Preparing for NIH R01 Submissions with Grants'gov

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Preparing for NIH R01 Submissions with Grants.gov

• OSP/Department Administrators Meeting
• December 12, 2006

2
Agenda

• News and Notices
• Overview of the Electronic Submission Process
• Walk Through the SF424 (RR) Application
• Question Answer

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News and Notices

• Parent Announcements For Unsolicited or
  Investigator-Initiated Applications Released
• http//grants.nih.gov/grants/guide/parent_announce
  ments.htm
• Establishment of Multiple Principle Investigator
  Awards for the Support of Team Science Projects
• NOT-OD-07-017 (see http//grants.nih.gov/grants/m
  ulti5Fpi/)
• Change in Standing Receipt Dates for
  NIH/AHRQ/NIOSH Beginning in January 2007
• NOT-OD-07-001 (see http//grants1.nih.gov/grants/
  guide/notice-files/NOT-OD-07-001.html)

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The Plan

• OMB set the following FY 2007 goal for agencies
  Post 100 of funding opportunities on Grants.gov
  Apply.
• By the end of Sept. 2007, NIH plans to
• Require electronic submission through Grants.gov
  for all NIH grant applications
• Transition from the PHS 398 application form to
  the SF424 (RR)

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Progress

• NIH has received over 18,000 unique electronic
  applications
• Over 16 mechanisms have transitioned
• Record-breaking June submissions went smoothly
• NIHs eRA Processing capabilities have increased
  dramatically from Dec. 2005

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NIH Prepares for R01s

• NIH expects 4,500-5,000 unique R01 applications
  in February
• Increased resources for Help Desk and staff
  training

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Electronic Submission Process

• Prepare to Apply
• Find Opportunity and Download Application Package
• Submit Application Package to Grants.gov
• Check Submission Status in eRA Commons
• Check Assembled Application

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Two Systems Working Together

• Grants.gov
• Federal governments 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

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Prepare to Apply

• UVM is Registered with Grants.gov
• Individual PIs and staff do not need to register
• UVM is Registered with NIH eRA Commons
• Individual PIs need to be Registered in eRA
  Commons and know User ID
• If a PI is registered through another
  institution, make sure PI is affiliated with UVM
• Is eRA Commons profile up to date?

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Prepare to Apply

• Software Required
• PureEdge Viewer free at Grants.gov
• http//www.grants.gov/resources/download_software
  .jsppureedge
• PDF generation software list provided on
  Grants.gov website
• http//www.grants.gov/agencies/software.jsp3

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Prepare to Apply

• Options for Mac users (using downloadable forms)
• Download free CITRIX server to remotely launch a
  Windows session
• 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.
  jspnon_window

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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

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Investigator Initiated Research

• NIH is committed to investigator-initiated
  research and they want your unsolicited
  applications!
• Since all applications must be submitted in
  response to an FOA NIH created Parent FOAs
• Apply using the Parent electronic application
  package for your chosen mechanism

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Office of Extramural Researchhttp//grants.nih.go
v/grants/oer.htm
New Parent FOA page added for quick reference
to unsolicited applications.
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Enter search criteria or Select Advanced Search
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Select the FOA number to open the announcement.
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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

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Download FOA From Grants.gov
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Download Application Instructions
Important Tip Sign up to receive notification of
changes to the FOA!
Download the application and instructions from
this location.
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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.
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Features of the SF424 (RR)

• A complete application to NIH will include a
  combination of (RR) 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.

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Features of the SF424 (RR)

• Applicants cannot use any sample form packages or
  form packages from other announcements.
• Dont use application packages from prior
  submissions
• The applicant will complete data entry in all
  necessary components and upload appropriate
  attachments.

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Features of the SF424 (RR)

• SF424 (RR) Components include
• SF424 (RR)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)
• RR Subaward Budget Attachment Form
• SBIR/STTR Information

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Features of the SF424 (RR)

• 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
  RR Cover)
• PHS 398 Modular Budget
• PHS 398 Research Plan
• PHS 398 Checklist

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Features of the SF424 (RR)

• 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 (eRA Commons will add these)

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Features of the SF424 (RR) Application Guide

• NIH has developed 2 Application Guides specific
  to the SF424 (RR)
• General Instructions
• General SBIR/STTR
• Includes instructions embedded in the actual
  forms as well agency-specific instructions
• Agency-specific instructions denoted with the HHS
  Logo

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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

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Features of the SF424 (RR) Application Guide

• Documents have same part structure as PHS 398
  Instructions
• Part I Instructions for Preparing and
  Submitting an Application
• Part IISupplemental Instructions for
  Preparing the Human Subjects Section of the
  Research Plan
• Part III Policies, Assurances, Definitions

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Features of the SF424 (RR)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

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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.
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Prepare Your Application
Click this button for field-specific help.
Grants.gov mandatory fields will have an asterisk
and will be highlighted
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SF424 (RR) Cover Component Page 1
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SF424 (RR) Cover Component Page 2
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Component SF424 (RR) 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.)

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SF424 (RR) - A Cover Component A Few Data
Issues

• Item 1, Type of Submission
• Pre-application - do not use unless specifically
  noted in FOA
• Changed/Corrected ApplicationTo 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

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SF424 (RR) - 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

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SF424 (RR) - 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

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Project/Performance Site Locations
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RR Project/Performance Site Locations

• Equivalent to the PHS 398 Form Page 2 Performance
  Site section
• Collects individual data for up to 8 locations
• gt8 locations information is provided in an
  attachment (not structured data, just text)
• Format for the gt8 attachment available on SF424
  (RR) Forms Page http//grants.nih.gov/grants/fun
  ding/424/index.htm

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Other Project Information
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RR 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

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Senior/Key Person Profile
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RR 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)
• gt8 information is provided in an attachment (not
  structured data, just text)
• Format for the gt8 attachment available on SF424
  (RR) Forms Page http//grants.nih.gov/grants/fu
  nding/424/index.htm

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Senior/Key Person Profile (Expanded)
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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.

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Senior/Key Person Profile (Expanded) Additional
Senior/Key Person Form Attachments
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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 RR 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).

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Senior/Key Person Profile (Expanded) Additional
Senior/Key Person Form Attachments
Clicking on the Select to Extract the RR
Additional Senior/Key Person Form button
produces the PureEdge form shown above.
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RR 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 datebut not for UVM!)
• 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

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RR 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

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RR Budget Sections A B
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RR Budget, Sections A B

• Personnel separated into 2 sections
• A. Senior/Key Person
• Allows 8 as named individuals structured data
• gt 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

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RR 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

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RR Budget Sections C - E
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RR Budget, Sections C - D

• C. Equipment
• Allows itemization of up to 10
• gt10 equipment items details provided in an
  attachment total funds requested in attachment
  are entered in Line 11
• D. Travel
• RR separates out Domestic Foreign
• This will not change any NIH policy/practice. We
  will continue to award as a single category.

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RR 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

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RR Budget Sections F - K
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RR 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 (GH)

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RR Budget, Sections J - K

• J. Fee (for SBIR/STTR)
• 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.

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RR 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

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RR 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

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RR Subaward Budget Attachment Form

• Allows up to 10 separate budget attachmentsone
  for each consortium grantee
• Applicant sends the RR 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

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

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

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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

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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

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PHS 398 Cover Page Supplement Page 1
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PHS 398 Cover Page Supplement Page 2
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PHS 398 Cover Page Supplement

• Companion form to the (RR) 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

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PHS 398 Cover Page Supplement

• For the Business Official Contact, includes
  complete contact information (title mailing
  address missing from section 5 of the RR Cover)
• Includes Human Embryonic Stem Cells section

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PHS 398 Modular Budget
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PHS 398 Modular Budget

• Provides data entry for each budget period
• A. Direct Costs
• DC less consortium FA
• Consortium FA
• 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

74
PHS 398 Research Plan
75
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.

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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/NO
  T-OD-07-018.html

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PHS 398 Research PlanHelpful 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)

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PHS 398 Checklist Page 1
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PHS 398 Checklist Page 2
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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

81
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.
82
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.
83
The AOR submits the application to Grants.gov.
Registration with Grants.gov and eRA Commons must
be complete to successfully submit.
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The AOR Signs Submits
Only the AOR may sign and submit the application
on behalf of the organization.
85
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.
86
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

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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

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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

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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

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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.h
  tm5

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Email Notifications - eRA Commons

• AOR/SO and PI receive emails

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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.
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View Errors/Warnings
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Errors Warnings

• Errors must be addressed before the application
  can move on to Referral.
• Warnings may be fixed at the applicants
  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.

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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.
96
Check Assembled Application
View the Application Image by clicking on the
Application ID
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Check Assembled Application
Next, click on the e-Application link to view the
image.
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Application Image
Be sure to review the entire application
carefully! Your application is not considered
received by NIH until you see the application
image in the eRA Commons.
99
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.
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Application Complete!
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OSP Process

• Routing Requirements Remain the Same
• Signed Routing form
• 2 Copies of Complete Proposal
• Deadlines for February March
• NIH Deadline                 February 5     
  March 5
• Draft due to OSP           January 22     Feb.
  19    
• Final application due To OSP
• January 29        February 26

102
Resources for Assistance
103
Electronic Submission Information http//era.nih.
gov/ElectronicReceipt/
104
Resources

• Sample Document eRA Assembly of the SF424
  (RR) 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

105
Application Guide(s), Sample Application
Packages, Additional Format Pages found at
http//grants.nih.gov/grants/funding/424/index.htm
106
Training Tools

• Registration
• eRA Commons Registration Automated Training
  Demo http//era.nih.gov/virtualschool/external/c10
  1_GranteeRegistrationProcess.htm
• Working with the Application Form
• A Walk Through the SF424 (RR) - 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

107
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/ElectronicRece
  ipt/training.htm

108
Training Tools

• Presentations
• Archive of this training session will be
  available in streaming video and downloadable
  formats http//era.nih.gov/ElectronicReceipt/trai
  ning.htm
• Review the Application Guides Sample
  Application Packages
• SF424 (RR) application guides, sample
  application packages and related resources
  http//grants.nih.gov/grants/funding/424/index.htm
  

109
Training Tools

• Registration in the eRA Commons (Demo)
  http//era.nih.gov/virtualschool/external/c101_Gra
  nteeRegistrationProcess.htm
• Grants.govs How to Complete An Application
  Package Demo
• SF424 (RR) application guides, sample
  application packages and related resources
  http//grants.nih.gov/grants/funding/424/index.htm
  

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Other Tools

• Frequently Asked Questions http//era.nih.gov/Elec
  tronicReceipt/faq.htm
• Electronic Submission Transition Timeline
  http//era.nih.gov/ElectronicReceipt/strategy_time
  line.htm
• Avoiding Common Errors http//era.nih.gov/Electron
  icReceipt/avoiding_errors.htm
• Communications and Outreach Resources (brochures,
  presentations, drop-in newsletter articles)
  http//era.nih.gov/ElectronicReceipt/communication
  .htm

111
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 [phone]
• Business Hours M-F 7 a.m.- 9 p.m. EST
• Email support_at_grants.gov

112
Finding Help eRA Commons
Registration Validations Processes

• If help is needed with eRA Commons registration
  or validations after submission through
  Grants.gov
• Check the eRA Commons website
• https//commons.era.nih.gov/commons/index.jsp
• eRA Commons Help Desk
• Phone [phone]
• Toll Free 866-504-9552
• TTY 301-451-5939
• Business hours M-F, 7am-8pm EST
• Web support http//ithelpdesk.nih.gov/eRA/

Use the web support! Enter your own help ticket!
113
Finding Help Application Preparation

• Review the Application Instruction Guide(s)
• Contact Grants Info
• Grants Info
• Phone [phone]
• TTY 301-451-0088
• Email GrantsInfo_at_nih.gov

114
Finding Help

• All of these resources and forms are found on
  the Electronic Submission website at
• http//era.nih.gov/ElectronicReceipt/