NIH Announces Interim Changes to the PHS398 Application and Instructions

Notice Number: NOT-OD-06-056

Key Dates
Release Date: April 7, 2006

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

The PHS398 has been revised to incorporate a number of business process changes that have been implemented since the publication of the 9/2004 revision. This Guide Notice describes the particular business process change and the corresponding changes to the PHS398 application forms and instructions. Applicants should also review several other companion announcements:

Revised forms (dated rev. 4/06) and instructions are available for immediate use and are required for paper applications being prepared for submission/receipt dates on/after May 10, 2006 . After this date, applications submitted using previous versions of form pages that have been updated, may be delayed in the review process.

Change in Business Process: Replacing PI Signature on the Application with an Institutional Compliance Requirement

A new business practice is being implemented by replacing the signature of the Principal Investigator (PI) as a part of competing applications with an institutional compliance requirement where applicant organizations will capture and retain the PI signature as part of their institutional review/approval process.

Effective with PHS398 applications prepared for submission/receipt dates on/after May 10, 2006 , the signature of the Principal Investigator is no longer required as a part of a submitted application. Instead, a new compliance requirement is now implemented whereby the applicant organization agrees to secure and retain at the organization a written assurance from the Principal Investigator (PI) prior to submitting an application to the PHS.  While this assurance is no longer required as part of the submitted application, it remains a compliance requirement.  Therefore, organizations must retain a unique signature and date for each submitted application.  This assurance must be available to the sponsoring agency or other authorized HHS or Federal officials upon request.  Such an assurance must include at least the following certifications:  (1) that the information submitted within the application is true, complete and accurate to the best of the PI's knowledge; (2) that any false, fictitious, or fraudulent statements or claims may subject the PI to criminal, civil, or administrative penalties; and (3) that the PI agrees to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of the application.  When multiple PIs are proposed in an application, this assurance must be retained for all named PIs.

Specific Changes include:

See NIH Guide Notice NOT-OD-06-054 for additional information on this particular business process change.

Change in Business Process: Measuring Effort Devoted to Projects

Transitioning to the SF424 Research and Related (R&R) has introduced a new business practice for measuring effort devoted to a project—person months (see Usage of Person Months Frequently Asked Questions and Percent Effort to Person Months Calculator Excel spreadsheet). Personnel working on projects now indicate effort by indicating the number of calendar, academic, and/or summer months. To keep a consistent business practice in place for all applications, regardless of which set of forms is being used, the PHS398 has also been revised to reflect this new effort measure. Specific changes include:

Change in Business Process: Including Publications as Appendix Material

As described in NIH Guide Notice NOT-OD-06-051 and clarified in Notice NOT-OD-06-053, effective for applications for submission/receipt dates of May 10, 2006 and beyond, the instructions for including paper publications as appendix material has changed. The new process is:

Implementing Multiple Principal Investigators (PIs)

NIH Guide Notice OD-06-036 released February 7, 2006 announced NIH's preliminary plans to incorporate multiple PIs into the application business process. The PHS398 has now been modified to accommodate multiple PIs in competing applications.

Applicants are reminded that this initiative is still in a pilot phase. Only applications in response to specific funding opportunity announcements that included multiple PIs as an option should be following these new instructions at this time.

Changes to specific Form Pages and corresponding instructions include:

Revised Requirements for Select Agent Research

The requirements of the Research Plan have been revised to include a new section dedicated specifically to Select Agent Research. This new section (G. Select Agent Research) is only required when applicable. Additionally, the Resource Format Page instructions have been revised to request specific information on the biocontainment resources available when applicable. Finally, the Select Agent Research section in Part III Policy/Assurance/Definitions has been revised to include additional informational websites.

Change in Business Process: Eliminating Biographical Sketch Subsection Limits

The requirements for the biographical sketch have been changed to eliminate the 2-page subsection limit for sections A&B. The entire biographical sketch continues to have a 4-page limit (including the table at the top of the first page); however, the 2-page subsection limit for sections A&B has been eliminated.

Removal of all Instructions and Data Requirements Specifically for Programs Transitioned to the SF424 (R&R)

As NIH continues to transition all funding mechanisms to electronic submission and the SF424 (R&R) application, the data requirements and instructions to the PHS398 will be changed accordingly. With this revision, all instructions and data requirements specific to SBIR and STTR applications (R43/R44 & R41/R42), AREA applications (R15s); and Conference applications (R13/U13s) have been removed.

A consolidated list of changes to each Form or Format Page follows:

Form Page 1 : Face Page (Rev. 4/06)

Form Page 2 (Rev. 4/06):

Form Page 3 : Table of Contents (Rev. 4/06)

Form Page 4 : Detailed Budget (Rev. 4/06)

Form Page 5 : Budget for Entire Proposed Period of Support (Rev. 4/2006)

The budget item for SBIR/STTR Fee has been removed

Modular Budget Format Page (Rev. 4/06):

Resources Format Page (Rev. 4/06):

Checklist Form Page (Rev. 4/06):

Key Personnel Format Page (Rev. 4/06) :

The column requesting annual effort has been modified to now reflect person months (calendar, academic, summer)

Personal Data Form Page (Rev. 4/06) :

Instructions have been revised to cover the collection of this demographic information for all PIs.

Biographical Sketch Format Page (Rev. 4/06):

Instructions have been revised to eliminate the 2-page subsection page limit for sections A&B. The entire biographical sketch still has a 4-page limit, including the table at the top of page one.

Other Support Format Page Example (Rev 4/06) :

Instructional text and the example have been modified to reflect effort measurements in person months (calendar, academic, summer).

Inquiries

Questions concerning this guide notice or any changes to the PHS 398 forms and instructions may be directed to:

Division of Grants Policy
Office of Policy for Extramural Research Administration
National Institutes of Health
Telephone: (301) 435-0938
Email: GrantsPolicy@od.nih.gov


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