Contents 1 NIH Guidelines & Forms 1.1 NIH Guidelines 1.1.1 SF 424 (R&R) 1.1.2 PHS 398 1.2 NIH Forms

NIH Guidelines & Forms

NIH Guidelines

SF 424 (R&R)

• The SF424 (R&R) is used for electronic submissions (AKA e-Submission) of New, Renewal, and Resubmission proposals and is gradually replacing the PHS 398.It was most recently revised on 7/25/2011. Here is the link to the guidelines: SF 424 (R&R) Adobe Forms B Application Guide
• Enhancing Peer Review
  • Link to Shortened/Restructured Applications
  • Link to [1] Training & Communication]
    • This site contains outreach, one-page fliers, videos, PowerPoint Presentations, and other supporting materials to assist you with the new NIH submission processes and application packages.
• Notable Changes to the SF 424 (R&R) Application Guide & Forms (rev. 11/24/2010): Application Guide has been updated for the transition to modified the Adobe B1 form series, which includes bug fixes & minor modifications to the R&R Other Project Information and Project/Performance Site Location forms. Also includes clarifications regarding elimination of the error correction window, clarification to the policy on post-submission application materials, simplified instructions for the Research Training Program Plan data tables, revised instructions for the Responsible Conduct of Research in the Research Training Program Plan, as well as various other updates.
• Notable Changes to the SF 424 (R&R) Application Guide & Forms (rev. 12/22/2009): The General Adobe-B Application Guide has been updated to include revised instructions for addressing the Responsible Conduct of Research in grant applications, clarifying how preliminary studies and data should be provided in the Research Strategy, changing instructions for providing indirect cost information for application that use both the R&R Budget and PHS 398 Training Budget forms, and revising instructions for submitting applications proposing human Embryonic Stem Cells. A description of the more notable edits is attached (MS Word - 67 KB). Application Guides for SBIR/STTR and Fellowship applications are still being revised and will be updated soon.
• Notable Changes to the SF 424 (R&R) Application Guide & Forms (rev. 11/13/2009): The General Application guide has been updated for the transition to Adobe Forms B. This includes changes to the SF424 (R&R) form instructions necessitated by the June, 2008 OMB renewal of the forms, which includes changes to assist agencies implementing the Federal Funding Accountability and Transparency Act. Changes have also been made to various PHS398 forms as part of the NIH initiative to enhance peer review. Changes to the PHS398 forms were approved by OMB in June, 2009. This version of the application guide now also includes a separate instruction section for Institutional Training Grants to accommodate their transition to electronic submission effective with submissions on/after January 25, 2010. Application Guides for SBIR/STTR and Fellowship applications will be updated soon.

PHS 398

PHS 398 (rev. 06/2009): Link to PHS 398 Application Guide.

• Applies to all mechanisms that do not use the SF 424 (R&R) for New, Renewal, and Resubmission proposals with due dates on or after January 25, 2010 (AKA Paper Submission).
• Notable Changes to the PHS 398 Guide & Forms (rev. 06/2009): The PHS 398 instructions pertain to applications for research project grants that have not transitioned to electronic submission using the SF424 (R&R) [p. I-12]. This edition of the PHS 398 implements a number of important policy changes, including NIH Policy for Sharing of Data Obtained in NIH-Supported or Conducted Genome-Wide Association Studies (GWAS), and registration of clinical trials in ClinicalTrials.gov as required by Public Law 110-85. Focus of review for the PHS 398 Instructions for HS Departments and HS SPPO is mainly with regards to Section # This section focuses on the preparation of the PHS 398 application and submission.

both SR424 (R&R) & PHS 398 *Guide & Forms* Notable Changes:

• Research Strategy - Research Plan: The science portion of the Research Plan section of the application has been revised. The Research Strategy replaced Background and Significance; Preliminary Studies/Progress Report; ad Research Design and Methods. One PDF will not be uploaded to replace these three sections. Specific Aims is still included, but now is separate from the page limitations of the Research Plan. Per NIH, the single attachment for the Research Strategy "increases the applicant's control over the look and feel of the application."
  • Use the following sub-headings for the new Research Strategy section of the application:
    • Research Strategy
      • 1. Significance
      • 2. Innovation
      • 3. Approach
        • a. Preliminary Studies for New Applications.
        • b. Progress Report for Renewal/Revision
  • Structuring the Research Strategy Section of Your Application

OLD NUMBERING SYSTEM	NEW NUMBERING SYSTEM
1. Introduction	1. Introduction
2. Specific Aims	2. Specific Aims
3. Background & Significance	3. Research Strategy
4. Preliminary Studies/Progress Report	4. Inclusion Enrollment Report (Renewal or Revision applications only)
5. Research Design & Methods	5. Progress Report Publication List
6. Inclusion Enrollment Report (Renewal or Revision applications only)	6. Protection of Human Subjects
7. Bibliography & References Cited/Progress Report Publications List	7. Inclusion of Women & Minorities
8. Protection of Human Subjects	8. Targeted/Planned Enrollment Table
9. Inclusion of Women & Minorities	9. Inclusion of Children
10. Targeted/Planned Enrollment Table	10. Vertebrate Animals
11. Inclusion of Children	11. Select Agency Research
12. Vertebrate Animals	12. Multiple PD/PI Leadership Plan
13. Select Agent Research	13. Consortium/Contractual Arrangements
14. Multiple PD/PI Leadership Plan	14. Letters of Support
15. Consortium,/Contractual Arrangements	15. Resource Sharing Plan(s)
16. Letters of Support (e.g., Consultants)	16. Appendix
17. Resource Sharing Plan(s)
18. Appendix

• Biographical Sketch Revisions
  • A Personal Statement has been added to the Biographical Sketch. The Personal Statement briefly describes your experience and qualifications that make you particularly well-suited for your assigned role in the project.
  • The Publications section is now limiting the number listed to no more than 15. It is requested the selections be based on recency, importance to the field, and/or relevance to the application.
  • Link to Sample Biographical Sketch.
• Resources Revisions
  • Other Project Information, Item 10
  • Now you are required to provide a description of how the scientific environment will contribute to the probability of success to the project (e.g., institutional support, physical resources, and intellectual rapport). In describing the scientific environment in which the work will be done, discuss ways in which the proposed studies will benefit from unique features of the scientific environment or subject populations or will employ useful collaborative arrangements.
  • With regards to Early Stage Investigators (ESIs), you are required to additionally describe the institutional investment in the success of the investigator.
• Select Agents Research Revision
  • If applicable, you are to describe the biocontainment resources available at all performance sites.
• NEW PAGE LIMIT REVISIONS!!!

Old Page Limits (Research Plan - Items 2-5)	New Page Limits (Research Strategy - Item 3) *
<25 pages	6 pages
25 pages	12 pages
>25 pages	Follow the FOA Instructions
Section of Application with Page Limits	Page Limits
Introduction to Resubmission Application - For all Activity Codes, except Training (T&D) and K12	1 page
Introduction to Resubmission Application -For Training (T), D43, D71, and K12	3 pages
Introduction to Revision Application - For all Activity Codes	1 page
Specific Aims - For all Activity Code that use an application form with the Specific Aims section	1 page
Research Strategy - For Activity Codes R03, R13/U13, R21, R36, R41, R42, Fellowships (F), SC2,SC3	6 pages
Research Strategy - For Activity Codes R01, single project U01, R10, R15, R18, U18, R21/R33, R34, R42, R44, DP3, G08, G11, G13, UH2, UH3, SC1	12 pages
Research Strategy - For each Project of a multi-component applications, such as Program Project/Center (P) applications	12 pages
Research Strategy - For each Core of a multi-component applications, such as Program Project/Center (P) applications	6 pages
Research Strategy - For all other Activity Codes	Follow FOA Instructions
Combined Candidate Information and Research Strategy	12 pages
Program Plan - For Institutional Career Development and Research Training Awards, including K12, Ruth # Kirschstein Institutional NRSA Applications, D42, D71, and R25	25 pages
Biographical Sketch -For all Activity Codes except DP1 and DP2 (unless otherwise stated in FOA, i.e. ARRA funding)	4 pages
Biographical Sketch - For DP1 and DP2	2 pages

PHS 2590 (rev. 06/2009): Link to PHS 2590 Application Guide.

• Applies to Non-Competing Continuation Progress Reports.
• Notable Changes to the Revised PHS 2590 Guide & Forms (rev 06/2009):
  • Biographical Sketch Revisions
    • A Personal Statement has been added to the Biographical Sketch. The Personal Statement briefly describes your experience and qualifications that make you particularly well-suited for your assigned role in the project.
    • The Publications section is know limiting the number listed to no more than 15. It is requested the selections be based on recency, importance to the field, and/or relevance to the application.
    • Link to Sample Biographical Sketch.
  • Progress Report Summary Revisions
    • New - Item E. Embryonic Stem Cell Line(s)
      • Section D. Plans - need to check the above box yes or no if there are any changes in stem cell, including use of a different line then what was originally proposed.
    • New - Inclusion of Changes to Innovate Potential
      • Section B. Studies and Results - PD/PIs are asked, if applicable, to address any changes to the innovative potential of the project. This information is not part of the Progress Report Summary.
      • Include an explanation of how research plans differ, and if different cell lines are to be used, provide the cell line number(s)/ Only cell lines listed on the NIH hESC Registry as approved for use in NIH funded research may be used.
    • The All Personnel Report has replaced the Senior/Key Personnel Report.
      • List all personnel (salaried and unsalaried) for the current budget period who participated in the project for at least one person month or more. A person month equals approximately 160 hours or 8.3% of annualized effort. This includes undergraduate and graduate students. NOte - a student's effort needs to be shown acadmic months and/or summer months only.
      • An eRA Commons ID is required for all PD/PIs and all individuals with a postdoctoral role.
      • Other Significant Contributors (OSCs) should NOT be included unless their role has changed.
    • Changes to the Training Grant Progress Report
      • Link to NOT-OD-09-141
      • New Assurance for Institutions Receiving Awards for Training of Graduate Students for Doctoral Degrees. This is a new requirement for Graduate Student Assurance, NIH Reform Act of 2006 (P:L. 109-482).
        • NOTE - Table 12A - Predoctoral Trainees Supported by this Training Grant - needs to be completed and included in the annual progress reports. It has been modified to collect data related to the Graduate Student Assurance requirement.

NIH Forms

• SF 424 (R&R) ( *rev. 11/24/2010* ): NIH requires all text attachments in an SF424 (R&R) application to be PDF. However, to avoid system errors, applicants should create text attachments using word processing software and then convert to PDF using PDF-generating software, such as Adobe Acrobat. While Word samples are provided below, applicants will need to convert the finished product to PDF before attaching within an SF424 (R&R) application. Do not use the PDF samples from the PHS398 application page. Those are fillable-PDF forms which will cause an error in the electronic submission of an SF424 (R&R) applications.
  • NIH Adobe Forms B Application Walk-Through: NIH Adobe Forms B Application Walk-Through w/ Instructions from SF 424 (R&R) Guidelines attached to each appropriate section of the application.
  • Link to NIH_eRA_Items_of_Interest_1-12-2010.pdf. In the Weeds is an informational email that was sent out by NIH eRA Items of Interest - January 12, 2010 email. It goes in depth on the changes that have occurred with the new forms. It is highly suggested you download and read this informational email before you start work on your first Adobe-Forms-B application!
  • Link to Sample SF 424 (R&R) Form Quick Reference
  • Link to Biographical Sketch Format Page.
  • Link to Biographical Sketch Example.
  • Link to Targeted/Planned Enrollment Table Format Page.
  • Link to Inclusion Enrollment Report Format Page.
  • Link to Modular Budget Sample - Same Modules.
  • Link to Modular Budget Sample - Variable Modules.
  • Link to Additional Senior/Key Person Profiles.
    • This format is for those applications requiring > 8 Senior/Key Person Profiles.
  • Link to Additional Performance Sites.
    • This format is for those applications requiring >8 Project/Performance Sites.
  • Link to Modified Aims, Project Summary/Abstract, and Project Narrative.
    • This format is for those applications submitting modified Specific Aims, Project Summary/Abstract, and Public Health Relevance Statements to ICs when requested by NIH Staff.
• Data Tables (updated 11/24/2010)
  • Link to Introduction to Data Tables
    • read this before reading the instructions for data tables!
  • Link to Instructions for Data Tables
  • Link to Instructions for Data Tables
  • Link to Instructions for Data Tables
  • Link to Sample All Data Tables
  • Link to All Tables
  • Link to Data Table 1 (New)
  • Link to Data Table 1 (Renewal/Revision)
  • Link to Data Table 2
  • Link to Data Table 3
  • Link to Data Table 4
  • Link to Data Table 5
  • Link to Data Table 6A (Predoc - New)
  • Link to Data Table 6B (postdoc - New)
  • Link to Data Table 6A (Predoc - Renewal/Revision)
  • Link to DataTable 6B (Postdoc - Renewal/Revision)
  • Link to Data Table 7A
  • Link to Data Table 7B
  • Link to Data Table 8A
  • Link to Data Table 8B
  • Link to Data Table 9A (Predoc - New)
  • Link to Data Table 9B (Postdoc - New)
  • Link to Data Table 9A (Predoc - Renewal/Resubmission)
  • Link to Data Table 9B (Postodc - Renewal/Resubmission)
  • Link to Data Table 10
  • Link to Data Table 11
  • Link to Data Table 12A
  • Link to Data Table 12B
  • Link to Combined File of Data Tables 1-12
• PHS 398 (rev. 06/09):
  • Link to PHS 398 Form Pages.
  • Link to Pre-Populated School of Medicine Face Page
  • Link to Pre-Populated Skaggs School of Pharmacy and Pharmaceutical Sciences

• PHS 2590 (rev. 06/09):
  • Link to PHS 2590 Form Pages.
  • Link to Pre-Populated School of Medicine Face Page
  • Link to Pre-Populated Skaggs School of Pharmacy and Pharmaceutical Sciences