Transcript Administrative Core - CLU-IN

Welcome to the CLU-IN Internet Seminar
Superfund Research Program P42 RFA Briefing
(RFA ES 15-019)
Sponsored by:
National Institute of Environmental Health Sciences,
Superfund Research Program
Presenters:
William Suk, Director, Superfund Research Program (SRP), NIEHS ([email protected])
Heather Henry, Program Administrator, SRP NIEHS ([email protected])
Danielle Carlin, Program Administrator, SRP NIEHS ([email protected])
Linda Bass, Scientific Review Officer, NIEHS ([email protected])
Lisa Archer-Edwards, Grants Management Specialist, NIEHS ([email protected])
Contributors:
Michelle Heacock, Program Administrator, SRP NIEHS ([email protected])
Alicia Lawson, Health Specialist, SRP NIEHS ([email protected])
Michelle Victalino, Grants Management Specialist, NIEHS ([email protected])
December 1, 2015 1:00 – 2:00 p.m. EST
Link to RFA: http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-15-019.html
Link to RFA Information Page:
http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/index.cfm
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Funding Opportunity Webinar –
P42 Center RFA ES-15-019
Agenda
• Welcome: William Suk (SRP Director)
• Overview of SRP and its funding mechanisms: Heather Henry
(Program Administrator)
• P42 RFA
– General Information: Danielle Carlin (Program
Administrator)
– Review Criteria: Linda Bass (Scientific Review Officer)
– Budget: Lisa Archer-Edwards (Grants Management
Officer)
• Question / Answer
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SRP Mandates under SARA
University-based basic research program established
in 1986 under Superfund Amendments
Reauthorization Act (SARA)
Development of:
Health Effects
• Advanced techniques for the detection,
assessment, and evaluation of the human
health effects of hazardous substances
Assessing Risks
• Methods to assess the risks to human
health presented by hazardous
substances
Detection
Remediation
• Methods and technologies to detect
hazardous substances in the environment
• Basic biological, chemical, and physical
methods to reduce the amount and
toxicity of hazardous substances
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SRP Strategic Plan
• Relevance
– Interaction with stakeholders
– Problem-based, solution-oriented research
– Critical research areas
• Impact
• Innovation
SRP Stakeholders
Sister Superfund Programs:
• US Environmental Protection Agency (EPA)
• Agency for Toxic Substances and Disease Registry (ATSDR)
Others: federal agencies, state, local, and tribal entities responsible for
sites; individuals and communities living near hazardous waste sites
http://www.niehs.nih.gov/research/supported/dert/programs/srp/about/register/index.cfm
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SRP Funding Mechanisms
Multi-Project Centers (P42)
Designed for integration across disciplines: Biomedical and
Environmental Science and Engineering; Community Engagement,
Research Translation, and Training (Research Support (Optional).
Basic and application-oriented.
Next P42 Request for Applications (RFA) will be re-released in
Spring 2017 (see NOT-ES-15-018)
Small Business Research Grants
SBIR/STTR (R41-44)
Foster the commercialization of technologies,
relevant to hazardous substance clean-up and
monitoring. Ongoing Funding Opportunity
Conference Grants (R13)
Provides funding for conferences related to
SRP mandates. Ongoing Funding Opportunity
Individual Research Project
(R01)
Designed to address specific issues to
complement the multi-project research
program; tackle issues of emerging
concern for Superfund. Closed.
Occupational Training (R25)
Emerging issues in EHS training. Closed.
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Funding Opportunities: http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/index.cfm
P42 Multi-Project Centers
RFA-ES-15-019
SUPERFUND HAZARDOUS SUBSTANCE
RESEARCH AND TRAINING PROGRAM (P42)
Improve public health by
supporting integrative,
multi-disciplinary research.
Provide sound science, data,
information, and knowledge to
inform the risk assessment and
remediation management processes.
Bring expertise of multiple biomedical
and environmental science and
engineering disciplines to address
scientific uncertainties facing the
National Superfund Program.
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Key Dates
• Open Date (Earliest Submission Date): March
11, 2016
• Letter of Intent Due Date(s): March 11, 2016
• Application Due Date(s): April 11, 2016, by
5:00 PM Eastern Time
• Scientific Merit Review: October 2016
• Advisory Council Review: January 2017
• Earliest Start Date: April 1, 2017
P42 Multi-Project Centers
Biomedical
Science
Research
Translation
Research and Training
Problem
Environmental
Science and
Engineering
Community
Engagement
Stakeholder Communities
Superfund Stakeholders
Solution
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P42 Multi-Project Centers
Scope of Research
Broad Scope –
Ultimately should be a
clear link to Superfund.
Suggested Research Topics:
High priority areas for
EPA/ATSDR colleagues
Programmatic Balance
(See Current Grantees:
http://tools.niehs.nih.gov/sr
p/programs/index267.cfm)
SRP Mandates
• Advanced techniques for the detection,
assessment, and evaluation of the effect of
hazardous substances on human health
• Methods to assess the risks to human health
presented by hazardous substances
• Methods and technologies to detect hazardous
substances in the environment
• Basic biological, chemical, and physical methods
to reduce the amount and toxicity of
hazardous substances
Strategic Plan
Relevance: to Superfund
Impact: to Stakeholders
Innovation: Trans-disciplinary/Paradigm-shifting
Not Required: Superfund Site; CERCLA Substance
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P42 Multi-Project Centers
All Components Interacting, Addressing Problem
Administrative Core
Biomedical
(≥ 2 Projects)
Research Translation
Core
Community Engagement
Core
Training Core
Environmental
Science and
Engineering
(≥ 2 Projects)
Research Support
Core(s)
optional
Total: 8 - 11
Components
New and Renewal Proposals: up to $1.75M/year direct costs
for 5 years
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P42 Multi-Project Centers
All Components Interacting, Addressing Problem
Administrative Core
Research Translation
Core
Biomedical
(≥ 2 Projects)
Community Engagement
Core
Overall
Environmental
Science and
Engineering
(≥ 2 Projects)
Training Core
Research Support
Core(s)
optional
Total: 8 - 11
Components
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P42: Projects
Mechanistic Toxicology
Health Effects
Epidemiology
Hydrogeology
Biomedical
(≥ 2 Projects)
• Each project is stand-alone
• independent testable hypothesis
• logical progression of tasks
• Basic to application – oriented
• Relation to Overall Center
Environmental Science
and Engineering
(≥ 2 Projects)
Fate and Transport
Remediation Engineering
Maximum of 6 projects
•Integration with other projects
•Interaction with Cores
• Research Translation
(including investigatorinitiated research
translation)
• Sharing: data,
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specimens, technology
P42: Projects
Resource Sharing Plans
For investigators to explore opportunities for sharing
research products and broad opportunities for
research translation during project development.
1 paragraph PLAN for each:
Data Sharing Plan:
• Publication-based data-sharing
opportunities; databases
• Explain if sharing not appropriate.
Must follow all NIH required datasharing.
Investigator-Initiated Research Translation
Plan: Identify potential interactions
between researcher and end-user (not
researcher to researcher) drawing from
SRP’s 4 research translation components.
(Consistency with RTC).
See “Suggested Research and Activities” for InvestigatorInitiated Research Translation suggestions.
http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/index.cfm
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P42: Projects
FOCUS!!!!
Centers should be VERY judicious in assembling
research projects. Center should, with projects,
keep a clear focus and not try to do too much!!
Include projects with most solid connection to
the Center’s problem-solving theme.
Lean Times: Not too big! Come in under budget,
well under 11-component limit.
Especially True for New
Center Proposals!
Interactions:
Cross-reference interactions
between projects and cores.
Should be consistent
throughout.
Abstract / Titles – Avoid Jargon
• P42 Reviewers have broad expertise
• Write abstracts/titles for a general audience
• Write Specific Aims for technical experts
• http://grants.nih.gov/grants/plain_language.htm
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P42: Administrative Core (Required)
Administrative Core (AC) Functions
–
–
–
–
Planning and coordination
Promote cross-discipline interaction
Ensure research translation
Oversee fiscal and quality management
External Advisory Committee (EAC)
– Provides Guidance to Director
– Scientific Merit
– Relevance, Integration
– Research Translation, Community
Engagement, Training activities
Anticipated EAC Members*
Academics (biomedical AND environmental science
and engineering), Stakeholders, EPA/ATSDR,
Industry, Community
Provides Points of Contact
Data Collection Tool and
NIEHS/SRP CareerTrac
Promotes Careers
Trainees, Early Stage Investigators,
Succession Planning (if applicable)
*New Applicants: include expertise
of potential EAC members, not
names
Not to exceed $100,000 Direct
Costs; Center Director must
commit a minimum of 1.8 person
15
months
Research Translation Core (Required)
Research Translation Core Function:
Communicating and facilitating the use of
research findings emanating from the Center in
the manner most appropriate for their
application and the advancement of research
objectives.
Note: SRP Research Translation
– much broader scope than
NIH’s Clinical Translation (bench
to bedside).
Include Plan for Four Components
1. Communication
2. Government Partnerships
3. Technology Transfer
4. Information Dissemination
Not to exceed $100,000
Direct Costs
Information from Center to
Center as well as Center
outward (to all end-users)
Plan for Reporting News to SRP:
•
For Example: reporting to the SRP
Data Collection Form:
http://tools.niehs.nih.gov/srp/resources/rtc.cfm
See Suggested Research and Activities Document for ideas for the RTCs:
http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/index.cfm
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Research Translation Core (RTC)
1. Communicating within SRP
a. Investigator-initiated research
translation (IIRT)
b. SRP communication
c. Cross-Center communication
2.
Partnerships with Government
Agencies
EPA/ATSDR partnerships a priority,
but not a requirement.
3. Technology Transfer
4. Information
Dissemination to Other
End-Users
IIRT- Identify and coordinate research
translation opportunities for each Center
project and cores.
Examples provided in the “Suggested Research
and Activities”
Where to start?
• SRP’s Additional Resources Webpage*
• Find your EPA Region’s Superfund Technical Liaison /
ATSDR staff
RTC identifies opportunities and delineates mechanisms for the
transfer of technologies generated by the Center’s projects into
the hands of an end-user; Formal and informal technology
transfer mechanisms should be used
Outreach to general audiences such as education groups, hazardous
waste practitioners, lay public, other academic researchers
Examples: Educational materials, Web sites, webinars, “outreach,” etc.
http://www.niehs.nih.gov/research/supported/dert/programs/srp/assets/docs/srp_2015_suggested_research_and_activities_508.pdf
http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/rfa_resources/index.cfm
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Community Engagement Core (Required)
Community Engagement Core
Function:
Capacity building, developing tools/resources,
facilitating bi-directional exchange between
Center scientists and the community with the
overall intent to prevent and/or intervene in
order to reduce exposure and protect health
Target communities
• SRP defines target communities as those
impacted by hazardous substances
• Examples: local government groups, Tribal
councils, community service groups, nongovernmental organizations working
closely with a community, economically
disadvantaged, and environmental justice
communities
HIGHLIGHT “Bidirectionality”
between community and
Center (not “outreach”)
Where to start?
• Suggested Research and Activities
Document
• SRP Additional Resources Webpage
Include a timeline with milestones; a plan
to measure and verify outcomes (e.g., a
logic model); and a process to guarantee
effective bi-directional exchange of needs,
recommendations, and results
Not to exceed
$100,000 Direct Costs
http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/index.cfm
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Research Translation
Research
Products
Community Engagement
Theme of Center
ITERATIVE
Appropriate
Application
BIDIRECTIONAL
End-users
Impacted Community
• Initiated by the Center
(RTC/Investigator)
• Based on research “product”
• Opportunistic and rapid response
• Critical role reporting successes
• Partnership-driven
• Finite/Defined Activities focuses
on Prevention/Intervention
• Activities should have the goal of
reducing exposures
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Training Core (Required)
Training Core Function:
Graduate and Post-doctoral level
cross-disciplinary training
• Promote interactions between
biomedical and environmental
science trainees
• Professional development
• Communicating research
effectively
• Involvement in Research
Translation, Community
Engagement, etc.
• Achieves program integration
Inquiring Reviewers want
to know:
• Recruitment
• Past trainee successes
• Mentorship of Trainees
• Use of CareerTrac (for
renewals)
Not to exceed $100,000
Direct Costs
Use NRSA formatting for
Training Core: includes
Background, Program Plan,
and Recruitment and
Retention Plan to Enhance
Diversity
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P42: Research Support Core (Optional)
• Research Support Core
– Provides centralized services
– Shared by at least 2 projects
• Pros and Cons of RSC
– Pros:
If Research Support Core
is not included, project
– Excellent Interactions/Integration
should adequately detail
– Opportunities for Training
research support
– Assurance of Quality
activities (e.g. QA/QC)
– Cons:
– May not be critical (if facilities already available)
– 11 component limit
Since optional, RSCs do
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not have a set budget.
Cost Limitations (Direct)
Cores Sum ≤ 20% Total Center
Administrative
Research Translation
Community Engagement
Training
20%
AC, RTC,
CEC, TC
80%
Research
Projects,
Research
Support
Cores
Core Limitations (Direct):
•
•
•
•
•
Administrative - $100K
Research Translation - $100K
Community Engagement - $100K
Training Cores - $100K
Research Support Core (Optional)
– no set budget
Center:
New and Renewal Applicants: up to
$1.75M/year direct costs for 5 years
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Recent Changes
• Budget ceilings for Overall Center and Cores
• Community Engagement Core: focus on prevention and
intervention to reduce exposures
• A minimum of two Biomedical and two Environmental Science
and Engineering Research Projects (maximum of 6 projects);
Total Projects and Cores limited to 11 Components
• Administrative Core indicates who points of contact will be for
Data Collection Tool and CareerTrac
• Rigor and Reproducibility (for both Project and Cores):
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16011.html
• “New” NIH Biographical Sketch Format:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15032.html
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A Successful P42 Center
* Projects and Cores Uniformly Meritorious
Biomedical
Approaches
Research and Training
Environ. Science
and Engineering
* Integration, Interaction, Synergy:
- Biomedical and Environmental Science &
Engineering
- Projects and Cores
Research
Community
Translation
Engagement
Problem
* Addressing Important
Problem
Superfund Stakeholders
Stakeholder Communities
* Aids Stakeholders in Effective
Decision-Making
Solution
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Review
NIEHS SCIENTIFIC PEER REVIEW
LINDA BASS, PHD (2015 P42 REVIEW )
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The Peer Review Process
Receive Applications
(April 11, 2016)
Letters of Intent
(March 11, 2016)
Administrative Review
Non-responsive
Responsive
(return to applicant)
Review Committee
Peer Review Meeting (Fall 2016)
Discussed
Summary
Statements
Not - Discussed
NAEHS Council
(Jan 2017)
Funding decisions
and awards
(June/July 2017)
Summary
Statements
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Pre-Submission of P42 Application
• Submission of Letter of Intent (LOI):
– Assists in review planning
– Email to Dr. Linda Bass at [email protected] Requested by March
11, 2016 (not required, but highly recommended)
•
Include in the LOI:
– Descriptive title of the Overall Center
• Brief description of the research proposed in the Center
• Include the title of each Research Project and Core
– Name, address, and telephone number of the PD(s)/PI(s)
– Names of key personnel (Project and Core Leaders)
– Names of any participating institutions
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P42 Peer Review Process
• Review Criteria are in the solicitation:
http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-15-019.html
• Review of the Individual Research Projects, Cores
• Review the Overall Center
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Research Projects
•
•
•
•
•
Significance
Investigator(s)
Innovation
Approach
Environment
NIH’s Five
Review
Criteria
(criterion
scores 10-90)
• Contribution to SRP Center
• Other Specific Criteria*
Impact Score
(10-90)
Each Project reviewed.
Each Receive Criterion Scores
and written critiques. NoteApplications not discussed will
not be provided an overall
impact score (e.g Center ,
individual Projects, and Cores).
Note: Human Subjects, Animal Care, and Biohazards can be considered in the overall
score. Budget Concerns are not considered in score.
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Cores
• Contribution to SRP Center
• Other Criteria Specific to Each Core
– Administrative
– Research Translation
– Community Engagement
– Training
– Research Support Cores
(see RFA for specific criteria)
Impact Score
(10-90)
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Overall Center
Addresses a critical problem relevant to the SRP
Relevance/Merit of Projects and Cores (scientific gain)
Collaboration/Integration/Synergy
Final Score
(Range: 10-90)
Leadership
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Helpful Hints
• Read and understand the Funding Announcement
• Contact Program Staff for clarification of scientific matters
and Grants Management Staff for budget issues.
• Follow the guidelines: page limits, font size, etc.
• Start early………because:
 Any mistakes made with electronic submission (i.e.,
ASSIST) may cause your application to be returned
without further deliberation by NIEHS Review staff.
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Grantsmanship Issues
• Be clear and concise….don’t expect reviewers to “know
what you mean.”
• All the components are important. One weak research
project will impact the overall score. Extraneous or
unnecessary cores will reduce cohesiveness of the center.
• Too many projects…application sinks under its own
weight.
• Inadequate time allowed to prepare application.
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• RFA Webpage
P42 Resources
– Suggested Research and Activities - Numerous areas of general
interest as well as specific needs identified by stakeholders
– Tips for Applicants – electronic submission, what to include, etc.
– Additional Resources – Links to EPA, ATSDR, information to aid in
community engagement activities, and other helpful websites
– Program Contacts
RFA Webpage:
http://www.niehs.nih.gov/research/supported/srp/funding/rfa/index.cfm
Also see “Current P42 Grantees:”
http://tools.niehs.nih.gov/srp/programs/index267.cfm
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Budget
NIEHS GRANTS MANAGEMENT
LISA EDWARDS, MBA
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Electronic Budget
• Webinar for Applicants: Initial Look at the Electronic
Submission Process of Multi-Project Applications
http://grants.nih.gov/grants/webinar_docs/webinar_20121213.htm
• SF424 (R&R) Detailed Budget forms differ from Paper PHS398
Budget Forms in both look/feel and substance
o Some items in different places
o Some items not collected as specific line items
• Budget data collected at component and subaward levels only
Component and subaward budget data used to auto-calculate
“Cumulative” (Composite) budget
Budget pages required for parent site and all consortium sites
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Budget Preparation
Form Pages, Approvals, Other Support, Notices
Forms (http://grants.nih.gov/grants/forms.htm)
SF424 (R&R) electronic submission
Approvals
Important Notices
• Revised Grants Policy
Statement: NOT-OD-15-087
• Salary caps: NOT-OD-15-049
http://grants1.nih.gov/grants/po
licy/salcap_summary.htm.
IACUC Approval (Vertebrate Animals)
IRB Approval (Human Subjects)
Begin process at time of application, but final approval will be requested for
Just In Time*
Other Support
“0%”, “Varies”, “As Needed”, etc., are not acceptable
Total time commitment cannot exceed 12 calendar months
*Just in Time: Request for information required prior to award.
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Budget Preparation
Non-Modular
Provide detailed categorical budgets
• Each Project
• Each Core
• Each Subaward/Consortium (Note: SF424 will not allow Subawards on
Subawards)
• For Training Budget Pages – NRSA Budget forms must be used.
Escalation
Budgets submitted in subsequent years
may request an escalation on recurring
direct costs. (Note: Currently NIH does
provide an escalation in subsequent years)
Must be justified:
• Is the amount of escalation requested
supported by institutional policies?
• Is the amount clearly stated?
Travel to Annual Meeting
Administrative Core Budget: Funds for
travel by appropriate staff (i.e., Center
Director, Center Administrator, and four
trainees) to attend the Superfund
Research Program three-day annual
meeting shall be included in the
Administrative Core’s budget for each
year.
Escalation in outyears will be removed at the time of award.
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Budget Preparation
• Parent Grant Direct Costs
– Consideration of equipment in the out-years will be based upon justification
and availability of funds
• Subawards/Consortium
– must follow same guidelines as parent; budget pages required and should
follow associated project or core
– Subawards/consortium direct costs are included in the parent grant Subtotal
Direct Costs, which may be subject to budget caps
– F&A of subawards/consortium is included in Total direct Costs of parent grant,
but will not count against budget cap
• Budget Justifications (Be detailed and specific)
• Are all costs itemized?
• Are all additions and changes in subsequent/future years fully justified
and identified clearly; specifically changes in personnel effort?
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R&R Budget Sections A & B
Personnel separated into 2 sections:
• A. Senior/Key Person
o First field must be completed, even if person on a component given
role of “Project Leader” and not PD/PI
• B. Other Personnel
o Postdocs, Grad Students, Undergrads: Only number of personnel
required (not specific names)
*Include only personnel employed by (e.g., receiving salary from) your
organization.
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Itemize up to 100 pieces of equipment. If more,
include total dollars in line 11 and provide
details in the Additional Equipment attachment
R&R Budget
Sections C - E
Not required for P42
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R&R Budget Sections C - E
• Item D, Travel
o 424 form differentiates between foreign and domestic
travel
o Continues to be treated as single cost (regardless of type)
similar to 398 budget
• Item E, Participant/Trainee Support Costs
o Do not use for NIH FOAs
o Costs for NRSA Training-type components should use
Training Budget form
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R&R Budget
Sections F - K
Subaward/Consortium/Contractual Cost not prepopulated. Include both Total Direct and Indirect
cost
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R&R Budget Sections F-K
• Tuition remission
o Include in Item F, Other Direct Costs (boxes 8, 9 or 10)
• Supplies
o Not a major line item on 424 budgets
o Included as line F.1 (Other Direct Costs: Materials and Supplies)
• Alteration and Renovations
o Not a major line item on 424 budgets
o Included as line F.7 (Other Direct Costs: Alterations and Renovations)
• Inpatient and Outpatient Care Costs
o 424 does not include as major / minor line item
o Current instructions require inserting in fields F.8-F.10 (Other Direct
Costs: Other Costs)
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Resources
•
•
•
•
•
SF424 (R&R) Application and Electronic Submission Information” webpage:
– http://grants.nih.gov/grants/funding/424/index.htm#inst
Applying Electronically to Multi-project Applications:
– http://grants.nih.gov/grants/ElectronicReceipt/com_index.htm
Help with ASSIST
– http://grants.nih.gov/grants/ElectronicReceipt/assist.htm
“New” NIH Biographical Sketch Format: http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-15-032.html
NIH Guidance on Rigor and Reproducibility:
http://grants.nih.gov/reproducibility/index.htm
eRA Commons - https://commons.era.nih.gov/commons/index.jsp
Registered PD/PIs can check assignment/contact information, review outcome, and other
important information.
eRA Commons Help Desk:
Hours: Mon-Fri, 7AM-8PM EDT/EST; Web: http://grants.nih.gov/support/; Toll-free: 1-866504-9552. Phone: 301-402-7469
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P42 Multi-Project Centers
• NIEHS Contacts
William Suk, Director, Superfund Research Program (SRP), NIEHS
([email protected])
Heather Henry, Program Administrator, SRP NIEHS ([email protected])
Danielle Carlin, Program Administrator, SRP NIEHS ([email protected])
Michelle Heacock, Program Administrator, SRP NIEHS ([email protected])
Alicia Lawson, Health Specialist, SRP NIEHS ([email protected])
Linda Bass, Scientific Review Officer, NIEHS ([email protected])
Lisa Edwards, Grants Management Specialist, NIEHS ([email protected])
Michelle Victalino, Grants Management Specialist, NIEHS
([email protected])
Link to RFA: http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-15-019.html
Link to RFA Information Page:
http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/index.cfm
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QUESTIONS??
Thank You!
Acknowledgements:
EPA’s CLU-In.org
Jean Balent, EPA TIFSD
Justin Crane, MDB, Inc.
Sara Mishamandani, MDB, Inc.
Kevin O’Donovan, MDB, Inc.
Questions not covered during seminar will be answered offline and posted on P42 Funding Opportunity Webpage:
http://www.niehs.nih.gov/research/supported/dert/progra
ms/srp/funding/rfa/index.cfm
Audio Archive will be available in approximately 4 weeks and are accessible
from the above website.
Extra Slides about Rigor &
Reproducibility
P42