SBIR: Training the Trainers

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Transcript SBIR: Training the Trainers

Grantsmanship:
The Good, the Bad and the Ugly!
or
How to Swim with the Sharks and Survive!
Jerry Heindel, Ph.D
.
Scientific Program Administrator
Division of Extramural Research and Training, NIEHS
[email protected]
.
NIH/DHHS/NIEHS
I am from the Government
and I am here to help you!
NIH
Overview

Problems first time (and other) applicants
make…..
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What to do about it!

Principles of grantsmanship-
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Grants.gov and electronic submissions
Start With the End in Mind!
Elements of Grant Success
Good
Ideas
Good
Reviewers
Good
Timing
Good
Luck
Good
Grantsmanship
NIH GRANT$
Formula for Grant Success
Good Luck
The consequence of:
• Good Ideas
• Good Presentation
• Good Timing
• Good Reviewers
• Good Grantsmanship
NIH GRANT$
Formula for Grant Success
Grant writing is a learned skill

Writing manuscripts that get published in
peer reviewed journals is a learned skill.
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Writing grant applications, is also a
learned skills.
Grantsmanship is a full time job….
Knowing the Science is not enough!
Common Problems with Applications
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Overly ambitious
Lack of innovation
Lack of linkage to human health problem
Lack of focused/mechanistic hypothesis
Lack of focused aims that will prove and only prove the
hypothesis
Unfocused research plan that does not test feasibility
Questionable reasoning in approach
Lack of experimental detail
Lack of experience with methods
What to do…..
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Start early!
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Learn to move from lab experiments to the big picture.
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Learn to think in terms of hypotheses to test and how to test
them….even in everyday lab work.
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Develop a specific niche research area of your own…you
need to be known as an expert in a specific area…think long
term not just one application.

Focus on specific aims page.
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Think salesmanship/grantsmanship.

Get help reviewing drafts and working through the entire
process ( Mentor and Granting Organization).
Start Planning Early!!!!!
Planning Schedule…..
Applying for Funding
NIH
THE NIEHS EXTRAMURAL TEAM !
PROGRAM
ADMINISTRATOR
GRANTS
MANAGEMENT
SPECIALIST
SCIENTIFIC
REVIEW
ADMINISTRATOR
Scientific Program Administrator
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Develop program initiatives
Provide guidance and assistance to applicants
Attend Scientific review group (SRG) meetings as
program resource person(s)
Communicate results of review to applicants
Make funding recommendations
Monitor progress during the award period
Scientific Review
Administrator
Review administrators setup and conduct
scientific and technical reviews of grant
applications to identify those of highest scientific
and technical merit in their respective discipline
and disease areas.
Grants Management
Specialist
Grants Management Officials ensure that business
management actions for NIH programs and awards are
performed correctly, efficiently, and in accordance with
pertinent grant policies and good business practices,
including responsibility for maintaining official grant
files.
When to Interact with Various Staff Members
Scientific Program Administrator:
Prior to submission
 After the review is complete
 Prior to the award
 During the progress of the research

Grants Management Official:

Fiscal or Administrative questions prior to
submission or award and throughout award
Scientific Review Administrator:
After Submission
 Prior to Summary Statement

Assistance (Grant) Mechanisms
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Regular Research Grant-R01
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Others

Small grants - R03
http://grants.nih.gov/grants/funding/r03.htm

New Investigator-K99/00
http://grants.nih.gov/grants/guide/pa-files/PA-06-133.html

Exploratory – R21
http://grants.nih.gov/grants/funding/r21.htm

Academic Research Enhancement Award
(AREA) - R15
http://grants.nih.gov/grants/funding/area.htm
Principles of Grantsmanship
Preparing an R01(R03, R21) Application
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Title
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Abstract (200 words)
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Research Plan
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Specific Aims ( 1 page)
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Significance ( bkg) (2-3 pages)
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Preliminary Studies

Experimental Methods/Approach

Budget/Timeline
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References
It is not the will to win that’s
important. Everyone wants to
win! It is the will to prepare to
win that makes the difference.
Bobby Knight
Important Point to Remember
There is an art to writing applications!
TIP: MELD SCIENCE, SALESMANSHIP
AND COMMUNICATION SKILLS
Grantsmanship : General Preparation
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Assess the field….know state of field and
opportunities.
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Check out the “competition”.
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Brainstorm ideas….match them to NIH.
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Novel, innovative, impact
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Check with NIH program directors.
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Give yourself plenty of time….3-6 mo!
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Start with the end in mind !
Grantsmanship
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Start With the End in Mind!
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Receipt and Referral ( Institute and Study Section)
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Review System
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Study Sections
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Reviewers
Review Criteria
Overall goal: To make everyone involved in the
process happy…to make their job easier.
The key to success in grant
writing is to engender
enthusiasm in the reviewer--who then becomes an advocate
for the proposal!
Grantsmanship:Start With The End in Mind
1. Know your Audience!
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The Reviewers
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Accomplished, dedicated, fair
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Overly committed, tired, inherently
skeptical, overly critical
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General understanding only
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Used to reviewing R01 applications
Start with the End in Mind!
2. Review Criteria
SIGNIFICANCE:
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Does this study address and important
problem?
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If the aims are achieved, how will scientific
knowledge or clinical practice be
advanced?
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What will be the effect of these studies on
the concepts, methods, technologies,
treatments, services or preventative
interventions that drive the field?
Start with the End in Mind!
2. Review Criteria
INNOVATION:
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Is the project original and innovative?
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Does the project challenge existing
paradigms or clinical practice: address
an innovative hypothesis or critical
barrier to progress in the field?
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Does the project develop or employ
novel concepts, approaches,
methodologies, tools or technologies
for this area of research?
Start with the End in Mind!
2. Review Criteria
APPROACH
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Are the conceptual or clinical framework,
design, methods, and analyses
adequately developed, well integrated,
and appropriate to the aims of the
project?
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Does the applicant acknowledge
potential problem areas and consider
alternative strategies?
Start with the End in Mind!
2. Review Criteria
INVESTIGATOR:
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Is the Principal Investigator capable of
coordinating and managing the proposed
work ?
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Is the work proposed appropriate to the
experience level of the Principal Investigator
and other researchers, including consultants
and subcontractors (if any)?
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Are the relationships of the key personnel to
the University and to other institutions
appropriate for the work proposed?”
Start with the End in Mind!
2. Review Criteria
ENVIRONMENT:
 Is
there sufficient access to resources (e.g.,
equipment, facilities)?
 Does
the scientific and technological
environment in which the work will be done
contribute to the probability of success?
 Do
the proposed experiments take advantage
of unique features of the scientific
environment or employ useful collaborative
arrangements?
Start with the End in Mind!
3.Selling Yourself and Your Ideas!
Knowing the Science is not enough.
 Scientist
 Spokesperson
 Communicator ( writer & speaker)
 Salesperson
Grantsmanship : A Research Focus
The Scientist as a Salesperson :
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You are a Business : Big Business
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CEO ; Scientific Director ; Sales Representative
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Sell yourself and your ideas
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Use Your Communication skills
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Written and Oral
Grantsmanship: Sell yourself
and your ideas!
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What are you selling?
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Why is it important?
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Impact (who will benefit)
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How will you do it?
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Advantages/strengths/limitations
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Track record (can you do it?)
And put it in the proper form !
Principle of Successful Selling
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Make people like you…develop rapport
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Find out what they need or want
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Get the other person point of view
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Know your product
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Show advantages of your product
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Develop a desire for your product
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Get people saying YES
Principles of Grantsmanship
Preparing an R01(R03, R21) Application

Title

Abstract (200 words)

Research Plan

Specific Aims ( 1 page)

Significance ( bkg) (2-3 pages)

Preliminary Studies

Experimental Methods/Approach

Budget/Timeline

References
ABSTRACT:Stated Guidelines
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State the application’s broad, long term objectives
and specific aims.
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Make reference to the health-relatedness of the
project.
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Describe concisely the research design and
methods for achieving goals.
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Discuss potential for innovation.
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Avoid summaries of past accomplishments and the
use of first person.
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Do not exceed 200 words.
Grantsmanship: ABSTRACT
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IDENTIFY PROBLEM:
 What is the problem addressed? ( Must be public health
problem!!)
 Who cares
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SOLUTION:
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Hypothesis/goal/product
PLAN:
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Approach
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Specific aims/milestones
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Techniques/methodologies used
BENEFITS:
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Expected results
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Application/benefit
Grantsmanship : The Heart of The
Application
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Specific Aims
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Background and Significance

Preliminary Studies

Research Design/Methods
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Literature Cited
Specific Aims
Hypothesis
Abstract
Research
Plan
DO NOT write the
application for the
“Specialist”
You MUST convince the
entire review committee
Jargon: Be careful what you say…..
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One reason some branches of government have
trouble operating jointly is that they don’t speak
the same language.

Goal: “Secure a Building”

Air Force
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Army
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Marines
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Navy
Grantsmanship: Specific Aims
Section (One Page)
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Introductory Paragraph
 Statement of long term health-related goal (1 sentence)
 Background/significance of problem (1-2 sentences)
 Preliminary data/state of the art (2-3 sentences)
 Data gaps/controversy (1-2 sentences)
 Clearly defined hypothesis/specific goal
( 1-2 sentences)
The flow of logic must be compelling!!!
Specific Aims (Cont’d)
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Specific Aims/Milestones
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2-5 aims ( One sentence each)
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Specifically focused to prove
hypothesis/develop product
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Logical order with no dead ends
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To characterize, To determine the, To relate...
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Focus on scientific goal not technology
Summary Statement
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Emphasize novel product and innovative
approach and impact on field ( 2-3 sentences)
The aims should be endpoints…
so it can be easily determined if they
have been met!!
Aim 1. To determine if……
or
Aim 1. To characterize
Idea and Hypothesis. NOVEL!!!
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New, innovative and novel ideas…paradigm
shifters.
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You need to be first….we don’t fund followers!
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We don’t fund gap filling.
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We don’t fund verification/repetition.
Why is this application special….what singles out
this application?
Hypothesis
 We
hypothesize that calcium causes
reproductive dysfunction by interfering
with pituitary gonadotropin secretion,
testosterone synthesis and secretion,
androgen metabolism in target organs
and sex steroid hormone receptor
binding in the neuroendocrine system
and in the reproductive organs.
Hypothesis

We hypothesize that estrogen-like endocrine
disruptors alter uterine growth by altering
HOX gene expression via disruption of
estrogen stimulation of HOX gene cis
regulatory DNA elements.
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Our overall hypothesis is that TCDD exerts
its effects on ovarian steroidogenesis by
binding to the AhR and specifically
inhibiting P450 aromatase gene expression.
Background and Significance
Goal: To convince the reviewers that you are familiar with the
field and to justify need for proposed study.
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Logical development of background information that forms basis of
proposal.
Critical evaluation of current knowledge. …show how proposed work
builds on previous work.
Identification of data gaps, conflicts, needs, what’s new and novel and
innovative.
Importance of research and how it will fill need.
 Thus these studies demonstrate the importance of this area….
 These studies provide important background for this study in….
 The proposed project will build on this previous work….by….
Public health benefit….significance paragraph to frame current status of
work in the field and explain how the proposed project will make a
contribution.
Preliminary Data
Goal: To establish your experience and competence in the
area of application.
 Convince reviewers you are familiar with and have done all
the techniques proposed including data analysis and
interpretation…
 that the work is feasible…
 that suitable groundwork has been done (preliminary data).
 Simple graphs and tables with descriptive legends.
 No extraneous or irrelevant data.
 Black and white.
Experimental Methods/Research Plan
For Each Aim/Milestone:
Rationale for approach
 Experimental Design in detail including data
analysis and interpretation
 Potential Difficulties/Limitations
 Alternative approaches
Justify everything including number of animals,
assays, statistical analysis, timetable and that you
have experience and expertise needed.
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General Issues
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Attention to details
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Layout and format
NIH Support of New Investigators
Implementation
Review groups received orientation during
the 1998 review round . They are reminded
each review round.
Reviewers are informed of the “New”
investigator “ definition and honor the
guidelines.
Review groups are provided with a list of
first-time applicants with review assignments
and at review.
Common Problems with Applications









Overly ambitious
Lack of innovation
Lack of linkage to human health problem
Lack of focused/mechanistic hypothesis
Lack of focused aims that will prove and only prove the
hypothesis
Unfocused research plan that does not test feasibility
Questionable reasoning in approach
Lack of experimental detail
Lack of experience with methods
Grantsmanship Guidance at NIH
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http://www.niaid.nih.gov/ncn/grants/default.htm
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http://grants1.nih.gov/grants/funding/sbir_policy.htm
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http://grants1.nih.gov/grants/funding/sbirgrantsmanship.pdf
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http://niaid.nih.gov/ncn/sbir/advice/advice.pdf
What is Grants.gov?
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The Federal government’s single, online
portal for any person, business, or State,
Local and Tribal government to
electronically:
 Find Grant Opportunities
 Apply for Grants

A cross-agency initiative involving

900 grant programs
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26 grant-making agencies
Posting Funding Opportunity
Announcements on Grants.gov

Funding opportunities will continue to be
posted in the NIH Guide and Contracts as usual.


NIH will continue to use RFAs and PAs, but
all solicitations will be referred to as funding
opportunity announcements in Grants.gov.
They will simultaneously be posted to
Grants.gov by OER staff along with the
appropriate application package.
NIH’s Electronic Receipt Goal
By the end of May 2007, NIH plans to:
1.
Require electronic submission through
Grants.gov for all NIH grant applications
2.
Transition from the PHS 398 application form
to SF424 family of forms data set
 SF424 Research and Research-Related
(SF424 (R&R))
Announced in the NIH Guide, Aug. 19, 2005:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html
Electronic Receipt: How it works
Applying for Grants at Grants.gov:
After finding the grant opportunity on Grants.gov:
Step 1: Download the grant application package.
(PureEdge Software required to view.)
Step 2: Complete the application.
Step 3: Submit the application to Grants.gov.
(Processed through Authorized Organizational
Representative (AOR)).
Step 4: Track the status of the submitted application
package you are notified it has been retrieved by NIH.
Electronic Receipt: How it works
Step 5: eRA software checks the application against
NIH business rules.
Step 6: NIH notifies PI and Signing Official via email
to check the eRA Commons for results of NIH rule
checking.
Step 7: If the application passes NIH rules, SF424 (R&R)based grant image appears.
 Principal Investigator (PI) and Signing Official (SO)
review application.
 If acceptable, the application is accepted in 24 hrs
in Commons.
 If not, the PI or SO rejects the application in
Commons, makes changes and resubmits via
Grants.gov
Electronic Receipt: How it works
Apply for Grants (cont.):
Step 8: If application does not pass NIH
rules, errors and warnings are listed.

Fix errors and resubmit to Grants.gov
Step 9: After verification, data and grant
image are saved and application begins
getting processed by NIH staff.
NIH Timeline:
Submission of Grant Applications through Grants.gov
Using SF424 Family of Grant Application Forms
Submit R03, R21 & R33 via
Grants.gov (6/1/06)
Submit R01 via Grants.gov
(2/1/07)
2006
APR MAY JUN
2007
JUL AUG
SEP OCT NOV DEC JAN
FEB MAR APR MAY JUN
JUL AUG SEP
71
APPLICATION, REVIEW, and AWARD
National Institutes of Health
University Researcher
Submits
Grant
Application
Applicant Initiates
Research Idea
Center for Scientific Review
Assign to
Scientific Review Group
~2-3 months
after submission
Review for
~2-3
months
after review
Allocates
Funds $$
Scientific Merit
Institute
Evaluate for
Conducts
Research
IC and IRG
Relevance
Advisory Council or Board
Recommends
Action
Institute Director
Takes final action for NIH Director