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Welcome to the CLU-IN Internet SeminarSuperfund Research Program P42 RFA Briefing(RFA ES 14-007 – rerelease of RFA ES 14-001)

Sponsored by: National Institute of Environmental Health Sciences,

Superfund Research Program

Presenters:William A. Suk, Director, Superfund Research Program (SRP), NIEHS (suk@niehs.nih.gov)

Heather Henry, Program Administrator, SRP NIEHS (henryh@niehs.nih.gov) Danielle Carlin, Program Administrator, SRP NIEHS (danielle.carlin@nih.gov)

Lisa Edwards, Grants Management Specialist, NIEHS (archer3@niehs.nih.gov)Michelle Victalino, Grants Management Specialist, NIEHS (victalinom@niehs.nih.gov)

Leroy Worth, Scientific Review Officer, NIEHS (worth@niehs.nih.gov)

Contributors:Michelle Heacock, Health Scientist, NIEHSBeth Anderson, Program Analyst, NIEHS

Link to RFA: http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-14-007.htmlLink to RFA Information Page: http://

www.niehs.nih.gov/research/supported/dert/cris/programs/srp/funding/rfa/index.cfm

June 27, 2014

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Today’s Focus: RFA Re-Release Updates

Notice to terminate RFA-ES-14-001: Posted

May 16, 2014

RFA Re-released as RFA-ES-14-007:

Posted June 12, 2014

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Funding Opportunity Webinar – P42 Center RFA - Rerelease

Agenda• Update of Changes in RFA (20 minutes)

– General and Training-specific: Dr. Danielle Carlin – Training Review Criteria and Budget: Dr. Heather Henry

• Question / Answer (30 minutes)

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RFA Re-Release – General Updates• Clarifications:

– “Relation to Overall Center" statement is in the Research Strategy section and is part of the 12 page limit for that section. The length of the statement is not specified in RFA-ES-14-007 (RFA-ES-14-001 specified 1 page limit).

– “Community Engagement Statement” goes in the Research Strategy for Community Engagement Cores and Community Engagement Research Projects.

– Travel to annual meeting – Admin Core Budget should include travel for Center Director, Center Administrator, Training Core leader, Research Translation Core leader, Community Engagement Core leader, and four trainees.

– Project Narrative for all projects and cores (except Training Core).

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RFA Re-Release – General Updates• Do not include “Table of All Personnel” in the Overall “Other

Attachments”. This was eliminated because ASSIST will automatically generate a list of all personnel.

• Table of Trainees is no longer a part of the Training Core “Other Attachments”. It is now called the “Trainee List” and must be included in the Training Core “Progress Report” section (for competitive renewal applications only).

• New Biographical Sketches: DOES NOT APPLY to this RFA; applies to all NIH grant applications planned for FY 2016 and beyond.

• NOT ES 14-009: Only one application per institute is allowable.

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Goals and purpose of Training Core remains unchanged• Training Core must follow Ruth L. Kirschstein National

Research Service Award (NRSA) Application Guidelines with modifications specified in the RFA.

• What’s New – Use (NRSA) ASSIST Application Component and Budget – Recruitment & Retention Plan to Enhance Diversity – Plan for Responsible Conduct of Research– Trainee List (required only for renewals)

• What’s Modified– Review criteria– Budget– Sections/Page Limits

RFA Re-Release – Training Updates

SRP Training Core ≠ NRSASRP TCs must adapt to NRSA Forms, but much of prior application’s text should be sufficient.

Training Core Function: Graduate and Post-doctoral level cross-disciplinary training

Training Core: Goals Unchanged

Cost Limitations:• New Applicants:

$100,000 Direct Costs• Renewal Applicants:

$125,000 Direct Costs

• Promote interactions between biomedical and environmental science/engineering 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• Use of CareerTrac (for

renewals)

“Suggested Research and Activities” document http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm)

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P42 Funding Opportunity Announcement

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Must Use “NRSA Training” component for the Training Core.

The Training Core is 25 pages (i.e., 25 pages include Background, Program Plan, and Recruitment and Retention Plan to Enhance Diversity).

NRSA Training Component - Information page

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Look for ‘NRSA Training’ in the

menu

Follow RFA-ES-14-007 instructions

(and SF424 instructions, where applicable) for each

‘Tab’

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See next slides with instructions for filling out these attachments

No Data Tables for this RFA.

Biosketches

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Training Core • Follow Section “8.7” in the SF424 (R&R) Supplemental Instructions for

Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA):

• Introduction to Application: For Resubmission applications only.• Background

– Provide the rationale for the Training Core and the need for the cross-training proposed.

– Indicate how the Training Core will relate to current training activities at the applicant institution.

• Program Plan– Program Administration– Program Faculty– Proposed Training– Program Evaluation– Trainee Candidates– Institutional Environment and Commitment to the Program

Page Limit = 25Includes Background, Program Plan, and Recruitment and Retention Plan to Enhance Diversity (Attachments 2-4 of Research Training Program Plan form).

Note: NRSA Tables are not applicable to this FOA.

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Training - Program Plan

• Program Administration– Strengths of the Training Core Leader– Planned strategy and administrative structure to oversee and monitor

the core

• Program Faculty – Include information about Center faculty who will serve as

preceptors/mentors and provide guidance and expertise appropriate to the level of trainees proposed in the application.

– Describe the complementary expertise and experiences of the proposed Center Faculty.

– For any proposed Center Faculty lacking research training experience, describe a plan to ensure successful trainee guidance by these individuals.

– Describe the criteria used to appoint and remove Center Faculty and to evaluate their participation.

Note: Program Plan should be saved as a single file

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• Proposed Training– Overview of the Training Core – Objectives and activities – Training level and proposed number of trainees– Reflect the interdisciplinary nature of the Center

• Use of interdisciplinary approaches to training • Opportunities to develop the trainees’ current research/activities

to enhance their own professional career development and to receive training on best practices in Responsible Conduct of Research

• Reporting of information about the Center’s trainees to the SRP • Recruitment plan for all trainees (see also "Diversity Recruitment

and Retention Plan”)

Training - Program Plan (Cont’d)

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• Program Evaluation– Plan to review and determine the quality and effectiveness of the

Training Core – Include the utilization and frequency for trainee information

submission to NIH CareerTrac (https://careertrac.niehs.nih.gov/)– Metrics to be evaluated (e.g., Core activities completed, degree

completion, publications, fellowships/honors, and subsequent post-training positions)

– Feedback from current and former trainees to help identify weaknesses/strengths

• Trainee Candidates– Size and qualifications of the trainee candidate pool– Plan to recruit candidates and implementation (see also section on

Recruitment and Retention Plan to Enhance Diversity)

Training - Program Plan (Cont’d)

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• Institutional Environment and Commitment to the Program– Sponsoring institution must assure support for the proposed Training

Core (assurance that sufficient time will be allowed for the Training Core Leader and other Center Faculty to contribute to the proposed training)

– SRP Training Core is distinctive from existing Training Programs; indicate synergy between programs, if applicable

Training - Program Plan (Cont’d)

Timeline and Milestones: The Training Core description should indicate the frequency for trainee information submission/updates to the NIH CareerTrac database.

"Relation to Overall Center" statement within the Program Plan • State the relevance of the core to the goals of the overall Center, how this

core integrates with other projects and cores, and how the findings/activities of this core assist in solving the problem(s) that the Center is addressing.

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• Recruitment and Retention Plan to Enhance Diversity– Follow instructions as provided in Chapter 8 of the SF424 (R&R) Application

Guide – Include description of plans to recruit a diverse trainee pool and may wish to

include data in support of past accomplishments– Information should be included on both successful and unsuccessful

recruitment strategies (as applicable) – Note – this used to be a separate attachment in the Training Core.

• Plan for Instruction in the Responsible Conduct of Research – Follow instructions as provided in Chapter 8 of the SF424 (R&R) Application

Guide. General plan description is acceptable. Utilizing/referencing existing institutional training (including online) is acceptable.

Training Core

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Training Core - Renewals

• Progress Report (Renewal Applications Only):• As part of your progress report, provide a "Trainee List” (Note –

this used to be a separate attachment in the Training Core).• Identify the graduate students and post-doctoral researchers

who participated in the Training Core during the previous funding cycle. – Include the names of the trainees, their SRP Center-associated mentor

name, project/core. – All trainees should be entered into NIH CareerTrac database:

https://careertrac.niehs.nih.gov/.

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Example of a “Trainee List” found on “Tips for Applicants” webpage.http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/rfa_tips/index.cfm

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Training Core - Review Criteria• Training Program and Environment

– Objectives, design, and direction– Approaches and methods employed to develop the training curriculum and

reflect the interdisciplinary nature of Center– Institutional commitment

• Training Leadership PD(s)/PI(s) – Experience in development of training programs– Encouragement of trainees to participate in professional development

and/or leadership opportunities– Plan for communicating with SRP about training activities and trainees – For renewal applications, tracking of trainees (e.g. in CareerTrac) and their

accomplishments

Score based on review criteria below and its contribution to Overall SRP Center

Note: Individual criterion scores will not be provided (this is for all Cores)

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• Preceptors/Mentors – Project and Core Leaders as strong preceptors/mentors– Plans to ensure that preceptors lacking sufficient research training

experience will be successful mentors • Trainees

– Plans for recruitment of trainees – Research/activities supported by the Center listed within the Training

Core • Training Record

– Success of trainees in completing their research programs– Productivity: e.g. research accomplishments, publications, fellowship

or career development awards, achievement of career goals, scientific leadership positions, etc.

– Plan to assess the quality and effectiveness of the training

Training Core (Updated) - Review Criteria

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Training Core (Updated) - Review Criteria• Recruitment & Retention Plan to Enhance Diversity

– Evaluation of recruitment and retention plan to enhance diversity and strategies to enhance diversity

• Training in the Responsible Conduct of Research– Plan to fulfill NIH requirements for instruction in the Responsible

Conduct of Research (RCR) – Relation to the five instructional parts outlined in the NIH Policy on

Training in the RCR: format, subject matter, faculty participation, duration, and frequency

Additional Review Considerations • Reviewers will consider the following items, but will

not consider them in providing an overall impact/priority score

• Rated as Acceptable or Unacceptable

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Note: Recommend place trainees on project/core budgets

Part A: If trainee is covered by the training core:• Use the stipend category to request “salary”

for the trainees• Stipend expected to be consistent with

trainee salaries listed in Projects and Cores and NIH policy

• "Tuition/Fees" in should be consistent with trainee Tuition/Fees from Project and Core budgets.

Note: NRSA stipend levels do not apply to this FOA.

Note: The SRP mandates specify that training is graduate-level and is not intended for undergraduates.

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Part B: • Include expenses associated with the

training core (such as salary support for Training Core Leader and other staff, consultant costs, equipment, research supplies, staff travel, etc.) in the "Training Related Expenses."

F. Budget Justification• Indicate the total number of trainees

participating in the Training Core, including those whose salary/costs are being covered in their respective research projects/cores

• Provide details on level of effort and salary of core leader/staff, description other expenses, etc. in the justification section. Be sure to provide a breakdown of the Training Related Expenses.

Note: 8% NRSA indirect cost rates do not apply to this FOA.

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• All values on this form are calculated automatically

NRSA training budget will be rolled up into the Composite Budget and the Overall Budget summaries.

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Frequently Asked Questions and Tips

Frequently Asked Questions – posted on http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/

Application Tips: http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/rfa_tips/index.cfm

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More on ASSISTFollow all special instructions noted in Section IV. of the announcement.The eRA validations will catch many, but not all, submission requirements. FOA-specific requirements are not typically system-enforced. Applications that do not comply with the instructions may be delayed or not accepted for review.http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm

• Will process application with wrong/expired RFA number – be sure to use: RFA-ES-14-007.

• Will NOT automatically roll your old application into the new RFA. You must reload the entire application.

• Will allow you to add attachments that are not allowed/required. Any additional/extra attachments not required in the RFA may cause your application to be rejected by CSR or NIEHS.

• Take Home Message – please submit at least a week before due date and make sure everything is there that should be (and nothing more).

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Resources• RFA Webpage: http

://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/

• SF424 (R&R) Application and Electronic Submission Information” webpage:– http://grants.nih.gov/grants/funding/424/index.htm

• Applying Electronically to Multi-project Applications:– http://grants.nih.gov/grants/ElectronicReceipt/com_index.htm

• Need help with ASSIST?– http://grants.nih.gov/grants/ElectronicReceipt/faq_full.htm#about

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://era.nih.gov/help/ Toll-free: 866-504-9552. Phone: 301-402-7469. TTY: 301-451-5939.

PLEASE PRINT THIS AND KEEP A COPY HANDY!!!!!

NIEHS Contacts:Program: William A. Suk suk@niehs.nih.gov, (919) 541-0797Heather Henry henryh@niehs.nih.gov, (919) 541-5330Danielle Carlin danielle.carlin@nih.gov, (919) 541-1409

Grants Management: Lisa Edwards, archer@niehs.nih.gov, (919) 541-0751 Michelle Victalino, victalinom@niehs.nih.gov, (919) 316-4666

Scientific Review:Leroy Worth, worth@niehs.nih.gov, (919) 541-0670

P42 Multi-Project Centers

Acknowledgements:EPA’s CLU-In.org

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Thank You!

QUESTIONS??

Webinar Gurus Jean Balent, EPA TIFSDJustin Crane, MDB, Inc.Kevin O’Donovan

SRP TeamBill Suk, DirectorDanielle CarlinHeather HenryBeth AndersonMichelle HeacockRosemary Moody

SRP TeamBill Suk, DirectorDanielle CarlinHeather HenryBeth AndersonMichelle HeacockRosemary Moody

NIEHS StaffLeroy Worth, SROAlfonso Latoni, Review ChiefLisa Archer Edwards, GMOMichelle Victalino, GMSGwen Collman, DERT Director

Questions not covered during seminar will be answered off-line ASAP and posted on P42 Funding Opportunity Webpages.

Audio Archive will be available in approximately 2 weeks and are accessible from the above website.

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Slides from January 2014 Webinar

Updates indicated in RED TEXT

SRP Funding Mechanisms Multi-Project Centers (P42)Designed for integration across disciplines: Biomedical and Non-Biomedical Research; Community Engagement, Research Translation, and Training. Basic and application-oriented.Request for Applications. Annual RFA.

Multi-Project Centers (P42)Designed for integration across disciplines: Biomedical and Non-Biomedical Research; Community Engagement, Research Translation, and Training. Basic and application-oriented.Request for Applications. Annual RFA.

Individual Research Project (R01)Designed to address specific issues to complement the multi-project research program; tackle issues of emerging concern for Superfund. Closed.

Individual Research Project (R01)Designed to address specific issues to complement the multi-project research program; tackle issues of emerging concern for Superfund. Closed.

Small Business Research Grants SBIR/STTR (R41-44)Foster the commercialization of technologies, relevant to hazardous substance clean-up and monitoring. Ongoing Funding Opportunity

Small Business Research Grants SBIR/STTR (R41-44)Foster the commercialization of technologies, relevant to hazardous substance clean-up and monitoring. Ongoing Funding Opportunity

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Conference Grants (R13)Provides funding for conferences related to SRP mandates. Ongoing Funding Opportunity

Funding Opportunities: http://www.niehs.nih.gov/research/supported/dert/cris/programs/srp/funding/index.cfm

Occupational Training (R25)Emerging issues in EHS training. Closed.

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SRP Mandates under SARA

Development of:

• Advanced techniques for the detection, assessment, and evaluation of the human health effects of hazardous substances

• 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

University-based basic research program established in 1986 under Superfund Amendments Reauthorization Act (SARA)

Health Effects

Assessing Risks

Detection

Remediation

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SRP Strategic Plan (2010)• Relevance

– Interaction with stakeholders– Problem-based, solution-oriented research– Critical research areas

• Impact• Innovation

http://www.niehs.nih.gov/research/supported/assets/docs/r_s/srp_about_2010_plan.pdf

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

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RFA-ES-14-007SUPERFUND HAZARDOUS SUBSTANCE RESEARCH AND TRAINING PROGRAM (P42)

Improve public health by supporting integrative, inter-disciplinary research.

Provide sound science, data, information, and knowledge to inform the risk assessment and remediation management processes for hazardous waste sites.

P42 Multi-Project Centers

Bring expertise of multiple biomedical and environmental science disciplines to address scientific uncertainties facing the National Superfund Program.

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Community Engagement

Research Translation Problem

Solution

Environmental Science and Engineering

Biomedical Science

P42 Multi-Project Centers

Superfund Stakeholders Stakeholder Communities

Research and Training

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P42 Multi-Project CentersScope of Research

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 PlanRelevance: to SuperfundImpact: to StakeholdersInnovation: Trans-disciplinary/Paradigm-shifting

Programmatic Balance(See Current Grantees: http://tools.niehs.nih.gov/srp/programs/index267.cfm)

Broad Scope – Ultimately should be a clear link to Superfund.

Suggested Research Topics: High priority areas for EPA/ATSDR colleagues

Not Required: Superfund Site; CERCLA Substance

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Community Engagement Core

Administrative Core

Research Translation Core

Biomedical(≥ 2 Projects)

Environmental Science and Engineering

(≥ 2 Projects)

Training Core

Research Support Core(s) optional

P42 Multi-Project CentersAll Components Interacting, Addressing Problem

New Proposals: up to $1.6M/year direct costs for 4 yearsRenewal Proposals: up to $2.0M/year direct costs for 5 years

Total: 8 - 12 Components

Health Effects

Epidemiology

Mechanistic Toxicology

Fate and Transport

Hydrogeology

Remediation Engineering

Biomedical(≥ 2 Projects)

Environmental Scienceand Engineering

(≥ 2 Projects)

P42: Projects

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• Each project is stand-alone• independent testable hypothesis• logical progression of tasks

• Basic to application - oriented• Integration with other projects

• Research Aims• Sharing: data, specimens, technology

• Interaction with Cores• Training, Community

Engagement• Research Translation

(including investigator-initiated research translation)

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P42: Projects

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

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 12-component limit. Especially True for New

Center Proposals!

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http://www.niehs.nih.gov/research/supported/dert/programs/srp/funding/rfa/index.cfm

P42: Projects

NEW: for investigators to explore opportunities for sharing research products and broad opportunities for research translation during project development. 1 paragraph PLAN for each:

Resource Sharing Plans

Research Data Sharing Plan:• Publication-based data-sharing

opportunities; databases• Explain if sharing not appropriate.Must follow all NIH required data-sharing.

See “Suggested Research and Activities” for Investigator-Initiated Research Translation suggestions.

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).

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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

*New Applicants: include expertise of potential EAC members, not names

Not to exceed $125,000 Direct Costs

AC Breaks Silos• Between Disciplines• Basic to Applied• Lab to End-user

AC Promotes CareersTrainees, Early Stage Investigators,Succession Planning (if applicable)

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.

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Include Plan for Four Components1. Communication2. Government Partnerships3. Technology Transfer4. Information Dissemination

Note: SRP Research Translation – much broader scope than

NIH’s Clinical Translation (bench to bedside).

Not to exceed $125,000 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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2. Partnerships with Government Agencies

Research Translation Core (RTC)

4. Information Dissemination to Other End-Users

End-Users: formal/informal education groups, hazardous waste practitioners, lay public, other academic researchers

Examples: Educational materials, Web sites, webinars, “outreach,” etc.

Where to start?• SRP’s Additional Resources Webpage* • Find your EPA Region’s Superfund

Technical Liaison / ATSDR staff• Superfund Site Remedial Project Manager

1. Communicating within SRPa. Project-Specific: Within Centerb. Center-Specific: Center Outc. Between Center/SRPd. Between Centers

EPA/ATSDR a priority, but not a requirement.

Expertise: staff with experience in diverse science topics.

RTC – work with investigators on research translation plan for each project (clusters of projects).

* http://www.niehs.nih.gov/research/supported/srp/funding/rfa/index.cfm

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Community Engagement Core Function: To enhance knowledge exchange and to support community needs with regard to

the science emanating from the Center

Community Engagement Core (Required)

Target communitiesSRP defines target communities as those impacted by sites contaminated with hazardous substances.• Members of the affected community• May also include: local government,

tribal councils, community service groups, non-governmental organizations Not to exceed

$100,000 Direct Costs

A Community Engagement Component Statement must be included in application.

HIGHLIGHT “Bidirectionality” between community and Center (not “outreach”)

Where to start?• SRP Additional Resources Webpage*• Suggested Research and Activities

Document• Develop logic model

* http://www.niehs.nih.gov/research/supported/srp/funding/rfa/index.cfm

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Theme of Center

Impacted Community

BIDIRECTIONAL

Research Products

Appropriate Application

ITERATIVE

End-users

Research Translation

• Initiated by the Center (RTC/Investigator)

• Based on research “product”• Opportunistic and Rapid Response• Critical role reporting successes

• Partnership-driven• Finite/Defined Activities

• Provide access to expertise or conduct community-based projects

Community EngagementShared Challenge: Finding the most Appropriate End-User /

Community Group for Center Research and Activities

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Training Core Function: Graduate and Post-doctoral level cross-disciplinary training

Training Core (Required)

Cost Limitations:• New Applicants:

$100,000 Direct Costs• Renewal Applicants:

$125,000 Direct Costs

• 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• Use of CareerTrac (for

renewals)

Please refer to Training Core

Changes section of webinar for Format

Changes in ES-14-007

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• Research Support Core – Provides centralized services– Shared by at least 2 projects

P42: Research Support Core (Optional)

• Pros and Cons of RSC – Pros:

– Excellent Interactions/Integration– Opportunities for Training– Assurance of Quality

– Cons: – May not be critical (if facilities already available)– 12 component limit

If Research Support Core is not included, project should adequately detail research support activities (e.g. QA/QC)

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Cost Limitations (Direct)

Core Limitations (Direct):• Administrative - $125K• Research Translation - $125K• Community Engagement - $100K • Training Cores

– New applicants: $100K– Renewal applicants: $125K

Cores Sum ≤ 20% Total Center Administrative

Research TranslationCommunity Engagement

Training

Center: New Applicants: up to $1.6M/year direct costs for 4 yearsRenewal Applicants: up to $2.0M/year direct costs for 5 years

Renewal Applicants: ≤ $400K

20%AC, RTC, CEC, TC

80%Research Projects, Research Support Cores

New Applicants: ≤ $320K

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• Budget Ceilings for Overall Center and Cores• Total Projects and Cores limited to 12

Components• Training Cores required• Research Support Cores optional• Environmental Science and Engineering

replaced “Environmental Science” and “Non-biomedical”

Recent Changes

Resource Sharing Plan for Projects

Review Criteria Changes• Modifications to overall center description of Significance,

Investigator, Innovation, Approach and Environment• Cores: each core has specific review criteria

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Recent Changes

• Research Translation Core– Translation plan for each project

• Research Strategy (12 page limit)• Review Scoring System• One Resubmission (A1)• Community Engagement

– Core is Required– Community Engagement Projects (CEPs)

• explicitly mentioned (had always been welcome)• e.g. community-based participatory research (biomedical and

environmental science)

– New: “Community Engagement Component Statement” section for CEC and CEPs.

Unchanged Characteristics• Not a site-specific program• Basic to application-oriented research• Innovative approaches to research

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Community Engagement

Research Translation Problem

Solution

Non-Biomedical Approaches

Biomedical Approaches

A Successful P42 Center

Superfund Stakeholders Stakeholder Communities

Research and Training

* Addressing Important Problem

* Projects and Cores Uniformly Meritorious

* Integration, Interaction, Synergy:- Biomedical and Environmental Science &

Engineering- Projects and Cores

* Aids Stakeholders in Effective Decision-Making

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NIEHS SCIENTIFIC PEER REVIEW

LEROY WORTH, PHD (2014 P42 REVIEW )

Review

Non-responsive(return to applicant)

Responsive

Review Committee

Discussed

Funding decisionsand awards

(June/July 2015)

SummaryStatements

Letters of Intent(August 3, 2014)

NAEHS Council(May 2015)

SummaryStatements

Not - Discussed

The Peer Review Process

Administrative Review

Peer Review Meeting (Winter 2015)

Receive Applications(September 3, 2014)

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• Submission of Letter of Intent (LOI):– Assists in review planning – Email to Dr. Leroy Worth at worth@niehs.nih.gov Requested by

August 3, 2014 (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

Pre-Submission of P42 Application

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P42 Peer Review Process• Review Criteria are in the solicitation: http://

grants.nih.gov/grants/guide/rfa-files/RFA-ES-14-007.html • Review of the Individual Research Projects, Cores• Review the Overall Center

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Research Projects

• Significance• Investigator(s)• Innovation• Approach• Environment

• Contribution to SRP Center• Other Specific Criteria*

NIH’s Five Review Criteria(criterion

scores 10-90)

Impact Score(10-90)

Each Project reviewed. Each Receive Criterion Scores and written critiques. Note-Applications 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 Core– Community Engagement– Training (NOTE – see previous slides for

review criteria changes from ES 14-001)– Research Support Cores(see RFA for specific criteria)

Impact Score(10-90)

Overall Center

Final Score (Range: 10-90)

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Addresses a critical problem relevant to the SRP

Relevance/Merit of Projects and Cores (scientific gain) Collaboration/Integration/Synergy

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.

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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NIEHS GRANTS MANAGEMENT

LISA EDWARDS, MBA

Budget

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 substanceo Some items in different placeso Some items not collected as specific line items

• Budget data collected at component and subaward levels onlyComponent and subaward budget data used to auto-calculate “Cumulative” (Composite) budget

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Budget Preparation

*Just in Time: Request for information required prior to award.

Form Pages, Approvals, Other Support, Notices

Forms (http://grants.nih.gov/grants/forms.htm) SF424 (R&R) electronic submission

ApprovalsIACUC 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 acceptableTotal time commitment cannot exceed 12 calendar months

New Notices• Revised Grants Policy Statement: NOT-OD-12-157

• Salary caps: NOT-OD-12-035http://grants1.nih.gov/grants/policy/salcap_summary.htm.

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Travel to Annual Meeting

Administrative Core Budget: Funds for travel by appropriate staff (i.e., Center Director, Project/Core Leaders, 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.

EscalationBudgets 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?

Budget PreparationNon-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. Please see previous slideset.

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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?• For Training Budget Justification – Please see previous slideset for additional

details.

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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 Personnelo 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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R&R Budget

Sections C - E

Itemize up to 100 pieces of equipment. If more, include total dollars in line 11 and provide details in the Additional Equipment attachment

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 BudgetSections F - K

Subaward/Consortium/Contractual Cost not pre-populated. 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 budgetso Included as line F.1 (Other Direct Costs: Materials and Supplies)

• Alteration and Renovationso Not a major line item on 424 budgetso Included as line F.7 (Other Direct Costs: Alterations and Renovations)

• Inpatient and Outpatient Care Costso 424 does not include as major / minor line itemo Current instructions require inserting in fields F.8-F.10 (Other Direct

Costs: Other Costs)

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P42 Multi-Project Centers• Announcement:

– RFA-ES-14-007: http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-14-007.html

• Applications Details– One application per institution– Letters of Intent: August 3, 2014 March 10, 2014 – Due Date: Sept 3, 2014 April 10, 2014 by 5:00 PM local time of applicant

organization.– Scientific Review: Jan/Feb 2015 October, 2014– Awards Start Date: June/July 2015 April, 2015

• Consultation with SRP Program Administrator Staff is highly recommended (in person or teleconference)

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P42 Resources• RFA Webpage

– 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

Also see “Current P42 Grantees:” http://tools.niehs.nih.gov/srp/programs/index267.cfm

RFA Webpage: http://www.niehs.nih.gov/research/supported/srp/funding/rfa/index.cfm

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SRP PROGRAM ADMINISTRATOR

DANIELLE CARLIN, PHD, DABT

Electronic Submission:Using ASSIST

Note – There is additional information about ASSIST in the previous slides set.

What is ASSIST?

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ASSIST - Application Submission System & Interface for Submission Tracking

• Web-based system for the preparation and submission of multi-project applications

• ASSIST replaces Grants.gov• Grants.gov for single-project applications• ASSIST for multi-project applications

ASSIST allows applicants to…

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• Use existing eRA Commons and Grants.gov accounts

• Pre-populate data from eRA Commons profiles• Control application access• Have multiple users within and outside the

applicant organization work concurrently• Check application against Grants.gov and NIH

business rules before submitting• Preview/print NIH application image before

submitting• Track Grants.gov and eRA Commons submission

status

P42 Funding Opportunity Announcement

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Announcement text indicates electronic

submission is required.

Apply for Grant Electronically button brings applicant to the

ASSIST site.

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P42 Funding Opportunity Announcement

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Types of components allowed for the FOA and available in ASSIST for application preparation.

The Research Strategy page limits enforced in

ASSIST for each component.

Applicants will rely on the SF424 (R&R) Application Guide and the FOA text, especially Section IV. Application and Submission Information, when preparing their applications in ASSIST.

ASSIST Login

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https://public.era.nih.gov/assist

ASSIST leverages the eRA Commons accounts that most applicants already

have.

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Overall Component

The Overall Component is added to the component navigation.

The required forms are presented for the

component.

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Adding Additional Components

Click Add New Component to continue building your application.

Select from the drop-down list of

component types available for the FOA.

Adding Components

Applicants continue adding components to build out their application.

Components are grouped by Component Type.

Each component is given a random 3-digit, system-generated number for identification during application

preparation. Components will be given sequential numbers in the assembled application image.

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Projects & Cores – Additional Information

• Projects • Research Strategy: Each project should also include a "Relation

to Overall Center" statement.

• Administrative, Research Translation, Community Engagement, and Training Cores (Research Support Cores are optional)

• Research Strategy: each core will have a "Relation to Overall Center" statement; For CEC, include Community Engagement Statement in Research Strategy

• Other Attachments: Training Core will also have Diversity Recruitment and Retention Plan; Trainee List (required only for renewals)

• Other Attachments: Research Support Cores will also have Quality Assurance Statement

Refer to previous slides for instructions on using NRSA ASSIST Pages as well as additional attachment tables.

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Resources• SF424 (R&R) Application and Electronic Submission Information”

webpage:– http://grants.nih.gov/grants/funding/424/index.htm

• Applying Electronically to Multi-project Applications:– http://grants.nih.gov/grants/ElectronicReceipt/com_index.htm

• Need help with ASSIST?– http://grants.nih.gov/grants/ElectronicReceipt/faq_full.htm#about

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://era.nih.gov/help/ Toll-free: 866-504-9552. Phone: 301-402-7469. TTY: 301-451-5939.

NIEHS Contacts:Program: William A. Suk suk@niehs.nih.gov, (919) 541-0797Heather Henry henryh@niehs.nih.gov, (919) 541-5330Danielle Carlin danielle.carlin@nih.gov, (919) 541-1409

Grants Management: Lisa Edwards, archer@niehs.nih.gov, (919) 541-0751 Michelle Victalino, victalinom@niehs.nih.gov, (919) 316-4666

Scientific Review:Leroy Worth, worth@niehs.nih.gov, (919) 541-0670

P42 Multi-Project Centers

Acknowledgements:EPA’s CLU-In.org

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Thank You!

QUESTIONS??

Webinar Gurus Jean Balent, EPA TIFSDJustin Crane, MDB, Inc.

SRP TeamBill Suk, DirectorHeather HenryBeth AndersonDanielle CarlinMichelle HeacockRosemary Moody

SRP TeamBill Suk, DirectorHeather HenryBeth AndersonDanielle CarlinMichelle HeacockRosemary Moody

NIEHS StaffLeroy Worth, SROLisa Archer Edwards, GMOMichelle Victalino, GMS

Questions not covered during seminar will be answered off-line ASAP and posted on P42 Funding Opportunity Webpages:• On SRP Website: http://www.niehs.nih.gov/research/supported/dert/cris/programs/srp/funding/rfa/index.cfm

Audio Archive will be available in approximately 4 weeks and are accessible from the above website.