Category Rule# Rule Categories Validation Error Message Error/ Warning Comments Mandatory (Y/N) Shared (Y/N) Agency Specific (Lists Agencies) Form Version FOA Specific Activity Specific Lists Activity Code (Inclusion & Exclusion) Applies to Single Project, Multi Project or Both Applies to Com- ponent Type (Multi Project only) Cross (Multi Project Only) Global Validation 000.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Both Both DUNS numbers: Validation to apply to all forms containing a DUNS number present in the package downloaded. If DUNS provided on any forms has any invalid characters (meaning other than 9 or 13 numbers) after stripping of dashes, provide error. The DUNs number for <insert form name > is not in the valid format of DUNS or DUNS+4 number (DUNS should be 9 or 13 digits; no letters or special characters). E Global Validation 000.4 N N Incl : NIH, CDC, FDA, AHRQ, VA Multi Both Y For New and Renewal type of application, the number of iteration of a given component (defined by the component label in the FOA) need to match the number of iteration provided in the FOA data. The Application submitted contains more occurrences of <component type> than are allowed for this Funding Opportunity Announcement <FOA Number>. E Global Validation 000.5 N N Incl : NIH, CDC, FDA, AHRQ, VA Multi Both Y For New and Renewal type of application, the number of iteration of a given component (defined by the component label in the FOA) need to match the number of iteration provided in the FOA data. The Application submitted contains less occurrences of <component type> than are required for this Funding Opportunity Announcement <FOA Number>. E Global validation 000.6 Y N Both Both If the application schema does not match the opportunity schema, return Error The format of the application does not match the format of the Funding Opportunity Announcement (FOA). Please contact the Help E
Attachment Validations 000.20 Y N Both Both Provide error if filename is not valid. Valid file names may only include the following UTF-8 characters: A-Z, a-z, 0-9, underscore, hyphen, space, period, parenthesis, curly brackets, square brackets, tilde, exclamation point, comma, semi colon, apostrophe, at sign, number sign, dollar sign, percent sign, plus sign, and equal sign. The <attachment> attachment filename is invalid. Valid filenames may only include the following characters: A-Z, a-z, 0-9, underscore ( _ ), hyphen (-), space, period, parenthesis, curly brackets({}), square brackets, tilde, exclamation point, comma, semi colon, apostrophe, at sign, number sign, dollar sign, percent sign, plus sign and equal sign. No other special characters can be part of the filename. E Attachment Validations 000.21 N N Incl : NIH, CDC, FDA, AHRQ, VA Multi Both Y Provide error at the entire application level if a Biosketch attachment for the same Senior/Key Person is provided on multiple components on Research and Related Senior/Key Person Profile (Expanded). Senior Key Person entries will be determined to be for the same person if: Senior Key Person Profile or PD/PI Profile Credentials match. The grantor agency allows only one biosketch per Senior/Key Person to be submitted with this application. The application contains more than one biosketch for Senior/Key Person(s): <Last E
name, First name> on components <component ID>: <Component Title>, <component ID>: <Component Title>..; <Last name, First name> on components <components ID>: <Component Title>, <component ID><Component Title>... Attachment Validations 000.22 N N Incl : NIH, CDC, FDA, AHRQ, VA Multi Both Y Provide warning at the entire application level if a Biosketch attachment for the potentially same Senior/Key Person is provided on multiple components on Research and Related Senior/Key Person Profile (Expanded). The system will consider person to be potential matches if Credentials are not provided for both entries, then if Senior Key Person Profile or PD/PI Profile First Name and Last Name and Organization Name match. The grantor agency allows only one biosketch per Senior/Key Person to be submitted with this application. The application contains more than one biosketch for Senior/Key Person(s) with the same last name, first name, and organization name. Specifically: <Last name, First name>; on components <component ID>: <Component Title>, E
<component ID>: <Component Title>..; <Last name, First name> on components <components ID>: <Component Title>, <component ID><Component Title>... Attachment Validations 000.23 N N Incl : NIH, CDC, FDA, AHRQ, VA Multi Both Y Provide error if at the entire application level every unique senior key does not have at least one biosketch attachment included. A unique senior key entry is one that shares the same credential or the same first name, last name, and organization name. The grantor agency requires a biosketch attachment for each Senior/Key Person for this application. The following Senior/Key Person do not have a biosketch attachment: <Last name, First name>; on component <component ID>: <Component Title> E Attachment Validations 000.25 N N Incl : NIH, CDC, FDA, AHRQ, VA Both Both Provide error if attachments file names are not unique within a form within a component. The <attachment filename> attachment has been uploaded multiple times on the <Form name>. Please make sure all files uploaded on the <Form name> have unique file names. E
Attachment Validations 000.26 N N Incl : NIH, CDC, FDA, AHRQ, VA Both Both Provide error if any attachments filenames are missing The file attached to <attachment label> on form <form name> does not have a specified filename. Please make sure all files submitted with your application have a distinct filename. E SF 424 (R&R)
opportunity ID is not the same as that of the other application. simultaneous reviews of an application are not allowed. SF 424 Date Submitted 001.2.1 N N Incl: NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Incl: R44, U44, R42, UT2 Single If Phase II SBIR/STTR and prior grant is a Phase I is found in the database, provide warning if date submitted is more than 2 years after Phase I project period end date. Exclude Direct Phase II applications based on RFA_PA_NOTICES_T. Phase II SBIR/STTR (excluding Direct Phase II applications) submissions should be submitted within 6 receipt dates after the expiration of the Phase I budget. W SF 424 Applicant Identifier 001.3 SF 424 Date Received by State 001.4.1 SF 424 State Identifier 001.5 SF 424 Federal Identifier 001.6.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both If a resubmission, renewal or revision, this component is mandatory A Federal Identifier is required for Resubmission, Revision and Renewal applications. Include only the institute code and serial number of the prior application/grant number in the Federal Identifier field (e.g., use CA987654 extracted from full application/grant number 1R01CA987654-A1). E
VA SF 424 Agency Routing Identifier 001.7 N SF 424 Previous Grants.gov Tracking ID 001.95.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Required if Type of Submission is a Changed/Corrected Application The Previous Grants.gov Tracking ID is required if the application is marked as ‘Changed/Corrected’. E SF 424 Applicant DUNS 001.8.1 Y N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Must match the primary DUNS recorded for IPF in Commons. Validate the leftmost 9 characters only, discarding any characters submitted in places 10-13. For comparison purposes, treat trailing zeroes after leftmost 9 characters as blanks. The DUNS provided in the application does not match the DUNS in the eRA Commons Institution Profile. Make sure that the DUNS number on your application matches the DUNS number used in both Grants.gov and the eRA Commons. E SF 424 Applicant DUNS 001.8.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both For a revision, provide a warning if it doesn’t represent the same organization as the parent grant, by matching the DUNS provided against the primary DUNS recorded for the organization. The organization associated with the DUNS provided in the application does not match the organization associated with the grant identified by the Federal Identifier. Revision applications are typically submitted for the same organization as the parent grant. W SF 424 Applicant DUNS 001.8.3 Y N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Provide error if the organization is marked as ‘closed’ in IMPAC II database grant by matching the DUNS provided against the primary DUNS recorded for the organization. The organization associated with the DUNS provided is not active in eRA Commons. Make sure that the DUNS number on your application matches the DUNS number used in both Grants.gov and the eRA Commons. E
SF 424 Applicant DUNS 001.8.4 N N Incl : NIH, CDC, FDA, AHRQ, VA V 1.0 Multi Y Provide warning if application contains at least one component lead at a different organization than the Overall Organization (based on the DUNS number) and the PHS Additional Indirect Costs form is not present in the Overall component. If appropriate, you may use the PHS Additional Indirect Cost form to capture indirect costs for components led by other organizations. W SF 424 Applicant Legal Name 001.9 SF 424 Applicant 001.10 SF 424 Applicant Division 001.11 SF 424 Applicant Street 1 001.12 SF 424 Applicant Street 2 001.13 SF 424 Applicant City 001.14 SF 424 Applicant 001.15 , , , Information Information Information , , , , ,
SF 424 Applicant State 001.16.1 Y Y Incl: V 2.0 Both State is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State must be supplied for US addresses. E SF 424 Applicant State 001.16.2 Y Y Incl: V 2.0 Both If country not US, State must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State should not be provided for all countries other than the United States. E SF 424 Applicant Province 001.17.1 Y Y Incl: V 2.0 Both Province is required if country is Canada. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province must be supplied for Canadian addresses. E SF 424 Applicant Province 001.17.2 Y Y Incl: V 2.0 Both If country not Canada, Province must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province should not be provided for all countries other than Canada. E SF 424 Applicant Province 001.17.3 Y Y Incl: V 2.0 Both If Country is Canada and province name can’t be transformed, give error. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province is not a valid province name. E SF 424 Applicant Country 001.18.1 N N Incl: NIH, CDC, FDA, AHRQ, VA Incl: SC1, SC2, SC3, S10, S11, S21, S22, DP2, DP5, UP5, C06, UC6, G08, G20, K02, K05, K24, K26, Single Provide an error if country is not US The Applicant Organization for this application must be located in the US. E Update to existing rule (added DP2, DP5, UP5) Update to existing rule (added G08, G20) Information Information Information Information Information Information , , , , , ,
K01, K07, K08, K18, K22, K23, K25, K99, K99/R00, R15, UA5, T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, R50, K76, F99/K00 Update to existing rule (removed KM1) Update to Existing Update to existing( added C06, UC6 and G20) Update to existing( Added R50) December 2015 Release January 16, 2016 Release, Update to Existing Rule (added K76, F99/K00) SF 424 Applicant Country 001.18.2 N N Incl: NIH, CDC, FDA, AHRQ, VA Incl: R13, U13, R18, U18 Single Provide a warning if country is not US The type of program you are applying to is typically restricted to US applicants. Please verify eligibility in the Funding Opportunity Announcement (FOA). W SF 424 Applicant Country 001.18.3 N N Incl: VA Single For an application in response to a VA announcement, return an error if country is not US The Applicant Organization for this application must be located in the US. E Information Information
SF 424 Applicant Zip Code 001.19.1 Y Y Incl: V 2.0 Both ZIP Code is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the ZIP Code must be supplied for US addresses. E SF 424 Applicant Zip Code 001.19.2 Y Y Incl: V 2.0 Both ZIP Code must be 9 numeric digits if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, a 9 digit ZIP Code must be supplied for US addresses. E SF 424 Applicant Zip Code SF 424 Person to be Contacted, Prefix SF 424 Person to be Contacted, First Name SF 424 Person to be Contacted, Middle Name SF 424 Person to be Contacted, Last Name SF 424 Person to be Contacted, Suffix SF 424 Person to be Information Information Information
Contacted, Position/ Title SF 424 Person to be Contacted, Street 1 SF 424 Person to be Contacted, Street 2 SF 424 Person to be Contacted, City SF 424 Person to be Contacted, County/ Parish SF 424 Person to be Contacted, State 001.101.1 Y Y Incl: V 2.0 Both State is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State must be supplied for US addresses. E SF 424 Person to be Contacted, State 001.101.2 Y Y Incl: V 2.0 Both If country is not US, the State must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State should not be provided for all countries other than the United States. E SF 424 Person to be Contacted, Province 001.102.1 Y Y Incl: V 2.0 Both Province is required if country is Canada. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province must be supplied for Canadian addresses. E SF 424 Person to be 001.102.2 Y Y Incl: V 2.0 Both If country is not Canada, Province must be blank. For < Person First, Last name or Organization name, E
Contacted, Province or DUNS if Org name is not available>, the Province should not be provided for all countries other than Canada. SF 424 Person to be Contacted, Province 001.102.3 Y Y Incl: V 2.0 If Country is Canada and province name can’t be transformed, give error. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province is not a valid province name. E SF 424 Person to be Contacted, Country SF 424 Person to be Contacted, ZIP Code 001.104.1 Y Y Incl: V 2.0 Both ZIP Code is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the ZIP Code must be supplied for US addresses. E SF 424 Person to be Contacted, ZIP Code 001.104.2 Y Y Incl: V 2.0 Both ZIP Code must be 9 numeric digits if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, a 9 digit ZIP Code must be supplied for US addresses. E SF 424 Person to be Contacted, Phone Number SF 424 Person to be Contacted, Fax Number SF 424 Person to be 001.27.1 N N Incl : NIH, CDC, Incl: V 2.0 Both If e-mail is not provided, display Warning The e-mail address for the Person to Be Contacted was not included. The AOR email W
SF 424 Type of Application (New, Resub, Renewal, Contin, Revision) 001.33.3 N N Incl: VA Incl: V 2.0 Single For an application in response to a VA announcement, return an error if Type of Application is 'Revision' Revision applications may not be submitted to VA. E SF 424 Type of Application (New, Resub, Renewal, Contin, Revision) 001.33.4 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Incl: R41, UT1, R43, U43 Single Renewal is not a valid type of application for Phase I SBIR/ STTR. (Based on program type code and Phase I is indicated on the SBIR/STTR form) A renewal cannot be submitted for this application. E SF 424 Type of Application (New, Resub, Renewal, Contin, Revision) 001.33.25 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, S10, X01, R50, F99/K00 Single Revision is not a valid type of application. Revision applications are not allowed for this Funding Opportunity Announcement. E Update to existing (add S10) Update to existing (added X01) Update to Exiting (Added R50 – December 2015 Release)
January 14, 2016 Release, Update to Existing Rule (added F99/K00) SF 424 Type of Application (New, Resub, Renewal, Contin, Revision) 001.33.26 N N Incl: NIH, CDC, FDA, AHRQ VA Incl: V 2.0 Incl: DP1, DP2, DP3, DP4, DP5, UP5 Single Provide error if application type is not marked as New. A resubmission, renewal, or revision Type of Application is not allowed... E SF 424 Type of Application (New, Resub, Renewal, Contin, Revision) 001.33.27 N N Incl: NIH, CDC, FDA, AHRQ VA Incl: V 2.0 Incl: SC1 Single For SC1, provide error for a renewal if the PI has been awarded any R01 or R21 grants, whether as a single PI or as a multiple PI. The PI, <first name last name) has been awarded R01 or R21 grants in the past. SC1 applications may not be submitted if the PI has been awarded any R01 or R21 grants. E SF 424 Type of Application (New, Resub, Renewal, Contin, Revision) 001.33.28 N N Incl: NIH, CDC, FDA, AHRQ VA Incl: V 2.0 Incl: SC1 Single For an SC1 application, provide error for a renewal if there has already been an awarded renewal for this grant. Only one renewal is allowed for an SC1. E SF 424 Type of Application (New, Resub, Renewal, Contin, Revision) 001.33.29 N N Incl: NIH, CDC, FDA, AHRQ VA Incl: V 2.0 Single For FOA with activity code is 333/666/777 application must be Revision <Type of Application> provided in the SF424 RR Cover is invalid. The Type of Application must be Revision. E
SF 424 Type of Application (New, Resub, Renewal, Contin, Revision) 001.33.30 N N Incl: NIH, CDC, FDA, AHRQ VA Incl: V 2.0 Incl: SB1, UB1 Single For an SB1 or UB1 application, provide error if the submission is not Renewal, Resubmission, or revision. Commercialization Readiness Phase (SB1/UB1) have to be submitted as Renewal, Resubmission, or Revision. E SF 424 Type of Application Revision Code description SF 424 Type of Application Revision Code Other SF 424 Submitted to other agencies? SF 424 Submitted to other agencies? (Y/N) SF 424 Submitted to other agencies? Name of agencies 001.36.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Required if Submitted to Other Agencies is 'Yes'. The name of the Other Agency is required if the Submit to Other Agency selection is ‘Yes’. E SF 424 Name of Federal Agency SF 424 Catalog of Federal
Domestic Assistance Number SF 424 Descriptive Title 001.40 SF 424 Proposed project start date 001.41.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Must be later than current date The Proposed Project Start Date) must be later than today's date. E SF 424 Proposed project ending date 001.42.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Must be later than Project Start Date The Proposed Project Ending must be later than the Proposed Project Start Date. E SF 424 Proposed project ending date 001.42.2 N N Incl: NIH Incl: V 2.0 Both Must be no more than 20 years greater than today’s date. The Proposed Project Ending Date cannot be more than 20 years in the future. E SF 424 Proposed project ending date 001.42.3 N N Incl: NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 = N Incl: R03, R21, R36, UH2 Single Project Provide error if project period is more than two years long. The project period for this type of application is limited to two years. E SF 424 Proposed project ending date 001.42.8 N N Incl: NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 = Y Incl: R03, R21, R36, UH2 Single Project Provide warning if project period is more than two years long. Be sure that you have complied with the allowable project period limitations for this FOA. Applications that do not comply with these instructions may be delayed or not accepted for review. W
name ( first name,) FDA, AHRQ, VA recognized), provide warning if last name and first name on account doesn’t match provided last name and first name. Comparison to ignore case and embedded spaces, but not embedded punctuation. listed on the eRA Commons account: <First name last name>. The application image will display the name as submitted here. If the name listed in the eRA Commons is not current, please update it in the eRA Commons. Instructions on updating profile information are available at SF 424 PD/PI Contact name (middle name) 001.46 SF 424 PD/PI Contact name (Last name) 001.47 SF 424 PD/PI Contact name (suffix) 001.48.1 SF 424 PD/PI Contact 001.49 SF 424 PD/PI Contact 001.49 Information Information Information Information Information
SF 424 PD/PI Contact Name 001.50 SF 424 PD/PI Contact 001.51 SF 424 PD/PI Contact Division 001.52 SF 424 PD/PI Contact Street 1 001.53 SF 424 PD/PI Contact Street 2 001.54 SF 424 PD/PI Contact City 001.55 SF 424 PD/PI Contact 001.56 SF 424 PD/PI Contact state 001.57.2 Y Y Incl: V 2.0 Both State is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not E Information Information Information Information Information Information Information Information
available>, the State must be supplied for US addresses. SF 424 PD/PI Contact state 001.57.3 Y Y Incl: V 2.0 Both If country not US, State must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State should not be provided for all countries other than the United States. E SF 424 PD/PI Contact province 001.58.1 Y Y Incl: V 2.0 Both If Country is Canada and province name can’t be transformed, give an error. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province is not a valid province name. E SF 424 PD/PI Contact province 001.58.2 Y Y Incl: V 2.0 Both Province is required if country is Canada. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province must be supplied for Canadian addresses. E SF 424 PD/PI Contact province 001.58.3 Y Y Incl: V 2.0 Both If country not Canada, Province must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province should not be provided for all countries other than Canada. E SF 424 PD/PI Contact country SF 424 PD/PI Contact ZIP/Postal Code 001.60.1 Y Y Incl: V 2.0 Both ZIP Code is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the ZIP Code must be supplied for US addresses. E Information Information Information Information Information Information
SF 424 PD/PI Contact ZIP/Postal Code 001.60.2 Y Y Incl: V 2.0 Both ZIP Code must be 9 numeric digits if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, a 9 digit ZIP Code must be supplied for US addresses. E SF 424 PD/PI Contact phone number SF 424 PD/PI Contact fax number SF 424 PD/PI Contact email 001.63.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Must contain a ‘@’, with at least 1 and at most 64 chars preceding and following the ‘@’. Control characters (ASCII 0 through 31 and 127), spaces and special chars < > ( ) [ ] \ ; : are not valid. The submitted e-mail address for the PD/PI {0}, is invalid. E SF 424 Total Federal Funds Requested 001.64.1 N N Incl : NIH, CDC, FDA, AHRQ, Incl: V 2.0 Incl: S10 Single Provide warning if Total Federal Funds Requested is equal to or more than 500K. Note: Exclude RFAs Total Federal Funds Requests of $500K or more need agreement to accept assignment from Institute/Center staff, except for RFAs or Pas with budgetary limits. Applications may be delayed or not accepted for review. W May 2016 Release SF 424 Total Federal Funds Requested 001.64.2 N N Incl : NIH, CDC, FDA, AHRQ, Incl: V 2.0 Incl: X01, Single Provide Error if non-zero values are entered in Total Federal Funds Requested The Total Federal Funds Requested in the Estimated Project Funding section must be zero. E Information Information Information Information
SF 424 State executive order review date 001.69.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Required if answer to ‘Subject to state executive order review’ is ‘Yes’ A State executive order review date must be entered, if the answer to the ‘Subject to state executive order review’ is ‘Yes’. E SF 424 Agreement and certification 001.70 SF 424 SFLLL or Other Attachment 001.71 SF 424 Authorized prefix 001.72.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Display warning if first or last name>30 chars, or if suffix>5 chars. The Authorized Representative <element name> (SF 424 RR Cover page) exceeds the agency character limit. The application image will display the name as submitted; the agency will store the first <database length> characters in the eRA database. W SF 424 Authorized first name 001.73 SF 424 Authorized middle name 001.74 SF 424 Authorized last name 001.75
SF 424 Authorized suffix 001.76.1 SF 424 Authorized 001.77 SF 424 Authorized 001.78 SF 424 Authorized department 001.79 SF 424 Authorized division 001.80 SF 424 Authorized street 1 001.81 SF 424 Authorized street 2 001.82 SF 424 Authorized city 001.83 SF 424 Authorized 001.84
SF 424 Authorized state 001.85.2 Y Y Incl: V 2.0 Both State is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State must be supplied for US addresses. E SF 424 Authorized state 001.85.3 Y Y Incl: V 2.0 Both If country not US, state must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State should not be provided for all countries other than the United States. E SF 424 Authorized province 001.86.1 Y Y Incl: V 2.0 Both If Country is Canada and province name can’t be transformed, give error. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province is not a valid province name. E SF 424 Authorized province 001.86.2 Y Y Incl: V 2.0 Both Province is required if country is Canada. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province must be supplied for Canadian addresses. E SF 424 Authorized province 001.86.3 Y Y Incl: V 2.0 Both If country not Canada, Province must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province should not be provided for all countries other than Canada. E SF 424 Authorized country 001.87 SF 424 Authorized zip/postal code, 001.88.1 Y Y Incl: V 2.0 Both ZIP Code is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the ZIP Code must be supplied for US addresses. E
SF 424 Authorized zip/postal code, 001.88.2 Y Y Incl: V 2.0 Both ZIP Code must be 9 numeric digits if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, a 9 digit ZIP Code must be supplied for US addresses. E SF 424 Authorized phone number 001.89 SF 424 Authorized fax number 001.90 SF 424 Authorized email 001.91.3 Y N Incl: V 2.0 Both Must contain a ‘@’. Control characters (ASCII 0 through 31 and 127), spaces and special chars < > ( ) [ ] \ ; : are not valid. The submitted email address for the Authorized Representative {0}, is invalid. E SF 424 Authorized signature and date 001.92 SF 424 attachment 001.93 SF 424 Cover Letter Attachment 001.94.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: K01, K07, K08, K18, K22, K23, K25, K99, K99/R00, K76, F99/K00 Single Cover letter is required A cover letter must be attached for this application. Please include the names of the referees for this application in the cover letter. E January 14, 2016 Release, Update to Existing Rule (added K76, F99/K00)
(R&R) MP Changed App) SF 424 (R&R) MP Date 002.2 SF 424 (R&R) MP Applicant Identifier 002.3 SF 424 (R&R) MP Date Received by State 002.4 SF 424 (R&R) MP State Identifier 002.5 SF 424 (R&R) MP Federal Identifier 002.6 SF 424 (R&R) MP Agency Routing Identifier 002.7 SF 424 (R&R) MP Previous Tracking ID 002.8 SF 424 (R&R) MP Applicant DUNS 002.9.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi DUNS is required The Component Organization DUNs number is required. E
SF 424 (R&R) MP Applicant Legal Name 002.10.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Organization Legal Name is required The Component Organization's Legal Name is required. E SF 424 (R&R) MP Applicant 002.11 SF 424 (R&R) MP Applicant Division 002.12 SF 424 (R&R) MP Applicant Street 1 002.13.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Address line 1 is required The Component Organization Street address must be provided. E SF 424 (R&R) MP Applicant Street 2 002.14 SF 424 (R&R) MP Applicant City 002.15.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi City is required The Component Organization City must be provided. E SF 424 (R&R) MP Applicant 002.16 SF 424 (R&R) MP Applicant State 002.17.1 Y Y Incl: V1.0 Multi State is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not E
available>, the State must be supplied for US addresses. SF 424 (R&R) MP Applicant State 002.17.2 Y Y Incl: V1.0 Multi If country is not US, the State must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State should not be provided for all countries other than the United States. E SF 424 (R&R) MP Applicant Province 002.18.1 Y Y Incl: V1.0 Multi Province is required if country is Canada. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province must be supplied for Canadian addresses. E SF 424 (R&R) MP Applicant Province 002.18.2 Y Y Incl: V1.0 Multi If country is not Canada, Province must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province should not be provided for all countries other than Canada. E SF 424 (R&R) MP Applicant Province 002.18.3 Y Y Incl: V1.0 Multi If Country is Canada and province name can’t be transformed, give error. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province is not a valid province name. E SF 424 (R&R) MP Applicant Country 002.19.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Country is required The Component Organization Country is required. E SF 424 (R&R) MP Applicant Zip Code 002.20.1 Y Y Incl: V1.0 Multi ZIP Code is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the ZIP Code must be supplied for US addresses. E
SF 424 (R&R) MP Applicant Zip Code 002.20.2 Y Y Incl: V1.0 Multi ZIP Code must be 9 numeric digits if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, a 9 digit ZIP Code must be supplied for US addresses. E SF 424 (R&R) MP Person to be Prefix 002.21 SF 424 (R&R) MP Person to be First Name 002.22.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi First Name is required The Component Person to be Contacted first name is required. E SF 424 (R&R) MP Person to be Middle Name 002.23 SF 424 (R&R) MP Person to be Last Name 002.24.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Last Name is required The Component Person to be Contacted last name is required. E SF 424 (R&R) MP Person to be Suffix 002.25 SF 424 (R&R) MP Person to be Position/ Title 002.26
SF 424 (R&R) MP Person to be Street 1 002.27.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Address line 1 is required For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the first line of address is required.. E SF 424 (R&R) MP Person to be Street 2 002.28 SF 424 (R&R) MP Person to be City 002.29.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi City is required For < Person First, Last name or Organization name, or DUNS if Org name is not available>,City is required.. E SF 424 (R&R) MP Person to be County/ Parish 002.30 SF 424 (R&R) MP Person to be State 002.31.1 Y Y Incl: V1.0 Multi State is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State must be supplied for US addresses. E SF 424 (R&R) MP Person to be State 002.31.2 Y Y Incl: V1.0 Multi If country is not US, the State must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State should not be provided for all countries other than the United States. E SF 424 (R&R) MP Person to be Province 002.32.1 Y Y Incl: V1.0 Multi Province is required if country is Canada. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province must E
be supplied for Canadian addresses. SF 424 (R&R) MP Person to be Province 002.32.2 Y Y Incl: V1.0 Multi If country is not Canada, Province must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province should not be provided for all countries other than Canada. E SF 424 (R&R) MP Person to be Province 002.32.3 Y Y Incl: V1.0 Multi If Country is Canada and province name can’t be transformed, give error. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province is not a valid province name. E SF 424 (R&R) MP Person to be Country 002.33.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Country is required The Component Person to be contacted Country is required. E SF 424 (R&R) MP Person to be ZIP Code 002.34.1 Y Y Incl: V1.0 Multi ZIP Code is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the ZIP Code must be supplied for US addresses. E SF 424 (R&R) MP Person to be ZIP Code 002.34.2 Y Y Incl: V1.0 Multi ZIP Code must be 9 numeric digits if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, a 9 digit ZIP Code must be supplied for US addresses. E SF 424 (R&R) MP Person to be Phone Number 002.35.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Phone Number is required The Component Person to be contacted Phone number is required. E
SF 424 (R&R) MP Person to be Fax Number 002.36 SF 424 (R&R) MP Person to be e-mail 002.37 SF 424 (R&R) MP Person to be e-mail 002.38 SF 424 (R&R) MP Employer 002.39 SF 424 (R&R) MP Type of Applicant (other, woman owned, 002.40 SF 424 (R&R) MP Type of Applicant (other, Specify) 002.41 SF 424 (R&R) MP Type of (New, Resub, Renewal, Contin, Revision) 002.42 SF 424 (R&R) MP Type of Revision Code 002.43
(R&R) MP FDA, AHRQ, VA SF 424 (R&R) MP Proposed project start date 002.50.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Must be later than current date The Component Proposed Project Start Date must be later than today's date. E SF 424 (R&R) MP Proposed project start date 002.50.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Y Must be equal or after the proposed start date of the Overall The Component Proposed Project Start Date must be equal to or after the proposed start date of the Overall component. E SF 424 (R&R) MP Proposed project ending date 002.51.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi End date is required The Component Proposed Project Ending Date is required. E SF 424 (R&R) MP Proposed project ending date 002.51.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Must be later than Project Start Date The Component Proposed Project Ending Date must be later than the Proposed Project Start Date. E SF 424 (R&R) MP Proposed project ending date 002.51.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Must be no more than 20 years greater than today’s date. The Component Proposed Project Ending Date cannot be more than 20 years in the future. E SF 424 (R&R) MP Proposed project ending date 002.51.4 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Multi Y Must be equal or before the proposed ending date of the Overall The Component Proposed Project End Date must be equal to or before the Proposed End Date of the Overall component. E
SF 424 (R&R) MP districts of applicant 002.52 SF 424 (R&R) MP PD/PI Contact name (prefix,) 002.53 SF 424 (R&R) MP PD/PI Contact name ( first name,) 002.54 SF 424 (R&R) MP PD/PI Contact name (middle name) 002.55 SF 424 (R&R) MP PD/PI Contact name (Last name) 002.56 SF 424 (R&R) MP PD/PI Contact name (suffix) 002.57 SF 424 (R&R) MP PD/PI Contact 002.58
SF 424 (R&R) MP PD/PI Contact 002.59 SF 424 (R&R) MP PD/PI Contact Name 002.60 SF 424 (R&R) MP PD/PI Contact 002.61 SF 424 (R&R) MP PD/PI Contact Division 002.62 SF 424 (R&R) MP PD/PI Contact Street 1 002.63 SF 424 (R&R) MP PD/PI Contact Street 2 002.64 SF 424 (R&R) MP PD/PI Contact City 002.65 SF 424 PD/PI Contact 002.66
(R&R) MP SF 424 (R&R) MP PD/PI Contact state 002.67 SF 424 (R&R) MP PD/PI Contact province 002.68 SF 424 (R&R) MP PD/PI Contact country 002.69 SF 424 (R&R) MP PD/PI Contact Code 002.70 SF 424 (R&R) MP PD/PI Contact phone number 002.71 SF 424 (R&R) MP PD/PI Contact fax number 002.72 SF 424 (R&R) MP PD/PI Contact email 002.73 SF 424 Total Federal 002.74
(R&R) MP Funds SF 424 (R&R) MP Total Federal and Funds 002.75 SF 424 (R&R) MP Program Income 002.76 SF 424 (R&R) MP Subject to state executive order review? 002.77 SF 424 (R&R) MP State executive order review date 002.78 SF 424 (R&R) MP and 002.79 SF 424 (R&R) MP SFLLL or Other 002.80 SF 424 (R&R) MP prefix 002.81
SF 424 (R&R) MP first name 002.82 SF 424 (R&R) MP middle name 002.83 SF 424 (R&R) MP last name 002.84 SF 424 (R&R) MP suffix 002.85 SF 424 (R&R) MP 002.86 SF 424 (R&R) MP 002.87 SF 424 (R&R) MP 002.88
SF 424 (R&R) MP division 002.89 SF 424 (R&R) MP street 1 002.90 SF 424 (R&R) MP street 2 002.91 SF 424 (R&R) MP city 002.92 SF 424 (R&R) MP 002.93 SF 424 (R&R) MP state 002.94 SF 424 (R&R) MP province 002.95 SF 424 (R&R) MP country 002.96
SF 424 (R&R) MP zip/postal code, 002.97 SF 424 (R&R) MP phone number 002.98 SF 424 (R&R) MP fax number 002.99 SF 424 (R&R) MP email 002.100 SF 424 (R&R) MP signature and date 002.101 SF 424 (R&R) MP 002.102 SF 424 (R&R) MP Cover Letter 002.103
Project/Performance Site(s) Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments Mandatory (Y/N) Shared (Y/N) Agency Specific (Lists Agencies) Form Version FOA Specific Activity Specific Lists Activity Code (Inclusion & Exclusion) Applies to Single Project, Multi Project or Both Applies to Com- ponent Type (Multi Project Only) Cross Components (Multi Project Only) Project/ Performance Site (R&R) I am submitting an application as an individual, and not on behalf of a company, state, local or tribal government, academia, or other type of organization 003.1 Project/ Performance Site (R&R) Primary Location, Organization Name 003.2.1 N N Incl : NIH Incl: V 2.0 Both Both Primary Location Organization Name is required The Organization Name for the Primary Location for <DUNS (if available)> is required. E Project/ Performance Site (R&R) Primary Location, DUNS Number 003.3.1 N N Incl : NIH Incl: V 2.0 Both Both Primary Location DUNS is required The DUNS Number for the Primary Location for <Organization name (if available)> is required. E Project/ Performance Site (R&R) Primary Location, Street 1 003.4 Project/ Performance Site (R&R) Primary Location, Street 2 003.5 Project/ Performance Site (R&R) Primary Location, City 003.6 Project/ Performance Site (R&R) Primary Location, County/Parish 003.7
Project/ Performance Site (R&R) Primary Location, Zip code 003.10.1 Y Y Incl; V2.0 Both Both ZIP Code is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the ZIP Code must be supplied for US addresses. E Project/ Performance Site (R&R) Primary Location, Zip code 003.10.2 Y Y Incl; V2.0 Both Both ZIP Code must be 9 numeric digits if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, a 9 digit ZIP Code must be supplied for US addresses. E Project/ Performance Site (R&R) Primary Location, Country 003.11 Project/ Performance Site (R&R) Primary Location, Congressional District 003.12.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl; V2.0 Both Both Required if Country is US. For <Organization name or DUNS (if Org name not available)>, the Congressional District is required since country is United States. E Project/ Performance Site (R&R) Primary Location, Congressional District 003.12.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl; V2.0 Both Both Must be a valid congressional district code (after truncating). Truncation logic: Parse from left to right, and take the first two digits encountered, skipping leading zeroes (return error if no digits are encountered, but no error if only zeroes are encountered). Before validating, pad out with a leading zero Congressional district <Congressional District> is invalid for <Organization name or DUNS (if Org name not available)>. To locate your district, visit http://www.house.gov/ If the applicant organization is a foreign institution, refer to the application guide for instructions. E
Project/ Performance Site (R&R) Location 1, City 003.18 Project/ Performance Site (R&R) Location 1, County/Parish 003.19 Project/ Performance Site (R&R) Location x, State 003.20.1 Y Y Incl; V2.0 Both Both State is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State must be supplied for US addresses. E Project/ Performance Site (R&R) Location x, State 003.20.2 Y Y Incl; V2.0 Both Both If country not US, State must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State should not be provided for all countries other than the United States. E Project/ Performance Site (R&R) Location x, Province 003.21.1 Y Y Incl; V2.0 Both Both If Country is Canada and province name can’t be transformed, give an error. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province is not a valid province name. E Project/ Performance Site (R&R) Location x, Province 003.21.2 Y Y Incl; V2.0 Both Both Province is required if country is Canada. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province must be supplied for Canadian addresses. E Project/ Performance Site (R&R) Location x, Province 003.21.3 Y Y Incl; V2.0 Both Both If country not Canada, Province must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province should not be E
Other Project Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency Specific (Lists Form FOA Activity Specific Lists Activity Code & to Single Multi or Both to Com- Type (Multi Only) Cross (Multi Project Only) Research and Related Other Project Human Subjects Involved? 004.1.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both If Human Subjects Used Question is false, Exemption Number must not be specified. When Human Subjects is “No”, Exemption Number must not be specified. E Research and Related Other Project Human Subjects Involved? 004.1.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both If Human Subjects Used Question is false, provide a warning if Assurance Number is specified. When Human Subjects is “No”, Assurance Number may not be specified. W Research and Related Other Project Human Subjects Involved? 004.1.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both Must be true if Human Subjects Clinical Trial question is true on Cover Page Supp. The ‘Human Subjects Involved’ question must be "Yes" if the Human Subjects Clinical Trial question on the PHS 398 Cover Page Supplement is “Yes”. E Research and Related Other Project Human Subjects Involved? 004.1.4 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Provide Warning if Human Subject Involved is Yes and Is the Project Exempt from Federal Regulations is No and Is the IRB review Pending is Yes and Human Assurance Number is not provided. The Human Subject Assurance Number may be requested later as part of the eRA Commons Just In Time (JIT) process. W Research and Related Human Subjects Involved? 004.1.5 N N Incl : NIH, CDC, Incl: V1.3 Multi Y If Human Subject Involved is Yes on any component of the application and the Overall If Human Subjects Involved is "Yes" on any component of the application, then "Yes" must be selected for the Overall component E
Other Project FDA, AHRQ, VA Human Subject Involved is No, provide Error Research and Related Other Project Human Subjects Involved? 004.1.6 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For New and Renewal applications, If Human Subject Involved is No on all components of the application and the Overall if Human Subject Involved is Yes, provide Error If Human Subjects Involved is "No" on all components of the application, then "No" must be selected for the Overall component E Research and Related Other Project Human Subjects Involved? 004.1.7 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For Revision and Resubmission applications, If Human Subject Involved is No on all components of the application and the Overall if Human Subject Involved is Yes, provide Warning Answering ‘Yes’ to Human Subjects on the Overall component and ‘No’ to Human Subjects on all other components is typically not allowed unless your Revision application (or Resubmission of a Revision) does not include the components that involve human subjects. W Research and Related Other Project Human Subjects Involved? 004.1.8 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Incl: S10, S21, S22, Single Provide warning if Human Subject is true. The answer to the Human Subjects Involved should be ‘No’ for this application. W Research and Related Other Project Human Subjects Involved? 004.1.9 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Incl:R50 Single Provide error if Human Subjects is true The answer to the Human Subjects Involved should be ‘No’ for this application. E December 2015 Release
Research and Related Other Project Project Exempt from Federal Regulations 004.2.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both If Human Subjects Used Question is true, the Project Exempt from Federal Regulations question cannot be blank If the answer to Human Subject Used is ‘Yes”, an answer to the Project Exempt from Federal Regulations must be provided. E Research and Related Other Project Exemption number 1-6 004.3.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both If Project Exempt from Federal Regulations is True, the Exemption number cannot be blank. If the answer to Project Exempt from Federal Regulations is ‘Yes’, an Exemption Number must be provided. E Research and Related Other Project Exemption number 1-6 004.3.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For New and Renewal applications, if Overall Exemption number is 'E4' and all Components Human Subject is 'Yes' with no exemption number checked or an Exemption number not equal to ‘E4’, provide error. If the Human Subjects Involved question on the Overall component is Yes with exemption 4, then all other components with human subjects must also use exemption 4. E Research and Related Other Project Exemption number 1-6 004.3.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For Revision and Resubmission applications, provide a warning if Overall Human Subject is Yes and Exception code is E4 and all Components with Human Subject is Yes and Exception code is different than E4 or not any are selected Human Subjects exemption number 4 is typically not allowed on the Overall component unless exemption 4 is selected for all components that include Human Subjects. W Research and Related Other Exemption number 1-6 004.3.4 N N Incl: NIH, CDC, FDA, AHRQ Excl: T15, T32, T34, T35, Both Provide warning if applicant selected Yes to Human subjects with an Exemption Number not equal to ‘4’ on the Research & You have answered "Yes" to the Human Subjects Involved question on the Research & Related Other Project form, but have not included W Forms D, March 2016 Release
Research and Related Other Project Vertebrate animals used? 004.7.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For New and Renewal applications, If ‘vertebrate animal is answered No on all Other Components and Overall component is marked Yes, then provide error. If Vertebrate animals used is "No" on all components of the application, then "No" must be selected for the Overall component E Research and Related Other Project Vertebrate animals used? 004.7.4 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For Revision and Resubmission applications, If Vertebrate Animals is No on all components of the application and if the Overall Vertebrate Animals is Yes, provide Warning Answering ‘Yes’ to Vertebrate Animals on the Overall component and ‘No’ to Vertebrate Animals on all other components is typically not allowed unless your Revision application (or Resubmission of a Revision) does not include the components that involve vertebrate animals. W Research and Related Other Project Vertebrate animals used? 004.7.5 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Incl: S10 Single Provide warning if Vertebrate Animals Used is true. The answer to the Vertebrate Animals Used should be ‘No’ for this application. W Research and Related Other Project Vertebrate animals used? 004.7.6 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Incl: R50 Single Provide Error if Vertebrate Animals Used is true. The answer to the Vertebrate Animals Used question should be ‘No’ for this application. E December 2015 Release Research and Related Other IACUC review pending? 004.8.1 N N Incl : NIH, CDC, FDA, AHRQ, Incl: V1.3 Both Provide a warning if Vertebrate Animals Used is ‘N’ and IACUC Approval Pending indicator is checked. When Vertebrate Animals is “No” IACUC Approval Pending indicator does not apply. W
Related Other Project Indicator, If yes, please explain CDC, FDA, AHRQ, VA statement (EIS) are required if Environmental Exemption is Yes. Research and Related Other Project Performance Site a historic place? 004.16 Research and Related Other Project Performance Site a historic place, If yes, please explain 004.17.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both An explanation is required if Historic Designation is Yes If you indicated that any performance site is designated, or eligible to be designated, as a historic place, provide an explanation. E Research and Related Other Project Activities outside of US? 004.18.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y Provide error if 'Activities Outside of US' on Component is Yes and 'Activities Outside of US' on Overall is No. If 'This Project involve activities outside of US' is "Yes" on any component of the application, then "Yes" must be selected for the Overall component. E Research and Related Other Project Activities outside of US? 004.18.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For New and Renewal applications, If Activities Outside of US is No on all components of the application and the Overall Activities Outside of US is Yes, provide Error If 'This Project involve activities outside of US' is "No" on all components of the application, then "No" must be selected for the Overall component. E
Research and Related Other Project Activities outside of US? 004.18.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For Revision and Resubmission applications, If Activities Outside the US is No on all components of the application and the Overall if Activities Outside the US is Yes, provide Warning Answering ‘Yes’ to Activities Outside the US on the Overall component and ‘No’ on all other components is typically not allowed unless your Revision application (or Resubmission of a Revision) does not include the components that the Activities Outside the US. W Research and Related Other Project Identify Countries 004.19.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both A list of countries is required if Activities outside of US is Yes Enter the countries with which international cooperative activities are involved. E Research and Related Other Project Optional explanation 004.19 Research and Related Other Project Project 004.20.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both Attachment is required The Project Summary/Abstract attachment is required. E
Research and Related Other Project Bibliography and References Cited 004.22.3 N N Incl: NIH, CDC, FDA, AHRQ VA Incl: V 1.3 Incl: DP1, DP2, DP4 Single Provide error if Bibliography attached. The Bibliography and References attachment cannot be included.. E Research and Related Other Project Facilities and other resources 004.23.1 N N Incl: NIH, CDC, FDA, AHRQ VA Incl: V 1.3 Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R, SI2/R00, R50 Single Provide error if Facilities and other resources attachment is not attached The Facilities & Other Resources attachment is required. E Update to existing rule (removed KM1) Update to existing (Added R50) December 2015 Release Research and Related Other Project Equipment 004.24.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Incl: S10 Single Equipment attachment is required The Equipment Attachment is required. E
Research and Related Other Project Other attachments 004.25.7 N N Incl: VA Incl: V1.3 Incl: IK6 Single E For VA applications and activity code is IK6, where a file named '02a_VA_Research_Plan.pdf' has been submitted, it cannot be greater than pages. The Research Plan, submitted as an Other Attachment on the Other Project Information page, is limited to 7 pages. Research and Related Other Project Other attachments 004.25.8 N N Incl: VA Incl: V1.3 Incl: IK6 IS1 Single E For VA applications and activity code is IK6 or IS1 a file named is required. A Letter from the VA R&D Committee is required for this application. Please submit it as an 'Other Attachment' on the Other Project Information page, titled ‘08a_VA_R_D_Committee_letter.pdf'. Research and Related Other Project Other attachments 004.25.9 N N Incl: VA Incl: V1.3 Single E For VA applications where a file named '02_VA_Specific_Aims.pdf' has been submitted, it cannot be greater than 1 page. The Specific Aims, submitted as an ‘Other Attachment’ on the Other Project Information page, is limited to 1 page Research and Related Other Project Other attachments N N Incl: VA Incl: V1.3 Single E For VA applications, a file named '02_VA_Specific_Aims.pdf' is required A Specific Aims is required for this application. Please submit it as an 'Other Attachment' on the Other Project Information page, titled '02_VA_Specific_Aims.pdf'.
Research and Related Other Project Other attachments N N Incl: VA Incl: V1.3 Incl: IP1, I50, IK4, IS1,IU1 Single For VA applications and activity code is IP1, I50, IK3, IK4, IS1 or IU1 where a file named 02a_VA_Research_Plan.pdf has been submitted, it cannot be greater than 24 pages The Research Plan, submitted as an Other Attachment on the Other Project Information page, is limited to 24 pages. E October 2016 Release. Removed Activity code IK3 Research and Related Other Project Other attachments N N Incl: VA Incl: V1.3 Single For VA applications, require the submission of a file named ‘02a_VA_Research_Plan.pdf A Research Plan is required for this application. Please submit it as an ‘Other Attachment’ on the Other Project Information page, titled ‘02a_VA_Research_Plan.pdf’ E Research and Related Other Project Other attachments N N Incl: VA Incl: V1.3 Single For VA applications where Type of Application is ‘Renewal’, a file named ‘03_VA_Prog_Report_Pubs.pdf‘ is required A bibliography of publications resulting from the last period of VA funding must be included for all renewals. Please submit it as an ‘Other Attachment’ on the Other Project Information page, titled ‘03_VA_Prog_Report_Pubs.pdf’. E Research and Related Other Project Other attachments N N Incl: VA Incl: V1.3 Single For VA applications where Human Subjects is ‘Y’, a file named ‘04_VA_Human_Subjects.pdf’ is required A Human Subjects attachment must be included if the response to the Human Subjects question on the Other Project Information page is ‘Yes’. Please submit it as an ‘Other Attachment’ on the Other Project Information page, titled ‘04_VA_Human_Subjects.pdf’. E 6
Research and Related Other Project Other attachments N N Incl: VA Incl: V1.3 Incl: is IK1, I21, I34 Single For VA applications and activity code is IK1, I21, or I34 where a file named '02a_VA_Research_Plan.pdf' has been submitted, it cannot be greater than 9 pages. The Research Plan, submitted as an Other Attachment on the Other Project Information page, is limited to 9 pages. E Research and Related Other Project Other attachments N N Incl: VA Incl: V1.3 Incl: 'IK2', Single For VA applications and activity code is 'IK2', where a file named '02a_VA_Research_Plan.pdf' has been submitted, it cannot be greater than 19 pages The Research Plan, submitted as an Other Attachment on the Other Project Information page, is limited to 19 pages E Research and Related Other Project Other attachments N N Incl: VA Incl: V1.3 Incl: IK5 Single For VA applications and activity code is IK5 where a file named '02a_VA_Research_Plan.pdf' has been submitted, it cannot be greater than 4 pages The Research Plan, submitted as an Other Attachment on the Other Project Information page, is limited to 4 pages E Research and Related Other Project Other attachments N N Incl: VA Incl: V1.3 Single For VA applications where a file named ‘01_VA_Intro.pdf’ has been submitted for a resubmission, it cannot be greater than 3 pages The Introduction for a resubmission, submitted as an Other Attachment on the Other Project Information page, is limited to three pages. E
Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) Shared (Y/N) Agency Specific (Lists Form FOA Specific Activity Specific Lists Activity Code (Inclusion & Exclusion) Applies to Single Multi Project or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Prefix 005.1 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, First Name 005.2 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Middle Name 005.3 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Last Name 005.4 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Suffix 005.5.1 Research and Related Senior/Key PD/PI Profile, Position/Title 005.6
Person Profile (Expanded) Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Department 005.7 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Organization Name 005.8.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Both Both Organization name is required The organization name for Key Person <Key Person First Name Last Name> must be provided. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Division 005.9 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Street 1 005.10 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Street 2 005.11 Research and Related Senior/Key PD/PI Profile, City 005.12
Person Profile (Expanded) Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, County/Parish 005.13 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, State 005.14.1 Y Y Incl: V 2.0 Both Both State is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State must be supplied for US addresses. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, State 005.14.2 Y Y Incl: V 2.0 Both Both If country not US, State must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State should not be provided for all countries other than the United States. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Province 005.15.1 Y Y Incl: V 2.0 Both Both If Country is Canada and province name can’t be transformed, give an error. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province is not a valid province name. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Province 005.15.2 Y Y Incl: V 2.0 Both Both If country not Canada, Province must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province should not be provided for all countries other than Canada. E
Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Province 005.15.3 Y Y Incl: V 2.0 Both Both Province is required if country is Canada. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province must be supplied for Canadian addresses. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Country 005.16 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, ZIP/Postal Code 005.17.1 Y Y Incl: V 2.0 Both Both ZIP Code is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the ZIP Code must be supplied for US addresses. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, ZIP/Postal Code 005.17.2 Y Y Incl: V 2.0 Both Both ZIP Code must be 9 numeric digits if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, a 9 digit ZIP Code must be supplied for US addresses. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Phone Number 005.18 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Fax Number 005.19
Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Email 005.20 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, credential 005.21.1 Y N Incl: V2.0 Both Overall Credential is required for PD/PI role The Commons Username must be provided in the PD/PI Credential field for the PD/PI <Last Name, First Name>. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, credential 005.21.2 Y N Incl: V2.0 Both Overall If credential is specified, it must be a valid Commons account, The Commons Username <Credential> provided in the PD/PI Credential field for <Last Name, First Name> is not a recognized Commons account. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, credential 005.21.3 Y N Incl: V2.0 Both Overall For the PD/PI, this account must be affiliated with the organization (matching on the Org Primary DUNs) submitting the application and have the PI role The Commons account provided in the Credential field for the PD/PI <Last Name, First Name> is not affiliated with the applicant organization. Check with your Commons Account Administrator to make sure you have been affiliated with the applicant organization. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, credential 005.21.4 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Both Overall For a revision, the PI should be assigned to the parent grant. If the person profile for this Commons account is not the same person profile assigned as the PI to the parent grant, and the last name of the PI assigned to the parent grant matches the last name that is submitted for the PI The parent grant information provided in the SF424 RR Cover Federal Identifier is not associated with the PD/PI Commons account for <Last Name, First Name>. W
Person Profile (Expanded) FDA, AHRQ, VA regardless of the project role specified Director/Principal Investigator section of the Sr/Key Person Profile form. Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, credential 005.21.9 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Multi Credential provided for component lead in PD/PI section regardless of the project role specified, must be valid. The Commons Username <Credential> provided for <Last Name, First Name> is not a recognized Commons account. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, project role 005.22.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Both Overall If No PD/PI project role are selected give error <Last Name, First Name> listed in the Project Director/Principal Investigator section of the Sr/Key Person Profile form must have the role PD/PI . E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, project role 005.22.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Multi If PI role selected give Error The PD/PI role can only be selected on the Overall Component. Please specify a different Project Role for <Last Name, First Name>. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, other project role category 005.23 Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Degree Type 005.24 Research and Related Senior/Key PD/PI Profile, Degree Year 005.25
Person Profile (Expanded) Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Biosketch 005.26.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Both Both Provide Error if the Biosketch attachment is more than 5 pages The Biosketch for Senior/Key Person, <first name last name>, exceeds the 5 page limit. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Biosketch 005.26.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Single Provide error if Biosketch attachment is not provided The Biographical Sketch attachment is required for Senior/Key Person < First Name, Last Name>. E Research and Related Senior/Key Person Profile (Expanded) PD/PI Profile, Current & Pending Support 005.27.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Incl: DP1, DP2, DP4 Single Current and Pending Support is required. The Current and Pending Support attachment for the PD/PI is required . E Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, Prefix 005.28 Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, First Name 005.29.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Incl: DP1, DP2, DP4, DP5, UP5 Single Provide error if any senior/key persons included (other than the PD/PI on the SF 424 RR Cover) The PD/PI is the only allowable senior/key person ., E
Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, Middle Name 005.30 Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, Last Name 005.31.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Both Both If the name provided and credential provided (and Commons account is recognized), provide warning if last name and first name on account don’t match provided name. Comparison to ignore case and embedded spaces, but not embedded punctuation. The name provided for Key Person <submitted first name last name> on the Senior/Key Person page does not match the eRA Commons account name (<Commons profile first name last name>) provided in the credential. The application image will display the name as submitted. W Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, Last Name 005.31.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V2.0 Both Both Provide warning if more than one PD/PI profile or Senior/Key person with the same first, middle name and last name has been found within component. More than one Senior/Key person with the same first and last name has been found within the Snr/Key Person Profile form. Specifically: <Last name, First name>; <Last name, First name>; .. Senior/key individuals should be listed once on the Snr/Key Person Profile form. Duplicate entries should be removed. Please consider providing additional differentiating information (e.g., middle name, suffix) if the entries are not the same person. W Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, Suffix
Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, City 005.39 Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, County/Parish 005.40 Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, State 005.41.1 Y Y Incl: V2.0 Both Both If country not US, State must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State should not be provided for all countries other than the United States. E Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, State 005.41.2 Y Y Incl: V2.0 Both Both State is required if country is US. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the State must be supplied for US addresses. E Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, Province 005.42.1 Y Y Incl: V2.0 Both Both Province is required if country is Canada. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province must be supplied for Canadian addresses. E Research and Related Senior/Key Profile, senior/ key person x, Province 005.42.2 Y Y Incl: V2.0 Both Both If country not Canada, Province must be blank. For < Person First, Last name or Organization name, or DUNS if Org name is not available>, the Province should not be provided for all countries other than Canada. E
Other and an Other Project Role Category of ‘Sponsor’ Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, other project role category 005.50.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Both Accept "Other Project Role Category" only when "Project Role" is "Other" or "Other Professional" For key person <First Name Last Name> on the Senior/Key Person page, an ‘Other Project Role Category’ was submitted for a project role of <project role>. This can be used only when Project Role is "Other" or "Other Professional". E Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, Degree Type 005.51 Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, Degree Year 005.52 Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, Biosketch 005.53.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Both Both Provide Error if the Biosketch attachment is more than 5 pages The Biosketch for Senior/Key Person, <first name last name>, exceeds the 5 page limit. E Research and Related Senior/Key Person Profile (Expanded) Profile, senior/ key person x, Biosketch 005.53.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 2.0 Single Provide error if Biosketch is not provided The Biographical Sketch attachment is required for Senior/Key Person < First Name, Last Name>. E
Person Profile (Expanded) Pending Support(s) 100 senior/key person (including PD/PI) have been entered on the Sr Key Person Profile (including PD/PI) have been entered on the Sr Key Person Profile. Research and Related Senior/Key Person Profile (Expanded) Additional Current and Pending Support(s) 005.55.6 N N Incl: NIH, CDC, FDA, AHRQ VA Incl: V 2.0 Incl: DP1, DP2, DP4, DP5, UP5 Single Provide error if Additional Person Current and Pending Support is included The Additional Senior/Key Person Current and Pending Support attachment cannot be included. E Cover Page Supplement
the Overall, then provide Error. PHS 398 Cover Page Supplement Human Subjects Clinical Trial (Y/N) 008.1.5 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi Overall Y For Revision and Resubmission applications, If Clinical Trial is No on all components of the application and the Overall Clinical Trial is Yes, provide Warning Answering ‘Yes’ to Clinical Trial on the Overall component and ‘No’ to Clinical Trial on all other components is typically not allowed unless your Revision application (or Resubmission of a Revision) does not include the components that involve Clinical Trial. W PHS 398 Cover Page Supplement Human Subjects Clinical Trial (Y/N) 008.1.6 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Incl: S10 SIngle Provide a warning if Human Subjects Clinical Trial is mark ‘Yes’. Clinical Trials are not typically allowed for this type of funding opportunity announcement. W Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.1 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both An answer is required if the answer to ‘Human Subjects Clinical Trial’ is "Yes". You must answer the “Agency-Defined Phase III Clinical Trial” question if you answer Yes to the “Clinical Trial?” question. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.2 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both If Human Subjects Clinical Trial is No, this cannot be equal to Yes. You cannot answer Yes to the “Agency-Defined Phase III Clinical Trial”question if you anser No to the “Clinical Trial?” question E Update to existing rule (modified language on error message), Forms D, Defined Defined
March 2016 Release PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.3 N Incl : NIH, CDC, FDA, AHRQ Multi Overall Y If NIH-Defined Phase III Clinical Trial is Yes on any component of the application and the Overall if NIH-Defined Phase III Clinical Trial is No, provide Error The NIH-Defined Phase III Clinical Trial question on the Overall component must be marked as "Yes", in order for any NIH-Defined Phase III Clinical Trial question in any other component to be marked as "Yes". E PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.4 N Incl : NIH, CDC, FDA, AHRQ Multi Overall Y For New and Renewal applications, if NIH Clinical Trial is Yes and NIH-Defined Phase III Clinical Trial is not ‘Yes’ on all components of the application and Phase III Clinical Trial is Yes on the Overall, then provide Error The NIH-Defined Phase III Clinical Trial question must be ‘No’ on the Overall component, if NIH-Defined Phase III Clinical Trial question is ‘No’ for all other components in the application. E PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.5 N Incl : NIH, CDC, FDA, AHRQ Multi Overall Y For Revision and Resubmission applications, If NIH Clinical Trial is Yes and NIH Defined Phase III clinical trial is not ‘Yes’ on all components of the application and the Overall NIH Phase III clinical trial is Yes, provide Warning Answering ‘Yes’ to Phase III clinical trial on the Overall component and ‘No’ on all other components is typically not allowed unless your Revision application (or Resubmission of a Revision) does not include the components that involve Phase III clinical trial. W PHS 398 Cover Page Supplement Disclosure Permission Statement 008.24 PHS 398 Cover Page Supplement Program Income N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Incl: T01, T02, T03, T14, T42, T90, T90/R90, Single Provide warning if checked yes for Training grants applications Program Income is typically not allowed for this type of funding opportunity announcement. W Update to existing rule (modified language on error
TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Program Income N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Incl : S10 Single Provide error id Program income is mark ‘Yes’. Program Income is typically not allowed for this type of funding opportunity announcement. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Program Income, Budget Period 1-5 N Incl : NIH, CDC, FDA, AHRQ Excl: V3.0 Both If Program Anticipated question= N and Program Income data is provided, give error. If the answer to Program Income Anticipated question is ‘No’, no program income details may be entered. E October 2016 Release Rule updated to apply to Component Only. PHS 398 Cover Page Supplement Program Income, Budget Period 1-5 N Incl : NIH, CDC, FDA, AHRQ Excl: V3.0 Both Y The number of program income budget periods must be less than or equal to the number of budgets provided in the budget form. The Program Income Anticipated Amount has been provided for <x> budget periods. Only <y> periods of budgets were provided for this application. E October 2016 Release Rule updated to apply to Component Only. PHS 398 Cover Page Supplement Program Income, Sources 1-5 008.26 PHS 398 Cover Page Supplement Program Income, Anticipated Amount 1-5 Y N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Must be less than 10,000,000,000 The Program Income Anticipated Amount for budget period <budget period> exceeds the allowable amount for the agency. E October 2016 Release Rule updated to apply to Component Only.
PHS 398 Cover Page Supplement Human Embryonic Stem Cells (HESC) Involved (Y/N) N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both A response is required for Human Embryonic Stem Cells (HESC) Involved (Y/N) You must answer the “Does the proposed project involve human embryonic stem cells?” question. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Human Embryonic Stem Cells (HESC) Involved (Y/N) N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi Overall Y If Human Embryonic Stem Cells (HESC) Involved is Yes on any Other Component, then the answer must be Yes on the Overall Component The Human Embryonic Stem Cells (HESC) Involved on the Overall must be marked as "Yes", in order for any Human Embryonic Stem Cells (HESC) Involved in any component to be marked as "Yes". E PHS 398 Cover Page Supplement Human Embryonic Stem Cells (HESC) Involved (Y/N) N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi Overall Y For New and Renewal applications, If Human Embryonic Stem Cells (HESC) Involved is No on all Other Components, then the answer must also be No on the Overall Component Human Embryonic Stem Cells (HESC) Involved must be No on the Overall section of the application, if Human Embryonic Stem Cells (HESC) Involved is No for all other components of the application. E PHS 398 Cover Page Supplement Human Embryonic Stem Cells (HESC) Involved (Y/N) N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi Overall Y For Revision and Resubmission applications, If Human Embryonic Stem Cells Involved is No on all components of the application and the Overall if Human Embryonic Stem Cells Involved is Yes, provide Warning Answering ‘Yes’ to HESC Involved on the Overall component and ‘No’ to HESC Involved on all other components is typically not allowed unless your Revision application (or Resubmission of a Revision) does not include the components that involve Human Embryonic Stem Cells. W
CDC, FDA, AHRQ stem cell lines cannot be referenced at this time” box. Component Only. PHS 398 Cover Page Supplement HESC Cell Lines N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi overall Y Specific stem cells lines in overall should reflect all stem cell lines included in the components. Provide error if cell lines are listed in other components but not in the overall component Specific stem cells lines in the Overall component should reflect all stem cell lines included in the components. E October 2016 Release Rule disabled Cover Page Inventions and Patents, Yes/No N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Overall Required if the type of application is either "Renewal". You must answer the “Inventions and Patents” question if you select Renewal as the Type of Application on the SF424 (R&R) Form. E Update to existing rule (modified language on error message), Forms D, March 2016 Release Cover Page Inventions and Patents, Yes/No N N Incl: NIH, CDC, FDA, AHRQ V 2.0 Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Single Error if Inventions and Patents, Yes is selected Inventions and Patents are not allowed for this type of funding opportunity announcement. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Inventions and Patents, Previously Reported (Yes or No) N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Overall Must be answered if response to Inventions and Patents is ‘Yes’ You must answer the “Previously Reported” queston if you answer Yes to the “Inventions and Patents” question E Update to existing rule (modified language on error message), Forms D, H) H)
March 2016 Release PHS 398 Cover Page Supplement Inventions and Patents, Previously Reported (Yes or No) N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Overall Should not be answered if response to Inventions and Patents is ‘No’ You cannot answer the “Previously Reported” question if you answer No to the “Inventions and Patents” question E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Change of of Inst.: Change of PI N N Incl : NIH, CDC, FDA, AHRQ, V 2.0 Both Overall Not accepted for revisions. A change of Project Director / Principle Investigator is not allowed if you select Revision as the Type of Application on the SF424 (R&R) form. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Change of of Inst.: Change of PI N N Incl : NIH, CDC, FDA, AHRQ Incl: K02, K05, K24, K26, K01, K07, K08, K18, K22, K23, K25, K99, K99/R00 Single Provide error if Change of PI indicator is selected. A change of Project Director / Principle Investigator is not allowed for this type of funding opportunity announcement. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Change of of Inst.: Name of former PI, First Name N Incl : NIH, CDC, FDA, AHRQ Both Overall First name must be included if application is for change of PI You must provide the first name of the former PD/PI if you check the “Change of Project Director / Priniciple Investigator” box. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Change of of Inst.: Name of 008.32
Veterinary Medical Association (AVMA) guidelines required if the answer to “Are vertebrate animals euthanized’ is “Yes”. animals euthanized?” question. PHS 398 Cover Page Supplement Vertebrate Animals: If “No” to AVMA guidelines, describe method and provide a scientific justification N N Incl: NIH Excl: V2.0 Both Both If “No” to AVMA guidelines, method and scientific justification must be provided. You must provide the euthanasia method and scientific justification if you answer No to the “Is method consistent with AVMA guidelines?” question. E Forms D, March 2016 Release PHS 398 Cover Page Supplement Program Income, Budget Period 1-10 N N Incl:NIH Exc: V2.0 Both If Program Anticipated question = N and Program Income data is provided, give error You cannot provide program income details when you answer No to the “Is program income anticipated?” question. E October 2016 Release Rule updated to apply to Component Only. PHS 398 Cover Page Supplement Program Income, Budget Period 1-10 N N Incl:NIH Exc: V2.0 Both The number of program income budget periods must be less than or equal to the number of budgets provided in the budget form You provided anticipated program income amounts for <x> budget periods, but only <y> periods were included in the budget form. E October 2016 Release Rule updated to apply to Component Only. Modular Budget
Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments Mandatory (Y/N) Shared (Y/N) Agency Specific (Lists Agencies) Form Version FOA Specific Activity Specific Lists Activity Code (Inclusion & Exclusion) Applies to Single Project, Multi Project or Both Applies to Com- ponent Type (Multi Project only) Cross (Multi Project Only) Modular Budget, Years 1-5 (NIH) 018.0.2 N N Incl: NIH Incl: V 1.2 Single Project Do not accept a modular budget for an application where the applicant organization is foreign. Applications from foreign organizations must use the R&R Budget form.. E Modular Budget, Years 1-5 (NIH) 018.0.3 N N Incl: NIH Incl: V 1.2 Excl: C06, UC6, G20 Single Project For a revision, if the parent grant budget is non-modular, only a detailed budget form may be submitted. This application should be submitted with the same type of budget as the last competing segment. W Modular Budget, Years 1-5 (NIH) 018.0.4 N N Incl : NIH, CDC, FDA, AHRQ V 1.2 Incl: R15, RF1, UF1, UA5 Single Return error if more than one budget period has been included. All budget information for this multi-year funded application must be submitted in a single budget period. Be sure to comply with the Funding Opportunity Announcement (FOA) instructions E Modular Budget, Years 1-5 (NIH) Start Date 018.1.1 N N Incl: NIH Incl: V 1.2 Single Project For budget period 1, if entered, for new and resubmissions applications, must be the same as the Project Start Date listed on the SF 424 RR Face Page . The modular budget start date for budget period <budget year> for new and resubmission applications must be the same as the proposed project start date listed on the SF424 RR cover form. W Modular Budget, Start Date 018.1.2 N N Incl: NIH Incl: V 1.2 Single Project For budget years after budget year 1, if entered, must be The start date for budget period W
Years 1-5 (NIH) greater than or equal to the Proposed Project Start Date listed on the SF 424 RR Face Page. <budget year> must be equal to or later than the proposed project start date listed on the SF 424 RR cover form. Modular Budget, Years 1-5 (NIH) Start Date 018.1.3 Y N Incl: NIH Incl: V 1.2 Single Project Start date is required The start date for budget period <budget year> is required. E Modular Budget, Years 1-5 (NIH) End Date 018.2.1 N N Incl: NIH Incl: V 1.2 Single Project The Budget period end date must be greater than budget period start date and less than or equal to project period end date listed on the SF424 RR.. For Budget period <budget year> the budget dates must be within the proposed project period dates listed on the SF424 RR cover form. E Modular Budget, Years 1-5 (NIH) End Date 018.2.2 Y N Incl: NIH Incl: V 1.2 Single Project End date is required The end date for budget period <budget year> is required. E Modular Budget, Years 1-5 (NIH) Direct Costs, Direct Cost Less Consortium, F&A 018.3.1 N N Incl: NIH Incl: V 1.2 Single Project Must be <= 250K, must be a multiple of 25K for each budget year For budget period <budget year>, the Direct Cost Less Consortium, F&A must be in $25K increments and cannot exceed $250K. E Modular Budget, Years 1-5 (NIH) Direct Costs, Direct Cost Less Consortium, F&A 018.3.2 N N Incl: NIH Incl: V 1.2 = N Incl: R03, R21, UH2 Single Project Provide error if this value for any budget year is >50K for R03 or budget year is >200K for R21 or budget year is >200K for UH2 For budget period <budget year>, the Direct Cost Less Consortium, F&A requests are limited to <direct cost limit> per E
period for this program. Modular Budget, Years 1-5 (NIH) Direct Costs, Direct Cost Less Consortium, F&A 018.3.3 N N Incl: NIH Incl: V 1.2 = N Incl: R34, U34 Single Project Provide warning if this value for any budget year is >225K For budget period <budget year>, the Direct Cost Less Consortium, F&A requests are typically limited to <direct cost limit> for this type of application. Be sure to comply with the Funding Opportunity Announcement (FOA) instructions. W Modular Budget, Years 1-5 (NIH) Direct Costs, Direct Cost Less Consortium, F&A 018.3.4 N N Incl: NIH Incl: V 1.2 Incl: SC1, SC2, SC3 Single Project Provide error if the Direct cost less F&A for any budget year is >75K for SC3, or is > 100K for SC2, or is > 250K for SC1. Note: Depending upon the type of application, generate the specific error message. For budget period <budget year>, the Direct Cost requests are limited to <direct cost limit> a year for this application. E Modular Budget, Years 1-5 (NIH) Direct Costs, Consortium, F&A 018.4.1 Y N Incl: V 1.2 Single Project Must be less than 10,000,000,000. For budget period <budget year>, the Direct Cost Less Consortium provided exceeds E
the allowable limit. Modular Budget, Years 1-5 (NIH) Direct Costs, Total Direct Costs 018.5.1 N N Incl: NIH Incl: V 1.2 Single Project Must equal sum of Direct Cost Less Consortium, F&A and Consortium, F&A for the corresponding budget year (if both are submitted). If only Direct Cost Less Consortium, F&A is submitted for that budget year, must equal that. The ‘Total Direct Costs’ in budget period <budget year> must equal the ‘Direct Cost less Consortium F&A’ plus ‘Consortium F&A’. E Modular Budget, Years 1-5 (NIH) Direct Costs, Total Direct Costs 018.5.2 Y N Incl: V 1.2 Single Project Must be less than 10,000,000,000. For budget period <budget year>, the Total Direct Costs provided exceeds the allowable limit. E Modular Budget, Years 1-5 (NIH) Indirect Costs, Indirect Cost Type 018.6 Modular Budget, Years 1-5 (NIH) Indirect Costs, Indirect Cost Rate 1-4 018.7.1 N N Incl: NIH Incl: V 1.2 Single Project Provide warning if greater than 0 and less than 1. For budget period <budget year>, the Indirect Cost Rate must be represented as a percentage. (e.g., ’25.5’, not .255) W Modular Budget, Years 1-5 (NIH) Indirect Costs, Indirect Cost Base 1-4 018.8.1 Y N Incl: V 1.2 Single Project Must be less than 10,000,000,000. For budget period <budget year>, the Indirect Cost Base provided exceeds the allowable limit. E Modular Budget, Years Indirect Costs, Funds 018.9.1 Y N Incl: V 1.2 Single Project Must be less than 10,000,000,000. For budget period <budget year>, the Funds Requested E
1-5 (NIH) Requested 1-4 amount provided exceeds the allowable limit. Modular Budget, Years 1-5 (NIH) Indirect Costs, Cognizant Agency 018.10 Modular Budget, Years 1-5 (NIH) Indirect Costs, Indirect Cost Rate Agreement Date 018.11 Modular Budget, Years 1-5 (NIH) Indirect Costs, Total Indirect Costs 018.12.1 N N Incl: NIH Incl: V 1.2 Single Project Must equal sum of Indirect Costs, Funds Requested 1-4 for the corresponding budget year, if any Indirect Costs were entered. The ‘Total Indirect Costs’ in budget period <budget year> must equal the sum of ‘Funds Requested’ for all ‘Indirect Cost Types’. E Modular Budget, Years 1-5 (NIH) Indirect Costs, Total Indirect Costs 018.12.2 Y N Incl: V 1.2 Single Project Must be less than 10,000,000,000. For budget period <budget year>, the Total Indirect Costs amount provided exceeds the allowable limit. E Modular Budget, Years 1-5 (NIH) Total Direct and Indirect Costs, Funds Requested 018.13.1 N N Incl: NIH Incl: V 1.2 Single Project Must be greater than 0 for first budget period. For Modular Budget period 1, Total Direct and Indirect Costs must be greater than zero. E Modular Budget, Years 1-5 (NIH) Total Direct and Indirect Costs, Funds Requested 018.13.2 N N Incl: NIH Incl: V 1.2 Single Project Must be equal to the sum of Total Direct Costs and Total Indirect Costs for the corresponding budget period. The ‘Total Direct and Indirect Costs (A+B)’ in budget period <budget year> E
Project Period must equal the sum of ‘Consortium F&A’ values for all budget periods. Modular Budget, (NIH Total Consortium F&A for Entire Project Period 019.2.2 Y N Incl: V 1.2 Single Project Must be less than 10,000,000,000. The Total Consortium F&A for Entire Project Period amount provided exceeds the allowable limit. E Modular Budget, (NIH) Total Costs, Total Direct Costs for Entire Project Period 019.3.1 N N Incl: NIH Incl: V 1.2 Single Project Must be equal to the sum of Total Direct Costs for all budget years. The cumulative ‘Total Direct Costs for the Entire Proposed Project Period’ must equal the sum of ‘Total Direct Costs’ values for all budget periods. E Modular Budget, (NIH) Total Costs, Total Direct Costs for Entire Project Period 019.3.2 Y N Incl: V 1.2 Single Project Must be less than 10,000,000,000. Total Direct Costs for Entire Project Period amount provided exceeds the allowable limit. E Modular Budget, (NIH) Total Costs, Total Indirect Costs for Entire Project Period 019.4.1 N N Incl: NIH Incl: V 1.2 Single Project Must be equal to the sum of Total Indirect Costs for all budget years. The cumulative ‘Total Indirect Costs Requested for Entire Project Period‘ must equal the sum of ‘Total Indirect Costs’ values for all budget periods. E Modular Budget, Total Costs, Total Direct and Indirect Costs for 019.5.1 N N Incl: NIH Incl: V 1.2 Single Project Must be equal to the sum of all Total Direct and Indirect Costs values for all budget years. The cumulative ‘Total Direct and Indirect Costs (A+B) for Entire E
(NIH) Entire Project Period Project ‘ must equal the sum of ‘Total Direct and Indirect Costs’ values for all budget periods. Modular Budget, (NIH) Total Costs, Total Direct and Indirect Costs for Entire Project Period 019.5.2 Y N Incl: V 1.2 Single Project Must be less than 10,000,000,000. The Total Direct and Indirect Costs for Entire Project Period amount provided exceed the allowable limit. E Modular Budget, (NIH) Budget Personnel Justification 019.6.1 N N Incl: NIH Incl: V 1.2 Single Project Provide a warning if this attachment hasn’t been included with a modular budget. In most cases, a Personnel Justification attachment should be included. W Modular Budget, (NIH) Budget Consortium Justification 019.7 Modular Budget, (NIH) Budget Additional Narrative Justification 019.8
& 5YR, (R&R) 020.0.4 N Y Incl: NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Incl: R15, RF1, UF1, UA5 Single Return error if more than one budget period has been included. All budget information for this multi-year funded application must be submitted in a single budget period. Be sure to comply with the Funding Opportunity Announcement (FOA) instructions. E & 5YR, (R&R) Organizational DUNS 020.1.1 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Budget marked as ‘Project’ must contain (left string match) the DUNS number for the component organization on the 424 RR The budget marked as ‘Project’ must contain the DUNS number for the organization from the SF 424 RR Cover. E & 5YR, (R&R) Organizational DUNS 020.1.2 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Budget marked as ‘Subaward’ cannot contain DUNS number for the component application organization on the 424 RR The <Organization Name> subaward’ budget cannot contain the DUNS number provided on the SF 424 RR Cover. E & Name of organization 020.2.1 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Name of Organization is required The Organization name is required for <DUNS>. E
5YR, (R&R) & 5YR, (R&R) Budget type (project, 020.3.1 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 There must be one and only one occurrence of budget with a value of ‘Project’ in the application. Only one budget with a budget type of ‘Project’ may be submitted for the application. E & 5YR, (R&R) Budget type (project, 020.3.2 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Incl: R41. R42, UT1, UT2 For an STTR submission, there must be at least one budget included with budget type of subaward/consortium for each year of the STTR (project) budget. A research institution Budget page must be included for each year of an STTR submission. E & 5YR, (R&R) Start Date 020.4.1 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single For budget year 1, for Budget Type ‘Project’, for new applications and resubmissions, must be the same as the Proposed Project Start Date listed on the SF 424 RR. For <Organization name> for budget period < Budget Year>, the start date for new and resubmission applications must be the same as the proposed project start date listed on the SF 424 RR Cover. W Start Date 020.4.2 N Y Incl : NIH, Incl: V 1.3 Single For budget years after budget year 1, must be For <Organization name> budget for budget beriod < W
& 5YR, (R&R) CDC, FDA, AHRQ, VA greater than or equal to the Proposed Project Start Date listed on the SF 424 RR. Budget Year>, the start date should the same or later than the proposed project start date listed on the SF 424 RR Cover. & 5YR, (R&R) End Date 020.5.1 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single The Budget end date must be greater than the budget start date and less than or equal to the Project Period End Date listed on the SF 424 RR Face Page For <Organization name> budget for budget period < Budget Year>, the end date must be later than the budget start date and less than or to the same as the proposed project end date listed on the SF 424 RR Cover. E & 5YR, (R&R) Senior/Key Person x Name, Prefix 020.6 & Senior/Key Person x Name, First Name 020.7
5YR, (R&R) & 5YR, (R&R) Senior/Key Person x Name, Middle Name 020.8 & 5YR, (R&R) Senior/Key Person x Name, Last Name 020.9 & 5YR, (R&R) Senior/Key Senior/Key Person Project Role N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Excl: R41, R42, UT1, UT2 Single For Budget type project, the first senior/key person with Project Role of PD/PI must match last name and first name on the PD/PI on the SF424 Cover . Exclude: STTR applications For <Organization Name>, the PD/PI name for budget period <budget year>) does not match the PD/PI name on the SF 424 RR Cover. E & Senior/Key Person Project Role N Y Incl : NIH, CDC, FDA, AHRQ, Incl: V 1.3 Excl: R41, R42, UT1, UT2 Single For budgets type ‘Project’, there must be at least one record for the budget year with a project role of PD/PI. For <Organization Name>, a Personnel entry with a project role of “PD/PI” is required for budget period <budget year>. E
5YR, (R&R) VA Exclude: STTR applications & 5YR, (R&R) Senior/Key Person x Name, Base Salary ($) Y Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Cannot be greater than 99,999,999.99. For <Organization name> budget for Budget Period < Budget Year>, the Base Salary for Senior/Key Person <Last Name, First Name> exceeds the allowable amount for the agency. E & 5YR, (R&R) Senior/Key Person x Name, Cal. Months N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Excl: R13, U13 A non-zero value for calendar months, academic months, or summer months is required for each senior/key person. (except for PD/PIs on STTR (R41, R42, UT1, UT2) submissions), For <Organization name> budget for Budget Period < Budget Year>, Senior/Key Person <Last Name, First Name> must include effort of a value greater than zero in calendar months, academic months, or summer months. Note: use either calendar months or a combination of academic and summer months. For information about calculating person months, see E & Senior/Key Person x Name, Cal. Months N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Incl: R13, U13 Single A value for calendar months, academic months, or summer months is required for each senior/key For <Organization name> budget for Budget Period < Budget Year>, Senior/Key Person <Last Name, First Name> must include effort (zero or greater) in calendar E
5YR, (R&R) person. The value may be zero. months, academic months, or summer months. Note: use either calendar months or a combination of academic and summer months. For information about calculating person months, see . & 5YR, (R&R) Senior/Key Person Cal. Mos N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 For PD/PIs (submission of R41, R42, UT1, UT2) STTR submissions, a value for calendar months, academic months, or summer months is required on either the project budget or the subaward budget. It is not required on both but can be provided. For Budget Period <Budget Year>, at least one person with the project role of PD/PI must include effort of a value greater then zero in calendar months, academic months or summer months. Note: use either calendar months or a combination of academic and summer months. For information about calculating person months, see . E & 5YR, (R&R) Senior/Key Person x Name, Acad. Months N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Provide warning if both academic and calendar months have been provided for a person for a budget year. For <Organization name> budget for Budget Period < Budget Year>, Senior/Key Person <Last Name, First Name>, both academic and calendar months have been included. Please use either calendar months or a combination of academic and summer months. If effort does not change throughout the year, use the calendar months column. If effort varies between academic and summer months, leave the calendar months column blank and use only the academic and summer month’s columns. W
& 5YR, (R&R) Senior/Key Person x Name, Sum. Months 020.14 & 5YR, (R&R) Senior/Key Person Requested salary 020.15 & 5YR, (R&R) Senior/Key Person x Name, Fringe Benefits ($) Y Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Cannot be greater than 99,999,999.99. For <Organization name> budget for Budget Period < Budget Year>, the Fringe Benefits for Senior/Key Person < Last Name, First Name> exceed the allowable amount for the agency. E & Senior/Key Person Funds Requested N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Must be equal to the sum of Requested Salary and Fringe Benefits for the Senior/Key Person for the budget year. For <Organization name> budget for Budget Period < Budget Year>, the Funds Requested amount for Senior/Key Person < Last Name, First Name> does not equal the sum of the E
5YR, (R&R) & 5YR, (R&R) Other Personnel, Acad Months 020.22 & 5YR, (R&R) Other Personnel, Sum Months 020.23 & 5YR, (R&R) Other Personnel, Requested Salary 020.24
& 5YR, (R&R) Other Personnel, Fringe Benefits 020.25 & 5YR, (R&R) Other Personnel, Funds Requested 020.26 & 5YR, (R&R) Total number other personnel 020.27 & Total Funds Requested other personnel 020.28
5YR, (R&R) & 5YR, (R&R) Total salary, wages and fringe benefits N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Must equal the sum of Total Funds requested for all senior/key persons and Total Funds Requested other personnel For <Organization name> budget for Budget Period < Budget Year>, the Total Salary, Wages and Fringe Benefits amount does not equal the sum of the Total Senior/Key Persons Funds Requested and Total Other Personnel Funds Requested. E & 5YR, (R&R) Equipment description, equipment item 020.30 & 5YR, (R&R) Equipment description, x equip funds req. 020.31 & Equipment description, total funds requested in attachment N Y Incl : NIH, CDC, FDA, AHRQ, Incl: V 1.3 Single Required if Additional Equipment Attachment is included. For <Organization name> for Budget Period < Budget Year>, the ‘Total Funds requested for all equipment listed in the attached file’ is E
5YR, (R&R) VA required since an attachment is provided. & 5YR, (R&R) Equipment description, total equipment 020.33 & 5YR, (R&R) Additional equipment attachment N Y Incl: NIH Incl: V 1.3 Single Provide error if attachment is provided and less than 10 equipment items have been entered for that budget period For <Organization name> budget for Budget Period < Budget Year>, the Additional Equipment attachment cannot be provided unless all 10 Equipment item entries are used. E & 5YR, (R&R) Travel, domestic travel costs, funds req 020.25
& 5YR, (R&R) Travel, foreign travel costs, funds req 020.26 & 5YR, (R&R) Total travel cost, funds req 020.27 & 5YR, (R&R) support costs: Insurance, funds req 020.28 & support costs: stipends, funds req 020.29
5YR, (R&R) & 5YR, (R&R) support costs: Number of N N Incl: NIH, CDC, FDA, AHRQ VA Incl: V 1.3 Incl: K12 Single If Number of participants/Trainees is zero or blank, provide warning For <Organization name> budget for Budget Period < Budget Year>, the Number of Participants/Trainees should be provided in the Participant/Trainee Support Costs section of the budget. W Update to existing rule (removed KM1) & 5YR, (R&R) support costs: Total Support Costs 020.35 & 5YR, (R&R) Other Direct Costs materials & supplies; Funds Req 020.36
& 5YR, (R&R) Other Direct Costs Publication Costs; Funds Req 020.37 & 5YR, (R&R) Other Direct Costs Consultant Services; Funds Req 020.38 & 5YR, (R&R) Other Direct Costs ADP/Computer Services; Funds Req 020.39 & Other Direct Costs Costs) N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Provide warning for Project budget if Consortium cost is Null or '0' for all budget periods and a A Subaward/Consortium Budget form is included in the application. The total costs of all subawards submitted for this application should be reflected in the Other Direct Costs section of the Project W
5YR, (R&R) subaward exists for the application budget in the Funds requested Subaward/Consortium Costs field. & 5YR, (R&R) Other Direct Costs Equipment or Facility Rental/User Fees; Funds Req 020.41 & 5YR, (R&R) Other Direct Costs (Alterations and Renovations) 020.42 & 5YR, (R&R) Other Direct Costs (8. other description 1) 020.43 & Other Direct Costs (other1 funds requested) 020.44
5YR, (R&R) & 5YR, (R&R) Other Direct Costs (9. other description 2) 020.45 & 5YR, (R&R) Other Direct Costs (other2 funds requested) 020.46 & 5YR, (R&R) Other Direct Costs (10. other description 3) 020.47
& 5YR, (R&R) Other Direct Costs (other3 funds requested) 020.48 & 5YR, (R&R) Other Direct Costs, Total Other Direct Costs N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Must be equal to the sum of other direct costs for the budget yea For <Organization name> budget for Budget Period < Budget Year>, the Total Other Direct Costs does not equal the sum of the individual Other Direct Cost categories. E & 5YR, (R&R) Total Direct Costs (A-F) 020.50 & Total Direct Costs (A-F) N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Must be equal to the sum of total salary, wages and fringe benefits, total funds requested for equipment, total travel cost, total participant/trainee For <Organization name> budget for Budget Period < Budget Year>, the Total Direct Costs Funds Requested (does not equal the sum of individual direct costs in Sections A through F. E
5YR, (R&R) support costs, and total other direct costs & 5YR, (R&R) Total Direct Costs (A-F) N Y Incl : NIH Incl: V 1.3 Include: R03, R21, R01, U01, R34, U34, UH2 Single For Project Budget, provide warning if subtotal direct costs for every budget period is < = $250K. Applications where the applicant organization is foreign are exempt from this validation. Calculate subtotal direct costs as follows: Total Direct Costs minus the sum of Total Indirect Costs for all budgets for the corresponding year with budget type ‘subaward/consortium’. An application with a direct cost request of $250K or less for each period should use the PHS 398 Modular Budget. W Year x (R&R) Total Direct Costs (A-F) N Y Incl: NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Excl: R41, R42, UT1, UT2., R43, R44, U43, U44, S21, S22, Single Provide warning if Subtotal Direct Cost is equal to or more than 500 K for any budget period. Note: Exclude SBIR/STTR. Exclude RFAs) Calculate subtotal direct costs as follows: Total Direct Costs (A-F) minus the sum of Total Indirect Costs for all budgets for the corresponding year with budget type ‘subaward/consortium’ Direct cost requests of $500K or more a year need agreement to accept assignment from Institute/Center staff, except for RFAs or PAs with budgetary limits. Applications without such agreement may be delayed or not accepted for review. W May 2016 Release (Message text updated) Update to existing (add exclusion of S21, S22) Message text updated Total Direct Costs (A-F) N Y Incl : NIH, V 1.3 Incl: R15, UA5 Single Provide warning if subtotal direct costs for Direct cost requests are typically limited to $300k for this type of application. Be W
Year x (R&R) CDC, FDA, AHRQ, VA any budget period is > $300K. Calculate subtotal direct costs as follows: Total Direct Costs minus the sum of Total Indirect Costs for all budgets for the corresponding year with budget type ‘subaward/consortium’. sure to comply with the Funding Opportunity Announcement (FOA) instructions. Year x (R&R) Total Direct Costs (A-F) N Y Incl : NIH, CDC, FDA, AHRQ, VA V 1.3 Incl: G13 Single The subtotal direct costs on the project budget cannot be greater than 50k. Calculate subtotal direct costs as follows: Total Direct Costs minus the sum of Total Indirect Costs for all budgets for the corresponding year with budget type ‘subaward/consortium’. Direct cost requests are typically limited to $50k. E & 5YR, (R&R) Indirect Costs, Indirect Cost Rate N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Provide warning if less than 1. For <Organization name> budget for Budget Period < Budget Year, the Indirect Cost Rate is less than 1. Please note that this figure represents a percentage (e.g., ’25.5’, not ‘.255’). W & Indirect Costs, Indirect Cost Rate N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: K02, K05, K24, K26, K01, K07, K08, K18, K22, K23, Single If Indirect cost rate is provided and not equal to 8, generate warning For <Organization name> budget for budget period < Budget Year>, the Indirect Cost Rate should be equal to 8. W Update to existing rule (removed KM1)
5YR, (R&R) K25, K99, K99/R00, K12, K30 & 5YR, (R&R) Indirect Costs, x Indirect Cost Base N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: G08, G13, S21, S22 Single Provide an error if Indirect Cost Base is greater than 0. For <Organization name> for budget period < Budget Year>, no indirect cost base is allowed. E & 5YR, (R&R) Indirect Costs, x Funds Requested N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Incl: G08, G13, S21, S22 Single Provide an error if Indirect Cost Funds requested is greater than 0. For <Organization name> for budget period < Budget Year>, no indirect cost Funds Requested funds is allowed. E & 5YR, (R&R) Total Indirect Costs N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Must be equal to funds requested for all indirect cost types For <Organization name> budget for Budget Period < Budget Year>, the Total Indirect Costs does not equal the sum of individual indirect costs for each indirect cost type. E Total Indirect Costs 020.57
& 5YR, (R&R) & 5YR, (R&R) Total Direct and Indirect Costs N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Must be equal to the sum of Total Direct Costs and Total Indirect Costs For <Organization name> budget for Budget Period < Budget Year>, the Total Direct and Indirect Costs Funds Requested do not equal the sum of individual direct and indirect costs. E & 5YR, (R&R) Fee N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single A fee cannot be entered for a subaward/consortium budget. For <Organization name> budget for Budget Period < Budget Year>, a fee has been entered. Fees are not allowed for ‘Subaward/Consortium’ budgets. E & Budget Justification 020.60
5YR, (R&R) R&R Budget(5Year) Cumulative Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency (Lists Form FOA Specific Activity Specific Lists Activity Code & to Multi or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) & Related Budget 5YR, (R&R) Section A. Senior/Key Person, Totals ($) 020.61 & Related Budget Section B. Other Personnel, Totals ($) 020.62
5YR, (R&R) & Related Budget 5YR, (R&R) Total number other personnel 020.63 & Related Budget 5YR, (R&R) Total Salary, wages and fringe benefits (A+B), Totals ($) 020.64 & Related Budget 5YR, (R&R) Section C. Equipment, Totals ($) 020.65 & Related Budget Section D. Travel, Totals ($) 020.66
5YR, (R&R) & Related Budget 5YR, (R&R) 1. Domestic, Totals ($) 020.67 & Related Budget 5YR, (R&R) 2. Foreign, Totals ($) 020.68 & Related Budget 5YR, (R&R) Section E. Support Costs, Totals ($) 020.69 & Related Budget 1. Insurance, Totals ($ 020.70
5YR, (R&R) & Related Budget 5YR, (R&R) 2. Stipends, Totals ($) 020.71 & Related Budget 5YR, (R&R) 3. Travel, Totals ($) 020.72 & Related Budget 5YR, (R&R) 4. Subsistence, Totals ($) 020.73 & Related Budget 5. Other, Totals ($) 020.74
5YR, (R&R) & Related Budget 5YR, (R&R) 6. Number of 020.75 & Related Budget 5YR, (R&R) Section F. Other Direct Costs, Totals ($) 020.76 & Related Budget 5YR, (R&R) 1. Materials and Supplies 020.77 & Related Budget 2. Publication Costs 020.78
5YR, (R&R) & Related Budget 5YR, (R&R) Section G, Direct Costs total 020.87.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Incl: G08 For a submission with one budget period, must be less than or equal to $100k. The cumulative ‘Total Direct Costs for Entire Project Period’ is limited to $100K if one (1) budget period has been included. E & Related Budget 5YR, (R&R) Section G, Direct Costs total 020.87.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Incl: G08 For a submission with two budget periods, must be less than or equal to $200k. The cumulative ‘Total Direct Costs for Entire Project Period’ is limited to $200K if two (2) budget periods have been included. E & Related Budget 5YR, (R&R) Section G, Direct Costs total 020.87.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Incl: G08 For a submission with three budget periods, must be less than or equal to $300k. The cumulative ‘Total Direct Costs for Entire Project Period’ is limited to $300K if three (3) budget periods have been included. E & Related Budget Section G, Direct Costs (A thru F) 020.88.1 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Must be equal to the sum of Total Direct Costs for every budget year for this budget. For <Organization name> budget, the Cumulative Direct Costs does not equal the sum of Total Direct Costs for all budget periods. E
5YR, (R&R) R&R Budget(10Year) (Use only for Single-project) Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) Shared (Y/N) Agency Specific (Lists Form FOA Specific Activity Specific Lists Activity Code (Inclusion & Exclusion) to Single Multi or Both Applies to Com- ponent Type Cross (Multi Project Only) Unless specifically stated, all project budget validations also apply to the subaward budget. & Related 022.0.1 N Y Incl: NIH Incl: V 1.3 Incl: R03, R21, UH2 Single The application should be submitted with a modular budget. Applications submitted by domestic institutions (U.S.) must use the PHS 398 E
Budget 10YR, (R&R) CDC, FDA, AHRQ, VA ‘Project’ in the application. be submitted for the application. & Related Budget 10YR, (R&R) Budget type (project, 022.3.2 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Incl: R41. R42, UT1, UT2 For an STTR submission, there must be at least one budget included with budget type of subaward/consortium for each year of the STTR (project) budget. A research institution Budget page must be included for each year of an STTR submission. E & Related Budget 10YR, (R&R) Start Date 022.4.1 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single For budget year 1, for Budget Type ‘Project’, for new applications and resubmissions, must be the same as the Proposed Project Start Date listed on the SF 424 RR. For <Organization name> for budget period < Budget Year>, the start date for new and resubmission applications must be the same as the proposed project start date listed on the SF 424 RR Cover. W & Related Budget 10YR, (R&R) Start Date 022.4.2 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single For budget years after budget year 1, must be greater than or equal to the Proposed Project Start Date listed on the SF 424 RR. For <Organization name> budget for budget period < Budget Year>, the start date should be the same or later than the proposed project start date listed on the SF 424 RR Cover. W & Related Budget 10YR, (R&R) End Date 022.5.1 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single The Budget end date must be greater than the budget start date and less than or equal to the Project Period End Date listed on the SF 424 RR Face Page For <Organization name> budget for budget period < Budget Year>, the end date must be later than the budget start date and less than or to the same as the proposed project end date listed on the SF 424 RR Cover. E
& Related Budget 10YR, (R&R) Senior/Key Person x Name, Prefix 022.6 & Related Budget 10YR, (R&R) Senior/Key Person x Name, First Name 022.7 & Related Budget 10YR, (R&R) Senior/Key Person x Name, Middle Name 022.8 & Related Budget 10YR, (R&R) Senior/Key Person x Name, Last Name 022.9 & Related Budget 10YR, (R&R) Senior/Key Senior/Key Person Project Role N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Excl R41, R42, UT1, UT2 Single For Budget type project, the first senior/key person with Project Role of PD/PI must match last name and first name on the PD/PI on the SF424 Cover Exclude: STTR applications For <Organization Name>, the PD/PI name for budget period <budget year>) does not match the PD/PI name on the SF 424 RR Cover. E & Related Budget 10YR, (R&R) Senior/Key Person Project Role N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Excl R41, R42, UT1, UT2 Single For budgets type ‘Project’, there must be at least one record for the budget year with a project role of PD/PI. For <Organization Name>, a Personnel entry with a project role of “PD/PI” is required for budget period <budget year>. E
Exclude: STTR applications & Related Budget 10YR, (R&R) Senior/Key Person x Name, Base Salary ($) Y Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Cannot be greater than 99,999,999.99. For <Organization name> budget for Budget Period < Budget Year>, the Base Salary for Senior/Key Person <Last Name, First Name> exceeds the allowable amount for the agency. E & Related Budget 10YR, (R&R) Senior/Key Person x Name, Cal. Months N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Excl: R13, U13 A non-zero value for calendar months, academic months, or summer months is required for each senior/key person. (except for PD/PIs on STTR (R41, R42, UT1, UT2) submissions), For <Organization name> budget for Budget Period < Budget Year>, Senior/Key Person <Last Name, First Name> must include effort of a value greater than zero in calendar months, academic months, or summer months. Note: use either calendar months or a combination of academic and summer months. For information about calculating person months, see E & Related Budget 10YR, (R&R) Senior/Key Person x Name, Cal. Months N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Incl: R13, U13 Single A value for calendar months, academic months, or summer months is required for each senior/key person. The value may be zero. For <Organization name> budget for Budget Period < Budget Year>, Senior/Key Person <Last Name, First Name> must include effort (zero or greater) in calendar months, academic months, or summer months. Note: use either calendar months or a combination of academic and summer months. For information about calculating person months, see . E
& Related Budget 10YR, (R&R) Senior/Key Person Cal. Mos N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 For PD/PIs on STTR submissions (R41, R42, UT1, UT2), a value for calendar months, academic months, or summer months is required on either the project budget or the subaward budget. It is not required on both but can be provided. For Budget Period <Budget Year>, at least one person with the project role of PD/PI must include effort of a value greater then zero in calendar months, academic months or summer months.Note: use either calendar months or a combination of academic and summer months. For information about calculating person months, see . E & Related Budget 10YR, (R&R) Senior/Key Person x Name, Acad. Months N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Provide warning if both academic and calendar months have been provided for a person for a budget year. For <Organization name> budget for Budget Period < Budget Year>, Senior/Key Person <Last Name, First Name>, both academic and calendar months have been included. Please use either calendar months or a combination of academic and summer months. If effort does not change throughout the year, use the calendar months column. If effort varies between academic and summer months, leave the calendar months column blank and use only the academic and summer month’s columns. W & Related Budget 10YR, (R&R) Senior/Key Person x Name, Sum. Months 022.14 & Related Senior/Key Person 022.15
Budget 10YR, (R&R) Requested salary & Related Budget 10YR, (R&R) Senior/Key Person x Name, Fringe Benefits ($) Y Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Cannot be greater than 99,999,999.99. For <Organization name> budget for Budget Period < Budget Year>, the Fringe Benefits for Senior/Key Person < Last Name, First Name> exceed the allowable amount for the agency. E & Related Budget 10YR, (R&R) Senior/Key Person Funds Requested N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Must be equal to the sum of Requested Salary and Fringe Benefits for the Senior/Key Person for the budget year. For <Organization name> budget for Budget Period < Budget Year>, the Funds Requested amount for Senior/Key Person < Last Name, First Name> does not equal the sum of the Requested Salary and the Fringe Benefits. E & Related Budget 10YR, (R&R) Total funds requested for Senior Key Persons in attachment N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Required if Additional Senior Key Persons Attachment is included. For <Organization name> budget for Budget Period < Budget Year>, the ‘Total Funds requested for all Senior Key Persons in the attached file’ is required since an attachment is provided. E & Related Budget 10YR, (R&R) Total Funds requested for all senior/key persons 022.19 & Related Budget 10YR, (R&R) Additional Senior Key Persons attachment N Y NIH Single Provide error if attachment is provided and less than eight key personnel have been submitted on the budget page for this year. For <Organization name> budget for budget period < Budget Year>, the Additional Senior/Key Person attachment cannot be provided unless all 8 Sr/Key Person entries are used. E
& Related Budget 10YR, (R&R) Other Personnel, Cal Months 022.21 & Related Budget 10YR, (R&R) Other Personnel, Acad Months 022.22 & Related Budget 10YR, (R&R) Other Personnel, Sum Months 022.23 & Related Budget 10YR, (R&R) Other Personnel, Requested Salary 022.24 & Related Budget 10YR, (R&R) Other Personnel, Fringe Benefits 022.25 & Related Budget 10YR, (R&R) Other Personnel, Funds Requested 022.26 & Related Budget Total number other personnel 022.27
10YR, (R&R) & Related Budget 10YR, (R&R) Total Funds Requested other personnel 022.28 & Related Budget 10YR, (R&R) Total salary, wages and fringe benefits N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Must equal the sum of Total Funds requested for all senior/key persons and Total Funds Requested other personnel For <Organization name> budget for Budget Period < Budget Year>, the Total Salary, Wages and Fringe Benefits amount does not equal the sum of the Total Senior/Key Persons Funds Requested and Total Other Personnel Funds Requested. E & Related Budget 10YR, (R&R) Equipment description, equipment item 022.30 & Related Budget 10YR, (R&R) Equipment description, x equip funds req. 022.31 & Related Budget 10YR, (R&R) Equipment description, total funds requested in attachment N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Required if Additional Equipment Attachment is included. For <Organization name> for Budget Period < Budget Year>, the ‘Total Funds requested for all equipment listed in the attached file’ is required since an attachment is provided. E & Equipment description, 022.33
Related Budget 10YR, (R&R) total equipment & Related Budget 10YR, (R&R) Additional equipment attachment N Y Incl: NIH Incl: V 1.3 Single Provide error if attachment is provided and less than 10 equipment items have been entered for that budget period For <Organization name> budget for Budget Period < Budget Year>, the Additional Equipment attachment cannot be provided unless all 10 Equipment item entries are used. E & Related Budget 10YR, (R&R) Travel, domestic travel costs, funds req 022.35 & Related Budget 10YR, (R&R) Travel, foreign travel costs, funds req 022.36 & Related Budget 10YR, (R&R) Total travel cost, funds req 022.37 & Related Budget 10YR, (R&R) support costs: Insurance, funds req 022.38 & Related support 022.39
Budget 10YR, (R&R) costs: stipends, funds req & Related Budget 10YR, (R&R) support costs: travel, funds req 022.40 & Related Budget 10YR, (R&R) support costs: funds req 022.41 & Related Budget 10YR, (R&R) support costs: description of other 022.42 & Related Budget 10YR, (R&R) support costs: other, funds req 022.43 & Related Budget support costs: Number of N N Incl: NIH, CDC, FDA, AHRQ VA Incl: V 1.3 Incl: K12 Single If Number of participants/Trainees is zero or blank, provide warning For <Organization name> budget for Budget Period < Budget Year>, the Number of Participants/Trainees should be provided in the W Update to existing rule (removed KM1)
10YR, (R&R) Participant/Trainee Support Costs section of the budget. & Related Budget 10YR, (R&R) support costs: Total Support Costs 022.45 & Related Budget 10YR, (R&R) Other Direct Costs materials & supplies; Funds Req 022.46 & Related Budget 10YR, (R&R) Other Direct Costs Publication Costs; Funds Req 022.47 & Related Budget 10YR, (R&R) Other Direct Costs Consultant Services; Funds Req 022.48 & Related Budget Other Direct Costs Services; Funds Req 022.49
Related Budget 10YR, (R&R) funds requested) & Related Budget 10YR, (R&R) Other Direct Costs (9. other description 2) 022.55 & Related Budget 10YR, (R&R) Other Direct Costs (other2 funds requested) 022.56 & Related Budget 10YR, (R&R) Other Direct Costs (10. other description 3) 022.57 & Related Budget 10YR, (R&R) Other Direct Costs (other3 funds requested) 022.58 & Related Budget Other Direct Costs, Total Other Direct Costs N Y Incl : NIH, Incl: V 1.3 Single Must be equal to the sum of other direct costs for the budget yea For <Organization name> budget for Budget Period < Budget Year>, the Total Other Direct Costs does not E
Related Budget 10YR, (R&R) NIH, CDC, FDA, AHRQ, VA R41, R42, UT1, UT2, R43, R44, U43, U44, S21, S22, SB1,UB1 or greater than 500K for any budget period Exclude SBIR/STTR. Exclude RFAs Calculate subtotal direct costs as follows: Total Direct Costs minus the sum of Total Indirect Costs for all budgets for the corresponding year with budget type ‘subaward/consortium’. approval to accept assignment from Institute/Center staff, except for RFAs or PAs with budgetary limits. Applications without such approval may be delayed or not accepted for review. (add exclusion of S21, S22) Updated Message text May 2016 Release: Update to Existing trigger and rule & Related Budget 10YR, (R&R) Total Direct Costs (A-F) N Y Incl : NIH, CDC, FDA, AHRQ, VA V 1.3 Incl: R15, UA5 Single Provide warning if subtotal direct costs for any budget period is > $300K. Calculate subtotal direct costs as follows: Total Direct Costs minus the sum of Total Indirect Costs for all budgets for the corresponding year with budget type ‘subaward/consortium’. Direct cost requests are typically limited to $300k for this type of application. Be sure to comply with the Funding Opportunity Announcement (FOA) instructions. W & Related Budget 10YR, (R&R) Total Direct Costs (A-F) N Y Incl : NIH, CDC, FDA, AHRQ, VA V 1.3 Incl: G13 Single The subtotal direct costs on the project budget cannot be greater than 50k. Calculate subtotal direct costs as follows: Total Direct Costs minus the sum of Total Indirect Costs for all budgets for the corresponding year with budget type ‘subaward/consortium’. Direct cost requests are typically limited to $50k. E
& Related Budget 10YR, (R&R) Indirect Costs, Indirect Cost Rate N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Provide warning if less than 1. For <Organization name> budget for Budget Period < Budget Year, the Indirect Cost Rate is less than 1. Please note that this figure represents a percentage (e.g., ’25.5’, not ‘.255’). W & Related Budget 10YR, (R&R) Indirect Costs, Indirect Cost Rate N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl:K02, K05, K24, K26, K01, K07, K08, K18, K22, K23, K25, K99, K99/R00, K12, K30, Single If Indirect Cost rate is provided and not equal to 8, generate warning For <Organization name> budget for budget period < Budget Year>, the Indirect Cost Rate should be equal to 8. W Update to existing rule (removed KM1) & Related Budget 10YR, (R&R) Indirect Costs, x Indirect Cost Base N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: G08, G13, S21, S22 Single Provide an error if Indirect Cost Base is greater than 0. For <Organization name> for budget period < Budget Year>, no indirect cost base is allowed. E & Related Budget 10YR, (R&R) Indirect Costs, x Funds Requested N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Incl: G08, G13, S21, S22 Single Provide an error if Indirect Cost Funds requested greater than 0. For <Organization name> for budget period < Budget Year>, no indirect cost base is allowed. E & Related Budget 10YR, (R&R) Total Indirect Costs N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Must be equal to funds requested for all indirect cost types For <Organization name> budget for Budget Period < Budget Year>, the Total Indirect Costs does not equal the sum of individual indirect costs for each indirect cost type. E
& Related Budget 10YR, (R&R) Total Indirect Costs 022.66 & Related Budget 10YR, (R&R) Total Direct and Indirect Costs N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single Must be equal to the sum of Total Direct Costs and Total Indirect Costs For <Organization name> budget for Budget Period < Budget Year>, the Total Direct and Indirect Costs Funds Requested do not equal the sum of individual direct and indirect costs. E & Related Budget 10YR, (R&R) Fee N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Single A fee cannot be entered for a subaward/consortium budget. For <Organization name> budget for Budget Period < Budget Year>, a fee has been entered. Fees are not allowed for ‘Subaward/Consortium’ budgets. E & Related Budget 10YR, (R&R) Budget Justification 022.69 R&R Budget(10Year) Cumulative
Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency (Lists Form FOA Specific Activity Specific Lists Activity Code & to Multi or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) & Related Budget 10YR, (R&R) Section A. Senior/Key Person, Totals ($) 022.70 & Related Budget 10YR, (R&R) Section B. Other Personnel, Totals ($) 022.71 & Related Budget 10YR, (R&R) Total number other personnel 022.72 & Related Budget 10YR, (R&R) Total Salary, wages and fringe benefits (A+B), Totals ($) 022.73 & Related Budget 10YR, (R&R) Section C. Equipment, Totals ($) 022.74
Budget 10YR, (R&R) & Related Budget 10YR, (R&R) 1. Materials and Supplies 022.86 & Related Budget 10YR, (R&R) 2. Publication Costs 022.87 & Related Budget 10YR, (R&R) 3. Consultant Services 022.88 & Related Budget 10YR, (R&R) 4. ADP/Computer Services 088.89 & Related Budget 5. Costs 022.90
10YR, (R&R) & Related Budget 10YR, (R&R) 6. Equipment or Facility Rental/Use Fees 022.91 & Related Budget 10YR, (R&R) 7. Alterations and Renovations 022.92 & Related Budget 10YR, (R&R) 8. Other1 022.93 & Related Budget 10YR, (R&R) 9. Other2 022.94 & Related Budget 10YR, (R&R) 10. Other3 022.95
& Related Budget 10YR, (R&R) Section I, Total Direct and Indirect Costs 022.99 & Related Budget 10YR, (R&R) Section I, Total Direct and Indirect Costs (G + 022.100.1 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.3 Must be equal to the sum of Total Direct and Indirect Costs for every budget year for this budget. For <Organization name> budget, the Cumulative Total Direct and Indirect Costs does not equal the sum of Direct and Indirect Costs for all budget periods. E & Related Budget 10YR, (R&R) Section J, Fee 022.101 R&R Budget (10Year) MP (Use only for Multi-project)
SF 424 RR MP for a given component. & Related Budget 10YR, (R&R) MP Start Date 006.4.2 Incl: V1.0 Multi Y For budget years after budget year 1, must be greater than or equal to the Proposed Project Start Date listed on the SF 424 RR MP for a given component. On the <Organization name> budget for Budget Period < Budget Year>, the start date should equal to or later than the proposed project start date listed on the Component SF 424 RR Cover page. W & Related Budget 10YR, (R&R) MP End Date 006.5.1 Incl: V1.0 Multi Y The Budget end date must be greater than the budget start date and less than or equal to the Project Period End Date listed on the SF 424 RR MP for a given component. On the <Organization name> budget for Budget Period < Budget Year>, the end date must be later than the budget start date and less than or equal to the proposed project end date listed on the Component SF 424 RR Cover page. E & Related Budget 10YR, (R&R) MP End Date 006.5.2 Incl: V1.0 flag= 'No' Multi Y End date of last budget period should not be later than 5 years after the start date of the first budget period if the Project_Period_Except flag is set to 'No' in rfa_pa_notices_t. The end date cannot be later than 5 years after the start date for <Organization name or DUNS (if Org name not available)> for Budget Period < Budget Year>. E & Related Budget 10YR, Senior/Key Person x Name, Prefix 006.6
(R&R) MP & Related Budget 10YR, (R&R) MP Senior/Key Person x Name, First Name 006.7 & Related Budget 10YR, (R&R) MP Senior/Key Person x Name, Middle Name 006.8 & Related Budget 10YR, (R&R) MP Senior/Key Person x Name, Last Name 006.9 & Related Budget 10YR, (R&R) MP Senior/Key Person x Name, Suffix 006.10 & Related Budget 10YR, (R&R) MP Senior/Key Senior/Key Person Project Role 006.11 & Related Budget Senior/Key Person x Name, Base Salary ($) Incl: V1.0 Multi N Cannot be greater than 99,999,999.99. On the <Organization name> budget for Budget Period < Budget Year>, the Base Salary for E
throughout the year, use the calendar months column. If effort varies between academic and summer months, leave the calendar months column blank and use only the academic and summer months. & Related Budget 10YR, (R&R) MP Senior/Key Person x Name, Sum. Months 006.15 & Related Budget 10YR, (R&R) MP Senior/Key Person Requested salary 006.16 & Related Budget 10YR, (R&R) MP Senior/Key Person x Name, Fringe Benefits ($) Incl: V1.0 Multi N Cannot be greater than 99,999,999.99. On the <Organization name> budget for Budget Period < Budget Year>, the Fringe Benefits for Senior/Key Person < Last Name, First Name> exceed the allowable amount for the agency. E & Related Budget 10YR, Senior/Key Person Funds Requested Incl: V1.0 Multi N Must be equal to the sum of Requested Salary and Fringe Benefits for the On the <Organization name> budget for Budget Period < Budget Year>, the Funds Requested amount for Senior/Key Person < Last Name, First E
& Related Budget 10YR, (R&R) MP Total number other personnel 006.29 & Related Budget 10YR, (R&R) MP Total Funds Requested other personnel 006.30 & Related Budget 10YR, (R&R) MP Total salary, wages and fringe benefits Incl: V1.0 Multi N Must equal the sum of Total Funds requested for all senior/key persons and Total Funds Requested other personnel On the <Organization name> budget for Budget Period < Budget Year>, the Total Salary, Wages and Fringe Benefits amount does not equal the sum of the Total Senior/Key Persons Funds Requested (Section A) and Total Other Personnel Funds Requested (Section B). E & Related Budget 10YR, (R&R) MP Equipment description, equipment item 006.32 & Related Budget 10YR, Equipment description, x equip funds req. 006.33
(R&R) MP & Related Budget 10YR, (R&R) MP Equipment description, total funds requested in attachment Incl: V1.0 Multi N Required if Additional Equipment Attachment is included. On the <Organization name> budget for Budget Period < Budget Year>, the ‘Total Funds requested for all equipment listed in the attached file’ is required since an attachment is provided. E & Related Budget 10YR, (R&R) MP Equipment description, total equipment 006.35 & Related Budget 10YR, (R&R) MP Additional equipment attachment Incl: V1.0 Multi N Provide error if attachment is provided and less than 100 equipment items have been entered for that budget period On the <Organization name> budget for Budget Period < Budget Year>, the Additional Equipment attachment cannot be provided unless all 100 Equipment item entries are used. E & Related Budget 10YR, (R&R) MP Travel, domestic travel costs, funds req 006.37 & Related Budget 10YR, Travel, foreign travel costs, funds req 006.38
Budget 10YR, (R&R) MP costs: description of other & Related Budget 10YR, (R&R) MP support costs: other, funds req 006.45 & Related Budget 10YR, (R&R) MP support costs: Number of 006.46 & Related Budget 10YR, (R&R) MP support costs: Total Support Costs 006.47 & Related Budget 10YR, (R&R) MP Other Direct Costs materials & supplies; Funds Req 006.48 & Related Budget 10YR, (R&R) MP Other Direct Costs Publication Costs; Funds Req 006.49
& Related Budget 10YR, (R&R) MP Other Direct Costs Consultant Services; Funds Req 006.50 & Related Budget 10YR, (R&R) MP Other Direct Costs Services; Funds Req 006.51 & Related Budget 10YR, (R&R) MP Other Direct Costs Costs) Incl: V1.0 Multi N provide warning for Project budget if all budget periods Consortium cost is Null or '0' and a subaward exists for the component A Subaward/Consortium Budget form is included in the component. The total costs of all subawards submitted for this component should be reflected in the Other Direct Costs section of the Project budget in the Funds requested Subaward/Consortium Costs field. W & Related Budget 10YR, (R&R) MP Other Direct Costs Equipment or Facility Rental/User Fees; Funds Req 006.53 & Related Budget 10YR, Other Direct Costs (Alterations and 006.54
(R&R) MP & Related Budget 10YR, (R&R) MP Other Direct Costs (8. other description 1) 006.55 & Related Budget 10YR, (R&R) MP Other Direct Costs (other1 funds requested) 006.56 & Related Budget 10YR, (R&R) MP Other Direct Costs (9. other description 2) 006.57 & Related Budget 10YR, (R&R) MP Other Direct Costs (other2 funds requested) 006.58 & Related Budget 10YR, (R&R) MP Other Direct Costs (10. other description 3) 006.59 & Related Budget Other Direct Costs (other3 006.60
10YR, (R&R) MP funds requested) & Related Budget 10YR, (R&R) MP Other Direct Costs, Total Other Direct Costs Incl: V1.0 Multi N Must be equal to the sum of other direct costs for the budget year. On the <Organization name> budget for Budget Period < Budget Year>, the Total Other Direct Costs (Section F-K) does not equal the sum of the individual Other Direct Cost categories. E & Related Budget 10YR, (R&R) MP Total Direct Costs (A-F) Incl: V1.0 Multi N Must be equal to the sum of total salary, wages and fringe benefits, total funds requested for equipment, total travel cost, total participant/trainee support costs, and total other direct costs On the <Organization name> budget for Budget Period < Budget Year>, the Total Direct Costs Funds Requested (Section G) does not equal the sum of individual direct costs in Sections A-F. E & Related Budget 10YR, (R&R) MP Indirect Costs, Indirect Cost Rate 006.63 & Related Budget 10YR, (R&R) MP Indirect Costs, Indirect Cost Rate Incl: V1.0 Multi N Provide warning if less than 1. On the <Organization name> budget for Budget Period < Budget Year, the Indirect Cost Rate is less than 1. Please note that this figure represents a W
percentage (e.g., ’25.5’, not ‘.255’). & Related Budget 10YR, (R&R) MP Indirect Costs, x Indirect Cost Base 006.65 & Related Budget 10YR, (R&R) MP Indirect Costs, x Funds Requested 006.66 & Related Budget 10YR, (R&R) MP Total Indirect Costs Incl: V1.0 Multi N Must be equal to funds requested for all indirect cost types On the <Organization name> budget for Budget Period < Budget Year>, the Total Indirect Costs (section F-K) does not equal the sum of individual indirect costs for each indirect cost type. E & Related Budget 10YR, (R&R) MP Indirect Costs, Cognizant Federal Agency 006.68 & Related Budget 10YR, Total Direct and Indirect Costs Incl: V1.0 Multi N Must be equal to the sum of Total Direct Costs and Total Indirect Costs On the <Organization name> budget for Budget Period < Budget Year>, the Total Direct and Indirect Costs Funds E
10YR, (R&R) MP & Related Budget 10YR, (R&R) MP Section D. Travel, Totals ($) 006.77 & Related Budget 10YR, (R&R) MP 1. Domestic, Totals ($) 006.78 & Related Budget 10YR, (R&R) MP 2. Foreign, Totals ($) 006.79 & Related Budget 10YR, (R&R) MP Section E. Support Costs, Totals ($) 006.80 & Related 1. 006.81
& Related Budget 10YR, (R&R) MP 6. Number of 006.86 & Related Budget 10YR, (R&R) MP Section F. Other Direct Costs, Totals ($) 006.87 & Related Budget 10YR, (R&R) MP 1. Materials and Supplies 006.88 & Related Budget 10YR, (R&R) MP 2. Publication Costs 006.89 & Related Budget 3. Consultant Services 006.90
10YR, (R&R) MP & Related Budget 10YR, (R&R) MP 4. ADP/Computer Services 006.91 & Related Budget 10YR, (R&R) MP 5. Costs 006.92 & Related Budget 10YR, (R&R) MP 6. Equipment or Facility Rental/Use Fees 006.93 & Related Budget 10YR, (R&R) MP 7. Alterations and Renovations 006.94 & Related 8. Other1 006.95
& Related Budget 10YR, (R&R) MP Section I, Total Direct and Indirect Costs (G + H) 006.107.1 Incl: V1.0 Multi N Must be equal to the sum of Total Direct and Indirect Costs for every budget year for this budget. For <Organization name> budget, the Cumulative Total Direct and Indirect Costs does not equal the sum of Direct and Indirect Costs for all budget periods. E & Related Budget 10YR, (R&R) MP Section J, Fee 006.101 PHS 398 Research Plan
Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency Specific (Lists Form FOA Specific Activity Specific Lists Activity Code (Inclusion & Exclusion) to Single Multi Project or Both to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) PHS Plan Research Plan Attachments: Introduction N N Incl : NIH, CDC, FDA, AHRQ Both Overall Required for resubmission applications. The Introduction attachment is required for resubmissions. E PHS Plan Research Plan Attachments: Introduction N N Incl : NIH, CDC, FDA, AHRQ Both Overall Required for revisions. The Introduction attachment is required for revisions. E PHS Plan Research Plan Attachments: Introduction N N Incl : NIH, CDC, FDA, AHRQ Both Overall Must not be included for a new or renewal application. The Introduction should not be attached for a new or renewal type of application. E PHS Plan Research Plan Attachments: Introduction N N Incl : NIH, CDC, FDA, AHRQ Excl: RM1, UM1 Both Both Y Limited to 1 page for revisions. Exclude component type 'Complex Component' The Introduction attachment for revision application is limited to one (1) page. E PHS Plan Research Plan Attachments: Introduction N N Incl : NIH, CDC, FDA, AHRQ Excl: RM1, R25, UM1, DP7 Both Both Y Limited to 1 page for resubmissions. Exclude component type 'Complex Component' The Introduction attachment for a resubmission application is limited to one (1) page. E PHS Plan Research Plan Attachments: Introduction N N Incl : NIH, CDC, FDA, AHRQ Multi Y Give warning if not attached for revisions and Resubmissions type The Introduction is usually required for revisions and resubmissions. W PHS Plan Research Plan Attachments: Introduction N N Incl : NIH, CDC, FDA, AHRQ Incl: R25, DP7 Single Limited to 3 pages for resubmissions The Introduction attachment for a resubmission application is limited to three (3) pages. E PHS Plan Research Plan N N Incl : NIH, Excl: DP1, DP2, DP4, Both Both Required attachment The Specific Aims attachment is required. E Update to existing rule
PHS Plan Research Plan Attachments: Research Strategy N N Incl : NIH, CDC, FDA, AHRQ Incl: R25, DP7 Single Research Strategy Attachment must be less than or equal to 25 pages. The Research Strategy attachment is limited to twenty five (25) pages. E PHS Plan Research Plan Attachments: Research Strategy N N Incl : NIH, CDC, FDA, AHRQ = N Incl : R42, UT2, R44, U44, SB1,UB1 Single Research Strategy Attachment must be less than or equal to 12 pages Validation applies to:STTR Phase II), SBIR Phase II and Fast-Track) The Research Strategy attachment is limited to twelve (12) pages. E PHS Plan Research Plan Attachments: Research Strategy N N Incl : NIH, CDC, FDA, AHRQ = Y Incl : R42, UT2, R44, U44 Single Research Strategy Attachment must be less than or equal to 30 pages Validation applies to:STTR Phase II), SBIR Phase II and Fast-Track) The Research Strategy attachment is limited to thirty (30) pages. E PHS Plan Research Plan Attachments: Research Strategy N N Incl : NIH, CDC, FDA, AHRQ = N Incl : R41, UT1, R43, U43 Single Research Strategy Attachment must be less than or equal to 6 pages. Validation applies to: R41(STTR Phase I), R43 (SBIR Phase I)), U43, UT1 The Research Strategy attachment is limited to six (6) pages. E PHS Plan Research Plan Attachments: Research Strategy N N Incl : NIH, CDC, FDA, AHRQ flag = Y Incl : R41, UT1, R43, U43 Single Research Strategy Attachment must be less than or equal to 12 pages Validation includes: R41(STTR Phase I) and R43 (SBIR Phase I), U43 (SBIR Phase I), UT1 (STTR Phase I) The Research Strategy attachment is limited to twelve (12) pages. E PHS Plan Research Plan Attachments: N N Incl: NIH, CDC, Incl: DP1, DP4 SIngle Research Strategy Attachment must be less than or equal to 5 pages. The Research Strategy attachment is limited to five (5) pages. E
Research Strategy FDA, AHRQ PHS Plan Research Plan Attachments: Research Strategy N N Incl: NIH, CDC, FDA, AHRQ Incl: DP2 Single Research Strategy Attachment must be less than or equal to 10 pages The Research Strategy attachment is limited to ten (10) pages. E PHS Plan Research Plan Attachments: Research Strategy N N Incl: NIH, CDC, FDA, AHRQ Incl: X01,X02, OT1 Single Provide a warning if Research Strategy Attachment is greater than 6 pages and less than or equal to12 pages The Research Strategy page limit for < Activity code> applications varies by opportunity. Be sure to comply with the Funding Opportunity Announcement (FOA) instructions . W PHS Plan Research Plan Attachments: Research Strategy N N Incl: NIH, CDC, FDA, AHRQ Incl: X01, X02, OT1 Single Provide error if Research Strategy Attachment is greater than 12 pages You have exceeded the page limit for the Research Strategy. Be sure to comply with the Funding Opportunity Announcement (FOA) instructions. E PHS Plan Research Plan Attachments: Research Strategy N N Incl: NIH, CDC, FDA, AHRQ Incl: OT2 Single Provide a warning if Research Strategy Attachment is greater than 12 pages and less than or equal to 30 pages The Research Strategy page limit varies by opportunity. Be sure to compy with the Funding Opportunity Announcement (FOA) instructions. W PHS Plan Research Plan Attachments: Research Strategy N N Incl: NIH, CDC, FDA, AHRQ Incl: OT2 Single Provide error if Research Strategy Attachment is greater than 30 pages. You have exceeded the page limit for the Research Strategy. Be sure to comply with the Funding Opportunity Announcement (FOA)instructions. E PHS Plan Research Plan Attachments: Progress Report Publication List N N Incl: NIH, AHRQ Excl: V2.0 Both Both Required for renewals. The Progress Report Publication List attachment is required for renewal applications. E Forms D, March 2016 Release
PHS Plan Research Plan Attachments: Progress Report Publication List N N Incl: NIH, AHRQ Excl: V2.0 Both Both Must not be included for a new or revision application The Progress Report Publication List should not be attached for a new or revision type of application. E Forms D, March 2016 Release PHS Plan Research Plan Attachments: Protection of Human Subjects N N Incl : NIH, CDC, FDA, AHRQ Both Required, if Human Subjects is ‘yes’,on Other Project Information form within the same component The Protection of Human Subjects attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’. E PHS Plan Research Plan Attachments: Inclusion of Women and Minorities N N Incl : NIH, CDC, FDA, AHRQ Both Required if Human Subjects is yes and Exemption is not E4 on Other Project Information form within the same component The Inclusion of Women and Minorities attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’ and the Exemption Number is not 4. E PHS Plan Research Plan Attachments: Inclusion of Children N N Incl : NIH, CDC, FDA, AHRQ Both Required if Human Subjects is yes and Exemption is not E4 on Other Project Information form within the same component The Inclusion of Children attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’ and the Exemption Number is not 4. E PHS Plan Research Plan Attachments: Vertebrate Animals N N Incl : NIH, CDC, FDA, AHRQ Excl: S10 Both Required if Vertebrate Animals Used Question is Yes on Other Project Information form within the same component The Vertebrate Animals attachment is required if the response to the Vertebrate/Animals Subject Used question on the Other Project Information is ‘Yes’ E PHS Plan Research Plan Attachments: Select Agent Research 010.11 N N
PHS Plan Research Plan Attachments: Multiple PI Leadership Plan N N Incl : NIH, CDC, FDA, AHRQ Both Overall Required if multiple PD/ PIs are included with the submission The Multiple PI Leadership Plan attachment on the PHS 398 Research Plan must be included if multiple PD/PIs have been included on the Senior/Key Person Profile. E PHS Plan Research Plan Attachments: Multiple PI Leadership Plan N N Incl : NIH, CDC, FDA, AHRQ Both Overall Return error if Leadership Plan is included and there is only one PD/PI identified with the submission For multiple PD/PI applications, be sure to mark each PD/PI with a project role of PD/PI on the Senior/Key Person Profile. If not intending to submit a multiple PD/PI application, remove the Multiple PI Leadership Plan attachment. E PHS Plan Research Plan Attachments: 010.13 PHS Plan Research Plan Attachments: Letters of Support N N Incl: NIH, CDC, FDA, AHRQ Incl: R36 Single Required for an R36 application (activity code on funding opportunity = ‘R36’). Letters of Support must be included for this application. E PHS Plan Research Plan Attachments: Resource Sharing Plan 010.15 PHS Plan Research Plan Attachments: of Key 010.18
Biological and/or Chemical Resources PHS Plan Research Plan Attachments: Appendix N N Incl: NIH Both Both Limited to 10 appendixes You have submitted more than 10 appendices. There is a limit of 10 appendix attachments allowed. E PHS Plan Research Plan Attachments: Appendix N N Incl: NIH, CDC, FDA, AHRQ Incl : R41, UT1, R43, U43 Single Appendixes are not allowed for SBIR or STTR Phase I applications, Exclude RFA Appendices may not be submitted for a Phase I SBIR or STTR application. E PHS Plan Research Plan Attachments: Appendix N N Incl: NIH, CDC, FDA, AHRQ Incl : R41, UT1, R43, U43 Single Provide a warning if an appendix is submitted for an SBIR or STTR Phase I application For RFA ONLY For most RFAs, the submission of appendices with a Phase I SBIR or Phase I STTR is not permitted. Be sure that you have complied with the guidance provided for appendices in this FOA. Applications that do not comply with these instructions may be delayed or not accepted for review. E PHS Plan Research Plan Attachments: Data Safety Monitoring Plan N N Incl : NIH, AHRQ Excl: V 2.0 Both Required if “yes” is selected as the answer to the “Clinical Trial?” question on the PHS Cover Page Supplemental Form The Data Safety Monitoring Plan attachment is required if the response to the Clinical Trial question on the cover Page Supplement is “Yes”. E Forms D March 2016 Release Career Developement Award Supplemental
Career Dev. Award (NIH) Career Dev. Award Attachments: Institutional Commitment to Candidate’s Research Career Development N N Incl : NIH, CDC, FDA, AHRQ Incl: K02, K05, K24, K26, K01, K07, K08, K18, K22, K23, K25, K99, K99/R00, K76 Both Other Limited to 1 page The Institutional Commitment to Candidate’s Research Career Development attachment may be subject to a page limitation. Be sure to comply with announcement and application guide instructions. W January 14, 2016 Release, Update to Existing Rule (added K76) Career Dev. Award (NIH) Career Dev. Award Attachments: Specific Aims N N Incl : NIH, CDC, FDA, AHRQ Incl: K02, K05, K24, K26, K01, K07, K08, K18, K22, K23, K25, K99, K99/R00, K76 Both Other Required attachment The Specific Aims attachment is required. E January 14, 2016 Release, Update to Existing Rule (added K76) Career Dev. Award (NIH) Career Dev. Award Attachments: Specific Aims N N Incl : NIH, CDC, FDA, AHRQ Incl: K02, K05, K24, K26, K01, K07, K08, K18, K22, K23, K25, K99, K99/R00, K76 Both Other Limited to 1 page The Specific Aims is limited to 1 page. E January 14, 2016 Release, Update to Existing Rule (added K76) Career Dev. Award (NIH) Research Strategy 013.12 Career Dev. Award (NIH) Career Dev. Award Attachments: Progress Report 013.13
Career Dev. Awarch (NIH) Citizenship: U.S. Citizen or Non-Citizen National N N Incl; NIH, AHRQ Excl: V2.0 Incl: K43 If “Yes” is selected for K43 application provide error. U.S. Citizen or National is not a valid option for this application E Forms D, March 2016 Release Career Dev. Award (NIH) Career Dev. Award Attachments: Candidate Information and Goals to Career Development N N Incl: NIH, AHRQ Excl: V2.0 Both Both Required Attachment Canididate Information and Goals for Career Development is required. E Forms D, March 2016 Release Career Dev. Award (NIH) Career Dev. Award Attachments: Candidate Information and Goals to Career Development N N Incl: NIH, AHRQ Excl: V2.0 = “N” Both Both Provide a warning if the Candidate Information and Goals for Career Development and Research Strategy attachment are greater than 12 pages and less than or equal to 13 pages. The “Candidate Information and Goals for Career Development” and “Research Strategy” attachments are limited to a combined total of 12 pages. Your combined total for the two attachments is 13 pages. If the additional page is the result of page breaks and white space from splitting the information into two separate attachments, then no action is needed. If the additional page is full of text, you must reduce your content to fit within the combined 12 page limit. W Forms D, March 2016 Release Career Dev. Career Dev. Award Attachments: Candidate N N Incl: NIH, AHRQ Excl: V2.0 = “N” Both Both Provide an error if the Candidate Information and Goals for Career Development plus the Research Strategy The “Candidate Information and Goals for Career Development” and “Research Strategy” E Forms D, March 2016 Release
Award (NIH) Information and Goals to Career Development combined is greater than 13 pages. attachments are limited to a combined total of 12 pages. This may span to 13 pages to accommodate page breaks and white space resulting from splitting the information into two separate attachments. Your combined total for the two attachments is over 13 pages. Career Dev. Award (NIH) Career Dev. Award Attachments. Data Safety Monitoring Plan N N Incl: NIH, AHRQ Excl: V2.0 Both Required if “Yes” is selected as the answer to the “Clinical Trial?” question on the Cover Page Supplemental Form The Data Safety Monitoring Plan attachment is required if the response to the Clinical Trial question on the Cover Page Supplemetn is “Yes” E Forms D, March 2016 Release PHS 398 Training Program Plan
Training Plan FDA, AHRQ TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R PHS 398 Training Plan Program Plan 014.3.2 N N Incl: NIH, AHRQ Excl: V2.0 Both Provide error if Program Plan is greater than 25 pages The Program Plan is limited to 25 pages E Forms D, March 2016 Release PHS 398 Training Plan Recruitment and Retention Plan to Enhance Diversity 014.4.1 N N Incl: NIH, CDC, FDA, AHRQ Excl V3.0 Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, Both Required attachment The Recruitment and Retention Plan to Enhance Diversity attachment is required. E Removed D43, D71 and U2R 07/28/2015 Update to existing rule (removed KM1) Update to existing rule (excluding v3.0), for Forms D, March Release PHS 398 Training Plan Plan for Instruction in the Responsible Conduct of Research 014.5.1 N N Incl: NIH, CDC, FDA, AHRQ Incl: T15, T32, T34, T35, T36 K12, T37, D71, D43, U2R T01, T02, T03, T14, T42, T90, T90/R90, T90/R90, TU2 Both Required attachment The Plan for Instruction in the Responsible Conduct of Research attachment is required. E Update to existing rule (removed KM1) PHS 398 Training Plan for Instruction in the Responsible 014.5.2 N N Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, Both If provided, limited to 3 pages The Plan for Instruction in the Responsible Conduct of Research attachment on the E Update to existing rule (removed KM1)
Plan Conduct of Research T37, K12, D43, D71, U2R PHS 398 Research Training Program Plan is limited to 3 pages. PHS 398 Training Plan Plan for Instruction in Methods for Enhancing Reproducibility N N Incl: NIH, AHRQ Excl: V2.0 Both Will only apply to specific pilot FOAs until new rigor and transparency requirements are rolled out for training grants in 2017. The Plan for Instruction in Methods for Enhancing Reproducibility is required. E Forms D, March 2016 Release PHS 398 Training Plan Plan for Instruction in Methods for Enhancing Reproducibility N N Incl: NIH, AHRQ Excl: V2.0 Both Provide an error if the Plan for Instruction in Methods for Enhancing Reproducibility attachment is included unless it is specifically requested in the FOA. Do not submit a Plan for Instruction in Methods for Enhancing Reproducibility attachment. See . E Forms D, March 2016 Release PHS 398 Training Plan Progress Report (for RENEWAL applications only) 014.6.1 N N Incl: NIH, AHRQ Excl: V2.0 Both Both Required for renewals. The Progress Report Publication List attachment is required for renewal applications. E Forms D, March 2016 Release PHS 398 Training Plan Progress Report (for RENEWAL applications only) 014.6.2 N N Incl: NIH, AHRQ Excl: V2.0 Both Both Must not be included for a new or revision application The Progress Report Publication List should not be attached for a new or revision type of application. E Forms D, March 2016 Release
PHS 398 Training Plan Human Subjects 014.7.1 N N Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Both Required if Human Subjects is ‘yes’ on the Other Project Info form within the same component A Human Subjects attachment must be included if the response to the Human Subjects question on the Other Project Information form is ‘Yes’. E Update to existing rule (removed KM1) PHS 398 Training Plan Data Safety Monitoring Plan N N Incl: NIH, AHRQ Excl: V2.0 Both Required if “Yes” is selected as the answer to the “Clinical Trial?” question on the PHS Cover Page Supplemental Form The Data Safety Monitoring Plan attachment is required if the response to the Clinical Trial question on the Cover Page Supplement is “Yes” E Forms D, March 2016 Release PHS 398 Training Plan Vertebrate Animals 014.8.1 N N Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Both Required Vertebrate Animals is true on Other Project Information form within the same component A Vertebrate Animals attachment must be included if the response to the Vertebrate Animals Used Question on the Other Project Information form is ‘Yes’. E Update to existing rule message Update to existing rule (removed KM1) PHS 398 Training Plan Select Agent Research 014.9
Plan T37, K12, D43, D71, U2R included for this application. PHS 398 Training Plan Data Tables Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Both Warning if not included The Data Tables attachment may be required in whole or in part for this application. Check the announcement and application guide for requirements. W Update to existing rule (removed KM1) PHS 398 Training Plan Letters of Support 014.15 PHS 398 Training Plan Appendix Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Both Limited to 10 appendixes Only 10 appendix attachments are allowed. E Update to existing rule (removed KM1)
PHS 398 Training Budget Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency Specific (Lists Form FOA Specific Activity Specific Lists Activity Code (Inclusion & Exclusion) to Multi or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) PHS 398 Training Budget PHS 398 Training Budget, Period "x" Unless specifically stated, all project budget validations also apply to the subaward budget. PHS 398 Training Budget Organizational DUNS: 015.1.1 Incl: V1.0 Multi Only 'Project' Budget Type can contain the Organization DUNs of the component The budget marked as ‘Project’ must contain the DUNS number for the component organization on the 424 RR Cover. E PHS 398 Training Budget Organizational DUNS: 015.1.2 N Y Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Both Budget marked as ‘Subaward’ cannot contain DUNS number for the component application organization on the 424 RR The <Organization Name> subaward’ budget cannot contain the DUNS number provided on the SF 424 RR Cover. E PHS 398 Training Budget Budget type (project) 015.2 PHS 398 Training Budget Budget type 015.3.1 N Y Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Both There must be one and only one occurrence with a value of ‘Project’ per component. Only one budget with a budget type of ‘Project’ may be submitted for the application. E
PHS 398 Training Budget Name of organization 015.4.1 N Y Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.0 Both The Name of Organization is required The Organization name is required for <DUNS>. E PHS 398 Training Budget Start Date 015.5.1 N Y Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Both For budget year 1, for budget type Project, for new applications and resubmissions, must be the same as the Proposed Project Start Date listed on the component SF 424 RR For <Organization name> for budget period < Budget Year>, the start date for new and resubmission applications must be the same as the proposed project start date listed on the SF 424 RR Cover. W PHS 398 Training Budget Start Date 015.5.2 N Y Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Both For budget years after budget year 1, must be greater than or equal to the Proposed Project Start Date listed on the component SF 424 RR For <Organization name> budget for budget period < Budget Year>, the start date should the same or later than the proposed project start date listed on the SF 424 RR Cover. W PHS 398 Training Budget End Date 015.6.1 N Y Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Both Must be greater than the budget start date and less than or equal to the Project Period End Date, both listed on the component SF 424 RR For <Organization name> budget for budget period < Budget Year>, the end date must be later than the budget start date and less than or the same as the proposed project end E
date listed on the SF 424 RR Cover. PHS 398 Training Budget A. Stipends, of Trainees, Undergraduate: Full Time 015.7.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Incl: T34 Provide error if Number of Full time and/or short term undergraduate trainees is not provided (0 or NULL) For <Organization name> for budget period < Budget Year>,the number of Full time and/or Short term Undergraduate trainees is required. E PHS 398 Training Budget A. Stipends, Tuition/Fees Number of Trainees, Undergraduate: Full Time 015.7.2 N N Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Incl: T15, T32, T35 Provide error if Number or stipends of Full time or short term undergraduate trainees is provided (greater than 0) For <Organization name> for budget period < Budget Year>, the Undergraduate information cannot be included for this application. E PHS 398 Training Budget A. Stipends, of Trainees, Undergraduate: Short Term 015.8 PHS 398 Training Budget A. Stipends, of Trainees, Undergraduate: Stipends Requested ($) 015.9.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Incl: T34 Provide error if undergraduate Stipends requested is not provided (0 or NULL) For <Organization name> for budget period < Budget Year>, the Undergraduate stipend requested is required. E PHS 398 Training Budget A. Stipends, of 015.10
or other stipends requested, is greater than 0. PHS 398 Training Budget A. Stipends, of Trainees, Predoctoral, Single Degree: Short Term 015.14 PHS 398 Training Budget A. Stipends, of Trainees, Predoctoral, Single Degree: Stipends Requested ($) 015.15 PHS 398 Training Budget A. Stipends, of Trainees, Predoctoral, Single Degree: Tuition/Fees Requested ($) 015.16 PHS 398 Training Budget A. Stipends, of Trainees, Predoctoral, Dual Degree: Full Time 015.17
PHS 398 Training Budget A. Stipends, of Trainees, Predoctoral, Dual Degree: Short Term 015.18 PHS 398 Training Budget A. Stipends, of Trainees, Predoctoral, Dual Degree: Stipends Requested ($) 015.19 PHS 398 Training Budget A. Stipends, of Trainees, Predoctoral, Dual Degree: Tuition/Fees Requested ($) 015.20 PHS 398 Training Budget A. Stipends, of Trainees, Predoctoral, Total Predoctoral: Full Time 015.21 PHS 398 Number of Trainees, 015.22
Training Budget Predoctoral, Total Predoctoral: Short Term PHS 398 Training Budget A. Stipends, of Trainees, Predoctoral, Total Predoctoral: Stipends Requested ($) 015.23 PHS 398 Training Budget A. Stipends, of Trainees, Predoctoral, Total Predoctoral: Tuition/Fees Requested ($) 015.24 PHS 398 Training Budget A. Stipends, of Trainees, Seeking; Full Time 015.25 PHS 398 A. Stipends, of 015.26 degree
Training Budget Trainees, Seeking; Short Term PHS 398 Training Budget A. Stipends, of Seeking per stipend level (0-7) 015.27 PHS 398 Training Budget A. Stipends, of Trainees, Seeking: Stipends Requested ($) 015.28 PHS 398 Training Budget A. Stipends, of Trainees, Seeking: Tuition/Fees Requested ($) 015.29 PHS 398 A. Stipends, 015.30 Non- degree degree degree degree
Training Budget Trainees, Degree Seeking; Full Time PHS 398 Training Budget A. Stipends, of Trainees, Degree Seeking; Short Term 015.31 PHS 398 Training Budget A. Stipends, of Degree Seeking per stipend level 015.32 PHS 398 Training Budget A. Stipends, of Trainees, Degree Seeking: Stipends Requested ($) 015.33 PHS 398 A. Stipends, of 015.34
Stipends Requested ($) PHS 398 Training Budget A. Stipends, of Trainees, Total post-doctoral: Tuition/Fees Requested ($) 015.39 PHS 398 Training Budget A. Stipends, of Trainees, Other: Full Time 015.40 PHS 398 Training Budget A. Stipends, of Trainees, Other: Short Term 015.41 PHS 398 Training Budget A. Stipends, of Trainees, Other: Stipends Requested ($) 015.42 PHS 398 Training Budget A. Stipends, of Trainees, Other: 015.43
Tuition/Fees Requested ($) PHS 398 Training Budget A. Stipends, Stipends Requested ($) N N Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Excl: T02, T03 Both Provide error If number of undergrad full-time, or number undergrad short term, or total pre-doctoral full-time, or total pre-doctoral short term, or total post-doctoral full-time, or total post-doctoral short term, or number of other or number of other short term, is greater than 0 and total stipends requested total is not greater than 0 For <Organization name> for budget period < Budget Year>, if Number of Trainees information is then corresponding Stipends Requested information must also be included. E PHS 398 Training Budget A. Stipends, Stipends Requested ($) N N Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Excl: T02, T03 Both Provide error If total stipends requested is greater than 0 and number of undergrad full-time, and number undergrad short term, and total pre-doctoral full-time, and total pre-doctoral short term, For <Organization name> for budget period < Budget Year>, if Stipends Requested information is provided then corresponding Number of Trainees information must also be included. E
PHS 398 Training Budget B. Other Direct CostsTotal Direct Costs from R&R Budget Form (if applicable), Funds Requested ($) N N Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Provide error if RR budget (project budget) is present in the application and if the Total Direct Costs from RR Budget for all budget periods is Null or '0' If an R&R Budget is part of the application, the Total direct costs from the R&R Budget should be provided in the Total direct Cost from R&R Budget form section. E PHS 398 Training Budget B. Other Direct Training Costs (if applicable), Funds Requested ($) N N Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Excl: T02, T03 Both provide warning for Project budget if all budget periods Consortium cost is Null or '0' and a subaward exists for the component A Subaward/Consortium Budget form is included in the application. The total costs of all subawards submitted for this application should be reflected in the Other Direct Costs section of the Project budget in the Consortium training costs section. W PHS 398 Training Budget B. Other Direct CostsTotal Other Direct Costs Requested, Funds Requested ($) 015.51 PHS 398 Training Budget C. Total Direct Costs Requested (A + B) 015.52
Training Budget PHS 398 Training Budget D. Indirect Costs Funds Requested 2 ($) 015.60 PHS 398 Training Budget D. Indirect Costs Total Indirect Costs Requested 015.61 PHS 398 Training Budget E. Total Direct and Indirect Costs Requested (C + D) 015.62 PHS 398 Training Budget F. Budget Justification N N Incl : NIH, CDC, FDA, AHRQ Incl: V1.0 Both The budget justification attachment is required The budget justification attachment is required. E PHS 398 Training Budget Cumulative
Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency (Lists Form FOA Specific Activity Specific Lists Activity Code & to Multi or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) PHS 398 Training Budget, Budget A. Stipends, Stipends Requested ($) 015.64 PHS 398 Training Budget, Budget A. Stipends, Tuition/Fees Requested ($) 015.65 PHS 398 Training Budget, Budget A. Stipends, Single Degree, Stipends Requested ($) 015.66 PHS 398 Training Budget, Budget A. Stipends, Single Degree, Tuition/Fees Requested ($) 015.67 PHS 398 Training Budget, A. Stipends, Dual Degree, 015.68
Budget Stipends Requested ($) PHS 398 Training Budget, Budget A. Stipends, Dual Degree, Tuition/Fees Requested ($) 015.69 PHS 398 Training Budget, Budget A. Stipends, Total Predoctoral, Stipends Requested ($) 015.70 PHS 398 Training Budget, Budget A. Stipends, Total Predoctoral, Tuition/Fees Requested ($) 015.71 PHS 398 Training Budget, Budget A. Stipends, Degree Seeking, Stipends Requested ($) 015.72 PHS 398 A. Stipends, 015.73
Budget Tuition/Fees Requested ($) PHS 398 Training Budget, Budget A. Stipends, Stipends Requested ($) 015.78 PHS 398 Training Budget, Budget A. Stipends, Tuition/Fees Requested ($) 015.79 PHS 398 Training Budget, Budget A. Stipends, Stipends Requested 015.80 PHS 398 Training Budget, Budget A. Stipends, Tuition And Fees Requested 015.81 PHS 398 A. Stipends, 015.82
Training Budget, Budget Stipends + Tuition/Fees Requested PHS 398 Training Budget, Budget B. Other Direct Costs Trainee Travel 015.83 PHS 398 Training Budget, Budget B. Other Direct Costs Training Related Expenses 015.84 PHS 398 Training Budget, Budget B. Other Direct Costs Total Direct Costs from R&R Budget Form (if applicable) 015.85 PHS 398 Training Budget, B. Other Direct Costs Consortium Training Costs (if applicable) 015.86
Budget PHS 398 Training Budget, Budget B. Other Direct Costs Total Other Direct Costs Requested 015.87 PHS 398 Training Budget, Budget C. Total Direct Costs Requested (A + B) 015.88 PHS 398 Training Budget, Budget D. Total Indirect Costs Requested 015.89 PHS 398 Training Budget, Budget E. Total Direct and Indirect Costs Requested (C + D) 015.90
SBIR/STTR Form Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency Specific (Lists Form FOA Specific Activity Specific Lists Activity Code (Inclusion & Exclusion) to Multi or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) (NIH) Program Type (SBIR, STTR, Both) 023.1.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.1 Incl: R41, R42, UT1, UT2, R43, R44, U43, U44 Choice must be consistent with the information stored for the announcement: if the announcement is indicated as ‘SBIR’, ‘SBIR’ must be selected; if announcement is indicated as ‘STTR’, ‘STTR’ must be selected. You have selected a Program Type of <Program Type>. That is not the correct program type for this announcement. Please refer to the FOA for the correct program type for this application. E (NIH) Program Type (SBIR, STTR, Both) 023.1.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.1 Incl: R41, R42, UT1, UT2, R43, R44, U43, U44 One and only one choice may be made. Please select one Program Type, SBIR or STTR.. E (NIH) SBIR/STTR Type (Phase I, Phase II, 023.2
(NIH) Question 1.a Small Business Eligibility (Y/N) 023.3.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.1 Incl: R41, R42, UT1, UT2, R43, R44, U43, U44, SB1, UB1 Provide error if Small Business Eligibility is No The Small Business Eligibility Certification must be marked ‘Yes’ for SBIR and STTR applications. E (NIH) Question 1b. Anticipated number of personnel 023.4 (NIH) Question 2. Are Subcontracts Included? (Y/N) 023.5 (NIH) Name of Labs/Agencies For Subcontracts 023.6.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.1 Incl: R41, R42, UT1, UT2, R43, R44, U43, U44 Required entry if response to ‘Are Subcontracts Included?’ is ‘Yes’. If it is indicated in question 2 that subcontracts are included, the name(s) of labs or agencies for subcontracts must be included. E (NIH) Name of Labs/Agencies For Subcontracts 023.6.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.1 Incl: R41, R42, UT1, UT2, R43, R44, U43, U44, SB1, UB1 Cannot be included if response to ‘Are Subcontracts Included?’ is ‘No’. If it is indicated in question 2 that subcontracts are not included, the name(s) of labs or agencies for subcontracts cannot be included. E
(NIH) Question 3. Located in HUBZone (Y/N) 023.7 (NIH) Question 4. Research to be Performed in US? (Y/N) 023.8 (NIH) Explanation of Foreign Performance 023.9.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.1 Incl: R41, R42, UT1, UT2, R43, R44, U43, U44, SB1,UB1 Must be included if answer to ‘work to be performed in US’ question is ‘no’. If it is indicated in question 4 that research is not to be performed in the US, an explanation attachment must be provided. E (NIH) Explanation of Foreign Performance 023.9.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.1 Incl: R41, R42, UT1, UT2, R43, R44, U43, U44 Cannot be included if answer to ‘work to be performed in US’ question is ‘yes’. If it is indicated in question 4 that research is to be performed in the US, an explanation attachment cannot be provided. E (NIH) Question 5. Equivalent Submissions (Y/N) 023.10
(NIH) Names of other Federal agencies for equivalent work N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.1 Incl: R41, R42, UT1, UT2, R43, R44, U43, U44, SB1, UB1 Required entry if answer to ‘submittal of equivalent work to other agencies’ question is ‘yes’. If it is indicated in question 5 that applications for essentially equivalent work have been proposed to or awarded by other Federal agencies, the names of the other Federal agencies must be provided. E (NIH) Names of other Federal agencies for equivalent work N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.1 Incl: R41, R42, UT1, UT2, R43, R44, U43, U44, SB1, UB1 Cannot be included if answer to ‘submittal of equivalent work to other agencies’ question is ‘no’. If it is indicated in question 5 that applications for essentially equivalent work have not been proposed to or awarded by other Federal agencies, then no other Federal agencies can be listed. E (NIH) Question 6. Disclosure Permission Statement (Y/N) N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V 1.1 Incl: R41, R42, UT1, UT2, R43, R44, U43, U44, SB1, UB1 Provide warning if Disclosure Permission Statement answer is different on SBIR/STTR form and the Cover Page Supplement form The Disclosure Permission Statement answer provided on the PHS398 Cover Page Supplement form does not match the answer provided on the SBIR/STTR Information form. Please verify and correct as needed. W
Employment (Y/N) (NIH) Question 10. STTR PD/PI Commitment (Y/N) 023.17 (NIH) Question 11. STTR work percentages (Y/N) 023.18 PHS Fellowship Supplemental
PHS Supp. Form Research Plan Attachments: Progress Report Publication List 024.4 PHS Supp. Form Human Subjects Involved? (Y/N) 024.5 PHS Supp. Form Human Subjects Involvement Indefinite (Y/N) 024.7.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 An answer to Human Subjects Involvement Indefinite is required if the answer to ‘Human Subjects Involved’ is "Yes" on the Other Project Information. The Human Subjects Involvement Indefinite question must be answered if the answer to Human Subjects Involved is ‘Yes’ on the Other Project Information. E January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Supp. Form Human Subjects Involvement Indefinite (Y/N) 024.7.2 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 If Human Subject Involved is ‘No’ on the Other Project Information and Human Subjects Involvement Indefinite is ‘Yes’, provide error The Human Subjects Involvement Indefinite question cannot be marked ‘if the answer to Human Subjects Involved is ‘No’ on the Other Project Information. E January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Supp. Form Human Subjects Clinical Trial (Y/N) 024.8.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, If Human Subjects NIH-Defined Phase III Clinical Trial is Yes, Clinical Trial must be Yes. The Human Subjects Clinical Trial question must be “Yes” if the answer to Human Subjects Phase III E January 14,2016 Release, Update to Existing Rule (added F99/K00)
PHS Supp. Form Fellowship Supplemental Form Attachments: Inclusion of Women and Minorities 024.11.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 Inclusion of Women and Minorities attachment is required if Human Subjects is true and Exemption is not E4 on the Other Project Information. The Inclusion of Women and Minorities Attachment must be included if the response to the Human Subjects question on the Other Project Information Page is ‘Yes’ and if the Exemption Number is not 4. E January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Supp. Form Fellowship Supplemental Form Attachments: Inclusion of Children 024.12.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 Inclusion of Children attachment is required if Human Subjects is true and Exemption is not E4 on the Other Project Information. The Inclusion of Children Attachment must be included if the response to the Human Subjects question on the Other Project Information Page is ‘Yes’ and if the Exemption Number is not 4. E January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Supp. Form Vertebrate animals used? 024.13 PHS Supp. Form Vertebrate Animals Use Indefinite (Y/N) 024.14.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 An answer to Animals Use Indefinite is required if Vertebrate Animals Used is ‘Yes’ The Vertebrate Animals Use Indefinite question must be answered if the answer to Vertebrate Animals Used is ‘Yes’. E January 14,2016 Release, Update to Existing Rule (added F99/K00)
PHS Supp. Form Vertebrate Animals Use Indefinite (Y/N) 024.14.2 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 If Vertebrate Animals is ‘No’ on the Other Project Info and Vertebrate Animals Use Indefinite is ‘Yes’, provide error The Vertebrate Animals Use Indefinite question cannot be marked ‘Yes’ if the answer to Vertebrate Animals Used is ‘No’. E January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Supp. Form Fellowship Supplemental Form Attachments: Vertebrate Animals 024.15.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2 F99/K00 Vertebrate Animals attachment is required if Vertebrate Subjects is true The Vertebrate Animals attachment must be included if the response to the Vertebrate Animals Used question on the Other Project Information page is ‘Yes’ E January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Supp. Form Fellowship Supplemental Form Attachments: Select Agent Research 024.16 PHS Supp. Form Fellowship Supplemental Form Attachments: Resource Sharing Plan 024.17 PHS Supp. Form Fellowship Supplemental Form Attachments: Respective Contributions 024.18.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 Respective Contributions attachment is limited to 1 page The Respective Contributions attachment is limited to one (1) page. E January 14,2016 Release, Update to Existing Rule (added F99/K00)
checkbox must not be checked. PHS Supp. Form HESC Cell Lines 024.23.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 If specific stem cell line is included, provide error if stem cell line is not in eRA database or is marked as invalid. Comparison should not be case-sensitive. Stem cell line <cell line number> is invalid. The cell line must be an approved line on the NIH Registry: E January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Supp. Form HESC Cell Lines PHS Supp. Form HESC Cell Lines PHS Supp. Form HESC Cell Lines PHS Supp. Form Fellowship Applicant : Alternate Phone Number 024.24 PHS Fellowship Applicant: 024.25
PHS Supp. Form Fellowship Applicant: field of training 024.28 PHS Supp. Form Fellowship Applicant: current or prior support (y/n)? 024.29.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 If ‘Yes’ is selected on’ Current or Prior Kirschstein-NRSA support’, one level and type is required on the same row of the grid and at least one row of the grid. At least one entry for Current or Prior Kirschstein-NRSA support information is required. E January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Supp. Form Fellowship Applicant: current or prior support x, level 024.30 PHS Supp. Form Fellowship Applicant: current or prior support x, type 024.31 PHS Supp. Form Fellowship Applicant: current or prior support x, start date 024.32 PHS Fellowship Applicant: current orprior 024.33.1 N N Incl : NIH, CDC, Incl: V2.0 Incl: F05, F30, Current or Prior Kirschstein-NRSA Support End date must The Current or Prior Support End E January 14,2016 Release, Update to
Supp. Form support x, end date FDA, AHRQ F31, F32,F33, F37, F38, FI2, F99/K00 be greater than Support Start Date on the same row of the grid Date must be later than Support Start Date. Existing Rule (added F99/K00) PHS Supp. Form Fellowship Applicant: current or prior support x, grant number 024.34 PHS Supp. Form Fellowship Applicant: Applications for concurrent support (Y/N)? 024.35 PHS Supp. Form Fellowship Applicant: concurrent support description attachment 024.36.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 If ‘Yes’ selected for Concurrent Support, the Application for Concurrent Support attachment is required An Application Concurrent Support attachment must be included. E January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Supp. Form Fellowship Applicant: goals for fellowship training and career attachment 024.37.1 N N Incl : NIH, CDC, FDA, AHRQ Excl: V3.1 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 Limited to 1 page The Goals for Fellowship Training and Career attachment is limited to one (1) page. E January 14,2016 Release, Update to Existing Rule (added F99/K00) Forms D, May 2016 Release (Update to Existing Rule to exclude V3.0) PHS Fellowship Applicant: activities 024.38.1 N N Incl : NIH, CDC, Excl: V3.1 Incl: F05, F30, Limited to 1 page The Activities planned under this Award attachment E January 14,2016 Release, Update to
PHS Supp. Form Citizenship: If no, select most appropriate Non-U.S. Citizen Option 024.40.5 N N Incl: NIH, AHRQ Excl: V2.0 Incl: F05, U.S. Citizen or National should be "No" AND "With a Permanent U.S. Resident U.S. visa" should not be selected for F05 applications. Response to "U.S. Citizen or National" must be "No" and selection of "With a Temporary U.S. visa" is required. E Forms D, May 2016 Release PHS Supp. Form Citizenship: If no, select most appropriate Non-U.S. Citizen Option 024.40.6 N N Incl: NIH, AHRQ Excl: V2.0 Only one citizenship option should be selected More than one Non-U.S. Citizen option has been selected. Please review your selections and choose only one option. W Forms D, May 2016 Release August 8, 2016 Rule Severity updated to warning from error in Production. PHS Supp. Form Citizenship: If with a temporary U.S. visa who has applied for a permanent resident status and expect to hold a permanent resident visa by the earliest 024.40.7 N N Incl: NIH, AHRQ Excl: V2.0 Incl: F30, F31, F32, F33, F37, F38, FI2, Provide a warning if “Non-U.S. Citizen with a Trmporary U.S. visa” is selected and the “If with a temporary U.S. visa who has applied for a permanent resident status and expect to hold a permanent resident visa by the earliest possible start date of the award” is not selected. You have selected a citizenship choice of citizen with a temporary U.S. visa” as your citizentship status. This is not a valid citizenship choice for this application unless you have applied for permanent resident status and expect to hold a permanent resident visa at the time of award. W Forms D, May 2016 Release PHS Supp. Form Institution: Change of sponsoring institution 024.41
PHS Supp. Form Budget: stipends/salary during first year, federal stipend requested, number of months 024.51.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F33 Federal stipend requested, number of months should be greater than 0 for F33 The Number of Months for the Federal Stipend Requested Salary is required for Senior Fellowship Applicants. E PHS Supp. Form Budget: stipends/salary during first year, from other sources, amount 024.52.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F33 Supplementation from other sources, amount should be greater than 0 for F33 The Amount for the Supplementation from other sources is required for Senior Fellowship Applicants. E PHS Supp. Form Budget: stipends/salary during first year, from other sources, # of months 024.53.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F33 Supplementation from other sources, # of months should be greater than 0 for F33 The Number of Months for the Supplementation from other sources is required for Senior Fellowship. E PHS Supp. Form Budget: stipends/salary during first year, from other sources, type 024.54.1 N N Incl : NIH, CDC, FDA, AHRQ Incl: V2.0 Incl: F33 Supplementation from other sources, type is a required for F33 The Type of Supplementation from other sources is required for Senior Fellowship Applicants. E
PHS Supp. Form Fellowhsip Supplemental Form Attachments: Letters of Support from Collaborators, Contributors and Consultants 024.58.1 N N Incl: NIH, AHRQ Excl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 Letters of Support from Collaborators, Contibutors, and Consultants attachment should be no more than 6 pages The Letters of Support from Collaborators, Contributors, and Consultants attachment should be no more than six (6) pages. E Forms D, May 2016 Release PHS Supp. Form Fellowhsip Supplemental Form Attachments: Desciption of Institutional Environment and Commitment to Training 024.59.1 N N Incl: NIH, AHRQ Excl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 Description of Institutional Environment and Commitment to Training attachment is required. The Description of Institutional Environment and Commitment to Training attachment is required for this application E Forms D, May 2016 Release PHS Supp. Form Fellowhsip Supplemental Form Attachments: Desciption of Institutional Environment and Commitment to Training 024.59.2 N N Incl: NIH, AHRQ Excl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 Description of Institutional Environment and Commitment to Training attachment is limited to 2 pages. The Description of Institutional Environment and Commitment to Training attachment is limited to two (2) pages. E Forms D, May 2016 Release PHS Fellowhsip Supplemental Form Attachments: 024.60.1 N N Incl: NIH, AHRQ Excl: V2.0 Incl: F05, F30, F31, F32,F33, Required if “Yes” is selected as the answer to the “Clinical Trial?” question on the Cover page. The Data Safety Monitoring Plan attachment is required if the response to the E Forms D, May 2016 Release
Supp. Form Data Safety Monitoring Plan F37, F38, FI2, F99/K00 Clinical Trial question on the Cover Page Supplement is “Yes”. PHS Supp. Form Vertebrate Animals: Is method consistent with American Verinary Medical Association (AVMA) guidelines 024.61.1 N N Incl: NIH, AHRQ Excl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 An answer to “Is method consistent with American Veterinary Medical Association (AVMA) guidelines” question is required if the answer to ‘Are Vertebrate Animals euthanized’ is “Yes” You must answer the “Is method consistent with AVMA guidelines?” question if you answer Yes to the “Are animals euthanized?” question. E Forms D, May 2016 Release PHS Supp. Form Vertebrate AnimalsIf “No” to AVMA guidelines describe method and provide a scientific justification 024.62.1 N N Incl: NIH, AHRQ Excl: V2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, F99/K00 If ‘No’ to AVMA guidelines, method and scientifiec justification must be provided You must provide the euthanasia method and scientific justification if you answer No to the “Is method consistent with AVMA guidelines?” question E Forms D, May 2016 Release
Cumulative Inclusion Enrollment Report Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency (Lists Form FOA Specific Activity Specific Lists Activity Code & to Multi or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) Report Study Title X of Y Report Study Title: 016.2 Report Comments: 016.3 Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Not Hispanic or Latino, Female 016.4
Report Racial Category: Asian; Ethnic Category: Unknown/ Not Reported, Male 016.21 Report Racial Category: Asian; Ethnic Category: Unknow/ Not Reported, Unknown/ Not Reported 016.22 Report Racial Category: Asian; Total 016.23 Report Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: Not Hispanic or Latino, Female 016.24 Racial Category: 016.25
Report Hispanic or Latino, Male Report Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: Hispanic or Latino, Unknown/ Not Reported 016.29 Report Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: Unknown/ Not Reported, Female 016.30 Report Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: Unknown/ Not Reported, Male 016.31
Report Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: Unknow/ Not Reported, Unknown/ Not Reported 016.32 Report Racial Category: Native Hawaiian or Other Pacific Islander; Total 016.33 Report Racial Category: Black or African American; Ethnic Category: Not Hispanic or Latino, Female 016.34 Report Racial Category: Black or African American; Ethnic Category: Not 016.35
Hispanic or Latino, Male Report Racial Category: Black or African American; Ethnic Category: Not Hispanic or Latino, Unknown/ Not Reported 016.36 Report Racial Category: Black or African American; Ethnic Category: Hispanic or Latino, Female 016.37 Report Racial Category: Black or African American; Ethnic Category: Hispanic or Latino, Male 016.38 Racial Category: Black or African American; Ethnic 016.39
Report Category: Hispanic or Latino, Unknown/ Not Reported Report Racial Category: Black or African American; Ethnic Category: Unknown/ Not Reported, Female 016.40 Report Racial Category: Black or African American; Ethnic Category: Unknown/ Not Reported, Male 016.41 Report Racial Category: Black or African American; Ethnic Category: Unknown/ Not Reported, Unknown/ Not Reported 016.42
Report Racial Category: Black or African American; Total 016.43 Report Racial Category: White; Ethnic Category: Not Hispanic or Latino, Female 016.44 Report Racial Category: White; Ethnic Category: Not Hispanic or Latino, Male 016.45 Report Racial Category: White; Ethnic Category: Not Hispanic or Latino, Unknown/ Not Reported 016.46 Racial Category: White; Ethnic Category: 016.47
Report Hispanic or Latino, Female Report Racial Category: White; Ethnic Category: Hispanic or Latino, Male 016.48 Report Racial Category: White; Ethnic Category: Hispanic or Latino, Unknown/ Not Reported 016.49 Report Racial Category: White; Ethnic Category: Unknown/ Not Reported, Female 016.50 Report Racial Category: White; Ethnic Category: Unknown/ Not Reported, Male 016.51
Report Racial Category: White; Ethnic Category: Unknown/ Not Reported, Unknown/ Not Reported 016.52 Report Racial Category: White; Total 016.53 Report Racial Category: More than One Race; Ethnic Category: Not Hispanic or Latino, Female 016.54 Report Racial Category: More than One Race; Ethnic Category: Not Hispanic or Latino, Male 016.55 Racial Category: More than One Race; Ethnic 016.56
Report Category: Not Hispanic or Latino, Unknown/ Not Reported Report Racial Category: More than One Race; Ethnic Category: Hispanic or Latino, Female 016.57 Report Racial Category: More than One Race; Ethnic Category: Hispanic or Latino, Male 016.58 Report Racial Category: More than One Race; Ethnic Category: Hispanic or Latino, Unknown/ Not Reported 016.59 Racial Category: More than One Race; Ethnic Category: 016.60
Report Hispanic or Latino, Female Report Racial Category: Unknown or Not Reported; Ethnic Category: Not Hispanic or Latino, Male 016.65 Report Racial Category: Unknown or Not Reported; Ethnic Category: Not Hispanic or Latino, Unknown/ Not Reported 016.66 Report Racial Category: Unknown or Not Reported; Ethnic Category: Hispanic or Latino, Female 016.67 Racial Category: 016.68
Report Category: Unknown/ Not Reported, Male Report Racial Category: Unknown or Not Reported; Ethnic Category: Unknown/ Not Reported, Unknown/ Not Reported 016.72 Report Racial Category: Unknown or Not Reported; Total 016.73 Report Ethnic Category; Not Hispanic or Latino, Female; Total 016.74 Ethnic Category; Not Hispanic or 016.75
Report Latino, Male; Total Report Ethnic Category; Not Hispanic or Latino, Unknown/ Not Reported; Total 016.76 Report Ethnic Category; Hispanic or Latino, Female; Total 016.77 Report Ethnic Category; Hispanic or Latino, Male; Total 016.78 Report Ethnic Category; Hispanic or Latino, Unknown/ Not Reported; Total 016.79 Ethnic Category; 016.80
Planned Enrollment Report Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency (Lists Form FOA Specific Activity Specific Lists Activity Code (Inclusion & to Multi or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) Planned Report Study Title X of Y 017.1.1 N N Incl : NIH, CDC, FDA, AHRQ V 1.0 Excl: T15, T32, T34, T35, T36, K12, T37, D71, D43, U2R, T01, T02, T03, T14, T42, T90, T90/R90, TU2, S10, C06, UC6, G20, X02, OT1, X01, I01, IP1, IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 Both Provide Warning if Planned Enrollment Report form is not part of the application when HS = Y and Exemption not E4 Note: Training component of a complex should be excluded from this rule. Human Subjects are involved but no Planned Enrollment Report(s) for inclusion has been included. W Update to existing rule (removed KM1) Update to existing (Added OT1)
Planned Report Study Title X of Y 017.1.2 N N Incl : NIH, CDC, FDA, AHRQ V 1.0 Both Provide warning if Planned Enrollment Report is submitted with all zeros Planned Enrollment Report(s) was submitted with no data. If not a Delayed Onset study, is planned enrollment data needed? W Planned Report Study Title: 017.2 Planned Report 017.3 Planned Report Comments: 017.4 Planned Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Not Hispanic or Latino, Female 017.5 Planned Racial Category: American 017.6
Report Indian/ Alaska Native; Ethnic Category: Not Hispanic or Latino, Male Planned Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Hispanic or Latino, Female 017.7 Planned Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Hispanic or Latino, Male 017.8 Planned Report Racial Category: American Indian/ Alaska Native; Total 017.9 Planned Report Racial Category: Asian ; Ethnic Category: Not Hispanic or Latino, Female 017.10
Planned Report Racial Category: Asian; Ethnic Category: Not Hispanic or Latino, Male 017.11 Planned Report Racial Category: Asian; Ethnic Category: Hispanic or Latino, Female 017.12 Planned Report Racial Category: Asian; Ethnic Category: Hispanic or Latino, Male 017.13 Planned Report Racial Category: Asian; Total 017.14 Planned Report Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: Not Hispanic or Latino, Female 017.15
Planned Report Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: Not Hispanic or Latino, Male 017.16 Planned Report Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: Hispanic or Latino, Female 017.17 Planned Report Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: Hispanic or Latino, Male 017.18 Planned Report Racial Category: Native Hawaiian or Other Pacific Islander; Total 017.19
Planned Report Racial Category: White; Total 017.29 Planned Report Racial Category: More than One Race; Ethnic Category: Not Hispanic or Latino, Female 017.30 Planned Report Racial Category: More than One Race; Ethnic Category: Not Hispanic or Latino, Male 017.31 Planned Report Racial Category: More than One Race; Ethnic Category: Hispanic or Latino, Female 017.32 Planned Report Racial Category: More than One Race; Ethnic Category: Hispanic or Latino, Male 017.33
Planned Report Racial Category: More than One Race; Total 017.34 Planned Report Ethnic Category; Not Hispanic or Latino, Female; Total 017.35 Planned Report Ethnic Category; Not Hispanic or Latino, Male; Total 017.36 Planned Report Ethnic Category; Hispanic or Latino, Female; Total 017.37 Planned Report Ethnic Category; Hispanic or Latino, Male; Total 017.38 Planned Report Ethnic Category Total; Racial Category Total