National Institutes of Health

Dec 3/09 National Institutes of Health Presented by: Van Nhan Senior Grants Advisor Health Research Services Faculty of Health Sciences HSC 1B7 Phone: (905) 525-9140, Ext. 22057 Email: nhanvt@mcmaster.ca

Discussion Topics • About NIH - Basics, Deadlines, Foreign Eligibility, Advantages/Disadvantages as Foreign Institution • NIH’s Electronic Application Process http://era.nih.gov/ElectronicReceipt/process.htm • Major Changes for Due Dates on or after January 25, 2010 – Restructured Application Forms and Shorter Page Limits http://enhancing-peer-review.nih.gov/docs/application_changes.pdf • Tips on getting funded by the NIH

What is NIH? • The National Institutes of Health is the United States’ medical research agency • It is part of the larger U.S. Department of Health and Human Services (DHHS) • The NIH funds research both internally and externally • Externally funded research managed by the Office of Extramural Research • The NIH is not one body, but is comprised of 27 different Institutes and Centers (IC), each with its own specific research agenda. • A listing of those institutes & centers http://www.nih.gov/icd/

Office of Extramural Research http://grants.nih.gov/ BASICS NIH GUIDE INITIATIVES eRA, Commons,eSubmission GET CONECTED GLOSSARY, FAQS POLICY FORMS & INSTRUCTIONS, SUBMISSION DATES

Grants Foreign Institutions Are Most Commonly Eligible For:

NIH Standard Receipt Dates/Application Deadlines http://grants.nih.gov/grants/funding/submissionschedule.htm

Foreign Eligibility • Foreign institutions must be able to provide research that does not have comparable work being conducted in the U.S. If it is, the grant will likely not be funded. • If you are a highly qualified foreign investigator with unique expertise or resources not available in the U.S., the likelihood of obtaining an NIH award increases. • Foreign applicants are strongly encouraged to review Section III. Eligibility Information of the FOA.

Applying as a Foreign Institution

Discussion Topics • About NIH - Basics, Deadlines, Foreign Eligibility, Advantages/Disadvantages as Foreign Institution • NIH’s Electronic Application Process http://era.nih.gov/ElectronicReceipt/process.htm • Major Changes for Due Dates on or after January 25, 2010 – Restructured Application Forms and Shorter Page Limits http://enhancing-peer review.nih.gov/docs/application_changes.pdf • Tips on getting funded by the NIH

NIH’s Electronic Application Process • The majority of competing applications now require electronic application submission. • In order to successfully submit an electronic application, investigators must follow both NIH and University-specific procedures

eSubmission Process Prepare to Apply Find Opportunity and Download Application Package Prepare Application If errors, correct & submit again Submit Application to Grants.gov Check Submission Status Check Assembled Application Submission Complete

Two Systems Working Together • eRA Commons – electronic Research Administration system that allows applicants, grantees and Federal staff to access, share and transmit information related to their applications and grants • Used by NIH and a few other HHS components • Grants.gov – the Federal government’s single online portal to find and apply for Federal grant funding • Used by all 26 Federal grant-making agencies IMPORTANT:Each system has its own registration and validations requirements

Applying to the NIHFirst Step – Get Registered All Principal Investigator’s applying to the NIH must have two things: • an NIH eRA Commons ID • Authorized Organization Representative status on grants.gov

How to obtain an eRA Commons ID • Contact your research administration office: • For all other Faculties, contact • What we need: • Name and e-mail address of person requesting ID • After requesting ID, PI will receive e-mail from eRA Commons indicating how to proceed with account set-up Applications without an eRA Commons ID for the PI will be automatically rejected

AOR on Grants.gov • An AOR is an individual authorized to submit applications on behalf of your organization (i.e. McMaster University) • If you are not designated as an AOR you will not be able to submit an application via grants.gov • You cannot be designated an AOR without authorization from the University’s E-Business Point of Contact (E-Biz POC) • Van Nhan in HRS • Sonya Strohm in ORS

Register on Grants.gov http://apply07.grants.gov/apply/OrcRegister McMaster’s DUNS

Internal Process Considerations For FHS • Send electronic copy of application to HRS at hsresadm@mcmaster.ca and submit hardcopy of completed HRS Checklist (signed by Dept. Chair) along with any ethics/biohazard approvals that may be applicable • Once reviewed, HRS will authorize PI as an AOR on grants.gov and PI will be able to submit application electronically Note: HRS deadline is two weeks in advance of NIH This process must be followed with every application as AOR status will be removed once application process is complete

Find Opportunity & Download Package • ALL applications must be submitted in response to a Funding Opportunity Announcement (FOA) • NIH simultaneously posts FOAs on: • NIH Guide for Grants and Contracts http://grants.nih.gov/grants/guide/index.html • Announcements include button to download package and instructions from Grants.gov • Grants.gov

Finding FOAs in NIH Guide NIH Guide for Grants & Contractshttp://grants.nih.gov/grants/guide/ Enter search string or click Advanced Search

Announcement Notes • FOAs in the NIH Guide include button to download app from Grants.gov Click Apply for Grant Electronically Click download Verify information

Grant Application Package Screen Mandatory Grants.gov fields highlighted; Check App Guide for additional NIH required fields Save locally Header info is pre-populated and not editable Complete the SF424 (R&R) first –populates fields in other forms Check Application Guide to determine which Optional Documents to submit

Application Guide • Read and follow application guide instructions • Agency-specific instructions are marked with the HHS logo

Announcement • Read and follow announcement instructions • Pay special attention to Section IV. Application and Submission Information • Includes any FOA-specific submission instructions • Instructions in FOA trump instructions in the application guide

Submit Application • Save & Submit button will not become active until: • All fields marked as mandatory on the forms are completed • All Mandatory Documents are moved to Mandatory Documents for Submission box and completed • The application is Saved Check Package for Errors only checks 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.

Submit Application Enter your Grants.gov username and password – you must be fully registered to successfully submit. Only the AOR can Submit application.

Submit Application Click Sign and Submit Application button to record electronic signature and initiate submission process to Grants.gov

Upon Submission Grants.gov Will Check to Ensure: • All Grants.gov mandatory fields have been completed • All mandatory documents have been completed and moved to the Completed Documents box (Submission List) • The validity of the organizational DUNS # • Date format, e-mail address format, and virus-free

E-mail Notifications – Grants.gov AOR receives Grants.gov e-mails • Submission Receipt – app received and is being validated (Grants.gov validations only) 2. Rejection Notice – app is not validated because of Grants.gov errors OR Submission Validation Receipt – app has been validated (Grants.gov validations only) 3. Grantor Agency Retrieval Receipt – app has been retrieved by the agency 4. Agency Tracking Number – app has been assigned a tracking number by the grantor agency (NIH)

Back to NIH You’re not done yet! Make sure you follow the application through to NIH.

Application Processing in eRA Commons • eRA system retrieves applications from Grants.gov and checks them against NIH business rules defined in application guide instructions and FOA • Complete list of NIH validations: http://era.nih.gov/ElectronicReceipt/prepare_app.htm#5 • Remember, the SF424 (R&R) forms are owned by Grants.gov and used by many agencies, so unfortunately NIH cannot build agency-specific business rules into the forms

E-mail Notifications - eRA Commons AOR/SO, PD/PI and Contact receive e-mails

Check Status in Commons – PD/PI Select Recent/Pending eSubmissions Or provide Grants.gov tracking number from email notification 36

Status – eSub Errors/Warnings Indicates eSubmission Error Grants.gov Tracking # Grants.gov tracking # and date are displayed followed by the list of errors/warnings for each submission attempt

Status – eSub Errors/Warnings • Errors stop application processing and must be corrected • Warnings do not stop application submission and are corrected at the discretion of the applicant Helpful LinksAvoiding Common Errors page:http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm Full list of Commons Validations http://era.nih.gov/ElectronicReceipt/files/SF424RR_Validation.pdf

On-time Submission • All registrations must be completedprior to initial submission • Submission must be accepted by Grants.gov with a timestamp on or before 5:00 p.m. local time of applicant organization on submission deadline date • Errors/Warnings must be corrected within the 2-business day error correction window

Error Correction Window • NIH currently allows applicants to correct errors/warnings during the two (2) business days after the submission deadline • Referred to as “error correction window” • Your original application submission must have been submitted on time with all appropriate registrations in place • Cover letter attachment must be included identifying the system - identified errors/warnings that have been corrected. See Notice in NIH Guide for Grants & Contracts (11/30/2007): http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-018.html

Correcting eSub Errors/Warnings Make changes to address the error/warning messages in the local copy of the application • Select Changed/Corrected on SF424 (R&R) cover (box #1) • Federal Identifier on SF424 (R&R) cover (box #4) is a required field when Changed/Corrected is selected • If New is selected in box #8, use Grants.gov tracking number for original submission • Otherwise, continue to use the Institute/Center and serial number from original grant award (ex. CA123456) • Include cover letter if after submission deadline • AOR must submit the entire changed/corrected application to Grants.gov • Track submission through to Commons NOTE:Reviewers do not see applicant errors/warnings.

Status – View Application Image • Once an error-free application is received, the eRA system will: • Assemble the grant application image • Insert headers (PI name) & footers (page numbers) on all pages • Generate Table of Contents and bookmark important sections • Post the assembled application image in the PI’s eRA Commons account

Application Viewing Window • Applicants have two (2) business days to view the assembled application before it automatically moves forward to NIH for further processing • SO (Institution) can Reject application within viewing window to address Warnings (if within error correction window) or to address a system issue affecting the application image • If Rejected after deadline for any other reason, application is subject to late policy • PI will receive email notification if SO rejectsapplication If you can’t VIEW it, NIH can’t REVIEW it!

Status – View Application Image Status is Pending Verification Follow link to detailed status info Follow e-Application link to view assembled application image View Appendices and Cover Letter

Status – e-Application TIP:Carefully review the entire application. This is your first chance to view/print the same application image that will be used by Reviewers!

Reject Application Must have SO role Enter Search Criteria Click Search Select Recent/ Pending eSubmissions

Reject Application Select Reject eApplication Enter comment to be sent with email notification Click Reject

Discussion Topics • About NIH - Basics, Deadlines, Foreign Eligibility, Advantages/Disadvantages as Foreign Institution • NIH’s Electronic Application Process http://era.nih.gov/ElectronicReceipt/process.htm • Major Changes for Due Dates on or after January 25, 2010 – Restructured Application Forms and Shorter Page Limits http://enhancing-peer review.nih.gov/docs/application_changes.pdf • Tips on getting funded by the NIH

National Institutes of Health