NIH Update Spring 2005 University of North CarolinaChapel Hill Research Administration Support Group

1
NIH UpdateSpring 2005 University of North
Carolina-Chapel Hill Research Administration
Support Group April 21, 2005
2
Current IssuesRemindersCompliance
Electronic Research AdministrationOutreach
3
Current Issues
4
Imperatives for NIH

• Accelerate pace of discoveries in life sciences
• Enable deeper understanding of pathobiology of
  disease prior to irreversible damage
• Translate research more rapidly from laboratories
  to patients and back
• Explore novel biomedical strategies orders of
  magnitude more effective than current ones
• NIH Roadmap

5
What is the NIH Roadmap?

• A framework of priorities the NIH as a whole must
  address in order to optimize its entire research
  portfolio.
• A set of initiatives that are central to
  extending the quality of healthy life for people
  in this country and around the world.
• A vision for a more efficient and productive
  system of biomedical and behavioral research.

6
Three Themes of the Roadmap
7
NIH Roadmap Trans-NIH teams manage
Re-engineering the Clinical Enterprise
New Pathways to Discovery
Research Teams of the Future
8
New Pathways to DiscoveryGenomic era offers
unprecedented opportunities

• Building Blocks for Biological Pathways, Networks
• Molecular Libraries and Imaging
• Structural Biology
• Bioinformatics and Computational Biology
• Nanomedicine

9
Research Teams of the FuturePromoting innovation

• Interdisciplinary Research Teams
• Centers
• Training
• Out-of-the-Box Thinkers
• Directors Pioneer Award
• Public-Private Partnerships
• Central point of contact at NIH

10
Re-engineering the Clinical Research Enterprise

• Translational Research through
• Regional Centers
• Core Services
• Harmonize and Simplify Clinical Research
  Regulatory Processes
• Integrate Clinical Research Networks
• Strengthen Clinical Research Workforce
• Regional Centers of Excellence for Training
• National Clinical Research Corps

11
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

12
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

13
The NIH Budget
14
FY 2005 Budget 28.59 Billion
Research Project Grants 53 15.3 billion
Training 3 761 million
15
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

16
RPG Success Rates
16
27
29
25
18
20
29
29
25
19
21
31
30
31
28
27
32
31
32
25
25
25
17
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
January 7, 2005 NIH Guide Notice http//grants.nih
.gov/grants/guide/notice-files/NOT-OD-05-024.html
18
Public Access to NIH Research Information
19
New Public Access Policyto Publications
Resulting from NIH-funded Research

• 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.

Effective May 2, 2005
NIH Guide, February 3, 2005 http//grants1.nih.gov
/grants/guide/notice-files/NOT-OD-05-022.html
20
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.

21
Updated Criteria for Evaluating Research Grant
Applications
22
Updated Review CriteriaEffective Jan 2005

• Significance. Does this study address an
  important problem? If the aims of the application
  are achieved, how will scientific knowledge or
  clinical practice be advanced? What will be the
  effect of these studies on the concepts, methods,
  technologies, treatments, services, or
  preventative interventions that drive this field?
  
• Approach. Are the conceptual or clinical
  framework, design, methods, and analyses
  adequately developed, well integrated, well
  reasoned, and appropriate to the aims of the
  project? Does the applicant acknowledge potential
  problem areas and consider alternative tactics?

23
Updated Review Criteria (cont)

• 3. Innovation. Is the project original and
  innovative? For example Does the project
  challenge existing paradigms or clinical
  practice address an innovative hypothesis or
  critical barrier to progress in the field? Does
  the project develop or employ novel concepts,
  approaches, methodologies, tools, or technologies
  for this area?
• 4. Investigators. Are the investigators
  appropriately trained and well suited to carry
  out this work? Is the work proposed appropriate
  to the experience level of the principal
  investigator and other researchers? Does the
  investigative team bring complementary and
  integrated expertise to the project (if
  applicable)?

24
Updated Review Criteria (cont)

• 5. Environment. Does the scientific environment
  in which the work will be done contribute to the
  probability of success? Do the proposed studies
  benefit from unique features of the scientific
  environment, or subject populations, or employ
  useful collaborative arrangements? Is there
  evidence of institutional support?

NIH Guide Notice, October 12, 2004
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-05-002.html
25
NIH Policy on Late Submission of Grant
Applications
26
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
27
Model Organisms
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New 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.go
  v/grants/guide/notice-files/NOT-OD-04-042.html
• FAQs and sample sharing plans available at
  http//grants.nih.gov/grants/policy/model_organism
  /index.htm

29
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.

30
National Science Advisory Board for Biosecurity
(NSABB)
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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

32
FY 2005 Kirschstein-NRSA News
33
FY 2005 Kirschstein-NRSA News

• 1,000 increase in Institutional Allowance for
  Individual Postdoctoral Fellowships only
• No stipend increase this year
• Revising the Individual Fellowship Application
  and Progress Report Form Pages and Instructions.
  Expect new version to be available by Fall 2005.

NIH Guide, February 4, 2005 http//grants1.nih.gov
/grants/guide/notice-files/NOT-OD-05-032.html
34
Revised PHS 398 and 2590 Forms
35
PHS 398 (rev. 9/04)

• Revised PHS 398 forms are accepted for
  submission/receipt dates on or after 12/1/04.
• All applications received on or after May 10,
  2005 must use the new instructions and forms.
• Applications using the old forms received after
  May 9 will be returned.

NIH Guide, November 2, 2004 http//grants1.nih.gov
/grants/guide/notice-files/NOT-OD-05-006.html Revi
sed instructions and forms http//grants.nih.gov/
grants/forms.htm
36
PHS 398 (rev. 9/04)

• Reorganized into 3 Parts
• Part I Instructions (now are truly just
  application instructions)
• Part II Supplement Instructions for Preparing
  the Human Subjects Section of the Research Plan
• Part III Policies, Assurances, Definitions
  Other Information

37
Changes of Note to the PHS 398 (rev. 9/04)
Instructions

• Font Size Requirement NIH now requires the use
  of Arial-11 or Helvetica-11 point font.
• Face Page Added Clinical Trials Indicator.
• Form Page 2
• Description now includes separate instruction for
  PI to clearly describe public health relevance.
• Created designated area for Stem Cell
  information.
• Added new section for Other Significant
  Contributors.

38
Changes of Note to the PHS 398 (rev. 9/04)
Instructions

• Significant Revisions, particularly in Part II,
  Human Subjects Research Supplement, to address
  NIH implementation of OHRP Guidance on research
  involving coded private information or biological
  specimens.
• Instructions for Modular and Non-Modular Budgets
  and have been revised to implement the new policy
  on Direct Cost Limitations.
• The modular budget format no longer applies to
  SBIR/STTR grant applications.

39
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.
Effective for all applications that have
submission/receipt dates on or after Dec 1, 2004
NIH Guide notice, November 2, 2004
http//grants1.nih.gov/grants/guide/notice-files/
NOT-OD-05-004.html
40
New PHS 398 Modular Budget Format Page

• Added 2 new rows (DC less Consortium FA and
  Consortium FA) and 1 new column (Sum Total)

41
New PHS 398 Budget Page - Form Page 4

• Separated Consortium DC FA Costs
• Instructions revised to use Subtotal for Face
  Page Item 7a

42
PHS 2590 (rev. 9/04)

• Revised PHS 2590 forms may be used now
• All progress reports received on or after May 1,
  2005 must use the new version.

NIH Guide, November 2, 2004 http//grants1.nih.gov
/grants/guide/notice-files/NOT-OD-05-007.html Revi
sed instructions and forms http//grants.nih.gov/
grants/forms.htm
43
Changes of Note to the PHS 2590 Instructions

• Grantees need only submit a signed original and
  one copy.
• Uses new definition of Key Personnel
  implemented in the NIH Grants Policy Statement
  (rev. 12/03)
• Other Significant Contributors introduced in
  the PHS398 (rev. 9/04) has been incorporated
• The SNAP progress report instructions for the
  first 2 SNAP questions have been modified as
  follows
• SNAP Question 1 - requires submission of
  complete Other Support information with any
  change
• SNAP Question 2, Reworded so level of effort
  question only applies to the PI and other
  personnel named on the Notice of Grant Award.

44
Centralized Receipt of Non-Competing Progress
Reports

• Effective with non-competing progress reports due
  on/after October 1, 2004
• Does NOT change the mailing address used for all
  new and competing grants nor that process
• Only for NIH progress reports
• Goal of improving efficiency

NIH Guide Notices, July 23 and September 2,
2004 http//grants.nih.gov/grants/guide/notice-fil
es/NOT-OD-04-054.html http//grants1.nih.gov/grant
s/guide/notice-files/NOT-OD-04-063.html
45
Applications and FormsQuestions?

• Dedicated e-mail address for questions on
  format
• format_at_mail.nih.gov
• Frequently asked questions on format
• http//www.format.nih.gov

46
New Grant Mechanism
47
New High Priority, Short-term Project Award (R56)

• Funding high-priority new or competing renewal
  R01 applications that fall just outside the
  funding limits of the participating NIH
  Institutes and Centers
• One or two years of funding
• INVESTIGATORS MAY NOT APPLY FOR AN R56 GRANT -
  Recipients of R56 awards will be selected by IC
  staff
• Awarded beginning in Fiscal Year 2005
• Additional information is available at
  http//grants.nih.gov/grants/funding/r56.htm

NIH Guide, June 15, 2004 http//grants1.nih.gov/gr
ants/guide/notice-files/NOT-OD-04-047.html
48
Career Development Awards
49
Mentored career awardees (K awardees) may now
hold concurrent support from an NIH career award
and as a PI an NIH research grant or project
leader on a multi-project grant.
Policy on Concurrent Support for Mentored Career
Awardees
NIH Guide, November 14, 2003 http//grants.nih.gov
/grants/guide/notice-files/NOT-OD-04-007.html Inf
ormation About Career Development
Awards http//grants.nih.gov/training/careerdevelo
pmentawards.htm
50
New 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

51
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
52
SBIR/STTR(Small Business Research)
53
SBIR/STTR

• Use the "SBIR/STTR Supplementary Instructions for
  Completing the Newly Revised (09/04) PHS 398
  Forms
• SBIR/STTR may no longer use modular budget format
• FDA Resources and useful websites provided in
  SBIR/STTR solicitation
• Type 2 competing Phase II awards
• NIH SBIR Conference in Bethesda, MD on July 28
  29, 2005
• Technical Assistance Program for NIH Awardees

NIH Small Business Funding Opportunities web
page http//grants.nih.gov/grants/funding/sbir.ht
m
54
Protecting Research Subjects
55
New 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

56
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/oh
rp/humansubjects/guidance/cdebiol.pdf
57
Reminders
58
Data Sharing
59
NIH Policy on Data Sharing
Reminder

• 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
60
Applications and FormsRestriction on Submission
Reminder

• Prior approval is required for competing
• applications that request 500,000 total direct
  costs or more for any budget period. (This limit
  is now exclusive of any consortium FA costs.)

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

61
Graduate Student Compensation
Reminder

• 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, 12/10/2001
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-02-017.html

62
Other Support
Reminder

• 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-files/NO
  T-OD-03-029.html

63
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/grants/guide/notice-files/N
  OT-OD-00-040.html
• http//grants2.nih.gov/grants/guide/notice-files/n
  ot95-179.html

64
Closeout Final Reports
Reminder

• 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

65
Revised Policy on Amended Applications
Reminder

• 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-files/NO
  T-OD-03-041.html

66
Revised Policy on Application Resubmissions
Reminder

• Unfunded RFA applications--resubmit as NEW
  investigator initiated apps
• 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-files/NO
  T-OD-03-019.html

67
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
• New Business Process Beginning 10/1/2004
  Centralized Receipt of ALL NIH Progress Reports
  http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-04-054.html

68
Non-competing Continuation Grant Progress Reports
Reminder

• 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/userre
  ports/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-files/N
  OT-OD-03-054.html

69
Intellectual Property
70
Invention Reporting Requirements of
Grantee/Contractors per the Bayh-Dole Act
Administrative Requirements (per 37CFR, 401.14)
Reminder

• 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

71
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

72
COMPLIANCE
73
Common Institutional Compliance Issues

• Misuse of funds
• Unallowable costs
• Misallocation of costs
• Excessive cost transfers
• Inaccurate effort reporting
• Incomplete other support
• Inadequate subrecipient monitoring
• Large unobligated balances

74
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 control systems are not
  necessary

75
What Can You Do?Elements of an Effective
Compliance Program

• Formalized compliance function
• Current, written policies and procedures
• Defined roles and responsibilities
• Ongoing training and education program
• Effective communication
• Effective management systems and internal
  controls
• Enforcement of compliance standards
• Appropriate and prompt response to non-compliance

76
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77
eRA StatisticsNIH Commons
78
Commons Capabilities

• Administration
• Create and maintain institutional profiles (IPFs)
• Create and maintain user accounts and
  professional profiles (PPFs)
• Status
• Display summary and detail grant info, notice of
  grant award and other documents, progress report
  face page, NIH staff contact info
• Link to study section dates and rosters
• Submit Just-in-Time (JIT) info
• Submit request for No-Cost Extension

79
Commons Capabilities (cont)

• Electronic Simple Non-Competing Award Process
  (eSNAP)
• Review simple, non-competing grant info
• Submit simple, non-competing progress report
• Financial Status Report (FSR)
• Submit FSR
• Internet Assisted Review (IAR)
• Submit critiques and scores prior to review
  meeting
• Review all critiques prior to meeting
• Generate summary statement body
• Demo Facility
• Try out most Commons capabilities in a simulated
  session

80
Benefits of Electronic Submissions

• Just-in-Time Info
• Enter IACUC and IRB approval dates, other support
  and education info for key personnel involved
  with human subjects
• Request for No-Cost Extensions
• Automatically updates end dates
• Generates notifications
• Eliminates 10-day window for hardcopy requests

81
Benefits of Electronic Submissions (Cont)

• eSNAPs
• Due 45 days before budget start date (vs. 60 days
  for paper)
• IRB and IACUC approval dates not required with
  submission
• Image stored in electronic grant folder for
  online viewing
• Reviewer Critiques
• Laptops (PC and Mac) are easier to use than paper
  at meetings
• Reviewers come to the table prepared for
  discussion, resulting in shorter and more
  productive meetings
• Study section chairperson/SRA creates better
  meeting schedule by knowing in advance which
  applications need the most discussion
• Electronic critiques facilitate the generation of
  summary statements

82
Update on Electronic Competing Application
Process (eCGAP)

• More than 30 research institutions were early
  adopters during pilots
• In January 2005, NIH opened access to electronic
  submission for
• modular non-consortia R01, R03 and R21
  applications
• new, competing continuation and revised
  applications
• Grantee institutions work with Service Providers
  to transmit system-to-system

83
Collaboration with Grants.gov

• NIH Pioneer Award applications submitted via
  Grants.gov
• eRA and Grants.gov completed initial
  system-to-system tests
• eRA and Grants.gov preparing for joint pilot in
  spring 2005
• eRA mapped SF 424 RR to eRA data elements
• Grants.gov completing PHS 398 NIH-specific forms
  to supplement SF 424
• eRA defined business validations for applications
  thru Grants.gov
• eRA integrating Grants.gov Web service calls with
  eRA eXchange

84
Why e-Applications

• To satisfy the requirements of the Government
  Paperwork Elimination Act (Public Law 105-277) as
  well as Public Law 106-107 and the Presidents
  Management Agenda, which mandates improving
  access to federal grants via the Internet.
• To save 200,000,000 pieces of paper per year and
  countless hours of human effort. These savings
  mean more money and more time to dedicate to
  scientific discovery.
• To create a comprehensive electronic repository
  of eRA data that can be mined with intelligent
  tools to promote health research and accelerate
  discoveries.

85
OPDIV Integration with eRA

• New DHHS Enterprise Grants Management System
  Board oversees integration of all Department
  research grants processing under eRA.
• Benefits of Integration
• streamline work processes to provide improved
  services to citizens
• capitalize on existing advanced technology and
  best practices
• create an opportunity for cost-effective,
  intra-agency sharing
• provide a single point-of-interface with
  Grants.gov and the HHS Unified Financial
  Management System
• maintain reliable and common data across
  Operating Divisions
• simplify the implementation of new policies and
  regulations
• Status of Migration (January 2005)- AHRQ is
  performing 100 of its research grant
  transactions using eRA CDC, 95 FDA, 30, HRSA,
  15 and SAMHSA, 15

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Plans for 2005

• Pilot e-applications with full budgets,
  supplements and possibly addenda
• Implement One View, to achieve a consistent
  look and feel for data input, processing and
  reporting throughout the grant lifecycle
• Release new version of X-Train
• Develop complex, electronic non-competing
  application process (eNAP)
• Create infrastructure for electronic notification
• Implement organizational hierarchy, a new Commons
  security scheme that will accommodate each
  institutions unique structure (i.e.,
  schools/divisions/departments) and the many
  roles/rights required by large institutions

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Commons User Support

88
Outreach and Resources
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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
• 2005 seminars
• April 7-8, 2005 in Albuquerque, NM
• June 23-24, 2005 in West Lafayette, IN
• Seminar information http//grants.nih.gov/grants/
  seminars.htm

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Workshops and Seminars http//grants1.nih.gov/gra
nts/outreach.htm
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Webpage for New Investigators
http//grants1.nih.gov/grants/new_investigators/in
dex.htm
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• Grants Information
• http//grants.nih.gov/grants/oer.htm
• Phone [phone]
• E-Mail GrantsInfo_at_nih.gov

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NIH Preserving public trust while supporting
discoveries to improve human health.
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Dorothy Duke, Chief Grants Management Officer
National Institute of Environmental Health
Sciences National Institutes of
Healthduke3_at_niehs.nih.gov
Thank You! Questions?