Sheri Cummins November 2015

ASSIST is NIH's online system for the preparation, submission & tracking of grant applications through Grants.gov to NIH 2 2

Secure web-based data entry Use of eRA Commons credentials already in place for many users Collaboration of multiple users Pre-submission validation of many NIH and Grants.gov business rules Pre-population of data from eRA Commons profiles Pre-submission print/preview of application in NIH format Submission status tracking for both Grants.gov and eRA Commons within a single system 3

4 Downloadable Forms* System-to-System ASSIST * Single-project only Learn about options:

Subjected 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 5 …regardless of submission option used.

You must have an eRA Commons account to use ASSIST 6 Fun Fact: Over 308,000 people have eRA Commons accounts, including over 202,000 PIs.

Grants.gov  Designate E-Business Point of Contact (E-Biz POC)  Approves Authorized Organization Representatives (AORs) providing authority to submit applications eRA Commons  Designate Signing Official (SO)  Registers or affiliates Project Director/Principal Investigator (PD/PI)  The same person can be both an SO and a PI, but need two separate eRA Commons accounts 7

8 Success is where preparation and opportunity meet. -Bobby Unser

9 NIH Guide for Grants & Contracts Grants.gov Search Opportunity

10 The SBIR/STTR website provides direct links to omnibus and other funding opportunity announcements. SBIR: PA STTR: PA Standard Due Dates: Sept 5 Jan 5 April 5

11 Due Dates section links to standard dates web page or lists specific due dates Carefully read full announcement Check for updates in Related Notices Guide notices supersede announcement and application guide instructions

12 Pay special attention to Section IV. Application and Submission Information Includes any FOA-specific submission instructions Instructions in FOA supersede instructions in the application guide Link to Application Guide

Read and follow application guide instructions  Part I: Instructions for Preparing and Submitting an Application Agency-specific instructions are marked with the HHS logo 13

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 14

Excerpt from FOA in NIH Guide… 15 Login with eRA Commons Username & Password

16 A smart man makes a mistake, learns from it, and never makes that mistake again. But a wise man finds a smart man and learns from him how to avoid the mistake altogether. -Roy H. Williams, Businessman

17 Form navigation Actions - vary based on application context and access ASSIST messages Screen tips Access online help

ASSIST automatically provides application access to some individuals based on their role in eRA Commons or role on the application Examples:  Users with eRA Commons accounts that have the Signing Official (SO) or Administrative Official (AO) role have access to all applications for their organization  PD/PIs have access to all their applications  Application initiator has access to that application 18

Signing Officials (SOs) can provide application access to anyone with an eRA Commons account  SOs can delegate Access Maintainer authority to others to manage application access for a specific application Application access can be controlled across these variables:  Read vs. Edit  Budget vs. Non-budget data 19

Whether an attachment is required or not is often based on how you answer specific questions throughout the application  Examples:  Human Subjects = Yes, then Human Subjects section of the PHS 398 Research Plan is 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 20

21 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 feature to bundle multiple files into a single PDF  Disable security features such as password protection Keep file names to 50 characters or less Use meaningful filenames 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 22 PDF Guidelines:

23 Page Limits:

Errors and Warnings are displayed

Errors stop application processing and must be corrected  You will be unable to submit in ASSIST until all identified errors are corrected Warnings do not stop application processing and are corrected at the discretion of the applicant 25

26 Conformance to all instructions is required and strictly enforced 1. Notices in the NIH Guide for Grants and Contracts 2. Funding Opportunity Announcement  Pay special attention to FOA-specific notices in the Related Notices section and to FOA-specific requirements in section IV 3. Application guide and supplemental instructions eRA systems will catch many, but not all errors  Some items are checked by staff post-submission without the opportunity to correct for the same due date

27 I love deadlines. I like the whooshing sound they make as they fly by. -Douglas Adams

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 to address any unforeseen issues  NIH’s late policy does not allow corrections after the due date 28

Submit Application button prompts for Grants.gov Authorized Organizational Representative (AOR) login information Must be logged into ASSIST with an eRA Commons account with the Signing Official (SO) role Application must be error- free and status updated to Ready for Submission

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

31 Trust, but verify. -Ronald Reagan

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 notification  can be unreliable – proactively check application status 32

33 Click View Submission Status Details

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

eApplication is the application image reviewers use. Cover Letter and Appendices (when allowed) are stored separate from the application image.

36 TIP: This is the same application image that will be accessed by reviewers and staff, so check it carefully!

You have two (2) business days to view your assembled application image before it automatically moves forward for further processing SO can Reject application in eRA Commons within viewing window and submit a Changed/Corrected application before the submission deadline 37 If you can’t VIEW it, we can’t REVIEW it!

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  NOT-OD

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40 You must follow NIH’s standard ‘system issue’ procedure if you run into problems beyond your control that threaten your on-time submission:

HELP DESKS ON-LINE RESOURCES &WEB SITES 41

eRA Service Desk  Web:  Phone:  TTY:  Hours : Mon-Fri, 7a.m. to 8 p.m. ET 42

SBIR/STTR Application Guide SF424 (R&R) Forms Version C  _SBIR_STTR_VerC.pdf _SBIR_STTR_VerC.pdf Small Business Grant Applications: Annotated SF424 (R&R) Form Set  ed_Forms_FORMS-C_SmallBus-1.pdf ed_Forms_FORMS-C_SmallBus-1.pdf 43

Getting Started: Preparing Your Single-project Application Using ASSIST  Getting-Started-Single-project.pdf Getting-Started-Single-project.pdf ASSIST Online Help  ASSIST User Guide 

eRA Commons: ASSIST: NIH SBIR/STTR: NIH About Grants: Electronic Research Administration:

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