Notice Number: NOT-OD-06-057

Key Dates
Release Date: April 7, 2006

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

The Application Guides for the SF424 (R&R) have been revised to incorporate a number of business process changes. This Guide Notice describes the particular business process change and the corresponding changes to the SF424 (R&R) Application Guides. Applicants should also review several 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-06-058: NIH Announces Interim Changes to the PHS2590 Noncompeting Progress Report Forms and Instructions.

Revised Application Guides are available for immediate use at: http://grants.nih.gov/grants/funding/424/index.htm.

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 applications submitted electronically through Grants.gov 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.

For applications submitted electronically through Grants.gov, this business process change specifically affects the PI verification step in the eRA Commons . Effective for submissions with open dates May 10, 2006 and thereafter, the PI verification step in the eRA Commons is being eliminated. Instead, once an application package has been successfully submitted through Grants.gov, all errors corrected, and the application assembled by the eRA Commons , PD/PIs (and AOR/SOs) will have two business days to review the application. If everything is acceptable, no further action is necessary. The application will automatically move forward in the process after two business days. If, however, it is determined that the some part of the application was lost or didn't transfer correctly during the submission process, the AOR/SO will have the option to Reject the image and submit a Changed/Corrected application. See NIH Guide Notice NOT-OD-06-055 for additional details.

In the Application Guides, information on this changing business process has been added to Part I, and Part III/Section II/Assurances has been revised to include the PI Assurance as an institutional compliance requirement.

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 actual publications as PDF attachments in the Appendix material has changed. The new process is:

• Publications in press : Include only a publication list with a link to the on-line journal article or the NIH PubMed Central (PMC) submission identification number. Do not include the entire article.
  
  
• Manuscripts accepted for publication but not yet published : The entire article may be submitted as a PDF attachment as part of the Appendix material.
  
  
• Manuscripts published but an online journal link is not available : The entire article may be submitted as a PDF attachment as part of the Appendix material.
  

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 SF424 (R&R) forms already have some ability to accommodate Multiple PIs. Specifically the Senior/Key Person Profile Component allows more than one individual to be assigned the Project Role of PD/PI . However, NIH is also modifying the PHS398 Research Plan Component to accommodate a separate PDF attachment for the Multiple PI Leadership Plan.Until that new component is available ( anticipated August 2006 ), interim instructions have been added for applicants to use the Consortium/Contractual Arrangements PDF attachment section for the Multiple PI Leadership Plan.

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.

Revised Requirements for Select Agent Research

NIH is also modifying the PHS398 Research Plan Component to accommodate a separate PDF attachment for the 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 is only required when applicable. Additionally, the instructions for item 9. Facilities & Other Resources in the Other Project Information Component 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.

Miscellaneous Instruction Edits

PDF Text Attachments : An instruction has been added strongly encouraging applicants use only a single-column format for all text sections of the application. Since reviewers will be reviewing applications as electronic documents, applicants should avoid using a two-column format since it can cause difficulties when reviewing the document electronically.

Change in Submission Time : Instructions have been revised to reflect the change in submission/receipt time announced March 16, 2006 in NIH Guide Notice NOT-OD-06-050.

Senior/Key Person Profile Component/eRA Commons UserName : Instructions have been added to clarify that the Credential field (assigned eRA Commons UserName) refers to the unique name used by the PD/PI to log into the eRA Commons system.

PHS398 Research Plan Component/6. Protection of Human Subjects: Previously the instructions required a PDF attachment for this section of the Research Plan even when no Human Subjects were involved. This requirement has been eliminated. Unless an explanation is necessary, if No Human Subjects are involved, and this has been appropriately indicated in the Other Project Information Component, no additional information is needed in the Research Plan Component.

Other instructions have been edited to provide better clarity. All instructional changes have been made using a purple font color.

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: [email protected]