Research Forms D

FORMSVERSIONDSERIES
UPDATEDMARCH25,2016
RESEARCHINSTRUCTIONSFORNIH
ANDOTHERPHSAGENCIES
SF424(R&R)APPLICATIONPACKAGES
GuidancedevelopedandmaintainedbyNIHforpreparingand
submittingapplicationsviaGrants.govtoNIHandotherPHS
agenciesusingtheSF424(R&R)
Research Instructions for NIH and Other PHSAgencies - Forms Version D Series
TABLEOFCONTENTS
TABLEOFCONTENTS
R.100-HowtoUsetheApplicationInstructions
R.110-ApplicationProcess
R.120-SignificantChanges
10
R.130-ProgramOverview
13
R.200-SF424(R&R)Form
14
R.210-PHS398CoverPageSupplementForm
27
R.220-R&ROtherProjectInformationForm
30
R.230-Project/PerformanceSiteLocation(s)Form
37
R.240-R&RSenior/KeyPersonProfile(Expanded)Form
41
R.300-R&RBudgetForm
51
R.310-R&RSubawardBudgetAttachment(s)Form
63
R.320-PHS398ModularBudgetForm
66
R.400-PHS398ResearchPlanForm
70
R.500-PHSInclusionEnrollmentReport
80
R.600-PHSAssignmentRequestForm
83
FormScreenshots
Instructions for Preparing and Submitting an Application
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R.100-HowtoUsetheApplication
Instructions
Usetheseapplicationinstructionstofillouttheformsthatarepostedinyourfundingopportunity
announcement.
QuickLinks
- Step1.Becomefamiliarwiththeapplicationprocess
- Step2.Selectthecorrectapplicationinstructions.
- Step3.ChooseanApplicationGuideformat.
- Step4.Completetheappropriateforms.
- Step5.Stayinformedofpolicychangesandupdates.
Step1.Becomefamiliarwiththeapplicationsubmissionprocess.
Understandingtheapplicationprocessiscriticaltosuccessfullysubmittingyourapplication.Usethe
ApplicationProcesssectionoftheseinstructionstolearntheimportanceofcompletingrequired
registrationsbeforesubmission,howtosubmitandtrackyourapplication,wheretofindpagelimits
andformattingrequirements,andmore.
Step2.Usetheseinstructionstogetherwiththeformsandinformationfound
inthefundingopportunityannouncement.
Thefundingopportunityannouncementwillincludetheformsneededforyourapplicationsubmission.
Rememberthatthefundingopportunityannouncementinstructionsalways
supersedetheseapplicationinstructions.
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Step3.Choosewhichapplicationinstructionformatyouprefertouse.
ComprehensiveInstructions
Program-SpecificInstructions
UsetheGeneral(G)instructions,availablein TakeadvantageofthefilteredPDFstoview
bothHTMLandPDFformat,tocompletethe specificapplicationinstructionsfor:
applicationformsforanytypeofgrantprol Research(R)
gram.
l CareerDevelopment(K)
l Training(T)
l Fellowship(F)
l Multi-project(M)
l SBIR/STTR(B)
RefertothechartonSelectingtheCorrectApplicationInstructionstodeterminewhichsetof
applicationinstructionsappliestothetypeofgrantprogramtowhichyouareapplying.
Step4.Completetheappropriateforms.
Foreachfield,followthestandardinstruction,aswellas,anyadditionalprogram-specific
instructionspresentedinthegraycalloutboxes.Program-specificinstructionsarecolorcodedto
simplifyreviewingthedocument.ConsulttheProgramOverviewsectionforcontextforprogram
specificinstructions.
Step5.Stayinformedofpolicychangesandupdates.
l RefertotheSignificantChangessectionforthemostrecentchangestotheseapplication
instructions.
l ReviewchangestoNIHpolicysincethepostingoftheapplicationguide.
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R.110-ApplicationProcess
Understandingtheapplicationprocessiscriticaltosuccessfullysubmittingyourapplication.Use
thissectionofthisguidetolearntheimportanceofcompletingrequiredregistrationsbefore
submission,howtosubmitandtrackyourapplication,wheretofindpagelimitsandformatting
requirements,informationaboutduedatesandsubmissionpolicies,andmore.Thisapplication
processinformationisalsoavailableonourhowtoapplyapplicationguidepage.
QuickLinks
- PreparetoApplyandRegister
- AfterSubmission
- FormatandWrite
- Resources
- SubmissionProcess
- InformationCollection
- DueDatesandSubmissionDeadlines
PreparetoApplyandRegister
UnderstandKey Systems and Roles
Learnaboutthemainsystemsinvolvedinapplicationsubmissionandtheroleyouandyour
colleaguesplayinthesubmissionprocess.Grants.gov,eRACommons,ASSIST.
https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/keysystems-and-roles.htm
GetRegistered!
Determineyourregistrationstatus.Organizations,organizationalrepresentatives,investigators,and
othersneedtoregisterinmultiplefederalsystemsinordertoapply.Registrationcantake6weeksor
moretocomplete.Starttoday!
http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-andregister/registration.htm
Findand UnderstandFundingOpportunities
Identifytherightfundingopportunityannouncementforyouandyourresearchandlearnaboutthekey
informationyouwillfindintheopportunity.
http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/find-andunderstand-foas.htm
Identifythe TypeofApplication Submission
Areyousubmittinganew,renewal,revision,orresubmissionapplication?Learnaboutspecial
submissionrequirementsforrevisionsandresubmissions.
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http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/type-ofapplication-submission.htm
Choosea SubmissionOption
DeterminewhichsystemismostconvenientforyoursubmissiontoNIH:NIHsASSISTon-line
applicationsubmissionsystem,Grants.govdownloadableforms,oryourorganizationmayhavetheir
ownsubmissionsystem.
http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/choose-asubmission-option.htm
ObtainSoftware
ApplicantsmusthavethefreeAdobeReadersoftware,aPDFgenerator,aswellaswebbrowserto
submitanapplication.Learnwhichversionsarecompatiblewithoursystems.
http://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/obtainsoftware.htm
FormatandWrite
WriteYourApplication
Readtipsfordevelopingastrongapplicationthathelpsreviewersevaluateitsscienceandmerit.
http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/write-yourapplication.htm
DevelopYourBudget
Learnaboutthekindsofcostsyoumayincludeinyourbudgetsubmission,thedifferencebetween
modularanddetailedbudgets,andmore.
http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/develop-yourbudget.htm
FormatAttachments
Followtheserequirementsforpreparingthedocumentsyouattachtoyourapplication,including
criteriaforthepdffiles,fonts,margins,headersandfooters,papersize,citations,formatpagesand
more.
http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/formatattachments.htm
RefertoTable ofPageLimits
Followthepagelimitsspecifiedinthistableunlessinstructedotherwisebythefundingopportunity
announcementtowhichyouareapplying.
http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/table-of-page-limits.htm
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UtilizeBiosketch,DataTablesand Other FormatPages

Acomprehensivelistingoftheformatpagesyouwillusewhenyouattachvariousfilestoyour
application,includinginstructionsforsubmissionofareferenceletter.
SubmissionProcess
Submit,TrackandViewYourApplication
LearnhowtosubmityourapplicationtoGrants.gov,andyourresponsibilityfortrackingyour
applicationandviewingtheapplicationimageintheeRACommonsbeforetheapplicationdeadline.If
youcantviewyourapplicationineRACommons,wecantreviewit.
http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/submit-trackview.htm
LearnHowWeCheck YourApplicationforCompleteness
Itisimportantthatallapplicationsbeingreviewedtogetheradheretothesamerules.Consequently,
yourapplicationwillbecheckedatGrants.gov,byeRAsystemsandfinallybyfederalstaffbeforeit
isreferredforreview.
http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/check-yourapplication.htm
Submita Changed/Corrected Application
Youwillneedtosubmitachanged/correctedapplicationtocorrectissuesyoufind,oroursystems
findwithyourapplication.Learnhowandwhenyoumaysubmitachange/correctedapplication.
http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/changed-correctedapplication.htm
Submita Reference letter
Sometypesofprogramsrequirethesubmissionofreferencelettersbythereferee.Refereesmust
submittheselettersbytheapplicationdeadlineinordertobeconsideredaspartoftheapplication.
Learntheprocessandpoliciesforsubmissionofreferenceletters.
http://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/reference-letter.htm
DueDatesandSubmissionDeadlines
DueDates
ViewstandardduedatesforNIHprograms.TheFOAwillidentifyifaspecificduedateshouldbe
used.
http://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submissionpolicies/standard-due-dates.htm
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SubmissionPolicies
Learnthenuancesofsubmissionpolicies,includingwhenwemightallowlateapplications,whatto
doifduedatesfallonaweekendorholiday,whetherweallowpost-submissionmaterials,howto
documentsystemissues,therulesaroundresubmissionapplications,andmore.
http://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submissionpolicies/application-submission-policies.htm
Guidelinesfor ApplicantsExperiencingSystemIssues
ExperiencingsystemissueswithASSIST,Grants.gov,SAM,orNIH'seRACommonsthatyou
believethreatenyourabilitytosubmitontime?NIHwillnotpenalizeapplicantswhoexperience
confirmedissuesbeyondtheircontrolwithfederalsystems.Youmustreporttheproblembeforethe
submissiondeadline.
http://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submissionpolicies/guidelines-for-applicants-experiencing-system-issues.htm
AfterSubmission
ReceiptandReferral
Understandhowandwhenapplicationsaregivenanapplicationidentificationnumberandassigned
toareviewgroupandanNIHinstituteorcenterforpossiblefunding.
http://grants.nih.gov/grants/receipt_referral.htm
PeerReview
Learnaboutourtwophasepeerreviewsystem,includinginitialpeerreview,Councilreview,review
criteria,scoring,summarystatements,andmore.
http://grants.nih.gov/grants/peer_review_process.htm
Pre-AwardProcess
Learnwhathappensbetweenpeerreviewthroughawardforapplicantswhoseapplicationshave
beendeemedhighlymeritoriousinthescientificpeerreviewprocess.Beready,ifyoureceiveda
greatscoreinpeerreviewwewillaskyoutosubmitjust-in-timeinformation.
http://grants.nih.gov/grants/pre-award-process.htm
PostAward MonitoringandReporting
IfyouaretherecipientofagrantfromtheNIH,thereisagreatdealofinformationthatyouwillneedin
ordertobeasuccessfulstewardoffederalfunds.Thispageprovidesabriefoverviewofgrantee
monitoringandreportingrequirements.
http://grants.nih.gov/grants/post-award-monitoring-and-reporting.htm
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Resources
News- Items ofInterest
TheeSubmissionItemsofInterestprovidecomprehensiveinformationonthechangesimpacting
applicationdevelopmentandsubmissioninafriendly,informalformat.
https://grants.nih.gov/grants/how-to-apply-application-guide/resources/news-items-of-interest.htm
AnnotatedFormSets
Thesehandydocumentsareagreatvisualresourceforunderstandingmanyofthebusinessrule
checkswewillrunagainstyoursubmittedapplication.
http://grants.nih.gov/grants/how-to-apply-application-guide/resources/annotated-form-sets.htm
ContactingNIH Staff
NIHstaffisheretohelp.Westronglyencourageapplicantsandgranteestocommunicatewithus
throughoutthegrantlifecycle.UnderstandingtherolesofNIHstaffcanhelpyoucontacttheright
personateachphaseoftheapplicationandawardprocess.
http://grants.nih.gov/grants/how-to-apply-application-guide/resources/contacting-nih-staff.htm
ContactingStaffatOtherPHSAgencies
Applicantsarestronglyencouragedtocommunicatewithagencystaffthroughouttheentire
applicationreviewandawardsprocess.
https://grants.nih.gov/grants/how-to-apply-application-guide/resources/contacting-staff-at-otherpublic-health-service-agencies.htm
InformationCollection
Authorization
DescribesNIHsstatutoryauthoritiesforawardinggrants.
http://grants.nih.gov/grants/authorization.htm
PaperworkBurden
Providesestimatedtimeforcompletingagrantapplication.
http://grants.nih.gov/grants/paperwork-burden.htm
CollectionofPersonalDemographic Data
NIHcollectspersonaldatathroughtheeRACommonsPersonalProfile.Thedataisconfidential,and
ismaintainedunderthePrivacyActrecordsystem.
http://grants.nih.gov/grants/collection-of-personal-demographic-data.htm
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R.120-SignificantChanges
Modificationsincludethefollowing:
ApplicationGuideRestructure
l Formsreordered.Forminstructionshavebeenreorderedtomatchtheorderofappearanceinthe
applicationpackage.
l Consolidatedinstructions.SBIR/STTRinstructionshavebeenincorporatedintothegeneral
instructions.
l Separatedforminstructionsfromapplicationprocessinformation.Createdanapplication
guidelandingpagethatprovidesat-a-glanceaccesstoallforminstructionsandapplicationprocess
information.Linkstoallgrantsprocessinformationappearintheforminstructionsaswell.
l Combinedandstreamlinedinstructions.ForResearchandRelated(R&R)forms,wehave
combinedFederal-wideandagency-specificinstructionstoreduceconfusion,contradictions,
and/orredundantlanguage.UserswillnolongerseetheHHSlogodisplayed,asallinstructionsare
nowapplicabletoNIHandPHSagencies.
l Betterintegratedmechanism-specificinstructions.Variancesininstructionsforeachtypeof
grantprogram(research,careerdevelopment,etc.),arenowcalledoutandintegratedinthegeneral
instructionstomakethemeasytofollow.
l Newmechanism-specificviewsofapplicationguide.UsetheGeneral(G)instructionstosee
instructionsforallmechanismsinoneplace.Takeadvantageofthefilteredviewstoseejustthe
instructionsyouneedforresearch(R),careerdevelopment(K),training(T),fellowship(F),multiproject(M)orSBIR/STTR(B)applications.
l Newsectionnumberingsystem.Forminstructionswillfollowthesamenumberingsystemfor
eachsetofinstructions.Forexample,theSF424(R&R)CoverFormwillalwaysbe.100,andthe
letterprecedingitwillreflectthespecificinstructionsyouareusing.FortheGeneral(G)
instructions,thisformwillbelocatedinG.100;fortheResearch(R)instructions,thiswillbeR.100;
andsoon.
l Newpagenumberingsystem.Pagenumberswilldenotewhichsetofinstructionsyouare
lookingat(e.g.,G-56forpage56oftheGeneralinstructions;R-56forpage56oftheResearch
(R)instructions;etc.).Thisdistinctionwillbeimportantwhenyoureferenceaparticularinstruction.
l Formscreenshots.Providedattheendofeachsetofinstructionsforyourreference.
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SF424ResearchandRelated(R&R)FormChanges
R&ROtherProjectInformationForm
l AlistofrefereesisnolongerrequiredasanOtherAttachmentontheR&ROtherProject
InformationForm.Thisinformationisonlyrequiredinthecoverletterattachment.Referenceletters
willcontinuetobesubmittedthrougheRACommons.
R&RSenior/KeyPersonProfile(Expanded)Form
l MentorsmustprovideaCommonsusernameforCareerapplications(See
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-082.html)
l Consolidatedbiosketchinstructionsforresearch,institutionalresearchtraining,institutionalcareer
development,researcheducation,fellowship,anddissertationawards,aswellasdiversity
supplements.Clarifiedpolicyrequirements.Seehttp://grants.nih.gov/grants/guide/noticefiles/NOT-OD-16-080.html.
Forms-DChanges
PHS398CoverPageSupplement
l NewVertebrateAnimalssectionadded:
l Areanimalseuthanized?Yes/No
l IfYes,ismethodconsistentwithAVMAguidelines?Yes/No
l IfNotoAVMAguidelines,describemethod/providescientificjustification
l DisclosurePermissionStatementquestionremoved
l AbilitytoaddProgramIncomeinformationfor10budgetperiods(previously5)
l Fieldorderandlabelchanges
l Added/updatedburdenstatementandformexpirationdate
l Updatedforminstructions
PHS398ModularBudget
l Indirect(F&A)Costssectionchangedtodynamicallyaddindirectcostsratherthanprovidingstatic
fieldsforfourentries
l Minorlabelchanges
PHS398ResearchPlan
l NewDataSafetyMonitoringPlanattachment
l NewAuthenticationofKeyBiologicaland/orChemicalResourcesattachment
l Minorformatandlabelchanges
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PHSAssignmentRequestForm
l New,optionalform
l ProvidesstructuredinformationtoNIHreferralstaffregarding:fundingcomponentassignment
preference,studysectionpreference,individualswhoshouldnotreviewyourapplicationdueto
conflicts,andscientificareasofexpertiseneededtoreviewyourapplication
l ComplementsexistingCoverLetterAttachmentonSF424(R&R)form
PHSInclusionEnrollmentReport
l CombinesPlannedEnrollmentReportandCumulativeInclusionEnrollmentReportformsintoa
singleform
l Questionsusedtoidentifytypeofreport:
l Delayedonsetstudy?Yes/No
l EnrollmentType?Planned/Cumulative(Actual)
l UsinganExistingDatasetorResource?Yes/No
l EnrollmentLocation?Domestic/Foreign
l ClinicalTrial?Yes/No
l NIH-DefinedPhaseIIClinicalTrial?Yes/No
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R.130-ProgramOverview
QuickLinks
- ResearchandOther("R"Series)
ResearchandOther("R"Series)
ThepurposeofResearchandOtherawardsistoprovidesupportforhealth-relatedresearchand
developmentbasedonthemissionoftheNIH.Someexamplesofsupportincludepilotstudies;
conferencesandscientificmeetings;smallresearchprojects;institutionaltrainingandDirector
programprojects;resourceprograms;andnew,exploratoryanddevelopmentalresearchprojects;
andmaybeintheformofgrantsorcooperativeagreements.
Additionalresearchinstructionswillbedenotedbyayellowboxand"AdditionalInstructionsfor
Research"heading.
BeforeApplying:
l BecomefamiliarwithActivityCode:Applicantsshouldbecomefamiliarwiththeresearchactivity
codeforwhichsupportisbeingrequested.TheseincludemanyRactivitycodes,aswellassome
DP,G,S,andUactivitycodes.Acomprehensivelistofallactivitycodesisalsoavailable
here:https://grants.nih.gov/grants/funding/ac_search_results.htm.
l RefertoyourspecificFOA:ItisimportanttorefertoyourFOAforspecificinformationassociated
withtheawardmechanismincludingtheeligibilityrequirements,reviewcriteria,awardprovisions,
anyspecialapplicationinstructions,andnamesofindividualswhomaybecontactedpriorto
submissionforadditionalorclarifyinginformation.
l ContactAwardingComponent:ItisstronglyrecommendedthatapplicantsconsultwiththeNIH
Scientific/Researchcontactoftheappropriateawardingcomponentpriortosubmittingan
applicationaseligibilitycriteria,supportlevels,andavailabilityofawardsmayvaryamongNIH
InstitutesorCentersandotherPHSagencies.
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R.200-SF424(R&R)Form
TheSF424(R&R)Formisusedinallgrantapplications.
Thisformcollectsinformationincludingtypeofsubmission,
applicantinformation,typeofapplicant,andproposed
projectdates.
Viewlargerimage
QuickLinks
1. TypeofSubmission
2. DateSubmittedandApplicantIdentifier
3. DateReceivedbyStateandStateApplication
Identifier
4a. FederalIdentifier
4b. AgencyRoutingIdentifier
4c. PreviousGrants.govTrackingID
5. ApplicantInformation
6. EmployerIdentification
7. TypeofApplicant
8. TypeofApplication
9. NameofFederalAgency
10. CatalogofFederalDomesticAssistance(CFDA)
NumberandTitle
11. DescriptiveTitleofApplicant'sProject
12. ProposedProject
13. CongressionalDistrictofApplicant
14. ProgramDirector/PrincipalInvestigator(PD/PI)
ContactInformation
15. EstimatedProjectFunding
16. IsApplicationSubjecttoReviewbyStateExecutive
Order12372Process?
17. Certification
18. SFLLL(DisclosureofLobbyingActivities)orOther
ExplanatoryDocumentation
19. AuthorizedRepresentative
20. Pre-Application
21. CoverLetterAttachment
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1.TypeofSubmission
Thisfieldisrequired.CheckoneoftheTypeofSubmissionboxes:
Pre-Application:
UnlessspecificallynotedinaFundingOpportunityAnnouncement,thePre-applicationoptionis
notusedbyNIHandotherPHSagencies.
Changed/CorrectedApplication:
Thisboxmustbeusedifyouneedtosubmitthesameapplicationagaintocorrectsystem
validationerrors,applicationassemblyproblems,ortoincorporateotherchanges.When
submittingaChanged/CorrectedApplication:
l Ifsubmittingafterthesubmissiondate,includeanexplanationintheCoverLetter
attachment.
l SubmittingaChanged/Correctedapplicationreplacestheprevioussubmissionandremoves
theprevioussubmissionfromconsideration.Onceanapplicationhasmovedforwardto
agencystafffollowingthetwo-dayapplicationviewingwindow,subsequent
Changed/Correctedapplicationswillnotbeacceptedunlesstheapplicationiswithdrawn.
Notethatifyouaresubmittingadditionalgrantapplicationmaterialsafterthesubmission
datesomespecialguidelinesmayapply.SeeNIHGuideNoticeNOT-OD-10-115
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-115.html)fortheNIHPolicyon
Post-SubmissionApplicationMaterials.
l WhenyouchecktheChanged/CorrectApplicationboxthePreviousGrants.govTrackingID
becomesarequiredfield.
l DonotusetheChanged/CorrectedApplicationboxtodenoteasubmissionofa
resubmissionoramendedapplication.ThatwillbeindicatedintheTypeofApplication.
2.DateSubmittedandApplicantIdentifier
TheApplicantIdentifierfieldisacontrolnumbercreatedbytheapplicantorganization,nottheFederal
agency.
3.DateReceivedbyStateandStateApplicationIdentifier
ForsubmissionstoNIHandotherPHSagencies,leavethesefieldsblank.
4.a.FederalIdentifier
WhenaNewApplicationisbeingsubmittedfollowingaPre-Application,entertheagency-assigned
pre-applicationnumber,ifapplicable.Ifthisisacontinuation,revision,orrenewalapplication,enter
theassignedFederalIdentifiernumber(forexample,awardnumber)--evenifsubmittinga
Changed/Correctedapplication.
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ForsubmissionstoNIHandotherPHSagencies,includeonlytheICandserialnumberofthe
previouslyassignedapplication/awardnumber(e.g.,useCA987654from1R01CA987654-01A1).
TheFederalIdentifierisrequiredforResubmission,Renewal,andRevisionapplications.
ApplicantstoNIHandotherPHSagenciesshouldcompletethisfieldwhensubmittinga
resubmission,renewalorrevisionapplication.WhensubmittingaNewapplication,thisfieldshould
remainblank.
4.b.AgencyRoutingIdentifier
Unlessspecificallynotedinaprogramannouncement,theAgencyRoutingIdentifierisnotusedby
NIHorotherPHSagencies.
4.c.PreviousGrants.govTrackingID
EnterthepreviousGrants.govtrackingnumber,ifapplicable.
5.ApplicantInformation
ThisinformationisfortheApplicantOrganization,notaspecificindividual.
OrganizationalDUNS:
EntertheDUNSorDUNS+4numberoftheapplicantorganization.Thisfieldisrequired.
ForsubmissiontoNIHandotherPHSagencies,thisDUNSmustmatchthenumberenteredin
theeRACommonsInstitutionalProfilefortheapplicantorganization.TheapplicantAORis
encouragedtoconfirmthataDUNShasbeenenteredintheeRACommonsInstitutionalProfile
(IPF)priortosubmittinganapplication.IfyourorganizationdoesnotalreadyhaveaDUNS
number,youwillneedtogototheDun&Bradstreetwebsiteathttp://fedgov.dnb.com/webform
toobtainthenumber.ThesameDUNSshouldbeusedintheeRACommonsIPF,Grants.gov,
SystemforAwardManagement(SAM)registrationandintheDUNSfieldintheapplication.
LegalName:
Enterthelegalnameoftheapplicantwhichwillundertaketheassistanceactivity,enterthe
completeaddressoftheapplicant(includingcounty/parishandcountry),andname,telephone
number,e-mail,andfaxofthepersontocontactonmattersrelatedtothisapplication.
Department:
Enterthenameoftheprimaryorganizationaldepartment,service,laboratory,orequivalentlevel
withintheorganizationthatwillundertaketheassistanceactivity.
Division:
Enterthenameoftheprimaryorganizationaldivision,office,ormajorsubdivisionwhichwill
undertaketheassistanceactivity.
Street1:
EnterthefirstlineofthestreetaddressfortheapplicantinStreet1field.Thisfieldisrequired.
Street2:
EnterthesecondlineofthestreetaddressfortheapplicantintheStreet2field.Thisfieldis
optional.
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City:
EntertheCityforaddressoftheapplicant.Thisfieldisrequired.
County/Parish:
Enterthecounty/parishforaddressoftheapplicant.
State:
EntertheStatewheretheapplicantislocated.Thisfieldisrequirediftheapplicantislocatedin
theUnitedStates.
Province:
Entertheprovince.IfCountryisnotCanada,pleaseleaveblank.
Country:
Selectthecountryfortheapplicantaddress.Thisfieldisrequired.
ZIPCode:
Enterthenine-digitpostalcode(e.g.,ZIPcode)ofapplicant.Thisfieldisrequirediftheapplicant
islocatedintheUnitedStates.ThisfieldisrequiredifaStateisselected;optionalforProvince.
Persontobecontactedonmattersinvolvingthisapplication:
ThisinformationisfortheAdministrativeorBusinessOfficial,notthePD/PI.Thispersonisthe
individualtobenotifiedifadditionalinformationisneededand/orifanawardismade.Toavoid
potentialerrorsanddelaysinprocessing,pleaseensurethattheinformationprovidedinthissection
isidenticaltotheAOprofileinformationcontainedintheeRACommons.
Prefix:
Entertheprefix(e.g.,Mr.,Mrs.,Rev.)forthenameofthepersontocontactonmattersrelated
tothisapplication.
FirstName:
Enterthefirst(given)nameofthepersontocontactonmattersrelatedtothisapplication.This
fieldisrequired.
MiddleName:
Enterthemiddlenameofthepersontocontactonmattersrelatedtothisapplication.
LastName:
Enterthelast(family)nameofthepersontocontactonmattersrelatedtothisapplication.This
fieldisrequired.
Suffix:
Enterthesuffix(e.g.,Jr.,Sr.,Ph.D.)forthepersontocontactonmattersrelatedtothis
application.
Position/Title:
EnterthePosition/Titleforthepersontocontactonmattersrelatedtothisapplication.
Street1:
Enterfirstlineofthestreetaddressforthepersontocontactonmattersrelatedtothis
applicationintheStreet1field.Thisfieldisrequired.
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Street2:
Enterthesecondlineofthestreetaddressforthepersontocontactonmattersrelatedtothis
applicationintheStreet2field.Thisfieldisoptional.
City:
EntertheCityforaddressofthepersontocontactonmattersrelatedtothisapplication.This
fieldisrequired.
County/Parish:
Enterthecounty/parishforaddressofthepersontocontactonmattersrelatedtothis
application.
State:
EntertheStatewherethepersontocontactonmattersrelatedtothisapplicationislocated.
ThisfieldisrequirediftheapplicantislocatedintheUnitedStates.
Province:
Entertheprovinceforthepersontocontactonmattersrelatedtothisapplication.IfCountryis
notCanada,pleaseleaveblank
Country:
Selectthecountryforthepersontocontactonmattersrelatedtothisapplicationaddress.
ZIPCode:
Enterthenine-digitpostalcode(e.g.,ZIPcode)ofthepersontocontactonmattersrelatedto
thisapplication.ThisfieldisrequirediftheperformancesitelocationisintheUnitedStates.
PhoneNumber:
Enterthedaytimephonenumberforthepersontocontactonmattersrelatedtothisapplication.
Thisfieldisrequired.
FaxNumber:
Enterthefaxnumberforthepersontocontactonmattersrelatedtothisapplication.
E-mail:
Enterthee-mailaddressforthepersontocontactonmattersrelatedtothisapplication.
6.EmployerIdentification
EntereitherTINorEINasassignedbytheInternalRevenueService.Ifyourorganizationisnotinthe
U.S.,enter44-4444444.
Ifyouhavea12-digitEINestablishedforgrantawardsfromNIHorotherPHSagencies,enterall12
digits(e.g.,1123456789A1);thisincludesnon-U.S.organizations.Thisfieldisrequired.
7.TypeofApplicant
Selecttheappropriateapplicanttypecode.ForeligibleAgenciesoftheFederalGovernment,select
X:Other(specify),andthenindicatethenameoftheappropriateFederalagencyinthespacebelow.
ForSBIR/STTRapplicantorganizations,selectR.SmallBusiness.IfSmallBusinessisselectedas
TypeofApplicant,thennoteiftheorganizationisWoman-ownedand/orSociallyandEconomically
Disadvantaged.
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Other(Specify):
CompleteonlyifOtherisselectedastheTypeofApplicant.
WomanOwned:
Checkifyouareawoman-ownedsmallbusinessasmallbusinessthatisatleast51%owned
byawomanorwomen,whoalsocontrolandoperateit.
SociallyandEconomicallyDisadvantaged:
Checkifyouareasociallyandeconomicallydisadvantagedsmallbusiness,asdeterminedby
theU.S.SmallBusinessAdministrationpursuanttoSection8(a)oftheSmallBusinessAct
U.S.C.637(a).
8.TypeofApplication
SelectthetypefromthefollowinglistofexistingdefinitionsforNIHandotherPHSagencies.Check
onlyone.Thisfieldisrequired.
l New.Checkthisoptionwhensubmittinganapplicationforthefirsttimeorinaccordancewithother
submissionpolicies.SeeNOT-OD-14-074.
l Resubmission.Checkthisoptionwhensubmittingarevised(alteredorcorrected)oramended
application.SeealsotheNIHPolicyonResubmissionApplications.
l Renewal.Anapplicationrequestingadditionalfundingforaperiodsubsequenttothatprovidedbya
currentaward.Arenewalapplicationcompeteswithallotherapplicationsandmustbedeveloped
asfullyasthoughtheapplicantisapplyingforthefirsttime.
l Continuation.ForthepurposesofNIHandotherPHSagencies,theboxforContinuationisonly
usedforspecificFOAs.
l Revision.Forcompetingrevisionsandnon-competingadministrativesupplements.
ThisfieldalsoaffectshowyoucompletetheFederalIdentifier.IfTypeofApplicationisNew,you
canleavetheFederalIdentifierfieldblankunlessotherwisespecifiedinthefundingopportunity
announcement.
IfTypeofApplicationisRenewal,Revision,orResubmission,entertheICandserialnumberof
thepreviouslyassignedapplication/awardnumber(e.g.,useCA987654from1R01CA987654-01A1).
IfRevision,markappropriatebox(es).Mayselectmorethanone:
1. IncreaseAward
2. DecreaseAward
3. IncreaseDuration
4. DecreaseDuration
5. Other
IfOtherisselected,pleasespecifyinthetextboxprovided.
ForthepurposesofNIHandotherPHSagencies,theboxesforoptionsB,C,D,andEwillgenerally
notbeusedandshouldnotbeselectedunlessspecificallyaddressedinaparticularFOA
Isthisapplicationbeingsubmittedtootheragencies?
InthefieldIsthisapplicationbeingsubmittedtootheragencies?,pleasechecktheboxyesif
oneormoreofthespecificaimssubmittedinyourapplicationarealsocontainedinasimilar,
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identical,oressentiallyidenticalapplicationsubmittedtoanotherFederalagency.Indicatethe
agencyoragenciestowhichtheapplicationhasbeensubmitted.Foradditionalinformation,
pleaseseeNIHGuideNoticeNOT-OD-09-100,ReminderandClarificationofNIHPolicieson
Similar,Identical,orEssentiallyIdenticalApplications,SubmissionofApplicationsFollowing
RFAReview,andSubmissionofApplicationswithaChangedActivityCode
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-100.html.Thisfieldisrequired.
WhatOtherAgencies?
EnterAgencyName
9.NameofFederalAgency
NametheFederalagencyfromwhichassistanceisbeingrequestedwiththisapplication.Thisfieldis
pre-populatedfromtheopportunitypackage.
10.CatalogofFederalDomesticAssistance(CFDA)NumberandTitle
ThisistheCatalogofFederalDomesticAssistancenumberoftheprogramunderwhichassistance
isrequested.Thisfieldispre-populatedfromtheopportunitypackage.
ThisfieldmaybeblankifyouareapplyingtoanopportunitythatreferencesmultipleCFDAnumbers.
Whenthisfieldisblank,leaveitblank;thefieldwillnotallowanydataentry.TheappropriateCFDA
numberwillbeautomaticallyassignedbytheagencyoncetheapplicationisassignedtothe
appropriateawardingcomponent.
11.DescriptiveTitleofApplicantsProject
Enterabriefdescriptivetitleoftheproject.Thisfieldisrequired.
AnewapplicationmusthaveadifferenttitlefromanyotherPHSprojectsubmittedforthesame
applicationduedatewiththesamePD/PI.Aresubmissionorrenewalapplicationshouldnormally
havethesametitleasthepreviousgrantorapplication.Ifthespecificaimsoftheprojecthave
significantlychanged,chooseanewtitle.
Arevisionapplicationmusthavethesametitleasthecurrentlyfundedgrant.
NIHandotherPHSagencieslimittitlecharacterlengthto200characters,includingthespaces
betweenwordsandpunctuation.
12.ProposedProject
StartDate:
Entertheproposedstartdateoftheproject.Thisfieldisrequired.
EndingDate:
Entertheproposedendingdateoftheproject.Thisfieldisrequired.
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13.CongressionalDistrictofApplicant
EntertheCongressionalDistrictintheformat:2characterStateAbbreviation3characterDistrict
Number.Examples:CA-005forCalifornias5thdistrict,CA-012forCalifornias12thdistrict.
IfoutsidetheU.S.,enter00-000.
Tolocateyourcongressionaldistrict,visittheGrants.govWebsite.
ForStatesandU.S.territorieswithonlyasinglecongressionaldistrictenter001forthedistrict
code.Forjurisdictionswithnorepresentative,enter099.Forjurisdictionswithanonvotingdelegate,
enter098forthedistrictnumber.Example:DC-098,PR-098.
14.ProgramDirector/PrincipalInvestigator(PD/PI)ContactInformation
IfsubmittinganapplicationreflectingMultiplePD/PIs,theindividualdesignatedastheContactPI
mustbeaffiliatedintheCommonswiththeapplicantorganizationshouldbeenteredhere.See
SectionR.240-Senior/KeyPersonProfile(Expanded)FormforadditionalinstructionsforMultiple
PD/PIs.Toavoidpotentialerrorsanddelaysinprocessing,pleaseensurethattheinformation
providedinthissectionisidenticaltothePD/PIprofileinformationcontainedintheeRACommons.
Prefix:
TheProjectDirector/PrincipalInvestigator(PD/PI)istheindividualresponsiblefortheoverall
scientificandtechnicaldirectionoftheproject.Entertheprefix(e.g.,Mr.,Mrs.,Rev.)forthe
nameofthePD/PI.
FirstName:
Enterthefirst(given)nameofthePD/PI.Thisfieldisrequired.
MiddleName:
EnterthemiddlenameofthePD/PI.
LastName:
Enterthelast(family)nameofthePD/PI.Thisfieldisrequired.
Suffix:
Enterthesuffix(e.g.,Jr.,Sr.)ofthePD/PI.Donotusethisfieldtorecorddegrees(e.g.,Ph.D.).
DegreesforthePD/PIarerequestedseparatelyintheSenior/KeyPersonProfile.
Position/Title:
EnterthePosition/TitleofthePD/PI.
OrganizationName:
EnterthenameoforganizationforthePD/PI.Thisfieldisrequired.
Department:
Enterthenameofprimaryorganizationaldepartment,service,laboratory,orequivalentlevel
withintheorganizationofthePD/PI.
Division:
Enterthenameofprimaryorganizationaldivision,office,ormajorsubdivisionofthePD/PI.
Street1:
EnterfirstlineofthestreetaddressforthePD/PIintheStreet1field.Thisfieldisrequired.
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Street2:
EnterthesecondlineofthestreetaddressforthePD/PIintheStreet2field.Thisfieldis
optional.
City:
EntertheCityforaddressofthePD/PI.Thisfieldisrequired.
County/Parish:
Enterthecounty/parishforaddressofthePD/PI.
State:
EntertheStatewherethePD/PIislocated.ThisfieldisrequiredifthePD/PIislocatedinthe
UnitedStates.
Province:
EntertheprovinceforPD/PI.IfCountryisnotCanada,pleaseleaveblank
Country:
SelectthecountryforthePD/PIaddress.
ZIP/PostalCode:
Enterthepostalcode(e.g.,ZIPcode)ofthePD/PI.Anine-digitZIPCodeisrequired.
PhoneNumber:
EnterthedaytimephonenumberforthePD/PI.Thisfieldisrequired.
FaxNumber:
EnterthefaxnumberforthePD/PI.
E-mail:
Enterthee-mailaddressforthePD/PI.Thisfieldisrequired.
15.EstimatedProjectFunding
a.TotalFederalFundsRequested
EntertotalFederalfundsrequestedfortheentireprojectperiod.Thisfieldisrequired.
b.TotalNon-FederalFunds
ForapplicationstoNIHandotherPHSagencies,enter0inthisfieldunlesscostsharingisa
requirementforthespecificannouncement.Thisfieldisrequired.
c.TotalFederal&Non-FederalFunds
ForNIHandotherPHSagenciesapplicants,thisfieldwillbethesameasTotalFederalFunds
Requestedaboveunlessthespecificannouncementindicatesthatcostsharingisa
requirement.Thisfieldisrequired.
d.EstimatedProgramIncome
IdentifyanyProgramIncomeestimatedforthisprojectperiod,ifapplicable.Thisfieldis
required.
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16.IsApplicationSubjecttoReviewbyStateExecutiveOrder12372
Process?
ForNIHandotherPHSagenciessubmissionsusingtheSF424(R&R),applicantsshouldcheckNo,
ProgramisnotcoveredbyE.O.12372.
17.Certification
ThelistofNIHandotherPHSagenciesAssurances,Certifications,andotherPoliciesisfoundin
SupplementalInstructions,PartIII.
Theapplicantorganizationisresponsibleforverifyingitseligibilityandtheaccuracy,validity,and
conformitywiththemostcurrentinstitutionalguidelinesofalltheadministrative,fiscal,andscientific
informationintheapplication,includingtheFacilitiesandAdministrativerate.Deliberatewithholding,
falsification,ormisrepresentationofinformationcouldresultinadministrativeactions,suchas
withdrawalofanapplication,suspensionand/orterminationofanaward,debarmentofindividuals,as
wellaspossiblecriminalpenalties.Thesignerfurthercertifiesthattheapplicantorganizationwillbe
accountablebothfortheappropriateuseofanyfundsawardedandfortheperformanceofthegrantsupportedprojectoractivitiesresultingfromthisapplication.Thegranteeinstitutionmaybeliablefor
thereimbursementoffundsassociatedwithanyinappropriateorfraudulentconductoftheproject
activity.
CheckIagreetoprovidetherequiredcertificationsandassurances.Thisfieldisrequired.
18.SFLLL(DisclosureofLobbyingActivities)orOtherExplanatory
Documentation
Ifapplicable,attachtheSFLLLorotherexplanatorydocumentperagencyinstructions.
IfunabletocertifycomplianceinwiththeCertificationaboveattachanexplanation.Additionally,as
applicable,attachtheSFLLL(StandardFormLLL,DisclosureofLobbyingActivities)orother
documentsinthisitem.AfillableversionoftheSFLLLformisavailableat
http://www.whitehouse.gov/omb/assets/omb/grants/sflllin.pdf.
19.AuthorizedRepresentative
Thisisequivalenttotheindividualwiththeorganizationalauthoritytosignforanapplication;
otherwiseknownastheAuthorizedOrganizationRepresentativeortheSigningOfficial.
Prefix:
Entertheprefix(Mr.,Mrs.,Rev.)forthenameoftheAuthorizedRepresentative.
FirstName:
Enterthefirst(given)nameoftheAuthorizedRepresentative.Thisfieldisrequired.
MiddleName:
EnterthemiddlenameoftheAuthorizedRepresentative.
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LastName:
Enterthelast(family)nameoftheAuthorizedRepresentative.Thisfieldisrequired.
Suffix:
Enterthesuffix(e.g.,Jr.,Sr.,Ph.D.)fortheAuthorizedRepresentative.
Position/Title:
EntertheTitleofthenameoftheAuthorizedRepresentative.Thisfieldisrequired.
OrganizationName:
EnterthenameoftheorganizationfortheAuthorizedRepresentative.Thisfieldisrequired.
Department:
Enterthenameoftheprimaryorganizationaldepartment,service,laboratory,orequivalentlevel
withintheorganizationoftheAuthorizedRepresentative.
Division:
Enterthenameoftheprimaryorganizationaldivision,office,ormajorsubdivisionofthe
AuthorizedRepresentative.
Street1:
EnterthefirstlineofthestreetaddressfortheAuthorizedRepresentativeintheStreet1field.
Thisfieldisrequired.
Street2:
EnterthesecondlineofthestreetaddressfortheAuthorizedRepresentativeintheStreet2
field.Thisfieldisoptional.
City:
CityforaddressoftheAuthorizedRepresentative.Thisfieldisrequired.
County/Parish:
Enterthecounty/parishforaddressoftheAuthorizedRepresentative.
State:
EntertheStatewheretheAuthorizedRepresentativeislocated.Thisfieldisrequiredifthe
AuthorizedRepresentativeislocatedintheUnitedStates.
Province:
EntertheprovincefortheAuthorizedRepresentative.IfCountryisnotCanada,pleaseleave
blank.
Country:
SelectthecountryfortheAuthorizedRepresentativeaddress.
ZIP/PostalCode:
EnterPostalCode(e.g.,ZIPcode)oftheAuthorizedRepresentative.Thisfieldisrequiredifthe
AuthorizedRepresentativeislocatedintheUnitedStates.Anine-digitZipcodeisrequired.
PhoneNumber:
EnterthedaytimephonenumberfortheAuthorizedRepresentative.Thisfieldisrequired.
FaxNumber:
EnterthefaxnumberfortheAuthorizedRepresentative.
E-mail:
Enterthee-mailaddressfortheAuthorizedRepresentative.Thisfieldisrequired.
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SignatureofAuthorizedRepresentative:
Itistheorganizationsresponsibilitytoassurethatonlyproperlyauthorizedindividualssignin
thiscapacityand/orsubmittheapplicationtoGrants.gov.Ifthisapplicationissubmittedthrough
Grants.gov,leaveblank.Ifahardcopyissubmitted,theAORmustsignthisblock.
DateSigned:
IfthisapplicationissubmittedthroughGrants.gov,thesystemwillgeneratethisdate.If
submittingahardcopy,enterthedatetheAORsignedtheapplication.
20.Pre-Application
UnlessspecificallynotedinaFundingOpportunityAnnouncement,NIHandotherPHSagenciesdo
notusePre-applicationsandthisattachmentfieldshouldnotbeusedforanyotherpurpose.
Ifsubmittingapre-application,provideasummarydescriptionoftheprojectinaccordancewiththe
announcementand/oragencyspecificinstructions,andsavethefileinalocationyouremember.
ClickAddAttachment,browsetowhereyousavedthefile,selectthefile,andthenclickOpen.
21.CoverLetterAttachment
Attachthecoverletter,addressedtotheDivisionofReceiptandReferral,inaccordancewiththe
announcementand/ortheagencyspecificinstructions.
Applicantsareencouragedtoincludeacoverletterwiththecompetingapplication.Pleaseattachthe
coverletterinthecorrectlocation,specificallyverifythatthecoverletterhasnotbeenuploaded
tothepre-applicationfieldwhichisdirectlyabovethecoverletterfield.Thiswillensurethe
attachmentiskeptseparatefromtheassembledapplicationinCommonsandonlymadeavailableto
appropriatestaff.
Acoverlettershouldnotbeincludedwithpost-awardsubmissionssuchasadministrative
supplements,changeofgranteeinstitution,orsuccessor-in-interest.Thecoverletterisonlyfor
internaluseandwillnotbesharedwithpeerreviewers.Thelettershouldcontainanyofthefollowing
informationthatappliestotheapplication:
1. Applicationtitle.
2. FundingOpportunity(PAorRFA)titleoftheNIHinitiative.
3. Forlateapplications(seeLateApplicationpolicyin
http://grants.nih.gov/grants/funding/submissionpolicies.htm)includespecificinformation
aboutthetimingandnatureofthecauseofthedelay.
4. WhensubmittingaChanged/CorrectedApplicationaftertheduedate,acoverletteris
requiredexplainingthereasonforlatesubmissionoftheChanged/CorrectedApplication.If
youalreadysubmittedacoverletterwithaprevioussubmissionandarenowsubmittingalate
Changed/CorrectedApplication,youmustincludeallpreviouscoverlettertextintherevised
coverletterattachment.Thesystemdoesnotretainanypreviouslysubmittedcoverletters;
therefore,youmustrepeatallinformationpreviouslysubmittedinthecoverletteraswellas
anyadditionalinformation.
5. Explanationofanysubawardbudgetcomponentsthatarenotactiveforallperiodsofthe
proposedgrantSectionR.240-Senior/KeyPersonProfile(Expanded)Form.
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6. Statementthatyouhaveattachedanyrequiredagencyapprovaldocumentationforthetypeof
applicationsubmitted.Thismayincludeapprovalforapplications$500,000ormore,approval
forConferenceGrantorCooperativeAgreement(R13orU13),etc.Itisrecommendedthat
youincludetheofficialcommunicationfromanNIHofficialaspartofyourcoverletter.
7. Whenintendingtosubmitavideoaspartoftheapplication,thecoverlettermustinclude
informationabouttheintenttosubmitit;ifthisisnotdone,avideowillnotbeaccepted.See
NOT-OD-12-141foradditionalinformation.
8. Includeastatementinthecoverletteriftheproposedstudieswillgeneratelarge-scalehuman
ornon-humangenomicdataasdetailedintheNIHGenomicDataSharingPolicy(NOT-OD14-11andNOT-OD-15-027.)
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R.210-PHS398CoverPageSupplement
Form
ThePHS398CoverPageSupplementFormisusedfor
allgrantapplicationsexceptFellowships.Thisform
collectsinformationonhumansubjects,vertebrate
animals,programincome,humanembryonicstemcells,
inventionsandpatents,andchangeof
investigator/changeofinstitution.
Viewlargerimage
QuickLinks
1. HumanSubjectsSection
2. VertebrateAnimalsSection
3. ProgramIncomeSection
4. HumanEmbryonicStemCellsSection
5. InventionsandPatentsSection(Forrenewal
applicationsonly)
6. ChangeofInvestigator/ChangeofInstitutionSection
1.HumanSubjectsSection
ClinicalTrial?
Check"yes"or"no"toindicatewhethertheprojectincludesaclinicaltrial.SeeSupplemental
Instructions,PartIIISection3forthespecificdefinition.
Agency-DefinedPhaseIIIClinicalTrial:
CheckYesorNotoindicatewhethertheprojectisanNIH-definedPhaseIIIclinicaltrial.
AnNIH-definedPhaseIIIclinicaltrialisabroadlybasedprospectivePhaseIIIclinicalinvestigation,
(usuallyinvolvingseveralhundredormorehumansubjects)toevaluateanexperimentalintervention
incomparisonwithastandardorcontrolinterventionortocomparetwoormoreexistingtreatments.
Thedefinitionincludespharmacologic,non-pharmacologic,andbehavioralinterventionsgivenfor
diseaseprevention,prophylaxis,diagnosis,ortherapy.Communitytrialsandotherpopulation-based
interventiontrialsalsoareincluded.
2.VertebrateAnimalsSection
Areanimalseuthanized?
Check"Yes"or"No"toindicatewhetheranimalsintheprojectareeuthanized.
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IfYestoeuthanasia:IsmethodconsistentwithAVMAguidelines?
CheckYesorNotoindicatewhetherthemethodofeuthanasiaisconsistentwiththeAmerican
VeterinaryMedicalAssociation(AVMA)GuidelinesfortheEuthanasiaofAnimals.See
https://www.avma.org/KB/Policies/Pages/Euthanasia-Guidelines.aspxformoreinformation.
IfNotoAVMAguidelines,describemethodandprovideascientificjustification:
IfyouansweredNotothequestionIsmethodconsistentwithAVMAguidelines?describethe
methodofeuthanasiaandprovideascientificjustificationforitsuse.IfyouansweredYes,leave
thesectionblank.
3.ProgramIncomeSection
Isprogramincomeanticipatedduringtheperiodsforwhichthegrantsupportisrequested?
Ifprogramincomeisanticipatedduringtheperiodsforwhichthegrantsupportisrequested,check
Yes,andthencompletethesectionbelow.Ifnoprogramincomeisanticipated,checkNoand
leavethefollowingsectionblank.
BudgetPeriod:
Ifprogramincomeisanticipated,enterthebudgetperiodsinthiscolumn.Iftheapplicationisfunded,
theNoticeofGrantAwardwillprovidespecificinstructionsregardingtheuseofsuchincome.
AnticipatedAmount($):
Ifprogramincomeisanticipated,entertheamountanticipatedforeachbudgetperiodlisted.
Source(s):
Ifprogramincomeisanticipated,enterthesourceforeachbudgetperiodlisted.
4.HumanEmbryonicStemCellsSection
Doestheproposedprojectinvolvehumanembryonicstemcells?
Iftheproposedprojectinvolveshumanembryonicstemcells,checkYesandcompletethesection
below.Iftheproposedprojectdoesnotinvolvehumanembryonicstemcells,checkNo.
Specificstemcelllinecannotbereferencedatthistime.Onefromtheregistrywillbeused.
Ifaspecificlinecannotbereferencedatthetimeofapplicationsubmission,checkthisbox.
Additionally,provideastrongjustificationforwhyanappropriatecelllineisnotavailablefromthe
Registryatthistime.ThejustificationshouldbeincludedaspartoftheResearchStrategyor
ProgramPlanasappropriate.
CellLine(s):
Listinthissectionthe4-digitregistrationnumberofthespecificcellline(s)fromtheNIHHuman
EmbryonicStemCellRegistry(e.g.0123).
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5.InventionsandPatentsSection(Forrenewalapplicationsonly)
InventionsandPatents:
ThisblockneedonlybecompletedifsubmittinganR&RRenewalapplicationoraResubmissionof
aRenewalapplication.Ifnoinventionswereconceivedorreducedtopracticeduringthecourseof
workunderthisproject,checkNo.Theremainingpartsoftheitemarethennotapplicable.Ifany
inventionswereconceivedorfirstactuallyreducedtopracticeduringthepreviousperiodofsupport,
checkYes.
Note:NIHrecipientorganizationsmustpromptlyreportinventionstotheDivisionof
ExtramuralInventionsandTechnologyResources(DEITR)BranchoftheOfficeofPolicyfor
ExtramuralResearchAdministration(OPERA),OER,NIH,Bethesda,MD20892-2750,(301)
435-1986.Inventionreportingcomplianceaccordingtoregulationsat37CFR401.14is
describedathttp://www.iedison.gov.Thegranteeisrequiredtosubmitreportselectronically
usingInteragencyEdison(http://www.iedison.gov).SeeNOT-OD-15-080.
PreviouslyReported:
Iftheitemaboveischecked"Yes",indicatewhetherthisinformationhasbeenreportedpreviouslyto
thePHSortotheapplicantorganizationofficialresponsibleforpatentmatters.
6.ChangeofInvestigator/ChangeofInstitutionSection
ChangeofProjectDirector/PrincipalInvestigator:
Checkhere,ifthisapplicationreflectsachangeinprincipalinvestigator/programdirectorfromthat
indicatedonapreviousapplication.Thisisnotgenerallyapplicabletoa"New"application.Fora
multiplePD/PIapplication,checkhereifthisapplicationrepresentsachangeintheContactPI.
Prefix:
IfthisapplicationreflectsachangeinPD/PI,enterthenameprefix(forexample,Mr.,Mrs.,
Rev.)oftheformerPD/PI.
FirstName:
IfthisapplicationreflectsachangeinPD/PI,enterthefirstnameoftheformerPD/PI.
MiddleName:
IfthisapplicationreflectsachangeinPD/PI,enterthemiddlenameoftheformerPD/PI.
LastName:
IfthisapplicationreflectsachangeinPD/PI,enterthelastnameoftheformerPD/PI.
Suffix:
IfthisapplicationreflectsachangeinPD/PI,providethesuffix(forexample,Jr.,Sr.,PhD)of
theformerPD/PI.
ChangeofGranteeInstitution:
Checkhere,ifthisapplicationreflectsachangeingranteeinstitutionfromthatindicatedona
previousapplication.Thisisnotgenerallyapplicabletoa"New"application.
NameofFormerInstitution:
Ifthisapplicationreflectsachangeingranteeinstitution,insertthenameoftheformer
institutionhere.
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R.220-R&ROtherProjectInformation
Form
TheOtherProjectInformationFormisusedforallgrant
applications.Thisformincludesquestionsontheuseof
humansubjectsandvertebrateanimals,aswellasfieldsto
uploadanabstract,projectnarrative,references,equipment
lists,andfacilitiesdescriptions.
Viewlargerimage
QuickLinks
1. AreHumanSubjectsInvolved?
1a. IfYEStoHumanSubjects
2. AreVertebrateAnimalsUsed?
2a. IfYEStoVertebrateAnimals
3. Isproprietary/privilegedinformationincludedinthe
application?
4. EnvironmentalQuestions
5. Istheresearchperformancesitedesignated,or
eligibletobedesignated,asahistoricplace?
Yes/No
6. Doesthisprojectinvolveactivitiesoutsideofthe
UnitedStatesorpartnershipswithInternational
Collaborators?
7. ProjectSummary/Abstract
8. ProjectNarrative
9. Bibliography&ReferencesCited
10. Facilities&OtherResources
11. Equipment
12. OtherAttachments
1.AreHumanSubjectsInvolved?
Ifactivitiesinvolvinghumansubjectsareplannedatanytimeduringtheproposedprojectatany
performancesite,checkyes.CheckYeseveniftheproposedprojectisexemptfromRegulationsfor
theProtectionofHumanSubjects.Ifactivitiesinvolvinghumansubjectsarenotplannedatanytime
duringtheproposedprojectatanyperformancesite,selectnoandskiptherestofblock1.Thisfield
isrequired.
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Notethatapplicationsinvolvingtheuseofhumanbiospecimensordatamayormaynotbe
consideredasresearchinvolvinghumansubjectsdependingonthedetailsofthematerialstobe
used.ApplicationsthatinvolvetheuseofhumanmaterialsthatcheckNoforhumansubjects
involvementmustprovideaclearjustificationaboutwhythisusedoesnotconstitutehumansubjects
research.Formoredetail,refertoSupplementalInstructions,PartII.
1.a.IfYEStoHumanSubjects
IstheProjectExemptfromFederalRegulations?Yes/No
Yes:IftheprojectisexemptfromFederalregulations,checkYes.Ifyes,checktheappropriate
exemptionnumber.
No:IftheprojectisnotexemptfromFederalregulations,checkNo.
Ifyes,checkappropriateexemptionnumber1,2,3,4,5,6:
Selecttheappropriateexemptionnumberfrom1,2,3,4,5,6.
IfhumansubjectactivitiesareexemptfromFederalregulations,providetheexemptionnumbers
correspondingtooneormoreoftheexemptioncategories.Thesixcategoriesofresearchthatqualify
forexemptionfromcoveragebytheregulationsaredefinedintheCommonRulefortheProtectionof
HumanSubjects.Theseregulationscanbefoundat
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
OHRPguidancestatesthatappropriateuseofExemptionsdescribedin45CFR46shouldbe
determinedbyanauthorityindependentfromtheinvestigators
(http://answers.hhs.gov/ohrp/categories/1564).InstitutionsoftendesignatetheirIRBtomakethis
determination.BecauseNIHdoesnotrequireIRBapprovalatthetimeofapplication,theexemptions
designatedoftenrepresenttheopinionofthePD/PI,andthejustificationprovidedfortheexemption
bythePD/PIisevaluatedduringpeerreview.
Proposedresearchmayincludemorethanoneresearchproject;thustheapplicationmayinclude
individualprojectsthatmeettherequirementsfornon-exemptorexempthumansubjectsresearch,or
arenotdefinedashumansubjectsresearch.Humansubjectsresearchshouldbedesignatedas
exemptifalloftheproposedresearchmeetsthecriteriaforoneormoreofthesixexemptions.
Ifno,istheIRBreviewPending?Yes/No
IfIRBreviewispending,checkYes.IfIRBreviewisnotpending,checkNo.
IRBApprovalDate:
EnterthelatestInstitutionalReviewBoard(IRB)approvaldate(ifavailable).LeaveblankifPending.
ApplicantsshouldcheckYestothequestionIstheIRBreviewPending?eveniftheIRB
review/approvalprocesshasnotyetbegunatthetimeofsubmission.AlsonotethatanIRBApproval
Dateisnotrequiredatthetimeofsubmission.Thismayberequestedlaterinthepre-awardcycleas
aSupplementalInstructions,PartIIISection1.7requirement.
HumanSubjectAssuranceNumber:
EntertheapprovedFederalwideAssurance(FWA)numberthattheapplicanthasonfilewiththe
OfficeforHumanResearchProtections.Enterthe8-digitnumber.DonotenterFWAbeforethe
number.
InsertNoneiftheapplicantorganizationdoesnothaveanapprovedFWAonfilewithOHRP.Inthis
case,theapplicantorganization,bythesignatureintheCertificationsignaturesectionontheSF424
R - 31
(R&R)Coverform,isdeclaringthatitwillcomplywith45CFRpart46andproceedtoobtainaFWA
(seehttp://www.hhs.gov/ohrp).DonotinserttheFWAnumberofanycollaboratinginstitutioninthe
spaceprovided.
2.AreVertebrateAnimalsUsed?
Ifactivitiesinvolvingvertebrateanimalsareplannedatanytimeduringtheproposedprojectatany
performancesite,checkyes.Ifno,skiptherestofblock2.Thisfieldisrequired.
Notethatthegenerationofcustomantibodiesconstitutesanactivityinvolvingvertebrateanimals.If
animalinvolvementisanticipatedwithintheperiodofawardbutplansareindefinite,check"Yes"and
addtheVertebrateAnimalsattachmenttoprovideanexplanationandtoindicatewhenitis
anticipatedthatanimalswillbeused.Ifanawardismadepriortotheinvolvementofanimals,the
granteemustprovidealloftheinformationrequiredbyaddingaVertebrateAnimalsattachmentinthe
ResearchPlanandverifyinganIACUCapprovaltotheawardingcomponent.
2.a.IfYEStoVertebrateAnimals
IstheIACUCreviewPending?
IndicateifanInstitutionalAnimalCareandUseCommittee(IACUC)reviewispending.
ClickYesifanIACUCreviewispending.ClickNo,ifnoreviewispending.CheckYesevenifthe
IACUCreviewandapprovalprocesshasnotyetbegun.
IACUCApprovalDate:
EnterthelatestIACUCapprovaldate(ifavailable).LeaveblankifPending.IACUCapprovalmust
havebeengrantedwithinthreeyearstobevalid.NotethatanIACUCApprovalDateisnotrequired
atthetimeofsubmission.NIHdoesnotrequireverificationofreviewandapprovaloftheproposed
researchbytheIACUCbeforepeerreviewoftheapplication.However,thisinformationisrequired
underSupplementalInstructions,PartIIISection1.7.
AnimalWelfareAssuranceNumber
EntertheFederallyapprovedassurancenumber,ifavailable.EnterNoneiftheapplicant
organizationdoesnothaveanOLAW-approvedAnimalWelfareAssurance.Todetermineifthe
applicantorganizationholdsanAnimalWelfareAssurance,seethelistsofDomesticandForeign
Assuredinstitutions.DonotentertheAnimalWelfareAssurancenumberfora
Project/PerformanceSiteofacollaboratinginstitution.Whenanapplicantorganizationdoesnot
haveanAnimalWelfareAssurance,theAuthorizedOrganizationRepresentativessignatureonthe
applicationconstitutesdeclarationthattheapplicantorganizationwillsubmitanAnimalWelfare
AssurancewhenrequestedbyOLAW.Iftheapplicantorganizationhasneitherananimalcareand
useprogram,facilitiestohouseanimalsandconductresearchonsite,noranIACUC,andtheanimal
workwillbeconductedataninstitutionwithanAnimalWelfareAssurance,theapplicantmustobtain
anInter-institutionalAssurancefromOLAWpriortoanaward.
3.Isproprietary/privilegedinformationincludedintheapplication?
Patentableideas,tradesecrets,privilegedorconfidentialcommercialorfinancialinformation,
disclosureofwhichmayharmtheapplicant,shouldbeincludedinapplicationsonlywhensuch
informationisnecessarytoconveyanunderstandingoftheproposedproject.Iftheapplication
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includessuchinformation,checkyesandclearlymarkeachlineorparagraphonthepages
containingtheproprietary/privilegedinformationwithalegendsimilarto:Thefollowingcontains
proprietary/privilegedinformationthat(nameofapplicant)requestsnotbereleasedtopersons
outsidetheGovernment,exceptforpurposesofreviewandevaluation.Thisfieldisrequired.
Ifagrantisawardedasaresultoforinconnectionwiththesubmissionofthisapplication,the
Governmentshallhavetherighttouseordisclosetheinformationtotheextentauthorizedbylaw.
AlthoughthegranteeinstitutionandthePD/PIwillbeconsultedaboutanysuchdisclosure,thePHS
willmakethefinaldetermination.Anyindicationbytheapplicantthattheapplicationcontains
proprietaryorprivilegedinformationdoesnotautomaticallyshieldtheinformationfromreleasein
responsetoaFreedomofInformationAct(FOIA)requestshouldtheapplicationresultinanaward
(see45CFRPart5).Ifanapplicantfailstoidentifyproprietaryinformationatthetimeofsubmission
asinstructedintheapplicationguide,asignificantsubstantivejustificationwillberequiredto
withholdtheinformationifrequestedunderFOIA.
4.EnvironmentalQuestions
MostNIHresearchgrantsarenotexpectedtoindividuallyorcumulativelyhaveasignificanteffecton
theenvironment,andNIHhasestablishedseveralcategoricalexclusionsallowingmostapplicantsto
answerNotothisquestionunlessaspecificFOAindicatesthattheNationalEnvironmentalPolicy
Act(NEPA)applies.However,ifanapplicantexpectsthattheproposedprojectwillhaveanactualor
potentialimpactontheenvironment,orifanypartoftheproposedresearchand/orprojectincludes
oneormoreofthefollowingcategoricalexclusionslistedbelow,theboxmarkedYesshouldbe
checkedandanexplanationprovidedinfield4.b.
1. Thepotentialenvironmentalimpactsoftheproposedresearchmaybeofgreaterscopeorsize
thanotheractionsincludedwithinacategory.
2. TheproposedresearchthreatenstoviolateaFederal,State,orlocallawestablishedforthe
protectionoftheenvironmentorforpublichealthandsafety.
3. Potentialeffectsoftheproposedresearchareuniqueorhighlyuncertain.
4. Useofespeciallyhazardoussubstancesorprocessesisproposedforwhichadequateand
acceptedcontrolsandsafeguardsareunknownornotavailable.
5. Theproposedresearchmayoverloadexistingwastetreatmentplantsduetonewloads
(volume,chemicals,toxicity,additionalhazardouswasted,etc.)
6. Theproposedresearchmayhaveapossibleimpactonendangeredorthreatenedspecies.
7. Theproposedresearchmayintroducenewsourcesofhazardous/toxicwastesorrequire
storageofwastespendingnewtechnologyforsafedisposal.
8. Theproposedresearchmayintroducenewsourcesofradiationorradioactivematerials.
9. Substantialandreasonablecontroversyexistsabouttheenvironmentaleffectsofthe
proposedresearch.
4.a.Doesthisprojecthaveanactualorpotentialimpactontheenvironment?
Indicateifthisprojecthasanactualorpotentialimpactontheenvironment?ClickNohereifthisis
notthecase.Thisfieldisrequired.
4.b.Ifyes,pleaseexplain
Explanationoftheactualorpotentialimpactontheenvironment.
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4.c.Ifthisprojecthasanactualorpotentialimpactontheenvironment,hasanexemptionbeen
authorizedoranEnvironmentalAssessment(EA)oranEnvironmentalImpactStatement(EIS)
beenperformed?
Checkyesorno.Thisfieldisrequired.
4.d.Ifyes,pleaseexplain
EnteradditionaldetailsabouttheEAorEIS.
5.Istheresearchperformancesitedesignated,oreligibletobedesignated,
asahistoricplace?Yes/No
Ifanyresearchperformancesiteisdesignated,oreligibletobedesignated,asahistoricplace,if
Yes,checktheYesboxandthenprovideanexplanationintheboxprovidedin5.a.Otherwise,check
theNobox.Thisfieldisrequired.
5.a.Ifyes,pleaseexplain
IfyoucheckedtheYesboxindicatinganyperformancesiteisdesignated,oreligibletobe
designated,asahistoricplace,providetheexplanationhere.
6.DoesthisprojectinvolveactivitiesoutsideoftheUnitedStatesor
partnershipswithInternationalCollaborators?
IndicatewhetherthisprojectinvolvesactivitiesoutsideoftheUnitedStatesorpartnershipswith
internationalcollaborators.Checkyesorno.Thisfieldisrequired.
ApplicantstoNIHandotherPHSagenciesmustcheckYesiftheapplicantorganizationisaforeign
institutionoriftheprojectincludesaforeigncomponent.Foradefinitionofaforeigncomponent,see
DefinitionssectionofSupplementalInstructions,PartIII.
6.a.Ifyes,identifycountries
Enterthecountrieswithwhichinternationalcooperativeactivitiesareinvolved.
6.b.OptionalExplanation
Enteranexplanationforinvolvementwithoutsideentities(optional).
IfyouhavecheckedYesto6,applicantstotheNIHandotherPHSagenciesmustdescribespecial
resourcesorcharacteristicsoftheresearchproject(e.g.,humansubjects,animals,disease,
equipment,andtechniques),whethersimilarresearchisbeingdoneintheUnitedStatesandwhether
thereisaneedforadditionalresearchinthisarea.Providethisinformationinaseparatefile,
attachingitasItem12,OtherAttachments.Inthebodyofthetext,beginthesectionwithaheading
indicatingForeignJustification.Whensavingthisfile,pleasenameitForeignJustificationaswell.
7.ProjectSummary/Abstract
TheProjectSummaryismeanttoserveasasuccinctandaccuratedescriptionoftheproposedwork
whenseparatedfromtheapplication.
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Statetheapplication'sbroad,long-termobjectivesandspecificaims,makingreferencetothehealth
relatednessoftheproject(i.e.,relevancetothemissionoftheagency).Describeconciselythe
researchdesignandmethodsforachievingthestatedgoals.Thissectionshouldbeinformativeto
otherpersonsworkinginthesameorrelatedfieldsandinsofaraspossibleunderstandabletoa
scientificallyortechnicallyliteratereader.Avoiddescribingpastaccomplishmentsandtheuseofthe
firstperson.Finally,pleasemakeeveryefforttobesuccinct.
Thissectionmustbenolongerthan30linesoftext,andfollowtherequiredfontandmargin
specifications.Anabstractwhichexceedsthisallowablelengthmaybeflaggedasanerrorbythe
agencyuponsubmission.Thiswouldrequireacorrectiveactionbeforetheapplicationwillbe
accepted.
Asnotedabove,donotincludeproprietary,confidentialinformationortradesecretsinthedescription
section.Iftheapplicationisfunded,theProjectDescriptionwillbeenteredintoanNIHdatabaseand
madeavailableontheNIHResearchPortfolioOnlineReportingTool(RePORT,availableat
http://report.nih.gov)andwillbecomepublicinformation.
TheattachmentmustbeinPDFformat.(SeeFormattingAttachmentsforadditionalinformationon
preparingattachments.)
8.ProjectNarrative
ProvideProjectNarrativeinaccordancewiththeannouncementand/oragency-specificinstructions.
PleaseclicktheAddAttachmentbuttontotherightofthisfieldtocompletethisentry.
ForNIHandotherPHSagenciesapplications,usingnomorethantwoorthreesentences,describe
therelevanceofthisresearchtopublichealth.Forexample,NIHapplicantscandescribehow,inthe
shortorlongterm,theresearchwouldcontributetofundamentalknowledgeaboutthenatureand
behavioroflivingsystemsand/ortheapplicationofthatknowledgetoenhancehealth,lengthenlife,
andreduceillnessanddisability.Iftheapplicationisfunded,thispublichealthrelevancestatement
willbecombinedwiththeprojectsummary(above)andwillbecomepublicinformation.
AseparateResearchPlanformisrequiredforNIHandotherPHSagenciesapplications.Referto
SectionR.400-PHS398ResearchPlanForm,ResearchPlanforseparatefileuploadsand
instructions.
9.Bibliography&ReferencesCited
ProvideabibliographyofanyreferencescitedintheProjectNarrative.Eachreferencemustinclude
thenamesofallauthors(inthesamesequenceinwhichtheyappearinthepublication),thearticle
andjournaltitle,booktitle,volumenumber,pagenumbers,andyearofpublication.Includeonly
bibliographiccitations.ToattachadocumentforBibliographyandReferencesCited,clickAdd
Attachment.
UnlessotherwisenotedinanFOA,thissectionisrequiredforsubmissionstoNIHandotherPHS
agencies.ThissectionshouldincludeanyreferencescitedinSectionR.400-PHS398Research
PlanForm.WhencitingarticlesthatfallunderthePublicAccessPolicy,wereauthoredorcoauthoredbytheapplicantandarosefromNIHsupport,providetheNIHManuscriptSubmission
referencenumber(e.g.,NIHMS97531)orthePubMedCentral(PMC)referencenumber(e.g.,
PMCID234567)foreacharticle.IfthePMCIDisnotyetavailablebecausetheJournalsubmits
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articlesdirectlytoPMConbehalfoftheirauthors,indicatePMCJournalInProcess.Alistofthese
journalsispostedat:http://publicaccess.nih.gov/submit_process_journals.htm.
CitationsthatarenotcoveredbythePublicAccessPolicy,butarepubliclyavailableinafree,online
formatmayincludeURLsorPubMedID(PMID)numbersalongwiththefullreference(notethat
copiesofpubliclyavailablepublicationsarenotacceptedasappendixmaterial).Thereferences
shouldbelimitedtorelevantandcurrentliterature.Whilethereisnotapagelimitation,itisimportant
tobeconciseandtoselectonlythoseliteraturereferencespertinenttotheproposedresearch
10.Facilities&OtherResources
NospecialformisrequiredbutthissectionmustbecompletedandattachedforsubmissionstoNIH
andotherPHSagenciesunlessotherwisenotedinanFOA.Describehowthescientificenvironment
inwhichtheresearchwillbedonecontributestotheprobabilityofsuccess(e.g.,institutionalsupport,
physicalresources,andintellectualrapport).Indescribingthescientificenvironmentinwhichthe
workwillbedone,discusswaysinwhichtheproposedstudieswillbenefitfromuniquefeaturesof
thescientificenvironmentorsubjectpopulationsorwillemployusefulcollaborativearrangements.
ForEarlyStageInvestigators(ESIs),describeinstitutionalinvestmentinthesuccessofthe
investigator,e.g.,resourcesforclasses,travel,training;collegialsupportsuchascareerenrichment
programs,assistanceandguidanceinthesupervisionoftraineesinvolvedwiththeESIsproject,and
availabilityoforganizedpeergroups;logisticalsupportsuchasadministrativemanagementand
oversightandbestpracticestraining;andfinancialsupportsuchasprotectedtimeforresearchwith
salarysupport.Seehttp://grants.nih.gov/grants/new_investigators/.
Iftherearemultipleperformancesites,describetheresourcesavailableateachsite.
Describeanyspecialfacilitiesusedforworkingwithbiohazardsorotherpotentiallydangerous
substances.Note:InformationaboutselectagentsmustbedescribedintheResearchPlan,
SelectAgentResearch.
PleaseclicktheAddAttachmentbuttontotherightofthisfieldtocompletethisentry.
11.Equipment
Listmajoritemsofequipmentalreadyavailableforthisprojectand,ifappropriateidentifylocationand
pertinentcapabilities.PleaseclicktheAddAttachmentbuttontotherightofthisfieldtocomplete
thisentry.
12.OtherAttachments
Attachafileonlytoprovideanyotherprojectinformationnotprovidedaboveorinaccordancewith
theannouncementand/oragency-specificinstruction.
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R.230-Project/PerformanceSite
Location(s)Form
TheProject/PerformanceSiteLocation(s)Formisusedfor
allgrantapplications.Indicatetheprimarysitewherethe
workwillbeperformed.Ifaportionoftheprojectwillbe
performedatanyothersite(s),identifythesitelocation(s)in
theblocksprovided.
Viewlargerimage
QuickLinks
1. Project/PerformanceSitePrimaryLocation
2. Project/PerformanceSiteLocation1
3. AdditionalPerformanceSiteLocations
Project/PerformanceSitePrimaryLocation
Generally,thePrimaryLocationshouldbethatoftheapplicantorganizationoridentifiedasoff-sitein
accordancewiththeconditionsoftheapplicantorganizationsnegotiatedFacilitiesand
Administrative(F&A)agreement.ThisinformationmustagreewiththeF&Ainformationonthebudget
formoftheapplication.
Ifthereismorethanoneperformancesite,includinganyDepartmentofVeteransAffairs(VA)
facilitiesandforeignsites,listtheminthefieldsprovidedforLocation1-#below.Applicantsshould
alsoprovideanexplanationofresourcesavailablefromeachProject/PerformanceSiteonthe
FacilitiesandResourcesattachmentoftheSectionR.220-R&ROtherProjectInformationform,and
describeanyconsortium/contractualarrangementsinSectionR.400-PHS398ResearchPlan,
Consortium/ContractualArrangements.
UnlessotherwiseinstructedintheFOA,donotchecktheIamsubmittinganapplicationasan
individual,andnotonbehalfofacompany,state,localortribalgovernment,academia,orothertype
oforganizationbox.
HumanSubjects:
IfaProject/PerformanceSiteisengagedinresearchinvolvinghumansubjects,theapplicant
organizationisresponsibleforensuringthattheProject/PerformanceSiteoperatesunderan
appropriateFederalWideAssurancefortheprotectionofhumansubjectsandcomplieswith45CFR
part46andotherNIHhumansubjectrelatedpoliciesdescribedinSupplementalInstructionsPartII
ofthisApplicationGuideandintheNIHGrantsPolicyStatement.
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VertebrateAnimals:
Forresearchinvolvinglivevertebrateanimals,theapplicantorganizationmustensurethatall
Project/PerformanceSitesholdanOLAW-approvedAnimalWelfareAssurance.Iftheapplicant
organizationhasneitherananimalcareanduseprogram,facilitiestohouseanimalsandconduct
researchonsite,noranIACUC,andtheanimalworkwillbeconductedataninstitutionwithan
AnimalWelfareAssurance,theapplicantmustobtainanInter-institutionalAssurancefromOLAW
priortoanaward.
OrganizationName:
Indicatetheorganizationnameoftheprimarysitewheretheworkwillbeperformed.Ifaportion
oftheprojectwillbeperformedatanyothersites(s),identifythesitelocation(s)intheblock(s)
provided.
DUNSNumber:
EntertheDUNSnumberassociatedwiththeorganizationwheretheprojectwillbeperformed.
TheDUNSNumberisarequiredfieldforthePrimaryPerformanceSite.
Street1:
Enterfirstlineofthestreetaddressoftheprimaryperformancesitelocation.Thisfieldis
required.
Street2:
Entersecondlineofthestreetaddressoftheprimaryperformancesitelocation,ifapplicable.
City:
Enterthecityforaddressoftheprimaryperformancesitelocation.Thisfieldisrequired.
County/Parish:
EntertheCountyorparishoftheprimaryperformancesitelocation.
State:
EntertheStatewheretheprimaryperformancesitelocationislocated.Thisfieldisrequiredif
theProjectPerformanceSiteislocatedintheUnitedStates.
Province:
Entertheprovincefortheprimaryperformancesitelocation.IfCountryisnotCanada,please
leaveblank.
Country:
SelecttheCountryofthePrimaryPerformanceSitelocation.Thisfieldisrequired.
ZIPCode:
Enterthenine-digitpostalcode(e.g.,ZIPcode)oftheperformancesitelocation.Thisfieldis
requirediftheperformancesitelocationisintheUnitedStates.Anine-digitZipcodeisrequired.
Project/PerformanceSiteCongressionalDistrict:
EntertheCongressionalDistrictintheformat:2characterStateAbbreviation3character
DistrictNumber.Examples:CA-005forCalifornias5thdistrict,CA-012forCalifornias12th
district.
Ifalldistrictsinastateareaffected,enterallforthedistrictnumber.ExampleMD-allforall
congressionaldistrictsinMaryland.
Ifnationwide(alldistrictsinallstates),enterUS-all.
Iftheprogram/projectisoutsidetheU.S.,enter00-000.
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Tolocateyourcongressionaldistrict,visittheGrants.govWebsite.Noteitislikelythisfieldwill
beidenticaltotheCongressionalDistrictofApplicantfieldprovidedelsewhereinthe
application.
code.Forjurisdictionswithnorepresentative,enter099.Forjurisdictionswithanonvoting
delegate,enter098forthedistrictnumber.Example:DC-098,PR-098.
Project/PerformanceSiteLocation1
OrganizationName:
Enterthenameoforganizationoftheperformancesitelocation.Ifaportionoftheprojectwillbe
performedatanyothersites(s),identifythesitelocation(s)intheblock(s)provided.
DUNSNumber:
EntertheDUNSnumberassociatedwiththeorganizationwheretheprojectwillbeperformed.
Thisfieldisoptional.
Street1:
EnterfirstlineofthestreetaddressfortheperformancesitelocationintheStreet1field.This
fieldisrequired.
Street2:
EnterthesecondlineofthestreetaddressfortheperformancesitelocationintheStreet2field.
Thisfieldisoptional.
City:
Enterthecityoftheperformancesitelocation.Thisfieldisrequired.
County:
Enterthecountyoftheperformancesitelocation.
State:
EntertheStatewheretheprimaryperformancesitelocationislocated.Thisfieldisrequiredif
theProjectPerformanceSiteislocatedintheUnitedStates.
Province:
Entertheprovincewheretheprimaryperformancesitelocationislocated.IfCountryisnot
Canada,pleaseleaveblank.
Country:
Selectthecountryfortheperformancesitelocation.Thisfieldisrequired.
ZIPCode:
Enterthenine-digitpostalcode(e.g.,ZIPcode)oftheperformancesitelocation.Thisfieldis
requirediftheperformancesitelocationisintheUnitedStates.
Project/PerformanceSiteCongressionalDistrict:
EntertheCongressionalDistrictintheformat:2characterStateAbbreviation3character
DistrictNumber.Examples:CA-005forCalifornias5thdistrict,CA-012forCalifornias12th
district.
Ifalldistrictsinastateareaffected,enterallforthedistrictnumber.ExampleMD-allforall
congressionaldistrictsinMaryland.
Ifnationwide(alldistrictsinallstates),enterUS-all.
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Iftheprogram/projectisoutsidetheU.S.,enter00-000.
Tolocateyourcongressionaldistrict,visittheGrants.govWebsite.Noteitislikelythisfieldwill
beidenticaltotheCongressionalDistrictofApplicantfieldprovidedelsewhereinthe
application.
code.Forjurisdictionswithnorepresentative,enter099.Forjurisdictionswithanonvoting
delegate,enter098forthedistrictnumber.Example:DC-098,PR-098.
AdditionalPerformanceSiteLocations
Foradditionalperformancesitelocations,clickNextSitetodisplaythefieldsfor
Project/PerformanceSiteLocations2through300.
Ifyouneedtoaddmorethan300locations,entertheinformationinaseparatefile.IntheAdditional
Locationssectionatthebottomoftheform,clickAddAttachment,selectthefile,andthenclick
Open.AsampleAdditionalPerformanceSitesformatpageforgreaterthaneightlocationscanbe
foundathttp://grants.nih.gov/grants/forms/additional-performance-site.htm.
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R.240-R&RSenior/KeyPersonProfile
(Expanded)Form
TheSenior/KeyPersonProfile(Expanded)Formisusedfor
allgrantapplications,andallowsthecollectionofdatafor
allsenior/keypersonsassociatedwiththeproject.The
informationforthePD/PIispre-populatedfromtheSF424
(R&R)form.SeeinstructionsinSectionR.200-SF424
(R&R)Formifthesefieldsareempty.
Viewlargerimage
QuickLinks
- Profile-ProjectDirector/PrincipalInvestigator(PD/PI)
- InstructionsforaBiographicalSketch
- Profile-Senior/KeyPerson
- AdditionalSenior/KeyPersonProfile(s)
MultiplePD/PIs(notapplicabletoCareerDevelopmentorFellowships Awards)
NIHacceptsapplicationsreflectingMultiplePD/PIsforallgrantactivitycodesusingtheSF424(R&R)
application.WhensubmittinganapplicationinvolvingMultiplePD/PIs,theContactPD/PImustbe
affiliatedintheCommonswiththeapplicantorganizationandshouldbelistedasthePD/PIintheSF424
R&Rform(seeSectionR.200-SF424(R&R)Form).Thatinformationautomaticallyprepopulatesthefirst
senior/keypersonprofilerecordinthisform.FortheadditionalPD/PIs,completealltherequested
information.EachPD/PImustbeassignedthePD/PIrole,eventhoseatsubaward/consortiumsiteswhen
applicable(donotusetheCo-PD/PIorCo-Investigatorrole.).Formoreinformation,pleaseseeSection
R.310-R&RSubawardBudgetAttachment(s)Form.
EachPD/PImustalsoberegisteredintheeRACommonsandmustbeassignedthePIRoleinthat
system(noteotherrolessuchasSOorIARwillnotgivePD/PIstheappropriateaccesstotheapplication
records).EachPD/PImustincludetheirrespectiveeRACommonsIDintheCredentialfield.Formore
informationonNIHImplementationofMultiplePD/PIs,see:http://grants.nih.gov/grants/multi_
pi/index.htm.
Whencompletingthedetailedbudgetformforeithertheprimeorganizationorasubaward/consortium
organization,theprojectroleslistedinthebudgetformshouldbeconsistentwiththoseusedinthe
Senior/KeyPersonForm.
Profile-ProjectDirector/PrincipalInvestigator(PD/PI)
Unlessotherwisespecifiedinanagencyannouncement,senior/keypersonnelaredefinedasall
individualswhocontributeinasubstantive,meaningfulwaytothescientificdevelopmentor
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executionoftheproject,whetherornotsalariesarerequested.Consultantsshouldbeincludedifthey
meetthisdefinition.
Datamustbeenteredforthefirst100individuals(PD/PI+99others)beforetheAdditional
Senior/KeyPersonFormAttachmentssectionbecomesavailable.
Prefix:
Pre-populatedfromtheSF424(R&R).Theprefix(e.g.,Mr.,Mrs.,Rev.)forthenameofthePD/PI
FirstName:
Pre-populatedfromtheSF424(R&R).Thefirst(given)nameofthePD/PI.Thisfieldisrequired.
MiddleName:
Pre-populatedfromtheSF424(R&R).ThemiddlenameofthePD/PI.
LastName:
Pre-populatedfromtheSF424(R&R).Thelast(family)nameofthePD/PI.Thisfieldisrequired.
Suffix:
Pre-populatedfromtheSF424(R&R).Thesuffix(e.g.,Jr,Sr,PhD)forthenameofthePD/PI.
Position/Title:
Pre-populatedfromtheSF424(R&R).ThetitleofthePD/PI.
Department:
Pre-populatedfromtheSF424(R&R).Thenameofprimaryorganizationaldepartment,service,
laboratory,orequivalentlevelwithintheorganizationofthePD/PI.
OrganizationName:
Pre-populatedfromtheSF424(R&R).ThenameoforganizationofthePD/PI.
Division:
Pre-populatedfromtheSF424(R&R).Thenameofprimaryorganizationaldivision,office,ormajor
subdivisionofthePD/PI.
Street1:
Pre-populatedfromtheSF424(R&R).ThefirstlineofthestreetaddressforthePD/PIinthe"Street
1"field.Thisfieldisrequired.
Street2:
Pre-populatedfromtheSF424(R&R).ThesecondlineofthestreetaddressforthePD/PIinthe
"Street2"field.Thisfieldisoptional
City:
Pre-populatedfromtheSF424(R&R).ThecityforaddressofPD/PI.Thisfieldisrequired.
County/Parish:
Pre-PopulatedfromtheDF424(R&R).Thecounty/parishforaddressofPD/PI.
State:
Pre-populatedfromtheSF424(R&R).ThestatewherethePD/PIislocated.Thisfieldisrequiredif
thePD/PIislocatedintheUnitedStates.
Province:
Pre-populatedfromtheSF424(R&R).TheProvincewherethePD/PIislocated.IfCountryisnot
Canada,thiswillbeblank.
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Country:
Pre-populatedfromtheSF424(R&R).ThecountryforthePD/PIaddress.Thisfieldisrequired.
ZIPCode:
Pre-populatedfromtheSF424(R&R).ThepostalCode(e.g.,ZIPcode)ofPD/PI.Thisfieldis
requiredifthePD/PIislocatedintheUnitedStates.Anine-digitZipcodeisrequired.
PhoneNumber:
Pre-populatedfromtheSF424(R&R).ThedaytimephonenumberforthePD/PI.Thisfieldis
required.
FaxNumber:
Pre-populatedfromtheSF424(R&R).ThefaxnumberforthePD/PI.
E-mail:
Pre-populatedfromtheSF424(R&R).Thee-mailaddressforthePD/PI.Thisfieldisrequiredfor
PD/PI.
Credential,e.g.,agencylogin:
ForNIHandotherPHSagencies,registrationintheeRACommonsforallPD/PIsisrequired.The
assignedCommonsusername(theuniquenameusedtologintothesystem)foranyoneassigned
thePD/PIrolemustbeenteredhereandmusthavethePIroleineRACommons.Thisisarequired
fieldforapplicationssubmittedtoNIHandotherPHSagencies.Applicationswillnotpassagency
validationrequirementswithoutthisfield.
NoteforapplicationsreflectingMultiplePD/PIs,theCommonsusernamemustbeprovidedforall
individualsassignedthePD/PIRoleontheapplication.
ProjectRole:
SelectPD/PIforthisperson.
OtherProjectRoleCategory:
CompleteifyouselectedOtherProfessionalorOtherasaprojectrole;e.g.,Engineer,Chemist.
DegreeType:
Enterthehighestacademicorprofessionaldegreeorothercredentials(e.g.,R.N.).Thisisoptional
information.
DegreeYear:
Entertheyearthehighestdegreeorothercredentialwasobtained.Thisisoptionalinformation.
AttachBiographicalSketch
Seeinstructionsbelow
AttachCurrent&PendingSupport:
UnlessotherwiserequiredinaspecificFOA,donotusethisattachmentuploadforNIHandother
PHSagencysubmissions.Thisinformationisnolongerrequiredatthetimeofapplication
submission.Thisinformationmayberequestedlaterinthepre-awardcycle.Whenthisoccurs,you
willbeinstructedtorefertoSupplementalInstructions,PartIIISection1.8.
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InstructionsforaBiographicalSketch
Pleasenotethatthese instructionsapplytoResearch(R),CareerDevelopment(K),Training(T),Fellowship(F),Multi-Project(M) and SBIR/STTR (B).
l Includebiographicalsketchesofallsenior/keypersonnelandOtherSignificantContributors.
l UsethesampleformatontheBiographicalSketchFormatPagetopreparethissectionforall
(modularandother)grantapplications.
l TheBiographicalSketchmaynotexceedfivepagesperperson.Thisfive-pagelimitincludesthe
tableatthetopofthefirstpage.
l Completetheeducationblockatthetopoftheformatpagebeginningwiththebaccalaureateor
otherinitialprofessionaleducation,suchasnursing.Includepostdoctoraltraining,separately
referencingresidencyandclinicalfellowshiptraining,ifapplicable.
eRACommonsUserName
IftheindividualisregisteredintheeRACommons,includetheCommonsUserName.This
dataitemisrequiredforthePD/PI(includingfellowshipapplicants),primarysponsorsof
fellowshipapplicants,andallmentorsofcandidatesformentoredcareerdevelopmentawards.
CommonsUserNameisoptionalforotherprojectpersonnel.Inotherfederalformsthis
informationisreferredtoasCredential,e.g.,agencylogin.ForinformationontheeRA
Commons,seehttps://commons.era.nih.gov/commons/index.jsp.
Education
Completetheeducationblockatthetopoftheformatpagebeginningwiththebaccalaureateor
otherinitialprofessionaleducation,suchasnursing.Includepostdoctoraltraining,separately
referencingresidencyandclinicalfellowshiptraining,ifapplicable.Foreachentryprovide:
l thenameandlocationoftheinstitution
l thedegreereceived(ifapplicable)andthemonthandyearofentryandcompletion(or
expectedcompletion)
l thefieldofstudy(forresidencyentriesthefieldofstudyshouldreflecttheareaofresidency
training)
Followingtheeducationblock,completeSectionsA,B,C,andDasdescribedbelow.
A.PersonalStatement
Brieflydescribewhyyouarewell-suitedforyourrole(s)inthisproject.Therelevantfactorsmay
include:aspectsofyourtraining;yourpreviousexperimentalworkonthisspecifictopicor
relatedtopics;yourtechnicalexpertise;yourcollaboratorsorscientificenvironment;and/oryour
pastperformanceinthisorrelatedfields.Notethefollowingadditionalinstructions:
l Forinstitutionalresearchtraining,institutionalcareerdevelopment,orresearcheducation
grantapplications,facultywhoarenotsenior/keypersonsareencouragedtocompletethis
section,butnotrequiredtodoso.
l Applicantsfordissertationresearchawardsshouldincludeadescriptionoftheircareergoals
andintendedcareertrajectoryandtheirinterestinthespecificareasofresearchdesignated
intheFOA,inadditiontotheinformationoutlinedabove.
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l CandidatesforResearchSupplementstoPromoteDiversityinHealth-RelatedResearch
shouldincludeadescriptionoftheirgeneralscientificachievementsand/orinterests,aswell
asspecificresearchobjectivesandcareergoals,inadditiontotheinformationoutlined
above.Indicateanycurrentsource(s)ofeducationalfunding.
l Iftherearefactorsaffectingyourpastproductivitythatyouwishtoexplain,suchasfamily
careresponsibilities,illness,disability,ormilitaryservice,youmayaddresstheminyour
personalstatement.
l Indicateifyouhavepublishedorcreatedresearchproductsunderanothername.
l YoumaymentionspecificcontributionstosciencethatarenotincludedinSectionC.Donot
presentorexpandonmaterialsthatshouldbedescribedinothersectionsofthisbiosketch
ortheapplication.
l Figures,tablesandgraphicsarenotallowed.
Youmayciteuptofourpublicationsorresearchproductsthathighlightyourexperienceand
qualificationsforthisproject.Researchproductscanincludeaudioorvideoproducts;
conferenceproceedingssuchasmeetingabstracts,postersorotherpresentations;patents;
dataandresearchmaterials;databases;educationalaidsorcurricula;instrumentsor
equipment;models;protocols;andsoftwareornetware.
B.PositionsandHonors
Listinchronologicalorderpositionsheldsincethecompletionofyourmostrecentdegree,
concludingwithyourpresentposition.Highschoolstudentsandundergraduatesmayinclude
anypreviouspositions.Forindividuals,suchasfellowshipapplicantsorcareerdevelopment
awardcandidates,whoarenotcurrentlylocatedattheapplicantorganization,includethe
expectedpositionattheapplicantorganization,withtheexpectedstartdate.
Listanyrelevantacademicandprofessionalachievementsandhonors.Inparticular:
l Students,postdoctorates,andjuniorfacultyshouldincludescholarships,traineeships,
fellowships,anddevelopmentawards,asapplicable.
l Cliniciansshouldincludeinformationonclinicallicensureandspecialtyboardcertification,if
applicable.
l IncludepresentmembershiponanyFederalGovernmentpublicadvisorycommittee.
C.ContributionstoScience
CandidatesforResearchSupplementstoPromoteDiversityinHealth-RelatedResearchwho
arehighschoolstudents,undergraduates,andpostbaccalaureatesarenotrequiredtocomplete
thissection.
Brieflydescribeuptofiveofyourmostsignificantcontributionstoscience.Whileallapplicants
maydescribeuptofivecontributions,graduatestudentsandpostdoctoratesareencouragedto
considerhighlightingtwoorthreetheyconsidermostsignificant.Descriptionsmayincludea
mentionofresearchproductsunderdevelopment,suchasmanuscriptsthathavenotyetbeen
acceptedforpublication.
Eachcontributionshouldbenolongerthanonehalfpage,includingcitations.These
contributionsdonothavetoberelatedtothisproject.Foreachcontribution:
l Indicatethehistoricalbackgroundthatframesthescientificproblem;thecentralfinding(s);
theinfluenceofthefinding(s)ontheprogressofscienceortheapplicationofthosefinding(s)
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tohealthortechnology;andyourspecificroleinthedescribedwork.
l Youmayciteuptofourpapersacceptedforpublicationorresearchproductsthatare
relevanttothecontribution.
l Researchproductscanincludeaudioorvideoproducts;conferenceproceedings
suchasmeetingabstracts,postersorotherpresentations;patents;dataand
researchmaterials;databases;educationalaidsorcurricula;instrumentsor
equipment;models;protocols;andsoftwareornetware.
l Thesecitationsdonothavetobeauthoredbyyou.
YoumayprovideaURLtoafulllistofyourpublishedwork.ThisURLmustbetoaFederal
Governmentwebsite(a.govsuffix).NIHrecommendsusingMyBibliography.ProvidingaURL
toalistofpublishedworkisnotrequired,andreviewersarenotrequiredtolookatthelist.
D.AdditionalInformation:ResearchSupportand/orScholasticPerformance
Notethefollowinginstructionsforspecifictypesofapplicants/candidates:
l Highschoolstudentsarenotrequiredtocompletethissection.
l Applicantsforpredoctoralandpostdoctoralfellowships,dissertationresearchgrants,and
candidatesforResearchSupplementstoPromoteDiversityinHealth-RelatedResearch
fromtheundergraduatethroughpostdoctorallevelsshouldusethissectiontoprovide
informationabouttheirscholasticperformance,followingtheinstructionsbelow.In
situationswhereapplicants/candidatesinthesecategoriesalsohaveresearchsupport,they
shouldcompletebothpartsofthissection.
ResearchSupport
Forallotherindividualsrequiredtocompleteabiosketch,listselectedongoingandcompleted
researchprojectsforthepastthreeyears(Federalornon-Federalsupport).Brieflyindicatethe
overallgoalsoftheprojectsandyourresponsibilities.Donotincludenumberofpersonmonths
ordirectcosts.
DonotconfuseResearchSupportwithOtherSupport.Thoughtheysoundsimilar,these
partsoftheapplicationareverydifferent.
l Aspartofthebiosketchsectionoftheapplication,ResearchSupporthighlightsyour
accomplishments,andthoseofyourcolleagues,asscientists.Thisinformationwillbeused
bythereviewersintheassessmentofeachindividualsqualificationsforaspecificrolein
theproposedproject,aswellastoevaluatetheoverallqualificationsoftheresearchteam.
l Incontrast,OtherSupportinformationisrequiredforallapplicationsthatareselectedto
receivegrantawards.NIHstaffwillrequestcompleteandup-to-dateothersupport
informationfromyouafterpeerreview.
ScholasticPerformance
Predoctoralapplicants/candidates(includingundergraduatesandpostbaccalaureates):Listby
institutionandyearallundergraduateandgraduatecourses,withgrades.Inaddition,inthe
spacefollowingthechart,explainanygradingsystemifotherthan1-100,A,B,C,D,F,or04.0.Showlevelsrequiredforapassinggrade.
Postdoctoralapplicants:Listbyinstitutionandyearallundergraduatecoursesandgraduate
scientificand/orprofessionalcoursesgermanetothetrainingsoughtunderthisaward,with
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grades.Inthespacefollowingthechart,explainanygradingsystemifotherthan1-100,A,B,C,
D,F,or0-4.0.Showlevelsrequiredforapassinggrade.
ProfileSenior/KeyPerson
Theremainingsenior/keypersonprofilesshouldbelistedinalphabeticalorder.Whilealphabetical
orderispreferred,itisnotrequired.However,beawarethattheseprofileswillappearinthe
applicationintheorderprovidedbytheapplicant.Therefore,peerreviewerswillseethemintheorder
presented.Thosewithapostdoctoralroleshouldbeincludediftheymeetthedefinitionofsenior/key
personnel.
AlsousethissectiontolistanyOtherSignificantContributors(OSCs),whoarethoseindividuals
whocommittocontributetothescientificdevelopmentorexecutionoftheproject,butdonotcommit
anyspecifiedmeasurableeffort(i.e.,personmonths)totheproject.Theseindividualsaretypically
presentedateffortofzeropersonmonthsor"asneeded."Individualswithmeasurableeffortmay
notbelistedasOtherSignificantContributors(OSCs).Consultantsshouldbeincludediftheymeet
theOSCdefinition.OSCsshouldbelistedafterallsenior/keypersons.
Abiosketch,includingResearchSupportinformation,isrequiredforallsenior/keypersonsand
OSCsasthishighlightstheiraccomplishmentsasscientists.Reviewersusethesepagestoaddress
theinvestigatorreviewcriterion.However,ifanawardistobemade,OtherSupportinformationwill
notberequiredoracceptedforOSCssinceconsiderationsofoverlapdonotapplytothese
individuals.
ShouldthelevelofinvolvementchangeforanindividuallistedasanOSC,requiringmeasurableeffort
ontheaward,theindividualshouldberedesignatedassenior/keypersonnel.Thischangeshouldbe
madebeforeanycompensationischargedtotheproject.
Afterprovidingdataforeachindividualsenior/keyperson(thefollowinginstructionsalsoapplyto
OSCs),clicktheNextPersonbuttonatthebottomoftheformtoenterdataforthenextsenior/key
person.Continueinthismanneruntildatahasbeenprovidedforupto100senior/keypersons.To
ensureproperperformanceofthisform,afteradding20additionalsenior/keypersonspleasesave
yourapplication,closetheAdobereader,andreopenit.Forapplicationsinvolvingmorethan100
senior/keypersons,theAdditionalSenior/KeyPersonProfilesfieldswillbecomeavailableonce
dataforthefirst100senior/keypersonshasbeenprovided.
Prefix:
Entertheprefix(e.g.,Mr.,Mrs.,Rev.)forthenameoftheSenior/KeyPerson.
FirstName:
Enterthefirst(given)nameoftheSenior/KeyPerson.Thisfieldisrequired.
MiddleName:
EnterthemiddlenameoftheSenior/KeyPerson,ifapplicable.
LastName:
Enterthelast(family)nameoftheSenior/KeyPerson.Thisfieldisrequired.
Suffix:
Enterthesuffix(e.g.,Jr.,Sr.,Ph.D.)forthenameoftheSenior/KeyPerson.
Position/Title:
EnterthetitleoftheSenior/KeyPerson.
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Department:
Enterthenameofprimaryorganizationaldepartment,service,laboratory,orequivalentlevelwithin
theorganizationoftheSenior/KeyPerson.
OrganizationName:
EnterthenameoforganizationoftheSenior/KeyPerson.Thisisarequiredfieldforapplications
submittedtoNIHandotherPHSagencies.
Division:
Enterthenameofprimaryorganizationaldivision,office,ormajorsubdivisionoftheSenior/Key
Person.
Street1:
EnterfirstlineofthestreetaddressfortheSenior/KeyPersoninthe"Street1"field.Thisfieldis
required.
Street2:
EntersecondlineofthestreetaddressfortheSenior/KeyPersoninthe"Street2"field.Thisfieldis
optional.
City:
CityforaddressofSenior/KeyPerson.Thisfieldisrequired.
County/Parish:
County/ParishforaddressofSenior/KeyPerson.
State:
EntertheStatewheretheSenior/KeyPersonislocated.Thisfieldisrequiredifthesenior/keyperson
islocatedintheUnitedStates.
Province:
EntertheProvincewheretheSenior/KeyPersonislocated.IfCountryisnotCanada,pleaseleave
blank.
Country:
SelectthecountryfortheSenior/KeyPersonaddress.Thisfieldisrequired.
ZIPCode:
EnterthePostalCode(e.g.,ZIPcode)ofSenior/KeyPerson.ThisfieldisrequirediftheSenior/Key
PersonislocatedintheUnitedStates.Anine-digitZipcodeisrequired.
PhoneNumber:
EnterthedaytimetelephonenumberfortheSenior/KeyPerson.Thisfieldisrequired.
FaxNumber:
EnterthefaxnumberfortheSenior/KeyPerson.
E-mail:
Enterthee-mailaddressfortheSenior/KeyPerson.ThisfieldisrequiredfortheSenior/KeyPerson.
Credential,e.g.,agencylogin:
Ifyouaresubmittingtoanagency(e.g.,NIH)whereyouhaveanestablishedpersonalprofile,enter
theagencyID.Ifnot,leaveblank.
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AdditionalInstructionsforResearch:
CandidatesfordiversityandreentrysupplementsupportmustprovideaCommons
Username.
ProjectRole:
Selectone.Use"Other"ifacategoryisnotlistedinthepicklist.
ForapplicationsreflectingMultiplePD/PIs,allsuchindividualsmustbeassignedthePD/PIrole,
eventhoseatorganizationsotherthantheapplicantorganization.TheroleofCo-PD/PIisnot
currentlyusedbyNIHandotherPHSagencies.Assigninganindividual(s)theroleof"Co-PD/PI"will
notidentifytheapplicationasaMultiplePD/PIapplication.Ifapplicantswishtouseadifferentrole,
selectOtherfortheProjectRolefieldandtheninserttheappropriateroledescriptorintheOther
ProjectRoleCategoryfield.
IfincludingindividualsclassifiedasOtherSignificantContributors(OSCs),usetheOthercategory
andindicateOtherSignificantContributorastheroleintheOtherProjectRoleCategory.OSCs
shouldbelistedlastafterallothersenior/keypersonshavebeenlisted.
OtherProjectRoleCategory:
CompleteifyouselectedOtherProfessionalorOtherasaprojectrole;e.g.,Engineer,Chemist.
DegreeType:
Enterthehighestacademicorprofessionaldegreeorothercredentials(e.g.,R.N.).Thisisoptional
information.
DegreeYear:
Entertheyearthehighestdegreeorothercredentialwasobtained.Thisisoptionalinformation.
ApplicantsshouldensurethattheirdegreeinformationiscurrentintheirCommonsProfile.
AttachBiographicalSketch:
Provideabiographicalsketchforeachsenior/keyperson.Biographicalsketchesmustfollowthe
formatdescribedabove.
AttachCurrent&PendingSupport:
submission.Thisinformationmayberequestedlaterinthepre-awardcycle.Whenthisoccursrefer
toSupplementalInstructions,PartIIISection1.8.
AdditionalSenior/KeyPersonProfile(s)
Ifmorethan99senior/keypersonprofilesareproposed,entertheinformationinaseparatefileand
attachithere.AsampleAdditionalSenior/KeyPersonProfilesformatpageforgreaterthan100
profilescanbefoundat:http://grants.nih.gov/grants/forms/additional-senior-key-person-profile.htm.
AdditionalBiographicalSketch(es)(Senior/KeyPerson):
Provideabiographicalsketchforeachsenior/keyperson.Biographicalsketchesmustfollowthe
formatdescribedabove.
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AdditionalCurrentandPendingSupport(s):
submission.Thisinformationmayberequestedlaterinthepre-awardcycle.Whenthisoccurs,refer
toSupplementalInstructions,PartIIISection1.8.
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R.300-R&RBudgetForm
TheR&RBudgetFormisusedinthemajorityof
applications;however,itisimportantthatallapplicants
refertotheirspecificFOAforguidanceonwhichbudget
form(s)areallowedforyourapplication.
Someapplicationformspackagesincludetwooptional
budgetforms(1)R&RBudgetForm;and,(2)PHS398
ModularBudgetForm.However,applicationsmust
includeonlyoneoftheseforms,butnotboth.
Viewlargerimage
QuickLinks
- A.Senior/KeyPerson
- B.OtherPersonnel
- C.EquipmentDescription
- D.Travel
- E.Participant/TraineeSupportCosts
- F.OtherDirectCosts
- G.TotalDirectCosts(AthroughF)
- H.IndirectCosts
- I.TotalDirectandIndirectInstitutionalCosts(G+H)
- J.Fee
- K.BudgetJustification
-CumulativeBudget
UsingtheR&RBudgetForm:
TheR&RBudgetformincludesthreeseparatedataentryscreens:(1)SectionsAandB;(2)SectionsC
throughE;and(3)SectionsFthroughK.Tonavigatebetweenthevariousscreens,usethePreviousand
Nextbuttonsatthetopoftheformorusethescrollbaronthesideofthescreen.CompletetheR&R
Budgetformfollowingtheinstructionsprovided.Youmustcompleteaseparatedetailedbudgetforeach
yearofsupportrequested.Theformwillgenerateacumulativebudgetforthetotalprojectperiod.Ifno
fundsarerequestedforarequiredfield,enter0.
Whilethedollarfieldsallowcentstobeentered,alldollarfieldsshouldbepresentedinwholenumbers.
Pleaseroundtothenearestwholenumber.
PersonMonths:
NIHandotherPHSagenciesusetheconceptofpersonmonthsasametricfordeterminingpercentof
effort.Toassistapplicantsunfamiliarwiththisconcept,resourcesareavailableonthewebat:
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http://grants.nih.gov/grants/policy/person_months_faqs.htm.Frequentlyaskedquestionsanda
conversioncalculatorareavailable.
AdditionalBudgetPeriods:
Iffundsarebeingrequestedformorethanonebudgetperiod,clicktheNextPeriodbuttonatthetopofthe
thirdbudgetscreen(SectionsFthroughK)tonavigatetoscreensforthenextbudgetperiod.
Revision(Supplemental)Application:
ForaRevisionapplication,showonlythoseitemsforwhichadditionalfundsarerequested.Iftheinitial
budgetperiodoftheRevisionapplicationislessthan12months,proratethepersonnelcostsandother
appropriateitemsofthedetailedbudget.
ForeignGranteeBudgetGuidelines:
Allcompeting(new,renewal,resubmission,andrevision)grantapplicationsfromforeign(non-U.S.)
institutionsmustincludeonlydetailed(non-modular)budgets.Foradditionalinformation,seeNIHGuide
NoticeNOT-OD-06-096,http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-096.html.
ApplicationsfromforeignorganizationsmustrequestbudgetsinU.S.dollars.
IntroductoryFields
OrganizationalDUNS:
EntertheDUNSorDUNS+4numberoftheapplicantorganization.Forprojectapplicant,this
fieldispre-populatedfromtheSF424(R&R)form.Forsubawardapplicants,thisfieldisa
requiredenterablefield.
EnternameofOrganization:
Pre-populatedfromtheSF424(R&R)form.Enterthenameoftheorganization.
BudgetType:
Project,Subaward/Consortium:Checktheappropriateblock.Thisfieldisrequired.
Project:
Thebudgetrequestedfortheprimaryapplicantorganization.
Subaward/Consortium:
Thebudgetrequestedforsubawardee/consortiumorganization(s).Note,separatebudgetsare
requiredonlyforsubawardee/consortiumorganizationsthatperformasubstantiveportionofthe
project.
IfcreatingSubawardBudget,usetheR&RSubawardBudgetAttachmentandattachasa
separatefileontheR&RBudgetAttachment(s)form.
Ifyouarepreparinganapplicationthatincludesasubaward/consortium,seeSectionR.310-
R&RSubawardBudgetAttachment(s)Form.
StartDate:
Pre-populatedfromtheSF424(R&R).Entertherequested/proposedstartdateofeachbudget
period.Thisfieldisrequired.
EndDate:
Entertherequested/proposedenddateofeachbudgetperiod.Thisfieldisrequired.
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BudgetPeriod:
Identifythespecificbudgetperiod(forexample,1,2,3,4,5).IfsubmittingthroughGrants.gov,
thesystemwillautomaticallygenerateacumulativebudgetforthetotalprojectperiod.Thisisa
requiredfield.
(IftheResetEntriesbuttonispressed,pleasenavigatetopreviousyeartoenablethe
submissionoftheform.)
A.Senior/KeyPerson
Thissectionshouldincludethenamesofallsenior/keypersonsattheapplicantorganizationwhoare
involvedontheprojectinaparticularbudgetyear.Includeallcollaboratinginvestigators,andother
individualsmeetingthesenior/keypersondefinitioniftheyarefromtheapplicantorganization.
DetailsofcollaboratorsatotherinstitutionswillbeprovidedintheSubawardbudgetforeach
subaward/consortiumorganization.PersonnellistedasOtherSignificantContributorswhoarenot
committinganyspecificmeasurableefforttotheprojectshouldnotbeincludedinthePersonnel
sectionofthebudgetsincenoassociatedsalaryand/orfringebenefitsshouldberequestedfortheir
contribution.Consultantsdesignatedassenior/keypersonsintheSenior/KeyPersonProfileForm
canbeincludedinBudgetSectionAonlyiftheyarealsoemployeesoftheapplicantorganization.
Otherwise,consultantcostsshouldbeincludedinConsultantServices.
Prefix:
Entertheprefix(e.g.,Mr.,Mrs.,Rev.)forthenameofeachSenior/KeyPerson.
FirstName:
Enterthefirst(given)nameofeachSenior/KeyPerson.
MiddleName:
EnterthemiddlenameofeachSenior/KeyPerson,ifapplicable.
LastName:
Enterthelast(family)nameofeachSenior/KeyPerson.Thisfieldisrequired.
Suffix:
Enterthesuffix(e.g.,Jr.,Sr.,PhD)ofeachSenior/KeyPerson.
BaseSalary($):
EntertheannualcompensationpaidbytheemployerforeachSenior/KeyPerson.Thisincludes
allactivitiessuchasresearch,teaching,patientcare,orother.Youmaychoosetoleavethis
columnblank.Anapplicantorganizationmaychoosetoleavethisblank;however,PHSstaff
willrequestthisinformationpriortoaward.
Cal.Months:
Identifythenumberofmonthsdevotedtotheprojectforeachsenior/keyperson(i.e.,calendar,
academic,summer).Ifeffortdoesnotchangethroughouttheyear,itisOKtouseonlythe
calendarmonthscolumn.However,youmayusebothacademicandsummermonthscolumns
ifyourinstitutionalbusinessprocessrequiresnotingeachseparatelyevenifeffortremains
constant.Ifeffortvariesbetweenacademicandsummermonths,leavethecalendarmonths
columnblankanduseonlytheacademicandsummermonthscolumns.Pleaseuseeither
calendarmonthsORacombinationofacademicandsummermonths.Somemeasurableeffort
isrequiredforeverySenior/KeyPersonentry.
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Acad.Months:
Identifythenumberofmonthsdevotedtotheprojectforeachsenior/keyperson(forexample,
calendar,academic,summer).Ifyourinstitutiondoesnotusea9-monthacademicyear,
indicateyourinstitutionsdefinitionofacademicyearinthebudgetjustification.Some
measurableeffortisrequiredforeverySenior/KeyPersonentry.
Sum.Months:
Identifythenumberofmonthsdevotedtotheprojectforeachsenior/keyperson(forexample,
calendar,academic,summer).Ifyourinstitutiondoesnotusea3-monthsummerperiod,
indicateyourinstitutionsdefinitionofsummerinthebudgetjustification.Somemeasurable
effortisrequiredforeverySenior/KeyPersonentry.
RequestedSalary($):
Regardlessofthenumberofmonthsbeingdevotedtotheproject,indicateonlytheamountof
salarybeingrequestedforthisbudgetperiodforeachsenior/keyperson.Thisfieldisrequired.
SomePHSgrantprogramsarecurrentlysubjecttoalegislativelyimposedsalarylimitation.Any
adjustmentforsalarylimitswillbemadeatthetimeofaward;thereforerequestedsalaryshould
bebasedoninstitutionalbasesalaryatthetimetheapplicationissubmittedandnotadjustedfor
anylimitation.Forguidanceoncurrentsalarylimitations,seetheSalaryCapSummaryonthe
NIHgrantswebsiteorcontactyourofficeofsponsoredprograms.
NIHgrantsalsolimitthecompensationforgraduatestudents.Compensationincludessalaryor
wages,fringebenefitsandtuitionremission.Whileactualinstitutional-basedcompensation
shouldberequestedandjustified,thismaybeadjustedatthetimeoftheaward.Formore
guidanceonthispolicy,see:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02017.html.
FringeBenefits($):
Enterapplicablefringebenefits,ifany,foreachsenior/keyperson.
FundsRequested($):
Therequestedsalaryandfringebenefitsforeachsenior/keyperson.Thisfieldisautocalculated.
ProjectRole:
Identifytheprojectroleofeachsenior/keypersoninthissection.Rolesshouldcorrespondto
therolesincludedontheSectionR.240-R&RSenior/KeyPersonProfile(Expanded)Form.
AdditionalSenior/KeyPersons:
Iffundsarerequestedformorethaneightsenior/keypersons,includeallpertinentbudget
informationasidentifiedinthissectionandattachasafilehere.Enterthetotalfundsrequested
foralladditionalsenior/keypersonsinline9ofSectionA.Thisattachmentisrequirediffunds
areenteredinline9ofSectionA.Usethesameformatasthebudgetformandincludeall
requiredinformation.
TotalFundsrequestedforallpersonsintheattachedfile:
Enterthetotalfundsrequestedforallsenior/keypersons.Thisisrequiredinformation.
TotalSenior/KeyPersons:
Thetotalfundsrequestedforallsenior/keypersons.
SpecialInstructions:JointUniversityandDepartmentofVeteransAffairs(V.A.)Appointments
IndividualswithjointuniversityandV.A.appointmentsmayrequesttheuniversitysshareof
theirsalaryinproportiontotheeffortdevotedtotheresearchproject.Theindividualssalarywith
theuniversitydeterminesthebaseforcomputingthatrequest.Signaturebytheinstitutional
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officialontheapplicationcertifiesthat:(1)theindividualisapplyingaspartofajoint
appointmentspecifiedbyaformalMemorandumofUnderstandingbetweentheuniversityand
theV.A.;and(2)thereisnopossibilityofdualcompensationforthesamework,orofanactual
orapparentconflictofinterestregardingsuchwork.Additionalinformationmayberequestedby
theawardingcomponents.
B.OtherPersonnel
NumberofPersonnel:
Foreachprojectrolecategoryidentifythenumberofpersonnelproposed.
Inmostcircumstances,thesalariesofadministrativeorclericalstaffateducationalinstitutions
andnonprofitorganizationsareincludedaspartofindirectcosts.Examples,however,of
situationswheredirectchargingofadministrativeorclericalstaffsalariesmaybeappropriate
maybefoundat:http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html#exc.The
circumstancesforrequiringdirectchargingoftheseservicesmustbeclearlydescribedinthe
budgetjustification.
ForallPostdoctoralAssociatesandGraduateStudentsnotalreadynamedinSectionA.
Senior/KeyPerson,individuallylistnames,roles(e.g.,PostDocorGraduateStudent),
associatedmonths,andsalary&fringebenefitsrequestedintheBudgetJustification.
ThesalariesofadministrativeandclericalpersonnelshouldnormallybetreatedasF&Acosts.
Inclusionofsuchcostsmaybeappropriateonlyifallofthefollowingconditionsaremet:
1. Administrativeorclericalservicesareintegraltoaprojectoractivity;
2. Individualsinvolvedcanbespecificallyidentifiedwiththeprojectoractivity;
3. Suchcostsareexplicitlyincludedinthebudgetorhavepriorwrittenapprovalofthe
Federalawardingagency;and
4. Thecostsarenotalsorecoveredasindirectcosts.
RequestsfordirectchargingorSecretarial/ClericalPersonnel(i.e.,administrativeandclerical
staff)mustbeappropriatelyjustifiedintheBudgetJustification.
ProjectRole:
Foreachprojectrolecategoryidentifythenumberofpersonnelproposed.Listanyadditional
projectrole(s)intheblank(s)provided,e.g.,Engineer,ITProfessionals,etc.Donotinclude
consultantsinthissection.ConsultantsareincludedbelowinSectionF.OtherDirectCosts.
Cal.Months:
Identifythenumberofmonthsdevotedtotheprojectintheapplicableboxforeachprojectrole
category(i.e.,calendar,academic,summer).
Acad.Months:
category(i.e.,calendar,academic,summer).Ifyourinstitutiondoesnotusea9-month
academicyear,indicateyourinstitutionsdefinitionofacademicyearinthebudgetjustification.
Sum.Months:
category(i.e.,calendar,academic,summer).Ifyourinstitutiondoesnotusea3-monthsummer
period,indicateyourinstitutionsdefinitionofsummerinthebudgetjustification.
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RequestedSalary($):
Regardlessofthenumberofmonthsbeingdevotedtotheproject,indicateonlytheamountof
salary/wagesbeingrequestedforeachprojectrole.SomePHSgrantprogramsarecurrently
subjecttoalegislativelyimposedsalarylimitation.Anyadjustmentforsalarylimitswillbemade
atthetimeofaward;thereforerequestedsalaryshouldbebasedoninstitutionalbasesalaryat
thetimetheapplicationissubmittedandnotadjustedforanylimitation.Forguidanceoncurrent
salarylimitations,seetheSalaryCapSummaryontheNIHgrantswebsiteorcontactyour
officeofsponsoredprograms.
wages,fringebenefitsandtuitionremission.Whileactualinstitutional-basedcompensation
shouldberequestedandjustified,thismaybeadjustedatthetimeoftheaward.Formore
guidanceonthispolicy,see:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02017.html.
FringeBenefits($):
Enterapplicablefringebenefits,ifany,forthisprojectrolecategory.
FundsRequested($):
Thisfieldisauto-calculated.
TotalNumberofOtherPersonnel:
Thistotalwillauto-calculate.TotalNumberofPersonnel.
TotalOtherPersonnel:
TotalFundsrequestedforallotherPersonnel.
TotalSalary,WagesandFringeBenefits(A+B):
TotalFundsrequestedforallSenior/KeypersonsandallOtherPersonnel.Thistotalwillautocalculate.
Tonavigatetothenextpage(SectionsCthroughE),clicktheNextbuttonatthetopoftheformor
usethescrollbarontheleft-handsideofthescreen.
C.EquipmentDescription
Listofitemsanddollaramountforeachitemexceeding$5,000.
EquipmentItem:
Equipmentisdefinedasanitemofpropertythathasanacquisitioncostof$5,000ormore
(unlesstheorganizationhasestablishedlowerlevels)andanexpectedservicelifeofmorethan
oneyear.Listeachitemofequipmentseparatelyandjustifyeachinthebudgetjustification
section.Allowableitemsordinarilywillbelimitedtoresearchequipmentandapparatusnot
alreadyavailablefortheconductofthework.General-purposeequipment,suchasapersonal
computer,isnoteligibleforsupportunlessprimarilyorexclusivelyusedintheactualconductof
scientificresearch.
FundsRequested:
Listtheestimatedcostofeachitemofequipmentincludingshippingandanymaintenance
costsandagreements.Thisisrequiredinformation.
AdditionalEquipment:
Ifthissectioncannotaccommodatealltheequipmentproposed,attachafileintheblock
provided.Listeachadditionalitemandthefundsrequested.Foralladditionalitemsinthe
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attachedfile,listthetotalfundsrequestedinthefollowingfield.
Totalfundsrequestedforallequipmentlistedintheattachedfile:
Totalfundsrequestedforallequipmentlistedintheattachedfile.Dollaramountforeachitem
shouldexceed$5000.
TotalEquipment:
TotalFundsrequestedforallequipment.
D.Travel
DomesticTravelCosts(Incl.Canada,Mexico,andU.S.Possessions):
Identifythetotalfundsrequestedfordomestictravel.DomestictravelincludesCanada,
Mexico,andU.S.possessions.Inthebudgetjustificationsection,includethepurpose,
destination,datesoftravel(ifknown),andnumberofindividualsforeachtrip.Ifthedatesof
travelarenotknown,specifyestimatedlengthoftrip(e.g.,3days).
ForeignTravelCosts:
Identifythetotalfundsrequestedforforeigntravel.Foreigntravelincludesanytraveloutsideof
NorthAmericaand/orU.S.possessions.Inthebudgetjustificationsection,includethe
purpose,destination,datesoftravel(ifknown)andnumberofindividualsforeachtrip.Ifthe
datesoftravelarenotknown,specifyestimatedlengthoftrip(e.g.,3days).
TotalTravelCost:
TotalFundsrequestedforalltravel.
E.Participant/TraineeSupportCosts
Unlessspecificallystatedotherwiseinanannouncement,NIHandotherPHSagenciesapplicants
shouldleaveblankSectionE.Note:Tuitionremissionforgraduatestudentsshouldcontinuetobe
includedinSectionF.OtherDirectCostswhenapplicable.
Tuition/Fees/HealthInsurance:
ListtotalfundsrequestedforParticipant/TraineeTuition/Fees/Healthinsurance.
Stipends:
ListtotalfundsrequestedforParticipant/Traineestipends.
Travel:
ListtotalfundsrequestedforParticipant/Traineetravel.
Subsistence:
ListtotalfundsrequestedforParticipant/Traineesubsistence.
Other:
Describeanyotherparticipanttraineefundsrequested.Listtotalfundsrequestedforanyother
Participant/Traineecostsdescribed.
NumberofParticipants/Trainees:
ListtotalnumberofproposedParticipants/Trainees.Valuecannotbegreaterthan999.
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TotalParticipant/TraineeSupportCosts:
TotalFundsrequestedforalltraineecosts.Thisfieldisrequiredifanydatahasbeenenteredin
sectionE.
F.OtherDirectCosts
1.MaterialsandSupplies:
Listtotalfundsrequestedformaterialsandsupplies.Inthebudgetjustification,indicategeneral
categoriessuchasglassware,chemicals,animalcosts,includinganamountforeachcategory.
Categorieslessthan$1,000arenotrequiredtobeitemized.
2.PublicationCosts:
Listthetotalpublicationfundsrequested.Theproposalbudgetmayrequestfundsforthecosts
ofdocumenting,preparing,publishing,orotherwisemakingavailabletoothersthefindingsand
productsoftheworkconductedundertheaward.Inthebudgetjustificationincludesupporting
information.
3.ConsultantServices:
Listthetotalcostsforallconsultantservices.Inthebudgetjustification,identifyeach
consultant,theserviceshe/shewillperform,totalnumberofdays,travelcosts,andthetotal
estimatedcosts.Inthebudgetjustificationalsoprovidethenamesandorganizational
affiliationsofallconsultants,otherthanthoseinvolvedinconsortium/contractualarrangements.
Includeconsultantphysiciansinconnectionwithpatientcareandpersonswhoareconfirmedto
serveonexternalmonitoringboardsoradvisorycommitteestotheproject.Describethe
servicestobeperformed.
4.ADP/ComputerServices:
ListtotalfundsrequestedforADP/computerservices.Thecostofcomputerservices,including
computer-basedretrievalofscientific,technicalandeducationinformationmayberequested.In
thebudgetjustification,includetheestablishedcomputerserviceratesattheproposing
organizationifapplicable.
5.Subawards/Consortium/ContractualCosts:
Listtotalfundsrequestedfor1)allsubaward/consortiumorganization(s)proposedfortheproject
and2)anyothercontractualcostsproposedfortheproject.Thislineitemshouldincludeboth
directandindirectcostsforallsubaward/consortiumorganizations.Contractualcostsfor
supportservices,suchasthelaboratorytestingofbiologicalmaterials,clinicalservices,ordata
processing,areoccasionallysufficientlyhightowarrantacategoricalbreakdownofcosts.
Whenthisisthecase,providedetailedinformationaspartofthebudgetjustification.
NIHpolicyprovidesforexclusionofconsortium/contractualF&Acostswhendeterminingifan
applicantisincompliancewithadirectcostlimitation.PleaseseetheSupplemental
Instructions,PartIIISection1.1.
6.EquipmentorFacilityRental/UserFees:
ListtotalfundsrequestedforequipmentorfacilityRental/Usefees.Inthebudgetjustification,
identifyeachrentaluserfeeandjustify.
7.AlterationsandRenovations:
Listtotalfundsrequestedforalterationsandrenovations.Inthebudgetjustification,itemizeby
categoryandjustifythecostsofalterationsandrenovationsincludingrepairs,painting,removal
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orinstallationofpartitions,shielding,orairconditioning.Whereapplicable,providethesquare
footageandcosts.
Undercertaincircumstancesthepublicpolicyrequirementsthatapplytoconstructionactivities
mayalsoapplytoA&Ractivities.PleaserefertotheNIHGrantsPolicyStatementsectionon
ConstructionGrantsPublicPolicyRequirementsandObjectivesformoreinformation.
Note,costsforanyAlterationsandRenovations(A&R)werepreviouslyunallowableon
applicationsfromforeigninstitutions,internationalorganizationsanddomesticapplicationswith
foreignsubawards.However,anHHSpolicychangenowallowsforminorA&R($500,000)on
theseapplications.NotapplicableforSBIR/STTR.
WhenrequestingminorA&Rcostsunderthispolicy,pleaseprovidedetailedinformationonthe
plannedA&Rinthebudgetjustification.
8-10Other:
Addtexttodescribeanyotherdirectcostsnotrequestedabove.Usethebudgetjustificationto
furtheritemizeandjustify.
Listtotalfundsrequestedforitems8-10Other.Uselines8-10forsuchcostsaspatientcare
andtuitionremission.Ifrequestingpatientcarecosts,requestinpatientandoutpatientcosts
separatelyusinglines8and9.
TotalOtherDirectCosts:
TotalFundsrequestedforallotherdirectcosts.
SpecialInstructionsforPatientCareCosts:Ifinpatientand/oroutpatientcostsare
requested,providethenamesofanyhospitalsand/orclinicsandtheamounts
requestedforeachinthebudgetjustification.
StatewhethereachhospitalorclinichasacurrentlyeffectiveHHS-negotiatedresearch
patientcarerateagreementand,ifnot,whatbasisisusedforcalculatingcosts.Ifan
applicantdoesnothaveaHHS-negotiatedrate,thePHSawardingcomponentcan
approveaprovisionalrate.Indicate,indetail,thebasisforestimatingcostsinthis
category,includingthenumberofpatientdays,estimatedcostperday,andcostper
testortreatment.Ifbothinpatientandoutpatientcostsarerequested,provide
informationforeachseparately.Ifmultiplesitesaretobeused,providedetailed
informationbysite.
Includeinformationregardingprojectedpatientaccrualfortheproject/budgetperiods
andrelatethisinformationtothebudgetrequestforpatientcarecosts.Ifpatientaccrual
isanticipatedtobeloweratthestartorduringthecourseoftheproject,planbudget(s)
accordingly.
ProvidespecificinformationregardinganticipatedsourcesofOtherSupportforpatient
carecosts,e.g.,thirdpartyrecoveryorpharmaceuticalcompanies.Includeany
potentialorexpectedutilizationoftheClinicalandTranslationalScienceAwards
(CTSA)program.
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G.TotalDirectCosts(AthroughF)
Totalfundsrequestedforalldirectcosts.
H.IndirectCosts
IndirectCostType:
Indicatethetypeofcost(e.g.,Salary&Wages,ModifiedTotalDirectCosts,orOther[explain]).
AlsoindicateifOff-site.Ifmorethanonerate/baseisinvolved,useseparatelinesforeach.If
youdonothaveacurrentindirectrate(s)approvedbyaFederalagency,indicate,None--will
negotiateandincludeinformationforaproposedrate.Usethebudgetjustificationifadditional
spaceisneeded.
IndirectCostRate($):
Indicatethemostrecentindirectcostrate(s)(alsoknownasFacilities&AdministrativeCosts
[F&A])establishedwiththecognizantFederaloffice,orinthecaseoffor-profitorganizations,
therate(s)establishedwiththeappropriateagency.Ifyouhaveacognizant/oversightagency
andareselectedforanaward,youmustsubmityourindirectrateproposaltothatofficefor
approval.Ifyoudonothaveacognizant/oversightagency,contacttheawardingagency.Ifthis
fielddoesnotallowafiguregreaterthan100%tobeentered,usetwolinestoshowtheentire
calculation.Thisfieldshouldbeenteredusingaratesuchas55.5.
IndirectCostBase($):
Entertheamountofthebaseforeachindirectcosttype.
FundsRequested:
Enterfundsrequestedforeachindirectcosttype.Enterthefundsrequestedfortheindirectcost
type.
TotalIndirectCosts:
Totalfundsrequestedforindirectcosts.
CognizantFederalAgency:
EnterthenameofthecognizantFederalAgency,nameandphonenumberoftheindividual
responsiblefornegotiatingyourrate.Ifnocognizantagencyisknown,enterNone.
SpecialInstructions:ForeignOrganizations(Non-domestic[non-U.S.Entities]):
ForeigninstitutionsandinternationalorganizationsmayrequestfundsforlimitedF&Acosts(8
percentofmodifiedtotaldirectcostslessequipment)tosupportthecostsofcompliancewith
HHSandNIHrequirementsincluding,butnotlimitedto,protectionofhumansubjects,animal
welfare,inventionreporting,financialconflictofinterestandresearchmisconduct.
Foreignorganizationsmaynotincludeanycharge-backofcustomsandimportfees,suchas
consularfees,customssurtax,value-addedtaxes(VAT)andotherrelatedcharges.
I.TotalDirectandIndirectInstitutionalCosts(G+H)
TotalFundsrequestedfordirectandindirectcosts.
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J.Fee
Generally,afeeisnotallowedonagrantorcooperativeagreement.Donotincludeafeeinyour
budget,unlesstheprogramannouncementspecificallyallowstheinclusionofafee(e.g.,
SBIR/STTR).Ifafeeisallowable,entertherequestedfee.
K.BudgetJustification
Usethebudgetjustificationtoprovidetheadditionalinformationrequestedineachbudgetcategory
identifiedaboveandanyotherinformationtheapplicantwishestosubmittosupportthebudget
request.Thefollowingbudgetcategoriesmustbejustified,whereapplicable:equipment,travel,
participant/traineesupportandotherdirectcostcategories.Onlyonefilemaybeattached.The
attachmentisrequired.
Usethissectiontolistthenames,role(e.g.,PostDocorGraduateStudent),associatedmonths,
salaryandfringebenefitsforallPostdoctoralAssociatesandGraduateStudentsincludedinBudget
SectionB.OtherPersonnel.
3. SuchcostsareexplicitlyincludedinthebudgetorhavepriorwrittenapprovaloftheFederal
awardingagency;and
Forallindividualsclassifiedasadministrative/secretarial/clerical,provideajustificationdocumenting
howtheymeetallfourconditions.NIHICsmayrequestadditionalinformationforthesepositionsin
ordertoassessallowability.
Includeajustificationforanysignificantincreasesordecreasesfromtheinitialyearbudget.Justify
budgetswithmorethanastandardescalationfromtheinitialtothefutureyear(s)ofsupport.Alsouse
thissectiontoexplainanyexclusionsappliedtotheF&Abasecalculation.
Iftheapplicationincludesasubaward/consortiumbudget,aseparatebudgetjustificationis
submittedforthatbudget.SeeSectionR.310-R&RSubawardBudgetAttachment(s)Form.
CompletingBudgetPeriods2-5:
Iffundsarebeingrequestedformorethanonebudgetperiod,youmustcompleteaseparatedetailed
budgetforeachyearofsupportrequested.Tonavigatetoscreensforthenextbudgetperiod,clickthe
NextPeriodbuttonatthetopofthe3rdbudgetscreen(SectionsFthroughK).Youmustcompleteallthe
requiredinformation(i.e.,thosefieldsthatarehighlightedandoutlinedinred)and/orconfirm/updateany
pre-populatedinformationbeforetheNextPeriodbuttonisactivated.Ifnofundsarerequestedfora
requiredfield,enter0.NotetheBudgetJustificationisalsoarequireditemandmustbeattachedbefore
theNextPeriodbuttonisactivated.
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Supplemental/RevisionApplication:
Forasupplemental/revisionapplication,showonlythoseitemsforwhichadditionalfundsarerequested.If
theinitialbudgetperiodofthesupplemental/revisionapplicationislessthan12months,proratethe
personnelcostsandotherappropriateitemsofthedetailedbudget.
WhenauthorizedorrequestedbytheappropriateNIHIC,applicantsmaysubmitapplicationswithmore
than5budgetperiods.Inthesesituationscompletethedetailedbudgetforperiods1-5asusual.However,
includethesamelevelofdetailforPeriod6intheBudgetJustificationalongwithanexplanationofthe
situation.Also,besuretoincludeacoverletterthataddressestheseextrabudgetperiods,andincludethe
ICProgramOfficialspreapprovalaspartoftheCoverLetterPDF.
CumulativeBudget
Allvaluesonthisformarecalculatedautomatically.Theypresentthesummationsoftheamounts
thatyouhaveenteredpreviously,underSectionsAthroughK,foreachoftheindividualbudget
periods.Therefore,nodataentryisallowedorrequired,inordertocompletethisCumulativeBudget
section.
Ifanyoftheamountsdisplayedonthisformappearstobeincorrect,youmaycorrectitbyadjusting
oneormoreofthevaluesthatcontributetothattotal.Tomakeanysuchadjustments,youwillneed
torevisittheappropriatebudgetperiodform(s),toentercorrectedvalues.
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R.310-R&RSubawardBudget
Attachment(s)Form
TheR&RSubawardBudgetAttachment(s)Formisusedfor
applicationswithasubawardorconsortium.
Thisformisonlyrequiredwhentheprimegranteeis
submittingadetailedbudgetusingtheR&RBudgetForm.
Donotusethissubaward/consortiumbudgetformfor
applicationsusingthePHS398ModularBudgetForm.
ApplicantsusingtheModularBudgetFormshouldsee
SectionR.320-ModularBudgetFormforinstructions
concerninginformationonconsortiumbudgets.
Viewlargerimage
Acompletesubaward/consortiumbudgetform(includingthebudgetjustificationsection)shouldbe
completedbyeachconsortiumgranteeorganization.Separatebudgetsarerequiredonlyfor
subawardee/consortiumorganizationsthatperformasubstantiveportionoftheproject.
Foranysubawardorconsortiumsites,itisappropriateandexpectedthatsomeonemaybedesignatedas
theconsortiumleadinvestigatorresponsibleforensuringproperconductoftheprojectorprogramatthat
site.However,whencompletingtheProjectRolefortheconsortiumleadinvestigator,theprojectroleof
PD/PIshouldonlybeusediftheentireapplicationisbeingsubmittedundertheMultiplePIpolicy.
Otherwise,thisindividualshouldbeassignedsomeotherprojectroleinthesenior/keypersonnelsection
oftheapplication.Also,theroleofCo-PD/PIisnotcurrentlyusedbyNIHandotherPHSagencies.
Assigninganindividual(s)theroleof"Co-PD/PI"willnotidentifytheapplicationasaMultiplePD/PI
application.AlthoughNIHnowrecognizestheroleofCo-Investigator,ifapplicantswishtousetheroleof
ConsortiumPIorsomeothersimilarrole,selectOtherfortheProjectRolefieldandtheninsertthe
appropriateroledescriptorintheOtherProjectRoleCategoryfield.
Consortium/ContractualF&ACosts:
NIHcontinuestosupportthepolicyestablishedinApril2004,(revisedinNovember2004)regarding
applicationsthatinvolveconsortium/contractualF&Acosts(SeeNOT-OD-05-004).Thispolicyallows
applicantstoexcludeconsortium/contractualF&Acostswhendeterminingcomplianceforanyapplication
whereadirectcostlimitapplies.TheuseoftheSF424(R&R)applicationwithseparatelysubmitted
subaward/consortiumbudgetsallowsNIHtotakeadvantageofasystemvalidationforthispolicy.When
anapplicationissubmittedinresponsetoaprogramwithadirectcostlimit,theeRAsystemwillperform
thecalculationbytakingthetotaldirectcostsrequestedbytheprime/parentorganizationintheirdetailed
budget,andsubtractingallsubaward/consortiumF&Afromeachandeverysubawardbudgetattached.
Whenthevalidationcalculationequalsorexceedstherespectivedirectcostlimit,theapplicationwill
receiveawarning.Therearecircumstances,whenthesystemdoesnothavesufficientinformationto
excludeallallowableF&Acosts.Applicantsshoulddocumentintheirbudgetjustification,howtheirbudget
fallsbelowthedirectcostlimit(notapplicableforSBIR/STTR).
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UsingtheR&RSubawardBudgetAttachment(s)Form:
Thisformaccommodatesasetnumberofseparatesubawardbudgets(30).Ifyouaresubmittingan
applicationwithmoresubawardbudgetsthantheformallows,theremainingbudgetsshouldbeconverted
toPDFandincludedaspartofSectionK.BudgetJustificationoftheparentbudget.
Reminder,thesumofallsubawardbudgets;e.g.,thoseattachedseparatelyandthoseprovidedaspartof
thebudgetjustification,mustbeincludedinLineF.5Subawards/Consortium/ContractualCostsofthe
projectbudget.
Tostarttheprocess,theapplicantorganizationshould:
l SelecttheSubawardBudgetAttachmentFormfromtheOptionalDocumentsintheGrant
ApplicationPackage.
l Opentheform,andclicktheClickheretoextracttheR&RSubawardBudgetAttachment
buttoninthemiddleoftheform.ASAVEdialogboxappears.
l Savethefilelocallyusingthefirsttenlettersoftheconsortiumorganizationsnameanduse.pdf
asthefileextension.(TheextractedfileisanAdobePDFfile.)Onceyouhavesavedthefilethere
isnoneedtoextractanotherbudgetattachment.Doingsomaycauseyoutoloseanydataalready
storedinthesavedfile.
l E-mailtheextracted,savedformtotheconsortiumgrantee.Note:consortiumgranteesmusthave
installedacompatibleversionofAdobeReaderbeforetheycancompletetheform.Theconsortium
granteeshouldcompleteallthebudgetinformationasinstructedinSectionR.300-R&RBudget
Form.TheBudgetTypeshouldbesettoSubaward/Consortium.OrganizationalDUNSandName
ofOrganizationfieldsmustreflectthatofthesubaward/consortiumgrantee.
l Theconsortiumgranteemustcompletethebudgetformande-mailitbacktotheapplicant
organization.
l ReturntotheSubawardBudgetAttachmentFormandattachtheconsortiumgranteesbudgetto
oneoftheblocksprovidedontheform.
SubmittingSubawardBudgetsthatare notActiveforallPeriodsofthe Prime Grant
CompleteallbudgetperiodsintheR&RBudgetformforyoursubawardbudgets,aligningthebudget
periodnumbers,startdatesandenddateswiththebudgetperiodsoftheprimegrant.
Example:TheprimefillsoutanR&RBudgetformwiththefollowingperiods:
l period1-Jan1,2016Dec31,2016
ThebudgetperiodnumbersanddatesshouldbethesameintheR&RBudgetformsforthe
subawards.
TheR&RBudgetformsdonotallowfor"empty"budgetperiods.Theyincludeseveralrequiredfields
whichmustbecompleted(evenforinactiveperiods)inordertosuccessfullysubmit.
l Providethefollowinginformationforinactivebudgetperiods:
l OrganizationDUNS
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l BudgetType=Subaward/Consortium
l BudgetPeriodStart/EndDates(alignwithbudgetperiodsanddatesoftheprimebudget)
l InsectionA:Senior/KeyPerson,provideasingleentryincludingthefollowing:
l PD/PIorsubawardleadFirstandLastnames
l ProjectRole(maydefaulttoPD/PI;canbeadjustedasneeded)
l CalendarMonths=.01(smallestamounteffortallowedinthefield)
l RequestedSalary=$0
l FringeBenefits=$0
l Explanationoftheinactivebudgetperiodsinthebudgetjustification
NotethisapproachmaycauseavalidationwarningregardingtheNIH$500,000peryearlimiton
directcosts,thereforeyoushoulddocumentinboththecoverletterandthesubawardbudget
justificationthatthesubawardisonlyactiveforspecificperiodsoftheprime.AppropriateNIHstaff
hasaccesstothecoverletterandreviewershaveaccesstothebudgetjustification.This
documentationwillmakethedatecorrelationimmediatelyapparentandwillhelpavoidanyconfusion.
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R.320-PHS398ModularBudgetForm
ThePHS398ModularBudgetFormisonlyapplicableto
researchapplicationsfromdomesticorganizationsthatare
requesting$250,000orlessperyearindirectcosts.
Internationalorganizationsandothersthatdonotfallunder
thisdefinitionshouldusethedetailedbudgetforms
describedinSectionR.300-R&RBudgetForm.
ItisimportantthatallapplicantsrefertotheirFOAfor
guidanceonwhichbudgetform(s)areallowedforyour
application.
Notethatsomeapplicationformspackagesincludetwo
optionalbudgetforms(1)R&RBudgetForm;and,(2)PHS
398ModularBudgetForm.However,applicationsmust
includeonlyoneoftheseforms,butnotboth.
Viewlargerimage
QuickLinks
A. DirectCosts
B. Indirect(F&A)Costs
C. TotalDirectandIndirect(F&A)Costs(A+B)Funds
Requested($)
-
CumulativeBudgetInformation
ModularBudgetGuidelines
Modularbudgetsareapplicabletocertainresearchgrantapplicationsfromdomesticorganizations
requesting$250,000orlessperyearfordirectcosts.Internationalorganizationsandothersthatdonotfall
underthisdefinitionshouldusethedetailedbudgetformsdescribedinSectionR.300-R&RBudgetForm.
Note,consortium/contractualF&Acostsarenotfactoredintothedirectcostlimit.Theymayberequested
inadditiontothe$250,000limit.Modularbudgetsaresimplified;therefore,detailedcategoricalinformation
isnottobesubmittedwiththeapplication.
Forallmodularbudgets,requesttotaldirectcosts(inmodulesof$25,000),reflectingappropriatesupport
fortheproject.Therewillbenofutureyearescalations.Atypicalmodulargrantapplicationwillrequestthe
samenumberofmodulesineachyear.Provideanadditionalnarrativebudgetjustificationforanyvariation
inthenumberofmodulesrequested.
NIHmayrequest(priortoaward)additionalbudgetjustificationinexceptionalcircumstances.Forfurther
information,seehttp://grants.nih.gov/grants/funding/modular/modular.htm.
NotethatAHRQdoesnotacceptmodularbudgets.
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UsingtheModularBudgetForm
TheModularBudgetFormprovidesbudgetfieldsforupto5yearsofsupport(e.g.,budgetperiods1-5).If
requestinglessthan5yearsofsupport,completeonlythoseyearsrequestedandleavetheothersblank.
NOTE:Theformallowsforuptofivebudgetperiodsfollowedbyacumulativebudgetforallbudget
periods.Thefieldsarethesameforallbudgetperiods.Thefollowinginstructionscanbeusedforeach
BudgetPeriod1
StartDate:
Entertherequested/proposedstartdateofthebudgetperiod.Usethefollowingformat:
MM/DD/YYYY.
EndDate:
Entertherequested/proposedenddateofthebudgetperiod.Usethefollowingformat:
MM/DD/YYYY.
A.DirectCosts
DirectCostlessConsortiumIndirect(F&A):
EntertheamountofDirectCosts,lessactualconsortiumindirect(F&A)costsforthisbudget
period.Thisfiguremustbein$25,000increments,anditmaynotexceed$250,000.Any
consortiumindirect(F&A)costsareexcludedfromthisfigure.Thisfieldisrequired.
ConsortiumIndirect(F&A):
Ifthisprojectinvolvesaconsortium,entertheactualconsortiumindirect(F&A)costsforthis
budgetperiod.Ifthisprojectdoesnotinvolveaconsortium,leaveblank.
TotalDirectCosts:
Thisfieldauto-calculates.
B.Indirect(F&A)Costs
Indirect(F&A)Type:
Indicatethetypeofbase(forexample,Salary&Wages,ModifiedTotalDirectCosts,Other
[explain]),andindicateifOff-site.Ifmorethanonerate/baseisinvolved,useseparatelinesfor
each.Ifyoudonothaveacurrentindirect(F&A)rate(s)approvedbyaFederalagency,indicate,
Nonewillnegotiateandincludeinformationforaproposedrate.Usethebudgetjustificationif
additionalspaceisneeded.
Indirect(F&A)Rate(%):
IndicatethemostrecentIndirect(F&A)rate(s)(alsoknownasFacilities&AdministrativeCosts
[F&A])establishedwiththecognizantFederaloffice,orinthecaseoffor-profitorganizations,
therate(s)establishedwiththeappropriateagency.Ifyouhaveacognizant/oversightagency
andareselectedforanaward,youmustsubmityourindirectrateproposaltothatofficefor
approval.Ifyoudonothaveacognizant/oversightagency,contacttheawardingagency.
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Indirect(F&A)Base($):
Entertheamountofthebaseforeachindirect(F&A)type.
FundsRequested($):
Enterfundsrequestedforeachindirectcosttype.
Onceyouhaveenteredallrequiredinformationforindirect(F&A)costs,presstheAdd
AdditionalIndirectCostbuttontoenterinformationforanadditionalindirectcost.Atotaloffour
indirect(F&A)costscanbeadded.
CognizantAgency(AgencyName,POCNameandPhoneNumber):
EnterthenameofthecognizantFederalAgency,name,andphonenumberoftheindividual
responsiblefornegotiatingyourrate.Ifnocognizantagencyisknown,enterNone.
Indirect(F&A)RateAgreementDate:
Ifyouhaveanegotiatedrateagreement,entertheagreementdate.
TotalIndirect(F&A)Costs:
Thisfieldauto-calculates.
C.TotalDirectandIndirect(F&A)Costs(A+B)FundsRequested($)
Thetotalfundsrequestedfordirectandindirect(F&A)costs.Thisfieldisrequired.
Onceyouhaveenteredallrequiredinformationforbudgetperiod1,presstheNextPeriodbuttonto
enterinformationforthesubsequentbudgetperiod.
CumulativeBudgetInformation
1.TotalCosts,EntireProjectPeriod
AllvaluesfortheCumulativeBudgetInformationarecalculatedautomatically.Theyequalthe
summationsoftheamountsthatyouhaveenteredpreviouslyforeachoftheindividualbudget
periods.Therefore,nodataentryisallowedorrequired,inordertocompletethisCumulativeBudget
section.
Ifanyoftheamountsdisplayedonthisformappearstobeincorrect,youmaycorrectitbyadjusting
oneormoreofthevaluesthatcontributetothattotal.Tomakeanysuchadjustments,youwillneed
torevisittheappropriatebudgetperiodform(s),toentercorrectedvalues.
2.ModularBudgetJustifications
PersonnelJustification:
Listallpersonnel,includingnames,percentofeffortandrolesontheproject.NIHandother
PHSagenciesusetheconceptofpersonmonthsasametricfordeterminingpercentofeffort.
Toassistapplicantsunfamiliarwiththisconcept,resourcesareavailableonthewebat
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http://grants.nih.gov/grants/policy/person_months_faqs.htm.Frequentlyaskedquestionsanda
conversioncalculatorareavailable.
Noindividualsalaryinformationshouldbeprovided.Sincethemodulesshouldbeareasonable
estimateofcostsallowable,allocable,andappropriatefortheproposedproject,applicantsmust
usethecurrentlegislativelyimposedsalarylimitationwhenestimatingthenumberofmodules.
Forguidanceoncurrentsalarylimitationscontactyourofficeofsponsoredprograms.
3. SuchcostsareexplicitlyincludedinthebudgetorhavepriorwrittenapprovaloftheFederal
awardingagency;and
Forallindividualsclassifiedassecretarial/clerical,inadditiontothename,percenteffortand
role,provideajustificationdocumentinghowtheymeetallfourconditions.NIHICsmay
requestadditionalinformationforthesepositionsinordertoassessallowability.
wages,fringebenefitsandtuitionremission.Thislimitshouldalsobeusedwhenestimatingthe
numberofmodules.See:http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html
Savetheinformationinasinglefileandclicktheaddattachmentbuttontocompletethisentry
ConsortiumJustification:
Provideanestimateoftotalcosts(directplusFacilitiesandAdministrative)foreachyear,
roundedtothenearest$1,000.Listtheindividuals/organizationswithwhomconsortiumor
contractualarrangementshavebeenmade.Listallpersonnel,includingpercentofeffort,using
themetricofpersonmonths,androlesontheproject.Noindividualsalaryinformationshouldbe
provided.Indicatewhetherthecollaboratinginstitutionisforeignordomestic.Whileonlythe
directcostforaconsortium/contractualarrangementisfactoredintoeligibilityforusingthe
modularbudgetformat,thetotalconsortium/contractualcostsmustbeincludedintheoverall
requestedmodulardirectcostamount.
AttachthisinformationasaPDFfile.
AdditionalNarrativeJustification:
Iftherequestedbudgetrequiresanyadditionaljustification;e.g,variationsinthenumberof
modulesrequested,savetheinformationinasinglefileandclicktheaddattachmentbuttonto
completethisentry.
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R.400-PHS398ResearchPlanForm
ThePHS398ResearchPlanformisusedonlyforResearch,
Multi-Project,andSBIR/STTRapplications.Thisform
includesfieldstouploadseveralattachments,includingthe
specificaimsandresearchstrategy.
TheResearchPlanshouldincludesufficientinformation
neededforevaluationoftheproject,independentofanyother
document(e.g.,previousapplication).Bespecificand
informative,andavoidredundancies.
Viewlargerimage
QuickLinks
- Introduction
- ResearchPlanSection
- HumanSubjectsSection
- OtherResearchPlanSection
- Appendix
Applicantsmustfollowallpoliciesandrequirementsrelatedtoproprietaryinformation,pagelimits
andformatting.Seethefollowingpagesformoreinformation:
l ProprietaryInformation:Sections2.3.11.2and2.3.11.2.2oftheNIHGrantsPolicy
Statement
l PageLimits:http://grants.nih.gov/grants/forms_page_limits.htm
l FormattingAttachments:http://grants.nih.gov/grants/how-to-apply-applicationguide/format-and-write/format-attachments.htm
Introduction
1.IntroductiontoApplication(forResubmissionorRevisiononly)
NIHpolicyallowsathirty-sevenmonthwindowforresubmissions(A1applications).TheNIHwillnot
acceptaresubmission(A1)applicationthatissubmittedlaterthan37monthsaftersubmissionofthe
new(A0)applicationthatitfollows.SeeNIHNoticeNOT-OD-12-128andNOT-OD-14-074for
additionalinformation/clarificationofNIHpolicy.
RequiredonlyifTypeofApplicationisResubmissionorRevision.Seespecificinstructionsonthe
contentoftheintroductionathttp://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-
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apply-and-register/type-of-application-submission.htm.Firsttime(new)applicationsshouldnot
includeanIntroductionunlessspecifiedintheFOA.
FollowthepagelimitsfortheIntroductionintheTableofPagelimitsat
http://grants.nih.gov/grants/forms_page_limits.htmunlessotherwisespecifiedintheFOA.
ResearchPlanSection
2.SpecificAims
Stateconciselythegoalsoftheproposedresearchandsummarizetheexpectedoutcome(s),
includingtheimpactthattheresultsoftheproposedresearchwillexertontheresearchfield(s)
involved.
Listsuccinctlythespecificobjectivesoftheresearchproposed,e.g.,totestastatedhypothesis,
createanoveldesign,solveaspecificproblem,challengeanexistingparadigmorclinicalpractice,
addressacriticalbarriertoprogressinthefield,ordevelopnewtechnology.
TheSpecificAimsattachmentisrequiredunlessotherwisespecifiedintheFOA.Followthepage
limitsfortheSpecificAimsintheTableofPagelimitsathttp://grants.nih.gov/grants/forms_page_
limits.htmunlessspecifiedotherwiseintheFOA.
3.ResearchStrategy
Thisattachmentisrequired.FollowthepagelimitsfortheResearchPlan,unlessspecifiedotherwise
intheFOA.
OrganizetheResearchStrategyinthespecifiedorderandusingtheinstructionsprovidedbelow,or
asstatedintheFundingOpportunityAnnouncement.Starteachsectionwiththeappropriatesection
headingSignificance,Innovation,Approach.CitepublishedexperimentaldetailsintheResearch
StrategysectionandprovidethefullreferenceinSectionR.220-R&ROtherProjectInformation
Form,BibliographyandReferenceCited.
FollowthepagelimitsfortheResearchStrategyinthetableofpagelimits
http://grants.nih.gov/grants/forms_page_limits.htm,unlessspecifiedotherwiseintheFOA.Note
thatthepagelimitforthisattachmentwillbevalidatedasasinglefile.
1.Significance
l Explaintheimportanceoftheproblemorcriticalbarriertoprogressinthefieldthatthe
proposedprojectaddresses.
l Describethescientificpremisefortheproposedproject,includingconsiderationofthe
strengthsandweaknessesofpublishedresearchorpreliminarydatacrucialtothesupportof
yourapplication.
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l Explainhowtheproposedprojectwillimprovescientificknowledge,technicalcapability,
and/orclinicalpracticeinoneormorebroadfields.
Describeoftheconcepts,methods,technologies,treatments,services,or
preventativeinterventionsthatdrivethisfieldwillbechangediftheproposedaimsare
achieved.
2.Innovation
l Explainhowtheapplicationchallengesandseekstoshiftcurrentresearchorclinical
practiceparadigms.
l Describeanynoveltheoreticalconcepts,approachesormethodologies,instrumentationor
interventionstobedevelopedorused,andanyadvantageoverexistingmethodologies,
instrumentation,orinterventions.
l Explainanyrefinements,improvements,ornewapplicationsoftheoreticalconcepts,
approachesormethodologies,instrumentation,orinterventions.
3.Approach
l Describetheoverallstrategy,methodology,andanalysestobeusedtoaccomplishthe
specificaimsoftheproject.Describetheexperimentaldesignandmethodsproposedand
howtheywillachieverobustandunbiasedresults.UnlessaddressedseparatelyinItem15
(ResourceSharingPlan),includehowthedatawillbecollected,analyzed,andinterpreted
aswellasanyresourcesharingplansasappropriate.
l Discusspotentialproblems,alternativestrategies,andbenchmarksforsuccessanticipated
toachievetheaims.
l Iftheprojectisintheearlystagesofdevelopment,describeanystrategytoestablish
feasibility,andaddressthemanagementofanyhighriskaspectsoftheproposedwork.
l Explainhowrelevantbiologicalvariables,suchassex,arefactoredintoresearchdesigns
andanalysesforstudiesinvertebrateanimalsandhumans.Forexample,strongjustification
fromthescientificliterature,preliminarydata,orotherrelevantconsiderations,mustbe
providedforapplicationsproposingtostudyonlyonesex.
l Ifyourstudy(s)involveshumansubjects,thesectionsontheInclusionofWomenand
MinoritiesandInclusionofChildrencanbeusedtoexpandyourdiscussiononinclusionand
justifytheproposedproportionsofindividuals(suchasmalesandfemales)inthesample,
butitmustalsobeaddressedhereintheApproachsection.
l PleaserefertoNOT-OD-15-102forfurtherconsiderationofNIHexpectationsaboutsexasa
biologicalvariable.
l Pointoutanyprocedures,situations,ormaterialsthatmaybehazardoustopersonneland
precautionstobeexercised.Afulldiscussionontheuseofselectagentsshouldappearin
Item5,below.
l IfresearchonHumanEmbryonicStemCells(hESCs)isproposedbutanapprovedcellline
fromtheNIHhESCRegistrycannotbeidentified,provideastrongjustificationforwhyan
appropriatecelllinecannotbechosenfromtheRegistryatthistime.
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IfanapplicanthasmultipleSpecificAims,thentheapplicantmayaddressSignificance,Innovation
andApproachforeachSpecificAimindividually,ormayaddressSignificance,Innovationand
ApproachforalloftheSpecificAimscollectively.
Asapplicable,alsoincludethefollowinginformationaspartoftheResearchStrategy,
keepingwithinthethreesectionslistedabove:Significance,Innovation,andApproach.
PreliminaryStudiesforNewApplications:
Fornewapplications,includeinformationonPreliminaryStudies.DiscussthePD/PIspreliminary
studies,data,andorexperiencepertinenttothisapplication.ExceptforExploratory/Developmental
Grants(R21/R33),SmallResearchGrants(R03),andAcademicResearchEnhancementAward
(AREA)Grants(R15),preliminarydatacanbeanessentialpartofaresearchgrantapplicationand
helptoestablishthelikelihoodofsuccessoftheproposedproject.EarlyStageInvestigatorsshould
includepreliminarydata.
ProgressReportforRenewalandRevisionApplications.
Forrenewal/revisionapplications,provideaProgressReport.Providethebeginningandendingdates
fortheperiodcoveredsincethelastcompetitivereview.Summarizethespecificaimsoftheprevious
projectperiodandtheimportanceofthefindings,andemphasizetheprogressmadetowardtheir
achievement.Explainanysignificantchangestothespecificaimsandanynewdirectionsincluding
changestothespecificaimsandanynewdirectionsincludingchangesresultingfromsignificant
budgetreductions.ForanystudiesmeetingtheNIHdefinitionforclinicalresearch,discussprevious
participantenrollment(e.g.,recruitment,retention,inclusionofwomen,minorities,childrenetc.)as
partoftheprogressreport,particularlyifrelevanttostudiesproposedintherenewalorrevision
application.YoushouldnotsubmitaPHSInclusionEnrollmentReportformunlesstheenrollmentis
partofneworongoingstudiesintherenewalorrevisionapplication.
Alistofpublications,patents,andotherprintedmaterialsshouldbeincludedintheProgressReport
PublicationListattachment;donotincludethatinformationhere.
4.ProgressReportPublicationList(RenewalApplicationsOnly)
Listthetitlesandcompletereferencestoallappropriatepublications,manuscriptsacceptedfor
publication,patents,andotherprintedmaterialsthathaveresultedfromtheprojectsinceitwaslast
reviewedcompetitively.WhencitingarticlesthatfallunderthePublicAccessPolicy,wereauthored
orco-authoredbytheapplicantandarosefromNIHsupport,orarosefromAHRQfundingprovided
after2/19/16(seehttps://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-008.html),providethe
NIHManuscriptSubmissionreferencenumber(e.g.,NIHMS97531)orthePubMedCentral(PMC)
referencenumber(e.g.,PMCID234567)foreacharticle.IfthePMCIDisnotyetavailablebecause
theJournalsubmitsarticlesdirectlytoPMConbehalfoftheirauthors,indicatePMCJournalIn
Process.Alistofthesejournalsispostedat:http://publicaccess.nih.gov/submit_process_
journals.htm.
CitationsthatarenotcoveredbythePublicAccessPolicy,butarepubliclyavailableinafree,online
formatmayincludeURLsorPubMedID(PMID)numbersalongwiththefullreference(notethat
copiesofthesepublicationsarenotacceptedasappendixmaterial.
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HumanSubjectsSection
5.ProtectionofHumanSubjects
RefertoSupplementalInstructions,PartIISection4.1.
CompletethissectionifyouansweredyestothequestionArehumansubjectsinvolved?onthe
SectionR.220-R&ROtherProjectInformationform.IftheanswerisNotothequestionbutyour
proposedresearchinvolveshumanspecimensand/ordatafromsubjectsyoumustprovidea
justificationinthissectionforyourclaimthatnohumansubjectsareinvolved.Followtheinstructions
providedintheApplicationGuideandtheFOAregardingtheProtectionofHumanSubject
attachment.
DonotusetheprotectionofhumansubjectssectiontocircumventthepagelimitsoftheResearch
Strategy.
6.DataSafetyMonitoringPlan
RefertoSupplementalInstructions,PartIISection4.1.5
CompletethissectionifyouansweredyestoItem1,ClinicalTrialoftheSectionR.210-PHS398
CoverPageSupplementalForm.
7.InclusionofWomenandMinorities
RefertoSupplementalInstructions,PartII.Thissectionisrequiredforapplicantsansweringyesto
thequestionArehumansubjectsinvolved?ontheSectionR.200-R&ROtherProjectInformation
formandtheresearchdoesnotfallunderExemption4.
Also,pleaserefertoSectionR.500-PHSInclusionEnrollmentReportoftheseinstructionsaswell
astheSupplementalInstructions,PartII(Section4.2,4.3,and5.6)formoreinformationonsubmitting
PHSInclusionEnrollmentReportformaspartofyourapplication.
8.InclusionofChildren
RefertoSupplementalInstructions,PartII(Section4.4and5.8).
ThissectionisrequiredforapplicantsansweringyestothequestionArehumansubjects
involved?ontheSectionR.200-R&ROtherProjectInformationformandtheresearchdoesnotfall
underExemption4.
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OtherResearchPlanSection
9.VertebrateAnimals
CompletethissectionifyouansweredyestothequestionAreVertebrateAnimalsUsed?onthe
SectionR.200-R&ROtherProjectInformationform.
IfVertebrateAnimalsareinvolvedintheproject,addresseachofthefollowingcriterialistedbelow.
1. DescriptionofProcedures.Provideaconcisedescriptionoftheproposedprocedurestobe
usedthatinvolvevertebrateanimalsintheworkoutlinedintheResearchStrategysection.
Identifythespecies,strains,ages,sex,andtotalnumbersofanimalsbyspecies,tobeused
intheproposedwork.Ifdogsorcatsareproposedprovidethesourceoftheanimals.
2. Justifications:Providejustificationthatthespeciesareappropriatefortheproposedresearch.
Explainwhytheresearchgoalscannotbeaccomplishedusinganalternativemodel(e.g.
computational,human,invertebrate,invitro).
3. MinimizationofPainandDistress:Describetheinterventionsincludinganalgesia,
anesthesia,sedation,palliativecareandhumaneendpointstominimizediscomfort,distress,
pain,andinjury.
Foradditionalinformation,seehttp://grants.nih.gov/grants/olaw/VASchecklist.pdf.Donotusethe
VertebrateAnimalssectiontocircumventthepagelimitsoftheResearchStrategy.
Provideaconcise,completedescriptionoftheanimalsandproposedprocedures.
l Theresponsestothecriteriabelowmustbewell-integratedwiththeothersections.There
shouldbesufficientdetailintheresponsesforpeerreviewersandNIHstafftoevaluate.
Additionaldetails,ifany,maybeincludedintheResearchStrategy.
l Identifyallproject/performanceorcollaboratingsite(s)anddescribeactivitiesofproposed
researchwithvertebrateanimalsinthosesites.
l Anincompleteapplicationwillnotbeconsideredforreview.Itwillbeconsideredincomplete
iftheabovecriteriaarenotaddressed.
l Ifplansfortheuseofanimalshavenotbeenfinalized,explainwhenandhowanimalsare
expectedtobeused.
l Ifanawardismade,thegranteemustprovidedetailedinformationonthecriteriaabove,and
verificationofIACUCapproval.ThesemustbesubmittedtotheNIHawardingofficepriorto
theinvolvementofanimals.
AnapplicableAnimalWelfareAssurancewillberequiredifthegranteeinstitutiondoesnothave
one(seeSupplementalInstructions,PartIIISection2.2formoreinformation).
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10.SelectAgentResearch
SelectagentsarehazardousbiologicalagentsandtoxinsthathavebeenidentifiedbyHHSorUSDA
ashavingthepotentialtoposeaseverethreattopublichealthandsafety,toanimalandplanthealth,
ortoanimalandplantproducts.CDCandtheAnimalAPHISSelectAgentProgramsjointlymaintain
alistoftheseagents.Seehttp://www.selectagents.gov/.
Iftheactivitiesproposedintheapplicationinvolveonlytheuseofastrain(s)ofselectagentswhich
hasbeenexcludedfromthelistofselectagentsandtoxinsasper42CFR73.3,theselectagent
requirementsdonotapply.Usethissectiontoidentifythestrain(s)oftheselectagentthatwillbe
usedandnotethatithasbeenexcludedfromthislist.TheCDCmaintainsalistofexclusions,which
isavailableathttp://www.selectagents.gov/SelectAgentsandToxinsExclusions.html.
Ifthestrain(s)isnotcurrentlyexcludedfromthelistofselectagentsandtoxinsbutyouhaveapplied
orintendtoapplytoHHSforanexclusionfromthelist,usethissectiontoindicatethestatusofyour
requestoryourintenttoapplyforanexclusionandprovideabriefjustificationfortheexclusion.
Ifanyoftheactivitiesproposedinyourapplicationinvolvetheuseofselectagentsatanytimeduring
theproposedprojectperiod,eitherattheapplicantorganizationoratanyotherperformancesite,
addressthefollowingthreepointsforeachsiteatwhichselectagentresearchwilltakeplace.
Althoughnospecificpagelimitationappliestothissection,besuccinct.
1. Identifytheselectagent(s)tobeusedintheproposedresearch.
2. Providetheregistrationstatusofallentities*whereselectagent(s)willbeused.
l Iftheperformancesite(s)isaforeigninstitution,providethename(s)ofthe
countryorcountrieswhereselectagentresearchwillbeperformed.
l *Anentityisdefinedin42CFR73.1asanygovernmentagency(Federal,
State,orlocal),academicinstitution,corporation,company,partnership,
society,association,firm,soleproprietorship,orotherlegalentity.
3. Provideadescriptionofallfacilitieswheretheselectagent(s)willbeused.
l Describetheproceduresthatwillbeusedtomonitorpossession,useandtransferofselect
agent(s).
l Describeplansforappropriatebiosafety,biocontainment,andsecurityoftheselectagent
(s).
l Describethebiocontainmentresourcesavailableatallperformancesites.
Ifyouarerespondingtoaspecificfundingopportunityannouncement(e.g.,PAorRFA),addressany
requirementsspecifiedbytheFOA.
ReviewerswillassesstheinformationprovidedinthisSection,andanyquestionsassociatedwith
selectagentresearchwillneedtobeaddressedpriortoaward.
11.MultiplePD/PILeadershipPlan
ForapplicationsdesignatingmultiplePD/PIs,aleadershipplanmustbeincluded.Forapplications
designatingmultiplePD/PIs,allsuchindividualsmustbeassignedthePD/PIroleontheSenior/Key
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Profileform,eventhoseatorganizationsotherthantheapplicantorganization.Arationalefor
choosingamultiplePD/PIapproachshouldbedescribed.Thegovernanceandorganizational
structureoftheleadershipteamandtheresearchprojectshouldbedescribed,including
communicationplans,processformakingdecisionsonscientificdirection,andproceduresfor
resolvingconflicts.Therolesandadministrative,technical,andscientificresponsibilitiesforthe
projectorprogramshouldbedelineatedforthePD/PIsandothercollaborators.Donotsubmita
leadershipplanifyouarenotsubmittingaMultiplePD/PIapplication.
Ifbudgetallocationisplanned,thedistributionofresourcestospecificcomponentsoftheprojector
theindividualPD/PIsshouldbedelineatedintheLeadershipPlan.Intheeventofanaward,the
requestedallocationsmaybereflectedinafootnoteontheNoticeofGrantAward.
12.Consortium/ContractualArrangements
Explaintheprogrammatic,fiscal,andadministrativearrangementstobemadebetweentheapplicant
organizationandtheconsortiumorganization(s).Ifconsortium/contractualactivitiesrepresenta
significantportionoftheoverallproject,explainwhytheapplicantorganization,ratherthanthe
ultimateperformeroftheactivities,shouldbethegrantee.ThesignatureoftheAuthorized
OrganizationRepresentativeonthe(SectionR.200-SF424(R&R),Item19)signifiesthatthe
applicantandallproposedconsortiumparticipantsunderstandandagreetothefollowingstatement:
Theappropriateprogrammaticandadministrativepersonnelofeachorganizationinvolvedinthis
grantapplicationareawareoftheagencysconsortiumagreementpolicyandarepreparedto
establishthenecessaryinter-organizationalagreement(s)consistentwiththatpolicy.
13.LettersofSupport(e.g.,Consultants)
Attachallappropriatelettersofsupport,includinganylettersnecessarytodemonstratethesupportof
consortiumparticipantsandcollaboratorssuchasSenior/KeyPersonnelandOtherSignificant
Contributorsincludedinthegrantapplication.Lettersarenotrequiredforpersonnel(suchasresearch
assistants)notcontributinginasubstantive,measurablewaytothescientificdevelopmentor
executionoftheproject.Lettersshouldstipulateexpectationsforco-authorship,andwhethercell
lines,samplesorotherresourcespromisedintheletterarefreelyavailabletootherinvestigatorsin
thescientificcommunityorwillbeprovidedtotheparticularinvestigatorsonly.Forconsultants,
lettersshouldincluderate/chargeforconsultingservicesandlevelofeffort/numberofhoursperyear
anticipated.Inaddition,lettersensuringaccesstocorefacilitiesandresourcesshouldstipulate
whetheraccesswillbeprovidedasafee-for-service.DonotplacetheselettersintheAppendix.
ConsultantbiographicalsketchesshouldbeintheBiographicalSketchsection.
14.ResourceSharingPlan(s)
NIHconsidersthesharingofuniqueresearchresourcesdevelopedthroughNIH-sponsoredresearch
animportantmeanstoenhancethevalueandfurthertheadvancementoftheresearch.When
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resourceshavebeendevelopedwithNIHfundsandtheassociatedresearchfindingspublishedor
providedtoNIH,itisimportantthattheybemadereadilyavailableforresearchpurposestoqualified
individualswithinthescientificcommunity.SeeSupplementalInstructions,PartIII1.5.
Note:ForproposedstudiesgeneratinghumangenomicdataunderthescopeoftheGDSPolicy,an
InstitutionalCertificationmaybesubmittedatthetimeofapplicationsubmission,butitisnotrequired
atthattime;theInstitutionalCertificationhowever,willberequestedasJust-in-Time(JIT)
informationpriortoaward.TheInstitutionalCertification,orinsomecases,aProvisionalInstitutional
Certification,mustbesubmittedandacceptedbeforetheawardcanbeissued.
15.AuthenticationofKeyBiologicaland/orChemicalResources
Ifapplicabletotheproposedscience,brieflydescribemethodstoensuretheidentityandvalidityof
keybiologicaland/orchemicalresourcesusedintheproposedstudies.Nomorethanonepageis
suggested.
l Keybiologicaland/orchemicalresourcesmayormaynotbegeneratedwithNIHfundsand:
1)maydifferfromlaboratorytolaboratoryorovertime;2)mayhavequalitiesand/or
qualificationsthatcouldinfluencetheresearchdata;and3)areintegraltotheproposed
research.Theseinclude,butarenotlimitedto,celllines,specialtychemicals,antibodies,
andotherbiologics.
l Standardlaboratoryreagentsthatarenotexpectedtovarydonotneedtobeincludedinthe
plan.Examplesarebuffersandothercommonbiologicalsorchemicals.
ReviewerswillassesstheinformationprovidedinthisSection.Anyreviewerquestionsassociated
withkeybiologicaland/orchemicalresourceauthenticationwillneedtobeaddressedpriortoaward.
Applicationsidentifiedasnon-compliantwiththislimitationwillbewithdrawnfromthereviewprocess
(seeNOT-OD-15-095andNOT-OD-16-011).
Appendix
16.Appendix
Amaximumof10PDFattachmentsisallowedintheappendix.Ifmorethan10appendix
attachmentsareneeded,combinetheremaininginformationintoattachment#10.Notethatthisis
thetotalnumberofappendixitems,notthetotalnumberofpublications.
DonotusetheappendixtocircumventthepagelimitsoftheresearchStrategyoranyothersectionof
theapplicationforwhichapagelimitapplies.Foradditionalinformationregardingappendixmaterial
andpagelimits,pleaserefertoNOT-OD-11-080.
Usefilenamesforattachmentsthataredescriptiveofthecontent.Asummarysheetlistingallofthe
itemsincludedintheappendixisalsoencouragedbutnotrequired.Whenincludingasummarysheet,
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itshouldbeincludedinthefirstappendixattachment.Applicationsthatdonotfollowtheappendix
requirementswillnotbereviewed.
Applicationsmayincludethefollowingmaterialsintheappendix(note,however,thatsomeFOAsdo
notpermitpublications):
l PublicationsNolongerallowedasappendixmaterialsexceptinthecircumstancesnotedbelow.
Applicantsmaysubmitupto3ofthefollowingtypesofpublications:
l Manuscriptsand/orabstractsacceptedforpublicationbutnotyetpublished:Theentire
articleshouldbesubmittedasaPDFattachment.
l Manuscriptsand/orabstractspublished,butafree,online,publiclyavailablejournallinkis
notavailable:TheentirearticleshouldbesubmittedasaPDFattachment.
l Patentsdirectlyrelevanttotheproject:TheentiredocumentshouldbesubmittedasaPDF
attachment.
l Surveys,questionnaires,andotherdatacollectioninstruments;clinicalprotocols,andinformed
consentdocumentsmaybesubmittedintheappendixasnecessary
FormaterialsthatcannotbesubmittedelectronicallyormaterialsthatcannotbeconvertedtoPDF
format(e.g.,medicaldevices,prototypes,DVDs,CDs),applicantsshouldcontacttheScientific
ReviewOfficerforinstructionsfollowingnotificationofassignmentoftheapplicationtoastudy
section.Applicantsareencouragedtobeasconciseaspossibleandsubmitonlyinformation
essentialforthereviewoftheapplication.
Itemsthatmustnotbeincludedintheappendix:
l Unpublishedthesesorabstracts/manuscriptssubmitted(butnotyetaccepted)forpublication.
l Digitalphotographsorcolorimagesofgels,micrographs,etc.arenolongeracceptedasappendix
material.TheseimagesmustbeincludedintheResearchStrategyPDF.However,images
embeddedinpublicationsareallowed.
l Publicationsthatarepubliclyaccessible.Forsuchpublications,theURLorPMCsubmission
identificationnumbersalongwiththefullreferenceshouldbeincludedasappropriateinthe
BibliographyandReferencescitedsection,theProgressReportPublicationListsection,and/orthe
BiographicalSketchsection.
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R.500-PHSInclusionEnrollmentReport
ThePHSInclusionEnrollmentReportformisusedforall
applicationsinvolvingNIH-definedclinicalresearch.
Thisformisusedtoreportbothplannedandcumulative
(oractual)enrollment,anddescribesthesex/gender,
race,andethnicityofthestudyparticipants.
NOTE:ThisreportformatshouldNOTbeusedfor
collectingdatafromstudyparticipants.Toensure
properperformanceoftheform,pleasesave
frequently.
Seebelowfortheformsdescriptionsandpleasereferto
SupplementalInstructions,PartIISection4.3for
additionalguidanceonhowandwhentousethePHSInclusionEnrollmentReport.
Viewlargerimage
StudyTitle:
Enterauniquetitlethatdescribesthestudythattheparticipantswillbeinvolvedin.Ifthereismore
thanonestudy,provideaseparateStudyTitleforeach.Followtheinstructionsprovidedinthe
ApplicationGuideandtheFOAregardingtheInclusionofWomenandMinorities.Maximum250
characters.Thisisarequiredfield.
Delayedonsetstudy?
Selectwhetherthestudyisconsidereddelayedonset.Thisgenerallymeansthatastudyhasnot
beendevelopedandcannotbedescribedintermsofhumansubjectsprotectionsandinclusion.This
doesNOTapplytoastudythatcanbedescribedbutwillnotstartimmediately.Additionalguidance
onwhetherastudymeetsthecriteriatobeconsidereddelayedonsetcanbefoundinSection2,
ScenarioDoftheSupplementalInstructions,PartII.Ifthestudyisdelayedonset,selectYES.Ifthe
studyisnotdelayedonset,selectNO.Thisisarequiredfield.
Ifyouhaveanswered"No"todelayedonset,youmustanswerthefollowingandcompletethe
enrollmenttable:
EnrollmentType:
SelectwhetherthetablereflectsPlannedEnrollmentofindividualstoberecruitedintothestudy
orCumulative(e.g.,actual)Enrollmentfor1)participantsalreadyrecruitedintothestudyor2)
studiesusinganexistingdatasetorresource.Thisisarequiredfield.
Usinganexistingdatasetorresource?
Selectwhetherthisstudyinvolvesuseofanexistingdatasetorresource.Thisgenerallymeans
thatinvestigatorsareutilizingdatafromapreviousstudyordatabank.DoNOTanswerYesfor
individualspreviouslyrecruitedspecificallyforthisstudy.Foradditionalguidanceonwhatis
consideredanexistingdatasetrefertoSupplementalInstructions,PartIISection4.2andthis
FAQ.Thisisarequiredfield.
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EnrollmentLocation:
SelectwhethertheparticipantsdescribedintheinclusionenrollmentreportarebasedataUSor
non-USsite.Ataminimum,participantsatUSandnon-USsitesmustbereportedseparately
evenifforthesamestudy.Foradditionalguidanceonworkingwithnon-USpopulationsreferto
thisFAQ.Thisisarequiredfield.
ClinicalTrial:
Selectwhetherthestudytheseparticipantsareinvolvedinisconsideredaclinicaltrial.Thisisa
requiredfield.
Agency-DefinedPhaseIIIClinicalTrial:
Selectwhetherthestudyisanagency-definedPhaseIIIclinicaltrial.Thisisarequiredfield.
Comments:
EnterinformationyouwishtoprovideaboutthisPHSInclusionEnrollmentreport.Thisincludes
butisnotlimitedtoaddressinginformationaboutdistinctivesubpopulationsifrelevanttothe
scientifichypothesesbeingstudiedand/orastudythatwillhaveadelayedonset.Maximum500
characters.
RacialCategories:
AmericanIndian/AlaskaNative:
Entertheexpectednumberoffemalesandmales(intherespectivefields)whoareAmerican
Indian/AlaskaNativeandNotHispanicorLatino,and;entertheexpectednumberoffemalesand
males(intherespectivefields)whoareAmericanIndian/AlaskaNativeandHispanicorLatino.
Unknown/notreportedfieldswillonlybeusedwhenreportingactualenrollmentonEnrollmentType
Cumulative.Thesearerequiredfields.
Asian:
Entertheexpectednumberoffemalesandmales(intherespectivefields)whoareAsianandNot
HispanicorLatino,and;entertheexpectednumberoffemalesandmales(intherespectivefields)
whoareAsianandHispanicorLatino.Unknown/notreportedfieldswillonlybeusedwhenreporting
actualenrollmentonEnrollmentTypeCumulative.Thesearerequiredfields.
NativeHawaiianorOtherPacificIslander:
Entertheexpectednumberoffemalesandmales(intherespectivefields)whoareNativeHawaiian
orOtherPacificIslanderandNotHispanicorLatino,and;entertheexpectednumberoffemalesand
males(intherespectivefields)whoareNativeHawaiianorOtherPacificIslanderandHispanicor
Latino.Unknown/notreportedfieldswillonlybeusedwhenreportingactualenrollmentonEnrollment
TypeCumulative.Thesearerequiredfields.
BlackorAfricanAmerican:
Entertheexpectednumberoffemalesandmales(intherespectivefields)whoareBlackorAfrican
AmericanandNotHispanicorLatino,and;Entertheexpectednumberoffemalesandmales(inthe
respectivefields)whoareBlackorAfricanAmericanandHispanicorLatino.Unknown/notreported
fieldswillonlybeusedwhenreportingactualenrollmentonEnrollmentTypeCumulative.Theseare
requiredfields.
White:
Entertheexpectednumberoffemalesandmales(intherespectivefields)whoareWhiteandNot
HispanicorLatino,and;entertheexpectednumberoffemalesandmales(intherespectivefields)
whoareWhiteandHispanicorLatino.Unknown/notreportedfieldswillonlybeusedwhenreporting
actualenrollmentonEnrollmentTypeCumulative.Thesearerequiredfields.
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MorethanOneRace:
Entertheexpectednumberoffemalesandmales(intherespectivefields)whoidentifywithmore
thanoneracialcategoryandareNotHispanicorLatino,and;entertheexpectednumberoffemales
andmales(intherespectivefields)whoidentifywithmorethanoneracialcategoryandareHispanic
orLatino.Unknown/notreportedfieldswillonlybeusedwhenreportingactualenrollmenton
EnrollmentTypeCumulative.Thesearerequiredfields.
UnknownorNotReported:
Enterthenumberoffemales,males,andindividualsofunknown/notreportedsex/gender(inthe
respectivefields)whoseraceisunknown/notreportedandwhoareNotHispanicorLatino,and;enter
thenumberoffemales,males,andindividualsofunknown/notreportedsex/gender(intherespective
fields)whoseraceisunknown/notreportedandwhoareHispanicorLatino;andenterthenumberof
females,males,andindividualsofunknown/notreportedsex/gender(intherespectivefields)who
areofunknown/notreportedraceandofunknown/notreportedethnicity.Unknown/notreportedfields
willonlybeusedwhenreportingactualenrollmentonEnrollmentTypeCumulative.Theseare
requiredfields.
Total:
Thetotalfieldsatthebottomareauto-calculatedtototalallracialcategoriesforfemales,malesand
individualsofunknown/notreportedsex/genderwhoareNotHispanicorLatinoandallracial
categoriesforfemales,malesandindividualsofunknown/notreportedsex/genderwhoareHispanic
orLatino.Unknown/notreportedfieldswillonlybeusedwhenreportingactualenrollmenton
EnrollmentTypeCumulative.Thetotalfieldsattherightareauto-calculatedtototalallindividualsin
agivenracialcategory.
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R.600-PHSAssignmentRequestForm
TheoptionalAssignmentRequestFormmaybeusedto
communicatespecificapplicationassignmentandreview
requeststotheDivisionofReceiptandReferral(DRR)and
toScientificReviewOfficers(SROs).
Thisinformationwillnotbepartofyourapplication,anditwill
notbemadeavailabletoprogramstafforprovidedto
reviewers.Itisusedspecificallytoconveyadditional,
optionalinformationaboutyourpreference(s)forassignment
andreviewofyourapplicationtoDRRandSROs.
ThisinformationwaspreviouslycollectedintheCoverLetter
Attachment,butnow,thisoptionalinformationmustbe
providedontheAssignmentRequestFormandnotintheCoverLetterAttachment.
Viewlargerimage
TheDivisionofReceiptandReferral(DRR),CenterforScientificReview(CSR)isresponsiblefor
assigningapplicationstoNIHinstitutes/centers(ICs)andotherPHSagenciesforfundingconsideration.
DRRalsoassignsapplicationtoNIHscientificreviewgroups(SRGs)andspecialemphasispanels
(SEPs).
Thisformisoptionalandmaybeomittedfromyourapplicationsubmissionifyoudonotwishtomakeany
specificassignmentorreviewrequests.Thereisnorequirementthatallfieldsintheformarecompleted;
youhavetheflexibilitytoenterasinglerequestorprovideextensiveinformationusingthisform.
AwardingComponentAssignmentRequest(optional)
Thissectionoftheformisoptional.Youmayrequestuptothreeinstitutes/centersforassignmentof
yourapplication
AssigntoAwardingComponent:
EnterpreferencesforNIHICassignmentintheboxesintheAssigntorow.Usethecolumn
labeled1toenteryourfirstchoice.
DoNotAssigntoAwardingComponent:
YoumayrequestthatyourapplicationnotbeassignedtoaspecificNIHICbyenteringthat
informationintheboxesintheDoNotAssignTorow.
Inmostcases,youwillonlywanttomakeoneortworequests;thereisnoneedtomakeanentryin
allsixboxes.Thehyperlinkinthissectionoftheform(http://grants.nih.gov/grants/phs_assignment_
information.htm#AwardingComponents)willtakeyoutoawebsitewheredescriptionsofthescience
coveredbyallNIHinstitute/centerscanbefound,includinglinkstootherPHSagencyinformation.
TofacilitateaccuratecommunicationofyourrequesttoNIHreferralandreviewstaff,pleaseusethe
shortabbreviationfortherequestedNIHIC(e.g.,NCIfortheNationalCancerInstitute).W hileNIH
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staffwillseriouslyconsiderallassignmentrequests,insomecasesthelocusofreviewispredeterminedandassignmentrequestscannotbehonored.
StudySectionAssignmentRequest(optional)
Thissectionoftheformisoptional.YoumayrequestuptothreeSRGsorSEPsforassignmentof
yourapplication.
Forthissection,youwillneedtoaccuratelytypeintheshortabbreviationoftheSRG/SEPyouwish
torequest.Thehyperlinkinthissectionoftheform(http://grants.nih.gov/grants/phs_assignment_
information.htm#StudySection)willtakeyoutoasitewhereyoucanfindmoreinformationabouthow
toidentifyCSRandNIHSRGsandSEPs,includingtheirshortabbreviations.Forexample,you
wouldenterCAMPifyouwishtorequestassignmenttotheCancerMolecularPathobiologystudy
sectionorenterZRG1HDM-RifyouwishtorequestassignmenttotheHealthcareDeliveryand
MethodologiesSBIR/STTRpanelforinformatics.Becarefultoaccuratelycaptureallformatting
(e.g.,spaces,hyphens)whenyoutypeintherequest.
AssigntoStudySection:
Entertheshortabbreviations(s)forSRGs/SEPstowhichyouwouldlikeyourapplication
assignedintheAssigntorow.UseoneboxperindividualSRG/SEPrequest.Typeyourfirst
choiceinthecolumnlabeled1.
DoNotAssigntoStudySection:
IfyouwishtorequestthatyourapplicationnotbeassignedtoaparticularSRG/SEP,enterthat
informationintheboxesfoundintheDoNotAssignTorow.
Inmostcases,youwillonlywanttomakeoneortworequests;thereisnoneedtomakeanentryin
allsixboxes.
PleasenotethatwhilethemajorityofNIHresearchgrantandfellowshipapplicationsarereviewedby
theCenterforScientificReview(CSR),someareassignedtoindividualinstitute/centerreview
groupsandsomeapplicationsareclusteredforreviewinSRGS/SEPswithoutflexibilityforhonoring
reviewrequests.However,itisstandardpracticetohonorsuchrequestswheneverpossible,
dependingonexistinglocusofreviewagreementswithinNIHandotherPHSagencies.
Listindividualswhoshouldnotreviewyourapplicationandwhy(optional)
Providesufficientinformation(e.g.,name,organizationalaffiliation)sothattheSROcancorrectly
identifytheindividual,andprovidesufficientinformationsothattheSROcanconfirmaconflictof
interestforthereview.SimplystatingDr.JohnSmithisinconflictwithmyapplicationisnothelpful.
Maximum1000characters.
Identifyexpertiseneededtoreviewyourapplication(optional)
Fivefieldsareprovidedifyouwishtoidentifygeneralorspecifictypesofexpertiseneededforthe
reviewofyourapplication.Maximum40characters/field.Donotenternamesofindividualsyou
wouldliketoreviewyourapplication.
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FormScreenshots
QuickLinks
- SF424(R&R)Form
- PHS398CoverPageSupplement
- R&ROtherProjectInformationForm
- Project/PerformanceSiteLocation(s)Form
- R&RSenior/KeyPersonsProfile(Expanded)
- R&RBudgetForm
- R&RSubawardBudgetAttachment(s)Form
- PHS398ModularBudgetForm
- PHS398ResearchPlan
- PHSInclusionEnrollmentReport
- PHSAssignmentRequestForm
Form Screenshots
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SF424(R&R)Form
Form Screenshots
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Form Screenshots
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PHS398CoverPageSupplement
Form Screenshots
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Form Screenshots
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OtherProjectInformationForm
Form Screenshots
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Project/PerformanceSiteLocation(s)Form
Form Screenshots
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Senior/KeyPersonsProfile(Expanded)
Form Screenshots
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R&RBudgetForm
Form Screenshots
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Form Screenshots
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Form Screenshots
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R&RSubawardBudgetAttachment(s)Form
Form Screenshots
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PHS398ModularBudget
Form Screenshots
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PHS398ResearchPlan
Form Screenshots
R - xiv
PHSInclusionEnrollmentReport
Form Screenshots
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PHSAssignmentRequestForm
Form Screenshots
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