Requested ($) or total or total short term, or total or total short term, or number of other full-time, or number of other short term, is greater than and total stipends requested total is not greater than information is then corresponding Stipends Requested information must also be included. PHS 398 A. Stipends, Stipends Requested ($) N N Incl : NIH, FDA, USU Incl: Excl: T02, T03 Provide error If total stipends requested is greater than and number of undergrad and number undergrad short For <Organization name> for budget period < Budget Year>, if Stipends Requested information is provided then corresponding E
term, and total and total short term, and total and total short term, and number of other full-time, and number of other short term, is not greater than 0. Number of Trainees information must also be included. PHS 398 A. Stipends, Tuition /Fees Requested ($) PHS 398 A. Stipends, 45
Stipends + Tuition/ Fees Requested ($) PHS 398 B. Other Direct Travel, Funds Requested ($) PHS 398 B. Other Direct Related Expenses, Funds Requested ($) N N Incl : NIH, FDA, USU Incl: Warning if Funds requested, training related expenses is not provided For <Organization name> for budget period < Budget Year>, the Funds Requested for Training Related Expenses should be provided. W PHS 398 B. Other Direct CostsTotal Direct Costs from N N Incl : NIH, FDA, Incl: Provide error if RR budget (project budget) is present in the application and if the Total Direct If an R&R Budget is part of the application, the Total direct costs from the R&R Budget E
R&R Budget Form (if applicable), Funds Requested ($) USU Costs from RR Budget for budget periods is Null or '0' should be provided in the Total direct Cost from R&R Budget form section. PHS 398 B. Other Direct Training Costs (if applicable), Funds Requested ($) N N Incl : NIH, FDA, USU Incl: Excl: T02, T03 provide warning for Project budget if all budget periods Consortium cost is Null or '0' and a subaward exists for the component A Budget form is included in the application. The total costs of 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 B. Other Direct CostsTotal Other Direct
Costs Requested, Funds Requested ($) PHS 398 C. Total Direct Costs Requested (A + B) PHS 398 D. Indirect Costs Indirect Cost Type 1 PHS 398 D. Indirect Costs Indirect Cost Rate 1 (%) N N Incl : NIH, FDA, USU Incl: Provide warning if not 8 For <Organization name> budget for budget period < Budget Year>, the Indirect Cost Rate should be equal to 8. W PHS 398 D. Indirect Costs
PHS 398 D. Indirect Costs Funds Requested 2 ($) PHS 398 D. Indirect Costs Total Indirect Costs Requested PHS 398 E. Total Direct and Indirect Costs Requested (C + D) PHS 398 F. Budget N N Incl : NIH, FDA, USU Incl: The budget justification attachment is required The budget justification attachment is required. E PHS 398 Training Budget Cumulative
Requested ($) PHS 398 A. Stipends, Single Degree, Requested ($) 015.67 PHS 398 A. Stipends, Dual Degree, Stipends Requested ($) 015.68 PHS 398 A. Stipends, 015.69
PHS 398 A. Stipends, Degree Seeking, Stipends Requested ($) 015.72 PHS 398 A. Stipends, Degree Seeking, Requested ($) 015.73 PHS 398 A. Stipends, Degree Seeking, Stipends 015.74
, Requested ($) PHS 398 A. Stipends, Stipends Requested ($) 015.78 PHS 398 A. Stipends, Requested ($) 015.79 PHS 398 A. Stipends, 015.80
Form (if applicable) PHS 398 B. Other Direct Costs Training Costs (if applicable) 015.86 PHS 398 B. Other Direct Costs Total Other Direct Costs Requested 015.87 PHS 398 C. Total Direct Costs Requested (A + B) 015.88
SBIR/STTR Form Form Field Rule Categories Validation Error Message Error/ Comments (Lists FOA Activity Specific Lists Activity Code (Inclusion & Exclusion) to or to or Both (Multi Only) (NIH) Program Type (SBIR, STTR, Both) N N Incl : NIH, FDA, VA 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) N N Incl : NIH, FDA, VA 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 Type (Phase I,
(NIH) Phase II, Fast-Track) (NIH) Question 1.a Small Business Eligibility (Y/N) N N Incl : NIH, FDA, VA 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 (NIH) Question 2. Are Included? (Y/N) (NIH) Name of For N N Incl : NIH, FDA, V 1.1 Incl: R41, R42, UT1, UT2, Required entry if response to ‘Are Subcontracts If it is indicated in question 2 that subcontracts are included, the E
VA R43, R44, U43, U44 Included?’ is ‘Yes’. name(s) of labs or agencies for subcontracts must be included. (NIH) Name of For N N Incl : NIH, FDA, VA 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) (NIH) Question 4. Research to be Performed in US? (Y/N)
(NIH) of Foreign N N Incl : NIH, FDA, VA 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 that research is not to be performed in the US, an explanation attachment must be provided. E (NIH) of Foreign N N Incl : NIH, FDA, VA 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 that research is to be performed in the US, an explanation attachment cannot be provided. E (NIH) Question 5. Equivalent (Y/N) (NIH) Names of other Federal agencies for N N Incl : NIH, FDA, V 1.1 Incl: R41, R42, UT1, UT2, R43, R44, Required entry if answer to ‘submittal of equivalent work to other If it is indicated in question 5 that applications for essentially equivalent work E
VA SBIR/STTR form and the Cover Page Supplement form Supplement form does not match the answer provided on the SBIR/STTR Information form. Please verify and correct as needed. (NIH) Plan N N Incl : NIH, FDA, VA Incl: Plan attachment cannot be submitted for SBIR or STTR Phase I A Plan should not be submitted for Phase I applications. E Updated to exclude verson 1.2 (NIH) Plan N N Incl : NIH, FDA, VA Incl: R42, UT2, R44, U44 Plan attachment is required for Phase II, Direct Phase II and Fast Track submissions The Plan is required for Phase II and Fast Track submissions. E Updated to exclude version 1.2
(NIH) Plan N N Incl : NIH, FDA, VA V 1.1 Incl: R42, UT2, R44, U44 Limited to 12 pages The Plan is limited to twelve (12) pages. E (NIH) Agency to which you are applying N N Incl : NIH, FDA, VA Incl: R41, R42, UT1, UT2, R43, R44, U43, U44, SB1, UB1 If DOE or USDA checked, trigger error DOE and USDA are not valid agency selections for this funding opportunity announcement. E New Rule October 2017 Release (NIH) Application Type: Direct Phase II N N Incl : NIH, FDA, VA = ‘Y’ Provide warning if an application type other than Direct Phase II is selected when applying to a Direct Phase II FOA. You have applied using a Direct Phase II Funding Opportunity Announcement, but a selection other than Direct Phase II has been made. W New Rule October 2017 Release Application Type: N N Incl : NIH, Provide warning if Direct Phase II selected when Check Funding Opportunity Announcement W New Rule 20.1
Government” is “Yes”. (NIH) Will the Project have his/her primary with the small business at the time of award? N N NIH, FDA, VA Incl: R43, R44, U43, U44 ,SB1, UB1 Provide error if response to question , “Will the Project Investigator have his/her primary employment with the small business at the time of award?” is not provided You have selected “SBIR” or “Both” as your program Type. You must provide a response to the question, “Will the Project Investigator have his/her primary employment with the small business at the time of award?” E New Rule October 2017 Release (NIH) Please indicate whether the answer to BOTH of the following questions is TRUE: (1) Does the Project N N NIH, FDA, VA Incl: R41, R42, UT1, UT2, R43, R44, U43, U44, SB1, UB1 Provide error response to questions 10(1) and 10(2) are not provided when program type is “STTR” or “Both” You have selected “STTR” or “Both” as your program Type. You must indicate whether questions 10 (1) E New Rule October 2017 Release
of the work? 30% of the work”. (NIH) Provide DUNS Number of non-profit research partner for STTR N N Incl : NIH, FDA, VA Incl: R41, R42, UT1, UT2 Provide error if the DUNS# on "+a/the+" subaward budget form does not match the DUNS # provided. **Note*: There may be multiple Subaward budget forms. Must match one.* The DUNS number provided in the SBIR/STTR form does not match the DUNS provided on any budget form. E New Rule October 2017 Release PHS Fellowship Supplemental
Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) FOA Lists Code & to or to or Both (Multi Only) PHS Form Type of Application 024.0 PHS Form Fellowship Form 024.1.1 N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, Introduction attachment is imited to 1 page The Introduction attachment is limited to one (1) page. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Fellowship Form 024.1.2 N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, Introduction attachment is required for resubmission The Introduction attachment is required for resubmissions. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Fellowship Form 024.2.1 N N Incl : NIH, FDA, Incl: Incl: F05, F30, F31, Specific Aims attachment is limited to 1 page The Specific Aims attachment is limited to (1) page . E New rule January 14,2016
Form Specific Aims USU F37, F38, FI2, Release, Update to Existing Rule (added F99/K00) PHS Form Fellowship Form Research Strategy 024.3.1 N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, Research Strategy must be less than or equal to 6 pages. The Research Strategy attachment is limited to six (6) pages. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Research Plan Progress Report Publication List 024.4 PHS Form Human Subjects Involved? (Y/N) 024.5
PHS Form Human Subjects Indefinite (Y/N) 024.7.1 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, 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 New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Human Subjects Indefinite (Y/N) 024.7.2 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, 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 New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Human Subjects Clinical Trial (Y/N) 024.8.1 N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, If Human Subjects 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 NIH-Defined Phase III Clinical Trial is “Yes. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00)
Form PHS Form Vertebrate Animals Use Indefinite (Y/N) N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, 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 New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Vertebrate Animals Use Indefinite (Y/N) N N Incl : NIH, FDA, USU 4.0 and Incl: F05, F30, F31, F37, F38, FI2, 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 New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Fellowship Form N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, 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 E New rule January 14,2016 Release, Update to Existing Rule .
Form Selection of Sponsor and Institution FDA, USU F31, F37, F38, FI2, attachment is limited to 1 page attachment is limited to one (1) page. January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Fellowship Form Conduct of Research N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, Responsible Conduct of Research attachment is limited to 1 page The Responsible Conduct of Research is limited to one (1) page. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form HESC Involved (Y/N) 024.21 PHS Form HESC ‘can’t be referenced’ checkbox N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, If HESC involved=’Y’, ‘can’t be referenced’ checkbox must be selected or cell line(s) must be provided (not both) If the answer to ‘HESC involved’ is “Yes” , HESC Cell Lines must be included or the ‘Can’t be Referenced’ checkbox must be checked. E New rule January 14,2016 Release, Update to Existing Rule
(added F99/K00) PHS Form HESC ‘can’t be referenced’ checkbox N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, If HESC involved=’N’, ‘can’t be referenced’ checkbox cannot be selected and/or cell line(s) cannot be provided. If the answer to ‘HESC involved’ is “No”, HESC Cell Lines may not be included and the ‘Can’t be Referenced’ checkbox must not be checked. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form HESC Cell Lines N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, 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 New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form HESC Cell Lines
PHS Form Fellowship Applicant: sought, other, type N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, If “other degree” is selected ( Other Degree(s): MOTH: Other Masters Degree DOTH: Other Doctorate DDOT: Other Doctor of Medical Dentistry MDOT: Other Doctor of Medicine VDOT: Other Doctor of Veterinary Medicine OTH: Other) , the type is required If one of the “Other Degree(s)” is selected, indicate the Degree Type. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Fellowship Applicant: degree sought, other, degree type N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, If “other degree” is not selected, the degree type must not be provided ‘Other Degree Type’ must not be provided if the degree selected is not one listed under ‘Other Degree(s)’. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Fellowship Applicant: degree sought, expected Y N Incl : NIH, FDA, Incl: Incl: F05, F30, F31, Provide error if degree date is not in the format of MM/YYYY. The Degree Sought Expected Completion Date must be in MM/YYYY format. E New rule January 14,2016
Form current or prior support x, level PHS Form Fellowship Applicant: current or prior support x, type 024.31 PHS Form Fellowship Applicant: current or prior support x, start date 024.32 PHS Form Fellowship Applicant: current orprior N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, Current or Prior Support End date must be greater than Support Start Date on the The Current or Prior Support End Date must be later than Support Start Date. E New rule January 14,2016 Release, Update to Existing Rule
Form and other research experience attachment USU F37, F38, FI2, limited to two (2) pages. PHS Form Fellowship Applicant: citizenship N N Incl : NIH, FDA, USU 3.1 and Incl: F30, F31, F37, F38, FI2, “Non-US Citizen with temporary U.S. visa” is not a valid selection for all F applications except F05 (Fogarty) “Non-US Citizen with temporary U.S. visa” is not a valid selection for this application. E Forms D, May 2016 Release (Update to Existing Rule to exclude V3.1) Updated to exclude version 4.0 PHS Form If no, select most appropriate Non-U.S. Citizen Option N N Incl: NIH, USU Required if ‘No’ is selected as the answer to the ‘U.S. Citizen or Non-Citizen National’ question on the Fellowship form. If response to “U.S. Citizen or Non-Citizen National” is “No”, selection of the most appropriate Non-U.S. Citizen option is required. E Forms D, May 2016 Release PHS Form If no, select most appropriate Non-U.S. Citizen Option N N Incl: NIH, USU Incl: F05, U.S. Citizen or Non-Citizen 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 Non-Citizen National" must be "No" and selection of "With a Temporary U.S. visa" is required. E Forms D, May 2016 Release PHS If no, N N Incl: NIH, Only one citizenship More than one Non-U.S. Citizen W Forms D, May 2016 Release
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
Form PHS Form Institution: Name of former institution N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, If change of Sponsoring Institution is selected, the Name of Former Institution is required The Name of the Former Institution is required, when the Change of Sponsoring Indicator is selected. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Sponsor(s) and Information attachment N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, The Sponsor(s) and Information attachment is limited to 6 pages The Sponsor(s) and Information attachment is limited to six (6) pages. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Sponsor(s) and Information attachment N N Incl: NIH, USU Incl: F05, F30, F31, F37, F38, FI2, Sponsor and statements are required Sponsor and statements is a required attachment. E Forms D, May 2016 Release
Form salary, amount USU Fellowship Applicants. PHS Form Budget: present institutional base salary, academic period N N Incl : NIH, FDA, USU Incl: Incl: F33 A selection is required for F33 The Academic Period for the Present Institutional Base Salary is required for Senior Fellowship Applicants. E New rule PHS Form Budget: present institutional base salary, # of months N N Incl : NIH, FDA, USU Incl: Incl: F33 Base salary, # of months should be greater than for F33 The Number of Months for the Present Institutional Base Salary is required for Senior Fellowship Applicants. E New rule PHS Form Budget: during first year, federal stipend requested, amount N N Incl : NIH, FDA, USU Incl: Incl: F33 Federal stipend requested, amount should be greater than for F33 The Amount for the Federal Stipend Requested Salary is required for Senior Fellowship Applicants. E New rule PHS Budget: during first year, N N Incl : NIH, FDA, Incl: Incl: F33 Federal stipend requested, number of months should The Number of Months for the Federal Stipend Requested Salary is E New rule
Form other sources, type USU Fellowship Applicants. PHS Form Budget: during first year, from other sources, source N N Incl : NIH, FDA, USU Incl: Incl: F33 Supplementation from other sources, source is a required for F33 The Source of Supplementation from other sources is required for Senior Fellowship Applicants. E New rule PHS Form Appendix N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, Limited to 10 appendixes You have submitted more than 10 appendices. There is a limit of 10 appendix attachments allowed. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form Fellowhsip Form Applicant’s and Goals for N N Incl: NIH, USU Incl: F05, F30, F31, F37, F38, FI2, Background and Goals for Fellowship Training is required. The Applicant’s Background and Goals for Fellowship Training attachment is required for this application E Forms D, May 2016 Release
Consultant Fellowship Training PHS Form Fellowhsip Form Applicant’s and Goals for Fellowship Training N N Incl: NIH, USU Incl: F05, F30, F31, F37, F38, FI2, Background and Goals for Fellowship Training is limited to 6 pages The Applicant’s Background and Goals for Fellowship Training attachment is limited to six (6) pages. E Forms D, May 2016 Release PHS Form Fellowhsip Form Letters of Support from and N N Incl: NIH, USU Incl: F05, F30, F31, F37, F38, FI2, 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 Fellowhsip Form N N Incl: NIH, Incl: F05, F30, F31, Description of Institutional Environment and Commitment to The Description of Institutional Environment and Commitment to E Forms D, May 2016 Release
Form Desciption of Institutional and to Training USU F37, F38, FI2, Training attachment is required. Training attachment is required for this application PHS Form Fellowhsip Form Desciption of Institutional and to Training N N Incl: NIH, USU Incl: F05, F30, F31, F37, F38, FI2, 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 Form Fellowhsip Form Data Safety Monitoring Plan N N Incl: NIH, USU Incl: F05, F30, F31, F37, F38, FI2, The Data Safety Monitoring Plan is required if the answer to the Clinical Trial question is “Yes” The Data Safety Monitoring Plan attachment is required if the response to the Clinical Trial question is “Yes”. E Forms D, May 2016 Release
PHS Form Vertebrate Animals: Is method consistent with American Verinary Medical (AVMA) guidelines N N Incl: NIH, USU Incl: F05, F30, F31, F37, F38, FI2, 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 Form Vertebrate AnimalsIf “No” to AVMA guidelines describe method and provide a scientific justification N N Incl: NIH, USU Incl: F05, F30, F31, F37, F38, FI2, 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
Native; Total Racial Category: Asian Ethnic Category: Not Hispanic or Latino, Female 016.14 Racial Category: Asian; Ethnic Category: Not Hispanic or Latino, Male 016.15 Racial Category: Asian; Ethnic Category: Not Hispanic or Latino, 016.16
Not Reported Racial Category: Asian; Ethnic Category: Unknown/ Not Reported, Female 016.20 Racial Category: Asian; Ethnic Category: Unknown/ Not Reported, Male 016.21 Racial Category: Asian; Ethnic Category: Unknow/ Not Reported, Unknown/ 016.22
Other Pacific Islander; Ethnic Category: Hispanic or Latino, Female Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: Hispanic or Latino, Male 016.28 Racial Category: Native Hawaiian or Other Pacific Islander; Ethnic Category: 016.29
Latino, Unknown/ Not Reported Racial Category: Black or African American; Ethnic Category: Unknown/ Not Reported, Female 016.40 Racial Category: Black or African American; Ethnic Category: Unknown/ Not Reported, Male 016.41 Racial Category: Black or African 016.42
Category: Hispanic or Latino, Male Racial Category: White; Ethnic Category: Hispanic or Latino, Unknown/ Not Reported 016.49 Racial Category: White; Ethnic Category: Unknown/ Not Reported, Female 016.50 Racial Category: White; Ethnic Category: Unknown/ 016.51
Planned Enrollment Report Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) FOA Lists Code & to or to or Both (Multi Only) Study Title X of Y 017.1.2 N N Incl : NIH, FDA, USU V 1.0 Provide warning if Planned Enrollment Report is submitted with zeros Planned Enrollment Report(s) was submitted with no data. If not a Delayed Onset study, is planned enrollment data needed? W Study Title: 017.2 017.3
Hispanic or Latino, Male Racial Category: Native Hawaiian or Other Pacific Islander; Total 017.19 Racial Category: Black or African American; Ethnic Category: Not Hispanic or Latino, Female 017.20 Racial Category: Black or African American; Ethnic Category: 017.21
Total; Racial Category Total PHS Inclusion Enrollment Report Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) FOA Lists Code & to or to or Both (Multi Only) PHS Study Title X of Y 033.1.2 N N Incl: NIH, Generate a warning if the study title For <Study Title>, Different studies with the same title cannot W New Rule for Forms D,
USU provided is not unique. be submitted for the same grant March 2016 Release May 2016 Release (added study title to message) PHS Delayed Onset Study? 033.2.2 N N Incl: NIH, USU If Delayed Onset is Yes then no values should exist on the form except for the Study Title For <Study Title>, If you answered “Yes” to the Delayed Onset Study then the only value that should exist on the form is the Study Title. E New Rule for Forms D, March 2016 Release May 2016 Release (added study title to message) PHS Delayed Onset Study? 033.2.3 N N Incl: NIH, USU If Delayed onset study is No then all Ethnic and Racial Category cell data values are required. For <Study Title>, If you answered No to the Delayed onset study question then you must provide a value for each Ethnic and Racial cell data in the table. E New Rule for Forms D, March 2016 Release
May 2016 Release (added study title to message) PHS Enrollment Type 033.3.1 N N Incl: NIH, USU Enrollment Type is required if answer to Delayed Onset Study is “No”. For <Study Title>, An answer to the “Enrollment Type” question must be provided if you answered “No” to the Delayed Onset Study question. E New Rule for Forms D, March 2016 Release May 2016 Release (added study title to message) PHS Enrollment Type 033.3.2 N N Incl: NIH, USU Enrollment Type must be “Planned” if answer to Using and Existing Dataset or Resource is “No” For <Study Title>, If you answered “No” to the Using an Existing Dataset or Resource question, then the Enrollment Type must be “Planned”. E New Rule for Forms D, March 2016 Release May 2016 Release
(added study title to message) PHS Enrollment Type 033.3.3 N N Incl: NIH, USU If enrollment type is planned then no data should be entered in any unknown/not reported columns / rows of the data table. For <Study Title>, If you answered “Planned” to the Enrollment Type questions, then you should not provide values for any on the Unknown or Not Reportted cells in the data table. E New Rule for Forms D, March 2016 Release May 2016 Release (added study title to message) PHS Using an Existing Dataset or Resource 033.4.1 N N Incl: NIH, USU Using an existing dataset or resource is required if answer to Delayed Onset Study question is “No”. For <Study Title>, An answer to the “Using an Existing Dataset or Resource” question must be provided if you answered “No” to the Delayed Onset Study question. E New Rule for Forms D, March 2016 Release May 2016 Release (added study title to message)
Clinical Trial Study question is “No”. the Delayed Onset Study question. May 2016 Release (added study title to message) PHS Phase III Clinical Trial 033.7.2 N N Incl: NIH, USU If Clinical Trial is set to No, then NIH-Defined Phase III Clinical Trial cannot be set to Yes. For <Study Title>, The answer to Phase III Clinical Trial question must be “No” if the answer to the Clinical Trial question is “No”. E New Rule for Forms D, March 2016 Release May 2016 Release (added study title to message) PHS Comments 033.8.1
Category: Not Hispanic or Latino, Female PHS Racial Category: Black or African American; Ethnic Category: Not Hispanic or Latino, Male 033.40.1 PHS Racial Category: Black or African American; Ethnic Category: Not Hispanic or Latino, Unknown 033.41.1 PHS Racial Category: Black or 033.42.1
African American; Ethnic Category: Unknown, Female PHS Racial Category: Black or African American; Ethnic Category: Unknown, Male 033.46.1 PHS Racial Category: Black or African American; Ethnic Category: Unknown, Unknown 033.47.1 PHS Racial Category: Black or African 033.48.1
Unknown, Female PHS Racial Category: White; Ethnic Category: Unknown, Male 033.56.1 PHS Racial Category: White; Ethnic Category: Unknown, Unknown 033.57.1 PHS Racial Category: White; Total 033.58.1 PHS Racial Category: More than One Race; Ethnic 033.59.1
Category: Hispanic or Latino, Female PHS Racial Category: More than One Race; Ethnic Category: Hispanic or Latino, Male 033.63.1 PHS Racial Category: More than One Race; Ethnic Category: Hispanic or Latino, Unknown 033.64.1 PHS Racial Category: More than One Race; Ethnic Category: 033.65.1
Unknown, Female PHS Racial Category: More than One Race; Ethnic Category: Unknown, Male 033.66.1 PHS Racial Category: More than One Race; Ethnic Category: Unknown, Male 033.67.1 PHS Racial Category: More than One Race; Ethnic Category: Unknown, Unknown 033.68.1 PHS Racial Category: 033.69.1
Not Hispanic or Latino, Female; Total PHS Ethnic Category; Not Hispanic or Latino, Male; Total 033.81.1 PHS Ethnic Category; Not Hispanic or Latino, Unknown/ Not Reported; Total 033.82.1 PHS Ethnic Category; Hispanic or Latino, Female; Total 033.83.1
Ethnicity, Male; Total PHS Ethnic Category; Reported Ethnicity, Unknown/ Not Reported; Total 033.87.1 PHS PHS Ethnic Category; Racial Category: Total Count 033.88.1 N N Incl: NIH, USU Total must be greater than zero if answer to Delayed Onset Study question is “No” For <Study Title>, The total count for Ethnic and Racial Categories must be greater than zero. E Forms D, March 2016 Release May 2016 Release (added study title to message) PHS Additional Indirect Cost (Use only for Multi-project)
Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) (Lists FOA Lists Code & to or to or Both Cross (Multi Only) PHS Costs DUNS 021.1.1 N N Incl : NIH, FDA, , USU V 1.0 DUNS is required The Organization DUNS number is required. E PHS Costs DUNS PHS Costs DUNS 021.1.3 N N Incl : NIH, FDA, , USU V 1.0 Y Provide error if PHS Additional Indirect Costs form is present in the Overall component and all other components are lead at the overall organization (based on the DUNS number). The PHS Additional Indirect Costs Form should not be included with the application, since the Organization is the same for the Overall and components. E
PHS Costs Name of 021.2 PHS Costs Budget Type: Project or 021.3.1 N N Incl : NIH, FDA, , USU V 1.0 Budget type must be marked as ‘Project’ The budget type must be marked as ‘Project’. E PHS Costs Start Date 021.4.1 N N Incl : NIH, FDA, , USU V 1.0 For budget year 1, for new applications and resubmissions, must be the same as the Proposed Project Start Date listed on the SF 424 RR. On the <Organization name> budget for Budget Period < Budget Year>, the start date should be equal to the proposed project start date listed on the Component SF 424 RR Cover page. E PHS Costs Start Date 021.4.2 N N Incl : NIH, FDA, , USU V 1.0 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. 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. E
PHS Costs End Date 021.5.1 N N Incl : NIH, FDA, , USU V 1.0 Must be greater than the budget start date and less than or equal to the Project Period End Date, both listed on the SF 424 RR. 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 PHS Costs End Date 021.5.2 N N Incl : NIH, FDA, , USU V 1.0 flag = 'No' End date of last budget period should not be later than 5 years after the start date of the first budget period. 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 PHS Costs Indirect Costs - Indirect Cost Type 021.6 PHS Costs Indirect Costs - Indirect Cost Rate % 021.7
PHS Costs Indirect Costs - Indirect Cost Base 021.8 PHS Costs Indirect Costs - Funds 021.9 PHS Costs Indirect Costs - Total Indirect Costs 021.10.1 N N Incl : NIH, FDA, , USU V 1.0 Must be equal to funds requested for all indirect cost types for each Budget period. On the <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 PHS Costs Budget 021.10.2 PHS Indirect Costs 021.11.1 N N Incl : NIH, V 1.0 Must be equal to funds requested for all indirect On the <Organization name> budget, the Total Indirect Costs does not equal the E
Costs FDA, , USU cost types for budget periods. sum of individual indirect costs for each indirect cost type for all budget periods. PHS Human Subject and Clinical Trial Information Form Field Rule# Rule Categories Validation Error Message Error/ Warning (Y/N) Form FOA or Lists Code & to or to or Both (Multi Only) PHS Human Subject and Clinical Trial If No to Human Human 034.1.1 N N NIH, 1.0 Both Provide error if response to “Are Human Subjects Involved”’ question is “No” on the Other Project Information In order to attach a Study Record or Delayed Onset Study to the PHS Human Subjects and Clinical Trials Information form, you must answer “Yes” to the E New Rule October 2017 Release Subject
Onset Study form, and a Study Record or or Delayed Onset Study Record is provided. question “Are Human Subjects Involved” on the Other Project Information form. PHS Human Subject and Clinical Trial If No to Human Does the involve human and/or data? 034.2.1 N N NIH, 1.0 Both Provide error if response to “Are Human Subjects Involved” question is “No” on the Other Project Information form and a response to the question “Does the proposed research involve human specimens and/or data?” has not been provided. If you answered “No” to the question “Are Human Subjects Involved?” on the Other Project Information form, you must answer the “Does the proposed research involve human specimens and/or data?” question. E New Rule October 2017 Release PHS Human Subject and Clinical Trial If No to Human If yes, provide an 034.2.2 N N NIH, 1.0 Both Provide error if response to “Does the proposed research involve human specimens and/or data is “Yes” and an explanation detailing why the If you answered “Yes” to the question “Does the proposed research involve human specimens and/or data, you must provide an explanation why the application does not involve human subject research. E New Rule October 2017 Release Subject Subject
of why the does not involve human subject proposed study does not constitute human subject research has not been provided. PHS Human Subject and Clinical Trial If Yes to Human Does the involve human and/or data and/or 034.2.3 N N NIH, 1.0 Both Provide error if response to “Are Human Subjects Involved” question is “Yes” on the Other Project Information form and a Yes response is also given to the question ‘Does the proposed research involve human specimens and/or data’ is provided with or without an explanation If you answered “Yes” to the question “Are Human Subjects Involved” on the Other Project Information form, a Yes response to the question “Does the proposed research involve human specimens and/or data” is not a valid response. E New Rule October 2017 Release Subject
PHS Human Subject and Clinical Trial If Yes to Human Add new study 034.3.1 N N NIH, 1.0 Provide error if response to “Are Human Subjects Involved” is “Yes” on the Other Project Information form and a Study Record or Delayed Onset study has not been included. If you answered “Yes” to the “Are Human Subjects Involved” question on the Other Project Information form, you must provide at least one Study Record or Delayed Onset Study. E New Rule October 2017 Release PHS Human Subject and Clinical Trial If Yes to Human Add new study 034.3.2 N N NIH, 1.0 Y Provide error if response to “Are Human Subjects Involved” is “Yes” on the Other Project Information form and a Study Record, Delayed Onset study or Other requested information has not been provided If you answered “Yes” to the question “Are Human Subjects Involved” on the Other Project Information form, you must provide at least one Study Record or Delayed Onset Study or an Other Requested Information attachment. E New Rule October 2017 Release PHS Human Subject and Clinical If Yes to Human 034.8.75 N N NIH, 1.0 = O Incl: D43, K12 Provide error if a Study Record is provided This Funding Opportunity Announcement only allows Delayed Onset Studies. E New Rule October 2017 Release Subject Subject
Trial Add new study PHS Human Subject and Clinical Trial If Yes to Human Add New Onset Study 034.4.1 N N NIH, 1.0 = R Provide error if a Clinical Trial Study Record or a Delayed Onset study that is marked as ‘Anticipated Clinical Trial’ is not provided on a Clinical Trial FOA. At least one Clinical Trial Study Record must be included. This includes either a full Study Record where you answer Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire or a Delayed Onset Study with the ‘Anticipated Clinical Trial’ box checked. E New Rule October 2017 Release PHS Human Subject and Clinical Trial If Yes to Human Add New 034.4.2 N N NIH, 1.0 = R Provide error if a Clinical Trial Study or a Delayed Onset study that is marked as ‘Anticipated Clinical Trial’, or Other Requested Information is At least one Clinical Trial Study must be included. This includes either a full study record where you answer Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire, or add a delayed onset study and check the ‘Anticipated Clinical Trial’ box. Or, you E New Rule October 2017 Release Subject Subject Subject
PHS Human Subject and Clinical Trial Section 1 – Basic 1.3 number 034.5.2 N N NIH, 1.0 Excl: D43, K12 Both Provide error if Exemption number is not provided when response to “Is this Study Exempt from Federal Regulations” is “Yes” Exemption number is required for Study Record <Study Title>, since you selected “Yes” to the question “Is this Study Exempt from Federal Regulations” E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 1 – Basic 1.3 number 7 -8 034.5.6 N N NIH, USU 1.0 Both Provide error if Exemption 7 and/or 8 is selected on the Human Subject Clinical Trial form and the response to the question, “Is this study exempt from Federal Regulations is “Yes” Exemption 7 and/or 8 are not valid selections New Rule October 2017 Release PHS Human Subject and Clinical Section 1 – Basic 034.5.3 N N NIH, 1.0 = “N” Excl: D43, K12 Both Provide error if responses to questions 1.4.a through 1.4.d are “Yes”, but You cannot answer “Yes” to questions 1.4a-1.4.d in the Clinical Trial Questionnaire since this Funding E New Rule October 2017 Release
Trial 1.4 Clinical Trial 1.4.a – 1.4.d Excl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Excl K’s: K01, K02, K05, K07, K08, K18, K22, K23, K26, the Funding Opportunity Announcement does not support clinical trials. Opportunity Announcement does not allow clinical trials. PHS Human Subject and Clinical Trial Section 1 – Basic 034.5.4 N N NIH, 1.0 Excl: D43, K12 Both Provide error if responses to questions 1.4.a through 1.4.d are “Yes” but the You’ve answered Yes to questions 1.4.a through 1.4.d in the Clinical Trial Questionnaire. Clinical trials are not allowed when E4 is E New Rule October 2017 Release
1.4 Clinical Trial 1.4.a – 1.4.d only exemption selected is E4. the only exemption selected. PHS Human Subject and Clinical Trial Section 1 – Basic 1.4 Clinical Trial 1.4.a – 1.4.d 034.5.5 N N NIH, 1.0 = “I" Excl: D43, K12 Both Provide error if Clinical Trial Study Record is not provided for a Clinical Trial FOA You must answer “Yes” to all questions 1.4a through 1.4d in at least one study record for this Funding Opportunity Announcement E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 2 – Study 034.6.1 N N NIH, 1.0 Excl: D43, K12 Both Provide error for a Human Subject and Clinical Trial Study Record if Condition or Focus of Study is not provided and the study is Conditions or Focus of Study is required for study titled <Study Title>. E New Rule October 2017 Release
or Focus of Study exempt from federal regulations (1.2 is yes) and E4 is not the only exemption number selected PHS Human Subject and Clinical Trial Section 2 – Study Criteria 034.6.2 N N NIH, 1.0 is Not = “I” Excl: D43, K12 Both Provide error for a Human Subject and Clinical Trial Study Record if Eligibility Criteria is not provided and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption number selected. Eligibility Criteria is required for study titled < Study Title>. E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 2 – Study 034.6.3 N N NIH, 1.0 is not = “I” Excl: D43, K12 Both Provide error for a Human Subject and Clinical Trial Study Record if Minimum Age limit is not provided, the Minimum Age is required for study titled <Study Title> E New Rule October 2017 Release
Age Limits Age selection is not NA and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption number selected. PHS Human Subject and Clinical Trial Section 2 – Study Age Limits Age – N/A (No limits) 034.6.11 N N NIH, 1.0 is not = “I” Excl D43, K12 Both Provide error if N/A (No limits) has been selected as Minimum Age unit and a number for Minimum Age is provided and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption number selected. A number for Minimum Age cannot be provided on Study titled <study title> since N/A (No limit) has been selected as the unit of a time. E New Rule October 2017 Release
PHS Human Subject and Clinical Trial Section 2 – Study 2.3 Age Limits Age 034.6.4 N N NIH, 1.0 is not = “I” Excl: D43, K12 Both Provide error for a Human Subject and Clinical Trial StudyRecord if Maximum Age limit is not provided and the selection is not NA and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption number selected Maximum is required for study titled <Study Title> E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 2 – Study 2.3 Age Limits – N/A (No limits) 034.6.12 N N NIH, 1.0 is not = “I” Excl D43, K12 Both Provide error if N/A (No limits) has been selected as Maximum Age unit and a number for Maximum is provided and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption A number for Maximum Age cannot be provided on study titled <study title> since N/A (No limit) has been selected as the unit of time. E New Rule October 2017 Release
2.5 and Plan response to question 1.4a is "Yes" PHS Human Subject and Clinical Trial Section 2 – Study 2.6 Status 034.6.7 N N NIH, 1.0 Excl: D43, K12 Both Provide error for a Human Subject and Clinical Trial study record if Recruitment Status is not provided and the response to question 1.4a is "Yes". Recruitment Status is required for study titled <Study Title>. E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 2 - Study 2.7 Study Timeline 034.6.8 N N NIH, 1.0 Excl: D43, K12 Both Provide error for a Human Subject and Clinical Trial study record if Study Timeline is not provided and the response to question 1.4a is "Yes". Study Timeline attachment is required for study titled < Study Title>. E New Rule October 2017 Release
PHS Human Subject and Clinical Trial Section 2 - Study 2.8 of First Subject 034.6.9 N N NIH, 1.0 Excl: D43, K12 Both Provide error for a Human Subject and Clinical Trial study record if Enrollment of First Subject is not provided and the response to question 1.4a is "Yes". Enrollment of First Subject date is required for study titled < Study Title>, and you must select either Anticipated or Actual for enrollment of the first subject E New Rule October 2017 Release S PHS Human Subject and Clinical Trial Section 2 - Study Add New Report 034.6.10 N N NIH, 1.0 is not = “I” K12 Both Provide error if Inclusion Enrollment Report is not provided and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption An Inclusion Enrollment Report is required for study tilted <Study Title>. E New Rule October 2017 Release
number selected. PHS Human Subject and Clinical Trial Section 2 – Report Ethnic Racial Total 034.6.13 N N NIH, 1.0 is not = “I” Excl: D43, K12 Both If "Using an Existing Dataset or Resource" is "Yes", "Cumulative Counts" must be greater than zero OR "Comment" must be provided. For study titled <study title>, IER <number>, if using an existing dataset or resource, cumulative counts for racial and ethnic categories must be greater than zero. E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 2 – Report Ethnic Racial 034.6.14 N N NIH, 1.0 is not = “I” Excl: D43, K12 Both If "Using an Existing Dataset or Resource" is "No", "Planned Counts" must be greater than zero OR "Comment" must be provided For study titled <study title>, IER <number>, if not using an existing dataset or resource, planned counts for racial and ethnic categories must be greater than zero E New Rule October 2017 Release
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 site? 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 PHS Human Section 3 – 034.7.3 N N NIH, 1.0 Excl: D43, K12 Both Provide error if N/A is selected N/A is only a valid selection for Training, Career E New Rule
Subject and Clinical Trial and Plans Is this a study that will use the same protocol to conduct human subjects at more than one site? Excl F’s F05, F30, F31, F32, F33, F37, F38, FI2, K05, K07, K08, K18, K22, K23, K26, K76, K43 in response to this question for any activity code other than K’s and F’s. Note: N/A is only a valid selection for, Career Development, and Fellowship applications Development, and Fellowship applications October 2017 Release PHS Human Subject and Section 3 – and 034.7.4 N N NIH, 1.0 Excl: D43, K12 Both Provide error if a response to the question “If yes, describe the Since you answered Yes to the question regarding multi-site studies, a single IRB E New Rule October 2017 Release
Clinical Trial Plans If yes, describe the single IRB plan single IRB plan” is not provided when the answer 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 “Yes” plan attachment is required for study titled <Study Title> PHS Human Subject and Clinical Trial Section 3 – and Plans 3.3 Data and Safety Plan 034.7.5 N N NIH, 1.0 = “R" or "O" or "I") AND to 1.4a 1.4d K12 Both Provide error for a Clinical Trial Study if Data and Safety Monitoring Plan is not provided For Study titled < Study Title>, a Data and Safety Monitoring Plan attachment 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
is Brief to 1.4a 1.4d are ALL clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.1 Brief 034.8.30 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error for a Human Subject Study if Brief Summary of Protocol is provided. For study titled <study title>, a brief summary of the protocol cannot be provided since you did not answer “Yes”to questions 1.4.a-1.4.d 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
is PHS Human Subject and Clinical Trial Section – 4.1 Brief 034.8.29 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, K26, Provide error if Brief Summary is provided For study titled <study title>, brief summary of the protocol 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
is is 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 and Clinical Trial Section 4- 4.2.a Study 034.8.31 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Subject Study if Narrative Study Description is provided For study titled <study title> a, Narrative Study Description cannot be provided since you did not answer “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are blocked for studies which do not involve
K26, PHS Human Subject and Clinical Trial Section – 4.2.b Primary Purpose 034.8.3 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 Record if Primary Purpose is not provided For study titled <Study Title>, a Primary Purpose 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 and Section – 034.8.4 N N NIH, 1.0 Excl: D43, K12 Both Provide error for a Clinical Trial Study if an explanation For study titled <Study Title>, an explanation is required if “Other” E Study Record fields in Sections IV and V
Clinical Trial 4.2.b Primary Purpose – Other = “R" or "O") AND to 1.4a 1.4d are ALL for“Other” Primary Purpose is not provided was selected for Primary Purpose and you answered “Yes” to questions in the Clinical Trial Questionnaire. are required for studies involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.b Primary Purpose 034.8.33 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error for a Human Subject Study if Primary Purpose or explanation for Primary Purpose is provided. For study titled <study title>, a Primary Purpose or explanation for Primary Purpose cannot be provided since you did not answer Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are blocked for studies which do not involve clinical trials.
Excl: New Rule October 2017 Release PHS Human Subject and Clinical Trial 4.2.b Primary Purpose 034.8.35 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 Primary Purpose or explanation for Primary Purpose is provided. For study titled <study title>, a Primary Purpose or explanation for Primary Purpose 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
Excl: K26, K43, K38 PHS Human Subject and Clinical Trial Section – 4.2.c 034.8.5 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 an intervention is not provided. For study titled<Study Title>, at least one Intervention 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 and Section – 034.8.57 N N NIH, 1.0 to 1.4a K12 Both Provide error for a Human Subject Study if For study titled<Study Title>, an Intervention cannot be provided E Study Record fields in Sections IV and V
Excl: Clinical Trial 4.2.c 1.4d are NOT all “Yes” Intervention is provided since you did not answer “Yes” to questions in the Clinical Trial Questionnaire. are blocked for studies which do not involve clinical trials. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.c 034.8.58 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: Provide error if Intervention is provided For study titled<Study Title>, an Intervention 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
Excl: K05, K07, K08, K18, K22, K23, K26, October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.c Type, 034.8.6 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 any Intervention Sub-element (Type , Description) is not provided. For study titled <Study Title>, Intervention <Type, Description> must be provided for Intervention Name<Intervention Name> 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)
Excl: Excl: New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.c Name 034.8.8 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 an Intervention Name is not provided For study titled<Study Title>, Intervention Name 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 and Clinical Trial Section – 034.8.10 N N NIH, 1.0 = “R" or K12 Both Provide error for a Clinical Trial Study if Study Phase is not provided For study titled <study title> a Study Phase 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
Excl: 4.2.d Study Phase "O") AND to 1.4a 1.4d are ALL Clinical Trial Questionnaire. for studies involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Study Phase – Other 034.8.11 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d K12 Both Provide error if “Other” Study Phase is selected but description for “Other” Study phase is not provided For study titled <study title> a Description is required if “Other” is selected as the Study Phase and 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
Excl: Excl: are ALL = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Study Phase 034.8.39 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Subject Study if Study Phase or description for study phase is provided. For study titled <study title>, a study phase or a description for study phase cannot be provided since you did not answer “Yes” to questions 1.4a through 1.4d 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 PHS Human Subject and Clinical Section – 034.8.56 N N NIH, 1.0 = K12 Provide error if Study Phase or description for For study titled <study title>, a Study Phase or description for Study Phase cannot be provided E Study Record fields in Sections IV and V are
Excl: Trial 4.2.d Study Phase “N”) AND ( to 1.4a 1.4d are ALL Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, K26, K43, K38 Study Phase is provided since this Funding Opportunity Announcement does not allow independent clinical Trials. blocked for F and K to Clinical Trial Not Allowed FOAs. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 034.8.12 N N NIH, 1.0 = “R" or K12 Both Provide error for a Clinical Trial study if response to the question “Is this an NIH-defined For study titled <study title> a response to the question “Is this an NIH-defined Phase III Clinical Trial?” is E Study Record fields in Sections IV and V are required
Excl: 4.2.d Is this an Phase III clinical trial? "O") AND to 1.4a 1.4d are ALL Phase III Clinical Trial” is not provided required since you answered “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. for studies involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Is this an Phase III 034.8.42 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error for a Human Subject Study if response to the question, “Is this an NIH-defined Phase III clinical trial?”, is “Yes” For study titled <study title>, a response to the question “Is this an NIH-defined Phase III Clinical Trial?” cannot be “Yes”, since you did not answer “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are blocked for studies which do not involve clinical trials.
Excl: clinical trial? New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Is this an Phase III clinical trial? 034.8.70 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, K26, Provide error if response to the question “Is this an NIH-defined Phase III Clinical Trial” is ”Yes” For study titled <study title> a response to the question “Is this an NIH-defined Phase III Clinical Trial?” cannot be “Yes”, 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
Excl: Excl: PHS Human Subject and Clinical Trial Section – 4.2.d Is this an Phase III clinical trial? 034.8.13 N N NIH, 1.0 = “N K12 Both Provide error for a Study Record when the response to the question “Is this an NIH-Defined Phase III Clinical Trial” is “Yes” and the FOA does not support Clinical Trials. For study titled <study title>, response to the question "Is this an NIH-defined Phase III clinical Trial cannot be "Yes" since the FOA does not support Clinical Trials. E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.e Model 034.8.14 N N NIH, 1.0 = “R" or "O") AND to 1.4a K12 Both Provide error for a Clinical Trial Study if Intervention model is not provided. For study titled <Study Title>, an Intervention Model 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
Excl: 1.4d are ALL = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.e Model – Other 034.8.15 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 “Other” is selected as the Intervention Model and a description for Other is not provided. For study titled <study title>, a description is required when “other” is selected as the Intervention Model and 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
Excl: PHS Human Subject and Clinical Trial Section – 4.2.e Model 034.8.43 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error for a Human Subject Study if Intervention Model or description of Intervention Model is provided. For study titled <study title>, an Intervention Model or description of Intervention Model cannot be provided since you did not answer “Yes” to questions 1.4a through 1.4d 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 PHS Human Subject and Clinical Trial Section – 4.2.e Model 034.8.74 N N NIH, 1.0 = “N”) AND ( to 1.4a 1.4d K12 Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Provide error if Intervention Model or description for Intervention Model is provided For study titled <study title>, an Intervention Model or description for Intervention Model cannot be provided since the 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.
are ALL Incl K’s: K01, K02, K05, K07, K08, K18, K22, K23, K26, K76, New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.f Masking 034.8.16 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are K12 Both Provide error for a study record if response to masking is not provided. For study titled <study title> a response to the masking question 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 clinical trials (unless = I).
4.2.f Masking ( to 1.4a 1.4d are ALL F05, F30, F31, F32, F33, F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, K26, K76, Announcement does not allow independent clinical trials. K to Clinical Trial Not Allowed FOAs. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 034.8.17 N N NIH, 1.0 = “R" or "O") AND K12 Both Provide error for a Study record if response to masking is “Yes”, but Participant, Care Provider, Investigator, For study titled <study title>, a selection of either Participant, Care Provider, Investigator and/or Outcomes Assessor is required if response to E Study Record fields in Sections IV and V are required for studies
4.2.f Masking Care to 1.4a 1.4d are ALL Outcomes Assessor is not selected. masking is “Yes” and you answered “Yes” to questions in the Clinical Trial Questionnaire. involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.f Masking Care 034.8.47 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error for a Study Record if response to masking is “Yes”, but Participant, Care Provider, Investigator, Outcomes Assessor is selected. For study titled <study title>, Participant, Care Provider, Investigator, and/or Outcomes Assessor cannot be selected since you did not answer “Yes” to questions 1.4.a-1.4.d 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 PHS Human Subject and Clinical Trial Section – 4.2.f Masking Care 034.8.38 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, K26, K76, Provide error for a Study Record if response to masking is “Yes”, but Participant, Care Provider, Investigator, Outcomes Assessor is selected. For study titled <study title>, Participant, Care Provider, Investigator, and/or Outcomes Assessor cannot be selected since the 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
4.2.g NOT all “Yes” Clinical Trial Questionnaire. which do not involve clinical trials. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.g 034.8.49 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, Provide error if Allocation is provided For study titled <study title> Allocation cannot be provided since the 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
K08, K18, K22, K23, K26, PHS Human Subject and Clinical Trial Section – 4.3 034.8.19 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL 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 Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are required for studies involving clinical trials (unless = I). New Rule
Excl: 1.4a 1.4d are ALL F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, K26, Allowed FOAs. New Rule October 2017 Release PHS Human Subject and Clinical Trial 4.3 – Type, 034.8.20 N N NIH, 1.0 = “R" or "O") AND to K12 Both Provide error fora Clinical Trial Study if an Outcome Measures subelement (type, timeframe, description) is not provided. For study titled <Study Title>, Outcome Measure <Type, Timeframe , 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
Excl: 1.4a 1.4d are ALL trials (unless = I). New Rule October 2017 Release PHS Human and Clinical Trial Section – 4.3 Name 034.8.21 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide an error for a Clinical Trial Study if an Outcome Measure Name is not provided For study titled <study title>, an Outcome Measure Name is required for Outcome Measures 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).
Excl: Excl: New Rule October 2017 Release PHS Human and Clinical Trial Section – 4.4 Design and Power 034.8.24 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 Statistical Design and Power is not attached to the Study For study titled <study title>, a Statistical Design and Power 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 clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Section – 034.8.60 N N NIH, 1.0 to 1.4a K12 Both Provide error for a Human Subject Study if Statistical Design and For study titled <study title> a Statistical Design and Power attachment cannot E Study Record fields in Sections IV and V are
Trial 4.4 Design and Power 1.4d are NOT “Yes” Power attachment is provided. be provided since you did not answer “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. blocked for studies which do not involve clinical trials. New Rule October 2017 Release PHS Human and Clinical Trial Section – 4.4 Design and Power 034.8.61 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, Provide error if Statistical Design and Power attachment is provided For study titled <study title> a Statistical Design and Power attachment cannot be provided since the 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. D43,
Excl: K07, K08, K18, K22, K23, K26, New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.5 Subject Duration 034.8.25 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 ‘Subject Participation Duration’ is not provided for the study For study titled <study title> a Participation Duration 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 clinical trials (unless = I). New Rule
Excl: Excl: October 2017 Release PHS Human Subject and Clinical Trial Section – 4.5 Subject Duration 034.8.62 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Study if Participation Duration is provided For study titled <study title> a Participation Duration attachment cannot be provided since you did not answer “Yes” to questions 1.4.a-1.4.d 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 PHS Human Subject and Clinical Trial Section – 4.5 Subject 034.8.63 N N NIH, 1.0 = “N”) AND ( to K12 Incl F’s: F05, F30, F31, F32, Provide error for a Human Subject Study if Subject Participation Duration is provided For study titled <study title>, a Subject Participation Duration attachment cannot be provided since the Funding Opportunity Announcement does not allow E Study Record fields in Sections IV and V are blocked for F and K to
Excl: Duration 1.4a 1.4d are ALL F33, F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, K26, independent clinical trials. Clinical Trial Not Allowed FOAs New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.6 Will the study use an FDA – 034.8.26 N N NIH, 1.0 = “R" or "O") AND to K12 Both Provide error for a Clinical Trial Study if response to the question, “Will the study use an FDA – regulated intervention? is not provided. For study titled <study title>, A response to the question “Will the study use an FDA – regulated intervention?” is required since you answered “Yes” to questions 1.4.a-1.4.d E Study Record fields in Sections IV and V are required for studies involving clinical
Excl: PHS Human Subject and Clinical Trial Section – 4.6 Will the study use an FDA – 034.8.65 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, K’s: K05, K07, K08, K18, K22, K23, K26, Provide error if response to question, “Will the study use an FDA – regulated intervention?” is “Yes” For study titled <study title> a response to the question “Will the study use an FDA – regulated intervention?” cannot be “Yes”, since the 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
Excl: Excl: regulated PHS Human Subject and Clinical Trial Section – 4.6a If yes, describe the of Product (IP) and New Drug Device (IDE) status? 034.8.27 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error if “If yes, describe the availability of Investigational Product (IP) and Investigational New Drug Device Exemption (IDE) status” is not provided when the response to the question “Will the study use an intervention?” is “Yes” For study titled <study title>, the Availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status attachment 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 and Section – 034.8.66 N N NIH, 1.0 to 1.4a K12 Both Provide error“If yes, describe the availability of Investigational For study titled <study title>, the Availability of Investigational E Study Record fields in Sections IV and V
Excl: Clinical Trial 4.6a If yes, describe the of Product (IP) and New Drug Device (IDE) status? 1.4d are NOT “Yes” Product (IP) and Investigational New Drug Device Exemption (IDE) status” is provided. Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status attachment cannot be provided since you did not answer “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. are blocked for studies which do not involve clinical trials. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 034.8.67 N N NIH, 1.0 = “N”) AND ( K12 Incl F’s: F05, F30, F31, Provide error “If yes, describe the availability of Investigational Product (IP) and Investigational New Drug For study titled <study title> the Availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational E Study Record fields in Sections IV and V are blocked for F and K
Excl: Plan 1.4a 1.4d are ALL clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.7 Plan 034.8.68 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Subject Study if Dissemination Plan attachment is provided For study titled <study title> a Dissemination Plan cannot be provided since you did not answer “Yes” to questions 1.4.a-1.4.d 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
Excl: Section – 4.7 Plan 034.8.69 N N NIH, 1.0 = “N”) AND ( to 1.4a 1.4d are ALL Excl: K12 Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Incl K05, K07, K08, K18, K22, K23, K26, Provide error for a Human Subject Study if Dissemination Plan attachment is provided for a F or K FOA For study titled <study title> a Dissemination Plan cannot be provided since the 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 PHS Human Subject Section 5 – Other 034.9.1 N N NIH, 1.0 K12 Both Provide error if the study is NOT Clinical Trial and Study titled <study titled> is not a Clinical Trial and E Study Record fields in
Excl: and Clinical Trial Clinical Trial Related = “N” or “O” AND to 1.4a 1.4d are NOT “Yes” Other Clinical Trial-related attachments are provided. cannot have clinical trial-related attachments. Sections IV and V are blocked for studies which do not involve clinical trials New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 5 – Other Clinical Trial Related 034.9.2 N N NIH, 1.0 = “R" or "O") AND to 1.4a K12 Both Provide error if more than ten Clinical attachments are provided for the study No more than 10 Clinical Trial-related attachment are allowed for Study titled <study title> E Study Record fields in Sections IV and V are required for studies involving clinical trials (unless
Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) FOA Lists Code & to or to or Both (Multi Only) SF 424 1. Type of 025.1.1 SF 424 1. Type of 025.1.2 N N Incl: V Do not accept ‘Application’ submission type if there is an associated prior successful Revision Type of application) This application has been identified as a duplicate of a previous submission. The ‘Type of Submission’ should be set to Changed/Corrected if you are addressing errors/warnings. E New rule SF 424 1.Type of 025.1.3 N N Incl: V 2.1 Do not accept changed/ corrected application if the original application has been verified and not withdrawn Your application has already been submitted for processing by Federal agency staff and can no longer be changed through the electronic submission process. E New rule
period of the previous awarded grant, it is a Type 5 application. Type 2: If the budget period start date and end date is after the project period end date of the previous awarded grant, it is a Type 2 application. 2. Type of New, Revision 025.2.2 N N Incl: Trigger rule if application type is ‘Revision’ AND activity code != 666 (Post Award Amendments) Request to increase award is not accepted at this time. Please contact your grants management specialist. E New Rule October 2016 Release SF 424 If select letter(s): 025.3.1 N N Incl: V 2.1 If Revision type of application, the letter selection is mandatory A Letter selection is required if Type of Application is Revision. E New rule
SF 424 Other (Specify) 025.4.1 N N Incl: V 2.1 If E. Other is checked, this component should be provided. The Other (specify) field should be provided if E. Other is checked. W New rule SF 424 Other (Specify) 025.4.2 N N Inc: If “E. Other” is checked and Type of application is post award amendment (Type 6), the amendment name provided in the "Other(Specify)" field should be valid. If not exact match, it should be rejected. The Post Award name provided in the “Other(Specify)" section, is not a valid Name. Please choose a valid name. E New Rule October 2016 Release SF 424 3. Date 025.5 SF 424 4. 025.6.1 N N Incl: Applicant Identifier is required The Commons Username must be provided in the Applicant Identifier field for the PD/PI. E New Rule October 2017 Release SF 424 4. 025.6.2 N N Incl: If Applicant Identifier is specified, it must be a valid The Commons Username provided in the Applicant Identifier field is not a E New Rule October 2017 Release
Identifier Identifier Commons account. recognized Commons account. SF 424 4. 025.6.3 N N Incl: Check the SF424 form for an existence of a Commons ID. If one exists but does not have a PI role or is not affiliated with organization of application then generate a warning. The Commons account provided on the SF424, #4, Applicant Identifier field is not affiliated with the applicant organization or has not been assigned the PD/PI role in Commons. Check with your Commons Account Administrator to make sure the PD/PI has been affiliated with the applicant organization and has the PD/PI role. Once this is done, please reach out to the Grants Management point of contact listed on the Funding Opportunity Announcement (FOA) Part I. They will ensure that the application is properly linked to the PD/PI Commons account. W New rule SF 424 5a. Federal Entity 025.7
Identifier SF 424 5b. Federal Award 025.8.1 N N Incl: V 2.1 If a continuation or revision, this the Federal award identifier is mandatory A Federal Identifier is required for Continuation or Revision 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 New rule SF 424 5b. Federal Award 025.8.2 N N Incl: V 2.1 For continuation applications, the prior grant number must exist in the system. Matching is performed only on IC and Serial number. The Federal Identifier included in the application cannot be found. Please ensure you are using the most recent assigned application/grant number (e.g., use CA987654 extracted from full application/grant number 1R01CA987654-A1) E New rule SF 424 5b. Federal Award 025.8.3 N N Incl: V 2.1 For a revision, the prior grant must exist in the NIH system (Matching is performed only The Federal Identifier included in the application cannot be found. Please ensure you are using the institute code and W New rule
Identifier on IC and serial number), the parent grant must be awarded and the application project dates must be within the parent grant. serial number of the most recent awarded grant number. If the Federal Identifier is correct, the project period of the revision application must fall within the awarded project period of the parent grant. SF 424 State Use Only:6. Date by State: 025.9 SF 424 State Use Only:7. State 025.10 SF 424 a. Legal Name: 025.11.1
SF 424 b. Number 025.12.1 SF 424 c. DUNS: 025.13.1 SF 424 c. DUNS: 025.13.2 N N Incl: V 2.1 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 New rule
SF 424 c. DUNS: 025.13.3 N N Incl: Generate an error when the organization is not registered in Commons but the DUNS provided is found in the SAM.gov data feed The DUNS provided does not match the DUNS for any registered organization within eRA Commons. Make sure that your organization is registered in eRA Commons and that the DUNS number on your application matches the DUNS number used in both Grants.gov and the eRA Commons. E SF 424 Street1: 025.14.1 SF 424 Street2: 025.15 SF 424 City: 025.16.1
Province SF 424 025.17 SF 424 State: 025.17.1 SF 424 State: 025.17.2 SF 424 025.18.1 Y Y Incl: V 2.1 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 New rule SF 424 025.18.2 Y Y Incl: V 2.1 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 E New rule
Name: SF 424 Contact Person: Prefix: 025.23 SF 424 Contact Person: First Name: 025.24.1 SF 424 Contact Person: Middle Name: 025.25 SF 424 Contact Person: Last Name: 025.26.1 SF 424 Contact Person: Suffix: 025.27 SF 424 Contact Person: Title: 025.28
SF 424 10. Name of Federal Agency: 025.37 SF 424 11. Catalog of Federal Number: 025.38 SF 424 CFDA Title: 025.39 SF 424 12. Funding Number: 025.40 SF 424 12. Funding Title: 025.41
Project: SF 424 Attach as specified in agency 025.46 SF 424 16. Districts Of: a. 025.47.1 N Y Incl: V 2.1 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 Congressional district <Congressional District> is invalid. To locate your district, visit If the applicant organization is a foreign institution, refer to the application guide for instructions. E New rule
validating, pad out with a leading zero if less than 2 digits are extracted in this way. Do not return error if ‘ALL’ is encountered. When Other Country than US selected and no Congressional District is entered, then populate db with 00-000. The validation should not fire. SF 424 16. Districts Of:b. 025.48.1 N Y Incl: V 2.1 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 Congressional district <Congressional District> is invalid. To locate your district, visit If the applicant organization is a foreign institution, refer to the application guide for instructions. E New rule
Districts if needed. SF 424 17. Project: a. Start Date: 025.50.1 N N Incl: V 2.1 Proposed Project Start Date < Proposed Project End Date Proposed Project Start Date must be before Proposed Project End Date E New Rule SF 424 17. Project: b. End Date: 025.50.2 N N Incl: V 2.1 Proposed Project End Date > Proposed Project Start Date Proposed Project End Date must be after Proposed Project Start Date E New rule SF 424 18. Funding ($): a. Federal 025.51.1 SF 424 18. Funding ($): b. 025.52.1
Process SF 424 18. Funding ($): g. TOTAL 025.57.1 N N Incl: V 2.1 Total estimated funding must be equal to the sum of total Federal, Applicant, State, Local, Other, and program Income Total Estimated Funding does not equal the sum of the individual funding categories E New rule SF 424 19. Is Subject to Review By State Under Order 12372 025.58 SF 424 19. a. This was made available to the State under the Order 025.59.1 N N Incl: V 2.1 Executive order answer is required if answer to ‘Subject to review by 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 New rule
12372 Process for review on (Date) SF 424 19. b. Program is subject to E.O. 12372 but has not been selected by the State for review. 025.60 SF 424 19. c. Program is not covered by E.O. 12372. 025.61 SF 424 20. Is the On 025.62.1
Any Federal Debt? (Yes/No) SF 424 20. Is the On Any Federal Debt? 025.63 SF 424 21. *By signing this I certify (1) to the in the list of and (2) 025.64
Number: SF 424 Email: 025.72 SF 424 Email: 025.72.1 N Y Incl: V 2.1 Must contain a ‘@’, with at least 1 and at most 60chars 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 Authorized Representative{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. The Person to be contacted email address also provided on the SF 424 will be used instead. W New rule SF 424 025.73
SF-424A Budget Information - Non-Construction Programs (Use only for non-research) Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) (Lists FOA Lists Code & to or to or Both Cross (Multi Only) SF 424A Section A – Budget Grant Program Function or Activity (a) (1-4) 026.1.1 N N Incl: Incl: At least one Grant Program Function or Activity is required. At least one Grant Program Function or Activity is required. W New Rule SF 424A Section A – Budget Catalog of Federal Number (b) (1-4) 026.2 SF 424A Section A – Budget 026.3
Funds: Federal (c) (1-4) SF 424A Section A – Budget Funds: Federal (c) Total 026.4.1 N N Incl: Incl: Provide error if Federal Total is not equal to Federal Estimated Unobligated Funds line 1 thru 4. The Total for Federal Funds for Estimated Unobligated Funds column does not equal the sum of Federal Funds (line 1 through 4) provided. W New Rule SF 424A Section A – Budget Funds: 026.5
New or Revised Budget: Federal (e) Total Revised Budget: line 1 thru 4. equal the sum of Federal Funds (line 1 through 4) provided. SF 424A Section A – Budget New or Revised Budget: (f) (1-4) 026.9 SF 424A Section A – Budget New or Revised Budget: (f) Total 026.10.1 N N Incl: Incl: Provide error if Non-Federal Total is not equal to Non-Federal New or Revised Budget: line 1 thru 4. The Total for Funds for New or Revised Budget column does not equal the sum of Federal Funds (line 1 through 4) provided. E New Rule
SF 424A Section A – Budget Total (g) (1) 026.11.1 N N Incl: Incl: For any Grant Program Function or Activity in Section provide warning if Total ( Column g) is not equal to “New or Revised Budget Federal amount (column e) + “Non-Federal” amount (column f). Note: Fire the above validation regardgless of the type of applicaiton Warning – there may be an error in the total shown. For Program Function and Activity <Text entered in Grant Program Function and Activity>, Total Column (g) should equal the sum of the Federal (e) and (f) amount. W New Rule SF 424A Section A – Budget Total (g) (5) 026.15.1 N N Incl: Incl: Provide error if Total (g) (5) is not equal to Total (g) (1) thru Total (g) (4) The Total (g) on line 5 does not equal the sum of Totals provided on line 1 through 4. E New Rule SF 424A B – Budget Grant 026.16.1
Function Or Activity (1 - 4) SF 424A B – Budget a. - Grant Function Or Activity (1 - 4) 026.17 SF 424A B – Budget a. Total (5) 026.18.1 N N Incl: Incl: Provide error if Personnel Total is not equal to Personnel amount(s) line 1 thru 4. The Total for Personnel does not equal the sum of Personnel amount(s) (line 1 through 4) provided. W New Rule SF 424A B – Budget 026. 19
b. Fringe Benefits - Grant Function Or Activity (1 - 4) SF 424A B – Budget b. Fringe Benefits Total (5) 026. N N Incl: Incl: Provide error if Fringe Benefits Total is not equal to Fringe Benefits amount(s) line 1 thru 4. The Total for Fringe Benefits does not equal the sum of Fringe Benefits amount(s) (line 1 through 4) provided. W New Rule SF 424A B – Budget c. Travel - Grant Function Or 026.21
Activity (1 - 4) SF 424A B – Budget c. Travel Total (5) 026.22.1 N N Incl: Incl: Provide error if Travel Total is not equal to Travel amount(s) line 1 thru 4. The Total for Travel does not equal the sum of Travel amount(s) (line 1 through 4) provided. W New Rule SF 424A B – Budget - Grant Function Or Activity (1 - 4) 026. SF 424A B – Budget d. 026. N N Incl: Incl: Provide error if Equipment Total is not equal to Equipment amount(s) line 1 thru 4. The Total for Equipment does not equal the sum of Equipment amount(s) (line 1 through 4) provided. W New Rule
Total (5) SF 424A B – Budget e. Supplies - Grant Function Or Activity (1 - 4) 026. 24 SF 424A B – Budget e. Supplies Total (5) 026. N N Incl: Incl: Provide error if Supplies Total is not equal to Supplies amount(s) line 1 thru 4. The Total for Supplies does not equal the sum of Supplies amount(s) (line 1 through 4) provided. W New Rule SF 424A B – Budget f. - Grant 026.
Program Function Or Activity (1 - 4) SF 424A B – Budget f. Total (5) 026. N N Incl: Incl: Provide error if Contractual Total is not equal to Contractual amount(s) line 1 thru 4. The Total for Contractual does not equal the sum of Contractual amount(s) (line 1 through 4) provided. W New Rule SF 424A B – Budget g. - Grant Function Or Activity (1 - 4) 026.28
Program Program SF 424A B – Budget g. Total (5) 026.29.1 N N Incl: Incl: Provide error if Construction Total is not equal to Construction amount(s) line 1 thru 4. The Total for Construction does not equal the sum of Construction amount(s) (line 1 through 4) provided. W New Rule SF 424A B – Budget h. Other - Grant Function Or Activity (1 - 4) 026. 30 B – Budget h. Other - Grant Function 026.30.1 N N Incl: Incl: Provide error if the order or text of any Grant Program, Function Or Activity in Section B does not match Budget Summary: Grant program function or Activity in Section A The order or the text for the Grant Program or Activity in Section B does not match the order or the text in Section A. W
Or Activity (1) SF 424A B – Budget h. Other Total (5) 026. N N Incl: Incl: Provide error if Other Total is not equal to Other amount(s) line 1 thru 4. The Total for Other does not equal the sum of Other amount(s) (line 1 through 4) provided. W New Rule SF 424A B – Budget Function Or Activity (1) - i. Total Direct Charges (sum of 6a-6h) 026. 32.1 N N Incl: Incl: For any Grant Program Function or Activity in Section B, provide error if Total Direct Charges is not equal to the sum of amounts provided for Personnel, Fringe Benefits, Travel, Equipment, Supplies, Contractual , Construction and Other” categories. For Grant Program Function or Activity < text entered in Grant Program Function or Activity >, the Total Direct Charges amount does not equal the sum of amounts provided for “Personnel, Fringe Benefits, Travel, Equipment, Supplies, Contractual , Construction and Other” categories. W New rule SF 424A B – Budget 026. N N Incl: Incl: Provide error if Total Direct Charges Total is not equal to Total The Total for Total Direct Charges does not equal the sum of Total Direct Charges W New Rule
SF 424A B – Budget Function Or Activity (1) - k. TOTALS (sum of 6i and 6j) 026.39.1 N N Incl: Incl: For any Grant Program Function or Activity in Section B, provide error if Totals (sum of 6i and 6j is not equal to Total Direct Charges(sum of 6a – 6h) + Indirect Charges. For Grant Program Function or Activity < text entered in Grant Program Function or Activity >, the Totals ( sum of 6i – 6j) is not equal to the sum of Total Direct Charges(6a-6h) and Indirect Charges. W New Rule SF 424A B – Budget Function Or Activity (1) - k. TOTALS (sum of 6i and 6j) 026.39.2 N N Incl: Incl: Provide error if Totals (Section B, row K, column 1) is not equal Total (Section row 1, column g) The Section B Totals amount for Program, Function Or Activity <Text entered in grant program function or Activity> must equal the total amount in Section A Total for Program, Function Or Activity (1). W New Rule
SF 424A B – Budget k. TOTALS (sum of 6i and 6j) Total (5) 026.43.1 N N Incl: Incl: Provide error if Totals Total is not equal to Totals amount(s) line 1 thru 4. The Total for Totals does not equal the sum of Totals amount(s) (line 1 through 4) provided. W New Rule SF 424A B – Budget k. TOTALS (sum of 6i and 6j) Total (5) 026.43.2 N N Incl: Incl: Provide error if Totals Total (k-5) is not equal to Totals Total (g-5) – cross sectional The SECTION B – Budget Categories: k. TOTALS Total (5) does not equal to SECTION A – Budget Summary: 5.Totals Total (g). E New Rule SF 424A B – Budget Program Income - Grant 026.44
Program (8) program function or Activity in Section A SF 424A C – (a) Grant Program (b) 026.47 SF 424A C – (a) Grant Program (c) State 026.48 SF 424A C – (a) Grant 026.49
Program (d) Other Sources SF 424A C – (a) Grant Program (8) (e) TOTALS 026.50.1 N N Incl: Incl: For any ‘grant program function or Activity’ in Section C, provide error if Total for that grant program does not equal the sum of (b) Applicant, (c) State, (d) other Sources for that grant program. The Totals for Grant Program Function and Activity <Text entered in Grant Program Function or Activity> does not equal the sum of Applicant (b), State (c) and Other Sources (d) Resources Funds, W New Rule SF 424A C – (a) Grant Program (8) (e) TOTALS 026.50.2 N N Incl: Incl: Provide warning if Totals (Section C, column row 8) is not equal to New or revised Budget (Section row 1, column f) For New or Continuation applications, the totals for Grant program < text entered in grant program > should equal the Section A New or revised Budget Non-Federal (f) amount. For supplemental grants and changes to existing grants this warning may not apply; follow agency guidance. W New Rule
SF 424A C – 12 TOTAL - (b) 026.54.1 N N Incl: Incl: Provide error if Applicant total sum is not equal to Applicant sums provided on line 8 thru 11. The Total for Resources for Applicant (b) column does not equal the sum of Applicant funds (line 8 through 11) provided. W New Rule SF 424A C – 12 TOTAL - (c) State 026.55.1 N N Incl: Incl: Provide error if State total sum is not equal to State sums provided on line 8 thru 11. The Total for Resources for State (c) column does not equal the sum of State funds (line 8 through 11) provided. W New Rule SF 424A C – 12 TOTAL - (d) Other Sources 026.56.1 N N Incl: Incl: Provide error if Other Sources total sum is not equal to Other Sources sums provided on line 8 thru 11. The Total for Resources for Other Sources (d) column does not equal the sum of Other Sources funds (line 8 through 11) provided. W New Rule SF 424A C – 026.57.1 N N Incl: Incl: Provide error if Totals total sum is not equal to The Total for Resources for Totals (e) column W New Rule
12 TOTAL - (e) TOTALS Totals sums provided on line 8 thru 11. does not equal the sum of Total funds (line 8 through 11) provided. SF 424A C – 12 TOTAL - (e) TOTALS 026.57.2 N N Incl: Incl: Provide error if Totals total sum is not equal to Section A New or Revised Budget Non-Federal Totals (f-5) Cross The Total for Resources for Totals (e) column does not equal the sum of Section A, New or Revised Budget Non-Federal Totals (f-5). For New or Continuation applications, the Total for Non-Federal Resources for Totals (e) should equal Section A New or revised Budget (f) amount. For supplemental grants and changes to existing grants this warning may not apply; follow agency guidance. W New Rule SF 424A D – Cash Needs: 13. Federal - 026.58.1 N N Incl: Incl: Provide error if Federal Total for 1st year is not equal to sum of Federal 1st Quarter + Federal 2nd Quarter + The Federal Total for 1st year does not equal to sum of Federal 1st Quarter + Federal 2nd Quarter + Federal 3rd Quarter + Federal 4th Quarter W New Rule
Federal Federal Total for 1st Federal 3rd Quarter + Federal 4th Quarter. SF 424A D – Cash Needs: 13. Federal - Total for 1st 026.58.2 N N Incl: Incl: Provide warning if Federal for 1st year sum is not equal to Section A, New or Revised Budget Federal Totals (e-5) The Federal Total for 1st year, in Section D- Forecasted Needs, does not equal the Section A, New or Revised Budget Federal Totals (e-5) amount. E New rule SF 424A D – Cash Needs: 13. Federal - 1st Quarter – 4th quarter 026.59 SF 424A D – Cash Needs: 14. - 026.60.1 N N Incl: Incl: Provide error if Non-Federal Total for 1st year sum is not equal to Estimated Unobligated Funds Totals The Non-Federal Total for 1st year does not equal the sum of Estimated Unobligated Funds Non-Federal Totals (d-5) and New or E New Rule
TOTAL (sum of lines 13 and 14) - Total for 1st SF 424A D – Cash Needs: 15. TOTAL (sum of lines 13 and 14) - Total for 1st 026.62.2 N N Incl: Incl: Provide errror if Total 1st year is not equal to Federal 1st year + Non-Federal 1st year amounts provided The Total for 1st year is not equal to the sum of Federal 1st year and Non-Federal 1st yeatr amounts provided. W New Rule SF 424A D – Cash Needs: 14. TOTAL (sum of lines 13 and 14) - 1st Quarter 026.63.1 N N Incl: Incl: Provide error if Total 1st Quarter is not equal to Federal 1st Quarter + 1st Quarter amounts provided. The Total for 1st Quarter is not equal the sum of Federal 1st Quarter and 1st Quarter amounts provided. W New Rule
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
(sum of lines 13 and 14) Quarter SF 424A E – Budget (a) Grant Program (16 – 19) 026.67 E – Budget (a) Grant Program (16) 026.67.1 N N Incl: Incl Provide error if the order or text of any Grant Program, Function Or Activity in Section E does not match Budget Summary: Grant program function or Activity in Section A The order or the text for the Grant Program or Activity in Section E does not match the order or the text in Section A. W SF 424A E – Budget Future 026.68.1 N N Incl: Incl Provide warning if number of budget years/periods does not match the span of the project Note: This rule will trigger differenet messages for and SAMHSA E
Opportunity Announcement (FOA) for additional guidance SF 424A E – Budget 20. TOTAL (sum of lines 16 - 19) - (b) First 026.69.1 N N Incl: Incl: Provide error if First (b) is not equal to First sums provided on line 16 thru 19. The Total of First (b) column does not equal the sum of First (b) funds (line 16 through 19) provided. W New Rule SF 424A E – Budget 20. TOTAL (sum of lines 16 - 19) - (c) Second 026.70.1 N N Incl: Incl: Provide error if Second (c) is not equal to Second sums provided on line 16 thru 19. The Total of Second (c) column does not equal the sum of Second (c) funds (line 16 through 19) provided. W New Rule SF 424A E – Budget 026.71.1 N N Incl: Incl: Provide error if Third (d) is not equal to Third The Total of Third (d) column does not equal the sum of W New Rule
20. TOTAL (sum of lines 16 - 19) - (d) Third sums provided on line 16 thru 19. Third (d) funds (line 16 through 19) provided. SF 424A E – Budget 20. TOTAL (sum of lines 16 - 19) - (e) Fourth 026.72.1 N N Incl: Incl: Provide error if Fourth Year (e) is not equal to Fourth Year sums provided on line 16 thru 19. The Total of Fourth Year (e) column does not equal the sum of Fourth Year (e) funds (line 16 through 19) provided. W New Rule SF 424A F – Other Budget Info: 21. Direct Charges: 026.73 SF 424A F – Other Budget Info: 22. 026.74
Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) (Lists FOA Lists Code & to or to or Both Cross (Multi Only) SF 424B of Official 027.1.1 N N Incl: Incl: V 1_1 Signature of Authorized Certifying Official is required The Signature of the Authorized Certifying Official is required. E New rule SF 424B Official Title 027.2.1 N N Incl: Incl: V 1_1 Title of Authorized Certifying Official is required The Title of the Authorized Certifying Official is required. E New rule SF 424B 027.3.1 N N Incl: Incl: V 1_1 Applicant Organization is required The Applicant Organization is required. E New rule SF 424B Date 027.4.1 N N Incl: Incl: V 1_1 Date Submittedis required The Date Submitted is required. E New rule SF-424C Budget Information - Construction Programs
Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) (Lists FOA Lists Code & to or to or Both Cross (Multi Only) SF 424C 1. and legal - a. Total Cost 028.1 SF 424C 1. and legal - b. Costs Not for 028.2 SF 424C 1. and legal - c. Total Costs 028.3.1 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 Administration and Legal Expenses (Construction Budget) must be equal to the difference of columns A (Total Cost) and B (Costs Not Allowable for Participation) E New Rule
a-b) SF 424C 2. Land, etc - a. Total Cost 028.4 SF 424C 2. Land, etc - b. Costs Not for 028.5 SF 424C 2. Land, etc - c. Total 028.6.1 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 Land, Structures, Appraisals, etc., (Construction Budget) must be equal to the difference of columns A (Total Cost) and B E New Rule
Costs a-b) (Costs Not Allowable for Participation) SF 424C 3. and - a. Total Cost 028.7 SF 424C 3. and - b. Costs Not for 028.8 SF 424C 3. and 028.9.1 N Y Incl: Incl: Provide error if not equal to column A (Total Cost) minus column B (Costs The Total Allowable Costs for Relocation Expenses and Payments (Construction Budget) must be equal to the E New Rule
fees - c. Total Costs a-b) column B (Costs Not Allowable for Participation). must be equal to the difference of columns A (Total Cost) and B (Costs Not Allowable for Participation) SF 424C 5. Other and fees - a. Total Cost 028.13 SF 424C 5. Other and fees - b. Costs Not for 028.14 SF 424C 5. Other and fees 028.15.1 N Y Incl: Incl: Provide error if not equal to column A (Total Cost) minus column B (Costs The Total Allowable Costs for Other Architectural and Engineering Fees (Construction Budget) must be equal to the E New Rule
- c. Total Costs a-b) Not Allowable for Participation). difference of columns A (Total Cost) and B (Costs Not Allowable for Participation) SF 424C 6. Project fees - a. Total Cost 028.16 SF 424C 6. Project fees - b. Costs Not for 028.17 SF 424C 6. Project fees - c. Total Costs 028.18.1 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 Project Inspection Fees (Construction Budget) must be equal to the difference of columns A (Total Cost) and B (Costs Not Allowable for Participation) E New Rule
a-b) SF 424C 7. Site work - a. Total Cost 028.19 SF 424C 7. Site work - b. Costs Not for 028.20 SF 424C 7. Site work - c. Total Costs a-b) 028.21.1 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 Site Work (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 8. and removal - a. Total Cost 028.22
for SF 424C 9. - c. Total Costs a-b) 028.27.1 N N 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 Construction (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 10. - a. Total Cost 028.28 SF 424C 10. - b. Costs Not for 028.29 SF 424C 10. 028.30.1 N N Incl: Incl: Provide error if not equal to column A (Total The Total Allowable Costs for Equipment (Construction Budget) E New Rule
SF 424C 12. (sum of lines 1-11) - a. Total Cost 028.34.1 N N Incl: Incl: Provide error if not equal to the sum of lines Total Cost The Total Cost Subtotal on the Construction Budget must be equal to the sum of total costs for all Administration and Legal Expenses entries E New Rule SF 424C 12. (sum of lines 1-11) - b. Costs Not for 028.35.1 N N Incl: Incl: Provide error if not equal to the sum of lines Costs Not Allowable for Participation The Costs Not Allowable for Participation Subtotal on the Construction Budget must be equal to the sum of all Administration and Legal Expenses entries E New rule SF 424C 12. (sum of lines 1-11) - c. Total Costs a-b) 028.36.1 N N Incl: Incl: Provide error if not equal to column A (Total Cost) minus column B (Costs Not Allowable for Participation). The Total Allowable Costs Subtotal on the Construction Budget must be equal to the difference of columns A (Total Cost) and B (Costs Not Allowable for Participation) E New Rule
a-b) (Costs Not Allowable for Participation) SF 424C 14. - a. Total Cost 028.40.1 N N Incl: Incl: Provide error if not equal to the sum of lines 12 and 13, Total Cost The Total Cost Subtotal on the Construction Budget must be equal to the sum of Contingencies and the subtotal of all Administration and Legal Expenses entries E New Rule SF 424C 14. - b. Costs Not for 028.41.1 N N Incl: Incl: Provide error if not equal to the sum of lines 12 and 13, Costs Not Allowable for Participation The Costs Not Allowable for Participation Subtotal on the Construction Budget must be equal to the sum of Contingencies and the subtotal of all Administration and Legal Expenses entries E New Rule SF 424C 14. - c. Total Costs a-b) 028.42.1 N N Incl: Incl: Provide error if not equal to column A (Total Cost) minus column B (Costs Not Allowable for Participation). The Total Allowable Costs Subtotal on the 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 14. - c. 028.42.2 N N Incl: Incl: Provide error if not equal to the sum of lines 12 The Total Allowable Costs Subtotal on the Construction Budget E New rule
Total Costs a-b) and 13, Total Allowable Costs must be equal to the sum of Contingencies and the subtotal of all Administration and Legal Expenses entries SF 424C 15. Project income - a. Total Cost 028.43 SF 424C 15. Project income - b. Costs Not for 028.44 SF 424C 15. Project income - c. Total Costs 028.45.1 N N Incl: Incl: Provide error if not equal to column A (Total Cost) minus column B (Costs Not Allowable for Participation). The Project (Program) Income, Total Allowable Costs on the Construction Budget must be equal to the difference of columns A (Total Cost) and B (Costs E New Rule
a-b) Not Allowable for Participation) SF 424C 16. TOTAL COSTS (subtract #15 from #14) - a. Total Cost 028.46.1 N N Incl: Incl: Provide error if not equal to line 14 minus line 15, Total Cost The Total Project Costs, Total Cost on the Construction Budget must be equal to the subtotal minus the Project Income. E New rule SF 424C 16. TOTAL COSTS (subtract #15 from #14) - b. Costs Not for 028.47.1 N N Incl: Incl: Provide error if not equal to line 14 minus line 15, Costs Not Allowable for Participation The Total Project Costs, Costs Not Allowable for Participation on the Construction Budget must be equal to the Subtotal Not Allowable minus the Project Income Not Allowable. E New Rule SF 424C 16. TOTAL 028.48.1 N N Incl: Incl: Provide error if not equal to column A (Total Cost) minus The Total Project Costs, Total Allowable Costs on the Construction Budget E New Rule
COSTS (subtract #15 from #14) - c. Total Costs a-b) column B (Costs Not Allowable for Participation). must be equal to the difference of columns A (Total Cost) and B (Costs Not Allowable for Participation) SF 424C 16. TOTAL COSTS (subtract #15 from #14) - c. Total Costs a-b) 028.48.2 N N Incl: Incl: Provide error if not equal to line 14 minus line Total Allowable Costs The Total Project Costs, Total Allowable Costs on the Construction Budget must be equal to the subtotal minus the Project Income. E SF 424C 17. Federal Enter 028.49
Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) (Lists FOA Lists Code & to or to or Both Cross (Multi Only) SF 424D of Official 029.1.1 N N Incl: Incl: V 1_1 Signature of Authorized Certifying Official is required The Signature of the Authorized Certifying Official is required. E New rule SF 424D Official Title 029.2.1 N N Incl: Incl: V 1_1 Title of Authorized Certifying Official is required The Title of the Authorized Certifying Official is required. E New rule SF 424D 029.3.1 N N Incl: Incl: V 1_1 Applicant Organization is required The Applicant Organization is required. E New rule SF 424D Date 029.4.1 N N Incl: Incl: V 1_1 Date Submittedis required The Date Submitted is required. E New rule
SF-LLL Disclosure Of Lobbying Activities (Use only for non-research ONLY) Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) (Lists FOA Lists Code & to or to or Both Cross (Multi Only) SF LLL 1. Type of Federal Action: (a. contract, b. grant, c. d. loan, e. loan : f. loan 030.1 SF LLL 2. Status of Federal Action: (a. :b. initial 030.2
award, c. SF LLL 3. Report Type: b. change : year 030.4 SF LLL 3. Report Type: b. change: quarter 030.5 SF LLL 3. Report Type: b. material change: date of last report 030.6 SF LLL 4. Name and Address of 030.7
Entity: (Prime, SF LLL Entity: Tier if known: 030.8 SF LLL Entity: Name: 030.9 SF LLL Entity: Street 1: 030.10 SF LLL Entity: Street 2: 030.11
SF LLL Entity: City: 030.12 SF LLL Entity: District, if known: 030.15 SF LLL If Entity in No.4 is Enter Name and Address of Prime: Street 2: 030.18 SF LLL If Entity in No.4 is Enter 030.22
SF LLL 8. Federal Action Number, if known: 030.26 SF LLL 9. Award Amount, if known: 030.27 SF LLL 10. a. Name and Address of Lobbying Prefix 030.28 SF LLL 10. a. Name and Address of Lobbying First Name: 030.29 SF LLL 10. a. Name and 030.30
Address of Lobbying Middle Name SF LLL 10. a. Name and Address of Lobbying Last Name 030.31 SF LLL 10. a. Name and Address of Lobbying Suffix 030.32 SF LLL 10. a. Name and Address of Lobbying 030.33
SF LLL 10. a. Name and Address of Lobbying Zip 030.37 SF LLL 10. b. Services Prefix: 030.38 SF LLL 10. b. Services First Name: 030.39 SF LLL 10. b. Services 030.40
Middle Name: SF LLL 10. b. Services Last Name: 030.41 SF LLL 10. b. Services Suffix: 030.42 SF LLL 10. b. Services Street1: 030.43 SF LLL 10. b. 030.44
Services Street2: SF LLL 10. b. Services City: 030.45 SF LLL 10. b. Services State: 030.46 SF LLL 10. b. Services Zip: 030.47 SF LLL 11. 030.48
HHS Checklist (Use only for non-research ONLY) Form Field Rule# Rule Categories Validation Error Message Comments (Y/N) (Lists FOA Lists Code & to or to or Both Cross (Multi Only) HHS Type of (New, 032.1.1 N N Incl: Incl: Application type selection is required An Application Type selection is required. E New rule HHS PART A: 1. Proper and Date on the SF 424 (FACE PAGE): Included 032.2 HHS PART A: 2. Civil Rights 032.3 Check list
(45 CFR 80) HHS Civil Rights Date 032.4.1 N N Incl: Incl: If Civil Rights Insurance is selected, a date is required If the ‘Civil Rights Insurance’ is selected, a date is required E New Rule HHS PART A: 2. the (45 CFR 84) 032.5 HHS the Date 032.6.1 N N Incl: Incl: If Assurance Concerning the Handicapped is selected, a date is required If the ‘Assurance Concerning the Handicapped’ is selected, a date is required. E New rule HHS PART A: 2. Sex 032.7
(45 CFR 86) HHS Sex Date 032.8.1 N N Incl: Incl: If Assurance Concerning Sex Discrimination is selected, a date is required If the ‘Assurance Concerning Sex Discrimination’ is selected, a date is required E New Rule HHS PART A: 2. Age (45 CFR 90 & CFR 91) 032.9 HHS Age Date 032.10.1 N N Incl: Incl: If Assurance Concerning Age Discrimination is selected, a date is required If the ‘Assurance Concerning Discrimination’ is selected, a date is required E New Rule
HHS PART C: Official: Last Name: 032.24 HHS PART C: Official: Suffix: 032.25 HHS PART C: Official: Title: 032.26 HHS PART C: Official: 032.27 HHS PART C: Official: Street1: 032.28
HHS PART C: Official: Street2: 032.29 HHS PART C: Official: City: 032.30 HHS PART C: Official: State: 032.31 HHS PART C: Official: ZIP Postal Code: 032.32 HHS PART C: Official: ZIP / 032.33
Postal Code4: HHS PART C: Program Address: 032.50.1 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 PD/PI {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 HHS PART C: Program Address: 032.50.2 N Y Incl: If the Applicant Identifier does not contain a value on the SF424, or if the applicant identifier listed on the SF424 has not been assigned the PI role in Commons then using the PD/PI last name and email address on the HHS Checklist, check for an existence of a Commons ID. If The Commons account provided on the SF424, #4, Applicant Identifier field is not affiliated with the applicant organization or has not been assigned the PD/PI role in Commons. with your Commons Account Administrator to make sure the PD/PI has been affiliated with the applicant organization and has the PD/PI role. Once this is done, please reach W
one exists but does not have a PI role or is not affiliated with organization of application then generate warning. out to the Grants Management point of contact listed on the Funding Opportunity Announcement (FOA) Part I. They will ensure that the application is properly linked to the PD/PI Commons account. HHS PART C: Program Number: 032.51 HHS PART C: Program Fax Number: 032.52