National Institutes of Health and Grants'gov

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National Institutes of Health and Grants.gov

• Dan Christmus
• Steve Etheredge

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Objectives

• You will learn about NIH eRA Initiatives.
• You will understand the NIH eRA application
  process.
• You will learn how to complete a NIH and
  Grants.gov application package.
• You will understand how to submit a NIH
  application using Grants.gov.

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Why e-submission?

• Public Law 106-107 (Federal Financial
  Assistance Management Improvement Act of 1999)
• improve the effectiveness and performance of
  Federal financial assistance programs
• simplify Federal financial assistance application
  and reporting requirements
• improve the delivery of services to the public
• facilitate greater coordination among those
  responsible for delivering services

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What is Grants.gov?

• A single source for finding grant opportunities.
• A standardized manner of locating and learning
  more about funding opportunities.
• A single secure source for applying for Federal
  grants online.
• A simplified grant application process with
  reduction of paperwork.
• A unified interface for all agencies to announce
  their grant opportunities, and for all grant
  applicants to find and apply for those
  opportunities.

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NIH e-Proposal Phase-In

• February 25, 2006
• Academic Research Enhancement Awards (AREA) (R15)
• June 1, 2006
• Small Grant Programs (R03)
• Exploratory/Development Research Grant Awards
  (R21)
• February 1, 2007
• Research Project Grant Program (R01)
• October 2007
• All Mechanisms submitted via Grants.gov

http//era.nih.gov/ElectronicReceipt/files/Electro
nic_receipt_timeline_Ext.pdf
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Application Process

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

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Prepare to Apply

• Register in NIH Commons
• If you have not previously registered, contact
  your SAM Administrator
• If you are currently registered, make sure your
  profile information is correct and complete,
  especially your e-mail address
• Grants.gov Registration
• USC and USCRF are registered
• INDIVIDUAL REGISTRATION IS NOT REQUIRED

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Prepare to Apply

• PureEdge Software
• PureEdge viewer is required to complete the
  Grants.gov forms
• Download the viewer
• http//www.grants.gov/DownloadViewer
• Check the Grants.gov site to make sure you have
  the latest version of the PureEdge viewer
• Non-windows platform users must use alternate
  solution (See Handout)
• PDF File Creator Software
• NIH requires all text attachments be submitted as
  PDF files

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Find Opportunity and Download Application Package

• Use the Find Opportunities section to locate
  the program
• http//www.grants.gov/Find
• Download the grant application package
• https//apply.grants.gov/forms_apps_idx.html
• Enter the Funding Opportunity Number
• NIH will not use CFDA Numbers to post application
  packages
• The Grants.gov application package will be one
  file with a .XFD extension
• e.g. NIH R01.XFD

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Prepare Application Package

• SF 424 (RR)

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SF 424 (RR)

• The SF 424 (RR) is an application form that is
  comprised of common data elements developed for
  use by Federal agencies funding Research and
  Research-Related programs
• Provides a consistent electronic submission
  process through Grants.gov

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SF 424 (RR) Features

• SF 424 (RR) data is arranged in components
• Not all components will be used for every Funding
  Opportunity Announcement (FOA)
• Agencies construct application packages for
  each FOA
• NIH will use several standard packages
• The FOA will indicate which components are
  required and which are optional

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SF 424 (RR) Features

• A complete application to NIH will include a
  combination of
• SF 424 (RR) components
• PHS 398 components
• The PI must complete the application package for
  the specific FOA
• Applicants can NOT use any sample form packages
  or form packages from other announcements

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SF 424 (RR) Features

• Application components include specific data
  fields as well as multiple attachments
• The PI must complete data entry in all necessary
  components and upload appropriate attachments
• NIH will require PDF for text attachments
• (Applicants will need some type of PDF-creation
  software)

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Application Guides

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

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SF 424 (RR) Components

• Application Package Header
• SF 424 (RR) - cover page
• Project/Performance Site Location(s)
• Other Project Information
• Senior/Key Person
• Budget
• Subaward Budget Attachment Form

See Handouts
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Application Package Header

• Header page is attached to every posted
  application package
• Some data is pre-filled from the actual
  announcement
• Lists which components are mandatory and which
  are optional
• Includes basic instructions

See Page 1 of Handouts
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Cover Page

• Similar to the PHS 398 Face Page
• Provides general information about the applicant
  organization, contact information for the PI and
  Authorized Organizational Representative
• Provides application-specific information (type,
  title etc)

See Page 2 of Handouts
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Cover Page

• Item 1, Type of Submission
• Pre-applicationUse only when specifically noted
  in Funding Opportunity Announcement (FOA)
• ApplicationUsed to note original application
• Changed/Corrected Application Use only when
  correcting an application that failed system
  validations. This is NOT a resubmission

See Page 2 of Handouts
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Cover Page

• Item 8, Type of Application
• New is the same as PHS 398 definition
• 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

See Page 2 of Handouts
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Cover Page

• Item 10, CFDA Number and Title
• CFDA Catalog of Federal Domestic Assistance
• Fields are pre-filled based on the specific
  announcement
• Fields will be blank for applications in response
  to a FOA that include multiple CFDAs
• A CFDA will be assigned by the eRA system once a
  specific Institute is assigned
• Item 19, Authorized Representative
• SAM Administrator will complete

See Page 2 3 of Handouts
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Project/Performance Site Location(s)

• Equivalent to the PHS 398 Form Page 2
• Collects individual data for up to 8 locations
• Information for more than 8 locations is provided
  in an attachment

See Page 4 of Handouts
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Other Project Information

• Includes information on involvement of Human
  Subjects, Vertebrate Animals, Environmental
  Impact, Foreign Involvement Separate PDF
  attachments are required for
• Project Summary/Abstract
• 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

Equivalent to PHS 398 Resources Format Page
See Page 5 of Handouts
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Senior/Key Person Profile

• Captures personal profile information on the
  PD/PI, Key Personnel, and Other Significant
  Contributors
• Allows structured data for 8 individuals (PI and
  7 others)
• Click the Next Person button to add and/or review
  additional Senior/Key Person(s)
• Information for more than 8 individuals is
  provided in an attachment
• In the Credential field, list your NIH Commons
  Username

See Page 6 of Handouts
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Senior/Key Person Profile

• Biosketches for each person must be attached
• Same data requirements
• Page limits change to 4 pages
• Eliminating the 2 page limit for subsections
• Note, Attachment for Current Pending Support
• (Other Support) will not be used

See Page 6 of Handouts
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Budget, Non-Modular Format

• Budgets requesting more than 250,000 direct
  costs per year
• Must prepare a detailed budget for every budget
  period
• No summary budget page (PHS 398 Form Page 5)
• Detailed cumulative budget is system-generated
  (Page 10 of Handout)

See Page 7 of Handouts
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Budget, Sections A B

• Personnel separated into two sections
• A. Senior/Key Person
• Allows for 8 individuals structured data
• Information for more than 8 is provided in an
  attachment
• B. Other Personnel
• Postdocs, Grad Students, Undergrads
• Captures number only
• More detail requested in Budget Justification

Business process change from percent effort to
person months
See Page 7 of Handouts
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Budget, Sections C - E

• C. Equipment
• Allows detail of up to 10 items
• If more than 10 items are included, then total
  dollar amount is listed in line 11 and details
  are provided in an attachment
• D. Travel
• Separates out Domestic Foreign
• 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

See Page 8 of Handouts
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Budget, Sections F - K

• F. Other Direct Costs
• Itemizes Supplies, Publication Costs,
  Consultants, Computer Services, Consortium Costs,
  Equipment or Facility Rental/User Fees,
  Alterations and Renovations
• 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
• J. Fee
• K. Budget Justification (PDF text attachment)

See Page 9 of Handouts
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Subaward Budget Attachment

• Detailed budget from consortium grantees
• Allows up to 10 separate budget attachments
• One for each consortium grantee
• Process for completing subaward budgets
• RR Budget Component is send to the consortium
  grantee for completion
• Consortium grantee returns the completed form to
  the applicant
• Applicant attaches the form to this component
• Include the total costs for all consortiums in
  applicant detailed budget (Section F.5)

See Page 11 of Handouts
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NIH-Specific Components

• PHS 398 Cover Letter File
• PHS 398 Cover Page Supplement
• PHS 398 Modular Budget
• PHS 398 Research Plan
• PHS 398 Checklist

See Handouts
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PHS 398 Cover Letter

• Provides a place to attach a cover letter which
  is prepared by SAM
• Instructions to applicant remain the same as in
  the PHS 398
• Will NOT be stored as part of the main
  application grant image in the eRA Grant Folder
• Not seen by peer reviewers

See Page 12 of Handouts
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PHS 398 Cover Page Supplement

• Companion form to the (RR) Cover Component
• Includes
• New Investigator Code and Degree fields for the
  PI
• Clinical Trial Agency-Defined Phase-III
  Clinical Trial indicators
• Complete contact information for the Business
  Official Contact
• Human Embryonic Stem Cells section

See Page 13 14 of Handouts
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PHS 398 Modular Budget

• Provides data fields for each budget period for
• A. Direct Costs
• Direct Cost less consortium FA
• Consortium FA
• Total Direct Cost
• B. Indirect Costs Calculation section
• C. Total Direct and Indirect Costs (A B)
• Cumulative Budget is system-generated
• Budget Justification for Personnel, Consortium
  and Other (PDF attachments)

See Page 15 - 17 of Handouts
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PHS 398 Research Plan

• Separate PDF attachments for each section
• Same formatting requirements in the PHS 398
  (margins, page limits, etc)
• Appendix Material
• Allows up to 10 separate attachments
• Stored separately in the eRA Grant Folder, not as
  a part of the main application grant image
• Accessible to appropriate NIH staff and peer
  reviewers

See Page 18 of Handouts
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PHS 398 Checklist

• Captures information currently captured in the
  PHS 398 Checklist
• Application Type
• Change of PI
• Change of Grantee Institution
• Inventions Patents
• Program Income
• Assurances/Certifications
• Indirect Costs are listed on budget pages

See Page 19 of Handouts
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Route Application through USCeRA

• Log into USCERA
• Complete all required internal forms
• Upload the Application (.XFD) file in USCeRA
• Route the proposal for internal approval
• SAM will submit the application to NIH through
  Grants.gov

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Submit Application to Grants.gov

• Applications must be submitted to Grants.gov by 5
  p.m. local time on the submission/receipt date
• Only the Authorized Organizational Representative
  (AOR) of the applicant institution is allowed to
  submit the application
• SAM is the AOR for the University
• Grants.gov performs basic checks

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Check Submission status in Commons

• eRA Commons sends e-mail notifications to the
  AOR/Signing Official (SO) and the Principal
  Investigator (PI)
• PI and SAM Administrator log into eRA Commons to
  the list of eSubmission errors/warnings.
• Warnings can be fixed at the applicants
  discretion but do NOT require action
• Errors must be addressed
• If corrections to the application forms are
  required, the entire changed/corrected
  application must be resubmitted through
  Grants.gov.
• Once an error-free application is received, the
  eRA system will assemble the application and the
  grant image will be available to the PI and
  Signing Official for a final check.

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Check Assembled Application

• If the application is acceptable, no further
  action is necessary.
• Application will automatically move forward after
  two business days
• Only the AOR/SO has the ability to reject the
  application within the two business days
• Address warnings or
• If the assembled application in eRA Commons does
  NOT correctly reflect the submitted application
  package
• If the AOR/SO rejects the application, a
  changed/corrected application can be submitted to
  Grants.gov within that two-day viewing window

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Check Assembled Application

• What will a completed application look like?
• After submission, the eRA system will
• Assemble the grant image
• Generate a Table of Contents
• Include headers (PI name) footers (page
  numbers) on all pages
• eRA Assembly of Grant Application
• http//grants.nih.gov/grants/funding/424/index.htm
  

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Submission is Complete
Congratulations!!!!!!
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Review of the Application Process

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

44
Conclusions

• You have learned about NIH eRA Initiatives.
• You understand the NIH eRA application process.
• You have learned how to complete a NIH and
  Grants.gov application package.
• You understand how to submit a NIH application
  using Grants.gov.