Title: Current Issues at NIH
1Current 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
2FROM 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
3NIH 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.
4FY 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
5FY 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
6NIH 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
7New 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
8New 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
9NIH Spring Line-Up!
NIH Grants Process
10Announcing 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.
11NIH 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.
12NIH 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
13Parent 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!)
14Change 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)
15Change 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.
16Modular 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.
17NIH 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
18Why 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.
19Implementation 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.
20Sample 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
21Multiple 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.
22NIH APPENDIXUPDATE THE RIGHT PROPS MAKE A
DIFFERENCE!
23New 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.
24New 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
25NOW SHOWING... A YEAR IN REVIEW
26SPOTLIGHT ON NEW INVESTIGATORS
27(No Transcript)
282007 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.
29 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
30NIH/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!
31NRSA 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.
32NRSA 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
33(No Transcript)
34(No Transcript)
35Extension 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.
36Extension 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
37Revised 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.
38Kirschstein-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!
39Guidance 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
40Kirschstein-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
41Behind the Scenes withCareer Awards
42NIH 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
43Mentored 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
44Policy 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
45Definition 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
46SBIR/STTR
- Small Business Innovation Research
- Small Business Technology Transfer Research
47SBIR/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
48Solicitations 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
49HAVE A R13 OR U13 CONFERENCE
GRANT?DONT FORGET TO ACKNOWLEDGE NIH!
50R13 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!
51FOR A FISTFUL OF (NIH) DOLLARS MAKE SURE
YOURE COMPLIANT!
52Compliance is an Institutional Commitment!
NON-COMPLIANCE IS RISKY BUSINESS!
Compliance Questions for NIH?
GrantsCompliance_at_nih.gov
53Division 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
54NIH 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
55FCOISummary 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
56Definition 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.
57National 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
58FY 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
59AUDIT ISSUESIRRECONCILABLE DIFFERENCES?
60Audit 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
62eRA COMMONS (Electronic Research Administration)
63Growing 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/
64eRA 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.
65No 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.
66THE NIH HELPS
LIGHT THE WAY
FOR ELECTRONIC SUBMISSION OF GRANT
APPLICATIONS
67Application Submission
Present
Past
Future
68Electronic 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
69Successful 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
70Mechanism 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
71Responded 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
72Successful R01 Transition
Present
Due to longer processing times, some applicants
resubmitted their applications before receiving
the results of the prior submission.
73Successful 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
74SystemToSystem 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
75Transition 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)
76Transition 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
77Transition 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.
78Continuing 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
79New 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
80New 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
81Our Focus is on the Future!
- We are actively
- Identifying ways to further improve our services
- Enhancing the process
- Planning for future mechanism transitions
Future
82New 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
83Are 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
84Electronic 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
85Registration 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!
86Application 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.
87On-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.
88Correction 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
89Application 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.
90Advice 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!
91Advice 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
92Where to Find More Information
Electronic Submission Website at http//era.nih.g
ov/ElectronicReceipt/
93Where 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 1-800-518-4726
- 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 1-866-504-9552 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 301-435-0714
For the fastest serviceEnter your own help
ticket!
94CURTAIN CALL! Application Reminders
95Clarification 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 -
96NIH 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
97NIH 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.
98Applications 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