nih update reference: not-od-08-018

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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 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

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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 must be complete prior to initial submission - PowerPoint PPT Presentation

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Page 1: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATEReference: 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

Page 2: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATE – PHS 398Reference: 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/

Page 3: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATE – PHS 398Reference: NOT-OD-08-028

Notable changes Implementation of Grants.Gov Terminology

OLD TERM NEW TERMCompeting Continuation Renewal Application

Revision or Amendment Resubmission Application

Competing Supplement Revision Application

Principal Investigator Program Director/Principal Investigator (PD/PI)

Key Personnel Senior/Key Personnel

Performance Site Project/Performance Site

Duly Authorized Representative Authorized Organizational Representative

Page 4: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATE – PHS 398Reference: 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

Page 5: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATE – PHS 398Reference: 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

Page 6: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATE – PHS 398Reference: 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

Page 7: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATE – PHS 2590Reference: 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

Page 8: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATE – PHS 2590Reference: 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

Page 9: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATE – PHS 2590Reference: NOT-OD-08-030

Implementation of Grants.Gov Terminology

OLD TERM NEW TERMNon-Competing Continuation Progress Report

Continuation Progress Report

Competing/Administrative Supplement

Revision application

Principal Investigator Program Director/Principal Investigator (PD/PI)

Key Personnel Senior/Key Personnel

Performance site Project/performance site

Duly authorized representative Authorized Organizational Representative

Page 10: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATE – PHS 2590Reference: 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

Page 11: NIH UPDATE Reference: NOT-OD-08-018

NIH UPDATE – PHS 2590Reference: 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

Page 12: NIH UPDATE Reference: NOT-OD-08-018

PHS 2271, PHS 3734 & HHS 568Reference: 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