U.S. Department of Health and Human Services
Public Health Service
Grant Application
PHS 398 (Revised 9/2004, Interim Revision 4/2006)
See the 4/7/2006 NIH Guide Notice NOT-OD-06-056 for important changes to this version.
All notable changes made to PHS 398 form pages are listed at the bottom of this page (Updated 1/14/2008).
Downloadable Instructions and Form Files
Some of the MS Word and PDF files are large and may take a few minutes to download.
PHS 398 Instructions - 4/2006 Revision
These instructions are to be used for all PHS 398 applications submitted for submission/receipt dates on or after May 10, 2006. See NIH Guide Notice NOT-OD-06-056.
This edition of the PHS 398 has been organized into three distinct parts, each of which is available as a separate file in the MS Word and PDF versions. Principal investigators and institutions will need to use all three parts of the instructions in order to prepare a complete and acceptable application.
| PHS 398 Instructions Files | |||
|---|---|---|---|
| Part I, Instructions | MS Word | Flash or HTML |
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| Part II, Human Subjects Research Supplement | MS Word | ||
| Part III, Policy, Assurances, Definitions | MS Word | ||
If the links between the three parts do not function properly when using the MS Word and PDF versions of these instructions, save the three files to your hard drive (see Saving Files Locally), rather than opening them in your browser. Be sure that the three files are saved to the same folder/directory.
PHS 398 Fillable Forms - 4/2006 Revision
Note while a number of the form pages have been revised 4/2006, not all form and format pages have been revised. The forms provided below include a mix of forms with the 'Rev. 4/06' and 'Rev. 9/04, Reissued 4/2006' revision dates. For those form pages that have been revised with the 4/06 date, these new versions are required to be used in all applications submitted for submission/receipt dates on or after May 10, 2006. For form and format pages showing the 'Rev. 9/04, Reissued 4/2006' note, no data fields on these have actually changed; therefore, applicants may continue to use existing Rev. 9/04 versions, even if they do not include the "Reissued 4/2006" reference. See NIH Guide Notice NOT-OD-06-056.
The links below allow for downloading of individual and combined form files in MS Word and PDF formats. Please see the Adobe Acrobat or PDF Forms section of the "Help Downloading Files" page for information on using the fillable PDF forms.
| Fillable Individual PHS 398 Forms (These forms are to be used only with paper submissions using the PHS 398. Do not use the PDF samples provided below in an SF424 (R&R) application. These are fillable PDF forms which will cause an error in the electronic submission of an SF424 (R&R) application. See the SF424 (R&R) application page for appropriate formats to be used for electronic submission.) |
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|---|---|---|
| Form Page 1: Face Page | MS Word | |
| Form Page 1-continued: Additional form for use only if Multiple PIs are proposed. Do not include if submitting a single-PI application. | MS Word | |
| Form Page 2: Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells | MS Word | |
| Form Page 3: Research Grant Table of Contents | MS Word | |
| Form Page 4: Detailed Budget for Initial Budget Period | MS Word | |
| Form Page 5: Budget for Entire Proposed Period of Support | MS Word | |
| Modular Budget Format Page | MS Word | |
| Modular Budget Sample: Same Modules | MS Word | |
| Modular Budget Sample: Variable Modules | MS Word | |
| Biographical Sketch Format Page | MS Word | |
| Biographical Sketch Sample | MS Word | |
| Resources Format Page | MS Word | |
| Checklist Form Page | MS Word | |
| Personal Data Form Page | MS Word | |
| Continuation Page | MS Word | |
| Targeted/Planned Enrollment Table Format Page | MS Word | |
| Inclusion Enrollment Report Format Page | MS Word | |
| Mailing Address and RFA Labels | MS Word | |
| Other Support Format Page: Example | MS Word | |
| Personnel Report Format Page | MS Word | |
| Fillable Research Career Development Award Forms | ||
| Substitute Form Page 3: Research Career Development Award Table of Contents | MS Word | |
| Research Career Development Award Reference Guidelines | MS Word | |
| Fillable Institutional National Research Service Award (NRSA) Forms | ||
| Substitute Table of Contents for Institutional NRSA | MS Word | |
| Substitute Detailed Budget for Initial Budget Period Direct Costs | MS Word | |
| Substitute Budget for Entire Proposed Period of Support Direct Costs | MS Word | |
| Small Business Innovation Research (SBIR)/
Small Business Technology Transfer (STTR) Forms IMPORTANT CHANGE: For submission dates on or after 12/1/2005, SBIR and STTR Applications MUST be submitted electronically using the SF424 (R&R) Forms. |
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| Combined PHS 398 Forms File
Does NOT include the Biographical Sketch page, Continuation Page, or any of the Sample/Example pages (Biosketch Sample, Other Support Sample). See Individual Form file links above. |
Combined PHS 398 Form Files (MS Word) |
Combined PHS 398 Form Files (PDF) |
For Questions Related to:
- Application Procedures/Forms Submission: contact GrantsInfo at grantsinfo@nih.gov or 301-435-0714.
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. Otherwise, application processing may be delayed, or the application may be returned to the applicant 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.
Notable Changes Made to PHS 398
- PHS 398 Instructions have been revised to clarify the definition of new investigator. In addition, the following recent policy changes are incorporated: 1) Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088; and 2) ClinicalTrials.gov Requirements, NIH Guide NOT-08-023 (1/14/2008).
- The PHS398 Instructions have been revised to clarify Instructions for Preparing an NRSA Application, Detailed Budget, Training Related Expenses (6/19/2007).
- The PHS398 Instructions have been revised. 1) The New Investigator definition has been revised to reflect current NIH policy; 2) Multiple PI instructions have been revised to clarify applicability now that the pilot is complete; and, 3) Appendix instructions have been revised for clarity--no additional policy changes are involved (4/19/2007).
- The PHS398 instructions have been revised to reflect recent changes in policy including: 1) broader implementation of the Multiple PI initiative (NOT-OD-07-017); 2) revised submission dates (NOT-OD-07-001); and, 3) updated Appendix instructions (NOT-OD-07-018). Instructions on the Biosketch Sample have also been revised to indicate that for all publicly available citations, URLs or PubMed Central submission identification numbers may now accompany the full reference. Finally, on the Career Development Award Table of Contents, another option has been added to the Citizenship section to accommodate a programmatic requirement for the K99 program (11/15/06).
- The PHS 398 has been revised to reflect the implementation of the new tuition, fees, and health insurance policy (See NOT-06-093). Also the Budget (Form Page 4) and Personnel Report Form Pages have been revised to clarify that "Sum" means "Summer" (9/8/06).
- Do not use the PDF samples provided above in an SF424 (R&R) application. These are fillable PDF forms which will cause an error in the electronic submission of an SF424 (R&R) application. See the SF424 (R&R) application page for appropriate formats to be used for electronic submission. Form Page 1-continued is provided for use only if Multiple PIs are proposed. Do not include if submitting a single-PI application (6/12/06).
- Links to the Rev. 9/04 instructions and form pages have been removed. The instructions provided above are to be used for all PHS 398 applications submitted for submission/receipt dates on or after May 10, 2006. The forms provided above include a mix of forms with the 'Rev. 4/06' and 'Rev. 9/04, Reissued 4/2006' revision dates. For those form pages that have been revised with the 4/06 date, these new versions are required to be used in all applications submitted for submission/receipt dates on or after May 10, 2006. For form and format pages showing the 'Rev. 9/04, Reissued 4/2006' note, no data fields on these have actually changed; therefore, applicants may continue to use existing Rev. 9/04 versions, even if they do not include the "Reissued 4/2006" reference. See NIH Guide Notice NOT-OD-06-056 (5/15/06).
- Footers in the form and format pages that were not revised in 4/06 have been modified to show 'Rev. 09/04, Reissued 4/2006' (5/3/06).
- Interim Revision 4/2006 - This interim revision implements a number of new and/or changing business processes: 1) Replacing the PI signature on the application with an Institutional compliance requirement; 2) Changes in measure for reporting effort devoted to a project from percent effort to person months; 3) Changing the requirements for including publications as appendix material; 4) Implementing multiple Principal Investigators for NIH grants; 5) Implementing specific requirements for Select Agent Research; 6) Modifying the requirements for Biographical Sketch; and 7) Harmonizing the PHS398 & SF424 (R&R) instructional text and removing data collection and instructions for those mechanisms that have transitioned to the SF424 (R&R) application and electronic submission. See the 4/7/2006 NIH Guide Notice for important details regarding changes made to this version (4/7/06).
- Revisions have been made in Part III to update contact information for The Office of Research Integrity and the Office of Human Research Protections (1/26/06).
- SBIR/STTR forms have been removed. For submission dates on or after 12/1/2005, SBIR and STTR Applications MUST be submitted electronically using the SF424 (R&R) Forms.
Implementing OHRP policy, all references to MPAs and CPAs have been removed from instructional text (12/13/05). - The following revisions have been made in the PHS 398, Part I, Instructions:
- Instructions for Revised Applications have been modified to remove the R03 exclusion from the guidelines on submission of up to two revised applications. See NIH Guide Notice, NOT-OD-05-046, for policy changes regarding the number of revisions for R03s.
- The "Submission Dates, Review, and Award Cycles" Table has been updated to reflect editorial changes in order to make the postmark/submission information more user-friendly (6/13/05).
- Minor formatting revisions have also been made to the following form pages to improve usability:
- Form Page 3, Introduction to Revised Application for SBIR/STTR Phase I has been clarified.
- Form Page 4, formatting of form fields in "% Effort on Project" column has been changed to allow insertion of asterisk.
- Biographical Sketch Format Page, instructions have been added for completing Sections A, B, and C.
- Biographical Sketch Sample, Project Period dates in Completed Research Support samples have been revised to reflect end dates within the last 3 years (6/13/05).
- Revisions have been made in the PHS 398, Part II, Human Subjects Research Supplement, to further address "How can you determine whether research that involves only the use of specimens and/or data from pathology archives or a specimen bank and/or data repository is human subjects research?" (4/26/05).
- Revisions have been made in the PHS 398 to specify additional acceptable font typefaces (Arial, Helvetica, Palatino Linotype or Georgia are now acceptable); to provide clearer budget guidance for applications that include consortium F&A costs; and to clarify format requirements for Appendix material (Appendix material may be two-sided). See the NIH Guide Notice for details regarding revisions made. Minor formatting revisions have been made to some form pages to improve usability (3/16/05).
- Revisions have been made in the PHS 398, Part II, Human Subjects Research Supplement, to further address NIH implementation of OHRP Guidance on research involving coded private information or biological specimens. Notable changes in content have been marked in purple. Minor revisions and formatting changes have been made in the PHS 398, Parts I and III (1/20/05).
- Chapter V of the PHS 398 has been revised to reflect that the modular budget format no longer applies to SBIR/STTR grant applications (1/14/05).
- Significant revisions have been made in the PHS 398, Part II, Human Subjects Research Supplement, to address NIH implementation of OHRP Guidance on research involving coded private information or biological specimens. Notable changes in content have been marked in purple. Minor revisions and formatting changes have been made in the PHS 398, Parts I and III. On Form Page 3, Research Grant Table of Contents, the ordering of items in the Research Plan has been revised (12/30/04).
- Page numbering on Form Page 2 and Form Page 2-continued has been changed to Page 2 and Page 3. Be sure to number all pages in application sequentially (11/23/04).
- Clarification of font and format specifications (11/17/04).
- New PHS 398 (Rev. 9/04) instructions and forms posted 11/02/2004. See the 11/2/2004 NIH Guide Notice for important details regarding changes made to this version.
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