# ![](media/image1.png){width="1.375in" height="0.5in"}![](media/image2.jpeg){width="0.4166666666666667in" height="0.2972222222222222in"} eRA Stee eRA Steering Committee Meeting Minutes

**Date:** January 16, 2003

**Time:** 2:00--4:00 p.m.

**Location:** Building 31, Conference Room 6A35

**Chair:** Dr. Paul Sieving

Dr. Sieving opened the meeting by asking for comments on the December 19
meeting minutes. There were no updates. He turned the floor to Dr.
McGowan.

# E-Grants Update

# *Clinical Research Revitalization*

Dr. McGowan began his remarks by updating the group on Dr. Zerhouni's
desire to reinvigorate Clinical Research at the NIH. Dr. Zerhouni has
established committees on *The Future of Science* and *Clinical Research
Informatics,* in part, to work towards the goal of gathering clinical
research data into a mega-database. This database could then be used for
data mining and analysis.

One difficult prerequisite to this goal is the need to create standard
definitions for clinical events. A related problem is that no software
currently exists to manage multi-site clinical trials. For these
reasons, although the initiative was on a fast track, the response to
the proposed schedule prompted the adoption of a slower timetable.

Dr. McGowan discussed the efforts of a ten-school coalition, currently
using "stove-piped" clinical systems to do their multi-site clinical
trials that are working to build a common data dictionary based on the
NLM.

Mr. Graeff described the DHHS e-Government *Consolidated Health
Informatics* initiative and its efforts to achieve:

-   Standard vocabularies

-   Standard messaging definitions

-   A process data dictionary

Mr. Graeff highlighted the difficulty of getting clinicians to agree on
terms and emphasized that NIH would need to implement a universal coding
system prior to any intra-NIH clinical data consolidation. He also noted
that any standardization project would entail considerable training and
data migration costs.

To illustrate the complexity involved, Mr. Graff explained that the NIH
has seventeen different clinical programs, each with its own IT systems
and processes. This complexity is reflected in every hospital and
clinical trial. The *Clinical Research Informatics* group needs to
decide whether it will address standardizing data dictionaries only or
whether to increase its scope to NIH process changes as well. The
development of an electronic patient record may be required.

In spite of all these obstacles, Dr. McGowan said the pharmaceutical
industry and research institutions hope that the Federal Government will
take the lead on resolving these issues. The costs and complexity of
current clinical trial methodologies are becoming too great.

# *DHHS Interfaces---E-Grants*

The E-Grants initiative is a government-wide response to statutory
requirements, including Public Law 106--107 and the Presidents
Management Agenda, for increased electronic-enabling and streamlining of
the grants application and management process. The NIH has a good
working relationship with the DHHS E-Grants team and will act as the
standard for the Department.

eRA, and in particular the SBIR projects and the NIH eRA Commons, will
provide the place for electronic receipt of grants into NIH. Dr. McGowan
reported that more than 600 grantee institutions have registered in
Commons so far and that a successful rollout of the registration process
continues.

As the E-Grants project examines the implementation of a single data
stream for electronic grant receipt, another interaction between
grantees and the Federal government has surfaced as a possible
conjunction point for trans-DHHS cooperation. NIH ICs require adverse
event reporting. The FDA also requires this kind of reporting. Grantee
institutions are asking when they will be able to fulfill these
reporting requirements to different agencies via a single electronic
data stream.

Additionally, DHHS has expressed an interest in learning more about eRA.
AHRQ and CDC already use eRA systems in part, and DHHS may mandate use
of IMPAC II by these Operating Divisions (OPDIVs). Dr. McGowan is in the
process of creating a resource and cost model for increased
participation in eRA by other OPDIVs.

# Getting Better Integration Through Architecture

Mr. Alan Graeff, the NIH Chief Information Officer (CIO), discussed the
CIT effort to reshape and clarify the NIH IT infrastructure budget. One
element of this clarification concerns separating such items as
laboratories supporting computational bioscience, imaging technologies
and other direct research applications from the NIH IT infrastructure.
Another strategy entails doing an analysis to come up with the cost per
NIH staff member for basic IT services (desktop, email, etc.) versus the
cost to provide mission-related software to enable a specific staff
role, such as Grants Management Specialist.

Mr. Graeff also described the CIT plan to do an accounting of the
portfolio of NIH IC administrative systems and services to see which
duplicated systems would be appropriate candidates for consolidation. It
was mentioned that NIH would benefit from a similar accounting of the
different work processes and desk procedures across NIH. One of the
elements of the former would be an analysis to determine whether the
differences between IC administrative systems represent something
critical to the mission of individual ICs or whether the processes and
the systems that support them could be standardized between ICs.

# *The NIH Architecture Program (Attachment A)*

Mr. Jack Jones gave a presentation on *The NIH Architecture Program*
(Attachment A) to the Steering Committee. The focus of the NIH
Enterprise Architecture (EA) function is to provide the needed IT
infrastructure to support the NIH's primary missions. Mr. Jones asked
the group to validate that the goals listed on *Slide #4* are the
appropriate goals for the EA function:

-   Identifies enterprise applications

-   Provides standards and a governance process during IT design and
    development

-   Documents the business processes so that changes can be considered

-   Simplifies application procurement by providing standards for
    contractor development

-   Gives us the ability to shape guidance from OMB and HHS.

The *EA Governance Structure* on *Slide #9* generated a lot of
discussion. It was noted that IC Executives Officers (EOs) possess
varying amounts of IT expertise. It may be more appropriate for IC CIOs
to provide input directly into the EA governance process rather than
through the EOs. Mr. Jones explained that the IT Architecture Domain
Teams will be the place where IC CIOs and other IC IT experts can
provide their direct input to the NIH Architect and his staff.

Mr. Jones highlighted the initial domain areas to be addressed on *Slide
#13,* of which the collaboration (email), network and security domains
are the most urgent. The first domain teams, requiring a part-time
three-month commitment from their members, are scheduled to begin work
in February and provide recommendations to the Architectural Review
Board by May--June.

*Slide #14* generated another discussion concerning requirements
management as part of the NIH EA process. It was proposed that the NIH
EA team maintain a repository of both addressed and un-addressed
requirements within the NIH ICs and sub areas. eRA could be seen as a
model. eRA Advocates and User Groups accumulate and prioritize specific
requirements for eRA systems. No such methodology currently exists for
all of NIH.

It was noted that specifically for eRA, and its role in the NIH, it is
important to capture the delta between the requirements that IC shadow
systems meet and those met by IMPAC II. Does it make sense for the
Enterprise Architecture function to maintain this kind of requirements
repository?

# 2004 eRA Budget

Dr. McGowan handed out paper copies of the submission to be made to the
IT Board of Governors (BOG) requesting an increase in the eRA budget.
The increase comprises these elements:

**FY 2003:** \$10M contingency fund allotment:

-   \$4.9M budget base increase

-   \$1.5M for the Loan Repayment Program integration

-   \$600K for QVR support

-   \$4M in contingency fund money (10%)

**FY 2004:**

-   \$4.9M budget base increase

-   10% contingency fund allotment

Additionally, Dr. Zerhouni has cut the original eRA FY 2004 budget by
\$850,000. eRA proposes adding \$300,000 of that back for CSR Summary
Statement generation costs. Dr. McGowan confirmed that the \$1.5M
increase to fund the Loan Repayment Program (LRP) integration is a
one-time cost. The LRP is not providing those funds. eRA has been using
its own resources.

The Steering Committee voted to endorse this increase in eRA funding.
Mr. Graeff stated that he would present the request to the IT BOG.

# Plans for the Next Meeting

The next eRA Steering Committee meeting is scheduled to take place
February 20, 2003.

# Attendees

Sieving, Paul, M.D., Ph.D., Chair, NEI

Breithaupt, Gahan, NINDS

Copeland, Zoe-Ann, OER

Du Buy, Yvonne H., NIDCR

Duff, Judy, NEI

Ellis, Joe, NIGMS

Fisher, Richard, Ph.D., NEI

Graeff, Alan, CIT

Jones, Jack, CIT

Kalt, Marvin, Ph.D., NCI

McGowan, John, Ph.D., NIAID/OER

Murphy, Tom, NIDCR

Ramm, Louise, Ph.D., NCRR

Stanfield, Brent, Ph.D., CSR

Albrecht, Lyn, LTS, Recorder

# Attachments

A.  The NIH Architecture Program

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