Inside eRA for Partners, August 6, 2004 (Volume 4, Issue 3)

eRA Accepts 31 Electronic Applications for January 2005 Council Round

eRA successfully completed its third electronic application (e-application) pilot by accepting submissions for the January 2005 council round. NIH accepted 17 electronic, new, modular, competing applications for the June 1 due date. For the July 1 deadline, NIH received a total of 14 applications: 1 full-budget, competing, continuation; 7 revised, modular, competing applications; and 6 modular, competing, continuation applications. This was the first time that NIH accepted full-budget e-applications.

Thus far, authorized Service Providers have submitted all applications on behalf of grantee institutions. During the third pilot, Service Providers comprised commercial companies with NIH awards to develop submission tools for e-grants. 

During the pilots, there was no exchange of paper. After accepting each e-application, NIH converted the data into an electronic application image and stored the image in the eRA database. From receipt to potential award, NIH staff will process these applications electronically.

Next Steps

1.  For the October/November 2004 receipt dates, eRA plans to conduct its fourth and final pilot for electronic, modular R01, R03 and R21 grant applications. At the same time, eRA will perform its second limited pilot for full-budget applications. eRA also is developing the capability to handle applications responding to Requests for Applications (RFAs) and Program Announcements (PAs) for supported types and mechanisms. 

2.  In the fall of 2004, eRA intends to perform system-to-system testing with Grants.gov in preparation for a live pilot in February/March 2005. Commons Working Group members will assist with the fall tests using previously submitted application data.

3.  In January 2005, eRA will achieve a major milestone when receipt of simple, modular grants (new, competing continuation, and revised) goes into full production.

4.  During the winter of 2005, eRA plans to develop a transaction for sending the Notice of Grant Award (NGA) as a data stream to Service Providers and research institutions that have implemented a system-to-system interface with NIH. The NGA transmission will allow grantee institutions to load award data directly into their local grants management systems. The electronic NGA will be an important step toward establishing two-way, post-award communication through the NIH eRA Exchange, eRA’s architecture for handling system-to-system transmissions.

Outreach

Later this summer, eRA will launch a campaign to promote e-application awareness and community involvement. In addition, NIH will encourage more commercial organizations and research institutions to become electronic Competitive Grant Application Process (eCGAP) Service Providers. (See article in this issue.)

Technical, Policy and Coordination Issues 

Although the eCGAP project is making excellent progress, a great deal of work remains to be done. In the upcoming months, the team will turn its attention to these outstanding issues.

• Electronic Signatures –– Establish a method of validating a “signed” application for a system-to-system transmission. There must be a formal way for the institution to delegate submission authority to a Service Provider.      
• Service Provider Certification –– Formalize the certification process for Service Providers at the transaction-type level. Automate the tracking and management of Service Provider certifications.      
• Support for Service Providers –– Provide a stable test environment and adequate technical assistance for Service Providers. This fall, the eRA Helpdesk will assume responsibility for this technical support. Also, eRA is developing the means to allow Service Providers to set up their own data in the eRA test environment.      
• Corrections – Define the business process and develop technical capability for grantees to submit updates and other corrections to their e-applications after verification by the principal investigator and signing official. This includes handling multiple versions of electronic applications.

Preparing for the Future

• New Task Order Award –– eRA recently awarded a task order to AC Technologies to provide NIH with a technical evaluation of software and approaches for implementing additional Electronic Business Extensible Markup Language (ebXML) capabilities. ebXML is the language of today’s commercial Web pages. Its message service supports the secure exchange of business data via the Internet; its registry enables business partners to find one another, define trading agreements, and exchange messages.

The contractor will install and compare the ebXML message service of three off-the-shelf software packages with the current eRA solution. The evaluators also will evaluate each registry’s ability to manage the growing number of Service Providers and types of transactions. After creating prototypes and running test scenarios, the contractor will recommend the best choice for eRA.

• Support for Standard Form (SF) 424, Research and Related (R&R) Application for Federal Assistance –– NIH is preparing to accept applications submitted through Grants.gov, where the SF 424 R&R is available for download. This form contains the core data elements defined in Office and Management and Budget (OMB) Guidance. Grants.gov has provided the SF 424 R&R schema to NIH and other agencies and is awaiting OMB clearance for the forms. eRA is working with Grants.gov to develop NIH-specific forms and schema that will supplement the SF 424 R&R with data required on the PHS398 that is not part of SF 424 R&R. Other tasks related to SF 424 support include:
  • Business Rule Validation ––Validate business rules, issue error messages, and restrict application types for applications arriving through Grants.gov, whose system does not perform business-rule checking.     
  • Communications Protocol –– Work with Grants.gov to adopt standards for ebXML communications.

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

Choosing the Right Service Provider for Your Institution’s e-Submissions

As NIH develops the means to receive and process electronic applications (see article in this issue), grantee institutions face the challenge of preparing and transmitting their application data. Over the past two years, eRA has established partnerships with various organizations that are developing software and services to assist the research community with electronic submissions. Last month, this newsletter invited each e-grant partner to complete a questionnaire about their product or service. 

The purpose of the questionnaire is to introduce the eRA Service Providers and help grantee institutions perform a preliminary comparison of available products and services. eRA has assembled the responses to a standard list of questions and posted them on era.nih.gov. The responses provide:

• Information on licensing agreements and service contracts   
• Requirements for hardware, system platforms, database and other software   
• Terms and conditions of customer support   
• Description of application data input methods   
• Contact information for the key individual(s) in each provider organization   
• Contact information for clients who have experience with Service Provider software/services

There are three categories of e-grants Service Providers:

1.      Commercial Companies –– At the current time, authorized Service Providers comprise six private-sector businesses that won Small Business Innovation Research (SBIR) awards in response to NIH RFA RR-02-004. 

2.      Federal Government –– Grants.gov is the government’s single interface for all federal grant-making agencies to post funding opportunities and application packages. Interested grantees can download the applications, fill them out and submit them to the agencies through the same website. See http://era.nih.gov/Docs/Grants-gov_questionnaire_08-02-04a.pdf for more details.

3.      Universities and Other Research Institutions –– Grantee institutions can choose to develop their own NIH electronic Competitive Application Process (eCGAP)-compliant software for submitting e-applications. The Massachusetts Institute of Technology (MIT) has developed the Coeus System, which it makes available to other institutions. See http://era.nih.gov/Docs/MIT_questionnaire_08-02-04a.pdf for more information about Coeus.

CWG Discusses New Commons Development at May Meeting

Representatives from 15 participating grantee institutions met with eRA staff and electronic application Service Providers at the May 19 meeting of the Commons Working Group (CWG) in Washington, D.C. 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.

eRA recently awarded a task order to AC Technologies to support new Commons development for three production releases, the first planned for October. These releases will include several major Commons enhancements.

• Grant Closeout Functionality –– Grantees will be able to identify their terminating grants and submit required closeout documents (Financial Status Report, Invention Statement, Final Progress Report) through the Commons.   
• Content Management Facility –– eRA staff will be able to edit Commons text as needed.   
• Access to PubMed Data –– eRA will be able to fill Commons database fields with data from PubMed. PubMed is the National Library of Medicine's (NLM’s) search service that provides access to more than 11 million citations in MEDLINE, NLM’s bibliographic database.   
• Web Query Tool (Web QT) –– Commons users will have access to eRA’s new, enterprise, Web-based tool for searching, viewing, printing and exporting data from the eRA production database.   
• Organizational Hierarchy –– eRA will replace its current role-based security with a more flexible rights-based security system.   
• New Version of X-Train ––eRA plans to reintroduce X-Train, the NIH Commons interface for tracking National Research Service Awards training appointments. The new version will be much more user friendly and more powerful than its predecessor.

The next maintenance release, Commons Version 2.6.4, will include electronic Simplified Non-competing Application Process (eSNAP) self-registration. Beginning mid-August, grantee officials authorized to modify the Institutional Profile (IPF) will be able to register their institution to submit eSNAPs. The August release also will contain numerous other enhancements and changes.

The next CWG meeting will take place on Wednesday, September 22 from 9:00 a.m. to 4:00 p.m. in the Lecture Room of the National Academy of Sciences, located at the intersection of C and 21^st Streets in Washington, D.C. NIH is holding its meeting in conjunction with the Federal Demonstration Partnership (FDP) Phase IV General Meeting, scheduled for September 20-21. Go to http://thefdp.org/Meeting_Info_Sep2004.html for more information about the FDP meeting. 

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.

eRA Requests $45 Million to Fund Project in FY2005

To achieve its four major goals for FY2005, eRA presented a $45 million funding request early this spring to the new NIH Information Technology Working Group (ITWG).

In making his case to the ITWG, Interim Project Manager Dr. Israel argued that eRA requires additional dollars “to keep up with the demand for its services…maintain momentum on current initiatives, satisfy departmental and federal mandates on schedule, and undertake new challenges.”

Some of the factors driving eRA costs upward are:

• Growth in client usage and expectations        
• NIH Roadmap initiative        
• Consolidation of all HHS research grant processing under eRA        
• Coordination with Grants.gov.

Proposed FY2005 Budget Breakdown

The largest share of the proposed budget ($30 million) will pay for system maintenance and improvements in performance and data quality. Support for electronic applications, eRA priority #2, will cost an estimated $4.6 million. This budget category finances production acceptance of modular, R01 competing grant applications beginning in January 2005 and early-adopter pilot acceptance of electronic Non-competing Application Process (eNAP) progress reports. It also supports electronic competing grant applications for a wide range of research grant mechanisms.

eRA can achieve its top two priorities with FY2004 levels of funding; however, without proposed increases, eRA will have to sacrifice other critical goals (see graph). End-to-end processing, priority #3, will cost an estimated $6.3 million to develop electronic document management, flexible permissions architecture, system-wide workflow, and other capabilities to automate and integrate Program, Budget and Grants Management activities.

Implementation of Knowledge Management (KM) tools, priority #4, requires $4.04 million. These dollars will fund the creation of a KM data archive, production support for KM-assisted reviewer selection, and piloting of disease-coding and other new prototypes.

OMB 300 Draft Preparation

The eRA Program Management Office (PMO), under Dr. Lederhendler’s leadership, has prepared its FY2006 “Capital Asset Plan and Business Case” for the Office of Management and Budget (OMB). The first draft of this document, a.k.a. OMB 300, was due to NIH on June 21. The final document, which includes FY2004 eRA results, must be submitted to OMB in August.

The purpose of OMB 300 reporting is to ensure that federal agencies invest public resources wisely. Efficient planning, acquisition and management of capital assets must guide the budget decision-making process, and agencies need to comply with the results-oriented requirements of federal legislation including the Government Performance and Results Act (GPRA) of 1993, the Chief Financial Officers Act of 1990, the Paperwork Reduction Act of 1995, the Clinger-Cohen Act of 1996 and others.

eRA received a good score for its FY2005 OMB 300 submission. As the Department’s enterprise extramural system, eRA will submit a stronger justification for FY2006. The PMO will update eRA goals to better reflect eRA’s expanded vision. Alternative analysis will address implementation of an eRA data mart and the use of KM tools. Regarding acquisition strategy, the PMO will improve measurements to confirm that eRA’s contractors are getting the work done on time and within budget. eRA also expects to complete its security Certification and Accreditation (C&A) in the near future, which will ensure a higher OMB 300 rating for security.

Address questions about the eRA budget and OMB 300 report to Donna Frahm at frahmd@mail.nih.gov or 301-594-9747.

Helpdesk Extends Hours of Service

In response to user demand, the eRA Helpdesk has extended its hours of operation and now is open from 7 a.m. to 8 p.m. Eastern Daylight Time on weekdays. As a rule, the Helpdesk is closed on weekends; however, during peak processing periods, the Helpdesk will provide limited service on weekends. We will post weekend hours in advance at https://commons.era.nih.gov/commons/index.jsp. There will not be Helpdesk support on official federal holidays. 

Since the beginning of the eRA Project in CY2000, NIH user sessions have increased from an average of 29,000 per month to an average of 53,000 per month in CY2003. The need for additional Helpdesk coverage also is consistent with the growth in Commons usage over the past 18 months. There now are 1,552 registered institutions and 22,800 active users. In addition, the extended schedule will accommodate normal business hours for users on the West Coast.

You can reach the Helpdesk by telephone or by email to request information or to report problems or issues:

To expedite the handling of your request, you will need to provide the following information:

• Full contact information: your name, address, email, telephone number, Commons username, and institution name. 
• The name of the software application and the action you are performing. Describe the problem in detail, the more information, the better. 
• The error messages you receive. If you send an email, provide a screen shot of the error message or problem. 
• Your request ticket number (for follow-up inquiries).

Callers will receive a ticket number from the Helpdesk specialist at the end of the telephone conversation. Email users will receive an email from the Helpdesk specialist with a ticket number. The goal of the Helpdesk is to respond to tickets within four working hours.

NIH Establishes Central Receiving Point for All Paper Non-competing Progress Reports

NIH will centralize the receipt and initial processing of all paper non-competing progress reports due on/after October 1, 2004. Guide Notice NOT-OD-04-054, dated July 23, 2004, announces this procedure change. In September, NIH will issue a separate Guide Notice to provide grantees with the new, central mailing address for submissions to all Institutes and Centers (ICs).

When NIH receives non-competing progress reports at the new address, NIH will scan and store them in the eRA database. Grantees will be able to view the scanned images through the Commons Status module. The scanning of incoming progress reports, like the scanning of paper grant applications, is an interim step toward the goal of end-to-end electronic research administration.

Grantees must continue to mail progress reports due prior to October 1 directly to the funding IC. See http://grants.nih.gov/grants/type5_mailing_addresses.htm for a list of IC addresses. Also, grantees that report to other Department of Health and Human Services agencies that use the PHS2590 and/or 416-9 forms must continue to send their forms directly to those agencies.

For additional information, contact grantspolicy@mail.nih.gov.

NIOSH To Migrate All Its Research Grants to eRA

The National Institute for Occupational Safety and Health (NIOSH), a user of NIH extramural information systems for 20 years, will begin processing all of its research grants under eRA by the end of FY2004 and all of its research training grants by the end of FY2005. Currently, NIOSH receives 400–500 research-grant applications per year and makes 200–300 awards.

“We are very enthusiastic about taking advantage of all eRA capabilities,” comments Dr. Michael Galvin, director of NIOSH’s Office of Extramural Programs (OEP). He recognizes that there will be a learning curve for NIOSH’s 30 internal users but is confident that they will adapt quickly. As lead program administrator for the Research Program Activity, Galvin especially looks forward to the new Program module and to eRA’s comprehensive and flexible reporting features.

NIOSH began using the original IMPAC mainframe system on a limited basis in the 1980s. The Institute also began announcing its extramural research programs in the NIH Guide for Grants and Contracts and relying on the Center for Scientific Review (formerly the Division of Research Grants) to handle receipt and referral activities for NIOSH applications.

In 1999, NIOSH successfully moved its research grants and cooperative agreements into the client-server IMPAC II system. According to Galvin, “the conversion five years ago enabled NIOSH to provide better service to the public.” eRA’s current migration to an Internet environment will further help NIOSH achieve its mission.

Part of the Centers for Disease Control and Prevention, NIOSH is the federal agency responsible for conducting research to reduce work-related illnesses and injuries, for promoting safe and healthy workplaces, and for enhancing global-worker well-being through international partnerships. Intervention and prevention are the main objectives of NIOSH’s extramural research program, which funds research grants and training grants as well as research and training cooperative agreements. These awards provide support for research efforts among federal, state, university, labor groups, and non-profit organizations.

Through the years, the NIOSH OEP and NIH’s Office of Extramural Research (OER) have worked together to accommodate NIOSH’s special processing requirements. For example, CDC requires Financial Management Officer (FMO) approval; therefore, eRA is adding “FMO Signature” to the signature block. CDC still needs a workaround to track multiple Institutional Review Board (IRB) approvals, since eRA stores only one site.

In Dr. Galvin’s view, the 2003 HHS recommendation to centralize all research grants processing under eRA makes good sense for NIOSH. “It enabled us to continue and expand our long relationship with NIH, to cut administrative costs, and to improve service to our clients.” In the near future, when the eRA Commons is available to CDC grantees, NIOSH intends to encourage its grantees to register in the Commons and take advantage of electronic submissions to the NIH.

New Division of Extramural Activities Support To Begin Operations in October

The NIH has restructured its extramural support services under the Office of the Director, Office of Administrative Operations and the Division of Extramural Activities Support (DEAS). Under the leadership Mary Frances Deutsch, DEAS will be open for business on October 3, 2004, the first day of FY2005. When fully staffed, DEAS will be NIH’s largest division with about 630 employees.

NIH conceived DEAS as part of its proposal to continue performing support services to Peer Review, Grants Management and Scientific Program Management activities in-house. Office of Management and Budget (OMB) Circular A-76 establishes federal procedures for determining whether government employees or commercial contractors should perform certain tasks. NIH’s proposed “most efficient organization (MEO)” vied with bids from the private sector and won the A-76 competition. 

Under DEAS, NIH seeks to improve organizational effectiveness, efficiency and accountability through the centralization of support services for Peer Review, Grants Management and Program functions. This strategy represents a major departure from NIH’s current structure, through which each Institute and Center (IC) carries out its own extramural activities support services. By contrast, DEAS, part of the Office of the Director, will provide extramural activities support services to all ICs but will not be aligned with any one. Thus, the implementation of DEAS introduces a major “culture” change at NIH.

DEAS Director Mary Frances Deutsch spoke about other challenges at the eRA Project Team meeting on June 22. In her view, the largest is transitioning a workload that is continuously in progress. Ms. Deutsch, recently appointed by Dr. Norka Ruiz Bravo, NIH deputy director for Extramural Research, joins the NIH from the Centers for Medicare and Medicaid Health Services where she earned the DHHS Secretary’s Award for Distinguished Service for improving the lives of persons with disabilities. She holds a Juris Doctorate from the Creighton University School of Law and is a member of the Minnesota State Bar Association. 

Interim eRA Project Manager Izja Lederhendler is committed to working with DEAS to carry out the NIH mission. At the June 22 meeting, he noted that the critical intersection between eRA and DEAS is through a common set of working procedures. He invited Ms. Deutsch to appoint a DEAS representative to the eRA Team.

DEAS currently is customizing an off-the-shelf software application by SiteScape™ that will assist extramural IC customers in ordering services from DEAS and assist DEAS management in tasking, tracking and balancing workload. Users will access the DEAS application through the eRA website and servers housed with eRA. SiteScape software is one of many available workload-balancing and prediction tools. During the evaluation, DEAS will work closely with eRA to integrate the DEAS system into the eRA architecture. IC customers will beta test the system before it goes into production.

For the latest information on the transition to DEAS, visit http://extramuralmeo.nih.gov.