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Notable Changes Made to PHS 398

  • Links to the Rev. 9/04 instructions and form pages have been removed. The instructions provided above are to be used for all PHS 398 applications submitted for submission/receipt dates on or after May 10, 2006. The forms provided above include a mix of forms with the 'Rev. 4/06' and 'Rev. 9/04, Reissued 4/2006' revision dates. For those form pages that have been revised with the 4/06 date, these new versions are required to be used in all applications submitted for submission/receipt dates on or after May 10, 2006. For form and format pages showing the 'Rev. 9/04, Reissued 4/2006' note, no data fields on these have actually changed; therefore, applicants may continue to use existing Rev. 9/04 versions, even if they do not include the "Reissued 4/2006" reference. See NIH Guide Notice NOT-OD-06-056 (5/15/06).

  • Footers in the form and format pages that were not revised in 4/06 have been modified to show 'Rev. 09/04, Reissued 4/2006' (5/3/06).

  • Interim Revision 4/2006 - This interim revision implements a number of new and/or changing business processes: 1) Replacing the PI signature on the application with an Institutional compliance requirement; 2) Changes in measure for reporting effort devoted to a project from percent effort to person months; 3) Changing the requirements for including publications as appendix material; 4) Implementing multiple Principal Investigators for NIH grants; 5) Implementing specific requirements for Select Agent Research; 6) Modifying the requirements for Biographical Sketch; and 7) Harmonizing the PHS398 & SF424 (R&R) instructional text and removing data collection and instructions for those mechanisms that have transitioned to the SF424 (R&R) application and electronic submission. See the 4/7/2006 NIH Guide Notice for important details regarding changes made to this version (4/7/06).

  • Revisions have been made in Part III to update contact information for The Office of Research Integrity and the Office of Human Research Protections (1/26/06).

  • SBIR/STTR forms have been removed. For submission dates on or after 12/1/2005, SBIR and STTR Applications MUST be submitted electronically using the SF424 (R&R) Forms.
    Implementing OHRP policy, all references to MPAs and CPAs have been removed from instructional text (12/13/05).

  • The following revisions have been made in the PHS 398, Part I, Instructions:
    • Instructions for Revised Applications have been modified to remove the R03 exclusion from the guidelines on submission of up to two revised applications. See NIH Guide Notice, NOT-OD-05-046, for policy changes regarding the number of revisions for R03s.
    • The "Submission Dates, Review, and Award Cycles" Table has been updated to reflect editorial changes in order to make the postmark/submission information more user-friendly (6/13/05).
  • Minor formatting revisions have also been made to the following form pages to improve usability:
    • Form Page 3, Introduction to Revised Application for SBIR/STTR Phase I has been clarified.
    • Form Page 4, formatting of form fields in "% Effort on Project" column has been changed to allow insertion of asterisk.
    • Biographical Sketch Format Page, instructions have been added for completing Sections A, B, and C.
    • Biographical Sketch Sample, Project Period dates in Completed Research Support samples have been revised to reflect end dates within the last 3 years (6/13/05).

  • Revisions have been made in the PHS 398, Part II, Human Subjects Research Supplement, to further address "How can you determine whether research that involves only the use of specimens and/or data from pathology archives or a specimen bank and/or data repository is human subjects research?" (4/26/05).

  • Revisions have been made in the PHS 398 to specify additional acceptable font typefaces (Arial, Helvetica, Palatino Linotype or Georgia are now acceptable); to provide clearer budget guidance for applications that include consortium F&A costs; and to clarify format requirements for Appendix material (Appendix material may be two-sided). See the NIH Guide Notice for details regarding revisions made. Minor formatting revisions have been made to some form pages to improve usability (3/16/05).

  • Revisions have been made in the PHS 398, Part II, Human Subjects Research Supplement, to further address NIH implementation of OHRP Guidance on research involving coded private information or biological specimens. Notable changes in content have been marked in purple. Minor revisions and formatting changes have been made in the PHS 398, Parts I and III (1/20/05).

  • Chapter V of the PHS 398 has been revised to reflect that the modular budget format no longer applies to SBIR/STTR grant applications (1/14/05).
  • Significant revisions have been made in the PHS 398, Part II, Human Subjects Research Supplement, to address NIH implementation of OHRP Guidance on research involving coded private information or biological specimens. Notable changes in content have been marked in purple. Minor revisions and formatting changes have been made in the PHS 398, Parts I and III. On Form Page 3, Research Grant Table of Contents, the ordering of items in the Research Plan has been revised (12/30/04).

  • Page numbering on Form Page 2 and Form Page 2-continued has been changed to Page 2 and Page 3. Be sure to number all pages in application sequentially (11/23/04).

  • Clarification of font and format specifications (11/17/04).

  • New PHS 398 (Rev. 9/04) instructions and forms posted 11/02/2004. See the 11/2/2004 NIH Guide Notice for important details regarding changes made to this version.




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