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N N Incl: Incl: Provide error if Total 2nd Quarter is W New Rule SF 026.64.1 Total 2nd not equal to Federal 424A D – Quarter is not 2nd Quarter + equal to Federal 2nd Quarter Cash 2nd Quarter + amounts provided. Needs: Non-Federal 2nd 14. Quarter amounts TOTAL provided. (sum of lines 13 and 14) 2nd – Quarter SF 026.65.1 N N Incl: Incl: Provide error if Total 3rd Quarter is W New Rule Total 3rd Quarter not equal to Federal 424A D – is not equal to 3rd Quarter + Federal 3rd 3rd Quarter Cash Quarter + amounts provided. Needs: 3rd 14. Quarter amounts TOTAL provided. (sum of lines 13 and 14) 3rd – Quarter SF 026.66.1 N N Incl: Incl: Total 4th Quarter Total 4th Quarter is W New Rule is not equal to not equal to Federal 424A D – Federal 4th 4th Quarter + Quarter + 4th Quarter Cash 4th amounts provided. Needs: Quarter amounts 14. provided. TOTAL
|
SF 424A D – Cash Needs: 14. TOTAL (sum of lines 13 and 14) – 2nd Quarter 026.64.1 N N Incl: Incl: Provide error if Total 2nd Quarter is not equal to Federal 2nd Quarter + Non-Federal 2nd Quarter amounts provided. Total 2nd Quarter is not equal to Federal 2nd Quarter + 2nd Quarter amounts provided. W New Rule SF 424A D – Cash Needs: 14. TOTAL (sum of lines 13 and 14) – 3rd Quarter 026.65.1 N N Incl: Incl: Provide error if Total 3rd Quarter is not equal to Federal 3rd Quarter + 3rd Quarter amounts provided. Total 3rd Quarter is not equal to Federal 3rd Quarter + 3rd Quarter amounts provided. W New Rule SF 424A D – Cash Needs: 14. TOTAL 026.66.1 N N Incl: Incl: Total 4th Quarter is not equal to Federal 4th Quarter + 4th Quarter amounts provided. Total 4th Quarter is not equal to Federal 4th Quarter + 4th Quarter amounts provided. W New Rule
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SF 8. 028.23 424C and removal - b. Costs Not for SF 8. 028.24.1 N Y Incl: Incl: Provide error if The Total Allowable E New Rule not equal to Costs for Demolition 424C column A (Total and Removal and Cost) minus (Construction Budget) removal column B (Costs must be equal to the - c. Total Not Allowable for difference of columns Participation). A (Total Cost) and B Costs (Costs Not Allowable for Participation) a-b) SF 9. 028.25 424C - a. Total Cost SF 9. 028.26 424C - b. Costs Not
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SF 424C 8. and removal - b. Costs Not for 028.23 SF 424C 8. and removal - c. Total Costs a-b) 028.24.1 N Y Incl: Incl: Provide error if not equal to column A (Total Cost) minus column B (Costs Not Allowable for Participation). The Total Allowable Costs for Demolition and Removal (Construction Budget) must be equal to the difference of columns A (Total Cost) and B (Costs Not Allowable for Participation) E New Rule SF 424C 9. - a. Total Cost 028.25 SF 424C 9. - b. Costs Not 028.26
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is K26, PHS Human Subject and Clinical Trial Section 4- 4.2.a Study 034.8.2 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error for a Clinical Trial Study if a Narrative Study Description is not provided. For study titled <Study Title>, a Narrative Study Description must be provided since you answered Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are required for studies involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject Section 4- 034.8.31 N N NIH, 1.0 to K12 Both Provide error for a Human Subject Study if For study titled <study title> a, Narrative Study E Study Record fields in Sections
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Rule Categories to Error/ Activity Error Category Rule# Validation Comments Specific to Message Lists Single Activity Code Multi (Lists Form & (Y/N) FOA or or Only (Y/N) Specific Both Both ) Global Validation 000.3 N Incl : Both Both DUNS numbers: The DUNs E N NIH, Validation to apply to number for CDC, all forms containing a <insert form FDA, DUNS number present name > is AHRQ, in the package not in the VA, downloaded. If DUNS valid format USU provided on any forms of DUNS or has any invalid DUNS+4 characters (meaning number other than 9 or 13 (DUNS numbers) after should be 9 stripping of dashes, or 13 digits; provide error. no letters or special characters). Global Validation 000.4 N N Incl : Multi Both Y For New and Renewal The E NIH, type of application, the Application CDC, number of iteration of a submitted FDA, given component contains AHRQ, (defined by the more VA, component label in the occurrences USU, FOA) need to match of the number of iteration <component provided in the FOA type> than data. are allowed for this Funding Opportunity <FOA Number>. Global Validation 000.5 N N Incl : Multi Both Y For New and Renewal The E NIH, type of application, the Application CDC, number of iteration of a submitted FDA, given component contains AHRQ, (defined by the less VA, component label in the occurrences USU, FOA) need to match of the number of iteration <component provided in the FOA type> than data. are required
|
Category Rule# Rule Categories Validation Error Message Error/ Comments (Y/N) (Y/N) (Lists Form FOA Specific Activity Specific Lists Activity Code & to Single Multi or Both to or Both Global Validation 000.3 N N Incl : NIH, CDC, FDA, AHRQ, VA, USU 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, USU, 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 <FOA Number>. E Global Validation 000.5 N N Incl : NIH, CDC, FDA, AHRQ, VA, USU, 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 E Only )
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eSub-validations-draft-08-21-2017.docx
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task-1019-65
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|
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SF Person Y Y Incl Both State is required if For < Person First, E to be : country is US. Last name or 4 Contact V Organization name, 2.0 or DUNS if Org name State is not available>, the State must be supplied for US addresses. SF Person Y Y Incl Both If country is not US, For < Person First, E to be : the State must be Last name or 4 Contact V blank. Organization name, 2.0 or DUNS if Org name State is not available>, the State should not be provided for all countries other than the United States. SF Person Y Y Incl Both Province is required if For < Person First, E to be : country is Canada. Last name or 2.1 4 Contact V Organization name, 2.0 or DUNS if Org name is not available>, the Province must be supplied for Canadian addresses. SF Person Y Y Incl Both If country is not For < Person First, E to be : Canada, Province Last name or 2.2 4 Contact V must be blank. Organization name, 2.0 or DUNS if Org name is not available>, the Province should not be provided for all countries other than Canada.
|
SF Person to be State Y Y 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 Person to be State Y Y 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 Person to be Y Y 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 Person to be Y Y V 2.0 Both 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 Contact Contact Contact Contact : : : : Incl Incl Incl Incl 2.1 2.2 4 4 4 4
| 0.568814
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eSub-validations-draft-08-21-2017.docx
|
task-1019-65
| 61
|
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SF Person Y Y Incl If Country is Canada For < Person First, E to be : and province name Last name or 2.3 4 Contact V be transformed, Organization name, can’t 2.0 give error. or DUNS if Org name is not available>, the Province is not a valid province name. SF Person to be 4 Contact Country SF Person Y Y Incl Both ZIP Code is required For < Person First, E to be 4.1 : if country is US. Last name or Contact V Organization name, ZIP 2.0 or DUNS if Org name Code is not available>, the ZIP Code must be supplied for US addresses. SF Person Y Y Incl Both ZIP Code must be 9 For < Person First, E to be : numeric digits if Last name or Contact V country is US. Organization name, ZIP 2.0 or DUNS if Org name Code is not available>, a 9 digit ZIP Code must be supplied for US addresses. SF Person to be Contact
|
SF Person to be Y Y 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 Person to be Country SF Person to be ZIP Code Y Y 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 Person to be ZIP Code Y Y 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 Person to be Contact Contact Contact Contact Contact : : : Incl Incl Incl 2.3 4.1 4 4
| 0.536717
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eSub-validations-draft-08-21-2017.docx
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task-1019-65
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Contin, VA, USU SF Type of N N Incl Incl: Revision is not a valid Revision applications E New rule NIH, : F05, type of application. are not allowed for CDC, V this Funding F30, (New, FDA, 2.0 Opportunity F31, Resub, Announcement. Update to F32,F33, existing F37, VA, (add S10) F38, FI2, Contin, USU S10, Update to X01, existing R50, (added X01) F99/K00 Update to Exiting (Added R50 December – 2015 Release) January 14, 2016 Release, Update to Existing Rule (added F99/K00) SF Type of N N Incl: Incl Incl: Provide error if A resubmission, E New rule : DP1, application type is not renewal, or revision NIH, DP2, marked as New. CDC,
|
Contin, VA, USU SF Type of (New, Resub, Contin, N N NIH, CDC, FDA, VA, USU V 2.0 Incl: F05, F30, F31, F32,F33, F37, F38, FI2, S10, X01, R50, F99/K00 Revision is not a valid type of application. Revision applications are not allowed for this Funding Opportunity Announcement. E New rule 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 Type of N N Incl: NIH, CDC, Incl: DP1, DP2, Provide error if application type is not marked as New. A resubmission, renewal, or revision E New rule : : Incl Incl
| 0.44505
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eSub-validations-draft-08-21-2017.docx
|
task-1019-65
| 67
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give an valid province error. name. Project/ Primary Y Y Incl; Both Both Province is For < Person E Location, V2.0 required if First, Last name Site Province country is or Organization (R&R) Canada. name, or DUNS if Org name is not available>, the Province must be supplied for Canadian addresses. Project/ Primary Y Y Incl; Both Both If country For < Person E Location, V2.0 not First, Last name Site Province Canada, or Organization (R&R) Province name, or DUNS if must be Org name is not blank. available>, the Province should not be provided for all countries other than Canada. Project/ Y Y Incl; Both Both ZIP Code is For < Person E Primary V2.0 required if First, Last name Site Location, country is or Organization (R&R) Zip code US. name, or DUNS if Org name is not available>, the ZIP Code must be supplied for US addresses. Project/ Primary Y Y Incl; Both Both ZIP Code For < Person E Location, V2.0 must be 9 First, Last name Site Zip code numeric or Organization (R&R) digits if name, or DUNS if country is Org name is not US. available>, a 9 digit ZIP Code must be supplied for US addresses.
|
give an error. valid province name. Project/ Site (R&R) Primary Location, Province 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/ Site (R&R) Primary Location, Province 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 Project/ Site (R&R) Primary Location, Zip code 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/ Site (R&R) Primary Location, Zip code 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
| 0.520384
|
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eSub-validations-draft-08-21-2017.docx
|
task-1019-65
| 118
|
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Other Project IRB and approval date Other Project Human 004.6 and subject assurance number Other Project Vertebrate N N Incl Incl: Both Overall If Vertebrate Animal When Vertebrate E NIH, V1.3 Used is then ONE of Animals is you and animals ‘Y’, “Yes”, CDC, the following must be must provide of the used? FDA, provided: Assurance following: (1) animal AHRQ Number + IACUC welfare assurance Other Approval Date OR number + IACUC Project VA, Assurance Number + approval date, (2) USU IACUC Approval animal welfare Pending OR the word assurance number + an indication that IACUC ‘None’ (case insensitive, on approval is pending OR don’t validate punctuation) (3) the word ‘None’.
|
Other Project and Other Project IRB approval date and Other Project Human subject assurance number 004.6 and Other Project Vertebrate animals used? N N Incl NIH, CDC, FDA, VA, USU Incl: V1.3 Both Overall If Vertebrate Animal Used is ‘Y’, then ONE of the following must be provided: Assurance Number + IACUC Approval Date OR Assurance Number + IACUC Approval Pending OR the word ‘None’ (case insensitive, don’t validate on punctuation) When Vertebrate Animals is “Yes”, you must provide of the following: (1) animal welfare assurance number + IACUC approval date, (2) animal welfare assurance number + an indication that IACUC approval is pending OR (3) the word ‘None’. E AHRQ
| 0.356008
|
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eSub-validations-draft-08-21-2017.docx
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task-1019-65
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N N : Incl: Incl: Provide warning if The answer to the W New rule Vertebrate NIH, V1.3 S10 Vertebrate Animals Used Vertebrate Animals and animals CDC, is true. Used should be for ‘No’ used? FDA, this application. AHRQ Other Project VA, USU Vertebrate N N Incl: Incl: Provide Error if The answer to the E New Rule NIH, V1.3 R50 Vertebrate Animals Used Vertebrate Animals December and animals CDC, is true. Used question should be 2015 used? FDA, for this application. Release ‘No’ AHRQ Other Project VA, USU IACUC N N Incl : Incl: Both Overall Provide a warning if When Vertebrate W NIH, V1.3 Vertebrate Animals Used Animals is IACUC and review “No” CDC, is and IACUC Approval Pending ‘N’ pending? FDA, Approval Pending indicator does not apply. AHRQ indicator is checked. Other Project VA, USU IACUC N N : Incl: Both Overall Provide a warning if When Vertebrate W NIH, V1.3 Vertebrate Animals Used Animals is IACUC and approval “No” CDC, Question is false and Approval Date does not date FDA, approval date is provided apply. AHRQ Other Project VA, USU
|
and Other Project Vertebrate animals used? N N : NIH, CDC, FDA, VA, USU Incl: V1.3 Incl: S10 Provide warning if Vertebrate Animals Used is true. The answer to the Vertebrate Animals Used should be ‘No’ for this application. W New rule and Other Project Vertebrate animals used? N N NIH, CDC, FDA, VA, USU Incl: V1.3 Incl: R50 Provide Error if Vertebrate Animals Used is true. The answer to the Vertebrate Animals Used question should be ‘No’ for this application. E New Rule December 2015 Release and Other Project IACUC review pending? N N Incl : NIH, CDC, FDA, VA, USU Incl: V1.3 Both Overall 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 and Other Project IACUC approval date N N : NIH, CDC, FDA, VA, USU Incl: V1.3 Both Overall Provide a warning if Vertebrate Animals Used Question is false and approval date is provided When Vertebrate Animals is “No” IACUC Approval Date does not apply. W AHRQ AHRQ AHRQ AHRQ
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|
Project References Cited is more than pages and Other Project and References Cited N N Incl: NIH, CDC, FDA, AHRQ VA, USU Incl: V 1.3 Incl: DP1, DP2, DP4 Provide error if Bibliography attached. The Bibliography and References attachment cannot be included.. E New rule and Other Project Facilities and other resources N N Incl: NIH, CDC, FDA, AHRQ VA, USU Incl: V 1.3 Incl: T01, T02, T03, T14, T42, T90, T32, T34, T35, T36, T37, K12, D43, D71, U2R, R50 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 and Equipment N N Incl : NIH, CDC, FDA, Incl: V1.3 Incl: S10 Equipment attachment is required The Equipment Attachment is required. E New rule 15,
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but not embedded display the name as punctuation. submitted. Research Profile, 005.31.2 N N Incl: Both Both Provide warning if More than one W NIH, V2.0 more than one Senior/Key person and senior/ CDC, PD/PI profile or with the same first and Related key FDA, Senior/Key person last name has been Senior/Key person x, with the same first, found within the Person Last middle name and Snr/Key Person Profile Name VA, last name has Profile form. USU been found within Specifically: <Last component. 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. Research Profile, and senior/ Related key Senior/Key person x, Person Suffix Profile Research Profile, 005.33 and senior/ Related key
|
but not embedded punctuation. display the name as submitted. Research and Related Senior/Key Person Profile Profile, senior/ key person x, Last Name 005.31.2 N N NIH, CDC, FDA, VA, USU 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 Profile, senior/ key person x, Suffix Research and Related Profile, senior/ key 005.33
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“Does the proposed project involve human embryonic stem cells?” question. PHS 398 Cover Page HESC Cell Lines N N NIH, CDC, FDA, AHRQ, USU V 2.0 Both If HESC involved=’N’, can’t include ‘HESC Cell Lines’ or can’t be referenced’ checkbox must not be checked You cannot provide specific human embryonic stem cell lines or check the “Specific stem cell lines cannot be referenced at this time” box if you answer No to the “Does the proposed project involve human embryonic stem cells?” question. E Rule updated to apply to Only. October 2016 Release PHS 398 Cover Page HESC Cell Lines N N NIH, CDC, FDA, AHRQ, USU V 2.0 Both 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 Rule updated to apply to Only. October 2016 Release PHS 398 Cover Page HESC Cell Lines N N NIH, CDC, FDA, AHRQ, USU V 2.0 Both If ‘Can’t Be Referenced’ is checked, no cell lines may be entered. You cannot provide specific human embryonic stem cell lines if you check the “Specific stem cell lines cannot be referenced at this time” box. E Rule updated to apply to Only. October 2016 Release
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eSub-validations-draft-08-21-2017.docx
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task-1019-65
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D71, U2R PHS 398 N N V Both Must be You must answer the E Update to Cover and NIH, 2.0 all answered if existing “Previously Reported” Page Patents, CDC, response to queston if you answer rule FDA, Inventions and Yes to the (modified “Inventions AHRQ, Patents is and question language ‘Yes’ Patents” Reported USU on error (Yes or message), No) Forms D, March 2016 Release PHS 398 N N V Both Should not be You cannot answer E Update to Cover and NIH, 2.0 all answered if the existing “Previously Page Patents, CDC, response to question if rule Reported” FDA, Inventions and you answer No to the (modified AHRQ, Patents is and language ‘No’ “Inventions Reported USU question on error Patents” (Yes or message), No) Forms D, March 2016 Release PHS 398 Change N N V Both Not accepted for A change of Project E Update to Cover of NIH, 2.0 all Director Principle existing revisions. Page CDC, Investigator is not rule FDA, allowed if you select (modified of Inst.: Revision as the Type language USU of Application on the on error of PI SF424 (R&R) form. message), Forms D, March 2016 Release PHS 398 Change N N Incl: Provide error if A change of Project E Update to Cover of NIH, K02, Change of PI Director Principle existing Page CDC, K05, indicator is Investigator is not rule FDA, K24, selected. allowed for this type of (modified of Inst.: K26, language
|
D71, U2R PHS 398 Cover Page and Patents, Reported (Yes or No) N N NIH, CDC, FDA, AHRQ, USU V 2.0 Both 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, March 2016 Release PHS 398 Cover Page and Patents, Reported (Yes or No) N N NIH, CDC, FDA, AHRQ, USU V 2.0 Both 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 Change of of Inst.: of PI N N NIH, CDC, FDA, USU V 2.0 Both 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 Change of of Inst.: N N NIH, CDC, FDA, Incl: K02, K05, K24, K26, Provide error if Change of PI indicator is selected. A change of Project Director Principle Investigator is not allowed for this type of E Update to existing rule (modified language all all all
| 0.325169
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eSub-validations-draft-08-21-2017.docx
|
task-1019-65
| 190
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task-1019-65
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eSub-validations-draft-08-21-2017.docx
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task-1019-65
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task-1019-65
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Person CDC, V submissions least person with Cal. FDA, 1.3 (R41, R42, UT1, the project role of Mos UT2), a non-zero PD/PI must include value for effort of a value 10YR, VA, calendar months, greater then zero in (R&R) USU academic calendar months, months, or academic months or summer months summer is required on months.Note: use either the project either calendar budget or the months or a subaward combination of budget. It is not academic and required on both summer months. For but can be information about provided. calculating person months, see . N Y Incl : Incl: Provide warning For <Organization W & NIH, V if both academic name> budget for Person CDC, 1.3 and calendar Budget Period < x Name, FDA, months have Budget Year>, Acad. been provided Senior/Key Person Months for a person for a <Last Name, First 10YR, VA, budget year. Name>, both (R&R) USU 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,
|
10YR, (R&R) Person Cal. Mos CDC, FDA, VA, USU V 1.3 submissions (R41, R42, UT1, UT2), a non-zero 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. least 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 . & 10YR, (R&R) Person x Name, Acad. Months N Y Incl : NIH, CDC, FDA, VA, USU 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, W
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eSub-validations-draft-08-21-2017.docx
|
task-1019-65
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entered for that 100 Equipment item budget period entries are used. Travel, & travel costs, funds req 10YR, (R&R) MP Travel, & foreign travel costs, funds req 10YR, (R&R) MP Total & travel cost, funds req 10YR, (R&R) MP & support costs: 10YR,
|
entered for that budget period 100 Equipment item entries are used. & 10YR, (R&R) MP Travel, travel costs, funds req & 10YR, (R&R) MP Travel, foreign travel costs, funds req & 10YR, (R&R) MP Total travel cost, funds req & 10YR, support costs:
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Rule Categories to to Form Field Rule# Validation Error Message Comments Lists , Type Code (Multi Age FOA & or (Y/N) Only) Section A. 006.72 Senior/Key & Person, Totals ($) MP Section B. 006.73 Other & Personnel, Totals ($) MP Total 006.74 number & other personnel
|
Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) FOA Lists Code & to or to Type (Multi Only) & MP Section A. Senior/Key Person, Totals ($) 006.72 & MP Section B. Other Personnel, Totals ($) 006.73 & Total number other personnel 006.74 , Age
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to F31, to 4.2.g independent clinical F32, Clinical trials. F33, Trial Not 1.4a F37, Allowed F38, FOAs. FI2, 1.4d are New ALL Rule Incl October 2017 K’s: Release K05, K07, K08, K18, K22, K23, K26, N N NIH, 1.0 Excl: Both E Study PHS Section 034.8.19 Provide error for For study titled Record Human a Study Record <study title> at least – K12 fields in if at least one one Outcome Sections and Outcome Measure is required IV and V Clinical Measure is not since you answered = are “R" Trial provided in the Yes to questions or required study. 1.4.a-1.4.d in the "O") for 4.3 AND studies involving
|
Excl: 4.2.g to 1.4a 1.4d are ALL F31, F32, F33, F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, K26, independent clinical trials. to Clinical Trial Not Allowed FOAs. New Rule October 2017 Release PHS Human and Clinical Trial Section – 4.3 034.8.19 N N NIH, 1.0 = “R" or "O") AND K12 Both Provide error for a Study Record if at least one Outcome Measure is not provided in the study. For study titled <study title> at least one Outcome Measure is required since you answered Yes to questions 1.4.a-1.4.d in the E Study Record fields in Sections IV and V are required for studies involving
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F37, Release, Update completion USU F38, to Existing Rule Form date FI2, (added F99/K00) PHS Fellowship 024.27 , USU Applicant: degree sought, expected completion Form date PHS Fellowship 024.28 Applicant: field of training Form PHS Fellowship N N Incl : Incl: Incl: If is At least one E New rule ‘Yes’ NIH, F05, selected Applicant: on’ entry for Current F30, Current or Prior current or or Prior F31, prior FDA, January support’, support one level and 14,2016 information is F37, type is required Release, Update Form support required. USU F38, on the same row to Existing Rule (y/n)? FI2, of the grid and at (added least one row of F99/K00) the grid. PHS Fellowship 024.30 Applicant:
|
Form completion date USU F37, F38, FI2, Release, Update to Existing Rule (added F99/K00) PHS Form Fellowship Applicant: degree sought, expected completion date 024.27 , USU PHS Form Fellowship Applicant: field of training 024.28 PHS Form Fellowship Applicant: current or prior support (y/n)? N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, If ‘Yes’ is selected on’ Current or Prior 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 support information is required. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Fellowship Applicant: 024.30
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option should be option has been select most selected selected. Please August 8, 2016 appropriate USU review your Rule Severity Non-U.S. selections and updated to Citizen choose only one warning from Form Option option. error PHS N N Incl: Incl: Provide a You have W Forms D, May NIH, F30, warning if selected a 2016 Release If with a F31, Citizen with citizenship temporary F32, a Trmporary choice of U.S. visa USU F33, U.S. is citizen with visa” who has F37, selected and the a temporary U.S. applied for F38, with a as your “If visa” Form a FI2, temporary U.S. citizentship permanent visa who has status. This is applied for a not a valid resident permanent citizenship status and resident status choice for this expect to and expect to application hold a hold a unless you have permanent permanent applied for resident resident visa by permanent the earliest resident status visa by the possible start and expect to earliest date of the hold a is not permanent award” selected resident visa at the time of award. PHS Institution: 024.41 Change of sponsoring institution
|
Form select most appropriate Non-U.S. Citizen Option USU option should be selected option has been selected. Please review your selections and choose only one option. August 8, 2016 Rule Severity updated to warning from error PHS Form 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 N N Incl: NIH, USU Incl: F30, F31, F32, F33, F37, F38, FI2, Provide a warning if 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 Institution: Change of sponsoring institution 024.41
| 0.220613
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|
African American; Ethnic Category: Not Hispanic or Latino, Female Racial Category: Black or African American; Ethnic Category: Not Hispanic or Latino, Male 016.35 Racial Category: Black or African American; Ethnic Category: Not Hispanic or Latino, Unknown/ 016.36
| 0.843631
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AND Questionnaire, or Add Clinical or Trial’, add a delayed onset New Other to study and check the Requested Clinical ‘Anticipated Information is box. Or, you Trial’ Onset not provided on 1.4a must provide an Study a component for Other Requested a Clinical Trial Information 1.4d attachment. FOA when is human subject ALL is “YES” “Yes) selected on the Other Project Information form within the component PHS Add 034.4.6 N N NIH, 1.0 Both Provide Error if The E New ‘Anticipated Clinical box Rule Trial’ Human New response to cannot be checked October Subject Delayed “Anticipated for Delayed Onset 2017 and Onset Clinical is Trial” = N Study titled <study Release Clinical Study checked for at title> since this Trial least one Funding Opportunity delayed onset Announcement does study when the not allow clinical trials. Clinical FOA does not Trial support Clinical Tria. PHS Add 034.4.7 N N NIH, 1.0 Both Provide error if A Justification E New attachment is Rule Human New Delayed Onset required for Delayed October Subject Delayed Study is present, Onset Study titled 2017 and but Justification <study title>. Release Clinical
|
Add New Onset Study AND to 1.4a 1.4d is ALL “Yes) Clinical Trial’, or Other Requested Information is not provided on a component for a Clinical Trial FOA when human subject “YES” is selected on the Other Project Information form within the component Questionnaire, or add a delayed onset study and check the ‘Anticipated Clinical Trial’ box. Or, you must provide an Other Requested Information attachment. PHS Human Subject and Clinical Trial Add New Delayed Onset Study Clinical Trial 034.4.6 N N NIH, 1.0 = N Both Provide Error if response to “Anticipated Clinical Trial” is checked for at least one delayed onset study when the FOA does not support Clinical Tria. The ‘Anticipated Clinical Trial’ box cannot be checked for Delayed Onset Study titled <study title> since this Funding Opportunity Announcement does not allow clinical trials. E New Rule October 2017 Release PHS Human Subject and Clinical Add New Delayed 034.4.7 N N NIH, 1.0 Both Provide error if Delayed Onset Study is present, but Justification A Justification attachment is required for Delayed Onset Study titled <study title>. E New Rule October 2017 Release
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Human Subjects PHS Section 034.7.2 N N NIH, 1.0 Both Provide error if a A response to the E New question regarding Rule Human 3 response to the – K12 multi-site studies is October Subject question this “Is required for Study 2017 and and a multi-site Record titled <Study Release Clinical study that will Title>. Trial use the same Plans protocol to conduct Is human this a subjects research at more than one study domestic site?” that will is not provided. use the same protocol to conduct human subjects at more than one
|
Human Subjects PHS Human Subject and Clinical Trial Section 3 – and Plans Is this a study that will use the same protocol to conduct human subjects at more than one 034.7.2 N N NIH, 1.0 K12 Both Provide error if a response to the question “Is this a multi-site study that will use the same protocol to conduct human subjects research at more than one domestic site?” is not provided. A response to the question regarding multi-site studies is required for Study Record titled <Study Title>. E New Rule October 2017 Release
| 0.434588
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|
3.3 Data and Safety Plan to 1.4a 1.4d is ALL in the Clinical Trial Questionnaire. PHS Human Subject and Clinical Trial Section 3 – and Plans 3.4 Will a Data and Safety Board be for this study? 034.7.6 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d is ALL K12 Both Provide error for a Clinical Trial Study Record if response to the question “Will a Data and Safety Monitoring Board be appointed for this study?” is not provided. For study titled <Study Title>, a response to the question “Will a Data and Safety Monitoring Board be appointed for this study?” is required since you answered Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E New Rule October 2017 Release
| 0.326096
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last name, and following organization name. Senior/Key Person do not have a biosketch attachment: <Last name, First name>; on component <component ID>: Title> Attachment N N Incl : Both Both Provide error if The E Validations NIH, attachments file names CDC, are not unique within a filename> FDA, form within a attachment AHRQ, component. has been VA, uploaded USU, multiple times on the <Form name>. Please make sure all files uploaded on the <Form name> have unique file names. Attachment N Incl : Both Both Provide error if any E N The file Validations NIH, attachments filenames attached to CDC, are missing FDA, label> on AHRQ, form <form VA, name> does USU, not have a specified
|
last name, and organization name. following Senior/Key Person do not have a biosketch attachment: <Last name, First name>; on component <component ID>: Title> Attachment Validations N N Incl : NIH, CDC, FDA, AHRQ, VA, USU, Both Both Provide error if attachments file names are not unique within a form within a component. The 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 N N Incl : NIH, CDC, FDA, AHRQ, VA, USU, Both Both Provide error if any attachments filenames are missing The file attached to label> on form <form name> does not have a specified E
| 0.567361
|
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task-1019-66
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(added support x, same row of the F99/K00) end date grid PHS Fellowship 024.34 Applicant: current or prior Form support x, grant number PHS Fellowship 024.35 Applicant: Application for concurrent support Form (Y/N)? PHS Fellowship N N Incl : Incl: Incl: If selected An Application E New rule ‘Yes’ NIH, F05, for Concurrent Concurrent Applicant: F30, Support, the Support concurrent F31, Application for attachment must support FDA, Concurrent be included. January description Support 14,2016 attachment F37, attachment is Release, Update Form USU F38, required to Existing Rule FI2, (added F99/K00)
|
Application support x, end date same row of the grid (added F99/K00) PHS Form Fellowship Applicant: current or prior support x, grant number 024.34 PHS Form Fellowship Applicant: for concurrent support (Y/N)? 024.35 PHS Form Fellowship Applicant: concurrent support description attachment N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, If ‘Yes’ selected for Concurrent Support, the Application for Concurrent Support attachment is required An Application Concurrent Support attachment must be included. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00)
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IS1, Project I34, IU1 Other N N Incl: Incl: Incl For VA applications and A Career Plan may not E VA V1.3 I01, activity code is I01, I21, be submitted for this and I21, I50, IP1, IK6, IK3, IS1, application. I50, I34 or IU1 do not accept IP1, file named Other IK6, Project IS1, I34, IU1 Other N N Incl: Incl: Incl: For VA applications and A Career Plan is E VA V1.3 IK1, activity code is IK1, IK2, required for this and attachment IK2, IK4 or IK5, a file named application. Please IK3, submit it as an 'Other IK4 is required Attachment' on the Other ,IK5, Other Project Project Information page, titled Other N N Incl: Incl: Incl: For VA applications and A Mentoring Plan is E VA V1.3 is IK1, activity code is IK1, IK2, required for this and IK2, IK4 or IK5, a file named application. Please IK3, submit it as an 'Other IK4, is required Attachment' on the Other IK5 Other Project Project Information page, titled Other N N Incl: Incl: Incl: For VA applications and The Research Plan, Updated E VA V1.3 IP1, activity code is IP1, I50, submitted as an Other Activity and attachment I50, IK4, IS1 or IU1 where a Attachment on the Other code and IK4, file named Project Information validation
|
attachment attachment Project IS1, I34, IU1 and Other Project Other N N Incl: VA Incl: V1.3 Incl I01, I21, I50, IP1, IK6, IS1, I34, IU1 For VA applications and activity code is I01, I21, I50, IP1, IK6, IK3, IS1, I34 or IU1 do not accept file named A Career Plan may not be submitted for this application. E and Other Project Other N N Incl: VA Incl: V1.3 Incl: IK1, IK2, IK3, IK4 ,IK5, For VA applications and activity code is IK1, IK2, IK4 or IK5, a file named is required A Career Plan is required for this application. Please submit it as an 'Other Attachment' on the Other Project Information page, titled E and Other Project Other N N Incl: VA Incl: V1.3 Incl: is IK1, IK2, IK3, IK4, IK5 For VA applications and activity code is IK1, IK2, IK4 or IK5, a file named is required A Mentoring Plan is required for this application. Please submit it as an 'Other Attachment' on the Other Project Information page, titled E and Other N N Incl: VA Incl: V1.3 Incl: IP1, I50, IK4, For VA applications and activity code is IP1, I50, IK4, IS1 or IU1 where a file named The Research Plan, submitted as an Other Attachment on the Other Project Information E Updated Activity code and validation
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eSub-validations-draft-09-12-2017.docx
|
task-1019-66
| 144
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VA, USU SF N N Incl : Incl Multi End date is required The Component E 424 NIH, : Proposed Project project CDC, one Ending Date is ending FDA, required. MP date VA, USU SF N N : Incl Multi Must be later than The Component E 424 NIH, : Project Start Date Proposed Project project CDC, one Ending Date must be ending FDA, later than the MP date Proposed Project Start Date. VA, USU SF N N Incl Multi Must be no more than The Component E 424 NIH, : 20 years greater than Proposed Project project CDC, one date. Ending Date cannot today’s ending FDA, be more than 20 MP date years in the future. VA, USU SF N N Incl Multi Y Must be equal or The Component E 424 NIH, : before the proposed Proposed Project End project CDC, one ending date of the Date must be equal to ending FDA, Overall or before the MP date Proposed End Date of the Overall VA, component. USU SF 002.52 424
|
VA, USU SF 424 MP project ending date N N Incl : NIH, CDC, FDA, VA, USU Multi End date is required The Component Proposed Project Ending Date is required. E SF 424 MP project ending date N N : NIH, CDC, FDA, VA, USU 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 MP project ending date N N NIH, CDC, FDA, VA, USU 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 MP project ending date N N NIH, CDC, FDA, VA, USU 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 424 002.52 : : Incl : Incl : Incl Incl one one one one
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|
and Other Project Other N N Incl: VA Incl: V1.3 Incl: I01 For VA applications and activity code is I01 or IK3 where a file named has been submitted, it cannot be greater than 14 pages The Research Plan, submitted as an Other Attachment on the Other Project Information page, is limited to 14 pages. E Update to Existing rule (Added Activity code IK3) October 2016 Release and Other Project Other N N Incl: VA Incl: V1.3 Excl: IK6 IS1 For VA applications and activity code is NOT IK6 or IS1 provide error if the file named is submitted. A Letter from the VA R&D Committee may not be submitted for this application. E and Other Project Other N N Incl: VA Incl: V1.3 Incl: IK6 E For VA applications and activity code is IK6, where a file named has been submitted, it cannot be greater than 7 pages. The Research Plan, submitted as an Other Attachment on the Other Project Information page, is limited to 7 pages. and Other Project Other N N Incl: VA Incl: V1.3 Incl: IK6 IS1 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
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Person Profile Org Primary DUNs) submitting the application and have the PI role either not affiliated with the applicant organization or does not hold the PI role. Check with your Commons Account Administrator to make sure your account affiliation and roles are set-up correctly May 2017 Release Research and Related Senior/Key Person Profile PD/PI Profile, credential 005.21.4 N N Incl NIH, CDC, FDA, VA, USU Incl: V2.0 Both 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 on the current application, provide the indicated warning. 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 Research and Related Senior/Key Person Profile PD/PI Profile, credential 005.21.5 N N Incl : NIH, CDC, FDA, VA, USU Incl: V2.0 Both For a revision, the PI should be assigned to the parent grant. If neither the profile nor the last name match, provide the indicated warning. 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 all all
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|
PHS 398 Cover Page Change of of Inst.: Name of former PI, Suffix PHS 398 Cover Page Change of of Inst.: Change of institution indicator N N Incl: NIH, CDC, FDA, AHRQ, USU Incl: V 1.3 Incl: T01, T02, T03, T14, T42, T90, T90/R90, T32, T34, T35, T36, T37, K12, D43, D71, U2R Warning if change of Grantee Institution is selected A change of grantee institution is typically not 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 Change of of Inst.: name of former inst. N Incl: NIH, CDC, FDA, AHRQ, USU Both The name of former institution is required if the answer to the "Change of Grantee Institution" question is "Yes". You must provide the name of former institution if you check the “Change of Grantee Institution” box. E Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Animals: Is method N N Incl: NIH, USU Both Both An answer to “is method consistent with American You must answer the “Is method consistent with AVMA guidelines?” question E Forms D, March 2016 Release all 36.1 38.1
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] |
R&R Budget(5Year) (Use only for Single-project) Rule Categories to to / Form Field Validation Error Message Comments Activity Specific Lists Activity Code (Inclusion (Multi (Lists FOA & or or (Y/N) Both Only) Unless & specifically stated, all project budget validations also 5YR, apply to the (R&R) subaward budget. N Y Incl: Incl: Incl: The application Applications E & NIH, V R03, should be submitted by USU 1.3 R21, submitted with a domestic institutions R34, modular budget. (U.S.) must use the U34, UH2 Applications PHS 398 Modular 5YR, where the Budget Form and not (R&R) applicant the RR Budget Form. organization is foreign are exempt from this validation.
|
R&R Budget(5Year) (Use only for Single-project) Form Field Rule Categories Validation Error Message Comments (Y/N) (Lists FOA Activity Specific Lists Activity Code (Inclusion & to or to or Both (Multi Only) & 5YR, (R&R) Unless specifically stated, all project budget validations also apply to the subaward budget. & 5YR, (R&R) N Y Incl: NIH, USU Incl: V 1.3 Incl: R03, R21, R34, U34, UH2 The application should be submitted with a modular budget. Applications where the applicant organization is foreign are exempt from this validation. Applications submitted by domestic institutions (U.S.) must use the PHS 398 Modular Budget Form and not the RR Budget Form. E /
| 0.412273
|
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N Y Incl: Incl: Exclude: For a revision, if This application W NIH, V 333, 666, the parent grant should be submitted & USU 1.3 777, C06, budget is with the same type of UC6, G20 modular, only a budget as the last modular budget competing segment. form may be 5YR, submitted (R&R) N Y Incl: Incl: Incl: Return error if All budget information E NIH, V R15, for this multi-year & more than one CDC, 1.3 RF1, funded application budget period FDA, UF1, must be submitted in has been UA5 a single budget included. period. Be sure to 5YR, VA, comply with the (R&R) USU Funding Opportunity Announcement (FOA) instructions. N Y : Incl: Budget marked The budget marked E NIH, V as must as must & ‘Project’ ‘Project’ DUNS CDC, 1.3 contain (left contain the DUNS FDA, string match) the number for the DUNS number organization from the for the SF 424 RR Cover. 5YR, VA, component (R&R) USU organization on the 424 RR N Y : Incl: Budget marked The <Organization E NIH, V as Name> & ‘Subaward’ subaward’ DUNS CDC, 1.3 cannot contain budget cannot FDA, DUNS number contain the DUNS for the number provided on component the SF 424 RR Cover. 5YR, VA, application (R&R) USU organization on the 424 RR
|
& 5YR, (R&R) N Y Incl: NIH, USU Incl: V 1.3 Exclude: 333, 666, 777, C06, UC6, G20 For a revision, if the parent grant budget is modular, only a modular budget form may be submitted This application should be submitted with the same type of budget as the last competing segment. W & 5YR, (R&R) N Y Incl: NIH, CDC, FDA, VA, USU Incl: V 1.3 Incl: R15, RF1, UF1, UA5 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) DUNS N Y : NIH, CDC, FDA, VA, USU Incl: V 1.3 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) DUNS N Y : NIH, CDC, FDA, VA, USU Incl: V 1.3 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
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eSub-validations-draft-09-12-2017.docx
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Total Indirect & Costs 5YR, (R&R) Total N Y Incl : Incl: Must be equal to For <Organization E Direct NIH, V the sum of Total name> budget for & and CDC, 1.3 Direct Costs and Budget Period < Indirect FDA, Total Indirect Budget Year>, the Costs Costs Total Direct and Indirect Costs Funds 5YR, VA, Requested do not (R&R) USU equal the sum of individual direct and indirect costs. Fee N Y Incl : Incl: A fee cannot be For <Organization E NIH, V entered for a name> budget for & CDC, 1.3 Budget Period < FDA, budget. Budget Year>, a fee has been entered. Fees are not allowed 5YR, VA, for (R&R) USU budgets. Budget & 5YR, (R&R)
|
& 5YR, (R&R) Total Indirect Costs & 5YR, (R&R) Total Direct and Indirect Costs N Y Incl : NIH, CDC, FDA, VA, USU Incl: V 1.3 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, VA, USU Incl: V 1.3 A fee cannot be entered for a budget. For <Organization name> budget for Budget Period < Budget Year>, a fee has been entered. Fees are not allowed for budgets. E & 5YR, (R&R) Budget
| 0.436073
|
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& Costs V two budget Costs for Entire total 1.3 periods, must be Project is Period’ FDA, less than or limited to $200K equal to $200k. if two (2) budget periods have VA, been included. USU Section G, 022.96.3 N N Incl : Incl: Incl: For a The cumulative E New rule Direct NIH, V G08 submission with Direct ‘Total & Costs 1.3 three budget Costs for Entire total periods, must be Project is Period’ FDA, less than or limited to $300K equal to $300k. if three (3) budget periods have VA, been included. USU Section G, 022.97.1 N Y Incl : Incl: Must be equal to For E Direct NIH, V the sum of Total <Organization & Costs (A 1.3 Direct Costs for name> budget, thru F) every budget the Cumulative FDA, year for this Direct Costs does budget. not equal the sum of Total VA, Direct Costs for USU all budget periods.
|
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|
(NIH) FDA, USU K08, K18, K22, K23, K25, K99, K99/R00, K76 attachments 2-4 and Research Strategy attachment is greater than 15 pages. sections together are limited to 12. This may span 15 pages due to page breaks Existing Rule (adding K76) Forms D, March 2016 Release Dev. (NIH) Career Dev. Award Career Goals and Objectives N N Incl : NIH, FDA, USU 3.0 and Incl: K02, K05, K24, K26, K01, K07, K08, K18, K22, K23, K25, K99, K99/R00, K76 Required attachment The Career Goals and Objectives attachment is required. E January 14, 2016 Release, Update to Existing Rule (adding K76) Forms D, March 2016 Release Dev. (NIH) Career Dev. Award Plan for Career Training Activities During Award Period N N Incl : NIH, FDA, USU 3.0 and Incl: K02, K05, K24, K26, K01, K07, K08, K18, K22, K23, K25, K99, K99/R00, K76 Required attachment The Candidate’s Plan for Career Development/ Training Activities During Award Period attachment is required. E January 14, 2016 Release, Update to Existing Rule (adding K76) Forms D, March 2016 Release Dev. Career Dev. Award N N Incl : NIH, Incl: K02, K05, K24, K26, Required attachment The Training in the Responsible Conduct of E January 14, 2016 Release, Update to 3.1
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trials in the Clinical Trial 1.4a (unless Questionnaire. 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.64 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study to Record Human a Human <study title> a – K12 fields in Subject Subject Study if response to Sections and response to question, the “Will 1.4a IV and V Clinical question, study use an FDA “Will – are Trial the study use an regulated blocked FDA regulated cannot 1.4d for – intervention?” 4.6 Will are studies is be since you intervention?” “Yes”, NOT which do the did not answer Yes “Yes” not study to questions involve “Yes” use an in the Clinical clinical FDA Trial Questionnaire. – trials. New Rule October 2017 Release
|
Excl: 1.4a 1.4d are ALL in the Clinical Trial Questionnaire. trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.6 Will the study use an FDA – 034.8.64 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Subject Study if response to question, “Will the study use an FDA – regulated intervention?” is “Yes” For study titled <study title> a response to question, “Will the study use an FDA – regulated intervention?” cannot be “Yes”, since you did not answer Yes to questions in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are blocked for studies which do not involve clinical trials. New Rule October 2017 Release
| 0.326101
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Existing Rule Statements K99/R00, is limited to USU (added K76) (NIH) of Mentor K76 6 pages. and Career N N Incl Incl: Provide Warning The Plans and W New rule NIH, K07, K22 if Plans and Dev. Statements of Statements by Dev. Award Mentor and Mentor, FDA, Plans is typically Contributors (NIH) and required for this attachment is Statements type of USU not provided of Mentor application. Be and sure to comply with the Funding Opportunity Announcement (FOA) instructions. N N Incl : Incl: Provide Warning The Letters of W January 14, Career NIH, K02, K05, if not included Support from 2016 Release, Dev. K24, K26, Collaborators, Update to Dev. Award K01, K07, Contributors, Existing Rule FDA, K08, K18, and Consultants (added K76) Letters K22, K23, attachment may (NIH) of Support K25, K99, be required for from USU K99/R00, this application. K76 Be sure to comply with the announcement and application and
|
(NIH) Statements of Mentor and USU K99/R00, K76 is limited to 6 pages. Existing Rule (added K76) Dev. (NIH) Career Dev. Award Plans and Statements of Mentor and N N Incl NIH, FDA, USU Incl: K07, K22 Provide Warning if Plans and Statements by Mentor, Contributors attachment is not provided The Plans and Statements of Mentor and is typically required for this type of application. Be sure to comply with the Funding Opportunity Announcement (FOA) instructions. W New rule Dev. (NIH) Career Dev. Award Letters of Support from and N N Incl : NIH, FDA, USU Incl: K02, K05, K24, K26, K01, K07, K08, K18, K22, K23, K25, K99, K99/R00, K76 Provide Warning if not included The Letters of Support from Collaborators, Contributors, and Consultants attachment may be required for this application. Be sure to comply with the announcement and application W January 14, 2016 Release, Update to Existing Rule (added K76)
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to F32, to 4.6a If Device Device Exemption F33, Clinical yes, Exemption (IDE) (IDE) status F37, Trial Not describe is attachment cannot status” 1.4a F38, Allowed the provided. be provided since FI2, FOAs. the Funding of Opportunity 1.4d Announcement does are New ALL Incl Rule not allow October K’s: Product independent clinical 2017 (IP) and trials. Release K05, K07, New K08, Drug K18, K22, K23, Device K26, (IDE) status? PHS Section 034.8.28 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study Record Human a CT study if <study title> a – K12 fields in Subject Dissemination Plan “Dissemination Sections and is required since you Plan” IV and V Clinical attachment is answered to “Yes” = are “R" Trial not attached questions 1.4.a-1.4.d or required in the Clinical Trial "O") for 4.7 AND Questionnaire. studies involving to
|
Excl: 4.6a If yes, describe the of Product (IP) and New Drug Device (IDE) status? to 1.4a 1.4d are ALL F32, F33, F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, K26, Device Exemption (IDE) status” is provided. Device Exemption (IDE) status attachment cannot be provided since the Funding Opportunity Announcement does not allow independent clinical trials. to Clinical Trial Not Allowed FOAs. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.7 034.8.28 N N NIH, 1.0 = “R" or "O") AND to K12 Both Provide error for a CT study if “Dissemination Plan” attachment is not attached For study titled <study title> a Dissemination Plan is required since you answered “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are required for studies involving
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(2) Will the Project devote at least 10% effort to the proposed project? In the joint N N NIH, Incl: R41, Provide error if You have E New Rule research R42, UT1, response to the selected “STTR” October 2017 and UT2, R43, question, the as your program “In Release (NIH) FDA, R44, U43, joint research type. You must U44, SB1, and provide a proposed UB1 development response to the in this VA proposed in this question, the “In project, project, does the joint research does the small business and small perform at least development business 40% of the work proposed in this perform at and the research project, does the least 40% institution named small business of the work in the application perform at least and the perform at least 40% of the work research 30% of the and the research institution is not institution work?” named in provided when named in the the program type application application selected is perform at least perform at STTR or Both. least 30%
|
(2) Will the Project devote at least 10% effort to the proposed project? (NIH) In the joint research and proposed in this project, does the small business perform at least 40% of the work and the research institution named in the application perform at least 30% N N NIH, FDA, VA Incl: R41, R42, UT1, UT2, R43, R44, U43, U44, SB1, UB1 Provide error if response to the question, “In the joint research and development proposed in this project, does the small business perform at least 40% of the work and the research institution named in the application perform at least 30% of the work?” is not provided when program type selected is STTR or Both. You have selected “STTR” as your program type. You must provide a response to the question, “In the joint research and development proposed in this project, does the small business perform at least 40% of the work and the research institution named in the application perform at least E New Rule October 2017 Release
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024.8.2 N N Incl : Incl: An answer to The Human E New rule PHS Human NIH, F05, Clinical trial Subjects Clinical Subjects 4.0 F30, question is Trial question and F31, required if the must be Clinical FDA, answer to answered if the January Trial (Y/N) Subjects answer to 14,2016 ‘Human F37, is Subjects Release, Update Involved’ ‘Human Form USU F38, "Yes". on the to Existing Rule Involved’ FI2, Other Project (added Information page F99/K00) is "Yes". PHS Human 024.9.2 N N Incl : Incl: If Human The Human E New rule NIH, F05, Subjects Clinical Subjects Subjects 4.0 F30, Trial is No, Phase III and F31, Phase Clinical Trial FDA, III Clinical Trial must be if “No” must be No or the answer to the Phase III F37, NULL Human Subjects January Clinical Form USU F38, Clinical Trial 14,2016 Trial (Y/N) FI2, question is Release, Update “No” to Existing Rule (added F99/K00) PHS Human 024.9.1 N N Incl : Incl: An answer to The Human E New rule NIH, F05, NIH-Defined Subjects Subjects 4.0 F30, Phase III Clinical Phase III and F31, Trial is required Clinical Trial FDA, if the answer to question must be January Subjects answered if the 14,2016 ‘Human Phase III F37, Clinical is answer to the Release, Update Trial’ Clinical Form USU F38, "Yes". Human Subjects to Existing Rule Trial (Y/N) FI2, Clinical Trial (added question is "Yes" F99/K00) PHS Fellowship N N Incl : Incl: Protection of The Protection of E New rule NIH, F05, Human Subjects Human Subjects 4.0 F30, attachment is attachment must Form and F31, required if be included if the
|
PHS Form Human Subjects Clinical Trial (Y/N) 024.8.2 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, An answer to Clinical trial question is required if the answer to ‘Human Subjects Involved’ is "Yes". The Human Subjects Clinical Trial question must be answered if the answer to ‘Human Subjects Involved’ on the Other Project Information page is "Yes". E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Human Subjects Phase III Clinical Trial (Y/N) 024.9.2 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, If Human Subjects Clinical Trial is No, Phase III Clinical Trial must be No or NULL The Human Subjects Phase III Clinical Trial must be “No” if the answer to the Human Subjects Clinical Trial question is “No” E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Human Subjects Phase III Clinical Trial (Y/N) 024.9.1 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, An answer to NIH-Defined Phase III Clinical Trial is required if the answer to ‘Human Subjects Clinical Trial’ is "Yes". The Human Subjects Phase III Clinical Trial question must be answered if the answer to the Human Subjects Clinical Trial question is "Yes" E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Fellowship Form N N Incl : NIH, 4.0 and Incl: F05, F30, F31, Protection of Human Subjects attachment is required if The Protection of Human Subjects attachment must be included if the E New rule
| 0.266054
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eSub-validations-draft-09-12-2017.docx
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task-1019-66
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be greater than required for federal for F33 Senior stipend USU Fellowship Form requested, Applicants. number of months PHS Budget: N N Incl : Incl: Incl: Supplementation The Amount for E New rule NIH, F33 from other the sources, amount Supplementation during should be from other first year, FDA, greater than sources is for F33 required for from Senior Form other USU Fellowship sources, Applicants. amount PHS Budget: N N Incl : Incl: Incl: Supplementation The Number of E New rule NIH, F33 from other Months for the sources, , # of Supplementation during months should from other first year, FDA, be greater than sources is for F33 required for from Senior Form other USU Fellowship. sources, , # of months PHS Budget: N N Incl : Incl: Incl: Supplementation The Type of E New rule NIH, F33 from other Supplementation sources, type is from other during a required for sources is first year, FDA, F33 required for Senior from
|
Form federal stipend requested, number of months USU be greater than for F33 required for Senior Fellowship Applicants. PHS Form Budget: during first year, from other sources, amount N N Incl : NIH, FDA, USU Incl: Incl: F33 Supplementation from other sources, amount should be greater than for F33 The Amount for the Supplementation from other sources is required for Senior Fellowship Applicants. E New rule PHS Form Budget: during first year, from other sources, , # of months N N Incl : NIH, FDA, USU Incl: Incl: F33 Supplementation from other sources, , # of months should be greater than for F33 The Number of Months for the Supplementation from other sources is required for Senior Fellowship. E New rule PHS Budget: during first year, from N N Incl : NIH, FDA, Incl: Incl: F33 Supplementation from other sources, type is a required for F33 The Type of Supplementation from other sources is required for Senior E New rule
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clinical trials. New Rule October 2017 Release PHS Section 034.8.32 N N NIH, 1.0 Provide error if For study titled E Study Record Human 4- Narrative Study <study title>, a K12 fields in Subject Description is Narrative Study Incl Sections and provided Description cannot IV and V F’s: Clinical be provided since = are Trial this Funding F05, blocked “N”) Opportunity AND F30, for F and 4.2.a ( F31, K Announcement does F32, not allow to F33, to Study independent clinical F37, Clinical trials. F38, Trial Not 1.4a FI2, Allowed FOAs. 1.4d are Incl ALL New K’s: Rule October 2017 K05, Release K07, K08, K18, K22, K23,
|
clinical trials. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 4- 4.2.a Study 034.8.32 N N NIH, 1.0 = “N”) AND ( to 1.4a 1.4d are ALL K12 Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, Provide error if Narrative Study Description is provided For study titled <study title>, a Narrative Study Description cannot be provided since this Funding Opportunity Announcement does not allow independent clinical trials. E Study Record fields in Sections IV and V are blocked for F and K to Clinical Trial Not Allowed FOAs. New Rule October 2017 Release
| 0.285959
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countries other than Canada. SF 424 025.19.1 Country SF 424 025.20.1 Zip / Postal Code: SF For < Person First, Last name or 424 ZIP Code must Organization name, Incl: 025.20.2 V be 9 numeric or DUNS if Org name New rule Zip / Y Y E 2.1 digits if country is not available>, a 9 Postal is US. digit ZIP Code must Code: be supplied for US addresses. SF 424 025.21 Name: SF 025.22 424
|
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| 0.458391
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eSub-validations-draft-09-12-2017.docx
|
task-1019-66
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SF Contact 424 Person: 025.29 SF Contact 424 Person: 025.30.1 Number: SF Contact 424 Person: 025.31 Fax Number: SF Must contain a The submitted e-mail E with at least address for the 424 ‘@’, 1 and at most 64 person to be chars preceding contacted {0}, is and following the invalid. Must contain Contact a with at least 1 ‘@’. Control ‘@’, Incl: Person: 025.32.1 V characters and at most 64 chars New rule N Y 2.1 (ASCII through preceding and Email: 31 and 127), following the ‘@’. spaces and Control characters special chars < > (ASCII through 31 ( [ ] \ , : are and 127), spaces and not valid. special chars < > ( [ ] \ , ; : are not valid.
|
SF 424 Contact Person: 025.29 SF 424 Contact Person: Number: 025.30.1 SF 424 Contact Person: Fax Number: 025.31 SF 424 Contact Person: Email: 025.32.1 N Y Incl: V 2.1 Must contain a ‘@’, with at least 1 and at most 64 chars preceding and following the ‘@’. Control characters (ASCII through 31 and 127), spaces and special chars < > ( [ ] \ , : are not valid. The submitted e-mail address for the person to be contacted {0}, is invalid. Must contain a ‘@’, with at least 1 and at most 64 chars preceding and following the ‘@’. Control characters (ASCII through 31 and 127), spaces and special chars < > ( [ ] \ , ; : are not valid. E New rule
| 0.426596
|
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eSub-validations-draft-09-12-2017.docx
|
task-1019-66
| 587
|
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SF 9. Type 424 of 1: 025.33.1 Select Type: SF 9 Type 424 of 2: 025.34 Select Type: SF 9 Type 424 of 3: 025.35 Select Type: SF 9 Type If Type of 424 of Applicant = Incl: If is selected ‘Other’ 025.36.1 V Other, Other Other N N for Applicant Type, E New rule 2.1 speify selection please specify. is required must not be blank.
|
SF 424 9. Type of 1: Select Type: 025.33.1 SF 424 9 Type of 2: Select Type: 025.34 SF 424 9 Type of 3: Select Type: 025.35 SF 424 9 Type of Other 025.36.1 N N Incl: V 2.1 If Type of Applicant = Other, Other speify selection is required must not be blank. If ‘Other’ is selected for Applicant Type, please specify. E New rule
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SF 13. 424 025.42 Number: SF 13. 424 025.43 Title: SF 14. 424 Areas Affected by Project (Cities, 025.44 States, etc.) SF 15. 424 025.45.1 Title of
|
SF 424 13. Number: 025.42 SF 424 13. Title: 025.43 SF 424 14. Areas Affected by Project (Cities, States, etc.) 025.44 SF 424 15. Title of 025.45.1
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SF 18. 424 025.53.1 Funding ($): c. State SF 18. 424 025.54.1 Funding ($): d. Local SF 18. 424 025.55.1 Funding ($): e. Other SF 18. 424 Funding 025.56.1 ($):f. Program Income
|
SF 424 18. Funding ($): c. State 025.53.1 SF 424 18. Funding ($): d. Local 025.54.1 SF 424 18. Funding ($): e. Other 025.55.1 SF 424 18. Funding ($):f. Program Income 025.56.1
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(d) (1-4) SF Section 026.6.1 N N Incl: Incl: Provide error if The Total for W New Rule Non-Federal Funds for 424A A – Total is not equal Estimated Budget to Federal Unobligated Funds Estimated column does not Unobligated equal the sum of Funds line 1 thru Funds (line 1 4. through 4) provided. Funds: (d) Total SF Section 026.7 424A A – Budget New or Revised Budget: Federal (e) (1-4) SF Section 026.8.1 N N Incl: Incl: Provide error if The Total for Federal E New Rule Federal Total is Funds for New or 424A A – not equal to Revised Budget Budget Federal New or column does not
|
(d) (1-4) SF 424A Section A – Budget Funds: (d) Total 026.6.1 N N Incl: Incl: Provide error if Non-Federal Total is not equal to Federal Estimated Unobligated Funds line 1 thru 4. The Total for Funds for Estimated Unobligated Funds column does not equal the sum of Funds (line 1 through 4) provided. W New Rule SF 424A Section A – Budget New or Revised Budget: Federal (e) (1-4) 026.7 SF 424A Section A – Budget 026.8.1 N N Incl: Incl: Provide error if Federal Total is not equal to Federal New or The Total for Federal Funds for New or Revised Budget column does not E New Rule
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eSub-validations-draft-09-12-2017.docx
|
task-1019-66
| 606
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