Transcript Slide 1
Fogarty International Center
National Institutes of Health (NIH)
Marya Levintova, Ph.D.
International Health Program Officer for Russia, Eurasia and Arctic Affairs International Health Program Officer for Europe and EU (Acting) Division of International Relations Fogarty International Center National 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 Secretary of Health and Human Services Administration for Children and Families (ACF) Administration on Aging (AoA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Center for Medicare & Medicaid Services (CMS) Agency for Healthcare Research and Quality (AHRQ) Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR) Indian Health Services (IHS) National Institutes Administration (SAMHSA) of Health (NIH) Substance Abuse and Mental Health Services
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 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 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 Institute of Child Health and Human Development 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 National Institute of Nursing Research National Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine NIH Clinical Center Fogarty International Center National Center for Research Resources Center for Information Technology National Library of Medicine Center for Scientific Review National Institute of Biomedical Imaging and Bioengineering No funding authority
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
U.S. budget $2,941
NIH Gets 1% of U.S. Budget
NIH Rest of U.S. Budget $29.5
NIH Budget: Congressional Appropriations $30 $25 $20 $15 $13.7
$15.6
$17.8
$20.5
$23.3
NIH FY 2008: Increase of $0.4 billion $27.1
$28.0
$28.6
$28.6
$29.1
$29.5
$10 $5 $0 1998 1999 2000 2001
Doubling
2002 2003 2004 Fiscal Year 2005 2006 2007 2008
NIH budget $24.7
Total FY 2008 Budget: $29.46 Billion $4.7
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%) Spending at NIH Spending Outside
Balanced National Biomedical Research Portfolio Clinical Research Translational Research Basic Research NIH - $29 B Clinical Research Translational Research Basic Research Private Sector - $59B
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 received 47,243 grant applications research grants awarded ($20.35
billion)
79% of NIH extramural awards institutions of higher education
Small Grant (R03) Research Project Grant (R01) Exploratory/Development Grant (R21) NIH Research Training and Career Development Timetable Approx. Stage of Research Training and Development GRADUATE/ MEDICAL STUDENT Mechanism of Support Predoctoral Institutional Training Grant (T32) 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) MIDDLE SENIOR Independent Scientist Award (K02) Midcareer Investigator Award in Patient-Oriented Research (K24) Senior Scientist Award (K05 )
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
United Kingdom, 131, 14% France, 146, 15% 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% Germany, 170, 18% Italy, 161, 17% 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
Research Grants
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
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
Training Grants – 14 programs
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
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?
GRANT Assistance CONTRACT Acquisition Government is Patron or Partner Purpose: to support and stimulate research Benefit a public purpose Investigator initiated 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
Grantee Institution Team
Successful grants require close coordination between all members of the grantee 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
Authorized Organizational Reps Research Administrator Principal Investigator
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
The NIH Extramural Team
Review Staff Grants Management Program Staff
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 Prepare Application Submit Application to Grants.gov (AOR submits) 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
Obtain EIN from IRS (one time) 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 – account may be affiliated with multiple organizations.
the same 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 website
http://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 session 2.
3.
Use PC emulation software 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 Research http://grants.nih.gov/grants/oer.htm
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 –
Electronically
button Click the
Apply for Grant
• 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 the
SF424(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.
Features of the SF424 (R&R) •
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.
Features of the SF424 (R&R) 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
Features of the SF424 (R&R) • 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
Features of the SF424 (R&R) • • • 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 Instructions 2) 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 Part III: Policies, Assurances, Definitions Plan
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
The CFDA Number will be left blank for NIH Opportunities All Mandatory Documents for the FOA will be included in the application package.
Click this button for field-specific help.
Prepare Your Application 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 (amendment). — To be used only when correcting an application that failed system validations. This is NOT a resubmission Item 5, Applicant Information: This is for the applicant organization
SF424 (R&R) - A Cover Component: A Few Data Issues • 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
SF424 (R&R) - A Cover Component: A Few Data Issues • • 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
SF424 (R&R) - A Cover Component: A Few Data Issues • 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 ” Facilities & Other Resources Equipment Resources section of the Abstract • Separate component developed for Research Plan Bibliography & References (previously section G. Literature cited)
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: http://grants.nih.gov/grants/funding/424/index.htm
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.
Senior/Key Person Profile (Expanded) Additional Senior/Key Person Form Attachments
Version 2A: Research & Related Senior/Key Person (Expanded) • • • Enter Senior/Key Person 1, click the
Next Person
Profile – Senior/Key Person 2.
button to display the fields for 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).
Senior/Key Person Profile (Expanded) 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 Budget Sections C - E
R&R Budget, Sections C - D • • C. Equipment Allows itemization of up to 10 >10 equipment items: details provided in an attachment – requested in attachment are entered in Line 11 total funds 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 Budget Sections 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 398 Cover 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
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.
PHS 398 Research Plan
• 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 to “Save” the completed application package to your local hard drive.
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.
The Check Package for Errors button will ONLY show Grants.gov errors.
You must Commons.
Submit application for it to go through the NIH validation process. NIH errors will be shown in the eRA the
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 – to 2 weekdays generally within hours, up eRA Commons response to an application submission – hours, up to 1 weekday generally within AOR/SO and PI review of application image – in eRA Commons within 2 weekdays of availability
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 – grantor agency app has been assigned a tracking number by the
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.
Check Assembled Application View the Application Image by clicking on the Application ID
Check Assembled Application 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.
Check Assembled Application
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!
Resources for 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: http://grants.nih.gov/grants/funding/424/index.htm
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 ” – Demo http://www.grants.gov/images/Application_Package.swf
Grants.gov Automated
Training Tools
• Learning the Electronic Submission Process Interacting Electronically with NIH Part I & II – Videos • Hands-On Learning Creating a Commons Demo Account – forms BEFORE you submit!
Learn the system and get familiar with the 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
Registration & Submission
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 Support Contact Center Phone: 1-800-518-4726 Business Hours M-F 7 a.m.- 9 p.m. EST Email [email protected]
Finding Help: eRA Commons
Registration
& Validations Processes
Check the eRA Commons website: https://commons.era.nih.gov/commons/index.jsp
eRA Commons Help Desk
Phone: 301-402-7469 Toll Free: 866-504-9552 TTY: 301-451-5939 Business hours M-F, 7am-8pm EST
Web support: http://ithelpdesk.nih.gov/eRA/
Finding Help: Application Preparation
• • Review the Application Instruction Guide(s) Contact Grants Info: Grants Info Phone: 301-435-0714 TTY: 301-451-0088 Email [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 – organizations 4 weeks; up to 8 weeks for newly established Read and follow all instructions in the FOA & the application package instructions!
Lessons Learned
• All non-PureEdge attachments MUST be in PDF format • • •
DO 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
availability of 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!