Submitting NIH Proposals through Grants gov using PureEdge Software

Submitting NIH Proposals through Grants.gov using PureEdge Software NYU Office of Sponsored Programs ~ August, 2006 With thanks to Johns Hopkins University School of Medicine Office of Research Administration and the University of Maryland Office of Research Administration and Advancement (College Park) • Deadlines ………………………………………………………………………….. 2 • eRA Commons o Registration ………………………………………………………………….. 3 o Access ……………………………………………………………………….. 3 o Note: Instructions on completing the Personal Profile can be found at http://www.nyu.edu/osp/proposal.html • New NIH Terminology …………………………………………………………… 4 • Grants.gov Introduction …………………………………………………………. 5 • PureEdge Software ……………………………………………………………… 6 • Finding and Saving Application Packages ……………………………………. 7 • Preparing Proposals o Mandatory & Optional Documents ………………………………………… 12 SF424 (R&R) ………………………………………………………… 14 PHS 398 Research Plan ……………………………………………. 18 PHS 398 Cover Page Supplement ………………………………… 20 PHS 398 Checklist …………………………………………………… 22 Research & Related Other Projects Information Component ……. 24 Research & Related Senior/Key Person ……………………………26 Research & Related Project/Performance Site Location(s) Component ……………………………………………………….. 28 Research & Related Budget ………………………………………… 29 Research & Related Modular Budget ……………………………… 35 Research & Related Subaward Budget …………………………… 37 PHS 398 Cover Letter ………………………………………………. 39 o Attachments Formatting ……………………………………………………………. 40 Converting Documents to .pdf format ……………………………… 40 • Completion of Documents and Error Checking ……………………………….. 42 • Submission to OSP ………………………………..……………………………. 42 • Post-Submission o Validation (Grants.gov messages, Commons messages) ………………. 44 Errors and Warnings Reviewing compiled proposal Window for corrections o NIH Two-Day Window ……………………………………………………… 44 o Common Errors …………………………………………………………….. 45 o NIH Late Policy ……………………………………………………………... 46 • Subawards ……………………………………………………………………….. 48 DEADLINES The Grants.gov system, particularly as it impacts NIH applications, increases the difficulty of submitting proposals that meet agency deadlines. Additional time has to be built in to the submission process to allow for electronic traffic jams and the timely correction of errors/warnings discovered through the proposal validation process. The following is the minimum deadline schedule for the submission of proposals through the Grants.gov system. Obviously, the greater the time allowed for submission, the less likely it is that problems will arise to impede our ability to meet deadlines. • • Notify OSP of intent to submit at least one full week (five full working days) before agency deadline. OSP must receive a completed proposal shell (all forms, final budget, budget justification) at least 72 hours (three full business days) in advance of the posted deadline. o If the proposal includes a modular budget, OSP requires a full, detailed budget for internal purposes. o Provide Dean’s Office with hard copy of the entire application, along with the original signed synopsis form at least 72 hours (three full business days) in advance of the posted deadline. OSP must receive completed, final, saved, and uploaded version of the PureEdge file no later than one full business day prior to the sponsor due date. o Email entire PureEdge file to osp.proposals@nyu.edu. o The email subject line should read: GG-yourname-sponsor-deadline (in MMDDYYYY format). o Print out all documents and provide OSP with a hard copy of the application, along with a copy of the synopsis form signed by the PI. • WARNING: Proposals retrieved by the NIH Commons from Grants.gov that contain any errors other than system errors must be corrected and submitted prior to the posted deadline for the competition. As the deadline approaches, the lag time between submission and receipt of Grants.gov and Commons messages increases significantly. In some cases, OSP may not be able to view the proposal in Commons to check for errors for up to 48 hours. Consequently, while we do not require that we receive proposals days before the deadline, it is in your best interests to get a proposal to OSP early to ensure that there is sufficient time to submit a proposal that both passes the validation process and meets the deadline. . 2 eRA COMMONS PI/PD Registration • Effective May 10, 2006 an eRA Commons name must be used on all applications submitted to NIH. • If you are not registered, or are already registered as a reviewer but have not registered as a PI, go to OSP’s web site: http://www.nyu.edu/osp/res/ and follow directions. • OSP will set up an eRA Commons account, generally within two business days. • When the account is established, the PI will receive an email from NIH that includes a temporary password and the eRA Commons weblink to access accounts. Access to eRA Commons Principal Investigators can use Commons to maintain their personal profiles, check the status of their proposals, and use eSNAP to submit non-competing continuations for projects that allow SNAP. https://commons.era.nih.gov/commons/ 3 NEW NIH TERMINOLOGY NIH Term (old terminology) PA and/or RFA Principal Investigator (PI) Authorized Signing Official (SO) Other Support New Competing Continuation Revision or Amendment Competing Supplement Literature Cited (Part G of PHS 398 Research Plan) Consortium Budget Electronic Submissions Term (new terminology) Funding Opportunity Announcement (FOA) PI/PD: combined term Principal Investigator/Project Director Authorized Organizational Representative (AOR) Current & Pending Support New (same) Renewal Resubmission (equivalent to Revision) Revision Bibliography & References Cited Subaward Budget Definitions • New – An application that is being submitted to an agency for the first time. • Resubmission – An application that has been previously submitted, but was not funded, and is being resubmitted for new consideration. • Renewal – An application requesting additional funding for a period subsequent to that provided by a current award. A renewal application COMPETES with all other applications and must be developed as fully as though that applicant is applying for the first time. • Continuation – A non-competing application for an additional funding/budget period within a previously approved project period. • Revision – An application that proposes a change in: o The Federal Government’s financial obligations or contingent liability from an existing obligation*, or o Any other change in the terms and conditions of the existing award. *A supplement, for example, increases the Federal Government’s financial obligation in relation to the award that is being supplemented. 4 INTRODUCING Grants.gov is the single cross-agency, web-based US government portal for accessing federal GRANT programs (not contracts). It provides 1) information on all grant opportunities, 2) a mechanism to obtain and complete the forms related to a specific opportunity, and 3) a portal through which institutions transmit the application packages to the sponsoring agency. Ultimately, all federal grant opportunities will be submitted through Grants.gov. Principal Investigators, departmental administrators, and anyone assisting with the preparation of grant proposals need to become familiar with using Grants.gov. More detailed guidance is available through the Grants.gov web site, which provides a user guide, tutorials, and demonstrations: http://www.GRANTS.GOV/CustomerSupport. A step-by-step overview can be found on the OSP website: http://www.nyu.edu/osp/guideGrantsGov.pdf Individual federal agencies are gradually developing their own user manuals to guide applicants through the proposal development process. The URL for the NIH manual, which is updated relatively frequently, is: http://era.nih.gov/ElectronicReceipt/training.htm. GRANTS.GOV 5 PureEdge SOFTWARE • • PureEdge software is required for the preparation and submission of proposals through Grants.gov. Installation of PureEdge is required on each computer that will be used to create Grants.gov proposals. It was created for use with PCs. Although Mac users can now use Virtual PC that Microsoft bundled with Office 10 professional, OSP strongly recommends that proposals be developed on a PC for the present. PureEdge software is available at no cost on the Grants.gov website. Download Instructions o Go to the Download Application Viewer screen at http://www.grants.gov/DownloadViewer. o Review system requirements. o Scroll down to the section Downloading and Installation and follow directions. • • Download PureEdge Viewer 6 FINDING AND SAVING APPLICATION PACKAGES Using the NIH OER Website Since NIH uses multiple Catalog of Federal Domestic Assistance (CFDA) numbers, it is easier to locate Funding Opportunity Announcements (FOs) on the NIH Office of Extramural Research (OER) home page. • • • Go to: http://grants1.nih.gov/grants/oer.htm Select Funding Opportunities (RFAs, PAs). Click on Program Announcements (PAs) link. 7 • • Click on column headers to sort results. Locate the program to which you wish to apply and click on the announcement number to open it. Scroll down the page until you see the Program Announcement number again. You will see a button that says Apply for Grant Electronically . 8 Getting the Application Package from Grants.gov • Clicking on the “Apply” link takes you into Grants.gov • Click on “Download” • Where Version 2 forms are an option, select these. Register here for FOA updates Click here to download NIH instructions Click here to download application package • Register for updates to the FOA: enter email address to be notified of any changes to the solicitation, deadline date, or other important information regarding this solicitation. 9 • Download Instructions: always check the guidelines for additional requirements and variations from directions about page limits, attachment placement, etc. o NOTE: For step-by-step NIH instructions for completing proposal packages, use the most current version of the SF424 (R&R) Application Guide: http://era.nih.gov/ElectronicReceipt/training.htm Download Application Package o PureEdge must be installed on your computer before you download the package. o You will be prompted to answer “Yes” or “No” to display non-secure items. Click “Yes” to display. Saving the Application Package to your Computer • To save the application package to your computer, click on the SAVE button near the top of the screen. • The first time you save, you will receive a warning message stating that the form contains an invalid value. Click “YES” to ignore message. • Create a file name to make it easy to find the package when you want to use it. • Allow sufficient time for the package to save. This may take up to a full minute. • Do not work on the package while you are in the browser. Your work may not save correctly. 10 Save button 11 Completing Application Documents - Mandatory & Optional Documents • • • Certain fields in the Mandatory & Optional Documents sections are automatically populated based on the FOA. IMPERATIVE – read the FOA to verify that the specific documents required are included in the application package and to identify the ones that must be used. Each announcement will have specific forms requirements: – Example: Certain FOAs require the use of the PHS 398 Modular Budget forms; others require the use of the full Research & Related Budget pages, which are also included under the Optional Documents, even though one or the other budget set is mandatory in the full proposal. Mandatory Documents • Open and complete all the Mandatory Document forms. These generally include: – SF424 (R&R) – PHS 398 Research Plan – PHS 398 Cover Page Supplement – PHS 398 Checklist – Research & Related Other Project Information – Research & Related Senior/Key Person – Research & Related Project Performance Site/Location • Once the documents are completed, move the documents to the Mandatory Completed Documents section on the right. Automatically populated from the PA/RFA/FOA Mandatory fields within forms are yellow until filled 12 Optional Documents • Open and complete the Optional Document(s) forms needed for your application. Read the FOA to determine which budget forms are required. Select from: o Research & Related Budget o PHS 398 Modular Budget o Research & Related Subaward Budget • PHS 398 Cover Letter File Forms Navigation • To open either Mandatory or Optional Documents (forms), highlight the form name, then click on the “Open Form” button immediately under the Mandatory Documents or the Optional Documents box. • Navigation buttons are found at the top of multi-page forms. • Click the “Next” tab to move to succeeding pages. • Click the “Previous” tab to go back to previous page. • Click the “Close Form” tab once the form is completed. • Save the entire package each time you close a form. Application Filing Name • Unless instructed otherwise by the FOA, the Application Filing Name field should be completed as follows: [PI last name]-[sponsor acronym]-[deadline mmddyyyy]-[projects officer initials] Example: Smith-DARPA-10012006-SB 13 COMPLETING THE SF424 R&R COMPONENT The SF424 (R&R) is the first form that should be completed. This form populates fields on all other forms. NOTE: required fields are Yellow • Item 1: Type of Application: PreApplication, Application, or Changed/Corrected Application. Changed/Corrected Application is used only if proposal has to be resubmitted because of errors or warnings. Item 2: Date Submitted: Enter the date the application is being submitted Item 3: Leave this item blank Item 4: Federal Identifier: NEW APPLICATIONS: LEAVE THIS FIELD BLANK. If this is a continuation, revision, or renewal, enter the assigned federal award number Item 5: Applicant Information: The Applicant Organization, not the PI/PD o Legal Name (in caps): NEW YORK UNIVERSITY o Organizational DUNS: 041968306 (add four zeros at the end) o Department: Office of Sponsored Programs o Division: o Street 1: 15 Washington Place, 1-H o City, County, State, Zip: New York, NY, NY 10003 Item 6: Employer Identification: 135562308 (Nine digits only) Item 7: Type of Applicant : L: Private Institution of Higher Education Item 8: Type of Application: New, Resubmission, Renewal, Continuation, Revision o New - an application being submitted to an agency for the first time o Resubmission - an application previously submitted, but not funded, being resubmitted for new consideration o Continuation - a non-competing application for an additional funding/ budget period within a previously approved project o Revision - an application that proposes a change Item 9: Name of Federal Agency - This field is pre-filled. Item 10: CFDA Number: When field is blank, leave it blank. (Field may be blank if you are applying to an opportunity that references multiple CFDA numbers.) Item 11: Descriptive TITLE of your Project: Enter a brief descriptive title of the project (maximum of 81 characters). • • • • • • • • • • 14 • • • Item 12: Areas Affected By Project: List only the largest political entities affected by the project OR enter “N/A” for not applicable. Item 13: Proposal Project - Start Date and Ending Date: enter project beginning/end dates. Item 14: Congressional Districts of Project o Enter the Congressional District of the primary project site. o (a) Applicant – 8th; (b) Project – 8th Item 15: PI/PD CONTACT INFORMATION: This is information about the PI/PD. Item 16: ESTIMATED PROJECT FUNDING o Total Estimated Project Funding o Total Federal & Non-Federal Funds o Estimated Program Income Item 17: Unless the FOA directs otherwise, check “No, Program is not covered by E.O. 12372” for NIH and other PHS agencies. Item 18: Check the “I agree” box to provide the required certification by PD/PI. Item 19: AUTHORIZED REPRESENTATIVE o Enter: Richard L. Louth, Director, Office of Sponsored Programs Item 20: Pre-application o Do not check pre-application box unless specifically noted in FOA o NIH and other PHS agencies do not use Pre-applications. • • • • • • 15 Complete both pages, then close Click here to move to page 2 of the form 16 17 COMPLETING THE PHS 398 RESEARCH PLAN COMPONENT NOTE: required fields are Yellow • • Item 1: Application Type: This section is repeated from the SF 424 (R&R) Cover Page and PHS398 Checklist Item 2: Research Plan Attachments: Separate .pdf attachments for each section. OSP strongly recommends that the Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods be prepared as a single document to ensure that the page limitations are met. Then convert the sections into and uploaded as separate .pdf documents. Follow the formatting requirements used in the PHS 398 regarding page limits, type font/size, margins, etc. o Introduction to Application (for Resubmission or Revision ONLY) o Specific Aims o Background and Significance o Preliminary Studies/Progress Report o Research Design and Methods Human Subjects Section: o Protection of Human Subjects o Inclusion of Women & Minorities o Targeted/Planned Enrollment Table o Inclusion of Children o Data and Safety Monitoring Plan Other Research Plan Sections o Vertebrate Animals o Select Agent Research o Multiple PI Leadership Plan – currently applies only to certain RFAs o Consortium/Contractual Arrangements o Letters of Support o Resource Sharing Plan(s) Appendix: Allows up to 10 separate attachments • • • NOTE: All attachments must be in PDF. 18 19 COMPLETING THE PHS 398 COVER PAGE SUPPLEMENT NOTE: required fields are Yellow • Item 1. Project Director/Principal Investigator o PI Name, Title, Address, etc are pre-filled. o New investigator Yes/No Question: You are a new investigator if you have not previously served as a PI on any PHS supported research project (other than an R03, R15, R21, K01, K08, K12). o Degrees Item 2. Human Subjects Item 3. Applicant Organization Contact Item 4. Embryonic Stem Cells • • • PI/PD name automatically fills from SF424 (R&R) 20 21 COMPLETING THE PHS 398 CHECKLIST COMPONENT • • • • Item 1. Application Type o Federal Identifier is only required if this is not a first-time submission. Item 2. Change of Investigator / Change of Institution Questions Item 3. Inventions and Patents (renewal applications only) Item 4. Program Income o It is highly unlikely that an NIH proposal would generate program income. 22 23 COMPLETING THE RESEARCH & RELATED OTHER PROJECT INFORMATION • Item 1. Human Subjects o Click “YES” if human subjects are planned at any time during the proposed project at any performance site. o Click “NO” if no activities involving human subjects are planned. o If IRB review is pending or not yet submitted, click the “Yes” box. Otherwise, click the “No” box. o NOTE: Depending on the type of application submitted, the IRB Approval Date may not be required at the time of submission. This may be requested later in the pre-award cycle as a Just-in-Time (JIT) requirement. o Enter the 8-digit number of NYU’s approved Federal Wide Assurance (FWA). DO NOT ENTER the letters FWA before the number. Item 2. Vertebrate Animals o Click “Yes” if activities involving vertebrate animals are planned at any time during the proposed project at any performance site. Click “No” is no activities involving vertebrate animals are planned. o If IACUC Approval Date is pending, click the “Yes” box. Otherwise, check the “No” box. o IACUC Approval Date is not required at the time of submission. This may be requested later in the pre-award cycle as a Just-in-Time (JIT) requirement. Item 3. Proprietary/Privileged Information o Patentable ideas, trade secrets, privileged or confidential commercial or financial information, disclosure of which may harm the applicant, should be included in applications only when such information is necessary to convey an understanding of the proposed project. Item 4. Impact on the Environment o Unless a specific FOA indicates that the National Environmental Policy Act (NEPA) applies, applicants should check “NO”. o If “Yes” explain in box 4.b. Item 5. Activities outside the US or partnership with International Collaborators o If your project involves activities outside the United States or partnerships with international collaborators, check the “Yes” box and then explain in box 5.b. Otherwise, check the “No” box. o If “Yes”, enter the countries. Item 6. Project Summary/Abstract: Description of the project, informative to other persons working in the same or related fields. Maximum of 30 lines. • • • • • 24 • Item 7. Project Narrative: Use no more than two or three sentences to describe the relevance of this research to public health. Use plain language that can be understood by a general, lay audience. DO NOT ATTACH THE RESEARCH PLAN HERE. Item 8. Bibliography & References Cited (Previously called Literature Cited) Item 9. Facilities & Other Resources (Previously called Resources & Environment) Item 10. Equipment: List major items of equipment already available for this project, identify location and pertinent capabilities. Item 11. Other Attachments o Provide any other project information not provided above IN ACCORDANCE with the announcement and/or agency-specific instructions. o Do not include appendices in this section • • • • 25 COMPLETING THE SENIOR/KEY PERSON PROFILE COMPONENT • Start with the PD/PI PROFILE (Project Director/Principal Investigator) o The following fields are automatically populated: Prefix, First Name, Middle Name, Last Name, Suffix Position/Title Department Organization Name Division Street 1, Street 2 City, County, State, Zip Code, Country Phone Number, Fax Number, E-Mail o Credential, agency login - this is your ERA Commons name. It is a mandatory field. o Project Role - select a project role from the list. Select “Other” if an appropriate role is not listed. o Other Project Role Category: If Senior/Key Person is not a Co-Investigator, select “Other Professional” or “Other” as a project role. Example: Other Professional could be a Project Coordinator/Data Manager/Postdoc Fellows, etc. o Attach Biographical Sketch (four page limit, includes the table at the top of the first page). Document should include: Positions and Honors Selected peer-reviewed publications or manuscripts in press (chronological order) Research Support – ongoing and completed (during the last three years) research projects (Federal and non-Federal support). DO NOT CONFUSE RESEARCH SUPPORT WITH OTHER SUPPORT. Other support for most applications, will continue to be a Just-In-Time (JIT) submission. List remaining Senior/Key individuals in alphabetical order. Also use this section to list any “Other Significant Contributors (OSCs). List OSCs after ALL Key Persons have been listed. o Definition of Senior/Key Person: Key Personnel are individuals who contribute to the scientific development or execution of the project in a substantive, measurable way, whether or not salaries are requested. Biosketch, including Research Support information, is required. o Definition of OSC: Individuals who have committed to contribute to the scientific development or execution of the project, but are not committing any specified measurable effort to the project. Typically “zero percent” effort or “as needed”. (Consultants, if they meet the definition; also, appropriate designation for mentors on Career awards). NOTE: As of August 1, 2006, Version-2-Forms for the Research and Related Senior/Key Person Profile Form Issue does not allow attachments for Additional Senior/Key Personnel when there are more than eight names. A workaround until this problem is resolved can be found at http://grants.nih.gov/grants/guid/notice-files/NOTOD-06-087.html • • • 26 PI information prefilled from SF 424 Biographical Sketch in PDF is attached here Enter Commons User Name here. This is a critical field. 27 COMPLETING THE R&R PROJECT/PERFORMANCE SITE LOCATION(S) COMPONENT • • • Project/Performance Site Primary Location: Complete this section for the Primary Location Form collects individual data for up to 8 locations To add additional Project/Performance Site Location, click “Next Site” 28 COMPLETING THE RESEARCH AND RELATED (NON-MODULAR) BUDGET COMPONENT General Information • There are three separate screens for each year. To navigate between screens click/use “Previous” and “Next” buttons at the top of the forms. o Sections A and B (Personnel) o Sections C through E (Equipment, Travel, Participant/Trainee Support Costs) o Sections F through K (Other Direct Costs, Indirect Costs, Total Direct & Indirect Costs, Budget Justification) • The SF 424 R&R component must be completed before you can enter data into the fields on this form. • You must complete each year, in sequence and including the budget justification, before you can proceed to the forms for the next year. • Each year of support must have a separate detailed budget. • A cumulative budget for the total project period will be generated as you enter information for each year. NOTE: required fields are Yellow Top of Form: Information captured from SF 424 R&R • • • • Organizational DUNS: Pre-filled item Budget Type: check the appropriate box Name of Organization: NEW YORK UNIVERSITY – pre-filled Start Date and End Date must be entered for each budget period. Research & Related Budget – Section A • Senior/Key Person (Spaces for eight individuals. If more than eight, attach additional budget page which includes all required information: o Name o Project Role o Base Salary o Person Months o Requested Salary 29 • • o Fringe Benefits o Funds Requested (NOTE: information for the PD/PI must be entered) Effort is calculated by Academic Months (Acad) and/or Summer Months (Sum) for nine-month appointments. Effort is calculated by Calendar Months (Cal) for 11- or 12-month appointments. Research & Related Budget – Section B • Other Persons: Postdoctorals, Graduate Students, Undergraduates, IT Professionals, Program Coordinators, Project Manager, Laboratory Technicians, etc. (captures the number only) o Number of Personnel – BY PROJECT ROLE. If there several people with the same project role, capture all individuals in one line item under the specified role. Example: two data managers/coordinators, two IT professionals, etc) o If the project role is other than PostDoc or students, enter the appropriate role in the blanks. o Person Months: enter the number of months devoted to the project for each project role category. If two individuals for one project role were requested, enter the total number of months devoted to the project for both individuals. o Requested Salary: regardless of the number of months devoted to the project, indicate only the amount of salary requested for each project role. o Fringe Benefits o Do not include consultants in this section. 30 Research & Related Budget – Section C • Equipment Description o Allows itemization of up to 10 items o Identified as an item of property >$3,000 and an expected service life of more than one year, Includes shipping and maintenance costs and agreements o Item 11. Total – enter the total funds requested if requesting >10 items of equipment. o Justify all requested equipment items in budget justification Research & Related Budget – Section D • Travel o Domestic o Foreign o Total Travel: field will calculate automatically o Justify in budget justification (purpose, destination, numbers of individuals for each trip, estimated length of trip) Research & Related Budget – Section E • Participant/Trainee Support Costs o Do not use unless NIH specifically notes this section in an announcement. o Tuition Remission should be included in Section F “Other Direct Costs”. Research & Related Budget – Section F • Other Direct Costs o Materials and Supplies o Publication Costs o Consultant Services o ADP/Computer Services o Subawards/Consortium/Contractual Costs o Equipment or Facility Rental/User Fees o Alterations and Renovations o Other (example: Patient care & tuition remission). If requesting inpatient and outpatient costs, use a blank field to separate each cost) o Blank Fields for items not listed above Research & Related Budget – Sections G, H, I, J, and K • Section G. Direct Costs • Section H. Indirect Costs o All federal sponsored research indirect costs rates are Modified Total Direct Costs (MTDC). o Cognizant Federal Agency: DHHS – Robert I. Aaronson – 212-264-2069 • Section I. Total Direct and Indirect Costs • Section J. Fee – not applicable • Section K. Budget Justification o ONLY ATTACH ONE FILE o Provide information requested in each budget category to support your budget request 31 o Use this section to also list the names, roles, months, salary and fringe included in budget section B. 32 33 Additional Budget Periods • If you are requesting funds for more than one budget period, click the “Next Period” button at the top of the 3rd budget screen (Sections F through K). • You must complete all the required information (highlighted files and noted with an “*”) before the “Next Period” button is activated. • If no funds are requested for a required field, enter “0”. A Cumulative Budget is automatically generated as each budget period is completed. 34 COMPLETING THE PHS 398 MODULAR BUDGET COMPONENT Modular Budget Period 1 – Sections A, B & C • Budget Period: 1 – Start Date and End Date • Section A - Direct Costs – Direct Costs Less consortium F&A – Consortium F&A – Total Direct Costs • Section B - Indirect Costs – Indirect Cost Type: MTDC (Modified Total Direct Costs) – Indirect Cost Rate (%) – Indirect Cost Base ($) Direct costs less exclusions (i.e., tuition, facility rental, patient care costs, subcontract costs over $25,000, etc) – Funds Requested – Cognizant Agency Name/Contact: DHHS Division of Cost Allocation and Liaison, Robert I. Aaronson, 212-264-2069 – Indirect Cost Rate Agreement: June 1, 2006 • Section C - Total Direct and Indirect Costs (A+B) (of Budget Period 1) Enter cognizant agency information for each budget year Modular Budget Period 2 – Sections A, B & C • Follow steps in Budget Period 1 for all out years of your project. • Budget Justification PDF text attachments for Personnel, Consortium and Other 35 Modular Budget Periods 3, 4, & 5 – Sections A, B & C • Click “Next” at the top of pages 1 and 2 to go to form pages for periods 3 and 4 and period 5 Cumulative Budget and Budget Justification (bottom of page 3 of Modular Budget form) • Cumulative budget is system-generated. • Budget justifications are entered as .pdf attachments. o Personnel justification o Consortium justification o Additional Narrative justification (for capital equipment items and other unusually large expenditures, for explanation of uneven number of modules). 36 COMPLETING THE RESEARCH & RELATED SUBAWARD BUDGET To other institutions when NYU is the prime applicant • PI from applicant organization (prime): o Select the Subaward Budget Attachment Form from the Optional Documents in the Grant Application Package. o Open the form, and click the “Click here to extract the R&R Subaward Budget Attachment” button in the middle of the form. o Save the file using the first 10 letters of the consortium organization’s name as the file name and leave “.xfd” as the file extension. (The extracted file is a PureEdge document.) o Send the form as an Email attachment to the consortium PI. Note: Consortium partners must install PureEdge Viewer before they can complete the form. • Consortium partner completes all the budget information. o Organizational DUNS and Name of Organization fields must reflect that of the subaward/consortium grantee. o Instruct consortium members to save after each year is completed. o Consortium members should click the “Check form for Errors” button after entering budget information. o The consortium grantee emails the following back to NYU PI: Budget file in .xfd format. Budget justification file in .pdf format o PI receives .xfd budget file and attaches the consortium grantee’s budget file to the “Subaward Budget Attachment Form.” o Budget Justification of consortium institution is uploaded as part of the NYU justification in the Research and Related Budget form. If NYU is submitting a modular budget, the Subaward Budget Attachment form is not included in the application package, but is retained by NYU. Click here to extract the R&R Subaward Budget Attachment 37 Use the consortium member’s name as the file title when Check for errors Save Consortium DUNS number Subaward/Consortium 38 COMPLETING THE COVER LETTER COMPONENT • • • Provides a text attachment for a cover letter. Instructions to applicant remain the same as in the PHS 398 Required when submitting a Changed/Corrected Application o If revising the cover letter for a Changed/Corrected application, include all previous letter text. Upload here 39 PREPARATION OF PROPOSAL ATTACHMENTS Formatting Requirements • All attached files must be in Portable Document Format (.pdf format). o OSP recommends that documents be converted to .pdf using the full Adobe Acrobat package. o ALWAYS check converted documents after uploading and after they are received by Commons. It is not unusual for .pdf documents to be corrupted or to disappear altogether in the submission process. • Formatting Specifications o Font: Arial, Helvetica, Georgia, Palatino Linotype - No other fonts are acceptable o Size: must be 11 points or larger No more than 15 characters per inch; no more than 6 lines/inch Black font color for text 8 ½ x 11 paper, ½” margins on all sides o NO HEADERS, FOOTERS, or PAGE NUMBERS o Figures, Graphics, Charts, Tables, etc Color can be used in figures; however all text must be in black. Text may be a smaller type size but must be in black font color. o Page Limits: same as previous NIH 398 applications; limits specified in PA or RFA take precedence over PHS 398 instructions. Converting MSWord Documents to .pdf Files (requires Adobe Acrobat) • To convert a text file to an Adobe .pdf file, click on File/Print on the toolbar. • Select printer: choose Adobe PDF. Click OK. • Select the directory on your computer where you want to save the .pdf file and enter the file name. Do not include unusual characters, symbols, or spaces in naming the file. Click Save. • Dialog box will show progress of conversion. 40 Select directory Name file 41 COMPLETION OF DOCUMENTS AND ERROR CHECKING When all documents have been completed, move documents from the left-hand boxes to the corresponding right-hand box. Highlight the filename and click on the “Move Form” button with the right-pointing arrow: Move documents from here To here Check the entire application package for Grants.gov errors by clicking on the “Check Package for Errors” button. The total number of errors will be shown, but errors must be viewed and corrected one-ata-time. 42 Save the entire package when all errors have been corrected. SUBMISSION TO OSP • • Send the entire electronic application to osp.proposals@nyu.edu as an email attachment. The email subject line should read: GG_yourname_deadline (in MMDDYYYY format). OSP will review the application as usual. If corrections/changes are required to attachments, OSP will notify you to make corrections to the original documents, upload them to the appropriate application form and re-send the complete file to OSP. Note that ONLY OSP, as the authorized office (AOR), can submit the proposal to Grants.gov. Proposals will be submitted after OSP receives chair/dean approvals and after appropriate review and corrections have been made. • 43 POST-SUBMISSION Validation • After OSP submits a proposal to Grants.gov, Grants.gov responds with a series of four validation messages. o We got it – this has the application filing name, PI name and tracking number. o It’s OK – if there are errors, such as incorrect DUNS number, they will be explained in this message. Tracking number the only identifier. o We sent it to the sponsor. Tracking number the only identifier. o The sponsor got it. Tracking number the only identifier. • Once the application has cleared Grants.gov, it goes into the NIH Commons, where it undergoes the NIH validation process. Another series of messages is generated. • We do not know who this is for: no credential (Commons username) OR We got it and know whose it is, but it has errors/warnings. To correct credential error, go to Key Persons and enter the PI’s Commons user name Proposals with error messages will not go on to the review process. Go into Commons to find the errors, fix them in the original PureEdge file on your computer, change the box on the 424R&R cover to reflect that this is a changed/corrected submission, and re-send it to OSP to resubmit. Warnings will not keep a proposal from passing on to review, but if you want to correct them, follow the same process as for errors. • It has no errors (maybe warnings, but these don’t hold up review). Go to Commons and check the proposal to see if it’s been compiled correctly. If it is OK, do nothing, and the proposal will pass to review in two days. If not, reject and send a new copy. Only OSP can reject the proposal. The NIH Two-day Window Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and OSP have two business days* to view the application image. *A business day is any Monday through Friday. Business days include holidays that fall on a weekday. • If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral after two business days. • Prior to the submission deadline, OSP can “Reject” the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if OSP determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission. • If the two-day window falls after the submission deadline, OSP will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., • 44 • • some part of the application was lost or didn't transfer correctly during the submission process). OSP must first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue. If OSP chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment. Both OSP and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days. Common Errors 1. Most common error: failure to include the Commons username. This gets entered, in caps, in the field labeled “Credential, e.g. agency login:” on the Senior/Key Personnel form. 2. Second most common error: typo in the DUNS number. It’s 0419683060000. Do not use dashes. 3. PDF issues: NIH only accepts attachments in PureEdge or PDF format. Do not submit attachments in other formats such as Microsoft Word, Word Perfect, etc. Do not put special characters in file names. Disable all security features in the PDF document. Turn the "signature" off when you create original documents. Do not send PDF documents with editable fields (fields that can be changed). If you are having trouble fixing the PDF settings, simply cut and paste from the PDF document into a Microsoft Word document and then reconvert. One of the PDF tools that have been working without issue for most applicants is CutePDF. Note: NIH had previously suggested that applicants not use active links in PDFs. NIH has since addressed the issue and applicants can now include active links in PDFs. 45 NIH Policy on Late Submission of Grant Applications Notice Number: NOT-OD-06-086 Release Date: August 11, 2006 This notice provides an update and further clarification of the policy published on January 27, 2005 (Notice OD-05-030). The new dates for AREA applications are included as is information about the New Investigator Pilot. Further details about the process of accepting late submissions are provided. NIH expects that grant applications will be submitted on time. Standing dates are listed at: http://grants.nih.gov/grants/funding/submissionschedule.htm. • • • For applications that are required to use paper format these are submission or postmark dates; applications are on time if they are sent on these dates. For applications that are required to use electronic submission this requires successful submission to Grants.gov by 5 p.m. local time on the date indicated. For both paper and electronic submissions, when these dates fall on a weekend or holiday, they are extended to the next business day. However, Requests for Applications (RFAs) and Program Announcements with Special Referral Considerations (PARs) with special receipt dates always must be received (by Grants.gov for electronic applications and the Center for Scientific Review for paper applications) on the dates designated in the announcement to be on time. This is clearly noted in the website above and in the text of each RFA/PAR. The long standing NIH policy on late applications is stated in the application instructions. Late applications are generally not accepted. Permission for a late submission is not granted in advance. In rare cases, late applications will be accepted but only when accompanied by a cover letter that details compelling reasons for the delay. While the reasons are sometimes personal in nature, an objective evaluation of their merit requires that some details be provided. It is not sufficient, for example, to state simply that there has been an unforeseen circumstance that delayed submission. Specific information about the timing and nature of the cause of the delay is necessary so that a decision can be made. Only the explanatory letter is needed; no other documentation is expected. NIH will consider accepting late applications based on the acceptability of the explanation and the processing time required for two different kinds of submission dates: • Regular Standing Submission Dates: January 10, February 1, February 25, March 1, May 10, June 1, June 25, July 1, September 10, October 1, October 25, November 1. Applications must be received at the NIH within two weeks of the standing submission date. 46 • Expedited Standing Submission Dates: April 1, April 5, April 15, May 1, August 1, August 5, August 15, September 1, December 1, December 5, December 15, and January 2. Applications must be received at the NIH within one week of the standing submission date. The windows of time for consideration of late applications have been carefully chosen so that the late applications can be processed with the cohort of on-time applications. In all cases, when the regular standing submission date or expedited submission date falls on a weekend or federal holiday and is extended to the next business day, the window of consideration for late applications will be calculated from that business day. Note that the late window always ends in a receipt (not submission) date for both paper and electronic applications. NIH will not consider accepting late applications for the Special Receipt Dates for RFAs and PARs. This includes the special receipt dates (March 20, July 20, and November 20) for resubmission/amended applications that are part of the New Investigator Pilot (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-060.html). NIH will consider all late applications received within the window of time specified above but will not automatically accept all of them. The reasons for the delay will be carefully considered by the Division of Receipt and Referral at the Center for Scientific Review and a decision made. In unusual cases the reasons provided will be considered by senior staff of CSR; Institutes/Centers will be consulted for applications that are their review responsibility. Applications submitted within the window with reasons that are not found to be acceptable will be returned without review. NIH does not expect to accept any applications received beyond the window of consideration. In the past, late applications have been accepted for reasons such as: death of an immediate family member of the Principal Investigator, sudden acute severe illness of the Principal Investigator or immediate family member, or large scale natural disasters. Recent service by the Principal Investigator only (this does not include other participants in the application) on an NIH extramural review group that could reasonably be expected to require a time commitment that could have been used to prepare an application is also an allowable reason. Note this applies only to NIH extramural review activities, not those of other Federal agencies or private organizations. Examples of reasons that have not led to the acceptance of a late application are: heavy teaching or administrative responsibilities, relocation of laboratory, health problems, personal events, or review service for participants other than the principal investigator, attendance at scientific meetings, or having a very busy schedule. It is important to emphasize that these various examples are just that, examples. No NIH staff member whether in the Center for Scientific Review or any of the other Institutes/Centers has the authority to give permission in advance for a late application. Contacting the Division of Receipt and Referral or any other component of the NIH will not lead to either permission to submit late or an evaluation of the acceptability of the reasons for a delay. 47 REQUIRED ITEMS FOR SUBAWARDS • NYU as Prime Applicant (in addition to NYU proposal & synopsis) – Subawardee scope of work – Subawardee budget (full detailed budget if modular) – Consortium agreement letter signed by subawardee’s authorized official/individual (email, scanned letter, etc) NYU as Subawardee – Signed synopsis form – Scope of work – NIH budget page(s) (full detailed budget if modular) – NYU Cooperating Institution form (NIH) http://www.nyu.edu/osp/proposal.html – Copy of full proposal submitted by the prime (after submission if necessary) • 48