NIHGuidelinesandForms

Contents 1 Updated Guidelines and Forms 2 NOT-OD-12-152: Revised Pre- and Post-Award Forms and Instructions 3 Previous Notable Changes to Forms & Instructions 3.1 SF 424 (R&R) 3.2 PHS 398 3.3 Both SR424 (R&R) & PHS 398 *Guide & Forms* Notable Changes 3.4 PHS 2590

Updated Guidelines and Forms

Document	Posting Date	Changes
SF424 (R&R) Application Guide Adobe Forms Version B Series	Revised  7/06/2012	General & SBIR/STTR Application Guides have been updated for the transition to modified Adobe B2 form series. Updates to Guides include emphasis regarding the prohibition of the use of the Appendix to circumvent page limits; removal of all references to the error correction window; clarification of the meaning of on-time submission; clarification regarding the use of the Co-PD/PI role; addition of the Federal Financial Report (FFR or SF-425/SF-425A) requirement; update of NIH contact information; allowability of additional attachments to the R&R Subaward Budget Attachment(s) Form; requirement to maintain registration in the Central Contractor Registry Database (CCR); updated references to current NIH Guide Notices; updated guidance regarding the application viewing window and correcting errors; additional instructions for the PHS 398 Research Training Program Plan Component; updated Table of Page limits; broken web links have been fixed and typographical errors have been corrected.
SF424 (R&R) Individual Fellowship Application Guide Adobe Forms Version B Series	POSTED 7-25-2011	General & SBIR/STTR Application Guides have been updated for the transition to modified Adobe B2 form series. Updates to Guides include emphasis regarding the prohibition of the use of the Appendix to circumvent page limits; removal of all references to the error correction window; clarification of the meaning of on-time submission; clarification regarding the use of the Co-PD/PI role; addition of the Federal Financial Report (FFR or SF-425/SF-425A) requirement; update of NIH contact information; allowability of additional attachments to the R&R Subaward Budget Attachment(s) Form; requirement to maintain registration in the Central Contractor Registry Database (CCR); updated references to current NIH Guide Notices; updated guidance regarding the application viewing window and correcting errors; additional instructions for the PHS 398 Research Training Program Plan Component; updated Table of Page limits; broken web links have been fixed and typographical errors have been corrected.
SF424 (R&R) SBIR/STTR Application Guide Adobe Forms Version B Series	POSTED 7-25-2011	General & SBIR/STTR Application Guides have been updated for the transition to modified Adobe B2 form series. Updates to Guides include emphasis regarding the prohibition of the use of the Appendix to circumvent page limits; removal of all references to the error correction window; clarification of the meaning of on-time submission; clarification regarding the use of the Co-PD/PI role; addition of the Federal Financial Report (FFR or SF-425/SF-425A) requirement; update of NIH contact information; allowability of additional attachments to the R&R Subaward Budget Attachment(s) Form; requirement to maintain registration in the Central Contractor Registry Database (CCR); updated references to current NIH Guide Notices; updated guidance regarding the application viewing window and correcting errors; additional instructions for the PHS 398 Research Training Program Plan Component; updated Table of Page limits; broken web links have been fixed and typographical errors have been corrected.
PHS Grant Application (PHS 398)	Posted 3-25-2011	The Biographical Sketch is modified to permit a description of factors that may have reduced productivity per NIH Guide NOT-OD-11-045. Incorporation of policy regarding use of FOAs (NOT-OD-10-134), Just-in-Time submissions (NOT-OD-10-120), new time limit on resubmissions (NOT-OD-10-140), post submission of application materials (NOT-OD-10-115), and implementation of the Federal Funding Accountability and Transparency Act reporting (NOT-OD-11-005). Additional edits include modification of the definition of foreign component to be consistent with the revised NIH Grants Policy Statement, clarifications to instructions, and updated hyperlinks and corrected typographical errors.  Revised Forms have been approved by OMB and are expected to be implemented in Summer 2013.
PHS Non-Competing Continuation Progress Report (PHS 2590)	Revised 8-2012	Some roles have changed in the All Personnel Section of the Progress Report. For these and other changes, see NOT-OD-12-152.  Note, these changes have not been made in eSNAP on eRA Commons due to the fact that eSNAP will be phased out in the Spring of 2013.  The Final Progress Report has been moved to its own guidebook.
Research Performance Progress Report (RPPR)	Revised 8-2012	The eRA RPPR module will be available to all grantees for most awards as of 10/19/2012.  See NIH Guide NOT-OD-12-142 for additional information.
NRSA Individual Fellowship Progress Report for Continuation Support (PHS 416-9)	Revised 8-2012	No change. Note: NIH grantees now have the option to use the RPPR module in the eRA Commons for Fellowship progress reports. The paper 416-9 will become obsolete for NIH grantees with the mandatory use of the RPPR expected in the Spring, 2013. See NIH Guide NOT-OD-12-142.
PHS Supplemental Grant Application Instructions	Revised 8/2012	Updated Parts II & III to be used in conjuction with the PHS 2590, PHS 416-1 and PHS 416-9 only at this time.

NOT-OD-12-152: Revised Pre- and Post-Award Forms and Instructions

This Notice announces the availability of newly revised forms and instructions used to submit interim and final progress reports, and other post-award documents associated the monitoring, oversight, and closeout of an award. Related revised Ruth L. Kirschstein National Research Service Award (NRSA) forms are also now available.

The new approved date is "Rev. 08/12" and the newly approved through date is 08/31/2015.

Minimal changes to forms:

Previous Role	New Role
Postdoc (Postdoctoral Scholar, Fellow, or Other Postdoctoral Position)	Postdoctoral (scholar, fellow, or other postdoctoral position)
Biostatistician	Statistician
Grad Rsch Asst (Graduate Research Assistant)	Graduate student (research assistant)
Rsch Asst (Research Assistant/Coordinator)	Non-student Research Assistant
Undergrad Rsch Asst (Undergraduate Research Assistant)	Undergraduate Student
N/A	High School Student

Note: The Final Progress Report has been relocated to its own document.

Previous Notable Changes to Forms & Instructions

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..
• 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. *NOTE: OMB has recently approved new PHS 398 forms. These should be in place by Summer 2013.

• 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.
  • ThePublications 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)
  • 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.
  • 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

• 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.
    • ThePublications 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.