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Alphabet Soup of NIH Funding Mechanisms

Alphabet Soup of NIH Funding Mechanisms. Rebecca D. Claycamp, MS, CRA Chief Grants Management Officer National Institute of Mental Health. Should I look for a PA or an RFA for the NIGMS R15?. The appropriate response may be EIEIO. 2. At the end of this session, you will….

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Alphabet Soup of NIH Funding Mechanisms

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  1. Alphabet Soup of NIH Funding Mechanisms Rebecca D. Claycamp, MS, CRA Chief Grants Management Officer National Institute of Mental Health

  2. Should I look for a PA or an RFA for the NIGMS R15? The appropriate response may be EIEIO. 2

  3. At the end of this session, you will… be able to decode NIH grant numbers be able to describe the categories of NIH funding mechanisms and detail the most commonly awarded activity codes. understand specific tools that you can use to identify appropriate NIH resources and funding opportunities. 3

  4. Sample Grant Number Used by HHS Agencies Serial Number Suffixes Activity Code 1R01 GM 01234501A1/S1 Application Type Institute/ Center (IC) Year of Support 4

  5. Application Type • New Competing - Type 1 (New) • Competing Continuation - Type 2 (Renewal) • Supplement - Type 3 • Competitive - outside the original scope (Revision) • Administrative - within the original scope • Extension (limited use) - Type 4 • Noncompeting Continuation - Type 5 (Continuation) • Successor-In-Interest/Name Change – Type 6 • Change of Recipient Institution – Type 7 • Change of Institute, Noncompeting – Type 8 (Continuation) • Change of Institute, Competing – Type 9 (Renewal) 5

  6. 24 Funding ICs and the NIH-OD AA - NIAAA DE - NIDCR HL - NHLBI AG - NIA DK - NIDDK LM - NLM AI - NIAID EB - NIBIB MD - NIMHD AR - NIAMS ES - NIEHS MH - NIMH AT -NICCIH EY - NEI NR - NINR CA - NCI GM - NIGMS NS - NINDS DA - NIDA HD - NICHD TR - NCATS DC - NIDCD HG - NHGRI TW - FIC Translation at…https://www.nih.gov/institutes-nih/list-nih-institutes-centers-offices

  7. Years IC’s Were Established NCI - 1937 NIBIB - 2000 NIMH - 1949 NEI - 1968 NICHD - 1962 NIMHD - 2010 NHLBI – 1948 NIDCD - 1988 NINDS - 1950 NHGRI -1989 NIDCR - 1948 NINR - 1986 NIA - 1974 NIDDK - 1950 NLM - 1956 NIAAA - 1970 NIDA - 1974 FIC - 1968 NIAID - 1948 NIEHS - 1969 NCATS - 2011 NIAMS - 1986 NIGMS - 1962 NCCIH - 1999 The different histories of the various IC’s dictate what programs are developed.

  8. Grant Number Life of a 4-Year Grant 1 R01 GM123456-01A1 1st year of grant (new) 5 R01 GM123456-02 2nd year of grant (continuation) 3 R01 GM123456-02S1 2nd year supplement 5 R01 GM123456-03 3rd year of grant 7 R01 GM123456-04 3rd year midyear transfer 5 R01 GM123456-05 4th year of grant 3 R01 GM123456-05S1 4th year supplement 2 R01 GM123456-06 5th year continuation application 9 R01 MH119784-06 5th year award from a new IC 8

  9. 117 Grant and Cooperative Agreement Activity Codes Awarded by NIH in FY2018 C06 FI2 K18 P30 R18 R42 S10 T90 U41 UG4 D43 G08 K22 P40 R21 R43 S21 TL1 U42 UH2 D71 G11 K23 P41 R24 R44 SB1 TL4 U43 UH3 DP1 G12 K24 P42 R25 R50 SC1 U01 U44 UH4 DP2 G13 K25 P50 R28 R56 SC2 U10 U45 UL1 DP5 K00 K43 P51 R33 R61 SC3 U13 U54 UM1 DP7 K01 K76 P60 R34 R90 T15 U18 UA5 UM2 F30 K02 K99 R00 R35 RC2 T32 U19 UC4UT1 F31 K05 KL2R01 R36 RF1 T34 U24 UC7 UT2 F32 K07 P01 R03 R37 RL5 T35 U2C UF1 F33 K08 P20 R13 R38 RM1 T36 U2R UG1 F99 K12 P2C R15 R41 S06 T37 U34 UG3

  10. 112 Grant and Cooperative Agreement Activity Codes Awarded by NIH in FY2019 C06 G08 K22 P40 R18 R42 S10 TL1 U42 UH3 D43 G11 K23 P41 R21 R43 S21 TL4 U43 UH4 D71 G11 K24 P42 R24 R44 SB1 U01 U44 UL1 DP1 G13 K25 P50 R25 R50 SC1 U10 U45 UM1 DP2 K00 K43 P51 R28 R56 SC2 U13 U54 UM2 DP5 K01 K79 P60 R33 R61 SC3 U18 U54 UT2 F30 K02 K99 PL1 R34 R90 T15 U19 UC7 F31 K05 KL2 R00 R35 RC2 T32 U24 UF1 F32 K07 P01R01 R36 RF1 T34 U2C UG1 F33 K08 P20 R03 R37 RL5 T35 U2R UG3 F99 K12 P2C R13 R38 RM1 T37 U34 UG4 FI2 K18 P30 R15 R41 S06 T90 U41 UH2

  11. FY2018 Grant Activity Code Facts • 117 activity codes awarded across the NIH • One IC (NCI) awarded 57 different activity codes; one IC awarded only 12 (FIC); median was 39 different codes • Only 34/117 codes awarded by more than half (13 or more) of the IC’s • 33 codes each awarded by only 1 IC (not counting 6 codes unique to the OD); 8 of these 37 awarded by one IC (NIGMS)

  12. Why are these “facts” important to note • Critical for PI’s look at each IC’s web page to see what mechanisms/activity codes each supports • Essential to review relevant PAs and RFAs from the NIH Guide • Invaluable for PI’s to talk to Program staff at an IC Comprehensive List of Activity Codes https://grants.nih.gov/grants/funding/funding_program.htm and https://grants.nih.gov/grants/funding/ac_search_results.htm

  13. Solicited vs. Unsolicited Applications All applications are submitted in response to a Funding Opportunity Announcement (FOA) published in the NIH Guide for Grants and Contractsand posted on Grants.gov. Most NIH funded grants are unsolicited. Unsolicited applications are submitted in response to a parent program announcement. Solicited funding opportunities are published as specific FOAs, including: • RFA – Request for Applications – one receipt date (typically) and funds set aside to fund (grants) • RFP – Request for Proposal (contracts) • PA – Program Announcement: both solicited and unsolicited (aka parent announcements); growing use of Notices of Special Interest (NOSI) rather than topic-specific PAs • PAS – Program Announcement with set aside funds • PAR – Program Announcement reviewed by the Institute/Center not Center for Scientific Review (CSR)

  14. Searching the NIH Guide Office of Extramural Research home page:https://grants.nih.gov/funding/about-nih-guide-to-grants-and-contracts.htm

  15. Weekly Table of Contents

  16. Searching the NIH GuideHome Page Enter search criteria or Select Advanced Search

  17. Searching the NIH Guide Advanced Search The Advanced Search feature provides a lot of options to narrow your search. Enter search criteria.

  18. Searching the NIH GuideLinks to FOAs Selecting the FOA title opens the announcement

  19. Once in the FOA… A button within the announcement allows applicants to access the NIH ASSIST application package directly from the NIH Guide. Other options are institutional S2S solutions or the Grants.gov workspace.

  20. Importance of the FOA • Details participating ICs • Defines whether clinical trials are required, not allowed or optional • Defines eligible PIs & institutions • Specifies budget format; may dictate budget caps and may identify unallowable cost items • Gives deadlines and any other requirements • Provides Program, Review and Grants Management contacts

  21. What are “Standard Deadlines” • Apply when specific deadlines are not given in the FOA: RFAs nearly always have specific deadlines. • Are activity code-specific: e.g., the standard deadline for the R01 is different that the R21 • Occur three times per year: generally January-March, May-July and September to November • All AIDS and AIDS-related activity codes have three single deadlines. https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm

  22. Where in the FOA will I find… Which ICs will accept applications? Part 1. Overview – Participating Organizations

  23. Where in the FOA will I find… Deadlines? Part 1. Overview – Key Dates, including due dates for applications and (if needed) letter of intent

  24. Where in the FOA will I find… Funds available, award budget and award project period? Part 2. Section II Award Information

  25. Where in the FOA will I find… Eligible (including foreign) organizations Part 2. Section III Eligibility Information

  26. Where in the FOA will I find… Individuals eligible to be PD/PI Part 2. Section III Eligibility Information

  27. Parent FOAs Parent announcements are broad funding opportunity announcements allowing applicants to submit investigator-initiated applications for specific activity codes. • They are open for up to 3 years and use standard due dates. • Not all NIH ICs participate on all parent announcements. • Critical to communicate to recipients to confirm an IC’s participation in a particular parent FOA.

  28. Activity Codes ≠ Funding Mechanisms Each budget line has specific activity codes associated with it. • Research Project Grants • SBIR/STTR Grants • Research Centers • Other Research • Career Awards • Other Research (Resource Grants) • Training • Individual • Institutional 28

  29. Research Project Grants (RPGs) • Research Project Grants (RPGs) • Primarily investigator-initiated • Not all “R’s” are RPGs; not all RPG’s are “R’s” • Includes DP1, DP2, DP3, DP5, DP7, R00, R01, R03, R15, R21, R33, R34, R35, R36, R37, R38, R50, R55, R56, R61, RC1, RC2, RC3, RC4, RF1, RM1, P01, P42, PN1, U01, U19, U34, UA5, UC1, UC2, UC4, UF1, UG3, UH2, UH3, UM1, and UM2 • Other R mechanisms are SBIRs/STTRs or are termed “other research”

  30. RPGs: Research Project Grant (R01) • Used to support a discrete, specified, circumscribed research project • No specific dollar limit unless specified in the FOA • Advanced permission required for $500,000 or more (direct costs) in any year – at least six weeks in advance • Generally awarded for 3-5 years; can be renewed. • Parent FOA (both clinical trial (CT) required with 14 ICs and CT not allowed with 22 ICs) as of 10-7-19 • NIH’s most commonly used grant program: 23 ICs awarded R01s in FY2018 http://grants.nih.gov/grants/funding/r01.htm

  31. RPGs: Research Project Grant (P01) • Support for integrated, multi-project research projects involving investigators who share knowledge and common resources • Each project contributes or is directly related to the common theme of the common effort, creating a well-defined research project goal • Typically with a specific dollar limit unless specified in the FOA • Typically awarded for 4-5 years • Only 13 ICs awarded P01s in FY2018

  32. RPGs: Small Grant Program (R03) • Provides limited funding to support a variety of types of projects, including: pilot or feasibility studies, collection of preliminary data, secondary analysis of existing data, small, self-contained research projects, development of new research technology, etc • Direct costs limited to $50,000/year • Limited to 2 years of funding, not renewable • Parent FOA (CT not allowed); only 9 ICs participate (10-7-19) • 18 ICs awarded R03s in FY2018 http://grants.nih.gov/grants/funding/r03.htm

  33. RPGs: NIH Research Enhancement Awards (R15) • In FY2019 program changed to • Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions • Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools • Supports small research projects conducted by undergraduate and/or graduate students and faculty in institutions of higher education. that have not been major recipients of NIH research grant funds (no more than $6 million in each of 4 of the last 7 years) • Direct costs limited to $300,000 for the project period, multi-year funded for project periods of up to 3 years; renewable. • Changes outlined in https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-015.html • 22 ICs awarded R15s in FY2018

  34. RPGs: Exploratory/ Developmental Research (R21) • Encourages exploratory and developmental research projects for early stages of development.  Sometimes used for pilot and feasibility studies. • Combined budget for direct costs $275,000 for the two year project period, no more than $200,000 in any one year; not renewable • Parent FOA (both clinical trial (CT) required with 11 ICs and CT not allowed with 14 ICs) as of 10-7-19 • 24 ICs awarded R21s in FY2018 https://grants.nih.gov/grants/funding/r21.htm

  35. RPGs: Planning Grant Program (R34) • Supports initial development of a clinical trial or research project. • Direct costs limited to $450,000 over the 3 year project period, no more than $225,000 in any one year; not renewable • IC-specific FOAs. • 9 ICs awarded R34s in FY2017; 12 ICs awarded R34s in FY2018 https://grants.nih.gov/grants/funding/r34.htm

  36. Small Business (SBIR/STTR) Grants (R41, R42, R43, R44) • For-profit concern at least 51% owned and controlled by individuals who are US citizens or permanent residents • Organization and its affiliates has 500 or fewer employees • Research is done 100% in the U.S. • Parent FOAs (both clinical trial (CT) required and CT not allowed). • All ICs except FIC participate.

  37. Small Business GrantsSBIR/STTR (R41, R42, R43, R44) • SBIRs (R43 and R44) • PI employed >50% by the small business during the award • Contractual and consultant costs are typically less that 33% of total amount • STTRs (R41 and R42) • PI spends at least 10% effort and has formal commitment/ appointment with the small business • Required research institution partner performing at least 30% of work; small business performing at least 40% of the work

  38. Center Grants • Established by ICs to meet special needs • Always in response to an RFA • Specialized Center Grants – P50 (17 ICs awarded in FY2018) • Core Center Grants - P30 (13 ICs awarded ) • Exploratory Center Grants – P20 (5 ICs in FY2018 awarded) https://grants1.nih.gov/grants/funding/funding_program.htm#PSeries

  39. Other Research • Conferences (R13) requires permission to submit letter https://grants.nih.gov/grants/funding/r13/index.htm • Resource-Related Research Projects (R24) (projects that will enhance the capability of resources) • Research Education Programs – R25 • Various and assorted activity codes

  40. U’s – Cooperative Agreements • Substantial programmatic involvement • Almost always initiated by the NIH as an RFA (special terms outlined in the FOA) or a conversion due to substantial NIH intramural involvement • RFA outlines special terms and conditions for an award • Generally referred to as a “grant”

  41. Examples of Grant – Cooperative Agreement Pairs • R01 – U01 • R15 – UA5 • R13 – U13 • R18 – U18 • R21 – UH2 • R24 – U24 • R33 – UH3 • D43 – U2R • R41 – UT1 • R42 – UT2 • R43 – U43 • R44 – U44 • P01 – U19 • P20 – U56 • P50 – U54 • C01 – UC6

  42. S10 – Shared Instrumentation Grant (SIG) Program (OD) • For instrumentation only • typically costing at least $50,000 to a maximum of $600,000 • Must have 3 or more active NIH RPG (e.g., R01, P01, U01, R37) PI users • Cost sharing not required • Single annual deadline

  43. Domestic NIH Research Training and Career Development Timetable Approximate Stage Mechanism of Support Predoctoral Institutional Training Grant (T32) GRADUATE/ MEDICAL STUDENT Predoctoral Individual NRSA (F31) Predoctoral Individual MD/PhD NRSA (F30) Postdoctoral Institutional Training Grant (T32) POST DOCTORAL Postdoctoral Individual NRSA (F32) Mentored Research Scientist Development Award (K01) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented RCDA (K23) Pathway to Independence Award (K99/R00) EARLY Small Grant (R03) CAREER Independent Scientist Award (K02) MIDDLE Research Project Grant (R01) Exploratory/Development Grant (R21) Midcareer Investigator Award in Patient-Oriented Research (K24) SENIOR Senior Scientist Award (K05)

  44. Fellowships • F30 - Individual Predoctoral NRSA for MD/PhD and Other Dual Degree Fellowships (Parent FOAs; 20 ICs awarded F30s in FY2018) • F31 - Predoctoral Individual NRSA Fellowship (Parent FOAs; 22 ICs awarded F31s in FY2018) • F32 - Postdoctoral Individual NRSA Fellowship (Parent FOAs; 20 ICs awarded F32s in FY2018) https:// researchtraining.nih.gov/programs/fellowships

  45. Institutional Training Grants • T32 - Ruth L. Kirschstein Institutional National Research Service Award (19 ICs in Parent FOA as of 10-7-19; 22 ICs awarded T32s in FY2018) • T35 - Ruth L. Kirschstein Short-Term Institutional Research Training Grants (T35) (10 ICs plus OD in Parent FOA; 10 ICs awarded T35s in FY2018) • D43 - International Research Training Grant for U.S. and low- and middle-income institution collaborations (not training, but “other research” https://grants1.nih.gov/training/nrsa.htm

  46. Research Career Development Award Programs (K) Career Development Programs help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the nation’s biomedical, behavioral, and clinical research needs. • Mentored Ks (K00, K01, K07 developmental, K08, K22, K23, K25, K43, K76, K99/R00) • Nonmentored Ks (K02, K05, K07 leadership, K18, K24, K26) • Institutional Mentored Programs (K12, KL2)

  47. Common Features of Mentored Career Awards Some costs vary widely across ICs, K99 outside of these norms. Almost all K award programs to domestic institutions. Review specific K announcements carefully. • Salary/fringe benefits • Depending on IC and the K, salaries capped between $75,000 and legislated salary cap; fringe benefits are over & above any cap • Salary supplementation OK, but must be from non-Federal sources & not require extra duties that would interfere w/K • Research/development costs • Depending on IC and the K, $20,000 to $50,000 per year • Commonly used for: supplies, equipment, technical personnel, travel to research meetings or training, tuition/fees related to career development, computational services • F&A Costs = 8% MTDC

  48. Policy for Mentored Career Awardees • May reduce level of effort on career awards in last two years of support to no less than 50%, replacing effort with that as PI of NIH research grant or subproject or a research grant from any federal agency • Applies to K01, K07 (developmental), K08, K22, K23, and K25, and individuals mentored via institutional K12 or KL2 awards See NIH Grants Policy Statement, Section 12.3.6.2

  49. Mentored Research Scientist Career Development Award (K01) • Provide support and protected time for an intensive, supervised career development experience for a research scientist in the biomedical, behavioral, or clinical sciences leading to research independence. • U.S. citizen or permanent resident, with research or clinical doctoral degree. • Parent FOAs (both CT required and independent CT not allowed) • 22 IC’s awarded K01s in FY2018 https://researchtraining.nih.gov/programs/career-development/K01

  50. Mentored Clinical Scientist RCDA (K08) • Provide support and protected time of a clinically trained individual for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. • U.S. citizen or permanent resident, with clinical doctoral degree. • Parent FOAs (both CT required and independent CT not allowed) • 19 IC’s awarded K08s in FY2018 https://researchtraining.nih.gov/programs/career-development/K08

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