NIH UPDATE

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ELECTRONIC ADMINISTRATION
NIH UPDATE Fall 2005
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THE PAST
The mind must be prepared not only by scientific
training and technological know-how, but
also by the awareness of social
needs. Louis Pasteur
Saturday
Review
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THE PRESENT
We live in a time when the words impossible and
unsolvable are no longer part of the scientific
community's vocabulary. Each day we move closer
to trials that will not just minimize the
symptoms of disease and injury but eliminate
them. Christopher Reeve

Testimony to US House of Representatives
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THE FUTURE
The future is not some place we are going to, but
one we are creating. The paths are not to be
found, but made, and the activity of making them,
changes both the maker and the destination.
John Schaar, Futurist
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AGENDA

• THE FUTURE
• Watch for These Hot Topics in FY2006!
• THE PRESENT
• Recent Policy Issues Affecting the Grants
  Process!
• THE PAST
• Past Policy Issues that Continue to Affect our
  Present
• and Impact our Future
• CONTACTS ELECTRONIC RESOURCES
• Helpful NIH Contact Information Web Pages

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THE FUTURE
Hot Topics In FY2006!

• FY2006 NIH Budget
• Public Access
• Knowledge Management
• Office of Portfolio Analysis Strategic
• Initiatives (OPASI)
• Electronic Receipt of Applications
• Electronic Research Administration (eRA)
• NRSA Application News
• Paperless Notification Mailers
• Multiple PIs
• OER Regional Seminars

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FY2006 NIH BUDGET
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FY 2005 Budget 28.59 Billion
Training 3
Research Project Grants 55 15 billion
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FY 06 Presidents Budget Request

• 28.740 billion
• .5 increase over FY 2005
• Approximately 9,463 competing RPG awards
• 247 over FY 2005
• Major initiatives
• NIH Roadmap
• Biodefense
• Neuroscience Blueprint
• AIDS
• http//www.nih.gov/news/budget/FY2006presbudget.
  pdf

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What Can You Expect in FY2006?

• Trans-NIH
• Roadmap (FY2004 - )
• NIH Strategic Plan for Obesity Research (FY2005 -
  )
• Neurosciences Blueprint (FY2006 - )
• RFAs Institute and Center specific initiatives
• PAs are posted in the NIH Guide for Grants
  Contracts
• http//grants1.nih.gov/grants/guide/index.html

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FY2006 and Beyond Science Management and
Administration

• Portfolio management and trans-NIH science
  investments
• Public Access Policy
• Knowledge Management
• Office of Portfolio Analysis and Strategic
  Initiatives (OPASI)
• Facilitating multidisciplinary collaborative
  research Multiple PIs
• New Investigators

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PUBLIC ACCESS
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Public Access Policy

• NIH-funded investigators are requested to submit
  to the NIH National Library of Medicine's (NLM)
  PubMed Central (PMC) an electronic version of the
  author's final manuscript upon acceptance for
  publication, resulting from research supported,
  in whole or in part, with direct costs from NIH.

• Applies to
• Currently funded NIH research projects
• Previously-supported NIH research projects if
  they are accepted for publication on or after May
  2, 2005.
• Does Not Apply to
• Book chapters, editorials, reviews, or conference
  proceedings.
• Publications resulting from non-NIH-supported
  research projects should not be submitted

Effective May 2, 2005
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Why Public Access?

• ACCESS Provide electronic access to NIH-funded
  research publications for patients, families,
  health professionals, teachers, and students.
• ARCHIVE Keep a central archive of NIH-funded
  research publicationsfor now and in the future,
  preserving vital medical research results and
  information for years to come.
• ADVANCE SCIENCE Create an information resource
  that will make it easier for scientists to mine
  medical research publications, and for NIH to
  better manage its entire research investment.

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Benefits to Principal Investigators and Authors

• In the future, Principal investigators and
  Institutions will be able to use the manuscript
  submission system as an alternative means to
  fulfill the existing requirement to provide
  publications as part of progress reports.
• Note Other aspects of annual Progress
  Reporting requirement cannot be completed
  through the manuscript submission system those
  must be submitted through the normal process.
• Submission heightens the visibility of the
  research and enhances the likelihood of early and
  increased citation.

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Public Access Policy Resources

• Public Access Policy Website http//www.nih.gov/a
  bout/publicaccess/
• NIH Manuscript Submission (NIHMS) System
• http//www.nihms.nih.gov/
• Public Access Policy in the NIH Guide
• http//grants.nih.gov/grants/guide/notice-files/N
  OT-OD-05-022.html
• Authors Manual
• http//www.nih.gov/about/publicaccess/publicacces
  s_Manual.htm
• Questions and Answers http//www.nih.gov/about/pu
  blicaccess/publicaccess_QandA.htm
• Public Access Policy Mailbox
• PublicAccess_at_nih.gov

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KNOWLEDGE MANAGEMENT
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Knowledge Management What Are We Talking
About?

• Definition Formalization of the management of
  the enterprises intellectual assets (human,
  organizational, relationship)
• Definition Distribution, access, and retrieval
  of unstructured information about human
  experiences between interdependent individuals
  or among members of a workgroup.
• Involves identifying a group of people that have
  a need to share knowledge developing
  technological support to enable sharing and
  creating a process for transferring and
  disseminating that knowledge.

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Knowledge Management (KM) How Would
NIH Benefit From Application of KM?

• Disease coding
• Peer review
• Referral and assignment of applications
• Identification of peer reviewers
• Identification of potential Conflict of Interest
• Portfolio analysis
• Scientific trend analysis
• Clinical relevance recognition tools
• Need-to-know-based security screening
• Clinical Center clustering of clinical research
• Office of Technology Transfer patent and
  royalties management

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Office of Portfolio Analysis and Strategic
Initiatives (OPASI)
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Office of Portfolio Analysis and Strategic
Initiatives (OPASI)

• Function Enhance the NIH priority-setting
  process while improving trans-agency coordination
• Will be achieved through
• Sound decision-support systems
• Rigorous and uniform sources of evidence
• Broad public and scientific input
• Will result in
• Identification of cross-cutting research
  requiring common investment
• Optimal balance between scientific opportunity
  and public health concerns
• Enhanced accountability to Congress, scientists,
  patients, and the public

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ELECTRONIC SUBMISSION OF GRANT APPLICATIONS
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NIH Electronic Submission Goals

• By the end of May 2007, NIH plans to
• Require electronic submission through Grants.gov
  for all NIH grant applications.
• Transition from the PHS 398 application form to
  SF424 family of forms data set.
• SF424 Research and Research-Related (SF424 (RR))
• SF424 Discretionary (of limited use for NIH)

Announced in the NIH Guide, Aug. 19, 2005
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-05-067.html
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This is a Huge Transition
for All of Us!

• The simultaneous transition to electronic
  application submission and a new set of
  application forms is a huge initiative for NIH
  with an aggressive time table
• It involves
• Numerous funding mechanisms
• Tens of thousands of applications ranging widely
  in size and complexity
• The transition relies upon many pieces for its
  success
• Technical development of eRA and Grants.gov
  systems
• Trans-agency resolution of policy and operational
  issues
• Lots of communication, training and outreach
• Acceptance of change by NIH staff
• Acceptance of change by our research partners in
  the extramural community.

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Why Transition to Electronic
Submission?

• It benefits our applicant community!
• Eliminates the burden of redundant or disparate
  electronic and paper-based data collection
  requirements.
• Resulting efficiencies, along with other
  improvements, may allow NIH to shorten the cycle
  from application receipt to award.
• Electronic submission creates a comprehensive
  repository of data that can be mined by knowledge
  management and other tools.
• Electronic validations improve data quality.
• Savings of gt200,000,000 pieces of paper/year
  (estimated) and countless hours of human effort.
• Reductions of scanning, printing, and data-entry
  costs.
• Grant image is clearer and in color.

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Why Transition to SF424 Family of
Forms?

• SF424 consolidates forms currently used by
  Federal grant-making agencies
• Applicants can use standard forms regardless of
  the program or agency to which they are applying.
• Reduces administrative burden on the Federal
  grants community.
• SF424 (RR) is the government-wide data set for
  research grant applications

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Why Transition? Its the Law

• Public Law (PL) 106-107
• Federal Financial Assistance Management
  Improvement Act of 1999
• Improve the effectiveness and performance of
  Federal financial assistance programs
• Simplify Federal financial assistance application
  and reporting requirements
• Improve the delivery of services to the public
• Presidents Management Agenda (2002)
• Agencies to allow applicants for Federal Grants
  to apply for, and ultimately manage, grant funds
  online through a common web site, simplifying
  grants management and eliminating redundancies .
  . .

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FY 2006 OMB Goal for Agencies Post 75 of
Funding Opportunities in Find on Grants.gov
Apply
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What is Grants.gov?

• A cross-agency initiative involving
• 900 grant programs
• 26 grant making agencies
• Over 350 billion in annual awards
• The Federal governments single, online portal
  for any person, business, or State, Local and
  Tribal government to electronically
• Find Grant Opportunities
• Apply for Grants

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NIHs Transition Strategy

• NIH will transition by individual research
  program/funding mechanism
• ALL applications in response to these
  announcements for transitioned mechanisms will
  require electronic submission through Grants.gov
  on the 424 family of forms
• Mechanisms not yet transitioned will continue to
  require submission on PHS 398 on paper or through
  service providers
• NIH will announce plans to transition mechanisms
  in NIH Guide for Grants and Contracts
• Funding Opportunity Announcements will be posted
  in Grants.gov Apply, as soon as possible, and
  generally have an Open Date (period when
  applications can actually be submitted) of 2
  months before the submission date.

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SF424 (RR) Grant Application Package

• SF424 (RR) includes the following
  set of standard components
• RR Application/Cover Component
• RR Project/Performance Site Location(s)
  Component
• RR Other Project Information Component
• RR Senior/Key Person Component
• RR Budget Component
• RR Personal Data Component (NIH will not use)
• RR Sub-award Budget Attachment Component
• SBIR/STTR Information

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SF424 (RR) Grant Application Package

• In addition to the standard components, the
  following agency specific components will be
  used by NIH as part of our application package
• PHS 398 Cover Letter File
• PHS 398 Cover Page Supplement
• PHS 398 Research Plan
• PHS 398 Modular Budget
• PHS 398 Checklist
• NIH requires additional data collection to
  accommodate the unique information required for
  review of its biomedical research portfolio.

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NIH Timeline Submission of Grant Applications
through Grants.gov Using SF424 Family of Grant
Application Forms
Post SBIR/STTR and R13/U13 Announcements on
Grants.gov
Submit SBIR/STTR via Grants.gov (12/1/05)
Post R36 Announcements on Grants.gov
Post R15 Announcements on Grants.gov
Submit R13 U13 via Grants.gov (12/15/05)
Submit R36 via Grants.gov (2/17/06)
Submit R15 via Grants.gov (2/25/06)
2006
2005
Post full schedule with all remaining mechanisms
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NIH Timeline Submission of Grant Applications
through Grants.gov Using SF424 Family of Grant
Application Forms (cont.)
Post R03, R21 R33 Announcements on Grants.gov
Abbreviation/Mechanism Key AREA/R15 Academic
Research Enhancement HTS/X01 High Throughput
Screening NRSA National Research Service
Award R01 Research Project Grant
Program R03 Small Grant Programs R13/U13 Conferenc
e Support R21/R33 Exploratory/ Development
Research R36 Research Dissertation Grant
Program SBIR/STTR Small Business Research
Submit R03, R21 R33 via Grants.gov (6/1/06)
Post R01 Announcements on Grants.gov
Submit R01 via Grants.gov (10/1/06)
Post NRSA (TF), Careers Complex Grants
Announcements on Grants.gov
Submit all Mechanisms via Grants.gov
2006
2007
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OMB Clearance for PHS398 form Expires
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Whats Next?

• Our plans are a work in progress!
• Many other mechanisms will be added
  to our timeline as we work towards
  full transition
• Stay tuned!

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Getting Started RegistrationGrants.gov and eRA
Commons registration is
required!

• Grants.gov Registration
• One time only registration good for electronic
  submission to all Federal agencies
• Registration on Grants.gov required only for
  institutions
• Detailed instructions at http//grants.gov/GetSta
  rted

It is critical for institutions to begin this
registration process at least 4 weeks before
applications are due!
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Getting Started Registration Grants.gov and
eRA Commons
registration is required!

• eRA Commons Registration
• Allows NIH to receive applications electronically
  from Grants.gov and validate them against NIH
  business rules.
• Provides a way for NIH and registered users to
  communicate electronically after submission.
• Both organizations and Principal Investigators
  (PIs) need to register
• One time only registration
• Detailed instructions at https//commons.era.nih.
  gov/commons

It is critical for institutions to begin this
registration process at least 4 weeks before
applications are due!
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Getting Started

• Download PureEdge Application Viewer from
  Grants.gov http//www.grants.gov/Do
  wnloadViewer
• Make sure you have an application to convert
  documents to .pdf format http//grants.gov/assets/
  PDFConversion.pdf

Grants.gov
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Electronic Submission Options

• Direct to Grants.gov using PureEdge Viewer
  (downloaded from Grants.gov site)
• Establish an electronic system that allows the
  institution to submit to Grants.gov using
  system-to-system (XML) data stream
• Can be created by institution OR
• Institution can establish an agreement with a
  commercial Service Providerhttp//era.nih.gov/Ele
  ctronicReceipt/sp.htm

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Where to Look for More Information

• NIH eRAs Electronic Submission Web site
• http//era.nih.gov/ElectronicReceipt/
• NIH Guide Notices
• Newsletters eRA, NIH institutes/centers, etc.
  SBIR/STTR
• Web site http//grants.nih.gov/grants/funding/sbi
  r.htm
• NIH Updates
• (e.g., National Council of University Research
  Administrators NCURA, Society of Research
  Administrators SRA, NIH Regional Meetings,
  etc.)
• Booths at Major Scientific Meetings

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Where to Go for Help

• Grants.gov registration and submission questions
• Grants.gov Customer Service
• Visit http//www.grants.gov/CustomerSupport
• Forms transition and NIHs overall plan for
  electronic submission
• NIH GrantsInfo.gov
• E-mail grantsinfo_at_nih.gov
• NIH eRA Commons registration and post submission
  questions
• Support Page http//era.nih.gov/commons/index.cfm
  
• Help Desk
• E-mail commons_at_od.nih.gov
• Phone [phone] OR 301-402-7469