Inside eRA, March 7, 2005 (Volume 6, Issue 1)

Israel Lederhendler Appointed to Head New OERRM

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). Zoe-Ann Copeland, Dr. Lederhendler’s senior advisor for the transition team, will facilitate building the new organization.

eRA is responsible for providing a comprehensive system for end-to-end electronic processing of extramural grant applications and awards. 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 (OPDIVs) within DHHS. 

ORA is responsible for overall NIH reports and analysis needs. This includes maintaining CRISP, conducting statistical investigations of extramural trends, and analyzing information relevant to policy or program issues. In addition, ORA supports communication with the biomedical research community regarding NIH's extramural programs through its GrantsInfo communication service. 

Dorrette Finch, ORA's acting director, said, "The ORA staff prides itself in providing the best service to the NIH staff, extramural community, and to the general public. Our merger clearly presents an added opportunity for the ORA and eRA teams to further their commitment to the constituents we serve."

Dr. Ruiz Bravo agrees. “The new office brings together the strengths of two talented teams to create an integrated extramural information environment. The consolidation of eRA and ORA will maximize the value and accessibility of extramural data 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.

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. 

Among his awards, the American Psychological Association (APA) honored Dr. Lederhendler recently 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). 

Extramural IT Steering Committee Approves eRA Priorities for FY 2005

On January 27, 2005, the NIH Extramural Information Technology (IT) Steering Committee, whose purview includes eRA and all Institute and Center grants and contract-management systems, approved eRA’s high-level plan for FY 2005. The cost of executing this plan, which includes 18 priorities grouped into 4 functional areas, is estimated to be about $42 million.

eRA analysts currently are completing Statements of Work (SOW) to accomplish these priorities. The SOWs will go out for bids. In accordance with its new procurement structure, eRA competes new task assignments among its three design, development and maintenance contractors: AC Technologies (ACT), Northrop Grumman Information Technology (NGIT), and Science Application International Corporation (SAIC). 

Address questions about eRA priorities and the budget to Donna Frahm at frahmd@mail.nih.gov or 301-594-9747.

NIH Now Accepts e-Applications

eRA accomplished a major milestone in January 2005 when NIH began receiving electronic, modular, non-consortia R01, R03 and R21 grant applications (new, competing continuation, and revised). This achievement follows more than a year of pilot testing by 31 research institutions participating as early adopters.

Since NIH opened access on January 12, researchers have submitted 18 new R01 e-applications with modular budgets and one with a full budget. Open access means that all grantees have the option to work with a Service Provider (SP) to submit an unlimited number of electronic R01, R03 and R21 grant applications.

eRA has scheduled additional pilots this year to test more complex grant types:

• February/March 2005 Pilot ––eRA continues to pilot full-budget applications.  
• June/July 2005 Pilot ––This pilot plans to accept supplements and possibly 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. eRA also has been working other Department of Health and Human Services (DHHS) Operating Divisions (OPDIVs) to accept their applications through Grants.gov. To this 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.  
  • eRA has submitted PHS-specific data analysis to supplement the SF 424 R&R. 
  • eRA, with input from other OPDIVs, has defined business validations for Grants.gov applications.  
  • eRA and Grants.gov have completed initial eRA/Grants.gov system-to-system testing.  
  • This month, Grants.gov is expected to complete the PHS-specific forms and schema to supplement the SF 424 R&R. 
  • NIH is actively developing and testing the code to accept SF 424 R&R-based applications and process them electronically in the NIH eRA system.

Next steps in preparation for the eRA/Grants.gov pilot include: 

• Integrate Grants.gov Web service calls with the eRA eXchange. 
• Implement business validations for Grants.gov applications. 
• Modify the existing eRA database for new data fields and changes in fields from SF 424 R&R. 
• Create mechanism to send warnings and error messages to the applicant through the Commons. 
• Finalize and post an 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.

For more information about electronic applications, contact Jennifer Flach, eCGAP team leader, at flachj@mail.nih.gov or 301-435-5092.

eRA to Implement One View for All Users

“One View” is eRA’s vision for a consolidated system designed to present grants administration data, accept requests, and process transactions in a consistent way throughout the grant lifecycle. Senior Requirements Analyst Dan Hall briefed the eRA team in January on specific 2004 accomplishments and 2005-2006 strategic plans for achieving One-View goals.

One View means that all Department of Health and Human Services (DHHS) extramural staff and grantee users ––grants specialists, scientific review administrators, program officials, principal investigators, signing officials and others–– will interact with the eRA system in the same way. They will use the same or similar interfaces and facilities to view grants administration data, receive notifications, enter requests, and execute transactions.

First Step: One Technology Platform for all Software Applications

At the current time, eRA comprises 13 internal-facing and 8 external-facing program modules that access a common database. A prerequisite for One View is a single technology platform for all software. To this end, in 2004, eRA began converting existing client/server applications to Internet-based applications using Java 2 Enterprise Edition (J2EE) technologies. During the first half of CY 2005 (J2EE Conversion Phase 2.1), eRA intends to deploy production pilots for Institute and Center Operations, Committee Management, and Review. The remaining modules (Receipt and Referral, Training Activities, Population Tracking, and CRISP Plus) will migrate to J2EE in the second half of the year (Conversion Phase 2.2).

During 2004, eRA also collaborated productively with five DHHS Operating Divisions (OPDIVs) to centralize their research grants processing under the NIH eRA system. This effort results from the August 2003 selection of eRA as the Department’s enterprise system for research grants management. Establishing a One-View environment will greatly simplify the OPDIV migration process and ongoing support for eRA’s projected 100,000 internal and external users. 

One View Objectives for 2005

• Single Login for All eRA Applications (IMPAC II and Commons)

One objective of One View is to enable NIH staff to access and navigate to all eRA applications through a single login.

Another objective is to permit seamless navigation across eRA components without the need to authenticate each user action. For example, many eRA applications rely on a common component to modify information about a person. In the client/server environment, the system invokes the Persons module without requiring another user logon. Accomplishing the same task in a transparent manner is more complex in J2EE. 

Eventually, eRA intends to use a portal or similar technology for seamless navigation across all applications. With a single logon, the user will be able to choose from a menu of applications.

• Single Method for Notification (See complete article.)

As part of One View, eRA intends to send all user notifications electronically through standard email messages and posting to a single login page. Notification events include:

• Assignment of institute, scientific review group and council   
• Release of score, summary statement, notice of grant award and award   
• Notification to approve, route, or process an electronic request such as an eSNAP, request for extension, change of institution

eRA will maintain a log of all notification events associated with a grant, most likely in the electronic grant folder. This information will become part of the public record.

• Standard User Interface for the Initiation and Processing of Requests

eRA intends to standardize the method for submitting, approving and processing all requests. This involves using the same interface and program code regardless of who initiates the request, where it originates, when it occurs in the grant cycle, and who issues the approval. In 2005, eRA will implement One View for the following electronic requests:

• Program officer and grants specialist approvals for Just-in-Time, eSnap, and Closeout requests   
• Other Prior Approval requests such as Change of Institution, Change of Principal Investigator, Request for No-Cost Extension, and Administrative Supplement   
• Internally initiated “901” requests such as Change of Institute   
• Post-submission changes to applications (eCorrections) through the eRA eXchange

One View Objectives for 2006

• Terminate support for paper requests from grantees   
• Integrate all OPDIV grantees into the Commons   
• Implement One View for remaining eRA requests

eRA staff currently are evaluating a One View demo. For more information, contact Dan Hall at hallda@mail.nih.gov.

CWG Discusses Commons Enhancements at January Meeting

Representatives from 17 participating grantee institutions met with eRA staff and electronic application Service Providers at the January 12, 2005 meeting of the Commons Working Group (CWG) in Las Vegas, Nevada. The majority of the agenda items concerned plans for the expansion of Commons capabilities over the next 12 months and ongoing activities related to the electronic submission of competing applications and other forms.

Highlights of the Meeting

• Standard Form (SF) 424 Research and Related (R&R)

SF 424 R&R is the federal form that Grants.gov uses to receive electronic applications for research grants. Since this form does not capture all required NIH data elements, Grants.gov and NIH, with input from several OPDIVs, are developing PHS-specific forms and schema to supplement the SF 424 R&R. CWG members recommended that PHS-specific forms follow the federal form and remain a separate part of the application package. If feasible, links from the 424 to related NIH-specific items would be helpful.

• Grantee Verification of Electronic Applications

Current procedures require that the principal investigator (PI) and signing official (SO) verify each electronic application online within 48 hours of submission. Verification through the Commons is the NIH equivalent of an electronic signature. The CWG discussed issues with the verification process. Has an applicant missed the deadline if he/she submits but fails to verify before the due date? Can the system support the traffic? Should NIH have different due dates for paper and electronic competing applications? (eSNAP submitters have 15 extra days.) Is verification necessary? Should it be optional?

• Complex Electronic Non-competing Application Process (eNAP)

The group discussed next steps in building the capability to accept complex, electronic non-competing progress reports for research grants, training grants, and fellowships. Many thought policy review and possible business process reengineering (BPR) should come before building the system. NIH implemented business-process improvements prior to developing eSNAP.

• Commons Update

Releases 2.7.0 and 2.7.1 are scheduled to deploy this month. Significant enhancements include enabling submission of closeout documents and display of eCGAP errors in Status.

Release 3.0.0, scheduled for May/June 2005, will introduce organizational hierarchy and the new version of X-Train.

• Reporting on eSNAP Research Subjects

One significant difference between paper and electronic progress reports 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. The CWG discussed non-compliance with this reporting requirement and recommended that the NIH evaluate its policy for non-compliant grantees.

• X-Train Update

Software to create, amend and reappoint trainees (Iteration 1) currently is in development. eRA now is gathering requirements for terminating training appointments (Iteration 2). Soon, the CWG will have the opportunity to comment on a draft user interface. Most likely there will be a new “role” for business decisions.

• Multiple-PI Support

NIH is moving toward recognizing multiple PIs on grant applications. This may require a change in grant regulations.

• Changes to the PHS 3734 Relinquishing Statement

NIH and grantee representatives are working together to improve the change of grantee institution process. One suggestion is to include estimated carryover money on the PHS 3734 Relinquishing Statement.

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.

Enterprise Grants Management Board Manages Integration with eRA

The Department of Health and Human Services (DHHS) Enterprise Grants Management System (EGMS) Board met on February 2 to continue coordinating the integration of the Department’s electronic research grant administration with eRA. Chartered on September 21, 2004, the EGMS Board is responsible for overseeing the systems migration of the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), and the Substance Abuse and Mental Health Services Administration (SAMHSA).

Robert M. Noonan, acting director of the DHHS Office of Grants Management and Policy (OGMP), chairs the Board; Diane Bogusz (OGMP) serves as the 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.

Under the Department-wide grants system, NIH acts as the service provider. DHHS Operating Divisions (OPDIVs), as the customers, are responsible for reimbursing NIH for the initial costs of migration. They also establish Service Level Agreements (SLAs) with NIH to cover ongoing costs. Infrastructure expenditures, incurred by NIH in becoming the DHHS “Center of Excellence” for research grants processing, may be funded by the DHHS Information Technology Investment Review Board (ITIRB) or another cooperatively funded model.

February 2005 Meeting

The EGMS Board discussed the items below at its February 2, 2005 meeting. The next meeting will take place on March 16, 2005.

• Quarterly presentation to the ITIRB 
• EGMS Policy, Structure and Procedures document 
• EGMS standards for success in achieving full integration into eRA, retirement of legacy grants administration systems, and CRISP reporting by all OPDIVs 
• Proposed policy directive requiring the use of a DHHS-wide grants numbering schema based on the NIH schema 
• Concept of Operations document

Status of Migration to eRA

According to the January 2005 EGMS status report, AHRQ is performing 100% of its research grant transactions using eRA; CDC, 95%; FDA, 30%, HRSA, 15%; and SAMHSA, 15%.

Integration Points of Contact

eRA Prepares for PHS 398 Changes

eRA is preparing to accept new and modified data fields on the revised “Application for a DHHS Public Health Service Grant” (PHS 398, rev. 9/04). Beginning on May 10, 2005, all applicants must begin using the updated form.

NIH has extensively rewritten the PHS 398 in accordance with the agency’s commitment to plain language. Changes also reflect other NIH goals including electronic processing, effective monitoring of stem cell and human-subjects research, and collecting more data on significant contributors.

Changes of Note to eRA

For eRA, supporting the four-digit SSN is the most complex task. This change impacts almost every internal and external business module and all search and reporting facilities. The eRA database must store both 9-digit and 4-digit SSNs, and eRA code must accommodate both formats. In particular, programmers need to develop new SSN-matching algorithms. 

For more information on changes to the PHS 398, see NIH Guide Notice NOT-OD-05-006. Contact eRA analyst Tina Milner with questions about changes to eRA.