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NIH Update - Fall 2007

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NIH Update - Fall 2007 Powered By Docstoc
					NIH Update – Fall 2007
              Marcia Hahn
           hahnm@od.nih.gov
               Pam Gilden
           gildenp@od.nih.gov
 Office of Policy for Extramural Research
         Administration/OER/NIH
                                            OPERA
NIH Budget News
    and Priorities


              OPERA
            President’s Budget Request
                      FY 2008
    • Requested $28.85
      billion
      • Increase of $232 million
        from FY2007 estimate
    • Estimated 10,188
      competing Research
      Project Grants
      • Approx. 566 over
        FY2007 estimates and
        1000 more than FY2006

3          More at: http://officeofbudget.od.nih.gov/PDF/Press%20info-2008.pdf
             President’s Budget Request
                       FY 2008
    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 RPGs (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

4           More at: http://officeofbudget.od.nih.gov/PDF/Press%20info-2008.pdf
    FY 2008 President’s Budget Request
                           $28.85 Billion

                           Training 3%
           Research Mgmt
            & Support 4%
                                            Research
          All Other 5%
                                            Project
    Other Research
                                            Grants 52%
          6%                                $15.165 B
        Research
      Centers 10%


           R&D Contracts
                10%
                             Intramural
                               Slice 1
                           Research 10%



5
             Current NIH Budget Status

• Continuing Resolution (P.L. 110-92) funds NIH
  and other agencies until November 16.
• NIH will issue non-competing research grant
  awards at ~80% of previously committed level.
    – Similar to FY2006 and FY2007
    – Upward adjustments will be considered after final
      appropriation is enacted.
• Institutions should monitor expenditures
  carefully during this period.
6     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-001.html
                     NIH Award Data By State
            (Data posted for FY 1998 – FY 2006)
       NIH funding data for your               Tennessee:
         state and organizations                FY 2006
            within your state.                                                    Grants
                                              Grant Type         Dollar Amount
                                                                                 Awarded
     Just click on any location on this       Construction            $699,945              1
            interactive map at                Fellowships           $2,500,429         57
    http://grants2.nih.gov/grants/award/trend
                                              Research Grants     $395,265,874        941
    s/State_Congressional/StateOverview.cfm
                                              Training Grants      $16,343,557         55
                                              Other Awards            $789,507              3
                                              Total               $415,599,312       1057

                                                                    Dollars      Cong.
                                              Organization
                                                                   Awarded       District
                                              Vanderbilt Univ.    $268,470,667              5
                                              Univ. of Memphis      $5,572,280              9


7              More Award Trends at: http://grants.nih.gov/grants/award/awardtr.htm
          NIH Ranking Tables Replaced
           with New Web-Based Tool




     Displays the dollars awarded by major component
      or department, as well as by mechanism.
8              More at: http://grants.nih.gov/grants/award/trends/FindOrg.cfm
              NIH Priority: Roadmap for
                  Medical Research
• “Version 1.5” Builds on Success of Original Roadmap
• NIH is Focusing on Three Roadmap “Themes”:
   – Research Teams of the Future
   – Re-engineering the Clinical Research Enterprise
   – New Pathways to Discovery
     •   Building Blocks, Biological Pathways, and Networks
     •   Molecular Libraries and Imaging
     •   Structural Biology
     •   Bioinformatics and Computational Biology
     •   Nanomedicine
     •   Human Microbiome Project – New in 2007!
     •   Epigenomics – New in 2007!
9                                    More at: http://nihroadmap.nih.gov
                 NIH Priority: Blueprint for
                  Neuroscience Research
     • Cooperative effort among 16 ICs to accelerate
       Neuroscience research.
     • RFAs in 2007, 2008, and 2009 will focus on three
       themes, respectively:
        – Neurodegeneration during disease and aging;
        – Neurodevelopment throughout the lifespan; and
        – Neuroplasticity, from molecular to behavioral levels.
     • Available neuroscience resources include: animal
       models; imaging tools; neuroinformatics
       (computational biology); core facilities; cells, tissue,
       and DNA; gene and protein expression; and
       training.
10                               More at: http://neuroscienceblueprint.nih.gov
     NIH Priority: Continued Focus
         on New Investigators




11   Available at: http://grants1.nih.gov/grants/new_investigators/index.htm
             NIH/CSR Shortens Review
               for New Investigators
• New investigators unsuccessful in a R01 grant submission who
  are readily able to address the concerns and issues identified
  in the Summary Statement may shorten the time to the next
  review.
• Available for all CSR study sections reviewing new investigator
  R01 applications submitted for standard receipt dates (not
  including RFAs and PARs with special dates).
• Policies and practices include:
   – Resubmission applications to be considered at the next
     cycle must be submitted by March 20, July 20, or November
     20.
   – New Investigators who do not choose this option may use
     the standard resubmission dates for subsequent
     submissions (March 5, July 5, or November 5).

12   More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html
               NIH Director’s
         New Innovator Award (DP2)


     • Stimulates highly innovative research.
     • Supports promising new investigators.
     • Awards will provide up to $1.5 million in direct
       costs for (up to) a 5 year project period.
     • Highly Popular: NIH received nearly 2,200
       applications.
     • Currently reviewing lessons-learned for future
       opportunities.
13       More at: http://grants.nih.gov/grants/new_investigators/innovator_award
               Pathway to Independence
                     (K99/R00)
     • Facilitates timely transition from mentored postdoctoral
       research to independent research position at earlier stage.
     • Primary, long-term goal 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 (February 12, June 12,
       October 12)
     • Program Announcement PA-07-297

14       Qs and As at: http://grants.nih.gov/grants/new_investigators/QsandAs.htm
              NIH Director’s Bridge Award
                         (R56)
     • Continued, limited funding for new and established PIs who
       have submitted a competing renewal, who just miss the
       nominal funding payline for the IC.
     • Additional funded time for PIs to strengthen a resubmission.
     • Selectees receive one-year of funding up to $333,000 DC +
       applicable F&A

     • Cannot apply, cannot self-nominate! Criteria:
        – Must have < $200,000 in other support (total costs) from
          all sources to fund research
        – No A2s are eligible
        – Applications submitted in FY2006 that are still being
          considered for funding & FY2007 submissions

15       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-056.html
New Scientific and Grants
   Management Policies


                     OPERA
           Enhancing Peer Review at NIH
     • Reviewing strengths and deficiencies of NIH peer review
     • Especially interested in creative suggestions regarding:
        – Challenges of NIH System of Research Support
        – Challenges of Peer Review Process
        – Solutions to Challenges
        – Core Values of NIH Peer Review Process
        – Peer Review Criteria and Scoring
        – Career Pathways
     • Public Consultation Period
        – Regional Consultation Meetings held September/October,
          2007
        – RFI for public comment period in Summer, 2007

17                             More at: http://enhancing-peer-review.nih.gov
                 Centralized NIH Database
                  of Human Genome Data
     •    Facilitates rapid and broad access to Genome-Wide
          Association Study (GWAS) datasets
     •    Policy addresses:
         – Principles governing the repository
         – Data sharing procedures and requirements
         – Research participant protection and privacy
         – Data Access Committees
         – Intellectual property and publication rights
         – Oversight and governance of repository
     •    Policy effective for applicants submitting 1/25/08
            http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-
                088.html

18                            GWAS Website: http://grants.nih.gov/grants/gwas
          Multiple Principal Investigators
               Supporting Team Science


     Goal: Encourage collaboration 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


19
                        Multiple Principal
                      Investigators (Cont.)
     • Available to all research grant applications
       submitted electronically through Grants.gov.
     • Does not apply to the following types of
       applications (Note: The restriction to a single PI
       will be described in FOAs for those programs.)
        – Individual Career Awards, Fellowships,
          Dissertation Grants, Director‟s Pioneer Awards,
          Construction Grants, and Shared
          Instrumentation Grants
     • Some PHS 398 applications submitted on paper
       will allow inclusion of multiple PIs, but only when
       clearly specified in the RFA or PA.
20      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html
                      Limits on Application
                         Resubmissions
     • Applicants often ask, “What constitutes a New
       Application?”
       – Substantially different in content and scope
       – Includes substantial changes in all sections of the
         Research Plan
       – Includes 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/policy/resubmission_q&a.htm

21      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-015.html
                    NRSA Pilot:
              Funding Policy for NRSA
 • FY2008 Update: No changes to levels announced
     in NOT-OD-06-093
 • Institutional Training Grants (T32, T34, T35,
   and T90)
     – Effective for new & competing renewals beginning in
       FY 2007, and non-competing awards in FY 2007 that
       were awarded as competing in FY 2006
     – Tuition & Fees: Formula provides 60% of the level
       requested by the applicant institution up to a specified
       cap.
     – Training Related Expenses: Funds per trainee
       increased and includes health insurance.
22    More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-057.html
             NRSA Pilot: Funding Policy
                 for NRSA (Cont.)
• Individual Fellowships (F30, F31, F32, F33,
  and F34)
     – Effective for awards beginning 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 includes health insurance.




23     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-057.html
                Institutional Training Grants
Institutional Training Grants
Award                     PREDOCTORAL                              POSTDOCTORAL
Category
                     OLD              NEW                    OLD                  NEW
Stipend         $20,772          $20,772            $36,996 - $51,036    $36,996 - $51,036
Tuition/Fee     $3,000 + 60%     60% up to          $3,000 + 60% above   60% up to $4,500
                above $3,000     $16,000            $3,000 (includes     60% up to $16,000
                (includes        60% up to          health insurance)    for additional
                health           $21,000 for dual                        degree
                insurance)       degree
Training        $2,200           $4,200             $3,850               $7,850
Related                          (includes health                        (includes health
Expenses                         insurance)                              insurance)
Trainee         $400 - $1,000 (typical range; varies by NIH awarding component)
Travel
(per trainee)
F&A (Old)       8% (excludes tuition/fees/health insurance, equipment)
F&A (New)       8% (excludes, tuition/fees, equipment)

24
                    Individual Fellowships
Individual Fellowships
Award                    PREDOCTORAL                 POSTDOCTORAL
Category
                     OLD           NEW             OLD               NEW
Stipend         $20,772        $20,772       $36,996 -          $36,996 -
                                             $51,036            $51,036
Tuition/Fees    $3,000 + 60%   60% up to     $3,000 + 60%       60% up to
                above $3,000   $16,000       above $3,000       $4,500
                (includes      60% up to     (does not          60% up to
                health         $21,000 for   include health     $16,000 for
                insurance)     dual degree   insurance)         additional
                                                                degree
Institutional   $2,750*        $4,200*       $7,000*            $7,850*
Allowance       $1,650**       $3,100**      $5,900**           $6,750**
                               (includes     (includes health   (includes health
                               health        insurance)         insurance)
                               insurance)

25
                  Current NIH Salary Cap
                         $186,600
     • Effective January 1, 2007, salary and wages on
       NIH grants limited to $186,600.

     • Stay tuned for FY 2008 cap requirements.

     • Grantees should provide information on full
       salary needs (if more than the cap) so NIH can
       adjust based on future limits.

     • Salary Cap Summary (Historical Information):
       http://grants.nih.gov/grants/policy/salcap_summa
       ry.htm
26     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-051.html
              New: Notice of Award (NoA)

     • Now a PDF attachment to an e-mail (no longer
       e-mail text)
     • Improves formatting and function (long terms
       can now be accommodated)
     • Summary & cumulative data provided when a
       separate supplement award has been issued
     • E-mailed to address designated in eRA
       Commons
     • NIH is working to eliminate hard copy mailing of
       all NoAs.
27     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-060.html
          Elimination of Paper Notification of
                Award Letters (NoAs)
     • As of January 1, 2008, NIH will no longer
       provide paper notification of NoA letters.
     • NoAs will be sent solely by e-mail and award
       letters will be accessible through the eRA
       Commons.
     • All award recipients must be e-mail enabled!
       – Edit your institutional profile in the eRA
         Commons.
       – If already enabled, confirm that the address is
         correct.
28      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-002.html
                       Electronic FSR
                     Submission Required
     • As of October 1, 2007, NIH requires all
       Financial Status Reports (FSRs) to be
       submitted using the electronic FSR
       system in the eRA Commons.
     • Applies to both domestic and foreign
       grantees.
     • Does not apply to other Federal
       agencies.
29     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-078.html
           Federal Funding Accountability
           and Transparency Act (FFATA)
     • NIH is actively involved with a variety of Federal-
       wide committees to implement the act and is
       tailoring processes to meet its requirements.
     • Federal Funding Accountability and Transparency
       Act (P.L. 109-282) requires reporting of all
       subrecipient awards above $25,000.
       – Requires information on every grant, including 1) the
         amount, 2) descriptive purpose of the grant, and 3) name
         and location of recipient of primary performance location.
       – Potential increased attention and scrutiny when data is
         made publicly available.
30                                      More at: www.FederalSpending.gov
       Highlights of New and
Existing Grant Requirements


                        OPERA
             Financial Conflict of Interest
                        (FCOI)
     • Targeted Site Reviews were a 2006 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 NIH‟s FY 2006 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/notice-
          files/NOT-OD-07-048.html

32                     FCOI questions for NIH?   FCOIcompliance@mail.nih.gov
                            FCOI
                  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 Investigator’s 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 individual‟s role, rather than title, and their degree of
       independence when applying the definition.

33
                    FCOI Summary of
                 Reporting Requirements
     1. At the time of application: Investigators must
        submit significant financial interests to the
        institution.
     2. 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.
     3. 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.

34     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-013.html
            Protecting Research Subjects
     Protecting Research Subjects from Harm Caused by
     Financial Conflicts of Interest
     • Guidance entitled, "Financial Relationships and Interests
       in Research Involving Human Subjects: Guidance for
       Human Subject Protection," published May 12, 2004.
        • Applies to all human subjects research conducted or
          supported by HHS agencies or regulated by the FDA.
     • Intended for:
        – Institutional Review Boards (IRBs)
        – Investigators
        – Research institutions
        – Other interested parties
35              More at: http://www.hhs.gov/news/press/2004pres/20040512.html
             Pilot FCOI Compliance Program
     • NIH will select a number of institutions for review of
       their FCOI policy and related information.
        – Based on 42 CFR Part 50, Subpart F: Responsibility of
          Applicants for Promoting Objectivity in Research for
          which PHS Funding is Sought
        – These are desk reviews, not site visits
        – Areas of noncompliance will be noted and must be
          resolved with the NIH Division of Grants Compliance
     • Results of the pilot program will be shared with the
       NIH research community for educational purposes
       to enhance and improve FCOI compliance.

36      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-010.html
           FY 2008 OIG Audit Work Plan
                     Selected Highlights
 • Colleges‟ and Universities‟ Compliance with Cost
   Principles
     – May include cost transfers, effort reporting, and other
       areas in OMB Circular A-21.
 • University Administrative and Clerical Salaries
     – Are salary costs appropriately charged?
 • NIH Monitoring of Extramural Conflicts of Interest
     – How NIH monitors extramural grantees‟ financial conflicts
       of interest and the effectiveness of NIH‟s oversight.


37            FY 08 Work Plan: http://oig.hhs.gov/publications/workplan.html#1
                  Audit Requirements

     • All NIH grantees that expend $500,000 or
       more within a year in Federal awards are
       subject to an audit requirement.
     • Audits are due no later than 9 months after
       the end of the grantee‟s audit period.
     • Grantees delinquent in submitting audits risk
       the imposition of sanctions and potential loss
       of Federal funds.

38
               Summary of Audit Requirements
     Grantee Type      Source of Audit       Where to Submit Audit Reports
                        Requirement
     State & Local    OMB Circular A-133          Federal Audit Clearinghouse
     Governments                                  1201 E. 10th Street
     Colleges &                                   Jeffersonville, IN 47132
     Universities                                 Questions:
     Non-Profits                                  1-800-253-0696
     Hospitals
                                             National External Audit Review Center
     For-Profits                             HHS Office of Audit Services
                     45 CFR Part 74.26 (d)   323 West 8th Street
                                             Lucas Place, Room 514
                                             Kansas City, MO 64105
                                             Phone: 800-732-0679/816-374-6714


     Foreign         NIH Grants Policy
                     Statement (same as          (same as For-Profits)
39
                     For-Profits)
                           Compensation for
                           Graduate Students
     •   Policy 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 are made to noncompeting award
         levels or future years.
     •   Grantees may rebudget to accommodate higher
         level of postdoc stipend in subsequent years.

40        More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html
                    Closeout Final Reports
       Grantees are strongly encouraged to submit closeout
       documents electronically through the eRA Commons!

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

41     More at:http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-051.htm/
            NIH Policy on Data Sharing
          Investigators
     submitting a research
     application requesting
      $500,000 or more of
       direct costs, in any
      single budget period
     to NIH, must include a
      plan for sharing final
        research data for
     research purposes, or
     state why data sharing
         is not possible.
42
                NIH Policy on Data Sharing
                          (cont.)
 Resources
 • Data Sharing Main Page http://grants.nih.gov/grants/policy/data_sharing
 • Data Sharing Chart: Quick guide for the purpose of identifying
   various data sharing regulation/policy/guidance documents
   applicable to NIH funding
     http://grants.nih.gov/grants/policy/data_sharing/data_sharing_chart%20.doc
 • NIH Guide Notice, 2/26/03: Final NIH Statement on Sharing
   Research Data http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-
     032.html
 • NIH Guide Notice,10/16/01: Revised Policy on the
   Acceptance for Review of Unsolicited Applications that
   Request $500,000 or More in Direct Costs
     http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html

43
        NIH Policy on Sharing of Model
      Organisms for Biomedical Research



               Investigators submitting an NIH
       application/proposal are expected to include a
      specific plan for sharing and distributing unique
       model organism research resources generated
     using NIH funding in the application/proposal OR
     state appropriate reasons for why such sharing is
                  restricted or not possible.
      FAQs and sample sharing plans available at:
      http://grants.nih.gov/grants/policy/model_organism/index.htm

44   More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html
Animal Welfare Requirements
 and Compliance Assistance


                       OPERA
                       OLAW
                Compliance Assistance
 • “What Investigators Need to Know About the Care and Use of
   Laboratory Animals”
     – Brochure explains the requirements for using animals in
       PHS-supported research
    – Contact OLAW to request multiple copies
 • FAQs on “PHS Policy on Humane Care and Use of
   Vertebrate Animals” available on the OLAW website
 • IACUC 101 is a series of workshops on the roles and
   responsibilities of IACUCs, including federal policies and
   regulations regarding animal welfare.
     – November 29, 2007: Virginia Beach, VA
     – March 26, 2008: Atlanta, GA
46                                           More at: http://olaw.nih.gov
          Policy on UnAllowable Costs for
            Activities Involving Animals
     • Institutions are not permitted to charge grants or
       contracts for animal activities when terms and
       conditions are not upheld, e.g.,
        – Absence/suspension of valid Assurance filed with OLAW
        – Absence/suspension of valid IACUC approval of the animal
          activity:
           • Failure to obtain IACUC approval for animal activity.
           • Continuing animal activities after IACUC approval has expired.
           • Continuing animal activities after suspension of IACUC approval.
     • Institutions must report noncompliant situations to:
        – OLAW (olawdco@mail.nih.gov or 301-594-2061)
        – Institute/Center (IC) supporting the award
47                          More at: Notice NOT-OD-07-044 at http://olaw.nih.gov
             Consortium Agreements:
           Subawards and Animals (Cont.)
     • Prime grantee is accountable to NIH and must confirm
       Assurance and IACUC approval (dated within 3 years)
     • Animal welfare requirements apply to all consortium
       participants and sub-projects
        – Inter-Institutional Assurance is needed:
            • Prime grantee has no animal program; animal work is
              being conducted at an Assured performance site
        – Foreign Assurance is needed:
            • Direct support to a foreign institution
            • Domestic prime grantee with a foreign performance
              site using animals (Domestic grantee‟s IACUC
              approves animal activities performed at foreign site)
48       GPS Page 224 at: http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
Electronic Submission



                 OPERA
          Electronic Submission Status

     • 80% of all competing grant
       applications to NIH are now
       submitted electronically
     • NIH continues to account for over
       50% of all application submissions
       to Grants.gov

50
                    Remaining Transitions

     •   Career Development (K)                     Transitions
     •   Fellowship (F)                            to electronic
     •   Training & Development (T&D)               submission
                                                      on hold
     •   Complex mechanisms
         – NIH, AHRQ and Grants.gov are working together to
           establish new transition dates. A notice announcing the
           adjusted timeline will be issued as soon as possible.
         – For now, applications for these mechanisms will continue
           to be submitted on paper using the applicable forms.

51
          Read & Follow All Instructions!

     • Avoid having to submit corrected
       applications – read and follow all
       application guide and
       announcement instructions
       – Look for the HHS logo in the
         application guide for any special
         instructions or fields not marked as
         mandatory on the federal-wide
         form that are required by NIH
52               More at: http://grants.nih.gov/grants/funding/424/index.htm
                 Avoid Common Errors
     NIH-specific requirements:
     • Use PDF format for text attachments
     • R&R Senior/Key Person Profile(s) form
       – Include eRA Commons Username in the
         “Credential, e.g. agency login” field for all
         individuals assigned a PD/PI role.
       – Include the Organization Name for all Senior/Key
         Persons listed
     • R&R Budget form - Senior/Key Person effort
       must be greater than zero
53            More at: http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm
                 Track Your Application

     • Clicking “Submit” is NOT the last step!
       – It is the applicant‟s responsibility to track the
         application through the submission process
       – Use eRA Commons to check for submission
         errors/warnings and to view your assembled
         application

     • If you can‟t view your application in eRA
       Commons – we can‟t review it!

54                             More at: http://era.nih.gov/ElectronicReceipt/
                     Recent Changes

     • Responded to applicant
       feedback…
       – Improved text of error/warning
         messages
       – Enhanced application guide
         instructions
       – Extended application viewing
         times through Federal holidays


55                          More at: http://era.nih.gov/ElectronicReceipt/
                      Future Changes
     • 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
       – No firm transition date set
     • Reduction of correction window in ERA
       Commons from 5 days to 2 days.
56            More at: http://www.grants.gov/aboutgrants/program_status.jsp
eRA Commons



        OPERA
             Servicing Other Agencies

• Continuing to service HHS partners
     – Agency for Healthcare Research & Quality (AHRQ)
     – Centers for Disease Control and Prevention (CDC)
     – Food & Drug Administration (FDA)
     – Substance Abuse & Mental Health Services
       Administration (SAMHSA)
• New partner
     – Veteran‟s Health Administration (VA)
       • Summer 2007 pilot

58
                         Enhanced
                   eRA Commons Features
     • Electronic Streamlined Non-competing Award
       Process (eSNAP)
       – Changes to Institutional Profile
         Assurances/Certifications
       – Updated to include changes to multi-PI Leadership
         Plan and research with Select Agents
     • Delegation of PI status to assistant for
       reviewing electronic applications
     • Ability to monitor the electronic submission of
       reference letters
59      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-064.html
                  Coming Soon: xTrain

     • xTrain is a new system to improve the
       administration of NIH Training Grants.
       – Allows PIs and staff to electronically submit
         appointment forms and termination notices
       – Allows institutional staff to track status and timing
         of appointment actions
       – Will be available through eRA Commons
     • Pilot - Fall 2007
     • Full production release – Expected early 2008
60
                  Enhanced eRA Commons
                      Features (cont.)
• Updated Status screens (October 26, 2007).
     – Added ability to search and track applications by
       Grants.gov tracking number.
     – Reorganized application/grant data to separate
       applications requiring further action in the
       submission process from all others.


• While the screens may look different, all the
  information you’re used to seeing is still
  available (plus more!)
61     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-007.html
62
                  Profile Maintenance
     • PIs have an obligation to keep information in
       their Personal Profile current and need to
       update it regularly
     • Profile data used in other electronic
       processes (e.g., Summary Statements,
       eNotifications)
       – Degrees
       – Position Titles
       – Addresses - e-mail & postal

63
Technical Assistance and
     Training Resources


                    OPERA
                       SBIR/STTR
                Pipeline to Partnerships
     • Showcase of SBIR/STTR grantee technology
       available to potential strategic partners and
       investors for development opportunities.
     • Searchable index organized by technology and
       stage of development.




65                More at: http://www.ott.nih.gov/p2p/p2p_writeup.html/
              Redesigned OER Web Site

     • Office of Extramural Research home page
       – Links to funding opportunities, grants policy,
         application and forms, awarded grant data
     • Redesign based on focus groups and visitor
       feedback
       – New search tools
       – Comprehensive glossary and acronyms list
       – New content walks through the NIH grant-
         making process
     • Also improved & updated eRA web site
66                         Visit at: http://grants.nih.gov/grants/oer.htm
67   OER web site located at http://grants.nih.gov/grants/oer.htm
               Redesigned eRA Web Site

     • Services for Applicants - 'plain language' fact
       sheets on eRA services
     • Commons - overview, quick link to system,
       user guides, release notes, FAQs and other
       resources
     • NIH & Grantor Agencies - highlights services
       and system modules available for NIH staff and
       other Federal agencies
     • News & Events - eRA updates and info on
       upcoming workshops/seminars
68                                         Visit at: http://era.nih.gov/
                       Summary of
                  Helpful NIH Web Pages
     • NIH Searchable Database of RFAs, PAs, and Guide Notices
        http://grants1.nih.gov/grants/guide/index.html
     • NIH Grants Policy Statement (Rev. 12/03)
       http://grants1.nih.gov/grants/policy/nihgps_2003/index.htm

     • NIH Extramural Nexus – Bimonthly newsletter for the extramural
       community
       http://grants.nih.gov/grants/nexus.htm

     • Electronic Submission of Grant Applications Homepage
       http://era.nih.gov/ElectronicReceipt/index.htm

     • CRISP database - Search to analyze an Institute‟s portfolio of
       funded projects, research areas, and more
       http://crisp.cit.nih.gov/crisp/crisp_querty.generate_screen

     • Grant Application Basics
       http://grants.nih.gov/grants/grant_basics.htm
69
           New OER Outreach Webpage
              New OER Outreach Webpage
     • NIH Regional Seminars on Program Funding and Grants
       Administration
        – Funding Opportunities for New Investigators
        – Application Preparation and the Review Process
        – Grant Administration Issues, Hot Topics, and More…
     • National Animal Welfare Workshops
     • Office of Human Research Protections Workshops
     • NIH Small Business Research Workshops
     • Office of Research Integrity Workshops and Conferences

70                     Visit at: http://grants.nih.gov/grants/outreach.htm
           NIH Regional Seminars on Program
           Funding and Grants Administration

                          2008 Regional Seminars:
                      March 25-26, 2008 in San Antonio, TX
                         June 19-20, 2008 in Chicago, IL
                    NIH electronic research administration labs
                 offered in conjunction with the two-day seminar.
     • Yearly seminars to educate research administrators,
       investigators new to NIH, and trainees.
     • Due to the popularity of these seminars and availability
       of space - Early Registration is Highly
       Recommended!                               Interested in hosting?
     • Seminar and Registration Information:                          Contact us!
       http://grants.nih.gov/grants/seminars.htm
71       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-076.html
                NIH OER Listserv Addresses
                     and Instructions
     •   Office of Biotechnology Activities (OBA):
         – https://list.nih.gov/archives/oba_news.html
     • Office of Human Research Protections (OHRP):
         – http://www.hhs.gov/ohrp/news/distributionlist.html
     • Office of Laboratory Animal Welfare (OLAW):
         – http://grants2.nih.gov/grants/olaw/references/list.htm
     • eSubmission:
         – http://era.nih.gov/ElectronicReceipt/listserv.htm
         – Separate listservs available for scientists and administrators
     • NIH Guide for Grants and Contracts:
         – http://grants.nih.gov/grants/guide/listserv.htm
         – The official publication for NIH medical and behavioral research
           Grant Policies, Guidelines and Funding Opportunities

72
                    Grants Information:
                     Who to Contact!
     • Institutional Resources – First, utilize the
       expertise of your organization‟s Office of
       Sponsored Programs

     Application Specific Questions
     • Administrative - Contact the Grants Management
       Specialist at the awarding Institute/Center
     • Scientific/Programmatic - Contact the designated
       Program Official/Director at awarding
       Institute/Center
     • Review Questions - Contact the assigned
       Scientific Review Officer
73
                       Grants Information:
                        Who to Contact!
     • Grants Administration individuals at all NIH ICs:
         – http://grants.nih.gov/grants/policy/grants_info.pdf
     • NIH Chief Grants Management Officers:
         – http://grants.nih.gov/grants/stafflist_gmos.htm


     • Grants Policy Interpretation & Consultation:
         – E-Mail: GrantsPolicy@mail.nih.gov
         – Phone: 301-435-0949 Toll-Free at (800) 518-4726
     •   Compliance Issues:
         – E-Mail: GrantsCompliance@mail.nih.gov
         – Phone: 301-435-0949 Toll-Free at (800) 518-4726

74
                   Grants Information:
                    Who to Contact!
 • General Application Questions: (e-Submission guidelines,
   resources & referrals, application review & award process,
   etc.)
     – E-Mail:   GrantsInfo@nih.gov
     – Phone:    301-435-0714
 • Customer Support for Grants.gov: (navigating forms, aspects
   of submitting through the system, resources available, etc.)
     – E-Mail: support@grants.gov
     – Webpage: http://grants.gov/
     – Phone: 1-800-518-4726
 • eRA Commons Help Desk: (Commons registration help,
   application verification, Commons functionality questions, etc.)
     – E-Mail: commons@od.nih.gov
     – Webpage: https://commons.era.nih.gov/commons/index.jsp
     – Phone: 301-402-7469 (Toll Free: 866-504-9552)


75
           Thank You!


Any Questions?
                  OPERA
Frequently Asked
      Questions


            OPERA
                        #1 – How do I prepare for
                                  eSubmission?
     • 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.

     It is critical for institutions to begin these registrations
         at least 2 – 4 weeks before applications are due!
78                   More at: http://era.nih.gov/ElectronicReceipt/preparing.htm
                                  #2 – How do I submit a
                                 multiple-PI application?
     • Applications
        – NIH Grant Applications Forms (PHS 398 and SF424 R&R) 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.

79                                       More at: http://grants.nih.gov/grants/multi_pi/
           #3 – Are there any fellowship programs for
          individuals from minority or disadvantaged
                                             groups?
     Yes, but a revised FOA includes the
               following changes:
 •   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 applicant‟s
     eligibility (See FOA for further details.)
 •   Updates information on Tuition/Fees and
     Institutional Allowance, published in the NIH
     Guide: NOT-OD-06-093.
80          FOA at: http://grants.nih.gov/grants/guide/pa-files/PA-07-106.html
                #4 - Does NIH still accept
          unsolicited grant applications?
     Yes, by using Parent Announcements
       – Used for “unsolicited” or “investigator-initiated”
         applications.
       – Available on Grants.gov and NIH web pages.
     • Program Announcements
       – Statement of new or ongoing NIH interest in a
         certain research area.
     • Requests for Applications (RFAs)
       – Statement soliciting applications in a well-
         defined scientific area to accomplish specific
         program objectives.
81              All Available at: http://grants.nih.gov/grants/guide/index.html
                     #5 – Can foreign applicants
                      submit modular budgets?
                                     No.

     • Receiving detailed budgets from foreign
       applications allows NIH staff to assist applicant
       community with applicable regulatory and policy
       requirements for grant funding expenditure.

     • This policy does not affect domestic (U.S.)
       institutions with subawards to foreign (non-U.S.)
       institutions.

82     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-096.html
                   #6 – Are fellowship candidates
           required to register in eRA Commons?
     • Yes, 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 record 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.


83      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-003.html
            #7- Are consortium F&A costs included
              as part of an applicant‟s direct costs?
      No. Applicants are to exclude the facilities and
      administrative (F&A) costs requested by consortium
      participants when determining if the budget exceeds a
      direct cost limit.
     • This policy applies to:
        – $250K direct cost calculation for modular budgets
        – $500K direct cost calculation for NIH data sharing
          policy and requirement to contact IC staff for
          unsolicited applications requesting over $500K
     • This policy does not apply to:
        – Small Business Innovation Research (SBIR) grants
        – Small Business Technology Transfer (STTR) grants

84      More at: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html
                        #8 – Does NIH accept late
                        application submissions?
     • 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 expects grant applications to be submitted on time
     • NIH will not consider accepting late applications for the
       Special Receipt Dates for RFAs and PARs

85     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-086.html
           #9 – Am I allowed to reduce my
                      effort on a K award?
 •   Yes, policy allows recipient to meet required 75%
     commitment of total professional effort as long as:
     –     The individual has a full-time appointment with the applicant
           organization
     –     The minimum percentage of the candidate‟s commitment required
           for the proposed Career award experience is covered by that
           appointment
 •   Grantees may reduce level of effort on most career awards
     in last two years of support and replace with an NIH
     research grant or subproject.
     –     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 >75% for the duration of
           the mentored career award.

86   More at: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html
             #10 – How do I calculate person-
          months in a 9-month academic year?
     • Person months are the metric expressing
       amount of effort faculty and other
       senior/key personnel devote to a project
     • How are person-months calculated?
       – Multiply the percentage of effort by the number
         of months of the appointment. For example:
         • 10% of a 9 month academic year appointment
           equals .9 person months (9 x .1 = .9 person
           months)
         • 10% of a 12 month calendar appointment equals
           1.2 months (12 x .10 = 1.2 person months)
87        More at: http://grants.nih.gov/grants/policy/person_months_faqs.htm
             #11- What are the requirements
            for recombinant DNA research?
     • Institutional Biosafety Committees must review and
       certify proposed recombinant DNA research.
     • Serious adverse events in human gene transfer
       research must be reported promptly!
        – Usually within 15 days, but
        – Within 7 days if life threatening or fatal.
        – Annual reporting is also required.
     • Full text of the guidelines are available:
        – http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.
        – Site also includes available training opportunities.

88      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-067.html
              #12 – Where do I send progress
               reports? Closeout documents?
     • Submit Continuation Progress Reports and
       Closeout Documents (including Final Progress
       Reports) electronically through eRA Commons or;
     • Mail to the appropriate grants specialist or the
       Central NIH unit at:
         Division of Extramural Activities Support
         OER National Institutes of Health
         6705 Rockledge Drive, Room 2207, MSC 7987
         Bethesda, MD 20892-7987 (for regular or US Postal
         Service Express mail)
         Bethesda, MD 20817 (for other courier/express mail
         delivery only)
89
           #13 - Where do I send Fellowship
                      Termination Notices?
     • Termination notices for NRSA Fellowships
       – Submit on Form PHS 416-7
       – Send to Grants Management Specialist listed on
         the NoA.




90
               #14 – Does NIH have a cap on
                           consultant fees?
     • There is no cap on consultant fees and the NIH
       salary cap does not apply.
                         HOWEVER,
     • Grantees must have written policies for paying
       consultants that:
       – Are consistently applied regardless of fund source.
       – Include conditions for paying consultant fees.
     • Consultants must be properly classified.
       – Defined as individuals who provide professional services
         or advice for a fee, but normally are not employees of the
         organization. Includes firms that provide advice or
         services.
91
                         #15 - Am I considered a
                            “New Investigator”?
     • “New” investigators cannot have successfully
       competed as a PD/PI for most research grants.
       – Does not include R03, R15, R21, R55, R66 grants
       – Does not include K01, K08, K22, K23, K30, or K99/R00
         grants

     • PD/PI‟s who did not initially compete for a major
       research grant but were later designated as PD/PI
       are still considered “new”.
     • All PD/PIs must meet the new investigator definition
       to receive special consideration on multi/PI grants.
92
           #16 – How different does a “new
                  application” have to be?
     • Expected to be substantially different in content and
       scope
     • More significant differences than normally
       encountered in resubmission applications.
       – Rewording the Title and Specific Aims not sufficient
       – Incorporating minor changes in response to reviewer
         comments not sufficient
     • Research Plan changes should produce a
       significant change in direction and approach. All
       research plan sections should have substantial
       changes, particularly the Specific Aims and
       Research Design and Methods sections.
93
              #17 – As PI, what happens if I
             change institutions mid-grant?
     • Prior, written approval is required for transferring
       legal and administrative authority for a grant to a
       different organization.
        – Transfer approval is not automatic and requires
          approval from both NIH and the original grantee
          organization.
        – Contact your GMO before moving to initiate the transfer
          process.

     • Grants to individuals may not be transferred but
       individual fellowships may transfer to a new
       sponsoring institution.
94

				
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