NIH UPDATE

1
ELECTRONIC ADMINISTRATION
NIH UPDATE Fall 2005
2
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
3
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
9
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 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 RECEIPT OF APPLICATIONS
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NIHs Electronic Receipt Goal

• 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
Receipt?

• 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 plan to transition mechanisms
  in NIH Guide for Grants and Contracts
• Funding Opportunity Announcements will be posted
  in Grants.gov Apply, generally 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

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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 R15 Announcements on Grants.gov
Submit R13 U13 via Grants.gov (12/15/05)
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.)
Submit R03 R21 via Grants.gov (6/1/06)
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 Exploratory/ Development
Research SBIR/STTR Small Business Research
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
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 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 Provider

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Where to Look for More Information

• NIH eRAs Electronic Receipt 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 receipt
• 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

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• NIH Prepares for Electronic Receipt!
• NIH is taking a strong stance by requiring the
  use of Grants.gov to make electronic grants a
  reality for all applications by May 2007.
• - Dr. Norka Ruiz Bravo Deputy Director of
  Extramural Research, NIH

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THE FUTURE OF ELECTRONIC RESEARCH ADMINISTRATION
(eRA)
44
What is eRA and the Commons?

• The eRA Commons is the external face of eRA
  and is used by the NIH to interact electronically
  with the extramural research community.

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Use of the CommonsIs Increasing Rapidly
46
Commons Functionality

• Administration
• Status
• Just-In-Time (JIT) Information
• Request for No-Cost Extensions
• Financial Status Reports (FSR)
• Closeout
• Electronic Streamlined Non-Competing Award
  Process (eSNAP)
• Internet Assisted Review (IAR)

47
Whats in the Future?
Organizational Hierarchy

• Ability for organizations, such as Institutes and
  Centers (ICs) and grantee institutions, to define
  different levels to their organization for
  different business areas and assign particular
  roles and rights associated with each.
• Initially, eRA Commons will be the first system
  to implement the Organizational Hierarchy
  structure.

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Organizational Hierarchy Features

• Allow grantees to
• Define hierarchy structure of their organization
• Assign rights to hierarchy levels
• Allocate staff within the hierarchy
• Staff will be able to view only the grants and
  projects to which they are given access

49
NRSA APPLICATION NEWS
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Current PHS 416-1 416-9 Applications Under
Revision

• PHS 416-1 and PHS 416-9 Individual National
  Research Service Award (NRSA) Applications and
  Related Forms have been revised and are pending
  OMB approval.
• Until further notice, applicants should use the
  current forms.
• Once approved, a transition period will be
  provided.
• NIH Guide Notice
• http//grants.nih.gov/grants/guide/notice-files/N
  OT-OD-05-050.html

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PAPERLESS NOTIFICATION MAILERS
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NIH Moves Toward Paperless Notification Process

• The NIH announced it is eliminating mailing of
  the following paper notifications
• Summary Statements Effective October 1, 2005
• Peer Review Outcome Letters Effective February
  1, 2006
• PIs and Fellows can access these documents
  through the eRA Commons
• In order to avoid delays in the e-notification
  process, it is vital that grantees and PIs
  register in the eRA Commons and periodically
  check e-mail addresses for accuracy. PIs should
  consult with their business office for
  creating a Commons account.
• eRA Commons Home Page https//commons.era
  .nih.gov/commons/
• NIH Guide Notice NOT-OD-05-075 (September
  8, 2005) http//grants.nih.gov/grants/guide/n
  otice-files/NOT-OD-05-075.html

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MULTIPLE PIs
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NIH Plans to Recognize Multiple Principal
Investigators

• As per a Federal directive by the Office of
  Science Technology Policy (OSTP) and in order
  to encourage team science, the NIH proposes to
  recognize more than one Principal Investigator on
  an individual award.
• A Request for Information (RFI) was issued by NIH
  in July for input on policies and issues of
  special interest to the health-related research
  community.
• The response deadline was September
  16, 2005
• NIH received over 900 responses!
• Details of the Multiple - PI Model are currently
  being finalized with consideration of input from
  grantees.
• The NIHs tentative plan is outlined in the
  following NIH Guide Notice
• NOT-OD-05-055 (Release Date July 29,
  2005)
• http//grants.nih.gov/grants/gui
  de/notice-files/NOT-OD-05-055.html

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NIH Electronic Tools Will be Modified to Support
Multiple PIs
NIH will update existing Electronic Research
Administration (eRA) Systems, databases,
official documents and reports (e.g. NGA
CRISP) to support a multiple-PI model and to
receive multiple-PI applications.
56
OER REGIONAL SEMINARS
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NIH Regional Seminars on Program Funding and
Grants Administration

• NIH holds 2 Regional Seminars a year to educate
  research administrators, investigators new to
  NIH, and trainees
• 2006 seminars
• March 30-31, 2005 in Boston, MA
• May 31-June 1, 2006 in Riverside, CA
• Seminar and Registration Information
  http//grants1.nih.gov/grants/seminars.htm
• Due to the popularity of these seminars and
• availability of space -
• Early Registration is Highly Recommended!

58
Workshops and Seminars http//grants1.nih.gov/gra
nts/outreach.htm
59
THE PRESENT
(and the Past)
Policy Issues that Affect Todays Grants Process
and Continue to
Impact Our Future

• NIH Roadmap
• NIH Response to Hurricane Katrina
• National Science Advisory Board for
• Biosecurity (NSABB)
• Clinical Practice Compensation
• Evaluation Criteria for Grant Applications
• PHS 398 PHS 2590 Application/Progress
• Report FAQs Important Reminders
• Grants Policy Statement Reminders
• Invention Reporting Intellectual Property
• Career Development Awards
• SBIR/STTR
• OHRP Guidance
• Compliance Audit Issues

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NIH ROADMAP
61
NIH Roadmap Goals

• Accelerate basic research discoveries and speed
  translation of those discoveries into clinical
  practice
• Explicitly address roadblocks that slow the pace
  of medical research in improving the health of
  the American people

62
Three Themes Emerged
New Pathways to Discovery
Re-engineering the Clinical Research Enterprise
Research Teams of the Future
63
New Pathways to Discovery -Molecular Libraries
-HTS Assay Tech.Dev -Nanomedicine Dev.
Centers -Predictive ADME-Tox . -Imaging probe
dev. Center -Standards and Critical Reagents
for Proteomics
Research Teams -Innovation in Interdisciplinary
Tech. Summit -NIH Directors Pioneer
Award Clinical Research -Clinical
and Translational Sciences Award
64
Notice of Institutional Clinical and
Translational Science Award RFA

• Based on recommendations of 5/23/05 meeting,
  Enhancing the Discipline of Clinical and
  Translational Sciences
• Focused on enabling innovative and
  transformational efforts to develop and advance
  clinical and translational sciences
• Intention to issue a RFA on or about 10/12/05
  with a receipt date of March 27, 2006.
  http//grants.nih.gov/grants/gui
  de/notice-files/NOT-RM-05-013.html
• RFA for Planning Grants will also be issued

65
Roadmap Funding(dollars in millions)
Directors Fund 35 59 83
Roadmap Initiative .9 of NIH budget Total NIH
in Same Period is gt 220 Billion
Totals on table may not add due to rounding
66
Additional Information on the NIH Roadmap

• Roadmap website
• http//nihroadmap.nih.gov/
• RFAs and PAs posted in the
• NIH Guide for Grants and
• Contracts
• http//grants1.nih.gov/grants/guide/index.html

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HURRICANE KATRINA
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NIH OER RESPONDS TO HURRICANE KATRINA

• NIH staff sent to assist with medical needs of
  those in the affected region
• NIH website dedicated to post-Katrina information
  for biomedical research community
  (http//grants.nih.gov/grants/katrina/index.htm).
  
• Letters to NIH Research Community - Related
  Federal Web Sites
• Research Community Information - Links for
  Affected Institutions
• Frequently Asked Questions - NIH
  Guide Notices
• Extension of application receipt dates
• Reporting system established to provide
  investigators contact information for their
  scientific program official (PO) and/or grants
  management official (GMO) based on active grant
  numbers.
• Website to match displaced investigators with
  medical facilities and possible temporary homes

69
Contact Info NIH Guide Notices
NIH Grants
Hurricane Recovery Contact Carol Alderson,
Division of Grants
Policy, OPERA, OER, OD Questions may be
addressed to a central mailbox address
(nihghr_at_nih.gov) or by phone at 301-435-0949.

• NIH Guide Notices
• 09/09/2005 - NIH Announces a Grants Query Report
  to Identify NIH Contact Information for Grantees
  Affected by Hurricane Katrina  (NOT-OD-05-077)
• 09/09/2005 - Delayed Receipt Dates for Principal
  Investigators who Assist in Recovery Efforts for
  Hurricane Katrina  (NOT-OD-05-076)
• 09/04/2005 - NIH Grantees Affected by Hurricane
  Katrina   (NOT-OD-05-074)
• 09/01/2005 - NIH Grantees Affected by Hurricane
  Katrina   (NOT-OD-05-073)
• 08/29/2005 - Delays in Grant Application
  Submission due to Hurricane Katrina  (NOT-OD-05-07
  2).

70
NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY
(NSABB)
71
National Science Advisory Board for Biosecurity
(NSABB)
New Board to provide advice and guidance
regarding biological research that has the
potential for misuse and could pose a biologic
threat to public health or national security.

• Will advise heads of Federal entities that
  conduct/support life sciences research
• Managed by NIH
• Further information and updates available at
  http//www.biosecurityboard.gov

72
CLINICAL PRACTICE COMPENSATION PLAN
73
Clinical Practice Compensation
NIH Guide Notice published in order to revise
established NIH requirements for the inclusion of
Clinical Practice Compensation (CPC) in
Institutional Base Salary (IBS).
The revision was completed in support of
conformance with applicable cost principles and
consistency in the treatment of compensation
across the institution regardless of the source
of support for compensated activities.
NIH Guide Notice NOT-OD-05-061 (August 4,
2005) http//grants.nih.gov/grants/guide/notice-fi
les/NOT-OD-05-061.html
74
Clinical Practice Compensation - Continued

• IBS Institutional Base Salary
• The annual compensation paid by an organization
  for an employee's appointment, whether that
  individual's time is spent on research, teaching,
  patient care, or other activities. Base salary
  excludes any income that an individual is
  permitted to earn outside of duties for the
  applicant/grantee organization. Base salary may
  not be increased as a result of replacing
  organizational salary funds with NIH grant funds.
• CPC Clinical Practice Compensation
• CPC is the compensation provided for the clinical
  service activities of an individual. Institutions
  manage CPC in a wide array of arrangements and
  the purpose of this guidance is neither to
  proscribe nor encourage a specific approach to
  the provision of this compensation or its
  inclusion in IBS.

75
Clinical Practice Compensation - Continued

• The following criteria must be met in order to
  include CPC in the
• IBS
• Clinical practice compensation must be set by the
  institution.
• Clinical practice activity must be shown on the
  institution's payroll or salary appointment forms
  and records approved by the institution.
• Clinical practice compensation must be paid
  through or at the direction of the institution.
• Clinical practice activity must be included and
  accounted for in the institution's effort
  reporting and/or payroll distribution system.
• The institution must assure that all financial
  reports and supporting documents associated with
  the combined IBS and resulting charges to NIH
  grants are retained and made available to Federal
  officials or their duly authorized
  representatives consistent with the requirements
  of 45 CFR Part 74.53 (A-110 Subpart C 53).

76
EVALULATION CRITERIA FOR GRANT APPLICATIONS
77
Updated Review Criteria
In response to the NIH Roadmap and in
consultation with the extramural scientific
community, the criteria used to evaluate research
grant applications now places appropriate
emphasis on interdisciplinary, translational, and
clinical aspects of biomedical research.

• Effective for grant applications received on or
  after
• Jan. 10, 2005 and those falling into the
  following categories
• Investigator initiated research grant
  applications.
• Investigator initiated research grant
  applications in response to Program
  Announcements (PAs)
• Solicited research grant applications submitted
  in response to Requests for Applications (RFAs)
  will continue to use the
  review criteria described in the RFA.

NIH Guide Notice, October 12, 2004
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-05-002.html
78
PHS 398
(Competing Grant Application) and PHS 2590
(NonCompeting Progress Report)
79
PHS 398 and PHS 2590Revised Forms Instructions
- Reminder!

• PHS 398 Competing Application (Rev. 09/04) -
  Mandatory use of revised instructions and forms
  for applications submitted on or after May 1,
  2005
• PHS 2590 Non-Competing Progress Reports (Rev.
  09/04) Mandatory use of revised instructions
  and forms for Progress Reports submitted on or
  after May 10, 2005.
• NIH Guide Notice, NOT-OD-006 (Released November
  2, 2004)
• http//grants1.nih.gov/grants/guide/notice-files/
  NOT-OD-05-006.html
• Revised instructions and forms
• http//grants.nih.gov/grants/forms.htm

80
Change in Calculation of Direct Costs for
Applications with Consortium FA Costs
All applications that involve consortium/contractu
al facilities and administrative (FA) costs are
to exclude the facilities and administrative
(FA) costs requested by consortium participants
from the total direct cost request.
NIH Guide Notice, NOT-OD-05-004 (November 2,
2004) http//grants1.nih.gov/grants/guide/notice
-files/NOT-OD-05-004.html
Effective for all applications that have
submission/receipt dates on or after Dec 1, 2004
81
PHS 398 2590
Frequently-Asked-Questionshttp//www.peacetech.co
m/phsforms/

• Q What if I use the old forms?
• A NIH screens the applications for correct
  formatting. If problems are identified, the
  investigator will be notified and given 4 days to
  resubmit using the proper format.
• ________________________________________
  _____
• Q Are certain fonts required now?
• A Applicants are required to use one of the
  following font types Arial, Helvetica, Palatino
  Linotype, or Georgia in size 11 or larger. Times
  New Roman is not an allowable font type.
• _________________________________________
  ____

82
PHS 398 2590
Frequently-Asked-Questionshttp//www.peacetech.co
m/phsforms/

• Q What is the proper procedure for determining
  if my budget exceeds the 500,000 DC level and
  will require NIH prior approval? Specifically,
  do I include or exclude 3rd party FA?
• A Applications exceeding 500,000 DC require
  NIH prior approval before submission. Grantees
  should exclude 3rd party FA costs to determine
  the appropriate requested direct cost level.
  http//grants1.nih.gov/grants/guide/notice-files/N
  OT-OD-05-004.html
• _________________________________________
  ____
• Q What is the difference between a Form page
  a Format Page in the application?
• A The Form Pages must be identical to those
  provided. The Format Pages are intended to
  assist grantees in the development of specific
  sections. Similar pages may be created, as long
  as requisite info is included.

83
Applications and FormsQuestions and Contacts

• Dedicated e-mail address for questions on format
• format_at_mail.nih.gov
• Additional Forms Formatting Contacts
• For questions relating to application/forms
  submission and policy, please contact
• NIH GrantsInfo Office at grantsinfo_at_nih.gov or
  [phone]http//grants.nih.gov/grants/forms.
  htmhelp.
• For technical assistance regarding the use of the
  PHS forms
• E-mail the PHS Forms Help Desk at
  phsforms_at_peacetech.com.
• For additional questions concerning format
  specifications, (e.g., font typeface and size,
  line and character spacing per inch, page limits,
  and margins)
• E-mail the following dedicated address at
  format_at_mail.nih.gov.

84
IMPORTANT APPLICATION REMINDERS
85
NIH Policy on Sharing of Model Organisms for
Biomedical Research
Investigators submitting an NIH
application/proposal beginning with the October
1, 2004 receipt date are expected to include a
specific plan for sharing and distributing unique
model organism research resources generated using
NIH funding in the application/proposal OR state
appropriate reasons for why such sharing is
restricted or not possible.

• NIH Guide Notice May 7, 2004
• http//grants.nih.gov/grants/guide/notice-files/N
  OT-OD-04-042.html
• FAQs and sample sharing plans available at
  http//grants.nih.gov/grants/policy/model_organism
  /index.htm

86
Sharing Model Organisms (cont.)

• Applicants should specify
• A reasonable time frame for periodic deposition
  of material and associated data
• If, or how, they will exercise their intellectual
  property rights
• Investigators may request funds in their
  application/proposal to defray reasonable costs
• Reviewers will review the plan and may comment in
  an administrative note
• Reviewers will generally not include their
  assessment in the overall priority score.
• Failure to comply with NIH research resource
  sharing policies, guidelines, and the accepted
  plan may be considered by NIH staff in future
  funding decisions.

87
NIH Policy on Data Sharing

• Investigators submitting a research application
  requesting 500,000 or more of direct costs in
  any single budget period to NIH on or after
  October 1, 2003 must include a plan for sharing
  final research data for research purposes, or
  state why data sharing is not possible.

February 26, 2003 NIH Guide Notice
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-03-032.html NIH Guide, October 16, 2001
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-02-004.html
88
Salary Cap

• Restricts the amount of direct salary under a
  grant or contract to Executive Level I of the
  Federal Executive Pay Scale
• Executive Level I increase effective January 1,
  2005

180,100
175,700
NIH Guide Notice Issued January 7,
2005 http//grants.nih.gov/grants/guide/notice-fil
es/NOT-OD-05-024.html
89
Graduate Student Compensation

• Ties compensation on research grants to the zero
  level NRSA postdoc stipend in effect at the time
  of award
• Compensation continues to include salary or
• wages, fringe benefits and tuition remission
• No adjustments will be made to noncompeting award
  levels or future years
• Grantees may rebudget to accommodate the higher
  level
• This policy was effective with awards issued on
  or after 12/10/2001
• See NIH Guide Notice, December 10, 2001
• http//grants.nih.gov/grants/guide/notice-fil
  es/NOT-OD-02-017.html

90
Applications and FormsRestriction on Submission

• Prior approval is required for competing
• applications that request 500,000 total direct
  costs or more for any budget period.

• NIH Guide, October 16, 2001
• http//grants.nih.gov/grants/guide/notice-files/N
  OT-OD-02-004.html

91
Revised Policy on Application Resubmissions

• Unfunded RFA applications--resubmit as NEW
  investigator initiated applications
• Previously unfunded investigator-initiated
  applications submitted in response to an RFA
  should be prepared as NEW applications
• Unfunded applications reviewed for a particular
  grant mechanism then submitted for a different
  grant mechanism--prepare as NEW applications
• NIH Guide Notice, January 16, 2003
• http//grants.nih.gov/grants/guide/notice-fil
  es/NOT-OD-03-019.html

92
Revised Policy on Amended Applications

• No longer time limit on submission of revised
  applications
• Limit of 2 revisions remains in effect
• Applies to all NIH extramural funding mechanisms
• NIH Guide Notice May 7, 2003
• http//grants.nih.gov/grants/guide/notice-fil
  es/NOT-OD-03-041.html

93
NIH Policy on Late Submission of Grant
Applications

• NIH expects grant applications to be submitted on
  time
• Late applications
• Generally are not accepted, except in rare
  instances
• Unaccepted late applications will be returned
  without review
• Are only considered for standing receipt dates
• Permission is not granted in advance
• Must be accompanied by a cover letter with
  compelling reasons for the delay
• Window of consideration for late applications is
  two weeks
• NIH will not consider accepting late applications
  for the Special Receipt Dates for RFAs and PARs

NIH Guide, January 27, 2005 http//grants2.nih.gov
/grants/guide/notice-files/NOT-OD-05-030.html
94
Non-Competing Continuation Progress Reports

• REMINDERDont Be Late! A recent OIG study
  concluded that major contributing factors to late
  awards were late and/or incomplete progress
  reports.

• An annual progress report is due two months
  prior to
• anniversary date
• Centralized Receipt of ALL NIH Progress Reports
  effective
• 10/1/04
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-04- 054.html

95
Non-Competing Continuation Grant Progress Reports

• It is important that progress reports be complete
  and timely
• All grantees have access to searchable list of
  due progress reports at http//era.nih.gov/us
  erreports/pr_due.cfm
• NIH e-mails 2 progress report reminders to the PI
• Two months prior to the due date
• Two weeks after the due date for overdue reports
• NIH Guide, August 5, 2003
• http//grants1.nih.gov/grants/guide/notice-fi
  les/NOT-OD-03-054.html

96
Other Support

• NIH requires complete and up-to-date other
  support information before an award can be made
• Complete means all sources of research support
  (including outside the applicant organization)
• Grantees must report changes in other support as
  part of the annual progress report
• NIH Guide, February 13, 2003
• http//grants.nih.gov/grants/guide/notice-fi
  les/NOT-OD-03-029.html

97
Mentored career awardees (K awardees) may now
hold concurrent support from an NIH career award
and an NIH research grant.
Policy on Concurrent Support for Mentored Career
Awardees
NIH Guide, November 14, 2003 http//grants.nih.go
v/grants/guide/notice-files/NOT-OD-04-007.html In
formation About Career Development
Awards http//grants.nih.gov/training/careerdevelo
pmentawards.htm
98
Policy on Concurrent Support for Mentored Career
Awardees

• May reduce level of effort on career awards in
  last two years of support and replace with an NIH
  research grant or subproject -- awardee must
  remain in mentored situation
• Awardee must serve as a PI or subproject Director
• Effort required on career award may be reduced to
  no less than 50 and be replaced by effort from
  the research award so total level of research
  commitment remains at gt75 for the duration of
  the mentored career award
• Applies to K01, K07, K08, K22, K23, and K25, and
  individuals mentored through institutional K12
  awards
• Policy effective for competing research
  applications submitted on or after February 1,
  2004

99
Revised Definition of Full Time Appointment for
Career Awards

• Require 75 commitment of full-time professional
  effort
• Revised policy allows recipient to meet required
  commitment of total professional effort as long
  as
• the individual has a full-time appointment with
  the applicant organization
• the minimum percentage of the candidates
  commitment required for the proposed Career award
  experience is covered by that appointment
• Applies to all existing Career Development Award
  announcements for all applications and
  resubmissions submitted on/after October 1, 2004

NIH Guide Notice, August 3, 2004 http//grants1.ni
h.gov/grants/guide/notice-files/NOT-OD-04-056.html

100
SBIR/STTR (Small Business
Research)
101
SBIR/STTR

• SBIR reauthorized through FY 2008
• Set aside remains at 2.5
• Commercialization plan required for Phase II
  applications
• New SBA data collection requirement for Phase II
  applications
• STTR reauthorized through FY 2009
• Set aside doubled to 0.30 in FY2004
• Phase II awards increase to 750,000
• Commercialization plan now required for Phase II
  applications
• New SBA data collection requirement for Phase II
  applications

102
GRANTS POLICY STATEMENT REMINDERS INVENTION
REPORTING INTELLECTUAL PROPERTY
103
Invention Reporting Requirements of
Grantee/Contractors per the Bayh-Dole Act
Administrative Requirements (per 37CFR, 401.14)

• Implement Employee Agreements ? at employment
• Disclose Each Invention ? within 60 days
• Resolve Election or Waive of Title ? within 2
  years
• File Patent ? within 1 yr. of election
• Provide License to the Govt. ? upon title
  election
• Indicate Govt. Support on Patent ? with patent
  appl.
• Share Royalties With Inventor ? when available
• License Small Businesses ? where feasible
• Product Manufacturing in U.S. ? required
• Report on Invention Utilization ? annually

104
Intellectual Property

• Information on reporting requirements and policy,
  as well as electronic systems to fulfill
  reporting requirements, may be found at
  Interagency Edison, http//www.iedison.gov.
• All foreign grantees, contractors, consortium
  participants and/or subcontractors are reminded
  that they must comply with Bayh-Dole invention
  reporting requirements

105
Closeout Final Reports

• Documents are due within 90 days of project
  period end date
• Final Financial Status Report (FSR)
• Final Inventions Statement Certification
• Final Progress Report
• Failure to submit timely reports may affect
  future funding to the organization!

106
OHRP GUIDANCE
107
NIH Implementation of OHRP Guidanceon Research
Involving Coded Private Information or Biological
Specimens

• NIH added definitions and clarifications relevant
  to the OHRP Guidance to the PHS 398 (rev. 9/04)
  instructions.
• All grant applications and progress reports
  involving coded private information or biological
  specimens submitted on or after January 10, 2005
  should follow the revised instructions.
• Although use of the 9/04 version of the PHS 398
  is not mandatory until May 10, 2005, this version
  includes instructions to help applicants apply
  the OHRP guidance.

NIH Guide, December 30, 2004 http//grants1.nih.go
v/grants/guide/notice-files/NOT-OD-05-020.html OHR
P Guidance, August 10, 2004 http//www.hhs.gov
/ohrp/humansubjects/guidance/cdebiol.pdf
108
Guidance for Protecting Research Subjects from
Possible Harm Caused by Financial Conflicts of
Interest

• New guidance entitled, "Financial Relationships
  and Interests in Research Involving Human
  Subjects Guidance for Human Subject Protection,"
  published May 12, 2004
• Applies to all human subjects research conducted
  or supported by HHS agencies or regulated by the
  FDA
• Intended for
• Institutional Review Boards (IRBs)
• Investigators
• Research institutions
• Other interested parties
• Federal Register notice http//ohrp.osophs.dhhs.g
  ov/humansubjects/finreltn/finalguid.pdf
• HHS press release http//www.hhs.gov/news/press/
  2004pres/20040512.html

109
COMPLIANCE ISSUES
110
Compliance is an Institutional Commitment!
Compliance Questions for NIH?
GrantsCompliance_at_nih.gov
111
Compliance Begins at Home

• You must be in compliance with institutional as
  well as Federal requirements
• When you have a policy or procedural question,
  start at your institution - institutional
  requirements may be more restrictive
• Read the Notice of Grant Award thoroughly

112
Recurring Problem Areas Related to Grant Awards

• Unallowable costs
• Improper cost allocation
• Accelerated expenditures
• Unobligated balances
• Numerous cost transfers
• Restrictions Terms of Award on NGA
• Financial conflict of interest reporting
• Time and effort reporting
• Incomplete other support

113
Common Contributors to Compliance Problems

• Inadequate resources
• Lack of understanding of roles and
  responsibilities of institutional staff
• Inadequate staff training and education
• Outdated or nonexistent policies and procedures
• Inadequate management systems (e.g., effort
  reporting, financial management)
• Perception that internal controls are not
  necessary

114
Elements of an
Effective Compliance Program

• Formalized compliance function
• Written, current policies and procedures
• Defined roles and responsibilities
• Effective communication
• Ongoing training and education
• Effective internal controls
• Audit oversight
• Appropriate and prompt response to
  non-compliance

115
Appropriate and Prompt Response to Non-Compliance
-The 3 Rs

• Respond to issues
• Remedy through the implementation of corrective
  and preventative actions
• Report problems to appropriate Federal agency

116
Increased Attention on Financial
Conflict of Interest

• Reminder
• When a conflict of interest is identified, the
  grantee must
• Notify Chief GMO to assure that the conflict of
  interest is being managed, reduced, or eliminated
• Provide additional information, if requested
• FCOI requirements must be addressed in consortium
  agreements

See the following NIH Guide Notices for
additional information http//grants2.nih.gov/gra
nts/guide/notice-files/NOT-OD-00-040.html http//g
rants2.nih.gov/grants/guide/notice-files/not95-179
.html
117
AUDIT ISSUES
118
Audit Requirement

• All NIH grantees that expend 500,000 (for
  fiscal years ending after December 31, 2003) or
  more in a year in Federal awards are subject to
  an audit requirement.
• Audits are due no later than 9 months after the
  end of the grantees audit period.
• Grantees delinquent in submitting audits risk
  the imposition of sanctions and potential loss of
  Federal funds.

119
National External Audit Review CenterHHS Office
of Audit Services323 West 8th StreetLucas
Place, Room 514Kansas City, MO 64105 Phone
800-732-0679 or 816-374-6714
120
NIH CONTACTS ELECTRONIC RESOURCES
121
Webpage for New Investigators
http//grants1.nih.gov/grants/new_investigators/in
dex.htm
122
Summary of Helpful NIH
Web Pages

• http//grants1.nih.gov/grants/oer.htm
• Office of Extramural Research Administration
  homepage Links to Funding opportunities, Grants
  Policy, Application and Forms, Awarded Grant data
• http//grants1.nih.gov/grants/guide/index.html
• NIH searchable database of RFAs, PAs, and Guide
  Notices
• http//grants1.nih.gov/grants/policy/nihgps_2003/i
  ndex.htm
• NIH Grants Policy Statement (Rev. 12/03)
• http//commons.era.nih.gov/
• The eRA Commons home page
• http//crisp.cit.nih.gov/crisp/crisp_querty.genera
  te_screen
• Search CRISP database to analyze an Institutes
  portfolio of funded projects research areas,
  as well as to locate experienced NIH funded
  investigators in a particular research area.
• http//www.niaid.nih.gov/ncn/grants/default.htm
• All About Grants Tutorial written by NIAID
  provides information on grant application basics,
  how to plan and write an application, how to
  manage a grant award, checklists, etc.

123
Updated Contact Sources

• Revised Grants Administration Information
  Sources is now available at http//grants.nih.g
  ov/grants/policy/grants_info.pdf
• Provides updated contact information for Grants
  Administration individuals at all NIH ICs
• Contact list for NIH Chief Grants Management
  Officers posted at http//grants.nih.gov/grants
  /stafflist_gmos.htm

124

• Grants Information
• Who to Contact!
• Application-Specific Questions
• Administrative Contact the
  Grants Management Specialist at the
• Awarding
  Institute/Center
• Scientific/Programmatic Contact
  designated Program Official/Director
• 
  at Awarding Institute/Center
• Review Questions Contact the
  assigned Scientific Review
• 
  Administrator
• General Application Questions
• Grants Information
• E-Mail GrantsInfo_at_nih.gov
• Phone [phone]
• Policy Interpretation Consultation

125
The NIH in the 21st Century

• We continue to manage for change in rapidly
  changing times and amidst unprecedented
  scientific opportunities.
• We are focused on shared resources, clear
  objectives, and the stronger teams needed to
  tackle the daunting complexity of biology.
• We are creating a strategic framework for future
  discovery.
• As the nations medical research agency, I am
  confident that we will continue our record of
  improving health through discovery at an
  accelerated pace in the 21st century.
• -Dr. Elias A. Zerhouni
• NIH Director