Superfund Research Program Funding Opportunity Web Seminar:

1. Biogeochemical Interactions Affecting Bioavailability for in situ Remediation of Hazardous Substances (R01) Superfund Research Program Funding Opportunity Web Seminar: Introduction: William A. Suk, SRP Director Presenters: Heather Henry, SRP Program Administrator Lisa Edwards, NIEHS Grants Management Specialist Sally Eckert-Tilotta, NIEHS Scientific Review Officer Moderators: Jean Balent, EPA/TIFSD Justin Crane, MDB, Inc. September 5, 2013

2. National Institutes of Health (NIH) NIH Research Mission Fundamental Knowledge Health Outcomes …reduced illness & disability …of living systems National Institute of Environmental Health Sciences (NIEHS) …with environmental exposures …caused by hazardous substances …including health effects, risk assessment, detection and remediation …relevant to Superfund stakeholders Superfund Research Program (SRP)

3. SRP Funding Mechanisms Individual Research Project (R01) Designed to address specific issues to complement the multi-project research program; tackle issues of emerging concern for Superfund. Current solicitation: Biogeochemical Interactions Affecting Bioavailability for in situ Remediation of Hazardous Substances (R01) 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. 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 Occupational Training (R25) Emerging issues in EHS training. Closed. Funding Opportunities: http://www.niehs.nih.gov/research/supported/dert/cris/programs/srp/funding/index.cfm

4. R01 Biogeochemical Interactions Purpose • Unveil complex biological, geological and chemical processes that have implications for both remediation effectiveness as well as exposure risk to humans. Mechanistic research that will advance effectiveness of "in situ" remediation of contaminated: • Soil • Sediment • surface water • Groundwater Goal • Utilize mechanistic knowledge • to understand how biogeochemical processes influence remediation effectiveness • To identify which biogeochemical processes drive the availability of hazardous substances to living systems • Make linkages to effective decision-making for Superfund-related exposure scenarios

5. R01 Biogeochemical Interactions • Interactive Teams • Interdisciplinary teams to adequately address the in situ environment (i.e. relevant biological, geological, and chemical conditions) • Real-world expertise through involvement of in situ remediation and risk assessment practitioners • Teams should target fundamental research areas • RFA lists examples of research topics within the scope of this RFA, but do not feel limited by this list…

6. Hazardous Substances • Responsive to FOA: • Relevant to SRP Stakeholders • Drivers of risk at hazardous waste sites: chemical contaminants such as halogenated organics, volatile organic compounds, DNAPLs/LNAPLs and metals/minerals (e.g., lead in soils, metal mixtures) • hazardous substances that are targeted for remediation in soils, sediments, surface water, or groundwater • CERCLA Priority List: http://www.atsdr.cdc.gov/cercla • Not Responsive to FOA: • work on hazardous substances that are not yet targeted for remediation in soils, sediments, surface water, or groundwater • petroleum or natural gas (including hazardous substances associated with hydraulic fracturing) • pharmaceuticals and personal care products (PPCP) (see: http://www.epa.gov/ppcp/) as the target hazardous substance • engineered nanoparticles/nanomaterials as a target hazardous substance (however, using nanotechnologies as a remediation/detection tool is fine)

7. Innovation • Please highlight the innovative aspect(s) of your application: • Innovative approaches or methodologies to provide new insight: • Advanced imaging or analytical techniques (e.g. synchrotron-based research) • Innovative use of stable isotope or bioavailability assays • Environmental molecular diagnostics, • Innovative, cutting-edge remediation technologies • Innovative “green technologies” for remediation that offer improved energy/resource-efficiency and reduce waste generation relative to other remediation technologies. • Innovative approaches to technology development through trans-disciplinary research (synthesis and extension of disciplinary boundaries)

8. Research Translation Plan • Applicants should include a "Research Translation Plan” - specific plans for translation of findings to end-users as well as any relevant and timely policy or risk assessment applications for their research • Such activities may include, but not be limited to: • Identifying potential end-users and delivering outcomes in a manner most appropriate for the given end-user audience. • Coordinating with end-users for optimization of technologies with regard to improving cost-effectiveness or sustainability of innovative techniques or remediation technologies. • Providing technical expertise for technical guidelines (e.g. standard operating procedures) as relevant to the SRP-funded work. SRP’s Key Stakeholders are Sister Superfund Programs (US Environmental Protection Agency and Agency for Toxic Substances and Disease Registry) as well as federal agencies, state, local, and tribal entities responsible for sites; individuals and communities living near hazardous waste sites. See: http://tools.niehs.nih.gov/srp/about/Strategic%20Plan.pdf

9. Research Translation Plan • One-paragraph plan should be sufficient. • This is not part of the Research Strategy (and therefore is not included in the 12 page limit). • Include this as part of the “Data Sharing Plan” (a subsection of the Resource Sharing Plan*). * Per SF424 (R&R), the Resource Sharing Plan includes three sections: a Data Sharing Plan, a Sharing Model Organisms, and Genome Wide Association Studies. The Data Sharing Plan is likely to be the only applicable section for this RFA.

10. Review NIEHS SCIENTIFIC REVIEWSALLY ECKERT-TILOTTA, PHDScientific Review Officer (SRO)

11. Letter of Intent (LOI) • Due October 1, 2013 • Not required, but requested to assist in planning the review • Descriptive title of project; can include summary if desired, but not required • Names, contact info, affiliations of principal investigator, co-investigators, performance sites • LOI commits you to nothing • Email to Sally.Tilotta@nih.gov

12. NIH Application Process Retrieved by R&R, assigned and distributed to IC or CSR Applications come from Grants.gov to NIH/Commons Retrieved by Scientific Review Officer (SRO) who organizes the review • Applications are reviewed for completeness on receipt. • Applications are administratively reviewed for responsiveness to the RFA. • Format, location, date for review are decided. • Reviewers are recruited for expertise, geographical distribution, and diversity. • After the review meeting, results are reported by Summary Statement • Watch PI eCommons account throughout the process.

13. Some Granularity… • Reviewers evaluate and score assigned applications at preliminary stage. • All formats involve discussions of some kind, either face-to-face, telephone, or chat room. Video conferencing is used occasionally. • Final scores are determined at the meeting. • Not all applications receive Overall Priority scores; generally streamline approximately half. • Poorer half receive scores on individual review criteria. • More meritorious half receives criteria scores, overall score. • ALL applications receive a Summary Statement composed of written critiques from assigned reviewers.

14. Review Criteria • Significance, Investigator(s), Innovation, Approach, Environment -- standard and required criteria for research grants and cooperative agreements. • Reviewer decides the weighing of each criterion. • Definitions are in the solicitation and are tailored to address program intent.

15. Scoring Uses a 9-point Range

16. Summary Statements • Released through the PI’s Commons Account • Critiques are reviewers’ verbatim comments, minimally edited. Resume and Summary of Discussion usually written by SRO. • First page contains Program Officer’s contact information on top left corner. “Next Steps” link on the first page provides guidance on what to do next.

17. What Makes an Application with a Good Idea Score Poorly? • Write a “trust me” application which fails to give adequate detail. • Give detailed background and fail to tell us what you will do on the project. • Fail to acknowledge barriers and provide potential alternatives. • Lack of clarity, inconsistencies, and cut-and-paste errors.

18. Specific Aims • What are specific aims? • Objectives, not milestones. If these are accomplished, the goals of the project will be met. Either prove hypothesis or develop an end product. • Related but don’t depend on each other; if one fails then the problem can be attacked through the other aims. • For an R01, typically see 3-5 specific aims. Specific Aims are limited to 1 Page

19. Research Strategy • Easiest and clearest organization is by the review criteria in the funding announcement, starting with background and significance. • Contains the details that builds foundation to the project, convincing reviewers of likelihood of success. • Use “touchstones” to guide reviewers through the story. Research Strategy is limited to 12 Pages

20. Investigators • Don’t necessarily see reference to investigators in the research strategy because have biosketches (including personal statements) to describe in detail (4 page cap) • In research strategy can highlight specific strengths, especially emphasize communication among the team if several collaborators and/or multiple institutions.

21. Innovation • Highlight novel aspects of the project, techniques used, strategies, or hypothesis. • If not particularly novel, emphasize state-of-the-art, filling a niche, or essential need for the project. • Refer to RFA

22. Approach • Scores still often driven by approach, with significance close behind. • How detailed? • Include all essential details. • Invest in yourself or ask a mentor to discover what the reviewers need to know. • Strongest applications have preliminary data section for R01 to establish feasibility. • Must address barriers and alternative strategies. • Timeline is strongly encouraged.

23. ……..Continued • Fill all the rest of available space with detail on the approach – what, why and how. • Give enough detail of methodologies to establish credibility, especially if not commonly used. • Extensive experimental detail least important, strategies most important. Give an example, if possible. If you can refer reader to specific references, then do so.

24. ….and Finally. • Explain decisions. • Use graphics if possible. • Use respectful margins, font size, and white space.

25. Budget NIEHS GRANTS MANAGEMENTLISA EDWARDS, MA

26. R01 Allowable Costs • Salary and fringe benefits for Principal Investigator, key personnel, and other essential personnel • Equipment and supplies • Consultant costs • Alterations and renovations • Publications and miscellaneous costs • Contract services • Consortium costs • Facilities and Administrative costs (indirect costs) • Travel expenses Travel to Annual Meeting – Budgets should include funds for travel of the PD/PI and one graduate student to attend the SRP Annual Meeting. (Meeting is held each fall and alternates between grantee locations and Research Triangle Park, NC)

27. Budget Preparation * Keep In Mind – Please do not circumvent the $150K ceiling through third party expenditures. NIEHS has finite funds for this entire FOA. • Grant Direct Cost Limit • Does NOT include third party F&A* • Consideration of equipment in the out-years will be based upon justification and availability of funds • Subcontracts • Must follow same guidelines as above; budget pages required

28. Budget Preparation • Other Support • “0”, “Varies”, “As Needed”, etc., are not acceptable • Total effort cannot equal more than 12 calendar months • Budget Justifications • Be detailed and specific • Are all costs itemized? • Are all additions and changes in future years fully justified? • Are all time and level of effort > 0?

29. Summary Important Dates, Resources, Contacts

30. Important Dates Applications Details Letters of Intent: October 1, 2013 Due Date: November 1, 2013 Direct Cost/Duration Limits: $150K per year / up to 4 years Scientific Review Special Emphasis Panel: expertise according to applications submitted Peer Review Dates: Spring 2014 Review Criteria in RFA Awards Start Date: Summer 2014 (earliest) • If you have never submitted to NIH, you must register in three places BEFORE you submit: • CCR, Central Contractor Registration (and renew annually), organizations • Grants.gov, organizations • NIH Commons, organizations, and key personnel must have a Commons ID • May take up to 4 weeks

31. Resources 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. General Information about Applying – the National Institute of Allergy and Infectious Diseases (NIAID) has an “All About Grants’ page that includes samples and examples of application components as well as numerous tips for applicants: http://www.niaid.nih.gov/researchfunding/grant/pages/aag.aspx Applying Electronically - For additional information on the electronic submission process, including self-help resources, training material and answers to frequently asked questions, see: http://grants.nih.gov/grants/ElectronicReceipt/index.htm Applicant Resources from the Center for Scientific Review - http://public.csr.nih.gov/ApplicantResources/Pages/default.aspx

32. NIEHS Contacts!!! Program: Heather Henry henryh@niehs.nih.gov (919) 541-5330 Scientific Review: Sally Eckert Tilottasally.tilotta@nih.gov, (919) 541-1446 Grants Management: Lisa Edwards archer@niehs.nih.gov (919) 541-0751 National Institute of Environmental Health Sciences Research Triangle Park, NC

33. Thank You! QUESTIONS?? SRP Team Bill Suk, Director Heather Henry Beth Anderson Danielle Carlin Michelle Heacock Rosemary Moody NIEHS Staff Sally Eckert-Tilotta Lisa Archer Edwards Webinar Gurus Jean Balent, EPA TIFSD Justin Crane, MDB, Inc.