dates, scores, and summary statements), notice of grant award, invention reporting, progress reporting, and other required reporting (e.g., women and minorities in clinical research, trainee appointments, and financial reporting). Of these, four are currently in pilot mode: the application shell, invention reporting (EDISON), trainee appointments, and streamlined noncompeting award process (SNAP). (updated 7/96) ELECTRONIC SUBMISSION OF THE GRANT APPLICATION SHELL: (pilot study under way) -- Under a Department of Energy (DOE) Cooperative Agreement, the NIH and several Department of Defense (DoD) agencies are participating in a pilot study to test a new system for the submission of grant application information. These agencies and eight research institutions will test the Electronic Data Interchange (EDI) standards developed collaboratively by the Federal agencies. Key administrative information in R01 grant applications, such as face page information, scientific abstract, certain budget items, and personal data for the Principal Investigator (but not including the project description), will be submitted directly into NIH's database, without intervening paper copies or manual rekeying of data. The rest of the application will be submitted on paper. The "institutional profile" will contain administrative information specific to each grantee organization that can be electronically linked to grant applications through the use of unique, organizational, identifying numbers. The institutional profile database will eliminate the need to provide the same information for each application submitted by an organization. By using EDI standards, commercial software vendors will be able to develop software that can create data streams for transmission to the NIH without the need for compatible processing systems. In December 1995, the NIH began receiving test EDI submissions from several of the cooperative agreement participants. The next phase of the pilot is to test the integration of grant application information submitted electronically with the IMPAC II data system. (updated 7/96) EDISON INVENTION REPORTING: (on-going production) -- The system, designed to receive, store, sort, and report, is now in production with forty grantee organizations authorized to report inventions, patents, and licensing information resulting from NIH support. Additional organizations continue to participate, and all grantee organizations are encouraged to explore the EDISON homepage (http://www.iedison.gov/). EDISON uses a world wide web (WWW) interface in a client server architecture whereby authorized grantee organizations and NIH staff can access a shared relational database. By using a browser that supports secure socket layer standards, e.g., Netscape or Microsoft Internet Explorer, grantees are able to send their information in a fully secured electronic environment. Data can be viewed and modified in real time in an interactive setting. An additional version of EDISON has been designed to simplify submission of invention information for grantee organizations with resident databases. Rather than asking these organizations to rekey information into EDISON via the web browser, the NIH has developed software, available free for use on all platforms. The software, called Internet Talkers, will enable computer to computer transfer of data and is now in beta testing. As a result of interagency cooperation and collaboration, most of the Federal agencies with invention reporting requirements such as DoD, USDA, NSF, DOE, USAID will be using EDISON as the common interface to government invention reporting in the near future. Further efforts to this end involve elaboration of the EDISON data elements to become a full public standard and finalization of a transaction set to be presented to the American National Standard Institute X12 committee. Many features of the user friendly EDISON prototype such as differential access to data, electronic security, and establishing test accounts to try out the system will be incorporated in future electronic research administration projects deployed by NIH such as the Streamlined Noncompeting Award Process (SNAP), the status system, and institutional profile. (updated 7/96) ELECTRONIC REPORTING OF TRAINEE APPOINTMENTS: (pilot project under way) -- The Office of Extramural Research (OER) has developed an interface for the collection of trainee appointment information. Like EDISON, the trainee appointment system is an interface on the world wide web (WWW) through which information about trainees appointed to a National Research Service Act (NRSA) Institutional Research Training Grant may be entered. This system will replace the printed Statement of Appointment form 2271. All eight DOE Cooperative Agreement demonstration centers are participating in the pilot project. It is anticipated that this system of reporting will be expanded to additional grantee users in FY 97. (updated 7/96) STREAMLINED NONCOMPETING AWARD PROCESS (SNAP): (electronic version will be piloted in September 1996)--In FY 95, NIH instituted a simplified noncompeting award process (SNAP) for the majority of noncompeting continuation awards that carry the expanded authorities (see notice in the NIH GUIDE 1/20/95 and the PHS 2590). Under SNAP, certain components of the noncompeting application are not required if there are no significant changes. This streamlined process eliminated, where nonessential, two of the financial documents that were part of the noncompeting application kit (PHS 2590): a categorical budget for the next budget period and an estimated report of expenditures for the current budget period. Three key questions must be answered in the annual progress report pertaining to significant changes in budget (rebudgeting or unobligated balance), other support, and effort of key personnel. If these responses indicate significant changes, then the supporting documentation (e.g., budget page) must be provided; if they are in the negative, then the budget and/or other support pages do not need to be submitted. In FY 96, NIH implemented Phase II of SNAP (see the NIH GUIDE 10/27/95), in which the Notice of Grant Award was changed to reflect only direct and indirect costs and indirect costs are now included in the future year recommended levels. In an attempt to further streamline the non-competing process, in FY 97 the NIH is implementing Phase III of SNAP by modifying the financial reporting requirements. Effective for SNAP awards with budget start dates of July 1, 1995 or later, the annual Financial Status Report (FSR, SF 269) will no longer be required. The FSR will only be required at the end of each competitive segment rather than at the end of the budget period. It is important to stress that this change in administrative requirements does not alter the grantee's responsibility to account for costs on a project basis and ensure that grant funds are expended in accordance with all applicable grant regulations and policies in support of the approved project. A detailed notice is published in the NIH GUIDE (Volume 25, Number 22, July 5, 1996) to further explain implementation guidelines for SNAP Phase III. Consistent with the ERA initiative, the Office of Extramural Research (OER) is developing a World Wide Web-based procedure for electronic submission of the SNAP information. This function, which eventually will be a part of the common file, will permit the applicant to submit electronically all the information necessary to initiate the noncompeting award process for SNAP awards. The principal investigator (PI) will see on the computer screen the information that NIH has on file for that grant. The PI and institution business official will then be able to make changes in that information, as appropriate, and add the progress report. Once the information has been submitted to NIH, it will be presented automatically to the program and grants management staff responsible for preparing the noncompeting award. It is expected that the electronic SNAP pilots will begin this fall and will involve testing with several Federal Demonstration Project participants, including the 8 DOE cooperative agreement participants. (updated 7/96) B. INTERAGENCY ELECTRONIC COMMERCE IN RESEARCH ADMINISTRATION -- Beginning in 1993, 11 federal agencies began to develop an integrated approach to electronic commerce in research administration. The term 'electronic commerce' is used broadly to include any use of automated information systems or electronic data that drives paper from the work place -- in the agencies and in the research community. Electronic commerce requires a variety of tools operating in many different environments to be successful. The tools include electronic mail, electronic funds transfer (EFT), electronic data interchange (EDI), World Wide Web (WWW), CD-ROM, electronic imaging, etc. The agencies have developed a strategic plan to guide their electronic commerce activities. The plan is grounded in the important principles that government-wide standards and multiple agency approaches should be developed wherever appropriate and practicable, while providing flexibility for each agency's unique mission and business requirement. The agencies have implemented several pilot projects, e.g., NIH Edison, NSF FastLane, DOE Electronic Research Administration, and ONR Electronic Invoicing. Based on the results of such pilot projects, the agencies will develop standards and systems that provide a variety of implementation assuring a common interface (e.g., a common interface for retrieving status information for multiple agencies). In establishing a shared system for organization or institution profiles, the obvious benefit is the reduction of applicants' repetitive submission of standard, seldom changing information, e.g., when the same or similar proposal is submitted to multiple agencies. Other benefits to the agencies and the recipient institutions are cost and time savings in receiving and evaluating proposals and also simplifying the awards process. The agencies will continue to use a wide variety of outreach mechanisms to assure the involvement of and communication with institutions, researchers, and others affected by electronic commerce in research administration. C. CONTRACTS REQUEST FOR PROPOSALS (RFP) ON THE NIH GOPHER SERVER: (expanded pilot experiments)-- The National Institute of Allergy and Infectious Diseases (NIAID) is posting all of its RFPs on the NIH Gopher server. A substantial savings in the cost of mailing and copying, and in contract staff effort will be realized through electronic distribution of RFPs. The re-engineered RFP provides information in a more logical sequence, making the process of reviewing the document much more efficient and effective for potential offerors. For example, the information generally used by potential offerors to determine their interest in responding to a requirement (the Work statement, Delivery/Reporting Requirements, and Evaluation Criteria) is now contained in the first section of the RFP. Instructions for proposal preparation and other documents (the contract format, clauses, and required forms) appear in separate sections. The National Cancer Institute (NCI) and the National Heart, Lung, and Blood Institute (NHLBI) have developed standard language for RFPs posted on the Gopher server. Other ICDs are expected to begin posting RFPs on the Gopher server using the standard language and instructions. (updated 7/96) PAPERLESS ACQUISITION: (pilot experiment) -- The NIAID is developing a system that will provide for electronic solicitation, receipt, and review of proposals. The entire text of an RFP is being posted on the Internet and will provide: information necessary for offerors to assess the nature of the Government's requirement; instructions for submitting an electronic proposal; and, details describing how resultant proposals will be evaluated. Proposals are planned to be submitted by offerors and reviewed using electronic mail. The "paperless" acquisition system will reduce the time and expense of all parties involved in the acquisition process. (added 7/96) II. APPLICATION OR PROPOSAL SUBMISSION A. GRANTS AMENDED APPLICATIONS: ( October 1996) -- Beginning with the October 1996 receipt date, the NIH will no longer consider any A3 or higher amendments to an application and, regardless of the number of amendments, the NIH will not accept an amended application that is submitted later than two years beyond the date of the receipt of the initial, unamended application. In FY 1995 the proportion of amended applications has risen to 34 percent of all research project grant (RPG) applications. Approximately half of the unfunded grant applications are amended and resubmitted in the hope that the quality of each resubmission will have improved sufficiently to reach the payline. Although a number of these applications are eventually funded, the statistics also indicate that investigators who receive initial funding based on an amended application, whether for a new submission (Type 1) or a competing renewal (Type 2), experience a lower success rate in subsequent efforts to secure funding for a competing renewal application, and the probability of subsequent success in the competing renewal process diminishes as the number of amendments per application goes up. We believe that after three unsuccessful attempts at funding, it is preferable for all applicants to take a fresh start at their research plans. Therefore, the NIH has adopted a policy that limits the number of amendments to two. This limit allows principal investigators sufficient time to generate preliminary data if it is required by the reviewers, and to consider new findings in the area of research. (added 7/96) EXPEDITED ASSIGNMENT OF AMENDED AND COMPETITIVE CONTINUATION APPLICATIONS: (fully implemented July 1994)-- The Division of Research Grants (DRG) has the responsibility for the receipt and assignment of all research grants to the appropriate ICs and initial review group (IRG). For each new application this referral process requires time and careful attention to reference the aims of the application with identified program areas of the ICs and expertise of the IRG. Since amended and competitive continuation applications have already gone through this referral process, the steps involved in making the referral for these applications could be abbreviated by automatically assigning these applications to the IC and IRG that previously were assigned to the original application. Of the 4,066 amended and competitive continuation applications that were received in July 1994, 96 percent were successfully assigned using either a fully automated referral to both ICs and IRG or partially automated referral to ICs with re-evaluation of the IRG. The most common reasons for the need for re-evaluation of the IRG were that the previous review had been conducted as a special review, thus the review group no longer existed, the investigator requested assignment to a different review group, or the application had been amended several times and required consideration for appropriate assignment. (added 7/96) JUST-IN-TIME: (expanded pilot experiments) -- The basic principle of "Just-in-Time" is to simplify and reduce the administrative and paperwork burdens of preparing an NIH grant application without compromising the initial review group determination of scientific merit or reasonableness of the proposed budget. Thus institutions are not required to submit certain kinds of information at the time of application, such as detailed budget for the initial budget period, the year-by-year categorical budget table, other support, and the checklist. An abbreviated budget justification and biographical sketch will suffice. The information for the applications with a likelihood of funding is submitted "just-in-time" for awards to be made. This delayed exchange of information significantly relieves the administrative burden for applicants who will not receive an award. Beginning in FY 1996, all NIH ICs have been encouraged to incorporate Just-In-Time procedures for RFAs, and the ICs may choose to incorporate modular budget instructions as well (see below). In addition, beginning with the June 1, 1996 receipt date for applications, all (new and revised) unsolicited First Independent
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