U.S. Department of Health and Human Services
Public Health Service

Grant application

Downloadable Instructions and Form Files

• PHS 398 Instructions (HTML) (PDF via FTP) (PDF via HTTP) - The files from the FTP and HTTP links are identical. The FTP link provides a faster connection for downloading. These files are very large and may take a few minutes to download.
  
  Note: If you experience problems opening the PDF PHS 398 Instruction files above, please update your Acrobat Reader to the most current version, which is available for free at http://www.adobe.com/products/acrobat/readstep2.html.
  
  
• PHS 398 Fillable Forms - Links below allow for downloading of Individual and Combined form files. Also, see the 08/29/2003 NIH Guide Notice for information on the Update of the PHS 398, 2590 and 416 Forms.

Information and Instructions

See below for information on Notable Changes to form pages.

Notice:  Requirement of DUNS Numbers on NIH Applications - Effective October 1, 2003, use of the Dun and Bradstreet (D&B;) Data Universal Numbering System (DUNS) number will be required when applying for Federal grants or cooperative agreements. See NIH Guide Notice dated August 14, 2003 and the DUNS Q&A; (MS Word) document for more information.

See FAQs: Revised PHS 398 and PHS 2590 Forms and Instructions (PDF or RTF) for detailed information on using the new fillable PDF forms and other important information.

Instructions For Downloading Documents and Electronic Forms are also available with help on downloading and processing (printing and viewing) Acrobat and other files. Acrobat Reader software, which is free, must be obtained in order to view and print Acrobat files. Please see the Adobe Acrobat or PDF Forms section for information on using the fillable PDF forms.

NOTE: Other software packages for completing these applications may be available from other sources; however, it is essential that the type size and format specifications are met or the application will be returned without review.

DISCLAIMER: Reference to these software packages neither constitutes nor should be inferred to be an endorsement or recommendation of any product, service, or enterprise by the National Institutes of Health, any other agency of the United States Government, or any employee of the United States Government. No warranties are stated or implied.

The files from the FTP and HTTP links above are identical. The FTP links provide a faster connection for downloading. However, if your browser experiences problems using these links, please try the HTTP links as an alternative. Note that, regardless of which links you select, these files are very large and may take a few minutes to download.

Table of Contents

***********IMPORTANT CHANGES AND REMINDERS**********

IMPORTANT CHANGES

INVESTIGATORS SHOULD BOOKMARK THIS WEBSITE AND CHECK IT FOR UPDATED INSTRUCTIONS AND POLICY INFORMATION PRIOR TO SUBMISSION OF APPLICATIONS.

Format and Availability

The PHS 398 grant application instructions are available electronically in Rich Text File (RTF) and Portable Document File (PDF) format. The Table of Contents includes direct links to specific sections of the document, and text searches are possible using the "CTRL-F." Moreover, the revised format includes dynamic website links and cross-references, which enable readers to easily navigate through sections the document. The PHS 398 forms have been modified to enable the fields to be filled in directly using word processing programs (RTF) or Adobe Acrobat Reader software (PDF).  Note:  Form pages prepared using PDF documents can be saved only if you have obtained Adobe Acrobat.  

Application Forms

Note:

All Form Pages and Format Pages have been renumbered.

Form Page 1: Face Page
Items for Social Security Number and Organizational Code have been eliminated.

Human Subjects Research box (Item 4) has been modified as follows:

      4a: No/Yes check boxes for “Research Exempt”
      4b: Human Subjects Assurance Number
      4c: No/Yes checkboxes for Phase III Clinical Trial

Modular Budget Format Page: Budget Justification Page for Modular Research Grant Applications.
A format page and specific instructions for preparing Modular Grant Applications are provided.

Biographical Sketch Format Page:
A standardized format for the Biographical Sketch (maximum of four pages for each key person) will be used for all (modular and other) research grant applications. A format page, including a sample biographical sketch, has been developed.

Resources Format Page:
A format page has been developed. See Section I, Item 7.

Checklist Form Page:
Assurances and Certifications. This section has been updated to include Research on Transplantation of Human Fetal Tissue; Women and Minority Inclusion Policy; Inclusion of Children Policy; Research Using Human Embryonic Stem Cells; Non-Delinquency on Federal Debt; Recombinant DNA; and for STTR only, Certification of Research Institution Participation. See Section III. G, "Assurances and Certifications .”

Facilities and Administrative (F&A) costs. This section includes spaces to calculate F&A costs for the initial year through the entire budget period. (F&A costs were formerly referred to as Indirect Costs for some types of applications.)

Other Support Format Page:
A standardized format for the Other Support information will be used for all (modular and other) research grant applications. Do NOT submit Other Support information with the application. NIH staff will request this information at an appropriate time after peer review. See Section III-B.

Appendix Material:
Applicants may ONLY include manuscripts that have been accepted for publication. Manuscripts submitted for publication may no longer be included. See Section I-9.

Instructions

Human Subjects Research

Specific instructions regarding the use of human subjects in research, including new format pages for Women and Minority Inclusion enrollment and reporting and instructions regarding inclusion of a Data and Safety Monitoring Plan for clinical trials. Information about inclusion of women, minorities, and children are no longer part of the 25-page limit of the research plan. See Section I-8, Item E.

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Programs

PHS 398 Application Forms and Instructions incorporate the SBIR and STTR Grant Programs. See instructions in Section VI.

reminders

• Type size and format specifications must be followed or the application will be designated as incomplete and will be returned to the applicant organization without peer review.
  
• Prepare a succinct Research Plan. There is no requirement for applicants to use the maximum allowable pages allotted to the Research Plan (Items a-d).
  
• Required Education in the protection of human research subjects (submitted prior to award.) See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Notable Changes Made to PHS 398 Form Pages (Revised 05/2001):

September 9, 2003 Changes:
• The following form pages have been reloaded:
  • checklist.pdf - added important help note to enter rate as a decimal
  • 398_forms.pdf - combined file with replaced checklist page
  • biosketch.pdf - bookmark link to biosketch sample page changed from .rtf to .pdf
  • biosketchsample.pdf - added PI Name into header and page number into footer to resemble actual biosketch format page.

August 29, 2003 Changes:
• Shading was removed from the fillable form fields in the PDF files. This was to correct the problem when JavaScript was disabled or not supported, the forms fields would print with shaded backgrounds, rendering them unable to be scanned by NIH staff. Also, see the 08/29/2003 NIH Guide Notice for information on the Update of the PHS 398, 2590 and 416 Forms.

August 1, 2003 Changes:
• All forms have been modified to be more compatible with existing software and Microsoft Word (MS Word) files have replaced previous versions of Rich Text Format (RTF) files. In addition, links in the instructions have been updated to reflect these changes.

June 28, 2002 Changes:
• PHS 398 instructions have been updated to clarify instructions for research involving human subjects and for "Other Support" on Research Career Awards. The updates are marked in purple to make them more easily identifiable. The PHS 398 Form, Replacement of RCA Substitute Format Page 3, has been updated to clarify placement of Other Support. Update: See the July 2, 2002 NIH Guide Notice for further information on these changes.

May 3, 2002 Changes:
PHS 398 Forms/Format Pages have been reloaded due to very minor, but necessary, formatting adjustments, as follows:

RTF Files

• We have removed the scanning symbols (circular bullets in the headers and square bullets in the footers).
• RCA Form Page 3 has been clarified to indicate placement of "Other Support" for the Mentor (not the candidate).
• We have inserted a watermark on the Biographical Sketch Sample Page to emphasize that this is just a sample.

PDF Files

• In addition to the removal of the symbols in the headers and footers, we have made improvements to the form fields tab order to facilitate easier navigation through the form.

January 25, 2002 Changes:
• In the individual files, we have separated the fillable Biographical Sketch Format Page from the Biographical Sketch Sample for your convenience.
• See Form Page 3 for placement of modular budget.

January 18, 2002 Changes:
• PHS 398 Forms/Format Pages have been reloaded due to necessary formatting adjustments of margins, headers and footers. Applicants who are experiencing problems with printing the forms are encouraged to use these forms. If you have not encountered printer errors, you may continue using the set of forms previously posted. Institutions may want to link to the PHS 398 Forms and Instructions page rather than maintaining copies of forms on internal web sites, to be sure the most current forms are available for applicants. The following changes were made:



• Margins. The margins on the Face Page have been set to 0.5" (top, bottom, left, right and header) and 0.40" (footer). Margins for all other Form/Format pages have been set to 0.5" (top, bottom, left, right, header and footer).
• Printing. If comments print, check to be sure that printer is set to "Print Document."



• NIH Guide Notice (January 11, 2002) : Specific updates made to the PHS 398 instructions:



• Instructions for preparing the budget section have been clarified in the section for preparing Modular and non-modular grant applications.
• Instructions in the "Human Subjects Research" section have been updated:
• The 398 instructions reflect the requirements for race and ethnicity data that were announced in August of 2001, "NIH POLICY ON REPORTING RACE AND ETHNICITY DATA: SUBJECTS IN CLINICAL RESEARCH," located at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html
• The 398 instructions include reference to changes to 45 CFR 46, effective 12/13/2001, which provide additional protections for pregnant women and human fetuses involved in research, found at http://www.hhs.gov/ohrp
• Instructions include assurance of compliance if research involves stem cells
• Instructions for budget requests greater than $500,000 direct costs in a single year reflect the "REVISED POLICY ON THE ACCEPTANCE FOR REVIEW OF UNSOLICITED APPLICATIONS THAT REQUEST $500,000 OR MORE IN DIRECT COSTS", effective January 1, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html
• The sample biographical sketch aligns with the instructions. Note: percent effort and amount of award are not to be included.
• Instructions for preparing SBIR/STTR applications have been clarified in the section for preparing Modular and non-modular grant applications.

January 10, 2002 Changes:
• PHS 398 and PHS 2590 Forms/Format Pages have been reloaded due to necessary formatting adjustments.

December 11, 2001 Changes:
• The PHS 398 Forms (RTF Full Set only) have been replaced. Headers and Footers. For any page on which you wish to edit a Header or Footer, select "Unprotect Document" on the Tools menu, double-click in the Header/Footer, and enter your text. Note: The Principal Investigator's name will automatically carry to Form/Format Pages that have the same header. Re-protect Form/Format pages by selecting "Protect Document for Forms" on the Tools menu.

November 30, 2001 Changes:

• PHS 398 and PHS 2590 General Instructions Read and follow the instructions carefully to avoid delays, misunderstandings and possible return of applications. NOTE: SBIR/STTR applicants should refer to Chapter VI of the PHS 398 instructions prior to preparing an application.

  The PHS 398 and PHS 2590 Rich Text File (RTF) and Portable Document File (PDF) Form pages as provided are acceptable by NIH. All other sections of the application (e.g., Biographical Sketch, Introduction, if necessary, and the Research Plan must conform to the following four requirements: 1. The height of the letters must not be smaller than 10 point; Helvetica or Arial 12-point is the NIH-suggested font. 2. Type density, including characters and spaces, must be no more than 15 characters per inch (cpi). 3. No more than 6 lines of type within a vertical inch; 4. Margins, in all directions, must be at least ½ inch.

  You may substitute computer-generated facsimiles for government-printed forms; however, they must maintain the exact wording and format of the government-printed forms, including all captions and spacing. The PHS 398 and 2590 includes Form Pages and Format Pages. The format pages are intended to assist you in the development of specific sections of the application. Format Pages have been left "unprotected" to allow you to format text, insert graphics, diagrams, or tables. Alternatively, you may create a page similar to the format provided and inclusive of requisite information.

November 21, 2001 Changes:
• An HTML version of the PHS 398 Instructions have been added to this page and the PHS 398 Forms/Format Pages have been reloaded due to necessary formatting adjustments.

October 18, 2001 Changes:
• PHS 398 Forms/Format Pages have been reloaded due to necessary formatting adjustments.

October 10, 2001 Changes:
• PHS 398 Forms/Format Pages now available as a Rich Text Format (RTF) or Portable Document Format (PDF).
• PHS 398 Form Page 1 (PDF) has been reloaded due to necessary formatting adjustments.
• See October 10, 2001 NIH Guide Notice for details.

July 27, 2001 Changes:
• PHS 398 Form/Format Pages have been reloaded due to necessary formatting adjustments.
• Instructions on the Personal Data Page have been clarified.

July 23, 2001 Changes:
• Guidance for Preparing the Human Subjects Research Section (see pp. 19 and 24)
• Table 2. Receipt, Review and Award Cycles: Dates organized chronologically. Research Career Award receipt dates have been corrected. (see p. 31)
• All PHS 398 Form Pages have been reloaded.

August 8, 2001 Changes:
• PHS 398 Checklist and Continuation Form/Format Pages have been reloaded due to necessary formatting adjustments.

Note: If you need help accessing any files above that are labeled as PDF, RTF, MS Word, Excel, PowerPoint or RealPlayer, see Instructions For Downloading Documents and Electronic Forms.