Notice Number: NOT-OD-09-004

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/

EFFECTIVE DATE: The newly revised “Application for an Individual Fellowship Ruth L. Kirschstein National Research Service Award” (PHS 416-1, Rev. 9/08) forms and instructions are now available and will be accepted for submission/receipt dates beginning in December 2008.  All applications received for submission dates in December 2008 and thereafter must use only the new forms and instructions.  NIH and AHRQ anticipate this to be the last paper-based submission for Individual Fellowship applications.  Plans are still on target to transition Individual Fellowship applications to electronic submission beginning with the April 2009 cycle.   For more information on NIH's transition plans, including a timeline for the transition, see the website for Electronic Submission of Grant Applications http://era.nih.gov/ElectronicReceipt/.

The newly revised forms and instructions are available at http://grants.nih.gov/grants/funding/416/phs416.htm. The previous version of the PHS 416-1 (Rev. 10/05) will remain available on the NIH Forms Page at http://grants.nih.gov/grants/funding/416_ver1005/phs416.htm to accommodate the October 23 submission for PAR-06-536.

Applicants and their sponsors submitting fellowship applications for submission/receipt dates in December 2008 and thereafter are hereby notified that instructions in the existing fellowship FOAs may not always correspond to those in the newly revised PHS 416-1 (Rev. 9/08). Applicants are advised to follow instructions in the newly revised PHS 416-1 (Rev. 9/08).

When preparing competing fellowship applications, fellows and sponsoring institution officials are encouraged to review the FOA instructions carefully for any updated information.

The forms available on the website continue to be provided in two formats—MS Word and PDF-fillable using Adobe Acrobat Reader Software. Free Adobe Software may be accessed at http://www.adobe.com/products/acrobat/readstep.html. Applicants are strongly encouraged to access the forms and instructions via the Internet because they provide valuable links to current policy documents and allow easy navigation of the instructions. For further information, contact GrantsInfo@nih.gov.

The new edition of the PHS 416-1 (Rev. 9/08) includes significant changes to the overall structure of the application. Applicants must use only the form pages provided in the new version of the PHS 416-1. Do not mix old and new versions.

As in the past, applicants should read the instructions carefully. The following is a list of notable changes.

Notable Changes to Form PHS 416-1 (Rev. 9/08):

Form Page 1 (Face Page)

• Citizenship data fields updated to modify for Permanent Resident of U.S. Pending,and add checkboxes for Permanent Resident of U.S. and Non-U.S. Citizen with Temporary U.S. Visa.  Note the additions to the Citizenship section are to allow broader use of these forms for Individual Fellowship programs outside of the Ruth L. Kirschstein National Research Service Award (NRSA) authority.  There are no changes in NRSA policy regarding citizenship requirements.
• Delete IACUC approval date. Information collected as a Just-in-Time submission.
• Implements a change in business process by replacing the Applicant (Fellow) and Sponsor Signatures on the Face Page with a Sponsoring Institution assurance (see companion NIH Guide Notice NOT-OD-09-007).  This change in business process removes these signatures from the Face Page.  The only required signature remaining on the Face Page is that of the official signing for the sponsoring organization.

Form Page 3

• Training Site(s) –Updated to collect specific information for each Training (Project/Performance) Site; added DUNS and Congressional District fields for each Training (Project/Performance) Site.  This structured data requirement is necessary to comply with the Federal Financial Accountability and Transparency Act (FFATA) 0f 2006.

General Changes of Note to the PHS 416-1 Instructions (Rev. 9/08):

This edition of the PHS 416-1 incorporates numerous policy changes and notifications implemented since the 10/05 revision of the PHS 416-1 application.

The PHS 416-1 Instructions includes a Summary of Changes (see Page I-1).  Additional changes are highlighted as follows:

Implementation of Grants.Gov Terminology

As part of the ongoing effort to keep the PHS 416-1, PHS 398 and the SF424 (R&R) synchronized, new terminology is implemented:

Structure of Document:

• A new numerical reference system is incorporated.  
• Part II is revised for purposes of clarity and ease of reference, and the definitions related to human subjects research are moved to Part III.

Cover Letter:  A suggested cover letter format is provided for greater consistency and to facilitate the use of requests for specific Institutes or Centers (ICs) or Scientific Review Groups.

Other Content Changes:

• The requirements of the Research Training Plan have been revised to include a new section dedicated specifically to Select Agent Research. This new section is only required when applicable.
• Instructions for the Research Training Plan sections addressing human subjects and vertebrate animals are modified to provide clearer guidance to applicants when plans are indefinite at the time of application.
• Added instructions in Responsible Conduct of Research (RCR) to include peer review, collaboration, and fellow/sponsor relationship.
• Changes to Human Subjects scenarios in Part II:

-All six human subjects exemptions are provided in one scenario; corresponding instructions modified accordingly.  
-New scenario "Delayed Onset Human Subjects Research" incorporated.

• Changes to Part III:
  
  
• Incorporates all policy changes since the last (10/05) PHS 416-1 revision, and includes links from Part I (“Instructions”) as necessary.  
• Prospective applicants and sponsoring institutional officials should take particular note to the new Fellow and Sponsor Assurance.
• Includes information on NIH Public Access Policy requirements (for NIH awardees only). 

Appendix Format: Incorporates the new NIH policy requiring appendix material to be submitted only on CDs in PDF format, and no longer on paper. See NIH Guide Notice NOT-OD-08-031, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

When applicable, instructions have been revised to incorporate appropriate policy changes. However, detailed information pertaining to policies, assurances, definitions and other information continues to be found in Part III: Policies, Assurances, Definitions and Other Information.

Inquiries

Inquiries on any changes to the forms and instructions may be directed to:

Grants Information
Office of Extramural Research
National Institutes of Health
Phone: 301-435-0714
TTY: 301-451-5936
Email: grantsinfo@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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