Why_Not_Explore_TransNIH_Initiatives by liwenting


									  Why Not Explore
Trans-NIH Initiatives?
Dr. Alicia Dombroski, Director DEA, NIDCR

Dr. Pamela McInnes, Director DER, NIDCR

Dr. Kevin Hardwick, Chief, Research Training and Career
                           Development Branch, NIDCR

Dr. Renée Joskow, Dental Officer, NCRR

Dr. Emily Harris, Chief Translational Genomics Research
                         Branch, NIDCR
         Session Outline
1)American Recovery and Reinvestment Act
  (ARRA) Opportunities

2) NIH Office of the Director (OD) Programs

3) Other Trans-NIH Programs

4) New Principal Investigator/Early Stage
   Investigator Policies
  American Recovery and Reinvestment Act
(ARRA)- Impact of Economic Stimulus on NIH
NIDCR is grateful to President Obama and Congress for the
opportunity for NIDCR to play its part in improving the Nation’s
health and economy
American Recovery and Reinvestment Act
   (ARRA) Opportunities Overview
Fund the best science while stimulating the economy

 Recovery Act provides NIH with $10.4 billion for 2

 $8.2 billion to support scientific research priorities

$7.4 billion transferred to Institutes and Centers, and
          the Common Fund (CF)
 $800 million to OD, not including CF
 $1 billion for Construction, Repairs and Alterations

 $300 million for Shared Instrumentation

 $500 million for NIH buildings and facilities

 $400 million for Comparative Effectiveness

Investment in Scientific Research and Facilities:

Support for the construction of new research and
educational facilities as well as groundbreaking
scientific research that will improve the health of
the nation.
              Funding Impact
 Stimulatethe economy
 Create and preserve jobs
 Advance biomedical research
Scientific Research Approach
    Stimulate and accelerate biomedical research with
     existing mechanisms
        Funding additional meritorious RO1s, R21s and R03s that
         have been peer reviewed and approved by IC Councils
        Administrative supplements to accelerate ongoing research
    Expand science with new programs
        Revisions to extant programs (“Competitive supplements”)
        New ARRA NIH-wide programs
        New ARRA IC-specific programs
Opportunities Available
New ARRA NIH-wide Programs
    Challenge Grants
    Grand Opportunities (“GO” Grants)
    Recruit new faculty to conduct research
    Provide summer jobs for high school / college
     students and teachers to work in science labs
    AREA (R15) Grants
    Supplements
       Challenge Grants
 Atleast $200M total to address
 priority avenues of research
        Challenge Grants
   Up to $500K total costs/year for up to two

   45 Topics identified by NIDCR

   10 are high priority *

   April 27, 2009 receipt date

   CSR cluster review
Grand Opportunity Grants
 Grand Opportunity (GO) Grants (at
 least $200M total):
    High impact
    Well defined
    Large scale
                 “GO” Grants
    8 Topics identified by NIDCR

1.   Testing Mechanisms of Action Hypotheses in Behavioral
     and/or Social Interventions
2.   Treatment of Tobacco and Drug Dependence in Multiple
     Dental Clinics
3.   Validation of Biomarkers of Oral Diseases or Salivary
4.   Detection of Oral Premalignant and Malignant Lesions
5.   Genome-wide studies in Craniofacial, Dental and Oral
     Conditions: Data Generation, Analysis and Integration
6.   Multidisciplinary Approaches to Craniofacial Regeneration
     and Preclinical Testing
7.   Oral Cancer Genome Analysis
8.   Human Pain Phenotypes and Pain Circuitry

    April 27, 2009 letter of intent receipt date
    May 27, 2009 receipt date
    IC peer review
Administrative Supplements
   NIDCR Strategic Plan 2009-2013
   List of interests on NIDCR website
   Priority to requests under $100,000
   Receipt date June 1, 2009
   Eligible: All mechanisms except Fs,
    T32, L30/40, R13/U13, R25
   Up to $12M to the ARRA supplement
    program – 65% to the Collaborative
    Sciences Program
Administrative Supplements for
   Collaborative Science
   Enable NIDCR-funded investigators to form
    new collaborations to promote the discovery
    of novel insights required to achieve
    significant research advances.
   Must be within scope of the approved aims
    of the parent award.
   Existing collaborations not eligible.
   Up to $120,000 total direct annual costs for
    the first collaboration. An additional $60,000
    for a second collaborating group.
   Term is up to duration of the grant.
   Eligible: R01, R15, R37, P01, P50, R42,
    R44, U01, U19, U54
       Competing Revisions
 To  support a significant expansion of
  the scope of approved and funded
 Requests must be consistent with
  the goals of the Recovery Act.
 Up to $10M to the Competing
  Revision program.
 Eligible: All mechanisms except Fs,
  Ks, T32, L30/40, R13/U13, R25
 Summer Jobs in Research for
   Students and Teachers
 Engage  students and educators in
 Encourage students to pursue research
 Provide summer internships at NIH-funded
  laboratories for science teachers
    ARRA Summer Student Supplements

   Notice OD-09-060
   To further science of parent research grant
   High school and undergrad students
   High school, community college teachers, faculty
    from non-research intensive universities
   Dental students allowed
   NOT substitute for T35/T32 summer training program
   No post-docs
             New Faculty
     Centers for Enhancing Research
 Core
 Capacity in U.S. Academic Institutions
     Newly trained scientists
     Start-up packages
     Pilot research projects
     Supporting New Faculty Recruitment to
      Enhance Research Resources through
     Biomedical Research Core Centers (P30)

   RFA OD-09-005
   Develop a Center for conducting research in a specific
    scientific topic or problem
   Recruit and hire new tenure-track research faculty to
    develop and conduct this research
   “awards will be directed towards hiring investigators and
    providing appropriate start-up research resources (e.g.,
    research salary, equipment, and supplies for initiating
    their research) that will help strengthen or expand the
    scientific capacity of the Biomedical Research Core
    Center. ”
             Core Center
       defined scientific/research purpose

New independent
tenure-track faculty       Salary (75% protected
hired and appointed        research effort)
to the Core Center to
develop and conduct
research projects          Start-up package
which fit the
purpose/mission of
                           Funds for research
the Center
         NIH P30: Supporting New Faculty
        Development to Enhance Research
         Productivity through Biomedical
              Research Core Centers
   $500,000 per year for two years (direct costs)
       Salary
       Start-up costs, including supplies, equipment and support for
        technical personnel
       Research costs to conduct projects within scientific mission of

   Joint appointment, with at least 75% protected research
   Priority given to applications offering commitment
    beyond the 2-year duration of the grant
      NIH P30: Supporting New Faculty
     Development to Enhance Research
      Productivity through Biomedical
           Research Core Centers
New faculty hired through P30

   Appointed to independent tenure-track (or equivalent)
    research position at the Assistant Professor level with at
    least 75% protected research time
   New to the faculty and not previously held a tenure-track
    research appointment
   Record of research training and career development in a
    research area relevant to the primary mission of the
    Core Center
      NIH P30: Supporting New Faculty
     Development to Enhance Research
      Productivity through Biomedical
           Research Core Centers
New faculty hired through P30
   Receive joint appointment(s) with other
    academic unit(s) at the institution, allowing
    access to University-wide research resources
    and core facilities, and to serve as mentors for
    graduate programs affiliated with other
    academic unit(s)
   Receive a start-up package, including supplies,
    equipment and support for technical personnel
NCRR Initiatives

        Renée W. Joskow, D.D.S., M.P.H., FAGD
            CAPT, U.S. Public Health Service
                      Dental Officer (Research)
     Division for Clinical Research Resources
     National Center for Research Resources
    National Center for Research
NCRR will administer more than
 $1.6 billion in federal grants in the
 following areas:$1 billion for
    construction, repair and renovation of
       research facilities
   $300 million for shared instrumentation and
    other capital research equipment
   Up to $310 million in support of biomedical
    research priorities
American Recovery and Reinvestment Act
   (ARRA or Recovery Act) of 2009
   Four related Funding Opportunity Announcements
    (FOAs) have been released in response to the
    Recovery Act
      Two for instrumentation

         • PAR-09-028 Shared Instrumentation (SIG Program)
         • PAR-09-118 High End Instrumentation (HEI Program)
       Two that allow alterations and repairs
         • RFA-RR-09-008 (supports construction, renovation
           and repair improvement projects; C06 mechanism)
         • RFA-RR-09-007 (supports core facilities improvement
           projects; G20 mechanism)
Shared and High-End Instrumentation
     Program (S10): Overview
   Unique and critical NIH mechanisms
   Provide funding in cost-range from $100k to $8.0M
      SIG Program (funding range $100k to $500k)-

      HEI Program (funding range $600k to $8.0M)-

   Equipment which is too costly to obtain with regular
    NIH research grants
   Highly cost-effective mechanisms
   Instruments placed in core facilities
   Shared by an average of 8-10 grantees
    High End Instrumentation (S10)
   Program Announcement: PAR-09-118
   Notice update: NOT-RR-09-008
   Single major item of equipment
   $600k – $8.0 Million
      Deadline May 6, 2009

   One Year
   No limit on number of applications
   3 or more NIH-funded users
   Approximately $160 Million in FY2010
   Two levels of review
        Extramural Research Facilities
         Improvement Program (C06)

   To construct, renovate or repair biomedical
    or behavioral research extramural facilities.
   Provides $2 – 15M for direct costs that
    improve non-federal basic and clinical
    research support
      No more than 3 applications per

      Project period not to exceed 5 years
 Extramural Research Facilities (C06)
What are the application deadlines?
 The  receipt date of May 6, 2009, is for
  projects between $2 million and $5 million.
 The receipt date of June 17, 2009, is for
  projects between $10 million and $15
 The receipt date of July 17, 2009, is for
  projects between $5 million and $10
     Core Facility Renovation, Repair and
            Improvement (G20)
   To renovate or repair extramural core facilities to support
    biomedical and/or behavioral research, funded by the
    U.S. Public Health Service (PHS)
      A core facility is defined as a centralized shared

       resource that provides access to instruments or
       technologies or services, as well as expert
       consultation to NIH-funded investigators.
      Deadline for applications is Sept. 17, 2009

      Budgets between $1 million and $10 million may be

      No more than 2 applications per institution
        Comparison of G20 and C06 RFAs

Item                           RFA-RR-09-007                        RFA-RR-09-008
                               (Core facilities)                    (Construction etc.)
Mechanism                      G20                                  C06

Budget/application (direct     $1 - 10 Million                      $2 - 15 Million
cost only)

Number of applications/per
institution*               no more than 2                           no more than 3

                          general purpose & fixed                   fixed equipment only
Type of equipment allowed equipment

Equipment maximum              up to $100K for specialized          Not Applicable
*An institution is defined as an organization with a separate IPF code identifier.
Comparison of G20 and C06 RFAs (II)
Item                    RFA-RR-09-007        RFA-RR-09-008
                        (Core facilities)    (Construction, etc.)

New construction, and   No                   Yes
completion of shell
Receipt date(s)         September 17, 2009   May 6, 2009 ($2 – 5 M)
                                             June 17, 2009 ($10 – 15 M)
                                             July 17, 2009 ($5 – 10 M)

Award start dates       July 2010            December 2009 & April 2010
Green technology &      Yes                  Yes
design approaches

Creation/retention of   Yes                  Yes
American jobs
        ARRA/Recovery Act Construction
   C06/G20 Applicant Help Videocast
      CO6

         • RFA: http://grants.nih.gov/grants/guide/rfa-
         • FAQs: www.ncrr.nih.gov/C06_Q&A.asp
      G20

         • RFA: http://grants.nih.gov/grants/guide/rfa-
         • FAQs: www.ncrr.nih.gov/G20_Q&A.asp
   NIH Enhancing Peer Review Web site
         • http://enhancing-peer-review.nih.gov/
             NCRR Challenge Grants
   Bioethics
      02-RR-101* Recontact Issues in Genotype and Genome-

       Wide Association Studies
      02-OD(OSP)-103* Ethical Issues Associated with Electronic
       Sharing of Health Information
   Comparative Effectiveness Research
      05-RR-101* Build CER Capacity Through Education
      05-RR-102* Support Pilot CER Projects in Community
   Enabling Technologies
      06-RR-101* Virtual environments for Multidisciplinary and

       Translational Research
      06-RR-102* Infrastructure for Biomedical Knowledge
       NCRR Challenge Grants (II)
 Information Technology for Utilizing Health Care
  Data Research
    10-RR-101* Information Technology

     Demonstration Projects Facilitating Secondary
     Use of Healthcare Data for Research
 Translational Science
    15-RR-101* Applied Translational Technology

    15-RR-102 Develop a Nationwide Electronic

     Material Transfer Agreement (MTA) Database
The application due date is April 27, 2009
     Competitive Revision Applications

   Investigators and U.S. institutions and
    organizations with active NIH funded
    investigator-initiated awards (R01, R33, R37,
    R21, U01) reviewed by the Center for Scientific
    Review (CSR) to leverage the resources,
    expertise, and infrastructure of the NCRR
    centers and center-like programs through
    significant expansion of the scope or research
    protocol of approved and funded projects.
   Deadlines are: April 21, 2009 or July 10, 2009
     Centers and Center-like Programs

   Animal and Biological Material Resources
   Biomedical Technology Research Centers
   Clinical and Translational Science Awards
   General Clinical Research Centers
   Institutional Development Award
   National Primate Research Centers
   Research Centers in Minority Institutions
   Science Education Partnership Awards
      Administrative Supplements for
             NCRR Awards
   Investigators and U.S. institutions or
    organizations with active NIH research grants
    may request administrative supplements for
    the purpose of accelerating the tempo of
    scientific research on active grants.
   The NCRR administrative supplement
    application due date is May 18, 2009
   Can apply for up to two years of support
    Administrative Supplement Priorities
   Administrative Supplements to Advance Translational
    (T1 & T2) Research
   Administrative Supplements for the CTSA Consortium
    Strategic Goals
   Administrative Supplements for Enhancing NCRR Pilot
    Project Mechanism
   Administrative Supplements for Collaborative
    Community Engagement Research
   Administrative Supplements for Research Workforce
    Development and Dissemination
   Administrative Supplements for Science Education and
Estimated Proportions of NCRR ARRA Funding
for Administrative Supplements
NCRR Funding Opportunities

Renée W. Joskow, D.D.S., M.P.H., FAGD
    CAPT, U.S. Public Health Service
        Dental Officer (Research)
Division for Clinical Research Resources
National Center for Research Resources
     Stimulating the economy
   Creating and preserving jobs
  Advancing biomedical research
  Improving people’s health
      NIH Office of the Director Programs:
           “The NIH Common Fund”

• Codified into law by 2006 NIH Reform Act

•    Purpose: to support cross-cutting, trans-NIH
    programs that require participation by at least two NIH
    Institutes or Centers

• Typically involves initiatives (RFAs and policy
  changes) developed by multiple NIH Institutes or

• Centerpiece is NIH Roadmap for Medical Research
Main Goals of the NIH Roadmap:

1) Foster high-risk/high-reward research

2) Enable the development of transformative tools and

3) Fill fundamental knowledge gaps

4) Change academic culture to foster collaboration
Example Initiatives from the NIH Roadmap:

• Roadmap Transformative R01 Program

  •     NIH Director’s Pioneer and New Innovator Programs
      (DP1 and DP2)

  •    Multiple Principal Investigator Policy Change

  •    Clinical and Translational Science Awards
High-Risk/High-Reward Research:

1) Transformative R01 (T-R01) Program
    • “exceptionally innovative, high risk, original and/or
      unconventional research with the potential to
      create new or challenge existing scientific
      paradigms. Projects must clearly demonstrate
      potential to produce a major impact in a broad area
      of biomedical or behavioral research”
           Human behavior change
           3-dimensional tissue models
           Transitions from acute to chronic pain
       •  Due Jan 29, 2009; $25 million for up to 60
   •   http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-
High-Risk/High-Reward Research:

2) NIH Director’s Pioneer Award (DP1)
   • Purpose: to support individual scientists of
      exceptional creativity at any career stage who
      propose pioneering/transforming approaches to
      major challenges in biomedical and behavioral
       •   “pioneering” = highly innovative approaches that have the
           potential to produce an unusually high impact on a broad area
           of biomedical or behavioral research; substantially different
           from those already being pursued in the investigator’s
           laboratory or elsewhere
   •   Pre-application due Dec 17, 2008; $5 million for up
       to 10 projects
   •   http://grants.nih.gov/grants/guide/pa-files/PAR-09-
High-Risk/High-Reward Research:

3) NIH Director’s New Innovator Award (DP2)
   • Purpose: to support individual scientists with
      exceptionally innovative research ideas at early
      stages of their careers, but without the preliminary
      data required to fare well in the traditional NIH peer
      review system
   • Pre-application due Dec 15, 2008; $55.7 million for
      up to 24 projects
   • http://grants.nih.gov/grants/guide/pa-files/PAR-09-
Change Academic Culture to Foster

1) Multiple Principal Investigator Policy Change
   • Purpose: to give appropriate credit to significant
     collaborators on team science and
     multidisciplinary science projects
   • Established November, 2006:
   • Available for most grant opportunities (specified in
     the Funding Opportunity Announcement)
Change Academic Culture to Foster

2) Clinical and Translational Science Award (CTSA)
   • Purpose: to create a multidisciplinary academic
      home with research resources for new and
      established investigators, with the goal of fostering
      research and collaborations that lead to
      improvements in patient care
   • Letters of intent due September 14, 2009;
      Applications due October 14, 2009
   • $20 million for up to 4 awards
   • http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-
The future directions of the NIH Roadmap are
  uncertain, BUT…

  Across all of NIH, announcements are calling for creative,
  innovative, transforming, paradigm-shifting research, and…

  In general, science is becoming more team-oriented, crossing
  disciplinary boundaries, and…

  Each field needs to make opportunities for new investigators in
  order to keep growing, so…

It’s likely that creative team science approaches,
   for new and established investigators, will
   continue to be reflected in NIH Roadmap
Other Trans-NIH Activities
• Genes, Environment, and Health Initiative
• NIH Blueprint for Neuroscience Research
• Exceptional, Unconventional Research
  Enabling Knowledge Acceleration (EUREKA)
Genes, Environment, and
Health Initiative (GEI)
• Supports research that will lead to
  understanding genetic contributions and
  gene-environment interactions in common
• Announced in February 2006
• 4-year program, with funding for FY07
  through FY10
• Supported by additional funds
  ($40M/year) allocated to NIH by Congress
           PROGRAM                   GENETICS PROGRAM

       Develop technology                 Identify genetic
        and biomarkers        GXE            variants

                              Human       •   Identifying and
•   Environmental stressor                    characterizing potential
    monitoring               Health and       genetic variants
•   Biological response       Disease     •   Statistical methods
    indicators                                development
                                          •   Translational studies
GEI Genetics
 Identifyingand characterizing potential
  genetic variants
     Genome-wide association studies
     Replication and fine-mapping studies
     Functional studies
     Systems biology approaches
            methods development
 Statistical
 Translational research
Genome-wide Association Studies
Primary outcomes:
   Addiction
   Blood clots in the veins        Shared exposures across
   Blood pressure                    studies:
   Birth weight & maternal          Tobacco use
    metabolism                       Alcohol use
   Chronic obstructive pulmonary
   Coronary heart disease
   Dental caries
   Glaucoma
                                    GEI funding: RFAs HG-06-014,
   Lung cancer
                                    HG-06-032, HG-06-033, HG-07-012
   Oral clefts
   Preterm birth                   Additional funding: NHLBI, NIAAA,
                                    NIDA, NIDCR
   Prostate cancer
   Stroke
   Type 2 diabetes
GEI Exposure Biology

   Environmental stressor monitoring
       Sensor technologies for environmental exposure
       Improved measures of diet and physical activity
       Tools for measuring exposure to psychosocial stress
        and addictive substances
   Biologic response indicators
       Biomarkers and biosensors that reflect alterations in
        key physiologic pathways after exposure to
        environmental stressors
NIH Blueprint for
Neuroscience Research
• Framework to enhance cooperative
  activities across NIH that support research
  on the nervous system
• Confronts challenges too large for any
  single NIH Institute or Center
• Develops research tools and infrastructure
  that serve the entire neuroscience
Blueprint Thematic Initiatives
 Neurodegeneration
     Developing research tools, resources, and
      training activities to accelerate progress
 Neurodevelopment
     Creating, expanding and distributing tools and
     Implementing guidelines for advancing model
      systems of neurodevelopment
 Neuroplasticity
     Developing new tools to monitor and
      manipulate nervous system plasticity
Recent Blueprint Activities
 NIH   Neuroscience Microarray Consortium
 Gene   Expression Nervous System Atlas
 NIHToolbox for Assessment of
 Neurological and Behavioral Function
 Recombinase-Expressing     Mouse Lines
 Mouse   Archiving and Central Distribution
Exceptional, Unconventional
Research Enabling Knowledge
Acceleration (EUREKA)
• Fund exceptionally innovative research that, if
  successful, will have an unusually high impact
• Targets investigators: testing novel,
  unconventional hypotheses; or pursuing major
  methodological or technical challenges
• Potential impact of the proposed research
  substantial: size of the scientific community
  affected; and the magnitude of the effect on the
New Principal Investigator/
Early Stage Investigator Policies
 NIH has strong commitment to support
      New Investigators

 Average age of first R01: 37 in 1980, 42 in 2005

 2009 new policy to identify Early Stage Investigators

 Applications from ESIs given special consideration at
     at peer review and for funding

New Investigator- has not previously competed
successfully as a PD/PI for a significant NIH
independent research award. Exclusions – R00,
R03, R15, R21, R34, R36, R42, R43, R55, R56,
SC2, SC3, Fs, Ks, Ls, Gs, Ss.

Early Stage Investigator (ESI)- PD/PI who qualifies
as a New Investigator and is within 10 years of
completing terminal research degree or medical
residency (or equivalent).
New Investigators should update eRA Commons profiles
     -degree date information
     -residency completion date information
     -notified by email if eligible

Multi-PI grants-all PIs must be ESIs for the application
      to be given the ESI designation

FY2009 NIH expects to fund New Investigators at success
     Rates equivalent to established investigators

The majority of New PIs supported in 2009 will also be

NIH encourages New PIs and ESIs to apply for R01s
Requesting an Extension of the ESI Period

 -lapse in research/training or periods of part-time effort

 -reasons may include medical concerns, disability,
 family care responsibilities, extended periods of
 clinical training, natural disasters, active duty military


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