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NIH UPDATE Reference: NOT-OD-08-018 Error correction window REDUCED from 5 to 2 business days Proposal “on time” if ALL of the following are met Registrations.

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Presentation on theme: "NIH UPDATE Reference: NOT-OD-08-018 Error correction window REDUCED from 5 to 2 business days Proposal “on time” if ALL of the following are met Registrations."— Presentation transcript:

1 NIH UPDATE Reference: NOT-OD-08-018 Error correction window REDUCED from 5 to 2 business days Proposal “on time” if ALL of the following are met Registrations must be complete prior to initial submission Initial successful submission time stamped on/before 5:00 p.m. local time on the receipt date Errors and/or warnings must be corrected w/in 2 business days following receipt date (error correction window) Only corrections to system-identified errors/warnings accepted – other changes may = returned proposal Submit cover letter identifying errors/warnings corrected if final submission is after the receipt date

2 NIH UPDATE – PHS 398 Reference: NOT-OD-08-028 Revised 11/07 PHS 398 accepted starting January 25, 2008 http://grants.nih.gov/grants/forms.htm Mandatory for May 25, 2008 and after Paper PHS 398 required for all mechanisms that have not transitioned to the SF424 Training grants, career development, change of grantee institution, cooperative agmts., program projects and center grants. http://era.nih.gov/ElectronicReceipt/

3 NIH UPDATE – PHS 398 Reference: NOT-OD-08-028 Notable changes Implementation of Grants.Gov Terminology OLD TERMNEW TERM Competing ContinuationRenewal Application Revision or AmendmentResubmission Application Competing SupplementRevision Application Principal InvestigatorProgram Director/Principal Investigator (PD/PI) Key PersonnelSenior/Key Personnel Performance SiteProject/Performance Site Duly Authorized RepresentativeAuthorized Organizational Representative

4 NIH UPDATE – PHS 398 Reference: NOT-OD-08-028 Definition of New Investigator Structure of Document – Primarily reorganized for greater consistency with the SF424 Suggested Cover Letter Format Budget Justification – Foreign applicant or component Instructions - Indefinite Involvement of Human Subjects or Use of Vertebrate Animals, Protection of Human Subjects Section of Research Plan, Career Development Awards and Institutional Training Applications Appendix Format – submit on CDs instead of paper

5 NIH UPDATE – PHS 398 Reference: NOT-OD-08-028 Changes to PHS 398 Form & Format FACE PAGE: IACUC approval date removed (JIT) PAGE 2 Revised – Project/Performance Site Format Page Created MODULAR BUDGET PAGE – No longer included – part of electronic submission not paper CHECKLIST – Disclosure permission checkbox added INSTITUTIONAL TRAINING GRANT DATA TABLES – Fillable format

6 NIH UPDATE – PHS 398 Reference: NOT-OD-08-031 Effective May 25, 2008 appendices must be submitted on CDs for paper PHS 398 applications Encouraged to submit listing of appendix items as first file on CD Submit 5 identical CDs of appendix material Use PDF format Label each disk w the PD/PI name & application title Use ISO 9660 for Mac CD-ROM disks DO NOT compress files DO NOT password protect, encrypt, use digital signature and/or certification in PDF file

7 NIH UPDATE – PHS 2590 Reference: NOT-OD-08-030 Revised PHS 2590, rev. 11/07 available http://grants.nih.gov/grants/forms.htm 11/07 version MANDATORY by March 1, 2008 Policy changes included Sharing of Data Obtained in NIH-Supported or Conducted Genome-Wide Association Studies Registration of clinical trials in ClinicalTrials.gov

8 NIH UPDATE – PHS 2590 Reference: NOT-OD-08-030 Notable Changes Effective March 1, 2008 only signed original required to be submitted Instructions more consistent with SF424 & PHS398 format SNAP question #3 – instructions clarify “Total approved budget” Instructions for Career Development Award & Institutional Research Training Application

9 NIH UPDATE – PHS 2590 Reference: NOT-OD-08-030 Implementation of Grants.Gov Terminology OLD TERMNEW TERM Non-Competing Continuation Progress Report Continuation Progress Report Competing/Administrative Supplement Revision application Principal InvestigatorProgram Director/Principal Investigator (PD/PI) Key PersonnelSenior/Key Personnel Performance siteProject/performance site Duly authorized representativeAuthorized Organizational Representative

10 NIH UPDATE – PHS 2590 Reference: NOT-OD-08-030 Training and Career Development Awards (T’s and K’S) Progress report narrative expanded from 2 to 4 pages Registration Reminders DUNS & CCR – WU is registered – RO maintains

11 NIH UPDATE – PHS 2590 Reference: NOT-OD-08-030 Form and Format Changes FACE PAGE: FFATA data included – Deleted full or expedited IRB review boxes – Item 11a. Incorporated into 2a. & 2e. PROJECT/PERFORMANCE SITE FORMAT: (Form Page 1 – Continued) created to collect information on each project/performance site CHECKLIST: Reference replaces itemized list of assurances/certifications

12 PHS 2271, PHS 3734 & HHS 568 Reference: NOT-OD-08-029 PHS 2271 – Statement of Appointment – Rev 11/07 – Mandatory on May 1, 2008 PHS 3734 – Official Statement Relinquishing Interest and Rights in a Research Grant – Rev 11/07 – May be used now, no mandatory date HHS 568 – Final Invention Statement & Certification – Rev 11/07 – May be used now, no mandatory date – PD/PI signature no longer required – Institutional signature still required


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