Current Issues at NIH

1
Current Issues at NIH
Joe EllisDirectorNIH Office of Policy for
Extramural Research Administration (OPERA), OER,
OD, NIHCarol WigglesworthGrants Policy
OfficerDivision of Grants PolicyOPERA, OER, OD,
NIH
Fiscal Year 2007
Spring Production
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FROM THE DIRECTORS CHAIR...NIH at the
Crossroads!

• FY 2007
• Budget Strategies
• FY 2008
• Presidents Budget Request
• Summary of the FY2007 Presidents Budget
  http//officeofbudget.od.nih.gov/pdf/Press20info
  20final.pdf
• Summary of the FY2008 Presidents Budget
• http//officeofbudget.od.nih.gov/PDF/Press20info
  -2008.pdf

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NIH Continued Funding for FY2007!
HOT NEWS!

• Public law 110-005 Revised Continuing
  Appropriations Resolution, FY 2007.
  (Extending Legislative Mandates
  http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-07-050.html
• What does this mean for grantees?
• Non-Competing Research Awards http//grants.nih.g
  ov/grants/guide/notice-files/NOT-OD-07-049.html)
• Awards will be made at 97.1 of the FY2007
  Committed level (future year commitments will
  also be adjusted accordingly.)
• Awards previously issued in FY07 at reduced
  levels will be revised to restore funds to the
  level indicated above (including all research
  mechanisms - modular and categorical).
• This policy does not apply to Career Awards,
  SBIR/STTRs, and RLK-NRSA Individual Fellowships
  and Institutional Training Grants.
• Note These mechanisms receive funding at
  committed levels.
• (For RLK-NRSA stipends categorical info - see
  NOT-OD-07-052 No Changes to Fy2007 previously
  published levels.)
• Competing Awards
• No change in procedures. Non-Modular grants
  continue to receive 3 future year escalations.

4
FY 2008 Presidents Budget Request

• Request for 28.85 billion (Increase of 232
  million from FY2007 Estimate)
• Estimated 10,188 competing RPGs (Approx. 566 over
  FY2007 estimates and 1000 more than the FY2006)
• Areas of Focus
• Bolster funding to New Investigators especially
  in novel and recently emerging areas of
  opportunity - Expansion of the Pathway to
  Independence program
• Encourage established investigators through
  investigator-initiated Research Project Grants
  (FY2008 estimate is highest level in NIH history)
• Roadmap/Common Fund Important for projects and
  initiatives that accelerate the pace of discovery
  across NIH
• Global Fund for HIV/AIDS, Tuberculosis and
  Malaria
• Support studies of the Genes, Environment and
  Health Initiative Accelerate discovery of the
  major genetic factors for diseases
• NIH Summary of the FY 2008 Presidents Budget
• http//officeofbudget.od.nih.gov/PDF/Press20info
  -2008.pdf

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FY 2008 Presidents Budget Request28.850 Billion
Research Mgmt
Training 3
Support 4
Research Project Grants 52 15.165
All Other 5
Other Research
6
Research
Centers 10
RD Contracts
10
Intramural
Slice 1
Research 10
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NIH Congressional Appropriations
NIH FY2007 Increase of 620 million
30
29.2
28.6
28.6
28.0
27.1
25
23.3
20
20.5
17.8
15
Billions of Dollars
15.6
13.7
10
5
0
FY
FY
FY
FY
FY
FY
FY
FY
FY
FY
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
DOUBLING
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New Grant Applications and Success Rates During
and After Doubling Period
35
60,000
49,656
31
30
50,000
43,069
25
40,000
Projected
20
22
Number of Applications
Success Rate of Grants Funded
30,000
19
24,154
15
20,000
10
10,000
5
0
0
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
Success Rates
Applications
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New Salary Cap in Effect - 186,600Updated
guidance See NOT-OD-07-051http//grants.nih.gov
/grants/guide/notice-files/NOT-OD-07-051.html

• Effective January 1, 2007, the salary limit was
  increased to 186,600 by the Office of Personnel
  Management.
• See NOT-OD-07-033 http//grants.nih.gov/grants/g
  uide/notice-files/NOT-OD-07-033.html
• For FY2007, Public Law 110-005 Revised
  Continuing Appropriations Resolution extends the
  legislative provisions provided in the FY2006
  Appropriations Act through the end of FY2007.
• Executive Level 1 annual salary rate was 183,500
  for the period January 1 through December 31,
  2006.
• Salary Cap Summary (Historical Information)
  http//grants.nih.gov/grants/policy/salcap_summary
  .htm

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NIH Spring Line-Up!
NIH Grants Process
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Announcing the (R56)
NIH Directors Bridge
Awards (NDBA)http//grants.nih.gov/grants/guide/n
otice-files/NOT-OD-07-056.html

• Applies to competing renewal research project
  grant (R01) applications or the first revision of
  the competing renewal applications (A1)
• Applications which just miss the nominal payline
  for a particular Institute/Center (IC) may be
  nominated.
• The PI must have less than 200,000 in other
  support (total costs) from all sources to fund
  their research. 
• Up to 500K Total Costs may be provided the first
  year of the project using a one year R56 grant. 
• At this time, the second revision (A2) of an R01
  will not be considered for selection as an NDBA. 
  
• Note Applicants may not apply for an R56 grant
  and applicants may not nominate themselves.

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NIH Ranking Tables Replaced with New Web-Based
Tool http//grants.nih.gov/grants/award/trends/Fi
ndOrg.cfm

• The NIH tracks its funding of critical medical
  research and other support at universities,
  hospitals, small businesses and other
  organizations, and annually compiles this
  information and makes it available to the public.
  
• In the past, this funding information was
  available in the form of tables that showed
  comparative rankings in terms of dollars
  received.
• Ranking tables have been replaced with a
  Web-based tool that allows grantees to determine
  the dollars awarded to any one organization or
  department.
• This change comes in part from responses received
  from the grantee community that suggested that
  the current ranking tables were not necessary
  (see NIH Guide notice Request for Information on
  the Plan to Recognize Multiple Principal
  Investigators on NIH Grants) and in part by the
  establishment of Multiple Investigator Awards
  (see NIH Guide notice Establishment of Multiple
  Principal Investigator Awards for the Support of
  Team Science Projects) making the total dollar
  amounts of funds received by individual
  departments impractical.

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NIH Award Data By State(Information posted for
FY 1998 FY 2005)

• Interested in NIH funding data for your state and
  organizations within your state for FY 2005?

Just click on any state located on this
interactive map at http//grants2.nih.gov/grants/a
ward/trends/State_Congressional/StateOverview.cfm
...and get information like this!
TEXAS FY 2005
Additional Award Data/Ranking Info also available
at http//grants.nih.gov/grants/award/awardtr.ht
m
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Parent Announcements... What
Does It Mean For You?

• Funding Opportunity Announcement (FOA)
• All electronic applications must be submitted in
  response to a Funding Opportunity Announcement
  (FOA).
• Grants.gov term which NIH refers to as Program
  Announcements (PA), Request for Applications
  (RFA), and Program Announcement with special
  receipt, referral and/or review considerations
  (PAR).
• Parent Announcement
• The NIH and other HHS Agencies publish omnibus
  Parent or (umbrella) announcements for
  investigator-initiated applications (formerly
  known as unsolicited).
• Responding to such an omnibus or umbrella Parent
  FOA ensures that the correct application package
  is used and enables NIH to receive the
  application from Grants.gov.
• Parent Announcements are not new to the NIH which
  are currently available for several mechanisms.
  (e.g. Small Research Grants R03, Conference
  Grants R13, Development/Exploratory R21, and
  more!)

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Change in Standing Receipt Dates!

• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-07-001.html
• Updated http//grants.nih.gov/grants/guide/noti
  ce-files/NOT-OD-07-026.html
• When? Effective February 2007 (Exclusion AIDS
  AIDS related apps.)
• What? Change in standard receipt dates for paper
  and electronic grant applications submitted to
  NIH/AHRQ/NIOSH
• Applications with special receipt dates remain on
  the specified dates listed on the FOA
• Why? The transition to electronic application
  submission has heightened our awareness of
  challenges posed by having very large numbers of
  incoming grant applications on any single day.
• Sample of New Receipt Dates

(All dates available at http//grants.nih.gov/gran
ts/funding/submissionschedule.htm)
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Change in Standard Receipt Dates for AIDS
Aids-Related Applicationshttp//grants.nih.gov/gr
ants/guide/notice-files/NOT-OD-07-053.html

• Effective May 7, 2007 for NIH/AHRQ
• Standard Receipt Dates will change to
• Cycle 1 May 7 (Old date May 1)
• Cycle 2 Sept. 7 (Old date Sept. 1)
• Cycle 3 Jan. 7 (Old date Jan. 2)
• New, Renewal, Resubmissions, Revisions
• Includes paper and electronic submissions
• Note Funding Opportunity Announcements (FOAs)
  will continue to list any special receipt dates
  for RFAs, PAs, PARs, PASs, etc.

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Modular Budget Format Now Excluded from Foreign
Institution Competing Grant
Applicationshttp//grants.nih.gov/grants/guide/n
otice-files/NOT-OD-06-096.html

• Effective for all competing grant applications
  from foreign (non-U.S.) institutions with
  submission dates on or after October 1, 2006.
• Allows NIH staff to assist applicant community
  with applicable regulatory and policy
  requirements for grant funding expenditure.
• NIH Guide Notice, NOT-OD-06-096, replaces
  instructions in all active Funding Opportunity
  Announcements.
• Does not affect domestic (U.S.) institutions with
  subawards to foreign (non-U.S.) institutions.

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NIH Establishes Multiple Principal Investigator
Awards for the Support of Team Science Projects
Goal Encourage collaborations among equals when
that is the most appropriate way to address a
scientific problem, a Team Science
approach. Multiple Principal Investigator
website and FAQs http//grants.nih.gov/grants/mul
ti_pi/index.htm
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Why Multiple PIs?

• Need for change
• Recommendations from NIH Bioengineering
  Consortium (BECON) Symposium 2003
• NIH Roadmap initiative to stimulate
  interdisciplinary science 2004
• Directive from Office of Science and Technology
  Policy January 2005 (OSTP)
• Requests for Information (RFIs) issued by OSTP
  and NIH
• OSTP found overwhelming support for concept of
  listing more than one PI
• NIH explored nuances including
• Apportionment to individual PIs
• The use of linked awards for projects spanning
  more than one institution
• Discontinuation of Departmental Ranking Tables
• The NIH RFI also indicated strong support for the
  ability to recognize more than one PI.

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Implementation of the Multiple PI
Policyhttp//grants.nih.gov/grants/guide/notice-f
iles/NOT-OD-07-017.html

• As a result of the RFIs and successful NIH Pilot,
  the NIH now allows applicants and their
  institutions to identify more than one PI (as of
  Feb. 2007 receipt dates).
• Extended to most research grant applications
  submitted electronically through Grants.gov using
  the SF 424 RR application package. (For most
  research grant applications that have not
  transitioned, the extension will apply once they
  transition to an electronic format.)
• Does not apply to some types of applications
  (Note The restriction to a single PI will be
  described in announcements to those programs.)
• Individual career awards (K08, K23, etc.)
• Individual Fellowships (F31, F32, etc.)
• Dissertation Grants (R36)
• Directors Pioneer Awards (DP1)
• Construction Grants (C06/UC6)
• Shared Instrumentation Grants (S10)
• Some PHS 398 applications will allow inclusion of
  multiple PIs, but only when clearly specified in
  the RFA or PA.

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Sample Features of the Multiple PI OptionMore
features outlined in NIH Guide Notice
http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-07-017.html

• Applications
• NIH Grant Applications Forms (PHS 398 and SF424
  RR) will accommodate more than one PI
• Leadership Plan required describing roles,
  responsibilities, and the working relationship of
  the identified PIs
• Principal Investigators
• The Contact PI will be responsible for
  communication between the NIH and the leadership
  team (and will be listed first on the
  application)
• All PIs share the responsibility and authority
  for leading and directing the project
• New Investigator Policies
• New Investigator box on the application may only
  be checked when all PIs are classified as New
  Investigators
• Review Criteria
• Standard NIH review criteria have been modified
  accordingly
• Awards Involving More than One Institution
• PIs from different institutions will be managed
  though subcontracts until options involving
  linked awards have been developed

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Multiple Investigators Roles Responsibilities

• PI defined
• The individual(s) judged by the applicant
  organization to have the appropriate level of
  authority and responsibility to direct the
  project or program supported by the grant.  The
  applicant organization may designate multiple
  individuals as PIs who share the authority and
  responsibility for leading and directing the
  project, intellectually and logistically. Each
  PI is responsible and accountable to the
  applicant organization, or, as appropriate, to a
  collaborating organization, for the proper
  conduct of the project or program including the
  submission of all required reports.
• The presence of more than one identified PI on an
  application or award diminishes neither the
  responsibility nor the accountability of any
  individual PI
• The decision to apply for a single PD/PI or
  multiple PD/PI grant is the responsibility of the
  investigators and the applicant organization and
  should be determined by the scientific goals of
  the project.

22
NIH APPENDIXUPDATE THE RIGHT PROPS MAKE A
DIFFERENCE!
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New Limits on Appendix Materials(NIH/AHRQ/NIOSH)
http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-07-018.html

• Effective for any application with
  submission/receipt dates on or after Jan. 3, 2007
• Goal Encourage applicants to be concise while
  containing the information needed for scientific
  review.
• See NIH Guide Notice NOT-OD-07-018 for formatting
  guidelines and Funding Opportunity (FOA) details
• Information that May be Included in the Appendix
• Published manuscripts and/or abstracts that are
  publicly available in a free, online format may
  be referenced, include graphic images of gels,
  micrographs, photos, etc. in the Research Plan
  PDF however these images may not be included in
  the Appendix.
• SF424 (RR) applications may include graphic
  images of gels, micrographs, photographs, etc. in
  the Research Plan PDF however these images may
  not be included in the Appendix (except when part
  of a qualifying publication).  See the SF 424
  (RR) Application Guide for guidance as to size
  and resolution of images.

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New Limits on Appendix Materials(NIH/AHRQ/NIOSH)
http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-07-018.html

• Materials Allowed in the Appendix
• Publications Applicants may submit up to 3 of
  the following types of publications. (Any
  exceptions will be noted in specific FOAs.)
• Manuscripts and/or abstracts accepted for
  publication but not yet published.
• Published manuscripts and/or abstracts only when
  a free, online, publicly available journal link
  is not available.
• Patents materials directly relevant to the
  project.
• Other
• Surveys, questionnaires, data collection
  instruments, clinical protocols, and informed
  consent documents may be submitted in the
  Appendix as necessary.
• Paper PHS398 applications only may include
  full-sized glossy photographs of material such as
  electron micrographs or gels in the Appendix
  however, an image of each (may be reduced in size
  but readily legible) must also be included within
  the page limitations of the Research Plan

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NOW SHOWING... A YEAR IN REVIEW
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SPOTLIGHT ON NEW INVESTIGATORS
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2007 NIH Directors
New Innovator Award (DP2)http//grants.ni
h.gov/grants/guide/rfa-files/RFA-RM-07-009.htmlHo
me Page (Includes link to FAQs)
http//grants.nih.gov/grants/new_investigators/inn
ovator_award

• Goals 1) Stimulate highly innovative research
  and 2) Support promising new investigators.
• The application period opens on April 25 and
  closes on May 22, 2007.
• Awards will provide up to 1.5 million in direct
  costs for up to a 5 year project period.
• Reminder This support mechanism requires
  Electronic Submission which requires a
  registration process that may take several weeks.

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Pathway to Independence (K99/R00)http//grants.n
ih.gov/grants/guide/pa-files/PA-07-297.html

• Designed to facilitate a timely transition from a
  mentored postdoctoral research position to a
  stable independent research position at an
  earlier stage than the norm.  
• The primary, long-term goal of the PI Award
  Program is to increase and maintain a strong
  cohort of new and talented, NIH-supported
  independent investigators.
• The Pathway to Independence Award will provide up
  to 5 years of support consisting of two phases. 
• The initial phase will provide 1-2 years of
  mentored support for highly promising,
  postdoctoral research scientists. 
• This phase will be followed by up to 3 years of
  independent support contingent on securing an
  independent research position.
• Contacts, Submission Dates, and Special
  Interests/Instructions
• http//grants.nih.gov/grants/guide/contacts/pa-07-
  297_contacts.htm
• Questions and Answers http//grants.nih.gov/grants
  /new_investigators/QsandAs.htm

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NIH/CSR Pilot Study for New Investigators Begins
Speedier NIH Review of
Research Applications Planned

• Pilot is designed to shorten the time to the next
  review for some new investigators who are not
  successful in a R01 grant submission and are
  readily able to address the concerns raised and
  issues identified in the Summary Statement.
• NIH Guide Notice (NOT-OD-06-13) provides special
  conditions which must be met and a timetable.
  Examples include
• A new or first resubmission of an R01 application
  must have been submitted for the February 1 or
  March 1, 2006 date.
• The application must be reviewed in one of the
  participating Study Sections.
• The Principal Investigator must agree that the
  resubmitted application be assigned to the same
  Study Section no change in review venue is
  permitted for the resubmission.
• NIH Guide Notice (NOT-OD-06-060) clarifies the
  resubmission procedures
• Applications in this pilot reviewed in May/June
  timeframe may choose to submit an amended
  application either
• For the July 20 special expedited resubmission
  date or
• On a subsequent standard resubmission date
  (November 1, March 1, or July 1).
• This will continue for each cycle that the pilot
  is in place.
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-06-013.html
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-06-060.html

NEW!
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NRSA and CAREER DEVELOPMENT
FY2006 FY2007 NEWS
PHS 416-1 RLK-NRSA Application and PHS 416-9
Progress Report Revised 10/05 and available at
http//grants.nih.gov/grants/forms.htm.
32
NRSA Pilot Funding Policy for NRSA

• Training Grants (T32, T34, T35, and T90)
• Effective for new competing renewals made in FY
  2007, as well as non-competing awards in FY2007
  that were awarded as competing in FY 2006
• Tuition Fees New Formula provides 60 of the
  level requested by the applicant institution up
  to a specified cap.
• Training Related Expenses Funds per trainee
  increased and now includes health insurance as
  part of this cost category.
• Individual Fellowships (F30, F32, F33, and F34)
• Effective for awards made in FY 2007
• Tuition Fees New formula provides 60 of the
  level requested by the applicant institution up
  to a specified cap.
• Institutional Allowance Funds provided per
  fellow increased and now includes health
  insurance as part of this cost category.
• Note Applicants should continue to request full
  needs and appropriate formula will be applied by
  the NIH awarding component at time of award.
• Original Announcement - NIH Guide Notice (August
  18, 2006)
• http//grants.nih.gov/grants/guide/notice-files/N
  OT-OD-06-093.html
• FY2007 Update No Changes to levels announced in
  NOT-OD-06-093 http//grants.nih.gov/grants/guide/
  notice-files/NOT-OD-07-052
• Clarification of FY2007 NRSA funding
  http//grants.nih.gov/grants/guide/notice-files/
  NOT-OD-07-057.html

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35
Extension of Several NRSA Training (T), NRSA
Fellowship (F), and Career Development (K)
Funding Opportunity Announcements
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-07-043.html

• NOTE The date of conversion of the T, F, and K
  mechanisms has been delayed (see NOT-OD-07-038).
  
• Due to the upcoming receipt dates for several
  FOAs using these mechanisms, their expiration
  dates are being extended until January 3, 2008.
• Participating NIH Institutes and Centers (ICs)
  will continue accepting paper applications in
  response to the effected FOAs (see Standard
  Postmark/Submission Dates for Competing
  Applications) until these mechanisms are
  converted to electronic submission via
  Grants.gov, and the use of the SF 424 Research
  and Related (RR) forms.
• In addition, applicants for T and F mechanisms
  are advised of the most recent NIH policy for
  funding of tuition, fees, and health insurance on
  NRSA training grants NOT-OD-06-093, released
  August 18, 2006.

36
Extension of Specific NRSA FOAshttp//grants.nih
.gov/grants/guide/notice-files/NOT-OD-07-043.html

• Institutional Training Programs
• T32 PAR-05-101 Ruth L. Kirschstein National
  Research Service Award (NRSA) Institutional
  Dental Research Training Program
• T32 RFA-HL-04-027 Minority Institutional Research
  Training Program
• T32 PAR-05-055 Jointly Sponsored Ruth L.
  Kirschstein National Research Service Award
  Institutional Predoctoral Training Program in the
  Neurosciences
• Individual Fellowship Programs
• F30 PAR-05-034 NIDCR Individual Predoctoral
  Dental Scientist Fellowship F31 PA-07-002 Ruth L.
  Kirschstein National Research Service Awards for
  Individual Predoctoral Fellows
• F32 PA-05-052 Ruth L. Kirschstein National
  Research Service Awards for Postdoctoral
  Fellowships in Muscle Disease Research
• Career Development Programs
• K01 RFA-HL-05-015 Mentored Career Development
  Award to Promote Faculty Diversity in Biomedical
  Research
• K01 RFA-HL-05-016 Mentored Career Award For
  Faculty At Minority Institutions
• K22 PAR-05-011 NCI Transition Career Development
  Award to Promote Diversity
• K22 PAR-04-143 NINR Career Transition Award
• K22 PAR-04-136 NEI Career Transition Award
• K24 PA-04-107 Midcareer Investigator Award in
  Patient-Oriented Research

37
Revised FOANRSA Individual Predoctoral
Fellowships (F31) to Promote Diversity in
Health-Related ResearchNIH Guide Notice
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-07-025.htmlProgram Announcement
http//grants.nih.gov/grants/guide/pa-files/PA-07
-106.html

• Revised FOA includes the following
  changes/amendments
• Effective January 1, 2007, all applications in
  response to this and subsequent FOAs will have
  the following tri-annual receipt dates
  April 13, August 13, and December 13.
• The revised FOA amends the application submission
  requirements.  Specifically, it adds a new bullet
  in the Content and Form of Application
  Submission section to require information that
  must be submitted by the applicant Institution in
  a letter certifying the applicants eligibility
  (See FOA for further details.)
• The revised FOA updates information on
  Tuition/Fees and Institutional Allowance,
  recently published in the NIH Guide
  NOT-OD-06-093.

38
Kirschstein-NRSA Fellowship Application (PHS
416-1) Clarified!Oct. 5, 2006
http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-07-002.html

• Face Page eRA Commons User Name
• Applicant/fellows must now be registered in the
  eRA Commons
• Required to access assignment mailer information,
  summary statements, more!
• Form Page 5 Doctoral Dissertation and Other
  Research Experience
• Unless otherwise instructed in a specific Funding
  Opportunity Announcement
• Applicants for early (pre-dissertation)
  Predoctoral and Senior Fellowships should omit
  their doctoral dissertation but include other
  research experience
• Advanced graduate students (ONLY) must include a
  narrative of their doctoral dissertation and any
  other research experience
• Checklist, Section I.D. Tuition and Fees
• Revised to reflect the new policy concerning
  reimbursement of
• tuition, fees and health insurance -
  NOT-OD-06-093
• Publications in Appendix Material
• Instructions revised to reflect NIH policy
  NOT-OD-06-053
• Links to publications available in on-line
  journals should be provided in lieu of providing
  a paper copy of the publication. 

Effective Immediately!
39
Guidance to Applicant Organizations Research
Fellows Registration in eRA CommonsOct. 5,
2006 http//grants.nih.gov/grants/guide/notice-fi
les/NOT-OD-07-003.html

• Applicant organizations should register any
  individual fellows submitting applications to NIH
  and AHRQ
• PI Role in the Commons does not provide special
  status only a name in the system that provides
  administrative authority to see pertinent
  application documents (e.g. summary statements,
  scores, electronic submission status, etc.)
• Individual Fellows registered by any
  organization other than the sponsoring
  organization should not have more than one eRA
  Commons account.
• Instructions provided in this Guide Notice to
  address affiliation process in eRA Commons and at
  https//commons.era.nih.gov/commons-help/175.htm

40
Kirschstein-NRSA Postdoctoral Fellowship
Application (F32)Now Uses Streamlined Review
ProcessNIH Guide Notice, June 20, 2006
http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-06-077.html

• Beginning with grant applications submitted Aug.
  5, 2006
• All study sections will use NIH streamlined
  review process
• Allows reviewers more time to discuss
  applications likely to be supported.
• Approx. 40 of F32 applications will be deemed
  non-competitive by unanimous vote and will not
  be scored.
• Will not receive full discussion at the study
  section meeting
• Will not have a Resume and Summary of
  Discussion paragraph
• Not routinely taken to second level of review

41
Behind the Scenes withCareer Awards
42
NIH Refreshes K Awards

• Recent Guide Notice
• Clarification of Eligibility for Mid-Career
  Investigator Award in Patient Oriented Research
  (K24)
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-06-095.html
• Sampling of Funding Opportunity Announcements
• Mentored Research Scientist Development Award
  (K01)
• http//grants.nih.gov/grants/guide/pa-files/PA-06-
  001.html
• Release Date October 4, 2005
• Independent Scientist Award (K02)
• http//grants.nih.gov/grants/guide/pa-files/PA-06-
  527.html
• Release Date August 15, 2006
• Mentored Clinical Scientist Research Career
  Development Award (K08)
• http//grants.nih.gov/grants/guide/pa-files/PA-06-
  512.html
• Release Date August 7, 2006
• Mentored Quantitative Research Development Award
  (K25)  
• http//grants.nih.gov/grants/guide/pa-files/PA-06-
  087.html
• Release Date December 2, 2005
• NIH Pathway to Independence (PI) Award (K99/R00)
• http//grants2.nih.gov/grants/guide/pa-files/PA-06
  -133.html

43
Mentored career awardees (K awardees) may 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.g
ov/grants/guide/notice-files/NOT-OD-04-007.html I
nformation About Career Development
Awards http//grants.nih.gov/training/careerdevel
opmentawards.htm
44
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 status
• 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

45
Definition of Full Time Appointment for Career
Awards

• Requires 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.n
ih.gov/grants/guide/notice-files/NOT-OD-04-056.htm
l
46
SBIR/STTR

• Small Business Innovation Research
• Small Business Technology Transfer Research

47
SBIR/STTR Program Updates

• Whats New?
• Receipt Dates
• Multiple PD/PI SBIR and STTR
• Appendix Instructions
• Pilot Manufacturing Assistance Program
• Reminders
• Electronic Submission
• Funding Opportunity Announcements
• (FOA) Solicitations

48
Solicitations and Receipt Dates

• SBIR/STTR Omnibus Grant Solicitation Parent FOAs
  (NIH, CDC, and FDA)
• SBIR PA-07-280 http//grants.nih.gov/grants/gui
  de/pa-files/PA-07-280.html
• STTR PA-07-281 http//grants.nih.gov/grants/guid
  e/pa-files/PA-07-281.html
• SBIR Contract Solicitation (NIH, CDC)
• Release August
• November receipt date
• NIH Guide for Grants and Contracts
• Release Weekly
• Receipt dates specified in each FOA

Standard Receipt Dates April 5, Aug. 5, Dec.
5 (AIDS/AIDS-related May 1, Sept. 1, Jan. 2)
No Change
49
HAVE A R13 OR U13 CONFERENCE
GRANT?DONT FORGET TO ACKNOWLEDGE NIH!
50
R13 U13 Acknowledgement of Funding Source and
DisclaimerEffective Immediately!

• Grantees must acknowledge NIH grant support and
  include the following statement on any conference
  materials (including promotional materials,
  agenda, publications, and Internet sites)
• "Funding for this conference was made possible
  (in part) by (Insert Grant/Cooperative Agreement
  ) from (Insert name of the awarding
  Institute/Center).   The views expressed in
  written conference materials or publications and
  by speakers and moderators do not necessarily
  reflect the official policies of the Department
  of Health and Human Services nor does mention by
  trade names, commercial practices, or
  organizations imply endorsement by the U.S.
  Government."

• Watch for a NIH Guide Notice soon!

51
FOR A FISTFUL OF (NIH) DOLLARS MAKE SURE
YOURE COMPLIANT!
52
Compliance is an Institutional Commitment!
NON-COMPLIANCE IS RISKY BUSINESS!
Compliance Questions for NIH?
GrantsCompliance_at_nih.gov
53
Division of Grants Compliance and Oversight,
OPERA, OER External Compliance Activities

• Institutional compliance
• Technical assistance
• Corrective action plans
• Outreach
• Educational seminars
• National and regional meetings
• NIH Regional Seminars
• Proactive Compliance Site Visits
• Targeted Site Reviews

54
NIH Targeted Site Reviews Financial Conflict
of Interest (FCOI)

• A new initiative to determine whether grantee
  institutions have
• Fully implemented the FCOI regulations as they
  pertain to grants (42 CFR Part 50 Subpart F), and
• Complied with reporting requirements
• Eighteen site reviews completed in FY 2006
• Observations from NIHs FY2006 Targeted Site
  Reviews on Financial Conflict of Interest have
  been posted on the OER Conflict of Interest
  page  http//grants.nih.gov/grants/policy/coi/ind
  ex.htm
• Guide Notice http//grants.nih.gov/grants/guide/n
  otice-files/NOT-OD-07-048.html

FCOI questions for NIH? FCOIcompliance_at_mail.nih
.gov
55
FCOISummary of Reporting Requirements
http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-05-013.html

• At the time of application Investigators must
  submit significant financial interests to the
  institution
• Prior to the expenditure of funds The
  institution must report a financial conflict of
  interest to the NIH and assure that it has been
  managed, reduced, or eliminated
• FCOI identified after the initial report The
  institution must report within 60 days of
  identification and assure that it has been
  managed, reduced, or eliminated
• (Note All reports should be sent to the
  funding ICs CGMO)

http//grants.nih.gov/grants/stafflist_gmos.htm
56
Definition of Investigator

• Investigator Principal Investigator (PI) and
  any other person who is responsible for the
  design, conduct, or reporting of research funded
  by PHS, or proposed for such funding
• The term Investigator includes the
  Investigators spouse and dependent children.
• To Clarify..
• An investigator is not just the Principal
  Investigator or Key Personnel conducting the PHS
  sponsored research.
• Recipient institutions are encouraged to broadly
  consider an individuals role, rather than title,
  and their degree of independence when applying
  the definition.

57
National Science and Technology Council
Government-wide Initiative Based on OIG Draft
Compliance Guidance

• National Science and Technology Council offered
  to expand upon the HHS OIGs initial efforts to
  provide voluntary compliance guidance to
  recipients of Federal research funding
• Initial OIG draft Compliance Guidance issued
  November 2005 for public comment
• Guidance will be developed under the auspices of
  the Research Business Models Subcommittee and
  published for public comment
• Press release http//oig.hhs.gov/publications/do
  cs/press/2006/ResearchCPG-finalrelease06072006.pdf
  search22HHS20OIG20Draft20Compliance20Nation
  al20Science20and20technology20council22

58
FY 2007 OIG Work PlanSelected Highlights

• University Administrative and Clerical Salaries
• Are salary costs appropriately charged?
• Level of Commitment and Effort Reporting
• Do salary charges accurately reflect effort?
• Cost Transfers
• Are cost transfers allowable, supported by
  appropriate documentation, and certified?

The entire FY 2007 Work Plan is available at the
HHS OIG website http//oig.hhs.gov/publications/w
orkplan.html1
59
AUDIT ISSUESIRRECONCILABLE DIFFERENCES?
60
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.

61
Summary of Audit Requirements
National External Audit Review CenterHHS Office
of Audit Services323 West 8th StreetLucas
Place, Room 514Kansas City, MO 64105 Phone
800-732-0679/816-374-6714
62
eRA COMMONS (Electronic Research Administration)
63
Growing Usage of eRA Commons

• Grants administration through the eRA Commons
  continues to expand
• Over 2,800,000 sessions in FY2006
• Over 8,400 registered organizations
• Over 108,000 registered users
• Over 14,600 eSNAPs submitted in FY2006
• Over 12,000 Just-In-Time submitted to date
• Over 18,000 No Cost Extensions submitted to date
• Over 84,600 Financial Status Reports processed to
  date
• Over 2,800 meetings held through Internet
  Assisted Review (IAR) in 2006
• eRA Commons demo facility available for training
  https//commonsdemo.era.nih.gov/commons-demo/

64
eRA Commons FunctionalityImportant for
Investigator and Individual Fellow Access

• Status
• Study Section and IC Assignments
• Priority Score
• Summary Statement
• Notice of Grant Award
• View errors/warnings associated with electronic
  submissions
• View assembled applications
• This is the only place
  for PIs
  and Individual Fellows to access this
  information.

65
No more Paper Chase!eRA Commons Your Only
Source for an Applications Status

• PIs and Fellows must access this information
  through the eRA Commons no more paper mailers
• eRA Commons https//commons.era.nih.gov/commons/
  
• Reminder! Effective May 10, 2006, all
  applications must include the eRA Commons User
  name for all Project Directors/Principal
  Investigators (PD/PI) and Individual Fellows
  Applies to paper and electronic applications
• To avoid delays in the e-notification process, it
  is vital that grantees and PIs register in the
  eRA Commons early. PIs should consult with their
  business office for creating a Commons account.
  PIs are responsible for maintaining their profile
  information and ensuring all pertinent
  information is up-to-date.

66
THE NIH HELPS
LIGHT THE WAY
FOR ELECTRONIC SUBMISSION OF GRANT
APPLICATIONS
67
Application Submission
Present
Past
Future
68
Electronic SubmissionWeve Come A Long Way
Already

• NIH has received over 30,000 unique electronic
  applications
• We have transitioned over 16 mechanisms
• Posted over 700 funding opportunities for
  electronic submission through Grants.gov
• Dramatically improved application processing time
  over the last year

Past
69
Successful Transitions
SBIR/STTR
R18/U18, R25, C06/UC6
R13/U13
R01 Multi-PI Pilot
R36
R15
S10
R01
X02
X01
DP1
R03, R21, R21/R33, R34
12
12
11
10
09
08
07
06
05
04
03
02
01
02
01
2006
2007
70
Mechanism Abbreviation Key

• C06/UC6 Research Facilities Construction
  Grants
• DP1 NIH Directors Pioneer Award
  Program
• D71/U2R International Training Cooperative
  Agreement/Phase 2 of FIC mechanism D71
• G Resource Program
• P Research Program Projects and Centers
• R01 Research Project Grant Program
• R03 Small Grant Programs
• R10/U10 Cooperative Clinical Research Grants
• R13/U13 Support for Conferences Scientific
  Meetings
• R15 Academic Research Enhancement
  Awards (AREA)
• R18/U18 Research Demonstration and
  Dissemination Projects
• R21 Exploratory Development Research
• R21/R33 Exploratory Development Research/Phase
  II
• R24/U24 Resource Related Research Projects
• R25 Education Projects
• R34 Clinical Trial Planning Grant
  Program
• R36 Research Dissertation Grant Program
• SBIR/STTR Small Business Innovation
  Research/Technology Transfer
• S06, S10, S11 Biomedical Research

71
Responded to Community Feedback

• Changed the submission deadline to 5 p.m. local
  time of the organization
• Streamlined verification process
• Adjusted the transition timeline
• Improved text of error/warning messages
• Provided training events resources
• Enhanced application guide instructions

72
Successful R01 Transition
Present
Due to longer processing times, some applicants
resubmitted their applications before receiving
the results of the prior submission.
73
Successful R01 Transition

• February 5 both NIH eRA and Grants.gov systems
  easily handled the load
• March 5 Grants.gov processing times were much
  longer than applicants are accustomed to,
  however, most applications were processed well
  within the Grants.gov 48 hour target
• NIH extended the five business day
  error-correction window by two business days for
  the applicants (4) that experienced Grants.gov
  processing times in excess of 48 hours

74
SystemToSystem SubmissionsOn the Rise

• Marked increase in applications submitted via
  System-to-System
• Application data elements are sent directly to
  Grants.gov
• Some institutions choose to develop their own
  interface and some pay a service provider to
  submit the data on their behalf

75
Transition to SF424 (RR)

• The following grant programs will transition to
  electronic submission through Grants.gov for the
  May 25, 2007 submission date and beyond
• Resource Program (G7, G8, G11, G13, G20)
• Minority Biomedical Research Support Thematic
  Project Grant (S11)
• Research and Institutional Resources Health
  Disparities Endowment Grants - Capacity Building
  (S21)
• Research and Student Resources Health Disparities
  Endowment Grants - Educational Programs (S22)

76
Transition to SF424 (RR)

• REMINDER ALL applications for transitioned
  mechanisms must be submitted electronically
  (paper PHS 398 applications will not be
  accepted).
• Previously submitted paper applications that are
  being resubmitted as amended applications must
  also submit electronically via Grants.gov using
  the SF424 (RR) forms. 
• For more information
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-07-038.html

77
Transition Delays

• Announcing Delay for Subsequent Transitions
• The change to electronic applications for grant
  programs currently targeted to transition after
  May 2007, including Career Development (K),
  Fellowship (F), Training Development (TD) and
  complex mechanisms will be delayed.
• NIH, AHRQ and Grants.gov are working together to
  establish new transition dates for these grant
  programs. A notice announcing the adjusted dates
  and timeline will be issued as soon as possible.
• Applications for these mechanisms will continue
  to be submitted on paper using the PHS 398 forms.

78
Continuing Outreach

• Newsletters, Articles, Press Releases
• Recent training webcast to over 10,000 viewers
• Presentations at industry meetings, conferences
  user-groups
• Dramatic increase in listserv membership
  targeted communications

79
New Training Resources

• Automated Training Tutorials
• eRA Commons Registration
• Completing an Application Package (Grants.gov)
• Find Download a Funding Opportunity
• Check Submission Status View Assembled
  Application (PI SO versions)

http//era.nih.gov/ElectronicReceipt/training.htm
80
New Training Resources

• Hands-On Learning
• Create Your Own Commons Demo Account
• Check the status of sample applications
• View errors warnings
• See sample application images
• Hands-On Workshop Guide
• Step-by-step notes instructions from the NIH
  eSubmission training labs
• eSubmission Pop-Quiz
• Test your understanding of eSubmission Basics

http//era.nih.gov/ElectronicReceipt/training.htm
81
Our Focus is on the Future!

• We are actively
• Identifying ways to further improve our services
• Enhancing the process
• Planning for future mechanism transitions

Future
82
New Grants.gov Solution

• Grants.gov Adobe eForms
• Platform Independent (PC and Mac compatible)
• Advanced Search Features
• Will have the same look feel as current forms
  to ease the transition
• NIH expects to transition to new forms mid-2007

83
Are You Ready for the Future?

• Applicant Community
• Determine implementation plans for your
  Institution
• How will your internal communications, review
  approval processes change?
• How will you share applications in progress?
• How will you manage last minute queue at
  Sponsored Programs rather than airport FedEx drop
  box?
• Share experiences Network at meetings, Join
  Listservs

84
Electronic Submission Process
Prepare to Apply
Find Opportunity and Download Application Package
Prepare Application
Submit Application to Grants.gov (AOR Submits)
if errors
Check Submission Status in Commons
Review the Application Image
Submission Complete
85
Registration Requirements

• Grants.gov requires registration for the
  organization
• eRA Commons registration is for both the
  organization and the PI
• These are separate processes that can be done
  simultaneously.
• All registrations must be completed prior to
  application submission.
• See http//era.nih.gov/ElectronicReceipt/preparing
  .htm for detailed information on registration
  requirements.

It is critical for institutions to begin these
registrations at least 2 4 weeks
before applications are due!
86
Application Packages

• The Application Form and Instructions are now
  part of an Application Package that NIH posts
  with each Funding Opportunity Announcement (FOA).
• Search for FOAs on the NIH Guide for Grants
  Contracts. (http//grants2.nih.gov/grants/guide/)
  
• Click the Apply for Grant Electronically button
  in the Announcement to download the package for
  the specific FOA.

RECOMMENDATION When developing a new proposal,
re-download the application package from the FOA
each time. Expired forms will not be accepted by
Grants.gov.
87
On-Time Submission

• All registrations must be completed prior to
  initial submission.
• Initial submission must have a Grants.gov
  timestamp on or before 500p.m. local time of
  submitting organization on the receipt date.

88
Correction Window

• NIH will allow changed/corrected applications to
  be submitted to address errors/warnings in the
  five business days after the receipt date.
• Initial application submission to Grants.gov must
  have been made on time
• Changes must be made in response to identified
  errors/warnings
• Cover letter required

89
Application Image Review

• After NIH receives an error-free application, an
  assembled application image is generated and
  placed in the eRA Commons.
• Applicants have two weekdays (M-F including
  holidays) to view the assembled application
  before it automatically moves forward to NIHs
  Division of Receipt and Referral.
• Signing Official (SO) has option to Reject.
• If Rejected after receipt date for any
  reasonother than a system formatting issue,
  subsequent corrected submission is subject to the
  NIH late policy.
• PI will receive e-mail notification if SO rejects
  application.

90
Advice From Experience

• IMPORTANT Read and follow all application
  instructions!
• Failure to follow instructions has resulted in
  applicants having to submit corrected
  applications.
• The HHS logo denotes any special instructions or
  fields not marked as mandatory on the
  federal-wide form that are required by NIH.
• Two most common problems with applications to
  date
• The credential field of the RR Senior/Key Person
  Profile component MUST contain the PIs assigned
  eRA Commons User ID for NIH to process the
  application
• All non-PureEdge attachments MUST be in PDF format

Important!
91
Advice From Experience

• Register Now! The registration process can take
  several weeks to complete.
• Start Early! Allow extra time for corrections.
• IMPORTANT Review assembled application in
  Commons - this is what the reviewers will see!
• When seeking support, be prepared to provide
  identifying information for your application and
  organization

92
Where to Find More Information
Electronic Submission Website at http//era.nih.g
ov/ElectronicReceipt/
93
Where To Go For Help

• Grants.gov registration, submission and PureEdge
  questions
• Visit http//www.grants.gov/CustomerSupport
• Grants.gov Customer Service
• E-mail support_at_grants.gov
• Phone [phone]
• eRA Commons registration and post submission
  questions on Commons functionality
• Web Help Ticket http//ithelpdesk.nih.gov/eRA/
• eRA Commons Help Desk
• E-mail commons_at_od.nih.gov
• Phone [phone] OR 301-402-7469
• Forms transition and questions on NIHs overall
  plan for electronic receipt
• NIH Grants Information
• E-mail grantsinfo_at_nih.gov
• Phone [phone]

For the fastest serviceEnter your own help
ticket!
94
CURTAIN CALL! Application Reminders
95
Clarification of Limits on Application
Resubmissionshttp//grants.nih.gov/grants/guide/n
otice-files/NOT-OD-07-015.html

• Clarifies the number of resubmissions (known
  previously as revisions or amendments) allowed
  for a NIH grant application and provides
  information on the application assignment
  process.
• REMINDER NIH will not consider a third
  resubmission (A3) or higher to any application
  for extramural support. However, there is no time
  limit for the submission of the first and second
  resubmissions (A1 and A2).
• Therefore, applicants in this situation often
  ask, What constitutes a New Application? (See
  Guide Notice NOT-OD-07-015 for more details.)
• Expected to be substantially different in content
  and scope
• Should include substantial changes in all
  sections of the Research Plan
• Should include fundamental changes in the
  questions being asked and/or the outcomes
  examined.
• Requests for review by a different review
  committee or funding consideration by a different
  NIH institute are not sufficient reasons to
  consider an application as new.  
• Resubmission FAQs http//grants.nih.gov/grants/po
  licy/resubmission_qa.htm

96
NIH Policy on Late Submission of Grant
Applications Guide Notice (August 11, 2006)
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-06-086.html
UPDATED POLICY!
UPDATED

• NIH expects grant applications to be submitted on
  time
• (See Guide Notice NOT-OD-06-086 for details on
  paper vs electronic general deadline information.
• Late applications
• Generally are not accepted, except in rare
  instances
• Unaccepted late applications will be returned
  without review
• Permission is not granted in advance
• Must be accompanied by a cover letter with
  compelling reasons for the delay (including
  timing and nature of the cause of the delay)
• Regular Standing Submission dates Late
  applications must be received within two weeks of
  standing submission date
• Expedited Standing Submission dates Late
  applications must be received within one week of
  standing submission date.
• NIH will not consider accepting late applications
  for the Special Receipt Dates for RFAs and PARs

97
NIH Policy on Late Submission of Grant
Applications Clarification for Multiple PI
Applicationshttp//grants.nih.gov/grants/guide/no
tice-files/NOT-OD-07-026.html

• One of the explanations for late submission that
  may lead to acceptance of an application is
  service by the Principal Investigator on an NIH
  extramural review group during the time frame
  that would reasonably be expected to be used to
  prepare the application. 
• For multiple PI applications, this will apply
  when any one (or more) of the Project
  Directors/Principal Investigators (PD/PIs) is
  involved with service on an NIH extramural peer
  review group.
• Note that this applies only to NIH extramural
  review activities, not to those of other Federal
  agencies or private organizations.  
• It also does not apply to other participants in
  the application who do not have the PD/PI role. 

98
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.
• Note This does not include 3rd party FA.

Reminder!
This applies to an application asking for direct
costs equal to or greater than