Inside eRA, August 22, 2005 (Volume 6, Issue 3)

New OERRM Organization Begins Operations

The Office of Electronic Research and Reports Management (OERRM) began operations on July 5, exactly six months after the Office of Extramural Research (OER) announced plans to merge the electronic Research Administration (eRA) and the Office of Reports and Analysis (ORA) into a new organization. OERRM currently is awaiting NIH approval of its proposed organizational structure.

Dr. Israel (Izja) Lederhendler, appointed OERRM director on January 11 by Dr. Norka Ruiz Bravo, NIH deputy director for Extramural Research, led the effort to create the new organization around a customer-oriented framework. With the assistance of Transition Manager Zoe-Ann Copeland and a 15-member transition team, Dr. Lederhendler supported wide participation in defining the new organizational structure. 

OERRM TRANSITION TEAM

From the earliest stages of planning, OERRM documented the progress of the project on its Intranet site and sought feedback from managers, staff and contractors. In addition, Dr. Lederhendler began hosting informal “Breakfasts with Izja” to encourage everyone to share ideas and ask questions. There was an All-Hands meeting on June 15 to update the entire organization. 

On August 9–10, Dr. Lederhendler led a two-day retreat at the Bolger Center in Potomac that brought together more than 70 people from across NIH to brainstorm ways of shaping OERRM into a responsive, thriving and successful system for electronically managing grants.

Early in the transition process, OERRM defined its vision ––Business serving knowledge…knowledge serving health–– and its mission:

To support the NIH and HHS research grants program from initiative planning and application submission through grant close-out and reporting to report that data as information to NIH and extramural communities and to enable the synthesis of that information into knowledge that can guide the management of the NIH research portfolio and improve the Nation’s health.

According to the proposed, new OERRM organizational structure, eight high-level managers, responsible for OERRM’s key business and service areas, report directly to Dr. Lederhendler. At the present time, all members of the OERRM management team have agreed to serve on an interim basis until the positions are filled through the federal competitive process.

INTERIM OERRM MANAGEMENT TEAM

If you have questions or comments, contact Transition Manager Zoe-Ann Copeland at copelanz@mail.nih.gov or 301-435-1418.

NIH Prepares to Adopt SF424 Research and Related Grant Application

NIH will phase in the Standard Form (SF) 424 Research and Related (R&R) dataset over the next two years in accordance with the federal initiative to simplify and standardize application data and forms across the government. At the same time, NIH will encourage full use of electronic submission through Grants.gov, the central posting and receiving site for 26 grant-making agencies.

NIH is committed to the success of the federal initiative and plans to replace the Public Health Service (PHS) 398, currently used by applicants for NIH grants, with the SF424 R&R. This conversion effort involves numerous funding mechanisms and tens of thousands of applications ranging widely in size and complexity. 

Transition to the new form and electronic submission will be by funding mechanism as per NIH Notice NOT-OD-05-067, issued on August 19. Applicants for NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants (R41, R42, R43 and R44) will be the first required to use the 424 R&R, effective for the December 1, 2005, submission date. See full article in this issue. Conference grants (R13 & U13) will be next, effective for the December 15, 2005, submission date; AREA grants (R15) will follow, effective for the January 25, 2006, submission date.

New Application Process

In accordance with the new application process, grantee institutions must have a Data Universal Numbering System (DUNS) number, be in the Central Contractor Registry (CCR), register with Grants.gov, and establish an institutional profile and person profiles in the eRA Commons. NIH is advising applicant organizations to register early since each registration can take several weeks to be processed.

After registration is completed, the applicant can download, complete and submit the 424 R&R using PureEdge™ software, which is provided by Grants.gov. Alternatively, research institutions can establish an electronic system or engage a Service Provider to transmit applications as XML data streams to Grants.gov.

Differences between the SF424 R&R and the PHS 398

Most data fields on the 424 R&R are the same or similar to those NIH currently collects on the 398; however, there are some significant differences. Earlier this year, the Grants Management Working Group identified data field and data format discrepancies.

For NIH-required data that the 424 R&R does not collect, there will be several 398-specific supplementary forms. These include a cover letter, cover page supplement, research plan, modular budget and checklist.

The eRA 424 Transition Team and the Joint Program/Review Working Group are meeting to address other differences between the forms and their impact on NIH grant administration business practices. Some differences are:

• The 424 R&R collects some data elements not captured on the 398.

Example: 424 R&R Cover #16b (Total Federal and Non-federal Funds)

Resolution: NIH programs generally do not involve cost sharing or matching. There will be an agency-specific instruction to leave 16b blank unless otherwise directed in the program announcement.

• Some 424 R&R and 398 field lengths or formats differ.

Example: 424 R&R Cover #11 (Title) is 150 bytes; eRA stores titles up to 81 bytes.

Resolution: For now, there will be an agency-specific instruction warning the applicant that a title with more than 81 characters will be truncated.

• Some response options (picklists) on the 424 R&R and 398 differ.

Example: On the 424 R&R, there are three choices for Type of Application: Preapplication, Application, and Changed/Corrected Application. The 398 does not include the Preapplication option.

Resolution: Include an NIH-specific instruction that "Preapplication" does not apply unless noted in the program announcement.

• Some 424 R&R instructions may be confusing to NIH applicants.

Example: The 424 R&R Cover #6 (EIN) instructs applicants to enter the 9-digit TIN or EIN assigned by the Internal Revenue Service. Many NIH grantees have an extended EIN (12 digits) assigned by the Department of Health and Human Services (DHHS).

Resolution: Include an agency-specific instruction requesting the applicant to enter the DHHS EIN, if assigned.

• The 424 R&R and the 398 sometimes use different units of measurement.

Example:  For the budget, the 424 R&R collects Person Months and the 398 collects Percent Effort.

Resolution: Still under consideration. One alternative is for NIH to calculate Person Months from the 424 R&R Budget Section A. NIH may need to change its business practices.

424 R&R Training and Outreach for NIH Staff

In preparation for receiving the first group of 424 R&R applications this fall, NIH staff needs to become familiar with the new 424 R&R form set and the 398-specific supplements. On August 4, there was a 424 R&R preview session at the Natcher Main Auditorium. Go to http://videocast.nih.gov/PastEvents.asp (DHHS only) to view the videocast of the 45-minute presentation and 75-minute question-and-answer panel session.

Background materials, including a PDF sample of the 424 R&R application package, are available to NIH extramural staff at http://odoerdb2.od.nih.gov/oer/training/esa/esa_training_20050804.htm. For more information, go to http://www.grants.gov/CustomerSupport, grantsinfo@nih.gov and the eRA Commons Support Page at http://era.nih.gov/commons/index.cfm.

New Animal Subject Codes Take Effect for FY 2005 Awards

The Office of Electronic Research and Reports Management (OERRM) and the Office of Laboratory Welfare (OLAW) have modified NIH animal subject (AS) codes, reducing the number of valid codes to six and aligning them with human subject codes.

The new AS codes take effect for all FY 2005 awards. The eRA system will edit the records for all FY 2005 applications to reflect the changes.

NIH policy governing the release of awards for research using vertebrate animals remains the same. The electronic Research Administration (eRA) system will continue to enforce existing business rules.

The six valid AS codes are:

10 = No live vertebrate animals involved

20 = Vertebrate animals involved

30 = Vertebrate animals involved, no SRG concerns noted

44 = Vertebrate animals involved, SRG concerns noted

48 = Conditional award with terms and conditions

54 = Concerns resolved, conditions removed

According to the new AS-tracking structure, there now are five data elements:

• AS Ethical/Scientific Assessment (codes 10, 20, 30, 44, 48, 54 above) 
• AS Institutional Assurance Number 
• AS Institutional Assurances Filed? (Y, N, C (conditional), R (resolved)) 
• Institutional Animal Care and Use Committee (IACUC) Study Date 
• IACUC Study Certifications Filed? (Y, N, C, R)

The AS-code changes affect several eRA application programs, screens and reports, including the Summary Statement. For details, see Release Notes for Grants Management (GM), Peer Review (REV), and Institute and Center Operations (ICO).

For more information, contact the eRA HelpDesk at helpdesk@od.nih.gov or 301-402-7469.

SBIR/STTR Applicants to Submit through Grants.gov

NIH will require Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) researchers to submit electronic applications for NIH R41, R42, R43 and R44 non-AIDs-related grants through Grants.gov beginning with the December 1. 2005, receipt date. NIH expects to receive approximately 2,500 SBIR/STTR applications at that time. 

AIDS-related SBIR/STTR applications will require electronic application submission through Grants.gov using the SF 424 (R&R) dataset beginning with the January 2, 2006, receipt date.

In accordance with new procedures, applicants must use SF 424 Research and Related (R&R), the new standard federal form, which NIH intends to phase in over the next two years. The SF 424 R&R will replace the Public Health Service (PHS) 398. See the full article in this issue.

NIH recently announced these planned changes at the Seventh Annual NIH SBIR/STTR Conference on July 28–29 in Bethesda, Maryland. Information also is available on the Office of Extramural Research (OER) Web site at http://grants1.nih.gov/grants/funding/sbirsttr_news.htm. Later this summer, there will be an official notice in the NIH Guide for Grants and Contracts.

To comply with the new submission process, SBIR/STTR applicant organizations first must register with the Central Contractor Registry (CCR), Grants.gov and the NIH eRA Commons. NIH encourages applicant organizations to go to http://www.grants.gov/GetStarted to complete the CCR and Grants.gov registration forms. These are one-time only registrations; NIH is advising applicant organizations to start early since each registration can take several weeks to be processed.

Applicant organizations also must register in the NIH eRA Commons. Once the institution is registered, principal investigators (PIs) contact their signing official (SO) to establish a Commons account. Both the SO and PI must verify the application online before NIH will process it. 

For additional information about Grants.gov, see the Grants.gov Web site at http://grants.gov/. For more information about the eRA Commons, see the Commons Web site at https://commons.era.nih.gov/commons/index.jsp.

To prepare NIH extramural staff for the conversion to the SF 424 R&R, the Office of Extramural Research (OER) hosted a training session on August 4 in the Natcher Main Auditorium. The archived videocast is available to DHHS staff at http://videocast.nih.gov/PastEvents.asp.

If you have questions about new SBIR/STTR application requirements, contact Kathleen Shino at shinok@mail.nih.gov or 301-435-2689. 

eRA Welcomes Tom Boyce, Starla Collins and George Gardner

Thomas Boyce has accepted a detail at NIH as the new interim eRA program manager. In announcing the appointment, Office of Electronic Research and Reports Management (OERRM) Director Dr. Israel Lederhendler stated, “Tom brings a wealth of knowledge and experience to our program.”

Mr. Boyce has been the Chief Information Officer for the Agency for Healthcare Research and Quality (AHRQ) for the past three and half years. He also is a senior fellow of the Council for Excellence in Government, having participated successfully in the Council's e-Government Fellow's program.

Prior to joining AHRQ, Mr. Boyce worked at NIH for 13 years, initially with the National Institute of General Medical Sciences (NIGMS) Information Resources Management Branch and later at the Center for Information Technology, where he managed enterprise information technology projects including the Integrated Time and Attendance System (ITAS). 

Earlier in his career, Mr. Boyce worked as a computer engineer for 3M and other private-sector companies. He holds a Bachelor of Science degree in Information Systems Management from the University of Maryland.

In an email message to eRA staff on July 21, Boyce wrote: ”I feel a tremendous responsibility to the entire eRA team to ensure continued accomplishments as we transition to the new [OERRM] organizational structure…We will face many challenges as we seek to transform into a more customer-focused organization. I will strive to do my part to manage the outside forces and bring a common sense approach…”

Starla Collins has joined eRA as Tom Boyce’s executive assistant. She has extensive experience in this capacity as well as in information systems and project management. Most recently, Ms. Collins worked in the Office of Extramural Research as executive assistant to the director of the Office of Scientific Affairs.

George Gardner has joined the eRA team as an advocate for Grants Policy. He is a new assistant grants policy officer in the Division of Grants Policy of the Office of Policy for Extramural Research Administration (OPERA). 

With more than a decade of grants management experience, he returned to NIH after spending  four years at AHRQ as a senior grants management specialist. Prior to that, Mr. Gardner served for eight years in NIGMS as a grants management specialist.

Public Access Policy Team Earns NIH Director’s Award

The NIH Public Access Policy Development and Implementation Team, under the leadership of Drs. Walter Goldschmidts and Timothy Hays, has earned a 2005 NIH Director’s Award for creating a new policy to facilitate public access to publications resulting from NIH-funded research. 

Dr. Norka Ruiz Bravo, NIH deputy director for Extramural Research, nominated the team, comprising 19 members from the National Library of Medicine (NLM) and several offices within the Office of the Director (OD): Valerie H. Bonham, J.D.; Ann Brewer, B.S.N.; John T. Burklow; Megan Columbus; Leslie A. DeGraff; Walter Goldschmidts, Ph.D.; Jo Anne Goodnight, B.Sc.; Jane Griffith; Marcia Hahn; Timothy C. Hays, Ph.D.; Robin Kawazoe; Lora Kutkat, M.S., M.P.H.; Anita M. Linde; David Lipman, M.D.; Barbara McGarey, J.D.; Jim Ostell, Ph.D.; Jim Schuttinga, Ph.D.; Marc Smolonsky; and David Wright.

About the New Policy

The new policy, issued after more than seven months of coordination with the Office of Management and Budget, Congress, and external groups, including publishers, investigators, health advocacy groups and other stakeholders, enables NIH to use 21^st-century information technology to fulfill its responsibility of preserving and disseminating biomedical information.

Beginning May 2, 2005, NIH requests that NIH-funded investigators submit an electronic version of their final manuscripts as soon as they are accepted for publication in peer-reviewed journals.

NIH's new public access policy will allow the public to access these peer-reviewed, published scientific works through the Internet and without a fee. The manuscripts will reside in the National Library of Medicine’s (NLM’s) PubMed Central (PMC), a searchable database accessible to the public at http://www.pubmedcentral.nih.gov/.

The PMC compendium also will enable NIH to analyze and better manage its research portfolios, monitor scientific productivity, and ultimately, help set research priorities. 

Designing the new policy was a complex process due to the high visibility and tracking of the project by both Congress and the public. The team made a concerted effort to balance the importance of the archive to NIH’s public health mission with the interests of authors, their institutions, and publishers. NIH received more than 6,000 public comments on the draft policy. The team developed a final policy reflective of the public input. Resources and tools also were developed to help authors and the public better understand both the policy and how to submit manuscripts to PMC.

The team created a new information technology system, the NIH Manuscript Submission (NIHMS) system, giving authors the ability to submit manuscripts for archiving on PMC. The NIHMS system became functional May 2, 2005. It is integrated with the NIH electronic Research Administration (eRA) system.

Text of the New Policy

The official new policy is available online in the NIH Guide for Grants and Contracts, NOT-OD-05-022. NIH also published its “Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research” in the Federal Register, Vol. 70. No. 26 on February 9.  Resources, tools and background information about the policy can be found at http://www.nih.gov/about/publicaccess/.

Check Out the Updated eRA Glossary

Getting scrambled with the growing number of eRA acronyms and terms? Does the eXchange have something to do with a computer store? Is OPDIV a mathematical operation? Can you take a ride on the eCGAP RR?

Help is available with a click of your mouse. Check out the updated eRA glossary (http://era.nih.gov/aboutera/glossary.cfm) for a translation of “eRAese” into plain English.