October 2015 electronic Research Administration (eRA) OER, OD, National Institutes of Health

Sheri Cummins  Office of Extramural Research (OER) Communications & Outreach Chief, Grants Information  Jessie Floura  Electronic Research Administration (eRA) Customer Relationship Manager  2

Submission Options Prepare to Apply & Register Process Overview Walk-through the Submission Process Demo & Discussion  Downloadable Forms  ASSIST Finding Help & Resources 3

Grantee and Organization Changes Reference Letters Program-specific Considerations Submission Policies Additional Questions & Wrap-up 4

ASSIST SYSTEM-TO-SYSTEM DOWNLOADABLE FORMS 5 You've got to think about big things while you're doing small things, so that all the small things go in the right direction. -Alvin Toffler

Required for  All competing single and multi-project grant applications Encouraged for  Single-project applications in response to:  Administrative Supplements - Type 3  Change of Organization Status – Type 6  Change of Grantee Organization – Type 7 Not yet available for  Merit extensions – Type 4  Multi-project applications in response to:  Administrative Supplements - Type 3  Change of Organization Status – Type 6  Change of Grantee Organization – Type 7 6

7 Downloadable Forms* System-to-System ASSIST * Single-project only

Key features  Online data entry  Multiple user access  Pre-submission verification of application against many agency and Grants.gov business rules  Pre-submission preview of assembled application image in agency format  Tracking application status within single system Considerations  All ASSIST users working on an application must have eRA Commons accounts 8

Available for all multi-project programs Support expanding to single-project programs in 2015  NIH Guide notices will announce ASSIST availability for each set of activity codes once in place 9 Timeline:

Key features  Offline data entry  Especially good option when Internet connectivity is unreliable  No registration required to begin application data entry Considerations  Single-project applications only  Requires a Grants.gov compatible version of Adobe ReaderGrants.gov compatible version of Adobe Reader  Applicants must track the application status in separate eRA Commons system after submitting to Grants.gov  No pre-submission verification of application against agency business rules  Unable to preview assembled application image in agency format prior to submission  Data entry access restricted to one user at a time 10

Key features  Features vary by solution  Some integrate with institutional databases and grant systems  Some provide pre-submission verification of application against agency business rules  Some provide pre-submission preview of assembled application image in agency format Considerations  Consult your institutional officials for preferred method of submission 11

Subject to the same registration requirements Completed with the same data items Routed through Grants.gov Validated against the same NIH business rules Assembled in a consistent format for review consideration Tracked in eRA Commons 12 …regardless of submission option used.

SOFTWARE NEEDED REGISTRATIONS 13 Success depends upon previous preparation, and without such preparation there is sure to be failure. -Confucius

Browser  Internet Explorer, Mozilla Firefox – fully supported & tested  Many others work fine Adobe Reader  Versions compatible with Grants.gov downloadable forms  support/recommended-software.html support/recommended-software.html PDF conversion program  All application attachments must be converted to PDF format 14

Allow a minimum of 6 weeks to complete all registrations! 15

A free nine-digit identification number issued by Dun & Bradstreet (D&B) is used to uniquely identify your business/ institution Dun & Bradstreet Data Universal Numbering System (DUNS)  Begin the process at:  After obtaining your DUNS, you can begin other registrations  System for Award Management (SAM)  eRA Commons  SBA Company 16 Telephone Number: Telephone Number:

Register your entity (i.e., organization) to do business with the Federal Government Designate an E-Business Point-of- Contact (E-Biz POC) SAM registration and E-Biz POC needed for Grants.gov registration Annual SAM renewal needed to keep Grants.gov credentials active 17 Telephone Numbers: US Calls: International Calls: DSN: Telephone Numbers: US Calls: International Calls: DSN:

Federal-wide portal to find and apply for Federal grant funding Used by all 26 Federal grant-making agencies Prior to registering in Grants.gov you must obtain a DUNS number and register in SAM E-Biz POC approves Authorized Organization Representatives (AORs) to submit applications No registration needed to find opportunities or download forms 18 Telephone Numbers: US Calls: International Calls: Telephone Numbers: US Calls: International Calls:

Agency system that allows applicants, grantees and Federal staff to share application/grant information Used by NIH and a few other HHS divisions Designate a Signing Official (SO)  Registers or affiliates Project Directors/Principal Investigators (PD/PIs) and other users NIH 2-week “good faith effort” for eRA Commons registration 19 Support: Support:

Organizations must register in eRA Commons Already registered?  Check with your Administrative Office before starting the process  Quick Query: New registrations  Institution Registration Form: ns.jsp ns.jsp  Carefully follow ALL steps including printing/signing/faxing registration page and responding to verification messages 20

During Commons registration, an applicant organization designates a Signing Official (SO)  SO has authority to legally bind the organization in grants administration matters  Equivalent to the Authorized Organization Representative (AOR) in Grants.gov  SO is responsible for:  maintaining institutional information  submitting documents that require signature authority to act on behalf of the organization  managing accounts 21

Designate more than one Signing Official  Certain Commons actions can only be taken by users with the SO role and you will want a back-up Administrators should always check to see if a user already has a Commons account before creating a new account with a scientific role  Ask the person if they already have an account, or search within the Commons  If a user already has an account with a different organization, the SO should affiliate the existing account with the user’s new organization 22

Don’t combine administrative and scientific roles (e.g., SO and PI) on the same account  Other combinations are fine  E.g., PI and Internet Assisted Review (IAR) roles are OK together  A person needing both the PI and SO roles should have two separate accounts - one for scientific roles (e.g., PI and IAR) and another for administrative roles (e.g., SO, AO) PIs should update their Commons profile prior to submitting  E.g., degree info used to determine Early Stage Investigator eligibility Log in to accounts prior to deadline to ensure you have access to the systems 23

At least 1 Signing Official (suggest having back-ups) PD/PI(s) Sponsor on a Fellowship application (NOT-OD )NOT-OD Component leads of multi-project applications Candidates for diversity supplement support Anyone doing application data entry in ASSIST 24

All SBIR and STTR applicants are required to register with the Company Registry Database Applies to all HHS SBIR/STTR programs, including NIH, CDC, FDA, and ACF Attach proof of registration in the Other Attachments section of the Other Project Information form  See section IV.2 of your FOA instructions for details 25 FAQs: FAQs:

26 RegistrationOrganizationIndividuals DUNSAll SAMAllE-Biz POC* Grants.govAllE-Biz POC Authorized Organization Representative (AOR) eRA CommonsAllSigning Official (SO)* PD/PI Multi-project Component Leads Fellowship Sponsor Diversity Supplement Candidate Data Entry in ASSIST SBASmall Business Only *Designated as part of organization registration

27 Find Enter Data Submit Plan Track Finalize Initiate Build Team

FINDING OPPORTUNITIES PARENT ANNOUNCEMENTS FUNDING OPPORTUNITY ANNOUNCEMENTS APPLICATION INSTRUCTIONS 28 Find Track PlanInitiate Build Team Enter Data FinalizeSubmit

29 NIH Guide for Grants & Contracts Grants.gov Search Opportunity Each system has robust search capabilities.

Funding Opportunity Announcement (FOA) A publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds.  Specific types of NIH FOAs include:  Parent Announcement  Program Announcement (PA) PA with special receipt, referral, and/or review considerations (PAR) PA with set-aside funds (PAS)  Request For Application (RFA) 30

Used for investigator- initiated research. Select Parent FOA for your chosen grant program (i.e. R01, R03, R21, etc.). 31

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33 Standard Due Dates Standard AIDS Due Dates Check for FOA updates & new policy guidance

Read and follow all announcement instructions Pay special attention to Section IV. Application and Submission Information  Includes FOA-specific submission instructions  Instructions in FOA supersede instructions in the application guide 34

Read and follow application guide instructions  Part I: Instructions for Preparing and Submitting an Application Agency-specific instructions are marked with the HHS logo 35

Be sure to select the appropriate application guide for your opportunity  Based on type of grant program  General Application Guide SF424 (R&R)  SBIR/STTR Application Guide SF424 (R&R)  Individual Fellowship Application Guide SF424 (R&R) Will be rolled into general guide in November 2015 Become familiar with what is included in the application guide, then use it as an electronic resource 36

Refer to Supplemental Instructions as needed  Part II: Supplemental Instructions for Preparing the Protection of Human Subjects Section of Research Plan  Part III: Policies, Assurances, Definitions and Other Information 37

MAKE A SUBMISSION PLAN 38 Track Find Initiate Build Team Enter Data FinalizeSubmit Plan

39 Make a plan before you need one! Read the FOA and note any special requirements Agree on application preparation responsibilities Decide how you will share applications in progress Discuss your internal review & approval process  Set internal deadlines Define post-submission responsibilities  How to deal with errors/warnings  Who will verify application in Commons?

INITIATE APPLICATION BASED ON SUBMISSION OPTION 40 Track Find PlanInitiate Build Team Enter Data FinalizeSubmit

Excerpt from single-project FOA in NIH Guide… 41

42 Track Find PlanInitiate Enter Data FinalizeSubmit Build Team

Signing Official (eRA Commons) Authorized Organization Representative (Grants.gov) Project Director/Principal Investigators (PD/PIs) Others?  Administrative Official  Sponsor  Mentor  Collaborator  Assistant  Someone with review experience 43

SF424 (R&R) DATASET TIPS 44 Enter Data Track Find PlanInitiate Build Team FinalizeSubmit

NIH uses the SF424 Research & Related (R&R) data set  Owned and maintained by Grants.gov NIH applications include:  Forms used federal-wide  Identified as: R&R, Research & Related  NIH cannot build agency-specific business rules into federal-wide forms  Forms used only by NIH and our serviced partners  Identified as: PHS for Public Health Services 45

SF424 (R&R) Project/Performance Site Location(s) R&R Other Project Info R&R Sr/Key Person Profile (Expanded) R&R Budget R&R Subaward Budget Attachment SF424C – Construction Budget SBIR/STTR Information 46

PHS 398 Cover Page Supp. PHS 398 Modular Budget PHS 398 Research Plan PHS 398 Checklist PHS 398 Career Dev. Award Supp. PHS Fellowship Supp. Form PHS 398 Research Training Program Plan PHS 398 Training Budget Training Subaward Budget Attachment Form Planned Enrollment Report Cumulative Inclusion Enrollment 47 Our agency-specific forms expired Sept We anticipate having updated application forms (FORMS-D) in place for due dates on or after May 25, For now, continue to use current forms (FORMS-C). NOT-OD

Follow FOA-specific (e.g., special attachments, specific section headings) and application guide requirements  eRA systems will catch many, but not all errors – some items are checked by staff post-submission  FOA-specific requirements are not typically system-enforced  Applications that do not comply with the instructions may be withdrawn from consideration Take advantage of posted ‘Additional Format Pages’ 

Whether or not an attachment is required is often based on how you answer specific application questions  Examples:  Human Subjects = Yes, then Human Subjects section of the PHS 398 Research Plan required  Vertebrate Animals = Yes, then Vertebrate Animals attachment is required  More than one entry on the R&R Sr/Key Person Profile form with the role of “PD/PI,” then the Multiple PD/PI Leadership Plan attachment on the PHS 398 Research Plan form is required 49

50 Annotated form sets are a great resource for helping identify many conditional requirements. Annotated form sets:

Use simple PDF-formatted files  Do not use Portfolio or similar features to bundle multiple files into a single PDF  Disable security features such as password protection and encryption Keep file names to 50 characters or less Use meaningful filenames  Other Project Information form, Other Attachments section  Appendices Do not include headers or footers  Section headings as part of the text (e.g., Significance, Innovation, Approach) are encouraged Follow guidelines for fonts and margins 51 PDF Guidelines:

52 Find page limits in: Table of Page Limits FOA text

53 Track Find PlanInitiate Build Team Enter Data FinalizeSubmit

Give your application one last good check Obtain internal approvals If using ASSIST, update application status from Work In Progress to Ready for Submission 54

SUBMITTING YOUR APPLICATION ON-TIME SUBMISSION 55 Track Find PlanInitiate Build Team Enter Data FinalizeSubmit

All NIH Applications Route Through Grants.gov regardless of submission option Only AOR’s can submit Your Grants.gov timestamp is used to determine “on-time” submission 56 Date/Time Stamp - due 5 p.m. local time of the applicant organization on deadline date even though timestamp recorded in Eastern Time

Error-free applications must be accepted by Grants.gov with a time stamp on or before 5:00 p.m. local time of the submitting organization on the due date. Important reminders: NIH recommends submitting early (days, not minutes!) to allow time for correcting any errors found during the application viewing window prior to the due date NIH’s late policy does not allow corrections after the due date/time All registrations must be completed before the due date/time 57

58 Application Successfully submitted to NIH Submitting to Grants.gov is NOT the last step in the process!

NOTIFICATIONS TRACKING YOUR APPLICATION IN ERA COMMONS VIEWING YOUR APPLICATION IN COMMONS REJECTING AN APPLICATION SUBMISSION COMPLETE – HAPPY DANCE! 59 Find PlanInitiate Build Team Enter Data FinalizeSubmit Track

AOR receives Grants.gov s  Submission Receipt  Grants.gov verifying receipt of application  Submission Validation  Grants.gov verifying successful submission to Grants.gov  OR rejection due to errors  Transmission to Agency  sent once agency retrieves submission  sent when agency tracking number assigned Sent to address on file for submitting AOR 60

eRA Commons Status is an integral part of electronic application submission  Applications that pass Grants.gov validations are picked up by eRA Commons and checked against application guide and opportunity instructions  Processing result available in eRA Commons Status to:  Signing Officials (SOs)  Administrative Officials (AOs)  Principal Investigators (PIs)  Delegated assistants  notifications sent 61

eRA s  Check assembled application  Check assembled application – Warnings only  ACTION REQUIRED – Errors and/or Warnings  ACTION REQUIRED– Missing or invalid eRA Commons Username (only sent to AOR/SO)  ACTION REQUIRED– System Error  SO has refused electronic application (rejected)  NIH has auto-verified the application (after 2-day viewing window) Sent to the AOR/SO, PD/PI and contact s listed on SF424 (R&R) form 62

Many notifications are sent throughout the process  DO NOT depend solely on notifications, it is YOUR responsibility to proactively check your application status in eRA Commons 63

64 eRA Commons:

65 Select Recent/Pending eSubmissions Or provide Grants.gov tracking number from confirmation screen or notification

66 Indicates eSubmission Error Grants.gov tracking #

Errors stop application processing and must be corrected Warnings do not stop application processing and are corrected at the discretion of the applicant 67

To correct system-identified errors found after submission: Make corrections to local copy of the application Update SF424 (R&R) form  Check “Changed/Corrected” as “Type of Submission”  Enter “Previous Grants.gov Tracking ID” (e.g., GRANT ) in field 4c Submit the entire Changed/Corrected application back through Grants.gov before the deadline Track submission through to eRA Commons 68 NOTE: Reviewers do not see applicant errors/warnings.

Once an error-free application is received by NIH, the eRA system will:  Assemble the grant application image  Insert headers (PI name) and footers (page numbers) on all pages  Generate Table of Contents and bookmark important sections  Post the assembled application image in the PD/PI’s eRA Commons account  Send notifications 69

Applicants have two (2) business days to view the assembled application image before the application automatically moves forward for further processing SO can Reject application within viewing window and submit a Changed/Corrected application before the submission deadline 70 If you can’t VIEW it, we can’t REVIEW it!

71 Status is Pending Verification Follow e-Application link to view assembled application image Application ID links to detailed status info View Appendices and Cover Letter

72 TIP: Carefully review the entire application. This is your chance to view/print the same application image that will be used by Reviewers!

73 Must have SO role Select Recent/ Pending eSubmissions Click Search Enter Search Criteria PIs: If the application image in the eRA Commons does not properly reflect the submitted material, work with your SO to reject the application!

74 Enter comment to be sent with notification

If no action is taken during the two business day viewing window, the application automatically moves forward for further processing at NIH Any subsequent application changes are subject to the NIH policy on late submission of grant applications and the NIH policy on post-submission application materials 75

SERVICE DESKS ON-LINE RESOURCES &WEB SITES 76

eRA Commons Service Desk eRA Commons Service Desk Grants.gov Contact Center Web: pport/index.html pport/index.html Phone: Hours : Mon-Fri, 7a.m. to 8 p.m. ET Toll-free: Hours : 24x7 (Except Federal Holidays) Help Resources: eb/grants/support.html eb/grants/support.html 77 ASSISTeRA Commons eRA Commons Registration eRA warnings & errors Status of applicationPost-award administration Contact for assistance with:

eRA Commons: Electronic Research Administration: Applying Electronically: NIH About Grants:

eRA-Information-L  For administrators, principal investigators and the people that support them  Used by NIH to notify the community of information related to eRA Commons, ASSIST and eSubmission NIH_ESUB_SYS2SYS-L  For technical personnel involved in system-to-system solution development and planning  Used to exchange information related to the implementation of system-to-system solutions for grant application preparation and submission to NIH 79

INITIATE APPLICATION MANAGE ACCESS FORM NAVIGATION & DATA ENTRY PRE-SUBMISSION VALIDATION PRE-SUBMISSION PREVIEW TRACKING SUBMISSION STATUS 80 Slides are for notes only & will be covered during demo.

Excerpt from single-project FOA in NIH Guide… 81

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83 FOA information pulled from Grants.gov Enter Project Title Drop-down list of organizations affiliated with your eRA Commons account

84 Data pre-populated from organization selection Can manually enter PD/PI information or provide eRA Commons username to auto-populate

85 Use Search Applications to access your in progress application

86 ASSIST messages Screen tips Access online help Available actions vary based on application context and access Form navigation

ASSIST automatically provides application access to some individuals based on their Commons roles or role on the application Examples:  Users with Commons accounts that have the Signing Official (SO) or Administrative Official (AO) role have access to all applications for their organization  All PD/PIs listed in the Overall component of the application have edit access for the entire application 87

Application access can be given to additional users with Commons IDs Application access can be controlled across these variables:  Read vs. Edit  Budget vs. Non-budget data  Entire application vs. specific components (multi-project) 88

SOs at the applicant institution can  Manage application access for other users  Manage application status  Delegate Access Maintainer and Status Maintainer authority to other users within their institution  Access the Submit action 89

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91 Click each tab to access form data entry screens Clicking Edit blocks other users from editing form

92 Select form and click Submit The form tab is added to navigation

93 Errors and Warnings are displayed

94 View last preview Generate new preview

95 Submit Application button is only active for SOs Must be an eRA SO and a Grants.gov AOR to submit.

96 Click View Submission Status Details 96

97 Happy path… ASSIST = Submitted Grants.gov = Agency Tracking Number Assigned Agency = Processed Agency Tracking # link brings you to the detailed status screen in eRA Commons

98 eApplication is the application image reviewers will use so check it carefully. Also check the Cover Letter and Appendices which are stored separate from the image.

GRANTS.GOV DOWNLOADABLE FORMS AVOIDING COMMON ERRORS 99 Slides are for notes only & will be covered during demo.

Excerpt from single-project FOA in NIH Guide… 100

101 Sign up for alerts of application package changes Use links to download application instructions and forms package

102 Make sure you have the correct application package. FOA information is automatically populated and not editable. Mandatory Grants.gov fields highlighted with red box. Not all fields required by NIH will be highlighted. *Application Form Screen - Top*

103 *Application Form Screen - Bottom* Complete the SF 424 (R&R) form first—info from this form pre-populates fields in other forms in the package See application guide to determine which Optional forms you need to complete Save the package locally

104 Check Package for Errors button only checks to make sure the application meets Grants.gov requirements. Agency requirements checked upon submission. Save & Submit button will not become active until application is saved and mandatory information is completed. Must be AOR

105 Grants.gov Tracking # Date/Time Stamp - due 5 p.m. local time of the applicant organization on deadline date Print/save your confirmation screen info.

106 Slides are for notes only & will be covered during demo.

DUNS number on the SF424 (R&R) cover form must match the DUNS number used for Grants.gov & Commons registrations 107

Primary site DUNS is required by NIH and is enforced with an agency validation 108

Provide correct Type of Submission (#1), Federal Identifier (#4), and Type of Application (#8) information on the SF 424 (R&R) cover form 109 Use Application for first submission attempt for the same deadline Use Changed/Corrected when submitting again to correct eRA-identified errors/warnings If Changed/Corrected in field #1, then enter previous Grants.gov tracking number

110 Federal ID & Types of Applicationis If Resubmission/Renewal/Revision in field #8, use Institute and serial # of previous NIH grant/app (e.g., use CA from 1R01CA ) See Application Guide for definition of application types

Type of Application on SF424 (R&R), field #8 111 TermNotes New An application that is submitted for funding for the first time and includes no references to a prior review. (Type 1; A0) Renewal Competing for additional years of funding to continue original project. (Type 2) Revision Request for additional funds for a current award to expand the scope of work. Applicants should contact the awarding agency for advice on submitting any revision/supplement application. (Type 3) Resubmission Application previously reviewed. A revised or amended application that addresses reviewer feedback. (A1) Continuation NIH does not use the SF 424 (R&R) for Continuation applications. (Type 5; progress reports for simplified non-competing (SNAP) applications are submitted directly to eRA Commons; for others, paper apps. are still submitted.)

Include the eRA Commons ID in the Credential field of the R&R Sr/Key Person Profile form for all PD/PIs  Also needed for:  Sponsor on a Fellowship application (NOT-OD )  Component leads of multi-project applications  Candidates for diversity supplement support If submitting a Multiple-PD/PI application, give all PIs the PD/PI role on the Sr/Key Person Profile form 112

113 Enter PI Commons Username eRA Commons username must be supplied in the Credential field For multiple PD/PI applications, select the PD/PI role for each PI and provide their eRA Commons username in the Credential field Enter PI Commons Username Select PD/PI role for each PI

Include Organization name for all Sr/Key listed on the R&R Sr/Key Person Profile (Expanded) form 114 Organization Name PD/PI Organization will auto-populate from SF424 (R&R) cover if available. NIH requires the Organization name for all Sr/Key listed. Enter Organization Name

Include a biosketch for every Sr/Key entry in correct format 115 Biosketch required for all, but only marked required on the federal-wide form for the PD/PI.

Include effort > 0 for all Sr/Key personnel listed on the R&R Budget form  Use either calendar months or a combination of academic and summer months  PD/PI must have effort >0 for every budget period 116

SUBMITTING A CHANGE OF GRANTEE OR TRAINING INSTITUTION REQUEST (TYPE 7) USING GRANTS.GOV SUBMITTING A CHANGE OF ORGANIZATION STATUS/SUCCESSOR IN INTEREST (TYPE 6) REQUEST USING GRANTS.GOV SUBMITTING AN ADMINISTRATIVE SUPPLEMENT REQUEST USING GRANTS.GOV 117

Also known as Change of Institution or transfer. Request for support of a funded project that has been transferred from one grantee or training institution to another Current submission options:  Grants.gov downloadable forms  Institutional system-to-system solutions 118

Formerly known as Successor-In- Interest. Request for support of a funded project at an institution where the legal status has been changed Current submission options:  Grants.gov downloadable forms  Institutional system-to-system solutions 119

Available for post-award requests for single- project activity codes for which competing applications are submitted through Grants.gov Though not yet required, applicants are encouraged to use and become familiar with the electronic option Talk to your awarding Institute prior to submission 120

Parent Announcement page has general use FOAs  tm#post tm#post When completing package…  Follow all FOA-specific instructions  Carefully choose appropriate application package  Use Revision as the Application Type (SF424 RR, item #8)  Include IC and Serial number of awarded grant as the Federal Identifier (SF424 RR, item #4a) 121

Similar to competing application process, except:  Many of the NIH business rule validations for competing applications are not enforced  Required forms may vary from competing applications  Modular budget forms not an option; must use detailed R&R Budget forms  No cover letters  Type 6 Only a few required forms SF424 (R&R) cover, Other Project Information, SR/Key Information Optional forms vary by program  Type 7 Budget forms added to some form packages (e.g., DP1, DP2, DP3) 122

 After the two-day viewing window, the request bypasses Receipt & Referral and goes directly to Grants Management staff for consideration  Requests move to List of Applications for PIs and General Search (for SOs) like competing applications 123

NOT-OD  Notice of Pilot Processes for Submitting of Post-Award Relinquishing Statements to NIH NOT-OD  Notice of Pilot for Processing Post-Award Changes in Grantee Organizational Status: Successor-in-Interest NOT-OD  Notice of Pilot Processes for Post-Award Change of Grantee Organization Applications to NIH 124

A request for additional funds during a current project period to provide for an increase in costs due to unforeseen circumstances. Requested additional costs must be within the scope of the peer reviewed and approved project Current submission options:  Grants.gov downloadable forms 1  Streamlined eRA Commons process 1  Commons pre-populates much of the data needed for request from awarded grant  Institutional system-to-system solutions 1  Paper process Available for single-project activity codes for which competing applications are submitted through Grants.gov.

Parent Announcement page has general use FOAs  tm#adminsupp tm#adminsupp  NIH Institutes can also post FOAs for administrative supplements targeting specific programs When completing package…  Follow all FOA-specific instructions  Carefully choose appropriate application package  Use Revision as the Application Type (SF424 RR, item #8)  Include IC and Serial number of awarded grant as the Federal Identifier (SF424 RR, item #4a) 126

Similar submission process as competing applications, except:  Many of the NIH business rule validations for competing applications are not enforced  Required forms may vary from competing applications for the same activity code  Modular budget forms not an option; must use detailed R&R Budget forms  No cover letters  After the two-day viewing window the request bypasses Receipt & Referral and goes directly to Grants Management staff for consideration  Move to Admin Supp Status tab in Commons 127

NOT-OD  New Electronic Submission Process Now Available for Administrative Supplement Requests 128

REFERENCE LETTERS 129

Some NIH grant programs require the submission of reference letters in addition to the grant application (e.g., Fellowship & Mentored Career Development programs) NOT part of the application through Grants.gov Submitted directly by the referee through eRA Commons Commons registration not required Can be submitted in advance of application submission Due by the application due date/time Applicants can track the submission of reference letters in the Commons, but cannot view the actual letter With FORMS-C, Fellowship reference letters no longer have a required format – just a letter 130 FAQs:

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FELLOWSHIP CAREER DEVELOPMENT TRAINING MULTI-PROJECT APPLICATIONS 132

Program-specific considerations Use Fellowship-specific Application Guide Designate Sponsor on the R&R Sr/Key Person Profile form  Select Role of “Other”, then indicate “Sponsor” in Other Role category  Include eRA Commons username in Credential field Cover Letter is required  Include list of referees that will submit reference letters through Commons Complete PHS Fellowship Supplemental Form 133

Notice to Emphasize the Requirement for Additional Educational Information  NOT-OD (Parent F31 – Diversity) NOT-OD  NOT-OD (Parent F31) NOT-OD  NOT-OD (F30) NOT-OD Notice to Discontinue Requirement for Additional Educational Information  NOT-OD (Parent F32) NOT-OD Sponsor eRA Commons Username Requirement  NOT-OD NOT-OD

(Ks, except K12 and KM1) Program-specific considerations PHS Cover Letter form is required for mentored Ks (K01, K07, K08, K18, K22, K23, K25, K99)  Include list of referees that will submit reference letters through eRA Commons Complete PHS 398 Career Development Award Supplemental form 135

136 Combined page limit

NOT-OD  Notice of Clarification of Career (K) Award Eligibility  Clarification related to Foreign Components NOT-OD  Notice of Clarification of 4-Year Limit of Postdoctoral Research Eligibility for K99 137

(Ts, Ds, K12 & KM1) Program-specific considerations Budget form used varies by FOA  Training Budget Only  T15, T32, T34, T35, T36  R&R Budget Only  K12, T37, KM1 D71, D43, U2R  Dual budgets  T01, T02, T03, T14, T42, T90, TU2 Complete PHS 398 Research Training Program Plan Data Tables – user defined bookmarks included in the attachment will be pulled into application image 138

139 Combined page limit Faculty Biosketches Data Tables

Single grant application submission with multiple, interrelated components with defined work, personnel, sites and budgets that share a common focus or objective. All electronic multi-project applications include:  A single Overall component  Some number of additional components  Automatically prepared data summaries 140

Multi-Project Application: Overall Component 141 Core-001 Project Title: Research Core 1 Project Lead: Ben A. Round Organization: A Project Title: Research Core 1 Project Lead: Ben A. Round Organization: A Core-002 Project Title: Research Core 2 Project Lead: Abel Tu Lead Organization: B Project Title: Research Core 2 Project Lead: Abel Tu Lead Organization: B Project-003 Project Title: Fabulous Research Focus 3 Project Lead: Ima Doer Organization: C Project Title: Fabulous Research Focus 3 Project Lead: Ima Doer Organization: C Project-002 Project Title: Fabulous Research Focus 2 Project Lead: Quin T. Sential Organization: B Project Title: Fabulous Research Focus 2 Project Lead: Quin T. Sential Organization: B Project-001 Project Title: Fabulous Research Focus 1 Project Lead: Cher D. Money Organization: A Project Title: Fabulous Research Focus 1 Project Lead: Cher D. Money Organization: A Subaward Budget Organization: D Component Type: Project Component Type: Core Admin Core-001 Project Title: Administrative Core Project Lead: Jed I. Knight Organization: A Project Title: Administrative Core Project Lead: Jed I. Knight Organization: A Component Type: Admin Core Overall Component PD/PIs: Cher D. Money, Ben A. Round Organization: A Project Title: Research Center to Cure the Diseases of the World PD/PIs: Cher D. Money, Ben A. Round Organization: A Project Title: Research Center to Cure the Diseases of the World Single Overall component Provides an overview of the entire application Examples: P01, P20, P50

Multi-Project Application: Component Types 142 Core-001 Project Title: Research Core Project Lead: Ben A. Round Organization: A Project Title: Research Core Project Lead: Ben A. Round Organization: A Core-002 Project Title: Research Core 2 Project Lead: Abel Tu Lead Organization: B Project Title: Research Core 2 Project Lead: Abel Tu Lead Organization: B Project-003 Project Title: Fabulous Research Focus 3 Project Lead: Ima Doer Organization: C Project Title: Fabulous Research Focus 3 Project Lead: Ima Doer Organization: C Project-002 Project Title: Fabulous Research Focus 2 Project Lead: Quin T. Sential Organization: B Project Title: Fabulous Research Focus 2 Project Lead: Quin T. Sential Organization: B Project-001 Project Title: Fabulous Research Focus 1 Project Lead: Cher D. Money Organization: A Project Title: Fabulous Research Focus 1 Project Lead: Cher D. Money Organization: A Subaward Budget Organization: D Component Type: Project Component Type: Core Admin Core-001 Project Title: Administrative Core Project Lead: Jed I. Knight Organization: A Project Title: Administrative Core Project Lead: Jed I. Knight Organization: A Component Type: Admin Core Overall Component PD/PIs: Cher D. Money, Ben A. Round Organization: A Project Title: Research Center to Cure the Diseases of the World PD/PIs: Cher D. Money, Ben A. Round Organization: A Project Title: Research Center to Cure the Diseases of the World Some number of additional component types Component types allowed will vary by opportunity Funding Opportunity Announcements (FOAs) will clearly indicate the types of components expected in a responsive application

Multi-Project Application: Components 143 Core-001 Project Title: Research Core Project Lead: Ben A. Round Organization: A Project Title: Research Core Project Lead: Ben A. Round Organization: A Core-002 Project Title: Research Core 2 Project Lead: Abel Tu Lead Organization: B Project Title: Research Core 2 Project Lead: Abel Tu Lead Organization: B Project-003 Project Title: Fabulous Research Focus 3 Project Lead: Ima Doer Organization: C Project Title: Fabulous Research Focus 3 Project Lead: Ima Doer Organization: C Project-002 Project Title: Fabulous Research Focus 2 Project Lead: Quin T. Sential Organization: B Project Title: Fabulous Research Focus 2 Project Lead: Quin T. Sential Organization: B Project-001 Project Title: Fabulous Research Focus 1 Project Lead: Cher D. Money Organization: A Project Title: Fabulous Research Focus 1 Project Lead: Cher D. Money Organization: A Subaward Budget Organization: D Component Type: Project Component Type: Core Admin Core-001 Project Title: Administrative Core Project Lead: Jed I. Knight Organization: A Project Title: Administrative Core Project Lead: Jed I. Knight Organization: A Component Type: Admin Core Overall Component PD/PIs: Cher D. Money, Ben A. Round Organization: A Project Title: Research Center to Cure the Diseases of the World PD/PIs: Cher D. Money, Ben A. Round Organization: A Project Title: Research Center to Cure the Diseases of the World Some number of components within a component type Announcements will clearly indicate the required minimum and/or maximum number of components expected

Subaward Budget Organization: B Multi-project Application Forms 144 Core-001 Project Title: Research Core Project Lead: Ben A. Round Organization: A Project Title: Research Core Project Lead: Ben A. Round Organization: A Core-002 Project Title: Research Core 2 Project Lead: Abel Tu Lead Organization: B Project Title: Research Core 2 Project Lead: Abel Tu Lead Organization: B Project-003 Project Title: Fabulous Research Focus 3 Project Lead: Ima Doer Organization: C Project Title: Fabulous Research Focus 3 Project Lead: Ima Doer Organization: C Project-002 Project Title: Fabulous Research Focus 2 Project Lead: Quin T. Sential Organization: B Project Title: Fabulous Research Focus 2 Project Lead: Quin T. Sential Organization: B Project-001 Project Title: Fabulous Research Focus 1 Project Lead: Cher D. Money Organization: A Project Title: Fabulous Research Focus 1 Project Lead: Cher D. Money Organization: A Subaward Budget Organization: D Component Type: Project Component Type: Core Admin Core-001 Project Title: Administrative Core Project Lead: Jed I. Knight Organization: A Project Title: Administrative Core Project Lead: Jed I. Knight Organization: A Component Type: Admin Core Overall Component PD/PIs: Cher D. Money, Ben A. Round Organization: A Project Title: Research Center to Cure the Diseases of the World PD/PIs: Cher D. Money, Ben A. Round Organization: A Project Title: Research Center to Cure the Diseases of the World “Optional” Forms PHS Additional Indirect Costs Required Forms SF424 (R&R) Project/Performance Sites R&R Other Project Info R&R Senior/Key Persons PHS 398 Cover Page Supplement PHS 398 Research Plan “Optional” Forms R&R Subaward Budget Planned Enrollment Report Cumulative Inclusion Enrollment Required Forms SF424 (R&R) Project/Performance Sites R&R Other Project Info R&R Senior/Key Persons PHS 398 Cover Page Supplement PHS 398 Research Plan R&R Budget

Understand how your application image will be assembled by NIH for funding consideration  The Overall component is presented first  Including system-generated data summaries  Additional component types are presented in alphabetical order (e.g., Cores before Projects)  Components of the same type are grouped together  Components are identified by type and sequential number (e.g., Core-001, Core-002) 145 Check out this resource: project_application_image.pdf project_application_image.pdf

Friday, Oct. 16 2:00-3:15 146

SYSTEM ISSUES DUE DATES ON HOLIDAYS & WEEKENDS LATE POLICY POST-SUBMISSION APPLICATION MATERIALS CONTINUOUS SUBMISSION RULES FOR RESUBMISSIONS EVALUATION OF OVERLAPPING APPLICATIONS APPENDIX POLICY & “OVERSTUFFED” APPLICATIONS 147

148 Keep an eye on the NIH Guide for Grants and Contracts for policy and process updates. Subscribe for weekly s of new postings:

When Grants.gov or eRA system issues threaten your on-time submission…  Contact appropriate support team to try to get resolution  If working with Grants.gov, contact eRA Service Desk to document issue and steps taken toward resolution  If eRA Service Desk confirms a system issue, your application will not be considered late as long as you work diligently with the Service Desk to resolve problems as quickly as possible 149 NIH Guide Notice: NOT-OD

When a submission due date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day. Federal holiday 150

Two-week window of consideration  See notice for exceptions Permission is not granted in advance Late applications are accepted only in extenuating circumstances Cover letter required Evaluated on a case-by-case basis 151 NIH Guide Notice: NOT-OD

NIH will only accept post-submission grant application materials resulting from unforeseen administrative issues for most applications  See Guide Notice for details on acceptable and unacceptable material, exceptions, and page limits  When exceptions do apply, materials must be received at least 30 days prior to the peer review meeting and must be sent by (or with the explicit concurrence of) the AOR 152 NIH Guide Notice: NOT-OD

Alternative submission policy for PD/PIs serving as appointed members of NIH chartered standing study sections, NIH Boards of Scientific Counselors, NIH Advisory Boards or Councils, NIH Program Advisory Committees, and/or peer reviewers who have served as regular or temporary members six times in 18 months Applies to R01, R21, and R34 applications that would normally be received on standard application submission dates (not special receipt dates) 153 Continuous Submission page:

NIH allows a single Resubmission (A1) Applicants must submit Resubmission applications (A1) within thirty-seven (37) months of the initial New, Renewal, or Revision application due date 154 NIH Guide Notice: NOT-OD NIH Guide Notice: NOT-OD

Following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate new application due date 155 NIH Guide Notice: NOT-OD NIH Policy on Resubmission Applications page:

While NIH no longer limits the number of times you can submit an application with essentially the same content and scope as an earlier unsuccessful application, it is not allowable to have overlapping applications under review at the same time. 156 NIH Guide Notice: NOT-OD

Applicants must follow application guide and announcement instructions regarding appropriate appendix materials  Applicants should not use the Appendix section to circumvent page limits  In particularly egregious cases NIH has the authority to withdraw the application from review or consideration for funding 157 Don’t Overstuff: NOT-OD Full Appendix Policy: NOT-OD

Page limit extended from 4 to 5 pages Up to 5 significant contributions to science  Up to 4 relevant peer-reviewed publications or non- publication research products Option to include link to full list of published work Required for due dates on/after May 25, NIH Guide Notice: NOT-OD

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