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NIHTransforming medicine through discovery

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

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletaland Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Healthand HumanDevelopment

National Instituteof Allergy andInfectious Diseases

National Instituteof Diabetes andDigestive andKidney Diseases

National Instituteof Dental andCraniofacialResearch

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and OtherCommunicationDisorders

National EyeInstitute

National HumanGenome ResearchInstitute

National Heart,Lung, and BloodInstitute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders andStroke

National Instituteof GeneralMedical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementaryand AlternativeMedicine

FogartyInternationalCenter

National Centerfor ResearchResources

National Instituteof Biomedical Imaging and Bioengineering

No funding authority

NIHClinical Center

Centerfor Information Technology

Center for Scientific Review

National Center on Minority Health and Health Disparities

Office of the Director

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NIH INTRAMURAL RESEARCHNIH 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

Supports:•Over 3,000 institutions worldwide•Over 150,000 PIs & Key Personnel•Awards issued to over 100 countries•Clinical, Basic, & Translational Research•Approximately 83% of the NIH budget

*All figures are estimates.

NIH supports institutions

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)

HDNational Institute of Child Health and Human Development (NICHD)

HGNational Human Genome Research Institute (NHGRI)

HL National Heart, Lung and Blood Institute (NHLBI)

LMNational 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 2007Approx. 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

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NIH uses “Activity Codes” to identify specific categories of research:

GRANTAssistance

Government is Patron or Partner

Purpose: to support and

stimulate research

Benefit a public purpose

Investigator initiated

CONTRACTAcquisition

Government is Purchaser

Purpose: to acquire goods or

services

The direct benefit and use of the government

Government initiatedCOOPERATIVE AGREEMENT – means substantial NIH Involvement

Substantial Federal scientific or programmatic involvement

NIH involved in scientific and/or programmatic guidance, coordination or participation in project activities

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 : February 5•Cycle II: June 5•Cycle III: 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. Non-renewable.

•Only one resubmission is allowed

1 R18 AI 183723 -01 A1 S1

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

Training Grants – T Institutional Predoctoral and Postdoctoral

Fellowships – F Individual

▪ Predoctoral – F31▪ Postdoctoral – F32

Career Development Awards – KCenter 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)

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)

Predoctoral Individual NRSA (F31)Predoctoral Individual NRSA (F31)Predoctoral Individual MD/PhD NRSA Predoctoral Individual MD/PhD NRSA

(F30)(F30)

Postdoctoral Institutional Training Grant (T32) Postdoctoral Institutional Training Grant (T32)

Postdoctoral Individual NRSA (F32)

Small Grant (R03) Small Grant (R03)

Research Project Research Project Grant (R01)Grant (R01)

Independent Scientist Award (K02)Independent Scientist Award (K02)

Senior Scientist Award (K05Senior Scientist Award (K05) )

Approx. Stage of ResearchApprox. Stage of ResearchTraining and DevelopmentTraining and Development Mechanism of SupportMechanism of Support

GRADUATE/GRADUATE/MEDICALMEDICALSTUDENTSTUDENT

POSTPOSTDOCTORALDOCTORAL

EARLYEARLY

MIDDLEMIDDLE

SENIORSENIOR

CA

RE

ER

CA

RE

ER

Predoctoral Institutional Training Grant (T32)Predoctoral Institutional Training Grant (T32)

NIH Pathway to Independence (PI) Award (K99/R00)NIH Pathway to Independence (PI) Award (K99/R00)Mentored Research Scientist Development Award Mentored Research Scientist Development Award (K01)(K01)Mentored Clinical Scientist Development Award (K08)Mentored Clinical Scientist Development Award (K08)Mentored Patient-Oriented RCDA (K23)Mentored Patient-Oriented RCDA (K23)Mentored Quantitative RCDA (K25)Mentored Quantitative RCDA (K25)

Midcareer Investigator Award in Midcareer Investigator Award in Patient-Oriented Research (K24) Patient-Oriented Research (K24) Exploratory/Exploratory/

Development Grant Development Grant (R21) (R21)

“Credential” mandatory for all PD/PIsDo 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

Budget Justification R&R Forms Page available at: grants.nih.gov/grants/funding/424/index.htm

Item 8, Type of Application- 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

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.

Effective January 1, 2009, salary and wages on NIH grants limited to an annual rate of $196,700 (equal to Executive Level I).

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.

Appointed members of chartered Study Sections may submit applications as they are developed and NIH will review within 120 days of receipt.

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

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

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

Any errors must be fixed and the application resubmitted before it can be accepted for review.

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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.

Information not required to review the application but which is necessary to implement the grant.

Don’t submit unless requested via email from the NIH

Request for updated information on “Other Support” for PI and Key Personnel FM should add up the calendar months <= more than

12?

FM should verify the IACUC or IRB approval dates with the appropriate MSU administrators: IACUC dates: Diane Harn X6803 IRB dates: Cheryl Johnson X4706

Log In to eRA Commons Click on Status Tab

▪ Click on “Just in Time” Hot Link▪ Enter PI’s last nameReview 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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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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National Advisory Council

Assesses Quality of SRG Review

Makes Recommendation to Institute Staff on Funding

Evaluates Program Priorities and Relevance

Advises on Policy

Scientific Review Group (SRG) Independent outside reviewers Evaluate scientific merit & significance Recommend length and level of

funding

1st Level

2nd Level

Scientist peers with appropriate expertise -- recruited by the SRO

Standing study section typically has 12-24 members

4-year terms 3 face-to-face

meetings each year Review 60 - 100

applications at each meeting

National Advisory Council or Board assesses quality of 1st level review Concurs with or modifies IRG action Reads summary statements only

Can also designate application as “High” or “Low” program priority

The Institute Director makes actual funding decision

8th Month

ReceiptDate

February 5

June 5

October 5

ScientificReview

July

October

March

CouncilReview

October

January

May

AwardDate

December

April

July

Mandatory: Application with budget >$500,000 direct

costs for any single year R13 Conference GrantsOptional:When RFA’s request a Letter of IntentRecommended:When you think about applying for any

grant

LEGALLY BINDING DOCUMENT

Award Data & Fiscal InformationAward Data & Fiscal Information

Grant Payment InformationGrant Payment Information

OIG* Hotline InformationOIG* Hotline Information

Terms and ConditionsTerms 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.

NIH looks at PI effort in Person/Months

Can get tricky – use the link below

Person/Months FAQ & calculator: http://grants.nih.gov/grants/policy/

person_months_faqs.htm

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 Contact the PI; usually a misunderstanding or

typo If not, Prior Approval should be documented.

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?

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

Refer to NIH Grants Policy Statement for further information.

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

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.

Prior, written approval is required for transferring legal and administrative authority for a grant to a different organization.

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

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

Grantees are strongly encouraged to submit closeout documents electronically through the eRA Commons!

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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

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******

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)]

NIH Searchable Database of RFAs, PAs, and Guide Notices http://grants.nih.gov/grants/guide/index.html

NIH Grants Policy Statement (Rev. 12/03) http://grants.nih.gov/grants/policy/nihgps_2003/index.htm

NIH Extramural Nexus – Bimonthly newsletter for the extramural communityhttp://grants.nih.gov/grants/nexus.htm

Electronic Submission of Grant Applications Homepagehttp://era.nih.gov/ElectronicReceipt/index.htm

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

Grant Application Basics http://grants.nih.gov/grants/grant_basics.htm

Grants Administration individuals at all NIH ICs: http://grants.nih.gov/grants/

staff_list_grants_admin.htm NIH Chief Grants Management Officers:

http://grants.nih.gov/grants/stafflist_gmos.htm

Grants Policy Interpretation & Consultation: E-Mail: GrantsPolicy@mail.nih.gov Phone: 301-435-0949

Compliance Issues: E-Mail: GrantsCompliance@mail.nih.gov Phone: 301-435-0949

General Application Questions: (e-Submission guidelines, resources & referrals, application review & award process, etc.) E-Mail: GrantsInfo@nih.gov Phone: 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

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!