Christopher L. Hatch, Ph.D.

1

Electronic Submission (eSubmission) of Grant
Applications to the NIH
NCI Orientation for Extramural Staff
January 29, 2007

• Christopher L. Hatch, Ph.D.
• Chief, Program Coordination and Referral Branch
• Division of Extramural Activities, NCI

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eSubmission vs. Hard Copy Submission of Grant
Application

• Mandated by Federal law and the Presidents
  Management Agenda
• Use of the Standard Form (SF) 424 Research
  Research-Related (RR) instead of the Public
  Health Service (PHS) 398 Form
• Electronic Pre-Registrations of Institutions and
  Applicants/Principal Investigators (PIs)
• Use of Grants.gov instead of mail and express
  couriers

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Advantages of eSubmission, eReceipt, and eReview
of Grant Applications

• Eliminates the burden of paper-based data
  handling (including scanning) possible savings
  of gt200 million pieces of paper/year
• Electronic validations improve data quality
• Grant images are clearer (than scanned copies)
  and enable presentation of high resolution color
  figures
• Electronic data can be mined by knowledge
  management and other tools
• Resulting efficiencies may allow NIH to shorten
  the cycle from application receipt to award

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NIHs Electronic Grants Goal

• By the end of September 2007, NIH plans to
• Require electronic submission through Grants.gov
  for almost all NIH grant applications
• Transition from the PHS 398 application form to
  SF424 family of forms data set (for almost all
  grant mechanisms)
• SF424 Research and Research-Related SF424 (RR)
• SF424 Discretionary (of limited use for NIH)

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NIH Timeline
Timeline of Transition
SBIR/STTR (Dec. 1, 2005)
Resource (G), S11, S21, S22 (May 25, 2007)
R13/U13 (Dec. 15, 2005)
Career Dev. Ks - K12 (Jun 12, 2007)
R36 (Feb. 17, 2006)
Fellowship (F) (Aug. 8, 2007)
R15 (Feb. 25, 2006)
Training (TD), Projects/Centers (P), M01,
R10/U10, S06, U01, U19, U54, U56, R24/U24, others
(Sept. 25, 2007)
R18/U18, R25, C06/UC6 (Oct. 1, 2006)
S10 (Mar. 22, 2006)
DP1(Jan. 16, 2007)
X02 (April 18, 2006)
R01(Feb. 5, 2007)
Potential R01 Multi-PI Pilot (Oct. 1, 2006)
R03, R21/R33, R34(June 1, 2006)
K12(Oct. 12, 2007)
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07
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09
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2006
2007

• Current as of January 5, 2007. Visit the Web site
  for the latest version http//era.nih.gov/Electro
  nicReceipt/

Mechanism Abbreviation Key C06/UC6 Research
Facilities Construction Grants DP1 NIH Directors
Pioneer Award Program D71/U2R International
Training Cooperative Agreement/
Phase 2 of FIC mechanism D71 P Research Program
Projects and Centers R01 Research
Project Grant Program R03 Small Grant
Programs R10/U10 Cooperative Clinical Research
Grants R13/U13 Support for Conferences
Scientific Meetings R15 Academic
Research Enhancement Awards (AREA) R18/U18
Research Demonstration and Dissemination Projects
R21/R33 Exploratory/Development
Research R24/U24 Resource Related Research
Projects R25 Education Projects R34
Clinical Trial Planning Grant Program R36
Research Dissertation Grant Program SBIR
Small Business Innovation Research STTR
Small Business Technology Transfer S06,S10,S11
Biomedical Research S21,22 Health Disparities
Endowment Grants U Cooperative
Agreement Awards X02 Pre-application for
Interdisciplinary Research Consortium
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Funding OpportunityAnnouncements (FOAs)

• All eApplications must be created with use of an
  appropriate SF424 and submitted to the NIH
  through Grants.gov in response to an FOA.
• All FOAs will be posted on Grants.gov by NIH
  staff along with the appropriate application
  package.
• All FOAs will continue to be posted in the NIH
  Guide for Grants and Contracts.
• NIH will continue to use the terms Requests for
  Applications (RFAs) and Program Announcements
  (PAs), but all grants solicitations will be
  referred to as FOAs in Grants.gov.

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Current Funding OpportunityAnnouncements (FOAs)

• NCIs NCI on other ICs NIHs
• R03 FOAs 7 15 83
• R21 FOAs 33 39 170
• R01 FOAs 27 45 225

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(No Transcript)
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Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle

Type NCAB ALL NIH CA 1o CA 1o 2o
         
R03 Jan-05 1237 125 137
  May-05 1359 154 228
  Oct-05 1353 146 151
  Jan-06 1136 151 157
  May-06 1376 171 225
  Oct-06 1311 165 171
  Jan-07 1099 188 191
  May-07 1081 147 189
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Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle

Type NCAB ALL NIH CA 1o CA 1o 2o
R21 Jan-05 2956 565 672
  May-05 3422 618 798
  Oct-05 3541 497 806
  Jan-06 3607 580 853
  May-06 4044 699 862
  Oct-06 3934 743 913
  Jan-07 3988 785 892
  May-07 4278 793 975
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Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle Numbers of Applications Received per Cycle

Type NCAB ALL NIH CA 1o CA 1o 2o
R01 Jan-05 10297 1476 2017
  May-05 11317 1715 2415
  Oct-05 11160 1601 2339
  Jan-06 10322 1607 2300
  May-06 11494 1671 2489
  Oct-06 10425 1554 2092
  Jan-07 10158 1433 1946
  May-07 10493 1497 2137
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NIH Guide for Grants and Contracts(http//grants1
.nih.gov/grants/guide/index.html)

• Basic Search
• Search For Exact Keyword(s) or Phrase(s)
• Preset Search for
• Active Funding Opportunities Only (RFAs PAs)
• Recent Notices Only (Released in Last 12 Months)
• Both Active Funding Opportunities Recent
  Notices               
• Advanced Search
• Search by number  (e.g. RFA-HL-05-018 or
  PA-05-058)
• Search by title or keyword
• Search matches exact keyword or phrase - Leave
  blank to display all records
• Search by grant mechanism (R01, R21, R03, etc.)
• Separate Multiple Search Terms  with comma  (e.g.
  diabetes,  liver disease,  kidney disease)
• Search for Active and Inactive Announcements

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What is Grants.gov?

• The Federal governments single, online portal
  for any eligible person, business, institution,
  organization, and State, local, or Tribal
  government to electronically find and apply for
  grant opportunities
• A cross-agency initiative involving
• 1000 grant programs
• 26 grant-making agencies
• Over 400 billion in annual awards

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Searching Grants.gov

• To perform a basic search for a grant, go to
  http//www.grants.gov/search/basic.do and
  complete
• Keyword Search
• Search by Funding Opportunity Announcement
  number OR
• Search by Catalog of Federal Domestic Assistance
  (CFDA) number field
• then click the "Search" button.
• For the Advanced Search capability, go to
  http//www.grants.gov/search/advanced.do

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NCIs Catalog of Federal Domestic Assistance
(CFDA) Numbers and Categories

• 93392 Cancer Construction
• 93393 Cancer Cause and Prevention
• 93394 Cancer Detection and Diagnosis
• 93395 Cancer Treatment
• 93396 Cancer Biology
• 93397 Cancer Centers Support
• 93398 Cancer Research Manpower
• 93399 Cancer Control

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Using Standard Forms to Apply through Grants.gov
is a Very Different Model

• The application form and instructions (i.e., for
  the SF424 (RR)) will now be part of a package
  that NIH posts on Grants.gov along with each FOA
  a direct link to this package can also be found
  on the first page of the FOA in the NIH Guide
• After downloading a free PureEdgeTm (or
  soon-to-arrive replacement) software package onto
  their desktops (or utilizing the system-to-system
  software of a third-party provider), applicants
  can download the application package for the
  specific FOA from within Grants.gov

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Features of the SF424 (RR)

• SF424 (RR) Components include
• SF424 (RR)An application cover component
• RR Project/Performance Site Location(s)
• RR Other Project Information
• RR Senior/Key Person
• RR Budget
• RR Personal Data (NIH does not use)
• RR Subaward Budget Attachment Form
• SBIR/STTR-specific Information (where applicable)

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Modifications of SF424 (RR) Grant Application
Package for NIH

• NIH requires additional data collection to
  accommodate the unique information required for
  review of its biomedical research portfolio.
• In addition to the standard components, the
  following agency specific components will be
  used by NIH as part of our application package
• PHS 398 Cover Letter File
• PHS 398 Cover Page Supplement
• PHS 398 Research Plan
• PHS 398 Modular Budget
• PHS 398 Checklist

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Preparing for eSubmission Registration with
Grants.gov

• Applicant institutions must complete a
  one-time-only registration
• Detailed instructions at http//grants.gov/GetStar
  ted
• Grants.gov registration requires institutions to
• Obtain a DB Data Universal Numbering System
  (DUNS) number and
• Register in Central Contractor Registry (CCR)
• Registration not required to find funding
  opportunities or to download application
  packages, only to submit completed grant
  applications

It is critical for institutions to begin this
registration process at least 4 weeks before
applications are due!
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Preparing for Submission Registration with eRA
Commons

• Applicant institutions must complete one-time
  only registration
• PIs must work through their institutions to
  register
• PIs currently registered only for
  Internet-Assisted Review (IAR) must work through
  their institutions for full Commons registration

It is critical for institutions and applicants to
begin this registration process at least 4 weeks
before applications are due!
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Find FOA in NIH Guide or on Grants.gov, then
download application package by clicking button
on first page

• Program Announcement (PA) Number PA-07-298
• For Assistance downloading this or any Grants.gov
  application package, please contact Grants.gov
  Customer Support at http//grants.gov/CustomerSupp
  ort

APPLY FOR GRANT ELECTRONICALLY
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Find FOA in NIH Guide or on Grants.gov, then
download application package by clicking button
on first page

• Program Announcement (PA) Number PA-07-298
• For Assistance downloading this or any Grants.gov
  application package, please contact Grants.gov
  Customer Support at http//grants.gov/CustomerSupp
  ort

APPLY FOR GRANT ELECTRONICALLY
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Electronic Receipt How It Works

• Applying for Grants at Grants.gov
• After finding the funding opportunity on
  Grants.gov, the applicant
• Step 1 Downloads the grant application package
  (PureEdgeTm or replacement software or uses a
  system-to-system package required to view)
• Step 2 Completes the grant application (with
  prior use of pdf conversion software for
  attachments)
• Step 3 Submits the application to Grants.gov
  (through Authorized Organizational Representative
  AOR) by 500 PM on the receipt deadline date
• Step 4 Tracks status of the submitted
  application (e.g., notification of retrieval by
  NIH) -- fixes errors, if necessary, and resubmits

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Electronic Receipt How It Works

• Applying for Grants (continued) the applicant
• Step 5 Waits for electronic Research
  Administration (eRA) software to check the
  application against NIH business rules
• Step 6 Receives notification (with simultaneous
  notification of AOR) via email to check eRA
  Commons for results of NIH rule-checking
• Step 7 Sees errors and warnings (if application
  does not pass NIH rules), then
• fixes errors, and AOR resubmits entire
  application to Grants.gov

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Electronic Receipt How It Works

• Applying for Grants (continued) the applicant
• Step 8 Sees SF424 (RR)-based grant image appear
  (if it passes NIH rules), and,
• If acceptable to PI and AOR, AOR verifies
  application in Commons and
• Step 9 Knows that data and grant image have been
  saved, and that the application will be processed
  by NIH staff.

Grant image becomes available to NIH staff and to
assigned peer reviewers Applicant can follow
progress of application via the NIH eRA Commons
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Generic Validations of eApplications

• Means that NIH can automatically
• Check for type of application
• Match to prior application(s) when applicable
• Check numbers of resubmissions (amendments)
• Verify and match DUNS number and Commons ID(s)
• Check Exception and Assurance numbers
• Ensure one page limit for project summary
• Ensure one page Introduction for resubmissions
• Ensure adherence to other page limitations
• Check budgets for basic eligibility and accuracy
• Verify presence of components of Research Plan
• Check for Inclusion Plans, Clinical Trials, etc.
  and
• Check for other required elements.

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Receipt Referral of Electronic Applications

1. CSR electronically receives assigns
   applications using IMPAC II
2. NCI releases refers applications electronically
   using the Referral Module of the Workbench
   system and
3. Weekly, PCRB sends emails to Cancer Activity
   Point of Contact listing all applications
   awaiting action that were referred the previous
   week.

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Advantages of eReceipt and eReferral of
eApplications

• CSR will no longer have to receive and physically
  process paper copies of grant applications
• CSR Project Control Staffers will process all
  applications electronically
• Applications should be more complete and error
  free
• CSR Referral Officers and NCI (and other IC)
  Referral Officers will view and assign
  applications only electronically (with eventual
  use of IT knowledge management tools and easier
  identifications of duplicate applications).

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eReview of Grant Applications

• Means that
• CSR and NCI scientific review administrators will
  no longer have to deal with printing/copying/maili
  ng paper grant applications
• Peer reviewers will generally not receive paper
  copies of grant applications to read and
  critique
• Internet-Assisted Review (IAR) will hopefully
  improve the efficiency of the peer review
  process and
• Applicants will be able to more easily check
  milestones for their applications.

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Clearance for Application Submission with Use of
Awaiting Receipt of Application (ARA) through
Workbench

• Reasons for use of ARA include
• Unsolicited R01 applications requesting greater
  than 2.5M direct costs (d.c.) for any year
  (Executive Committee EC approval required)
• P01 applications requesting greater than 6.0M
  d.c. for any year (EC approval required)
• Applications (new, revised, type 2) requesting gt
  or 500,000 d.c. for any year, but lt2.5 M for
  an R01 or lt6.0M for a P01
• Locus of review should be NCI (Provide
  justification in 'ARA Justification' Box)
• Application with special programmatic interest
• Late receipt.

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Adjustments to Applications with Use of the 901
Form

• 901 form is available in two electronic formats
  on the DEA intranet site (http//deaintranet.nci.n
  ih.gov/form901/).
• 901 form is used for the following purposes
• To Change Study Section
• From CA to another IC or CSR
• To CA from another IC or CSR
• To Change Council Date
• To Change Application Number and
• To Withdraw or Return an Application.
• (A 901 function is being developed for the
  Workbench.)

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The 901 Form is Not Used

• To correct a P.I.s name
• To change the institution
• To change an SRG within CSR
• To change an FOA number and
• To change anything not listed on the 901 form.

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Where to Go for Help

• General information on Electronic Submission and
  the SF424 (RR)
• Visit http//era.nih.gov/ElectronicReceipt
• Forms transition and questions on NIHs overall
  plan for electronic receipt
• Visit GrantsInfo.gov
• E-mail grantsinfo_at_nih.gov
• Phone [phone]
• eRA Commons registration and post submission
  questions on Commons functionality
• Visit http//era.nih.gov/commons/index.cfm
• E-mail commons_at_od.nih.gov
• Phone [phone] or 301-402-7469
• Grants.gov registration and submission questions
• Visit http//www.grants.gov/CustomerSupport
• E-mail support_at_grants.gov
• Phone [phone]

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Thanks for Listening!

• My contact information
• Christopher L. Hatch, Ph.D.
• Chief, Program Coordination and Referral Branch
• Division of Extramural Activities
• National Cancer Institute
• 6116 Executive Boulevard, Room 8047
• Bethesda, MD 20892-8329
• Rockville, MD 20852 (for express delivery)
• Telephone [phone]
• Fax [phone]
• E-mail ch29v_at_nih.gov or ncirefgrp_at_mail.nih.gov