NIH
Transforming medicine
through discovery
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NIH is the Nation’s leading medical research
agency
NIH Bethesda campus is world’s largest research
organization
Birthplace of the NIH: 1887
Marine Hospital -- Staten Island, NY
NIH Campus -- 1947
NIH Campus Today
NIH Organizational Structure
Office of the Director
National Institute
on Aging
National Institute
on Alcohol Abuse
and Alcoholism
National Institute
of Allergy and
Infectious Diseases
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
National Cancer
Institute
National Institute
of Child Health
and Human
Development
National Institute on
Deafness and Other
Communication
Disorders
National Institute
of Dental and
Craniofacial
Research
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National Institute
on Drug Abuse
National Institute
of Environmental
Health Sciences
National Eye
Institute
National Institute
of General
Medical Sciences
National Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National Institute
of Mental Health
National Institute
of Neurological
Disorders and
Stroke
Fogarty
International
Center
National Center
for Research
Resources
National Center on
Minority Health
and Health
Disparities
National Center
for Complementary
and Alternative
Medicine
NIH
Clinical Center
Center
for Information
Technology
National Library
of Medicine
Center
for Scientific
Review
National Institute
of Nursing Research
National Institute
of Biomedical
Imaging and
Bioengineering
No funding
authority
NIH INTRAMURAL
RESEARCH
NIH is an institution
Supports:
•Over 6,000 scientists
•10% of NIH budget
•Primary location: Bethesda, MD
•A few labs throughout U.S.
NIH EXTRAMURAL
RESEARCH
NIH supports institutions
Supports:
•Over 3,000 institutions worldwide
•Over 150,000 PIs & Key Personnel
•Awards issued to over 100 countries
•Clinical, Basic, & Translational Research
•Approximately 83% *All
of figures
the NIH
budget 7
are estimates.
AA National Institute on Alcohol Abuse and Alcoholism (NIAAA)
AG National Institute on Aging (NIA)
AI National Institute of Allergy and Infectious Diseases (NIAID)
AR National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
AT National Center for Complementary and Alternative Medicine (NCCAM)
CA National Cancer Institute (NCI)
DA National Institute on Drug Abuse (NIDA)
DC National Institute on Deafness and Other Communication Disorders (NIDCD)
DE National Institute of Dental & Craniofacial Research (NIDCR)
DK National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
EB National Institute of Biomedical Imaging and Bioengineering (NIBIB)
ES National Institute of Environmental Health Sciences (NIEHS)
EY National Eye Institute (NEI)
EY National Eye Institute (NEI)
GM National Institute of General Medical Sciences (NIGMS)
HD National Institute of Child Health and Human Development (NICHD)
HG National Human Genome Research Institute (NHGRI)
HL National Heart, Lung and Blood Institute (NHLBI)
LM National Library of Medicine (NLM)
MD National Center on Minority Health and Health Disparities (NCMHD)
MH National Institute of Mental Health (NIMH)
NR National Institute of Nursing Research (NINR)
NS National Institute of Neurological Disorders and Stroke (NINDS)
RR National Center for Research Resources (NCRR)
Fiscal Year 2007
 Approx. 80,000 grant applications
received (all mechanisms)
 47,243 research grants awarded
($20.35 billion)
 79% of NIH extramural awards go to
institutions of higher education
NIH uses “Activity Codes” to identify specific categories of research:
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GRANT
CONTRACT
Assistance
Acquisition
Government is Patron or
Partner
Government is Purchaser
Purpose:
to support and stimulate
research
Purpose:
to acquire goods or services
Benefit a public purpose
The direct benefit and use of
the government
Investigator initiated
Government initiated
COOPERATIVE AGREEMENT – means substantial NIH Involvement
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Substantial Federal scientific or
programmatic involvement
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NIH involved in scientific and/or
programmatic guidance, coordination or
participation in project activities
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Colorado State Research Center for
Excellence (RCE) – pass through to MSU
1 R01 AI 183723 -01 A1 S1
The application number identifies:
type of application (1)
activity code (R01)
organization or institute (AI)
serial number (183723)
suffix year (-01)
AND,
other information identifying a supplement (S1), or an amendment (A1) .
1 R01 AI 183723 -01 A1 S1
• Traditional – R01 “Research Project”
• Floating due dates:
• Cycle I :
• Cycle II:
• Cycle III:
February 5
June 5
October 5
• Check institute and request for proposal
for variations
1 R03 AI 183723 -01 A1 S1
• Smaller Grants – R03
• Ro3 “Small Research Grants” – limited time
and amount, flexibility for PI initiating studies,
preliminary short-term projects. Nonrenewable.
• Only one resubmission is allowed
1 R18 AI 183723 -01 A1 S1
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Research Demonstration and
dissemination Projects (R18): Develop,
test, and evaluate health service activities, and
to foster the application of existing knowledge
for the control of categorical diseases.
1 R21 AI 183723 -01 A1 S1
• Exploratory/Developmental Grants –
R21/R33:
• R21 “Exploratory/Developmental Grants” to
encourage new research activities in
categorical program areas.
• R33 – Phase II of the R21
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Training Grants – T
 Institutional
 Predoctoral and Postdoctoral
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Fellowships – F
 Individual
▪ Predoctoral – F31
▪ Postdoctoral – F32
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Career Development Awards – K
Center Grants – P20 **Montana INBRE**
 Groups of investigators, long-term, multi-disciplinary
Continued, limited funding for new and established PIs
who have submitted a competing renewal, who just
miss the nominal funding payline.
 Additional funded time for PIs to strengthen a
resubmission.
 Selectees will receive one-year of funding up to
$500,000 DC + applicable F&A (increased from
$333,000)
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Cannot apply, cannot self-nominate! Criteria:
 Must have < $400,000 in other support (total costs)
from all sources to fund research (increased from
$200,000)
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
EARLY
NIH Pathway to Independence (PI) Award (K99/R00)
Mentored Research Scientist Development Award (K01)
Mentored Clinical Scientist Development Award (K08)
Mentored Patient-Oriented RCDA (K23)
Mentored Quantitative RCDA (K25)
Research Project
Grant (R01)
Exploratory/Develop
ment Grant (R21)
CAREER
Small Grant (R03)
MIDDLE
Independent Scientist Award (K02)
Midcareer Investigator Award in
Patient-Oriented Research (K24)
SENIOR
Senior Scientist Award (K05)
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“Credential” mandatory for all PD/PIs
Do not attach “Current & Pending Support”
unless requested in FOA. This will be requested
later during the just-in-time process.
Modular or detailed budget?
 Modular budgets reduce burden by eliminating the need for
specific budget numbers
 Available for grants at or below $250,000 per year
 Grantees awarded grants in “modules” of $25,000
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Budget Justification
R&R Forms Page available at: grants.nih.gov/grants/funding/424/index.htm
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Item 8, Type of Application
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New is an application submitted for the first time
Resubmission is a revised or amended application
Renewal is equivalent to a Competing Continuation
Continuation is equivalent to a Progress Report. For
the purposes of NIH and other PHS agencies, the box
for Continuation will not be used and should not be
checked.
 Revision is somewhat equivalent to a Competing
Supplement
Effective January 1, 2009, salary and wages on
NIH grants limited to an annual rate of $196,700
(equal to Executive Level I).

An individual's base salary is NOT constrained by the
legislative provision for a limitation of salary. An
institution may pay an individual's salary amount in
excess of the salary cap with non-federal funds.
Appointed members of chartered Study Sections may
submit applications as they are developed and NIH
will review within 120 days of receipt.
Chartered Study Section member must be the PD/PI.
Multi-PI applications are eligible if one or more PD/PI is
an appointed Study Section member.
 Limited to R01, R21 and R34 (including AIDS-related)
applications submitted for standard due dates.
 Not available for temporary or ad hoc reviewers, or
reviewers for other Federal agencies.
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PIs should create the proposal as a single
document using any word processing software.
Separate only at the end before uploading
Do not include headers or footers
Do include section headings as part of the text;
i.e., Specific Aims, Background & Significance
R&R Budget form - Senior/Key Person effort
must be greater than zero
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Do not scan paper documents. Instead, produce
documents with word-processing software and
then convert electronically to PDF.
Use meaningful titles for file names
Only use standard characters in file names: A-Z,
0-9, Hyphen (-), Underscore ( _ ).
Disable write-protection features.
A zero-byte attachment is an invalid PDF.
More at: era.nih.gov/electronicreceipt/pdf_guidelines.htm
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After submission, the eRA system will:
 Assemble the grant image
 Generate a Table of Contents
 Include headers (PI name) & footers (page numbers)
on all pages
 Perform agency validations
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Any errors must be fixed and the application
resubmitted before it can be accepted for review.
Application Image
Be sure to review the entire
application carefully…….
Your application is not
considered received by NIH until
you see the application image in
the eRA Commons & the 2-day
viewing window has elapsed.
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Information not required to review the application
but which is necessary to implement the grant.
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Don’t submit unless requested via email from the NIH
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Request for updated information on “Other Support” for
PI and Key Personnel
 FM should add up the calendar months <= more than 12?
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FM should verify the IACUC or IRB approval dates with
the appropriate MSU administrators:
 IACUC dates:
 IRB dates:
Diane Harn X6803
Cheryl Johnson X4706
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Log In to eRA Commons
 Click on Status Tab
▪ Click on “Just in Time” Hot Link
▪ Enter PI’s last name
 Review documents – you’re certifying they’re
accurate on behalf of MSU
 Hit Submit – PI receives an email that you
submitted the JIT information
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2
1. Application ID is the link to the application details.
2. Right side of hit list are links to other Commons applications.
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1st Level
Scientific Review Group (SRG)
 Independent outside reviewers
 Evaluate scientific merit & significance
 Recommend length and level of
funding
2nd Level
National Advisory Council
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Assesses Quality of SRG Review
Makes Recommendation to
Institute Staff on Funding
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Evaluates Program Priorities and
Relevance
Advises on Policy
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Scientist peers with
appropriate expertise -recruited by the SRO
Standing study section
typically has 12-24
members
4-year terms
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3 face-to-face meetings
each year
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Review 60 - 100
applications at each
meeting
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National Advisory Council or Board assesses
quality of 1st level review
 Concurs with or modifies IRG action
 Reads summary statements only
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Can also designate application as “High” or
“Low” program priority
The Institute Director makes actual funding
decision
8th Month
Receipt
Date
Scientific
Review
Council
Review
Award
Date
February 5
July
October
December
June 5
October
January
April
October 5
March
May
July
Mandatory:
Application with budget >$500,000 direct costs for any
single year
 R13 Conference Grants
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Optional:
 When RFA’s request a Letter of Intent
Recommended:
 When you think about applying for any grant
LEGALLY BINDING DOCUMENT
 Award Data & Fiscal Information
 Grant Payment Information
 OIG* Hotline Information
 Terms and Conditions
* Office of the Inspector General
The grantee indicates acceptance of the
terms and conditions of the award by
drawing down funds against the grant
from the Payment Management
System.
MSU’s current negotiation of $7.9 Million
COBRE years 6-10…don’t just set up
the accounts/grants. (Blue Handout)
Carry over of unspent funds may or MAY NOT
be allowed
 Spending suspended pending IACUC approval?
Highlight these terms and follow-up on them.
 Also, communicate with the investigator
regarding the limitations.
 Spending suspended based on select agent use?
 Non-competitive renewal or competitive
renewal?
 Final year of award……Financial Status Report
due? Put in blue sheet to trigger report.
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NIH looks at PI effort in Person/Months
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Can get tricky – use the link below
Person/Months FAQ & calculator:
http://grants.nih.gov/grants/policy/person_months_faqs.htm
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FM should pull the grant file and an ITD
Review the proposal for effort committed
For example - the PI’s effort in the grant proposal
was 5 person months (42%) and he has put 1.2
person months (10%) in his eSNAP progress
report. Is this an issue?
 Yes, because the effort reduction or fluctuation is greater than 25%
 5.0 – 1.2 = 3.8 person months and 3.8 mo / 5 mo. = 76% change
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Contact the PI; usually a misunderstanding or typo
If not, Prior Approval should be documented.
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Pull an ITD and review the % that will be
carried forward if any
Is it greater than 25% of the current year’s
total funding?
Remember, payroll hits on the 11th of the
following month – ok to calculate that into
expenditures.
Also good time to check individual budget
categories – should an OPAS be processed?
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Change in Scope:
 Grantee makes initial determination of significance of a change,
consulting the grants management specialist as needed.
 The following items may indicate a change in scope:
▪ Change in aims: Change to a different animal model
▪ Significant rebudgeting (deviation between categories of more
than 25% of total awarded costs)
▪ Change in use of animals or humans
▪ Significant change in key personnel
▪ Shift in research emphasis: Shift of research emphasis to a different
disease area
▪ Application of new technology
▪ Reduce his/her time by more than 25% of approved effort at time
of award
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All requests for prior approval must be:
 Submitted in writing or via email – include complete grant
number, PI name and contact information, grantee name
 Submitted to the awarding IC’s Grants Management
Specialist no later than 30 days before the proposed
change
 Signed by the PI and administrative official
 Only responses to prior approval requests signed by the
GMO are valid
Prior, written approval is required for transferring
legal and administrative authority for a grant to a
different organization.
Transfer approval is not automatic and requires
approval from both NIH and the original grantee
organization.
 Contact NIH GMO before moving to initiate the
transfer process.
 Grants to individuals may not be transferred but
individual fellowships may transfer to a new sponsoring
institution.
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Grantees are strongly encouraged to submit
closeout documents electronically through the eRA
Commons!
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Documents are due within 90 days of
project period end date
 Final Financial Status Report (now required
electronically)
 Final Inventions Statement & Certification
 Final Progress Report
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Failure to submit timely reports may affect
future funding to the organization!
More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-051.html
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TTO files invention statements in our grant files
– review file for invention
Double check with TTO to see if there have been
any inventions or patents filed
If there have been, fill in the invention report
with information on NIH screen from the TTO
report
If not, “negative” report still needs to be
submitted
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Green Handout
Print an MSU Inception to Date report for the grant
Any “Invalid” expenses? If so, get them corrected
off the grant
Calculate the IDC base – see handout
Review MSU Authorized Amount – should equal line
“o. Total Federal funds authorized for this funding
period” on the online FSR
Double check amounts with Financial Officer if
something looks off.
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***ON CURRENT “THIS PERIOD” ONLY******
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Click on “Save”
Print “Draft” via the “View FSR” in the FSR screen to
review again with the Financial Officer
If there is a residual that is unobligated, LOC will be
effected!
Once FM has confirmed the numbers are correct,
then go back into the FSR and hit “Submit”
Make a hard copy for the grant file and for the LOC
Financial Officer [Peggy :0)]
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NIH Searchable Database of RFAs, PAs, and Guide Notices
http://grants.nih.gov/grants/guide/index.html
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NIH Grants Policy Statement (Rev. 12/03)
http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
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NIH Extramural Nexus – Bimonthly newsletter for the extramural
community
http://grants.nih.gov/grants/nexus.htm
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Electronic Submission of Grant Applications Homepage
http://era.nih.gov/ElectronicReceipt/index.htm
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CRISP database - Search to analyze an Institute’s portfolio of funded
projects, research areas, and more
http://crisp.cit.nih.gov/crisp/crisp_querty.generate_screen
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Grant Application Basics http://grants.nih.gov/grants/grant_basics.htm
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Grants Administration individuals at all NIH ICs:
 http://grants.nih.gov/grants/staff_list_grants_admin.htm
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NIH Chief Grants Management Officers:
 http://grants.nih.gov/grants/stafflist_gmos.htm
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Grants Policy Interpretation & Consultation:
 E-Mail: GrantsPolicy@mail.nih.gov
 Phone: 301-435-0949
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Compliance Issues:
 E-Mail: GrantsCompliance@mail.nih.gov
 Phone: 301-435-0949
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General Application Questions: (e-Submission guidelines,
resources & referrals, application review & award process, etc.)
 E-Mail:
 Phone:

GrantsInfo@nih.gov
301-435-0714
Customer Support for Grants.gov: (navigating forms, aspects of
submitting through the system, resources available, etc.)
 E-Mail: support@grants.gov
 Webpage: http://grants.gov/
 Phone: 1-800-518-4726
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eRA Commons Help Desk: (Commons registration help, application
verification, Commons functionality questions, etc.)
 Webpage: http://ithelpdesk.nih.gov/era/
 Phone: 301-402-7469 (Toll Free: 866-504-9552)
Enter your own
help ticket!