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

# Grant ApplicationPHS 398 (Revised 03/2020)

**All notable changes made to PHS 398 instructions and form pages are listed at the bottom   of this page (updated 03/16/2021).**

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## Downloadable Instructions and Form Files  

### PHS 398 Instructions - 3/2020   Revision            PDF (454  KB)

### PHS 398 Fillable Forms - 3/2020  Revision

The links below allow for the downloading of individual and combined form files in MS Word and PDF formats. Some  of the  files are large and may take a few minutes to download.
| 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 How to Apply - Application Guide for appropriate formats to be used for electronic submission. |
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| Form Page 1:  Face Page                                                                                                                                                                                                                                                                                                                                                                                           | MS Word | PDF (414 KB) |
| Form Page 1-continued:  Additional form for use **only** if Multiple PD/PIs are proposed. Do **not** include if submitting a single-PD/PI application.                                                                                                                                                                                                                                                            | MS Word | PDF (434 KB) |
| Form Page 2:  Summary, Relevance, Project/Performance Sites,  Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells                                                                                                                                                                                                                                                                | MS Word | PDF (565 KB) |
| Project/Performance Site Format Page - use only if additional space is needed.                                                                                                                                                                                                                                                                                                                                              | MS Word | PDF (282 KB) |
| Form Page 3:  Research Grant Table of Contents                                                                                                                                                                                                                                                                                                                                                                    | MS Word | PDF (273 KB) |
| Form Page 4:  Detailed Budget for Initial Budget Period                                                                                                                                                                                                                                                                                                                                                           | MS Word | PDF (210 KB) |
| Form Page 5:  Budget for Entire Proposed Project Period                                                                                                                                                                                                                                                                                                                                                           | MS Word | PDF (342 KB) |
| Resources Format Page                                                                                                                                                                                                                                                                                                                                                                                                       | MS Word | PDF (281 KB) |
| Checklist Form Page                                                                                                                                                                                                                                                                                                                                                                                                         | MS Word | PDF (528 KB) |
| Continuation Format Page                                                                                                                                                                                                                                                                                                                                                                                                    | MS Word | PDF (224 KB) |
| PHS Human Subjects and Clinical Trials Information                                                                                                                                                                                                                                                                                                                                                                          |   | PDF (118 KB) |
| Mailing Address                                                                                                                                                                                                                                                                                                                                                                                                             | MS Word | PDF (27 KB) |
| All Personnel Report Format Page                                                                                                                                                                                                                                                                                                                                                                                            | MS Word | PDF (281 KB) |
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### Other Support: see http://grants.nih.gov/grants/forms/othersupport.htm

### Biosketches: see http://grants.nih.gov/grants/forms/biosketch.htm

Biosketch FAQs

#### For Questions Related to:

      - Application Procedures/Forms Submission:  contact GrantsInfo at  grantsinfo@nih.gov 	  or 301-480-7075.

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.

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## Notable Changes Made to PHS 398

***03/2021*****Form Page 4: Detailed Budget for Initial Budget Period**
      - Fixed the Row 7 Total field in the Personnel section; it is an editable form field.

***03/2020***Updated the OMB expiration date to 2/28/2023. **PHS Human Subjects and Clinical Trials  Information form**
      - Changes were made to the form’s organization in the following  sections: 
      Who should use the PHS Human Subjects and Clinical Trials  Information form 
Using the PHS Human Subjects and Clinical Trials Information  form 
Use of Human Specimens and/or Data 

      - Clarified and updated instructions throughout. Significant  changes were made for the following fields: 
      “Provide the ClinicalTrials.gov Identifier” 
“Section 2 – Study Population Characteristics” instructions now  reflect updated exceptions for required questions. 
Study Timeline 
Section 3.2: "Is this a multi-site study that will use the  same protocol to conduct non-exempt human subjects research at more than one  domestic site?" - reflect updated instructions. 
“Data and Safety Monitoring Plan” attachment 

      - Updated instructions for delayed onset studies regarding use of  single IRB. 
      - Added new “Inclusion of Individuals Across the Lifespan”  attachment. 
      - Updated instructions for the “Inclusion of Women and Minorities”  attachment to reflect separate “Inclusion of Individuals Across the Lifespan”  attachment. 
      - Added new “Inclusion Enrollment Report Title” field. 
      - Removed the “Brief Summary” field. 
      - Changed the “Narrative Study” field to “Detailed Description.” 
      - Updated instructions to Section 3.2 "Is this a multi-site  study that will use the same protocol to conduct non-exempt human subjects  research at more than one domestic site?" and the single IRB plan  attachment. Included instructions specific for AHRQ applicants. 
      Included instructions  specific for AHRQ applicants to Section 3.3 "Data and Safety Monitoring  Plan." 

      - Added new "Is this an applicable clinical trial under  FDAAA?" field. 
      - Renumbered form fields. 

**01/25/2018**
**Biographical Sketch**
- Updated biosketch instructions so that scholastic  performance requires only scientific/professional graduate courses to be listed

**Research Plan**
- PHS Inclusion Enrollment Report: Discontinued use  (data collection moved to new PHS Human Subjects and Clinical Trials Information  form)

PHS Human Subjects and Clinical Trials  Information form   
- There is a  new form  for consolidated human subjects,  inclusion enrollment report, and clinical trial information.
- Includes attachment to comply with  NIH Policy on the Use of a Single Institutional Review Board  for Multi-Site Research . 
- Includes the updated appendix policy that  eliminates clinical trial-related materials. See the NIH Guide Notice  on  Allowable Appendix Materials  for more  information.

Go   to NIH Forms and Applications Page