sf424 rr guide general verc

U.S. Department of Health and Human ServicesPublic 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)

Forms Version C application packages

Updated November 25, 2014

Table of Contents1. Foreword 1

1.1ApplicationGuideFormat 4

1.2NIHExtramuralResearchandResearchTrainingPrograms 4

1.3ResearchGrantActivityCodesandProgramGuidelines 4

1.4InteractionswithPHSStaff 5

1.5GrantsPolicyStatements 9

1.6References 9

1.7Authorization 11

1.7.1CollectionofPersonalDemographicData 11

1.8PaperworkBurden 12

2. Process for Application Submission via Grants.gov 13

2.1Overview 13

2.2RegistrationProcess 14

2.2.1Grants.govRegistration 14

2.2.2eRACommonsRegistration 15

2.2.2.1CommonsRegistrationfortheOrganization 15

2.2.2.2CommonsRegistrationfortheProgramDirectors/PrincipalInvestigators

(PD/PIs) 16

2.2.2.3CommonsRegistrationforOtherIndividualsParticipatinginNIHProgress

Reports 17

2.3SoftwareRequirements 18

2.3.1AdobeReader 18

2.3.2CreatingPDFsforTextAttachments 18

2.4FundingOpportunities 19

2.4.1NIHGuideforGrantsandContracts 19

2.4.2FundingOpportunityAnnouncements 20

2.4.3FindingaFundingOpportunityAnnouncement(FOA)forGrants.govSubmission 21

2.5FormsforanApplicationtoNIHorOtherPHSAgencies 24

2.6FormatSpecificationsforText(PDF)Attachments 26

2.7"Resubmission"Applications 28

2.8"Revision"Application 29

2.9Similar,EssentiallyIdentical,orIdenticalApplications 30

2.10SubmittingyourApplicationViaGrants.gov 31

2.11AfteryouSubmityourApplicationviaGrants.gov 32

2.12CorrectingErrors 34

2.13Post-SubmissionApplicationMaterials 37

2.14ApplicationSubmissionDates 39

2.15Submission,ReviewandAwardCycles 40

2.16ResourcesforFindingHelp 41

2.16.1FindingHelpforGrants.govRegistrationorSubmissions 41

2.16.2FindingHelpfortheeRACommonsRegistrationoreRACommonsValidation

Processes 42

2.16.3FindingHelpforApplicationPreparation 43

3. Using the Grant Application Package 44

3.1VerifyGrantInformation 44

3.2EntertheNamefortheApplication 45

3.3OpenandCompleteMandatoryDocuments 45

3.4OpenandCompleteOptionalDocuments 45

3.5SubmittingtheApplicationviaGrants.gov 46

4. Completing the SF 424 Research and Related (R&R) Forms 47

4.1Overview 47

4.2SF424(R&R)Form 48

4.3Project/PerformanceSiteLocationsForm 66

4.4OtherProjectInformationForm 71

4.5Senior/KeyPersonProfile(Expanded)Form 79

4.6SelectingtheAppropriateBudgetForm 90

4.7R&RBudgetForm 90

4.7.1SectionAandB 91

4.7.2SectionsCthroughE 99

4.7.3SectionsFthroughK 102

4.7.4CumulativeBudget 108

4.8SpecialInstructionsforPreparingApplicationswithaSubaward/Consortium 110

5. Completing PHS 398 Forms 114

5.1Overview 114

5.2(Reserved) 115

5.3CoverPageSupplementForm 116

5.4ModularBudgetForm 123

5.4.1BudgetPeriodForm 124

5.4.2CumulativeBudgetInformation 126

5.5PHS398ResearchPlanForm 129

5.6(Reserved) 145

5.7(Reserved) 145

5.8PlannedEnrollmentReportandCumulativeInclusionEnrollmentReport 145

5.8.1PlannedEnrollmentReport 146

5.8.2CumulativeInclusionEnrollmentReport 149

6. Peer Review Process 152

7. Supplemental Instructions to the SF424 (R&R) for Preparing an Individual

Research Career Development Award (CDA) Application ("K" Series) 157

7.1Introduction 157

7.2IndividualCareerDevelopmentAwardPrograms 158

7.3LettersofReference(mustbesubmittedelectronicallythroughtheeRACommons) 158

7.4K-SpecificInstructionsforKApplicationsusingtheSF424(R&R)Application 161

7.4.1SpecialInstructionsfor4.2SF424(R&R)Form 161

7.4.2SpecialInstructionsfor4.3Research&RelatedProject/PerformanceSiteLoca-

tionsForm 162

7.4.3SpecialInstructionsfor4.4OtherProjectInformationForm 162

7.4.4SpecialInstructionsfor4.5Senior/KeyPersonProfile(s)Form 162

7.4.4.1TheCandidate 162

7.4.4.2Mentor,Co-mentor,andOtherSenior/KeyPersons 164

7.4.5SpecialInstructionsfor4.6SelectingtheAppropriateBudgetForm 165

7.4.6SpecialInstructionsfor4.7R&RBudgetForm 166

7.4.7SpecialInstructionsfor5.CompletingPHS398Forms 167

7.5PHS398CareerDevelopmentAwardSupplementalForm 169

7.6CareerDevelopmentAwardPeerReviewProcess 197

8. Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L.

Kirschstein National Research Service Award (NRSA) Application 199

8.1Introduction 199

8.2InstitutionalResearchTrainingPrograms 200

8.3Reserved 200

8.4SpecificInstructionsforInstitutionalTrainingGrantApplicationsusingtheSF424

(R&R)Application 200


8.4.2SpecialInstructionsfor4.3Research&RelatedProject/PerformanceSiteLoca-

tions 200

8.4.3SpecialInstructionsfor4.4Research&RelatedOtherProjectInformationForm 201

8.4.4SpecialInstructionsfor4.5Senior/KeyPersonProfile(Expanded)Form 203

8.4.5SpecialInstructionsfor4.7Research&RelatedBudget 203

8.4.6SpecialInstructionsfor5.3PHS398CoverPageSupplement 203

8.5PHS398TrainingBudget 204

8.6PHS398TrainingSubawardBudgetAttachment(s)Form 210

8.7ResearchTrainingProgramPlanForm 212

8.8TrainingGrantPeerReviewProcess 231

9. Supplemental Instructions to the SF 424 (R&R) for using ASSIST to Prepare a

Multi-Project Application 233

9.1Introduction 233

9.2Multi-ProjectApplications 233

9.2.1CollaboratingwithOtherOrganizations 234

9.3ApplicationSubmissionSystem&InterfaceforSubmissionTracking(ASSIST) 235

9.4SpecialInstructionsfortheSF424R&RforMulti-ProjectApplications 236


9.4.2SpecialInstructionsfor4.3Project/PerformanceSiteLocations 238

9.4.3SpecialInstructionsfor4.4OtherProjectInformation 238

9.4.4SpecialInstructionsfor4.5Senior/KeyPersonProfile(Expanded) 240

9.4.5SpecialInstructionsfor4.7R&RBudget 242

9.4.5.1SpecialInstructionsforPHSAdditionalIndirectCostsform 242

9.4.6SpecialInstructionsfor5.3PHS398CoverPageSupplement 244

9.4.7SpecialInstructionsfor5.5PHS398ResearchPlan 245

PART I

Instructions for Preparing and Submitting an

Application

PHS SF 424 (R&R) Forms Version C Application Guide

Part I: Instructions for Preparing and Submitting an Application

1. Foreword

Forms Version C Application Guide Revised November 25, 2014

ThisapplicationguideincludeschangestotheSF424Research&Related(R&R)formCinstructionsnecessitatedbytheOMBrenewalandGrants.govssubsequentreleaseofupdatedformsinJune2013.ChangeshavealsobeenmadetovariousPHS398formsandinstructionsapprovedbyOMBinAugust2012andreleasedbyGrants.govinJune2013.PartsII(SupplementalInstructionsforPreparingtheHumanSubjectsSectionoftheResearchPlan)andIII(Policies,Assurances,Definitions,andOtherInformation)ofthepreviousversionoftheapplicationguidehavebeenmovedtoastand-alonedocumenttitled,SupplementalGrantApplicationInstructions.

Modificationsincludethefollowing:

SF424 (R&R) Forms

SystemforAwardManagement(SAM)Registration

l AchangefromtherequirementtoregisterwiththeCentralContractorRegistryDatabase(CCR)totheSystemforAwardManagement(SAM).

SF424(R&R)Form

l Anamechange,previouslytheSF424(R&R)CoverForml AnewfieldforthePreviousGrants.govTrackingIDisincluded.Formbehaviorwillbe

adjustedsothatapplicationswithSubmissionTypeofChange/CorrectedApplicationrequireanentryinthePreviousGrants.govTrackingIDfieldratherthanrequiringanentryintheFederalIdentifierfield.

l ThePersontobecontactedsectionoftheApplicantInformationhasexpandedtoincludetheadditionalcontactinformationwehavebeenincludingonthePHS398CoverPageSupplementform.TheadditionalcontactinformationhasbeenremovedfromthePHS398CoverPageSupplement.

l ThelabelfortheSFLLorotherExplanatoryDocumentationhasbeenchangedtoSFLLL(DisclosureofLobbyingActivities)orotherExplanatoryDocumentation.

l AnewCoverLetterAttachmenthasbeenaddedandaseparatePHSCoverLetterformwillnolongerbeused.However,NIHwillcontinuetokeeptheCoverLetterseparatefromtheassembledapplicationimageandavailableonlytoauthorizedstaff.

SF424(R&R)BudgetForm

l ThecumulativeNumberofParticipants/TraineesallowedontheSF424(R&R)budgetformandassociatedSubawardBudgetformshasbeenexpandedfrom999to9999toaddressaformbug.Onpreviousformversions,maxingouttheNumberofParticipants/Traineesonallbudgetperiodscausedanapplicationtofailbecausetheformsdidntallowabiggernumberforthecumulativetotal.

SF424(R&R)Sr/KeyPersonExpandedForm

l ThenumberofSr/KeyPersonsthatcanbeenteredhasbeenexpandedfrom40to100.

SF424(R&R)ProjectPerformanceSiteLocationsForm

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l ThenumberofPerformanceSitesthatcanbeenteredhasbeenexpandedfrom30to300.

PHS 398 Forms

PlannedEnrollmentReportForm&PHS398CumulativeInclusionEnrollmentReportForm

l Addedoptionalinclusionformsinapplicationpackagestoallowforthecollectionasdiscretedataratherthan.pdfattachments.

l RemovedenrollmentandinclusionattachmentfieldsfromPHS398ResearchPlan,PHS398CareerDevelopmentAwardSupplementalForms.

PHS398CareerDevelopmentAwardSupplementalForm

l RemovedApplicationTypesection.l RemovedCareerDevelopmentAwardAttachmentheader.l RemovedInclusionandEnrollmentattachments(nowseparateformsintheapplication

package).l AddedanewattachmentforLettersofSupportfromCollaborators,Contributors,and

Consultants.l RenamedattachmentfromCareerDevelopment/TrainingActivitiesDuringAwardPeriod

toCandidatesPlanforCareerDevelopment/TrainingActivitiesDuringAwardPeriod.l RenamedattachmentfromMentoringPlantoCandidate'sPlantoProvideMentoring(as

applicable).l ChangedsectionheaderfromStatementsofSupporttoStatementsandLettersof

Support.l Madeadjustmentstoformatandnumbering.

PHS398ResearchPlanForm

l RemovedApplicationTypesection.l RemovedResearchPlanAttachmentheader.l RemovedInclusionandEnrollmentattachments(nowseparateformsintheapplication

package).l Madeadjustmentstoformatandnumbering.

PHS398TrainingProgramPlanForm

l RemovedApplicationTypesection.l RemovedResearchTrainingProgramPlanAttachmentheader.l RenamedattachmentfieldfromIntroductiontoApplication(forREVISIONor

RESUBMISSIONapplicationsonly)toIntroductiontoApplication(forRESUBMISSIONorREVISIONonly).

l Madeadjustmentstoformatandnumbering.

PHS398TrainingSubawardBudgetAttachmentForm

l Limitofsubawardbudgetattachmentshasincreasedfrom10to30.

PHS398CoverPageSupplementForm

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l RemovedApplicantOrganizationContactinformationthatwillbeincludedonSF424R&RForm.

l AddedfieldsfromPHS398Checklistform.TheseparatePHS398ChecklistFormwillnolongerbeused.

l Limitofcollectionofhumanembryonicstemcelllineshasincreasedfrom20to200.l Madeadjustmentstoformatandnumbering.

Notes

ThisversionoftheApplicationGuidenowalsoincludesaseparateinstructionsectionformulti-componentapplicationstoaccommodatetheirtransitiontoelectronicsubmissioneffectivewithsubmissionson/afterSeptember25,2013.

Foradditionaldetailsonalltheformchangesnotedabove,seeNIHGuideNoticeNOT-OD-13-074.

________________________________________

ThisapplicationguidecontainsinstructionsandotherusefulinformationforpreparinggrantapplicationstotheNationalInstitutesofHealth(NIH)andotherPublicHealthService(PHS)agenciesfor:

Public Health Service (PHS) Research Grants

Career Development (K) Awards

Institutional Training (T) Grants

Supplemental Instructions to the SF424 (R&R) for Preparing a Multi-Project Application

ThisapplicationguideisusedasacompaniondocumenttotheSF424ResearchandRelated(R&R)applicationforms.InadditiontotheSF424(R&R)forms,applicationstoNIHandotherPHSagencieswillincludeagency-specificforms,titledPHS398.ThesePHS398formsweredevelopedtocontinuethecollectionofagency-specificdatarequiredforacompleteapplication.Whiletheseagency-specificformsarenotidenticaltothePHS398applicationformpages,thePHS398referenceisusedtodistinguishtheseadditionaldatarequirementsfromthedatacollectedintheSF424(R&R)forms.AcompleteapplicationtoNIHandotherPHSagencieswillincludeSF424(R&R)formsandPHS398forms.Instructionsforallapplicationforms,SF424(R&R)andPHS398,arefoundinthisdocument.

TheuseoftheseformsalsoinvolveselectronicsubmissionofcompletedapplicationsthroughGrants.gov.NIHandotherPHSagenciescontinuestotransitionallactivitycodestothenewapplicationformsandGrants.govsubmission.NIHwillcontinuetouseRequestsforApplications(RFAs)andProgramAnnouncements(PAs)ascategoriesofFOAs.SeeSection2.4.2fordefinitions.

ApplicantsmustcarefullyreviewFOAsforguidanceonwhentousetheSF424(R&R)forms,instructions,andelectronicsubmissionforaspecificactivitycode(i.e.,P01,P20,P50,etc.).Thisprocesswillapplytoalltypesofcompetingsubmissionsfortheannouncedactivitycodenew,resubmission,revision,andrenewalgrantapplications.EachFOAwillincludealinktothemostcurrentversionoftheseinstructions.Applicantsareencouragedtocheckthewebsitefrequentlyforthemostcurrentversion.

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Forpurposesofthisdocument,anyreferencestoNIHmayalsomeanNIHandotherPHSagenciessuchtheCentersforDiseaseControlandPrevention(CDC),theFoodandDrugAdministration(FDA),andtheAgencyforHealthcareResearchandQuality(AHRQ).

1.1 Application Guide Format

Thisapplicationguideisorganizedintothreedistinctparts:

PartI:Instructions for Preparing and Submitting the Application.PartIincludesspecificinstructionsforcompletingtheapplicationformsaswellasinformationonelectronicallysubmittingapplicationsthroughGrants.gov.

PartsIIandIIIareincorporatedintothisapplicationguidebyreference.Theyareinaseparatedocumenttitled,SupplementalInstructions.

PartII:Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan.PartIIistobeusedifyourproposedresearchwillinvolvehumansubjects.TheseinstructionsassistindeterminingwhetherhumansubjectsareinvolvedandincludescenariosanddetailedinstructionsforcompletingthePHS398ResearchPlanform.

PartIII: Policies, Assurances, Definitions, and Other Information.PartIIIincludesinformationonpolicies,assurances,definitions,andotherinformationrelatingtosubmissionofapplicationstothePHS.Applicantsshouldrefertothisdocumentaswellastheinstructionalmaterials,GrantsInformation(GrantsInfo),andtherelevantGrantsPolicyStatementforadditionalsourcesofinformation.TheNIH Grants Policy StatementappliestoallNIHawardees;otherPHSagenciesusetheHHS Grants Policy Statement.

1.2 NIH Extramural Research and Research Training Programs

TheNIHOfficeofExtramuralResearchGrantshomepage(http://grants.nih.gov/grants/oer.htm)providesanarrayofhelpfulinformation.Applicantsareencouragedtobookmarkthissiteandvisititoften.

TheDivisionofCommunicationsandOutreach(DCO)isthecentralsourceforgeneralinformationaboutNIHextramuralresearchandresearchtrainingprograms,fundingactivitycodes,thepeerreviewsystem,andapplicationprocedures.GrantsInformation(GrantsInfo)isacommunicationservicewithintheDCO.InformationabouttheNIHextramuralresearchandresearchtrainingprograms,fundingopportunities,andthegrantapplicationprocess,canbeobtainedbye-mailingyourrequestto:[email protected](301)435-0714.

1.3 Research Grant Activity Codes and Program Guidelines

Apartiallistofresearchgrantactivitycodesandprogramsareprovidedbelow.AsnotedinthedescriptionsinSupplementalInstructionsPartIII:Policies,Assurances,Definitions,andOtherInformation,notallawardingcomponentsuseallactivitycodesorprograms.Foracompletelisting

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ofprogramguidelines,visittheOERGrantswebsitehttp://grants.nih.gov/grants/funding/funding_program.htm.

Research Grants

l BasicResearchGrant(R01)l SmallResearchGrant(R03)l AcademicResearchEnhancementAward(AREA)(R15)l Exploratory/DevelopmentalGrant(R21,R33,R21/R33)l SmallBusinessInnovationResearchGrant(SBIR)(R43/R44)l SmallBusinessTechnologyTransferGrant(STTR)(R41/R42)l ProgramProjectGrant(P01)l ResearchCenterGrant(P50)l ScientificMeetingSupport(R13,U13)l ResearchProjectCooperativeAgreement(U01)l ResearchGrantstoForeignInstitutionsandInternationalOrganizations

Training, Fellowships and Career Development Programs

l NIHInstitutionalRuthL.KirschsteinNationalResearchServiceAward(T32)l IndividualRuthL.KirschsteinNationalResearchServiceAwardFellowships(NRSA)

(F30,F31,F32,F33,F34,etc.)l ResearchCareerDevelopmentAward(KAward)

Applications Available from Other Offices

l HealthServicesProjectApplication(5161-1)

1.4 Interactions with PHS Staff

Applicantsarestrongly encouragedtocommunicatewithPHSstaffthroughouttheentireapplication,reviewandawardprocess.WebsiteaddressesandstaffphonenumbersofrelevantNIHawardingcomponentsandotherPHSagenciesarelistedinthetablebelow.

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PHS AGENCY (LINK

TO WEBSITE)

AWARDING COMPONENT(LINK TO WEBSITE)

TELEPHONE

NUMBER

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development

301-496-0104

NIH Fogarty International Center 301-496-1653

NIH National Cancer Institute 301-496-3428

NIHNational Center for Complementary and Alternative Medi-cine

301-496-4792

NIH National Center for Advancing Translational Sciences 301-496-6023

NIH National Eye Institute 301-451-2020

NIH National Heart, Lung, and Blood Institute 301-435-0260

NIH National Human Genome Research Institute 301-496-7531

NIH National Institute on Aging 301-496-9322

NIH National Institute on Alcohol Abuse and Alcoholism 301-443-4375

NIH National Institute of Allergy and Infectious Diseases 301-496-7291

NIHNational Institute of Arthritis and Musculoskeletal and Skin Diseases

301-594-2463

NIHNational Institute of Biomedical Imaging and Bioen-gineering

301-451-4792

NIHNational Institute on Deafness and Other Com-munication Disorders

301-496-1804

NIH National Institute of Dental and Craniofacial Research 301-594-4800

NIHNational Institute of Diabetes and Digestive and Kidney Diseases

301-594-8834

NIH National Institute on Drug Abuse 301-443-2755

NIH National Institute of Environmental Health Sciences 919-541-7723

NIH National Institute of General Medical Sciences 301-594-4499

NIH National Institute of Mental Health 301-443-3367

NIHNational Institute on Minority Health and Health Dis-parities

301-402-1366

NIH National Institute of Neurological Disorders and Stroke 301-496-9248

[Table 1.4-1. PHS Agency Contact Table]

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PHS AGENCY (LINK

TO WEBSITE)

AWARDING COMPONENT(LINK TO WEBSITE)

TELEPHONE

NUMBER

NIH National Institute of Nursing Research 301-594-6906

NIH National Library of Medicine 301-496-4621

NIH Center For Scientific Review 301-435-0715

Agency for Healthcare Research and Quality

Agency for Healthcare Research and Quality 301-427-1447

Centers for Disease Con-trol and Prevention (CDC)

Coordinating Center for Health Information and Services 404-498-1186

CDC Office of Infectious Disease 404-639-3770

National Center for Environmental Health 770-488-4668

National Center for Injury Prevention and Control 800-232-4636

National Center for Chronic Disease Prevention and Health Promotion

770-488-8390

National Institute for Occupational Safety and Health 404-498-2530

Procurement and Grants Office 770-488-2700

Food and Drug Admin-istration

Food and Drug Administration 301-827-7185

Indian Health Service Indian Health Service 301-443-0578

Agency for Toxic Sub-stances and Disease

RegistryAgency for Toxic Substances and Disease Registry 404-842-6630

Office of Public Health and Science

Office of Population Affairs 301-594-4004

Office of Public Health and Science

Office of Family Planning 301-594-4008

Before Submission

ApplicantsarestronglyencouragedtocontactNIHstaffwiththeirquestionsbeforesubmittinganapplication.

ContactGrantsInfoand/ortheDivisionofReceiptandReferral,CenterforScientificReview(CSR),NIH:

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l ToidentifyInstitutes/Centers(ICs)atNIHorothernon-NIHagenciesand/oraScientificReviewGroup(SRG)thatmightbeappropriateforyourapplication.Note: requests for assignment to an Institute/Center and/or an SRG may be made in the SF424 (R&R)Formin theCoverLetterattachment at the time of application submission.

l Tolearnaboutgrantprograms.l Toreceiveadviceonpreparingandsubmittinganapplication(e.g.,format,structure).

Contactprogramstaffintherelevantawardingcomponent:

l TodeterminewhetheryourproposedapplicationtopicwouldfitintotheNIHICsorothernon-NIHagency'sprogrammaticarea.

l TolearnaboutprogrammaticareasofinteresttotheICorothernon-NIHagencies.l TofindoutaboutrequestinganassignmenttoanIC.l TodiscusswhetheryoushouldrespondtoanRFA.

ContactScientificReviewOfficersintheCSRtodiscussrequestingassignmenttoaCSRSRG.

After Submission

IftheinitialassignmenttoanICorSRGseemsinappropriate,theProgramDirector/PrincipalInvestigator(PD/PI)mayrequestreassignment.Suchrequestsshouldbemadeinwritingto:

DivisionofReceiptandReferralCenterforScientificReviewNationalInstitutesofHealth6701RockledgeDrive,Suite2030,MSC7720Bethesda,MD20892-7720

Faxrequests(301-480-1987)arealsoacceptable.

Althoughtheserequestswillbecarefullyconsidered,thefinaldeterminationwillbemadebythePHSagency.

Applicantsmustnevercontactreviewersregardingtheirapplicationsbecausediscussionofthescientificcontentofanapplicationoranattempttoinfluencereviewoutcomeswillcreateseriousbreachesofconfidentialityinthereviewprocess.ReviewersarerequiredtonotifytheScientificReviewOfficeriftheyarecontactedbyanapplicant.Communicationbytheapplicanttoareviewermaydelaytherevieworresultinthereturnoftheapplicationwithoutreview.

CommunicationsfromtheDivisionofReceiptandReferral(DRR)areaccessibletoapplicantsandapplicantorganizationsintheeRACommonsinanewCorrespondencesectionoftheCommonsdetailedstatusscreenfortheapplication.ApplicantswillbenotifiedbyemailtochecktheirCommonsaccount.DRRwillnotifyanapplicantwhen:1)additionalinformationisrequiredbeforeher/hisapplicationcanbeassignedtoascientificreviewgroup(SRG)andNIHInstituteorCenter(IC)forfundingconsideration;2)anapplicantsrequestforanICassignmentcannotbehonored;or3)ithasbeendeterminedthattheapplicationdoesnotcomplywithNIHpolicy.Foradditionalinformation,seeNIHGuideNoticeNOT-OD-12-108.

After Assignment

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ContactyourScientificReviewOfficertodiscussthereviewassignment,torequestpermissiontosendadditional/correctivematerials,and/ortodiscussanyreviewconcerns(e.g.,expertiseneededonyourSRG,conflicts,reviewersthatmayhavebias).

After Peer Review

Feedbacktoapplicantsisveryimportant.OncethePD/PIreviewstheSummaryStatementintheeRACommons(papercopiesofthePeerReviewOutcomeLetterandSummaryStatementwillnotbemailedtothePI.ElectroniccopiesmaybeaccessedthroughtheeRACommons),theappropriateawardingcomponentprogramofficialnotedintheSummaryStatementmaybecontacted:

l Todiscussthereviewoutcomeoftheapplicationandobtainguidance.l TogetfeedbackandanswerstoanyquestionsabouttheSummaryStatement.l Tofindoutthemeaningofanumericaldesignationpertainingtohumansubjectsor

vertebrateanimalsintheSummaryStatement.l Tofindoutthefundingstatusofanapplication.

1.5 Grants Policy Statements

l TheNIH Grants Policy StatementservesasatermandconditionofawardandisacompilationofthesalientfeaturesofpoliciesandvariouspolicyissuesregardingtheadministrationofNIHawards.

l TheHHS Grants Policy StatementservesasatermandconditionofawardandisacompilationofthesalientfeaturesofpoliciesandvariouspolicyissuesregardingtheadministrationofgrantawardsfromotherPHSagencies,excludingNIHawards.

1.6 References

Applicants New to NIH: Getting Started

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

Award Information and Data

http://report.nih.gov/index.aspx

NIHResearchPortfolioOnlineReportingTool(RePORT)

Contact Information for an NIH Staff Person

http://ned.nih.gov

NIHlocator:(301)496-4000

Applying Electronically

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Foradditionalinformationontheelectronicsubmissionprocess,includingself-helpresources,trainingmaterialandanswerstofrequentlyaskedquestions,see:

http://grants.nih.gov/grants/ElectronicReceipt/index.htm

eRA Commons

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

InstitutionsandPD/PIsarerequiredtoregisterwiththeeRACommons.RegisteredPD/PIscancheckassignment/contactinformation,reviewoutcome,andotherimportantinformation.FormoredetailsonCommonsregistration,seeSection2.2.2.

Telephone:1-866-504-9552(toll-free)or301-402-7469.BusinesshoursareM-F7am-8pmEasternTime.

eRACommonsHelpDesk:http://era.nih.gov/help/

Grant Writing Tips and Sample Applications

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

http://grants.nih.gov/grants/grants_process.htm

Grants Information

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

E-mail:[email protected]

Telephone:(301)435-0714;(301)451-5936(TTY)

Grants.gov User Guide

TheGrants.govUserGuideisacomprehensivereferencetoinformationaboutGrants.gov.ApplicantscandownloadtheUserGuideatthefollowingaddress:.http://www.grants.gov/documents/19/18243/GrantsgovApplicantUserGuide.pdf

NIH Grants and Funding Help Page

http://grants.nih.gov/support/index.html

Thissiteprovidesaself-helpwizardtoguideinquiriestothecorrectNIHwebsiteforadditionalinformationonspecifictopics.

NIH Office of Extramural Research Human Subjects Website

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

Thissiteprovides,inoneplace,HHSandNIHrequirementsandresourcesfortheextramuralcommunityinvolvedinhumansubjectsresearch.

Office for Human Research Protections (Department of Health and Human Services)

http://www.hhs.gov/ohrp

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Informationabouthumansubjectprotections,InstitutionalReviewBoards,andFederalWideAssurances

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

Office of Laboratory Animal Welfare (OLAW)

http://olaw.nih.gov

Informationaboutanimalwelfarepolicyrequirements,InstitutionalAnimalCareandUseCommittees(IACUC),andAnimalWelfareAssurances

Telephone:(301)496-7163

Receipt/Referral of an Application

https://grants.nih.gov/grants/receipt_referral.htm

DivisionofReceiptandReferral

CenterforScientificReview

Telephone:(301)435-0715

Fax:(301)480-1987

Email:[email protected]

Specific Application: Before Review

Telephoneore-mailtheScientificReviewOfficeridentifiedfortheapplicationintheeRACommons.

Specific Application: Post Review

Telephoneore-mailtheNIHProgramOfficialnamedintheSummaryStatementfortheapplication.

1.7 Authorization

ThePHSrequeststheinformationdescribedintheseinstructionspursuanttoitsstatutoryauthoritiesforawardinggrants,containedinSections301(a)and487ofthePHSAct,asamended(42U.S.C.241aand42U.S.C.288).Therefore,suchinformationmustbesubmittedifanapplicationistoreceivedueconsiderationforanaward.LackofsufficientinformationmayhindertheabilityofthePHStoreviewanapplicationandtomonitorthegranteesperformance.

1.7.1 Collection of Personal Demographic Data

Federalagencieshaveacontinuingcommitmenttomonitortheoperationofitsreviewandawardprocessestodetect,anddealappropriatelywith,anyinstancesofrealorapparentinequities.Inaddition,section403ofthe2007NIHReformActrequiresNIHtoreporttoCongressspecificallyonpostdoctoralindividualssupportedonresearchgrants,andsection489ofthePHSActrequires

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NIHtoperformacontinuingassessmentofresearchpersonnelneeds.PersonaldemographicdataonPD/PIsandthosewithapostdoctoralroleisvitaltocomplywiththeserequirements.

NIHcollectspersonaldatathroughtheeRACommonsPersonalProfile.Thedataisprovidedone-timebytheindividualthroughasecure,electronicsystem,isconfidential,andismaintainedunderthePrivacyActrecordsystem09-25-0036,Grants:IMPAC(Grant/ContractInformation).WhencompletingthedataentryintheCommonsPersonalProfile,theindividualisresponsibleforprovidingtrue,accurate,andcompletedata.Allanalysesconductedondateofbirth,citizenship,gender,race,ethnicity,disability,and/ordisadvantagedbackgrounddatawillreportaggregatestatisticalfindingsonlyandwillnotidentifyindividuals.Decliningtoprovideinformationdoesnotaffectconsiderationofanapplication;however,forsomeprograms(e.g.,RuthL.KirschsteinNationalResearchServiceAwardsandResearchCareerDevelopmentAwards)citizenshipdataisrequiredtodetermineeligibility.

ThePHSalsorequeststhelastfourdigitsoftheSocialSecurityNumber(SSN)foraccurateidentificationofindividualsandformanagementofPHSgrantprograms.Pleasebeawarethatnoindividualwillbedeniedanyright,benefit,orprivilegeprovidedbylawbecauseofrefusaltodisclosethisportionoftheSSN.ThePHSrequeststhelastfourdigitsoftheSSNunderSection301(a)and487ofthePHSactasamended(42U.S.C.241aandU.S.C.288).

1.8 Paperwork Burden

ThePHSestimatesthatitwilltakeapproximately22hourstocompletethisapplicationforaregularresearchprojectgrant.Thisestimateexcludestimefordevelopmentofthescientificplan.Otheritemssuchashumansubjectsareclearedandaccountedforseparatelyandthereforearenotpartofthetimeestimate.AnagencymaynotconductorsponsorthecollectionofinformationunlessitdisplaysacurrentlyvalidOMBcontrolnumber.Norisapersonrequiredtorespondtorequestsforthecollectionofinformationwithoutthiscontrolnumber.Sendcommentsregardingthisburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingthisburden,to:NIH,ProjectClearanceOffice,6705RockledgeDriveMSC7974,Bethesda,MD20892-7974,ATT:PRA(0925-0001).Donotsendapplicationstothisaddress.

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2. Process for Application Submission via Grants.gov

ApplicationsubmissionthroughGrants.govinvolvesseveralsteps.Someofthestepsneedonlybedoneonetime.Othersareongoingstepsthatwillbenecessaryforeachapplicationsubmission.Beforebeginningtheapplicationprocess,youareencouragedtoreviewGrants.govandalltheresourcesavailablethere.

2.1 Overview

AllregistrationsrequirethatapplicantsbeissuedaDunandBradstreetUniversalNumberingSystem(DUNS)number.AfterobtainingaDUNSnumber,applicantscanbeginbothSystemforAwardManagement(SAM)(formerlyCCR)andeRACommonsregistrations.ThesameDUNSnumbermustbeusedforallregistrationsandonthegrantapplicationitself.

Note that all applicant and grantee organizations must complete and maintain an active entity registration in SAM which requires renewal at least annually.Thisrequiresthatyoureviewandupdatetheinformationatleastannuallyaftertheinitialregistration,andmorefrequentlyifrequiredbychangesinyourinformationoranotherawardterm.Therenewalprocessmayrequireasmuchtimeastheinitialregistration.SAMregistrationincludestheassignmentofaCommercialandGovernmentEntity(CAGE)CodefordomesticorganizationswhichhavenotalreadybeenassignedaCAGECode.ForeignorganizationsmustobtainaNATOCommercialandGovernmentEntity(NCAGE)Code(inlieuofaCAGECode)inordertoregisterinSAM.UsetheSAM.gov"ManageEntity"functiontomaintainyourentityregistrations.SeetheGrantsRegistrationsUserGuideathttp://www.sam.govforadditionalinformation.

ForadditionalinformationregardingmaintaininganactiveSAMregistration,pleaseseeNIHGuideNoticeNOT-OD-11-004.

ThefollowingstepsmustbetakeninordertosubmitagrantapplicationthroughGrants.gov.PleasebesuretocompleteallstepstoensurethatNIHreceivestheapplicationinatimelymanner.

1. RegisteryourorganizationatGrants.gov.(Thisisaone-timeonlyregistrationprocessforallFederalagencies.However,anannualrenewalofinformationprovidedtotheSystemforAwardManagement(SAM)isnecessarytoretainactiveGrants.govcredentials.IfyourorganizationhasalreadycompletedthisstepforanyFederalagencysubmission,skiptostep#2.Ifyourorganizationhasnotcompletedthisstep,seeSection2.2formoredetails.)

2. RegisteryourorganizationandProgramDirector/PrincipalInvestigator(PD/PI)intheeRACommons.(Thisisaone-timeonlyregistrationprocess.Ifyourorganizationhasalreadycompletedthisstep,skiptostep#3.Ifyourorganizationhasnotcompletedthisstep,seeSection2.2formoredetails.)

3. FindaFundingOpportunityAnnouncement(FOA)ofinterestusingtheNIHGuideforGrantsandContractsorGrants.govsSearchGrantsfeature.(SeeSection2.4formoredetails.)

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4. DownloadtheassociatedApplicationPackagefromGrants.gov.(AdobeReaderrequiredfordownload.SeeSection2.3.1formoredetails.)

5. Completetheappropriateapplicationforms,includingalltextandPDFattachments.Uploadallattachmentsintotheappropriateapplicationform(SeeSection2.6formoredetailsontherequirementsfortext(PDF)attachments).

6. Reviewthecompletedapplicationthroughyourownorganizationalreviewprocess.7. CoordinatewithanAuthorizedOrganizationRepresentative(AOR)attheapplicant

organizationtosubmittheapplicationbythedateandtimespecifiedintheFOA.(Keep a copy locally at the Applicant Organization/Institution.)

8. ReceivetheGrants.govtrackingnumber.9. AftersuccessfullypassingGrants.govandagencyvalidation,receivetheagencytracking

number(accessionnumber).Note: Any errors encountered at Grants.gov or eRA Commons must be corrected in order to successfully complete your submission successfully.

10. PD/PIandSigningOfficial(SO)mustviewtheapplicationineRACommonstoensuretheassembledapplicationcorrectlyreflectstheirsubmission.(SeeSection2.11fordetailedinformation.)

Thefollowingsectionsexplaineachstepinmoredetail.

2.2 Registration Process

New/potentialapplicantorganizationsmusthavecompletedbothGrants.govandeRACommonsregistrationsinordertosubmitanapplication.Grants.govandeRACommonsaredistinct,one-timeregistrationswhichmaybecompletedsimultaneously.Eachregistrationprocessisdescribedbelow.

2.2.1 Grants.gov Registration

Grants.govrequiresaone-timeregistrationby the applicant organizationinordertosubmitapplications.Registrationisnotneededtodownloadanapplicationpackageortoprepareanapplicationforsubmission.PD/PIsdonothavetoindividuallyregisterinGrants.govunlesstheyalsoserveastheAuthorizedOrganizationRepresentative(AOR)fortheirinstitution/organization.IfanapplicantorganizationhasalreadycompletedGrants.govregistrationforanotherFederalagency,theycanskipthissectionandfocusontheeRACommonsregistrationstepsnotedbelow.ForthoseapplicantorganizationsstillneedingtoregisterwithGrants.gov,registrationinformationcanbefoundattheGrants.govApplicantstab.WhileGrants.govregistrationisaone-timeonlyregistrationprocess,itdoesinvolveseveralstepsandwilltakesometime.Applicantorganizationsneedingtocompletethisprocessareencouragedtostart earlyallowingatleastsix(6)weekstocompleteallthestepsbeforeactuallysubmittinganapplicationthroughGrants.gov.

TheAORisanindividualauthorizedtoactfortheapplicantorganizationandtoassumetheobligationsimposedbytheFederallaws,requirements,andconditionsforagrantorgrantapplication,includingtheapplicableFederalregulations.Thisindividualhastheauthoritytosigngrantapplicationsandrequiredcertificationsand/orassurancesthatarenecessarytofulfillthe

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requirementsoftheapplicationprocess.Oncethisindividualisregistered,theorganizationcanthenapplyforanygovernmentfundingopportunitylistedinGrants.gov,includingNIHandotherPHSagenciesgrants.

QuestionsregardingGrants.govregistrationshouldbedirectedtotheGrants.govContactCenterattelephone:1-800-518-4726orbye-mailatsupport@grants.gov.TheContactCenterisavailable24hoursaday,7daysaweek.

2.2.2 eRA Commons Registration

TheapplicantorganizationandallPD/PIs,allindividualswiththeroleofprojectleadonmulti-projectapplications,andindividualswiththeroleofSponsoronindividualfellowshipapplicationsmustalsocompleteaone-timeregistrationintheeRACommonsasarequirementforapplicationsubmission.IndividualsinotherrolesdonotneedaneRACommonsIDforapplicationsubmission.However,iftheapplicationisfunded,thoseindividualswhoseeffortwillbeincludedinNIHprogressreportsmustalsohaveaneRACommonsID.AccesstotheCommonsisvitalforallstepsintheprocessafterapplicationsubmission.Anorganization,PD/PIs,andindividualsinotherrolesthatrequireanIDmustberegisteredintheCommonsinordertohaveaccesstoelectronicsubmissionandretrievalofgrantinformation,suchasreviewinggrantapplications,institute/centerassignments,reviewoutcomes,andSummaryStatements(accessvariesbytypeofrole).ApplicantsmusthaveanactiveDUNSnumberinordertocompletetheeRACommonsregistration.OrganizationscanregisterwiththeeRACommonsastheyareworkingthroughtheirSAMorGrants.govregistration.eRACommonsrequiresorganizationstoidentifyatleastoneSigningOfficial(SO),alsoknownastheAuthorizedOrganizationRepresentative(AORinGrants.gov),andatleastoneProgramDirector/PrincipalInvestigator(PD/PI)accountinordertosubmitanapplication.Institutional/organizationalofficialsareresponsibleforregisteringPD/PIsandotherindividualswitharoleinNIHprogressreportsintheeRACommons.PD/PIsandotherindividualsshouldworkwiththeirAOR/SOtodeterminetheirinstitutional/organizationalprocessforregistration.

IMPORTANT:TheeRACommonsregistrationprocessshouldbestartedatleastsix(6)weekspriortothesubmittaldateofaGrants.govsubmission.FailuretoregisterintheCommonsandtoincludeavalidPD/PICommonsIDinthecredentialfieldoftheSenior/KeyPersonProfileFormwillpreventthesuccessfulsubmissionofanelectronicapplicationtoNIH.

2.2.2.1 Commons Registration for the Organization

OrganizationsmayverifytheircurrentregistrationstatusbyaccessingtheCommonsRegisteredOrganizationslinkathttps://public.era.nih.gov/chl/public/search/index.jsp.

ToregisteranOrganizationintheeRACommons:

1. CompletetheonlineInstitutionRegistrationFormat:https://public.era.nih.gov/commons/public/registration/registrationInstructions.jsp

2. Printandfaxtheregistrationpagea. TheSigningOfficial(SO)mustsign,dateandfaxtheregistrationtothenumberlisted

ontheform

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3. SigningOfficialmustverifyemailaddressa. Oncetheregistrationissubmittedelectronically,emailverificationissentandtheSO

mustclickthelinktoverifyemailb. TheabovestepsmustbecompletedbeforeNIHcanprocesstheregistrationc. TheSOwillreceiveanApprovalemailfromNIHd. TheApprovalemailcontainsalinktoinformationthatyoumustverifyascorrect

beforetheconfirmationprocessiscompleted4. AccountAdministrator(AA)receivesusernamesandtemporarypasswords

a. Afterthecompletionoftheconfirmation,theSOandAAwillreceivetwoemailsthatcontaintheusernamesandtemporarypasswordfortheSOandAAaccountscreatedduringtheregistrationprocess

5. LogintoCommonsa. TheSOandAAlogintoCommonsandadministeradditionalaccountsasneeded

6. AffiliateyourPD/PIsa. YourPrincipalInvestigatorsmustworkwithyourorganizationtoberegisteredin

eRACommonsiftheydonothaveanexistingaccount.IFtheyhaveanaccount,youmustaffiliateitwithyourorganization.Verifythatyou'veselectedthecorrectPIaccount!

Formoreinformation,seehttp://era.nih.gov/commons/faq_commons.cfm#II2

ThisregistrationisindependentofGrants.govandmaybedoneatanytime.

Organizationaldataelements,suchasInstitutionalProfileNumber(IPF),EntityIdentificationNumber(e.g.,5555555555A5)andDUNSNumbermustbeaccuratelyidentified. 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) Form in Section 5, Applicant Information.

Priortosubmission,theAOR/SOshouldverifythattheirorganizationseRACommonsprofilecontainsthevalidDUNSnumberthatwillbeusedforthesubmissionprocess.TheSOhastheabilitytoeditthisfieldintheorganizationprofileinCommons.

ToconfirmthatyourorganizationhasaDUNSnumberortofindoutiftheDUNSnumberyouhavematchestheoneinCommons,accesstheListofGranteeOrganizationsRegisteredineRACommonshttps://public.era.nih.gov/chl/public/search/index.jsp.ThislistingofgranteeorganizationsregisteredinCommonsandtheirDUNSnumberscanbeaccessedwithoutloggingintoCommons.

2.2.2.2 Commons Registration for the Program Directors/Principal Investigators (PD/PIs)

OncetheorganizationisregisteredintheCommons,individualscanthenberegistered.

PD/PIs

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AllPD(s)/PI(s)musthaveaneRACommonsaccountandthePIRoleandshouldworkwiththeirorganizationalofficialstoeithercreateanewaccountortoaffiliateanexistingaccountwiththeapplicantorganizationseRACommonsaccount.IfthePD/PIisalsotheorganizationalsigningofficial,theymusthavetwodistincteRACommonsaccounts,oneforeachrole.The initial registration must be done by an Authorized Organization Representative (AOR) who has the SO role in Commons,orotherauthorizedaccountsadministratorattheorganization.However,aftertheinitialregistrationprocessiscomplete,itbecomestheresponsibilityofeachindividualtomaintaintheinformationinhis/herpersonalprofile.IfsubmittinganapplicationreflectingMultiplePD/PIs,theindividualdesignatedasthecontactPImustbeaffiliatedwiththeapplicantorganization.

ToregisterPD/PIsintheCommons,refertotheeRACommonsSystemUsersGuide(http://era.nih.gov/commons/user_guide.cfm).ForapplicationsreflectingMultiplePD/PIs,allsuchindividualsmustbeassignedthePIrole,eventhoseatorganizationsotherthantheapplicantorganization.

OnceaPD/PIhasreceivede-mailconfirminghis/herregistrationwithintheCommons,thePD/PImustverifythatallPersonalInformationlocatedwithinthePersonalProfiletabintheeRACommonsSystemisaccurate.ThePD/PIshouldupdate,asneeded,dataelementssuchasfirstname,middleinitial,lastname,prefixand/orsuffixtoPD/PIname(includingallembeddedpunctuation),e-mail,phone,fax,streetaddress,city,state,country,zipanddegreesearned.Thesedatamustcontainthemostrecentinformationinorderfortheapplicationtobeprocessedaccurately.

BothPD/PIandSOneedseparateaccountsinCommonssinceeachroleenablesdifferentfeatureswithineRACommons.Forexample,anSOcanRejectasubmittedapplicationtopreventitfrombeingsentontoagencystaff.APIhasaccesstoreviewoutcomeinformation(scoresandsummarystatement).IfyouaretheSOforyourorganizationaswellasaPD/PIofthegrant,youwillneedtwoseparateaccountswithdifferentusernamesonewithSOauthorityandonewithPIauthority.Whenanorganizationisregistered,anSOaccountiscreated.LogontotheaccountwiththeSOauthorityroleandcreateanotheraccountwithPIauthority.

Foradditionalinformationonhowtoprepareforelectronicsubmission,see:http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm.

2.2.2.3 Commons Registration for Other Individuals Participating in NIH Progress Reports

AnyindividualwithanUndergraduate,GraduateStudent,and/orPostdoctoralRolewhoparticipatesinanNIH-fundedprojectforatleastonepersonmonthormoreshouldalsoberegisteredintheeRACommonsandshouldverifythatallPersonalInformationlocatedwithinthePersonalProfiletabintheeRACommonsSystemisaccurate.Thisisrequiredregardlessofwhethersalaryisactuallychargedtotheproject.Forgraduatestudentssupportedonaparticularresearchgrant,thiscouldincludeprojectrolesofgraduateresearchassistantorgraduatestudent.Forpostdoctoralindividualssupportedonaparticularresearchgrant,thiscouldincludeprojectrolessuchasPostdoctoralAssociateandothersimilarPostdoctoralpositions.

WhenanindividualisassignedtheUndergraduate,GraduateStudent,orPostdoctoralRoleintheCommons,responsestocertaindataitemsinthePersonalProfiletabwillberequiredtomeetNIHreportingrequirementstoCongressincludedintheNIHReformAct,P.L.109-482.TheCommons

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usernameIDforthosewithanUndergraduate,GraduateStudent,orPostdoctoralRoleisnotrequiredatthetimeofapplicationsubmission,butwillberequiredaspartoftheResearchPerformanceProgressReport(RPPR).

Forindividualsatthepostdoctorallevel,thisrequirementisalreadyineffectandprogressreportswillnotbeacceptediftheCommonsIDisnotprovided.Forindividualsattheundergraduateandgraduatestudentlevels,aCommonsIDwillberequiredeffectivewithRPRRssubmittedOctober2014andbeyond.TheUndergraduateandGraduateStudentRoleshavebeenaddedtotheCommonstoaccommodatethisrequirement;granteesareencouragedtobeginregisteringtheseindividualsnow.

SeeNOT-OD-14-129(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-129.html)

Note,theGraduateStudentandPostdoctoraleRACommonsRolesshouldNOTbeusedforindividualssubmittingIndividualFellowships;thePD/PIroleisusedforthosesubmissions.NorshouldtheybeusedforindividualssupportedoninstitutionaltraininggrantsandreportedusingxTrain;theTraineeRolemustcontinuetobeusedforthoseindividuals.

ACommonsIDisstronglyencouraged,butcurrentlyoptional,forallotherprojectpersonnel.AgeneralCommonsRoleofProjectPersonnelisavailableforthosenotassignedotherCommonsRoles.

Foradditionalinformationonhowtoprepareforelectronicsubmission,see:http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm.

2.3 Software Requirements

2.3.1 Adobe Reader

Inordertoaccess,completeandsubmitapplicationsusingGrants.govsdownloadableforms,applicantswillneedtodownloadandinstallacompatibleversionoftheAdobeReaderavailableattheGrants.govwebsitehttp://www.grants.gov/web/grants/support/technical-support/software/adobe-reader-compatibility.html.

Forminimumsystemrequirementsanddownloadinstructions,pleaseseetheGrants.govUserGuide

2.3.2 Creating PDFs for Text Attachments

NIHandotherPHSagenciesrequirealltextattachmentstotheSF424(R&R)applicationformstobesubmittedasPDFfiles.

Applicantsshouldpreparetextattachmentsusinganywordprocessingprogram(followingtheformatrequirementsinSection2.6)andthenconvertthosefilestoPDFbeforeattachingthefilestotheappropriateformintheapplicationpackage.(ThePDFformatisusedtopreservedocumentformatting.)Saveallfileswithdescriptivefilenamesof50charactersorless.Donotusetheampersand(&)characterinfilenames.Useonespace,(nottwoormore)betweenwordsorcharacters.Justlikeletters,aspacecountsasonecharacter.

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SometypeofPDF-creationsoftwareisnecessarytocreatethePDF.(ThefreeAdobeReaderwillnotcreateaPDF.)ToassistapplicantssearchingforfreePDF-creationsoftware,Grants.govhaspublishedalistofavailabletoolsandsoftware,seeGrants.govsDownloadSoftwarepageathttp://www.grants.gov/web/grants/support/technical-support/software/pdf-conversion-software.html.

NotethatallPDFattachmentsmustbesubmittedasindividualfiles.AlthoughsomesoftwarepackagesallowbundlingofmultiplePDFsintoasinglefile,eRAsystemscannotsupportBundlingorPortfoliofeaturesatthistime.Useofthesefeaturesmayresultindelaysinthereviewofanapplicationoranapplicationnotbeingreviewed.

Itisrecommendedthat,asmuchaspossible,applicantsavoidscanningtextdocumentstoproducetherequiredPDFs.Instead,NIHrecommendsproducingthedocumentselectronicallyusingtextorword-processingsoftwareandthenconvertingdocumentstoPDF.Scanningpaperdocuments,withouttheproperOpticalCharacterRecognition(OCR)process,willhamperautomatedprocessingofyourapplicationforNIHanalysisandreporting.

SeeadditionalinformationatNIHPDFGuidelineshttp://grants.nih.gov/grants/ElectronicReceipt/pdf_guidelines.htm

DISCLAIMER:ReferencestosoftwarepackagesorInternetservicesneitherconstitutenorshouldbeinferredtobeanendorsementorrecommendationofanyproduct,service,orenterprisebytheNIHorotherPHSagencies,anyotheragencyoftheUnitedStatesGovernment,oranyemployeeoftheUnitedStatesGovernment.Nowarrantiesarestatedorimplied.

2.4 Funding Opportunities

Grantsforhealth-relatedresearchandresearchtrainingprojectsoractivitiesmakeupthelargestcategoryoffundingprovidedbytheNIHInstitutes/Centers(ICs)andothernon-NIHagencies.MostapplicationsforsupportareunsolicitedandoriginatewithindividualinvestigatorswhodevelopproposedplansforresearchorresearchtrainingwithinanareathatisrelevanttotheNIH.Researchprojectgrantsareawardedtoorganizations/institutionsonbehalfofPD/PIstofacilitatethepursuitofascientificobjectivewhentheideafortheresearchisinitiatedbytheinvestigator.Ifthefundingagencyanticipatessubstantialprograminvolvementduringtheconductoftheresearch,acooperativeagreementwillbeawarded,ratherthanagrant.TheNIHtypicallyawardsgrantsandcooperativeagreementsfortermsrangingfromonetofiveyears.Organizational/institutionalsponsorshipassuresthattheawardeeorganizationwillprovidethefacilitiesandthefinancialstabilitynecessarytoconducttheresearch,andbeaccountableforthefunds.Foralistandbriefdescriptionofgrantactivitycodes,seeSupplementalInstructionsPartIII:Policies,Assurances,Definitions,andOtherInformation.

2.4.1 NIH Guide for Grants and Contracts

TheNIHGuideforGrantsandContracts(http://grants.nih.gov/grants/guide),aweeklyelectronicpublication,containsannouncementsaboutfundingopportunities,suchasRequestsfor

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Applications(RFAs)andProgramAnnouncements(PAs),includingParentAnnouncements,fromNIHandotherPHSagencies.TheNIHGuidealsocontainsvitalinformationaboutpoliciesandprocedures.TosubscribetotheNIHGuide,visithttp://grants.nih.gov/grants/guide/listserv.htm.

2.4.2 Funding Opportunity Announcements

Tohastenthedevelopmentofaprogramortostimulatesubmissionofapplicationsinanareaofhighpriorityorspecialconcern,anawardingcomponentwillencourageapplicationsthroughtheissuanceofaPAtodescribenew,continuing,orexpandedprograminterests,orissuanceofanRFAinvitingapplicationsinawell-definedscientificareatoaccomplishascientificpurpose.

Definitionsareasfollows:

Parent Announcements: ElectronicgrantapplicationsmustbesubmittedinresponsetoaFundingOpportunityAnnouncement(FOA).Forapplicantswhowishtosubmitwhatwereformerlytermedinvestigator-initiatedorunsolicitedapplications,NIHandotherPHSagencieshavedevelopedParentAnnouncements.RespondingtosuchanomnibusorumbrellaParentFOAensuresthatthecorrectapplicationpackageisusedandenablesNIHtoreceivetheapplicationfromGrants.gov.Additionalinformationabout,aswellaslinkstopublishedParentAnnouncements,canbefoundat:http://grants.nih.gov/grants/guide/parent_announcements.htm.

Program Announcement (PA):Aformalstatementaboutaneworongoingextramuralactivityorprogram.Itmayserveasareminderofcontinuinginterestinaresearcharea,describemodificationsinanactivityorprogram,and/orinviteapplicationsforgrantsupport.MostapplicationsinresponsetoPAsmaybesubmittedtoastandingsubmissiondateandarereviewedwithallotherapplicationsreceivedatthattime.NIHmayalsomakefundsavailablethroughPARs(ProgramAnnouncementswithspecialreceipt,referral,and/orreviewconsiderations)andPASs(ProgramAnnouncementswithset-asidefunds).

Request for Applications (RFA):Aformalstatementthatsolicitsgrantorcooperativeagreementapplicationsinawell-definedscientificareatoaccomplishspecificprogramobjectives.AnRFAindicatestheestimatedamountoffundssetasideforthecompetition,theestimatednumberofawardstobemade,andtheapplicationsubmissiondate(s).ApplicationssubmittedinresponsetoanRFAareusuallyreviewedbyaScientificReviewGroup(SRG)speciallyconvenedbytheawardingcomponentthatissuedtheRFA.

PAs(includingParentAnnouncements)andRFAsarepublishedintheNIH Guide for Grants and Contracts(http://grants.nih.gov/grants/guide),theFederal Register(http://www.gpoaccess.gov/nara/index.html),andonGrants.govunderGrants.govunderSearchGrants(http:/www.grants.gov/web/grants/search-grants.html).Readtheannouncementcarefullyforspecialinstructions.Theinstructionsintheannouncementmaydifferfromthesegeneralinstructions,andtheinstructionsintheannouncementalwayssupersedethesegeneralinstructions.Eachannouncementpublishedinthe NIH Guide for Grants and Contracts,theFederal Register,Grants.govSearchGrants,orotherpublicdocumentcontainscontactinformationunderInquiriesinadditiontoinformationspecifictotheannouncement.

WhileindividualannouncementswillcontinuetocarryanannouncementnumberreferencetoPAorRFA,allannouncementsareFundingOpportunityAnnouncements(FOAs).Thisgeneraltermwillbeusedtoreferenceanytypeoffundingannouncement.NIHwillcontinuetouse

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thePAandRFAreferencesintheactualannouncementnumbertodistinguishbetweenthevarioustypesofannouncements.

InreadinganyFOAintheNIHGuideforGrantsandContracts:

l APostedDatereferstothedatetheFOAispostedonGrants.gov.Anapplicantcandownloadtheapplicationpackageonthatdateandbeginfillingitout.However,theapplicanthastowaituntiltheFOAsopendatetosubmittheapplication.

l Anapplicationcanbesubmittedanytimebetweentheopendateandtheapplicationduedate(s)notedforAIDSandnon-AIDSapplications.(Standarddatesmayapply;checkhttp://grants.nih.gov/grants/funding/submissionschedule.htmfordetails.)

l WhenyoudownloadanapplicationpackagefromGrants.gov,theexpirationdateispre-populated.Donotgostrictlybythisdatesinceitmaynotapplytoyourparticularsituation;forinstance,itmayreflectthesubmissiondateforAIDSapplicationsandyoumaybesubmittinganon-AIDSapplicationthatisdueearlier.Inthiscase,thepre-populateddatehasnobearingonyourapplicationandyoushouldnotbeconcernedbyit.

AllapplicationssubmittedtotheNIHmustbesubmittedinresponsetoanFOApublishedintheNIHGuideforGrantsandContracts.

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

ImplementationoftheSF424(R&R)applicationandelectronicsubmissionthroughGrants.govwillbeannouncedthroughspecificFOAspostedintheNIHGuideforGrantsandContractsandonGrants.govunderSearchGrants(a.k.a.Search)andApplyforGrants(a.k.a.Apply).FromtheApplicantssectionoftheGrants.govhomepage,selectApplyforGrantsandfollowthestepsprovided.FOAspostedinGrants.govSearchreflectthosetheagencyispreparedtoreceivethroughelectronicGrants.govsubmission.ApplicantsareencouragedtoreadeachFOAcarefullyforspecificguidanceontheuseofGrants.govsubmission.

ThereareseveralwaysaprospectiveapplicantcanfindaFOAonGrants.gov.

Using the NIH Guide for Grants and Contracts

FOAsintheNIH Guide for Grants and ContractsthatreferenceelectronicsubmissionviaGrants.govincludealinkfromtheFOAdirectlytotheGrants.govsitewhereyoucandownloadthespecificapplicationpackage.TheApply for Grants ElectronicallybuttonisfoundintheNIH GuideFOAdirectlyundertheRequiredApplicationInstructionssection.ThislinkisonlyprovidedinthoseannouncementsinvolvingelectronicsubmissionthroughGrants.gov.

Using Search Grants

Grants.govSearchGrantsprovidesgeneralsearchcapabilities.FromtheSearchGrantspage,youwillfindvariousoptionsfor:providingsearchcriteria(e.g.,keyword,FundingOpportunityNumber,status,etc.)andidentifyingFOAsofinterest.

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Onceyoufindanopportunityforwhichyouwishtoapply,youmayinitiatetheapplicationdownloadprocessfromtheSearchpagebyselectingtheFOAthenselectingtheApplicationPackagetabandusingthedownloadlink.

Using Apply for Grants

IfyouknowthespecificFundingOpportunityAnnouncement(FOA)number,fromtheGrants.govhomepage,selectApplicantsthenApplyforGrantsandfollowthestepsprovided.Step1allowsyoutodownloadanapplicationpackagebyinsertinganFOAnumber.IfyoudonotknowthespecificFOANumberyoumayuseSearchGrantstofindit.

Clickthecorrespondingdownloadlinktoaccesstheactualapplicationformpagesandinstructionmaterial.Ifmorethanoneapplicationpackageislisted,usetheCompetitionIDandCompetitionTitletodeterminetheappropriatepackagetodownload.Thefollowingscreensappear:

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Toaccesstheinstructions,click Download Application Instructions.ForNIHopportunitiesandotherPHSagenciesusingthisApplicationGuide,thisactionwilldownloadadocumentcontainingalinktotheNIHwebsitewherethemostcurrentsetofapplicationinstructionsisavailable(http://grants.nih.gov/grants/funding/424/index.htm).Applicantsareencouragedtocheckthissiteregularlyforthemostcurrentversion.

Toaccesstheformpages,clickDownload Application Package.Section2.5providesspecificinformationregardingtheformsforanApplicationPackage.Section3providesadditionalinstructionsforproperlyusingapackage.

OntheDownloadOpportunityInstructionsandApplicationsscreenyouwillbegivenanopportunitytoprovideane-mailaddressifyouwouldliketobenotifiedofanychangestothisparticularopportunity.ApplicantstoNIHandotherPHSagenciesarestronglyencouragedto

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completethisinformation.Theagencycanthenuseittoprovideadditionalinformationtoprospectiveapplicants.

Note:TheformsmayormaynotshowaCFDAnumberandtheCFDAfieldisnoteditable.Donotbeconcerned.TheCFDAnumberisnotusedforassignmentoftheapplication.Be assured the correct CFDA number will be assigned to the record once the appropriate IC assignment has been made.

2.5 Forms for an Application to NIH or Other PHS Agencies

TheSF424(R&R)formsetcomprisesanumberofforms,eachlistedinthetablebelowasaseparatedocument.Inadditiontotheseforms,NIHandotherPHSagenciesapplicantswillalsocompletetherequiredsupplementalformslistedasPHS398formsinthetablebelow.

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DOCUMENT REQUIRED OPTIONAL INSTRUCTIONS

SF424 (R&R) x Section 4.2

Project/Performance Site Locations x Section 4.3

SF424 (R&R) Other Project Information x Section 4.4

SF424 (R&R) Senior / Key Person Profile Expanded x Section 4.5

SF424 (R&R) Budget

(Use when required or allowed by the FOA)* Section 4.7

SF424 (R&R) Subaward Budget Attachment Form

(Use when required or allowed by the FOA) x Section 4.8

PHS 398 Cover Page Supplement x Section 5.3

PHS 398 Modular Budget


PHS 398 Research Plan

(Not required for Career Development Award (K) or Institutional Training Award (T) applications)

x Section 5.5

Planned Enrollment Report x Section 5.8

PHS 398 Cumulative Inclusion Enrollment Report x Section 5.8.2

PHS 398 Career Development Award Supplemental Form

(Required only for Career Development Award (K) applications)

x Section 7.5

PHS 398 Research Training Program Plan

(Required only for Institutional Training Award (T) applications)

x Section 8.7

PHS 398 Training Budget


Table 2.5-1. Forms for an NIH or Other PHS Agency Application

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DOCUMENT REQUIRED OPTIONAL INSTRUCTIONS

PHS 398 Training Subaward Budget Attachment

(Use when required or allowed by the FOA) * Section 8.6

* The application forms package associated with most NIH research grant funding opportunities includes two optional budget forms: (1) SF424 (R&R) Budget and (2) PHS 398 Modular Budget. NIH application submissions must include either the SF424 (R&R) Budget Form or the PHS 398 Modular Budget Form, but never both. (Note AHRQ does not accept modular budgets.) Unless otherwise stated in a funding announcement, an application must always be submitted with a budget form. 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 form to use for NIH applications, consult the modular budget guidelines found in Section 5.4. 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 forms. 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).For a small number of programs (e.g., S10, DP1, DP2, DP3, X01, X02), neither budget form is included and the only budget information required is the Estimated Project Funding section of the SF424 (R&R).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.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. Forms from other sources may include extraneous headers/footers or other information that could interfere with the electronic application process

2.6 Format Specifications for Text (PDF) Attachments

Designedtomaximizesystem-enforcedvalidations,multipleseparateattachmentsarerequiredforacompleteapplication.Whentheapplicationisreceivedbytheagency,allsubmittedformsandallseparateattachmentsarecombinedintoasingledocumentthatisusedbypeerreviewersandagencystaff.

NIHandotherPHSagenciesrequirealltextattachmentstotheAdobeapplicationformsbesubmittedasPDFsandthatalltextattachmentsconformtotheagency-specificformattingrequirementsnotedbelow.Failuretofollowtheserequirementsmayleadtorejectionoftheapplicationduringagencyvalidationordelayinthereviewprocess.(SeeSection2.3.2formoreinformationoncreatingPDFs.)

TextattachmentsshouldbegeneratedusingwordprocessingsoftwareandthenconvertedtoPDFusingPDFgeneratingsoftware.AvoidscanningtextattachmentstoconverttoPDFsincethatcausesproblemsfortheagencyhandlingtheapplication.AdditionaltipsforcreatingPDFfilescanbefoundathttp://grants.nih.gov/grants/ElectronicReceipt/pdf_guidelines.htm.

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WhenattachingaPDFdocumenttotheactualforms,pleasenoteyouareattachinganactualdocument,notjustpointingtothelocationofanexternallystoreddocument.Therefore,ifyourevisethedocumentafterithasbeenattached,youmustdeletethepreviousattachmentandthenreattachthereviseddocumenttotheapplicationform.UsetheView Attachmentbuttontodetermineifthecorrectversionhasbeenattached.

File Name

Saveallfileswithdescriptivefilenamesof50charactersorless.Donotusetheampersand(&)characterinfilenames.Useonespace,(nottwoormore)betweenwordsorcharacters.Justlikeletters,aspacecountsasonecharacter.

Font

PreparetheapplicationusingArial,Helvetica,PalatinoLinotype,orGeorgiatypefaceinblackfontcolor.AftertextattachmentsareconvertedtoPDF,fontsizeineachfinalPDFdocumentmustbeatleast11points(orlarger).(ASymbolfontmaybeusedtoinsertGreeklettersorspecialcharacters;thefontsizerequirementstillapplies.)

SincesomePDFconvertersmayreducefontsizes,itisimportanttoconfirmthattypedensityineachfinalPDFdocument,includingbothcharactersandspaces,isnomorethan15characters+spacesperlinearinchandnomorethansixlinesperverticalinch.

Paper Size and Page Margins

FinalPDFdocumentsshouldbeformattedtobenolargerthanstandard paper size (8 " x 11).

ThefinalPDFdocumentshouldhaveatleastone-halfinchmargins(top,bottom,left,andright)forallpages.Noinformationshouldappearinthemargins,includingthePIsnameandpagenumbers.

Page Formatting

Sinceanumberofreviewerswillbereviewingapplicationsasanelectronicdocumentandnotapaperversion,applicantsarestronglyencouragedtouseonlyastandard,single-columnformatforthetext.Avoidusingatwo-columnformatsinceitcancausedifficultieswhenreviewingthedocumentelectronically.

Donotincludeanyinformationinaheaderorfooteroftheattachments.Aheaderwillbesystem-generatedthatreferencesthenameofthePD/PI.Pagenumbersforthefooterwillbesystem-generatedinthecompleteapplication,withallpagessequentiallynumbered.

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

Youmayuseasmallertypesizebutitmustbeinablackfontcolor,readilylegible,andfollowthefonttypefacerequirement.Colorcanbeusedinfigures;however,alltextmustbeinablackfontcolor,clearandlegible.

Grantsmanship

UseEnglishandavoidjargon.

Iftermsarenotuniversallyknown,spelloutthetermthefirsttimeitisusedandnotetheappropriateabbreviationinparentheses.Theabbreviationmaybeusedthereafter.

Page Limits

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Althoughmanyofthesectionsofthisapplicationareseparatetext(PDF)attachments,pagelimitsreferencedintheseinstructionsand/orfundingopportunityannouncementsmuststillbefollowed.Agencyvalidationswillincludemanychecksforpagelimits.Someaccommodationwillbemadeforsectionsthatwhencombinedmustfitwithinaspecifiedlimitation.Notethatwhilethesecomputervalidationswillhelpminimizeincompleteand/ornon-compliantapplications,theymaynotaddressallpagelimitrequirementsforaspecificFOAanddonotreplacethevalidationsconductedbyNIHstaff.Applicationsfoundnottocomplywiththerequirementsmayleadtorejectionoftheapplicationduringagencyvalidationordelayinthereviewprocess.

AllapplicationsforNIHandotherPHSagencyfundingmustbeself-containedwithinspecifiedpagelimits.UnlessotherwisespecifiedinanNIHsolicitation,InternetWebsiteaddresses(URLs)maynotbeusedtoprovideinformationnecessarytothereviewbecausereviewersareundernoobligationtoviewtheInternetsites.Moreover,reviewersarecautionedthattheyshouldnotdirectlyaccessanInternetsiteasitcouldcompromisetheiranonymity.

ObservethepagenumberlimitsgiveninthedetailedTableofPageLimitsathttp://grants.nih.gov/grants/forms_page_limits.htm.OnlywhenspecificallyallowedinanFOAwillthePHSacceptapplicationsthatexceedthepagenumberlimitationsnotedintheTable.However,specificpagenumberlimitsmaystillapplytoeachsubproject.Forinformationpertainingtopagenumberlimitsforsuchprojects,contacttheawardingcomponenttowhichtheapplicationmaybeassigned.(SeeTable1.4-1.AgencyContactTable.)The page number limitations may also be different for other specialized grant applications.

ApplicantsareprohibitedfromusingtheAppendixtocircumventpagelimitationsinanysectionoftheapplicationforwhichapagelimitapplies.ForadditionalinformationregardingAppendixmaterialandpagelimits,pleaserefertotheNIHGuideNoticeNOT-OD-11-080.

2.7 "Resubmission" Applications

TheNationalInstitutesofHealth(NIH)andtheAgencyforHealthcareResearchandQuality(AHRQ)haveupdatedtheirpoliciesforapplicationsubmission.Followinganunsuccessfulresubmission(A1)application,applicantsmaysubmitthesameideaasanew(A0)applicationforanyduedateinthefuturethatisappropriateforthegrantmechanismandFundingOpportunityAnnouncement.Thepolicydoesnotprecludesubmissionofanew(A0)applicationfollowinganunsuccessfulnew(A0)application,withoutaninterveningresubmission(A1)application.TheNIHandAHRQwillnotassessthesimilarityofthescienceinthenew(A0)applicationtoanypreviouslyreviewedsubmissionwhenacceptinganapplicationforreview(seeNOT-OD-14-074).

Theupdatedpolicyappliestomajortypesofapplicationsandactivitycodes,including,theNIHSmallBusinessInnovationResearch(SBIR)andSmallBusinessTechnologyTransfer(STTR)programs,EligibilitycriteriaandanyotherrestrictionsorrequirementsintheFundingOpportunityAnnouncement(FOA)prevail.Forexample,anSBIR/STTRapplicationmustmeettheeligibilityrequirementsforeachapplicationsubmission.Anapplicationthatwasnotacceptedpreviouslyforbeingtoosimilartoaresubmissionapplicationthathadbeenreviewedpreviouslycanbesubmittedasanewapplication.

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NIH'spolicyforacceptingoverlappingapplicationsremainsineffect(seeNOT-OD-09-100).TheNIHwillnotacceptduplicateorhighlyoverlappingapplicationsunderreviewatthesametime.ThismeansthattheNIHwillnotaccept:

l anew(A0)applicationthatissubmittedbeforeissuanceofthesummarystatementfromthereviewofanoverlappingresubmission(A1)application.

l aresubmission(A1)applicationthatissubmittedbeforeissuanceofthesummarystatementfromthereviewofthepreviousnew(A0)application.

l anapplicationthathassubstantialoverlapwithanotherapplicationpendingappealofinitialpeerreview(seeNOT-OD-11-101).

TheNIHtimelimitforacceptingresubmission(A1)applicationsremainsineffect(seeNOT-OD-12-128andNOT-OD-10-140).TheNIHwillnotacceptaresubmission(A1)applicationthatissubmittedlaterthan37monthsaftersubmissionofthenew(A0)applicationthatitfollows.

NIHhasestablishedpoliciesforapplicationresubmissionsofcertaincategories.SeeResubmissionofUnpaidRFAApplicationsandResubmissionofApplicationswithaChangedGrantActivityCodeinPartIII,1.2.

TherearefourrequirementsforaResubmissionapplication:

l TheSummaryStatementfromthepreviousnewapplicationthatitfollowsmustbeavailableintheeRACommons(http://commons.era.nih.gov/commons).

l ThePD/PI(s)mustmakesignificantchangestotheapplication,comparedtothenewapplicationthatitfollows.

l AnIntroductionmustbeincludedthatsummarizesthesubstantialadditions,deletions,andchangestotheapplication.TheIntroductionmustalsoincludearesponsetotheissuesandcriticismraisedintheSummaryStatement.TheIntroductionisseparatefromtheCoverLetter.UseItem2.1IntroductionofthePHS398ResearchPlanFormtoprovidethisinformation.ThepagelimitfortheIntroductionmaynotexceedonepageunlessindicatedotherwise.PleaserefertotherelevantsectionoftheapplicationinstructionsandtheFOA.

Acceptanceofaresubmissionapplicationwillnotautomaticallywithdrawthepriorversion.eRAkeepsallversions(e.g.,01,A1)ofagrantapplicationactiveandprovidesaninternalMultipleActiveApplications(MAA)flagforeachapplicationinanactivecluster.Theclusterallowsapplicantstoidentifyquicklyallversionsofoneapplication.Ifanyversioninaclusterisawarded,allotherapplicationswithintheclusterwillbeautomaticallywithdrawnwithoutanyadditionalactionbyapplicantsorstaff.

2.8 "Revision" Application

ARevisionapplication(formerlycalledacompetingsupplement)maybesubmittedtorequestsupportforasignificantexpansionofaprojectsscopeorresearchprotocol.ApplicationsforrevisionsarenotappropriatewhenthesolepurposeistorestoreawardstothefullSRG-recommendedleveliftheywereadministrativelyreducedbythefundingagency.Arevisionapplicationshouldnotbesubmitteduntilaftertheoriginalapplicationhasbeenawardedandmustnotextendbeyondthetermofthecurrentawardperiod.

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Provideaone-pageIntroductionthatdescribesthenatureofthesupplementandhowitwillinfluencethespecificaims,researchdesign,andmethodsofthecurrentgrant.UseIntroductiontoapplication,ofthePHS398ResearchPlanformtoprovidethisinformation.Thebodyoftheapplicationshouldcontainsufficientinformationfromtheoriginalgrantapplicationtoallowevaluationoftheproposedsupplementinrelationtothegoalsoftheoriginalapplication.NotethatallrevisionapplicationsmustbesubmittedbythesamePD/PI(orContactPD/PIformulti-PIgrants)aslistedonthecurrentawardandapplicantsmustusethesamebudgetformat(i.e.R&RBudgetFormorPHS398ModularBudgetForm)asthecurrentaward.Also,anybudgetarychangesfortheremainderoftheprojectperiodofthecurrentgrantshouldbediscussedintheBudgetJustification.

IftherevisionapplicationrelatestoaspecificlineofinvestigationpresentedintheoriginalapplicationthatwasnotrecommendedforapprovalbytheSRG,thentheapplicantmustrespondtothecriticismsinthepriorSummaryStatement,andsubstantialrevisionsmustbeclearlyevidentandsummarizedintheIntroduction.

Administrative Supplements

Anadministrativesupplementisanoncompetingawardthatprovidesadditionalfundingtoacurrentlyfundedgranttomeetincreasedcoststhatarewithinthescopeoftheapprovedproject,butthatwereunforeseenwhentheneworcompetingrenewalapplicationwassubmitted.Ifyouareconsideringrequestingadministrativesupplementfunding,youmustconsultinadvancewithyourdesignatedGrantsManagementOfficerandProgramOfficial.Itisimportanttosubmitarequestforsupplementalfundingbeforetheawardedgrantexpires.NIHnowpublishesalladministrativesupplementprogramsasFOAs,whichincludespecificprogramssuchastheResearchSupplementstoPromoteDiversity,andageneralFOAforrequeststhatdonotfallunderaspecificprogram.AdministrativeSupplementrequestsmaynowbesubmittedinresponsetoanFOAthrougheithertheeRACommonsorGrants.gov,asdescribedinNOT-OD-12-024,orthroughtheexisting,paper-basedprocess.EachFOAwilllinktoanapplicationpackagetousewiththesubmission.Itisimportanttonotethatsincetheapplicationsforadministrativesupplementsarenon-competing,acoverletterattachmentisnotallowedtobeincludedinanapplicationsubmittedthrougheRACommonsorGrants.govandwillgenerateanerrormessageifincluded.Ifyousubmitarequestinwriting,youmustsubmittotheICwhichawardedtheoriginalfundedgrant(nottotheDivisionofReceiptandReferral,CenterforScientificReview).Foradditionalinformation,seeNIHGuideNoticeNOT-OD-12-043.TherequestmustbesignedbytheauthorizedBusinessOfficialanddescribetheneedforadditionalfundingandthecategoricalcosts.ThejustificationshouldalsopointoutwhatwillNOTbeabletobeaccomplishedifsucharequestisdenied.

2.9 Similar, Essentially Identical, or Identical Applications

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

SimultaneoussubmissionofidenticalapplicationstooneormorecomponentsofthePHSarenotallowed,andtheNIHwillnotacceptsimilargrantapplicationswithessentiallythesameresearchfocusfromthesameapplicantorganizationforthesamereceiptdate.Thisincludesderivativeormultipleapplicationsthatproposetodevelopasingleproduct,processorservicethat,withnon-substantivemodifications,canbeappliedtoavarietyofpurposes.Likewise,identicalor

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essentiallyidenticalgrantapplicationssubmittedbydifferentapplicantorganizationswillnotbeacceptedforthesamereceiptdate.Applicantorganizationsshouldascertainandassurethatthematerialstheyaresubmittingonbehalfoftheprincipalinvestigatoraretheoriginalworkoftheprincipalinvestigatorandhavenotbeenusedelsewhereinthepreparationandsubmissionofasimilargrantapplication.ApplicationstotheNIHaregroupedbyscientificdisciplineforreviewbyindividualScientificReviewGroupsandnotbydiseaseordiseasestate.Thereviewerscanthuseasilyidentifymultiplegrantapplicationsforessentiallythesameproject.Inthesecases,applicationprocessingmaybedelayedortheapplication(s)maynotbereviewed.

Essentiallyidenticalapplicationswillnotbereviewedexceptfor:1)individualssubmittinganapplicationforanIndependentScientistAward(K02)proposingessentiallyidenticalresearchinanapplicationforanindividualresearchproject;2)individualssubmittinganindividualresearchprojectidenticaltoasubprojectthatispartofaprogramprojectorcentergrantapplication;3)submissionsofapplicationspreviouslysubmittedtoanRFAthatwerenotpaidorresubmissionsofinvestigator-initiatedapplicationsoriginallysubmittedtoanRFA(seeGrantsPolicyStatementsection2.3.7.3);and4)resubmissionsofapplicationswithachangedgrantactivitycode.

2.10 Submitting your Application Via Grants.gov

TheAuthorizedOrganizationRepresentatives(AORs)registeredinGrants.govaretheonlyofficialwiththeauthoritytoactuallysubmitapplicationsthroughGrants.gov.Therefore,PD/PIswillneedtoworkcloselywiththeirAOR(s)todeterminethatallthenecessarystepshavebeenaccomplishedpriortosubmittinganapplication.Thisincludesanyinternalreviewprocessrequiredbytheapplicantorganization.

Beforestartingthefinalsubmissionstep, applicants are encouraged to save a copy of the final application locally.Onceyouhaveproperlycompletedallrequireddocumentsandattachedanyrequiredoroptionaldocumentation,clickontheCheck Package for ErrorsbuttontoensurethatyouhavesuccessfullycompletedallGrants.govrequireddatafields.Ifanyoftherequiredfieldsarenotcompletedyouwillreceiveanerrornoticewhichwillindicatewhererevisionisneededwithinyourpackage.Correctanyerrorsorifnonearefound,savetheapplicationpackage.NotethattheCheckPackageforErrorsbuttononlychecksasubsetofGrants.govapplicationchecksanddoesnotguaranteethatyourapplicationwillpasssubsequentGrants.govandagencybusinessrulechecksdoneaftersubmission.OnlyafterthepackagehasbeensavedwithnoerrorswilltheSave & Submitbuttonbecomeactive.ClickingtheSave & Submitbuttonwillbegintheapplicationsubmissionprocess.Theapplicationpackagemustthenbesavedoncemorebeforethesubmissionprocessbegins.OnlyanAORwillbeabletoperformthesubmitaction,andtheywillbetakentotheapplicantloginpagetoentertheGrants.govusernameandpasswordthatwasestablishedintheRegisterwithGrants.govprocess(ifnotconnectedtotheinternetyouwillbeinstructedtodoso).

Onceloggedin,theapplicationpackagewillbeautomaticallyuploadedtoGrants.gov.AconfirmationscreenwillappearoncetheuploadiscompleteandaGrants.govTrackingNumberwillbeprovidedonthisscreen.ApplicantsshouldrecordthisnumbersothattheymayrefertoitshouldtheyneedtocontactGrants.govContactCenterortheeRACommonsHelpDesk.

Foradditionalinformation,seehttp://www.grants.gov/applicants/apply_for_grants.jsp.

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Applicantsshouldbeawarethaton-timesubmissionmeansthatanapplicationissubmittederrorfree(ofbothGrants.govandeRACommonserrors)before5p.m.onthereceiptdate,localtimeoftheapplicantorganization.ApplicantsareencouragedtosubmittheirapplicationstoGrants.govseveraldaysearlytoensureenoughtimetocorrectanyerrorsbeforethedeadline.

2.11 After you Submit your Application via Grants.gov

Grants.govsTrackMyApplicationfeatureforApplicants(http://www.grants.gov/web/grants/applicants/track-my-application.html)providesbasicstatusinformationforaspecifiedGrants.govTrackingNumber.TheAuthorizedOrganizationRepresentative(AOR)canalsologintoGrants.govwiththeirusernameandpasswordtoobtainamoredetailedstatusofanapplicationbyusingtheCheckMyApplicationStatusfeature.

OnceanapplicationhasbeensubmittedviaGrants.gov,severale-mailsaresenttotheemailaddressonfilewithGrants.govfortheAOR(knownatNIH/ineRACommonsastheSigningOfficial[SO])whosubmittedtheapplication.EachemailnotificationwillreferenceaGrants.govtrackingnumberthatisassignedtothesubmission:

1. SubmissionReceipt:Ane-mailissentindicatingyourapplicationhasbeenreceivedbyGrants.govandiscurrentlybeingvalidated.

2. SubmissionValidationReceipt:Ane-mailissentindicatingyourapplicationhasbeenreceivedandvalidatedbyGrants.govandisbeingpreparedforGrantoragencyretrieval.

3. GrantorAgencyRetrievalReceipt:Ane-mailissentindicatingyourapplicationhasbeenretrievedbytheGrantoragency.

4. AgencyTrackingNumberAssignmentforApplication:Ane-mailissentindicatingyourapplicationhasbeenassignedanAgencyTrackingNumber.InGrants.gov,astatusofAgencyTrackingNumberAssignedalsoindicatesthatNIHhasprocessedtheapplicationwithoutidentifyinganyerrorsandanassembledapplicationimageisavailableineRACommonsforviewing.

IftheAOR/SOhasnotreceivedaconfirmationmessagefromGrants.govwithin48hoursofsubmission,pleasecontact:

Grants.govContactCenterTelephone:1-800-518-4726E-mail:[email protected]

Atthatpoint,theapplicationwillbescheduledfordownloadintotheeRAsystemforagencyvalidation.Itisimperativethatthee-mailaddressprovidedinblock14forthePD/PIand19fortheAOR/SOontheSF424(R&R)formbecurrentandaccurate.Onceagencyvalidationiscompleted,anagencynotification(notGrants.gov)willbee-mailedtothePD/PI,AOR/SO,andtheApplicantContacte-mail(ifprovided)namedintheapplication.

Thise-mailnotificationwillinformthePD/PI,AOR/SO,andtheApplicantContact(ifnamed)thattheapplicationhasbeenreceivedandprocessedbytheagencyandwillindicatewhetheranyerrorsorwarningsresultedduringthevalidationprocess.ThePD/PI,AOR/SO,andtheApplicantContactwillbeinvitedtologontheeRACommonstoviewtheassembledapplicationorreview

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thelistofwarnings/errorsthatwereencounteredduringthevalidationprocess.SOsfortheapplicantorganization,thePD/PIfortheapplicationandanyAssistantsthathavebeendelegatedineRACommonstoviewthePD/PIsstatusinformationwillhaveaccesstothesubmissionresultsineRACommons.

Iftherewerenovalidationerrors,thise-mailnotificationwillalsoinformthePD/PI,AOR/SO,andtheApplicantContactofanagencyaccessionnumber(e.g.,AN654321),whichrepresentstheagencytrackingnumber.TheGrants.govsystemwillindicatethattheagencytrackingnumberhasbeenassigned,andwillreflectbothnumbers.

TheeRAsystemwillmakeeveryefforttosendane-mailtothePD/PI,AOR/SO,andtheApplicantContactsummarizingdownloadandvalidationresults.Since e-mail can be unreliable, applicants are responsible for checking on their application status in the Commons.

Once an application package has been successfully submitted through Grants.gov, any encountered errors have been corrected by the applicant, and an application image has been assembled by the eRA Commons, PD/PIs and AORs/SOs will have two business days (Monday Friday, excluding Federal holidays) to check the assembled application before it automatically moves forward to NIH staff for further processing and consideration. Once the application has moved forward, no additional changes to the application will be accepted through Grants.gov or eRA Commons. This window is known as the application viewing window.

Within the viewing window, SOs have the authority to reject an application to stop it from completing the submission process. After an application is rejected, a changed/corrected application can be submitted to address warnings or other issues if it is still before the submission deadline. However, changed/corrected applications overwrite previous submissions and if submitted after the submission deadline will be subject to the NIH Late Policy and may not be accepted.

Remember, warnings do not stop further application processing. If an application submission results in warnings (but not errors), the application will automatically move forward after the application viewing window if no action is taken. Some warnings may need to be addressed later in the process.

It is your responsibility to view the entire assembled application in eRA Commons and notify the eRA Commons Help Desk within this window if the assembled application does not correctly reflect the information submitted to Grants.gov (e.g., submitted information is missing in image, graph/chart appears upside-down). The eRA Commons Help Desk will provide guidance on appropriate corrective actions.

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Only the eRA Help Desk can confirm whether a system issue has taken place and provide instructions on how to resolve the issue. Applications affected by confirmed system issues will not be considered late as long as the applicant works diligently with the eRA Help Desk on a resolution. If the application needs to be Rejected and resubmitted, applicants should follow the instructions for correcting errors in Section 2.12, including the

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

PD/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. LogintotheeRACommons(https://commons.era.nih.gov/commons/)withyourSigningOfficial(SO)account.

2. ClicktheStatustabontheCommonsmenubar.3. ClickRecent/Pending eSubmissionsontheleft-handsideofthescreen.4. Searchforyourapplicationbydatereceived,Grants.govtrackingnumber,oraccession

number,toviewahitlistofavailableapplications.5. Whenyoufindtheappropriateapplication,clicktheaccessionnumberintheApplication

IDcolumntoviewtheStatusInformationscreen.6. Click e-ApplicationfromtheOtherRelevantDocumentssectiontoviewtheassembled

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. LogintotheeRACommons(https://commons.era.nih.gov/commons/)withyourPrincipalInvestigator(PI)account.

2. ClicktheStatustabontheCommonsmenubar.3. ClickRecent/Pending eSubmissions nearthetopofthescreentoviewahitlistof

availableapplications.4. Whenyoufindtheappropriateapplication,clicktheaccessionnumberintheApplication

IDcolumntoviewthestatusinformationscreen.5. Clicke-ApplicationfromtheOtherRelevantDocumentssectiontoviewtheassembled

application.

2.12 Correcting Errors

Priortoaspecifiedapplicationduedate,applicantsmaymakecorrectionsandresubmitanapplicationthroughGrants.gov.Ifapplicantsmakecorrectionsandresubmittheapplicationaftertheduedate,theapplicationwillbeconsideredlate.Inthiscase,applicantsmustincludeacoverletterexplainingthereasonsforthedelayandacceptancewillbeconsideredonacase-by-casebasis.AlsoseeSection2.14foradditionalinformationonsubmissiondates.

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Iferrorsorwarningsresultfromthevalidationprocess,thePD/PI,AOR/SOandApplicantContactwillbeissuedane-mailinstructingthemtologontotheeRACommonstoreviewthelistofwarnings/errorsthatwereencounteredduringthevalidationprocess.TheeRAsystemwillmakeeveryefforttosendane-mailtothePD/PI,AOR/SOandApplicantContactindicatingwhethererrorsorwarningsweredetected.However,sincee-mailcanbeunreliable,applicantsareresponsibleforperiodicallycheckingontheirapplicationstatusintheeRACommons,sothatanyerrorsorwarningscanberesolvedinthetimeliestmannerpossible,beforethedeadline.SOsfortheapplicantorganization,thePD/PIfortheapplicationandanyAssistantsthathavebeendelegatedineRACommonstoviewthePD/PIsstatusinformationwillhaveaccesstothesubmissionresultsineRACommons.

Pleasebeawareofthedistinctionbetweenerrorsandwarnings.Theworderrorisusedtocharacterizeanyconditionwhichcausestheapplicationtobedeemedunacceptableforfurtherconsideration.Generally,errorswilli