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NIH UpdateSpring 2007 Dee Doherty Grants Management Specialist, NHLBI Natasha Spaid Grants Managemen

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P.L. 110-005: Revised Continuing Appropriations ... Non-Modular grants continue to receive 3% future year ... NIH Bioengineering Consortium (BECON) ... – PowerPoint PPT presentation

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Title: NIH UpdateSpring 2007 Dee Doherty Grants Management Specialist, NHLBI Natasha Spaid Grants Managemen


1
NIH Update--Spring 2007 Dee
Doherty Grants Management Specialist,
NHLBI Natasha Spaid Grants Management
Specialist, NHLBI
Office of Extramural Research
2
Budget News
3
Continued Funding for FY2007
  • P.L. 110-005 Revised Continuing Appropriations
    Resolution, FY 2007. (Extending Legislative
    Mandates http//grants.nih.gov/grants/guide/not
    ice-files/NOT-OD-07-050.html
  • What does this mean for grantees?
  • Competing Awards
  • No change in procedures. Non-Modular grants
    continue to receive 3 future year escalations.
  • Included 91 million for vulnerable research
    programs (See new R56 Bridge program)
  • Website of Financial Operations (including IC
    funding plans) http//grants1.nih.gov/grants/fina
    ncial/index.htm

4
Continued Funding for FY2007
  • Non-Competing Research Awards http//grants.nih.g
    ov/grants/guide/notice-files/NOT-OD-07-049.html
  • Awards for all research mechanisms - modular and
    categorical are being 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 have been revised to restore funds to the
    level indicated above.
  • Not applicable to Career Awards, SBIR/STTRs, and
    RLK-NRSA Individual Fellowships and Institutional
    Training Grants. These mechanisms receive funding
    at committed levels.
  • For RLK-NRSA stipends categorical info - see
    NOT-OD-07-057

5
New Salary Cap in Effect - 186,600
  • Effective January 1, 2007, salary limit increased
    to 186,600
  • 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.
    Cap remains at Executive Level 1.
  • 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
  • See NOT-OD-07-051 http//grants.nih.gov/grants/gui
    de/notice-files/NOT-OD-07-051.html

6
FY 2008 Presidents Budget Request
  • Requested 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

7
FY 2008 Presidents Budget Request 28.85 Billion
Training 3
Research Mgmt
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
8
Whats New for FY 2007
9
New Notice of Award (NOA)
NEW!
  • Now a PDF attachment to an e-mail (no longer
    e-mail text)
  • Improves formatting and function (even long terms
    can now be accommodated)
  • New summary cumulative data provided when a
    separate supplement award has been issued
  • New NameNotice of Award (NOA) instead of NGA
  • Does your institution get these via e-mail? If
    not, become NOA e-mail enabled using the
    Commons Institutional Profile
  • Expect to totally eliminate hard copy mailing of
    all NOAs in CY2007
  • Notice OD-07-060 http//grants.nih.gov/grants/gu
    ide/notice-files/NOT-OD-07-060.html

10
New NIH Directors Bridge Award (R56)
  • Provide continued, limited funding for new and
    established PIs who have submitted a competing
    renewal who just miss the nominal funding payline
    for the IC
  • Continued funding will permit the PIs additional
    time to strengthen a resubmission application. 
  • Cannot apply, cannot self-nominate! ICs nominate
    to NIH Office of the Director for final
    selection. 
  • Criteria
  • Must have lt 200,000 in other support (total
    costs) from all sources to fund research. 
  • No A2s eligible
  • Application submitted in FY2006 that are still
    being considered for funding FY2007 submissions
  • Selectees will receive one-year of funding up to
    333,000 DC applicable FA
  • Notice OD-07-056 http//grants.nih.gov/grants/gu
    ide/notice-files/NOT-OD-07-056.html

11
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 PHS Agencies now 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!)

12
Change in Standing Receipt Dates!
(All dates available at http//grants.nih.gov/gran
ts/funding/submissionschedule.htm)
  • When? Effective February 2007
  • 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 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

13
Modular Budget Format Now Excluded from Foreign
Institution Competing Grant Application
  • 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.
  • http//grants.nih.gov/grants/guide/notice-files/NO
    T-OD-06-096.html

14
Multiple Principal Investigator Program to
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/multi_pi/index.htm

15
Why Multiple PIs?
  • Drivers
  • 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 - Research Business
    Models Initiative)
  • 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.

16
Implementation of the Multiple PI
Policy http//grants.nih.gov/grants/guide/notice-f
iles/NOT-OD-07-017.html
  • 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.)
  • Some PHS 398 applications will allow inclusion of
    multiple PIs, but only when clearly specified in
    the RFA or PA.
  • 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)

17
Sample Features of the Multiple PI Option
  • Applications
  • NIH Grant Applications Forms (PHS 398 and SF424
    RR) 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 for now

18
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.

19
Limits on Appendix Materials (NIH/AHRQ/NIOSH)
  • 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.
  • http//grants.nih.gov/grants/guide/notice-files/NO
    T-OD-07-018.html

20
Limits on Appendix Materials 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

21
Limits on Appendix Materials Whats Been
Relocated
  • Published manuscripts and/or abstracts that are
    publicly available in a free, online format.
    These may be referenced in biosketch, progress
    report publication section, Literature
    cited/Bibliography References
  • 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.

22
NIH Ranking Tables Replaced with New Web-Based
Tool
  • 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.
  • http//grants.nih.gov/grants/award/trends/FindOrg.
    cfm

23
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?

...and get information like this!
Just click on any located on this interactive map
at http//grants2.nih.gov/grants/award/trends/Stat
e_Congressional/StateOverview.cfm
UTAH FY 2005

Additional Award Data/Ranking Info also available
at http//grants.nih.gov/grants/award/awardtr.ht
m
24
Continued Focus on New Investigators
http//grants1.nih.gov/grants/new_investigators/in
dex.htm
25
2007 NIH Directors New Innovator Award (DP2)
  • Goals 1) Stimulate highly innovative research
    and, 2) Support promising new investigators.
  • Application period opens on 4/25 closes
    5/22/2007
  • Awards will provide up to 1.5 million in direct
    costs for up to a 5 year project period.
  • FOA http//grants.nih.gov/grants/guide/rfa-files
    /RFA-RM-07-009.html
  • Home Page (Includes link to FAQs)
    http//grants.nih.gov/grants/new_investigators/inn
    ovator_award
  • Reminder This support mechanism requires
    Electronic Submission which requires a
    registration process that may take several weeks.

26
Pathway to Independence (K99/R00) http//grants.n
ih.gov/grants/guide/pa-files/PA-07-297.html
  • Designed to facilitate timely transition from
    mentored postdoctoral research position to
    independent research position at earlier stage  
  • Primary, long-term goal of the PI Award Program
    is to increase and maintain strong cohort of new
    and talented, NIH-supported independent
    investigators.
  • Provides up to 5 years of support consisting of
    two phases. 
  • Initial phase (K99) 1-2 years of mentored
    support for highly promising, postdoctoral
    research scientists. 
  • 2nd Phase (R00)Up to 3 years of independent
    support contingent on securing an independent
    research position.
  • Standard K Submission Dates (March 12, July 12,
    November 12)
  • Questions and Answers http//grants.nih.gov/grants
    /new_investigators/QsandAs.htm

27
NIH/CSR Expands Review Pilot for New Investigators
  • Designed to shorten the time to the next review
    for 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.
  • For the May/June 2007 expanded to 46 study
    sections. (See Notice for specifics)
  • By the September/October 2007 meetings all CSR
    study sections reviewing new investigator R01
    applications submitted for standard receipt dates
    (this does not include RFAs and PARs with special
    dates) will meet on a schedule to allow
    consecutive cycle resubmissions.   
  • Policies and practices initially established
    remain in effect
  • Study Sections participating will schedule
    meetings so that new investigators receive their
    summary statements no later than March 1, July 1,
    or November 1.
  • The Summary Statements for qualifying
    applications will have an explicit note
    indicating eligibility for next cycle
    submission. 
  • Resubmission applications for consideration at
    the next cycle must be submitted by March 20,
    July 20, or November 20.
  • Resubmission applications must be reviewed by the
    same study section that reviewed the previous
    version. 
  • New Investigators who do not choose the next
    cycle option or request review by a different
    study section will use the standard resubmission
    dates for subsequent cycle submission (March 5,
    July 5, or November 5).

http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-07-058.html
28
Kirschstein-NRSA Career Award News
29
NRSA Pilot Funding Policy for NRSA FY2007
Update No Changes to levels announced in
NOT-OD-06-093 http//grants.nih.gov/grants/guide/n
otice-files/NOT-OD-07-057
  • 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.

30
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31
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32
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.
    See Notice for specific FOA numbers.
  • 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.

33
Revised FOA NRSA Individual Predoctoral
Fellowships (F31) to Promote Diversity in
Health-Related Research
  • Revised FOA includes the following
    changes/amendments
  • Effective January 1, 2007 Now 3 submission
    dates--April 13, August 13, and December 13.
  • Amends application submission requirements. 
    Specifically, adds new bullet in Content and
    Form of Application Submission section to
    require information that must be submitted by
    applicant Institution in a letter certifying the
    applicants eligibility (See FOA for further
    details.)
  • Updates information on Tuition/Fees and
    Institutional Allowance, published in the NIH
    Guide NOT-OD-06-093.

NIH Guide Notice http//grants.nih.gov/grants/g
uide/notice-files/NOT-OD-07-025.html Program
Announcement http//grants.nih.gov/grants/guide/
pa-files/PA-07-106.html
34
Kirschstein-NRSA Fellowship Application (PHS
416-1) Clarified http//grants.nih.gov/grants/guid
e/notice-files/NOT-OD-07-002.html
  • Face Page eRA Commons User Name REQUIRED!
  • Applicant/fellows must now be registered in the
    eRA Commons
  • Required to access assignment mailer info,
    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. 

35
Guidance to Applicant Organizations Research
Fellows Registration in eRA Commons http//grants
.nih.gov/grants/guide/notice-files/NOT-OD-07-003.h
tml
  • 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, 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

36
Kirschstein-NRSA Postdoctoral Fellowship
Application (F32) Now Uses Streamlined Review
Process http//grants.nih.gov/grants/guide/notice-
files/NOT-OD-06-077.html
  • Began with grant applications submitted Aug. 5,
    2006
  • All study sections now 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

37
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

38
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
Reminder
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
39
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

40
Definition of Full Time Appointment for Career
Awards
Reminder
  • 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
41
Compliance News
Compliance is an Institutional Commitment!
Compliance Questions for NIH?
GrantsCompliance_at_nih.gov
42
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

43
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/index.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
44
FCOI Summary 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
45
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.

46
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

47
FY 2007 OIG Work Plan Selected 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
48
Audit Issues
49
Audit Requirement
Reminder
  • 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.

50
Summary of Audit Requirements
National External Audit Review Center HHS Office
of Audit Services 323 West 8th Street Lucas
Place, Room 514 Kansas City, MO 64105 Phone
800-732-0679/816-374-6714
51
eRA Commons
  • Electronic Research Administration

52
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/

53
eRA Commons Functionality Important 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.

54
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.

55
eRA Commons Profile Maintenance Reminder
  • PIs have an obligation to keep information in
    their Person Profile updated
  • Some data used in other electronic processes
    (e.g., Summary Statements, e-Notifications)
  • Degrees
  • Position Titles
  • Addressese-mail postal

56
Electronic Submission
57
Application Submission
Present
Past
Future
58
Electronic Submission Weve 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
59
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
60
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

61
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

62
Successful R01 Transition
Present
Due to longer processing times, some applicants
resubmitted applications before receiving results
of the prior submission.
63
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

64
SystemToSystem Submissions On 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

65
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)

66
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

67
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.

68
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

69
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
70
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
71
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
72
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

73
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

74
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
75
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!
76
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.
77
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.

78
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

79
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
    reason other 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.

80
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!
81
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

82
Where to Find More Information
Electronic Submission Website at http//era.nih.g
ov/ElectronicReceipt/
83
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 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 service…Enter your own help
ticket!
84
Application Other Reminders
85
Clarification of Limits on Application
Resubmissions http//grants.nih.gov/grants/guide/n
otice-files/NOT-OD-07-015.html
  • Clarifies the number of resubmissions (a.k.a
    revisions or amendments) allowed for a NIH grant
    application provides info on 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).
  • 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

86
NIH Policy on Late Submission of Grant
Applications http//grants.nih.gov/grants/guide/n
otice-files/NOT-OD-06-086.html
  • 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

87
NIH Policy on Late Submission of Grant
Applications Clarification for Multiple PI
Applications http//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. 

88
Applications and Forms Restriction 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
500,000!
NIH Guide Notice, October 16, 2001
http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-02-004.html
89
Calculation of Direct Costs for Caps
Applications that have a limitation on direct
costs are to exclude the facilities and
administrative (FA) costs requested by
consortium participants when determining if the
budget exceeds a direct cost limit.
  • This policy affects
  • Solicited applications
  • Investigator-Initiated applications
  • Modular 250K direct cost calculation
  • This policy does not affect
  • Small Business Innovation Research (SBIR) and
    Small Business Technology Transfer (STTR)
    programs.

NIH Guide Notice, November 2, 2004
http//grants1.nih.gov/grants/guide/notice-files/
NOT-OD-05-004.html
90
Compensation for Graduate Students
  • Ties compensation on research grants to the zero
    level NRSA postdoc stipend in effect at the time
    of award
  • Compensation continues to include salary or
    wages, fringe benefits and tuition remission
  • No adjustments will be made to noncompeting award
    levels or future years
  • Grantees may rebudget to accommodate the higher
    level
  • This policy was effective with awards issued on
    or after 12/10/2001 http//grants.nih.gov/grants/
    guide/notice-files/NOT-OD-02-017.html

91
Other Support Reminder
  • NIH requires complete and up-to-date other
    support information before an award can be made
  • Complete means all sources of research support
    (including Federal and non-Federal support)
  • Grantees must report changes in other support as
    part of the annual progress report
  • NIH Guide, February 13, 2003
    http//grants.nih.gov/grants/guide/notice-files/NO
    T-OD-03-029.html

92
Person Months FAQs http//grants.nih.gov/grants/
policy/person_months_faqs.htm
  • Definition of person months?
  • Metric for expressing the effort (amount of time)
    that PI(s), faculty and other senior personnel
    devote to a specific project.
  • Effort based on organization's regular academic,
    summer, or calendar year.
  • How do you calculate person months?
  • Multiply the percentage of your effort times the
    number of months of the appointment. For
    example
  • 10 of a 9 month academic year appointment equals
    .9 person months (9 x .10 .9 person months)
  • 10 of a 12 month calendar appointment equals 1.2
    months (12 x .10 1.2 person
    months)
  • How do I know if Im over committed?
  • Personnel with over 12 person months would be the
    indicator of over- commitment (i.e. 12 person
    months translates to 100 effort).
  • Actual figures for person months should be
    included in appropriate columns do not round up
    or down.

93
Non-Competing Continuation Progress Reports
  • REMINDERDont Be Late!
    A
    recent OIG study concluded that major
    contributing factors to late awards were late
    and/or incomplete progress reports.
  • An annual progress report is due two months
    prior to anniversary date.
  • All grantees have access to searchable list of
    due progress reports at http//era.nih.gov/user
    reports/pr_due.cfm
  • NIH e-mails 2 progress report reminders to the
    PI
  • Two months prior to the due date
  • Two weeks after the due date for overdue report
  • NIH Guide, August 5, 2003
  • http//grants1.nih.gov/grants/guide/notice-files/N
    OT-OD-03-054.html
  • Centralized Receipt of ALL NIH Progress Reports
    effective 10/1/04
  • http//grants.nih.gov/grants/guide/notice-files/NO
    T-OD-04-054.html

94
Applications and Forms Questions and Contacts
  • Dedicated e-mail address for questions on format
    format_at_mail.nih.gov
  • Additional Forms Formatting Contacts
  • For questions relating to application/forms
    submission and policy, please contact
  • NIH GrantsInfo Office at grantsinfo_at_nih.gov or
    (301) 435-0714 http//grants.nih.gov/grants/forms.
    htmhelp.
  • For technical assistance regarding the use of the
    PHS forms
  • E-mail the PHS Forms Help Desk at
    phsforms_at_peacetech.com.
  • For additional questions concerning format
    specifications, (e.g., font typeface and size,
    line and character spacing per inch, page limits,
    and margins)
  • E-mail the following dedicated address at
    format_at_mail.nih.gov.

95
Closeout Final Reports
Reminder!
  • Grantees are strongly encouraged to submit
    closeout documents electronically through the eRA
    Commons!
  • http//grants2.nih.gov/grants/guide/notice-files/N
    OT-OD-05-051.html
  • Documents are due within 90 days of project
    period end date
  • Final Financial Status Report (FSR)
  • Final Inventions Statement Certification
  • Final Progress Report
  • Failure to submit timely reports may affect
    future funding to the organization!

96
R13 U13 Acknowledgement of Funding Source and
Disclaimer
Reminder
  • 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."

97
Public Access Policy
  • NIH-funded investigators are requested to submit
    to the NIH National Library of Medicine's (NLM)
    PubMed Central (PMC) an electronic version of the
    author's final manuscript upon acceptance for
    publication, resulting from research supported,
    in whole or in part, with direct costs from NIH.
  • Applies to
  • Currently funded NIH research projects
  • Previously-supported NIH research projects if
    they are accepted for publication on or after May
    2, 2005.
  • Does Not Apply to
  • Book chapters, editorials, reviews, or conference
    proceedings.
  • Publications resulting from non-NIH-supported
    research projects should not be submitted

Note In an effort to drive knowledge activities
and achieve science management goals, the NIH
strongly encourages the Research community to
respond to this request.
Effective May 2, 2005
98
Public Access Policy Resources
  • Public Access Policy Website
    http//publicaccess.nih.gov/
  • NIH Policy Overview Public Access
    http//publicaccess.nih.gov/overview.htm
  • NIH Manuscript Submission (NIHMS) System
  • http//www.nihms.nih.gov/
  • Public Access Policy in the NIH Guide
  • http//grants.nih.gov/grants/guide/notice-files/N
    OT-OD-05-022.html
  • Authors Manual
  • http//publicaccess.nih.gov/publicaccess_manual.h
    tm
  • Final NIH Public Access Policy Implementation
    http//publicaccess.nih.gov/publicaccess_imp.htm
  • Questions and Answers http//publicaccess.nih.gov
    /publicaccess_QandA.htm
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