Inside eRA for Partners, January 21, 2005 (Volume 5, Issue 1)

OER Appoints Dr. Israel Lederhendler to Head New Office of Electronic Research and Reports Management

On January 11, National Institutes of Health (NIH) Deputy Director for Extramural Research Norka Ruiz Bravo, Ph.D., announced the appointment of Israel Lederhendler, Ph.D., as the director of the new Office of Electronic Research and Reports Management (OERRM).

OERRM represents the merger of two components of the Office of Extramural Research (OER): the electronic Research Administration (eRA), formerly part of the Office of Policy for Extramural Research Administration (OPERA), and the Office of Reports and Analysis (ORA). “The new office brings together the strengths of two talented teams to create an integrated extramural information environment,” stated Dr. Ruiz Bravo. “The consolidation of eRA and ORA will maximize the value and accessibility of extramural data. OERRM staff will perform increasingly complex data analysis to provide better information to NIH staff as well as to public and private decision-makers.”

For the past year, Dr. Lederhendler has served as interim eRA director. During this period, Dr. Lederhendler also continued in his role as project officer at the National Institute of Mental Health (NIMH), where he was chief of the Basic Behavioral and Systems Neuroscience Program. His strong commitment to NIH information management goals led him to accept the interim position, realistically a full-time job.

Under Dr. Lederhendler’s leadership, eRA’s role has continued to increase in size and complexity even as it prepares to integrate the grants systems of other Operating Divisions within DHHS. The program has made excellent progress toward providing a comprehensive system for end-to-end electronic processing of extramural grant applications and awards.

Dr. Lederhendler joined the NIH in 1987 as a senior staff fellow at the Laboratory of Biophysics, National Institute of Neurological, Communicative Disorders and Stroke (now NINDS). After moving to NIMH as a research administrator in 1991, he led NIH efforts to establish integrative and comparative perspectives within the neurosciences. In addition to administering a grants portfolio, he coordinated sleep and chronobiology research for NIMH, serving as a member of the Advisory Board of the National Center for Sleep Disorders Research at the National Heart, Lung, and Blood Institute and the Trans-NIH Sleep Research Coordinating Committee. 

The American Psychological Association (APA) recently honored Dr. Lederhendler  with an APA Research Service Commendation for his contribution to psychological research. Dr. Lederhendler is a fellow of the International Behavioral Neuroscience Society and was a member of the Scientific Advisory Board of the Society for Behavioral Neuroendocrinology. He has served as a guest editor for peer-reviewed journals and has co-edited several volumes dealing with behavioral neuroscience and its application to mental health. 

Dr. Lederhendler trained in psychology (McGill University), biopsychology (City University of New York, American Museum of Natural History), and behavioral neurobiology (Marine Biological Laboratory, Woods Hole.) 

e-Application Submission Opened to All on January 12

eRA achieved a major milestone on January 12 when NIH opened the submission of electronic, modular, non-consortia R01, R03, and R21 grant applications (new, competing continuation, and revised). Open access for these application types means that all grantees have the option to work with a Service Provider (SP) to submit an unlimited number of e-grant applications.

Beginning in the fall of 2003, eRA conducted a series of four e-application pilots; more than 30 research institutions participated as early adopters. eRA has scheduled additional pilots in 2005 to test more complex grant types.

Upcoming Pilots

• February/March 2005 Pilot ––eRA will continue piloting full-budget applications.     
• RFA Pilot –– eRA is developing the capability to handle applications responding to Requests for Applications (RFAs) and Program Announcements (PAs) for supported types and mechanisms. Many applications responding to RFAs do not go to the Center for Scientific Review (CSR) for review; instead, the announcing Institute/Center performs the review. Electronic receipt holds great promise for reducing the processing and review time for these applications. Upon receipt, there is the possibility of referring the RFA applications automatically to the IC review group rather than waiting for CSR to perform the processing and routing. NIH currently is identifying RFAs that are good candidates for an upcoming pilot.      
• June/July 2005 Pilot ––This pilot plans to accept supplements and support some post-receipt corrections (addenda).     
• eRA/Grants.gov Integration Pilot –– eRA has been collaborating with Grants.gov to determine the feasibility of conducting a live pilot in the spring of 2005. To that end, eRA has:
  • Mapped Standard Form (SF) 424 Research and Related (R&R) data elements to the eRA database. The 424 R&R is a federal form that Grants.gov uses to receive electronic applications for research grants.      
  • Submitted NIH-specific data analysis to supplement the SF 424 R&R.     
  • Defined business validations for Grants.gov applications.     
  • Completed initial eRA/Grants.gov system-to-system testing.     
  • Continued working with Grants.gov and NIH to develop the NIH-specific forms and schema to supplement the SF 424 R&R.

Next steps in preparation for the pilot include:

• Integrate Grants.gov Web service calls with the eRA eXchange.     
• Implement business validations for Grants.gov applications.     
• Create mechanism to send warnings and error messages to the applicant through the Commons.     
• Finalize and post the NIH-specific application package on Grants.gov.     
• Generate a grant image based on the SF 424 R&R format.     
• Invite Commons Working Group members to participate in tests using previously submitted application data.

Other Activities in Support of Electronic Grant Applications

• eCGAP Receipt and Referral (RR) Module –– eRA developed this module for internal use by the Center for Scientific Review (CSR) to process electronic grant applications received through the eRA eXchange. CSR has exercised the module during two rounds of pilot testing. Although eCGAP-RR currently accommodates only simple grants with modular funding, the mature module will handle all grant types.

eCGAP-RR incorporates a modified workflow for applications through the Receipt and Referral process. Since eCGAP performs business-rule validation at the time of submission, eCGAP-RR includes only a few quality and assurance (Q&A) checks. The eCGAP process automatically maps data into the eRA database and creates an electronic application image; therefore, there is no need for paper and minimal need for manual data entry.

The module comprises three processes:

1. First Contact –– notifies CSR that applications have arrived and have been verified by the principal investigator and signing official. The software enables CSR to perform additional validations such as checking for duplicate submissions.     
2. Breakout –– enables the breakout officer to refer the application for review. The selection of the Integrated Review Group (IRG), referral officer or Institute/Center (IC) is based on the application’s scientific content.     
3. Referral Workload –– notifies the referral officer of eCGAP applications and enables him/her to assign them to an IC and/or to to the appropriate IRG for review. The module then generates a unique grant number for each referred application and releases the application for review, bypassing additional Q&A and scanning required for paper applications.

• Expanded eCGAP Focus Group –– Recently NIH expanded the eCGAP focus group to include more perspectives on electronic receipt and downstream processing of electronic applications. New members represent  program, grants management, IC review, policy, and other areas of responsibility.     
• New PHS 398 Form –– OMB recently approved a new version of the PHS 398. eCGAP will be modified to accommodate this new form in May 2005.     
• Electronic Notice of Grant Award –– The Notice of Grant Award (NGA) will be the first major outgoing electronic transaction for the eRA eXchange. The requirements analysis is complete and development is expected to begin in early 2005.     
• New Test Environment –– eRA is creating a new test environment for SPs that integrates the eRA eXchange and the Commons demo facility. This will allow SPs to provide demonstrations and end-to-end training to applicants. For example, the PI and SO must learn to verify each electronic application in the Commons prior to CSR’s accepting the application.     
• Electronic Business Extensible Markup Language (ebXML) Standard –– ebXML is an international standard for specifying the electronic exchange of business information between electronic trading partners. With contractor assistance, eRA has compared the ebXML registry and message service of three off-the-shelf software packages with the current eRA solution. eRA will use the results of this comparison to plan and design the long-term architecture for the eRA eXchange.     
• NCRR GCRC Progress Reporting –– The National Center for Research Resources (NCRR) has begun a development effort to support system-to-system transmission of progress reports from the General Clinical Research Centers (GCRCs). The eRA team and NCRR are planning to use the eRA eXchange for this initiative.

More Information

• Information for Applicants –– For information about Service Providers, go to http://era.nih.gov/Projectmgmt/SBIR/sbir_grants.htm.     
• Information for Service Providers –– Go to http://era.nih.gov/Projectmgmt/SBIR/.     
• Questions about Electronic Applications –– Contact Jennifer Flach, eCGAP team leader, at flachj@mail.nih.gov or 301-435-5092.

Fourth Annual eRA Symposium Heralds e-Applications

Dr. Israel Lederhendler, then interim eRA director, urged 282 NIH participants at the eRA Symposium to imagine themselves as Principal Investigators (PIs) getting ready to submit electronic applications for the first time. In his opening remarks on December 2, Dr. Lederhendler announced that NIH would begin accepting modular R01, R03, and R21 electronic grant applications beginning January 12, 2005.

This year’s symposium, titled “The eRA eXchange: Making the Electronic Connection,” was dedicated to informing the internal community about what grantees will experience with the new NIH electronic submission process. In particular, NIH staff learned how commercial Service Providers (SPs) are assisting research institutions with their transition to e-applications. The symposium also updated NIHers about related Grants.gov and National Science Foundation (NSF) FastLane activities.

Keynote Address

In his keynote address, Kenneth Forstmeier, director of the Office of Research Information Systems at the Pennsylvania State University, provided a perspective from the grantee community. Although he praised the government’s modernization and standardization efforts, he identified several areas of concern:

• The success of e-grants will require a culture change that takes more time than the technology change.    
• Different e-forms required by each grantor or the same grantor pose impediments to change.    
• Federal standardization efforts focus on the “apply” phase. Failure to include the entire grant lifecycle means that agencies will unilaterally develop post-award systems. Accommodating multiple grantor systems is a huge burden for institutions and also results in redundant expenditures for the government.    
• Grantees should be able to submit e-applications using a single federal logon ID. If a single ID is not implemented, user administration for these redundant systems will add significant costs and complexity to future Grants.gov system-to-system transactions.

Center for Scientific Review Presentations

Dr. Brent Stanfield, acting director of the Center for Scientific Review (CSR), spoke about the expected and unexpected benefits of two eRA initiatives: applications on CDs for reviewers and Internet Assisted Review (IAR). NIH implemented CDs and IAR to reduce waste, improve service to its clients, provide user tools, and, with electronic receipt, eventually shorten the review cycle. 

NIH, its applicants, and peer reviewers are realizing the following benefits:

• Use of paper is reduced. Before CDs, NIH mailed large boxes of paper copies of every application for a study section to each reviewer. Now, NIH provides hardcopies only to the few reviewers specifically assigned to these applications; all of the other applications are available to the reviewers on CDs.    
• Shipping costs are reduced. CDs are easy to transport.    
• CDs are indexed and searchable, increasing usability.    
• Laptops (PC and Mac) require less space than paper at study section meetings, allowing reviewers to sit closer and possibly communicate better.    
• The use of IAR results in more productive study section meetings. Reviewers come to the table prepared for discussion. To realize the full benefits of IAR, however, all reviewers must post their reviews by the assigned deadline, before the meeting.    
• IAR allows the study section chairperson and the SRA to identify, in advance of the meeting, those applications requiring extensive discussion, enabling the leaders to better manage meeting time.    
• Electronic critiques facilitate the generation of summary statements.

Dr. Stanfield also spoke about the potential use of Knowledge Management (KM) tools to help refer applications to Institutes and Centers (ICs) and review groups, to identify candidate reviewers, to suggest assignments for reviewers, and to assist applicants in identifying study sections appropriate for their applications.

Dr. Suzanne Fisher, who directs Receipt and Referral (R&R) for CSR, then compared the R&R process for handling traditional paper applications with the new process. “CSR has been an active partner in moving NIH through the transition to electronic applications,” stated Fisher. She estimates that NIH will receive 80,000 applications in 2005, up from 35,000 in 1985. Automation certainly will assist NIH in handling the increasing workload and reducing errors. Equally important are the benefits to applicants. The new e-application process with checks and audits should free candidates to devote more time to science.

Throughout her presentation, Dr. Fisher emphasized that NIH will not change what it does, only how it achieves its mission. The Division of Receipt and Referral’s essential functions will remain the same: receiving applications for 24 NIH ICs and other HHS components, assigning applications to ICs, making assignments to CSR Integrated Review Groups, determining the appropriate grant activity code, providing information to applicants and NIH extramural staff, and serving as the clearance point for NIH Guide notices. 

According to Dr. Fisher, eRA still has many technical and cultural challenges to face in moving to e-applications:

• Determining timeframes for eliminating paper (e.g., sending electronic notifications through the Commons instead of paper mailers).    
• Determining when electronic submission will become mandatory.    
• Assuring equity in handling applications regardless of the mode of submission.    
• Involving PIs and signing officials in application verification (eRA’s method of obtaining electronic signatures).    
• Handling corrections and additions; documenting updates and versions.    
• Developing tracking and reporting systems to monitor performance/workload.    
• Utilizing multiple screens and other ways of viewing several documents at once.    
• Accommodating the full range of applicant organizations.    
• Incorporating KM.    
• Maintaining personal interactions with applicants.

Grants.gov

Rebecca Spitzgo, Grants.gov program manager, provided an update on the new central Web site for finding and applying for federal research grants. She was pleased to report that 100% of federal agencies now post announcements to Grants.gov, and the site is getting 1.4 million hits/week. Soon, applicants will have the ability to download the application package directly from the announcement.

Grants.gov also has successfully implemented its “apply” capability. More than 1,300 electronic applications already have arrived. These applicants completed a new standard federal form, SF 424 Research and Related (R&R), which was developed by a multi-agency Grants.gov work group. The R&R forms have been approved by the Office of Management and Budget (OMB) and are available for use on Grants.gov. Currently, Grants.gov and its partners are developing agency-specific forms, where needed, to capture additional data fields.

At present, Grants.gov accepts individual applications in Pure Edge format. (PC users can download Pure Edge forms from Grants.gov.) The government is working with Apple Computer on a Mac version. In addition, Grants.gov staff is collaborating with the academic community and commercial SPs to develop system-to-system submission capability.

Throughout her presentation, Ms. Spitzgo emphasized the importance of user feedback. In response to a question about expanding Grants.gov beyond “find and apply,” she urged the community to voice its requirements.

NSF FastLane Presentation

Daniel Hofherr, chief of the External Systems Branch in the National Science Foundation (NSF) Division of Information Systems, shared NSF’s ten-year experience with implementing the FastLane grants administration system. This year, NSF accepted 43,500 electronic applications (99.99%) through the system. Designed by its users, FastLane supports the full grant life cycle.

NSF continues to add new capabilities to its system. Most recently, it created modules to support letters of intent, National Science Board Office awards, and Graduate Research fellowships. NSF currently is working on integration with Grants.gov and enhancing its Guest Travel and Payment System.

For more information and copies of symposium presentations, visit http://era.nih.gov/eraworkshop4/. To view the videocast of the symposium, go to http://videocast.nih.gov/PastEvents.asp and select “Conferences.”

CWG Discusses e-Application Developments at January Meeting

The Commons Working Group (CWG) met with eRA staff to discuss ongoing activities related to the electronic submission and processing of grant applications. The meeting took place on Wednesday, January 12, 2005 from 9:00 a.m. to 4:00 p.m. at the Imperial Palace Hotel in Las Vegas. 

NIH held its CWG meeting in conjunction with the Federal Demonstration Partnership (FDP) Phase IV General Meeting, scheduled for January 13–14. For more information about the FDP meeting, go to http://thefdp.org/Meeting_Info_Jan2005.html.

Agenda Items

• NIH and the new standard federal grant application form, SF 424 Research and Related (R&R) 
• Update on electronic applications –– the eRA eXchange and Grants.gov 
• Progress on electronic, complex, non-competing progress reports (eNAPs) 
• Commons news 
• Implementation of organizational hierarchy 
• Steps toward achieving end-to-end electronic processing 
• Update on eSNAP research subject approval dates 
• X-Train usability 
• Plans to capture co-principal investigator data 
• New NIH public access policy –– implications for eRA

Since its formation in January 2001, the CWG has played a critical role in shaping, evaluating and fine-tuning eRA electronic interfaces to the extramural NIH grantee community.

CWG meetings are open to all interested persons. For more information, contact David Wright at david.wright@nih.gov or 301-435-1792.

Security Clearance Now Required for NIH Access to eRA

In compliance with NIH Information Technology (IT) Security Requirements, Institutes and Centers (ICs) have begun conducting public trust investigations for government staff and contractors who access the eRA system. These investigations comprise thorough background and credit checks as well as official fingerprinting by the NIH police.

The Department of Health and Human Services (DHHS) Automated Information Systems Security Program Handbook identifies the levels of risk associated with system access. Since eRA is a mission-critical system with highly sensitive data, eRA staff and users must have Minimum Background Investigations (MBIs) or Limited Background Investigations (LBIs). This requirement affects the following personnel:

• Employees or contractors with responsibility for systems design, operation, testing, maintenance and/or monitoring.       
• Employees or contractors who access or process proprietary data under the protection of the Privacy Act of 1974.       
• Employees or contractors who perform accounting, disbursement or authorization for disbursements from systems of less that $10 million per year.       
• Employees or contractors with other responsibilities that involve a degree of access to the systems that creates a significant potential for damage or for personal gain.

Based on the criteria above, approximately 3500 eRA technicians and users (grants technical assistants, scientific review administrators, grants management specialists, among others) require new or updated background checks. 

Strict implementation of DHHS/NIH security requirements is due, in part, to heightened national concern about terrorism and bio-terrorism. Furthermore, as the eRA database becomes the central repository for all DHHS research grants, its importance and vulnerability will increase.

Background checks represent another eRA strategy for tightening security. On November 10, 2003, eRA implemented a more stringent password policy. See previous article of this newsletter for details.

Enterprise Grants Management System Board Oversees Integration into eRA

The Department of Health and Human Services (DHHS) has begun holding regular meetings of the Enterprise Grants Management System (EGMS) Board. The EGMS Board will coordinate and resolve issues related to the integration of the Department’s research grant-administration systems into eRA. 

Diane Bogusz of the DHHS Office of Grants Management and Policy (OGMP) serves as the EGMS program manager (PMO). NIH Chief Information Officer Al Graeff and Office of Electronic Research and Reports Management Director Dr. Israel Lederhendler represent NIH on the EGMS Board. Booz Allen Hamilton and DigitalNet are providing professional support to the OGMP PMO.

December EGMS Board Meeting

The EGMS Board discussed the items below at its December 1, 2004 meeting. The next meeting will take place on February 2, 2005.

• Development of a unified, documented migration process  
• Comparison of the NIH CRISP and DHHS TAGGS systems  
• Creation of a uniform grant numbering system across DHHS  
• Migration funding through the DHHS Information Technology Investment Review Board   
• Drafting of an EGMS vision statement

Benefits of Consolidation

The Department-wide integration initiative follows the August 2003 DHHS selection of eRA as the enterprise system for research grants management. A central system should achieve the following objectives:

• Streamline work processes to provide improved services to citizens.  
• Capitalize on existing advanced technology and best practices.   
• Create an opportunity for cost-effective, intra-agency sharing and elimination of redundant spending.   
• Provide a single point-of-interface with Grants.gov and the DHHS Unified Financial Management System (UFMS).   
• Maintain reliable and common data across OPDIVs.   
• Simplify the implementation of new policies and regulations.

Status of Migration to eRA

For the past year, eRA has been collaborating productively with five DHHS OPDIVs to centralize their research grants processing under the NIH eRA system. The Centers for Disease Control and Prevention (CDC) and the Agency for Healthcare Research and Quality (AHRQ) already are using eRA; the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), and the Substance Abuse and Mental Health Services Administration (SAMHSA) are in the preliminary stages of integration.

Direct questions about migration status to the following agency points-of-contact.

eRA Tests Disaster Recovery Plan

eRA conducted its first semiannual disaster recovery test on December 5–7 to exercise its plan for recovering from a natural or man-made catastrophe. In the aftermath of 9/11, businesses and organizations worldwide have realized the critical need for a workable strategy to recover data and systems following a disaster.

eRA defines a disaster as “an unplanned disruption where mission-critical eRA functions are rendered inoperative on their primary site with no prospect of regaining operational capability within a 72-hour period.” While planning the exercise is prudent thinking on the part of eRA, it also is a federal requirement. eRA must have a disaster recovery plan and conduct disaster recovery exercises as part of the Certification and Accreditation process mandated by the Federal Information Processing Standard of 1983.

The goal of the eRA disaster recovery plan is to have systems up and running within 72 hours of a declared disaster. “The continuity of functionality for an enterprise system like eRA is crucial to NIH,” states Mr. Ali Ghassemzadeh, manager of the eRA Systems Management and Operations Branch. “We need a fallback plan in case a disaster occurs.” 

eRA contracted disaster recovery services with SunGard (a commercial “hot site” provider). The Center for Information Technology (CIT), which supports eRA’s test and production middle-tier Unix environments, also has a contract with SunGard. In the future, eRA plans to establish and manage its own exclusive standby site that always will be available for NIH training, testing and disaster recovery.

The December exercise, led by Mr. Ghassemzadeh and Ms. Nora Hermida, task lead for Operations Systems Administration, supplements eRA’s regular precautionary activities. These include backing up its data and continuously monitoring its firewalls for breaches in security.

eRA tested various aspects of its disaster recovery strategy during the December exercise.

• Applications –– The test focused on two modules: the client-server version of Receipt and Referral (R&R) and the Web version of Grants Management (GM). Testing did not interfere with the normal conduct of R&R and GM business. 
• Network Communication ––  eRA collaborated with Adrienne Yang, disaster recovery coordinator for CIT and SunGard staff. eRA synchronized its test with one planned by CIT. 
• Roles and Responsibilities — The eRA Disaster Recovery Plan specifies responsibilities of key NIH and SunGard personnel in the aftermath of a disaster. One objective of December’s test was to enable designated staff to practice their roles. The eRA Operations, User Support, and Quality Assurance branches and the Information Systems Security Officer took part. These groups will become more involved as future testing grows in scope and complexity.

eRA plans to conduct increasingly complex exercises every six months. For more information, contact Ali Ghassemzadeh at ghassema@mail.nih.gov.