Notice Number: NOT-OD-09-007

Key Dates
Release Date: October 14, 2008

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)
Agency for Healthcare Research and Quality (AHRQ), http://www.ahrq.gov/

This Notice informs the grantee community of changes regarding the signatures of the Applicant (Individual Fellow) and Sponsor(s) as a part of applications, certain post-submission information, progress reports, and post-award prior approval requests and the corresponding implementation of a new Institutional compliance requirement to secure and retain the Individual Fellow and Sponsor(s) signatures as part of the institutional review/approval process.  This change in business process for individual fellowships now brings them in line with the similar business process change instituted in 2006 for all other applications, progress reports and prior approval requests (see Notice NOT-OD-06-054 for historical reference).

The signatures of the Individual Fellow and Sponsor(s) are no longer required as a part of a submitted Fellowship 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 Fellow and Sponsor(s) 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 Fellow’s and Sponsor’s  knowledge; (2) that any false, fictitious, or fraudulent statements or claims may subject the Fellow and Sponsor(s) to criminal, civil, or administrative penalties; (3) that the Sponsor(s) will provide appropriate training, adequate facilities, and supervision if a fellowship is awarded as a result of the application; and (4) that the Fellow has read the Ruth L. Kirschstein National Research Service Award Payback Assurance and will abide by the Assurance if an award is made, and that the award will not support residency training. 

Changes to Specific Applications

PHS 416-1 Competing Application
 
This business process change applies to all competing applications prepared using the PHS 416-1 application for submission/receipt dates in December 2008 and thereafter. The Face Page (Form Page 1) of the PHS 416-1 has been revised to remove the Fellow and Sponsor signature item; corresponding instructions have also been deleted. Part III Policy/Assurances/Definitions has been revised to now include the Fellow/Sponsor Assurance as an institutional compliance requirement. See NIH Guide Notice NOT-OD-09-004 for additional details on changes to the PHS 416-1.

PHS 416-9 Annual Progress Reports for Continuation Support

Effective immediately, grantees may submit progress reports for continuation support on either PHS 416-9 (Rev. 10/05) or PHS 416-9 (Rev. 9/08). The change in business process described above will apply to all progress reports for continuation support submitted for submission/receipt dates of December 1, 2008 and thereafter. Effective with submission due on/after December 1, 2008, all progress reports must be submitted using the revised PHS 416-9 (Rev. 9/08). See NIH Guide Notice NOT-OD-09-005 for additional details on changes to the PHS 416-9.

Prior Approval Requests

Effective immediately, this policy also applies to all requests for NIH prior approval for individual fellowship applications and active awards. The signatures of the Fellow and Sponsor(s) are no longer required on requests submitted to the agency; however, the grantee institution must secure and retain such documentation within their own internal processes.
 
In all cases, this assurance must be available to the sponsoring agency or other authorized HHS or Federal officials upon request. 

Individual Fellowship Activation Notice (PHS 416-5), Termination Notice (PHS 416-7), Payback Agreement (PHS 6031) and Annual Payback Activities Certification (PHS 6031-1)

This change in business process does not currently affect the other companion forms used for individual fellowships; i.e., Individual Fellowship Activation Notice (PHS 416-5), Termination Notice (PHS 416-7), Payback Agreement (PHS 6031) and Annual Payback Activities Certification (PHS 6031-1).  Where applicable the signatures of the individual fellow and sponsor remain.  

Inquiries

Questions concerning this notice 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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