Notice Number: NOT-OD-06-058

Key Dates
Release Date: April 7, 2006

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

The PHS2590 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 PHS2590 forms and instructions. Applicants should also reviewseveral other companion announcements:

• NOT-OD-06-054: NIH Announces Change in Business Process: Replacing the Principal Investigator Signature on Grant Applications, Progress Reports, and Prior Approval Requests with an Institutional Compliance Requirement
  
  
• NOT-OD-06-055: NIH/AHRQ Announce Change in Business Process Concerning eRA Commons Verification of Electronically Submitted Applications
  
  
• NOT-OD-06-056: NIH Announces Interim Changes to the PHS398 Application and Instructions
  
  
• NOT-OD-06-057: NIH Announces Changes to the SF424 (R&R) Instructions

Revised forms (dated rev. 4/06) and instructions are available at: http://grants.nih.gov/grants/funding/2590/2590.htm and are required for paper progress reports being prepared for due dates on/after June 1, 2006 .

Change in Business Process: Replacing PI Signature on the Progress Report Face Page 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 noncompeting progress reports 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 PHS2590 progress reports submitted for due dates on/after June 1, 2006 , the signature of the Principal Investigator is no longer required as a part of a submitted progress report. Instead, a new compliance requirement is now implemented whereby the grantee organization agrees to secure and retain at the organization a written assurance from the Principal Investigator (PI) prior to submitting a progress report to the PHS.  While this assurance is no longer required as part of the submitted progress report, it remains a compliance requirement.  Therefore, organizations must retain a unique signature and date for each submitted progress report.  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:

• Face Page (Form Page 1 ): Has been revised to remove the PI signature item. Corresponding instructions have also been deleted.
• Form Page 6 (Checklist): Section 2. Assurances has been revised to include the PI Assurance.

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. 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 and progress reports, regardless of which set of forms is being used, the PHS2590 has also been revised to reflect this new effort measure. Specific changes include:

• Form Page 2 (Detailed Budget Page): The Personnel section of the budget has been revised to replace Type of Appointment and Percent Effort, with the 3 columns of person months—calendar, academic, and summer.
  
  
• Form Page 7 (Key Personnel Report): This form page has been revised to replace the Percent Effort column with the 3 columns of person months—calendar, academic, and summer.
  
  
• Other Support Instructions: The Other Support instructions have been revised to reflect person months (calendar, academic, and summer) as the measure for effort.
  
  
• General Instructions Changes: Changes have been made throughout the instructions to include appropriate guidance for measuring effort in terms of person months.

Change in Business Process: Including Links to Publications in lieu of Paper Copy

The instructions for publications have been revised to allow the submission of the link to a publicly available on-line journal or the NIH PubMed Central (PMC) submission identification number in lieu of submitting a paper copy. When such a link is available, this is the preferred option. One should only submit a paper copy of a publication when a link it not available.

Implementing Multiple Principal Investigators (PIs)

NIH Guide Notice NOT-OD-06-036 released February 7, 2006 announced NIH's preliminary plans to incorporate multiple PIs into the application business process. The PHS2590 has now been modified to accommodate multiple PIs in progress reports.

Grantees are reminded that this initiative is still in a pilot phase. Only progress reports submitted for any applications approved and funded with multiple PIs as an option will follow these new instructions at this time.

Changes to specific Form Pages and corresponding instructions include:

• Face Page (Form Page 1): This page has been revised to include a Form Page 1 (continued). Form Page 1 (continued) accommodates the collection of the PI information (section 3 of the Face Page) for all individuals designated as PI by the grantee organization. Form Page 1 (continued) is only required when Multiple PIs are being proposed. All applications proposing a single PI will continue to use only Form Page 1.
  
  
• Form Page 5 (Progress Summary ): This page has been revised to include checkboxes to capture any changes in the previously submitted Multiple PI Leadership Plan.
  
  
• General Instructions Changes: Changes have been made throughout the instructions to include appropriate guidance for multiple PIs.

Revised Requirements for Select Agent Research

Form Page 5 (Progress Report Summary) has been revised to include checkboxes to specifically capture any changes in Select Agent Research.

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.

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

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

• New form page developed (Form Page 1-continued) to capture PI information for multiple PIs.
• Item 13, PI Signature Assurance has been removed.

Form Page 2 : Detailed Budget (Rev. 4/06)

The Personnel Section has been revised to replace Type of Appointment & Percent Effort columns with Person Month columns (calendar, academic, and summer)

Form Page 5 : Progress Summary (Rev. 4/06)

Checkboxes to capture changes in Select Agents Research and/or the Multiple PI Leadership Plan have been added

Form Page 6: Checklist (Rev. 4/06)

Section 2. Assurance has been revised to include new PI Assurance

Form Page 7: Key Personnel Report (Rev. 4/06) : The column requesting annual effort has been modified to now reflect person months (calendar, academic, summer)

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 2590 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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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