1. Current Directions in NIEHS Extramural Programs J. Patrick Mastin, Ph.D. Chief, Cellular, Organs, and Systems Pathobiology Branch Division of Extramural Research & Training NIEHS mastin@niehs.nih.gov 919-541-3289

2.  NIH Grants Process  NIEHS Strategic Plan (more tomorrow morning, 7:30)  New Investigators  Pathway to Independence (K99/R00)  ONES Award  NIH New Investigators Policy  Training / Career Development Funding Opportunities Overview

3. The NIH Grant Process What happens in the Black Box ? NIH Grant Process

4. Funding Mechanisms Important Personnel Overview of NIH Grant Process Submission Referral Review Award Post-award The NIH Grant Process

5. Grant Mechanisms “R”: Research Project R01 R03 (Small Research Grants) R21 (Exploratory/Developmental Grants) R43 (Small Business Innovation Research Grants) “P”: Multi- component projects P01 (Program Projects) P30 & P50 (Center Grants) “T”: Institutional Training T32 T35: Short-term Training “F”: FellowshipsF30 (MD/PhD) F31 (Diversity pre-doctoral) F32 (National Service Research Award) “K”: Career Development K99/R00 (Pathways to Independence Award) Although there are many mechanisms, not all mechanisms are available at all Institutes under all circumstances. http://grants.nih.gov/grants/funding/ac.pdf

6. Important Personnel PROGRAM ADMINISTRATOR GRANTS MANAGEMENT SPECIALIST SCIENTIFIC REVIEW ADMINISTRATOR

7. Important Personnel  Responsible for the programmatic, scientific and/or technical aspects of a grant Program Administrator (PA)  Develop research programs  Provide guidance and assistance to applicants  Attend study section meetings  Communicate results of review  Make funding recommendations  Post-award administration GRANTS MANAGEMENT SPECIALIST SCIENTIFIC REVIEW ADMINISTRATOR PROGRAM ADMINISTRATOR

8.  Manages activities of a scientific review group Important Personnel Scientific Review Administrator (SRA)  Performs an initial administrative review of applications  Assembles study section panel and assigns applications to individual reviewers  Serves as the overall point of contact with applicants  Prepares Summary Statements PROGRAM ADMINISTRATOR GRANTS MANAGEMENT SPECIALIST SCIENTIFIC REVIEW ADMINISTRATOR

9.  Responsible for the business management aspects of grants Important Personnel Grants Management Specialist (GMS)  Evaluate grant applications for administrative content and compliance with statutes, regulations and guidelines  Negotiates grants  Provides consultation and technical assistance  Administers and closes out grants PROGRAM ADMINISTRATOR GRANTS MANAGEMENT SPECIALIST SCIENTIFIC REVIEW ADMINISTRATOR

10. Note: There are 3 “Council Rounds” per year. These correspond to the times when the institutes’ Advisory Councils meet. “September Council” (“October”) “January Council” (“February”) “May Council” Overview of NIH Grant Process

11.  Review  Award  Post-award  Submission  Receipt and Referral  Review  Award

12. Submission Types of applications Unsolicited “Investigator-Initiated” Program Announcements (PA) Request for Applications (RFA) Solicited Used when NIH wants to solicit applications in a particular area or on a particular topic or using a particular grant mechanism Funding Opportunity Announcement (FOA) Majority of applications, e.g., most R01s All applications, even the “unsolicited” ones, have FOA numbers

13. Submission Types of applications To find out about Funding Opportunity Announcements (FOA) NIH Guide for Grants and Contracts http://grants.nih.gov/grants/guide/index.html

14. What to submit: Application Forms All applications must be submitted on PHS 398 SF424 PastNow Most electronically http://era.nih.gov/ElectronicReceipt/ Electronic Submission Electronic Submission http://era.nih.gov/ElectronicReceipt/

17. Recommendation Contract an appropriate Program Administrator in an appropriate institute before submitting (and preferably before you finishing the writing) your application.

18. Overview of NIH Grant Process  Receipt and Referral  Review  Award  Post-award  Submission

19. Receipt and Referral Center for Scientific Review Division of Receipt and Referral  Receipt: Check for completeness, enter information into database, assign number, etc.  Referral (assignments)  To a review group (“study section”)  To a funding agency (e.g., NIEHS, NCI, etc.) Note: You can request a certain institute for funding or a study section for review. Requests won’t always be honored.

20. Overview of NIH Grant Process  Referral  Review  Award  Post-award  Submission

21. Review Study sections at the Institutions  For special circumstances e.g., RFAs & PAs (FOAs) Center for Scientific Review Study Sections (n = lots)  Most applications reviewed here

22. Review  “Streamlined”: Lower half; “Unscored”  Scored: 100 (best) to 500 (worst)  “Not Recommended for Further Consideration” (“nerfed”)  Applications are mailed to Reviewers (on CD)  Reviewers read and evaluate applications, and prepare written comments  Review meeting: Reviewers discuss applications individually and give them a rating

23. National Advisory Health Sciences Council (“Secondary Review”)  Council accepts or rejects review of the study section  If recommendations are rejected, the Council may defer for a re-review. It can’t change the score. Review

24. Overview of NIH Grant Process  Referral  Review  Award  Post-award  Submission

25. Funding Considerations Recommendations for funding are based on  Summary Statement: Score and summary statement narratives  Programmatic Priorities  Budgetary Considerations

26. If the application is approved for funding: there are negotiations between NIH and applicant, if necessary, and an award is made. If the application not approved for funding, applicant can revise and resubmit (up to 2 more times).

27. Overview of NIH Grant Process  Referral  Review  Award  Post-award  Submission

28. Post-Award Yearly Progress Reports Competitive Renewal (for some mechanisms) Fame and Fortune

29. NIEHS 2006-2011 Strategic Plan New Frontiers in Environmental Sciences and Human Health

30. The Plan, The Vision Input from the public and discussions at a Strategic Planning Forum resulted in development of three major Challenges and seven major Goals that are put forward in the Strategic Plan. These Challenges and Goals are in fulfillment of the NIEHS vision: The NIEHS vision is to prevent disease and improve human health by using environmental sciences to understand human biology and human disease.

31. Goals 1.Expand the role of clinical research in environmental health sciences. 2.Use environmental toxicants to understand basic mechanisms in human biology. 3.Build integrated environmental health research programs to address the cross-cutting problems in human biology and human disease. 4.Improve and expand community-linked research.

32. Goals 5.Develop sensitive markers of environmental exposure, early (preclinical) biological response, and genetic susceptibility. 6.Recruit and train the next generation of environmental health scientists. 7.Foster the development of partnerships between the NIEHS and other NIH institutes, national and international research agencies, academia, industry, and community organizations to improve human health.

33. Recent Requests for Applications  Gene-Environment Initiatives (GEI)  DISCOVER: Disease Investigation through Specialized Clinically-Oriented Ventures in Environmental Research  Comparative Biology Elucidation of Environmental Pathways and Susceptibility  Manufactured Nanomaterials: Physico-chemical Principles of Biocompatibility and Toxicity  Institutional Patient-Oriented Career Development Programs in the Environmental Health Sciences http://www.niehs.nih.gov/dert/announce.htm

34. http://grants2.nih.gov/grants/new_investigators/

35. New Investigators are identified in post-council funding discussions by program administrators at NIEHS, and are given preferential consideration. NIEHS has established the Outstanding New Environmental Health Scientist (ONES) award, a first time R01 grant for scientists in the early, formative stage (less than 8 years from the doctoral degree) of their career.

36. Transition from post-doc to faculty K99/R00

37. Outstanding New Environmental Scientist (ONES) Award

38. Outstanding New Environmental Scientists (ONES) Goals of the ONES Program: Identify outstanding scientists who are in the early, formative stages of their careers and who intend to make a long term career commitment to research in the mission areas of the NIEHS Assist them in launching an innovative research program focusing on problems of environmental exposures and human biology, human pathophysiology and human disease.

39. Provide R01 support Highly competitive review process Provide support for resource development and career enhancement, separate from research funding Can be used for training, sabbaticals, etc. Can be used as for resource development: equipment, staff, cohort development, etc. Unique Features of ONES awards Outstanding New Environmental Scientists (ONES)

40. To be qualified, applicants Must be New Investigator: < 8 years postdoctoral experience Must be Assistant, Research Assistant Professor, or equivalent, and must show evidence of independent productivity and facilities Must show a long-term commitment to Environmental Health Sciences research Must show strong departmental and institutional support for their career development ONES award would be first R01 Support Outstanding New Environmental Scientists (ONES)

41. 2007 NIH Director's New Innovator Award Program  New investigators who have not yet obtained an NIH R01 or similar grant  Must have received a doctoral degree or completed a medical internship and residency in 1997 or later  Up to $1.5 million in direct costs over five years  Application period opens on April 25 and closes on May 22, 2007  NIH expects to make at least 14 awards in September 2007 http://grants.nih.gov/grants/new_investigators/innovator_award/

42.  Outstanding New Environmental Scientist Award (ONES) (Recurring RFA)  NIH Director's New Innovator Award Program (RM-07-009)  NIH Pathway to Independence (PI) Award (K99/R00) (PA-07-297)  Human Genes and the Environment Research Training Program (ES07-002) -- Application Receipt Date June 29, 2007  Short Term Educational Experiences for Research (STEER) in the Environmental Health Sciences for Undergraduates and High School Students (R25) (ES06-009)  Administrative Supplements to Support High School Student and College Undergraduate Research Experiences  Research Supplements to Promote Diversity in Health- Related Research (PA-05-015) Current Training Funding Opportunities http://www.niehs.nih.gov/dert/announce.htm

43. Current Directions in NIEHS Extramural Programs J. Patrick Mastin, Ph.D. Chief, Cellular, Organs, and Systems Pathobiology Branch Division of Extramural Research & Training NIEHS mastin@niehs.nih.gov 919-541-3289