SF424 RR Guide General VerC
description
Transcript of SF424 RR Guide General VerC
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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
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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
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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
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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
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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
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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
8.4.1SpecialInstructionsfor4.2SF424(R&R)Form 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
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9.2.1CollaboratingwithOtherOrganizations 234
9.3ApplicationSubmissionSystem&InterfaceforSubmissionTracking(ASSIST) 235
9.4SpecialInstructionsfortheSF424R&RforMulti-ProjectApplications 236
9.4.1SpecialInstructionsfor4.2SF424(R&R)Form 237
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
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PART I
Instructions for Preparing and Submitting an
Application
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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.
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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
(Use when required or allowed by the FOA)* Section 5.4
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
(Use when required or allowed by the FOA)* Section 8.5
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