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NIH Mechanism Primer Rebecca Claycamp, CRA Chief Grants Management Officer National Institute of Mental Health NIH Regional Seminar Research Triangle Park, North Carolina April 2007 Solicited vs. Unsolicited Applications

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NIH Mechanism Primer

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NIH Mechanism Primer

Rebecca Claycamp, CRA

Chief Grants Management Officer

National Institute of Mental Health

NIH Regional Seminar

Research Triangle Park, North Carolina

April 2007


Solicited vs. Unsolicited Applications

Most NIH grants are unsolicited. Solicited funding opportunities are published in the NIH Guide for Grants and Contracts as:

  • RFA – Request for Applications – one receipt date and funds set aside to fund (grants)

  • RFP – Request for Proposal (contracts)

  • PA – Program Announcement

  • PAS – Program Announcement with set aside funds

  • PAR – Program Announcement reviewed by the

    Institute/Center not CSR

  • FOA – Funding Opportunity Announcement


Importance of the RFA/PA

  • Will define eligible mechanisms

  • Will define eligible PIs & institutions

  • Will specify budget format

  • May dictate budget caps

  • May identify certain allowable and/or unallowable cost elements


Contract Mechanisms

Contracts – Acquisition or purchase of services for the direct use or benefit of the government. Initiated by NIH, announced in FEDBIZOP

  • N01 – Research & Development (R&D)

  • N41 – Small Business Tech Transfer Phase I

  • N43 – Small Business Innovation Research

    Phase I


FY2006 Grant Mechanism Facts

The 24 ICs and the Office of the Director awarded grants representing 98 mechanisms including

  • 8 Fs

  • 17 Ks

  • 10 Ps

  • 19 Rs

  • 9 Ts

  • 19 Us


FY2006 Grant Mechanism Facts

  • One IC awarded 41 different mechanisms; one awarded only 9; median was 34 mechanisms

  • 23/24 ICs awarded R01s

  • 23/24 ICs awarded Ts

  • 21/24 ICs awarded Fs


FY2006 Grant Mechanism Facts

  • Only 26/98 mechanisms awarded by more than 13 or more of the ICs

  • 42 mechanisms each awarded by only one IC (not including DP1)

  • 12 of these 42 awarded by one IC (NCRR)


Why are these “facts” important to note?

  • Critical to look at each IC’s web page to see what mechanisms 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


Current NIH Series

  • C – Construction

  • D – Training Projects (International)

  • F – Fellowship Programs

  • G – Resource Programs

  • K – Research Career Awards

  • L – Loan Repayment

  • M – General Clinical Research Centers


Current NIH Series

  • N – R&D Contracts

  • P – Program Projects & Centers

  • R – Research Projects

  • S – Research-related Programs

  • T – Training Programs

  • U – Cooperative Agreements


Research Project Grants (RPGs)

  • Research Project Grants (RPGs)

    • Usually investigator-initiated

    • Includes R01, R03, R15, R21, R22, R23, R33, R34, R35, R36, R37, R55, R56, RC1, P01, P42, PN1, U01, U19, UC1 and NIGMS P41.

    • Other R mechanisms termed “other research”


R01 – Research Project

  • Original NIH mechanism

  • All Institutes, most Centers fund

  • Generally awarded for 1-5 years

  • Parent announcement at:

  • Annotated R01 and summary statement at:

  • http://grants1.nih.gov/grants/guide/pa-files/PA-07-070.html

  • http://www.niaid.nih.gov/ncn/grants/app/default.htm


R03 – Small Grant

  • One project period of up to 2 years

  • Budget for direct costs of up to 2- $25,000 modules or $50,000/year

  • Current investigator-initiated R03 PA (parent) accepted by 13 ICs

    http://grants.nih.gov/grants/guide/pa-files/PA-06 -180.html

  • 9 ICs only accept in response to their FOA; 2 do not fund R03’s


R13/U13 – Conferences & Scientific Meetings

  • Only domestic organizations eligible

  • International conferences only through US representative of an established international society

  • Advanced permission required

  • Current announcement for 22 ICs

  • http://grants1.nih.gov/grants/guide/pa-files/PA-06-041.html


R15 – Academic Research Enhancement Award (AREA)

  • Research projects at institutions with <$3 million annual NIH funds; currently funded by 22 IC’s

  • PI may not be PI of any active NIH research grant at time of award

  • Modular awards up to $150,000 total direct costs for project period of up to 3 years

http://grants.nih.gov/grants/guide/pa-files/PA-06-042.html


R21 – Exploratory/ Developmental Research

  • One project period of 1-2 years

  • Modular budget up to $275,000 total direct costs; no more than $200,000 in any one year

  • 15-pg limit for Research Plan (a-d)

  • Current parent R21 PA accepted by 18 ICs; other IC’s only through their specific FOA

http://grants.nih.gov/grants/guide/pa-files/PA-06-181.html


Small Business GrantsSBIR/STTR (R41-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 done entirely in the US

http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf


R41 – Phase I Small Business Technology Transfer (STTR)

  • Typically up to $100,000 for up to 1 year

  • PI spends at least 10% effort and has formal commitment/ appointment with the SBC

  • Required research institution partner performing at least 30% of work; SBC performing at least 40% of the work


R42 – Phase II Small Business Technology Transfer (STTR)

  • Typically up to $750,000 for up to 2 years

  • PI spends at least 10% effort and has formal commitment/ appointment with the SBC

  • Required research institution partner performing at least 30% of work; SBC performing at least 40% of the work


R43 – Phase I Small Business Innovation Research (SBIR)

  • Typically up to $100,000 for up to 6 months

  • PI employed >50% by the SBC during the award

  • Contractual and consultant costs are typically less that 33% of total amount


R44 – Phase II Small Business Innovation Research (SBIR)

  • Typically up to $750,000 for up to 2 years

  • PI employed >50% by the SBC during the award

  • Contractual and consultant costs are typically less that 50% of total amount


Just a Few More R’s

  • R24 – Resource-Related Research

  • R25 – Education Projects

  • R36 – Dissertation Award

  • R34 – Clinical Trial Planning Grant

  • R37 – Method to Extend Research in Time (MERIT) Award

  • R56 – High Priority Short-Term Project Award


P01 – Program Project

  • Broadly based, often multi disciplinary, long-term research program with a particular major theme; involves the organized effort of groups of investigators who conduct integrated research projects related to the overall program objectives.


P01 – Program Project

  • Typically, in response to IC’s PA/RFA

  • Not all IC’s fund: only 17/24 ICs awarded P01s in FY2006


P’s – Center Awards

  • P20 – Exploratory Grants

  • P30 – Center Core Grants

  • P40 – Animal & Biological Resource Grants

  • P41 – Biotechnology Resource Grant

  • P42 – Hazardous Substance Basic Research

  • P50 – Specialized Center

  • P60 – Comprehensive Center


P30, P50, P60 – Centers

  • Center grants support programs in critical health problem areas including: R&D; demonstration of advanced techniques for diagnosis, treatment, prevention, or control of disease; education; and other related nonresearch components


P30, P50, P60–Centers (con’t)

  • Always includes core/shared costs; may include project costs

  • Always in response to IC-specific request

  • Staff of appropriate IC should be contacted in advance of a submission


Us – Cooperative Agreements

  • Almost always initiated by the NIH in response to an RFA or PA

  • Substantial programmatic involvement

  • Generally referred to as a “grant”

  • Cooperative Agreements

    • U01 – single project

    • U10 – multiple project

    • U54 – multiple center project


S10 – Shared Instrumentation Grant (SIG) Program (NCRR)

  • For instrumentation typically costing at least $100,000 to a maximum of $500,000

  • Must have 3 or more active NIH (R01, P01, U01, R37) PI users

  • Cost sharing not required

  • Most recent PA (single deadline) at:

http://grants.nih.gov/grants/guide/pa-files/PAR-07-105.html


NIH Research Training & Career Development Timetable

Approx. Stage of Research

Training and Development

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)

Postdoctoral Individual NRSA (F32)

POST

DOCTORAL

Mentored Research Scientist Development Award (K01)

Mentored Clinical Scientist Development Award (K08)

Mentored Patient-Oriented RCDA (K23)

Mentored Quantitative RCDA (K25)

Pathway to Independence Award (K99/R00)

EARLY

Small Grant (R03)

CAREER

Independent Scientist Award (K02)

MIDDLE

Research Project Grant (R01)

Midcareer Investigator Award in

Patient-Oriented Research (K24)

Exploratory/Development

Grant (R21)

SENIOR

Senior Scientist Award (K05)


T32 – Institutional NRSAs Training Grants

  • Predoctoral and postdoctoral slots

  • Allowable Costs

    • Stipends

    • Tuition, fees, and health insurance

    • Other trainee costs

    • Trainee related expenses

  • Most IC’s accept applications; most have a single annual deadline

  • http://grants1.nih.gov/grants/guide/pa-files/PA-06-468.html


F30 – MD/PhD Predoctoral Fellowship

  • 7 IC’s, plus the Office of Dietary Supplements; NIDCD with own

  • US citizens and citizen nationals only

  • Allowable Costs

    • Stipend

    • Tuition and Fees

    • Health Insurance

    • Institutional Allowance

http://grants2.nih.gov/grants/guide/pa-files/PA-05-151.html


F31 - PhD Predoctoral Fellowship

  • 7 IC’s, plus ODS participate

  • US citizens and citizen nationals only

  • Foreign institution study possible

  • Allowable Costs

    • Stipend

    • Tuition and Fees

    • Health Insurance

    • Institutional Allowance

http://grants.nih.gov/grants/guide/pa-files/PA-07-002.html


F32 - Postdoctoral Fellowship

  • 20 IC’s plus Office of Dietary Suppements

  • US citizens and citizen nationals only

  • Foreign institution and Federal lab study possible

  • Allowable Costs

    • Stipend

    • Tuition and Fees

    • Institutional Allowance

http://grants2.nih.gov/grants/guide/pa-files/PA-07-107.html


K – Research Career Programs

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.


Common Features of K Awards

Some costs vary widely across ICs. Review specific announcements carefully.

  • Salary/fringe benefits

    • Salaries capped between $75,000 and legislated cap (now at $183,500); 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

    • Generally $25,000 to $50,000

    • Commonly used for: supplies, equipment, technical personnel, travel to research mtgs or training, tuition/fees related to career development, computational services

      • F&A Costs = 8% MTDC


Common Features of NIH Career Awards

  • Duration: three, four, or five years

  • No salary from other federal funding sources

  • Extensions in time – award terms remain in effect (i.e. minimum effort, no salary from other federal funding source)


Mentored K Awards

  • K01 – Mentored Research Scientist Development

  • K07 – Academic Career

  • K08 – Mentored Clinical Development Scientist

  • K12 – Institutional Clinical Scientist Development Program

  • K23 – Mentored Patient-oriented Research Career Development

  • K25 – Mentored Quantitative Research Career Development

  • K99/R00 NIH Pathway to Independence


Non-Mentored K Awards

  • K02 – Independent Scientist

  • K05 – Senior Scientist

  • K18 – Career Enhancement for Stem Cell Research

  • K24 – Midcareer Investigator in Patient-Oriented Research

  • K26 – Midcareer Investigator in Mouse Pathobiology Research

  • K30 – Clinical Research Curriculum Development


Important to Remember

  • Visit each IC’s web page to see what mechanisms each supports

  • Review relevant PAs and RFAs from the NIH Guide

  • Contact relevant/appropriate Program staff at an IC


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