Inside eRA for Partners, February 27, 2004 (Volume 4, Issue 1)

Dr. Izja Lederhendler Becomes Interim eRA Project Manager

Dr. Israel (Izja) Lederhendler has accepted the position of interim eRA project manager. Under the terms of his appointment, Dr. Lederhendler will devote 50 percent of his time to eRA and 50 percent to the National Institute of Mental Health (NIMH), where he is a program officer. His strong belief in the importance of eRA in achieving the NIH mission led him to accept the eRA position, which realistically is a full-time job.

Prior to his appointment, Dr. Lederhendler served with Dr. Carlos Caban as co-Advocate for the Scientific Program Management community. He also participated in the Program Officers/Program Officials Forum, the electronic Program Users Group, and the Program Portal Joint Application Design team.

Dr. Lederhendler chaired his first eRA Project Team meeting on February 10. In his opening remarks, he spoke about his professional obligation. As a program officer, he deems that his principal function is to ensure that tax dollars lead to useful public health advances and that eRA serves to facilitate the same mission. To this end, eRA has been working to develop effective management tools to make optimal use of the extramural grants administration database. This direction offers the greatest opportunity for eRA to contribute to national and international efforts to improve public health. Technically oriented efforts often can get caught up in the latest systems and how they work and risk losing sight of our public-health mandate.

According to Dr. Lederhendler, his two principal responsibilities are maintaining project momentum and communicating project challenges and opportunities to the community-at-large. He encouraged business-area advocates to generate enthusiasm by engaging in productive “cross-talk.” He highlighted the current Grants Management (GM) redesign effort as a great opportunity to get GM, Budget, and Program representatives together to collaborate for the best end-to-end design. 

At NIMH, his home institute, Dr. Israel Lederhendler serves as the chief, Basic Behavioral and Systems Neuroscience Program. He was trained in psychology (McGill University), biopsychology (City University of New York, American Museum of Natural History) and behavioral neurobiology (Marine Biological Laboratory, Woods Hole). In addition to administering a grants portfolio, he was coordinator of sleep and chronobiology research for NIMH, serving as a member of NHLBI's Advisory Board of the National Center for Sleep Disorders Research and the Trans-NIH Sleep Research Coordinating Committee.

Register Early for Commons Training at Upcoming NIH Regional Seminars

eRA will offer Commons training on May 5 in Miami and on June 23 in Seattle in conjunction with upcoming NIH Regional Seminars. Signing officials (SOs), principal investigators (PIs) and preparers of Financial Status Reports (FSRs) will receive hands-on training in Commons functions and tools relevant to their jobs. Priority registration for these labs will be given to seminar attendees.

The session designed for SOs and other grants administrators will cover activities such as creating and maintaining accounts, and viewing and updating institutional and personal profile information. Participants will learn how to run status queries and generate reports. Instructors will offer tips for efficient system use and will discuss upcoming Commons updates.

PIs will have the opportunity to learn how to review and update their personal profiles and to initiate an electronic simplified Non-competing Application Process (eSNAP) progress report. Participants also will receive training in displaying NIH review group assignments, priority scores, summary statements and award status, and in creating queries. The third hands-on session will target grantees who prepare, submit and track FSRs, which are required by the NIH Office of Financial Management. This training will cover the process of entering, revising and submitting an electronic FSR and troubleshooting errors.

In addition to the training laboratories described above, the NIH will provide an 80-minute eRA overview as part of the regular Regional Seminar agenda. The next seminar, scheduled for May 6-7, will be hosted by the University of Miami and Florida A&M University, College of Pharmacy and Pharmaceutical Sciences. The complete program for the seminar is posted at http://grants2.nih.gov/grants/seminar_agenda_miami_20040506.doc. Contact umcme@med.miami.edu for registration and accommodation information.

The University of Washington School of Medicine will host the second Regional Seminar on June 24-25 in Seattle. Go to http://uwcme.org/site/courses/NIHdownloads.php for registration information. See  http://grants2.nih.gov/grants/seminar_agenda_seattle_20040624.doc for the complete agenda.

Second eRA e-Application Pilot Underway

The eRA team, benefiting from the experience of its October/November electronic grants pilot, is conducting a second pilot for the March 1 receipt date. NIH has accepted a limited number of e-applications from Service Providers for simple, Type 2 competing continuation research grants. Currently, authorized Service Providers include commercial companies that won NIH awards to develop submission vehicles for e-grants.

Thirteen e-applications submitted for the October/November due dates have been verified by the grantees, successfully processed through the Receipt and Referral office and assigned to a study section or initial review group through the eRA system. Two of the original 15 applicants decided to use their paper applications and opted out of the pilot. Members of the eRA team are meeting with scientific review administrators to brief them on the new electronic process and to request feedback from reviewers at the end of the review meetings. The 13 applications will be tracked closely through peer review, council, and possibly award to ensure that all processing runs smoothly.

Unlike the fall pilot, no paper copies of the applications will be generated in March for internal use by NIH staff. Thus, from Receipt and Referral to potential award, these applications can be handled electronically.

The electronic Competing Grant Application Process (CGAP) software was upgraded this month. Based on lessons learned from the first pilot, the CGAP team added a validation service to enable submitters to perform a “test run.” The test submission will undergo all the business-rule checks required for the NIH to generate a database record and a grant image. Principal Investigators (PIs) and Service Providers will be able to correct errors or update personal profile data before resubmitting the “live” and final e-application. The validation service should minimize the data discrepancy problems that were encountered in the first pilot. 

To further facilitate data checks and reduce mismatched error conditions, NIH also added a Web service to retrieve some key administrative information. This will allow the PI and Service Provider to compare the person information in the Commons with data in the application image generated by the NIH.

The eRA team also has improved documentation for grantees and Service Providers and supplementary instructions for applicants. Terms and conditions and procedures for submitting applications are available online. In addition, NIH has prepared a tool kit for Service Providers and institutions with instructions on establishing a system-to-system interface with the eRA Exchange. (See the NIH Partnership information page.) The tool kit also documents NIH validation rules and explains how to handle error messages. eRA recommends that grantees adopt the system-to-system submission method.

Grantee institutions interested in participating in the next pilot are encouraged to contact one of NIH’s authorized Service Providers. See the eRA Web site for contact information. Alternatively, grantee institutions can choose to develop their own NIH-compliant grant application submission software. Institutions and commercial companies interested in becoming authorized Service Providers should send an email request to Scarlett Gibb, chief, eRA Planning, Communications and Outreach Branch at gibbs@mail.nih.gov.

Direct questions about the CGAP project to Jennifer Flach, the new CGAP team leader, at flachj@mail.nih.gov or 301-435-5092.

eRA Opens eSNAP Pilot to FDP

Effective January 1, 2004, the National Institutes of Health (NIH) invites all Federal Demonstration Partnership (FDP) members to participate in its NIH electronic Research Administration (eRA) electronic Streamlined Non-competing Award Process (eSNAP) pilot. eSNAP, a component of the Commons, enables extramural grantees to submit an electronic version of the SNAP Type 5 (non-competing) progress report through a Web interface. 

Currently, 56 of the 826 organizations registered in the Commons are authorized to submit eSNAP progress reports. Since the start of the eSNAP pilot in November 2003, these users have transmitted a total of 972 eSNAPs to the NIH. To access the eSNAP Web interface, institutions and users first must enroll in the Commons. Once an institution is registered, an authorized business official needs to request eSNAP functionality from the NIH eRA Commons Helpdesk.

As part of the eSNAP pilot, the NIH is testing potential changes to certain progress report business processes. Therefore, before granting eSNAP access, NIH requires that the participating institutions agree to test these new business processes through an up-front agreement. Although there are no significant technical obstacles to full implementation, eSNAP will continue in pilot mode until policy issues are resolved.

One significant difference in the pilot involves the reporting of approval dates for the human subjects Institutional Review Board (IRB) and vertebrate animal Institutional Animal Care and Use Committee (IACUC). In the electronic process, these dates are not captured at the time of submission. Instead, participating grantees agree to provide this data on a retrospective quarterly basis. NIH will send each institution a spreadsheet listing all progress reports submitted via eSNAP that involve human or animal subjects. The institution will be responsible for entering the approval date for each project and returning the spreadsheet to NIH by the specified due date.

The immediate goal of collecting approval dates is to continue to assure full compliance. Once data has been collected and analyzed from a larger population of participating grantees, the NIH expects the results to support a permanent change to the business process, i.e., eliminating routine reporting of approval dates for SNAP progress reports.

NIH extramural staff and Commons users are welcome to visit the eRA Commons demonstration site at https://commonsdemo.era.nih.gov/commons-demo/index.jsp to simulate the entire eSNAP process from initiation through final submission. An eSNAP users guide also is available online.

For more information on the eSNAP pilot, see NIH Guide Notice NOT-OD-04-024, issued on February 5, 2004.

e-Grants and Commons Top eRA Priorities for FY2004

Two of eRA’s highest priorities for FY2004 are improving and expanding the capabilities of electronic applications and the Commons. The top-ten list also includes other initiatives designed to standardize, simplify and expedite grant-related interactions between NIH and the grantee community.

Among plans to enhance e-applications are support for all non-competing Type 5 grant progress reports, resubmissions, National Research Service Award (NRSA) forms, and electronic Notices of Grant Awards (NGAs). eRA also intends to integrate its electronic competing application process (CGAP) software with Grants.gov, where institutions can apply for Federal grants online through a unified process.

New Commons facilities will include a Web Query Tool (QT) interface for the Status module. Web QT is a user-friendly search facility already available to internal NIH staff. Prototypes of new, directed query screens are available online at http://era.nih.gov/UI/Commons/StatusQuery2.

eRA also plans to upgrade X-Train, the NIH Commons interface for tracking National Research Service Awards (NRSA) training appointments. X-Train will be converted to Java Version 2 Enterprise Edition (J2EE), the industry standard for building large-scale business applications for the Web.

The grantee community also will benefit from other funded eRA priorities, including:

• Consolidation of all Department of Health and Human Services (HHS) research grant processing under eRA (priority #3).    
• Implementation of organizational hierarchy structures that accommodate security, supervisory oversight, workflow requirements and delegation of authority for internal and grantee users (priority #6).    
• Development of a comprehensive electronic notification system (priority #7).

In planning for this year, the eRA Project Team worked to balance and satisfy requirements from many sources, including internal and external users, legislation, and Federal, HHS and NIH policy and plans. At the same time, the team strove to accomplish its objectives in accordance with industry best practices.

As the eRA team works to achieve the goals of its funded priorities, new and shifting priorities continue to emerge. NIH management will need to decide whether to provide additional funding for new requirements or to replace scheduled initiatives with new ones. Emerging requirements result, in part, from the following initiatives:

• The NIH Roadmap –– The Roadmap provides a framework of NIH priorities for sponsoring research in the 21^st century. “Research Teams of the Future” is one of the Roadmap’s core themes. To accelerate medical discovery, NIH plans to encourage interdisciplinary and public/private sector collaboration. Undoubtedly, eRA will assume the responsibility of tracking a widening network of co-investigators and key personnel. In addition, NIH leaders have recognized the potential role of Knowledge Management (KM) in maximizing the utility of eRA data for promoting health research by informing the public and hastening discoveries. KM is as yet an unfunded eRA priority.    
• Most Efficient Organization (MEO) –– OMB Circular A-76 establishes Federal procedures for determining whether certain activities should be performed under contract with commercial sources or in-house using government personnel. According to standard review procedures, agencies develop proposals for a “most efficient organization” to compete with bids from the private sector. In response to A-76 requirements, NIH established the Office of Grants Support Services (OGSS) within the Office of Extramural Research (OER) in the NIH Office of the Director (OD). The OGSS strategy to improve organizational effectiveness, efficiency and accountability is critically dependent on the continued development of eRA capabilities.    
• Grants.gov –– In compliance with Public Law 106-107 and the President’s Management Agenda, Grants.gov was established as a unified “storefront” for customers of Federal grants to electronically find opportunities, apply, and manage grants. Grants.gov is one of 24 Federal, cross-agency, E-Government initiatives focused on improving access to services via the Internet. Concurrent with work on the NIH CGAP, the eRA team meets regularly with the Grants.gov team to define standards, conduct pilot testing, and coordinate efforts.

For more information about eRA plans for FY2004, contact Scarlett Gibb, Chief, Planning, Communications, and Outreach Branch, at gibbs@mail.nih.gov or 301-435-0690, x603.

Zerhouni Forms Working Group to Oversee NIH IT Management

NIH Director Dr. Elias Zerhouni has formed an enterprise Information Technology Working Group (ITWG) to provide governance and oversight on NIH IT management issues. The new governance structure replaces the IT Board of Governors, NIH’s decision-making body for the past five years. 

The function of the ITWG, as defined in its charter approved by the NIH Steering Committee on December 18, 2003, is to advise the NIH director, the NIH Steering Committee and the NIH Chief Information Officer (CIO) on IT management issues, focusing on IT principles, infrastructure strategies, architecture, business application needs, and investment priorities. The ITWG currently comprises the following members, appointed by the NIH director for terms not to exceed three years. Deputy directors do not vote on funding issues impacting their own areas of responsibility.

A new Extramural IT Steering Committee, whose purview includes eRA and all IC grants and contract management systems, will report to the ITWG. Dr. Louise Ramm, deputy director, NCRR, will chair the steering committee, and Dr. Norka Ruiz Bravo, deputy director for Extramural Research, will be the program official on the committee.

The recent restructuring of NIH IT governance carries out the centralization and standardization agenda of the Department of Health and Human Services (HHS). To this end, other HHS initiatives include a unified financial management system, the consolidation of grants management under NIH’s eRA and the Administration for Children and Families’ GATES systems, and the requirement that all infrastructure IT services within an operational division (OPDIV) report to the OPDIV CIO. NIH’s new IT hierarchy also is consistent with the Office of Management and Budget’s e-Government program.

eRA Awards Contracts for Software Development

eRA has awarded design, development and maintenance contracts to three vendors who will compete for individual task orders. The three companies are Northrop Grumman Information Technology (NGIT), Science Application International Corporation (SAIC), and AC Technologies (ACT). As task orders/work assignments are developed, these tasks will be competed among the three software design, development and maintenance contractors, who may establish partnerships with subcontractors to assist them. Under the terms of the contract, partnering arrangements must remain intact until the completion of the task order.

Recently, AC Technologies recently won the task order for system maintenance, and NGIT won the task order for the iEdison project. Proposals for the Datamart task order currently are under review by the eRA technical evaluation team. According to the new procurement structure, the eRA planning team will create a statement of work (SOW) when the need for support arises. 

NGIT, headquartered in Herndon, Virginia, is one of the nation’s largest technology providers with annual sales exceeding $4 billion and 23,000 employees worldwide. Currently, NGIT is partnering with Silicon Spirit and Global Solutions on the eRA contract. Founded by a small group of scientists in 1969, SAIC now ranks as the largest employee-owned research and engineering firm in the nation. SAIC and its subsidiaries have more than 42,000 employees with offices in more than 150 cities worldwide. Thus far, Altum and Turner Consulting Group are SAIC’s partners on the eRA project. ACT, the third eRA awardee, is a rapidly growing 8(a) information technology company serving the U.S. Postal Service, the Department of Commerce, the Veterans Administration, the National Oceanic and Atmospheric Administration and other organizations in the public and private sectors. ACT will team with Booz Allen Hamilton on eRA activities.

eRA awarded the following GSA Schedule delivery orders during the fall of 2003:

Direct questions about eRA contracts to Donna Frahm at frahmd@mail.nih.gov.

Commons Usage Continues to Grow

eRA Commons usage continues to rise dramatically as grantee users establish more online sessions to perform administrative tasks, check the status of their applications, submit electronic Financial Status Reports (FSRs) and electronic simplified Non-competing Application Process (eSNAP) progress reports, and use Internet Assisted Review (IAR). Between February 2003 and January 2004, Commons logons increased from 2,505 per month to 19,216 per month. The number of online sessions for the first 18 days of February already exceeds the total for all of January.

Since the deployment of the NIH eRA Commons in October 2002, 826 grantee organizations and 10,094 persons have enrolled in the Commons system. More than 6,000 principal investigators (PIs) are among these grantees. Thus far, users have submitted 972 eSNAPs and 23,410 FSRs.

System usage is expected to continue to increase as capabilities are added and pilot applications are released into full production. For example, only 56 institutions currently are enabled to submit eSNAPs. Ultimately, the Commons will become the vehicle for the two-way exchange of all grant-related information between the NIH and the grantee community.