Notice Number: NOT-OD-05-006 (See also, NOT-OD-05-039 and NOT-OD-05-043)

Key Dates
Release Date: November 02, 2004

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

EFFECTIVE DATE: The newly revised Application for a DHHS Public Health Service Grant (PHS 398, rev. 9/04) instructions and forms are now available and will be accepted for submission/receipt dates on or after December 1, 2004. All applications received on or after May 10, 2005 must use the new instructions and forms. During the transition period, applications using the previous version (rev. 5/01) of the PHS 398 will be accepted through May 9, 2005. However, after this date, applications submitted using instructions and forms other than the PHS 398 (rev 9/04) 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].

SBIR/STTR applicants who are preparing an application for the December 1, 2004 submission date may use the previous PHS 398 version (rev. 05/01) in accordance with instructions in Chapter IV of the PHS 2004-2 Omnibus SBIR/STTR Grant Solicitation. However, applicants who wish to use the new forms should use the set of instructions in the PHS 2004-2 Omnibus SBIR/STTR Grant Solicitation. The PHS 2005-2 Omnibus Solicitation, with updated instructions, will be released on or around January 14, 2005.

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

Notable Changes to the PHS 398 (rev. 9/04):

This edition of the PHS 398 has been extensively rewritten with a focus on clarity and special emphasis on simplicity and plain language.

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.
• 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.

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 (5/01) PHS398 revision, and includes links from Part I ( Instructions ) as necessary.
• Definitions have been harmonized with those used in the NIH Grants Policy Statement .
• This section also includes a description of various grant mechanisms that NIH uses to fund research

Changes of Note to Specific PHS 398 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.
• The IPF option data field in block 9 has been eliminated

Form Page 2:

• Now 2 pages (Form Page 2 & Form Page 2-continued with 5 distinct sections Description, Performance Sites, Key Personnel, Other Significant Contributors, and Stem Cells.
• Description/Abstract : Instructions have been added requiring the PI to succinctly (2-3 sentences) describe the relevance of the proposed research to public health. Plain language is suggested.
• Key Personnel Section : A field has been added for the eRA Commons User Name. This new data item is currently optional.
• Other Significant Contributors: This is a new field that allows the PI to identify individuals who have committed to contribute to the scientific development or execution of the project but are not committing any specified measurable effort. (Biographical sketches will be required for these individuals; Other Support information will not be required.)
• Human Embryonic Stem Cells: Previously embedded 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.

Form Pages 4 and 5: Budget pages have been modified to implement the broader application of the policy on Direct Cost Limitations (e.g., excluding consortium/contractual F&A costs when determining eligibility for any application with a direct cost limitation.) Specifically, the Consortium/Contractual Direct Costs budget row has been moved to above the Subtotal Direct Costs line. Instructions have been revised to implement the new policy.

Modular Budget Format Page : The budget data fields have been modified to implement the new policy on Direct Cost Limitations. Specifically, users must now separate the Consortium F&A costs from the other Direct Costs. Instructions have also been revised to implement the new policy.

Biographical Sketch Format Page : A field has been added for the eRA Commons User Name. This data item is currently optional.

Personal Data Page: Applicants are 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.

Key Personnel Report Format Page: The request for a Social Security Number is now limited to the last four digits.

Checklist Form Page:

• A field has been added for Change in Grantee Institution .
• Foreign Application: Two distinct options are now provided 1) Grants at Foreign Institutions or 2) Domestic Grants with Significant Foreign Involvement. This data area also includes a text entry section to list countries involved.

Specific Changes of Note to the PHS398 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-11 or Helvetica-11 point font.
NIH Peer Review Criteria have been updated to better accommodate interdisciplinary, translational, and clinical projects.
Instructions for Modular and Non-Modular Budgets and have been revised to implement the new policy on Direct Cost Limitations; e.g., excluding consortium/contractual F&A costs when determining eligibility for any application with a direct cost limitation.
Research Plan instructions now include a distinct section on Resource Sharing.
Research Career Development Award Instructions:

• Added clarifying instructions for completing sections of Form Page 2
• Changed requirement in Career Award Instructions for Checklist Page. This page is now required at time of submission.

Institutional Training Grant Instructions: Added clarifying instructions for completing sections of Form Page 2
SBIR/STTR Instructions: Clarification has been added on the preparation of the Final Progress Report.

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]

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