Fogarty International Center National Institutes of Health (NIH) Marya Levintova, Ph.D....

Fogarty International Center

National Institutes of Health (NIH)

Marya Levintova, Ph.D.International Health Program Officer for Russia, Eurasia and Arctic AffairsInternational Health Program Officer for Europe and EU (Acting)

Division of International RelationsFogarty International CenterNational Institutes of Health

Bridges in Life Sciences US-CEE Regional

Networking Meeting IV

Debrecen, Hungary

April 5, 2009

Today’s Topics

• Introduction to the NIH

History Mission & Organization Funding Facts Funding opportunities for foreign

researchers• Fundamentals of the Grants Process

Types of Grants Roles & Responsibilities:

Yours & Ours

• Fundamentals of the NIH Grant Application process Registration Forms

NIH Campus -- 1947

NIH Campus Today

U.S. Dept. of Health and Human Services

Administration forChildren and Families

(ACF)

Administration forChildren and Families

(ACF)

Food and DrugAdministration

(FDA)

Food and DrugAdministration

(FDA)

Health Resourcesand Services

Administration(HRSA)

Health Resourcesand Services

Administration(HRSA)

Secretary of Health and

Human Services

Secretary of Health and

Human Services

Administration onAging(AoA)

Administration onAging(AoA)

Center for Medicare &

Medicaid Services

(CMS)

Center for Medicare &

Medicaid Services

(CMS)

Indian HealthServices

(IHS)

Indian HealthServices

(IHS)

National Institutesof Health

(NIH)

National Institutesof Health

(NIH)

Centers for Disease Controland Prevention

(CDC)

Centers for Disease Controland Prevention

(CDC)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for Healthcare

Research and Quality(AHRQ)

Agency for Healthcare

Research and Quality(AHRQ)

NIH Mission

NIH is the steward of medical and behavioral research for the Nation

Our mission: to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability …

… from the rarest genetic disorder to the common cold

Fulfilling Our Mission

• Support research by non-Federal scientists across U.S. and abroad

• Train research investigators

• Conduct research at the NIH laboratories

• Foster communication of medical and health sciences information

NIH Organizational Structure

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

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

Did You Know?

• NIH is the Nation’s leading medical research agency

• NIH Bethesda campus is world’s largest research organization 6,000 scientists (18,000 employees) 5 Nobel Prize winners Over 50 members of the National Academy of Sciences

11 of 27 IC Directors are members of Institute of Medicine

3 Office of NIH Director staff

• NIH Extramural Research Program 105 Nobel Prize winners trained or funded by NIH More than half of all American Nobel Prize winners

NIH Gets 1% of U.S. Budget $2,941

$29.5

NIH Rest of U.S. Budget

U.S. budget

NIH Budget: Congressional Appropriations

$13.7

$15.6

$17.8

$20.5

$23.3

$27.1$28.0 $28.6 $28.6 $29.1 $29.5

$0

$5

$10

$15

$20

$25

$30

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Fiscal Year

Bill

ion

s o

f D

olla

rs

NIH FY 2008: Increase of $0.4 billion

Doubling

NIH budget

$24.7

$4.7

Spending at NIH

Spending Outside

84% Outside NIH> 325,000 Scientists > 3,000 Organizations Worldwide

16% Inside NIH $2.9 B Intramural Research (10%)$1.2 B Staff & Buildings (4%)$0.6 B Other (2%)

Total FY 2008 Budget: $29.46 Billion

Balanced National Biomedical Research Portfolio

NIH - $29 B

Clinical Research

Basic Research

Translational Research

Private Sector - $59B

Clinical Research

Basic Research

Translational Research

NIH – Extramural and Other Grant Awards, by Type

• Research Grant Programs (8 types)• New Investigators Program (2 types)• Multiple Principal Investigators (NEW in Feb 2007)• Research Supplemental Programs (1 type)• Ruth L. Kirschstein

National Research Service Awards (NRSA) (8 types)• Research Ethics and Training Grant Programs (2 types)• NIH Career Development (K) Awards (15 types)• Small Business Awards (1 type)• Other Programs (8 types)

Source: http://grants2.nih.gov/grants/funding/funding_program.htm

NIH – Extramural Awards, by Type

NIH Grant Statistics

Fiscal Year 2007

• Approx. 80,000 grant applications received

• 47,243 research grants awarded ($20.35 billion)

• 79% of NIH extramural awards - institutions of higher education

Small Grant (R03)

Research Project Grant (R01)

Independent Scientist Award (K02)

Approx. Stage of ResearchTraining and Development

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)

Exploratory/Development Grant (R21)

NIH Research Training and Career Development Timetable

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

(F30)

Postdoctoral Institutional Training Grant (T32)

Postdoctoral Individual NRSA (F32)

Senior Scientist Award (K05)

Mechanism of Support

GRADUATE/MEDICALSTUDENT

POSTDOCTORAL

EARLY

MIDDLE

SENIOR

CA

RE

ER

Predoctoral Institutional Training Grant (T32)

Midcareer Investigator Award in Patient-Oriented Research (K24)

Funding Opportunities for Foreign Researchers

Intramural program at NIH

Training Opportunities for Foreign Researchers at NIH

Training opportunities at NIH are available for foreign national scientists through the NIH Visiting Program. More info at

http://dis.ors.od.nih.gov/visitingprogram/01_vpmain.html.

The Visiting Program is open to scientists at all career levels. There are two categories of program participants:

• Visiting Fellows who receive awards for research training

• Visiting Scientists who receive appointments to conduct research

The NIH has long considered close interaction with foreign scientists in the conduct of collaborative research to be an essential ingredient

in achieving its mission.

NIH Intramural Program, Visiting Fellows and Guest Researchers, by E.U. Member/Candidate Countries, 2005

Germany, 170, 18%Italy, 161, 17%

France, 146, 15%

United Kingdom, 131, 14%

Spain, 76, 8%Poland, 60, 6%

The Netherlands, 46, 5%

Turkey, 32, 3%

Sweden, 29, 3%

Ireland, 23, 2%

Austria, 21, 2%

Czech Republic, 20, 2%

Bulgaria, 14, 1%Denmark, 12, 1%Belgium, 9, 1%

Finland, 5, 1%

Portugal, 5, 1%

Lithuania, 3, 0%

Croatia, 2, 0%

Estonia, 1, 0%

N=966 x average stipend cost $50,000/yr = $48.3 million

Funding Opportunities for Foreign Researchers

Extramural Opportunities

Eligibility for NIH Funding

• In general, most NIH grants are available to: Foreign institutions and international

organizations Principal Investigators and other personnel who

are not U.S. citizens Domestic organizations with a foreign

component

Note: Exceptions are based on the type of program or grant (e.g., training and fellowships, small business awards, etc. are not eligible) and any specific eligibility requirements noted in a particular Funding Opportunity Announcement.

Peer Review of Foreign Grant Applications

• Standard Review Criteria is used in evaluating and scoring applications from both Domestic and Foreign Institutions

• Foreign Grant Applications also receive the following assessment: Does the project present opportunities for furthering

research programs in other countries that are not readily available in the U.S. or that augment existing U.S. resources?

Does the proposed project have specific relevance to the mission and objectives of an Institute or Center and have the potential for significantly advancing the health sciences in the United States?

Finding the opportunity announcements: http://grants.nih.gov

U.S. Grants & Funding Opportunities

www.Grants.Gov:

• Find grant opportunities 26 Federal grant-making agencies

• Register Allows organization to apply for U.S. grants Process may take up to 30 days

• Apply for grants

• Find electronic submission resources

• Track your application

FIC Organizational Structure

Research and Research Training• ~$50 million in grant awards

• 1/3 Research, 2/3 Research Training

• Awards range $10,000 - $1 million

• Low and Middle Income Countries

• Research Capacity Development and Equity

Millennium Challenge grants – Non-communicable diseases

Fogarty International Research Collaboration Award (FIRCA)

International Cooperative Biodiversity Groups (ICBG)

Ecology of Infectious Diseases (EID)

International Studies on Health and Economic Development (ISHED)

Int’l Tobacco and Health Research and Capacity Building Program

Global Research Initiative Program for New Foreign Investigators (GRIP)

Stigma and Global Health Research Program

Brain Disorders in the Developing World: Research Across the Lifespan

Research Grants

Training Grants

Generally institutional training grant to U.S. universities and non-profit research institutions in response to a specific request for applications (RFA)

Awardees are generally current NIH grant recipients with demonstrated research collaboration with foreign research institutions

Purpose – support training for research-capacity building for scientists from developing nations

Fogarty International Collaborative Trauma and Injury Research Training

International Clinical, Operational, and Health Services Research Training Awards for HIV/AIDS and Tuberculosis

International Maternal and Child Health Research Training

Fogarty International Clinical Research Scholars Training

Informatics Training for Global Health

International Collaborative Genetics Research Training

International Clinical, Operational, and Health Services Research Training Awards for Malaria

Global Infectious Diseases Research Training

International Research Ethics Education and Career Development

International Training Program in Environmental and Occupational Health

Global Research Training in Population Health

AIDS International Training and Research

Framework Programs for Global Health

International Research Scientist Development Awards

Training Grants – 14 programs

Additional funding resources

Looking for collaborators?

http://crisp.cit.nih.gov/

Fundamentals of the Grants Process

Grant Mechanisms

What’s the Difference Between Grants and Contracts?

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 initiated

Award Mechanisms: Research Project Grants

• Traditional – R01• Exploratory/Development Grants – R03/R21/R33/R34• Program Project – P01• Research Center Grants – P50• Small Business – R41, R42, R43, R44

Research Training and Career Awards

• Training Grants – T Institutional Predoctoral and Postdoctoral

• Fellowships – F Individual

• Predoctoral – F31• Postdoctoral – F32

• Career Development Awards – K

Cooperative Agreements (U)

• Specialized Grant mechanism

• Substantial NIH staff involvement in program and science

• Typically initiated by NIH

• Cooperative Agreement Kiosk

http://odoerdb2-2.od.nih.gov/oer/programs/coop/

Fundamentals of the Grants Process

Team Players

PrincipalInvestigator

Authorized Organizational

Reps

ResearchAdministrator

Grantee Institution Team

• Grants are awarded to institutions as represented by AORs

• PD/PIs manage and perform the science

• Research Administrators support business aspects of the grant

Successful grants require close coordination between all members of the grantee team.

The Grantee Institution

• Actual recipient of award

• Legally responsible for proper conduct and execution of grant

• Provides fiscal management

• Provides oversight on allocation decisions

• Assures compliance with Federal, NIH, and organization-wide requirements

Responsibilities of the Authorized Organization Representative (AOR)

[aka Authorized Organizational Official (AO)][aka Signing Official (SO)]

• Designated Representative of the grantee institution Accountable for appropriately utilizing Federal funds

and for the performance of a project Signs all official correspondence to NIH, including

grant applications, financial reports, assurances, and certifications.

Responsibilities of the Principal Investigator(s) (PIs)

• Designated by the grantee institution Responsible for the scientific and technical aspects of

project Directly manages the project on a day-to-day basis Assures scientific compliance by maintaining contact with

the NIH Program Officer Coordinates with other PIs on projects with multiple PIs

Responsibilities of the Research Administrator

• Acts as an agent of the PI and Authorized Organizational Representative: Gathers information needed to ensure compliance

with Federal regulations, as well as organization-wide requirements

Provides essential grant-related support Cannot assume responsibilities assigned to the

Authorized Organizational Representative or the PI

ProgramStaff

ReviewStaff

GrantsManagement

The NIH Extramural Team

Who Ya Gonna’ Call?

• If someone needs help with their application before the review?…

Review Staff: Scientific Review Officer (SRO)

• Responsible to NIH for the scientific and technical review of applications Ensure fair and unbiased evaluation of the scientific and

technical merit of the proposed research Provide accurate summaries of the evaluation to aid

funding recommendations made by National Advisory Councils and Institute Directors

Review applications for completeness and conformance with application requirements

• Point of contact for applicants during the review process

Who Ya Gonna Call?

• If someone needs help with scientific and technical aspects of their application?…

Program Staff: Program Administrator

(aka Program Officer, Program Director or Program Official)

Responsible for the programmatic, scientific, and/or technical aspects of a grant

Who Ya Gonna’ Call?

• If someone needs help with business aspects of their application?…

Grants Staff: Chief Grants Management Officer (CGMO)

Responsible for ensuring that all required business management actions are performed by the grantee and the federal government in a timely and appropriate manner both prior to and after award.

Grants Staff: Grants management specialists

• Assist GMOs/CGMOs in managing and awarding grants

• Answer questions about completing application forms

• Provide guidance on the administrative and fiscal aspects of an award

• Help navigate NIH grants management information on the Web

Fundamentals of the NIH Grants Application Process

Agenda

• Overview of the Electronic Submission Process• Walk Through the SF424 (R&R) Application• Lessons Learned • Question & Answer

Overview of Electronic Submission

Electronic Submission Process

Prepare to Apply

Find Opportunity and Download Application Package

Submit Application to Grants.gov (AOR submits)

Prepare Application

Check Submission Status in Commons

Check Assembled Application

Submission Complete

Two Systems Working Together

Grants.gov• Federal government’s single online portal to find and apply for Federal grant

funding• Used by all 26 Federal grant-making agencies

eRA Commons• NIH electronic Research Administration system that allows

applicants/grantees to electronically receive and transmit application and award information

• Used by NIH and other HHS components

Prepare to Apply

Registration

Prepare to Apply

Registration – Grants.gov• Applicant Organization only (one time)

Obtain EIN from IRS Request DUNS from Dun & Bradstreet Register with CCR – identify the eBiz Point of Contact (POC) Register the Authorized Organization Reps (AORs) who can officially

submit on behalf of your organization

Can take 2 – 4 weeks; up to 8 for newly established businesses

Prepare to Apply

Registration eRA Commons - Organization• Register your organization/institution (one time)• Register your Signing Official (SO)• Register and create a separate account for your Project Director/Principal

Investigator• Registration may be completed simultaneously with the Grants.gov registration (as

soon as the DUNS # is obtained)• Allow 2 – 4 weeks to complete

Prepare to Apply

Registration eRA Commons – PD/PI• Principal Investigators (PIs) must work through their institutions to register.

• The PI and Signing Official (SO) need separate accounts in eRA Commons because each has different privileges.

• PIs have one account that follows them throughout their careers – the same account may be affiliated with multiple organizations.

• Allow 4 - 5 business days to complete.

Prepare to Apply

Software• PureEdge Viewer – free at Grants.gov:

http://www.grants.gov/resources/download_software.jsp#pureedge

• PDF generation software – list provided on Grants.gov websitehttp://www.grants.gov/agencies/software.jsp#3

Prepare to Apply

Options for Mac users (using downloadable forms)

1. Download free CITRIX server to remotely launch a Windows session2. Use PC emulation software3. Download the IBM Workplace Forms (PureEdge) Viewer for Mac

• Early release version with significant limitations

See the Grants.gov website for detailed info:http://www.grants.gov/resources/download_software.jsp#non_window

Prepare to Apply

• Determine your internal review & approval process

• Determine how you will share applications in progress

• Decide how to manage the last minute queue at Sponsored Programs (rather than using an airport FedEx drop box!)

Choose Submission Method

• Forms-based submission using PureEdge software

• System-to-System using XML data stream

• Use commercial service provider to submit applications on behalf of the organization

Find A Funding Opportunity

Find Opportunity & Download Package

• ALL applications must be submitted in response to a Funding Opportunity Announcement (FOA)

• NIH will simultaneously post FOAs in the NIH Guide for Grants and Contracts and Grants.gov Find

• The NIH Guide is located on the Office of Extramural Research Homepage at: http://grants.nih.gov/grants/oer.htm

Investigator – Initiated Research

• NIH is committed to investigator-initiated research and we want your unsolicited applications!

• Since all applications must be submitted in response to an FOA – we’ve created “Parent” FOAs

• Apply using the Parent electronic application package for your chosen mechanism

Office of Extramural Researchhttp://grants.nih.gov/grants/oer.h

tm

New “Parent” FOA page added for quick reference to unsolicited applications.

Enter search

criteria or

Select Advanced

Search

Select the FOA number to open the announcement.

Find Opportunity & Download FOA

• Within the announcement – Click the Apply for Grant Electronically button

• This will take you directly to Grants.gov so you may download the package

Download FOA From Grants.gov

Download Application & Instructions

Important Tip: Sign up to receive notification of changes to the FOA!

Download the application and instructions from this location.

Select “Save” to save the application package to your local hard drive.

You will receive a warning message each time you save until all required data is entered.

A Walk Through theSF424(R&R)

Features of the SF424 (R&R)

• A complete application to NIH will include a combination of (R&R) components & PHS 398 components.

• The applicant must complete the application using the package attached to that particular FOA. Information from the specific FOA is used in the forms.


• Applicants cannot use any sample form packages or form packages from other announcements.

• The applicant will complete data entry in all necessary components and upload appropriate attachments.


SF424 (R&R) Components include: SF424 (R&R)—An application cover component Research & Related Project/Performance Site Location (s) Research & Related Other Project Information Research & Related Senior/Key Person (Expanded) Research & Related Budget Research & Related Personal Data (NIH will not use) R&R Sub-award Budget Attachment Form SBIR/STTR Information


• NIH requires additional information for review of its biomedical research portfolio. Therefore, NIH has developed agency-specific components (titled PHS 398):

• PHS 398 Cover Letter File• PHS 398 Cover Page Supplement (supplements the

R&R Cover)• PHS 398 Modular Budget• PHS 398 Research Plan• PHS 398 Checklist


• Application components include specific data fields as well as multiple attachments

• Most attachments are text• NIH requires PDF text attachments

Create attachments using any word processing software but convert to PDF before attaching to the application form

Do not include headers or footers in the text pages

Features of the SF424 (R&R): Application Guide

• NIH has developed 2 Application Guides specific to the SF424 (R&R):

1) General Instructions2) General +SBIR/STTR

• Includes instructions embedded in the actual forms as well agency-specific instructions

• Agency-specific instructions denoted with the HHS Logo

Application Guide

There are two versions of the application guide in use.• Version 1 (expires end of 2006)

Competition ID field will be blank

• Version 2 (including 2A) Competition ID field includes VERSION-2-FORMS or VERSION-2A-FORMS

• A link to the appropriate application guide is in the FOA application package

Features of the SF424 (R&R): Application Guide

• Documents have same part structure as PHS 398 Instructions:

Part I: Instructions for Preparing and Submitting an Application

Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan

Part III: Policies, Assurances, Definitions

Features of the SF424 (R&R):Application Package Header

• Header page is attached to every posted application package• Header data is pre-filled from the announcement• Notes which components are required (mandatory) and which are

optional for the announcement• Includes basic instructions• Includes Application Submission Verification & Signature screen

Prepare Your Application

Header Information

Pre-filled from Announcement

All Mandatory Documents for the FOA will be included in the application package.

The CFDA Number will be left blank for NIH Opportunities

Prepare Your ApplicationClick this button for field-specific help.

Grants.gov mandatory fields will have an asterisk and will be highlighted

SF424 (R&R)

Cover Component

Page 1

SF424 (R&R) Cover Component Page 2

Component: SF424 (R&R) – A Cover Component

• Similar to the PHS 398 Face Page• Provides general information about the applicant organization, contact

information for the PD/PI and AOR/SO• Provides application-specific information (type, title etc.)

SF424 (R&R) - A Cover Component: A Few Data Issues

• Item 1, Type of Submission Pre-application - do not use unless specifically noted in FOA Changed/Corrected Application—To be used only when correcting an

application that failed system validations. This is NOT a resubmission (amendment).

• Item 5, Applicant Information: This is for the applicant organization


• Item 5, Organizational DUNS: Must match DUNS in eRA Commons profile for Applicant Institution AOR should verify DUNS in Commons profile before submission Use Organizational DUNS (not any DUNS for a specific individual) If Organization has multiple DUNS, pick a single one for NIH grants


• Item 8, Type of Application--New Terminology New is the same Resubmission is equivalent to a Revision (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 • Terminology crosswalk provided in instructions


• Item 10, CFDA Number & Title CFDA = Catalog of Federal Domestic Assistance Fields are pre-filled based on the specific announcement Fields may be blank for applications in response to an FOA that includes

multiple CFDAs When multiple CFDAs are listed in an announcement, a CFDA will be

assigned by the eRA system once a specific Institute assignment is made

Project/Performance Site Locations

R&R Project/Performance Site Locations

• Equivalent to the PHS 398 Form Page 2 Performance Site section • Collects individual data for up to 8 locations• >8 locations – information is provided in an attachment (not

structured data, just text)• Format for the >8 attachment available on SF424 (R&R) Forms Page:

http://grants.nih.gov/grants/funding/424/index.htm

Other Project Information

R&R Other Project Information

• Includes information on involvement of Human Subjects, Vertebrate Animals, Environmental Impact, Foreign Involvement

• Includes separate PDF attachments for Project Summary/Abstract (Description) Project Narrative

• NIH will use this upload for the “Relevance” section of the Abstract• Separate component developed for Research Plan

Bibliography & References (previously section G. Literature cited) Facilities & Other Resources Equipment Resources

Senior/Key Person Profile

R&R Senior/Key Person

Version 1 & 2• Captures personal profile information on the PD/PI, Key Personnel,

and Other Significant Contributors• Captures structured data for 8 individuals (PI and 7 others)• >8 information is provided in an attachment (not structured data, just

text)• Format for the >8 attachment available on SF424 (R&R) Forms Page:


Senior/Key Person Profile (Expanded)

Research & Related Senior/Key Person (Expanded)

Version 2A

• This is the only change in the forms for packages noted as Version 2A.

• Captures structured data for up to 40 Senior/Key Persons.


Additional Senior/Key Person Form Attachments

Version 2A: Research & Related Senior/Key Person (Expanded)

• Enter Senior/Key Person 1, click the Next Person button to display the fields for Profile – Senior/Key Person 2.

• After the first 8 are entered (PI + 7 others), the Select to Extract the R&R Additional Senior/Key Person Form button becomes active.

• Click to open a new page that allows up to four additional Senior/Key Person (PureEdge) components to be attached (each containing another 8 individuals).


Additional Senior/Key Person Form Attachments

Clicking on the “Select to Extract the R&R Additional Senior/Key Person Form” button produces the PureEdge form shown above.

R&R Senior/Key Person & Sr./Key Expanded

• Credential: Must enter the eRA Commons User Name - for the PD/PI, this is a mandatory field for NIH submissions. (Most common validation failure to date)

• Biosketch is attached for each person Same data requirements exist; however, page limits slightly change to

just 4 pages Eliminated the 2-page limit for subsections

R&R Senior/Key Person & Sr./Key Expanded

• Attachment for Current & Pending Support (a.k.a. Other Support) is not required at submission unless specified in FOA.

• For most applications, this will continue to be a Just-In-Time submission

R&R Budget Sections A & B

R&R Budget, Sections A & B

Personnel separated into 2 sections• A. Senior/Key Person

Allows 8 as named individuals & structured data > 8 information is provided in an attachment (not structured data, just text) Info for PD/PI must be entered, even if $ = 0

• B. Other Personnel Postdocs, Grad Students, Undergrads: captures # only NIH will request more detail in Budget Justification

R&R Budget, Sections A & B

• Change from Percent Effort to Person Months Must enter either Calendar, Academic and/or Summer for all

Senior/Key Persons

Incorporated this business process change throughout--See 4/2006 Interim change to PHS 398 & PHS 2590 Progress Report, including Budget Pages, Other Support documentation, Key Personnel Reports, etc.

FAQs and Calculator available at: http://grants.nih.gov/grants/policy/person_months_faqs.htm

R&R BudgetSections C - E

R&R Budget, Sections C - D

• C. Equipment Allows itemization of up to 10 >10 equipment items: details provided in an attachment – total funds

requested in attachment are entered in Line 11

• D. Travel R&R separates out Domestic & Foreign This will not change any NIH policy/practice. We will continue to award

as a single category.

R&R Budget, Section E

• E. Participant/Trainee Support Costs

Will not be used by NIH unless specifically noted in an announcement

Tuition Remission will continue to be included in Section F Other Direct Costs

R&R BudgetSections F - K

R&R Budget, Sections F - I

• F. Other Direct Costs

Itemizes: Supplies, Publication Costs, Consultants, ADP/Computer Services, Consortium Costs, Equipment or Facility Rental/User Fees, Alterations & Renovations

Have included agency-specific instructions to use this section to also account for patient care costs & tuition remission

• G. Total Direct Costs (A – F)• H. Indirect Costs• I. Total Costs (G+H)

R&R Budget, Sections J - K

• J. Fee

• K. Budget Justification – a PDF text attachment

• Next Period Button: At the top of the last budget page. All required data fields in this component must be entered before this button is available. This includes the Budget Justification.

R&R Budget, General Notes

• Applicant prepares a detailed budget for every budget period

• There is no summary budget page like the PHS 398 Form Page 5

• A detailed Cumulative budget is system-generated

R&R Subaward Budget Attachment Form

• Use for detailed budget from any consortium grantee only when the prime is submitting detailed budget

• Do not use if prime is submitting Modular Budget

• Consortium grantee(s) must have PureEdge installed

R&R Subaward Budget Attachment Form

• Allows up to 10 separate budget attachments—one for each consortium grantee

• Applicant sends the R&R budget component to the consortium grantee for completion; it is returned to the applicant; applicant attaches it in this component

• Applicant still needs to include the total costs for all consortiums in their own detailed budget, Section F.5

SBIR/STTR Information

Page 1

SBIR/STTR Information Page 2

SBIR/STTR Information

• Includes eligibility questions answered by both SBIR & STTR applicants as well as separate sections for SBIR & STTR-specific questions

• Includes Commercialization Plan as PDF Attachment

Agency-specific Components (a.k.a. PHS 398 Components)

• PHS 398 Cover Letter File• PHS 398 Cover Page Supplement (supplements the R&R Cover)• PHS 398 Modular Budget• PHS 398 Research Plan• PHS 398 Checklist

PHS 398 Cover Letter

• Provides a text attachment for a cover letter

• Instructions to applicant remain the same as in the PHS 398

• Is stored separately in the eRA Grant Folder, not as a part of the main application grant image

PHS 398 Cover Letter

• Is seen only by appropriate NIH staff; not peer reviewers

• Required when submitting a Changed/Corrected Application after submission date

• If revising the cover letter for a Changed/Corrected application, include all previously submitted letter text

PHS 398

Cover Page Supplement

Page 1

PHS 398Cover Page Supplement Page 2

PHS 398 Cover Page Supplement

• Companion form to the (R&R) Cover Component• For the PI, includes New Investigator Code & Degree fields (Note,

PD/PI info at the top is pre-filled. Provided here for reference only.)• Includes Clinical Trial & Phase-III defined clinical trial indicators

PHS 398 Cover Page Supplement

• For the Business Official Contact, includes complete contact information (title & mailing address missing from section 5 of the R&R Cover)

• Includes Human Embryonic Stem Cells section

PHS 398 Modular Budget

PHS 398 Modular Budget

• Provides data entry for each budget period A. Direct Costs

• DC less consortium F&A• Consortium F&A• Total DC

B. Indirect Costs Calculation section C. Total Costs (A + B)

• Cumulative Budget is system-generated• Budget Justification: PDF text attachments for Personnel, Consortium

and Other

PHS 398 Research Plan


• Separate PDF attachments for each section (designed to maximize benefits of system validations & to accommodate bookmarking of the image)

• Same formatting requirements in the PHS 398 continue here – margins, page limits, etc.


• Appendix Material Allows up to 10 separate attachments Will be stored separately in the eRA Grant Folder, not as a part of the

main application grant image Will be accessible to appropriate NIH staff and peer reviewers See recent changes in Appendix Material, Guide Notice NOT-OD-07-

018:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

PHS 398 Research Plan Helpful Hints

• Create as a single document using any word processing software. Separate at the end before uploading.

• Do not include headers or footers

• Include a section heading as part of the text (i.e., Specific Aims, Background & Significance)

• Avoid 2-column format for text (difficult for reviewers to read electronically)

PHS 398

Checklist Page 1

PHS 398

Checklist

Page 2

PHS 398 Checklist

• Captures additional information currently in the PHS 398 Checklist Change of PI Change of Grantee Institution Inventions & Patents Program Income PDF text upload for an Assurances/Certifications explanation

Application Complete…

Next Steps

Be sure all Mandatory Documents are completed and moved to the submission list.

Refer to the agency-specific instructions for which Optional Documents are required.

Be sure to “Save” the completed application package to your local hard drive.

The Check Package for Errors button will ONLY show Grants.gov errors.You must Submit the application for it to go through the NIH validation process. NIH errors will be shown in the eRA Commons.

The AOR submits the application to Grants.gov. Registration with Grants.gov and eRA Commons

must be complete to successfully submit.

The AOR Signs & Submits

Only the AOR may sign and submit the application on behalf of the organization.

Submit Application

Scroll to the bottom of the Grants.gov

confirmation screen to receive your

Tracking Number and Date/Time

Stamp.

Applications are due 5 p.m. local time of

the applicant org. on day of submission

deadline.

Expected Turnaround Times

• Grants.gov response to an application submission – generally within hours, up to 2 weekdays

• eRA Commons response to an application submission – generally within hours, up to 1 weekday

• AOR/SO and PI review of application image – within 2 weekdays of availability in eRA Commons

Grants.gov Validations

• All Grants.gov mandatory fields have been completed• All mandatory documents have been completed and moved to

the Completed Documents box (Submission List)• Checks the DUNS # • Checks date format, email address format, and scans for viruses

Email Notifications – Grants.gov

• AOR receives emails• Submission Receipt – app received and is being validated• Rejection Notice – app is not validated because of Grants.gov errors• Submission Validation Receipt – app has been validated• Grantor Agency Retrieval Receipt – app has been retrieved by the agency• Agency Tracking Number – app has been assigned a tracking number by the

grantor agency

Check Status in eRA Commons

After submission, the eRA Commons system will: Apply the NIH validations Assemble the grant image Generate a Table of Contents Include headers (PI name) & footers (page numbers) on all

pages

eRA Commons Validations

• The eRA Commons checks the application against NIH business rules

Detailed check against the instructions in the application guide

Validates against the instructions in the specific FOA For a detailed list of NIH validations:

http://era.nih.gov/ElectronicReceipt/prepare_app.htm#5

Email Notifications - eRA Commons

AOR/SO and PI receive emails

Validations Complete/Check Assembled Application

Validations Complete/Check Assembled Application – Warnings Only

Action Required: Errors and/or Warnings, Missing or Invalid Commons Username, System Error

SO has refused application – SO rejected the application

Check Status in Commons – PD/PI

1. Click the Status tab to view the PI Status.

2. Find application that shows “eSubmission Error” in the Application Status column.

3. Follow the link on the Application ID to see specific Error/Warning messages.

View Errors/Warnings

Errors & Warnings

• Errors must be addressed before the application can move on to Referral.

• Warnings may be fixed at the applicant’s discretion but do not require action for the application to move on.

• If the PI corrects any Warnings or Errors, they should contact the AOR/SO. The AOR/SO must submit the entire changed/corrected application again through Grants.gov.

Check Status in Commons AOR/SO

Search screen allows the AOR/SO to narrow the list of results. Click Show Prior eSubmission Errors to view application errors.


View the Application Image by clicking on the Application ID


Next, click on the e-Application link to view the image.

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 AOR/SO has a 2 weekday viewing window to reject an application that has system formatting errors. If the application is not rejected within the 2 weekdays it will automatically proceed to Receipt & Referral.

Application Complete!

Resourcesfor Assistance

Electronic Submission Information:

http://era.nih.gov/ElectronicReceipt/

Resources

Sample Document: “eRA Assembly of the SF424 (R&R) Application” Includes a sample Table of Contents, and; a chart cross-referencing the location in the forms

components for each piece of the grant image.http://grants.nih.gov/grants/funding/424/index.htm

Application Guide(s), Sample Application Packages, Additional Format Pages found at:


Training Tools

Registration• eRA Commons Registration – Automated Training Demo

http://era.nih.gov/virtualschool/external/c101_GranteeRegistrationProcess.htm Working with the Application Form• A “Walk Through the SF424 (R&R)” - Video

http://helix.od.nih.gov/oervideo/grantsgov/A_Walk_Through_SF424/index.html• “Completing an Application Package” – Grants.gov Automated Demo

http://www.grants.gov/images/Application_Package.swf

Training Tools

Learning the Electronic Submission Process• Interacting Electronically with NIH

Part I & II – Videos

Hands-On Learning• Creating a Commons Demo Account – Learn the system and get familiar with the

forms BEFORE you submit! Check the status of sample applications in various stages of submission View errors & warnings See application images

Videos/Hands-On: http://era.nih.gov/ElectronicReceipt/training.htm

Training Tools

Review the Application Guides & Sample Application Packages

• SF424 (R&R) application guides, sample application packages and related resources http://grants.nih.gov/grants/funding/424/index.htm

Training Tools

• Registration in the eRA Commons (Demo) http://era.nih.gov/virtualschool/external/c101_GranteeRegistrationProcess.htm

Grants.gov’s “How to Complete An Application Package” Demo SF424 (R&R) application guides, sample application packages and

related resources http://grants.nih.gov/grants/funding/424/index.htm

Other Tools

• Frequently Asked Questions http://era.nih.gov/ElectronicReceipt/faq.htm

• Electronic Submission Transition Timeline http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm

• Avoiding Common Errors http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm

• Communications and Outreach Resources (brochures, presentations, drop-in newsletter articles) http://

era.nih.gov/ElectronicReceipt/communication.htm

Finding Help: Grants.gov

If help is needed with the Grants.gov registration process or with technical aspects of submitting through the Grants.gov system or PureEdge:

Check the resources available on the Grants.gov website (http://grants.gov/ )

Grants.gov help is also provided by the following office: Grants.gov Customer SupportContact Center Phone: 1-800-518-4726Business Hours M-F 7 a.m.- 9 p.m. ESTEmail [email protected]

Registration & Submission

Finding Help: eRA Commons

Check the eRA Commons website:https://commons.era.nih.gov/commons/index.jsp

eRA Commons Help Desk

Phone: 301-402-7469Toll Free: 866-504-9552TTY: 301-451-5939Business hours M-F, 7am-8pm ESTWeb support: http://ithelpdesk.nih.gov/eRA/

Registration & Validations Processes

Finding Help: Application Preparation

• Review the Application Instruction Guide(s)• Contact Grants Info:

Grants InfoPhone: 301-435-0714TTY: 301-451-0088Email [email protected]

Finding Help

All of these resources and forms are found on the Electronic Submission website at:

http://era.nih.gov/ElectronicReceipt/

Lessons Learned

• Work with your Office of Sponsored Research to determine your internal process flow (review, approval, document sharing etc.)

• Register now to be prepared All PIs and Fellows need to be registered Can take 2 – 4 weeks; up to 8 weeks for newly established organizations

• Read and follow all instructions in the FOA & the application package instructions!

Lessons Learned

• All non-PureEdge attachments MUST be in PDF formatDO NOT:• Use special characters in file names• Write-protect the PDF file; you should disable all security features in

the PDF• Scan text attachments. Generate using word processing package

and then convert to PDF.For more information:http://era.nih.gov/ElectronicReceipt/faq_prepare_app.htm#2e

Lessons Learned

• Organizational DUNS in the application must match DUNS in the eRA Commons profile for the Applicant Institution

• The “credential e.g., agency login” field on the R&R Senior/Key Person Profile component MUST contain the PI’s eRA Commons User ID for NIH to process the application submission

Lessons Learned

• When submitting a Changed/Corrected application, make sure you check the “Changed/Corrected” box in Field #1 Type of Submission

• Allow extra time for corrections

Lessons Learned

• Take time to closely review the grant image within 2 weekdays of availability Ensure ALL PDFs are attached Check each one for proper conversion & formatting

Questions:

Marya Levintova, Ph.D.

International Program Officer for Russia, Eurasia and Arctic Affairs

International Program Officer for Europe and EU (Acting)

Division of International Relations

Fogarty International Center

National Institutes of Health

+1(301) 49604784

Email: [email protected]

THANK YOU!

Fogarty International Center National Institutes of Health (NIH) Marya Levintova, Ph.D....

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