Proposal submission to NIH via Grants.gov

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Proposal submission to NIH via Grants.gov
Overview of NIH eSubmission and Internal Routing
Processes Includes Review and Submission of a
Changed/Corrected Application

• Updated June 2007

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Getting started

• Overview
• Funding Opportunity Announcements
• Software requirements

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Grants.gov and NIH

• Grants.gov
• is being used by 26 Federal grant-making agencies
• Is a web-based portal that facilitates finding
  grant opportunities and applying for funding
• Grants.gov electronic submission is already
  required for a number of NIH mechanisms including
  R01 applications
• Once a mechanism transitions to Grants.gov, paper
  submissions are no longer permitted
• Noncompeting continuation applications (progress
  reports) will continue to be submitted in hard
  copy or via eSNAP (NIH eRA Commons)

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Getting Started

• DO NOT register on Grants.gov or in CCR - the
  University is registered as an institution
• ORD staff are registered as Authorized
  Organizational Representatives (AORs)

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Getting started

• Faculty applying for NIH grants must register in
  NIH eRA Commons https//commons.era.nih.gov/common
  s/
• If you have a username from a prior institution,
  you must affiliate with UMB
• If you have a username because you are a
  reviewer, you must set up a different account as
  a PI
• Contact Colin Hunter (chunter_at_umaryland.edu)
  regarding NIH eRA Commons accounts
• The PI will also need a login for the web-based
  routing form
• PIs may request username and login online via the
  link at https//ord2.umaryland.edu/uom/index.las
  so

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Software

• Download PureEdge Viewer - free via the
  Grants.gov website
• http//www.grants.gov/PEViewer/ICSViewer602_grants
  .exe
• Grants.gov Grant Application Packages can only be
  viewed and completed with PureEdge Viewer
• Mac/Non-Windows users will also need to purchase
  Windows emulation software or check the NIH and
  Grants.gov site for other options
• http//era.nih.gov/ElectronicReceipt/files/mac_opt
  ions.htm
• Contact Colin Hunter for additional Mac expertise
  chunter_at_umaryland.edu
• Ensure that you have software to create PDF files
  from Word or other word processing applications
• SOM obtain Adobe software (50) through the
  Deans Office - Sharon Bowser, 6-0412

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Finding the application package

• You must locate a Funding Opportunity
  Announcement for ANY and ALL NIH electronic
  submissions
• The Grant Application Package is specific to the
  NIH mechanism (R01, R21, etc) even if you are
  submitting a new general, investigator-initiated
  application or a Renewal application,
  Resubmission (formerly known as revised or
  amended) application
• Program Announcements (PA) and Requests for
  Applications (RFA) still exist - and you must
  download the specific Grant Application Package
  for each PA or RFA

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Where to look

• Find out what mechanisms have transitioned to
  electronic submission http//era.nih.gov/Electroni
  cReceipt/strategy_timeline.htm
• Search for NIH grant opportunities via the NIH
  Guide for Grants and Contracts
• http//grants.nih.gov/grants/guide/index.html
  
• The NIH now refers to the general,
  investigator-initiated (unsolicited) program
  opportunity as the PARENT - eg Parent R01
  http//grants.nih.gov/grants/guide/parent_ann
  ouncements.htm

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The Grant Application Package

• When you identify the right Program Opportunity
  Announcement, click on the Apply for Grant
  Electronically button within the program
  announcement to download the PureEdge Grant
  Application Package for that announcement.
• You must download the Grant Application Package
  for each specific Funding Opportunity
  Announcement (FOA)
• For example, the Grant Application Package
  downloaded from an R03 FOA may not be used for an
  R01 application
• Always check for an updated version, i.e., do not
  use an older R21 Grant Application Package that
  was downloaded for a prior deadline

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Finding the application package

• For Resubmissions (amended/revised applications)
  of application submitted in response to a
  specific Program Announcement - check to
  determine whether the PA is still active. When
  in doubt, contact the Program Officer. Download
  either the Grant Application Package from the
  current PA, or use the Parent announcement and
  refer to the prior PA in a cover letter.
• Note - search for grant opportunities from other
  Federal agencies using the Find Grant
  Opportunities area of Grants.gov
• http//www.grants.gov/applicants/find_grant_opport
  unities.jsp

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PureEdge Files and File Sharing

• PureEdge Grant Application Packages are like
  Word documents -
• The Grant Application Package document must be
  saved on a local hard drive, server, etc - it is
  NOT a web-based system
• Only one person can work on the document at a
  time
• Adding information or editing must be done
  sequentially in the same document
• PIs and their administrators need to discuss how
  the Grant Application Package will be shared for
  completion and review, and who will complete the
  fields in the forms, upload attachments, etc.

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Saving and sharing the file

• Save the downloaded Grant Application Package on
  your computer for completion
• The Grant Application Package needs to be saved
  on your local hard drive, server, USB drive, etc.
• You will get a warning message when you first
  save the package from the FO because no data have
  been entered yet
• You will continue to get this message each time
  you save until all required data are entered
• OK to ignore message until ready to submit
• Re-save as you add information (similar to
  working with a Word document - save early and
  often!)
• When you Save, be careful with the file name and
  location (avoid creating multiple versions in
  various places).
• PureEdge files have an .xfd extension

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Instructions!

• When you download the Grant Application Package,
  download any accompanying Instructions.
• Keep your Funding Opportunity Announcement
  (program announcement or request for
  applications) handy for reference - this document
  normally includes information about required
  forms and attachments as well as page limitations
• Follow any links within these documents for
  additional information (for example, information
  specific to an NIH institute)
• The Grants.gov Application Guide SF424 (RR) is
  invaluable and may be downloaded from
• http//grants.nih.gov/grants/funding/424/index.htm

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Internal Routing and Review

• Timelines
• Routing requirements
• Review in ORD
• Validations by Grants.gov and NIH

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When its time to submit

• Electronic submission through Grants.gov means
  that PIs no longer submit the application to NIH
  or other Federal agencies this is now ORDs
  responsibility.
• Therefore, ORD needs the FINAL - READY TO SUBMIT
  version of your PureEdge file well before the
  actual agency deadline

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Grants.gov Submission and Retrieval
Your Grant Application
Grants.gov
Federal Agency
Submitted by ORD via web interface
Application retrieved from Grants.gov by Agency
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Submission Timeline
FINAL PureEdge file to ORD
3 to 5 days
Review
Receipt Validation Retrieval Errors/Warnings? Resu
bmission
Deadline
Proposal submission
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Grant Routing Policies

• The School of Medicine has implemented a grant
  routing policy - other schools have similar
  policies
• Hard copy of application with routing form should
  be submitted to the Deans Office 7 business days
  before the deadline
• By 5 business days before the deadline, the
  signed routing form should be provided to ORD, AS
  WELL AS the completed electronic grant
  application in FINAL form (the completed PureEdge
  file with final attachments)
• The web-based routing form is required for
  routing all applications and facilitates
  transmission of PureEdge application packages
• https//ord2.umaryland.edu/uom/index.lasso

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Save form data and send PDF instructs the
program to send Routing Form pdf to PI and other
contact person to be printed out for routing.
Screen shot of routing form
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Hard copy - Routing Form and required Attachments

• Attach detailed budget spreadsheet (include
  personnel names and percent effort/person months)
  
• Attach a DRAFT of the research plan
• If your application includes subcontractors, you
  must also attach documentation of organizational
  sign-off from the subrecipient
• SOM If your application includes human subjects
  or involves use of animals in the research,
  attach those portions of the research plan as
  well as a print-out of the completed Other
  Project Information form from the Grant
  Application Package
• The next slide shows the form and the Print
  button to print that form only.

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Check Yes for pending or to-be-submitted
protocols
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Routing Form - Upload Attachments (Web-based form)

• While the hard copy is in the routing process,
  put the final touches on your application and
  upload the FINAL completed PureEdge file to the
  existing routing form
• Do not create a new routing form - use the View,
  Edit link to identify the routing form for this
  project, open that form, and upload the file
• Email or call your ORD contact person to advise
  that the FINAL file has been uploaded for ORD
  review.

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Click on View, Edit Routing Forms (circled) to
access an existing routing form. Then, click on
Upload Files.
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Upload the Budget, the PureEdge Grant Application
Package, and other relevant documents
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Routing form print-out of budget, draft
proposal
Routing for signatures
PI/Dept prepare application forms attachments
Grants.gov review/ validation
Agency receipt/ error check
ORD review
ORD submits application
PureEdge Application Packet
Upload to web-based Routing Form
Resubmission, when required
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Your Routing and ORD

• After signature at the Deans Office, the signed
  routing form and hard copy attachments are
  delivered to ORD and logged in.
• The application is assigned to a Contract Grant
  Officer for review, normally to the individual
  assigned as the primary point of contact for your
  department or division.
• After you notify ORD that the PureEdge file has
  been uploaded to the routing form, ORD accesses
  the file via its database

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ORD Review

• ORD reviews the budget and administrative parts
  of the application, focusing on requirements
  (e.g., mandatory attachments, page limits).
• ORD verifies that fields are completed and that
  attachments are in PDF format, as required by NIH.

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ORD Review

• ORD notifies the PI and administrator of any
  concerns. Work with your ORD point of contact to
  determine the most expedient way to make the
  required corrections.
• ORD can make minor corrections to data in the
  form fields.
• ORD cannot correct or change the content of PDF
  file attachments.

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Revised PureEdge Files

• If substantive changes are needed, ORD may
  request that the department/PI provide a
  corrected PureEdge file to ORD.
• Upload the corrected PureEdge file to the
  existing routing form, and contact ORD to advise
  that the file is available.
• To minimize confusion, ORD requests that you give
  the revised PureEdge file a new file name (such
  as SmithR03Version5.xfd)

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Validations and eSubmission

• A key to successful submission is meeting the
  validation standards set by Grants.gov and NIH
  eRA Commons
• Computer programs check for completion of
  mandatory fields and inclusion of mandatory
  attachments, including page limits
• Use checklists and instructions to help minimize
  errors and warnings

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Errors and Warnings

• A validation Error means that the submission is
  not successful and the application will not go
  forward in the review process
• A validation Warning means that the computer
  found some inconsistency that you should check,
  but the application will move forward for further
  review

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Check package for errors

• The Check Package for Errors button (circled on
  the next slide) in the PureEdge Grant Application
  Package will ONLY show Grants.gov errors.
• We must Submit the application for it to go
  through the NIH validation process. NIH errors
  will be shown in the eRA Commons.
• Use our checklist and tips to avoid NIH
  validation errors

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This button only catches Grants.gov errors - not
NIH validation errors
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Submission and Validation

• ORD submits the application through Grants.gov
• A confirmation page is provided on the website,
  then at least four email messages begin to
  arrive. ORD forwards Grants.gov emails to the PI
  and Administrator
• Grants.gov receipt
• Grants.gov validation
• Agency retrieval
• Agency tracking number assigned
• NIH Commons emails regarding submission status
  are sent to the PI and ORD. These messages
  advise of the result of the NIH validation
  process and whether the application has been
  assembled for viewing in NIH Commons.
• These notifications have taken anywhere from
  minutes to days

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Errors, Warnings and Corrections

• An application with an ERROR will not go forward
  for review (and will not be available to view in
  NIH Commons)
• Applications with Errors should be corrected and
  resubmitted via Grants.gov prior to the agency
  deadline
• Review and correct Warnings as required.
  Applications with Warnings will go forward for
  review. Corrected/changed applications should be
  resubmitted via Grants.gov prior to the agency
  deadline.
• Most Warnings have been minor and have not
  required correction/resubmission.
• Avoid some Warnings by ensuring that PIs and Key
  Persons have updated their data in the eRA
  Commons Personal Profile

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What will a completed NIH application look like?

• After successful submission with no NIH
  validation Errors, the eRA system will
• Assemble the grant image (pdf document)
• Generate a Table of Contents
• Insert headers (PI name) footers (page numbers)
  on all pages
• Cover letter and Appendices are separated from
  the rest of the application, and no headers or
  footers are inserted on those documents.
• The Institutional Signing Official (ORD) and the
  PI can review and verify the grant image in the
  eRA Commons

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Review in Commons

• NIH allows 2 business days for the PI and Signing
  Official (SO) to review the application in eRA
  Commons, during which time the SO may reject the
  application.
• This option may be used if the PI or SO
  determines that warnings should be addressed, but
  should be avoided if possible
• If the application is rejected, a
  changed/corrected application must be submitted
  within the two day viewing window.
• If no action is taken within the 2-day period,
  the application will automatically move forward
  in the NIH review process.

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Corrected Applications

• Prior to the submission deadline, the AOR/SO can
  reject the application and submit a
  changed/corrected application to Grants.gov
  before the submission deadline. No cover letter
  is needed.

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Corrected Applications

• If the AOR/SO rejects the application after the
  submission deadline to address warnings, the
  AOR/SO can submit a changed/corrected application
  within the one week correction window NIH is
  allowing during the transition. A cover letter
  must be attached to the application package,
  explaining the reason for the delay.
• If the AOR/SO rejects the application after the
  submission deadline for some reason other than
  system issues or warnings, a changed/corrected
  application can be submitted to Grants.gov. But
  applicants need to be cautioned that these
  applications will be subject to the NIH late
  policy and may not be accepted. A cover letter
  must be attached to the application package,
  explaining the reason why the application is
  late.

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Resources

• NIH application instruction guide(s)
• http//grants.nih.gov/grants/funding/424/index.htm
  
• NIH Grants Info
• Phone [phone] (TTY)
• Email GrantsInfo_at_nih.gov
• http//era.nih.gov/ElectronicReceipt
• NIH - Avoiding Common Errors
• http//era.nih.gov/ElectronicReceipt/avoiding_erro
  rs.htm
• ORD
• Phone [phone]