1 Grants.gov & NIH Review September 2008 Tufts University Office of Research Administration Paul Murphy, Director Zoya Hamilton, Sr. Associate Director – Boston Campus Elizabeth Brady, Research Administration Assistant

2 SF424 (R&R) The SF424 (R&R) includes common data elements arranged in components Agencies are not required to use all components for every funding opportunity Agencies “construct” application packages for each funding opportunity Funding Opportunity Announcements will indicate which components are required and which are optional Each announcement will have the appropriate application package attached

3 Update Transition to Adobe REQUIRES downloading Adobe Reader Different versions are incompatible Package can be corrupted without users knowledge Acrobat v 9 now available NIH transitioning to Adobe in December Currently only on selected submissions See new guide at Adobe Guide at Its very similar to PureEdge with different features ie printing, scrolling. Free versions of Adobe Acrobat Professional are available to those eligible. NIH Faculty and administrators. Acrobat v9 updates available

4 Update ( con’t) NIH to limit competing resubmissions to 1 not 2 as of February 2009 (A1 no more A2s) This affects the March 5 R01 submissions Public Access Policy NIH applications, proposals and progress reports must include the PubMed Central reference number (PMCID) when citing an article that falls under the policy and is authored or co-authored by the investigator, or arose from the investigator’s NIH award. This policy includes applications, proposals and progress reports submitted to the NIH for the May 25, 2008 due date and subsequent due dates

5 Update ( con’t) Public Access Policy (con’t) Manuscripts Affected (They fall under the policy). Manuscript generated by NIH FY 2008 (or beyond) grant or cooperative agreement and accepted for publication on or after 07 April Manuscript generated by a continuing NIH grant or cooperative agreement that is active in FY 2008 (or beyond) and accepted for publication on or after 07 April Manuscript generated by a NIH contract awarded after 07 April 2008.

6 Update ( con’t) Public Access Policy (con’t) Manuscripts Not Affected (Because they don’t fall under the policy) Manuscript generated by NIH FY 2008 grant or cooperative agreement and accepted for publication BEFORE 07 April Manuscript generated by NIH FY 2007 (or earlier) grant or cooperative agreement that is no longer active and accepted for publication on or after 07 April Manuscript generated by NIH FY 2007 (or earlier) grant or cooperative agreement that is no longer active and accepted for publication BEFORE 07 April Manuscript generated by a continuing NIH grant or cooperative agreement that is active in FY 2008 and accepted for publication BEFORE 07 April Manuscript generated by a NIH contract awarded prior to 07 April 2008

7 Update ( con’t) Public Access Policy (con’t) Remember, NIH applications, proposals and progress reports must include the PubMed Central reference number (PMCID) when citing an article that falls under the revised NIH Public Access Policy. For further info: NIH Public Access NIH Public Access FAQ – very informative

8 NIH Use of the SF424 (R&R) NIH uses several “standard” packages The NIH Guide features a direct link to each FOA; Formerly “unsolicited” NIH applications will not have an associated FOA number (i.e., “parent” solicitation) A complete NIH application includes a combination of (R&R) components and PHS 398 components Applicants must complete data entry in all necessary components and upload with appropriate attachments to Grants.gov

9 SF424 (R&R) SF424 (R&R) Components include: SF424 (R&R)—An application cover component Research & Related Project/Performance Site Location (s) Research & Related Other Project Information Research & Related Senior/Key Person Research & Related Budget R&R Subaward Budget Attachment Form

10 SF424 (R&R) Application components include specific structured data fields as well as multiple attachments Most attachments are text NIH requires PDF versions of text attachments Attachments must be converted to PDF before they can be attached to the application form. Get Adobe Acrobat Professional Do not include page numbers, headers, or footers in the text pages – this is done automatically. The proposal will go through, but won’t look good.

11 ERA Commons and Grants.gov All NIH Grants.gov submissions will be transferred and validated in eRA Commons All PIs must have eRA Commons IDs (MultiPIs too) All PI data entered in Grants.gov should match eRA Commons user name and institutional data

12 Submit Application to Grants.gov (AOR submits) Prepare Application Check Submission Status in Commons View the Application Image Submission Complete Submission Process Prepare to Apply Notify ORA –”Heads up” Find Opportunity and Download Application Package if errors

Header Information Pre-filled from announcement

14 Item 4, Must enter Fed ID for renewals, resubmissions & revisions, ie. CA12345 Item 5, Organizational DUNS: Must match DUNS in eRA Commons profile for Applicant Institution Use correct DUNS for your campus: Boston & Grafton = Medford = Item 10, CFDA Number & Title CFDA = Catalog of Federal Domestic Assistance Fields are pre-filled Item 13. Dates should match budget

Item 16, Funding a. Total Estimated Proj Funding = $$$ b. Total Fed & Non Fed Funds = $$$ c. Est Prog Income = 0 Item 17 b, Check NO, to Program income not covered by E..O

Project/Performance Site Location(s)

Project Summary/Abstract (Description) – up to 30 textual lines – font & margin specs Project Narrative – 3 sentences in layman language Bibliography & References – Public Access issues - PubMedCentral

Credential: Must enter the eRA Commons User Name - for the PD/PI and for multiple PD/PIs Biosketch is attached for each person, 4 page limit Current & Pending Support not be used at time of submission unless specified in FOA. Will be requested via JIT Project Role NIH does not use Co-PD/PI- only PD/PI for multiple PIs. For Co-I, choose “Other” then in: Other Project Role Category – enter – “Co-Investigator” Can have up to 7 Key/Senior People then use Additional Profiles.

Info for PD/PI & Key people MUST have measurable effort even if no salary requested.

R&R Budget Sections C – E

Cognizant Fed Agency: DHHS Robert Aaronson Budget Justification – a PDF text attachment- Use a place holder to advance Next Period Button: At the top of the last budget page for that year. All required data fields in this component must be entered before this button is available, including the Budget Justification.

22 Component: Research and 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

Use this for detailed budget from a consortium grantee only when the prime is submitting detailed budget. Do not use if prime is submitting Modular Budget. Sub must have PureEdge installed. - Applicant sends the R&R budget component to the sub for completion; - Sub returns to applicant as a PureEdge file; - Applicant attaches it in this component Name of file should be name of Sub PI for the Sub should not be PD/PI unless truly so, should be Co-I or Collaborator.

Applicants are encouraged to include a cover letter with the application. The cover letter is only for internal use and will not be shared with peer reviewers. For Format info – see PHS 424 RR Guide, section 5.2 Cover Letter Component

Ensure the degrees are listed. This will come back as a warning because it uses this field to show the PIs degrees on the final form.

PHS 398 Cover Page Supplement Page 2

Use when direct costs are 250k or less unless FOA states otherwise. Enter in modules of 25k IC Rate date – 06/26/2008 Cognizant Fed Agency – DHHS, Robert Aaronson Personnel Justification – List all personnel, including names, number of person months devoted to project (indicate academic, calendar, and/or summer) and roles on the project. Do not provide individual salary information. Since the modules should be a reasonable estimate of costs allowable, allocable, and appropriate for the proposed project, you must use the current legislatively imposed salary limitation when estimating the number of modules

28 Consortium Justification – Provide an estimate of total costs (direct plus F&A) for each year, rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, along with all personnel, including percent of effort (in person months) and roles on the project. Do not provide individual salary information. Indicate whether the collaborating institution is foreign or domestic. While only the direct cost for a consortium/contractual arrangement is factored into eligibility for using the modular budget format, the total consortium/contractual costs must be included in the overall requested modular direct cost amount.

Do not exceed 25 pages for Items 2 – 5. All tables, graphs, figures, diagrams, and charts must be included within the 25-page limit. Separate PDF attachments for each section, can write the whole research plan as one doc then separate No headers, footers, page numbers Do include a section heading as part of the text i.e., Specific Aims, Background & Significance Appendix Material - Allows up to 10 separate attachments, but only 3 publications. Use links to on-line journals for publication references when available If you reference the appendix, don’t do it by number, they upload randomly

32 Completing the Package Make sure all Mandatory Documents have been moved to the Completed Documents box Be sure to save the package to a folder on your computer not as a “Temp File” Check for errors, add/correct any missing information

33 Rules for Submission Bring Tufts internal forms, signed by PI & School &/or Department Chair, with paper copy of budget, budget justification, narrative summary & full subcontract proposal(s) to Research Administration 10 business days in advance of due date. Send Grants.gov package as an attachment or bring a flash drive to ORA 5 business days in advance of due date. Applications are accepted by Grants.gov by 5:00PM EST on the submission date. DO NOT WAIT UNTIL THE LAST DAY!!

34 Rules for Submission (con’t) INTERNAL DATES FOR THE UPCOMING NIH "R" SERIES PROPSALS: R01 (PA ) Research Grants NEW PROPOSALS. Due to NIH on Sunday, October 5, meaning they are due on MONDAY, OCTOBER 6. Please send the business pages and abstract by MONDAY, SEPTEMBER 22 This includes the signed revised internal proposal coordination form, financial conflict disclosure form, SF424 Cover page, budget, budget justification, subcontract proposals if included & an abstract. NOTE: In lieu of the paper version, we will accept the above pages via the PureEdge file. Also NOTE - signed coordination and financial disclosure forms can be sent via as a scanned PDF file or fax, along with drop offs and campus mail. - Send the full proposal as a PureEdge attachment by MONDAY, SEPTEMBER 29.

35 Rules for Submission (con’t) R03/R21/R33 Other Research Grants, NEW PROPOSALS. Due to NIH on THURSDAY, OCTOBER 16. Keep in mind Monday, October 13 is Columbus Day, a University Holiday -Business pages to Tufts Research Administration by THURSDAY, OCTOBER 2. -Full proposal package as a PureEdge attachment by THURSDAY, OCTOBER 9. R01 (PA ) Research Grants RENEWAL, REVISION, RESUBMISSION PROPOSALS. Due to NIH on WEDNESDAY, NOVEMBER 5. -Business pages to Tufts Research Administration by WEDNESDAY, OCTOBER 22. -Full proposal package as a PureEdge attachment by WEDNESDAY, OCTOBER 29.

36 Rules for Submission (con’t) R03/R21/R33 Other Research Grants, RENEWAL, REVISION, RESUBMISSION PROPOSALS. Due to NIH on Sunday, November 16, meaning they are due on MONDAY, NOVEMBER 17. Keep in mind Tuesday, November 11 is Veterans Day, a University Holiday -Business pages to Tufts Research Administration by MONDAY, NOVEMBER 3. -Full proposal package as a PureEdge attachment by MONDAY, NOVEMBER 10

37 What Will a Completed Application Look Like? After submission, the eRA system will: Assemble the grant image Generate a Table of Contents Include headers (PI name) & footers (page numbers) on all pages Send out s Applicants (AOR/SO & PD/PI) will have 2 weekdays to view this grant image in the eRA Commons

38 Avoid Errors Follow All Application Instructions Most common problems with applications to date: Senior Key Personnel listed with no effort in budget All non-PureEdge attachments MUST be in PDF format Use no special characters in file names Abstract/Summary – only 30 textual lines EIN # is Fed ID, example CA12345, for renewal & resubmissions There are application fields not marked as mandatory on the federal-wide form that are required by NIH Example: The credential field of the R&R Senior/Key Person Profile component MUST contain the PI’s assigned eRA Commons User ID

39 Help & Tools Tufts OVP Website for Grants.gov information: Review Electronic Submission website: Familiarize yourself with the forms and application guide(s) Application guides and sample versions of application packages are available at: Must have PureEdge Viewer/Adobe installed in order to manipulate the sample application packages.

40 Finding Help: eRA Commons If help is needed with the eRA Commons registration or 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: eRA Commons Help Desk Phone: Toll Free: TTY: Business hours M-F, 7am-8pm EST Web support: