Inside eRA for Partners, July 28, 2003 (Volume 3, Issue 5)

CDC Migration Planning Continues as DHHS Decides to Process All Research Grants under eRA

The Centers for Disease Control (CDC) and the NIH are partnering to consolidate the processing of all CDC research grants under eRA in FY 2004. This collaboration is in concert with a recent decision by the Department of Health and Human Services (DHHS) to centralize all research grant processing under the eRA system.

The CDC currently uses an in-house Grant Management Information System (GMIS) to track the use of funds allocated to specific grants, monitor grantee compliance with grant terms, conditions and regulations, and provide reports for CDC management, DHHS and Congress. The GMIS application was developed in Natural programming language using the ADABAS database management system. It runs in CDC’s central IBM mainframe environment. 

NIH and CDC technical teams, under the respective leadership of Penelope Colbert and Teresa Kinley, have been meeting to gather and analyze requirements. They determined that the NIH eRA system meets 60 percent of CDC’s 300 requirements. Some of the outstanding CDC requirements can be resolved with workarounds and policy changes; however, others will require eRA system-level changes.

Planners propose to phase in the CDC workload, beginning with pre-award processing for research grants in FY 2004. Ultimately, the goal is to process CDC research grants for their entire lifecycle under the eRA system.

There will be a two-part pilot for each phase of the consolidation. Testing will begin with a proof of concept using dummy records in the eRA system. The second step will be to conduct end-to-end parallel processing in the eRA and GMIS systems.

Several DHHS Operating Divisions (OPDIVs) already use eRA’s IMPAC II grant processing system to varying degrees. Agency for Healthcare Quality and Research (AHRQ) grants are received, reviewed and funded through eRA. CDC’s National Institute for Occupational Safety and Health (NIOSH) also uses eRA systems, but has developed workarounds to meet its own business processing needs. Substance Abuse and Mental Health Services Administration (SAMHSA) applications are entered into the eRA database, but are processed elsewhere. eRA recently established a new partnering arrangement with the National Center for Infectious Diseases (NCID). In addition, representatives from the Food and Drug Administration (FDA) met with eRA on June 5 to explore teaming.

Pilot Testing Begins for Electronic Grant Applications

The first phase of the Grants.gov (formerly E-Grants) pilot began this month. The primary objective is to test the grantee’s ability to download, fill in and submit SF424 applications electronically. Over the course of the summer, NIH will conduct similar tests with several commercial service providers, funded through the NIH Small Business Innovation Research (SBIR) program to create mechanisms for the electronic submission of the PHS 398 application. Throughout the planning and development, eRA has been working closely with the Grants.gov team to ensure that the new federal grant submission process and the NIH eRA electronic Competitive Grant Application Process (CGAP) remain completely compatible.

Grants.gov, the “Trusted Broker”

Grants.gov will be the central storefront on the Web for customers of federal grants to find funding opportunities and to download and submit applications. The goal of Grants.gov is to improve the coordination, quality and efficiency of electronic grant administration operations for both grantors and grantees. To do business at Grants.gov, users must register according to instructions at http://grants.gov under the "Apply Pilot" link. Furthermore, to apply for grants at the NIH, grantee institutions and applicants must register in the NIH eRA Commons.

Preparing and Submitting an Electronic Grant Application (See Diagram)

There will be three methods for preparing and submitting an electronic application:

Method 1 –– Obtain application preparation support from a commercial vendor

Several commercial service providers have been awarded SBIR grants to develop systems for preparing electronic grant applications. The SBIR solutions may include downloadable forms, Web-based interactive forms, word processing forms and others. After receiving application data and attachments from the grantee institution, the service provider will format the application as an XML file with attachments for submission through Grants.gov.

Method 2 –– Develop a system to submit XML datastreams to Grants.gov

A grantee institution may choose to develop its own system to create XML datastreams using published XML schemas for computer-to-computer transmission to Grants.gov

Method 3 –– Download an electronic form from Grants.gov

Grants.gov will provide PureEdge™ downloadable electronic grant application forms. PureEdge supports off-line application preparation, including extensive data edit and validation at the user’s desktop and the automated propagation of data among forms. Work-in-progress can be stored and managed on the grantee’s network server or computer. Once complete, the application forms and attached files are submitted to Grants.gov.

Processing at Grants.gov

At the Grants.gov site, Northrop Grumman InFlowSuite™ software will authenticate the submitter, enforce role-based security rules, check for viruses, verify data format, send acknowledgement to the customer, and convert PureEdge XML-enabled forms into an XML datastream with included documents. Grants.gov then will package the XML stream as a Simple Object Access Protocol (SOAP) message and notify the appropriate agency that the application is ready for retrieval.

Retrieval and Processing of Applications by NIH

NIH currently is engaged in a Competitive Grant Application Process (CGAP) project. The goal of this initiative is to enable NIH to receive electronic grant applications from external sources (such as Grants.gov) as XML streams with attached documents. NIH and other agencies will retrieve their applications from the Grants.gov site using a number of methods specified in the Agency Integration Toolkit. Once received, NIH will process the electronic applications without printing or printing on demand only. NIH will review the grant proposal and consider it for funding according to established guidelines. All of the eRA internal systems supporting grant administration are being modified to support the electronic process.

Pilot Testing Schedule

Supporting electronic applications will introduce new technologies, new user interfaces, new policies, new business processes, and new workflows. To mitigate the risks of these changes, a number of gradually expanding tests and pilots will be conducted.

Grants.gov testing this summer

Beginning this month, Grants.gov will pilot test the submission of SF424 “Core” data elements and attachments. The second phase of the pilot will include “Core Plus” (research and agency-specific) data elements such as those on the PHS 398 used by the NIH. eRA has participated in Grants.gov planning and will take part in both phases of the pilot, using test applications. 

NIH eRA testing this summer

During the course of the summer, NIH will conduct a test with several commercial service providers funded through the NIH SBIR program. The tests, which will not use live data, will be iterative. Issues will be resolved by working jointly with the service providers. The purpose of the testing is to validate the technologies, gain experience in the process, and obtain preliminary feedback from the service providers.

NIH/Grants.gov collaborative testing this fall

NIH and Grants.gov plan to conduct a limited, live pilot in the October–November timeframe based on the full set of Core and Core Plus data for the PHS 398 application. NIH will work with volunteer institutions and applicants and will confine the test to R01 grants with modular budgets and competitive renewals.

Grants.gov will make a 398-based application package available on its Web site. To restrict participation in this test, NIH and Grants.gov will set up special funding opportunity numbers, which must be known to download an application.

During the fall tests, NIH also will pilot the internal NIH systems required to process electronic applications.

Future testing for the February 2004 NIH receipt cycle and beyond

The NIH CGAP pilot gradually will be expanded to add participants, application types and funding mechanisms.

eRA to Upgrade Commons Software on August 1

eRA will enhance the NIH eRA Commons and associated modules on August 1. Following are highlights of eRA Commons Version 2.2.3.0.

electronic Simplified Non-competing Application Process (eSNAP)

• Users will be able to submit a Population Tracking Inclusion Enrollment report.    
• Users will be able to enter a Signing Official (SO) as the Administrative Official (AO) on the face page of the eSNAP without having to create an AO role for the SO.    
• Users will be able to indicate that an individual section has been completed; the status of the section will be shown on the Manage eSNAP screen.    
• An Edit Business tab will enable the user to view and edit various business items.    
• There will be a new status for grants (“Not eSNAP eligible”).

eRA Commons

• A new tool will be available for NIH validation of the historical data associated with an IAR/PI eRA Commons account request.    
• The PI will be able to add additional NIH support to an account that is attached to another profile.    
• There will be a new system notification field on the Personal Information screen. This field will be activated in a future release.    
• Federal Demonstration Partnership assurances will be removed from the list of assurances and certifications.    
• There will be an “all” option for the role field on the Account List screen.    
• There will be an optional comment field on the Delete Account Confirmation screen.    
• A default Administrative Assistant (AO) account will be created for each user executing the eRA Commons demo facility.

Internet Assisted Review (IAR)

The August release moves IAR into production. All SRAs and GTAs with an IMPAC II account will be able to use IAR.

• A calendar on the Edit Dates screen will enable the user to choose a date from the calendar instead of typing it in.    
• A meeting-wide option for including reviewer names in the preliminary summary statement body will be available. Users can choose to include or omit reviewer names.    
• The grant application number will be a hyperlink for viewing the grant image (unless the reviewer is in conflict with the application).    
• If users submit or delete a critique for an application and then click back to the list of applications, they will return to the same application instead of the top of the list.    
• The ability to zip all preliminary summary statements into one zip file will be available.     
• The ability to view a critique on the Submit Successful screen will be added.    
• The option to view all meeting critiques (in Adobe PDF format) sorted by PI name will be available.    
• All SRAs and GTAs on the meeting roster will be able to see the meeting.    
• Reviewers assigned as discussants will not be blocked from reading other critiques even if they did not submit their own critiques during the Read phase.

Financial Status Report (FSR)

• There will be a new role for certain NIH Office of Financial Management staff who will be able to create/edit FSRs but will not be able to approve or reject them.   
• There will be new FSR management reports.   
• Users will be able to search for historical records in the eRA database.   
• Confirmation of critical actions (submit, accept, reject, revise) will be added.   
• There will be additional grant information fields and calculations.   
• The system will send email notification of rejected FSRs.   
• Minimum search criteria will be required to limit the number of displayed records.   
• There will be more room on the screen for the entry of remarks.

Internet Assisted Review Going Live in August

eRA will deploy IAR in production mode on August 1 after extensive testing. Sixteen NIH Scientific Review Administrators (SRAs) from CSR, NCRR, NIAID, NIDDK, NINDS, NINR, and NLM, their 55 study sections, and more than 375 reviewers from a variety of institutions have been participating in the IAR pilot, which began in December 2002. Reviewers access the IAR Web interface through the eRA Commons.

Both NIH SRAs and Grants Technical Assistants (GTAs) and peer reviewers use IAR to expedite the scientific review of grant applications. This software provides a standard process for the electronic submission of critiques and initial priority scores prior to the review meeting. More productive meetings result when reviewers have the opportunity to examine others’ critiques online prior to meetings and to modify their own critiques after meetings.

IAR also accelerates the grant approval and funding process by enabling easier, more efficient administration of reviews. Critiques are available immediately after review meetings, and IAR generates a preliminary summary statement comprising all critiques for an application. As a result, summary statements can be released more quickly. 

At present, IAR functionality includes:

• A Control Center for the SRA and GTA to manage aspects of a reviewer’s access during all IAR phases (Submit, Read and optional Edit)      
• Ability to submit critiques in Word or text format; ability to view critiques in Adobe PDF format      
• Ability to view a matrix of initial scores with the option to designate certain applications as lower half      
• After the meeting, ability for the SRA/GTA to view and download a Word document to be used as the preliminary summary statement body

The August release is expected to implement the following enhancements:

• Ability for reviewers and SRA/GTAs to view the scanned grant application image within IAR      
• Option of including Reviewer Names in the preliminary summary statement      
• Improvements to Score Matrix sorting      
• Ability to view all critiques for a PI in one Adobe PDF file      
• Ability for all SRAs and GTAs on the roster to have access to the meeting in IAR

New Version of iEdison Fully Deployed

iEdison enables grantee and contractor organizations to electronically manage extramural invention portfolios and report inventions that are made with NIH grant or contract funding. The same interface also can be used to report inventions funded by any of 18 other federal agencies. The original version of iEdison has been in production since 1995 and is used by more than 500 grantee/contractor organizations. 

The new software supports the same business processes as the original version; however, the technology upgrade provides for improved performance and improved functionality. 

The new iEdison interface supports enhanced functionality in key areas of the invention-reporting business process. The software now accepts all reports in electronic format. Previously, several required documents had to be submitted in hard copy. Users of the new iEdison now are able to upload all documents as PDF, TIFF or text files. Furthermore, all documents submitted electronically using iEdison Version 2 can be recalled for viewing by users through their Internet browser.

For the benefit of institutional administrators, Version 2 also offers improved management of iEdison accounts and reports of system usage. Most importantly, iEdison can display a graphical representation of any invention in relation to associated patents that have been reported. 

A Web-based tutorial is available to assist current and prospective users of iEdison. The tutorial can be found on the new iEdison home page (http://www.iedison.gov/), as well as on the NIH eRA Web site (http://era.nih.gov/) under the "Interagency Edison (iEdison)" topic. There will be additional learning opportunities at a series of workshops as listed in the table below. These workshops are designed to familiarize users with the look and feel, navigation, and enhancements of iEdison Version 2.

During the 90-minute workshop presentations, the attendees will learn about the architecture of the new iEdison system and how it differs from the old system. This information will be conveyed through a PowerPoint slide presentation and a live demo. In particular, the following features will be emphasized:

• Organization, registration and accounts administration
• Home page and navigation through the system
• iEdison test/demo site
• New streamlined logon procedures
• New binary document uploading of invention disclosure, confirmatory license and patent government support clause
• New graphical user representation of an invention and its associated patent(s)
• New messaging features

City	Date/Time	Location	Cost
Columbus, OH	Aug. 21 12:15–2:00 p.m.	Ohio State University Meiling Hall, Room 160 370 West 9th Avenue Columbus, OH 43210 http://www.osu.edu/map/linkbuildings/meilinghall.html	No cost; contact george.stone@nih.gov to confirm
Washington, DC	Aug. 27 1:00–2:30 p.m.	George Washington University Marvin Center Ballroom, 3rd Floor 800 21st Street, NW Washington, DC 20052 http://www.gwu.edu/~map/html/	No cost; contact george.stone@nih.gov to confirm
Baltimore, MD	Sept. 9 8:00–9:30 a.m.	AUTM Tools Course  Marriott Balt. Waterfront Hotel 700 Aliceanna Street Baltimore, MD 21202 http://www.autm.net/index_ie.html	Registration and fee; visit http://www.autm.net for details
St. Louis, MO	Sept. 25 1:00–2:30 p.m.	Washington University Eric P. Newman Education Center 320 South Euclid Avenue St. Louis, MO 63110 http://epnec.wustl.edu/index.html	No cost; contact george.stone@nih.gov to confirm

We look forward to sharing the benefits of the new iEdison with grantees and contractors. For more information, visit the iEdison Web site at http://www.iedison.gov/ or send email to edison@mail.nih.gov.

eRA Reconsiders Its Vision in View of New Requirements

Dr. John McGowan, eRA Project Manager, called for a re-evaluation of the eRA vision to ensure that the project remains in synch with federal and departmental policy, current technology, budget realities, and emerging user requirements, especially for new e-tools. Widening the scope of eRA’s vision is likely to have an impact on priorities and affect plans and schedules. Dr. McGowan urged eRA advocates, NIH staff and the grantee community to set reasonable expectations regarding the timeframe for change.

eRA’s original vision statement was formulated in FY 2000 and contains the following goals:

• Achieve end-to-end electronic research grant administration and reporting.      
• Recommend strategies for re-engineering grant management business processes to increase efficiency.      
• Electronically link the external grantee community with NIH staff and establish one common database.      
• Enable business processing in aggregate mode instead of on a grant-by-grant basis.

Over the past two years, multiple forces have begun driving the modification of the eRA vision. They include:

• The desire of NIH Institutes and Centers (ICs) to retire their extension systems when eRA is able to satisfy their processing requirements.      
• The requirement to build enterprise reporting tools.      
• The need for better data quality and security.      
• The decision to implement eRA as the common system for processing research grants throughout the Department of Health and Human Services (DHHS). See article in this issue.      
• The migration of legacy data from all DHHS Operational Divisions (OPDIVs) to the eRA system.      
• The incorporation of DHHS OPDIV requirements into the eRA system.

In addition to these forces, specific new business requirements have emerged for:

• Integration of a scientific management system to enable technology staff to track every stage of an initiative from concept development through implementation.      
• Creation of a document generator for Program Announcements (PAs) and Requests for Applications (RFAs) to standardize language across OPDIVs for the announcement of opportunities in the NIH Guide.      
• Links between NIH Guide announcements and grant records in the eRA system.      
• Integration of the assurance process for animal and human protection into eRA.      
• Enterprise budget and finance reports to simplify and standardize reporting across the NIH.      
• Reconciliation and data reporting between eRA and financial systems.      
• Development of a flexible workflow design for all ICs.      
• Development of a Council Operations module to support the Council Operations phase of the grant lifecycle and link the business processes of program, grants management and budget.      
• Integration of an electronic contract management system to support the administration of research and development contracts.      
• Incorporation of knowledge discovery and business intelligence tools.      
• Development of an enterprise-wide coding system to map individual IC codes into common elements for system-wide reporting and trend analysis.      
• Development of a system and common electronic interface for the reporting of adverse events.      
• Other requirements related to the Clinical Road Map effort.

eRA and NINDS Build NIH Type 5 e-Notification System

eRA is partnering with the National Institute of Neurological Disorders and Stroke (NINDS) to develop an NIH electronic notification system for Non-competing Continuation (Type 5) progress reports. This “push” notification is intended to remind Principal Investigators about upcoming due dates and late applications.

In the past, Type 5 grant kits were printed and mailed to grantees. Beginning in August 2002, NIH ceased mailing hardcopy reminders (see NIH Guide Notice NOT-OD-02-066) and created a Web site at http://era.nih.gov/userreports/pr_due.cfm for users to check progress reports due. When the new “pull” method proved inadequate, several ICs created their own notification systems to deal with the increased number of late submissions. As a result, grantees began receiving notices with different wording and formats.

NINDS has developed an e-notification system that it has shared with other ICs. The institute has agreed to turn over its software to eRA for centralized and standardized administration. eRA already has used modified NINDS code to issue about 700 late notifications to grantees. Blind copies also were sent to each corresponding IC.