A Walk Through The SF424 R

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A Walk Through The SF424 (RR) - NIH
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Handouts

• A Walk Through The SF424 (RR) - PowerPoint
  Presentation Slides
• Sample Application Package - PDF sample of all
  the SF424 (RR) components NIH agency-specific
  components (OUHSC
  information included)
• NIH Electronic SF424 (RR) Application Process
  through Grants.gov
• eRA Assembly of the SF424 (RR) Application
  -
  Document showing system-generated Table of
  Contents a chart referencing where each piece
  of the TOC is found in the (RR)

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Electronic Submission Process
Prepare to Apply
Find Opportunity and Download Application Package
Prepare Application
Submit Application to Grants.gov (AOR submits)
if errors
Check Submission Status in NIH eRA Commons
View the Application Image
Submission Complete
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New TerminologyType of Application
RR Type of Application also includes
Continuation. This is equivalent to NIH
Progress Report or T-5. NIH will not use the RR
for progress reports.
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New Terminology
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New Terminology
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Rules for Submission

• Applications are accepted by Grants.gov by 500pm
  local time of the applicant organization on the
  submission date
• Only the AOR is allowed to submit
  (currently Patti Benton or Lisa Asch)
• NIHs late application policy still in
  effect

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Business Process

• Separate PI AOR verification no longer required
• PI AOR strongly recommended to view grant image
  within 2 weekdays of availability in the NIH
  Commons
• AOR has authority to Reject the image
• If no rejection within 2 weekdays of image
  availability, application automatically proceeds
  to next step in NIH processing
• Announced in NIH Guide Notice NOT-OD-06-055
• http//grants.nih.gov/grants/guide/notice-fil
  es/NOT-OD-06-055.html

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Expected Turnaround Times

• Grants.gov response to application submission
  generally within hours, up to 2 weekdays
• eRA Commons response to application submission
  generally within hours, up to 1 weekday
• AOR/SO and PI review of application - within 2
  weekdays of availability in eRA Commons

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Guiding Principles

• NIH will not hold applicants accountable for
  Grants.gov or NIH system problems
• Applicants are expected to
• Complete required registration processes prior to
  submission
• Complete all steps of application submission in a
  timely way
• Submission to Grants.gov
• Correct any errors
• Review Image

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Features of the SF424 (RR)

• SF424 (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
• Each FOA will have the appropriate application
  package attached
• A direct link is provided on each FOA in the NIH
  Guide

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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 is drawn from the specific FOA and
  used in the forms)
• Applicants can not 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

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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
• 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 data collection to
  accommodate the unique information required for
  review of its biomedical research portfolio.
  Therefore, NIH has also 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
• Why call them PHS 398?
• Needed a generic term since other HHS agencies
  will use
• Its the OMB-cleared data collection instrument
  that gives NIH the authority to request these
  additional data elements

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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 for text attachments
• Applicants will need PDF-creation software
• Attachments can be generated using any word
  processing software but will need to be converted
  to PDF before they can be attached to the
  application form
• Do not include headers or footers in the text
  pages

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Features of the SF424 (RR)

• After submission, the eRA system will
• Generate a Table of Contents
• Assemble the grant image
• Include headers (PI name) footers (page
  numbers) on all pages
• Applicants (AOR/SO PD/PI) will have 2 weekdays
  to view this grant image in the eRA Commons

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Features of the SF424 (RR) Application Guide

• 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 as agency-specific
  instructions
• Agency-specific instructions denoted with the HHS
  Logo
• 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
  Plan
• Part III Policies, Assurances, Definitions

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Header Information Pre-filled from announcement
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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 actual
  announcement
• Notes which components are required
  (mandatory) and which are optional for
  this particular announcement
• Includes basic instructions
• Includes Application Submission Verification
  Signature screen

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Features of the SF424 (RR)Application Package
Header

• Saving an Application Package You will get a
  warning message when you first save a package
  from the FOA. This is because no data has been
  entered yet. Users will continue to get this
  message each time a package is saved until all
  data is entered. Click OK to ignore message.
• Just prior to submission use the Check Package
  for Errors tool to ensure all required
  information has been completed.

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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 (OUHSC), 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 Type of
Submission

• Item 1, Type of Submission
• Pre-applicationNIH instructs not to 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 (OUHSC not the PI)

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SF424 (RR) - A Cover Component DUNS

• Item 5, Organizational DUNS
• Use OUHSC DUNS (not any DUNS for a specific
  individual)
• 878648294

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SF424 (RR) - A Cover Component New Terminology

• Item 8, Type of Application New Terminology
• New is the same an application that is being
  submitted to an agency for the first time.
• 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 rarely used.

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RR Senior/Key Person Profile
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Component Research Related Senior/Key Person

• Captures personal profile information on the
  PD/PI, Key Personnel, and Other Significant
  Contributors
• Captures structured data for 8 individuals for
  Versions 1 and 2, 40 for Version 2a
• NIH no longer requires individuals to be listed
  in alphabetical order
• gt8 or gt40 information is provided in an
  attachment (not structured data, just text)
• Format for the gt8 or gt40 attachment available on
  SF424 (RR) Forms Page http//grants.nih.gov/gran
  ts/funding/424/index.htm

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Component Research Related Senior/Key Person

• Credential field Must enter the eRA Commons
  User Name - for the PD/PI, this is a mandatory
  field for NIH submissions. (2 Validation
  Failure to date as of November 8, 2006, 1
  Failure is non-PDF attachments)
• 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
• Note Attachment for Current Pending Support
  (a.k.a. Other Support) will not be used at time
  of submission unless specified in FOA. For most
  applications, this will continue to be a
  Just-In-Time submission

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Other Project Information
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Component Research Related Other Project
Information

• Includes information on involvement of Human
  Subjects, Vertebrate Animals, Environmental
  Impact, Foreign Involvement
• Includes separate PDF attachment fields for
• Project Summary/Abstract (Description)
• Project Narrative
• NIH uses this 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
• Other Attachments

Equivalent to PHS 398 Resources Format Page
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Project/Performance Site Location(s)
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Component Research Related Project/Performance
Site Location(s)

• 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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PHS 398 Cover Page Supplement Page 1
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PHS 398 Cover Page Supplement Page 2
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Component 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
• For the Business Official Contact, includes
  complete contact information this information
  is not automatically completed must be filled
  in (title mailing address missing from section
  5 of the RR Cover)
• Includes Human Embryonic Stem Cells section (must
  click next button to get to this page)

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PHS 398 Research Plan
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Component 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.
• Appendix Material See NIH instructions for
  limitations
• 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
• New! Effective for the May 10, 2006 submission
  dates and beyond, use links to on-line journals
  for publication references when available. See
  Guide Notice http//grants.nih.gov/grants/guide/
  notice-files/NOT-OD-06-051.html

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Component PHS 398 Research Plan Helpful Hints

• Create as a single document using any word
  processing software. Separate only at the end
  before uploading.
• Do not include headers or footers
• Do 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)
• Avoid scanning when text has been generated using
  a word processing tool (Specific Aims, etc.)
• Follow specific agency instructions for
  applications involving animal and/or human
  subjects research
• Consortium description 15
• Letters of support 16

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PHS 398 Checklist Page 1
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PHS 398 Checklist Page 2
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Component PHS 398 Checklist

• Captures additional information currently in the
  PHS 398 Checklist
• Change of PI
• Change of Grantee Institution
• Inventions Patents (for renewal applications
  only)
• Program Income This blank must be completed.
  Usually 0 (unless grant will be generating
  income, e.g., creating software or other items to
  be sold)
• PDF text upload for an Assurances/Certifications
  explanation (N/A to OUHSC)

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Component 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
• 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
  previous submitted letter text

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PHS 398 Modular Budget
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Component PHS 398 Modular Budget

• Provides data entry for each budget period for
• A. Direct Costs
• Direct Costs less consortium FA
• Consortium (subaward) FA
• Total Direct Costs
• 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
• Include travel statement and/or GRA health
  insurance statement in Personnel Justification

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RR Budget Sections A B
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Component Research Related Budget, Sections A
B

• Personnel separated into 2 sections
• A. Senior/Key Person
• Allows 8 as named individuals structured data
• gt8 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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Component Research Related Budget, Sections A
B

• Business Process Change from Percent Effort to
  Person Months
• Must enter either Calendar, Academic and/or
  Summer for all Senior/Key Persons (most OUHSC
  personnel will be calendar months)
• Incorporated this business process change
  throughout See 4/2006 Interim change to PHS 398
  PHS2590 Progress Report, including Budget
  Pages, Other Support documentation, Key Personnel
  Reports, etc. Announced 4/7/2006 in NIH Guide
  Notices.
• FAQs and a 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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Component Research Related Budget, Sections C
E

• 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.
  NIH will continue to award as a single category.
• 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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Component Research Related Budget, Sections F
- K

• F. Other Direct Costs
• Itemizes Supplies, Publication Costs,
  Consultants, ADP/Computer Services, Consortium
  Costs, Equipment or Facility Rental/User Fees,
  Alterations Renovations
• Have included NIH 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)
• 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.

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Component Research Related 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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Component 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
• 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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SBIR/STTR Information Page 1
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SBIR/STTR Information Page 2
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Component 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

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NIH eRA Commons Errors Warnings

• Error any condition which causes the
  application to be deemed unacceptable for further
  consideration. Generally, errors will indicate
  significant inaccuracies, inconsistencies,
  omissions, or incorrect formatting that have been
  identified in the body of the application.
• Error conditions must be corrected, and then the
  application may be submitted as a
  changed/corrected application in order for the
  application to be accepted.
• Warning any condition that is acceptable, but
  worthy of bringing to the applicants attention.
• It is at the applicants discretion whether a
  warning condition requires any action.

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What Will a Completed Application Look Like in
eRA?

• 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
• 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.ht
  m

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SF424 RR and PHS 398 Specific Table of
Contents Page Numbers SF 424 RR Face
Page _________ Table of Contents ________
_ Research Related Project/Performance Site
Location(s) _________ Additional
Locations _________ Research Related Other
Project Information _________ Project
Summary/Abstract (Description) _________ Public
Health Relevance Statement _________ Bibliograp
hy References Cited _________ Facilities
Other Resources _________ Equipment ______
___ Research Related Senior/Key
Person _________ Biographical Sketches for each
listed Senior/Key Person _________ Additional
Senior/Key Person Profiles _________ Additional
Biographical Sketches _________ Research
Related Budget Year 1 _________ Research
Related Budget Year 2 _________ Research
Related Budget Year 3 _________ Research
Related Budget Year 4 _________ Research
Related Budget Year 5 _________ Research
Related Budget Cumulative Budget _________ Rese
arch Related Consortium Budget __________
1
3
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SBIR/STTR Information Research
Development Outside the U.S. Commercializatio
n Plan Prior SBIR Phase II Awards PHS
398 Specific Cover Page Supplement PHS 398
Specific Modular Budget Personnel
Justification Consortium Justification
Additional Narrative Justification PHS 398
Specific Research Plan Introduction to
Application Specific Aims Background
and Significance Preliminary
Studies/Progress Report Research Design and
Methods Human Subjects Sections
Protection of Human Subjects
Data and Safety Monitoring Plan
Inclusion of Women and Minorities
Targeted/Planned Enrollment Table
Inclusion of Children Vertebrate
Animals Consortium/Contractual Arrangements
Resource Sharing Plan Letters of
Support PHS 398 Checklist PHS 398
Specific Assurances/Certification
Explanation Appendix
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Advice From Experience

• Read and Follow All Application Instructions!
• Failure to follow instructions has resulted in
  applicants having to submit corrected
  applications
• Two most common problems with applications to
  date
• There are application fields not marked as
  mandatory on the federal-wide form that are
  required by NIH
• Example The credential field of the RR
  Senior/Key Person Profile component MUST contain
  the PIs assigned eRA Commons User ID for NIH to
  process the application submission
• All non-PureEdge attachments MUST be in PDF
  format
• NIH systems cannot accommodate other types of
  documents

IMPORTANT!
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Advice From Experience

• Tips for creating PDF files
• Use no special characters in file names
• Do not write-protect the PDF file disable all
  security features in the PDF document
• Avoid scanning text attachments (particularly
  abstract specific aims). Generate using word
  processing package and then convert to PDF.
• For more information see Avoiding Common Errors
• http//era.nih.gov/ElectronicReceipt/avoiding_erro
  rs.htm

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Advice From Experience

• Get eRA Commons User ID now to be prepared
  e-mail your SPA to request an eRA Commons User
  ID if you do not already have one. Follow the
  instructions to complete your registration. Keep
  in mind this process can take up to two days.
• Allow time for submitting changed/corrected
  application.
• Review the image in eRA to be sure its formatted
  correctly.
• When seeking support from NIH, be prepared to
  provide identifying information for your
  application and organization.

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Next Steps NIH

• Ongoing areas NIH is addressing
• Help desk staffing
• Resolving technical system issues
• Better educating NIH staff
• Reviewing business rules (validations) enforced
  by the system
• Outreach to the applicant community
• Examining registration process for improvements

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Next Steps Grantees

• Review Electronic Submission website
  http//era.nih.gov/ElectronicReceipt/
• Familiarize yourself with the forms and
  application guide(s)
• Application guides and sample versions of
  application packages are available at
  http//grants.nih.gov/grants/funding/424/index.htm
  
• Must have PureEdge Viewer installed in order to
  manipulate the sample application packages.
  (Check with your IT folks for permission and
  assistance in downloading this software)
• Review available training resources brochures,
  video library, video webcasts
  http//era.nih.gov/ElectronicReceipt/training.htm
  

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Other Tools

• Frequently Asked Questions http//era.nih.gov/Elec
  tronicReceipt/faq.htm
• Electronic Submission Timeline http//era.nih.gov/
  ElectronicReceipt/strategy_timeline.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

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Finding Help Grants.gov

• If help is needed with technical aspects of
  submitting through the Grants.gov system
• Contact your SPA in ORA 405-271-2090
• 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

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Finding Help eRA Commons

• If help is needed with the eRA Commons review
  process in the eRA Commons after submission
  through Grants.gov by the applicant organization
  and principal investigators
• Check the resources available on the eRA Commons
  website
• https//commons.era.nih.gov/commons/index.jsp
• eRA Commons Help DeskPhone 301-402-7469
• Toll Free 866-504-9552 TTY
  301-451-5939
• Business hours M-F, 7am-8pm EST
  Email commons_at_od.nih.gov
• Recommended Web support NIH responds to
  these inquiries first http//ithelpdesk.nih.gov/e
  RA/

New Enter your own help ticket!
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Finding Help Application Preparation

• Review application instruction guide(s)
• Contact your Sponsored Programs Administrator
  405-271-2090
• Contact Grants Info
• Grants Info
• Phone [phone]
• TTY 301-451-0088
• Email GrantsInfo_at_nih.gov
• All these help resources are found at
  http//era.nih.gov/ElectronicReceipt/support.htm