![](media/image1.png){width="0.8298611111111112in"
height="0.8298611111111112in"}U.S. Department of Health and Human
Services\
Public Health Service

SF424 (R&R)

Application Guide\
for NIH and Other PHS\
Agencies

A guide developed and maintained by NIH for preparing and submitting
applications via Grants.gov to NIH and other PHS agencies using the
SF424 (R&R)

**Adobe Pilot Forms Version (to be used for FOAs specifying use\
of Adobe Reader application packages)**

**August 1, 2008**

Table of Contents

[Part I. Instructions for Preparing and Submitting an
Application](#Part_I)

[**1.** **Foreword I-1**](#foreword)

[1.1 Application Guide Format I-2](#application-guide-format)

[1.2 NIH Extramural Research and Research Training Programs
I-2](#nih-extramural-research-and-research-training-programs)

[1.3 Research Grant Mechanisms and Program Guidelines
I-3](#research-grant-mechanisms-and-program-guidelines)

[1.4 Interactions with PHS Staff I-3](#interactions-with-phs-staff)

[1.5 Grants Policy Statements I-6](#grants-policy-statements)

[1.6 References I-6](#references)

[1.7 Authorization I-8](#authorization)

[1.8 Paperwork Burden I-8](#paperwork-burden)

[2. Process for Application Submission via Grants.gov
I-8](#process-for-application-submission-via-grants.gov)

[2.1 Overview I-9](#overview)

[2.2 Registration Processes I-9](#registration-processes)

[2.2.1 Grants.gov Registration I-9](#grants.gov-registration)

[2.2.2 eRA Commons Registration I-10](#era-commons-registration)

[2.3 Software Requirements I-11](#software-requirements)

[2.3.1 Adobe Reader I-11](#adobe-reader)

[2.3.2 Creating PDFs for Text Attachments
I-12](#creating-pdfs-for-text-attachments)

[2.3.3 Special Instructions for Macintosh Users
I-12](#special-instructions-for-macintosh-users)

[2.4. Funding Opportunities I-12](#funding-opportunities)

[2.4.1 NIH Guide for Grants and Contracts
I-12](#nih-guide-for-grants-and-contracts)

[2.4.2 Grant and Cooperative Agreement Announcements
I-13](#grant-and-cooperative-agreement-announcements)

[2.4.3 Finding a Funding Opportunity Announcement (FOA) for Grants.gov\
Submission
I-14](#finding-a-funding-opportunity-announcement-foa-for-grants.gov-submission)

[2.5 Components of an Application to NIH or Other PHS Agencies
I-18](#components-of-an-application-to-nih-or-other-phs-agencies)

[2.6 Format Specifications for Text (PDF) Attachments
I-18](#format-specifications-for-text-pdf-attachments)

[2.7 "Resubmission" (Revised) Applications
I-21](#resubmission-revised-applications)

[2.8 "Revision" (Competing Supplemental) Application
I-22](#revision-competing-supplemental-application)

[2.9 Similar, Essentially Identical, or Identical Applications
I-22](#similar-essentially-identical-or-identical-applications)

[2.10 Submitting Your Application Via Grants.gov
I-23](#submitting-your-application-via-grants.gov)

[2.11 After You Submit Your Application Via Grants.gov
I-24](#after-you-submit-your-application-via-grants.gov)

[2.12 Correcting Errors I-26](#correcting-errors)

[2.13 Submission of Supplementary or Corrective Information
I-27](#submission-of-supplementary-or-corrective-information)

[2.14 Application Submission Dates I-27](#application-submission-dates)

[2.15 Submission, Review and Award Cycles
I-28](#submission-review-and-award-cycles)

[2.16 Resources for Finding Help I-31](#resources-for-finding-help)

[2.16.1 Finding Help for Grants.gov Registration or Submissions
I-31](#finding-help-for-grants.gov-registration-or-submissions)

[2.16.2 Finding Help for the eRA Commons Registration or eRA Commons
Validation Processes
I-32](#finding-help-for-the-era-commons-registration-or-era-commons-validation-processes)

[2.16.3 Finding Help for Application Preparation
I-32](#finding-help-for-application-preparation)

[3. Using the Grant Application Package
I-32](#using-the-grant-application-package)

[3.1 Verify Grant Information I-32](#verify-grant-information)

[3.2 Enter the Name for the Application
I-33](#enter-the-name-for-the-application)

[3.3 Open and Complete Mandatory Documents
I-33](#open-and-complete-mandatory-documents)

[3.4 Open and Complete Optional Documents
I-34](#open-and-complete-optional-documents)

[3.5 Submitting the Application via Grants.gov
I-34](#__RefHeading___Toc203452132)

[4. Completing the SF424 Research and Related (R&R) Forms
I-34](#completing-the-sf424-research-and-related-rr-forms)

[4.1 Overview I-34](#overview-1)

[4.2 Cover Component I-36](#cover-component)

[4.3 Project/Performance Site Locations Component
I-48](#projectperformance-site-locations-component)

[4.4 Other Project Information Component
I-51](#other-project-information-component)

[4.5 Senior/Key Person Profile (Expanded) Component
I-56](#seniorkey-person-profile-expanded-component)

[4.6 Selecting the Appropriate Budget Component
I-64](#selecting-the-appropriate-budget-component)

[4.7 R&R Budget Component I-64](#rr-budget-component)

[4.7.1 Section A and B I-65](#section-a-and-b)

[4.7.2 Sections C through E I-71](#sections-c-through-e)

[4.7.3 Sections F through K I-74](#sections-f-through-k)

[4.7.4 Cumulative Budget I-78](#cumulative-budget)

[4.8 Special Instructions for Preparing Applications with a
Subaward/Consortium
I-80](#special-instructions-for-preparing-applications-with-a-subawardconsortium)

[5. Completing PHS398 Components I-82](#completing-phs398-components)

[5.1 Overview I-82](#overview-2)

[5.2 Cover Letter Component I-83](#cover-letter-component)

[5.3 Cover Page Supplement Component
I-85](#cover-page-supplement-component)

[5.4 Modular Budget Component I-90](#modular-budget-component)

[5.4.1 Periods 1 through 4 I-92](#periods-1-through-4)

[5.4.2 Period 5 and Cumulative I-95](#period-5-and-cumulative)

[5.5 Research Plan Component I-98](#research-plan-component)

[5.6 Checklist Component I-109](#checklist-component)

[6. Peer Review Process I-113](#peer-review-process)

[Part II. Supplemental Instructions for Preparing the Human Subjects
Section of the Research Plan](#Human_Subjects_PartII)

[1. Introduction II-1](#introduction)

[2. Scenarios II-1](#scenarios)

[3. Instructions for Preparing the Section on Protection of Human
Subjects
II-3](#instructions-for-preparing-the-section-on-protection-of-human-subjects)

[4. Instructions Pertaining to Non-Exempt Human Subjects Research
II-7](#instructions-pertaining-to-non-exempt-human-subjects-research)

[4.1 Protection of Human Subjects II-7](#protection-of-human-subjects)

[4.1.1 Risks to Human Subjects II-7](#risks-to-human-subjects)

[4.1.2 Adequacy of Protection Against Risks
II-8](#adequacy-of-protection-against-risks)

[4.1.3 Potential Benefits of the Proposed Research to Human Subjects and
Others
II-9](#potential-benefits-of-the-proposed-research-to-human-subjects-and-others)

[4.1.4 Importance of the Knowledge to be Gained
II-9](#importance-of-the-knowledge-to-be-gained)

[4.1.5 Data and Safety Monitoring Plan
II-9](#data-and-safety-monitoring-plan)

[4.1.6 ClinicalTrials.gov Requirements
II-10](#clinicaltrials.gov-requirements)

[4.2 Inclusion of Women and Minorities
II-11](#inclusion-of-women-and-minorities)

[4.2.1 Additional Instructions and Requirements When NIH-Defined Phase
III Clinical Trials Are Proposed
II-12](#additional-instructions-and-requirements-when-nih-defined-phase-iii-clinical-trials-are-proposed)

[4.3 Instructions for Completing the Targeted/Planned Enrollment Tables
for Reporting Race\
and Ethnicity Data for Subjects in Clinical Research
II-13](#instructions-for-completing-the-targetedplanned-enrollment-tables-for-reporting-race-and-ethnicity-data-for-subjects-in-clinical-research)

[4.4 Inclusion of Children II-14](#inclusion-of-children)

[5. Human Subjects Research Policy
II-16](#human-subjects-research-policy)

[5.1 Protection of Human Subjects
II-16](#protection-of-human-subjects-1)

[5.2 Vulnerable Populations II-17](#vulnerable-populations)

[5.3 Data and Safety Monitoring Plans for Clinical Trials
II-17](#data-and-safety-monitoring-plans-for-clinical-trials)

[5.4 IRB Approval II-17](#irb-approval)

[5.5 Required Education in the Protection of Human Research Participants
II-18](#required-education-in-the-protection-of-human-research-participants)

[5.6 NIH Policy on the Inclusion of Women and Minorities in Clinical
Research
II-18](#nih-policy-on-the-inclusion-of-women-and-minorities-in-clinical-research)

[5.7 NIH Policy on Inclusion of Children
II-19](#nih-policy-on-inclusion-of-children)

[5.8 NIH Policy on Reporting Race and Ethnicity Data: Subjects in
Clinical Research
II-19](#nih-policy-on-reporting-race-and-ethnicity-data-subjects-in-clinical-research)

[5.9 Research on Transplantation of Human Fetal Tissue
II-21](#research-on-transplantation-of-human-fetal-tissue)

[5.10 Research Using Human Embryonic Stem Cells
II-21](#research-using-human-embryonic-stem-cells)

[5.11 ClinicalTrials.gov Requirements
II-21](#clinicaltrials.gov-requirements-1)

[Part III. Policies, Assurances, Definitions, and Other
Information](#Policy_PartIII)

[1. Policy III-1](#policy)

[1.1 Applications That Include Consortium/Contractual Facilities and
Administrative Costs
III-1](#applications-that-include-consortiumcontractual-facilities-and-administrative-costs)

[1.2 Resubmission of Unpaid RFA Applications and Resubmission of
Applications with a\
Changed Grant Activity Mechanism
III-1](#resubmission-of-unpaid-rfa-applications-and-resubmission-of-applications-with-a-changed-grant-activity-mechanism)

[1.3 NIH Policy on Resubmission Applications
III-2](#nih-policy-on-resubmission-applications)

[1.4 Policy on the Acceptance for Review of Unsolicited Applications
That Request \$500,000\
or More in Direct Costs
III-3](#policy-on-the-acceptance-for-review-of-unsolicited-applications-that-request-500000-or-more-in-direct-costs)

[1.5 Sharing Research Resources III-4](#sharing-research-resources)

[1.5.1 Data Sharing Policy III-4](#data-sharing-policy)

[1.5.2 Sharing Model Organisms III-5](#sharing-model-organisms)

[1.5.3 Policy for Genome-Wide Association Studies (GWAS)
III-5](#policy-for-genome-wide-association-studies-gwas)

[1.6 Inventions and Patents III-5](#inventions-and-patents)

[1.7 Just-In-Time Policy III-6](#just-in-time-policy)

[1.8 Other Support III-6](#other-support)

[1.9 Graduate Student Compensation
III-10](#graduate-student-compensation)

[1.10 DUNS Number III-11](#duns-number)

[1.11 Public Access Policy III-11](#public-access-policy)

[1.12 PHS Metric Program III-12](#phs-metric-program)

[1.13 NIH Plans to Transition to the SF424 (R&R) Application and
Electronic Submission\
through Grants.gov
III-12](#nih-plans-to-transition-to-the-sf424-rr-application-and-electronic-submission-through-grants.gov)

[2. Assurances and Certifications
III-13](#assurances-and-certifications)

[2.1 Human Subjects Research III-13](#human-subjects-research)

[2.1.1 Research on Transplantation of Human Fetal Tissue
III-15](#research-on-transplantation-of-human-fetal-tissue-1)

[2.1.2 Research Using Human Embryonic Stem Cells
III-15](#research-using-human-embryonic-stem-cells-1)

[2.1.3 NIH Policy on the Inclusion of Women and Minorities as Subjects
in Clinical Research
III-15](#nih-policy-on-the-inclusion-of-women-and-minorities-as-subjects-in-clinical-research)

[2.1.4 NIH Policy on Reporting Race and Ethnicity Data: Subjects in
Clinical\
Research
III-16](#nih-policy-on-reporting-race-and-ethnicity-data-subjects-in-clinical-research-1)

[2.1.5 NIH Policy on Inclusion of Children
III-16](#nih-policy-on-inclusion-of-children-1)

[2.1.6 ClinicalTrials.gov III-16](#clinicaltrials.gov)

[2.2 Vertebrate Animals III-17](#vertebrate-animals)

[2.3 Debarment and Suspension III-18](#debarment-and-suspension)

[2.4 Drug-Free Workplace III-18](#drug-free-workplace)

[2.5 Lobbying III-18](#lobbying)

[2.6 Non-Delinquency on Federal Debt
III-19](#non-delinquency-on-federal-debt)

[2.7 Research Misconduct III-19](#research-misconduct)

[2.8 Assurance of Compliance (Civil Rights, Handicapped Individuals, Sex
Discrimination,\
Age Discrimination)
III-20](#assurance-of-compliance-civil-rights-handicapped-individuals-sex-discrimination-age-discrimination)

[2.9 Research Involving Recombinant DNA, including Human Gene Transfer
Research
III-20](#research-involving-recombinant-dna-including-human-gene-transfer-research)

[2.10 Financial Conflict of Interest
III-21](#financial-conflict-of-interest)

[2.11 Smoke-Free Workplace III-21](#smoke-free-workplace)

[2.12 Prohibited Research III-22](#prohibited-research)

[2.13 Select Agent Research III-22](#select-agent-research)

[2.14 Principal Investigator Assurance
III-23](#principal-investigator-assurance)

[2.15 Impact of Grant Activities on the Environment and Historic
Properties
III-23](#impact-of-grant-activities-on-the-environment-and-historic-properties)

[3. Definitions III-25](#definitions)

[4. General Information III-35](#general-information)

[4.1 Research Grant Mechanisms III-35](#research-grant-mechanisms)

[4.2 Government Use of Information Under Privacy Act
III-37](#government-use-of-information-under-privacy-act)

[4.3 Information Available to the PD(s)/PI(s)
III-38](#information-available-to-the-pdspis)

[4.4 Information Available to the General Public
III-38](#information-available-to-the-general-public)

[4.5 Access to Research Data III-39](#access-to-research-data)

[]{#Part_I .anchor}PART I\
\
Instructions for Preparing and Submitting\
an Application

# 1. Foreword

#### Adobe Application Guide --- Released August 1, 2008  {#adobe-application-guide-released-august-1-2008 .Subhead---No-TOC}

This application guide includes changes to instructions necessitated by
the transition of the SF424-R&R form set to the Adobe Reader software
forms package that is universally available at no cost to users and
works on Windows, Mac, Linux, and UNIX operating systems as well as with
all major web browsers. Note that during the transition period not all
Funding Opportunity Announcements will utilize the new Adobe Reader
forms but will continue using the PureEdge form set. For applications
requiring use of the PureEdge form set, please see Version 2 of the PHS
SF424-R&R Application Guide.

While most of the changes are minor and not noticeable, there are a few
key changes that users should be aware of.

-   Opening Documents within a package: In a PureEdge application
    package, mandatory and optional documents (components) could be
    opened by just double clicking the desired document regardless if it
    was in the right or left side of the package. However, in the Adobe
    packages, documents must first be moved to the right into the
    "Documents for Submission" box before they can be opened.

-   In PureEdge, the "**Previous**" and "**Next**" buttons are always
    present at the top of the form. In the Adobe Portable Document
    Format (.pdf) based application packages, the "**Previous**" and
    "**Next**" buttons are part of the form, so they "move up the page"
    as you progress to the bottom. The Adobe Reader also allows
    scrolling from one form to the next, without requiring you to use
    the "**Previous**" and "**Next**" buttons.

-   Form fields that are mandatory for submission are now highlighted in
    yellow with a red border. Additionally, pop-up windows will appear
    whenever you skip a mandatory field.

-   Help tips with Adobe are always available. Just hover the cursor
    over any field for assistance.

Other modifications not related to the SF424-R&R form set transition to
Adobe Reader include:

-   Clarified instructions for preparing budgets that include personnel
    listed as Other Significant Contributors who are not committing any
    specific measurable effort to the project.

-   Clarified that applicants proposing human subjects research should
    only submit date of IRB approval for the entire application, not an
    individual protocol.

-   Clarified that Letters of Support are not required from all
    personnel listed in the application.

-   Revised definitions in Part III to reflect recent revisions to the
    PHS 398 family of forms.

-   Updated the R&R budget instructions to include new guidance on the
    allowability of minor alteration and renovation costs incurred by
    foreign institutions.

This application guide contains instructions and other useful
information for preparing grant applications to the National Institutes
of Health (NIH) and other Public Health Service (PHS) agencies for:

*Public Health Service (PHS) Research Grants*

This application guide is used as a companion document to the SF424
Research and Related (R&R) application forms. In addition to the SF424
(R&R) form components, applications to NIH and other PHS agencies will
include agency-specific form components, titled "PHS398." These PHS398
components were developed to continue the collection of agency-specific
data required for a complete application. While these agency-specific
components are not identical to the PHS398 application form pages, the
PHS398 reference is used to distinguish these additional data
requirements from the data collected in the SF424 (R&R) components. A
complete application to NIH and other PHS agencies will include SF424
(R&R) components and PHS398 components. Instructions for all application
components, SF424 (R&R) and PHS398, are found in this document.

The use of these new forms also involves electronic submission of
completed applications through Grants.gov. NIH and other PHS agencies
will gradually transition all mechanisms to the new application forms
and Grants.gov submission. Specific Funding Opportunity Announcements
(FOAs) will clearly indicate which forms and submission process an
applicant should use. NIH will continue to use Requests for Applications
(RFAs) and Program Announcements (PAs) as categories of FOAs. See
[Section 2.4.2](#PAsRFAs) for definitions.

Applicants must carefully review FOAs for guidance on when to use the
424 (R&R) forms, instructions, and electronic submission for a specific
mechanism (i.e., R13, R15, etc.). This process will apply to all types
of submissions for the announced mechanism---new, resubmission (formerly
"revised/amended"), renewal (formerly "competing continuation"), and
revision (formerly "competing supplemental") grant applications. Each
FOA will include a link to the most current version of these
instructions. Applicants are encouraged to check the Web site frequently
for the most current version.

For purposes of this document, any references to "NIH" may also mean
"NIH and other PHS agencies" such as the Agency for Healthcare Research
and Quality (AHRQ), the Centers for Disease Control and Prevention
(CDC), and the Food and Drug Administration (FDA).

## 1.1 Application Guide Format

This application guide is organized into three distinct parts:

> **[Part I](#Part_I): Instructions for Preparing and Submitting the
> Application.** Part I includes specific instructions for completing
> the application form components as well as information on
> electronically submitting applications through Grants.gov.
>
> **[Part II](#Human_Subjects_PartII): Supplemental Instructions for
> Preparing the Human Subjects Section of the Research Plan.** Part II
> is to be used if your proposed research will involve human subjects.
> These instructions assist in determining whether human subjects are
> involved and include scenarios and detailed instructions for
> completing Items 8 -- 11 of the PHS 398 Research Plan component.
>
> **[Part III](#Policy_PartIII): Policies, Assurance, Definitions, and
> Other Information.** Part III includes information on policies,
> assurances, definitions, and other information relating to submission
> of applications to the PHS. Applicants should refer to this document
> as well as the instructional materials, Grants Information
> (GrantsInfo), and [*NIH Grants Policy
> Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
> sections for additional sources of information.

## 1.2 NIH Extramural Research and Research Training Programs

The NIH Office of Extramural Research Grants homepage
(<http://grants.nih.gov/grants/oer.htm>) provides an array of helpful
information. Applicants are encouraged to bookmark this site and visit
it often.

The Division of Extramural Outreach and Information Resources (DEOIR) is
the central source for general information about NIH extramural research
and research training programs, funding mechanisms, the peer review
system, and application procedures. Grants Information (GrantsInfo) is a
communication service within the DEOIR. Information about the NIH
extramural research and research training programs, funding
opportunities, and the grant application process, can be obtained by
emailing your request to:
[[GrantsInfo@nih.gov]{.underline}](mailto:GrantsInfo@nih.gov) or by
calling (301) 435-0714.

## 1.3 Research Grant Mechanisms and Program Guidelines

A partial list of research grant mechanisms is provided below. As noted
in the descriptions in [Part III: Policies, Assurances, Definitions, and
Other Information](#Policy_PartIII), not all awarding components use all
programs. For a complete listing of program guidelines, visit the OER
Grants website
<http://grants.nih.gov/grants/funding/funding_program.htm>.

#### Research Grants {#research-grants .Subhead---No-TOC}

-   [Basic Research Grant (R01)](#R01)

-   [Small Research Grant (R03)](#R03)

-   [Academic Research Enhancement Award (AREA) (R15)](#R15)

-   [Exploratory/Developmental Grant (R21, R33, R21/R33)](#R21)

-   [Small Business Innovation Research Grant (SBIR) (R43/R44)](#R43)

-   [Small Business Technology Transfer Grant (STTR) (R41/R42)](#R43)

-   [Program Project Grant (P01)](#P01)

-   [Research Center Grant (P50)](#P50)

-   [Scientific Meeting Support (R13, U13)](#R13)

-   [Research Grants to Foreign Institutions and International
    Organizations](http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#__RefHeading___Toc54600260)

#### Training, Fellowships and Career Development Programs {#training-fellowships-and-career-development-programs .Subhead---No-TOC}

-   [NIH Institutional Ruth L. Kirschstein National Research Service
    Award (T32)](#T32)

-   [Individual Ruth L. Kirschstein National Research Service Award
    Fellowships (NRSA) (F31, F32, F33, F34, etc.)](#NRSA)

-   [Research Career Development Award (K Award)](#KAward)

#### Applications Available from Other Offices {#applications-available-from-other-offices .Subhead---No-TOC}

-   [International Research Fellowship Award Application (NIH
    1541-1)](#IntlFellow)

-   [Nonresearch Training Grant Application (PHS
    6025)](#NonresearchTraining)

-   [Health Services Project Application (5161-1)](#HealthServices)

## 1.4 Interactions with PHS Staff

The PHS agencies encourage applicants to communicate with staff
throughout the entire application, review and award process. Web site
addresses and staff phone numbers of relevant NIH awarding components
and other PHS agencies are listed in the table below.

[]{#Table_AwardingComponents .anchor}Table 1.4-1. PHS Agency Contact
Table

  ------------------------------------------------------------------------
  **PHS Agency Contact Table**                          
  ----------------------------------------------------- ------------------
  NATIONAL INSTITUTES OF HEALTH                          

   [Fogarty International                                301-496-1653
  Center](http://www.fic.nih.gov/)                      

   [National Cancer Institute](http://www.nci.nih.gov/)  301-496-3428

  [National Center for Complementary and Alternative    301-496-4792
  Medicine](http://nccam.nih.gov/)                      

  [National Center on Minority Health and Health        301-402-1366
  Disparities](http://ncmhd.nih.gov/)                   

   [National Center for Research                         301-496-6023
  Resources](http://www.ncrr.nih.gov/)                  

   [National Eye Institute](http://www.nei.nih.gov/)     301-451-2020

   [National Heart, Lung, and Blood                      301-435-0260
  Institute](http://www.nhlbi.nih.gov/index.htm)        

   [National Human Genome Research                       301-496-7531
  Institute](http://www.nhgri.nih.gov/)                 

   [National Institute on                                301-496-9322
  Aging](http://www.nih.gov/nia/)                       

   [National Institute on Alcohol Abuse and              301-443-4375
  Alcoholism](http://www.niaaa.nih.gov/)                

   [National Institute of Allergy and Infectious         301-496-7291
  Diseases](http://www.niaid.nih.gov/default.htm)       

   [National Institute of Arthritis and Musculoskeletal  301-594-2463
  and Skin Diseases](http://www.nih.gov/niams/)         

  [National Institute of Biomedical Imaging and         301-451-4792
  Bioengineering](http://www.nibib.nih.gov/)            

   [National Institute of Child Health and Human         301-496-0104
  Development](http://www.nichd.nih.gov/)               

   [National Institute on Deafness and Other             301-496-1804
  Communication Disorders](http://www.nidcd.nih.gov/)   

   [National Institute of Dental and Craniofacial        301-594-4800
  Research](http://www.nidr.nih.gov/)                   

   [National Institute of Diabetes and Digestive and     301-594-8834
  Kidney Diseases](http://www.niddk.nih.gov/)           

   [National Institute on Drug                           301-443-2755
  Abuse](http://www.nida.nih.gov/)                      

   [National Institute of Environmental Health           919-541-7723
  Sciences](http://www.niehs.nih.gov/)                  

   [National Institute of General Medical                301-594-4499
  Sciences](http://www.nigms.nih.gov/)                  

   [National Institute of Mental                         301-443-3367
  Health](http://www.nimh.nih.gov/)                     

   [National Institute of Neurological Disorders and     301-496-9248
  Stroke](http://www.ninds.nih.gov/)                    

   [National Institute of Nursing                        301-594-6906
  Research](http://www.nih.gov/ninr/)                   

   [National Library of                                  301-496-4621
  Medicine](http://www.nlm.nih.gov/)                    

  [**CENTER FOR SCIENTIFIC                              301-435-0715
  REVIEW**](http://www.csr.nih.gov/)                    

  **OTHER PHS AGENCIES WITHIN DHHS**                    

  [**AGENCY FOR HEALTHCARE RESEARCH AND                  301-427-1457
  QUALITY**](http://www.ahrq.gov/)                      

  [**CENTERS FOR DISEASE CONTROL AND                     
  PREVENTION**](http://www.cdc.gov/)                    

  [ National Institute for Occupational Safety and       404-498-2530
  Health](http://www.cdc.gov/niosh/homepage.html)       

   Procurement and Grants Office                         770-488-2700

  [**FOOD AND DRUG                                       301-827-7185
  ADMINISTRATION**](http://www.fda.gov/)                

  **OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH**       

   [Office of Adolescent Pregnancy                       301-594-4004
  Programs](http://www.hhs.gov/opa/titlexx/oapp.html)   

  [Office of Family                                      301-594-4008
  Planning](http://www.hhs.gov/opa/titlex/ofp.html)     

  [Agency for Toxic Substances and Disease              404-842-6630
  Registry](http://www.atsdr.cdc.gov/)                  

  [Indian Health Service](http://www.ihs.gov/)           301-443-0578
  ------------------------------------------------------------------------

#### Before Submission {#before-submission .Subhead---No-TOC}

You may wish to contact NIH staff with a variety of questions before
submitting an application.

Contact [GrantsInfo](#grants-information) and/or the [Division of
Receipt and Referral, Center for Scientific Review (CSR),
NIH](#receiptreferral-of-an-application):

-   To identify Institutes/Centers (ICs) at NIH or other non-NIH
    agencies and/or a Scientific Review Group (SRG) that might be
    appropriate for your application. Note requests for assignment to an
    Institute/Center and/or a SRG may be made in a [cover
    letter](#cover-letter-component) at the time of application
    submission.

-   To learn about [grant mechanisms](#research-grant-mechanisms).

-   To receive advice on preparing and submitting an application (e.g.,
    format, structure).

Contact program staff in the relevant awarding component:

-   To determine whether your proposed application topic would fit into
    the NIH IC's or other non-NIH agency's programmatic area.

-   To learn about programmatic areas of interest to the IC or other
    non-NIH agencies.

-   To find out about requesting an assignment to an IC.

-   To discuss whether you should respond to an RFA.

Contact Scientific Review Officers in the CSR to discuss requesting
assignment to a SRG.

#### After Submission {#after-submission .Subhead---No-TOC}

If the initial assignment to an IC or SRG seems inappropriate, the
Program Director/Principal Investigator (PD/PI) may request
reassignment. Such requests should be made in writing to:

Division of Receipt and Referral

Center for Scientific Review

National Institutes of Health

6701 Rockledge Drive, Suite 2030, MSC 7720

Bethesda, MD 20892-7720

Fax requests (301-480-1987) are also acceptable.

Although these requests will be carefully considered, the final
determination will be made by the PHS agency.

Applicants must never contact reviewers regarding their applications
because discussion of the scientific content of an application or an
attempt to influence review outcome will constitute a conflict of
interest in the review process. Reviewers are required to notify the
Scientific Review Officer if they are contacted by an applicant.
Communication by the applicant to a reviewer may delay the review or
result in the return of the application without review.

#### After Assignment {#after-assignment .Subhead---No-TOC}

Contact your Scientific Review Officer to discuss the review assignment,
to request permission to send additional/corrective materials, and/or to
discuss any review concerns (e.g., expertise needed on your study
section, conflicts, reviewers that may have bias).

#### After Peer Review {#after-peer-review .Subhead---No-TOC}

Feedback to applicants is very important. Once the PD/PI reviews the
[Summary Statement](#Summary_Statement) in the eRA Commons, the
appropriate awarding component program official noted in the Summary
Statement may be contacted:

-   To discuss the review outcome of the application and obtain
    guidance.

-   To get feedback and answers to any questions about the Summary
    Statement.

-   To find out the meaning of a numerical designation pertaining to
    human subjects or vertebrate animals in the Summary Statement.

-   To find out the funding status of an application.

A paper copy of the Peer Review Outcome Letter and Summary Statement
will not be mailed to the PI and may only be accessed through the eRA
Commons.

## 1.5 Grants Policy Statements

-   The [*NIH Grants Policy
    Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
    serves as a term and condition of award and is a compilation of the
    salient features of policies and various policy issues regarding the
    administration of NIH awards.

-   The [*HHS Grants Policy
    Statement*](http://www.hhs.gov/grantsnet/adminis/gpd/index.htm)
    serves as a term and condition of award and is a compilation of the
    salient features of policies and various policy issues regarding the
    administration of grant awards from other PHS agencies, excluding
    NIH awards.

## 1.6 References

#### Applicants New to NIH: Getting Started {#applicants-new-to-nih-getting-started .Subhead---No-TOC}

<http://grants.nih.gov/grants/useful_links.htm>

#### Award Data {#award-data .Subhead---No-TOC}

<http://grants.nih.gov/grants/award/award.htm>

([CRISP](http://crisp.cit.nih.gov/), [extramural research
grants](http://grants.nih.gov/grants/award/resgr.htm), [award
trends](http://grants.nih.gov/grants/award/awardtr.htm), [training and
career awards](http://grants.nih.gov/grants/award/granfell.htm))

#### Contact Information for an NIH Staff Person {#contact-information-for-an-nih-staff-person .Subhead---No-TOC}

[http://directory.nih.gov](http://directory.nih.gov/)\
NIH locator: (301) 496-4000

#### eRA Commons {#era-commons .Subhead---No-TOC}

<https://commons.era.nih.gov/commons/index.jsp>

Institutions and PDs/PIs are required to register with the eRA Commons.
Registered PDs/PIs can check assignment/contact information, review
outcome, and other important information. For more details on Commons
registration, see [Section 2.2.2](#era-commons-registration).

Email: <commons@od.nih.gov>.

Telephone: 1-866-504-9552 (toll-free) or 301-402-7469; 301-451-5939
(TTY). Business hours are M-F 7am-8pm Eastern Time.

#### Frequently Asked Questions on Differences between PureEdge and Adobe Reader Grant Applications  {#frequently-asked-questions-on-differences-between-pureedge-and-adobe-reader-grant-applications .Subhead---No-TOC}

<http://www.grants.gov/assets/AdobePEFAQs.pdf>

#### Grant Writing Tips and Sample Applications  {#grant-writing-tips-and-sample-applications .Subhead---No-TOC}

<http://grants.nih.gov/grants/grant_tips.htm>

#### Grants Information {#grants-information .Subhead---No-TOC}

<http://grants.nih.gov/grants/giwelcome.htm>

Email: [GrantsInfo@nih.gov](mailto:grantsinfo@nih.gov)\
Telephone: (301) 435-0714

#### Grants.gov User Guide {#grants.gov-user-guide .Subhead---No-TOC}

The Grants.gov User Guide is a comprehensive reference to information
about Grants.gov. Applicants can download the User Guide as a Microsoft
Word document or as a PDF document. The user guide can be accessed at
the following address: <http://www.grants.gov/CustomerSupport>.

#### NIH Office of Extramural Research Human Subjects Website {#nih-office-of-extramural-research-human-subjects-website .Subhead---No-TOC}

<http://grants.nih.gov/grants/policy/hs/index.htm>

This site provides, in one place, DHHS and NIH requirements and
resources for the extramural community involved in human subjects
research.

#### Office for Human Research Protections (Department of Health and Human Services) {#office-for-human-research-protections-department-of-health-and-human-services .Subhead---No-TOC}

<http://www.hhs.gov/ohrp>

Information about human subject protections, Institutional Review
Boards, and Federal Wide Assurances

Telephone: 1-866-447-4777 or (301) 496-7005

#### Office of Laboratory Animal Welfare (OLAW)  {#office-of-laboratory-animal-welfare-olaw .Subhead---No-TOC}

[http://olaw.nih.gov](http://olaw.nih.gov/)

Information about animal welfare policy requirements, Institutional
Animal Care and Use Committees (IACUC), and Animal Welfare Assurances

Telephone: (301) 496-7163

#### Receipt/Referral of an Application {#receiptreferral-of-an-application .Subhead---No-TOC}

<http://www.csr.nih.gov/EVENTS/AssignmentProcess.htm>

Division of Receipt and Referral\
Center for Scientific Review\
Telephone: (301) 435-0715\
Fax: (301) 480-1987

#### Specific Application: Before Review  {#specific-application-before-review .Subhead---No-TOC}

Telephone or email the Scientific Review Officer identified for the
application in the eRA Commons.

#### Specific Application: Post Review  {#specific-application-post-review .Subhead---No-TOC}

Telephone or email the NIH Program Official named in the Summary
Statement for the application.

## 1.7 Authorization

The PHS requests the information described in these instructions
pursuant to its statutory authorities for awarding grants, contained in
Sections 301(a) and 487 of the PHS Act, as amended (42 USC 241a and 42
USC 288). Therefore, such information must be submitted if an
application is to receive due consideration for an award. Lack of
sufficient information may hinder the ability of the PHS to review an
application and to monitor the grantee's performance.

## 1.8 Paperwork Burden

The PHS estimates that it will take approximately 40 hours to complete
this application for a regular research project grant. This estimate
excludes time for development of the scientific plan. Other items such
as human subjects are cleared and accounted for separately and therefore
are not part of the time estimate. An agency may not conduct or sponsor
the collection of information unless it displays a currently valid OMB
control number. Nor is a person required to respond to requests for the
collection of information without this control number. Send comments
regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to: NIH,
Project Clearance Office, 6705 Rockledge Drive MSC 7974, Bethesda, MD
20892-7974, ATT: PRA (0925-0001). Do not send applications or any
materials related to training or career award applications to this
address.

# 2. Process for Application Submission via Grants.gov

Application submission through Grants.gov involves several steps. Access
the "Get Started" tab on the Grants.gov Web site
([http://grants.gov](http://grants.gov/)). Some of the steps need only
be done one time. Others are ongoing steps that will be necessary for
each application submission. Before beginning the application process,
you are encouraged to review [Grants.gov](http://grants.gov/) and all
the resources available there.

## 2.1 Overview

The following steps must be taken in order to submit a grant application
through Grants.gov. Please be sure to complete all steps to ensure that
NIH receives the application in a timely manner.

1.  Register your organization at Grants.gov. (This is a one-time only
    registration process for all Federal agencies. If your organization
    has already completed this step for any Federal agency submission,
    skip to step #2. If your organization has not completed this step,
    see Section 2.2 for more details.)

2.  Register your organization and Program Director/Principal
    Investigator (PD/PI) in the eRA Commons. (This is a one-time only
    registration process. If your organization has already completed
    this step, skip to step #3. If your organization has not completed
    this step, see [Section 2.2](#registration-processes) for more
    details.)

3.  Find a Funding Opportunity Announcement (FOA) using the [Grants.gov
    "Apply"](http://grants.gov/Apply) feature that reflects use of the
    SF424 (R&R) forms and electronic submission through Grants.gov. (See
    [Section 2.4](#funding-opportunities) for more details.)

4.  Download the associated Application Package from Grants.gov. (Adobe
    Reader version 8.12 or later required for download. See [Section
    2.3](#software-requirements) for more details.)

5.  Complete the appropriate application components, including all text
    and PDF attachments. Upload all attachments into the appropriate
    application component (See [Section
    2.6](#format-specifications-for-text-pdf-attachments) for more
    details on the requirements for text (PDF) attachments).

6.  The completed application should be reviewed through your own
    organizational review process.

7.  Coordinate with a Authorized Organizational Representative (AOR) at
    the applicant organization to submit the application by the date
    specified in the FOA. (**Keep a copy locally at the Applicant
    Organization/Institution.**)

8.  Receive the Grants.gov tracking number.

9.  After agency validation, receive the agency tracking number
    (accession number).

10. PD/PI and Signing Official (SO) complete a verification process in
    the eRA Commons. (See [Section
    2.11](#after-you-submit-your-application-via-grants.gov) for
    detailed information.)

The following sections explain each step in more detail.

## 2.2 Registration Processes

### 2.2.1 Grants.gov Registration

Grants.gov requires a **one-time** registration *by the applicant
organization*. PDs/PIs do not have to individually register in
Grants.gov unless they also serve as the Authorized Organizational
Representative (AOR) for their institution/organization. If an applicant
organization has already completed Grants.gov registration for another
Federal agency, they can skip this section and focus on the NIH eRA
Commons registration steps noted below. For those applicant
organizations still needing to register with Grants.gov, registration
information can be found at Grants.gov/GetStarted
([[http://www.grants.gov/GetStarted]{.underline}](http://www.grants.gov/GetStarted)).
While Grants.gov registration is a one-time only registration process,
it does involve several steps and will take some time. Applicant
organizations needing to complete this process are encouraged to **start
early** allowing several weeks to complete all the steps before actually
submitting an application through Grants.gov.

The AOR is an individual authorized to act for the applicant
organization and to assume the obligations imposed by the Federal laws,
requirements, and conditions for a grant or grant application, including
the applicable Federal regulations. This individual has the authority to
sign grant applications and required certifications and/or assurances
that are necessary to fulfill the requirements of the application
process. Once this individual is registered, the organization can then
apply for any government funding opportunity listed in Grants.gov,
including NIH and other PHS agencies grants.

Questions regarding Grants.gov registration should be directed to the
Grants.gov Contact Center at telephone: 1-800-518-4726. Contact Center
hours of operation are Monday--Friday from 7:00 a.m. to 9:00 p.m.
Eastern Time.

### 2.2.2 eRA Commons Registration

The applicant organization and the PD/PI must also complete a
**one-time** registration in the eRA Commons. Access to the Commons is
vital for all steps in the process after application submission. An
organization and PDs/PIs must be registered in the Commons before they
can take advantage of electronic submission and retrieval of grant
information, such as reviewing grant applications, institute/center
assignments, review outcomes, and Summary Statements.
Institutional/organizational officials are responsible for registering
PDs/PIs in the eRA Commons. PDs/PIs should work with their AOR (also
known as the Signing Official in the eRA Commons) to determine their
institutional/organizational process for registration.

IMPORTANT: The eRA Commons registration process should be started at
least **two (2) weeks** prior to the submittal date of a Grants.gov
submission. Failure to register in the Commons and to include a valid
PD/PI Commons ID in the credential field of the Senior/Key Profile
Component will prevent the successful submission of an electronic
application to NIH.

#### 2.2.2.1 Commons Registration for the Organization

Organizations may verify their current registration status by accessing
the "List of Grantee Organizations Registered in NIH eRA Commons"
(<http://era.nih.gov/userreports/ipf_com_org_list.cfm>).

To register an Organization in the eRA Commons:

1\. Open the eRA Commons homepage
(<https://commons.era.nih.gov/commons/>).

2\. Click Grantee Organization Registration (found in "About the
Commons" links on the right side of the screen).

3\. Follow the step-by-step instructions. Remember to fax in the
registration signature page to eRA.

4\. Click Submit. The organization is registered when the NIH confirms
the information and sends an email notification of registered Signing
Official (SO) account (userid/password).

This registration is independent of Grants.gov and may be done at any
time.

Organizational data elements, such as Institutional Profile Number
(IPF), Entity Identification Number (e.g., 5555555555A5) and DUNS Number
must be accurately identified. **Note the DUNS number must be included
in the Institutional Profile for applications to be accepted. In
addition, the DUNS number in the Institutional Profile must match that
entered in the SF424 (R&R) Cover Component in Section 5, Applicant
Information.** This information will be used to generate the electronic
grant application image that the Signing Official and the PD/PI will be
asked to verify within the eRA Commons. See [Section
2.11](#after-you-submit-your-application-via-grants.gov) for details on
the Commons application verification process.

Since eRA has not required a DUNS number during eRA Commons
registration, there are many accounts that do not contain valid
information in this field. Prior to submission, the AOR/SO should verify
that their organization's eRA Commons profile contains the valid DUNS
number that will be used for the submission process. The SO has the
ability to edit this field in the organization profile in Commons.

To confirm that your organization has a DUNS number or to find out if
the DUNS number you have matches the one in Commons, access the List of
Grantee Organizations Registered in NIH eRA Commons
(<http://era.nih.gov/userreports/ipf_com_org_list.cfm>). This listing of
grantee organizations registered in Commons and their DUNS numbers can
be accessed without logging into Commons.

#### 2.2.2.2 Commons Registration for the Program Director/Principal Investigator (PD/PI)

The individual designated as the PD/PI on the application must also be
registered in the Commons. The PD/PI must hold a PI account **and** be
affiliated with the applicant organization. **This registration must be
done by an organizational official (or delegate) who is already
registered in the Commons.** To register PDs/PIs in the Commons, refer
to the NIH eRA Commons System Users Guide
(<http://era.nih.gov/Docs/COM_UGV2630.pdf>).

Once the PD/PI has received email confirming his/her registration within
the Commons, the PD/PI must verify that all Personal Information located
within the Personal Profile tab in the eRA Commons System is accurate.
Please have the PD/PI review and update, as needed, data elements such
as first name, middle initial, last name, prefix and/or suffix to PD/PI
name (including all embedded punctuation), email, phone, fax, street
address, city, state, country, zip and degrees earned. These data must
contain the most recent information in order for the application to be
processed accurately.

Both PD/PI and SO need separate accounts in Commons since both need to
verify the application. If you are the SO for your organization as well
as a PI of the grant, you will need two separate accounts with different
user names -- one with SO authority and one with PI authority. When an
organization is registered, an SO account is created. Log on to the
account with the SO authority role and create another account with PI
authority.

It is important to note that if a PD/PI is also an NIH peer-reviewer
with an Individual DUNS and CCR registration, that particular DUNS
number and CCR registration are for the individual reviewer only. These
are different than any DUNS number and CCR registration used by an
applicant organization. Individual DUNS and CCR registration should be
used only for the purposes of personal reimbursement and should not be
used on any grant applications submitted to the Federal Government.

For additional information on how to prepare for electronic submission,
see: <http://era.nih.gov/ElectronicReceipt/preparing.htm>.

## 2.3 Software Requirements

### 2.3.1 Adobe Reader

In order to access, complete and submit applications, applicants need to
download and install the Adobe Reader, version 8.1.1 or later. For
minimum system requirements and download instructions, please see the
[Grants.gov User
Guide](http://www.grants.gov/assets/ApplicantUserGuide.pdf).

Please note that you must set the Adobe Reader's page layout options to
"Continuous" instead of "Single Page" to ensure all features function
properly. To do this, choose View \> Page Layout, and then choose the
"Continuous" option.

### 2.3.2 Creating PDFs for Text Attachments

NIH and other PHS agencies require all text attachments to the SF424
(R&R) application forms to be submitted as PDF files.

Applicants should prepare text attachments using any word processing
program (following the format requirements in [Section
2.6](#format-specifications-for-text-pdf-attachments)) and then convert
those files to PDF before attaching the files to the appropriate
component in the application package. (The PDF format is used to
preserve document formatting.) In addition, be sure to save files with
descriptive file names.

Some type of PDF-creation software is necessary to create the PDF. (The
free Adobe Reader *will not create* a PDF.) To assist applicants
searching for PDF-creation software, Grants.gov has published the
following list of available tools and software:
<http://www.grants.gov/assets/PDFConversion.pdf>. Additionally,
applicants may find Planet PDF's "Find PDF Software" feature
(<http://www.planetpdf.com/find_software.asp>) useful to browse or
search a comprehensive database of free, shareware, or commercial PDF
products. Applicants should choose the PDF-creation software that best
suits their needs.

It is recommended that, as much as possible, applicants avoid scanning
text documents to produce the required PDFs. Instead, NIH recommends
producing the documents electronically using text or word-processing
software and then converting documents to PDF. Scanning paper documents,
without the proper Optical Character Recognition (OCR) process, will
hamper automated processing of your application for NIH analysis and
reporting.

DISCLAIMER: References to software packages or Internet services neither
constitute nor should be inferred to be an endorsement or recommendation
of any product, service, or enterprise by the NIH or other PHS agencies,
any other agency of the United States Government, or any employee of the
United States Government. No warranties are stated or implied.

### 2.3.3 Special Instructions for Macintosh Users

With the conversion to Adobe Reader applications submissions there are
no longer special instructions for Macintosh users.

## 2.4. Funding Opportunities

Grants for health-related research and research training projects or
activities make up the largest category of funding provided by the NIH
Institutes/Centers (ICs) and other non-NIH agencies. Most applications
for support are **unsolicited** and originate with individual
investigators who develop proposed plans for research or research
training within an area that is relevant to the NIH. Research project
grants are awarded to organizations/institutions on behalf of PDs/PIs to
facilitate the pursuit of a scientific objective when the idea for the
research is initiated by the investigator. If the funding agency
anticipates substantial program involvement during the conduct of the
research, a cooperative agreement will be awarded, rather than a grant.
The NIH awards grants and cooperative agreements for terms ranging from
one to five years. Organizational/institutional sponsorship assures that
the awardee organization will provide the facilities and the financial
stability necessary to conduct the research, and be accountable for the
funds. For a list and brief description of grant mechanisms, see [Part
III: Policies, Assurances, Definitions, and Other
Information.](#research-grant-mechanisms)

### 2.4.1 NIH Guide for Grants and Contracts

The [*NIH Guide for Grants and
Contracts*](http://grants.nih.gov/grants/guide)
(<http://grants.nih.gov/grants/guide>), a weekly electronic publication,
contains announcements about funding opportunities, such as Requests for
Applications (RFAs) and Program Announcements (PAs), including Parent
Announcements, from NIH and other PHS agencies. The *NIH Guide* also
contains vital information about policies and procedures. To subscribe
to the *NIH Guide*, visit
<http://grants.nih.gov/grants/guide/listserv.htm>.

### 2.4.2 Grant and Cooperative Agreement Announcements

To hasten the development of a program or to stimulate submission of
applications in an area of high priority or special concern, an awarding
component will encourage applications through the issuance of a PA to
describe new, continuing, or expanded program interests, or issuance of
an RFA inviting applications in a well-defined scientific area to
accomplish a scientific purpose.

[]{#PAsRFAs .anchor}Definitions are as follows:

**Parent Announcements:** Electronic grant applications must be
submitted in response to a Funding Opportunity Announcement (FOA). For
applicants who wish to submit what were formerly termed
"investigator-initiated" or "unsolicited" applications, NIH and other
PHS agencies have developed Parent Announcements. Responding to such an
omnibus or umbrella Parent FOA ensures that the correct application
package is used and enables NIH to receive the application from
[Grants.gov](http://www.grants.gov/). Additional information about, as
well as links to published Parent Announcements, can be found at:
<http://grants.nih.gov/grants/guide/parent_announcements.htm>.

**Program Announcement (PA):** A formal statement about a new or ongoing
extramural activity or mechanism. It may serve as a reminder of
continuing interest in a research area, describe modification in an
activity or mechanism, and/or invite applications for grant support.
Most applications in response to PAs may be submitted to a standing
submission date and are reviewed with all other applications received at
that time.

**Request for Applications (RFA):** A formal statement that solicits
grant or cooperative agreement applications in a well-defined scientific
area to accomplish specific program objectives. An RFA indicates the
estimated amount of funds set aside for the competition, the estimated
number of awards to be made, and the application submission date(s).
Applications submitted in response to an RFA are usually reviewed by a
Scientific Review Group (SRG) specially convened by the awarding
component that issued the RFA.

PAs (including Parent Announcements) and RFAs are published in the [*NIH
Guide for Grants and Contracts*](http://www.nih.gov/grants/guide)
(<http://grants.nih.gov/grants/guide>), the [*Federal
Register*](http://www.gpoaccess.gov/nara/index.html)
(<http://www.gpoaccess.gov/nara/index.html>), and on Grants.gov under
Find Grant Opportunities
(<http://www.grants.gov/applicants/find_grant_opportunities.jsp>). Read
the announcement carefully for special instructions. The instructions in
the announcement may differ from these general instructions, and the
instructions in the announcement **always** supersede these general
instructions. Each announcement published in the [*NIH Guide for Grants
and Contracts*](http://grants.nih.gov/grants/guide), the [*Federal
Register*](http://www.gpoaccess.gov/nara/index.html), [Grants.gov
Find](http://www.grants.gov/applicants/find_grant_opportunities.jsp), or
other public document contains contact information under Inquiries in
addition to information specific to the announcement.

While individual announcements will continue to carry an announcement
number reference to "PA" or "RFA", all announcements are "Funding
Opportunity Announcements (FOAs)." This general term will be used to
reference any type of funding announcement. NIH will continue to use the
PA and RFA references in the actual announcement number to distinguish
between the various types of announcements.

In reading any FOA in the *NIH Guide for Grants and Contracts*:

-   A "release/posted date" refers to the date the FOA is posted on
    [Grants.gov/Apply](http://www.grants.gov/Apply). An applicant can
    download the application package on that date and begin filling it
    out. However, the applicant has to wait until the FOA's "opening
    date" to submit the application.

-   An application can be submitted anytime between the "opening date"
    and the "application submission date(s)" noted for AIDS and non-AIDS
    applications. (Standard dates may apply; check
    <http://grants.nih.gov/grants/funding/submissionschedule.htm> for
    details.)

-   When you download an application package from Grants.gov, the
    "expiration date" is prepopulated. Do not go strictly by this date
    since it may not apply to your particular situation; for instance,
    it may reflect the submission date for AIDS applications and you may
    be submitting a non-AIDS application that is due earlier. In this
    case, the prepopulated date has no bearing on your application and
    you should not be concerned by it.

### 2.4.3 Finding a Funding Opportunity Announcement (FOA) for Grants.gov Submission

Implementation of the SF424 (R&R) application and electronic submission
through Grants.gov will be announced through specific FOAs posted in the
*NIH Guide for Grants and Contracts* and on Grants.gov under "Find Grant
Opportunities" (a.k.a. "Find") and "Apply for Grants" (a.k.a "Apply").
While all FOAs are posted in Grants.gov Find, not all reference
electronic submission via Grants.gov at this time. FOAs posted in
Grants.gov Apply reflect those the agency is prepared to receive through
electronic Grants.gov submission. Applicants are encouraged to read each
FOA carefully for specific guidance on the use of Grants.gov submission.

There are several ways a prospective applicant can find a FOA on
Grants.gov.

#### Using the *NIH Guide for Grants and Contracts* {#using-the-nih-guide-for-grants-and-contracts .Subhead---No-TOC}

FOAs in the *NIH Guide for Grants and Contracts* that reference
electronic submission via Grants.gov now include a link from the FOA
directly to the Grants.gov site where you can download the specific
application package. The "**Apply for Grants Electronically**" button is
found in the *NIH Guide* FOA directly under the announcement number.
This link is only provided in those announcements involving electronic
submission through Grants.gov.

#### Using "Find Grant Opportunities" (Find) Feature {#using-find-grant-opportunities-find-feature .Subhead---No-TOC}

Grants.gov Find provides general search capabilities. From the "Find
Grant Opportunities" page, you may search by clicking on the "Search
Grant Opportunities" link. This takes you to a screen providing options
for: 1) Basic Search; 2) Browse by Category; 3) Browse by Agency; and 4)
Advanced Search. To perform a **basic search** for a grant, complete the
"Keyword Search"; the "Search by Funding Opportunity Number"; **OR** the
"Search by CFDA Number" field; and then click the "**Search**" button
below.

Note that NIH has made it easier for applicants by adding a button
("**Apply for Grant Electronically**") to the *NIH Guide for Grants and
Contracts* announcements that allows applicants to access the Grants.gov
application package directly from the *NIH Guide*. See the preceding
paragraph *"Using the NIH Guide for Grants and Contracts"* for more
details.

Access Search Tips for helpful search strategies, or click the **Help**
button in the upper right corner of Grants.gov to get help with the
Search screen.

Once you find an opportunity for which you wish to apply, you may
initiate the application download process immediately by selecting the
"How to Apply" link that appears on the FOA synopsis page. Or you may
elect to initiate the application download at a later time. In this
case, you should record the Funding Opportunity number or CFDA number
and enter it manually later on the [Download Application
Packages](https://apply.grants.gov/forms_apps_idx.html) screen in the
[Grants.gov/Apply](http://grants.gov/Apply) section of this site.

#### Using "Apply for Grants" (Apply) Feature {#using-apply-for-grants-apply-feature .Subhead---No-TOC}

If you know the specific funding opportunity number, a more direct route
is to use the "Apply for Grants" feature. From the
[Grants.gov](http://www.grants.gov/) home page, select "Apply for
Grants" and follow the steps provided. "Step 1" allows you to download
an application package by inserting a specific Funding Opportunity
Number (FOA). If you do not know the specific Funding Opportunity Number
there is a link that will take you back to the Find Grant Opportunities
page.

![](media/image2.jpeg){width="6.486805555555556in" height="3.85in"}

A Funding Opportunity Number is referenced in every announcement. It may
be called a Program Announcement (PA) Number or a Request for
Application (RFA) Number. Enter this number in the Funding Opportunity
Number field and click "Download Package." This takes you to a "Selected
Grant Applications for Download" screen.

![](media/image3.jpeg){width="6.720833333333333in"
height="5.347222222222222in"}

If you searched only on a specific opportunity number, only one
announcement is provided in the chart. Click the corresponding
"download" link to access the actual application form pages and
instruction material. The following screen appears:

![](media/image4.jpeg){width="6.514583333333333in"
height="4.522916666666666in"}

To access the instructions, click "Download Application Instructions."
For NIH opportunities and other PHS agencies using this Application
Guide, this action will download a document containing a link to the NIH
Web site where the most current set of application instructions is
available (<http://grants.nih.gov/grants/funding/424/index.htm>).
Applicants are encouraged to check this site regularly for the most
current version.

To access the form pages, click "Download Application Package." Section
2.5 provides specific information regarding the components of an
Application Package. [Section 3](#using-the-grant-application-package)
provides additional instructions for properly using a package.

On the Download Opportunity Instructions and Applications screen you
will be given an opportunity to provide an e-mail address if you would
like to be notified of any changes to this particular opportunity.
Applicants to NIH and other PHS agencies are strongly encouraged to
complete this information. The agency can then use it to provide
additional information to prospective applicants.

Note: if multiple CFDA numbers are cited in the FOA, the Download
Opportunity Instructions and Applications screen may prefill a CFDA
number and description that may not correspond to the Institute/Center
of interest to you; or the CFDA information may not appear at all. In
either case, do not be concerned since the Center for Scientific Review,
NIH does not use the CFDA number for assignment of the application. Be
assured the correct CFDA number will be assigned to the record once the
appropriate IC assignment has been made.

## 2.5 Components of an Application to NIH or Other PHS Agencies

The SF424 (R&R) form set is comprised of a number of components, each
listed in the table below as a separate "document." In addition to these
components, NIH and other PHS agencies applicants will also complete
supplemental components listed as "PHS398" components in the table
below.

Table 2.5-1. Components of an NIH or Other PHS Agencies Application

  ---------------------------------------------------------------------------------------------------------------------------------------------
  Document                             Required   Optional   Instructions
  ------------------------------------ ---------- ---------- ----------------------------------------------------------------------------------
  SF424 (R&R) Cover                    x                     [Section 4.2](#cover-component)

  SF424 (R&R) Project/Performance Site x                     [Section 4.3](#_4.3_Project/Performance_Site_Locati)
  Locations                                                  

  SF424 (R&R) Other Project            x                     [Section 4.4](#other-project-information-component)
  Information                                                

  SF424 (R&R) Senior / Key Person      x                     [Section 4.5](#seniorkey-person-profile-expanded-component)
  Profile(s)                                                 

  SF424 (R&R) Budget\                  **\***                [Section 4.7](#rr-budget-component)
  *(If NOT using PHS398 Modular                              
  Budget.)*                                                  

  SF424 (R&R) Subaward Budget                     x          [Section
  Attachment Form                                            4.8](#special-instructions-for-preparing-applications-with-a-subawardconsortium)

  PHS398 Cover Letter                             x          [Section 5.2](#cover-letter-component)

  PHS398 Cover Page Supplement         x                     [Section 5.3](#cover-page-supplement-component)

  PHS398 Modular Budget\               **\***                [Section 5.4](#modular-budget-component)
  *(If NOT using SF424 (R&R) Budget)*                        

  PHS398 Research Plan                 x                     [Section 5.5](#research-plan-component)

  PHS398 Checklist                     x                     [Section 5.6](#checklist-component)
  ---------------------------------------------------------------------------------------------------------------------------------------------

**\*** The application forms package associated with most NIH funding
opportunities includes two optional budget components: (1) SF424 (R&R)
Budget and (2) PHS398 Modular Budget. NIH application submissions must
include either the SF424 (R&R) Budget Component or the PHS398 Modular
Budget Component, but never both. (Note AHRQ does not accept modular
budgets.) Unless other stated in a funding announcement, an application
must always be submitted with a budget component. For those programs
where either form is a possibility, the budget forms will be considered
"optional" by the Grants.gov package. Nonetheless, it is still required
that you select and submit one of these budget forms for an application
to be accepted by the NIH.

To determine which budget component to use for NIH applications, consult
the modular budget guidelines found in [Section
5.4](#modular-budget-component). Additional guidance may also be
provided in the specific funding opportunity announcement.

Some funding opportunities will explicitly state the use of only one of
the budget components. In this case, the application package will only
include the accepted budget form which will appear in the list of
"mandatory" forms (not in the optional list).

> All required and optional forms for electronic submission listed above
> are available through Grants.gov and should be downloaded from the FOA
> being applied to. Do not use any forms or format pages from other
> sources; these may include extraneous headers/footers or other
> information that could interfere with the electronic application
> process.

## 2.6 Format Specifications for Text (PDF) Attachments

Designed to maximize system-conducted validations, multiple separate
attachments are required for a complete application. When the
application is received by the agency, all submitted forms and all
separate attachments are concatenated into a single document that is
used by peer reviewers and agency staff.

NIH and other PHS agencies require all text attachments to the Adobe
application forms to be submitted as PDFs and that all text attachments
conform to the agency-specific formatting requirements noted below.
Failure to follow these requirements may lead to rejection of the
application during agency validation or delay in the review process.
(See [Section 2.3.2](#creating-pdfs-for-text-attachments) for more
information on creating PDFs.)

Text attachments should be generated using word processing software and
then converted to PDF using PDF generating software. Avoid scanning text
attachments to convert to PDF since that causes problems for the agency
handling the application. Additional tips for creating PDF files can be
found at <http://era.nih.gov/ElectronicReceipt/pdf_guidelines.htm>.

When attaching a PDF document to the actual forms, please note you are
attaching an actual document, not just pointing to the location of an
externally stored document. Therefore, if you revise the document after
it has been attached, you **must** delete the previous attachment and
then reattach the revised document to the application form. Use the
"**View Attachment**" button to determine if the correct version has
been attached.

[]{#font_spec .anchor}**Font**

Use an Arial, Helvetica, Palatino Linotype, or Georgia typeface, a black
font color, and a font size of 11 points or larger. (A Symbol font may
be used to insert Greek letters or special characters; the font size
requirement still applies.)

Type density, including characters and spaces, must be no more than 15
characters per inch.

Type may be no more than six lines per inch.

**Page Margins**

Use *standard paper size (8 ½\" x 11)*.

Use at least one-half inch margins (top, bottom, left, and right) for
all pages. No information should appear in the margins, including the
PI's name and page numbers.

**Page Formatting**

Since a number of reviewers will be reviewing applications as an
electronic document and not a paper version, applicants are strongly
encouraged to use only a standard, single-column format for the text.
Avoid using a two-column format since it can cause difficulties when
reviewing the document electronically.

Do not include any information in a header or footer of the attachments.
A header will be system-generated that references the name of the PD/PI.
Page numbers for the footer will be system-generated in the complete
application, with all pages sequentially numbered.

**Figures, Graphs, Diagrams, Charts, Tables, Figure Legends, and
Footnotes**

You may use a smaller type size but it must be in a black font color,
readily legible, and follow the font typeface requirement. Color can be
used in figures; however, all text must be in a black font color, clear
and legible.

**Grantsmanship**

Use English and avoid jargon.

If terms are not universally known, spell out the term the first time it
is used and note the appropriate abbreviation in parentheses. The
abbreviation may be used thereafter.

**Separate Attachments**

Separate attachments have been designed for the Research Plan sections
to maximize automatic validations conducted by the eRA system. When the
application is received by the agency, all of the Research Plan sections
will be concatenated in the appropriate order so that reviewers and
agency staff will see a single cohesive Research Plan.

While each section of the Research Plan needs to eventually be uploaded
separately, applicants are encouraged to construct the Research Plan as
a single document, separating sections into distinct PDF attachments
just before uploading the files. In this way the applicant can better
monitor formatting requirements such as page limits. When validating for
page limits, the eRA Commons will not count the white space created by
breaking the text into separate files for uploading.

**Page Limits**

Although many of the sections of this application are separate text
(PDF) attachments, page limitations referenced in these instructions
and/or funding opportunity announcement must still be followed. Agency
validations will include checks for page limits. Some accommodation will
be made for sections that when combined must fit within a specified
limitation. Note that while these computer validations will help
minimize incomplete and/or non-compliant applications, they do not
replace the validations conducted by NIH staff. Applications found not
to comply with the requirements may lead to rejection of the application
during agency validation or delay in the review process.

All applications and proposals for NIH and other PHS agency funding must
be self-contained within specified page limitations. Unless otherwise
specified in an NIH solicitation, Internet website addresses (URLs) may
not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Moreover,
reviewers are cautioned that they should not directly access an Internet
site as it could compromise their anonymity.

Observe the page number limitations given in Table 2.6-1. Only in cases
involving interdependent multiple subprojects (e.g., Program Projects
and Multi-Center Clinical Trials) will the PHS accept applications that
exceed the page number limitations. However, specific page number limits
may apply to each subproject. For information pertaining to page number
limits for such projects, contact the awarding component to which the
application may be assigned. (See [Table 1.4-1. Agency Contact
Table](#Table_AwardingComponents).) **The page number limitations may
also be different for other specialized grant applications (e.g., R03
and R21 applications). Consult and follow the additional instructions
for those applications.**

Table 2.6-1. Page Limitations and Content Requirements

+-------------------+---------------------+----------------------------+
| Section           | Page Limit          | Content                    |
+===================+=====================+============================+
| [Introductio      | Not required/Not to | See Instructions           |
| n](#Introduction) | be submitted        |                            |
|                   |                     |                            |
| \- New            | 1-3\                |                            |
| applications      | (check announcement |                            |
|                   | for\                |                            |
| \- Resubmission   | specific guidance)  |                            |
| applications      |                     |                            |
|                   | 1                   |                            |
| \- Revision       |                     |                            |
| applications      |                     |                            |
+-------------------+---------------------+----------------------------+
| [Research         | 25\*                | Text including all         |
| Plan](#researc    |                     | figures, charts, tables,   |
| h-plan-component) | \* Some exclusions  | and diagrams.              |
|                   | for renewal         |                            |
| Sections 2-5      | applications        |                            |
|                   |                     |                            |
| Sections 6 - 17   | none                |                            |
+-------------------+---------------------+----------------------------+
| [Biographical     | 4                   | No more than four pages    |
| S                 |                     | for each person listed as  |
| ketches](#Additio |                     | Senior/Key Persons.        |
| nal_Bio_Instruct) |                     |                            |
+-------------------+---------------------+----------------------------+
| [App              | none                | **New requirements         |
| endix](#Appendix) |                     | effective 1/3/2007**. See  |
|                   |                     | Instructions for           |
|                   |                     | specifics.                 |
|                   |                     |                            |
|                   |                     | Generally limited          |
|                   |                     | publications are allowed   |
|                   |                     | now only in certain        |
|                   |                     | situations. Only           |
|                   |                     | questionnaires and other   |
|                   |                     | materials are allowed.     |
+-------------------+---------------------+----------------------------+
| [PAs and          | Page limitations    | See specific instructions  |
| RFAs](#n          | specified in the PA | in PAs and RFAs published  |
| ih-guide-for-gran | and RFA             | in the *NIH Guide*.        |
| ts-and-contracts) | announcement in the |                            |
|                   | *NIH Guide* take    |                            |
|                   | precedence.         |                            |
+-------------------+---------------------+----------------------------+

## 2.7 "Resubmission" (Revised) Applications

NIH allows the submission of up to two revised applications (now known
as "Resubmission" applications) and no longer restricts those
submissions to a two-year timeframe. See [NIH Policy on Resubmission
Applications](#nih-policy-on-resubmission-applications) in Part III.

NIH has established new policies for application resubmissions of
certain categories. See [Resubmission of Unpaid RFA Applications and
Resubmission of Applications with a Changed Grant Activity
Mechanism](#resubmission-of-unpaid-rfa-applications-and-resubmission-of-applications-with-a-changed-grant-activity-mechanism)
in Part III.

Before a resubmission application can be submitted, the Program
Director/Principal Investigator (PD/PI) must have received the Summary
Statement from the previous review.

Acceptance of a resubmission application will not automatically withdraw
the prior version. As of February 2008, eRA keeps all versions (e.g.,
01, A1, A2) of a grant application active and provides an internal MAA
("Multiple Active Applications" flag for each application in an active
cluster. The cluster allows applicants to identify quickly all versions
of one application. If any version in a cluster is awarded, application
will notice that all other applications within the cluster will be
automatically withdrawn without any additional action by applicants or
staff.

**Introduction to Resubmission Application.** The resubmission must
include a brief Introduction (1-3 pages depending on the mechanism) that
*summarizes* the substantial additions, deletions, and changes. The
Introduction must also include responses to the criticisms and issues
raised in the Summary Statement. **Use Item 2.1, Introduction to
Application, of the PHS 398 Research Plan component to provide this
information.** Page limits for the Introduction vary for specialized
mechanisms (e.g., R03 and R21 applications). Applicants **must** follow
the page limits that are outlined in the specific announcement.

**Research Plan of Resubmission Application.** A resubmission
application must include substantial changes. Identify the changes in
each section of the Research Plan clearly by bracketing, indenting, or
changing typography, unless the changes are so extensive as to include
most of the text. This exception should be explained in the
Introduction. **Do not underline or shade changes.** The Preliminary
Studies/Progress Report section should incorporate any work done since
the prior version was submitted.

Application processing may be delayed or the application may be returned
if it does not comply with all of these requirements.

Investigators who have submitted three versions of an application and
have not been successful often ask NIH staff how different the next
application submitted needs to be, as it will be considered a new
application. It is recognized that investigators are trained in a
particular field of science and are not likely to make drastic changes
in their research interests. However, a new application following three
reviews is expected to be substantially different in content and scope
with more significant differences than are normally encountered in a
resubmission application. Simply rewording the title and Specific Aims
or incorporating minor changes in response to comments in the previous
Summary Statement does not constitute a substantial change in scope or
content. Changes to the Research Plan should produce a significant
change in direction and approach for the research project. Thus, a new
application would include substantial changes in all sections of the
Research Plan, particularly the Specific Aims and the Research Design
and Methods sections.

In the referral process, NIH staff look at all aspects of the
application, not just the title and Project Summary/Abstract. Requesting
review by a different review committee does not affect the
implementation of this policy. When necessary, previous applications are
analyzed for similarities to the present one. Thus, identical
applications or those with only minor changes will not be accepted for
review.

## 2.8 "Revision" (Competing Supplemental) Application

A competing supplemental application (now known as a "Revision"
application) may be submitted to request support for a significant
expansion of a project's scope or research protocol. Applications for
revisions are **not appropriate** when the sole purpose is to restore
awards to the full SRG-recommended level if they were administratively
reduced by the funding agency. A revision application **should not be
submitted** until after the original application has been awarded and
**may not extend beyond the term of the current award period.**

Provide a one-page "Introduction" that describes the nature of the
supplement and how it will influence the specific aims, research design,
and methods of the current grant. Use Item 2.1, Introduction to
Application, of the PHS 398 Research Plan component to provide this
information. Any budgetary changes for the remainder of the project
period of the current grant should be discussed in section K, Budget
Justification, of the Research & Related Budget component. The body of
the application should contain sufficient information from the original
grant application to allow evaluation of the proposed supplement in
relation to the goals of the original application.

If the revision application relates to a specific line of investigation
presented in the original application that was not recommended for
approval by the SRG, then the applicant must respond to the criticisms
in the prior Summary Statement, and substantial revisions must be
clearly evident and summarized in the "Introduction."

**Administrative "Revisions" (*a.k.a. Supplements*)**

An administrative supplement provides additional funding to meet
increased costs that are within the scope of your approved application,
but that were unforeseen when the new or competing renewal (formerly
"competing continuation") application was submitted. If you are
contemplating supplemental funding, you must consult in advance with
your designated Grants Management Officer and Program Official. It is
important for you to submit a request before your grant expires. To be
considered for an administrative supplement, you must submit a request
in writing to the IC (not to CSR), signed by the authorized Business
Official, describing the need for additional funding and the categorical
costs. In your letter, also be sure to point out what you will NOT be
able to accomplish if such a request is denied. At this time,
administrative revisions/supplements will not be submitted through
Grants.gov.

## 2.9 Similar, Essentially Identical, or Identical Applications

Submissions of identical applications to one or more components of the
PHS are not allowed.

The NIH will not accept similar grant applications with essentially the
same research focus from the same applicant organization. This includes
derivative or multiple applications that propose to develop a single
product, process or service that, with non-substantive modifications,
can be applied to a variety of purposes. Likewise, identical or
essentially identical grant applications submitted by different
applicant organizations will not be accepted. Applicant organizations
should ascertain and assure that the materials they are submitting on
behalf of the principal investigator are the original work of the
principal investigator and have not been used elsewhere in the
preparation and submission of a similar grant application. Applications
to the NIH are grouped by scientific discipline for review by individual
Scientific Review Groups and not by disease or disease state. The
reviewers can thus easily identify multiple grant applications for
essentially the same project. In these cases, application processing may
be delayed or the application(s) may be returned to the applicant
without review.

Essentially identical applications will not be reviewed except for: 1)
individuals submitting an application for an Independent Scientist Award
(K02) proposing essentially identical research in an application for an
individual research project; and 2) individuals submitting an individual
research project identical to a subproject that is part of a program
project or center grant application.

## 2.10 Submitting Your Application Via Grants.gov

The Applicant Organizational Representative (AOR) registered in
Grants.gov is the only official with the authority to actually submit
applications through Grants.gov. Therefore, PDs/PIs will need to work
closely with their AOR to determine that all the necessary steps have
been accomplished prior to submitting an application. This includes any
internal review process required by the applicant organization.

Before starting the final submission step, **applicants are encouraged
to save a copy of the final application locally**. Once you have
properly completed all required documents and attached any required or
optional documentation, click on the **Check Package for Errors** button
to ensure that you have successfully completed all required data fields.
If any of the required fields are not completed you will receive an
error notice which will indicate where revision is needed within your
package. Correct any errors or if none are found, save the application
package. The **Save & Submit** button will now become active and
clicking this button will begin the application submission process. Only
after the package has been saved with no errors will the **Save &
Submit** button become active. The application package must then be
saved once more before the submission process begins. Only an AOR will
be able to perform the submit action, and they will be taken to the
applicant login page to enter the Grants.gov username and password that
was established in the Register with Grants.gov process (if not
connected to the internet you will be instructed to do so).

Once logged in, the application package will be automatically uploaded
to Grants.gov. A confirmation screen will appear once the upload is
complete and a Grants.gov Tracking Number will be provided on this
screen. Applicants should record this number so that they may refer to
it should they need to contact Grants.gov Customer Support or the eRA
Commons Help Desk.

For additional information, access Grants.gov/Submit Application Package
(<http://grants.gov/SubmitApplication>).

**Note, on-time submission of an application is currently a 2-step
process: 1) accepted by Grants.gov on or before 5 p.m. Local Time (of
the applicant organization) on the submission date; and 2) reviewed
within two business days of the image being available in Commons. Note,
the image is available only once all errors are corrected. For a limited
time during the transition period, NIH provides a window of two weekdays
(Monday-Friday, excluding Federal holidays) for correction of any
validation errors after initial submission. Note that this has recently
been changed from the previous 5-day window available for making
corrections, and please refer to the NIH Guide for Grants and Contracts
for more information and updates on the eventual elimination of the
current two-day window.**

## 2.11 After You Submit Your Application Via Grants.gov

The Authorized Organizational Representative (AOR) can use Grants.gov to
check the status of an application at any time. Note that Grants.gov
requires a user login and password. To check the status of an
application, go to <https://apply.grants.gov/ApplicantLoginGetID>.

Once an application has been submitted via Grants.gov, several emails
are generated by Grants.gov and sent to the AOR (also known as the
Signing Official \[SO\]) named in the grant application indicating a
Grants.gov tracking number that is assigned to the submission:

1\) Submission Receipt: An email is sent indicating your application has
been received by Grants.gov and is currently being validated.

2\) Submission Validation Receipt: An email is sent indicating your
application has been received and validated by Grants.gov and is being
prepared for Grantor agency retrieval.

3\) Grantor Agency Retrieval Receipt: An email is sent indicating your
application has been retrieved by the Grantor agency.

4\) Agency Tracking Number Assignment for Application: An email is sent
indicating your application has been assigned an Agency Tracking Number.

If the AOR/SO has not received a confirmation message from Grants.gov
within 48 hours of submission, please contact:

Grants.gov Contact Center

Telephone: 1-800-518-4726

Email: <support@grants.gov>

At that point, the application will be scheduled for download into the
eRA system for agency validation. It is imperative that the email
address provided in blocks 15 for the PD/PI and 19 for the AOR/SO on the
SF424 (R&R) Cover component be current and accurate. Once agency
validation is completed, an agency notification (not Grants.gov) will be
emailed to the PD/PI and AOR/SO named in the application.

This email notification will inform the PD/PI and AOR/SO that the
application has been received and processed by the agency and will
indicate whether any errors or warnings resulted during the validation
process. The PD/PI and AOR/SO will be invited to log on the eRA
[Commons](https://commons.era.nih.gov/commons), to view the assembled
application or review the list of warnings/errors that were encountered
during the validation process.

If there were no validation errors, this email notification will also
inform the PD/PI and AOR/SO of an agency accession number, which
represents the "agency tracking number." This number replaces the
Grants.gov tracking number that was assigned when the application was
first submitted. The Grants.gov system will indicate that the agency
tracking number has been assigned, and will reflect both numbers. In
subsequent interaction with the eRA Commons, however, it is the agency
accession number that will be used to refer to the application, not the
Grants.gov tracking number.

The eRA system will make every effort to send an email to the PD/PI and
AOR/SO summarizing download and validation results. However, since email
can be unreliable, applicants are strongly encouraged to periodically
check on their application status in the Commons.

Once an application package has been successfully submitted through
Grants.gov, all errors are corrected and an application has been
assembled by the eRA Commons, PDs/PIs and AORs/SOs will have two
weekdays (Monday -- Friday, excluding Federal holidays) to view the
application. If everything is acceptable, no further action is
necessary. The application will automatically move forward to the
Division of Receipt and Referral in the Center for Scientific Review for
processing after two weekdays, excluding Federal holidays. (Note, the
previous PI & SO Verification steps have been eliminated effective with
submissions made on/after May 10, 2006.)

If, however, it is determined that some part of the application was lost
or did not transfer correctly during the submission process, the AOR/SO
will have the option to "Reject" the application and submit a
Changed/Corrected application. In these cases, please contact the eRA
Help Desk to ensure that the issues are addressed and corrected. Once
rejected, applicants should follow the instructions for correcting
errors in Section 2.12, including the requirement for cover letters on
late applications.

The "Reject" feature should also be used if you determine that warnings
are applicable to your application and need to be addressed now.
Remember, warnings do not stop further application processing. If an
application submission results in warnings (but no errors), it will
automatically move forward after two weekdays (Monday -- Friday,
excluding Federal holidays) if no action is taken. Some warnings may
need to be addressed later in the process.

PIs should work with their AOR/SO to determine when the "Reject" feature
is appropriate.

**To view the assembled application the AOR/SO should:**

1\. Login to the eRA Commons (<https://commons.era.nih.gov/commons/>)
with your Signing Official (SO) account.

2\. Click the **Status** tab on the Commons menu bar.

3\. Click **Recent/Pending eSubmissions** on the left-hand side of the
screen.

4\. Search for your application by date received, grants.gov tracking
number, or accession number, to view a hitlist of available
applications.

5\. When you find the appropriate application, click the accession
number in the **Application ID** column to view the status information
screen.

6\. Click e-Application from the Other Relevant Documents section to
view the assembled application.

> Note: The SO can Reject the application by clicking on the Reject
> eApplication hypertext link from the Action Column of the search hit
> list.

**To view the assembled application the PD/PI should:**

1\. Login to the eRA Commons (<https://commons.era.nih.gov/commons/>)
with your Principal Investigator (PI) account.

2\. Click the **Status** tab on the Commons menu bar.

3\. Click **Recent/Pending eSubmissions** near the top of the screen to
view a hitlist of available applications.

4\. When you find the appropriate application, click the accession
number in the **Application ID** column to view the status information
screen.

5\. Click e-Application from the Other Relevant Documents section to
view the assembled application.

## 2.12 Correcting Errors

Prior to a specified submission date, applicants may make corrections
and resubmit an application through Grants.gov. After a specified
submission date, if applicants make corrections and resubmit, the
application will be considered late. In this case, applicants *must*
include a cover letter explaining the reasons for the delay. Also see
[Section 2.14](#application-submission-dates) for additional information
on submission dates.

If validation errors or warnings result from the validation process, the
PD/PI and AOR/SO will be issued an email instructing them to log on to
the eRA Commons to review the list of warnings/errors that were
encountered during the validation process. The eRA system will make
every effort to send an email to the PD/PI and AOR/SO indicating whether
errors or warnings were detected. However, since email can be
unreliable, applicants are strongly encouraged to periodically check on
their application status in the eRA Commons, so that any errors or
warnings can be resolved in the timeliest manner possible.

Please be aware of the distinction between *errors* and *warnings*. The
word *error* is used to characterize any condition which causes the
application to be deemed unacceptable for further consideration.
Generally, errors will indicate significant inaccuracies,
inconsistencies, omissions, or incorrect formatting that have been
identified in the body of the application. Conversely, the word
*warning* characterizes any condition that is acceptable, but worthy of
bringing to the applicant's attention. It is at the applicant's
discretion, whether a warning condition requires any action.

Error conditions must be corrected, and then the application may be
submitted as a changed/corrected application (as outlined below) in
order for the application to be accepted. Please note that if validation
has identified *warnings only*, then the PD/PI and SO will be allowed to
view the application. Warnings do not require any action or submission
of a changed/corrected application at this time. However, please be
aware that some warnings may need to be addressed later in the process
or review stages. Failure to comply with stated NIH policies can also
result in a submitted application being returned to the applicant
without review. For this reason, applicants are strongly encouraged to
review all warnings, to ensure that they require no further attention
and that they are satisfied with the validation results. If desired,
warnings can be corrected in the same manner as errors.

A changed/corrected application may also be submitted if the PDF image,
as viewed in the eRA Commons is incomplete or inaccurate from that
submitted.

**Errors and warnings may be reviewed in the Commons by performing the
following steps:**

1\. After the application has been downloaded from Grants.gov and
validated by the system, access the eRA Commons
(<https://commons.era.nih.gov/commons/>).

2\. Click the **Status** tab on the Commons menu bar.

3\. Click **Recent/Pending eSubmissions** on the left-hand side of the
screen.

4\. Search for your application by date received, grants.gov tracking
number, or accession number.

5\. A hitlist of application numbers is displayed. If the application
was validated with warnings only, or without encountering any problems
whatsoever, then it is identified in the hitlist by its NIH accession
number (e.g., "AN:2911064"). This is the same number that Grants.gov
displays, and refers to as the "agency tracking number."

> If any *errors* were identified during validation, then the
> application still appears in the hitlist, but in this case it is
> identified by its Grants.gov tracking number (e.g., "GRANT12345678").
> This is the number that Grants.gov assigned to your application at the
> time of submission.

6\. When you find the appropriate application in the hitlist, click its
application link.

7\. The error/warning page appears, and you are then able to review all
conditions that were identified during validation. If only *warnings*
were identified, you may elect to take action and resubmit; however you
may accept the warnings and proceed to view the application, as
described earlier.

**To correct errors and resubmit the application:**

1.  Make whatever corrections are necessary, wherever appropriate. Most
    often this means that you have to edit the data within the
    application forms to correct whatever problem or inconsistency that
    was noted.

2.  Check the "Changed/Corrected Application" box in block 1 of the
    SF424 (R&R) Cover component.

```{=html}
<!-- -->
```
1.  If submitting after the submission date, include an explanation in
    the Cover Letter Component.

2.  When you check the Changed/Corrected Application box, Item 4.
    Federal Identifier becomes a required field.

3.  When submitting a Changed/Corrected Application for a "New" Type of
    Application (Item 8 = New), in the Federal Identifier field (Item 4)
    enter the Grants.gov tracking number for the previous application
    that you are correcting. If you are unable to recall the Grants.gov
    tracking number, enter "N/A."

4.  When submitting a Changed/Corrected Application for a
    "Resubmission," "Renewal," or "Revision" Type of Application (Item 8
    = Resubmission, Renewal, or Revision), in the Federal Identifier
    field (Item 4) enter the previously assigned grant number (e.g.,
    CA123456).

5.  Do not use the Changed/Corrected Application box to denote a
    submission of a revised or amended application. That will be
    indicated in item 8, Type of Application.

```{=html}
<!-- -->
```
3.  Have the AOR/SO submit the revised application package to Grants.gov
    again.

The same email notifications will be issued once the agency has
downloaded and validated the re-submitted application and the PD/PI and
AOR/SO will once again be required to log on to the Commons either to
view the application, or to review the errors that were encountered
during validation.

The application will only be assigned for scientific review once errors
are resolved.

In addition to the validations performed by the eRA system, further
administrative review will be conducted by agency staff. The PD/PI
and/or the applicant organization may be contacted for further
corrections/clarifications.

## 2.13 Submission of Supplementary or Corrective Information

Unless specifically required by these instructions (e.g., vertebrate
animals verification), do not send supplementary or corrective material
after the submission date unless the Scientific Review Officer (SRO) of
the Scientific Review Group solicits or agrees to accept this
information. Such additional information will be sent directly to the
SRO and will not be submitted through Grants.gov.

## 2.14 Application Submission Dates

For electronic submission through Grants.gov, each FOA posted in
Grants.gov Apply includes an Opportunity Open Date and an Opportunity
Close Date. Many announcements, including those using the "Standard
Submission Dates" noted in Table 2.15-1 below, include multiple
submission/receipt dates and are active for several years. These
announcements are posted in Grants.gov showing an Open/Close period that
spans the entire active period of the announcement. Applicants should
read the Funding Opportunity Announcement carefully for specific
submission/receipt dates. If specific dates are not referenced in the
announcement, applicants should refer to the Standard Submission Dates
for Competing Applications noted in Table 2.15-1.

Applications submitted for the Standard Submission Dates listed in Table
2.15-1 are considered on time if they are submitted to Grants.gov on or
before the appropriate date listed. When multiple submission dates are
included in a specific FOA, applications submitted for Special Receipt
Dates listed in a FOA are considered on time if they are submitted to
Grants.gov on or before the appropriate date listed. When only a single
submission date is referenced in the FOA, the Closing Date noted in
Grants.gov Apply will be that submission date. In this case,
applications are considered on time if they are submitted to Grants.gov
on or before the Grants.gov posted Closing Date.

**Weekend/Federal Holiday Submission Dates.** If a submission date falls
on a weekend, it will be extended to the following Monday; any time the
date falls on a Federal holiday, the submission date will be extended to
the following business day. The application will be on time if it is
submitted on or before the following business day.

[]{#Late_applications .anchor}**Late Applications.** Permission is not
granted in advance for submission of a late application. Late
applications are accepted only in extenuating circumstances. If an
application is submitted late, use the optional PHS 398 Cover Letter
component to explain the reasons for the delay and include this
component with the completed application. Late applications are
evaluated on an individual basis considering the reasons provided.
Contacting the [Division of Receipt and Referral, Center for Scientific
Review (CSR), NIH](#receiptreferral-of-an-application) in advance will
not influence the acceptance of a late application. For additional
information on late applications, see
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-086.html>.

## 2.15 Submission, Review and Award Cycles

The PHS submission, review, and award schedule is provided in Table
2.15-1. For specialized grant applications, consult with the appropriate
PHS agency prior to the preparation of an application.

Note, Table 2.15-1 references all funding mechanisms, regardless of
which application is currently used. Some of the mechanisms listed
continue to use applications other than the SF424 (R&R). Applicants
should refer to the OER Electronic Submission of Grant Applications
website: <http://era.nih.gov/ElectronicReceipt/> for details on
mechanisms that have transitioned to electronic submission using the
SF424 (R&R) application.

Table 2.15-1. Submission Dates, Review, and Award Cycles

+--------------------------------------+----------+----------+---+---------+
| New Schedule effective January 3,    |  Receipt |  Receipt |   |         |
| 2007                                 | Cycle I  | Cycle II |   | Receipt |
|                                      |          |          |   | Cycle   |
|                                      |          |          |   | III     |
+======================================+==========+==========+===+=========+
| **Program Project Grants and Center  | January  | May 25   | S |         |
| Grants** -- all P Series\*\*\*       | 25       |          | e |         |
|                                      |          | (old     | p |         |
| *new, renewal, resubmission,         | (old     | date\    | t |         |
| revision\**                          | date\    | June 1)  | e |         |
|                                      | Feb. 1)  |          | m |         |
|                                      |          |          | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 2 |         |
|                                      |          |          | 5 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | \ |         |
|                                      |          |          | O |         |
|                                      |          |          | c |         |
|                                      |          |          | t |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Research Grants** --R10, R18, R24, | January  | May 25   | S |         |
| R25                                  | 25       |          | e |         |
|                                      |          | (old     | p |         |
| *new, renewal, resubmission,         | (old     | date     | t |         |
| revision\**                          | date     | June 1,  | e |         |
|                                      | Feb. 1,  | July 1)  | m |         |
|                                      | March 1) |          | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 2 |         |
|                                      |          |          | 5 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | O |         |
|                                      |          |          | c |         |
|                                      |          |          | t |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | , |         |
|                                      |          |          | N |         |
|                                      |          |          | o |         |
|                                      |          |          | v |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Research-Related and Other         | January  | May 25   | S |         |
| Programs** -- all S and G Series,    | 25       |          | e |         |
| C06, M01                             |          | (old     | p |         |
|                                      | (old     | date\    | t |         |
| *new, renewal, resubmission,         | date\    | June 1)  | e |         |
| revision\**                          | Feb. 1)  |          | m |         |
|                                      |          |          | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 2 |         |
|                                      |          |          | 5 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | \ |         |
|                                      |          |          | O |         |
|                                      |          |          | c |         |
|                                      |          |          | t |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | ) |         |
|                                      |          |          |   |         |
+--------------------------------------+----------+----------+---+---------+
| **Institutional Ruth L. Kirschstein  | January  | May 25   | S |         |
| National Research Service** -- T     | 25       |          | e |         |
| Series (Training)\*\*                |          | (old     | p |         |
|                                      | (old     | date\    | t |         |
| *new, renewal, resubmission,         | date\    | May 10)  | e |         |
| revision\**                          | Jan. 10) |          | m |         |
|                                      |          |          | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 2 |         |
|                                      |          |          | 5 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | S |         |
|                                      |          |          | e |         |
|                                      |          |          | p |         |
|                                      |          |          | t |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | 0 |         |
|                                      |          |          | ) |         |
|                                      |          |          |   |         |
+--------------------------------------+----------+----------+---+---------+
| **Research Grants** --R01            | February | June 5   | O |         |
|                                      | 5        |          | c |         |
| *new*                                |          | (old     | t |         |
|                                      | (old     | date\    | o |         |
|                                      | date\    | June 1)  | b |         |
|                                      | Feb. 1)  |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 5 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | \ |         |
|                                      |          |          | O |         |
|                                      |          |          | c |         |
|                                      |          |          | t |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Research Career Development**      | Feb. 12  | June 12  | O |         |
| --all K Series                       |          |          | c |         |
|                                      | (old     | (old     | t |         |
| *new*                                | date\    | date\    | o |         |
|                                      | Feb. 1)  | June 1)  | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 1 |         |
|                                      |          |          | 2 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | \ |         |
|                                      |          |          | O |         |
|                                      |          |          | c |         |
|                                      |          |          | t |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Research Grants** --R03, R21, R33, | February | June 16  | O |         |
| R21/R33, R34, R36                    | 16       |          | c |         |
|                                      |          | (old     | t |         |
| *new*                                | (old     | date\    | o |         |
|                                      | date\    | June 1)  | b |         |
|                                      | Feb. 1)  |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 1 |         |
|                                      |          |          | 6 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | \ |         |
|                                      |          |          | O |         |
|                                      |          |          | c |         |
|                                      |          |          | t |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Academic Research Enhancement      | February | June 25  | O |         |
| Award (AREA)** -- R15                | 25       |          | c |         |
|                                      |          | (no      | t |         |
| *new, renewal, resubmission,         | (no      | change)  | o |         |
| revision\**                          | change)  |          | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 2 |         |
|                                      |          |          | 5 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | n |         |
|                                      |          |          | o |         |
|                                      |          |          | c |         |
|                                      |          |          | h |         |
|                                      |          |          | a |         |
|                                      |          |          | n |         |
|                                      |          |          | g |         |
|                                      |          |          | e |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Research Grants** --R01            | March 5  | July 5   | N |         |
|                                      |          |          | o |         |
| *renewal, resubmission, revision\**  | (old     | (old     | v |         |
|                                      | date     | date\    | e |         |
|                                      | March 1) | July 1)  | m |         |
|                                      |          |          | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 5 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | \ |         |
|                                      |          |          | N |         |
|                                      |          |          | o |         |
|                                      |          |          | v |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Research Career Development**      | March 12 | July 12  | N |         |
| --all K Series                       |          |          | o |         |
|                                      | (old     | (old     | v |         |
| *renewal, resubmission, revision\**  | date     | date\    | e |         |
|                                      | March 1) | July 1)  | m |         |
|                                      |          |          | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 1 |         |
|                                      |          |          | 2 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | \ |         |
|                                      |          |          | N |         |
|                                      |          |          | o |         |
|                                      |          |          | v |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Research Grants** --R03, R21, R33, | March 16 | July 16  | N |         |
| R21/R33, R34, R36                    |          |          | o |         |
|                                      | (old     | (old     | v |         |
| *renewal, resubmission, revision\**  | date     | date\    | e |         |
|                                      | March 1) | July 1)  | m |         |
|                                      |          |          | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 1 |         |
|                                      |          |          | 6 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | \ |         |
|                                      |          |          | N |         |
|                                      |          |          | o |         |
|                                      |          |          | v |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **New Investigator** --R01           | March 20 | July 20  | N |         |
|                                      |          |          | o |         |
| *resubmission\* for those            | (no      | (no      | v |         |
| applications involved in pilot ONLY  | change)  | change)  | e |         |
| (<http://grants.nih.gov/grants/guid  |          |          | m |         |
| e/notice-files/NOT-OD-06-060.html>)* |          |          | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 2 |         |
|                                      |          |          | 0 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | n |         |
|                                      |          |          | o |         |
|                                      |          |          | c |         |
|                                      |          |          | h |         |
|                                      |          |          | a |         |
|                                      |          |          | n |         |
|                                      |          |          | g |         |
|                                      |          |          | e |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Small Business Innovation Research | April 5  | August 5 | D |         |
| (SBIR),**                            |          |          | e |         |
|                                      | (old     | (old     | c |         |
| **Small Business Technology Transfer | date\    | date\    | e |         |
| (STTR) Grants** -- R41, R42, R43 and | April 1) | Aug. 1)  | m |         |
| R44                                  |          |          | b |         |
|                                      |          |          | e |         |
| *new, renewal, resubmission,         |          |          | r |         |
| revision\**                          |          |          | 5 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | \ |         |
|                                      |          |          | D |         |
|                                      |          |          | e |         |
|                                      |          |          | c |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Individual Ruth L. Kirschstein     | April 8  | August 8 | D |         |
| National Research Service Awards     |          |          | e |         |
| (Standard)** -- all F Series         | (old     | (old     | c |         |
| Fellowships\*\*\*\*                  | date\    | date     | e |         |
|                                      | April 5) | August   | m |         |
| *new, renewal, resubmission\**       |          | 5)       | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 8 |         |
|                                      |          |          |   |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | D |         |
|                                      |          |          | e |         |
|                                      |          |          | c |         |
|                                      |          |          | e |         |
|                                      |          |          | m |         |
|                                      |          |          | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 5 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **Conference Grants and Conference   | April 12 | August   | D |         |
| Cooperative Agreements** -- R13, U13 |          | 12       | e |         |
|                                      | (old     |          | c |         |
| *new, renewal, resubmission,         | date\    | (old     | e |         |
| revision\**                          | April    | date\    | m |         |
|                                      | 15)      | Aug. 15) | b |         |
|                                      |          |          | e |         |
|                                      |          |          | r |         |
|                                      |          |          | 1 |         |
|                                      |          |          | 2 |         |
|                                      |          |          | ( |         |
|                                      |          |          | o |         |
|                                      |          |          | l |         |
|                                      |          |          | d |         |
|                                      |          |          | d |         |
|                                      |          |          | a |         |
|                                      |          |          | t |         |
|                                      |          |          | e |         |
|                                      |          |          | \ |         |
|                                      |          |          | D |         |
|                                      |          |          | e |         |
|                                      |          |          | c |         |
|                                      |          |          | . |         |
|                                      |          |          | 1 |         |
|                                      |          |          | 5 |         |
|                                      |          |          | ) |         |
+--------------------------------------+----------+----------+---+---------+
| **AIDS and AIDS-Related Grants**     | May 7    | S        | J |         |
|                                      |          | eptember | a |         |
| All of the mechanisms cited above    |          | 7        | n |         |
|                                      |          |          | u |         |
| *new, renewal, resubmission,         |          |          | a |         |
| revision\**                          |          |          | r |         |
|                                      |          |          | y |         |
|                                      |          |          | 7 |         |
+--------------------------------------+----------+----------+---+---------+
| NOTE for all applications:           |          |          |   |         |
|                                      |          |          |   |         |
| -   RFAs and some PARs have special  |          |          |   |         |
|     receipt dates indicated in the   |          |          |   |         |
|     specific NIH Guide Announcement. |          |          |   |         |
|                                      |          |          |   |         |
| -   \* Change in Terminology: The    |          |          |   |         |
|     move to electronic applications  |          |          |   |         |
|     has brought a change in          |          |          |   |         |
|     terminology. The new Grants.gov  |          |          |   |         |
|     terminology (included in the     |          |          |   |         |
|     table above) corresponds to the  |          |          |   |         |
|     traditional NIH terms as         |          |          |   |         |
|     follows:                         |          |          |   |         |
|                                      |          |          |   |         |
| > **New** = New                      |          |          |   |         |
| >                                    |          |          |   |         |
| > **Resubmission** = A Revised or    |          |          |   |         |
| > Amended application                |          |          |   |         |
| >                                    |          |          |   |         |
| > **Renewal** = Competing            |          |          |   |         |
| > Continuation                       |          |          |   |         |
| >                                    |          |          |   |         |
| > **Continuation** = Noncompeting    |          |          |   |         |
| > Progress Report                    |          |          |   |         |
| >                                    |          |          |   |         |
| > **Revision** = Competing           |          |          |   |         |
| > Supplement                         |          |          |   |         |
|                                      |          |          |   |         |
| -   \*\*Institutional Research       |          |          |   |         |
|     Training Grants (T32) are        |          |          |   |         |
|     accepted by many NIH Institutes  |          |          |   |         |
|     and Centers (IC) for only one or |          |          |   |         |
|     two of the dates.                |          |          |   |         |
|                                      |          |          |   |         |
| -   \*\*\*Program Project and Center |          |          |   |         |
|     Grants -- Applicants should      |          |          |   |         |
|     check with individual ICs since  |          |          |   |         |
|     some ICs do not accept P series  |          |          |   |         |
|     applications three times a year. |          |          |   |         |
|                                      |          |          |   |         |
| -   \*\*\*\*Individual Pre-Doctoral  |          |          |   |         |
|     Fellowships (F31) to promote     |          |          |   |         |
|     diversity in health-related      |          |          |   |         |
|     research has special receipt     |          |          |   |         |
|     dates.                           |          |          |   |         |
|                                      |          |          |   |         |
| -   All AIDS and AIDS-related        |          |          |   |         |
|     applications (no matter the      |          |          |   |         |
|     type) are submitted on the AIDS  |          |          |   |         |
|     and AIDS-related dates.          |          |          |   |         |
+--------------------------------------+----------+----------+---+---------+

  -----------------------------------------------------------------------------
  **Review and Award Cycles:**           ** Cycle I**  ** Cycle    ** Cycle
                                                       II**        III**
  -------------------------------------- ------------- ----------- ------------
  **Scientific Merit Review**            June - July   October -   February -
                                                       November    March 

  **Advisory Council Review**            September -   January -   May - June 
                                         October       February    

  **Earliest Project Start Date**        December      April       July 

  Note: Awarding components may not                                
  always be able to honor the requested                            
  start date of an application;                                    
  therefore, applicants should make no                             
  commitments or obligations until                                 
  confirmation of the start date by the                            
  awarding component.                                              
  -----------------------------------------------------------------------------

#### Application Assignment Information {#application-assignment-information .Subhead---No-TOC}

Competing grant applications that have been successfully submitted
through Grants.gov (including correcting all errors and the grant
application assembled by the eRA Commons system) will be processed
through the Division of Receipt and Referral, CSR, NIH unless otherwise
stated. The application will be assigned to an appropriate Scientific
Review Group and awarding component(s). Assignment is based on the
scientific content of the application using established referral
guidelines. Business rule validations are conducted by the system as
well as NIH staff.

***[Assignment to Review Group]{.underline}***. The Center for
Scientific Review (CSR) will assign appropriately completed applications
to the Scientific Review Groups (commonly referred to as "SRGs" or
"study sections") that will perform the scientific/technical merit
review. The CSR lists the recurring review panels
(<http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/>), and
you may suggest a specific group in the PHS 398 Cover Letter component.

***[Assignment to Relevant Potential Awarding Component(s)
(ICs)]{.underline}***. In addition, CSR will assign each application to
the agency awarding component that is the potential funding component.
When the scientific areas and the research proposed in a grant
application are sufficiently relevant to the program responsibilities of
two or more awarding components, CSR may assign your application to all
such components. The component that has the most relevant program
responsibility is designated as the primary assignee. The other
components that have an interest in your application are designated as
secondary assignees. If your application is eligible for funding and the
primary assignee does not intend to make an award, the secondary
assignees will be given the opportunity to do so. Although these
suggestions will be taken into consideration, the final determination
will be made by the agencies participating in this solicitation.

After the submission date, usually within two (2) weeks, the PD/PI and
the applicant organization will be able to access in the eRA Commons the
application's assignment number; the name, address, and telephone number
of the Scientific Review Officer of the Scientific Review Group to which
the application has been assigned; and the assigned Institute contact
and phone number. Review outcome and other important information is also
available in the Commons.

If assignment information is not available in the eRA Commons within two
weeks of the submission date, contact the Division of Receipt and
Referral, Center for Scientific Review (CSR), National Institutes of
Health, Bethesda, MD 20892-7720, (301) 435-0715; TTY (301) 451-0088. If
there is a change in assignment, you will receive a notification.

Applicant investigators must not communicate directly with any review
group member about an application either before or after the review.
Failure to strictly observe this policy will create serious breaches of
confidentiality and conflicts of interest in the peer review process.
From the time of assignment to the time the review of your application
is complete, applicant investigators must direct all questions to the
Scientific Review Officer. This individual is in charge of the review
group and is identified in the assignment notice that is mailed to you.

## 2.16 Resources for Finding Help

### 2.16.1 Finding Help for Grants.gov Registration or Submissions

If help is needed with the Grants.gov registration process or with the
technical aspects of submitting an application through the Grants.gov
system, check first the resources available at Grants.gov
([[http://grants.gov/]{.underline}](http://grants.gov/)).

**Grants.gov customer support is also provided by the following
office:**

Grants.gov Program Management Office\
200 Independence Avenue, SW\
HHH Building, Room 739F\
Washington, DC 20201

Grants.gov Helpdesk: <support@grants.gov>

Grants.gov Contact Center Phone Number: 1-800-518-4726

The Contact Center's hours of operation are Monday-Friday from 7:00 a.m.
to 9:00 p.m. Eastern Time.

### 2.16.2 Finding Help for the eRA Commons Registration or eRA Commons Validation Processes

If help is needed with the eRA Commons registration process for the
applicant organization and PDs/PIs or with the application validation
process in the Commons after submission through Grants.gov, check first
the resources available at Electronic Submission of Grant Applications
([[http://era.nih.gov/ElectronicReceipt/]{.underline}](http://era.nih.gov/ElectronicReceipt/)).

**eRA Commons customer support is also provided by the eRA Commons
Helpdesk:**

eRA website: [http://era.nih.gov](http://era.nih.gov/)

eRA Commons website:
[[https://commons.era.nih.gov/commons/index.jsp]{.underline}](https://commons.era.nih.gov/commons/index.jsp)

eRA Commons Helpdesk Email:
[[commons@od.nih.gov]{.underline}](mailto:commons@od.nih.gov)

eRA Commons Phone: 301-402-7469\
866-504-9552 (Toll Free)\
301-451-5939 (TTY)

The eRA Commons Helpdesk hours of operation are Monday-Friday from 7:00
a.m. to 8:00 p.m. Eastern Time.

### 2.16.3 Finding Help for Application Preparation

If after reviewing this application instruction guide, help is still
needed in preparing the application, contact GrantsInfo:

GrantsInfo Phone: 301-435-0714\
301-451-0088 (TTY)

GrantsInfo Email: <GrantsInfo@nih.gov>

# 3. Using the Grant Application Package

This section describes the steps an applicant takes once the appropriate
FOA (see [Section 2.4](#funding-opportunities)) has been located and the
corresponding grant application package has been successfully
downloaded.

## 3.1 Verify Grant Information

![Image of grant information as shown on Grant Application
Package.](media/image5.png){width="4.7736220472440944in"
height="1.897244094488189in"}When you select a funding opportunity in
Grants.gov Apply, verify that the information shown in the Grant
Application Package screen corresponds to the funding opportunity for
which you wish to apply. Grants.gov auto-populates the following
information:

-   Opportunity Title

-   Offering Agency

-   CFDA Number

-   CFDA Description

-   Opportunity Number

-   Competition ID

-   Opportunity Open Date

-   Opportunity Close Date

-   Agency Contact

***[CFDA Number Field:]{.underline}*** Many FOAs include multiple CFDA
(Catalog for Domestic Assistance) numbers. When this is the case, the
CFDA Number and CFDA Description fields will appear blank in the
Grants.gov Grant Application Package screen shown above. The appropriate
CFDA number will be automatically assigned once the application is
assigned to the appropriate agency awarding component.

***[Opportunity Open Date & Close Date Fields:]{.underline}*** Many FOAs
posted by NIH and other PHS agencies include multiple submission/receipt
dates and are active for several years. These announcements are posted
in Grants.gov showing an Open/Close period that spans the entire active
period of the announcement. Applicants should read the funding
opportunity announcement carefully for specific submission/receipt
dates. If specific dates are not referenced in the announcement,
applicants should refer to the Standard Postmark/Submission Dates for
Competing Applications found in [Table 2.15-1. Submission Dates, Review,
and Award Cycles](#submission-review-and-award-cycles). Applications
submitted after a posted submission date will be held over into the next
review cycle. See also [Section 2.14](#Late_applications) above for the
late application policy.

## 3.2 Enter the Name for the Application

Enter a name for the application in the Application Filing Name field
(this is a required field). This name is for use solely by the applicant
for tracking the application through the Grants.gov submission process.
It is not used by the receiving agency.

![](media/image6.png){width="6.5in" height="0.5201388888888889in"}

## 3.3 Open and Complete Mandatory Documents

Open and complete all of the documents listed in the Mandatory Documents
box. **Complete the component titled SF424 (R&R) first.** Data entered
in this component populates other mandatory and optional forms where
applicable.

![](media/image7.png){width="6.5in" height="1.145138888888889in"}

To open an item:

1\. Click the document name in the Mandatory Documents box.

2\. Click **Move Form to Complete**.

3\. Click the document name in the Mandatory Documents for Submission
box and click **Open Form**.

4\. To remove a document from the Mandatory Documents for Submission
box, click the document name to select it and then click the **Move Form
to Delete** box. This returns the document to the Mandatory Documents
box.

## 3.4 Open and Complete Optional Documents

These documents can be used to provide additional information for the
application or may be required for specific types of grant activities.
Information on each of these documents is found later in these
instructions.[]{#__RefHeading___Toc203452132 .anchor} In some
application packages applicants will see two budget options; e.g.,
Research & Related Budget and PHS398 Modular Budget in the Optional
Documents section. While both appear as Optional Documents, one or the
other will always be required. See [Section 4.6 Selecting the
Appropriate Budget
Component](#selecting-the-appropriate-budget-component) for additional
details.

![](media/image8.png){width="6.5in" height="1.145138888888889in"}

## 3.5 Submitting the Application via Grants.gov

Once you have properly completed all required documents and attached any
required or optional documentation, click on the **Check Package for
Errors** button to ensure that you have successfully completed all
required data fields. If any of the required fields are not completed
you will receive an error notice which will indicate where revision is
needed within your package. Correct any errors or if none are found,
save the application package. The **Save & Submit** button will now
become active and clicking this button will begin the application
submission process. Only after the package has been saved with no errors
will the **Save & Submit** button become active. The application package
must then be saved once more before the submission process begins. Only
an AOR will be able to perform the submit action, and they will be taken
to the applicant login page to enter the Grants.gov username and
password that was established in the Register with Grants.gov process
(if not connected to the internet you will be instructed to do so).

# 4. Completing the SF424 Research and Related (R&R) Forms

## 4.1 Overview

This section contains all of the instructions you will need to complete
the SF424 (R&R) forms.

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}Any
agency-specific instructions are denoted by the DHHS logo displayed to
the left of the paragraph, as illustrated here.

Conformance to all instructions is required and strictly enforced.
Agencies may withdraw any applications from the review process that are
not consistent with these instructions.

As you navigate through the forms, required fields are highlighted in
yellow, outlined in red, and noted with an asterisk (\*). Optional
fields and completed fields are displayed in white. Data entered into a
specific field is not accepted until you have navigated to the next
field. If you enter invalid or incomplete information in a field, you
will receive an error message.

> ![](media/image9.png){width="0.37222222222222223in"
> height="0.3951388888888889in"} Note the highlighted fields required
> for submissions, and the "**Check Package for Errors**" button, only
> refer to requirements and errors in the actual Adobe Reader forms.
> They do not refer to requirements or data errors against PHS business
> processes. Those validations will be performed by the eRA Commons
> system after the application has been submitted.

For those form components that are more than one page, click the
**Next** button at the top of the form or scroll down (using the scroll
bar on the right hand side of the screen) to navigate to a subsequent
page. Once all data have been entered, click the **Close Form** button
at the top of the form or scroll up using the scroll bar to return to
the Grant Application Package Screen.

## 4.2 Cover Component

![](media/image10.png){width="6.188194444444444in"
height="8.42013888888889in"}

1\. Type of Submission

Select Type of Submission. If this submission is to change or correct a
previously submitted application, click Changed/Corrected Application
box and enter the Grants.gov tracking number in the Federal Identifier
field. **Unless requested by the agency, applicants may not use this to
submit changes after the closing date.** **This field is required.**

![](media/image9.png){width="0.3729166666666667in"
height="0.4in"}Pre-Application: Unless specifically noted in a program
announcement, the Pre-application option is not used by NIH and other
PHS agencies.

> Changed/Corrected Application: This box must be used if you need to
> submit the same application again because of corrections for system
> validation errors or if a portion of the application was lost or
> distorted during the submission process. This option is for correcting
> system validation errors only and may not be used to include last
> minute changes to any of the PDF attachments. When submitting a
> Changed/Corrected Application:

-   If submitting after the submission date, include an explanation in
    the Cover Letter Component.

-   When you check the Changed/Correct Application box, Item 4. Federal
    Identifier becomes a required field.

-   When submitting a Changed/Corrected Application for a "New" Type of
    Application (Item 8 = New), in the Federal Identifier field (Item
    4)) enter the Grants.gov tracking number for the previous
    application that you are correcting. If you are unable to recall the
    Grants.gov tracking number, enter "N/A."

-   When submitting a Changed/Corrected Application for a
    "Resubmission," "Renewal," or "Revision" Type of Application (Item 8
    = Resubmission, Renewal, or Revision), in the Federal Identifier
    field (Item 4) enter the previously assigned grant number (e.g.,
    only CA123456).

-   Do **not** use the Changed/Corrected Application box to denote a
    submission of a revised or amended application. That will be
    indicated in item 8. Type of Application.

    2\. Date Submitted and Applicant Identifier

In the Date Submitted field, enter the date the application is submitted
to the Federal agency (or state, if applicable). In the Applicant
Identifier field, enter the applicant's control number (if applicable).

![](media/image9.png){width="0.3729166666666667in" height="0.4in"}Note
the Applicant Identifier field is a control number created by the
applicant organization, not the Federal agency.

3\. Date Received by State and State Application Identifier

Enter the date received by state (if applicable). In the State
Application Identifier field, enter the state application identifier, if
applicable.

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}For
submissions to NIH and other PHS agencies, leave these fields blank.

4\. Federal Identifier

New project applications should leave this field blank, unless you are
submitting a Changed/Corrected application. When submitting a
changed/corrected "new" application, enter the Grants.gov tracking
number. If this is a continuation, revision, or renewal application,
enter the assigned Federal Identifier number (for example, award number)
even if submitting a changed/corrected application.

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}For
submissions to NIH and other PHS agencies, an example of a grant number
need only be CA123456.

> Existing definitions for NIH and other PHS agencies applications are
> somewhat different:

-   New is the same; i.e., an application that is submitted for the
    first time. See also the policy [Resubmission of Unpaid RFA
    Applications and Resubmission of Applications with a Changed Grant
    Activity
    Mechanism](#resubmission-of-unpaid-rfa-applications-and-resubmission-of-applications-with-a-changed-grant-activity-mechanism).

-   Resubmission is equivalent to NIH and other PHS agencies Revision;
    i.e., a revised or amended application. See also the [NIH Policy on
    Resubmission
    Applications](#nih-policy-on-resubmission-applications).

-   Renewal is equivalent to NIH and other PHS agencies Competing
    Continuation.

-   Continuation is equivalent to NIH and other PHS agencies Progress
    Report. For the purposes of NIH and other PHS agencies, the box for
    Continuation will **not** be used.

-   Revision is somewhat equivalent to NIH and other PHS agencies
    Competing Supplement. Applicants should contact the awarding agency
    for advice on submitting any revision/supplement application.

Applicants to NIH and other PHS agencies should complete this field when
submitting a resubmission, renewal or revision application. When
submitting a "New" application, this field should remain blank unless
you are submitting a Changed/Corrected Application. In this case, where
Item 1 = Changed/Corrected Application and Item 8 = New, the Federal
Identifier field becomes a required field. Therefore you must enter the
Grants.gov tracking number assigned to the application that you are
correcting. If you are unable to recall the tracking number, enter
"N/A."

5\. Applicant Information

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}This
information is for the Applicant Organization, not a specific
individual.

+--------------------+-------------------------------------------------+
| Field Name         | Instructions                                    |
+====================+=================================================+
| Organizational     | Enter your organization's DUNS or DUNS+4        |
| DUNS               | number.                                         |
|                    |                                                 |
|                    | ![]                                             |
|                    | (media/image9.png){width="0.3729166666666667in" |
|                    | height="0.4in"}For submission to NIH and other  |
|                    | PHS agencies, this DUNS **must** match the      |
|                    | number entered in the eRA Commons Institutional |
|                    | Profile for the applicant organization. The     |
|                    | applicant AOR is encouraged to confirm that a   |
|                    | DUNS has been entered in the eRA Commons        |
|                    | Institutional Profile prior to submitting an    |
|                    | application. If your organization does not      |
|                    | already have a DUNS number, you will need to go |
|                    | to the Dun & Bradstreet website at              |
|                    | <http://fedgov.dnb.com/webform> to obtain the   |
|                    | number.                                         |
+--------------------+-------------------------------------------------+
| Legal Name         | Enter the legal name of the applicant which     |
|                    | will undertake the assistance activity, enter   |
|                    | the complete address of the applicant           |
|                    | (including county and country), and name,       |
|                    | telephone number, e-mail, and fax of the person |
|                    | to contact on matters related to this           |
|                    | application.                                    |
+--------------------+-------------------------------------------------+
| Department         | Enter the name of the primary organizational    |
|                    | department, service, laboratory, or equivalent  |
|                    | level within the organization that will         |
|                    | undertake the assistance activity.              |
+--------------------+-------------------------------------------------+
| Division           | Enter the name of the primary organizational    |
|                    | division, office, or major subdivision that     |
|                    | will undertake the assistance activity.         |
+--------------------+-------------------------------------------------+
| Street1            | Enter the first line of the street address for  |
|                    | the applicant in "Street1" field.               |
+--------------------+-------------------------------------------------+
| Street2            | Enter the second line of the street address for |
|                    | the applicant in "Street2" field. This field is |
|                    | optional.                                       |
+--------------------+-------------------------------------------------+
| City               | Enter the city for address of applicant.        |
+--------------------+-------------------------------------------------+
| County             | Enter the county for address of applicant.      |
+--------------------+-------------------------------------------------+
| State              | Select the state where the applicant is         |
|                    | located. This field is required if the          |
|                    | applicant is located in the United States.      |
+--------------------+-------------------------------------------------+
| Province           | Enter the province where the applicant is       |
|                    | located.                                        |
+--------------------+-------------------------------------------------+
| Country            | Select the country for the applicant address.   |
+--------------------+-------------------------------------------------+
| ZIP Code           | Enter the postal code (e.g., ZIP code) of       |
|                    | applicant. This field is required if the        |
|                    | applicant is located in the United States. This |
|                    | field is required if a State is selected;       |
|                    | optional for Province.                          |
+--------------------+-------------------------------------------------+

**Person to be contacted on matters involving this application:**

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}This
information is for the Administrative or Business Official, not the
PD/PI. This person is the individual to be notified if additional
information is needed and/or if an award is made. To avoid potential
errors and delays in processing, please ensure that the information
provided in this section is identical to the AO profile information
contained in the eRA Commons.

+--------------------+-------------------------------------------------+
| Field Name         | Instructions                                    |
+====================+=================================================+
| Prefix             | Enter the prefix (e.g., Mr., Mrs., Rev.) for    |
|                    | the person to contact on matters related to     |
|                    | this application.                               |
|                    |                                                 |
|                    | ![]                                             |
|                    | (media/image9.png){width="0.3729166666666667in" |
|                    | height="0.4in"}See also the [PHS398 Cover Page  |
|                    | Supplement](#cover-page-supplement-component)   |
|                    | for additional required contact information.    |
+--------------------+-------------------------------------------------+
| First Name         | Enter the first (given) name of the person to   |
|                    | contact on matters relating to this             |
|                    | application.                                    |
+--------------------+-------------------------------------------------+
| Middle Name        | Enter the middle name of the person to contact  |
|                    | on matters relating to this application.        |
+--------------------+-------------------------------------------------+
| Last Name          | Enter the last (family) name of the person to   |
|                    | contact on matters relating to this             |
|                    | application.                                    |
+--------------------+-------------------------------------------------+
| Suffix             | Enter the suffix (e.g., Jr., Sr., Ph.D.) for    |
|                    | the person to contact on matters relating to    |
|                    | this application.                               |
+--------------------+-------------------------------------------------+
| Phone Number       | Enter the daytime phone number for the person   |
|                    | to contact on matters relating to this          |
|                    | application.                                    |
+--------------------+-------------------------------------------------+
| Fax Number         | Enter the fax number for the person to contact  |
|                    | on matters relating to this application.        |
+--------------------+-------------------------------------------------+
| Email              | Enter the email address for the person to       |
|                    | contact on matters relating to this             |
|                    | application.                                    |
|                    |                                                 |
|                    | ![](media/image9.png){width="0.375in"           |
|                    | height="0.3958333333333333in"}This is a         |
|                    | required field for applications submitted to    |
|                    | NIH and other PHS agencies.                     |
+--------------------+-------------------------------------------------+

6\. Employer Identification

Enter the TIN or EIN as assigned by the Internal Revenue Service. If
your organization is not in the US, type 44-4444444.

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}If
you have a 12-digit EIN established for grant awards from NIH or other
PHS agencies, **enter all 12digits (e.g., 1123456789A1).**

7\. Type of Applicant

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}This
information is for the Applicant Organization, not a specific
individual.

+--------------------+-------------------------------------------------+
| Field Name         | Instructions                                    |
+====================+=================================================+
| Type of Applicant  | Select from the menu or enter the appropriate   |
|                    | letter in the space provided.                   |
|                    |                                                 |
|                    | If Small Business is selected as Type of        |
|                    | Applicant, then note if the organization is     |
|                    | Woman-owned and/or Socially and Economically    |
|                    | Disadvantaged.                                  |
|                    |                                                 |
|                    | ![](media/image9.png){width="0.375in"           |
|                    | height="0.3958333333333333in"}For eligible      |
|                    | Agencies of the Federal Government, select X:   |
|                    | Other (specify), and then indicate the name of  |
|                    | the appropriate Federal agency in the space     |
|                    | below.                                          |
+--------------------+-------------------------------------------------+
| Other (Specify)    | Complete only if X: Oth*er* was selected as the |
|                    | Type of Applicant.                              |
+--------------------+-------------------------------------------------+
| Woman Owned        | Check the box if you are a woman-owned small    |
|                    | business: a small business that is at least 51% |
|                    | owned by a woman or women, who also control and |
|                    | operate it.                                     |
+--------------------+-------------------------------------------------+
| Socially and       | Check the box if you are a socially and         |
| Economically       | economically disadvantaged small business, as   |
| Disadvantaged      | determined by the US Small Business             |
|                    | Administration pursuant to Section 8(a) of the  |
|                    | Small Business Act U.S.C. 637(a).               |
+--------------------+-------------------------------------------------+

8\. Type of Application

+--------------------+-------------------------------------------------+
| Field Name         | Instructions                                    |
+====================+=================================================+
| Type of            | Select the type from the following list. Check  |
| Application        | only one:                                       |
|                    |                                                 |
|                    | -   New: An application that is being submitted |
|                    |     to an agency for the first time.            |
|                    |                                                 |
|                    | -   Resubmission: An application that has been  |
|                    |     previously submitted, but was not funded,   |
|                    |     and is being resubmitted for new            |
|                    |     consideration.                              |
|                    |                                                 |
|                    | -   Renewal: An application requesting          |
|                    |     additional funding for a period subsequent  |
|                    |     to that provided by a current award. A      |
|                    |     renewal application competes with all other |
|                    |     applications and must be developed as fully |
|                    |     as though the applicant is applying for the |
|                    |     first time.                                 |
|                    |                                                 |
|                    | -   Continuation: A non-competing application   |
|                    |     for an additional funding/budget period     |
|                    |     within a previously approved project        |
|                    |     period.                                     |
|                    |                                                 |
|                    | -   Revision: An application that proposes a    |
|                    |     change in                                   |
|                    |                                                 |
|                    | 1\) the Federal Government's financial          |
|                    | obligations or contingent liability from an     |
|                    | existing obligation, or                         |
|                    |                                                 |
|                    | 2\) any other change in the terms and           |
|                    | conditions of the existing award.               |
|                    |                                                 |
|                    | ![](media/image9.png){width="0.375in"           |
|                    | height="0.3958333333333333in"}Existing          |
|                    | definitions for NIH and other PHS agencies Type |
|                    | of Application are somewhat different:          |
|                    |                                                 |
|                    | 6.  New is the same. Check this option when     |
|                    |     submitting an application for the first     |
|                    |     time. See also the policy [Resubmission of  |
|                    |     Unpaid RFA Applications and Resubmission of |
|                    |     Applications with a Changed Grant Activity  |
|                    |     Mechanism](#resubmission-of-unpa            |
|                    | id-rfa-applications-and-resubmission-of-applica |
|                    | tions-with-a-changed-grant-activity-mechanism). |
|                    |                                                 |
|                    | 7.  Resubmission is equivalent to NIH and other |
|                    |     PHS agencies Revision. Check this option    |
|                    |     when submitting a revised or amended        |
|                    |     application. See also the [NIH Policy on    |
|                    |     Resubmission                                |
|                    |     Applicati                                   |
|                    | ons](#nih-policy-on-resubmission-applications). |
|                    |                                                 |
|                    | 8.  Renewal is equivalent to NIH and other PHS  |
|                    |     agencies Competing Continuation.            |
|                    |                                                 |
|                    | 9.  Continuation is equivalent to NIH and other |
|                    |     PHS agencies Progress Report. For the       |
|                    |     purposes of NIH and other PHS agencies, the |
|                    |     box for Continuation will **not** be used   |
|                    |     and should **not** be checked.              |
|                    |                                                 |
|                    | 10. Revision is somewhat equivalent to NIH and  |
|                    |     other PHS agencies Supplement, but would    |
|                    |     also include other changes as noted in the  |
|                    |     definition above. In general, changes to    |
|                    |     the "terms and conditions of the existing   |
|                    |     award" (as noted in example 2 above) would  |
|                    |     not require the submission of another       |
|                    |     application through Grants.gov. Applicants  |
|                    |     should contact the awarding agency for      |
|                    |     advice on submitting any                    |
|                    |     revision/supplement application.            |
|                    |                                                 |
|                    | > This field also affects how you complete Item |
|                    | > 4. Federal Identifier. If "Type of            |
|                    | > Application" is "New", you can leave the      |
|                    | > Federal Identifier field blank on the first   |
|                    | > submission attempt. However, the Federal      |
|                    | > Identifier field becomes a required field     |
|                    | > when submitting a Changed/Corrected           |
|                    | > application to address errors/warnings. When  |
|                    | > submitting a Changed/Corrected "New"          |
|                    | > application, enter the Grants.gov tracking    |
|                    | > number of the previous submission attempt     |
|                    | > (e.g. GRANT12345678). If you are unable to    |
|                    | > find the tracking number, enter "N/A".\       |
|                    | > \                                             |
|                    | > If "Type of Application" is "Renewal",        |
|                    | > "Revision" or "Resubmission", enter the IC    |
|                    | > and serial number of the prior                |
|                    | > application/award number (e.g. CA123456). For |
|                    | > these types of applications, do not change    |
|                    | > the Federal Identifier field when submitting  |
|                    | > Changed/Corrected applications.               |
+--------------------+-------------------------------------------------+
| If Revision, Enter | If application is a revision, check the         |
| Appropriate        | appropriate box(es):                            |
| Letter(s) in       |                                                 |
| Box(es)            | A. Increase Award                               |
|                    |                                                 |
|                    | B. Decrease Award                               |
|                    |                                                 |
|                    | C. Increase Duration                            |
|                    |                                                 |
|                    | D. Decrease Duration                            |
|                    |                                                 |
|                    | E. Other                                        |
|                    |                                                 |
|                    | May select more than one.                       |
+--------------------+-------------------------------------------------+
| Other (Specify)    | If *E. Other* was selected as the Revision,     |
|                    | enter text to explain.                          |
+--------------------+-------------------------------------------------+
| Is this            | Check the box, if applicable.                   |
| application being  |                                                 |
| submitted to other |                                                 |
| agencies?          |                                                 |
+--------------------+-------------------------------------------------+
| What Other         | Enter Agency name.                              |
| Agencies?          |                                                 |
+--------------------+-------------------------------------------------+

9\. Name of Federal Agency

Name the Federal agency from which assistance is being requested with
this application. This information is pre-populated by Grants.gov.

10\. Catalog of Federal Domestic Assistance (CFDA) Number and Title
(CFDA)

Use the Catalog of Federal Domestic Assistance number and title of the
program under which assistance is requested. This information is
pre-populated by Grants.gov.

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}This
field may be blank if you are applying to an opportunity that references
multiple CFDA numbers. When this field is blank, leave it blank; the
field will not allow any data entry. The appropriate CFDA number will be
automatically assigned by the agency once the application is assigned to
the appropriate awarding component.

11\. Descriptive Title of Applicant's Project

Enter a brief descriptive title of the project.

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}A
"new" application must have a different title from any other PHS project
with the same PD/PI. A "resubmission" or "renewal" application should
normally have the same title as the previous grant or application. If
the specific aims of the project have significantly changed, choose a
new title.

A "revision" application must have the same title as the currently
funded grant.

NIH and other PHS agencies limit title character length to 81
characters, including the spaces between words and punctuation. Titles
in excess of 81 characters will be truncated.

12\. Areas Affected by Project (Cities, Counties, States, Etc.)

List only the largest political entities affected by the project (for
example, state, counties, cities).

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Enter "N/A" for not applicable.

13\. Start Date and Ending Date

Enter the proposed start date of the project in the Start Date field.
Enter the proposed end date in the Ending Date field. Use the following
format: MM/DD/YYYY.

14\. Congressional District Applicant and Congressional District Project

***Congressional District -- Applicant:*** Enter the Congressional
District in the format: 2 character State Abbreviation -- 3 character
District Number. Examples: CA-005 for California's 5th district, CA-012
for California's 12th district.

If outside the U.S., enter 00-0000.

To locate your congressional district, visit the Grants.gov web site.

***Congressional District -- Project:*** Enter the Congressional
District in the format: 2 character State Abbreviation -- 3 character
District Number. Examples: CA-005 for California's 5th district, CA-012
for California's 12th district.

If all districts in a state are affected, enter "all" for the district
number. Example: MD-all for all congressional districts in Maryland.

If nationwide (all districts in all states), enter US-all.

If the program/project is outside the U.S., enter 00-0000.

To locate your congressional district, visit the Grants.gov web site.

Attach an additional list of Project Congressional Districts on page 2
(Item 21), if needed.

[]{#Section_4_2_15 .anchor}15. Program Director/Principal Investigator
(PD/PI) Contact Information

> ![](media/image9.png){width="0.3798611111111111in"
> height="0.40694444444444444in"}If submitting an application reflecting
> Multiple PDs/PIs, the individual designated as the Contact PI should
> be entered here. See [Section 4.5 Senior/Key Person Profile
> Components](#seniorkey-person-profile-expanded-component) for
> additional instructions for Multiple PDs/PIs. To avoid potential
> errors and delays in processing, please ensure that the information
> provided in this section is identical to the PD/PI profile information
> contained in the eRA Commons.

+--------------------+-------------------------------------------------+
| Field Name         | Instructions                                    |
+====================+=================================================+
| Prefix             | Enter the prefix (Mr., Mrs., Rev.) for the name |
|                    | of the PD/PI.                                   |
|                    |                                                 |
|                    | ![](media/image9.png){width="0.375in"           |
|                    | height="0.3958333333333333in"}See also the      |
|                    | [PHS398 Cover Page                              |
|                    | Supplement](#cover-page-supplement-component)   |
|                    | for additional PD/PI required data.             |
+--------------------+-------------------------------------------------+
| First Name         | Enter the first (given) name of the PD/PI.      |
+--------------------+-------------------------------------------------+
| Middle Name        | Enter the middle name of the PD/PI.             |
+--------------------+-------------------------------------------------+
| Last Name          | Enter the last (family) name of the PD/PI.      |
+--------------------+-------------------------------------------------+
| Suffix             | Enter the suffix (e.g., Jr., Sr., Ph.D.,) for   |
|                    | the name of the PD/PI.                          |
|                    |                                                 |
|                    | ![](media/image9.png){width="0.375in"           |
|                    | height="0.3958333333333333in"}Do not use this   |
|                    | field to record degrees. Degrees for the PD/PI  |
|                    | are requested separately in the PHS398 Cover    |
|                    | Page Supplement.                                |
+--------------------+-------------------------------------------------+
| Position/Title     | Enter the title of the PD/PI.                   |
+--------------------+-------------------------------------------------+
| Organization Name  | Enter the name of the organization for the      |
|                    | PD/PI.                                          |
+--------------------+-------------------------------------------------+
| Department         | Enter the name of the primary organizational    |
|                    | department, service, laboratory, or equivalent  |
|                    | level within the organization of the PD/PI.     |
+--------------------+-------------------------------------------------+
| Division           | Enter the name of the primary organizational    |
|                    | division, office, or major subdivision of the   |
|                    | PD/PI.                                          |
+--------------------+-------------------------------------------------+
| Street1            | Enter the first line of the street address for  |
|                    | the PD/PI. This field is required.              |
+--------------------+-------------------------------------------------+
| Street2            | Enter the second line of the street address for |
|                    | the PD/PI, if applicable.                       |
+--------------------+-------------------------------------------------+
| City               | Enter the city for the address of the PD/PI.    |
|                    | This field is required.                         |
+--------------------+-------------------------------------------------+
| County             | Enter the county for the address of the PD/PI.  |
+--------------------+-------------------------------------------------+
| State              | Select the state where the PD/PI is located in  |
|                    | the United States.                              |
+--------------------+-------------------------------------------------+
| Province           | Enter the province for PD/PI.                   |
+--------------------+-------------------------------------------------+
| Country            | Select the country for the PD/PI address.       |
+--------------------+-------------------------------------------------+
| ZIP Code           | Enter the Postal Code (e.g., ZIP Code) of the   |
|                    | PD/PI. This field is required if the PD/PI is   |
|                    | located in the United States.                   |
+--------------------+-------------------------------------------------+
| Phone Number       | Enter the daytime telephone number for the      |
|                    | PD/PI. This field is required.                  |
+--------------------+-------------------------------------------------+
| Fax Number         | Enter the fax number for the PD/PI.             |
+--------------------+-------------------------------------------------+
| Email              | Enter the email address for the PD/PI. This     |
|                    | field is required.                              |
+--------------------+-------------------------------------------------+

![](media/image11.png){width="6.5in" height="6.764583333333333in"}

16\. Estimated Project Funding

+--------------------+-------------------------------------------------+
| Field Name         | Instructions                                    |
+====================+=================================================+
| Total Estimated    | Enter the total Federal funds requested for the |
| Project Funding    | entire project period.                          |
+--------------------+-------------------------------------------------+
| Total Federal &    | Enter the total estimated funds for the entire  |
| Non-Federal Funds  | project period, including both Federal and      |
|                    | non-Federal funds.                              |
|                    |                                                 |
|                    | ![](media/image9.png){width="0.375in"           |
|                    | height="0.3958333333333333in"}For NIH and other |
|                    | PHS agencies applicants, this field will be the |
|                    | same as item 16a unless the specific            |
|                    | announcement indicates that cost sharing is a   |
|                    | requirement.                                    |
+--------------------+-------------------------------------------------+
| Estimated Program  | Identify any Program Income estimated for this  |
| Income             | project period, if applicable.                  |
+--------------------+-------------------------------------------------+

17\. Is Application Subject to Review by State Executive Order 12372
Process?

If yes, check the "Yes" box. If the announcement indicates that the
program is covered under Executive Order 12372, you should contact the
State Single Point of Contact (SPOC) for Federal Executive Order 12372.
If no, check the appropriate box. This field is required.

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}For
NIH and other PHS agencies submissions using the SF424 (R&R), applicants
should check "No, Program is not covered by E.O. 12372."

18\. Complete Certification

Check the "I agree" box to provide the required certifications and
assurances. This field is required.

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}The
list of NIH and other PHS agencies Assurances, Certifications, and other
Policies is found in [Part III, Policies, Assurances, Definitions, and
Other Information](#Policy_PartIII).

19\. Authorized Representative

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}This
is equivalent to the individual with the organizational authority to
sign for an application; otherwise known as the Authorized
Organizational Representative or the Signing Official.

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Prefix               Enter the prefix (Mr., Mrs., Rev.) for the name of
                       the Authorized Representative.

  First Name           Enter the first (given) name of the Authorized
                       Representative.

  Middle Name          Enter the middle name of the Authorized
                       Representative.

  Last Name            Enter the last (family) name of the Authorized
                       Representative.

  Suffix               Enter the suffix (e.g., Jr., Sr., Ph.D.) for the
                       name of the Authorized Representative.

  Position/Title       Enter the title of the Authorized Representative.

  Organization         Enter the name of the organization for the
                       Authorized Representative.

  Department           Enter the name of the primary organizational
                       department, service, laboratory, or equivalent
                       level within the organization of the Authorized
                       Representative.

  Division             Enter the name of the primary organizational
                       division, office, or major subdivision of the
                       Authorized Representative.

  Street1              Enter the first line of the street address for the
                       Authorized Representative. This field is required.

  Street2              Enter the second line of the street address for
                       the Authorized Representative, if applicable.

  City                 Enter the city for the address of the Authorized
                       Representative. This field is required.

  County               Enter the county for the address of the Authorized
                       Representative.

  State                Select the state where the Authorized
                       Representative is located. This field is required
                       if the Authorized Representative is located in the
                       United States.

  Province             Enter the province for the Authorized
                       Representative.

  Country              Select the country for the Authorized
                       Representative address.

  ZIP Code             Enter the postal code (e.g., ZIP code) of the
                       Authorized Representative. This field is required
                       if the Authorized Representative is located in the
                       United States.

  Phone Number         Enter the daytime telephone number for the
                       Authorized Representative. This field is required.

  Fax Number           Enter the fax number for the Authorized
                       Representative.

  Email                Enter the email address for the Authorized
                       Representative. This field is required.

  Signature of         It is the organization's responsibility to assure
  Authorized           that only properly authorized individuals sign in
  Representative       this capacity and/or submit the application to
                       Grants.gov. If this application is submitted
                       through Grants.gov, leave this field blank. If a
                       hard copy is submitted, the AOR must sign here.

  Date Signed          If this application is submitted through
                       Grants.gov, the system will generate this date. If
                       submitting a hard copy, enter the date the AOR
                       signed the application.
  -----------------------------------------------------------------------

20\. Pre-Application

If you are submitting a pre-application, provide a summary description
of the project in accordance with the announcement and/or agency
specific instructions, and save the file in a location you remember.
Click "Add Attachment," browse to where you saved the file, select the
file, and then click "Open."

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Unless specifically noted in a program
announcement, NIH and other PHS agencies do not use *Pre-applications*.

21\. Additional Project Congressional Districts

If additional Congressional Districts are affected, attach a file using
the appropriate buttons.

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

## 4.3 Project/Performance Site Locations Component

![](media/image12.png){width="6.5in" height="4.504166666666666in"}

Indicate the primary site where the work will be performed. If a portion
of the project will be performed at any other site(s), identify the site
location(s) in the blocks provided. If more than eight
project/performance site locations are proposed, provide the information
in a separate file, and then attach.

Project/Performance Site Primary Location

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Generally, the Primary Location should be
that of the applicant organization or identified as off-site in
accordance with the conditions of the applicant organization's
negotiated Facilities and Administrative (F&A) agreement. If there is
more than one performance site, list all additional sites in the fields
provided for Location 1 - \# below.

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Organization Name    Indicate the primary site where the work will be
                       performed.

  Street1              Enter first line of the street address of the
                       primary performance site location. This field is
                       required.

  Street2              Enter second line of the street address of the
                       primary performance site location, if applicable.

  City                 Enter the city for address of the primary
                       performance site location. This field is required.

  County               Enter the county of the primary performance site
                       location.

  State                Select the state of the primary performance site
                       location. This field is not active until USA has
                       been selected for the country. This field is
                       required if the performance site location is in
                       the United States.

  Province             Enter the province of the primary performance site
                       location.

  Country              Select the country of the primary performance site
                       location. This field is required.

  ZIP Code             Enter the postal code (e.g., ZIP code) of the
                       primary performance site location. This field is
                       required if the project performance site is
                       located in the United States.
  -----------------------------------------------------------------------

Project/Performance Site Location 1

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Organization Name    Enter the name of organization of the performance
                       site location.

  Street1              Enter first line of the street address of the
                       performance site location. This field is required.

  Street2              Enter second line of the street address of the
                       performance site location, if applicable.

  City                 Enter the city of the performance site location.
                       This field is required.

  County               Enter the county of the performance site location.

  State                Select the state where the performance site is
                       located. This field is not active until USA has
                       been selected for the country. This field is
                       required if the performance site location is in
                       the United States.

  Province             Enter the province of the performance site
                       location.

  Country              Select the country for the performance site
                       location. This field is required.

  ZIP Code             Enter the postal code (e.g., ZIP code) of the
                       performance site location. This field is required
                       if the performance site location is in the United
                       States.
  -----------------------------------------------------------------------

For additional performance site locations, click **Next Site** to
display the fields for Project/Performance Site Locations 3 through 8.

If you need to add more than eight locations, enter the information in a
separate file. In the Additional Locations section at the bottom of the
form, click **Add Attachment**, select the file, and then click
**Open**. A sample Additional Performance Sites format page for greater
than eight locations is found under "Additional Format Pages" at:
[http://grants.nih.gov/grants/forms.htm](http://grants.nih.gov/grants/funding/forms.htm).

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

## 4.4 Other Project Information Component

![](media/image13.png){width="6.5in" height="6.0in"}

1\. Are Human Subjects Involved?

If activities involving human subjects are planned at any time during
the proposed project at any performance site, check the Yes box. Check
Yes even if the proposed project is exempt from Regulations for the
Protection of Human Subjects. If no activities involving human subjects
are planned, check the No box, and skip the rest of block 1. This field
is required.

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Refer to [Part II, Supplemental
Instructions for Preparing the Human Subjects Section of the Research
Plan](#Human_Subjects_PartII).

1.a. Is the IRB review Pending?

If the Institutional Review Board (IRB) review is pending, check the Yes
box. Otherwise, check the No box. In the IRB Approval Date field, enter
the latest IRB approval date, if available. Leave blank if Pending.

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Applicants should check "Yes" to the
question "Is the IRB review Pending?" even if the IRB review/approval
process has not yet begun at the time of submission. Also note that an
IRB Approval Date is not required at the time of submission. This may be
requested later in the pre-award cycle as a
[Just-In-Time](#just-in-time-policy) requirement.

For Exemption Number, if human subject activities are exempt from
Federal regulations, provide the exemption numbers corresponding to one
or more of the exemption categories. The six categories of research that
qualify for exemption from coverage by the regulations are defined in
the Common Rule for the Protection of Human Subjects. These regulations
can be found at
<http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm>.

For Human Subject Assurance Number, enter the approved Federal Wide
Assurance (FWA) Number that the applicant has on file with the Office
for Human Research Protections, if available. Enter only the 8-digit
number; do not enter the "FWA" before the number.

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Insert "None" if the applicant
organization does not have an approved assurance on file with OHRP. In
this case, the applicant organization, by the signature in item 19 on
the SF424 (R&R) Cover component, is declaring that it will comply with
45CFR Part 46 and proceed to obtain a human subjects assurances (see
<http://www.hhs.gov/ohrp>). **Do not insert the human subjects assurance
number of any collaborating institution in the space provided.**

2\. Are Vertebrate Animals Used?

If activities involving vertebrate animals are planned at any time
during the proposed project at any performance site, check the Yes box.
Otherwise, check the No box, and skip the rest of block 2. This field is
required.

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}Note
that the generation of custom antibodies constitutes an activity
involving vertebrate animals.

2.a. If YES to Vertebrate Animals

For the "Is the IACUC review Pending" field, if an Institutional Animal
Care and Use Committee (IACUC) review is pending, check the Yes box.
Otherwise check the No box. For IACUC Approval Date, enter the IACUC
approval date, if available. Leave blank if Pending.

For Animal Welfare Assurance Number, enter the Federally approved
assurance number, if available. (To determine if your organization holds
an Animal Welfare Assurance, see
<http://grants.nih.gov/grants/olaw/olaw.htm#assur>.)

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Applicants should check "Yes" to the
question "Is the IACUC review Pending?" even if the IACUC
review/approval process has not yet begun at the time of submission.
Also note that an IACUC Approval Date is not required at the time of
submission. However, the approval date and other data may be requested
later in the pre-award cycle as a Just-In-Time requirement. If the
applicant organization does not have an approved Animal Welfare
Assurance on file with the [Office of Laboratory Animal Welfare (OLAW),
NIH](http://grants.nih.gov/grants/olaw/olaw.htm), enter : "None" in the
Animal Welfare Assurance Number field. **Do not enter the Animal Welfare
Assurance number of any collaborating institution.** By inserting "None"
at the time of submission, the applicant organization is essentially
declaring that it will comply with the [PHS Policy on Humane Care and
Use of Laboratory Animals](http://grants.nih.gov/grants/olaw/olaw.htm)
by submitting an Animal Welfare Assurance and verification of IACUC
approval when requested to do so by OLAW.

3\. Is proprietary/privileged information included in the application?

Patentable ideas, trade secrets, privileged or confidential commercial
or financial information, disclosure of which may harm the applicant,
should be included in applications only when such information is
necessary to convey an understanding of the proposed project. If the
application includes such information, check the "Yes" box and clearly
mark each line or paragraph on the pages containing the
proprietary/privileged information with a legend similar to: "The
following contains proprietary/privileged information that (name of
applicant) requests not be released to persons outside the Government,
except for purposes of review and evaluation."

4\. Environmental Questions

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Unless a specific FOA indicates that the
National Environmental Policy Act (NEPA) applies, applicants should
check "No."

4.a. Does this project have an actual or potential impact on the
environment?

If your project will have an actual or potential impact on the
environment, check the Yes box, and then explain in the box provided in
4.b. Otherwise, check the No box.

4.b. If yes, please explain

If you checked the Yes box indicating an actual or potential impact on
the environment, enter the explanation of the actual or potential impact
on the environment here.

4.c. If this project has an actual or potential impact on the
environment, has an exemption been authorized or an Environmental
Assessment (EA) or an Environmental Impact Statement (EIS) been
performed?

If an exemption has been authorized or an Environmental Assessment (EA)
or an Environmental Impact Statement (EIS) been performed, check the Yes
box, and then explain in the box provided in 4.d. Otherwise, check the
No box.

4.d. If yes, please explain

If you checked the Yes box indicating an exemption has been authorized
or an EA or EIS has been performed, enter the explanation here. If
desired, you can provide the information in a separate file, and attach
by clicking Add Attachments located to the right of Step 11 - Other
Attachments.

5\. Activities Outside US or with International Collaborators Questions

5.a. Does this project involve activities outside of the United States
or partnerships with International Collaborators?

If your project involves activities outside the United States or
partnerships with international collaborators, check the Yes box, and
then explain in the box provided in 5.b. Otherwise, check the No box.

> ![](media/image9.png){width="0.375in"
> height="0.3958333333333333in"}Applicants to NIH and other PHS agencies
> must check "Yes" if the applicant organization is a foreign
> institution or if the project includes a foreign component. For a
> definition of a [substantial foreign component](#Definitions_Foreign),
> see "Definitions" section of Part III: Policies, Assurances,
> Definitions, and Other Information.

5.b. If yes, identify countries

If you checked the Yes box indicating your project involves activities
outside the US, enter the countries with which international cooperative
activities are involved.

5.c. Optional Explanation

Use this block to provide any supplemental information, if necessary. If
desired, you can provide the information in a separate file, and attach
by clicking "Add Attachments" located to the right of Item 11, Other
Attachments.

> ![](media/image9.png){width="0.375in" height="0.3958333333333333in"}If
> you have checked "Yes" to 5.a, applicants to the NIH and other PHS
> agencies must describe special resources or characteristics of the
> research project (e.g., human subjects, animals, disease, equipment,
> and techniques), whether similar research is being done in the United
> States and whether there is a need for additional research in this
> area. Provide this information in a separate file, attaching it as
> Item 11, Other Attachments. In the body of the text, begin the section
> with a heading indicating "Foreign Justification." When saving this
> file, please name it "Foreign Justification" as well.

6\. Project Summary/Abstract

The Project Summary must contain a summary of the proposed activity
suitable for dissemination to the public. It should be a self-contained
description of the project and should contain a statement of objectives
and methods to be employed. It should be informative to other persons
working in the same or related fields and insofar as possible
understandable to a scientifically or technically literate lay reader.
This Summary must not include any proprietary/confidential information.

To attach a project summary/abstract file, click Add Attachment, browse
to where you saved the file, select the file, and then click Open.

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}The
first and major component of the Project Summary/Abstract (i. e.,
"Description") is a **Project Summary**. It is meant to serve as a
succinct and accurate description of the proposed work when separated
from the application. State the application's broad, long-term
objectives and specific aims, making reference to the health relatedness
of the project (i.e., relevance to the **mission of the agency**).
Describe concisely the research design and methods for achieving the
stated goals. This section should be informative to other persons
working in the same or related fields and insofar as possible
understandable to a scientifically or technically literate reader. Avoid
describing past accomplishments and the use of the first person.
Finally, please make every effort to be succinct. This section must be
no longer than 30 lines of text, and follow the required [font and
margin specifications](#font_spec). An abstract which exceeds this
allowable length may be flagged as an error by the agency upon
submission. This would require a corrective action before the
application will be accepted.

The attachment must be in PDF format. (See [Section
2.6](#format-specifications-for-text-pdf-attachments) for additional
information on preparing attachments.)

7\. Project Narrative

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}**For NIH and other PHS agencies
applications, this attachment will reflect the second component of the
Project Summary.** The second component of the Project Summary/Abstract
(i.e., "Description") is **Relevance**. Using no more than two or three
sentences, describe the relevance of this research to **public** health.
In this section, be succinct and use plain language that can be
understood by a general, lay audience.

A separate Research Plan component is required for NIH and other PHS
agencies applications. Refer to [Section 5.5, Research Plan
Component](#research-plan-component), for separate file uploads and
instructions.

8\. Bibliography & References Cited

Provide a bibliography of any references cited in the Project Narrative.
Each reference must include the names of all authors (in the same
sequence in which they appear in the publication), the article and
journal title, book title, volume number, page numbers, and year of
publication. Include only bibliographic citations. Be especially careful
to follow scholarly practices in providing citations for source
materials relied upon when preparing any section of the application.

To attach a bibliography, click "Add Attachment," browse to where you
saved the file, select the file, and then click "Open."

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Unless otherwise noted in an FOA, this
section is required for submissions to NIH and other PHS agencies. This
section (formerly "Literature Cited") should include any references
cited in the PHS 398 Research Plan component(see [Section
5.5](#research-plan-component) for details on completing that
component). When citing articles that fall under the Public Access
Policy, were authored or co-authored by the applicant and arose from NIH
support, provide the NIH Manuscript Submission reference number (e.g.,
NIHMS97531) or the Pubmed Central (PMC) reference number (e.g.,
PMCID234567) for each article. If the PMCID is not yet available because
the Journal submits articles directly to PMC on behalf of their authors,
indicate "PMC Journal -- In Process." A list of these journals is posted
at: <http://publicaccess.nih.gov/submit_process_journals.htm>.

> Citations that are not covered by the Public Access Policy, but are
> publicly available in a free, online format may include URLs or PMCID
> numbers along with the full reference (note that copies of publicly
> available publications are not accepted as appendix material). The
> references should be limited to relevant and current literature. While
> there is not a page limitation, it is important to be concise and to
> select only those literature references pertinent to the proposed
> research.

9\. Facilities & Other Resources

This information is used to assess the capability of the organizational
resources available to perform the effort proposed. Identify the
facilities to be used (Laboratory, Animal, Computer, Office, Clinical
and Other). If appropriate, indicate their capacities, pertinent
capabilities, relative proximity and extent of availability to the
project. Describe only those resources that are directly applicable to
the proposed work. Provide any information describing the Other
Resources available to the project (e.g., machine shop, electronic shop)
and the extent to which they would be available to the project.

To attach a facilities and other resources file, click Add Attachment,
browse to where you saved the file, select the file, and then click
Open.

![](media/image9.png){width="0.3729166666666667in" height="0.4in"}No
special form is required but this section must be completed and attached
for submissions to NIH and other PHS agencies unless otherwise noted in
an FOA. If there are multiple performance sites, then resources
available at each site should be described. 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 employ useful collaborative
arrangements. If research involving Select Agent(s) will occur at any
performance site(s), the biocontainment resources available at each site
should be described.

10\. Equipment

List major items of equipment already available for this project and, if
appropriate identify location and pertinent capabilities. To attach an
equipment file, click Add Attachment, browse to where you saved the
file, select the file, and then click Open.

11\. Other Attachments

Attach a file to provide any other project information not provided
above or in accordance with the announcement and/or agency-specific
instruction by clicking Add Attachment, browsing to where you saved the
file, selecting the file, and then clicking Open.

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

## 4.5 Senior/Key Person Profile (Expanded) Component

![](media/image14.png){width="6.350694444444445in"
height="8.474305555555556in"}

This component provides the ability to collect structured data for up to
40 Senior/Key Persons. Data must be entered for the first 40 individuals
(PD/PI + 39 others) before the Additional Senior/Key Person Form
Attachments section becomes available. The information for the PD/PI
continues to be pre-populated from the SF424 (R&R) Cover component. See
instructions in section 4.2 Cover Component if these fields are empty.
Unless otherwise specified in an agency announcement, senior/key
personnel are defined as all individuals who contribute in a
substantive, meaningful way to the scientific development or execution
of the project, whether or not salaries are requested. Consultants
should be included if they meet this definition.

![](media/image9.png){width="0.3798611111111111in"
height="0.4048611111111111in"}Multiple PDs/PIs

> NIH is now accepting applications reflecting Multiple PDs/PIs for all
> grant mechanisms using the SF424 (R&R) application. When submitting an
> application involving Multiple PDs/PIs, the Contact PI should be
> listed as the PD/PI in the SF424 R&R Cover Component (see [Section
> 4.2.15](#Section_4_2_15)). That information automatically prepopulates
> the first Senior/Key Person Profile record in this component. For the
> additional PDs/PIs, complete all the requested information. **Each
> PD/PI must be assigned the PD/PI role, even those at
> subaward/consortium sites when applicable.** (Do **not** use the
> "Co-PI" role.)
>
> **Each PD/PI must also be registered in the eRA Commons and must be
> assigned the PI Role in that system (note other roles such as SO or
> IAR will not give PDs/PIs the appropriate access to the application
> records). Each PD/PI must include their respective eRA Commons ID in
> the Credential field.** For more information on NIH Implementation of
> Multiple PDs/PIs, see:
> <http://grants.nih.gov/grants/multi_pi/index.htm>.

When completing the detailed budget component for either the prime
organization or a subaward/consortium organization, the project roles
listed in the budget component should be consistent with those used in
the Senior/Key Person component.

Profile -- Program Director/Principal Investigator (PD/PI)

+--------------------+-------------------------------------------------+
| Field Name         | Instructions                                    |
+====================+=================================================+
| Prefix             | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the prefix (e.g., Mr., Mrs., |
|                    | Rev.) for the name of the PD/PI.                |
+--------------------+-------------------------------------------------+
| First Name         | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the first (given) name of    |
|                    | the PD/PI. This field is required.              |
+--------------------+-------------------------------------------------+
| Middle Name        | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the middle name of the       |
|                    | PD/PI.                                          |
+--------------------+-------------------------------------------------+
| Last Name          | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the last (family) name of    |
|                    | the PD/PI. This field is required.              |
+--------------------+-------------------------------------------------+
| Suffix             | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the suffix (e.g., Jr., Sr.,  |
|                    | PhD) for the name of the PD/PI.                 |
+--------------------+-------------------------------------------------+
| Position/Title     | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the title of the PD/PI.      |
+--------------------+-------------------------------------------------+
| Department         | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the name of primary          |
|                    | organizational department, service, laboratory, |
|                    | or equivalent level within the organization of  |
|                    | the PD/PI.                                      |
+--------------------+-------------------------------------------------+
| Organization Name  | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the name of the organization |
|                    | of the PD/PI.                                   |
+--------------------+-------------------------------------------------+
| Division           | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the name of primary          |
|                    | organizational division, office, or major       |
|                    | subdivision of the PD/PI.                       |
+--------------------+-------------------------------------------------+
| Street1            | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the first line of the street |
|                    | address of the PD/PI.                           |
+--------------------+-------------------------------------------------+
| Street2            | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the second line of the       |
|                    | street address of the PD/PI, if applicable.     |
+--------------------+-------------------------------------------------+
| City               | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the city for the address of  |
|                    | the PD/PI.                                      |
+--------------------+-------------------------------------------------+
| County             | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the county for the address   |
|                    | of the PD/PI.                                   |
+--------------------+-------------------------------------------------+
| State              | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the state where the PD/PI is |
|                    | located. This field is required if the PD/PI is |
|                    | located in the United States.                   |
+--------------------+-------------------------------------------------+
| Province           | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the province where the PD/PI |
|                    | is located.                                     |
+--------------------+-------------------------------------------------+
| Country            | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the country for the PD/PI    |
|                    | address.                                        |
+--------------------+-------------------------------------------------+
| ZIP Code           | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the Postal Code (e.g., ZIP   |
|                    | Code) of the PD/PI. This field is required if   |
|                    | the PD/PI is located in the United States.      |
+--------------------+-------------------------------------------------+
| Phone Number       | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the daytime phone number for |
|                    | the PD/PI.                                      |
+--------------------+-------------------------------------------------+
| Fax Number         | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the fax number for the       |
|                    | PD/PI.                                          |
+--------------------+-------------------------------------------------+
| Email              | This field is automatically populated from the  |
|                    | SF424 (R&R). It is the email address for the    |
|                    | PD/PI.                                          |
+--------------------+-------------------------------------------------+
| Credential, e.g.,  | If you are submitting to an agency (e.g., NIH   |
| agency login       | and other PHS agencies) where you have an       |
|                    | established personal profile, enter the agency  |
|                    | ID. If not, leave blank.                        |
|                    |                                                 |
|                    | ![](media/image9.png){width="0.375in"           |
|                    | height="0.3958333333333333in"}For NIH and other |
|                    | PHS agencies, registration in the eRA Commons   |
|                    | for all PDs/PIs is required. **The assigned     |
|                    | Commons UserName (the unique name used to log   |
|                    | into the system) for anyone assigned the PD/PI  |
|                    | role must be entered here. This is a required   |
|                    | field for applications submitted to NIH and     |
|                    | other PHS agencies. Applications will not pass  |
|                    | agency validation requirements without this     |
|                    | field.**                                        |
+--------------------+-------------------------------------------------+
| Project Role       | Select a project role from the list. Select     |
|                    | "Other" if an appropriate project role is not   |
|                    | listed.                                         |
|                    |                                                 |
|                    | ![]                                             |
|                    | (media/image9.png){width="0.3763888888888889in" |
|                    | height="0.4027777777777778in"}Select Program    |
|                    | Director/Principal Investigator for this        |
|                    | person.                                         |
+--------------------+-------------------------------------------------+
| Other Project Role | Complete if you selected "Other Professional"   |
| Category           | or "Other" as a project role. For example,      |
|                    | Engineer, Chemist.                              |
+--------------------+-------------------------------------------------+
| Attach             | Provide a biographical sketch for the PD/PI.    |
| Biographical       | Recommended information includes: Education and |
| Sketch             | Training, Research and Professional Experience, |
|                    | Collaborators and Affiliations (for conflicts   |
|                    | of interest), Publications and Synergistic      |
|                    | Activities. Save the information in a single    |
|                    | file and attach by clicking Add Attachment.     |
|                    |                                                 |
|                    | ![](media/image9.png){width="0.375in"           |
|                    | height="0.3958333333333333in"}Biographical      |
|                    | sketches should follow the format described     |
|                    | [below](#Additional_Bio_Instruct).              |
+--------------------+-------------------------------------------------+
| Attach Current &   | ![](media/image9.png){width="0.375in"           |
| Pending Support    | height="0.3958333333333333in"}Unless otherwise  |
|                    | required in a specific FOA, do not use this     |
|                    | attachment upload for NIH and other PHS agency  |
|                    | submissions. This information is no longer      |
|                    | required at the time of application submission. |
|                    | This information may be requested later in the  |
|                    | pre-award cycle. When this occurs, you will be  |
|                    | instructed to refer to [Other                   |
|                    | Support](#other-support) in Part III, Policies, |
|                    | Assurances, Definitions and Other Information.  |
+--------------------+-------------------------------------------------+

Profile -- Senior/Key Person \[*n*\]

![](media/image9.png){width="0.3729166666666667in" height="0.4in"}The
remaining Senior/Key Person Profiles should be listed in alphabetical
order. While alphabetical order is preferred, it is not required.
However, be aware that these profiles will appear in the application in
the order provided by the applicant. Therefore, peer reviewers will see
them in the order presented. Also use this section to list any Other
Significant Contributors (OSCs). OSCs should be listed after all Key
Persons. OSCs are individuals who have committed to contribute to the
scientific development or execution of the project, but are not
committing any specified measurable effort (in person months) to the
project. These individuals are typically presented at "effort of zero
person months" or "as needed" (individuals with measurable effort cannot
be listed as Other Significant Contributors). Consultants should be
included if they meet this definition. This would also be an appropriate
designation for mentors on Career awards.

A biosketch, including Research Support information, will be required
for these individuals as this highlights their accomplishments as
scientists. Reviewers use these pages to address the "investigator"
review criterion. However, if an award is to be made, Other Support
information will not be required or accepted since considerations of
overlap do not apply to these individuals.

Should the level of involvement change for an individual listed as an
OSC, they should be redesignated as "key personnel." This change should
be made before any compensation is charged to the project.

> After providing data for each individual Senior/Key Person, click the
> **Next Person** button at the bottom of the form to enter data for the
> next Senior/Key Person. Continue in this manner until data has been
> provided for up to 40 Senior/Key Persons. For applications involving
> more than 40 Senior/Key Persons, the "Additional Senior/Key Person
> Profiles" fields will become available once data for the first 40
> Senior/Key Persons has been provided.

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| Prefix            | Enter the prefix (e.g., Mr., Mrs., Rev.) for the |
|                   | name of the Senior/Key Person.                   |
+-------------------+--------------------------------------------------+
| First Name        | Enter the first (given) name of the Senior/Key   |
|                   | Person. This field is required.                  |
+-------------------+--------------------------------------------------+
| Middle Name       | Enter the middle name of the Senior/Key Person,  |
|                   | if applicable.                                   |
+-------------------+--------------------------------------------------+
| Last Name         | Enter the last (family) name of the Senior/Key   |
|                   | Person. This field is required.                  |
+-------------------+--------------------------------------------------+
| Suffix            | Enter the suffix (e.g., Jr., Sr., Ph.D.) for the |
|                   | name of the Senior/Key Person.                   |
+-------------------+--------------------------------------------------+
| Position/Title    | Enter the title of the Senior/Key Person.        |
+-------------------+--------------------------------------------------+
| Department        | Enter the name of primary organizational         |
|                   | department, service, laboratory, or equivalent   |
|                   | level within the organization of the Senior/Key  |
|                   | Person.                                          |
+-------------------+--------------------------------------------------+
| Organization Name | Enter the name of organization of the Senior/Key |
|                   | Person.                                          |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}This is a required |
|                   | field for applications submitted to NIH and      |
|                   | other PHS agencies.                              |
+-------------------+--------------------------------------------------+
| Division          | Enter the name of primary organizational         |
|                   | division, office, or major subdivision of the    |
|                   | Senior/Key Person.                               |
+-------------------+--------------------------------------------------+
| Street1           | Enter first line of the street address for the   |
|                   | Senior/Key Person. This field is required.       |
+-------------------+--------------------------------------------------+
| Street2           | Enter second line of the street address for the  |
|                   | Senior/Key Person, if applicable.                |
+-------------------+--------------------------------------------------+
| City              | Enter the city for the address of the Senior/Key |
|                   | Person. This field is required.                  |
+-------------------+--------------------------------------------------+
| County            | Enter the county for the address of the          |
|                   | Senior/Key Person.                               |
+-------------------+--------------------------------------------------+
| State             | Enter the State where the Senior/Key Person is   |
|                   | located. This field is required if the           |
|                   | Senior/Key Person is located in the United       |
|                   | States.                                          |
+-------------------+--------------------------------------------------+
| Province          | Enter the Province of Senior/Key Person.         |
+-------------------+--------------------------------------------------+
| Country           | Select the country for the Senior/Key Person     |
|                   | address. This field is required.                 |
+-------------------+--------------------------------------------------+
| ZIP Code          | Enter the Postal Code (e.g., ZIP Code) of the    |
|                   | Senior/Key Person address. This field is         |
|                   | required if the Senior/Key Person is located in  |
|                   | the United States.                               |
+-------------------+--------------------------------------------------+
| Phone Number      | Enter the daytime telephone number for the       |
|                   | Senior/Key Person. This field is required.       |
+-------------------+--------------------------------------------------+
| Fax Number        | Enter the fax number for the Senior/Key Person.  |
+-------------------+--------------------------------------------------+
| Email             | Enter the email address for the Senior/Key       |
|                   | Person. This field is required for the           |
|                   | Senior/Key Person.                               |
+-------------------+--------------------------------------------------+
| Credential, e.g., | If you are submitting to an agency (e.g., NIH    |
| agency login      | and other PHS agencies) where you have an        |
|                   | established personal profile, enter the agency   |
|                   | ID. If not, leave blank.                         |
|                   |                                                  |
|                   | ![                                               |
|                   | ](media/image9.png){width="0.3729166666666667in" |
|                   | height="0.4in"}For NIH and other PHS agencies,   |
|                   | registration in the eRA Commons for all PDs/PIs  |
|                   | is required. **The assigned Commons UserName     |
|                   | (the unique name used to log into the system)    |
|                   | for anyone assigned the PD/PI role must be       |
|                   | entered here. This is a required field for       |
|                   | applications submitted to NIH and other PHS      |
|                   | agencies. Applications will not pass agency      |
|                   | validation requirements without this field.**    |
|                   |                                                  |
|                   | Note for applications reflecting Multiple        |
|                   | PDs/PIs, the Commons UserName must be provided   |
|                   | for all individuals assigned the PD/PI Role.     |
+-------------------+--------------------------------------------------+
| Project Role      | Select a project role from the list. Select      |
|                   | "Other" if an appropriate project role is not    |
|                   | listed.                                          |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}If you are         |
|                   | submitting an application reflecting Multiple    |
|                   | PDs/PIs, all such individuals **must** be        |
|                   | assigned the PD/PI role, even those at           |
|                   | organizations other than the applicant           |
|                   | organization. The role of "Co-PD/PI" is not      |
|                   | currently used by NIH and other PHS agencies. Do |
|                   | not assign any individual this role. If          |
|                   | applicants wish to use the role of               |
|                   | "Co-Investigator" or some other similar role,    |
|                   | select "Other" for the Project Role field and    |
|                   | then insert the appropriate role descriptor in   |
|                   | the Other Project Role Category field.           |
|                   |                                                  |
|                   | If including individuals classified as "Other    |
|                   | Significant Contributors (OSCs)," use the        |
|                   | "Other" category and indicate "Other Significant |
|                   | Contributor" as the role in the "Other Project   |
|                   | Role Category." OSCs should be listed last after |
|                   | all other Senior/Key Persons have been listed.   |
+-------------------+--------------------------------------------------+
| Other Project     | Complete if you selected "Other Professional" or |
| Role Category     | "Other" as a project role. For example,          |
|                   | Engineer, Chemist.                               |
+-------------------+--------------------------------------------------+
| Attach            | Provide a biographical sketch for the Senior/Key |
| Biographical      | Person. Recommended information includes:        |
| Sketch            | Education and Training, Research and             |
|                   | Professional Experience, Collaborators and       |
|                   | Affiliations (for conflicts of interest),        |
|                   | Publications and Synergistic Activities. Save    |
|                   | the information in a single file and attach by   |
|                   | clicking Add Attachment.                         |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}Biographical       |
|                   | sketches should follow the format described      |
|                   | [below](#Additional_Bio_Instruct).               |
+-------------------+--------------------------------------------------+
| Attach Current &  | ![](media/image9.png){width="0.375in"            |
| Pending Support   | height="0.3958333333333333in"}Unless otherwise   |
|                   | required in a specific FOA, do not use this      |
|                   | attachment upload for NIH and other PHS agency   |
|                   | submissions. This information is no longer       |
|                   | required at the time of application submission.  |
|                   | This information may be requested later in the   |
|                   | pre-award cycle. When this occurs, refer to      |
|                   | [Other Support](#other-support) in Part III,     |
|                   | Policies, Assurances, Definitions, and Other     |
|                   | Information.                                     |
+-------------------+--------------------------------------------------+

**Additional Senior/Key Person Profile(s)**

If more than forty Senior/Key Person profiles are proposed, enter the
information in a separate file and attach it here.

![](media/image9.png){width="0.4in" height="0.4270833333333333in"}A
sample Additional Senior/Key Person Profiles format page for greater
than 40 profiles is found under "Additional Format Pages" at:
<http://grants.nih.gov/grants/funding/424/index.htm>.

Additional Biographical Sketch(es) (Senior/Key Person)

Provide a biographical sketch for each Senior/Key Person. Recommended
information includes: Education and Training, Research and Professional
Experience, Collaborators and Affiliations (for conflicts of interest),
Publications and Synergistic Activities. Save the information in a
single file and attach here.

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Biographical Sketches should follow the
format described [below](#Additional_Bio_Instruct).

Additional Current and Pending Support(s)

Provide a list of all current and pending support for the PD/PI and each
Senior/Key Person (even if they receive no salary support from the
project(s) for ongoing projects and pending proposals. Show the total
award amount for the entire award period (including indirect costs) as
well as the number of person-months per year to be devoted to the
project by the senior/key person, regardless of source of support.
Concurrent submission of a proposal to other organizations will not
prejudice its review.

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}Unless otherwise required in a specific
FOA, do not use this attachment upload for NIH and other PHS agency
submissions. This information is no longer required at the time of
application submission. This information may be requested later in the
pre-award cycle. When this occurs, refer to [Other
Support](#other-support) in Part III, Policies, Assurances, Definitions,
and Other Information.

[]{#Additional_Bio_Instruct .anchor}Additional NIH and Other PHS
Agencies Instructions for a Biographical Sketch

Use the sample *format* on the [Biographical Sketch Format
Page](http://grants.nih.gov/grants/funding/424/SF424R-R_biosketch.doc)
to prepare this section for **all** (modular *and* other) grant
applications. Include biographical sketches of all **Senior**/**Key
Personnel and Other Significant Contributors**. The Biographical Sketch
may not exceed four pages per person. This 4-page limit includes the
table at the top of the first page. See the sample of a [completed
Biographical
Sketch](http://grants.nih.gov/grants/funding/424/SF424R-R_biosketchsample.doc).

If the individual is registered in the eRA Commons, include the Commons
User Name. This data item is required for the PD/PI but is currently
optional for all other Senior/Key Persons. In other federal forms this
information is referred to as "Credential, e.g., agency login." For
information on the eRA Commons, see
[https://commons.era.nih.gov/commons/index.jsp.](https://commons.era.nih.gov/commons/index.jsp)

Complete the educational block at the top of the format page, and
complete Sections A, B, and C.

A. **Positions and Honors.** List in chronological order previous
positions, concluding with your present position. List any honors.
Include present membership on any Federal Government public advisory
committee.

B. **Selected peer-reviewed publications or manuscripts in press (in
chronological order).** When citing articles that fall under the Public
Access Policy, were authored or co-authored by the applicant and arose
from NIH support, provide the NIH Manuscript Submission reference number
(e.g., NIHMS97531) or the Pubmed Central (PMC) reference number (e.g.,
PMCID234567) for each article. If the PMCID is not yet available because
the Journal submits articles directly to PMC on behalf of their authors,
indicate "PMC Journal -- In Process." A list of these journals is posted
at: <http://publicaccess.nih.gov/submit_process_journals.htm>. Citations
that are not covered by the Public Access Policy, but are publicly
available in a free, online format may include URLs or PMCID numbers
along with the full reference (note that copies of publicly available
publications are not accepted as appendix material, and do not include
manuscripts submitted but not accepted for publication or in
preparation).

C. **Research Support.** List both selected ongoing and completed
(during the last three years) research projects (Federal or non-Federal
support). Begin with the projects that are most relevant to the research
proposed in this application. Briefly indicate the overall goals of the
projects and responsibilities of the key person identified on the
Biographical Sketch. *Do not include number of person months or direct
costs.*

Don't confuse "Research Support" with "Other Support." Though they sound
similar, these parts of the application are very different. As part of
the biosketch section of the application, "Research Support" highlights
your accomplishments, and those of your colleagues, as scientists. This
information will be used by the reviewers in the assessment of each
individual's qualifications for a specific role in the proposed project,
as well as to evaluate the overall qualifications of the research team.
In contrast, "Other Support" information is required for all
applications that are selected to receive grant awards. NIH staff will
request complete and up-to-date "other support" information from you
after peer review. This information will be used to check that the
proposed research has not already been Federally-funded.

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

## 4.6 Selecting the Appropriate Budget Component

![](media/image9.png){width="0.375in" height="0.3958333333333333in"}The
application forms package associated with most NIH funding opportunities
includes two optional budget components---(1) R&R Budget Component; and,
(2) PHS398 Modular Budget Component. NIH applications will include
either the R&R Budget Component or the PHS398 Modular Budget Component,
but not both. (**Note AHRQ does not accept modular budgets.**)

To determine which budget component to use for NIH applications, consult
the modular budget guidelines below. Additional guidance may also be
provided in the specific funding opportunity announcement.

***[Modular Budget Guidelines.]{.underline}*** Modular budgets are
applicable to certain research grant applications requesting \$250,000
or less per year for direct costs. Note, consortium/contractual F&A
costs are not factored into the direct cost limit. Consortium F&A costs
may be requested in addition to the \$250,000 limit. Modular budgets are
simplified; therefore, detailed categorical information is not to be
submitted with the application. The modular budget is applicable only to
R01, R03, R15, R21, and R34 applications.

Instructions for completing a Modular Budget Component can be found in
[Section 5.4](#modular-budget-component). Instructions for completing
the R&R Budget Component are provided below.

## 4.7 R&R Budget Component

The R&R Budget component includes three separate data entry screens: (1)
Sections A and B; (2) Sections C through E; and (3) Sections F through
K. To navigate between the various screens, use the "**Previous**" and
"**Next**" buttons at the top of the form or use the scroll bar on the
side of the screen. Complete the R&R Budget component following the
instructions provided. You must complete a separate detailed budget for
each year of support requested. The form will generate a cumulative
budget for the total project period. You must complete all the required
information (i.e., those fields that are highlighted in yellow, outlined
in red and noted with an "\*") before the "**Next Period**" button is
activated. If no funds are requested for a required field, enter "0."

While the dollar fields allow cents to be entered, all dollar fields
should be presented in whole numbers. Please round to the nearest whole
number.

The concept of person months as a metric for determining percent of
effort is a new business process for the applicant community of the NIH
and other PHS agencies. To assist with this transition, resources are
available on the web at:
<http://grants.nih.gov/grants/policy/person_months_faqs.htm>. Frequently
asked questions and a conversion calculator are available.

If funds are being requested for more than one budget period, click the
"**Next Period**" button at the top of the third budget screen (Sections
F through K) to navigate to screens for the next budget period.

***Revision (Supplemental) Application***. For a "Revision"
(Supplemental) application, show only those items for which additional
funds are requested. If the initial budget period of the supplementation
application is less than 12 months, prorate the personnel costs and
other appropriate items of the detailed budget.

### 4.7.1 Section A and B

![](media/image15.png){width="6.5in" height="4.919444444444444in"}

**Organizational DUNS**

Enter the DUNS or DUNS+4 number of your organization. For project
applicants, this field is pre-populated from the R&R SF424 Cover Page.
For subaward applicants, this field is required.

**Budget Type**

Check the appropriate block. Check Project if the budget requested is
for the primary applicant organization. Check Subaward/Consortium if the
budget requested is for subawardee/consortium organization(s). Note:
Separate budgets are required only for subawardee/consortium
organizations that perform a substantive portion of the project. If
creating a Subaward Budget, use the R&R Subaward Budget Attachment and
attach as a separate file on the R&R Budget Attachment(s) form.

![](media/image9.png){width="0.3729166666666667in" height="0.4in"}If you
are preparing an application that includes a subaward/consortium, see
[Section 4.8 Special Instructions for Preparing Applications with a
Subaward/Consortium](#special-instructions-for-preparing-applications-with-a-subawardconsortium).

**Enter name of Organization**

Pre-populated from the R&R SF424. Enter the name of your organization.

**Start Date**

Pre-populated from the R&R SF424. Enter the requested/proposed start
date of each budget period. Use the following format: MM/DD/YYYY. This
field is required.

**End Date**

Enter the requested/proposed end date of each budget period. Use the
following format: MM/DD/YYYY.

**Budget Period**

Identify the specific budget period (for example, 1, 2, 3, 4, 5). If
submitting through Grants.gov, the system will automatically generate a
cumulative budget for the total project period.

**A. Senior/Key Person**

> ![](media/image9.png){width="0.3701388888888889in"
> height="0.3993055555555556in"}This section should include the names of
> all senior/key persons at the applicant organization who are involved
> on the project in a particular budget year. Include all collaborating
> investigators, and other individuals meeting the senior/key person
> definition if they are from the applicant organization. Details of
> collaborators at other institutions will be provided in the Subaward
> budget for each subaward/consortium organization. Personnel listed as
> Other Significant Contributors who are not committing any specific
> measurable effort to the project should not be included in the
> Personnel section of the budget since no associated salary and/or
> fringe benefits should be requested for their contribution.
> Consultants designated as Senior/Key Persons in the Senior/Key Person
> Profile Component can be included in Budget Section A only if they are
> also employees of the applicant organization. Otherwise, consultant
> costs should be included in F.3 Consultant Services.

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| Prefix            | Select from the list the prefix (for example,    |
|                   | Mr., Mrs., Rev.) of the Senior/Key Person.       |
+-------------------+--------------------------------------------------+
| First Name        | Enter the first (given) name of each Senior/Key  |
|                   | Person. This field is required.                  |
+-------------------+--------------------------------------------------+
| Middle Name       | Enter the middle name of each Senior/Key Person, |
|                   | if applicable.                                   |
+-------------------+--------------------------------------------------+
| Last Name         | Enter the last (family) name of each Senior/Key  |
|                   | Person. This field is required.                  |
+-------------------+--------------------------------------------------+
| Suffix            | Select from the list the suffix (for example,    |
|                   | Jr., Sr., PhD) of each Senior/Key Person.        |
+-------------------+--------------------------------------------------+
| Project Role      | Enter the project role of the Senior/Key person. |
|                   | This field could also include such roles as      |
|                   | Co-PD/PI, Postdoctoral Associates, and Other     |
|                   | Professionals.                                   |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}The role of the    |
|                   | PD/PI is auto-populated in the 01 year budget    |
|                   | only. Do not change or edit this field for the   |
|                   | PD/PI. For future year budgets, use consistent   |
|                   | terminology.                                     |
+-------------------+--------------------------------------------------+
| Base Salary (\$)  | Enter the annual compensation paid by the        |
|                   | employer for each Senior/Key person. This        |
|                   | includes all activities such as research,        |
|                   | teaching, patient care, or other. You may choose |
|                   | to leave this column blank.                      |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}An applicant       |
|                   | organization may choose to leave this blank;     |
|                   | however, PHS staff will request this information |
|                   | prior to award.                                  |
+-------------------+--------------------------------------------------+
| Cal. Months       | Enter the number of months devoted to the        |
|                   | project for each Senior/Key person (for example, |
|                   | calendar, academic, summer).                     |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}If effort does not |
|                   | change throughout the year, it is OK to use only |
|                   | the calendar months column. However, you may use |
|                   | both academic and summer months columns if your  |
|                   | institutional business process requires noting   |
|                   | each separately even if effort remains constant. |
|                   | If effort varies between academic and summer     |
|                   | months, leave the calendar months column blank   |
|                   | and use only the academic and summer months      |
|                   | columns.                                         |
+-------------------+--------------------------------------------------+
| Acad. Months      | Enter the number of months devoted to the        |
|                   | project for each Senior/Key person (for example, |
|                   | calendar, academic, summer).                     |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}If your            |
|                   | institution does not use a 9-month academic      |
|                   | year, indicate your institution's definition of  |
|                   | academic year in the budget justification.       |
+-------------------+--------------------------------------------------+
| Sum. Months       | Enter the number of months devoted to the        |
|                   | project for each Senior/Key person (for example, |
|                   | calendar, academic, summer).                     |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}If your            |
|                   | institution does not use a 3-month summer        |
|                   | period, indicate your institution's definition   |
|                   | of summer in the budget justification.           |
+-------------------+--------------------------------------------------+
| Requested Salary  | Regardless of the number of months being devoted |
| (\$)              | to the project, indicate only the amount of      |
|                   | salary being requested for this budget period    |
|                   | for each Senior/Key person.                      |
|                   |                                                  |
|                   | > ![                                             |
|                   | ](media/image9.png){width="0.3729166666666667in" |
|                   | > height="0.4in"}Some PHS grant programs are     |
|                   | > currently subject to a legislatively imposed   |
|                   | > salary limitation. Any adjustment for salary   |
|                   | > limits will be made at the time of award. For  |
|                   | > guidance on current salary limitations, see    |
|                   | > the [Salary Cap                                |
|                   | > Summary](http://                               |
|                   | grants.nih.gov/grants/policy/salcap_summary.htm) |
|                   | > on the NIH grants Web site or contact your     |
|                   | > office of sponsored programs.                  |
|                   | >                                                |
|                   | > NIH grants also limit the compensation for     |
|                   | > graduate students. Compensation includes       |
|                   | > salary or wages, fringe benefits and tuition   |
|                   | > remission. While actual institutional-based    |
|                   | > compensation should be requested and           |
|                   | > justified, this may be adjusted at the time of |
|                   | > the award. For more guidance on this policy,   |
|                   | > see: [http://grants.nih.gov/grants/            |
|                   | > guide/notic                                    |
|                   | e-files/NOT-OD-02-017.html](http://grants.nih.go |
|                   | v/grants/guide/notice-files/NOT-OD-02-017.html). |
+-------------------+--------------------------------------------------+
| Fringe Benefits   | Enter applicable fringe benefits, if any, for    |
| (\$)              | each Senior/Key person.                          |
+-------------------+--------------------------------------------------+
| Funds Requested   | Enter the requested salary and fringe benefits   |
| (\$)              | for each Senior/Key person.                      |
+-------------------+--------------------------------------------------+
| Total Funds       | Enter the total funds requested for all          |
| requested for all | Senior/Key persons listed in the attached file.  |
| Senior Key        |                                                  |
| Persons in the    |                                                  |
| attached file     |                                                  |
+-------------------+--------------------------------------------------+
| Total Senior/Key  | The total funds requested for all Senior/Key     |
| Person            | persons.                                         |
+-------------------+--------------------------------------------------+
| Additional Senior | If funds are requested for more than eight       |
| Key Persons       | Senior/Key persons, include all pertinent budget |
|                   | information and attach as a file here. Enter the |
|                   | total funds requested for all additional         |
|                   | senior/key persons in line 9 of Section A.       |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}Use the same       |
|                   | format as the budget component and include all   |
|                   | required information.                            |
+-------------------+--------------------------------------------------+

#### ![](media/image9.png){width="0.3729166666666667in" height="0.4in"}Special Instructions: Joint University and Department of Veterans Affairs (V.A.) Appointments  {#special-instructions-joint-university-and-department-of-veterans-affairs-v.a.-appointments .Subhead---No-TOC}

> Individuals with joint university and V.A. appointments may request
> the university's share of their salary in proportion to the effort
> devoted to the research project. The individual's salary with the
> university determines the base for computing that request. Signature
> by the institutional official on the application certifies that: (1)
> the individual is applying as part of a joint appointment specified by
> a formal Memorandum of Understanding between the university and the
> V.A.; and (2) there is no possibility of dual compensation for the
> same work, or of an actual or apparent conflict of interest regarding
> such work. Additional information may be requested by the awarding
> components.

B. Other Personnel

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| Number of         | For each project role category identify the      |
| Personnel         | number of personnel proposed. Note, for          |
|                   | Secretarial/Clerical Personnel, in most          |
|                   | circumstances the salaries of administrative or  |
|                   | clerical staff at educational institutions and   |
|                   | nonprofit organizations are included as part of  |
|                   | indirect costs. Examples, however, of where      |
|                   | direct charging of administrative or clerical    |
|                   | staff salaries may be appropriate may be found   |
|                   | at:                                              |
|                   | <http://www.w                                    |
|                   | hitehouse.gov/omb/circulars/a021/a21_2004.html>. |
|                   | The circumstances for requiring direct charging  |
|                   | of these services must be clearly described in   |
|                   | the budget justification.                        |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}For all            |
|                   | Postdoctoral Associates and Graduate Students    |
|                   | not already named in Section A. Senior/Key       |
|                   | Person, individually list names, roles (e.g.,    |
|                   | PostDoc or Graduate Student), associated months, |
|                   | and salary & fringe benefits requested in the    |
|                   | Budget Justification.                            |
+-------------------+--------------------------------------------------+
| Project Role      | If Project Role is other than Post Doctoral      |
|                   | Associates, Graduate Students, Undergraduate     |
|                   | Students, or Secretarial/Clerical, enter the     |
|                   | appropriate project role (for example, Engineer, |
|                   | IT Professional, etc.) in the blanks.            |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}Do not include     |
|                   | consultants in this section. Consultants are     |
|                   | included below in Section F. Other Direct Costs. |
+-------------------+--------------------------------------------------+
| Cal. Months       | Enter the number of months devoted to the        |
|                   | project in the applicable box for each project   |
|                   | role category (for example, calendar, academic,  |
|                   | summer).                                         |
+-------------------+--------------------------------------------------+
| Acad. Months      | Enter the number of months devoted to the        |
|                   | project in the applicable box for each project   |
|                   | role category (for example, calendar, academic,  |
|                   | summer).                                         |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}If your            |
|                   | institution does not use a 9-month academic      |
|                   | year, indicate your institution's definition of  |
|                   | academic year in the budget justification.       |
+-------------------+--------------------------------------------------+
| Sum. Months       | Enter the number of months devoted to the        |
|                   | project in the applicable box for each project   |
|                   | role category (for example, calendar, academic,  |
|                   | summer).                                         |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}If your            |
|                   | institution does not use a 3-month summer        |
|                   | period, indicate your institution's definition   |
|                   | of summer in the budget justification.           |
+-------------------+--------------------------------------------------+
| Requested Salary  | Regardless of the number of months being devoted |
| (\$)              | to the project, indicate only the amount of      |
|                   | salary/wages being requested for each project    |
|                   | role.                                            |
|                   |                                                  |
|                   | > ![                                             |
|                   | ](media/image9.png){width="0.3729166666666667in" |
|                   | > height="0.4in"}Some PHS grant programs are     |
|                   | > currently subject to a legislatively imposed   |
|                   | > salary limitation. Any adjustment for salary   |
|                   | > limits will be made at the time of award. For  |
|                   | > guidance on current salary limitations, see    |
|                   | > the [Salary Cap                                |
|                   | > Summary](http://                               |
|                   | grants.nih.gov/grants/policy/salcap_summary.htm) |
|                   | > on the NIH grants Web site or contact your     |
|                   | > office of sponsored programs.                  |
|                   | >                                                |
|                   | > NIH grants also limit the compensation for     |
|                   | > graduate students. Compensation includes       |
|                   | > salary or wages, fringe benefits and tuition   |
|                   | > remission. While actual institutional-based    |
|                   | > compensation should be requested and           |
|                   | > justified, this may be adjusted at the time of |
|                   | > the award. For more guidance on this policy,   |
|                   | > see: [http://grants.nih.gov/grants/            |
|                   | > guide/notic                                    |
|                   | e-files/NOT-OD-02-017.html](http://grants.nih.go |
|                   | v/grants/guide/notice-files/NOT-OD-02-017.html). |
+-------------------+--------------------------------------------------+
| Fringe Benefits   | Enter applicable fringe benefits, if any, for    |
| (\$)              | this project role category.                      |
+-------------------+--------------------------------------------------+
| Funds Requested   | Enter requested salary/wages & fringe benefits   |
|                   | for each project role.                           |
+-------------------+--------------------------------------------------+
| Total Number of   | The total number of other personnel.             |
| Other Personnel   |                                                  |
+-------------------+--------------------------------------------------+
| Total Other       | The total funds requested for all other          |
| Personnel         | Personnel.                                       |
+-------------------+--------------------------------------------------+
| Total Salary,     | Total Funds requested for all Senior Key Persons |
| Wages and Fringe  | and all Other Personnel.                         |
| Benefits (A+B)    |                                                  |
+-------------------+--------------------------------------------------+

To navigate to the next page (Sections C through E), click the
"**Next**" button at the top of the form or use the scroll bar on the
left-hand side of the screen.

### 4.7.2 Sections C through E

![](media/image16.png){width="6.5in" height="6.784722222222222in"}

The information for Organizational DUNS, Budget Type, Name of
Organization, and Start and End Dates is automatically filled in based
on the information entered on the first budget screen. To edit this
information, return to the initial budget screen (Sections A and B) by
clicking the "**Previous**" button.

C. Equipment Description

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Equipment item       Equipment is defined as an item of property that
                       has an acquisition cost of \$5,000 or more (unless
                       the organization has established lower levels) and
                       an expected service life of more than one year.
                       List each item of equipment separately and justify
                       each in the budget justification section.
                       Allowable items ordinarily will be limited to
                       research equipment and apparatus not already
                       available for the conduct of the work.
                       General-purpose equipment, such as a personal
                       computer, is not eligible for support unless
                       primarily or exclusively used in the actual
                       conduct of scientific research.

  Funds Requested      List the estimated cost of each item of equipment
                       including shipping and any maintenance costs and
                       agreements. This is required information.

  Total funds          Total funds requested for all equipment listed in
  requested for all    the attached file. Dollar amount for each item
  equipment listed in  should exceed \$5000.
  the attached file    

  Total Equipment      Total Funds requested for all equipment.

  Additional Equipment If the space provided cannot accommodate all the
                       equipment proposed, attach a file by clicking Add
                       Attachment. List each additional item and the
                       funds requested. For all additional items in the
                       attached file, list the total funds requested on
                       line 11 of this section.
  -----------------------------------------------------------------------

D. Travel

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Domestic Travel      Enter the total funds requested for domestic
  Costs (Incl. Canada, travel. Domestic travel includes Canada, Mexico,
  Mexico, and US       and US possessions. In the budget justification
  Possessions)         section, include the purpose, destination, dates
                       of travel (if known), and number of individuals
                       for each trip. If the dates of travel are not
                       known, specify estimated length of trip (for
                       example, 3 days).

  Foreign Travel Costs Enter the total funds requested for foreign
                       travel. Foreign travel includes any travel outside
                       of North America and/or US possessions. In the
                       budget justification section, include the purpose,
                       destination, dates of travel (if known) and number
                       of individuals for each trip. If the dates of
                       travel are not known, specify estimated length of
                       trip (for example, 3 days).

  Total Travel Cost    The total funds requested for all travel.
  -----------------------------------------------------------------------

**E. Participant/Trainee Support Costs**

![](media/image9.png){width="0.375in"
height="0.3958333333333333in"}**Unless specifically stated otherwise in
an announcement, NIH and other PHS agencies applicants should leave
blank Section E. Note: Tuition remission for graduate students should
continue to be included in Section F. Other Direct Costs when
applicable.**

  --------------------------------------------------------------------------
  Field Name              Instructions
  ----------------------- --------------------------------------------------
  Tuition/Fees/Health     Enter the total amount of funds requested for
  Insurance               Participant/Trainee tuition / fees / health
                          insurance.

  Stipends                Enter the total funds requested for
                          Participant/Trainee stipends.

  Travel                  Enter the total funds requested for
                          Participant/Trainee travel.

  Subsistence             Enter the total funds requested for
                          Participant/Trainee subsistence.

  Other                   Describe any other participant trainee funds
                          requested. Enter the total funds requested for any
                          other Participant/Trainee costs described.

  Number of               Enter the total number of proposed
  Participants/Trainees   Participants/Trainees.

  Total                   The total funds requested for all trainee costs.
  Participant/Trainee     
  Support Costs           
  --------------------------------------------------------------------------

### 4.7.3 Sections F through K

![](media/image17.png){width="6.2965277777777775in"
height="8.445833333333333in"}

The information for Organizational DUNS, Budget Type, Name of
Organization, and Start and End Dates is automatically filled in based
on the information entered on the first budget screen. To edit this
information, return to the initial budget screen (Sections A and B) by
clicking the "**Previous**" button.

F. Other Direct Costs

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| 1\. Materials and | Enter the total funds requested for materials    |
| Supplies          | and supplies. In the budget justification,       |
|                   | indicate general categories such as glassware,   |
|                   | chemicals, animal costs, including an amount for |
|                   | each category. Categories less than \$1,000 do   |
|                   | not have to be itemized.                         |
+-------------------+--------------------------------------------------+
| 2\. Publication   | Enter the total publication funds requested. The |
| Costs             | proposal budget may request funds for the costs  |
|                   | of documenting, preparing, publishing, or        |
|                   | otherwise making available to others the         |
|                   | findings and products of the work conducted      |
|                   | under the award. In the budget justification     |
|                   | include supporting information.                  |
+-------------------+--------------------------------------------------+
| 3\. Consultant    | Enter the total costs for all consultant         |
| Services          | services. In the budget justification, identify  |
|                   | each consultant, the services he or she will     |
|                   | perform, total number of days, travel costs, and |
|                   | the total estimated costs.                       |
|                   |                                                  |
|                   | > ![                                             |
|                   | ](media/image9.png){width="0.3729166666666667in" |
|                   | > height="0.4in"}In the budget justification     |
|                   | > also provide the names and organizational      |
|                   | > affiliations of all consultants, other than    |
|                   | > those involved in consortium/contractual       |
|                   | > arrangements. Include consultant physicians in |
|                   | > connection with patient care and persons who   |
|                   | > are confirmed to serve on external monitoring  |
|                   | > boards or advisory committees to the project.  |
|                   | > Describe the services to be performed.         |
+-------------------+--------------------------------------------------+
| 4\. ADP/Computer  | Enter total funds requested for ADP/computer     |
| Services          | services. The cost of computer services,         |
|                   | including computer-based retrieval of            |
|                   | scientific, technical and education information  |
|                   | may be requested. In the budget justification,   |
|                   | include the established computer service rates   |
|                   | at the proposing organization if applicable.     |
+-------------------+--------------------------------------------------+
| 5\.               | Enter the total funds requested for 1) all       |
| Suba              | subaward/consortium organization(s) proposed for |
| wards/Consortium/ | the project and 2) any other contractual costs   |
| Contractual Costs | proposed for the project.                        |
|                   |                                                  |
|                   | > This line item should include both direct and  |
|                   | > indirect costs for all subaward/consortium     |
|                   | > organizations.![                               |
|                   | ](media/image9.png){width="0.3729166666666667in" |
|                   | > height="0.4in"} Contractual costs for support  |
|                   | > services, such as the laboratory testing of    |
|                   | > biological materials, clinical services, or    |
|                   | > data processing, are occasionally sufficiently |
|                   | > high to warrant a categorical breakdown of     |
|                   | > costs. When this is the case, provide detailed |
|                   | > information as part of the budget              |
|                   | > justification.                                 |
+-------------------+--------------------------------------------------+
| 6\. Equipment or  | Enter the total funds requested for equipment or |
| Facility          | facility rental/user fees. In the budget         |
| Rental/User Fees  | justification, identify each rental user fee and |
|                   | justify.                                         |
+-------------------+--------------------------------------------------+
| 7\. Alterations   | Enter the total funds requested for alterations  |
| and Renovations   | and renovations. In the budget justification,    |
|                   | itemize by category and justify the costs of     |
|                   | alterations and renovations including repairs,   |
|                   | painting, removal or installation of partitions, |
|                   | shielding, or air conditioning. Where            |
|                   | applicable, provide the square footage and       |
|                   | costs.                                           |
|                   |                                                  |
|                   | > ![                                             |
|                   | ](media/image9.png){width="0.3798611111111111in" |
|                   | > height="0.40694444444444444in"}Under certain   |
|                   | > circumstances the public policy requirements   |
|                   | > that apply to construction activities may also |
|                   | > apply to A&R activities. Please refer to the   |
|                   | > NIH Grants Policy Statement section on         |
|                   | > "Construction Grants -- Public Policy          |
|                   | > Requirements and Objectives" for more          |
|                   | > information.\                                  |
|                   | > \                                              |
|                   | > Note, costs for any Alterations and            |
|                   | > Renovations (A&R) were previously unallowable  |
|                   | > on applications from foreign institutions,     |
|                   | > international organizations and domestic       |
|                   | > applications with foreign subawards. However,  |
|                   | > an HHS policy change now allows for minor A&R  |
|                   | > ([\<]{.underline}\$500,000) on these           |
|                   | > applications.                                  |
|                   | >                                                |
|                   | > When requesting minor A&R costs under this     |
|                   | > policy, please provide detailed information on |
|                   | > the planned A&R in the budget justification.   |
+-------------------+--------------------------------------------------+
| 8-10 Other        | Add text to describe any "other" direct costs    |
|                   | not requested above. Use the budget              |
|                   | justification to further itemize and justify.    |
|                   |                                                  |
|                   | ![](media/image9.png){width="0.375in"            |
|                   | height="0.3958333333333333in"}Use lines 8-10 for |
|                   | such costs as patient care and tuition           |
|                   | remission. If requesting patient care costs,     |
|                   | request inpatient and outpatient costs           |
|                   | separately using lines 8 and 9.                  |
|                   |                                                  |
|                   | If line space is an issue, combine all remaining |
|                   | "other direct costs" together on the last line   |
|                   | and include details in the budget justification  |
|                   | (description and funds requested).               |
+-------------------+--------------------------------------------------+
| Total Other       | The total funds requested for all other direct   |
| Direct Costs      | costs.                                           |
+-------------------+--------------------------------------------------+

![](media/image9.png){width="0.3729166666666667in"
height="0.4in"}**Special Instructions for Patient Care Costs**

> If inpatient and/or outpatient costs are requested, provide the names
> of any hospitals and/or clinics and the amounts requested for each in
> the budget justification
>
> State whether each hospital or clinic has a currently effective
> DHHS-negotiated research patient care rate agreement and, if not, what
> basis is used for calculating costs. If an applicant does not have a
> DHHS-negotiated rate, the PHS awarding component can approve a
> provisional rate. Indicate, in detail, the basis for estimating costs
> in this category, including the number of patient days, estimated cost
> per day, and cost per test or treatment. If both inpatient and
> outpatient costs are requested, provide information for each
> separately. If multiple sites are to be used, provide detailed
> information by site.
>
> Include information regarding projected patient accrual for the
> project/budget periods and relate this information to the budget
> request for patient care costs. If patient accrual is anticipated to
> be lower at the start or during the course of the project, plan
> budget(s) accordingly.
>
> Provide specific information regarding anticipated sources of Other
> Support for patient care costs, e.g., third party recovery or
> pharmaceutical companies. Include any potential or expected
> utilization of General Clinical Research Centers.

**G. Total Direct Costs (A through F)**

The total funds requested for all direct costs.

H. Indirect Costs

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| Indirect Cost     | Indicate the type of cost (for example, Salary & |
| Type              | Wages, Modified Total Direct Costs, or Other     |
|                   | \[explain\]). Also indicate if Off-site. If more |
|                   | than one rate/base is involved, use separate     |
|                   | lines for each. If you do not have a current     |
|                   | indirect rate(s) approved by a Federal agency,   |
|                   | indicate, "None---will negotiate" and include    |
|                   | information for a proposed rate. Use the budget  |
|                   | justification if additional space is needed.     |
+-------------------+--------------------------------------------------+
| Indirect Cost     | Indicate the most recent indirect cost rate(s)   |
| Rate (%)          | (also known as Facilities & Administrative Costs |
|                   | \[F&A\]) established with the cognizant Federal  |
|                   | office, or in the case of for-profit             |
|                   | organizations, the rate(s) established with the  |
|                   | appropriate agency. If you have a                |
|                   | cognizant/oversight agency and are selected for  |
|                   | an award, you must submit your indirect rate     |
|                   | proposal to that office for approval. If you do  |
|                   | not have a cognizant/oversight agency, contact   |
|                   | the awarding agency.                             |
|                   |                                                  |
|                   | ![                                               |
|                   | ](media/image9.png){width="0.3729166666666667in" |
|                   | height="0.4in"}If this field does not allow a    |
|                   | figure greater than 100% to be entered, use two  |
|                   | lines to show the entire calculation. This field |
|                   | should be entered using a rate such as "55.5."   |
+-------------------+--------------------------------------------------+
| Indirect Cost     | Enter the amount of the base for each indirect   |
| Base (\$)         | cost type.                                       |
+-------------------+--------------------------------------------------+
| Funds Requested   | Enter the funds requested for each indirect cost |
|                   | type.                                            |
+-------------------+--------------------------------------------------+
| Total Indirect    | The total funds requested for indirect costs.    |
| Costs             |                                                  |
+-------------------+--------------------------------------------------+
| Cognizant Federal | Enter the name of the cognizant Federal Agency,  |
| Agency            | name and telephone number of the individual      |
|                   | responsible for negotiating your rate. If no     |
|                   | cognizant agency is known, enter "None."         |
+-------------------+--------------------------------------------------+

**I. Total Direct and Indirect Institutional Costs (G + H)**

The total funds requested for direct and indirect costs.

**J. Fee**

Generally, a fee is not allowed on a grant or cooperative agreement. Do
not include a fee in your budget, unless the program announcement
specifically allows the inclusion of a "fee" (for example, SBIR/STTR).
If a fee is allowable, enter the requested fee.

**K. Budget Justification**

Use the budget justification to provide the additional information
requested in each budget category identified above and any other
information you wish to submit to support your budget request. Note this
is a single justification for all budget years so include all
justification information for all years in the same file. Click Add
Attachment to attach the file.

![](media/image9.png){width="0.3729166666666667in" height="0.4in"}Use
this section to also list the names, role (e.g., PostDoc or Graduate
Student), associated months, salary and fringe benefits for all
Postdoctoral Associates and Graduate Students included in Budget Section
B. Other Personnel.

> Include a justification for any significant increases or decreases
> from the initial year budget. Also, justify budgets with more than a
> standard escalation from the initial to the future year(s) of support.
>
> If the application includes a subaward/consortium budget, a separate
> budget justification is submitted for that budget. See [Section 4.8
> Special Instructions for Preparing Applications with a
> Subaward/Consortium](#special-instructions-for-preparing-applications-with-a-subawardconsortium).

**Completing Budget Periods 2-5**

If funds are being requested for more than one budget period, you must
complete a separate detailed budget for each year of support requested.
To navigate to screens for the next budget period, click the "**Next
Period**" button at the top of the 3^rd^ budget screen (Sections F
through K). You must complete all the required information (i.e., those
fields that are highlighted in yellow, outlined in red and noted with an
"\*") before the "**Next Period**" button is activated. If no funds are
requested for a required field, enter "0." Note the Budget Justification
is also a required item and must be attached before the "**Next
Period**" button is activated.

![](media/image9.png){width="0.3729166666666667in"
height="0.4in"}**Supplemental/Revision Application**

> For a supplemental/revision application, show only those items for
> which additional funds are requested. If the initial budget period of
> the supplemental/revision application is less than 12 months, prorate
> the personnel costs and other appropriate items of the detailed
> budget.\
> \
> **Submitting Budgets With More Than 5 Budget Periods**\
> \
> When authorized or requested by the appropriate NIH IC, applicants may
> submit applications with more than 5 budget periods. In these
> situations complete the detailed budget for periods 1-5 as usual.
> However, include the same level of detail for Period 6 in the Budget
> Justification along with an explanation of the situation. Also, be
> sure to include a cover letter that addresses these extra budget
> periods, and include the IC Program Official's preapproval as part of
> the Cover Letter PDF.

### 4.7.4 Cumulative Budget

All values on this form are calculated automatically. They present the
summations of the amounts that you have entered previously, under
Sections A through K, for each of the individual budget periods.
Therefore, no data entry is allowed or required, in order to complete
this "Cumulative Budget" section.

If any of the amounts displayed on this form appears to be incorrect,
you may correct it by adjusting one or more of the values that
contribute to that total. To make any such adjustments, you will need to
revisit the appropriate budget period form(s), to enter corrected
values.

![](media/image18.png){width="6.5in" height="7.239583333333333in"}

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

## 4.8 Special Instructions for Preparing Applications with a Subaward/Consortium

![](media/image19.png){width="6.5in" height="4.909722222222222in"}

A complete subaward/consortium budget component (including the budget
justification section) should be completed by each consortium grantee
organization. Separate budgets are required only for
subawardee/consortium organizations that perform a substantive portion
of the project.

Note, a complete subaward/consortium budget component is only required
when the prime grantee is submitting a detailed budget using the R&R
Budget Component. Do not use this subaward/consortium budget component
for applications using the PHS398 Modular Budget Component. Applicants
using the Modular Budget Component should see [Section
5.4](#modular-budget-component) for instructions concerning information
on consortium budgets.

When completing the Project Role for the investigator leading the
portion of the project at the consortium site, the project role of
"PD/PI" should only be used if the entire application is being submitted
under the Multiple PI policy. Also, the role of Co-PD/PI is not
currently used by NIH and other PHS agencies. Do not assign any
individual this role. If applicants wish to use roles of
"Co-Investigator" or "Consortium PI", select "Other" for the Project
Role field and then insert the appropriate role descriptor in the Other
Project Role Category field.

NIH continues to support the policy established in April 2004, (revised
in November 2004) regarding applications that involve
consortium/contractual F&A costs ([See
NOT-OD-05-004](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html)).
This policy allows applicants to exclude consortium/contractual F&A
costs when determining compliance for any application where a direct
cost limit applies. The use of the SF424 (R&R) application with
separately submitted subaward/consortium budgets allows NIH to take
advantage of a system validation for this policy. When an application is
submitted in response to a program with a direct cost limit, the eRA
system will perform the calculation by taking the total direct costs
requested by the prime/parent organization in their detailed budget, and
subtracting all subaward/consortium F&A from each and every subaward
budget attached. When the validation calculation equals or exceeds the
respective direct cost limit, the application will receive a warning.

This component currently accommodates up to 10 separate subaward
budgets. If you are submitting an application with \>10 subaward
budgets, budgets 11 and above should be converted to PDF and included as
part of Section K. Budget Justification of the parent budget (R&R Budget
Component). Reminder, the sum of all subaward budgets; e.g., those
attached separately and those provided as part of the budget
justification, must be included in Line F.5
Subawards/Consortium/Contractual Costs of the parent budget.

To start the process, the applicant organization should:

-   Select the Subaward Budget Attachment Form from the Optional
    Documents in the Grant Application Package.

-   Open the form, and click the "**Click here to extract the R&R
    Subaward Budget Attachment**" button in the middle of the form. A
    "SAVE" dialog box appears.

-   Save the file locally using the first ten letters of the consortium
    organization's name and use ".pdf" as the file extension. (The
    extracted file is an Adobe PDF file.) Once you have saved the file
    there is no need to extract another budget attachment. Doing so may
    cause you to lose any data already stored in the saved file.

-   Email the extracted, saved form to the consortium grantee. Note:
    consortium grantees must have installed the PureEdge Viewer before
    they can complete the form. The consortium grantee should complete
    all the budget information as instructed in the R&R Budget component
    instructions in [Section 4.7](#rr-budget-component). Note:
    Organizational DUNS and Name of Organization fields must reflect
    that of the subaward/consortium grantee.

-   The consortium grantee must complete the budget component and email
    it back to the applicant organization.

-   Return to the Subaward Budget Attachment Form and attach the
    consortium grantee's budget to one of the blocks provided on the
    form.

**Submitting Subaward Budgets that are not Active for all Periods of the
Prime Grant**

When submitting subaward budgets that are not active for all periods of
the prime grant, fill out the subaward R&R Budget form and include only
the number of periods for which the subaward is active. The budget
period start/end dates reflected in each period should reflect the
corresponding prime budget period start/end dates. This approach is the
most workable solution to the limitations in existing forms that do not
allow an "empty" budget period and do not allow submission of a subaward
budget with zero effort to skip a budget period.

For example, suppose the prime has filled out a budget form with the
following periods:

-   period 1    Jan 1 2008 -- Dec 31 2008

-   period 2    Jan 1 2009 -- Dec 31 2009

-   period 3    Jan 1 2010 -- Dec 31 2010

-   period 4    Jan 1 2011 -- Dec 31 2011

-   period 5    Jan 1 2012 -- Dec 31 2012

Now, suppose there is a subaward that performs in support year 1 and
does not become active again until support year 4. The subaward can fill
out the first two periods of their budget form as follows:

-   period 1   Jan 1 2008 -- Dec 31 2008   (dates correspond to prime
    period 1)

-   period 2   Jan 1 2011 -- Dec 31 2011   (dates correspond to prime
    period 4)

It is not necessary that the budget period numbers between the prime and
subaward match; the correlation is reflected in the dates. Do be
careful, however, that the dates exactly match what is listed for the
period in the prime budget.

Note this approach may cause a validation warning regarding the NIH
\$500,000 per year limit on direct costs, therefore you should document
in both the cover letter and the subaward budget justification that the
subaward is only active for specific periods of the prime. Appropriate
NIH staff has access to the cover letter and reviewers have access to
the budget justification. This documentation will make the date
correlation immediately apparent and will help avoid any confusion.

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

# 5. Completing PHS398 Components

## 5.1 Overview

In conjunction with the SF424 (R&R) components, NIH and other PHS
agencies grants applicants should also complete and submit additional
components titled "PHS398." Note the PHS398 components include
additional data required by the agency for a complete application. While
these are not identical to the PHS398 application form pages, the PHS398
reference is used to distinguish these additional data requirements from
the data collected in the SF424 (R&R) components. A complete application
to NIH and other PHS agencies will include SF424 (R&R) and PHS398
components. The PHS398 components include:

-   PHS398 Cover Letter Component (optional, however applicants are
    strongly encouraged to include this component)

-   PHS398 Cover Page Supplement (this supplements the data requirements
    in the R&R Cover component)

-   PHS398 Modular Budget Component (use only when a modular budget is
    submitted instead of a detailed budget)

-   PHS398 Research Plan Component

-   PHS398 Checklist Component

Complete each component using the instructions provided below.

## 5.2 Cover Letter Component

![](media/image20.png){width="6.488194444444445in" height="2.425in"}

Applicants are encouraged to include a cover letter with the
application. The cover letter is only for internal use and will not be
shared with peer reviewers. The letter should contain any of the
following information that applies to the application:

1\. Application title.

2\. Funding Opportunity (PA or RFA) title of the NIH initiative.

3\. Request of an assignment (referral) to a particular [awarding
component(s)](#Table_AwardingComponents) or [Scientific Review Group
(SRG)](http://www.csr.nih.gov/review/irgdesc.htm). The PHS makes the
final determination.

4\. List of individuals (e.g., competitors) who should not review your
application and why.

5\. Disciplines involved, if multidisciplinary.

6\. For late applications (see Late Application policy in [Section
2.14](#Late_applications)) include an explanation of the delay as part
of the cover letter attachment.

7\. When submitting a Changed/Corrected Application after the submission
date, a cover letter is required explaining the reason for the
Changed/Corrected Application. If you already submitted a cover letter
with a previous submission and are now submitting a Changed/Corrected
Application, you must include all previous cover letter text in the
revised cover letter attachment. The system does not retain any
previously submitted cover letters until after an application is
verified; therefore, you must repeat all information previously
submitted in the cover letter as well as any additional information.

8\. Explanation of any subaward budget components that are not active
for all periods of the proposed grant.

9\. Statement that you have attached any required agency approval
documentation for the type of application submitted. This may include
approval for applications \$500,000 or more, approval for Conference
Grant or Cooperative Agreement (R13 or U13), etc.

> Two types of approval documentation are cited as examples in item 6
> above: NIH IC approval for an application \$500,000 or more and NIH
> institute approval for a Conference Grant or Cooperative Agreement
> application (R13 or U13). To attach the approval documents to this
> submission, please append those referenced documents to your Cover
> Letter File, and upload as one attachment.

**Suggested Cover Letter Format**

The Division of Receipt and Referral (DRR), Center for Scientific Review
(CSR) is responsible for assigning applications to ICs and to scientific
review groups (SRGs). DRR will be utilizing knowledge management
approaches as an adjunct to the work of referral experts as part of an
overall plan to shorten the time from submission to review. Analysis has
shown that requests made by investigators are a valuable source of
information in this process. In order to facilitate the use of these
requests in conjunction with knowledge management analysis of the
content of the application, applicants are requested to use the
following format when assignment requests are contained in a cover
letter.

-   List one request per line.

-   Place institute/center (IC) and SRG review requests (if both are
    made) on separate lines.

-   Place positive and negative requests (if both are made) on separate
    lines.

-   Include name of IC or SRG, followed by a dash and the acronym. Do
    not use parentheses.

-   Provide explanations for each request in a separate paragraph.

Examples:

Please assign this application to the following:

Institutes/Centers

National Cancer Institute - NCI

National Institute for Dental and Craniofacial Research -- NIDCR

Scientific Review Groups

Molecular Oncogenesis Study Section -- MONC

Cancer Etiology Study Section -- CE

Please do not assign this application to the following:

Scientific Review Groups

Cancer Genetics Study Section -- CG

The reasons for this request are \[provide a narrative explanation for
the request(s)\].

Save this information in a single file in a location you remember and
convert the file to PDF. Click Add Cover Letter File, browse to where
you saved the file, select the file, and then click Open. The name of
the file attached will automatically appear in the "Mandatory Cover
Letter Filename" field.

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

## 5.3 Cover Page Supplement Component

![](media/image21.png){width="6.379861111111111in"
height="8.477083333333333in"}

**1. Program Director/Principal Investigator** (PD/PI)

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| Prefix            | Pre-populated from the SF424 (R&R). The prefix   |
|                   | (for example, Mr., Mrs., Rev.) for the name of   |
|                   | the PD/PI.                                       |
+-------------------+--------------------------------------------------+
| First Name        | Pre-populated from the SF424 (R&R). The first    |
|                   | (given) name of the PD/PI. This field is         |
|                   | required.                                        |
+-------------------+--------------------------------------------------+
| Middle Name       | Pre-populated from the SF424 (R&R). The middle   |
|                   | name of the PD/PI.                               |
+-------------------+--------------------------------------------------+
| Last Name         | Pre-populated from the SF424 (R&R). The last     |
|                   | (family) name of the PD/PI. This field is        |
|                   | required.                                        |
+-------------------+--------------------------------------------------+
| Suffix            | Pre-populated from the SF424 (R&R). The suffix   |
|                   | (for example, Jr., Sr., PhD) for the name of the |
|                   | PD/PI.                                           |
+-------------------+--------------------------------------------------+
| New Investigator  | Check "Yes" in the "New Investigator" box only   |
|                   | if the PD/PI has not previously competed         |
|                   | successfully for an NIH-supported research       |
|                   | project other than the following small or early  |
|                   | stage research awards:                           |
|                   |                                                  |
|                   | -   Pathway to Independence Award-Research Phase |
|                   |     (R00)                                        |
|                   |                                                  |
|                   | -   Small Grant (R03)                            |
|                   |                                                  |
|                   | -   Academic Research Enhancement Award (R15)    |
|                   |                                                  |
|                   | -   Exploratory/Developmental Grant (R21)        |
|                   |                                                  |
|                   | -   Clinical Trial Planning Grant (R34)          |
|                   |                                                  |
|                   | -   Dissertation Award (R36)                     |
|                   |                                                  |
|                   | -   Small Business Technology Transfer           |
|                   |     Grant-Phase I (R41)                          |
|                   |                                                  |
|                   | -   Small Business Innovation Research           |
|                   |     Grant-Phase I (R43)                          |
|                   |                                                  |
|                   | -   Shannon Award (R55)                          |
|                   |                                                  |
|                   | -   NIH High Priority, Short-Term Project Award  |
|                   |     (R56)                                        |
|                   |                                                  |
|                   | Additionally, the PD/PI is not excluded from     |
|                   | consideration as a "New Investigator" if he/she  |
|                   | has received an award from any of the following  |
|                   | classes of awards:                               |
|                   |                                                  |
|                   | Training-Related and Mentored Career Awards      |
|                   |                                                  |
|                   | -   Fellowships (F05, F30, F31, F32, F34, F37,   |
|                   |     F38)                                         |
|                   |                                                  |
|                   | -   Mentored-career awards (K01, K08, K22, K23,  |
|                   |     K25, K99-R00)                                |
|                   |                                                  |
|                   | -   Other mentored career awards (developmental  |
|                   |     K02 as used by NINDS and the developmental   |
|                   |     K07)                                         |
|                   |                                                  |
|                   | -   Loan repayment contracts (L30, L32, L40,     |
|                   |     L50, L60)\                                   |
|                   |     \                                            |
|                   |     Please note that current or past recipients  |
|                   |     of non-mentored career awards that normally  |
|                   |     require independent research support (K02,   |
|                   |     K05, K24, and K26) are not considered new    |
|                   |     investigators.                               |
|                   |                                                  |
|                   | Instrumentation, Construction, Education, or     |
|                   | Meeting Awards                                   |
|                   |                                                  |
|                   | -   G07, G08, G11, G13, G20                      |
|                   |                                                  |
|                   | -   S10, S15                                     |
|                   |                                                  |
|                   | -   X01, X02                                     |
|                   |                                                  |
|                   | -   R25                                          |
|                   |                                                  |
|                   | -   C06, UC6                                     |
|                   |                                                  |
|                   | -   R13, U13                                     |
|                   |                                                  |
|                   | In general, if the PD/PI has competed            |
|                   | successfully as PD/PI for a significant NIH      |
|                   | independent research award, he/she is not        |
|                   | considered a new investigator and must check     |
|                   | "No."                                            |
|                   |                                                  |
|                   | When Multiple PD/PIs are proposed, **all**       |
|                   | PD/PIs must meet the definition of New           |
|                   | Investigator to check "Yes" in the "New          |
|                   | Investigator" box.                               |
+-------------------+--------------------------------------------------+
| Degrees           | Indicate up to three academic and professional   |
|                   | degrees or other credentials, such as licenses   |
|                   | (for example, R.N.). These degrees should be a   |
|                   | subset of the degrees that are listed on the     |
|                   | PD/PI's Commons account. If the PD/PI's Commons  |
|                   | account does not include the degrees listed      |
|                   | here, please update the Commons account          |
|                   | information accordingly.                         |
+-------------------+--------------------------------------------------+

2\. Human Subjects

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Clinical Trial       Check the Yes or No box to indicate whether the
                       project is a clinical trial. The NIH defines a
                       clinical trial as a prospective biomedical or
                       behavioral research study of human subjects that
                       is designed to answer specific questions about
                       biomedical or behavioral interventions (drugs,
                       treatments, devices, or new ways of using known
                       drugs, treatments, or devices). Note that Public
                       Law 110-85, enacted 09/27/2007, mandates
                       registration and results reporting of applicable
                       clinical trials in ClinicalTrials.gov (see Part II
                       and Part III).

  Agency-Defined Phase Check the Yes or No box to indicate whether the
  III Clinical Trial   project is an NIH-defined Phase III clinical
                       trial. An NIH-defined Phase III clinical trial is
                       a broadly based prospective Phase III clinical
                       investigation, usually involving several hundred
                       or more human subjects, for the purpose of either
                       evaluating an experimental intervention in
                       comparison with a standard or control intervention
                       or of comparing two or more existing treatments.
                       Often the aim of such investigation is to provide
                       evidence leading to a scientific basis for
                       consideration of a change in health policy or
                       standard of care. The definition includes
                       pharmacologic, non-pharmacologic, and behavioral
                       interventions given for disease prevention,
                       prophylaxis, diagnosis, or therapy. Community
                       trials and other population-based intervention
                       trials are also included.
  -----------------------------------------------------------------------

**3. Applicant Organization Contact**

Person to be contacted on matters involving this application

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Prefix               Pre-populated from the SF424 (R&R). The prefix
                       (e.g., Mr., Mrs., Rev.) for the person to contact
                       on matters related to this application.

  First Name           Pre-populated from the SF424 (R&R). The first
                       (given) name for the person to contact on matters
                       related to this application. This field is
                       required.

  Middle Name          Pre-populated from the SF424 (R&R). The middle
                       name for the person to contact on matters related
                       to this application.

  Last Name            Pre-populated from the SF424 (R&R). The last
                       (family) name for the person to contact on matters
                       related to this application. This field is
                       required.

  Suffix               Pre-populated from the SF424 (R&R). The suffix
                       (e.g., Jr., Sr., PhD) for the person to contact on
                       matters related to this application.

  Phone Number         Pre-populated from the SF424 (R&R). The daytime
                       phone number for the person to contact on matters
                       related to this application. This field is
                       required.

  Fax Number           Pre-populated from the SF424 (R&R). The fax number
                       for the person to contact on matters related to
                       this application.

  Email                Pre-populated from the SF424 (R&R). The email
                       address for the person to contact on matters
                       related to this application.

  Title                Enter the title for the person to contact on
                       matters related to this application. This field is
                       required.

  Street1              Enter first line of the street address for the
                       person to contact on matters related to this
                       application. This field is required.

  Street2              Enter second line of the street address for the
                       person to contact on matters related to this
                       application. This field is optional.

  City                 Enter the city for address for the person to
                       contact on matters related to this application.
                       This field is required.

  County               Enter the county for address for the person to
                       contact on matters related to this application.

  State                Enter the state for address for the person to
                       contact on matters related to this application.

  Province             Enter the province.

  Country              Select the country for the person to contact on
                       matters related to this application. This field is
                       required.

  Zip Code             Enter the Postal Code (e.g., ZIP code) for the
                       person to contact on matters related to this
                       application.
  -----------------------------------------------------------------------

![](media/image22.png){width="6.5in" height="6.725in"}

4\. Human Embryonic Stem Cells

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Does the proposed    If the proposed project does not involve human
  project involve      embryonic stem cells, check the No box. If the
  human embryonic stem proposed project involves human embryonic stem
  cells?               cells, check the Yes box, and then complete the
                       section below.

  Cell Line(s)         List in this section the registration number of
                       the specific cell line(s) from the NIH Human
                       Embryonic Stem Cell Registry.

  Specific stem cell   If a specific line cannot be referenced at the
  line cannot be       time of application submission, check this box.
  referenced at this   
  time. One from the   
  registry will be     
  used.                
  -----------------------------------------------------------------------

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

## 5.4 Modular Budget Component

**Selecting the Appropriate Budget Component**

The application forms package associated with most NIH funding
opportunities includes two optional budget components---(1) R&R Budget
Component; and, (2) PHS398 Modular Budget Component. NIH applications
will include either the R&R Budget Component or the PHS398 Modular
Budget Component, but not both. (**Note AHRQ does not accept modular
budgets.**)

To determine which budget component to use for NIH applications, consult
the modular budget guidelines below. Additional guidance may also be
provided in the specific funding opportunity announcement.

**Modular Budget Guidelines**

Modular budgets are applicable to certain research grant applications
from domestic organizations requesting \$250,000 or less per year for
direct costs. International organizations and others that do not fall
under this definition should use the detailed budget forms described in
Section 4.7. Note, consortium/contractual F&A costs are not factored
into the direct cost limit. They may be requested in addition to the
\$250,000 limit. Modular budgets are simplified; therefore, detailed
categorical information is not to be submitted with the application. The
modular budget is applicable only to R01, R03, R15, R21, and R34
applications.

For all modular budgets, request total direct costs (in **modules of
\$25,000**), reflecting appropriate support for the project. There will
be no future year escalations. A typical modular grant application will
request the same number of modules in each year. Provide an additional
narrative budget justification for any variation in the number of
modules requested.

NIH may request (prior to award) additional budget justification in
exceptional circumstances. For further information, see
<http://grants.nih.gov/grants/funding/modular/modular.htm> and
<http://grants.nih.gov/grants/funding/modular/modular_review.htm>.

**Using the Modular Budget Component**

The Modular Budget Component provides budget fields for up to 5 years of
support (e.g., budget periods 1 - 5). If requesting less than 5 years of
support, complete only those years requested and leave the others blank.

### 5.4.1 Periods 1 through 4

![](media/image23.png){width="6.364583333333333in"
height="8.567361111111111in"}

NOTE: The fields are the same for budget periods 1 through 5, the
following instructions can be used for each.

Budget Period

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Start Date           Enter the requested/proposed start date of the
                       budget period. Use the following format:
                       MM/DD/YYY.

  End Date             Enter the requested/proposed end date of the
                       budget period. Use the following format:
                       MM/DD/YYY.
  -----------------------------------------------------------------------

A. Direct Costs

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Direct Cost less     Enter the amount of direct costs, less actual
  Consortium F&A       consortium F&A costs for this budget period. This
                       figure must be in \$25,000 increments, and it may
                       not exceed \$250,000. Actual consortium F&A costs
                       are excluded from this figure.

  Consortium F&A       If this project involves a consortium, enter the
                       actual consortium F&A costs for this budget
                       period. If this project does not involve a
                       consortium, leave blank.

  Total Direct Costs   The total direct costs. This field
                       auto-calculates.
  -----------------------------------------------------------------------

B. Indirect Costs

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| Indirect Cost     | Indicate the type of base (for example, Salary & |
| Type              | Wages, Modified Total Direct Costs, Other        |
|                   | \[explain\]), and indicate if Off-site. If more  |
|                   | than one rate/base is involved, use separate     |
|                   | lines for each. If you do not have a current     |
|                   | indirect rate(s) approved by a Federal agency,   |
|                   | indicate, "None---will negotiate" and include    |
|                   | information for a proposed rate. Use the budget  |
|                   | justification if additional space is needed.     |
+-------------------+--------------------------------------------------+
| Indirect Cost     | Indicate the most recent Indirect Cost rate(s)   |
| Rate (%)          | (also known as Facilities & Administrative Costs |
|                   | \[F&A\]) established with the cognizant Federal  |
|                   | office, or in the case of for-profit             |
|                   | organizations, the rate(s) established with the  |
|                   | appropriate agency. If you have a                |
|                   | cognizant/oversight agency and are selected for  |
|                   | an award, you must submit your indirect rate     |
|                   | proposal to that office for approval. If you do  |
|                   | not have a cognizant/oversight agency, contact   |
|                   | the awarding agency.                             |
|                   |                                                  |
|                   | Currently this field will not allow a figure     |
|                   | greater than 100% to be entered. If the Indirect |
|                   | Cost Rate exceeds 100%, use 2 lines to show the  |
|                   | entire calculation.                              |
+-------------------+--------------------------------------------------+
| Indirect Cost     | Enter the amount of the base for each indirect   |
| Base (\$)         | cost type.                                       |
+-------------------+--------------------------------------------------+
| Funds Requested   | Enter funds requested for each indirect cost     |
| (\$)              | type.                                            |
+-------------------+--------------------------------------------------+
| Cognizant Agency  | Enter the name of the cognizant Federal Agency,  |
| (Agency Name, POC | name, and phone number of the individual         |
| Name and Phone    | responsible for negotiating your rate. If no     |
| Number)           | cognizant agency is known, enter "None."         |
+-------------------+--------------------------------------------------+
| Indirect Cost     | If you have a negotiated rate agreement, enter   |
| Rate Agreement    | the agreement date.                              |
| Date              |                                                  |
+-------------------+--------------------------------------------------+
| Total Indirect    | The total funds requested for indirect costs.    |
| Costs             | This field auto-calculates.                      |
+-------------------+--------------------------------------------------+

**C. Total Direct and Indirect Costs (A+B) Funds Requested (\$)**

The total funds requested for direct and indirect costs. This field
auto-calculates.

Once you have entered all required information for budget periods 1 and
2, press the **Next** button or scroll down to enter information for
subsequent budget periods.

### 5.4.2 Period 5 and Cumulative

![](media/image24.png){width="6.3375in" height="8.447916666666666in"}

**Cumulative Budget Information**

All values for the Cumulative Budget Information are calculated
automatically. They equal the summations of the amounts that you have
entered previously for each of the individual budget periods. Therefore,
no data entry is allowed or required, in order to complete this
"Cumulative Budget" section.

If any of the amounts displayed on this form appears to be incorrect,
you may correct it by adjusting one or more of the values that
contribute to that total. To make any such adjustments, you will need to
revisit the appropriate budget period form(s), to enter corrected
values.

**Modular** Budget Justifications

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| Personnel         | List all personnel, including names, number of   |
| Justification     | person months devoted to the project (indicate   |
|                   | academic, calendar, and/or summer) and roles on  |
|                   | the project. Do not provide individual salary    |
|                   | information. Since the modules should be a       |
|                   | reasonable estimate of costs allowable,          |
|                   | allocable, and appropriate for the proposed      |
|                   | project, you must use the current legislatively  |
|                   | imposed salary limitation when estimating the    |
|                   | number of modules. For guidance on current       |
|                   | salary limitations contact your office of        |
|                   | sponsored programs.                              |
|                   |                                                  |
|                   | NIH grants also limit the compensation for       |
|                   | graduate students. Compensation includes salary  |
|                   | or wages, fringe benefits, and tuition           |
|                   | remission. This limit should also be used when   |
|                   | estimating the number of modules. See:           |
|                   | <http://grants.nih.go                            |
|                   | v/grants/guide/notice-files/NOT-OD-02-017.html>. |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| Consortium        | Provide an estimate of total costs (direct plus  |
| Justification     | facilities and administrative) for each year,    |
|                   | rounded to the nearest \$1,000. List the         |
|                   | individuals/organizations with whom consortium   |
|                   | or contractual arrangements have been made,      |
|                   | along with all personnel, including percent of   |
|                   | effort (in person months) and roles on the       |
|                   | project. Do not provide individual salary        |
|                   | information. Indicate whether the collaborating  |
|                   | institution is foreign or domestic. While only   |
|                   | the direct cost for a consortium/contractual     |
|                   | arrangement is factored into eligibility for     |
|                   | using the modular budget format, the **total**   |
|                   | consortium/contractual costs must be included in |
|                   | the overall requested modular direct cost        |
|                   | amount.                                          |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| Additional        | If the requested budget requires any additional  |
| Narrative         | justification, such as variations in the number  |
| Justification     | of modules requested, save this information in a |
|                   | single file in a location you remember. Click    |
|                   | Add Attachment, browse to where you saved the    |
|                   | file, select the file, and then click Open.      |
+-------------------+--------------------------------------------------+

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

## 5.5 Research Plan Component

![](media/image25.png){width="6.492361111111111in"
height="7.584027777777778in"}

The Research Plan should include sufficient information needed for
evaluation of the project, independent of any other document (e.g.,
previous application). Be specific and informative, and avoid
redundancies.

**1. Application Type**

This field is pre-populated from the SF424 (R&R) Cover Component.
Corrections to this field must be made in that component.

**2. Research Plan Attachments** (See also [Section 2.3.2 Creating PDFs
for Text Attachments](#software-requirements))

Although many of the sections of this application are separate PDF
attachments, page limitations referenced in the instructions and/or
funding opportunity announcement must still be followed. Agency
validations will include checks for page limits (and use of appropriate
font). Some accommodation will be made for sections that, when combined,
must fit within a specified limitation.

Text attachments should be generated using word processing software and
then converted to PDF using PDF generating software. Avoid scanning text
attachments to convert to PDF since that causes problems for the agency
handling the application. In addition, be sure to save files with
descriptive file names.

Do not include any information in a header or footer of the attachments.
A header will be system-generated that references the name of the PD/PI.
Page numbers for the footer will be system-generated in the complete
application, with all pages sequentially numbered.

Since a number of reviewers will be reviewing applications as an
electronic document and not a paper version, applicants are strongly
encouraged to use only a standard, single-column format for the text.
Avoid using a two-column format since it can cause difficulties when
reviewing the document electronically.

Full-sized glossy photographs of material such as electron micrographs
or gels must only be included within the page limitations of the
Research Plan. The maximum size of images to be included should be
approximately 1200 x 1500 pixels using 256 colors. Figures must be
readable as printed on an 8.5 x 11 inch page at normal (100%) scale.

Investigators must use image compression such as JPEG or PMG. Do not
include figures or photographs as separate attachments either in the
Appendix or elsewhere in the application.

**Separate Attachments**

Separate attachments have been designed for the Research Plan sections
to maximize automatic validations conducted by the eRA system. When the
application is received by the agency, all of the Research Plan sections
will be concatenated in the appropriate order so that reviewers and
agency staff will see a single cohesive Research Plan.

While each section of the Research Plan needs to eventually be uploaded
separately, applicants are encouraged to construct the Research Plan as
a single document, separating sections into distinct PDF attachments
just before uploading the files. In this way the applicant can better
monitor formatting requirements such as page limits. When validating for
page limits, the eRA Commons will not count the white space created by
breaking the text into separate files for uploading.

When attaching a PDF document to the actual forms, please note you are
attaching an actual document, not just pointing to the location of an
externally stored document. Therefore, if you revise the document after
it has been attached, you **must** delete the previous attachment and
then reattach the revised document to the application form. Use the
"**View Attachment**" button to determine if the correct version has
been attached.

**Page Limitations**

**Do not exceed 25 pages for Items 2 -- 5.** All tables, graphs,
figures, diagrams, and charts must be included within the 25-page limit.
Be succinct and remember that there is no requirement to use all 25
pages allotted to items 2-5 of the Research Plan.

**Follow page limitations as specified in Funding Opportunity
Announcements.**

All applications and proposals for NIH funding must be self-contained
within specified page limitations. Agency validations will include
checks for page limits. Some accommodation will be made for sections
that when combined must fit within a specified limitation. Note that
while these computer validations will help minimize incomplete and/or
non-compliant applications, they do not replace the validations
conducted by NIH staff. Applications found not to comply with the
requirements may be delayed in the review process. Unless otherwise
specified in an NIH solicitation, Internet website addresses (URLs) may
not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Moreover,
reviewers are cautioned that they should not directly access an internet
site as it could compromise their anonymity.

#### Notice of Proprietary Information {#notice-of-proprietary-information .Subhead---No-TOC}

Applicants are discouraged from submitting information considered
proprietary unless it is deemed essential for proper evaluation of the
application. However, when the application contains information that
constitutes trade secrets, or information that is commercial or
financial, or information that is confidential or privileged, make sure
you have checked the "Yes" box of question #3 in the "Other Project
Information" component. Identify the pages in the application that
contain this information by marking those paragraphs or lines with an
asterisk (\*) in the left-hand margin. Include a legend at the beginning
of Section 2, similar to "The following sections marked with an asterisk
contain proprietary/privileged information that (name of Applicant)
requests not be released to persons outside the Government, except for
purposes of review and evaluation."

When information in the application constitutes trade secrets or
information that is commercial or financial, or information that is
confidential or privileged, it is furnished to the Government in
confidence with the understanding that the information shall be used or
disclosed only for evaluation of this application. If a grant is awarded
as a result of or in connection with the submission of this application,
the Government shall have the right to use or disclose the information
to the extent authorized by law. This restriction does not limit the
Government's right to use the information if it is obtained without
restriction from another source.

Begin each text section of the Research Plan with a section header
(e.g., Introduction, Specific Aims, Background & Significance, etc).

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| 1\.               | Use only if you are submitting an R&R            |
| []{#Introduction  | Resubmission or Revision (Cover Page Item 8).    |
| .an               | The Introduction may not exceed 1-3 pages for    |
| chor}Introduction | resubmissions (previously known as a revision or |
| to Application    | amendment) or one page for revisions (previously |
| (for Resubmission | known as competing supplements). Page limits for |
| or Revision only) | the Introduction vary for specialized mechanisms |
|                   | (e.g., R03 and R21 applications). Applicants     |
|                   | **must** follow the page limits that are         |
|                   | outlined in the specific announcement.           |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| 2\. Specific Aims | List the broad, long-term objectives and the     |
|                   | goal of the specific research proposed, for      |
|                   | example, to test a stated hypothesis, create a   |
|                   | novel design, solve a specific problem,          |
|                   | challenge an existing paradigm or clinical       |
|                   | practice, address a critical barrier to progress |
|                   | in the field, or develop new technology. One     |
|                   | page is recommended.                             |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| 3\. Background    | Briefly sketch the background leading to the     |
| and Significance  | present application, critically evaluate         |
|                   | existing knowledge, and specifically identify    |
|                   | the gaps that the project is intended to fill.   |
|                   | State concisely the importance and health        |
|                   | relevance of the research described in this      |
|                   | application by relating the specific aims to the |
|                   | broad, long-term objectives. If the aims of the  |
|                   | application are achieved, state how scientific   |
|                   | knowledge or clinical practice will be advanced. |
|                   | Describe the effect of these studies on the      |
|                   | concepts, methods, technologies, treatments,     |
|                   | services or preventative interventions that      |
|                   | drive this field. Two to three pages are         |
|                   | recommended.                                     |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| 4\. Preliminary   | *Preliminary Studies.* For new applications, use |
| Studies/Progress  | this section to provide an account of the        |
| Report            | PD/PI's preliminary studies pertinent to this    |
|                   | application, including his/her preliminary       |
|                   | experience with and outreach to the proposed     |
|                   | racial/ethnic group members. This information    |
|                   | will also help to establish the experience and   |
|                   | competence of the investigator to pursue the     |
|                   | proposed project.                                |
|                   |                                                  |
|                   | Except for Exploratory/Development Grants        |
|                   | (R21/R33), Small Research Grants (R03), and      |
|                   | Phase I Small Business Research Grants           |
|                   | (R41/R43), peer review committees generally view |
|                   | preliminary data as an essential part of a       |
|                   | research grant application. Preliminary data     |
|                   | often aid the reviewers in assessing the         |
|                   | likelihood of the success of the proposed        |
|                   | project.                                         |
|                   |                                                  |
|                   | *Progress Report for Renewal (previously known   |
|                   | as Competing Continuation) and Revision          |
|                   | (previously known as Supplemental)               |
|                   | Applications.* A Progress Report must be         |
|                   | provided for renewal and revision applications.  |
|                   | Provide the beginning and ending dates for the   |
|                   | period covered since the project was last        |
|                   | reviewed competitively. Summarize the previous   |
|                   | application's specific aims and the importance   |
|                   | of the findings. Provide a succinct account of   |
|                   | published and unpublished results, indicating    |
|                   | progress toward their achievement. Discuss any   |
|                   | changes in the specific aims as a result of      |
|                   | budget reductions. **A list of publications,     |
|                   | manuscripts accepted for publication, patents,   |
|                   | and other printed materials will be included in  |
|                   | Section 7; do not include that information       |
|                   | here.**                                          |
|                   |                                                  |
|                   | **Six to eight pages are recommended** for the   |
|                   | narrative portion of this section.               |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| 5\. Research      | Describe the research design conceptual or       |
| Design and        | clinical framework, procedures, and analyses to  |
| Methods           | be used to accomplish the specific aims of the   |
|                   | project. Unless addressed separately in Item 17, |
|                   | include how the data will be collected,          |
|                   | analyzed, and interpreted as well as the         |
|                   | data-sharing plan as appropriate. Describe any   |
|                   | new methodology and its advantage over existing  |
|                   | methodologies. Describe any novel concepts,      |
|                   | approaches, tools, or technologies for the       |
|                   | proposed studies. Discuss the potential          |
|                   | difficulties and limitations of the proposed     |
|                   | procedures and alternative approaches to achieve |
|                   | the aims. As part of this section, provide a     |
|                   | tentative sequence or timetable for the project. |
|                   | Point out any procedures, situations, or         |
|                   | materials that may be hazardous to personnel and |
|                   | the precautions to be exercised.                 |
|                   |                                                  |
|                   | Although no specific number of pages is          |
|                   | recommended for the Research Design and Methods  |
|                   | section, be as succinct as possible. There is no |
|                   | requirement that all 25 pages allotted for items |
|                   | 2-5 be used.                                     |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| 6\. Inclusion     | If the renewal or revision application involves  |
| Enrollment Report | clinical research, then you must report on the   |
|                   | enrollment of research subjects and their        |
|                   | distribution by ethnicity/race and sex/gender.   |
|                   |                                                  |
|                   | See [Part II, Section                            |
|                   | 4.3](#Human_Subjects_Population_Tracking) for    |
|                   | more detailed instructions on which Target and   |
|                   | Enrollment Report or Table to use.               |
+-------------------+--------------------------------------------------+
| 7\. Progress      | List the titles and complete references to all   |
| Report            | appropriate publications, manuscripts accepted   |
| Publication List  | for publication, patents, and other printed      |
| (Renewal          | materials that have resulted from the project    |
| Applications      | since it was last reviewed competitively. When   |
| Only)             | citing articles that fall under the Public       |
|                   | Access Policy, were authored or co-authored by   |
|                   | the applicant and arose from NIH support,        |
|                   | provide the NIH Manuscript Submission reference  |
|                   | number (e.g., NIHMS97531) or the Pubmed Central  |
|                   | (PMC) reference number (e.g., PMCID234567) for   |
|                   | each article. If the PMCID is not yet available  |
|                   | because the Journal submits articles directly to |
|                   | PMC on behalf of their authors, indicate "PMC    |
|                   | Journal -- In Process." A list of these journals |
|                   | is posted at:                                    |
|                   | <http://pu                                       |
|                   | blicaccess.nih.gov/submit_process_journals.htm>. |
|                   |                                                  |
|                   | Citations that are not covered by the Public     |
|                   | Access Policy, but are publicly available in a   |
|                   | free, online format may include URLs or PMCID    |
|                   | numbers along with the full reference (note that |
|                   | copies of these publications are not accepted as |
|                   | appendix material).                              |
+-------------------+--------------------------------------------------+

Human Subjects Sections

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| 8\. Protection of | This section covers only the initial information |
| Human Subjects    | regarding the Protection of Human Subjects.      |
|                   | Follow the instructions in Part II,              |
|                   | [Supplemental Instructions for Preparing the     |
|                   | Human Subjects Section of the Research           |
|                   | Plan](#Human_Subjects_PartII). See separate      |
|                   | sections below for other human subjects related  |
|                   | sections that may apply.                         |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
|                   |                                                  |
|                   | Unless an explanation is necessary, if Human     |
|                   | Subjects research is not involved, and you have  |
|                   | checked the box marked "No" on the Other Project |
|                   | Information Component, you need not include any  |
|                   | additional information in this section.          |
+-------------------+--------------------------------------------------+
| 9\. Inclusion of  | To determine if Inclusion of Women and           |
| Women and         | Minorities applies to this application, follow   |
| Minorities        | the instructions in Part II, [Supplemental       |
|                   | Instructions for Preparing the Human Subjects    |
|                   | Section of the Research                          |
|                   | Plan](#inclusion-of-women-and-minorities).       |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| 10\.              | If this application involves the Inclusion of    |
| Targeted/Planned  | Women and Minorities, complete the               |
| Enrollment        | [Targeted/Planned Enrollment                     |
|                   | Table](http://grants.nih.                        |
|                   | gov/grants/funding/424/SF424R-R_enrollment.doc). |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| 11\. Inclusion of | To determine if Inclusion of Children applies to |
| Children          | this application, follow the instructions in the |
|                   | [Supplemental Instructions for Preparing the     |
|                   | Human Subjects Section of the Research           |
|                   | Plan](#inclusion-of-children).                   |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+

**Other** Sections

+-------------------+--------------------------------------------------+
| Field Name        | Instructions                                     |
+===================+==================================================+
| 12\. Vertebrate   | If you indicated that Vertebrate Animals are     |
| Animals           | involved in this project, address the following  |
|                   | five key points. In addition, when research      |
|                   | involving vertebrate animals will take place at  |
|                   | collaborating site(s) or other performance       |
|                   | site(s), provide this information before         |
|                   | discussing the five points. Although no specific |
|                   | page limitation applies to this section of the   |
|                   | application, be succinct.                        |
|                   |                                                  |
|                   | > 1\. Provide a detailed description of the      |
|                   | > proposed use of the animals in the work        |
|                   | > outlined in the Research Design and Methods    |
|                   | > section. Identify the species, strains, ages,  |
|                   | > sex, and numbers of animals to be used in the  |
|                   | > proposed work.                                 |
|                   | >                                                |
|                   | > 2\. Justify the use of animals, the choice of  |
|                   | > species, and the numbers to be used. If        |
|                   | > animals are in short supply, costly, or to be  |
|                   | > used in large numbers, provide an additional   |
|                   | > rationale for their selection and numbers.     |
|                   | >                                                |
|                   | > 3\. Provide information on the veterinary care |
|                   | > of the animals involved.                       |
|                   | >                                                |
|                   | > 4\. Describe the procedures for ensuring that  |
|                   | > discomfort, distress, pain, and injury will be |
|                   | > limited to that which is unavoidable in the    |
|                   | > conduct of scientifically sound research.      |
|                   | > Describe the use of analgesic, anesthetic, and |
|                   | > tranquilizing drugs and/or comfortable         |
|                   | > restraining devices, where appropriate, to     |
|                   | > minimize discomfort, distress, pain, and       |
|                   | > injury.                                        |
|                   | >                                                |
|                   | > 5\. Describe any method of euthanasia to be    |
|                   | > used and the reasons for its selection. State  |
|                   | > whether this method is consistent with the     |
|                   | > recommendations of the Panel on Euthanasia of  |
|                   | > the American Veterinary Medical Association.   |
|                   | > If not, present a justification for not        |
|                   | > following the recommendations.                 |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
|                   | For those applicants familiar with the PHS398,   |
|                   | please note that the Literature Cited section of |
|                   | the Research Plan is now captured as             |
|                   | "Bibliography & References Cited." Refer to Item |
|                   | 8 in the Other Project Information Component for |
|                   | instructions.                                    |
+-------------------+--------------------------------------------------+
| 13\. Select Agent | Select Agents are hazardous biological agents    |
| Research          | and toxins that have been identified by DHHS or  |
|                   | USDA as having the potential to pose a severe    |
|                   | threat to public health and safety, to animal    |
|                   | and plant health, or to animal and plant         |
|                   | products. CDC maintains a list of these agents.  |
|                   | See <http://www.cdc.gov/od/sap/docs/salist.pdf>. |
|                   |                                                  |
|                   | If the activities proposed in your application   |
|                   | involve only the use of a strain(s) of Select    |
|                   | Agents which has been excluded from the list of  |
|                   | select agents and toxins as per 42 CFR           |
|                   | 73.4(f)(5), the Select Agent requirements do not |
|                   | apply. Use this section to identify the          |
|                   | strain(s) of the Select Agent that will be used  |
|                   | and note that it has been excluded from this     |
|                   | list. The CDC maintains a list of exclusions at  |
|                   | <http://www.cdc.gov/od/sap/sap/exclusion.htm>.   |
|                   |                                                  |
|                   | If the strain(s) is not currently excluded from  |
|                   | the list of select agents and toxins but you     |
|                   | have applied or intend to apply to DHHS for an   |
|                   | exclusion from the list, use this section to     |
|                   | indicate the status of your request or your      |
|                   | intent to apply for an exclusion and provide a   |
|                   | brief justification for the exclusion.           |
|                   |                                                  |
|                   | If any of the activities proposed in your        |
|                   | application involve the use of Select Agents at  |
|                   | any time during the proposed project period,     |
|                   | either at the applicant organization or at any   |
|                   | other performance site, address the following    |
|                   | three points for each site at which Select Agent |
|                   | research will take place. Although no specific   |
|                   | page limitation applies to this section, be      |
|                   | succinct.                                        |
|                   |                                                  |
|                   | 1\. Identify the Select Agent(s) to be used in   |
|                   | the proposed research.                           |
|                   |                                                  |
|                   | 2\. Provide the registration status of all       |
|                   | entities\* where Select Agent(s) will be used.   |
|                   |                                                  |
|                   | -   If the performance site(s) is a foreign      |
|                   |     institution, provide the name(s) of the      |
|                   |     country or countries where Select Agent      |
|                   |     research will be performed.                  |
|                   |                                                  |
|                   |     \*An "entity" is defined in 42 CFR 73.1 as   |
|                   |     "any government agency (Federal, State, or   |
|                   |     local), academic institution, corporation,   |
|                   |     company, partnership, society, association,  |
|                   |     firm, sole proprietorship, or other legal    |
|                   |     entity."                                     |
|                   |                                                  |
|                   | 3\. Provide a description of all facilities      |
|                   | where the Select Agent(s) will be used.          |
|                   |                                                  |
|                   | -   Describe the procedures that will be used to |
|                   |     monitor possession, use and transfer of      |
|                   |     Select Agent(s).                             |
|                   |                                                  |
|                   | -   Describe plans for appropriate biosafety,    |
|                   |     biocontainment, and security of the Select   |
|                   |     Agent(s).                                    |
|                   |                                                  |
|                   | If you are responding to a specific funding      |
|                   | opportunity announcement (e.g., PA or RFA),      |
|                   | address any requirements specified by the        |
|                   | solicitation.                                    |
|                   |                                                  |
|                   | Reviewers will assess the information provided   |
|                   | in this Section, and any questions associated    |
|                   | with Select Agent research will need to be       |
|                   | addressed prior to award.                        |
|                   |                                                  |
|                   | Save this file in a location you remember. Click |
|                   | Add Attachment, browse to where you saved the    |
|                   | file, select the file, and then click Open.      |
+-------------------+--------------------------------------------------+
| 14\. Multiple     | For applications designating multiple PDs/PIs, a |
| PD/PI Leadership  | leadership plan must be included. A rationale    |
| Plan              | for choosing a multiple PD/PI approach should be |
|                   | described. The governance and organizational     |
|                   | structure of the leadership team and the         |
|                   | research project should be described, including  |
|                   | communication plans, process for making          |
|                   | decisions on scientific direction, and           |
|                   | procedures for resolving conflicts. The roles    |
|                   | and administrative, technical, and scientific    |
|                   | responsibilities for the project or program      |
|                   | should be delineated for the PDs/PIs and other   |
|                   | collaborators.                                   |
|                   |                                                  |
|                   | If budget allocation is planned, the             |
|                   | distribution of resources to specific components |
|                   | of the project or the individual PDs/PIs should  |
|                   | be delineated in the Leadership Plan. In the     |
|                   | event of an award, the requested allocations may |
|                   | be reflected in a footnote on the Notice of      |
|                   | Grant Award.                                     |
|                   |                                                  |
|                   | Save this file in a location you remember. Click |
|                   | Add Attachment, browse to where you saved the    |
|                   | file, select the file, and then click Open.      |
+-------------------+--------------------------------------------------+
| 15\.              | Explain the programmatic, fiscal, and            |
| Conso             | administrative arrangements to be made between   |
| rtium/Contractual | the applicant organization and the consortium    |
| Arrangements      | organization(s). If consortium/contractual       |
|                   | activities represent a significant portion of    |
|                   | the overall project, explain why the applicant   |
|                   | organization, rather than the ultimate performer |
|                   | of the activities, should be the grantee. The    |
|                   | signature of the authorized organizational       |
|                   | official on the SF424 (R&R) cover component      |
|                   | (Item 18) signifies that the applicant and all   |
|                   | proposed consortium participants understand and  |
|                   | agree to the following statement:                |
|                   |                                                  |
|                   | > *The appropriate programmatic and              |
|                   | > administrative personnel of each organization  |
|                   | > involved in this grant application are aware   |
|                   | > of the agency's consortium agreement policy    |
|                   | > and are prepared to establish the necessary    |
|                   | > inter-organizational agreement(s) consistent   |
|                   | > with that policy.*                             |
|                   |                                                  |
|                   | A separate statement is no longer required.      |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| 16\. Letters of   | Attach all appropriate letters of support,       |
| Support           | including any letters necessary to demonstrate   |
|                   | the support of consortium participants and       |
|                   | collaborators such as Senior/Key Personnel and   |
|                   | Other Significant Contributors included in the   |
|                   | grant application. Letters are not required for  |
|                   | personnel (such as research assistants) not      |
|                   | contributing in a substantive, measurable way to |
|                   | the scientific development or execution of the   |
|                   | project. For consultants, letters should include |
|                   | rate/charge for consulting services.             |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| 17\. Resource     | NIH considers the sharing of unique research     |
| Sharing Plan(s)   | resources developed through NIH-sponsored        |
|                   | research an important means to enhance the value |
|                   | and further the advancement of the research.     |
|                   | When resources have been developed with NIH      |
|                   | funds and the associated research findings       |
|                   | published or provided to NIH, it is important    |
|                   | that they be made readily available for research |
|                   | purposes to qualified individuals within the     |
|                   | scientific community. See Part III, 1.5 Sharing  |
|                   | Research Resources.                              |
|                   |                                                  |
|                   | 1\. *Data Sharing Plan*: Investigators seeking   |
|                   | \$500,000 or more in direct costs in any year    |
|                   | are expected to include a brief 1-paragraph      |
|                   | description of how final research data will be   |
|                   | shared, or explain why data-sharing is not       |
|                   | possible. Specific Funding Opportunity           |
|                   | Announcements may require that all applications  |
|                   | include this information regardless of the       |
|                   | dollar level. Applicants are encouraged to read  |
|                   | the specific opportunity carefully and discuss   |
|                   | their data-sharing plan with their program       |
|                   | contact at the time they negotiate an agreement  |
|                   | with the Institute/Center (IC) staff to accept   |
|                   | assignment of their application. See             |
|                   | [Data-Sharing Policy](#Policy_DataSharing) or    |
|                   | <http://grants.nih.go                            |
|                   | v/grants/guide/notice-files/NOT-OD-03-032.html>. |
|                   |                                                  |
|                   | 2\. *Sharing Model Organisms*: Regardless of the |
|                   | amount requested, all applications where the     |
|                   | development of model organisms is anticipated    |
|                   | are expected to include a description of a       |
|                   | specific plan for sharing and distributing       |
|                   | unique model organisms or state why such sharing |
|                   | is restricted or not possible. See [Sharing      |
|                   | Model Organisms                                  |
|                   | Policy](#sharing-model-organisms), and [NIH      |
|                   | Guide                                            |
|                   | NOT-OD-04-042](http://grants.nih.go              |
|                   | v/grants/guide/notice-files/NOT-OD-04-042.html). |
|                   |                                                  |
|                   | 3\. *Genome Wide Association Studies (GWAS):*    |
|                   | Applicants seeking funding for a genome-wide     |
|                   | association study are expected to provide a plan |
|                   | for submission of GWAS data to the               |
|                   | NIH-designated GWAS data repository, or an       |
|                   | appropriate explanation why submission to the    |
|                   | repository is not possible. GWAS is defined as   |
|                   | any study of genetic variation across the entire |
|                   | genome that is designed to identify genetic      |
|                   | associations with observable traits (such as     |
|                   | blood pressure or weight) or the presence or     |
|                   | absence of a disease or condition. For further   |
|                   | information see Policy for Sharing of Data       |
|                   | Obtained in NIH Supported or Conducted           |
|                   | Genome-Wide Association Studies, [NIH Guide      |
|                   | NOT-OD-07-088](http://www.nih.go                 |
|                   | v/grants/guide/notice-files/NOT-OD-07-088.html), |
|                   | and <http://grants.nih.gov/grants/gwas/>.        |
|                   |                                                  |
|                   | Save this information in a single file in a      |
|                   | location you remember. Click Add Attachment,     |
|                   | browse to where you saved the file, select the   |
|                   | file, and then click Open.                       |
+-------------------+--------------------------------------------------+
| 18\. []{#Appendix | Only one copy of appendix material is necessary. |
| .anchor}Appendix  | Use the **add attachments** button to the right  |
|                   | of this field to complete this entry.            |
|                   |                                                  |
|                   | A maximum of 10 PDF attachments is allowed in    |
|                   | the Appendix. If more than 10 appendix           |
|                   | attachments are needed, combine the remaining    |
|                   | information into attachment #10. Note that this  |
|                   | is the total number of appendix items, not the   |
|                   | total number of publications. When allowed there |
|                   | is a limit of 3 publications that are not        |
|                   | publicly available (see below for further        |
|                   | details and check the FOA for any specific       |
|                   | instructions), though not all grant mechanisms   |
|                   | allow publications to be included in the         |
|                   | appendix.                                        |
|                   |                                                  |
|                   | Do not use the appendix to circumvent the page   |
|                   | limitations of the research plan.                |
|                   |                                                  |
|                   | Appendix material may not appear in the          |
|                   | assembled application in the order attached, so  |
|                   | it is important to use filenames for attachments |
|                   | that are descriptive of the content. A summary   |
|                   | sheet listing all of the items included in the   |
|                   | appendix is also encouraged but not required.    |
|                   | When including a summary sheet, it should be     |
|                   | included in the first appendix attachment.       |
|                   | Applications that do not follow the appendix     |
|                   | requirements may be delayed in the review        |
|                   | process.                                         |
|                   |                                                  |
|                   | New, resubmission, renewal, and revision         |
|                   | applications **may** include the following       |
|                   | materials in the Appendix:                       |
|                   |                                                  |
|                   | -   **Publications -- No longer allowed as       |
|                   |     appendix materials except in the             |
|                   |     circumstances noted below**. Applicants may  |
|                   |     submit up to 3 of the following types of     |
|                   |     publications:                                |
|                   |                                                  |
|                   |     -   **Manuscripts and/or abstracts accepted  |
|                   |         for publication but not yet published:** |
|                   |         The entire article should be submitted   |
|                   |         as a PDF attachment.                     |
|                   |                                                  |
|                   |     -   **Manuscripts and/or abstracts           |
|                   |         published, but a free, online, publicly  |
|                   |         available journal link is not            |
|                   |         available:** The entire article should   |
|                   |         be submitted as a PDF attachment.        |
|                   |                                                  |
|                   |     -   **Patents directly relevant to the       |
|                   |         project:** The entire document should be |
|                   |         submitted as a PDF attachment.           |
|                   |                                                  |
|                   | (Do not include unpublished theses, or           |
|                   | abstracts/manuscripts **submitted** (but not yet |
|                   | accepted) for publication.)                      |
|                   |                                                  |
|                   | -   Surveys, questionnaires, and other data      |
|                   |     collection instruments; clinical protocols   |
|                   |     and informed consent documents may be        |
|                   |     submitted in the Appendix as necessary.      |
|                   |                                                  |
|                   | -   For materials that cannot be submitted       |
|                   |     electronically or materials that cannot be   |
|                   |     converted to PDF format (e.g., medical       |
|                   |     devices, prototypes, DVDs, CDs), applicants  |
|                   |     should contact the Scientific Review Officer |
|                   |     for instructions following notification of   |
|                   |     assignment of the application to a study     |
|                   |     section. Applicants are encouraged to be as  |
|                   |     concise as possible and submit only          |
|                   |     information essential for the review of the  |
|                   |     application.                                 |
|                   |                                                  |
|                   | Items that must **not** be included in the       |
|                   | appendix:                                        |
|                   |                                                  |
|                   | -   Photographs or color images of gels,         |
|                   |     micrographs, etc., **are no longer accepted  |
|                   |     as Appendix material**. These images must be |
|                   |     included in the Research Plan PDF. However,  |
|                   |     images embedded in publications are allowed. |
|                   |                                                  |
|                   | -   Publications that are publicly accessible.   |
|                   |     For such publications, the URL or PMC        |
|                   |     submission identification numbers along with |
|                   |     the full reference should be included as     |
|                   |     appropriate in the Bibliography and          |
|                   |     References cited section, the Progress       |
|                   |     Report Publication List section, and/or the  |
|                   |     Biographical Sketch section.                 |
+-------------------+--------------------------------------------------+

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

## 5.6 Checklist Component

![](media/image26.png){width="6.5in" height="7.469444444444444in"}

1\. Application Type

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Type of Application  This field is pre-populated from the SF424 (R&R)
                       Cover Component. Corrections to this field must be
                       made in that component.

  Federal Identifier   This field is pre-populated from the SF424 (R&R).
                       Corrections to this field must be made in that
                       component. For New applications this field will be
                       blank.
  -----------------------------------------------------------------------

2\. Change of Investigator/Change of Institution Questions

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Change of Program    Check this box if this application reflects a
  Director/Principal   change in PD/PI from the one who was indicated on
  Investigator         a previous application. This is not generally
                       applicable to a "New" application.

  Prefix               If this application reflects a change in PD/PI,
                       enter the name prefix (for example, Mr., Mrs.,
                       Rev.) of the former PD/PI.

  First Name           If this application reflects a change in PD/PI,
                       enter the first name of the former PD/PI.

  Middle Name          If this application reflects a change in PD/PI,
                       enter the middle name of the former PD/PI.

  Last Name            If this application reflects a change in PD/PI,
                       enter the last name of the former PD/PI.

  Suffix               If this application reflects a change in PD/PI,
                       provide the suffix (for example, Jr., Sr., PhD) of
                       the former PD/PI.

  Change of Grantee    Check this box if this application reflects a
  Institution          change in grantee institution from the one that
                       was indicated on a previous application. This is
                       not generally applicable to a "New" application.

  Name of Former       If this application reflects a change in grantee
  Institution          institution, enter the name of the former
                       institution.
  -----------------------------------------------------------------------

3\. Inventions and Patents (For renewal applications only)

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Inventions and       This block need only be completed if submitting an
  Patents              R&R "Renewal" application. If no inventions were
                       conceived or reduced to practice during the course
                       of work under this project, check the No box. The
                       remaining parts of the item are then not
                       applicable. If any inventions were conceived or
                       reduced to practice during the previous period of
                       support, check the Yes box.

  Previously Reported  If you checked the Yes box for Inventions and
                       Patents, above, indicate whether this information
                       has been reported previously to the PHS or to the
                       applicant organization official responsible for
                       patent matters.
  -----------------------------------------------------------------------

![](media/image27.png){width="6.5in" height="8.294444444444444in"}

**4. [Program Income](#Definitions_ProgramIncome)**

  -----------------------------------------------------------------------
  Field Name           Instructions
  -------------------- --------------------------------------------------
  Is program income    If program income is anticipated during the
  anticipated during   periods for which the grant support is requested,
  the periods for      check the Yes box, and then complete the section
  which the grant      below. If no program income is anticipated, check
  support is           the No box and leave the following section blank.
  requested?           

  Budget Period        If program income is anticipated, enter the budget
                       periods. If the application is funded, the Notice
                       of Award will provide specific instructions
                       regarding the use of such income.

  Anticipated Amount   If program income is anticipated, enter the amount
  (\$)                 anticipated for each budget period listed.

  Source(s)            If program income is anticipated, enter the source
                       for each budget period listed.
  -----------------------------------------------------------------------

**5. Assurances/Certifications**

In agreeing to the assurances/certification section 18 of the SF424
(R&R) form, the authorized organizational representative agrees to
comply with the following policies, assurances and certifications when
applicable. Descriptions of individual assurances/certifications are
provided in [Part III: Policies, Assurances, Definitions, and Other
Information](#assurances-and-certifications).

> Human Subjects Research; Research on Transplantation of Human Fetal
> Tissue; Research Using Human Embryonic Stem Cells; Women and Minority
> Inclusion Policy; Inclusion of Children Policy; Vertebrate Animals;
> Debarments and Suspension; Drug Free Workplace; Lobbying;
> Non-Delinquency of Federal Debt; Research Misconduct; Civil Rights;
> Handicapped Individuals; Sex Discrimination; Age Discrimination;
> Recombinant DNA, including Human Gene Transfer Research; Financial
> Conflict of Interest; Smoke-Free Workplace; Prohibited Research;
> Select Agent Research; Principal Investigator Assurance

If you are unable to certify compliance with the applicable policies,
assurances, and certifications listed, please provide an explanation in
a separate file. Click Add Attachment, browse to where you saved the
file, select the file, and then click Open.

Once all data have been entered, click the **Close Form** button at the
top of the form or use the scroll bar to scroll up. You will be returned
to the Grant Application Package screen. To remove a document from the
Submission box, click the document name to select it and then click the
**Move Form to Delete** button. This will return the document to the
Mandatory Documents Submission List or Optional Documents Submission
List.

# 6. Peer Review Process

A description of what happens to your research project grant application
after it is received for peer review can be found at the following
location:
<http://cms.csr.nih.gov/ResourcesforApplicants/Submission+And+Assignment+Process.htm>.

#### Overview {#overview-3 .Subhead---No-TOC}

Most applications submitted to the PHS will be reviewed through a
two-tier system. The first level of review will be performed by a
Scientific Review Group (SRG), often called a "study section" or "review
committee." The purpose of the SRG is to evaluate the scientific and
technical merit of applications. The SRG does not make funding
decisions. Additional detailed information on review procedures for
scientific review group meetings is located at:
<http://www.csr.nih.gov/guidelines/proc.pdf>. The complete listing of
[Rosters for NIH Scientific Review Groups
(SRGs)](http://era.nih.gov/roster/index.cfm) is available at
<http://era.nih.gov/roster/index.cfm>.

#### Streamlining {#streamlining .Subhead---No-TOC}

The initial scientific peer review of most research applications also
will include a process in which only those applications deemed by the
reviewers to have the highest scientific merit, generally the top half
of the applications under review, will be discussed at the SRG meeting,
assigned a priority score, and receive a second level review.
Applications in the lower half are not discussed or scored at the SRG
meetings. This process allows the reviewers to focus their discussion on
the most meritorious applications.

SRG members will be instructed to evaluate research applications by
addressing five review criteria (see below) and assigning a single,
global score for each scored application. The score will reflect the
overall impact that the proposed research could have on the field.
Requests for Applications (RFAs) and other types of funding
opportunities may have different and/or additional review criteria.

[]{#Summary_Statement .anchor}As part of the initial merit review and
regardless of whether an application is scored or unscored
(streamlined), all applicants will receive a written critique, called a
"Summary Statement." The Summary Statement represents a combination of
the reviewers' written comments and, for non-streamlined applications,
includes the SRO's summary of the members' discussion during the study
section meeting as well as the recommendations of the study section, a
recommended budget, and administrative notes of special considerations.

Information about charters and membership of SRGs, Councils, and Boards
may be obtained from the appropriate agency.

#### Research Project Evaluation Criteria {#research-project-evaluation-criteria .Subhead---No-TOC}

**Significance:** Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies
on the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?

**Approach:** Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well-integrated, well-reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics? For
applications designating multiple PDs/PIs, is the leadership approach,
including the designated roles and responsibilities, governance and
organizational structure consistent with and justified by the aims of
the project and the expertise of each of the PDs/PIs?

In conducting an evaluation of the scientific assessment of Approach
criterion, SRGs will also evaluate the involvement of human/animal
subjects, the proposed plans for inclusion of minorities and members of
both sexes/genders. The evaluation will be factored into the overall
score for scientific and technical merit of the application.

**Innovation:** Is the project original and innovative? For example:
Does the project challenge existing paradigms or clinical practice;
address an innovative hypothesis or critical barrier to progress in the
field? Does the project develop or employ novel concepts, approaches or
methodologies, tools, or technologies for this area?

**Investigator:** Are the PD/PI(s) and other key personnel appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level of the PD/PI(s) and other
researchers? Do the PD/PI(s) and investigative team bring complementary
and integrated expertise to the project (if applicable)?

**Environment:** Do(es) the scientific environment(s) in which the work
will be done contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific environment, or
subject populations, or employ useful collaborative arrangements? Is
there evidence of institutional support?

While these review criteria are intended for use primarily with
unsolicited research project applications (e.g., R01 or P01), to the
extent reasonable, they will also form the basis of the review of
solicited applications and non-research activities. However, for some
activities (e.g., construction grants), use of these criteria as stated
may not be feasible.

**Note: In addition to the above criteria, the following items will be
considered in the determination of scientific merit and the priority
score.**

Protection of Human Subjects: In conducting peer review for scientific
and technical merit, SRGs also will evaluate the involvement of human
subjects and proposed protections from research risk relating to their
participation in the proposed non-exempt Research Plan according to the
following five review criteria: (1) Risk to subjects, (2) Adequacy of
protection against risks (3) Potential benefits of the proposed research
to the subjects and others; (4) Importance of the knowledge to be
gained; and (5) Data and safety monitoring for clinical trials.

When human subjects are involved in research that involves one of the
six categories of research that are exempt under [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm), the SRG
will evaluate the justification for the exemption and (1) Human Subjects
Involvement and Characteristics, and (2) Sources of Materials.

**Inclusion of Women, Minorities, and Children:** When human subjects
are involved in the proposed clinical research, the SRG will also
evaluate the proposed plans for inclusion of minorities and members of
both sexes/genders, as well as the inclusion of children in clinical
research, as part of the scientific assessment of Approach criterion.

**Vertebrate animals:** As part of the peer review process, the SRG will
evaluate the proposed involvement and protection of vertebrate animals
as part of the scientific assessment of Approach and Environment
criteria and according to the following five points: (1) detailed
description of the proposed use of the animals; (2) justification for
the use of animals and for the appropriateness of the species and
numbers proposed; (3) adequacy of proposed veterinary care; (4)
procedures for limiting pain and distress to that which is unavoidable;
and (5) methods of euthanasia.

#### Dual-Level Peer Review {#dual-level-peer-review .Subhead---No-TOC}

The second level of review will usually be performed by the Advisory
Council or Board of the potential awarding component (Institute, Center,
or other unit). Council or Board recommendations are based not only on
considerations of scientific merit, as judged by the SRGs, but also on
the relevance of the proposed study to an Institute/Center's mission,
programs, and priorities.

[]{#Human_Subjects_PartII .anchor}PART II\
\
Supplemental Instructions for Preparing the Human Subjects Section of
the Research Plan

# 1. Introduction

A Protection of Human Subjects section of the Research Plan is required
for certain applications submitted using the SF424 R&R instructions and
forms. The information provided in the section on Protection of Human
Subjects should be consistent with the information provided on the face
page of the application. []{.mark}

For all research involving human subjects, the Scientific Review Group
(SRG) will assess the adequacy of protections for research participants
against research risks, and the appropriate inclusion of women,
minorities, and children, based on the information provided in the
application.

To assist in preparing the section on Protection of Human Subjects, six
possible scenarios are provided in Section 2 below. All research
projects will fall into one of these six scenarios. Determine which
scenario the proposed research falls into, then go to the specific
instructions applicable to that scenario in [Section
3](#instructions-for-preparing-the-section-on-protection-of-human-subjects).
Where appropriate, Section 3 provides instructions on addressing the
Inclusion of Women and Minorities, the Targeted/Planned Enrollment
Table, and the Inclusion of Children (items 9, 10, and 11 of the
Research Plan). All definitions related to human subjects research are
linked to text found in Part III.3 under Human Subjects Research
Definitions and Terms. [Section 5](#human-subjects-research-policy) of
this Part includes descriptions of and links to the DHHS Human Subjects
Protections regulations and NIH policies that apply to clinical
research.

# 2. Scenarios

#### Scenario A. No Human Subjects Research {#scenario-a.-no-human-subjects-research .Subhead---No-TOC}

If no human subjects research is proposed in the application, you will
have designated "No" in Item 1 on the SF424 R&R Other Project
Information page. If your proposed research involves human specimens
and/or data from subjects, you must provide a justification for your
claim that no human subjects are involved in the Protection of Human
Subjects section of the Research Plan.

See the [instructions for Scenario
A](#scenario-a.-no-human-subjects-research-proposed).

Unless you are providing a special justification as described above, no
additional information is necessary if no human subjects are involved.

#### Scenario B. Non-Exempt Human Subjects Research {#scenario-b.-non-exempt-human-subjects-research .Subhead---No-TOC}

If research involving human subjects is anticipated to take place under
the award, you will have designated "Yes" in Item 1 on the SF424 R&R
Other Project Information page and entered your OHRP assurance number in
Item 1a. In the Protection of Human Subjects section of the Research
Plan, you must provide sufficient information for reviewers to determine
that the proposed research meets (1) the requirements of the DHHS
regulations to protect human subjects from research risks ([45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)), and
(2) the requirements of NIH policies on inclusion of women, minorities,
and children. Research involving a clinical trial will fall under either
Scenario E or F below.

See the [instructions for Scenario
B](#scenario-b.-non-exempt-human-subjects-research-1).

#### Scenario C. Exempt Human Subjects Research {#scenario-c.-exempt-human-subjects-research .Subhead---No-TOC}

If **all** of the proposed research meets the criteria for one or more
of the exemptions from the requirements in the DHHS regulations
(46.101(b)), "yes" should be designated in Item 1 on the SF424 R&R Other
Project Information page, the appropriate exemption number checked in
Item 1a, and "NA" entered for the Human Subject Assurance Number since
no OHRP assurance number is needed for exempt research. In the section
on Protection of Human Subjects in the Research Plan, provide a
justification for the exemption(s) containing sufficient information
about the involvement of the human subjects to allow a determination by
peer reviewers and NIH staff that claimed exemption(s) is/are
appropriate.

The PHS will make a final determination as to whether the proposed
activities are covered by the regulations or are in an exempt category,
based on the information provided in the Research Plan. When in doubt,
consult with the Office for Human Research Protections (OHRP),
Department of Health and Human Services by accessing their website
<http://www.hhs.gov/ohrp/> for guidance and further information.

The exemptions appear in Part III under [Human Subjects Research
Definitions and Terms](#Human_Subjects_Exemption_Cat).

See the [instructions for Scenario
C](#scenario-c-human-subjects-research-claiming-exemption-1-2-3-4-5-or-6).

#### Scenario D. Delayed-Onset Human Subjects Research {#scenario-d.-delayed-onset-human-subjects-research .Subhead---No-TOC}

If human subjects research is anticipated within the period of the award
but plans for involvement of human subjects cannot be described in the
application as allowed by the DHHS regulations (45 CFR Part 46.118), you
will have designated "Yes" in Item 1 on the SF424 R&R Other Project
Information page and entered your OHRP assurance number in Item 1a. In
the section on Protection of Human Subjects in the Research Plan, you
should either include an explanation of anticipated protections for
human subjects or an explanation of why protections cannot be described.

Examples of delayed-onset of human subjects research include:

-   Human subjects research is dependent upon the completion of animal
    or other studies; or

-   Human subjects research protocols to be included will undergo an
    independent decision-making process (often defined by a FOA).

See [instructions for Scenario
D](#scenario-d-delayed-onset-human-subjects-research).

#### Scenario E. Human Subjects Research Involving a Clinical Trial {#scenario-e.-human-subjects-research-involving-a-clinical-trial .Subhead---No-TOC}

If research involving human subjects is anticipated to take place under
the award, and you intend to conduct a clinical trial during the project
period, you will have designated "Yes" in Item 1 on the SF424 R&R Other
Project Information page, entered your OHRP assurance number in Item 1a,
and checked "Yes" to Clinical Trial in Item 2 on the PHS 398 Cover Page
Component.

In the section on Protection of Human Subjects in the Research Plan, you
must provide sufficient information for reviewers to determine that the
proposed research meets:

1\) the requirements of the DHHS regulations to protect human subjects
from research risks ([45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm));

2\) NIH policy requirements for Data and Safety Monitoring for Clinical
Trials;

3\) the ClinicalTrials.gov requirements if applicable;

4\) the requirements of NIH policies on inclusion of women, minorities,
and children; and

5\) the requirements of NIH policy on reporting race and ethnicity data
for subjects in clinical research.

See [instructions for Scenario E](#scenario-e-clinical-trial).

#### Scenario F. Human Subjects Research Involving an NIH-Defined Phase III Clinical Trial {#scenario-f.-human-subjects-research-involving-an-nih-defined-phase-iii-clinical-trial .Subhead---No-TOC}

If research involving human subjects is anticipated to take place under
the award, and you intend to conduct an [NIH-defined Phase III clinical
trial](#Human_Subjects_Defs_NIH_PhaseIIIl) during the project period,
you will have designated "Yes" in Item 1 on the SF424 R&R Other Project
Information page, entered your OHRP assurance number in Item 1a, and
checked "Yes" to Agency-Defined Phase III Clinical Trial in Item 2 on
the PHS 398 Cover Page Component. In the section on Protection of Human
Subjects in the Research Plan, you must provide sufficient information
for reviewers to determine that the proposed research meets:

1\) the requirements of the DHHS regulations to protect human subjects
from research risks ([45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm));

2\) NIH policy requirements for Data and Safety Monitoring for Clinical
Trials;

3\) the ClinicalTrilas.gov requirements if applicable;

4\) the requirements of NIH policies on inclusion of women, minorities,
and children;

5\) additional Requirements for NIH-defined Phase III clinical trials;
and

6\) the requirements of NIH policy on reporting race and ethnicity data
for subjects in clinical research.

See [instructions for Scenario
F](#scenario-f-nih-defined-phase-iii-clinical-trial).

# 3. Instructions for Preparing the Section on Protection of Human Subjects

#### Scenario A. No Human Subjects Research Proposed {#scenario-a.-no-human-subjects-research-proposed .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human) No

[Exemption Claimed](#Human_Subjects_Exemption_Cat) No

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial) N/A

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl) N/A

## Instructions and Required Information

If proposed studies using coded human data or biospecimens do not
involve human subjects as described in the OHRP Guidance on Research
Involving Coded Private Information or Biological Specimens
(<http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm>), provide
an explanation of why the proposed studies do not constitute research
involving human subjects. Save this explanation as a .pdf file entitled
"Human Subjects Research.pdf" and attach in line 8 of the PHS 398
Research Plan.

The explanation could include: a description of the source of the
data/biospecimens; the role(s) of providers of the data/biospecimens in
the proposed research; and the manner by which the privacy of research
participants and confidentiality of data will be ensured.

Research that does not involve intervention or interaction with living
individuals, or identifiable private information, is not human subjects
research (see Definitions in Part III.3).

Research that only proposes the use of cadaver specimens is not human
subjects research because human subjects are defined as "living
individuals." The use of cadaver specimens is not regulated by 45 CFR
Part 46, but may be governed by other Federal, State or local laws.

#### Scenario B. Non-Exempt Human Subjects Research {#scenario-b.-non-exempt-human-subjects-research-1 .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human) Yes

[Exemption Claimed](#Human_Subjects_Exemption_Cat) No

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial) No

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl) No

## Instructions and Required Information 

Although no specific page limitation applies to this section of the
application, be succinct.

In the application narrative, provide the information that is requested
for each of the following topics below as a separate appendix. Save each
of the four appendices as a .pdf file and attach in lines 8-11 of the
PHS 398 Research Plan.

Protections for Human Subjects - [Section 4.1 -
4.1.4](#protection-of-human-subjects)

Inclusion of Women and Minorities - [Section
4.2](#inclusion-of-women-and-minorities)

Targeted/Planned Enrollment Table - [Section
4.3](#instructions-for-completing-the-targetedplanned-enrollment-tables-for-reporting-race-and-ethnicity-data-for-subjects-in-clinical-research)

Inclusion of Children - [Section 4.4](#inclusion-of-children)

If the research involves collaborating sites, provide the information
identified above for each participating site.

#### Scenario C: Human Subjects Research Claiming Exemption 1, 2, 3, 4, 5, or 6 {#scenario-c-human-subjects-research-claiming-exemption-1-2-3-4-5-or-6 .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human) Yes

[Exemption Claimed](#Human_Subjects_Exemption_Cat) 1, 2, 3, 4, 5, or 6

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial) Yes or No

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl) No

## Instructions and Required Information 

Although no specific page limitation applies to this section of the
application, be succinct. The exemptions appear in Part III under [Human
Subjects Research Definitions and Terms](#Human_Subjects_Exemption_Cat).

Although the research may be exempt from the DHHS regulatory
requirements, it is still research involving human subjects and the
application must follow the instructions that are identified for each of
the following topics and provide the information that is requested.

In the application narrative, provide the information that is requested
for each of the following topics below as a separate appendix. Save each
of the four appendices as a .pdf file and attach in lines 8-11 of the
PHS 398 Research Plan.

Protections for Human Subjects -- Include the following statement: 'This
Human Subjects Research falls under Exemption(s) ... .' Clearly identify
which exemption(s) (1, 2, 3, 4\*, 5, 6) you are claiming, and justify
why the research meets the criteria for exemption that you have claimed.
If the research will include a clinical trial, even if exempt, include a
Data and Safety Monitoring Plan -- [Section
4.1.5](#data-and-safety-monitoring-plan), and address the
ClinicalTrials.gov requirements if applicable -- [Section
4.1.6](#clinicaltrials.gov-requirements).

Inclusion of Women and Minorities - [Section
4.2](#inclusion-of-women-and-minorities)

Targeted/Planned Enrollment Table - [Section
4.3](#instructions-for-completing-the-targetedplanned-enrollment-tables-for-reporting-race-and-ethnicity-data-for-subjects-in-clinical-research)

Inclusion of Children - [Section 4.4](#inclusion-of-children)\
\
\*NOTE: If all the proposed research meets the criteria for Exemption 4,
then the requirements for inclusion of women and minorities,
targeted/planned enrollment table, and inclusion of children, do not
need to be addressed.

#### Scenario D: Delayed-Onset Human Subjects Research {#scenario-d-delayed-onset-human-subjects-research .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human) Yes

[Exemption](#Human_Subjects_Exemption_Cat) Yes or No

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial) Yes or No

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl) Yes or No

## Instructions and Required Information

In rare situations, applications are submitted with the knowledge that
human subjects will be involved during the period of support, but plans
are so indefinite that it is not possible to describe the involvement of
human subjects in the application. The kinds of activities that lack
definite plans are often institutional awards where the selection of
specific projects is the institution\'s responsibility, research
training grants, and projects in which the involvement of human subjects
depends upon completion of instruments, animal studies, or purification
of compounds.

If the involvement of human subjects is indefinite, create a heading
entitled "Protection of Human Subjects" and provide a detailed
explanation why it is not possible to develop definite plans at this
time. The explanation should be specific and directly related to the
Specific Aims in the application. If the involvement of human subjects
depends upon information that is not presently available (e.g.,
completion of instruments, animal studies, purification of compounds),
be explicit about the information and the factors affecting the
availability of the information. Describe the information that will be
necessary in order to develop definite plans for the involvement of
human subjects, why that information is not currently available, and
when the information is expected to become available during the course
of the project.

If an award is made, prior to the involvement of human subjects the
grantee must submit to the NIH awarding office for prior approval either
(1) detailed information as required in the Research Plan, Protection of
Human Subjects (addressing risks to the subjects, adequacy of protection
against risks, potential benefits of the proposed research, importance
of the knowledge to be gained, and data and safety monitoring plan if
applicable) and certification of IRB approval, OR (2) if all of the
research meets the criteria for one or more exemptions, identification
of which exemption(s) is/are applicable to the research, and a
justification for the exemption with sufficient information about the
involvement of human subjects to allow a determination that the claimed
exemption is appropriate. If the research is not exempt, the request for
prior approval must also address the inclusion of women and minorities,
the inclusion of children, and provide completed targeted/planned
enrollment tables as required in the Research Plan.

Under no circumstance may human subjects be involved in non-exempt
research until approval is granted by the awarding entity, and
certification of IRB approval has been accepted by the agency.

In the application narrative, provide the information that is requested
for each of the following topics below as a separate appendix. Save each
of the four appendices as a .pdf file and attach in lines 8-11 of the
PHS 398 Research Plan. Follow the instructions that are identified for
each of the following topics and EITHER provide as much of the
information that is requested as possible; OR describe why it is not
possible to provide the information due to delayed-onset of human
subjects research:

Protection of Human Subjects - [Section
4.1](#protection-of-human-subjects). If the research will include a
clinical trial, even if exempt, include a Data and Safety Monitoring
Plan as described in [Section 4.1.5](#data-and-safety-monitoring-plan),
and address the ClinicalTrials.gov requirements if applicable --
[Section 4.1.6](#clinicaltrials.gov-requirements).

Inclusion of Women and Minorities - [Section
4.2](#inclusion-of-women-and-minorities)

Targeted/Planned Enrollment Table - [Section
4.3](#instructions-for-completing-the-targetedplanned-enrollment-tables-for-reporting-race-and-ethnicity-data-for-subjects-in-clinical-research)

Inclusion of Children - [Section 4.4](#inclusion-of-children)

#### Scenario E: Clinical Trial {#scenario-e-clinical-trial .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human) Yes

[Exemption](#Human_Subjects_Exemption_Cat) Yes or No

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial) Yes

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl) No

## Instructions and Required Information

In the application narrative, provide the information that is requested
for each of the following topics below as a separate appendix. Save each
of the four appendices as a .pdf file and attach in lines 8-11 of the
PHS 398 Research Plan.

Protection of Human Subjects - [Section 4.1 -
4.1.6](#protection-of-human-subjects)

Inclusion of Women and Minorities - [Section
4.2](#inclusion-of-women-and-minorities)

Targeted/Planned Enrollment Table - [Section
4.3](#instructions-for-completing-the-targetedplanned-enrollment-tables-for-reporting-race-and-ethnicity-data-for-subjects-in-clinical-research)

Inclusion of Children - [Section 4.4](#inclusion-of-children)

If the research involves collaborating sites, provide the information
identified above for each participating site.

#### Scenario F: NIH Defined Phase III Clinical Trial {#scenario-f-nih-defined-phase-iii-clinical-trial .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human): Yes

[Exempt](#Human_Subjects_Exemption_Cat): No

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial): Yes

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl): Yes

## Instructions and Required Information

In the application narrative, provide the information that is requested
for each of the following topics below as a separate appendix. Save each
of the four appendices as a .pdf file and attach in lines 8-11 of the
PHS 398 Research Plan.

Protection of Human Subjects - [Section 4.1 -
4.1.6](#protection-of-human-subjects). Also include the statement that
'This Human Subjects Research involves an NIH-Defined Phase III Clinical
Trial.'

Inclusion of Women and Minorities - [Section 4.2 -
4.2.1](#inclusion-of-women-and-minorities)

Targeted/Planned Enrollment Table - [Section
4.3](#instructions-for-completing-the-targetedplanned-enrollment-tables-for-reporting-race-and-ethnicity-data-for-subjects-in-clinical-research)

Inclusion of Children - [Section 4.4](#inclusion-of-children)

If the research involves collaborating sites, provide the information
identified above for each participating site.

# 4. Instructions Pertaining to Non-Exempt Human Subjects Research

In your PHS398 Research Plan Component, include attachments for Items 8
through 11, if required. Although no specific page limitation applies to
this section of the application, be succinct. Scientific Review Groups
will assess each application as being acceptable or unacceptable with
regard to the protection of human subjects. DHHS regulations and
policies governing human subjects research are described and referenced
in Section 5 below. Use subheadings to address the issues listed under
items 4.1-4.4 below. If your research includes a clinical trial, include
a subheading \"Data and Safety Monitoring Plan\" and follow the
instructions in 4.2 below. If your research includes an NIH-Defined
Phase III Clinical Trial, follow the additional instructions in 4.2.1
below.

## 4.1 Protection of Human Subjects

### 4.1.1 Risks to Human Subjects

a\. ***[Human Subjects Involvement and Characteristics]{.underline}***

-   Describe the proposed involvement of human subjects in the work
    outlined in the Research Design and Methods section.

-   Describe the characteristics of the subject population, including
    their anticipated number, age range, and health status.

-   Identify the criteria for inclusion or exclusion of any
    subpopulation.

-   Explain the rationale for the involvement of special classes of
    subjects, such as fetuses, neonates, pregnant women, children,
    prisoners, institutionalized individuals, or others who may be
    considered vulnerable populations. Note that \'prisoners\' includes
    all subjects involuntarily incarcerated (for example, in detention
    centers) as well as subjects who become incarcerated after the study
    begins.

-   List any collaborating sites where human subjects research will be
    performed, and describe the role of those sites and collaborating
    investigators in performing the proposed research.

b\. ***[Sources of Materials]{.underline}***

-   Describe the research material obtained from living individuals in
    the form of specimens, records, or data.

-   Describe any data that will be collected from human subjects for the
    project(s) described in the application.

-   Indicate who will have access to individually identifiable private
    information about human subjects.

-   Provide information about how the specimens, records, or data are
    collected and whether material or data will be collected
    specifically for the proposed research project.

c\. ***[Potential Risks]{.underline}***

-   Describe the potential risks to subjects (physical, psychological,
    financial, legal, or other), and assess their likelihood and
    seriousness to the subjects.

-   Where appropriate, describe alternative treatments and procedures,
    including the risks and potential benefits of the alternative
    treatments and procedures, to participants in the proposed research.

### 4.1.2 Adequacy of Protection Against Risks

a\. ***[Recruitment and Informed Consent]{.underline}***

-   Describe plans for the recruitment of subjects (where appropriate)
    and the process for obtaining informed consent. If the proposed
    studies will include children, describe the process for meeting
    requirements for parental permission and child assent.

-   Include a description of the circumstances under which consent will
    be sought and obtained, who will seek it, the nature of the
    information to be provided to prospective subjects, and the method
    of documenting consent. If a waiver of some or all of the elements
    of informed consent will be sought, provide justification for the
    waiver. Informed consent document(s) need not be submitted to the
    PHS agencies unless requested.

b\. ***[Protections Against Risk]{.underline}***

-   Describe planned procedures for protecting against or minimizing
    potential risks, including risks to privacy of individuals or
    confidentiality of data, and assess their likely effectiveness.

-   Research involving vulnerable populations, as described in the DHHS
    regulations, Subparts B-D must include additional protections. Refer
    to DHHS regulations, and OHRP guidance:

-   Additional Protections for Pregnant Women, Human Fetuses and
    Neonates:
    <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartb>

-   Additional Protections for Prisoners:
    <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc>

    OHRP Subpart C Guidance:
    <http://www.hhs.gov/ohrp/policy/index.html#prisoners>

-   Additional Protections for Children:
    <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd>

    OHRP Subpart D Guidance: <http://www.hhs.gov/ohrp/children/>

-   Where appropriate, discuss plans for ensuring necessary medical or
    professional intervention in the event of adverse effects to the
    subjects. Studies that involve clinical trials (biomedical and
    behavioral intervention studies) must include a general description
    of the plan for data and safety monitoring of the research and
    adverse event reporting to the IRB, the NIH and others, as
    appropriate, to ensure the safety of subjects.

### 4.1.3 Potential Benefits of the Proposed Research to Human Subjects and Others

-   Discuss the potential benefits of the research to research
    participants and others.

-   Discuss why the risks to subjects are reasonable in relation to the
    anticipated benefits to research participants and others.

### 4.1.4 Importance of the Knowledge to be Gained

-   Discuss the importance of the knowledge gained or to be gained as a
    result of the proposed research.

-   Discuss why the risks to subjects are reasonable in relation to the
    importance of the knowledge that reasonably may be expected to
    result.

NOTE: Test articles (investigational new drugs, devices, or biologics)
including test articles that will be used for purposes or administered
by routes that have not been approved for general use by the Food and
Drug Administration (FDA) must be named. State whether the 30-day
interval between submission of applicant certification to the FDA and
its response has elapsed or has been waived and/or whether use of the
test article has been withheld or restricted by the FDA, and/or the
status of requests for an Investigational New Drug (IND) or
Investigational Device Exemption (IDE) covering the proposed use of the
test article in the Research Plan.

### 4.1.5 Data and Safety Monitoring Plan

The NIH Data and Safety Monitoring Plan Policy is described and
referenced in [Section
5.3](#data-and-safety-monitoring-plans-for-clinical-trials).

-   If the research includes a clinical trial, create a heading entitled
    \"Data and Safety Monitoring Plan.\"

-   Provide a general description of a monitoring plan that you plan to
    establish as the overall framework for data and safety monitoring.
    Describe the entity that will be responsible for monitoring and the
    process by which Adverse Events (AEs) will be reported to the
    Institutional Review Board (IRB), the funding I/C, the NIH Office of
    Biotechnology Activities (OBA), and the Food and Drug Administration
    (FDA) in accordance with Investigational New Drug (IND) or
    Investigational Device Exemption (IDE) regulations. Be succinct.
    Contact the FDA (<http://www.fda.gov/>) and also see the following
    websites for more information related to IND and IDE requirements:\
    <http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr312_01.html>
    (IND)\
    <http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr812_01.html>
    (IDE)

-   The frequency of monitoring will depend on potential risks,
    complexity, and the nature of the trial; therefore, a number of
    options for monitoring trials are available. These can include, but
    are not limited to, monitoring by a:

> a\. PD/PI (required)
>
> b\. Institutional Review Board (IRB) (required)
>
> c\. Independent individual/safety officer
>
> d\. Designated medical monitor
>
> e\. Internal Committee or Board with explicit guidelines
>
> f\. Data and Safety Monitoring Board (DSMB). NIH specifically requires
> the establishment of Data and Safety Monitoring Boards (DSMBs) for
> multi-site clinical trials involving interventions that entail
> potential risk to the participants, and generally for Phase III
> clinical trials. Although Phase I and Phase II clinical trials may
> also use DSMBs, smaller clinical trials may not require this oversight
> format, and alternative monitoring plans may be appropriate.

-   A detailed Data and Safety Monitoring Plan must be submitted to the
    applicant\'s IRB and subsequently to the funding IC for approval
    prior to the accrual of human subjects
    (<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html>).
    For additional guidance on creating this Plan, see the above
    reference.

### 4.1.6 ClinicalTrials.gov Requirements

Public Law 110-85 mandates registration and results reporting of
\"applicable clinical trials\" in ClinicalTrials.gov. Under the statute
these trials generally include: (1) [Trials of Drugs and
Biologics]{.underline}:  Controlled, clinical investigations, other than
Phase 1 investigations, of a product subject to FDA regulation; and (2)
[Trials of Devices]{.underline}: Controlled trials with health outcomes,
other than small feasibility studies, and pediatric postmarket
surveillance. Review the statutory definition of applicable clinical
trial to identify if registration is required to comply with the law
(See [PL
110-85](http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf),
Section 801(a), adding new 42 U.S.C. 282(j)(1)(A)).

NIH encourages registration of ALL trials whether required under the law
or not.

Registration is accomplished at the ClinicalTrials.gov Protocol
Registration System Information Website
(<http://prsinfo.clinicaltrials.gov/>). A unique identifier called an
NCT number will be generated during the registration process.

For new and renewal (competing) applications that include ongoing
clinical trials which require registration and results reporting,
provide the NCT number/s, Brief Title/s (as defined by
ClinicalTrials.gov, see
[http://prsinfo.clinicaltrials.gov](http://prsinfo.clinicaltrials.gov/)),
and the identity of the responsible party (or parties) in the human
subjects section of the Research Plan under a section heading entitled
ClinicalTrials.gov. The entity responsible for registering is the
"responsible party." The statute defines the responsible party as:

\(1\) the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3)
(<http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr50.3.pdf>),
or\
\
(2) the principal investigator of such clinical trial if so designated
by a sponsor, grantee, contractor, or awardee (provided that "the
principal investigator is responsible for conducting the trial, has
access to and control over the data from the clinical trial, has the
right to publish the results of the trial, and has the ability to meet
all of the requirements" for submitting information under the law)
(<http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf>).
*See* PL 110-85, Section 801(a), (adding new 42 U.S.C.
282(j)(1)(A)(ix)).

If a new applicable trial is proposed, under the heading
ClinicalTrials.gov include a statement that the application includes a
trial which requires registration in ClinicalTrials.gov. The signature
on the application of the Authorized Organizational Representative
assures compliance for the registration of any such trial.

## 4.2 Inclusion of Women and Minorities

In the attachment for Item 9, include a heading entitled "Inclusion of
Women and Minorities." Although no specific page limitation applies to
this section of the application, be succinct. The NIH Policy on the
Inclusion of Women and Minorities in Clinical Research is described and
referenced in [Section
5.6](#nih-policy-on-the-inclusion-of-women-and-minorities-in-clinical-research).

Scientific Review Groups will assess each application as being
acceptable or unacceptable with regard to the protection of human
subjects.

In this section of the Research Plan, address, at a minimum, the
following four points:

1\. The targeted/planned distribution of subjects by sex/gender and
racial/ethnic groups for each proposed study or protocol using the
format in the Targeted/Planned Enrollment Table. (Instructions for
completing this table are provided below in 4.3.) If using existing
specimens and/or data without access to information on the distribution
of women and minorities, so state and explain the impact on the goals of
the research as part of the rationale that inclusion is inappropriate
(item 3 below). Alternatively, describe the women and minority
composition of the population base from whom the specimens and/or data
will be obtained. Include the Targeted/Planned Enrollment Table in this
section.

2\. A description of the subject selection criteria and rationale for
selection of sex/gender and racial/ethnic group members in terms of the
scientific objectives and proposed study design. The description may
include, but is not limited to, information on the population
characteristics of the disease or condition under study.

3\. A compelling rationale for proposed exclusion of any sex/gender or
racial/ethnic group (see examples below).

4\. A description of proposed outreach programs for recruiting
sex/gender and racial/ethnic group members as subjects.

Examples of acceptable justifications for exclusion of:

A. ***[One gender:]{.underline}***

1\. One gender is excluded from the study because:

-   inclusion of these individuals would be inappropriate with respect
    to their health;

-   the research question addressed is relevant to only one gender;

-   evidence from prior research strongly demonstrates no difference
    between genders; or

-   sufficient data already exist with regard to the outcome of
    comparable studies in the excluded gender, and duplication is not
    needed in this study.

2\. One gender is excluded or severely limited because the purpose of
the research constrains the applicant\'s selection of study subjects by
gender (e.g., uniquely valuable stored specimens or existing datasets
are single gender; very small numbers of subjects are involved; or
overriding factors dictate selection of subjects, such as matching of
transplant recipients, or availability of rare surgical specimens).

3\. Gender representation of specimens or existing datasets cannot be
accurately determined (e.g., pooled blood samples, stored specimens, or
data-sets with incomplete gender documentation are used), and this does
not compromise the scientific objectives of the research.

B. ***[Minority groups or subgroups:]{.underline}***

1\. Some or all minority groups or subgroups are excluded from the study
because:

-   inclusion of these individuals would be inappropriate with respect
    to their health;

-   the research question addressed is relevant to only one racial or
    ethnic group;

-   evidence from prior research strongly demonstrates no differences
    between racial or ethnic groups on the outcome variables;

-   a single minority group study is proposed to fill a research gap; or

-   sufficient data already exists with regard to the outcome of
    comparable studies in the excluded racial or ethnic groups and
    duplication is not needed in this study.

2\. Some minority groups or subgroups are excluded or poorly represented
because the geographical location of the study has only limited numbers
of these minority groups who would be eligible for the study, and the
investigator has satisfactorily addressed this issue in terms of:

-   the size of the study;

-   the relevant characteristics of the disease, disorder or condition;
    or

-   the feasibility of making a collaboration or consortium or other
    arrangements to include representation.

3\. Some minority groups or subgroups are excluded or poorly represented
because the purpose of the research constrains the applicant\'s
selection of study subjects by race or ethnicity (e.g., uniquely
valuable cohorts, stored specimens or existing datasets are of limited
minority representation, very small numbers of subjects are involved, or
overriding factors dictate selection of subjects, such as matching of
transplant recipients or availability of rare surgical specimens).

4\. Racial or ethnic origin of specimens or existing datasets cannot be
accurately determined (e.g., pooled blood samples, stored specimens or
data sets with incomplete racial or ethnic documentation are used) and
this does not compromise the scientific objectives of the research.

### 4.2.1 Additional Instructions and Requirements When NIH-Defined Phase III Clinical Trials Are Proposed

If the proposed research includes an [NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl), the section on Inclusion of
Women and Minorities also must address whether clinically important
sex/gender and/or race/ethnicity differences are expected from the
intervention effect. The discussion may include supporting evidence
and/or data derived from animal studies, clinical observations,
metabolic studies, genetic studies, pharmacology studies, and
observational, natural history, epidemiology and other relevant studies.
The discussion of expected sex/gender and/or race/ethnicity differences
in intervention effect must include selection and discussion of one of
the following analysis plans:

-   Plans to conduct valid analyses to detect significant differences in
    intervention effect among sex/gender and/or racial/ethnic subgroups
    when prior studies strongly support these significant differences
    among subgroups, *or*

-   Plans to include and analyze sex/gender and/or racial/ethnic
    subgroups when prior studies strongly support no significant
    differences in intervention effect between subgroups.
    (Representation of sex/gender and racial/ethnic groups is not
    required as subject selection criteria, but inclusion is
    encouraged.), *or*

-   Plans to conduct valid analyses of the intervention effect in
    sex/gender and/or racial/ethnic subgroups (without requiring high
    statistical power for each subgroup) when the prior studies neither
    support nor negate significant differences in intervention effect
    between subgroups.

## 4.3 Instructions for Completing the Targeted/Planned Enrollment Tables for Reporting Race and Ethnicity Data for Subjects in Clinical Research

[]{#Human_Subjects_Population_Tracking .anchor}If your application
includes Targeted/Planned Enrollment tables, save all as a single PDF
file and attach them using section 10. Targeted/Planned Enrollment of
the PHS 398 Research Plan Component.

The NIH Policy on Reporting Race and Ethnicity Data for Subjects in
Clinical Research is described and referenced in [Section
5.8](#nih-policy-on-reporting-race-and-ethnicity-data-subjects-in-clinical-research).

A. New Applications

All new clinical research studies should collect and report information
on participants with respect to two categories of ethnicity and five
categories of race. The Inclusion Enrollment Report
(<http://grants.nih.gov/grants/funding/424/SF424R-R_enrollmentreport.doc>)
for reporting summary data on participants to NIH includes two
categories of ethnicity and five categories of race and is based on the
Office of Management and Budget (OMB) reporting standards for data on
race and ethnicity. Investigators should review the instructions and
Frequently Asked Questions about using the Enrollment Table format at
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html>.

When reporting these data in the aggregate, investigators should report:
(a) the number of research participants in each ethnic category; (b) the
number of research participants who selected only one category for each
of the five racial categories; (c) the total number of research
participants who selected multiple racial categories reported as the
"number selecting more than one race," and (d) the number of research
participants in each racial category who are Hispanic or Latino.
Investigators may provide the detailed distributions, including all
possible combinations, of multiple responses to the racial designations
as additional information. However, more detailed data should be
compiled in a way that they can be reported using the required
categories.

**Instructions for Completing Targeted/Planned Enrollment Table**
(<http://grants.nih.gov/grants/funding/424/SF424R-R_enrollment.doc>)

Attach the Targeted/Planned Enrollment Table as Item 10. Provide the
study title.

The "Total Planned Enrollment" means the number of subjects that are
expected to be enrolled enrolled in the study, consistent with the
definition in ClinicalTrials.gov.

The "Total Planned Enrollment" will be reported in two ways in the
table: by "Ethnic Category" and by "Racial Categories."

"Ethnic Category": Provide the numeric distribution of the Total Planned
Enrollment according to ethnicity and sex/gender in the top part of the
table.

"Racial Categories": Provide the numeric distribution of the Total
Planned Enrollment, this time by racial categories and sex/gender, in
the bottom part of the table. Note that Hispanic is an ethnic, not a
racial, category.

If there is more than one study/protocol, provide a separate table for
each.

List any proposed racial/ethnic subpopulations below the table.

**Submitting Applications or Proposals Using Existing Data in Clinical
Research with No Plans for Collecting New/Additional Data:**

Investigators are instructed to provide plans for the total number of
subjects proposed for the study and to provide the distribution by
ethnic/racial categories and sex/gender using the Targeted/Planned
Enrollment Table. Under these circumstances, investigators are not
required to re-contact subjects solely to comply with the newly revised
categories.

**If Data Collection is Ongoing, Such that New Human Subjects Will be
Enrolled and/or Additional Data Will be Collected from Human Subjects:**

Investigators should report ethnicity/race and sex/gender sample
composition using the Inclusion Enrollment Report.

**If Data Collection is Complete, Such that No New/Additional Subject
Contact is Planned**:

Investigators should use the Inclusion Enrollment Report.

**Research Conducted at Foreign Sites:**

If proposed studies involve a foreign site, investigators are encouraged
to design culturally sensitive and appropriate data collection
instruments that allow research participants to self-identify their
racial and ethnic affiliation. However, these items should be designed
in a way that they can be aggregated into the OMB-required categories.
Also, the investigator can report on any racial/ethnic subpopulations by
listing this information in an attachment to the required table. This
may be particularly useful when distinctive subpopulations are relevant
to the scientific hypotheses being studied.

When completing the tables that describe research in foreign sites,
investigators should asterisk and footnote the table indicating that
data includes research participants in foreign sites. If the aggregated
data only includes participants in foreign research sites, the
investigator should provide information in one table with an asterisk
and footnote. However, if the study includes both domestic and foreign
sites, the investigator should complete two separate tables -- one for
domestic and another for foreign participants.

B. Renewal Application and Progress Reports

The Inclusion Enrollment Report
(<http://grants.nih.gov/grants/funding/424/SF424R-R_enrollmentreport.doc>)
must be used for reporting accrual data to the NIH. For Revision
applications, any proposed additions to the Targeted/Planned Enrollment
Table should be provided, in addition to the Inclusion Enrollment
Report. In annual progress reports, investigators conducting clinical
research are required to provide the cumulative total enrollment of
subjects to-date, showing the distribution by ethnic/racial categories
and sex/gender on the Inclusion Enrollment Report, and update the
Targeted/Planned Enrollment Table as needed.

## 4.4 Inclusion of Children

The NIH Policy on Inclusion of Children is referenced and described in
[Section 5.7](#nih-policy-on-inclusion-of-children). Instructions for
Item 11 of the Research Plan are as follows:

-   Create a section entitled "Inclusion of Children" and place it
    immediately following the Targeted/Planned Enrollment Table.

-   For the purpose of implementing these guidelines, a *child* is
    defined as an individual under the age of 21 years (for additional
    information see
    <http://grants.nih.gov/grants/funding/children/children.htm> and
    <http://grants.nih.gov/grants/guide/notice-files/not98-024.html>).

-   Provide either a description of the plans to include children, or,
    if children will be excluded from the proposed research,
    application, or proposal, present an acceptable justification for
    the exclusion (see below).

-   If children are included, the description of the plan should include
    a rationale for selecting a specific age range of children. The plan
    also must include a description of the expertise of the
    investigative team for dealing with children at the ages included,
    of the appropriateness of the available facilities to accommodate
    the children, and the inclusion of a sufficient number of children
    to contribute to a meaningful analysis relative to the purpose of
    the study.

-   Scientific Review Groups will assess each application as being
    acceptable or unacceptable with regard to the age-appropriate
    inclusion or exclusion of children in the research project.

-   When children are involved in research, the Additional Protections
    for Children Involved as Subjects in Research ([45 CFR Part 46
    Subpart
    D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd))
    apply and must be addressed under the Protections Against Risk
    subheading (4.1.2.b).

**Justifications for Exclusion of Children**

For the purposes of this policy, all individuals under 21 are considered
children; however, exclusion of any specific age group, such as
individuals under 18, should be justified in this section. It is
expected that children will be included in all clinical research unless
one or more of the following exclusionary circumstances can be fully
justified:

1\. The research topic to be studied is not relevant to children.

2\. There are laws or regulations barring the inclusion of children in
the research.

3\. The knowledge being sought in the research is already available for
children or will be obtained from another ongoing study, and an
additional study will be needlessly redundant. Documentation of other
studies justifying the exclusions should be provided. NIH program staff
can be contacted for guidance on this issue if the information is not
readily available.

4\. A separate, age-specific study in children is warranted and
preferable. Examples include:

a\. The condition is relatively rare in children, as compared to adults
(in that extraordinary effort would be needed to include children,
although in rare diseases or disorders where the applicant has made a
particular effort to assemble an adult population, the same effort would
be expected to assemble a similar child population with the rare
condition); or

b\. The number of children is limited because the majority are already
accessed by a nationwide pediatric disease research network; or

c\. Issues of study design preclude direct applicability of hypotheses
and/or interventions to both adults and children (including different
cognitive, developmental, or disease stages or different age-related
metabolic processes). While this situation may represent a justification
for excluding children in some instances, consideration should be given
to taking these differences into account in the study design and
expanding the hypotheses tested, or the interventions planned, to allow
inclusion of children rather than excluding them.

5\. Insufficient data are available in adults to judge potential risk in
children (in which case one of the research objectives could be to
obtain sufficient adult data to make this judgment). Although children
usually should not be the initial group to be involved in research
studies, in some instances, the nature and seriousness of the illness
may warrant their participation earlier based on careful risk and
benefit analysis.

6\. Study designs are aimed at collecting additional data on
pre-enrolled adult study subjects (e.g., longitudinal follow-up studies
that did not include data on children).

7\. Other special cases can be justified by the investigator and found
acceptable to the review group and the Institute Director.

# 5. Human Subjects Research Policy

Human Subjects Research Policy includes DHHS regulations for the
protection of human subjects and the following NIH policies related to
human subjects research.

## 5.1 Protection of Human Subjects

The Department of Health and Human Services (DHHS) regulations for the
protection of human subjects provide a systematic means, based on
established, internationally recognized ethical principles, to safeguard
the rights and welfare of individuals who participate as subjects in
research activities supported or conducted by the DHHS. The regulations
stipulate that the awardee organization, whether domestic or foreign,
bears responsibility for safeguarding the rights and welfare of human
subjects in DHHS-supported research activities. The regulations require
that applicant organizations proposing to involve human subjects in
nonexempt research hold a Federal-wide Assurance (FWA) with the Office
for Human Research Protections (OHRP), and establish appropriate
policies and procedures for the protection of human subjects. These
regulations, [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm),
Protection of Human Subjects, are available from OHRP, Department of
Health and Human Services, The Tower Building, 1101 Wootton Parkway,
Suite 200, Rockville, MD; telephone: 1-866-447-4777 (toll-free) or (240)
453-6900; email: <ohrp@osophs.dhhs.gov>.

Nonexempt research involving human subjects may only be conducted under
a DHHS award if the organization is operating in accord with an approved
FWA and provides verification that an Institutional Review Board (IRB)
that is registered under the specific FWA has reviewed and approved the
proposed activity in accordance with the DHHS regulations. No award to
an individual will be made unless that individual is affiliated with an
assured organization that accepts responsibility for compliance with the
DHHS regulations. Foreign applicant organizations must also comply with
the provisions of the regulations unless a determination of equivalent
protections is made in accord with 45 CFR 46.101(h).

Under DHHS regulations to protect human subjects, certain research areas
are [exempt](#Human_Subjects_Exemption_Cat). However, if an applicant
makes inappropriate designations of the noninvolvement of human subjects
or of exempt categories of research, this may result in delays in the
review of an application or the return of the application without
review. The PHS will make a final determination as to whether the
proposed activities are covered by the regulations or are in an exempt
category, based on the information provided in the Research Plan. With
the exception of research projects that meet the criteria for Exemption
4, studies that are exempt from the human subjects regulatory
requirements must still address the inclusion of women, minorities and
children in the study design.

Regulations of the Food and Drug Administration (21 CFR 50, 21 CFR 56)
generally apply to biomedical research involving an unapproved drug,
device or biologic and may apply to certain studies of approved
products. Additional information on FDA regulations is available at
<http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm>.
If work falls under FDA\'s regulatory requirements, the grantee must
follow both DHHS and FDA human subject protection regulations.

The *National Institutes of Health Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines)* apply to all projects
(NIH-funded and non NIH-funded) involving recombinant DNA molecules that
are conducted at or sponsored by an institution that receives NIH
support for recombinant DNA research. See Part III, 2.9. Research
Involving Recombinant DNA, including Human Gene Transfer Research.

Federal requirements to protect human subjects apply to most research on
human specimens (such as cells, blood, and urine), residual diagnostic
specimens, and medical information. Research involving the collection or
study of existing data, documents, records, pathological specimens,
diagnostic specimens, or tissues that are individually identifiable is
considered "research involving human subjects." The NIH Office of
Extramural Research Human Subjects website contains additional
information and Frequently Asked Questions to help investigators
understand how these federal requirements apply to their research. See
<http://grants.nih.gov/grants/policy/hs/index.htm>.

The DHHS regulations require the NIH to evaluate all applications and
proposals involving human subjects
(<http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.120>).
This independent evaluation is conducted at the NIH through the peer
review system and NIH staff review, and, as required, will take into
consideration the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be
gained. On the basis of this evaluation, the NIH may approve or
disapprove the application or proposal, or enter into negotiations to
develop an approvable one.

## 5.2 Vulnerable Populations

Investigators who conduct research involving pregnant women, human
fetuses and neonates, prisoners, or children, must follow the provisions
of the regulations in Subparts
[B](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartb),
[C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc),
and
[D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd)
of [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm),
respectively. The subparts describe the additional protections required
for conducting research involving these populations. Relevant
information may be obtained at the OHRP website
(<http://www.hhs.gov/ohrp/policy/index.html>).

REMINDER: DHHS regulations at [45 CFR Part 46, Subpart
C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc)
describe requirements for additional protections for research involving
prisoners as subjects *or* individuals who become prisoners after the
research has started. Refer to:
[[http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm]{.underline}](http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm)
for complete instructions.

[Exemptions 1-6](#Human_Subjects_Exemption_Cat) do **not** apply to
research involving prisoners or subjects who become prisoners (see
[Subpart
C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc)).
Although Exemptions 1 and 3-6 apply to research involving children (see
[Subpart
D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd)),
[Exemption 2](#Human_Subjects_Exemption2) can only be used for research
involving educational testing or observations of public behavior when
the investigator(s) do not participate in the activities being observed.

## 5.3 Data and Safety Monitoring Plans for Clinical Trials 

For each proposed clinical trial, NIH requires a data and safety
monitoring plan that describes oversight and monitoring to ensure the
safety of participants and the validity and integrity of the data. The
level of monitoring should be commensurate with the risks and the size
and complexity of the clinical trial. Prior to the accrual of human
subjects, a detailed data and safety monitoring plan must be submitted
to the applicant's IRB and to the funding entity for approval. Adverse
Events must be reported to the IRB, the NIH funding Institute or Center,
and other appropriate offices or agencies. This policy requirement is in
addition to any monitoring requirements imposed by [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). NIH
policy specifically requires the establishment of a Data and Safety
Monitoring Board (DSMB) for multi-site clinical trials involving
interventions that entail potential risk to the participants, and
generally for Phase III clinical trials. See also Part III, 2.1 Human
Subjects Research.

## 5.4 IRB Approval

NIH does not require certification of IRB approval of the proposed
research prior to NIH peer review of an application. See
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html>.

[]{#Human_Subjects_NoIRBApproval .anchor}Following NIH peer review,
applicants and their institutions will be notified of the need for
review and approval of the proposed research by an IRB that is
registered with OHRP. See <http://www.hhs.gov/ohrp/> to register an IRB.
Certification of IRB approval must be sent to the Grants Management
Office identified in the notice requesting documentation. Certification
of IRB review and approval must include: the PHS application number,
title of the project, name of the program director /principal
investigator, date of IRB approval, and appropriate signatures. Grantees
may also use the optional form "Protection of Human Subjects - Assurance
Identification/IRB Certification/Declaration of Exemption (Common Rule)"
(OMB Form No. 0990-0263
<http://www.hhs.gov/ohrp/humansubjects/assurance/OF310.rtf>) to meet
this requirement.

The OHRP has determined that an institution is automatically considered
to be engaged in human subjects research when it receives an NIH award
to support nonexempt human subjects research. See
<http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm>. All
institutions engaged in human subjects research must obtain a Federal
Wide Assurance (FWA) from OHRP. Instructions for applying for a Federal
Wide Assurance (FWA) are available from the OHRP website at
<http://www.hhs.gov/ohrp/assurances/assurances_index.html>.

HHS human subject regulations at 45CFR46.101(f) require that each
application for non-exempt HHS-supported human subject research be
reviewed and approved by an IRB (see also
<http://www.hhh.gov/ohrp/humansubjects/guidance/aplrev.htm>). Only the
date of approval of the application should be submitted to NIH. However,
the IRB must ensure that any corresponding protocol(s) are consistent
with the application, and must maintain documentation of IRB approval of
all corresponding protocols, including those reviewed by consortium
participants.

Any modifications to the Research Plan in the application, required by
either NIH or by the IRB, must be submitted with follow-up certification
of IRB approval to the NIH before the competing award is made. It is the
responsibility of the PD/PI and the applicant organization to submit the
follow-up documentation.

If more than a year will have elapsed between the initial IRB review
date and the anticipated award date, the awarding unit staff shall
require re-review by the IRB prior to award.

## 5.5 Required Education in the Protection of Human Research Participants

NIH requires education on the protection of human research participants
for all individuals identified in PHS applications as Senior/key
Personnel who will be involved in the design or conduct of human
subjects research, before funds are awarded for applications or contract
proposals involving human subjects. For information relating to this
requirement, see the following notices
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html> and
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html>,
and Frequently Asked Questions at:
<http://grants.nih.gov/grants/policy/hs_educ_faq.htm>. Prior to award,
applicants will be required to provide a description of education
completed in the protection of human subjects for all Senior/key
Personnel involved in the design or conduct of human subjects research.
Although NIH does not endorse specific programs, there are curricula
available that can provide guidance or that can be modified to provide
training in this area. See
[http://phrp.nihtraining.com](http://phrp.nihtraining.com/) for
computer-based training developed for NIH that can be downloaded at no
charge. For information on facilitating education and developing
curricula, see <http://www.nih.gov/sigs/bioethics>.

## 5.6 NIH Policy on the Inclusion of Women and Minorities in Clinical Research

NIH policy requires that women and members of minority groups and their
subpopulations must be included in all NIH-supported biomedical and
behavioral research projects involving [clinical
research](#Human_Subjects_Defs_ClinicalResearch) unless a clear and
compelling rationale and justification establishes to the satisfaction
of the relevant IC Director that inclusion is inappropriate with respect
to the health of the subjects or the purpose of the research. Exclusion
under other circumstances may be made by the Director, NIH, upon the
recommendation of an IC Director based on a compelling rationale and
justification. Cost is not an acceptable reason for exclusion except
when the study would duplicate data from other sources. Women of
childbearing potential should not be routinely excluded from
participation in clinical research. All NIH-supported biomedical and
behavioral research involving human subjects is defined as clinical
research. This policy applies to research subjects of all ages.

The inclusion of women and members of minority groups and their
subpopulations must be addressed in developing a research design
appropriate to the scientific objectives of the study. The Research Plan
should describe the composition of the proposed study population in
terms of sex/gender and racial/ethnic group, and provide a rationale for
selection of such subjects. Such a plan should contain a description of
the proposed outreach programs for recruiting women and minorities as
participants. See
<http://grants.nih.gov/grants/funding/women_min/women_min.htm>.

## 5.7 NIH Policy on Inclusion of Children 

Research involving children (see definition of
"[child](#Human_Subjects_Defs_Child)") must comply with the NIH Policy
and Guidelines on the Inclusion of Children in Clinical Research.
Investigators should obtain full copies of the Policy and Guidelines
from NIH staff, or from
<http://grants.nih.gov/grants/funding/children/children.htm>.

NIH policy requires that children (i.e., individuals under the age of
21) must be included in all clinical research, conducted or supported by
the NIH unless there are clear and compelling reasons not to include
them. Therefore, proposals for clinical research must include a
description of plans for including children. If children will be
excluded from the research, the application or proposal must present an
acceptable justification for the exclusion.

The involvement of children as subjects in research must be in
compliance with all applicable subparts of [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) as well
as with other pertinent Federal laws and regulations.

IRBs have special review requirements to protect the well-being of
children who participate in research. These requirements relate to risk,
benefit, parental/guardian consent, and assent by children, and to
research involving children who are wards of the state or of another
institution. The local IRB approves research that satisfies the
conditions set forth in the regulations.

## 5.8 NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research

The Office of Management and Budget (OMB)
(<http://www.whitehouse.gov/omb/fedreg/ombdir15.html>) defines minimum
standards for maintaining, collecting and presenting data on race and
ethnicity for all Federal reporting agencies (including NIH). The
standards were revised in 1997 and include two ethnic categories
(Hispanic or Latino and Not Hispanic or Latino) and five racial
categories (American Indian or Alaska Native, Asian, Black or African
American, Native Hawaiian or Other Pacific Islander, and White). Reports
of data on race and ethnicity shall use these categories. The categories
in this classification are social-political constructs and should not be
interpreted as being anthropological in nature. NIH is required to use
these definitions to allow comparisons to other federal databases,
especially the census and national health databases. The following
definitions apply to the minimum standards for the ethnic and racial
categories.

#### Ethnic Categories: {#ethnic-categories .Subhead---No-TOC}

**Hispanic or Latino:** A person of Cuban, Mexican, Puerto Rican, South
or Central American, or other Spanish culture or origin, regardless of
race. The term, "Spanish origin," can be used in addition to "Hispanic
or Latino."

**Not Hispanic or Latino**

#### Racial Categories:  {#racial-categories .Subhead---No-TOC}

**American Indian or Alaska Native:** A person having origins in any of
the original peoples of North, Central, or South America, and who
maintains tribal affiliation or community attachment.

**Asian:** A person having origins in any of the original peoples of the
Far East, Southeast Asia, or the Indian subcontinent including, for
example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the
Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the
Philippine Islands have been recorded as Pacific Islanders in previous
data collection strategies.)

**Black or African American:** A person having origins in any of the
black racial groups of Africa. Terms such as "Haitian" or "Negro" can be
used in addition to "Black or African American."

**Native Hawaiian or Other Pacific Islander:** A person having origins
in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific
Islands.

**White:** A person having origins in any of the original peoples of
Europe, the Middle East, or North Africa.

**Ethnic/Racial Subpopulations:** In addition to OMB ethnic and racial
categories, NIH uses the following definition for ethnic/racial
subpopulations:

Subpopulations: Each ethnic/racial group contains subpopulations that
are delimited by geographic origins, national origins, and/or cultural
differences. It is recognized that there are different ways of defining
and reporting racial and ethnic subpopulation data. The subpopulation to
which an individual is assigned depends on self-reporting of specific
origins and/or cultural heritage. Attention to subpopulations also
applies to individuals who self identify with more than one race. These
ethnic/racial combinations may have biomedical, behavioral, and/or
social-cultural implications related to the scientific question under
study.

#### Guidance on Collecting Race and Ethnicity Data from Human Subjects {#guidance-on-collecting-race-and-ethnicity-data-from-human-subjects .Subhead---No-TOC}

When an investigator is planning to collect data on ethnicity and race,
the categories identified above should be used. The collection of
greater detail is encouraged, for example on ethnic/racial
subpopulations. However, any collection that uses more detail must be
designed in a way that data can be aggregated into these minimally
required categories. Use self-report or self-identification to collect
this information by asking two separate questions -- one on ethnicity
and one on race. Collect ethnicity information first followed by the
question on race and provide subjects with the option to select more
than one racial category. An example of a format for collecting
information from study subjects in the US that meets the OMB
requirements can be found in the Ethnic Origin and Race section of the
Personal Data Form Page
<http://grants.nih.gov/grants/funding/phs398/phs398.html> in the PHS
398.

See NIH Policy on [Inclusion of Women and
Minorities](#nih-policy-on-the-inclusion-of-women-and-minorities-in-clinical-research)
and <http://grants.nih.gov/grants/funding/women_min/women_min.htm>.

## 5.9 Research on Transplantation of Human Fetal Tissue

In checking the "I agree" box on line 18 of the SF424 (R&R) Cover
component, the Authorized Organizational Representative of the applicant
organization certifies that if research on the transplantation of human
fetal tissue is conducted, the applicant organization will make
available, for audit by the Secretary, DHHS, the physician statements
and informed consents required by section 498A (b)(2) and (c) of the
Public Health Service Act, 42 U.S.C. 289g (b)(2) and (c), or ensure DHHS
access to those records, if maintained by an entity other than the
applicant organization.

## 5.10 Research Using Human Embryonic Stem Cells

In checking the "I agree" box on line 18 of the SF424 (R&R) Cover
component, the Authorized Organizational Representative of the applicant
organization certifies that if research using human embryonic stem cells
is proposed, the applicant organization will be in compliance with the
"Notice of Extended Receipt Date and Supplemental Information Guidance
for Applications Requesting Funding that Proposes Research with Human
Embryonic Stem Cells"
(<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html>).
See <http://stemcells.nih.gov/index.asp> for additional information on
stem cells, and <http://stemcells.nih.gov/policy/guidelines.asp> for
Federal policy statements and guidelines on federally funded stem cell
research.

## 5.11 ClinicalTrials.gov Requirements

In checking the "I agree" box on line 18 of the SF424 (R&R) Cover
component, the Authorized Organizational Representative of the applicant
organization certifies that if the research is an applicable clinical
trial under Public Law 110-85, the applicant organization will be in
compliance with the registration and reporting requirements of Public
Law 110-85 (see Part III, [Section 2.1.6](#clinicaltrials.gov)).

[]{#Policy_PartIII .anchor}PART III\
\
Policies, Assurances, Definitions,\
and Other Information

# 1. Policy

## 1.1 Applications That Include Consortium/Contractual Facilities and Administrative Costs 

See:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html>.

NIH broadens the scope of Notice
[OD-04-040](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html)
to apply to all applications involving consortium/contractual facilities
and administrative (F&A) costs, regardless of budget amount or budget
format (e.g., modular and non-modular).

This policy applies to all solicited and investigator-initiated
applications. For solicited applications, this policy change now applies
to all currently active announcements (Request for Applications and
Program Announcements), regardless of the announcement issue date.

This policy is particularly relevant to all applications that include a
limitation on direct costs. While consortium F&A costs will continue to
be requested and awarded, applicants will now separate these costs when
determining if a budget exceeds a direct cost limit.

This policy impacts eligibility to submit a modular budget. The modular
budget format continues to be used for applications requesting \$250,000
or less in direct costs per year. However consortium/contractual F&A
costs are no longer factored into this direct cost limit. They may be
requested in addition to the \$250,000.

The policy also impacts applications requesting a budget of \$500,000 or
more direct costs for any year. These applications continue to require
prior approval from Institute/Center staff; however this limit is now
exclusive of any consortium F&A costs.

Note: The implications of this policy do not affect the Small Business
Innovation Research (SBIR) and Small Business Technology Transfer (STTR)
programs since the statutory budget guidelines are based on total costs,
not direct costs.

## 1.2 Resubmission of Unpaid RFA Applications and Resubmission of Applications with a Changed Grant Activity Mechanism 

See
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html>.

The majority of grant applications submitted to NIH each year are
investigator-initiated. However, the Institutes and Centers of NIH also
solicit grant applications on specific topics through the use of
Requests for Applications (RFAs). Resubmissions of grant applications
fall into the following categories:

> 1\. Applications that were originally submitted in response to an RFA
> and then resubmitted as an investigator-initiated application.
>
> 2\. Applications that were originally submitted as
> investigator-initiated applications and subsequently resubmitted in
> response to an RFA.
>
> 3\. Applications that were originally submitted using one grant
> mechanism and subsequently resubmitted using a different grant
> mechanism (for example, an application that was originally an R01 and
> then is resubmitted as an R21).

Since an RFA often has special considerations of eligibility, scientific
scope, and review criteria, it is felt that most unfunded applications
should be resubmitted as **new** applications. Similarly, a change of
grant mechanism (from an R01 to an R21 or from an R03 to an R01, for
example) usually involves a change of eligibility criteria, application
characteristics, dollar limits, time limits, or review criteria. This
also suggests that consideration as a new application is the most
appropriate course. Because the application will be new, it will be
easier to conform to the new application requirements, which should be
an advantage to the applicant in the review process. Additionally,
submission of a new application will allow the applicant to benefit
fully from the NIH policy that allows an applicant to submit two
resubmissions (see
<http://grants.nih.gov/grants/policy/amendedapps.htm>).

NEW APPLICATIONS: The new application must be submitted on the scheduled
due dates for new applications (see
<http://grants.nih.gov/grants/funding/submissionschedule.htm>). It must
not include an Introduction describing the changes and improvements made
and the text must not be marked to indicate the changes. Although the
investigator may still benefit from the previous review, the applicant
should not explicitly address reviewers' comments. The reviewers will
not be provided with the previous Summary Statement. The investigator
will be allowed to submit the new application and up to two
resubmissions of this application, should that be necessary.

POLICY: This general policy on application resubmission, stated below,
applies to all grant mechanisms that might be solicited via an RFA and
to instances where there is a change in mechanism. There may, however,
be exceptions to this policy, which will be clearly identified in the
original RFA or in a follow-up RFA.

1\. When an application that was submitted in response to an RFA is not
funded and the investigator wishes to resubmit an application on this
topic as an investigator-initiated application, it is to be submitted as
a **new** application, unless provisions for a resubmission are clearly
delineated in the RFA. In addition, if a subsequent RFA specifically
solicits resubmissions of unfunded applications from a previous RFA, the
instructions in the second RFA should be followed. In all other cases,
applications submitted in response to an RFA and then resubmitted as an
investigator-initiated application must be submitted as a **new**
application.

2\. When a previously unfunded application, originally submitted as an
investigator-initiated application is to be submitted in response to an
RFA, it is to be prepared as a **new** application.

3\. When an unfunded application that was reviewed for a particular
research grant mechanism (for example, R01) is to be submitted for a
different grant mechanism (for example, R03), it is to be prepared as a
**new** application.

## 1.3 NIH Policy on Resubmission Applications

See:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-041.html>.

The NIH will not consider a third resubmission (A3) or higher
resubmission to an application for extramural support. There is no
longer a time limit for the submission of the first and second
resubmissions (A1 and A2). This policy applies to all NIH extramural
funding mechanisms.

In submitting a resubmission application, it is worth noting that a
lengthy hiatus after the initial submission may be marked by significant
advances in the scientific field and the comments of the reviewers may
no longer be relevant. PDs/PIs and their institutions need to exercise
their best judgment in determining the advisability of submitting a
resubmission application after several years have elapsed.

The policy limiting the number of resubmissions was established
following analysis of data indicating that investigators who receive
initial funding for a resubmission application have a lower success rate
in obtaining support for a follow-on renewal application. The likelihood
of subsequent success decreased with an increasing number of
resubmissions. After three reviews, it was felt that it was time for
investigators to take a fresh approach to their research proposals.

Investigators who have submitted three versions of an application and
have not been successful often ask NIH staff how different the next
application submitted has to be to be considered a new application. It
is recognized that investigators are trained in a particular field of
science and are not likely to make drastic changes in their research
interests; however, a new application following three reviews is
expected to be substantially different in content and scope with more
significant differences than are normally encountered in a resubmission
application. Simply re-wording the title and/or Specific Aims or
incorporating minor changes in response to comments in the previous
Summary Statement does not constitute a substantial change in scope or
content. Changes to the Research Plan should produce a significant
change in direction and approach for the research project. Thus, a new
application would include substantial changes in all sections of the
Research Plan, particularly the Specific Aims and the Research Design
and Methods sections.

In the referral process, NIH staff look at all aspects of the
application, not just the title and Description (abstract). Requesting
review by a different review committee does not affect the
implementation of this policy. When necessary, previous applications are
analyzed for similarities to the present one. Thus, identical
applications or those with only minor changes will not be accepted for
review.

## 1.4 Policy on the Acceptance for Review of Unsolicited Applications That Request \$500,000 or More in Direct Costs

Applicants must seek agreement to accept assignment from
Institute/Center staff at least six weeks prior to the anticipated
submission of any application requesting \$500,000 or more in direct
costs for any year. Note for the purposes of determining whether or not
this policy applies, this \$500,000 limit now excludes any consortium
F&A costs.

The NIH supports research projects with large budgets but needs to
consider such awards as early as possible in the budget and program
planning process. Regardless of the merit of the application or the
budget justification, unanticipated requests for unusually high amounts
of direct costs are difficult for NIH to manage. It is in the best
interest of all parties if applicants anticipating large direct costs
contact the appropriate NIH program staff as early as possible to ensure
that an Institute/Center (IC) would be willing to accept the
application.

Applicants must seek agreement from IC staff at least six weeks prior to
the anticipated submission of any application requesting \$500,000 or
more in direct costs for any year. Note for the purposes of determining
whether or not this policy applies, this limit now excludes any
consortium F&A costs. If the proposed budget excluding consortium F&A
costs equals or exceeds the \$500,000 level, then prior approval is
required. If staff is contacted less than six weeks before submission,
there may be insufficient time to make a determination about assignment
prior to the intended submission date. If the requested dollars are
significantly greater than \$500,000, then approval should be sought
even earlier.

This prior acceptance policy does not apply to applications submitted in
response to RFAs or in response to other Announcements that include
specific budgetary limits. Such applications must be responsive to any
budgetary limits specified; however, any specified budgetary limit now
excludes consortium F&A costs.

PROCEDURES

-   An applicant planning to submit a grant application with \$500,000
    or more in direct costs for any year (excluding consortium F&A
    costs) is required to contact in writing or by telephone NIH IC
    program staff. This contact should be made during the development
    process of the application but no later than six weeks before the
    anticipated submission date. If the IC is willing to accept
    assignment of the application for consideration of funding, the
    staff will notify the Center for Scientific Review before the
    application is submitted.

-   The PD/PI must include a cover letter with the application. That
    cover letter must identify the program staff member contacted and
    the Institute/Center that has agreed to accept assignment of the
    application.

-   An application received without indication of prior staff
    concurrence and identification of program staff contacted will be
    returned to the applicant without review. Therefore, NIH strongly
    encourages applicants to contact appropriate IC staff at the
    earliest possible time.

For additional information about this policy, contact the program staff
at any Institute/Center. Applicants who are uncertain about which IC may
have the greatest interest in the research for which support is sought
should contact the NIH CSR Receipt and Referral Office at (301)
435-0715.

## 1.5 Sharing Research Resources

[]{#Policy_DataSharing .anchor}Investigators conducting biomedical
research frequently develop unique research resources. NIH considers the
sharing of such unique research resources (also called research tools)
an important means to enhance the value of NIH-sponsored research.
Restricting the availability of unique resources can impede the
advancement of further research. Therefore, when these resources are
developed with NIH funds and the associated research findings have been
published or after they have been provided to NIH, it is important that
they be made readily available for research purposes to qualified
individuals within the scientific community. At the same time NIH
recognizes the rights of grantees and contractors to elect and retain
title to subject inventions developed with federal funding pursuant to
the Bayh Dole Act. See the NIH Grants Policy Statement, and the Office
of Extramural Research, Division of Extramural Inventions & Technology
Resources (DEITR), Intellectual Property Policy page:
[http://inventions.nih.gov](http://inventions.nih.gov/).

The adequacy of resource sharing plans are considered by reviewers when
a competing application is evaluated. Reviewers are asked to describe
their assessment of the sharing plan in an administrative note, and will
not normally include their assessment in the overall priority score.
Program staff are responsible for overseeing resource sharing policies
and for assessing the appropriateness and adequacy of any proposed
resource sharing plans.

### 1.5.1 Data Sharing Policy 

All investigator-initiated applications with direct costs of \$500,000
or greater in any single year are expected to address data-sharing in
their application. Applicants are encouraged to discuss data-sharing
plans with their program contact at the time they negotiate an agreement
with the Institute/Center (IC) staff to accept assignment of their
application as described at [http://grants.nih.gov/grants/guide/
notice-files/NOT-OD-02-004.html](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html).

Applicants are reminded that agreement to accept assignment of
applications \$500,000 or greater must be obtained at least six weeks in
advance of the anticipated submission date. Instructions related to the
data-sharing policy as it is applied to applications and proposals
responding to a specific Request for Application (RFA) or Request for
Proposals (RFP) will be described in the specific solicitation. In some
cases, other Funding Opportunity Announcements (FOAs) may request
data-sharing plans for applications that are less than \$500,000 direct
costs in any single year.

NIH recognizes that in some cases data-sharing may be complicated or
limited by institutional policies, local IRB rules, as well as local,
state and Federal laws and regulations, including the HIPAA Privacy
Rule. The rights and privacy of individuals who participate in
NIH-sponsored research must be protected at all times. Thus, data
intended for broader use should be free of identifiers that would permit
linkages to individual research participants and variables that could
lead to deductive disclosure of the identity of individual subjects.
When data-sharing is limited, applicants should explain such limitations
in their data-sharing plans.

For more information on data-sharing, please see
<http://grants.nih.gov/grants/policy/data_sharing> and the NIH Final
Policy on Sharing Research Data,
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html>.

### 1.5.2 Sharing Model Organisms 

All applications where the development of model organisms is anticipated
are expected to include a description of a specific plan for sharing and
distributing unique model organism research resources generated using
NIH funding so that other researchers can benefit from these resources,
or state appropriate reasons why such sharing is restricted or not
possible. Model organisms include but are not restricted to mammalian
models, such as the mouse and rat; and non-mammalian models, such as
budding yeast, social amoebae, round worm, fruit fly, zebra fish, and
frog. Research resources to be shared include genetically modified or
mutant organisms, sperm, embryos, protocols for genetic and phenotypic
screens, mutagenesis protocols, and genetic and phenotypic data for all
mutant strains.

This expectation is for **all** applications where the development of
model organisms is anticipated, regardless of funding amount.

For additional information on this policy, see the NIH Model Organism
for Biomedical Research Website at: <http://www.nih.gov/science/models/>
and NIH Guide Notices OD-04-042:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html>,
and OD-04-066:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-066.html>.

### 1.5.3 Policy for Genome-Wide Association Studies (GWAS)

NIH is interested in advancing genome-wide association studies (GWAS) to
identify common genetic factors that influence health and disease
through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of
genetic variation across the entire human genome that is designed to
identify genetic associations with observable traits (such as blood
pressure or weight), or the presence or absence of a disease or
condition.

All applications, regardless of the amount requested, proposing a
genome-wide association study are expected to provide a plan for
submission of GWAS data to the NIH-designated GWAS data repository, or
provide an appropriate explanation why submission to the repository is
not possible. Data repository management (submission and access) is
governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, [NIH Guide
NOT-OD-07-088](http://www.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
For additional information see: <http://grants.nih.gov/grants/gwas/>.

## 1.6 Inventions and Patents

According to NIH Grants Policy and Federal law, NIH recipient
organizations must promptly report all inventions that are either
conceived or first actually reduced to practice using NIH funding.
Invention reporting compliance is described at
[http://www.iedison.gov](http://www.iedison.gov/). Grantees are
encouraged to submit reports electronically using Interagency Edison
([http://www.iedison.gov](http://www.iedison.gov/)). Information from
these reports is retained by the NIH as confidential and submission does
not constitute any public disclosure. Failure to report as described at
37 CFR Section 401.14 is a violation of 35 U.S.C. 202 and may result in
loss of the rights of the recipient organization. Inquiries or
correspondence should be directed to: **Division of Extramural
Inventions and Technology Resources, Office of Policy for Extramural
Research Administration, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC
7980, Bethesda, MD 20892-7980, Telephone: (301) 435-1986.**

## 1.7 Just-In-Time Policy

Several elements of an application are no longer required at the time
the application is submitted. Instead, this information will be
requested later in the review cycle (i.e., "just-in-time") to ensure
that it is current. The information eligible for just-in-time submission
includes:

-   **Current Other Support**: See [Other Support](#other-support)
    section for policy information. See Part II. Section 5.4 [IRB
    Approval](#Human_Subjects_NoIRBApproval). For all Key Personnel,
    provide details on how you would adjust any budgetary, scientific,
    or effort overlap if this application is funded.

-   For **Career Development Award** applicants, information on all
    active support for the candidate, sponsor(s), co-sponsor(s), and Key
    Personnel may be requested by the awarding component prior to award.

-   Certifications:

-   If human subjects are involved, provide the assurance type and
    number (if not previously provided) and the Certification of IRB
    Review and Approval. Pending or out-of-date approvals are not
    acceptable.

-   If vertebrate animals are involved and this information was not
    previously provided on the Research & Related Other Project
    Information Component of the application, provide assurance number,
    verification of IACUC approval with date, and any IACUC-imposed
    changes. Pending or out-of-date approvals are not acceptable.

-   **Human Subjects Education:** For grants involving Human Subjects,
    provide certification that each person identified under Key
    Personnel involved in the design or conduct of research involving
    human subjects has completed an educational program in the
    protection of human subjects. For further information refer to the
    separate section on [Required Education in the Protection of Human
    Research
    Participants](#required-education-in-the-protection-of-human-research-participants-1).

In addition, applicants for **Research Career Development Awards** will
be asked to provide detailed, categorical budget and narrative
justification pages prior to award.

Applicants are advised to submit this information (countersigned by an
authorized business official) only when requested by the awarding
component. Guidance for submitting this information will be provided at
the time of the request. Alternatively, this information may now be
submitted using the Just-In-Time feature of the eRA Commons found in the
**Status** section. For information on the Commons see:
[https://commons.era.nih.gov/
commons/index.jsp](https://commons.era.nih.gov/commons/index.jsp).

## 1.8 Other Support

Do not submit information on Other Support with the application beyond
that required in the biographical sketch. If this information is
included at the time of application, processing may be delayed or the
application may be returned to the applicant without review.

Information on Other Support is required for all applications that are
to receive grant awards; NIH will request complete and up to date
information from applicants at an appropriate time *after peer review*.
The Institute/Center scientific program and grants management staff will
review this information prior to award.

Do not confuse Research Support with Other Support. Though they sound
similar, these parts of the application are distinctly different. As
part of the biosketch section of the application, Research Support
highlights your accomplishments, and those of your colleagues, as
scientists. This information will be used by the reviewers in the
assessment of each individual's qualifications for a specific role in
the proposed project, as well as to evaluate the overall qualification
of the research team. In contrast, Other Support information is required
for all applications that are selected to receive grant awards and
includes detailed financial information. NIH staff will request complete
and up-to-date "other support" information after peer review. This
information will be used to check that the proposed research is not
already funded through other sources.

#### Other Support Policy {#other-support-policy .Subhead---No-TOC}

Other Support includes all financial resources, whether Federal,
non-Federal, commercial or institutional, available in direct support of
an individual's research endeavors, including but not limited to
research grants, cooperative agreements, contracts, and/or institutional
awards. Training awards, prizes, or gifts are not included.

Information on Other Support assists awarding agency staff in the
identification and resolution of potential overlap of support. Overlap,
whether scientific, budgetary, or commitment of an individual's effort
greater than 100 percent or 12 person months, is not permitted. The
goals in identifying and eliminating overlap are to ensure that
sufficient and appropriate levels of effort are committed to the
project; that there is no duplication of funding for scientific aims,
specific budgetary items, or an individual's level of effort; and that
only funds necessary to the conduct of the approved project are included
in the award.

Budgetary overlap occurs when duplicate or equivalent budgetary items
(e.g., equipment, salary) are requested in an application but are
already provided for by another source.

Commitment overlap occurs when a person's time commitment exceeds 100
percent or 12 person months, whether or not salary support is requested
in the application. While information on other support is only requested
for Key Personnel (excluding consultants), no individuals on the project
may have commitments in excess of 100 percent.

Scientific overlap occurs when: (1) substantially the same research is
proposed in more than one application or is submitted to two or more
different funding sources for review and funding consideration, or (2) a
specific research objective and the research design for accomplishing
that objective are the same or closely related in two or more
applications or awards, regardless of the funding source. Potential
scientific overlap is to be addressed by the SRG *only* by its
identification in an Administrative Note in the Summary Statement.

**Resolution of Overlap.** Resolution of overlap occurs at the time of
award in conjunction with applicant institution officials, the PD/PI,
and awarding agency staff.

#### Other Support Information {#other-support-information .Subhead---No-TOC}

Information on Other Support should be submitted ONLY when requested by
the NIH Institute/Center (IC).

There is no form page for Other Support. Follow the sample format
provided below. The sample is intended to provide guidance regarding the
type and extent of information requested.

The following instructions should be followed in completing the
information:

-   Information on active and pending Other Support is required for Key
    Personnel, excluding consultants. For individuals with no active or
    pending support, indicate "None." Neither the application under
    consideration nor the current PHS award for this project should be
    listed as Other Support. Do not include Other Support for
    individuals listed as "Other Significant Contributors" unless their
    involvement has changed so that they now meet the definition of "key
    personnel."

-   If the support is provided under a consortium/contractual
    arrangement or is part of a multiproject award, indicate the project
    number, PD/PI, and source for the overall project, and provide all
    other information for the subproject only.

#### Instructions for Selected Items {#instructions-for-selected-items .Subhead---No-TOC}

*Project Number:* If applicable, include a code or identifier for the
project.

Source: Identify the agency, institute, foundation, or other
organization that is providing the support. Include institutional,
federal, public, and private sources of support.

*Major Goals:* Provide a brief statement of the overall objectives of
the project, subproject, or consortium/contractual arrangement.

*Dates of Approved/Proposed Project:* Indicate the inclusive dates of
the project as approved/proposed. For example, in the case of NIH
support, provide the dates of the approved/proposed competitive segment.

*Annual Direct Costs:* In the case of an active project, provide the
current year's direct cost budget. For a pending project, provide the
proposed direct cost budget for the initial budget period.

*Percent Effor*t*/Person Months:* For an active project, provide the
level of actual effort in person months (even if unsalaried) for the
current budget period. Person months should be classified as academic,
calendar and/or summer. For a pending project, indicate the level of
effort in person months as proposed for the initial budget period. In
cases where an individual's appointment is divided into academic and
summer segments, indicate the proportion of each devoted to the project.

*Overlap:* After listing all support, summarize for each individual any
potential overlap with the active or pending projects and this
application in terms of the science, budget, or an individual's
committed effort.

Sample Format for Other Support

+---------------------------------+------------------------+----------+
| **OTHER SUPPORT**               |                        |          |
|                                 |                        |          |
| **Format**                      |                        |          |
+---------------------------------+------------------------+----------+
| **NAME OF INDIVIDUAL**          |                        |          |
|                                 |                        |          |
| [ACTIVE]{.u                     |                        |          |
| nderline}/[PENDING]{.underline} |                        |          |
+---------------------------------+------------------------+----------+
| Project Number (PD/PI)          | Dates of               | Person   |
|                                 | Approved/Proposed      | Months\  |
| Source                          | Project                | (Ca      |
|                                 |                        | l/Acad/\ |
| Title of Project *(or           | Annual Direct Costs    | Summer)  |
| Subproject)*                    |                        |          |
|                                 |                        |          |
| The major goals of this project |                        |          |
| are...                          |                        |          |
+---------------------------------+------------------------+----------+
| [OVERLAP]{.underline}           |                        |          |
| *(summarized for each           |                        |          |
| individual)*                    |                        |          |
+---------------------------------+------------------------+----------+
| **Samples**                     |                        |          |
|                                 |                        |          |
| ANDERSON, R.R.                  |                        |          |
|                                 |                        |          |
| [ACTIVE]{.underline}            |                        |          |
|                                 |                        |          |
| 2 R01 HL 00000-13 (Anderson)    |                        |          |
| 3/1/1997 -- 2/28/2002 3.60      |                        |          |
| calendar                        |                        |          |
|                                 |                        |          |
| NIH/NHLBI \$186,529             |                        |          |
|                                 |                        |          |
| Chloride and Sodium Transport   |                        |          |
| in Airway Epithelial Cells      |                        |          |
|                                 |                        |          |
| > The major goals of this       |                        |          |
| > project are to define the     |                        |          |
| > biochemistry of chloride and  |                        |          |
| > sodium transport in airway    |                        |          |
| > epithelial cells and clone    |                        |          |
| > the gene(s) involved in       |                        |          |
| > transport.                    |                        |          |
|                                 |                        |          |
| 5 R01 HL 00000-07 (Baker)       |                        |          |
| 4/1/1994 -- 3/31/2002 1.20      |                        |          |
| calendar                        |                        |          |
|                                 |                        |          |
| NIH/NHLBI \$122,717             |                        |          |
|                                 |                        |          |
| Ion Transport in Lungs          |                        |          |
|                                 |                        |          |
| > The major goal of this        |                        |          |
| > project is to study chloride  |                        |          |
| > and sodium transport in       |                        |          |
| > normal and diseased lungs.    |                        |          |
|                                 |                        |          |
| R000 (Anderson) 9/1/1996 --     |                        |          |
| 8/31/2002 1.20 calendar         |                        |          |
|                                 |                        |          |
| Cystic Fibrosis Foundation      |                        |          |
| \$43,123                        |                        |          |
|                                 |                        |          |
| Gene Transfer of CFTR to the    |                        |          |
| Airway Epithelium               |                        |          |
|                                 |                        |          |
| > The major goals of this       |                        |          |
| > project are to identify and   |                        |          |
| > isolate airway epithelium     |                        |          |
| > progenitor cells and express  |                        |          |
| > human CFTR in airway          |                        |          |
| > epithelial cells.             |                        |          |
|                                 |                        |          |
| [PENDING]{.underline}           |                        |          |
|                                 |                        |          |
| DCB 950000 (Anderson)           |                        |          |
| 12/01/2002 -- 11/30/2004 2.40   |                        |          |
| calendar                        |                        |          |
|                                 |                        |          |
| National Science Foundation     |                        |          |
| \$82,163                        |                        |          |
|                                 |                        |          |
| Liposome Membrane Composition   |                        |          |
| and Function                    |                        |          |
|                                 |                        |          |
| > The major goals of this       |                        |          |
| > project are to define         |                        |          |
| > biochemical properties of     |                        |          |
| > liposome membrane components  |                        |          |
| > and maximize liposome uptake  |                        |          |
| > into cells.                   |                        |          |
|                                 |                        |          |
| [OVERLAP]{.underline}           |                        |          |
|                                 |                        |          |
| > There is scientific overlap   |                        |          |
| > between aim 2 of NSF DCB      |                        |          |
| > 950000 and aim 4 of the       |                        |          |
| > application under             |                        |          |
| > consideration. If both are    |                        |          |
| > funded, the budgets will be   |                        |          |
| > adjusted appropriately in     |                        |          |
| > conjunction with agency       |                        |          |
| > staff.                        |                        |          |
|                                 |                        |          |
| RICHARDS, L.                    |                        |          |
|                                 |                        |          |
| [NONE]{.underline}              |                        |          |
|                                 |                        |          |
| HERNANDEZ, M.                   |                        |          |
|                                 |                        |          |
| [ACTIVE]{.underline}            |                        |          |
|                                 |                        |          |
| 5 R01 CA 00000-07 (Hernandez)   |                        |          |
| 4/1/1995 -- 3/31/2002 3.60      |                        |          |
| academic                        |                        |          |
|                                 |                        |          |
| NIH/NCI \$110,532               |                        |          |
|                                 |                        |          |
| Gene Therapy for Small Cell     |                        |          |
| Lung Carcinoma                  |                        |          |
|                                 |                        |          |
| > The major goals of this       |                        |          |
| > project are to use viral      |                        |          |
| > strategies to express the     |                        |          |
| > normal p53 gene in human SCLC |                        |          |
| > cell lines and to study the   |                        |          |
| > effect on growth and          |                        |          |
| > invasiveness of the lines.    |                        |          |
|                                 |                        |          |
| 5 P01 CA 00000-03 (Chen)        |                        |          |
| 7/1/2000 -- 6/30/2002 1.80      |                        |          |
| academic                        |                        |          |
|                                 |                        |          |
| NIH/NCI \$104,428 (sub only)    |                        |          |
| 3.00 summer                     |                        |          |
|                                 |                        |          |
| Mutations in p53 in Progression |                        |          |
| of Small Cell Lung Carcinoma    |                        |          |
|                                 |                        |          |
| > The major goals of this       |                        |          |
| > subproject are to define the  |                        |          |
| > p53 mutations in SCLC and     |                        |          |
| > their contribution to tumor   |                        |          |
| > progression and metastasis.   |                        |          |
|                                 |                        |          |
| BE 00000 (Hernandez) 9/1/1996   |                        |          |
| -- 8/31/2002 1.80 academic      |                        |          |
|                                 |                        |          |
| American Cancer Society         |                        |          |
| \$86,732                        |                        |          |
|                                 |                        |          |
| P53 Mutations in Breast Cancer  |                        |          |
|                                 |                        |          |
| > The major goals of this       |                        |          |
| > project are to define the     |                        |          |
| > spectrum of p53 mutations in  |                        |          |
| > human breast cancer samples   |                        |          |
| > and correlate the results     |                        |          |
| > with clinical outcome.        |                        |          |
|                                 |                        |          |
| [OVERLAP]{.underline}           |                        |          |
|                                 |                        |          |
| > Potential commitment overlap  |                        |          |
| > for Dr. Hernandez between 5   |                        |          |
| > R01 CA 00000-07 and the       |                        |          |
| > application under             |                        |          |
| > consideration. If the         |                        |          |
| > application under             |                        |          |
| > consideration is funded with  |                        |          |
| > Dr. Hernandez committed at    |                        |          |
| > 3.60 person months, Dr.       |                        |          |
| > Hernandez will request        |                        |          |
| > approval to reduce her months |                        |          |
| > on the NCI grant.             |                        |          |
|                                 |                        |          |
| BENNETT, P.                     |                        |          |
|                                 |                        |          |
| [ACTIVE]{.underline}            |                        |          |
|                                 |                        |          |
| Investigator Award (Bennett)    |                        |          |
| 9/1/1999 -- 8/31/2002 9.00      |                        |          |
| calendar                        |                        |          |
|                                 |                        |          |
| Howard Hughes Medical Institute |                        |          |
| \$581,317                       |                        |          |
|                                 |                        |          |
| Gene Cloning and Targeting for  |                        |          |
| Neurological Disease Genes      |                        |          |
|                                 |                        |          |
| > This award supports the       |                        |          |
| > PD/PI's program to map and    |                        |          |
| > clone the gene(s) implicated  |                        |          |
| > in the development of         |                        |          |
| > Alzheimer's disease and to    |                        |          |
| > target expression of the      |                        |          |
| > cloned gene(s) to relevant    |                        |          |
| > cells.                        |                        |          |
|                                 |                        |          |
| [OVERLAP]{.underline}: None     |                        |          |
+---------------------------------+------------------------+----------+

#### Special Instructions for Individuals with Multiple Research Appointments (e.g., dual university/Department of Veterans Affairs appointments) {#special-instructions-for-individuals-with-multiple-research-appointments-e.g.-dual-universitydepartment-of-veterans-affairs-appointments .Subhead---No-TOC}

When an individual holds multiple appointments involving support for
research activities, information from each appointment must be included
separately in the Other Support documentation. The support from each
funding source should be clearly and separately delineated so that the
separate appointments can be considered independently when determining
any potential overlap.

List each appointment separately and include enough information on the
type of appointment; (e.g., full time academic or 6/8 VA) so that an
assessment of an individual's commitment can be made. Within each
appointment, include appropriate sources of research support providing
the standard detailed information cited above.

Note that when an individual has multiple appointments it is possible
that the combined effort can result in excess of 12 calendar months (not
from any one institution, but a combination of multiple appointments).
In all cases, an individual's combined total professional effort must
meet a test of reasonableness.

## 1.9 Graduate Student Compensation

The maximum amount awarded by the NIH for the support of a graduate
student on a research grant or a cooperative agreement is tied to the
National Research Service Award (NRSA) zero-level stipend in effect at
the time the grant award is issued. The schedule for NRSA stipends can
be found at <http://grants.nih.gov/training/nrsa.htm>. Consistent with
cost principles for educational institutions described in Office of
Management and Budget (OMB) Circular A-21 at section J.41.b
([http://www.whitehouse.gov/omb/
circulars/a021/a021.html](http://www.whitehouse.gov/omb/circulars/a021/a021.html)),
the compensation of graduate students supported by research grants must
be reasonable. These operating principles associated with the
compensation of students performing necessary work on NIH funded
research projects are described in detail in the *NIH Grants Policy
Statement* at
<http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm>. As
before, the amount provided for compensation includes salary or wages,
fringe benefits, and tuition remission.

These guidelines apply to graduate students at the grantee institution
who are supported by NIH research grants and cooperative agreements and
not to individuals supported by NRSA training grants and fellowships.
NIH has separate appropriations to support research training under the
NRSA authorization at Section 487 of the Public Health Service Act.

The stipends provided to recipients of NRSA support offset the
cost-of-living during the period of training and are not considered
equivalent to salaries or other forms of compensation provided to
individuals supported on research grants. Nevertheless, the entry-level
postdoctoral NRSA stipend provides a useful benchmark for an award
amount that approximates a reasonable rate of compensation for graduate
students. Anticipated escalations in NRSA stipends (see
<http://grants.nih.gov/training/nas_report/NIHResponse.htm>) in future
years should permit annual increases in the maximum award amount for
such individuals.

For all new and competing grant and cooperative agreement awards, the
NIH will provide reasonable amounts for graduate compensation,
consistent with the requested budget for the position(s) and up to the
currently effective NRSA zero postdoctoral stipend level. NIH staff will
review the compensation requested for graduate students on competing and
cooperative agreement applications for which a detailed budget is
submitted. NIH will neither request nor accept budgets for those
applications using a modular budget format solely for the purpose of
reviewing graduate student compensation. However, applicants should use
this policy when estimating the number of modules.

When submitting detailed budgets that request support for a graduate
student, grantees are reminded to request actual institutional-based
compensation and to provide information justifying the requested
compensation level. If this information is not provided, NIH staff will
obtain this information from the institution's business office for any
request that appears excessive.

NIH institutes and centers will review the requested compensation level
and, if considered reasonable, will award the actual amount requested,
up to a maximum equal to the NRSA zero level postdoctoral stipend.
Revised budgets submitted solely to adjust requested levels for graduate
students will not be accepted.

Institutions may continue to rebudget funds to charge more than the
awarded amount provided that OMB cost principles requiring reasonable
compensation are observed. In general, graduate student compensation
will not be considered reasonable if in excess of the amount paid to a
first-year postdoctoral scientist at the same institution performing
comparable work.

## 1.10 DUNS Number

Applicant organizations **must have** a DUN and Bradstreet (D&B) Data
Universal Numbering System (DUNS) number as the Universal Identifier
when applying for Federal grants or cooperative agreements. Form Page 1
includes a field for the organization's DUNS number. The DUNS number is
a nine-digit number assigned by Dun and Bradstreet Information Services.
An authorized organizational official should be consulted to determine
the appropriate number. If the organization does not have a DUNS number,
an authorized organizational official should complete the [US D&B
D-U-N-S Number Request
Form](https://eupdate.dnb.com/requestoptions.html) or contact Dun and
Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain
one. A DUNS number will be provided immediately by telephone at no
charge. Note this is an organizational number. Individual PDs/PIs do not
need to register for a DUNS.

## 1.11 Public Access Policy

The Public Access Policy ensures that the public has access to the
published results of NIH funded research at the NIH Library of
Medicine's (NLM) PubMed Central (PMC), a free digital archive of
full-text biomedical and life sciences journal literature
(<http://www.pubmedcentral.nih.gov/>). Under the policy NIH-funded
investigators are required by Federal law to submit (or have submitted
for them) to PMC an electronic version of the final, peer-reviewed
manuscript upon acceptance for publication, to be made publicly
available no later than 12 months after the official date of
publication. The author's final peer-reviewed manuscript is defined as
the final version accepted for journal publication on or after 4/7/2008,
and includes all modifications from the publishing peer review process,
and all graphics and supplemental material associated with the article.
Institutions and investigators are responsible for ensuring that any
publishing or copyright agreements concerning submitted articles fully
comply with this Policy. Applicants citing articles in NIH application,
proposals, and progress reports that fall under the Policy, were
authored or co-authored by the applicant and arose from the NIH support
must include the PubMed Central reference number (PMCID) or NIH
Manuscript Submission Number (NIHMS ID).

This policy applies to all peer-reviewed articles resulting from
research supported in whole or in part with direct costs from NIH,
including research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L.
Kirschstein National Research Service Awards, SBIR/STTR awards, and NIH
intramural research studies.

Additional information can be found at <http://publicaccess.nih.gov/>.

## 1.12 PHS Metric Program

Consistent with Government-wide implementing regulations, 15 CFR Part
19, Subpart B and/or any other Government-wide requirements, PHS policy
is to support Federal transition to the metric system and to use the
metric system of measurement in all grants, cooperative agreements, and
all other financial assistance awards. Likewise, measurement values in
reports, publications, and other communications regarding grants will be
in metric.

## 1.13 NIH Plans to Transition to the SF424 (R&R) Application and Electronic Submission through Grants.gov

As first announced in August 2005 (See
[NOT-OD-05-067](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html)),
NIH is transitioning from the PHS398 application to the SF424 (R&R)
application and electronic submission through Grants.gov. This
transition is being done by grant mechanism. Applicants should refer to
the Timeline to determine when a particular mechanism has transitioned
to the new form and electronic submission. Information on Transition
Strategy and Timeline can be found at:
<http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm>.

As part of the ongoing effort to keep the PHS398 and the SF424 (R&R)
synchronized, changes in terminology are being implemented throughout
the PHS398 instructions. Specifically, you will see dual references to
types of applications:

-   "Competing Continuation" is now termed "Renewal"

-   "Revision" or "Amendment" is now termed "Resubmission"

-   "Competing Supplement" is now termed "Revision"

During this transition period, both terms are being used together; i.e.,
"Competing Continuation/Renewal."

For more information on NIH's transition plans, see the website for
Electronic Submission of Grant Applications:
<http://era.nih.gov/ElectronicReceipt/>.

# 2. Assurances and Certifications

Each application to the PHS requires that the following assurances and
certifications be verified by checking the "I agree" box on line 18 of
the SF424 (R&R) Cover Component.

#### PI and SO Verification {#pi-and-so-verification .Subhead---No-TOC}

After the PI and SO successfully submit an application, they will
receive an automatically generated email requesting them to view and
verify (or reject) the application on-line in the Commons. To do this,
the PI and SO need to:

1\. Make sure they can log onto the NIH eRA Commons. Before they receive
the email, they should be sure to know their Commons account names and
passwords.

2\. Verify the electronic grant application via the NIH eRA Commons.
Complete instructions on the verification process are in the Applicant
Package.

The assurances listed and explained below may or may not be applicable
to your project, program, or type of applicant organization. There are a
number of additional public policy requirements with which applicants
and grantees must comply. Contact your institution's research grant
administrative office or consult the *NIH Grants Policy Statement* for
additional information. A copy of the [NIH Grants Policy
Statement](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
may be obtained from the NIH website
([http://grants.nih.gov/grants/policy/
policy.htm](http://grants.nih.gov/grants/policy/policy.htm)). When
verifying the submitted application in the eRA Commons, the duly
authorized representative of the applicant organization certifies that
the applicant organization will comply with the following policies,
assurances and/or certifications:

## 2.1 Human Subjects Research

(See also [Part II: Supplemental Instructions for Preparing the Human
Subjects Section of the Research Plan](#Human_Subjects_PartII).)

The DHHS regulations for the protection of human subjects provide a
systematic means, based on established, internationally recognized
ethical principles, to safeguard the rights and welfare of individuals
who participate as subjects in research activities supported or
conducted by the DHHS. The regulations stipulate that the awardee
organization, whether domestic or foreign, bears responsibility for
safeguarding the rights and welfare of human subjects in DHHS-supported
research activities. The regulations require that applicant
organizations proposing to involve human subjects in non-exempt research
hold a Federal-wide Assurance (FWA) with the [Office for Human Research
Protections (OHRP)](http://www.hhs.gov/ohrp/), and establish appropriate
policies and procedures for the protection of human subjects. These
regulations, [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm),
Protection of Human Subjects, are available from the OHRP, Department of
Health and Human Services, The Tower Building, 1101 Wootton Parkway,
Suite 200, Rockville, MD 20852; telephone: 1-866-447-4777 (toll-free) or
(240) 453-6900; email: <ohrp@osophs.dhhs.gov>.

Non-exempt research involving human subjects may only be conducted under
a DHHS award if the organization is operating in accord with an approved
FWA and provides verification that an Institutional Review Board (IRB)
that is registered under the specific FWA has reviewed and approved the
proposed activity in accordance with the DHHS regulations. No award to
an individual will be made unless that individual is affiliated with an
assured organization that accepts responsibility for compliance with the
DHHS regulations. Foreign applicant organizations must also comply with
the provisions of the regulations unless a determination of equivalent
protections is made in accord with 45 CFR 46.101(h).

Under DHHS regulations to protect human subjects, certain research areas
are exempt. (See [Exemption Categories](#Human_Subjects_Exemption_Cat)).
With the exception of research projects that meet the criteria for
Exemption 4, studies that are exempt from the human subjects regulatory
requirements must still address the inclusion of women, minorities and
children in the study design.

Regulations of the Food and Drug Administration (21 CFR 50; 21 CFR 56)
generally apply to biomedical research involving an unapproved drug,
device or biologic, and may apply to certain studies of approved
products. Additional information on FDA regulations is available at
<http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm>.
If work falls under FDA's regulatory requirements, the grantee must
follow both DHHS and FDA human subject protection regulations.

#### Vulnerable Populations

Investigators who conduct research involving pregnant women, human
fetuses and neonates, prisoners, or children, must follow the provisions
of the regulations in Subparts
[B](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartb),
[C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc),
and
[D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd)
of [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm),
respectively. The subparts describe the additional protections required
for conducting research involving these populations. Relevant
information may be obtained at the OHRP website
(<http://www.hhs.gov/ohrp/policy/index.html>).

REMINDER: DHHS regulations at [45 CFR Part 46, subpart
C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc)
describe requirements for additional protections for research involving
prisoners as subjects *or* individuals who become prisoners after the
research has started. Refer to:
[[http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm]{.underline}](http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm)
for complete instructions.

[Exemptions 1-6](#Human_Subjects_Exemption_Cat) (see Exemptions under
Human Subjects Research Definitions and Terms, Part III.3) do **not**
apply to research involving prisoners or subjects who become prisoners
([see Subpart
C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc)).
Although Exemptions 1 and 3-6 apply to research involving children ([see
Subpart
D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd)),
[Exemption 2](#Human_Subjects_Exemption2) can only be used for research
involving educational testing or observations of public behavior when
the investigator(s) do not participate in the activities being observed.

#### Data and Safety Monitoring

For each proposed clinical trial, NIH requires a data and safety
monitoring plan that describes oversight and monitoring to ensure the
safety of participants and the validity and integrity of the data. The
level of monitoring should be commensurate with the risks and the size
and complexity of the clinical trial. Prior to the accrual of human
subjects, a detailed data and safety monitoring plan must be submitted
to the applicant's IRB and to the funding entity for approval. Adverse
Events must be reported to the IRB, the NIH funding Institute or Center,
and other appropriate offices or agencies. This policy requirement is in
addition to any monitoring requirements imposed by [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

NIH Policy specifically requires the establishment of Data and Safety
Monitoring Boards (DSMBs) for multi-site clinical trials involving
interventions that entail potential risk to the participants, and
generally for Phase III clinical trials. A DSMB also may be appropriate
for clinical trials if the studies are blinded (masked), employ
high-risk interventions, or involve vulnerable populations.

Summary reports of adverse events must be provided to the NIH funding IC
and to individual IRBs in order for them to address reports related to
the site for which they have responsibility. Grantees should address
questions on this subject to the NIH Program Official.

Further information concerning these requirements is contained in
several *NIH Guide for Grants and Contracts* notices
(<http://grants.nih.gov/grants/guide/notice-files/not98-084.html> and
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html>).

#### Required Education in the Protection of Human Research Participants

NIH requires education on the protection of human research participants
for all individuals identified in PHS applications as Senior/key
Personnel who will be involved in the design or conduct of human
subjects research, before funds are awarded for applications or contract
proposals involving human subjects. For information relating to this
requirement, see the following notices:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html> and
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html>,
and Frequently Asked Questions at
<http://grants.nih.gov/grants/policy/hs_educ_faq.htm>. Prior to award,
applicants will be required to provide a description of education
completed in the protection of human subjects for all Senior/key
Personnel involved in the design or conduct of human subjects research.
Although NIH does not endorse specific programs, there are curricula
available that can provide guidance or that can be modified to provide
training in this area. See
<http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp>
for computer-based training developed for NIH that can be downloaded at
no charge. For information on facilitating education and developing
curricula, see <http://www.nih.gov/sigs/bioethics>.

### 2.1.1 Research on Transplantation of Human Fetal Tissue

In checking the "I agree" box on line 18 of the SF424 (R&R) Cover
Component, the Authorized Organizational Representative of the applicant
organization certifies that if research on the transplantation of human
fetal tissue is conducted, the applicant organization will make
available, for audit by the Secretary, DHHS, the physician statements
and informed consents required by section 498A (b)(2) and (c) of the
Public Health Service Act, 42 U.S.C. 289g (b)(2) and (c), or ensure DHHS
access to those records, if maintained by an entity other than the
applicant organization.

### 2.1.2 Research Using Human Embryonic Stem Cells

In checking the "I agree" box on line 18 of the SF424 (R&R) Cover
Component, the Authorized Organizational Representative of the applicant
organization certifies that if research using human embryonic stem cells
is proposed, the applicant organization will be in compliance with the
"Notice of Extended Receipt Date and Supplemental Information Guidance
for Applications Requesting Funding that Proposes Research with Human
Embryonic Stem Cells"
(<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html>).
See also <http://stemcells.nih.gov/index.asp> for additional guidance on
stem cells and <http://stemcells.nih.gov/policy/guidelines.asp> for
Federal policy statements and guidelines on federally funded stem cell
research.

### 2.1.3 NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research

NIH policy requires that women and members of minority groups and their
subpopulations must be included in all NIH-supported biomedical and
behavioral research projects involving [clinical
research](#Human_Subjects_Defs_ClinicalResearch) unless a clear and
compelling rationale and justification establishes to the satisfaction
of the relevant IC Director that inclusion is inappropriate with respect
to the health of the subjects or the purpose of the research. Exclusion
under other circumstances may be made by the Director, NIH, upon the
recommendation of an IC Director based on a compelling rationale and
justification. Cost is not an acceptable reason for exclusion except
when the study would duplicate data from other sources. Women of
childbearing potential should not be routinely excluded from
participation in clinical research. All NIH-supported biomedical and
behavioral research involving human subjects is defined as clinical
research. This policy applies to research subjects of all ages.

The inclusion of women and members of minority groups and their
subpopulations must be addressed in developing a research design
appropriate to the scientific objectives of the study. The Research Plan
should describe the composition of the proposed study population in
terms of sex/gender and racial/ethnic group, and provide a rationale for
selection of such subjects. Such a plan should contain a description of
the proposed outreach programs for recruiting women and minorities as
participants. See
<http://grants.nih.gov/grants/funding/women_min/women_min.htm>.

### 2.1.4 NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research

See NIH Policy on Reporting Ethnicity/Race and Sex/Gender in Clinical
Research in [Part II,
5.8](#nih-policy-on-reporting-race-and-ethnicity-data-subjects-in-clinical-research).

The Office of Management and Budget (OMB) defines minimum standards for
maintaining, collecting, and presenting data on race and ethnicity for
all grant, contract, and intramural proposals and for all active
research grants, cooperative agreements, contracts, and intramural
projects. The minimum standards are described in the 1997 OMB Directive
15, <http://www.whitehouse.gov/omb/fedreg/ombdir15.html>.

The standards were revised in 1997 and include two ethnic categories
(Hispanic or Latino, and Not Hispanic or Latino) and five racial
categories (American Indian or Alaska Native, Asian, Black or African
American, Native Hawaiian or Other Pacific Islander, and White). The
categories in this classification are social-political constructs and
should not be interpreted as being anthropological in nature. NIH is
required to use these definitions to allow comparisons to other Federal
databases, especially the census and national health databases. Federal
agencies will not present data on detailed categories if doing so would
compromise data quality or confidentiality standards.

Collection of this information and use of these categories is required
for research that meets the NIH definition of [clinical
research](#Human_Subjects_Defs_ClinicalResearch). See Part II, 5.8 for
additional information.

### 2.1.5 NIH Policy on Inclusion of Children

Research involving children (see definition of
"[child](#Human_Subjects_Defs_Child)") must comply with the NIH Policy
and Guidelines on the Inclusion of Children in Clinical Research.
Investigators should obtain full copies of the Policy and Guidelines
from NIH staff, or from
<http://grants.nih.gov/grants/funding/children/children.htm>.

NIH policy requires that children (i.e., individuals under the age of
21) must be included in all clinical research, conducted or supported by
the NIH unless there are clear and compelling reasons not to include
them. Therefore, proposals for clinical research must include a
description of plans for including children. If children will be
excluded from the research, the application or proposal must present an
acceptable justification for the exclusion.

The involvement of children as subjects in research must be in
compliance with all applicable subparts of [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) as well
as with other pertinent Federal laws and regulations.

IRBs have special review requirements to protect the well-being of
children who participate in research. These requirements relate to risk,
benefit, parental/guardian consent, and assent by children, and to
research involving children who are wards of the state or of another
institution. The local IRB approves research that satisfies the
conditions set forth in the regulations.

### 2.1.6 ClinicalTrials.gov

In checking the "I agree" box on line 18 of the SF424 (R&R) Cover
Component, the Authorized Organizational Representative of the applicant
organization assures compliance with Public Law 110-85, enacted
09/27/2007, if applicable
(<http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf>).
The law amends the Public Health Service Act to expand the scope of
clinical trials that must be registered in ClinicalTrials.gov. It also
increases the number of registration fields that must be submitted,
requires certain results information to be included, and sets penalties
for noncompliance.

The trials that must be registered are called "applicable clinical
trials." Under the statute these trials generally include: (1) Trials of
Drugs and Biologics: Controlled, clinical investigations, other than
Phase 1 investigations, of a product subject to FDA regulation; and (2)
Trials of Devices: Controlled trials with health outcomes, other than
small feasibility studies, and pediatric postmarket surveillance. NIH
encourages registration of ALL trials whether required under the law or
not.

For additional information see NIH Guide Notices at
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html> and
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html>.

## 2.2 Vertebrate Animals

NIH no longer requires Institutional Animal Care and Use Committee
(IACUC) approval of the proposed research **before NIH peer review** of
an application ([http://grants.nih.gov/
grants/guide/notice-files/NOT-OD-02-064.html](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-064.html)).

In August, 2002 NIH announced an IACUC "just-in-time" process for
applications submitted for the October 1, 2002 deadline or other
deadlines where the applications had a May/June 2003 Council review. The
PHS policy requirement that no award may be made without an approved
Assurance and without verification of IACUC approval remains in effect.
The new policy gave institutions flexibility in the timing of IACUC
review relative to the submission of an application and the verification
of IACUC review. The policy does not require that IACUC approval be
deferred. Institutional officials retain the discretion to require IACUC
approval prior to NIH peer review in circumstances of their choosing if
deemed necessary. As part of the NIH peer review process, the scientific
review group will continue to address the adequacy of animal usage and
protections in the review of an application and will continue to raise
any concerns about animal welfare issues. Verification of IACUC approval
will be required in a "just-in-time" fashion prior to award.

The PHS *Policy on Humane Care and Use of Laboratory Animals* requires
that applicant organizations proposing to use vertebrate animals file a
written Animal Welfare Assurance with the Office of Laboratory Animal
Welfare (OLAW), establishing appropriate policies and procedures to
ensure the humane care and use of live vertebrate animals involved in
research activities supported by the PHS. The PHS policy stipulates that
an applicant organization, whether domestic or foreign, bears
responsibility for the humane care and use of animals in PHS-supported
research activities. This policy implements and supplements the *U.S.
Government Principles for the Utilization and Care of Vertebrate Animals
Used in Testing, Research, and Training* and requires that institutions
use the *Guide for the Care and Use of Laboratory Animals* as a basis
for developing and implementing an institutional animal care and use
program. This policy does not affect applicable state or local laws or
regulations that impose more stringent standards for the care and use of
laboratory animals. All institutions are required to comply, as
applicable, with the Animal Welfare Act as amended (7 USC 2131 et sec.)
and other Federal statutes and regulations relating to animals. These
documents are available from the Office of Laboratory Animal Welfare,
National Institutes of Health, Bethesda, MD 20892, (301) 496-7163.

The PHS policy defines "animal" as "any live, vertebrate animal used or
intended for use in research, research training, experimentation or
biological testing or for related purposes."

No PHS award for research involving vertebrate animals will be made to
an applicant organization unless that organization is operating in
accordance with an approved Animal Welfare Assurance and provides
verification that the IACUC has reviewed and approved the proposed
activity in accordance with the PHS policy. Applications may be referred
by the PHS back to the IACUC for further review in the case of apparent
or potential violations of the PHS policy. No award to an individual
will be made unless that individual is affiliated with an assured
organization that accepts responsibility for compliance with the PHS
policy. Foreign applicant organizations applying for PHS awards for
activities involving vertebrate animals are required to comply with PHS
policy or provide evidence that acceptable standards for the humane care
and use of animals will be met.

## 2.3 Debarment and Suspension

Executive Order 12549, "Debarment and Suspension," mandated development
of a Government-wide debarment and suspension system for nonprocurement
transactions with Federal agencies. Executive Order 12689 and Section
2455 of the Federal Acquisition Streamlining Act of 1994 further
required Federal agencies to establish regulations for reciprocal
Government-wide effect across procurement and nonprocurement debarment
and suspension actions. This reciprocity rule is effective for any
debarment, suspension or other Government-wide exclusion initiated on or
after August 25, 1995.

DHHS regulations implementing Executive Orders 12549 and 12689 and
Section 2455 of the Federal Acquisition Regulation are provided in 45
CFR 76, "Government-wide Debarment and Suspension (Nonprocurement)."
Changes in this Government-wide requirement (adopted in the November 26,
2003 Federal Register Notice) now implement this as a term and condition
of an award.

## 2.4 Drug-Free Workplace

DHHS regulations implementing the Drug-Free Workplace Act of 1988
(Public Law 100-690, Title V, Subtitle D) are now provided in 45 CFR 82,
"Government-wide Requirements for Drug-Free Workplace (Financial
Assistance)." Changes in this Government-wide requirement (adopted in
the November 26, 2003 Federal Register Notice) now implement this as a
term and condition of an award.

## 2.5 Lobbying

Title 31, United States Code, Section 1352, entitled "Limitation on Use
of Appropriated Funds to Influence Certain Federal Contracting and
Financial Transactions," generally prohibits recipients of Federal
grants and cooperative agreements from using Federal (appropriated)
funds for lobbying the Executive or Legislative Branches of the Federal
Government in connection with a specific grant or cooperative agreement.
Section 1352 also requires that each person who requests or receives a
Federal grant or cooperative agreement must disclose lobbying undertaken
with non-Federal (nonappropriated) funds. These requirements apply to
grants and cooperative agreements exceeding \$100,000 in total costs.
DHHS regulations implementing Section 1352 are provided in 45 CFR Part
93, "New Restrictions on Lobbying."

The complete Certification Regarding Lobbying is provided below.

"The undersigned (authorized official signing for the applicant
organization) certifies, to the best of his or her knowledge and belief
that:

"(1) No Federal appropriated funds have been paid or will be paid, by or
on behalf of the undersigned, to any person for influencing or
attempting to influence an officer or employee of any agency, a Member
of Congress, an officer or employee of Congress, or an employee of a
Member of Congress in connection with the awarding of any Federal
contract, the making of any Federal grant, the making of any Federal
loan, the entering into of any cooperative agreement, and the extension,
continuation, renewal, amendment, or modification of any Federal
contract, grant, loan, or cooperative agreement.

"(2) If any funds other than Federally appropriated funds have been paid
or will be paid to any person for influencing or attempting to influence
an officer or employee of any agency, a Member of Congress, an officer
or employee of Congress, or an employee of a Member of Congress in
connection with this Federal contract, grant, loan, or cooperative
agreement, the undersigned shall complete and submit Standard Form LLL,
"Disclosure of Lobbying Activities," in accordance with its
instructions.

"(3) The undersigned shall require that the language of this
certification be included in the award documents for all subawards at
all tiers (including subcontracts, subgrants, and contracts under
grants, loans and cooperative agreements) and that all subrecipients
shall certify and disclose accordingly.

"This certification is a material representation of fact upon which
reliance was placed when this transaction was made or entered into.
Submission of this certification is a prerequisite for making or
entering into this transaction imposed by section 1352, U.S. Code. Any
person who fails to file the required certification shall be subject to
a civil penalty of not less than \$10,000 and not more than \$100,000
for each such failure."

Standard Form LLL, "Disclosure of Lobbying Activities," its
instructions, and continuation sheet are available from GrantsInfo,
National Institutes of Health, email:
[GrantsInfo@nih.gov](mailto:grantsinfo@nih.gov), (301) 435-0714.

#### Prohibition on Awards to 501(c)4 Organizations That Lobby  {#prohibition-on-awards-to-501c4-organizations-that-lobby .Subhead---No-TOC}

Organizations described in section 501(c)4 of the Internal Revenue Code
of 1968 that engage in lobbying are not eligible to receive
grant/cooperative agreement awards. This is not to be confused with 45
CFR Part 93, Section 1352, "New Restrictions on Lobbying."

## 2.6 Non-Delinquency on Federal Debt

The Federal Debt Collection Procedure Act, 28 U.S.C. 3201 (e), provides
that an organization or individual that is indebted to the United
States, and has a judgment lien filed against it, is ineligible to
receive a Federal grant. NIH cannot award a grant unless the authorized
organizational official of the applicant organization (or individual as
in the case of an individual Ruth L. Kirschstein National Research
Service Award) certifies, by means of his/her signature on the
application, that the organization is not delinquent in repaying any
Federal debt. If the applicant discloses delinquency on a debt owed to
the Federal Government, NIH may not award the grant until the debt is
satisfied or satisfactory arrangements are made with the agency to which
the debt is owed.

## 2.7 Research Misconduct 

Each institution that receives or applies for a research, research
training, or research-related grant or cooperative agreement under the
Public Health Service Act must certify that the institution has
established administrative policies as required by 42 CFR Part 93,
"Public Health Service Policies on Research Misconduct."

In checking the "I agree" box on line 18 of the SF424 (R&R) Cover
Component, the Authorized Organizational Representative of the applicant
organization certifies that:

1\. The institution will comply with the requirements of the PHS
regulations for dealing with reporting possible scientific misconduct
under 42 CFR Part 50, Subpart A, and for protecting research misconduct
whistleblowers under 42 CFR Part 94;

2\. The institution has established policies and procedures
incorporating the provisions set forth in 42 CFR Part 50, Subpart A, and
42 CFR Part 94;

3\. The institution will provide its policies and procedures to the
Office of Research Integrity upon request; and

4\. The institution will submit an Annual Report on Possible Research
Misconduct (Form 6349). A copy of Form 6349, covering the previous year,
will be automatically sent to all PHS awardees by the Office of Research
Integrity each January.

Research Misconduct is defined by the Public Health Service as
"fabrication, falsification or plagiarism in proposing, performing, or
reviewing research, or in reporting research results."

\(a\) Fabrication is making up data or results and recording or
reporting them.

\(b\) Falsification is manipulating research materials, equipment, or
processes, or changing or omitting data or results such that the
research is not accurately represented in the research record.

\(c\) Plagiarism is the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit.

\(d\) Research misconduct does not include honest error or differences
of opinion.

For further information, please contact:

U.S. Department of Health and Human Services

Office of Research Integrity

1101 Wootton Parkway, Suite 750

Rockville, MD 20852

> <AskORI@osophs.dhhs.gov>

Phone: (240) 453-8200

Fax: (301) 443-5351.

## 2.8 Assurance of Compliance (Civil Rights, Handicapped Individuals, Sex Discrimination, Age Discrimination)

Before a grant award can be made, a domestic applicant organization must
certify that it has filed with the DHHS Office for Civil Rights: an
Assurance of Compliance (Form HHS 690) with Title VI of the Civil Rights
Act of 1964 (P.L. 88352, as amended), which prohibits discrimination on
the basis of race, color, or national origin; Section 504 of the
Rehabilitation Act of 1973 (P.L. 93-112, as amended), which prohibits
discrimination on the basis of handicaps; Title IX of the Education
Amendments of 1972 (P.L. 92-318, as amended), which prohibits
discrimination on the basis of sex; and the Age Discrimination Act of
1975 (P.L. 94-135), which prohibits discrimination on the basis of age.

The Assurance of Compliance Form HHS 690 is available from
<http://www.hhs.gov/ocr/ps690.pdf>.

Assurance of Compliance Form HHS 690 is now used in lieu of individual
assurances: Form HHS 441, Civil Rights; Form HHS 641, Handicapped
Individuals; Form HHS 639-A, Sex Discrimination; and Form HHS 680, Age
Discrimination.

## 2.9 Research Involving Recombinant DNA, including Human Gene Transfer Research

The *National Institutes of Health Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines)* apply to all projects
(NIH-funded and non-NIH-funded) involving recombinant DNA molecules that
are conducted at or sponsored by an institution that receives NIH
support for recombinant DNA research. As defined by the *NIH
Guidelines*, recombinant DNA molecules are either: (1) molecules that
are constructed outside living cells by joining natural or synthetic DNA
segments to DNA molecules that can replicate in a living cell; or (2)
DNA molecules that result from the replication of those described in
(1). The *NIH Guidelines* set forth principles and standards for safe
and ethical conduct of recombinant DNA research and apply to both basic
and clinical research studies. The *NIH Guidelines* should be carefully
reviewed and implemented to ensure that proper biosafety and containment
practices are employed for all projects involving recombinant DNA
research, including review by an Institutional Biosafety Committee that
meets the requirements of the *NIH Guidelines*. Further, the *NIH
Guidelines* include special review and reporting requirements for the
conduct of human gene transfer studies (under Appendix M). Failure to
comply with the *NIH Guidelines* may result in suspension, limitation,
or termination of NIH funds for recombinant DNA research at the
organization or a requirement for NIH prior approval of any or all
recombinant DNA projects at the organization. A copy of *the NIH
Guidelines* is posted at the following URL:
<http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html> and may be
obtained from the NIH Office of Biotechnology Activities, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892, 301-496-9838.

## 2.10 Financial Conflict of Interest

NIH requires grantees and investigators (except Phase I SBIR/STTR
applicants) to comply with the requirements of 42 CFR Part 50, Subpart
F, "Responsibility of Applicants for Promoting Objectivity in Research
for which PHS Funding is Sought." These requirements promote objectivity
in research by establishing standards to ensure there is no reasonable
expectation that the design, conduct, or reporting of research funded
under PHS grants or cooperative agreements will be biased by any
conflicting financial interest of an investigator.

In checking the "I agree" box on line 18 of the SF424 (R&R) Cover
Component, the Authorized Organizational Representative of the applicant
organization certifies compliance with the requirements of 42 CFR Part
50, Subpart F, including that:

1\. There is in effect at the organization a written and enforced
administrative process to identify and manage, reduce, or eliminate
conflicting financial interests with respect to research projects for
which NIH funding is sought.

2\. Prior to the expenditure of any NIH funds awarded under a new award,
the organization will inform NIH of the existence of any conflicting
financial interests of the type covered by 42 CFR 50.605 and assure that
the interest has been managed, reduced, or eliminated in accordance with
the regulations;

3\. The Institution will continue to make similar reports on
subsequently identified conflicts within 60 days of identification.

4\. When the Institution determines that a financial conflict of
interest exists (see #2 and #3 above), the Institution must notify the
NIH awarding component Chief Grants Management Officer of its existence
and provide the following information:

-   Grant number and Principal Investigator;

-   Name of Investigator with FCOI; and

-   Distinguish which method was used to protect the involved PHS funded
    research from bias (i.e., managed, reduced, or eliminated).

5\. When requested, the Institution will make information available to
NIH regarding all identified conflicting interests and how those
interests have been managed, reduced, or eliminated to protect the
research from bias.

## 2.11 Smoke-Free Workplace

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and to promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and advance
the physical and mental health of the American people.

## 2.12 Prohibited Research

#### BAN ON FUNDING OF HUMAN EMBRYO RESEARCH (Section 510) {#ban-on-funding-of-human-embryo-research-section-510 .Subhead---No-TOC}

This section continues the current ban that prohibits NIH from using
appropriated funds to support human embryo research. Grant, cooperative
agreement, and contract funds may not be used for: "(a)...(1) the
creation of a human embryo or embryos for research purposes; or
(2)research in which a human embryo or embryos are destroyed, discarded,
or knowingly subjected to risk of injury or death greater than that
allowed for research on fetuses in utero under 45 CFR Part 46.208(a)(2)
and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).
(b) For purposes of this section, the term 'human embryo or embryos'
includes any organism not protected as a human subject under [45 CFR
Part 46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) as
of the date of the enactment of this Act, that is derived by
fertilization, parthenogenesis, cloning, or any other means from one or
more human gametes or human diploid cells."

The NIH has published final guidelines on the allowability of Federal
funds to be used for research on existing human embryonic stem cell
lines. The URL is <http://stemcells.nih.gov/index.asp>.

#### LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED SUBSTANCES (Section 511) {#limitation-on-use-of-funds-for-promotion-of-legalization-of-controlled-substances-section-511 .Subhead---No-TOC}

"(a) None of the funds made available in this Act may be used for any
activity that promotes the legalization of any drug or other substance
included in schedule I of the schedules of controlled substances
established by section 202 of the Controlled Substances Act (21
U.S.C.812). (b)The limitation in subsection (a) shall not apply when
there is significant medical evidence of a therapeutic advantage to the
use of such drug or other substance or that Federally sponsored clinical
trials are being conducted to determine therapeutic advantage."

#### RESTRICTION ON DISTRIBUTION OF STERILE NEEDLES (Section 505)  {#restriction-on-distribution-of-sterile-needles-section-505 .Subhead---No-TOC}

"Notwithstanding any other provision of this Act, no funds appropriated
under this Act shall be used to carry out any program of distributing
sterile needles or syringes for the hypodermic injection of any illegal
drug."

#### RESTRICTION ON ABORTIONS (Section 508) {#restriction-on-abortions-section-508 .Subhead---No-TOC}

"(a) None of the funds appropriated under this Act, and none of the
funds in any trust fund to which funds are appropriated under this Act,
shall be expended for any abortion."

## 2.13 Select Agent Research

The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 (P.L. 107-188) is designed to provide protection against
misuse of select agents and toxins whether inadvertent or the result of
terrorist acts against the United States homeland or other criminal
acts. The Act was implemented, in part, through regulations published by
CDC at 42 CFR 73 \<[http://www.cdc.gov/od/sap/docs/
42cfr73.pdf](http://www.cdc.gov/od/sap/docs/42cfr73.pdf)\>, Select
Agents and Toxins.

As a term of award, grantees who conduct research involving Select
Agents (see 42 CFR 73 for the list; and 7 CRF 331 and 9 CFR 121 for the
relevant animal and plant pathogens) are reminded that they must
complete registration with CDC (or USDA, depending on the agent) before
using NIH funds. No funds can be used for research involving Select
Agents if the final registration certificate is denied.

In addition to the above requirements, research involving **both select
agents and recombinant DNA** is also subject to the NIH Guidelines for
Research Involving DNA Molecules (NIH Guidelines) (see Section 2.9
Research Involving Recombinant DNA, including Human Gene Transfer
Research in this subsection for applicability of these guidelines).

For additional information regarding Select Agent research, see the
following websites maintained by NIH, CDC, and USDA:

NIH Office of Extramural Research Select Agent Information:
<http://grants.nih.gov/grants/policy/select_agent/>

Center for Disease Control Select Agent Program:
<http://www.cdc.gov/od/sap/index.htm>

Center for Disease Control Select Agent Program Guidelines:
<http://www.cdc.gov/od/sap/guidelines.htm>

Center for Disease Control Select Agent Program Public Laws and
Regulations: <http://www.cdc.gov/od/sap/regulations.htm>

Center for Disease Control Select Agent Program Related Links:
<http://www.cdc.gov/od/sap/regulations.htm>

Animal and Plant Health Inspection Service (APHIS) Select Agent Program:
<http://www.aphis.usda.gov/programs/ag_selectagent/>

## 2.14 Principal Investigator Assurance

The applicant organization agrees to secure and retain a written
assurance from the Principal Investigator (PI) prior to submitting an
application to the PHS. While this assurance is no longer required as
part of the submitted application, it remains a compliance requirement.
Therefore, organizations must retain a unique signature and date for
each submitted application. This assurance must be available to the
sponsoring agency or other authorized DHHS or Federal officials upon
request. Such an assurance must include at least the following
certifications: 1) that the information submitted within the application
is true, complete and accurate to the best of the PI's knowledge; 2)
that any false, fictitious, or fraudulent statements or claims may
subject the PI to criminal, civil, or administrative penalties; and 3)
that the PI agrees to accept responsibility for the scientific conduct
of the project and to provide the required progress reports if a grant
is awarded as a result of the application. If multiple PIs are proposed
in an application, this assurance must be retained for all named PIs.

## 2.15 Impact of Grant Activities on the Environment and Historic Properties

All NIH grants, whether or not they include construction or major
alteration and renovation activities, are subject to the requirements of
the National Environmental Policy Act of 1969 (ACT), as amended. This
Act requires Federal agencies to consider the probable environmental
consequences of all grant-supported activities. As part of NIH's
implementation of this Act, grantees are required to promptly notify NIH
of any probable impacts on the environment from grant-supported
activities, or certify that no such activities exist upon receipt of a
grant award. This requirement is in addition to the other public policy
requirements for grants for construction and alteration and renovation
activities discussed more fully in the NIH Grants Policy Statement
Construction Grants -- Public Policy Requirements and Objectives.

Additionally, all NIH grant awards should not involve activities that
violate provisions of the National Historic Preservation Act of 1966 or
other statutory requirements. All grantees are subject to the
requirements of Executive Order 13287 -- Preserve America, requiring
notification to NIH of all activities that would affect any historic
property, or certification that no impact will occur upon receipt of the
grant award or in a post-award action without NIH prior approval. For
the purposes of the Order, historic property is defined to include any
prehistoric or historic district, site, or object included in, or
eligible for inclusion in, the National Register of Historic Places
maintained by the Secretary of the Interior. This term includes
artifacts, records, and remains that are related to and located within
such properties. The term includes properties of traditional religious
and cultural importance to an Indian tribe or Native Hawaiian
organization and that meet the National Register criteria.

# 3. Definitions

**AIDS Related.** Includes: (1) projects relating to the etiology,
epidemiology, natural history, diagnosis, treatment, or prevention of
AIDS; (2) various sequelae specifically associated with the syndrome;
and (3) preparation and screening of anti-AIDS agents as well as vaccine
development, including both preclinical and clinical studies. Not all
applications examining various influences on T-lymphocytes or
retroviruses will be appropriate for the expedited AIDS review process.
Applications only indirectly related to AIDS will be evaluated by
established Scientific Review Groups (SRGs) appropriate to the
scientific discipline during regular NIH review cycles and should not be
submitted in response to the expedited AIDS receipt dates. Applicants
are urged to take note of the yearly NIH Plan for HIV-Related Research
and indicate how their application addresses the NIH priorities set
forth in that Plan. The Plan can be found on the [NIH Office of AIDS
Research](http://www.oar.nih.gov/) homepage.

**Animal.** Any live, vertebrate animal used or intended for use in
research, research training, experimentation, or biological testing or
for related purposes at the applicant organization or any collaborating
site or other performance site.

#### Applicant Organization Types. {#applicant-organization-types. .Subhead---No-TOC}

***[Federal:]{.underline}*** A cabinet-level department or independent
agency of the Executive Branch of the Federal Government or any
component part of such a department or agency that may be assigned the
responsibility for carrying out a grant-supported program.

***[State:]{.underline}*** Any agency or instrumentality of a state
government of any of the United States or its territories.

***[Local:]{.underline}*** Any agency or instrumentality of a political
subdivision of government below the State level.

***[Nonprofit:]{.underline}*** An institution, corporation, or other
legal entity no part of whose net earnings may lawfully inure to the
benefit of any private shareholder or individual.

***[For profit:]{.underline}*** An institution, corporation, or other
legal entity, which is organized for the profit or benefit of its
shareholders or other owners. A "for profit" organization is considered
to be a small business if it is independently owned and operated, if it
is not dominant in the field in which research is proposed, and if it
employs no more than 500 persons. Also see definition for Small Business
Concern.

***[Small Business Concern:]{.underline}*** A small business concern is
one that, at the time of award of Phase I and Phase II, meets **all** of
the following criteria:

1\. Is independently owned and operated, is not dominant in the field of
operation in which it is proposing, has its principal place of business
located in the United States, and is organized for profit.

2\. Is at least 51% owned and controlled by either: (a) one or more
natural persons (individuals who are citizens of, or permanent resident
aliens in, the United States); or (b) another for-profit business
concern that is itself at least 51% owned and controlled by one or more
natural persons (individuals who are citizens of, or permanent resident
aliens in, the United States)(See 13 CFR 121.105 (defining "business
concern")).

3\. Has, including its affiliates, ***a number of employees not
exceeding 500***, and meets the other regulatory requirements found in
13 CFR Part 121. Business concerns, other than investment companies
licensed, or state development companies qualifying under the Small
Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates
of one another when either directly or indirectly, (a) one concern
controls or has the power to control the other; or (b) a
third-party/parties controls or has the power to control both.

Control can be exercised through common ownership, common management,
and contractual relationships. The term "affiliates" is defined in
greater detail in 13 CFR Part 121, as is the process for calculating
"number of employees."

Business concerns include, but are not limited to, any individual (sole
proprietorship), partnership, corporation, joint venture, association,
or cooperative. Further information may be obtained by contacting the
Small Business Administration Size District Office at
<http://www.sba.gov/size/>.

***[Socially and Economically Disadvantaged Small Business
Concern:]{.underline}*** A socially and economically disadvantaged small
business concern is one that is at least 51% owned by (a) an Indian
tribe or a native Hawaiian organization, or (b) one or more socially and
economically disadvantaged individuals; **and** whose management and
daily business operations are controlled by one or more socially and
economically disadvantaged individuals.

***[Women-Owned Small Business Concern]{.underline}***: A small business
concern that is at least 51% owned by a woman or women who also control
and operate it. "Control" in this context means exercising the power to
make policy decisions. "Operate" in this context means being actively
involved in the day-to-day management.

**Clinical Research.** See [Human Subjects Research Definitions and
Terms](#Human_Subjects_Res_Defs).

**Coded.** See [Human Subjects Research Definitions and
Terms](#Human_Subjects_Res_Defs).

**Co-investigator.** An individual involved with the Program
Director/Principal Investigator (PD/PI) in the scientific development or
execution of the project. The co-investigator (collaborator) may be
employed by, or be affiliated with, the applicant/grantee organization
or another organization participating in the project under a consortium
agreement. This individual would typically devote a specific percent of
effort to the project and would be identified as Senior/Key Personnel.
The designation of a co-investigator, if applicable, does not affect the
PD/PI's roles and responsibilities as specified in the [*Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).

**Commercialization.** The process of developing markets and producing
and delivering products for sale (whether by the originating party or by
others). As used here, commercialization includes both government and
private sector markets.

**Consortium Agreement.** A formalized agreement whereby a research
project is carried out by the grantee and one or more other
organizations that are separate legal entities. Under the agreement, the
grantee must perform a substantive role in the conduct of the planned
research and not merely serve as a conduit of funds to another party or
parties. These agreements typically involve a specific percent of effort
from the consortium organization's PD/PI and a categorical breakdown of
costs, such as personnel, supplies, and other allowable expenses,
including Facilities and Administrative costs.

**Consultant.** An individual who provides professional advice or
services for a fee, but normally not as an employee of the engaging
party. In unusual situations, an individual may be both a consultant and
an employee of the same party, receiving compensation for some services
as a consultant and for other work as a salaried employee. To prevent
apparent or actual conflicts of interest, grantees and consultants must
establish written guidelines indicating the conditions of payment of
consulting fees. Consultants may also include firms that provide paid
professional advice or services.

**Consulting fees.** The fee paid by an institution to a salaried member
of its faculty is allowable only in unusual cases and only if both of
the following conditions exist: (1) the consultation crosses
departmental lines or involves a separate operation; and (2) the work
performed by the consultant is in addition to his or her regular
workload.

In all other cases, consulting fees paid to employees of recipient or
cost-type contractor organizations in addition to salary may be charged
to PHS grant-supported projects only in unusual situations and when all
of the following conditions exist: (1) the policies of the recipient or
contractor permit such consulting fee payments to its own employees
regardless of whether Federal grant funds are received; (2) the
consulting services are clearly outside the scope of the individual's
salaried employment; and (3) it would be inappropriate or not feasible
to compensate the individual for these services through payment of
additional salary.

For additional clarification on the allowance and appropriateness of
consulting fees, refer to the [*NIH Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).

**Cooperative Agreement.** A financial assistance mechanism that will
have substantial Federal scientific and/or programmatic involvement.
Substantial programmatic involvement means that after award, scientific
or program staff will assist, guide, coordinate, or participate in
programmatic activities beyond the normal stewardship responsibility in
the administration of grants. Proposed cooperative agreements will be
published as policy announcements, Program Announcements, or Requests
for Applications.

**Equipment.** An article of tangible nonexpendable personal property
that has a useful life of more than one year and an acquisition cost per
unit that equals or exceeds the lesser of the capitalization threshold
established by the organization or \$5,000.

**Essentially Equivalent Work.** This term is meant to identify
"scientific overlap," which occurs when (1) substantially the same
research is proposed for funding in more than one contract proposal or
grant application submitted to the same Federal agency; **or** (2)
substantially the same research is submitted to two or more different
Federal agencies for review and funding consideration; **or** (3) a
specific research objective and the research design for accomplishing
that objective are the same or closely related in two or more proposals
or awards, regardless of the funding source.

**Feasibility.** The extent to which a study or project may be done
practically and successfully.

[]{#Definitions_Foreign .anchor}**Foreign Component.** The performance
of any significant scientific element or segment of a project outside of
the United States, either by the grantee or by a researcher employed by
a foreign organization, whether or not grant funds are expended.
Activities that would meet this definition include, but are not limited
to: (1) the involvement of human subjects or animals; (2) extensive
foreign travel by grantee project staff for the purpose of data
collection, surveying, sampling, and similar activities; or (3) any
activity of the grantee that may have an impact on U.S. foreign policy
through involvement in the affairs or environment of a foreign country.
Foreign travel for consultation is not considered a foreign component.

**Full-Time Appointment**. The number of days per week and/or months per
year representing full-time effort at the applicant/grantee
organization, as specified in organizational policy. The organization's
policy must be applied consistently regardless of the source of support.

**Grant.** A financial assistance mechanism providing money, property,
or both to an eligible entity to carry out an approved project or
activity. A grant is used whenever the NIH Institute or Center
anticipates no substantial programmatic involvement with the recipient
during performance of the financially assisted activities.

[]{#Human_Subjects_Res_Defs .anchor}**Human Subjects Research
Definitions and Terms.**

***[Autopsy Materials.]{.underline}*** The use of autopsy materials is
governed by applicable Federal, state and local law and is not directly
regulated by 45 CFR Part 46.

[]{#Human_Subjects_Defs_Child .anchor}***[Child.]{.underline}*** The NIH
Policy on Inclusion of Children defines a child as an individual under
the age of 21 years. The intent of the NIH policy is to provide the
opportunity for children to participate in research studies when there
is a sound scientific rationale for including them, and their
participation benefits children and is appropriate under existing
Federal guidelines. Thus, children must be included in NIH conducted or
supported clinical research unless there are scientific or ethical
reasons not to include them.

DHHS Regulations ([45 CFR Part 46, Subpart
D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd),
Sec.401-409) provide additional protections for children involved as
subjects in research, based on this definition: "Children are persons
who have not attained the legal age for consent to treatments or
procedures involved in research, under the applicable law of the
jurisdiction in which the research will be conducted." Generally, state
laws define what constitutes a "child." Consequently, the age at which a
child\'s own consent is required and sufficient to participate in
research will vary according to state law. For example, some states
consider a person age 18 to be an adult and therefore one who can
provide consent without parental permission.

[]{#Human_Subjects_Defs_ClinicalResearch .anchor}***[Clinical
Research.]{.underline}*** NIH defines human clinical research as
research with human subjects that is:

\(1\) Patient-Oriented Research.\
Research Conducted with human subjects (or on material of human origin
such as tissues, specimens, and cognitive phenomena) for which an
investigator (or colleague) directly interacts with human subjects.
Excluded from this definition are *in vitro* studies that utilize human
tissues that cannot be linked to a living individual. Patient-oriented
research includes (a) mechanisms of human disease, (b) therapeutic
interventions, (c) clinical studies, or (d) development of new
technologies.

\(2\) Epidemiologic and Behavioral Studies.

\(3\) Outcomes Research and Health Services Research.

Note: Studies falling under Exemption 4 for human subjects research are
not considered clinical research by this definition.

[]{#Human_Subjects_Defs_ClinicalTrial .anchor}***[Clinical
Trial.]{.underline}*** The NIH defines a *clinical trial* as a
prospective biomedical or behavioral research study of human subjects
that is designed to answer specific questions about biomedical or
behavioral interventions (drugs, treatments, devices, or new ways of
using known drugs, treatments, or devices).

Clinical trials are used to determine whether new biomedical or
behavioral interventions are safe, efficacious, and effective.

Behavioral human subjects research involving an intervention to modify
behavior (diet, physical activity, cognitive therapy, etc.) fits this
definition of a clinical trial.

Human subjects research to develop or evaluate clinical laboratory tests
(e.g. imaging or molecular diagnostic tests) might be considered to be a
clinical trial if the test will be used for medical decision making for
the subject or the test itself imposes more than minimal risk for
subjects.

Biomedical clinical trials of experimental drug, treatment, device or
behavioral intervention may proceed through four phases:

***[Phase I]{.underline}*** clinical trials test a new biomedical
intervention in a small group of people (e.g., 20-80) for the first time
to evaluate safety (e.g., to determine a safe dosage range and to
identify side effects).

***[Phase II]{.underline}*** clinical trials study the biomedical or
behavioral intervention in a larger group of people (several hundred) to
determine efficacy and to further evaluate its safety.

***[Phase III]{.underline}*** studies investigate the efficacy of the
biomedical or behavioral intervention in large groups of human subjects
(from several hundred to several thousand) by comparing the intervention
to other standard or experimental interventions as well as to monitor
adverse effects, and to collect information that will allow the
intervention to be used safely.

***[Phase IV]{.underline}*** studies are conducted after the
intervention has been marketed. These studies are designed to monitor
effectiveness of the approved intervention in the general population and
to collect information about any adverse effects associated with
widespread use.

[]{#Human_Subjects_Defs_NIH_PhaseIIIl .anchor}***[NIH-Defined Phase III
Clinical Trial.]{.underline}*** For the purpose of the Guidelines an
NIH-defined Phase III clinical trial is a broadly based prospective
Phase III clinical investigation, usually involving several hundred or
more human subjects, for the purpose of evaluating an experimental
intervention in comparison with a standard or controlled intervention or
comparing two or more existing treatments. Often the aim of such
investigation is to provide evidence leading to a scientific basis for
consideration of a change in health policy or standard of care. The
definition includes pharmacologic, non-pharmacologic, and behavioral
interventions given for disease prevention, prophylaxis, diagnosis, or
therapy. Community trials and other population-based intervention trials
are also included.

***[Coded.]{.underline}*** With respect to private information or human
biological specimens, *coded* means that:

\(1\) identifying information (such as name or social security number)
that would enable the investigator to readily ascertain the identity of
the individual to whom the private information or specimens pertain has
been replaced with a number, letter, symbol or combination thereof
(i.e., the code); and

\(2\) a key to decipher the code exists, enabling linkage of the
identifying information with the private information or specimens.

Research that involves only coded private information/data or coded
human biological specimens may not constitute human subjects research
under the DHHS human subjects regulations (45 CFR 46) if:

-   the specimens and/or information/data are not obtained from an
    interaction/intervention with the subject specifically for the
    research; and

-   the investigator(s) cannot readily ascertain the identity of the
    individual(s) to whom the coded private information or specimens
    pertain (e.g., the researcher\'s access to subject identities is
    prohibited).

Individuals who provide coded information or specimens for proposed
research and who also collaborate on the research involving such
information or specimens are considered to be involved in the conduct of
human subjects research.

(See the following guidance from the Office for Human Research
Protections (OHRP) for additional information and examples:
<http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf>.)

***[Data and Safety Monitoring Plan.]{.underline}*** For each clinical
trial, NIH requires a data and safety monitoring plan that will provide
oversight and monitoring to ensure the safety of participants and the
validity and integrity of the data. The level of monitoring should be
commensurate with the risks and the size and complexity of the clinical
trial. A detailed data and safety monitoring plan must be submitted to
the applicant's IRB and subsequently to the funding IC for approval
prior to the accrual of human subjects. The reporting of Adverse Events
must be reported to the IRB, the NIH funding Institute or Center, and
other required entities. This policy requirement is in addition to any
monitoring requirements imposed by [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

***[Data and Safety Monitoring Board (DSMB).]{.underline}*** NIH
requires the establishment of a Data and Safety Monitoring Board (DSMB)
for multi-site clinical trials involving interventions that entail
potential risk to the participants, *and generally for Phase III
clinical trials*.

[]{#Human_Subjects_Exemption_Cat .anchor}***[Exemptions.]{.underline}***
The six categories of research exempt from the DHHS human subject
regulations are:

***[Exemption 1:]{.underline}*** Research conducted in established or
commonly accepted educational settings, involving normal educational
practices, such as (i) research on regular and special education
instructional strategies, or (ii) research on the effectiveness of or
the comparison among instructional techniques, curricula, or classroom
management methods.

[]{#Human_Subjects_Exemption2 .anchor}***[Exemption 2:]{.underline}***
Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or
observation of public behavior, unless:

\(i\) information obtained is recorded in such a manner that human
subjects can be identified directly or through identifiers linked to the
subjects and (ii) any disclosure of the human subjects\' responses
outside the research could reasonably place the subjects at risk of
criminal or civil liability or be damaging to the subjects\' financial
standing, employability, or reputation.

> Exemption 2 for research involving survey or interview procedures or
> observation of public behavior, does not apply to research with
> children (see [45 CFR Part 46, Subpart
> D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd)),
> except for research involving observations of public behavior when the
> investigator(s) do not participate in the activities being observed.

***[Exemption 3:]{.underline}*** Research involving the use of
educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of public behavior that
is not exempt under paragraph (b)(2) of this section if: (i) the human
subjects are elected or appointed public officials or candidates for
public office; or (ii) Federal statute(s) require(s) without exception
that the confidentiality of the personally identifiable information will
be maintained throughout the research and thereafter.

***[Exemption 4:]{.underline}*** Research involving the collection or
study of existing data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly available or if the
information is recorded by the investigator in such a manner that
subjects cannot be identified, directly or through identifiers linked to
the subjects.

The humans subjects regulations decision charts
(<http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm>) of
the Office of Human Research Protection (OHRP) will determine whether
the research falls under the human subjects regulations and if so,
whether it meets the criteria for Exemption 4. The NIH Office of
Extramural Research website also contains information that is helpful
for determining whether human subjects research meets the criteria for
Exemption 4. See <http://grants.nih.gov/grants/policy/hs/index.htm>.

> Research that meets the criteria for Exemption 4 is not considered
> "clinical research" as defined by NIH. Therefore the NIH policies for
> inclusion of women, minorities and children in clinical research, and
> targeted/planned enrollment tables, do not apply to research projects
> covered by Exemption 4.

***[Exemption 5:]{.underline}*** Research and demonstration projects
that are conducted by or subject to the approval of Department or Agency
heads and that are designed to study, evaluate, or otherwise examine:
(i) public benefit or service programs (ii) procedures for obtaining
benefits or services under those programs (iii) possible changes in or
alternatives to those programs or procedures or (iv) possible changes in
methods or levels of payment for benefits or services under those
programs.

***[Exemption 6:]{.underline}*** Taste and food quality evaluation and
consumer acceptance studies (i) if wholesome foods without additives are
consumed or (ii) if a food is consumed that contains a food ingredient
at or below the level and for a use found to be safe, or agricultural,
chemical, or environmental contaminant at or below the level found to be
safe, by the Food and Drug Administration or approved by the
Environmental Protection Agency or the Food Safety and Inspection
Service of the U.S. Department of Agriculture.

***[Gender.]{.underline}*** Refers to the classification of research
subjects into either or both of two categories: women and men. In some
cases, representation is unknown, because gender composition cannot be
accurately determined (e.g., pooled blood samples or stored specimens
without gender designation).

[]{#Human_Subjects_Defs_Human .anchor}***[Human
Subjects.]{.underline}*** The DHHS regulations "Protection of Human
Subjects" (45 CFR 46, administered by OHRP) define a ***[human
subject]{.underline}*** as a living individual about whom an
*investigator* conducting *research obtains*:

-   data through *intervention* or *interaction* with the individual or

-   *identifiable private information*

***[Investigator.]{.underline}*** The OHRP considers the term
investigator to include anyone involved in conducting the research. OHRP
does not consider the act of solely providing coded private information
or specimens (for example, by a tissue repository) to constitute
involvement in the conduct of the research. However, if the individuals
who provide *coded* information or specimens also collaborate on other
activities related to the conduct of the research with the investigators
who receive such information or specimens, they will be considered to be
involved in the conduct of the research. (See OHRP's [2004 Coded
Specimen
Guidance](http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm).)

***[Research.]{.underline}*** DHHS regulations define *research* at 45
CFR 46.102(d) as follows:\
*Research* means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge. Activities which meet this definition
constitute research for purposes of this policy, whether or not they are
conducted or supported under a program which is considered research for
other purposes. For example, some demonstration and service programs may
include research activities.

***[Obtains.]{.underline}*** In its guidance for use of coded specimens,
OHRP has determined that under the definition of human subject at 45 CFR
46.102(f), *obtaining* identifiable private information or identifiable
specimens for research purposes constitutes human subjects research.
*Obtaining* means receiving or accessing identifiable private
information or identifiable specimens for research purposes. OHRP
interprets *obtaining* to include an investigator's use, study, or
analysis for research purposes of *identifiable private information* or
identifiable specimens already in the possession of the investigator.

***[Intervention]{.underline}*** includes both physical procedures by
which data are gathered (for example, venipuncture) and manipulations of
the subject or the subject\'s environment that are performed for
research purposes. (45 CFR 46.102(f))

***[Interaction]{.underline}*** includes communication or interpersonal
contact between investigator and subject. (45 CFR 46.102(f))

***[Private information]{.underline}*** includes information about
behavior that occurs in a context in which an individual can reasonably
expect that no observation or recording is taking place, and information
that has been provided for specific purposes by an individual and that
the individual can reasonably expect will not be made public (for
example, a medical record). Private information must be *individually
identifiable* (i.e., the identity of the subject is or may readily be
ascertained by the investigator or associated with the information) in
order for obtaining the information to constitute research involving
human subjects. (45 CFR 46.102(f))

***[Individually Identifiable Private Information.]{.underline}***
According to its guidance for use of coded specimens, OHRP generally
considers private information or specimens to be *individually
identifiable* as defined at 45 CFR 46.102(f) when they can be linked to
specific individuals by the investigator(s) either directly or
indirectly through *coding* systems. Conversely, OHRP considers private
information or specimens not to be individually identifiable when they
cannot be linked to specific individuals by the investigator(s) either
directly or indirectly through coding systems.

***[Significant Difference.]{.underline}*** For purposes of NIH policy,
a "significant difference" is a difference that is of clinical or public
health importance, based on substantial scientific data. This definition
differs from the commonly used "statistically significant difference,"
which refers to the event that, for a given set of data, the statistical
test for a difference between the effects in two groups achieves
statistical significance. Statistical significance depends upon the
amount of information in the data set. With a very large amount of
information, one could find a statistically significant, but clinically
small difference that is of very little clinical importance. Conversely,
with less information one could find a large difference of potential
importance that is not statistically significant.

***[Valid Analysis.]{.underline}*** This term means an unbiased
assessment. Such an assessment will, on average, yield the correct
estimate of the difference in outcomes between two groups of subjects.
Valid analysis can and should be conducted for both small and large
studies. A valid analysis does not need to have a high statistical power
for detecting a stated effect. The principal requirements for ensuring a
valid analysis of the question of interest are: allocation of study
participants of both sexes/genders (males and females) and from
different racial/ethnic groups to the intervention and control groups by
an unbiased process such as randomization; unbiased evaluation of the
outcome(s) of study participants; and use of unbiased statistical
analyses and proper methods of inference to estimate and compare the
intervention effects among the gender and racial/ethnic groups.

**Innovation.** Something new or improved, including research for (1)
development of new technologies, (2) refinement of existing
technologies, or (3) development of new applications for existing
technologies. For the purposes of PHS programs, an example of
"innovation" would be new medical or biological products for improved
value, efficiency, or costs.

**Institutional Base Salary.** The annual compensation paid by an
organization for an employee's appointment, whether that individual's
time is spent on research, teaching, patient care, or other activities.
Base salary excludes any income that an individual may be permitted to
earn outside of duties to the applicant/grantee organization. Base
salary may not be increased as a result of replacing institutional
salary funds with NIH grant funds.

Some PHS grant programs are currently subject to a legislatively imposed
salary limitation. Any adjustment for salary limits will be made at time
of award. Applicants are encouraged to contact their offices of
sponsored programs or see the [*NIH Guide for Grants and
Contracts*](http://www.grants.nih.gov/grants/guide) for current guidance
on salary requirements.

**Other Significant Contributors.** This category identifies individuals
who have committed to contribute to the scientific development or
execution of the project, but are not committing any specified
measurable effort to the projects. These individuals are typically
presented at "zero percent" effort or "as needed" (individuals with
measurable effort cannot be listed as Other Significant Contributors).
Consultants should be included if they meet this definition. This would
also be an appropriate designation for mentors on Career awards.

**Person Months.** A metric for expressing the effort (amount of time)
that PD/PIs, faculty and other senior/key personnel devote to a specific
project. Effort is expressed as a percentage of the total institutional
appointment and is based on the organization's regular academic-year,
summer or calendar-year.

**Principal Investigator, Program Director, or Project Director
(PD/PI).** The individual(s) designated by the applicant organization to
have the appropriate level of authority and responsibility to direct the
project or program to be supported by the award. The applicant
organization may designate multiple individuals as principal
investigators (PDs/PIs) who share the authority and responsibility for
leading and directing the project, intellectually and logistically. When
multiple principal investigators are named, each is responsible and
accountable to the applicant organization, or as appropriate, to a
collaborating organization for the proper conduct of the project or
program including the submission of all required reports. The presence
of more than one PD/PI on an application or award diminishes neither the
responsibility nor the accountability of any individual PD/PI.

[]{#Definitions_ProgramIncome .anchor}**Program Income.** Gross income
earned by the applicant organization that is directly generated by a
supported activity or earned as a result of the award. The *PHS Grants
Policy Statement* or [*NIH Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
contains a detailed explanation of program income, the ways in which it
may be generated and accounted for, and the various options for its use
and disposition.

Examples of program income include:

-   Fees earned from services performed under the grant, such as those
    resulting from laboratory drug testing;

-   Rental or usage fees, such as those earned from fees charged for use
    of computer equipment purchased with grant funds;

-   Third party patient reimbursement for hospital or other medical
    services, such as insurance payments for patients when such
    reimbursement occurs because of the grant-supported activity;

-   Funds generated by the sale of commodities, such as tissue cultures,
    cell lines, or research animals;

-   Patent or copyright royalties (exempt from reporting requirements);
    and

-   Registration fees generated from grant-supported conferences.

**Prototype.** A model of something to be further developed and includes
designs, protocols, questionnaires, software, and devices.

**Research or Research and Development (R/R&D).** Any activity that is:

-   A systematic, intensive study directed toward greater knowledge or
    understanding of the subject studied; or

-   A systematic study directed specifically toward applying new
    knowledge to meet a recognized need; or

-   A systematic application of knowledge toward the production of
    useful materials, devices, and systems or methods, including design,
    development, and improvement of prototypes and new processes to meet
    specific requirements.

**Research Institution.** A United States research organization that is:

-   A nonprofit college or university or

-   A nonprofit research institution, including nonprofit medical and
    surgical hospitals. (A "nonprofit institution" is defined as an
    organization that is owned and operated exclusively for scientific
    or educational purposes, no part of the net earnings of which inures
    to the benefit of any private shareholder or individual.) or

-   A contractor-operated, Federally funded research and development
    center, as identified by the National Science Foundation in
    accordance with the Government-wide Federal Acquisition Regulation
    issued in accordance with section 35(c)(1) of the Office of Federal
    Procurement Policy Act (or any successor legislation thereto).

> *(Laboratories staffed by Federal employees do not meet the definition
> of "research institution" for purposes of the STTR program.)*

**Senior/Key Personnel.** The PD/PI *and other individuals* who
contribute to the scientific development or execution of the project in
a substantive, measurable way, whether or not salaries or compensation
are requested under the grant.

Typically these individuals have doctoral or other professional degrees,
although individuals at the masters or baccalaureate level should be
included if their involvement meets the definition of Senior/Key
Personnel. Consultants should also be included if the meet the
definition of Senior/Key Personnel. Senior/Key Personnel must devote
measurable effort to the project whether or not salaries or compensation
are requested -- "zero percent" effort or "as needed" are not acceptable
levels for those designated as Senior/Key Personnel.

**Socially and Economically Disadvantaged Individual.** A member of any
of the following groups: Black Americans; Hispanic Americans; Native
Americans; Asian-Pacific Americans; Subcontinent Asian Americans; other
groups designated from time to time by the Small Business Administration
(SBA) to be socially disadvantaged; or any other individual found to be
socially and economically disadvantaged by SBA pursuant to Section 8(a)
of the Small Business Act, 15 U.S.C. 637(a).

**United States.** The 50 states, territories and possessions of the
U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific
Islands, and District of Columbia.

# 4. General Information

## 4.1 Research Grant Mechanisms

The following table summarizes the major mechanisms NIH uses to fund
research grants. For more detailed information, visit the OER Grants
website <http://grants.nih.gov/grants/oer.htm>.

Over the next several years, NIH will transition all the mechanisms
listed below to electronic submission through Grants.gov. Initial plans
are announced in the NIH Guide Notice, OD-05-067:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html>.
Additional notices will be posted in the Guide giving the community
several months notice of the transition of a specific mechanism.
Specific funding opportunity announcements will also be posted in the
NIH Guide and on Grants.gov, Apply for Grants, when a particular
mechanism is transitioned.

+--------------------------------+-------------------------------------+
| **Type (Mechanism)**           | **Description**                     |
+================================+=====================================+
| **Research Grants**            |                                     |
+--------------------------------+-------------------------------------+
| []{#R01 .anchor}**Basic        | **Basic Research Grants** are       |
| Research Grant (R01)**         | awarded to eligible institutions on |
|                                | behalf of a PD/PI to support a      |
|                                | discrete project related to the     |
|                                | investigator's area of interest and |
|                                | competence. These grants make up    |
|                                | the largest category of NIH         |
|                                | funding.                            |
+--------------------------------+-------------------------------------+
| []{#R03 .anchor}**Small        | **Small Research Grants** support   |
| Research Grant (R03)**         | small research projects that can be |
|                                | carried out in a short period of    |
| <http://grants.n               | time with limited resources for     |
| ih.gov/grants/funding/r03.htm> | projects such as pilot or           |
|                                | feasibility studies; secondary      |
|                                | analysis of existing data; small,   |
|                                | self-contained research projects;   |
|                                | development of research methodology |
|                                | and/or development of new research  |
|                                | technology. *Not all awarding       |
|                                | components accept                   |
|                                | investigator-initiated R03          |
|                                | applications.*\                     |
|                                | Applicants interested in the small  |
|                                | research grant program of           |
|                                | PHS-awarding components other than  |
|                                | NIH should contact an official of   |
|                                | the appropriate PHS-awarding        |
|                                | component.                          |
+--------------------------------+-------------------------------------+
| []{#R15 .anchor}**Academic     | **Academic Research Enhancement     |
| Research Enhancement Award     | Awards** provide support to         |
| (AREA) (R15)**                 | scientists at eligible domestic     |
|                                | institutions for small-scale        |
| <http://grants.ni              | health-related research projects,   |
| h.gov/grants/funding/area.htm> | such as pilot research projects and |
|                                | feasibility studies; development,   |
|                                | testing, and refinement of research |
|                                | techniques; and similar discrete    |
|                                | research projects that demonstrate  |
|                                | research capability. This award is  |
|                                | directed toward those smaller       |
|                                | public and private colleges and     |
|                                | universities that provide           |
|                                | undergraduate training for a        |
|                                | significant number of the U.S.      |
|                                | research scientists.                |
+--------------------------------+-------------------------------------+
| []{#R21                        | **Exploratory/Developmental         |
| .anch                          | Research Grants** seek to broaden   |
| or}**Exploratory/Developmental | the base of inquiry in fundamental  |
| Research Grant (R21/R33)**     | biomedical research by encouraging  |
|                                | applications for research projects  |
| <http://grants.n               | that involve an especially high     |
| ih.gov/grants/funding/r21.htm> | degree of innovation and novelty.   |
|                                | NIH provides pilot-scale support    |
|                                | for potentially ground-breaking     |
|                                | ideas, methods, and systems that    |
|                                | meet the following criteria: they   |
|                                | lack sufficient preliminary data    |
|                                | for feasibility to be established,  |
|                                | their successful demonstration      |
|                                | would have a major impact on        |
|                                | biomedical research, and they fall  |
|                                | within the areas supported by the   |
|                                | awarding I/C. *Not all awarding     |
|                                | components accept R21/R33           |
|                                | applications.*                      |
+--------------------------------+-------------------------------------+
| []{#R43 .anchor}**Small        | **SBIR and STTR grants** are made   |
| Business Innovation Research   | to eligible domestic for-profit     |
| Grant (SBIR: R43/R44)**        | small business concerns conducting  |
|                                | innovative research that has the    |
| **Small Business Technology    | potential for commercialization.    |
| Transfer Grant (STTR:          |                                     |
| R41/R42)**                     | SBIR/STTR awards are intended to    |
|                                | stimulate technological innovation, |
| <http://grants.ni              | use small business to meet Federal  |
| h.gov/grants/funding/sbir.htm> | research and development needs,     |
|                                | increase private sector             |
|                                | commercialization of innovations    |
|                                | derived from Federal research and   |
|                                | development, and foster and         |
|                                | encourage participation by minority |
|                                | and disadvantaged persons in        |
|                                | technological innovation.           |
+--------------------------------+-------------------------------------+
| []{#P01 .anchor}**Program      | **Program Project Grants** are more |
| Project Grant (P01)**          | complex in scope and budget than    |
|                                | the individual basic research (R01) |
|                                | grant. While R01s are awarded to    |
|                                | support the work of one PD/PI who,  |
|                                | with supporting staff, is           |
|                                | addressing a scientific problem,    |
|                                | program project grants are          |
|                                | available to a group of several     |
|                                | investigators with differing areas  |
|                                | of expertise who wish to            |
|                                | collaborate in research by pooling  |
|                                | their talents and resources.        |
|                                | Program project grants represent    |
|                                | synergistic research programs that  |
|                                | are designed to achieve results not |
|                                | attainable by investigators working |
|                                | independently. *Not all awarding    |
|                                | components accept P01               |
|                                | applications.*                      |
+--------------------------------+-------------------------------------+
| []{#P50 .anchor}**Research     | **Research Center Grants** serve    |
| Center Grant (P50/P60)**       | varying scientific and IC-specific  |
|                                | purposes, but they have elements in |
|                                | common. The grants are              |
|                                | multidisciplinary in scope and may  |
|                                | focus more on an area or discipline |
|                                | of science than on a specific theme |
|                                | or goal. Independent investigators  |
|                                | direct the projects and cores.      |
|                                | Center grants offer a greater       |
|                                | opportunity for scientific          |
|                                | interactions and overall progress   |
|                                | than with individually-funded       |
|                                | projects. *Not all awarding         |
|                                | components accept P50/P60           |
|                                | applications.*                      |
+--------------------------------+-------------------------------------+
| []{#R13 .anchor}**Scientific   | Most NIH ICs provide support for    |
| Meeting Support (R13)**        | scientific meetings, conferences,   |
|                                | and workshops that are relevant to  |
| <http://grants.nih.gov         | its scientific mission. Any U.S.    |
| /grants/funding/r13/index.htm> | institution or organization,        |
|                                | including an established scientific |
|                                | or professional society, is         |
|                                | eligible to apply. For more         |
|                                | information and guidelines, see     |
|                                | <http://grants.nih.gov/gran         |
|                                | ts/guide/pa-files/PAR-03-176.html>. |
|                                | *Applicants must obtain IC approval |
|                                | prior to submission.*               |
+--------------------------------+-------------------------------------+
| **Research Grants to Foreign   | [http://grants                      |
| Institutions and International | .nih.gov/grants/policy/nihgps_2003/ |
| Organizations**                | NIHGPS_Part12.htm#\_To              |
|                                | c54600260](http://grants.nih.gov/gr |
|                                | ants/policy/nihgps_2003/NIHGPS_Part |
|                                | 12.htm#__RefHeading___Toc54600260). |
+--------------------------------+-------------------------------------+
| **Training, Fellowships and    |                                     |
| Career Development Programs**  |                                     |
+--------------------------------+-------------------------------------+
| []{#T32 .anchor}**NIH          | These awards are made to domestic   |
| Institutional Ruth L.          | institutions that have the          |
| Kirschstein National Research  | facilities and faculty to provide   |
| Service Award (T32/ T34/T35)** | for research training programs in   |
|                                | scientific specialties. Grant funds |
| <http://gra                    | may be used for personnel,          |
| nts.nih.gov/training/nrsa.htm> | equipment, supplies, trainee        |
|                                | stipends (both pre- and             |
|                                | postdoctoral), and related costs.   |
+--------------------------------+-------------------------------------+
| []{#NRSA .anchor}**Individual  | These fellowships are awarded to    |
| Ruth L. Kirschstein National   | qualified individuals at the        |
| Research Service Award         | predoctoral, postdoctoral, or       |
| Fellowships) (NRSA:            | senior investigator level to pursue |
| F30/F31/F32/F33)**             | full-time research training in      |
|                                | designated biomedical or behavioral |
| <http://gra                    | science areas**. NRSA APPLICANTS    |
| nts.nih.gov/training/nrsa.htm> | MUST USE PHS 416-1                  |
|                                | FORMS/INSTRUCTIONS**                |
|                                | (<http://grants.nih.                |
|                                | gov/grants/funding/416/phs416.htm>) |
+--------------------------------+-------------------------------------+
| []{#KAward .anchor}**Career    | Among NIH components, several types |
| Development Award (K Award)**  | of career development awards are    |
|                                | available to research and academic  |
| <http://grants.nih.gov/trainin | institutions on behalf of           |
| g/careerdevelopmentawards.htm> | scientists who require additional   |
|                                | independent or mentored experience  |
|                                | in a productive scientific          |
|                                | environment in order to further     |
|                                | develop their careers in            |
|                                | independent biomedical or           |
|                                | behavioral research.                |
+--------------------------------+-------------------------------------+
| **APPLICATIONS AVAILABLE FROM  |                                     |
| OTHER OFFICES**                |                                     |
+--------------------------------+-------------------------------------+
| []{#IntlFellow                 | Fogarty International Center (FIC)\ |
| .anchor}**International        | (301) 496-1653                      |
| Research Fellowship Award      |                                     |
| Application (NIH 1541-1)**     |                                     |
+--------------------------------+-------------------------------------+
| []{#NonresearchTraining        | Health Resources and Services       |
| .anchor}**Nonresearch Training | Administration (HRSA)\              |
| Grant Application (PHS 6025)** | (301) 443-6960                      |
+--------------------------------+-------------------------------------+
| []{#HealthServices             | Substance Abuse and Mental Health   |
| .anchor}**Health Services      | Services Administration (SAMHSA)    |
| Project Application\           |                                     |
| (5161-1)**                     | \(301\) 436-8451                    |
+--------------------------------+-------------------------------------+

## 4.2 Government Use of Information Under Privacy Act

The Privacy Act of 1974 (5 U.S.C. 552a) is a records management statute
and regulates the collection, maintenance, use, and dissemination of
personal information by Federal agencies. In accordance with the Act,
the PHS is required to provide the following notification to each
individual whom it asks to supply information.

The PHS maintains applications and grant records pursuant to its
statutory authority for awarding grants. The purpose of the information
collection is to aid in the review, award, and administration of PHS
programs. Provision of information is voluntary; however, a lack of
sufficient information may hinder the ability of the PHS to review
applications, monitor grantee performance, or perform overall management
of grant programs.

The Privacy Act authorizes discretionary disclosure of this information
within the Department of Health and Human Services and outside the
agency to the public, as required by the Freedom of Information Act and
the associated DHHS regulations (45 CFR 5), including the Congress
acting within its legislative authority, the National Archives, the
General Accounting Office, the Bureau of Census, law enforcement
agencies, and pursuant to a court order. Information also may be
disclosed outside the Department, if necessary, for the following
purposes:

1.  To a Congressional office at the request of the record subject;

2.  To the Department of Justice as required for litigation;

3.  To the cognizant audit agency for auditing;

4.  To qualified experts not within the definition of Department
    employees as prescribed in Department Regulations (45 CFR 5b.2) for
    opinions as part of the application review/award process;

5.  For an authorized research purpose under specified conditions;

6.  To contractors for the purpose of processing, maintaining, and
    refining records in the system. Contractors will be required to
    maintain Privacy Act safeguards with respect to such records;

7.  To a Federal agency, in response to its request, in connection with
    the letting of a contract, or the issuance of a license, grant, or
    other benefit by the requesting agency, to the extent that the
    records are relevant and necessary to the requesting agency's
    decision on the matter; and

8.  To the applicant organization in connection with the review of an
    application or performance or administration under the terms and
    conditions of the award, or in connection with problems that might
    arise in performance or administration if an award is made.

## 4.3 Information Available to the PD(s)/PI(s)

Under the provisions of the Privacy Act, PDs/PIs may request copies of
records pertaining to their grant applications from the PHS component
responsible for funding decisions. PDs/PIs are given the opportunity
under established procedures to request that the records be amended if
they believe they are inaccurate, untimely, incomplete, or irrelevant.
If the PHS concurs, the records will be amended.

## 4.4 Information Available to the General Public

The PHS makes information about awarded grants available to the public,
including the title of the project, the grantee institution, the PD/PI,
and the amount of the award. The Project Summary/Abstract, from Item 6
on the Other Project Information Component, of a funded research grant
application is sent to the National Technical Information Service
(NTIS), U.S. Department of Commerce, where the information is used for
the dissemination of scientific information and for scientific
classification and program analysis purposes. These descriptions are
available to the public from the NTIS.

NIH also routinely places information about awarded grants, including
project title, name of the PD/PI, and project description (abstract) in
the [CRISP](http://crisp.cit.nih.gov/) system.

#### Freedom of Information Act Requirements {#freedom-of-information-act-requirements .Subhead---No-TOC}

The Freedom of Information Act and implementing DHHS regulations (45 CFR
Part 5) require the release of certain information about grants upon
request, regardless of the intended use of the information. Generally
available for release, upon request are: all funded grant applications
and progress reports **including** their derivative funded
**noncompeting supplemental** grant progress reports; pending and funded
**noncompeting continuation** progress reports; progress reports of
grantees; and final reports of any review or evaluation of grantee
performance conducted or caused to be conducted by the DHHS. Generally
**not** available for release to the public are: **competing** grant
progress reports (new, resubmission, renewal, and revisions) for which
awards have **not** been made; evaluative portions of site visit
reports; and summary statements of findings and recommendations of
review groups. Trade secrets and commercial, financial, or otherwise
proprietary information may be withheld from disclosure. Information,
which, if disclosed, would be a clearly unwarranted invasion of personal
privacy, may also be withheld from disclosure. Although the grantee
institution and the PD/PI will be consulted about any such release, the
PHS will make the final determination. If a requested document contains
both disclosable and nondisclosable information, the nondisclosable
information will be deleted and the balance of the document will be
released.

## 4.5 Access to Research Data

As required by regulation 45 CFR 74.36, grantees that are institutions
of higher education, hospitals, or non-profit organizations must release
"research data" first produced in a project supported in whole or in
part with Federal funds if they are cited publicly and officially by a
Federal agency in support of an action that has the force and effect of
law (i.e., regulations and administrative orders). The term "research
data" is defined as the recorded factual material commonly accepted in
the scientific community as necessary to validate research findings. It
does not include preliminary analyses; drafts of scientific papers;
plans for future research; peer reviews; communications with colleagues;
physical objects (e.g., laboratory samples, audio or video tapes); trade
secrets; commercial information; materials necessary to be held
confidential by a researcher until publication in a peer-reviewed
journal; information that is protected under the law (e.g., intellectual
property); personnel and medical files and similar files, the disclosure
of which would constitute an unwarranted invasion of personal privacy;
or information that could be used to identify a particular person in a
research study.

This requirement to release research data does not apply to commercial
organizations or to research data produced by state or local
governments. However, if a state or local governmental grantee contracts
with an educational institution, hospital or non-profit organization,
and the contract results in covered research data, those data are
subject to these disclosure requirements. See
<http://grants.nih.gov/grants/policy/data_sharing/index.htm>.