Notice Number: NOT-OD-06-016

Key Dates
Release Date: December 9, 2005

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

EFFECTIVE DATE: The newly revised “Application for an Individual Fellowship Ruth L. Kirschstein National Research Service Award” (PHS 416-1, rev. 10/05) instructions and forms are now available and will be accepted for submission/receipt dates on or after January 5, 2006. Between January 5 and May 9, 2006 applications using either the 6/02 or the 10/05 version of the form will be accepted. All applications received for submission dates on or after May 10 , 2006 must use only the new instructions and forms; otherwise, those applications will be returned to the applicant.

The newly revised instructions and forms are available at http://grants.nih.gov/grants/forms.htm. 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 instructions and forms via the Internet because they provide valuable links to current policy documents and allow easy navigation of the instructions. This is particularly important with this version due to the interactive format of the instructions. For further information, contact [email protected].

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

Notable Changes to the PHS 416-1 (rev. 10/05):

This edition of the PHS 416-1 has been extensively rewritten with a focus on clarity and special emphasis on simplicity and plain language. (Many of the overall changes are identical to those implemented in 2004 in the PHS398.) In addition, there are significant changes to the overall structure of the application. As a result, many of the form pages in the pervious version no longer exist. Applicants are encouraged to use only the form pages provided in the new version. Do not mix old and new versions.

Overall Format Changes

The format has been organized into three distinct, but integrally linked, parts:

Part I: Instructions for Preparing the Application

• Efforts have been made to include only instructional material related to the preparation, submission and review of your application.
• A number of the data items have been moved and/or consolidated into a new applicant/fellow biographical sketch . As a result some of the actual form pages have been eliminated causing those remaining to be renumbered.
• When applicable, instructions have been revised to incorporate appropriate policy changes. However, detailed information pertaining to policies, assurances, definitions and other information is now found in Part III: Policies, Assurances, Definitions and Other Information.
• Instructions have been revised so that application preparation better reflects a collaborative effort between the applicant/fellow and sponsor

Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan

• This section includes instructions for preparing the human subjects section of the research plan (Section e) and related policies related to Human Subjects Research.
• This section is also organized in a question/answer format to guide application writers through the decision making process regarding the involvement of human subjects in the proposed research.

Part III: Policies, Assurances, Definitions and Other Information

• This section contains non-instructional information relating to policies and assurances, incorporates all policy changes since the last (6/02) PHS 416-1 revision, and includes links from Part I ( Instructions ) as necessary.

Changes of Note to Specific PHS 416-1 Form/Format Pages:

Face Page:

• Title Form field length has been increased to 81 characters.
• eRA Commons User Name field has been added. This data item is currently optional.
• Human Subjects Research box has been modified to include a new data element for Clinical Trials.
• Vertebrate Animals box has been modified to allow IACUC approval date at the time of submission. This data field can be provided at the time of submission or later in the process as a Just-In-Time requirement.
• All signature approvals have been moved to the Face Page. The signature requirement for Approval of the Department Head has been eliminated.

Form Page 2:

• Sponsor/Co-Sponsor Information: Consolidated information on the Sponsor/Co-Sponsor in to one area. Eliminated separate data entry fields for Position/Title & Research Interests/Areas since this information is provided in the biographical sketch of the Sponsor/Co-Sponsor.
• Research Proposal Description: Instructions have been added requiring the applicant to succinctly (2-3 sentences) describe the relevance of the proposed research to public health. Plain language is suggested.

Form Page 3:

• Training Sites: A distinct section for Training Sites has been created. This information was previously imbedded in the text of the research training plan.
• Human Embryonic Stem Cells: Previously imbedded in the Description, information pertaining to projects that involve human embryonic stem cells has now been requested as a separate form field. A link to the Human Embryonic Stem Cell Registry is provided.

Applicant/Fellow Biographical Sketch Format Page:

Created a distinct biographical sketch for the applicant/fellow (distinct from the format used by the sponsor/co-sponsor). This consolidates into one concise area information on the applicant/fellow previously scattered throughout the application. Applicants should note this biosketch is unique to applicants/fellows since it includes information on scholastic performance. The Applicant/Fellow must use this format while the sponsor/co-sponsor will continue to use the traditional biosketch format.

Sponsor/Co-Sponsor Biographical Sketch Format Page:

A field has been added for the eRA Commons User Name. This data item is currently optional.

Personal Data Page:

The Applicant/Fellow is now requested to provide only the last four digits of the Social Security Number. While providing this information remains voluntary, it is hoped that by limiting the data to only the last four digits, individuals will be more receptive to providing it. This vital information continues provide the agency with accurate identification, referral, and review of applications and for management of PHS grant programs.

Checklist Form Page:

• A field has been added for Change in Sponsoring Institution .
• Tuition Section: This section has been enhanced by adding a separate checkbox for None and a chart specifying the funds requested for each year.

Specific Changes of Note to the PHS416-1 Instructions

• The Foreword now contains general information about the NIH Extramural Research and Research Training Programs, including useful Quick References , contacts within HHS and guidance for whom to contact when.
• Font Size Requirement: NIH now requires the use of Arial, Helvetica, Palatino Linotype or Georgia typeface and a font size of 11 points or larger.
• Research Training Plan instructions now follow an organization similar to research plans proposed in regular research grants; thus eliminating the need to fit text within confined form pages. Instructions have been rewritten to reflect a collaborative effort between the applicant/fellow and the sponsor. Finally, a distinct section on Resource Sharing has been included.

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

Division of Grants Policy
Office of Policy for Extramural Research Administration
National Institutes of Health
6705 Rockledge Drive, Suite 350
Bethesda, MD 20892
Telephone: (301) 435-0938
FAX: (301) 435-3059
Email: [email protected]