Submitting & Managing Complex Awards

1. Submitting & Managing Complex Awards Sponsored Projects Symposium III February 18, 2010 Presented by: Lorrie Awoyinka & Lori Wallin

2. What Will Be Covered: • What are complex proposals/awards? • Proposal Preparation and Processing • Award Acceptance and Set-Up • Post-Award Management

3. What Are Complex Awards? Complex awards are large, often multi-investigator, multi-site, research, training, or procurement activities that are funded under grants, contracts or cooperative agreements.

4. Common Features • Multiple Principal and Co-Investigators • Multiple Projects/Cores • Multiple Departments/Colleges • Multiple Institutions (thus subawards, IP & security plans) • Large dollars (typically >$500K per year) • Contain Governance Plan, Steering Committees, Internal and External Advisory Committees, Some with agency involvement

5. Examples Multi-site clinical trials/networks (NIH) Interdisciplinary training grants (NIH, NSF) Center grants (some with re-granting funds) Clinical & Translational Science Awards (NIH) Sea Grant (NOAA) Large contracts (DOD, NIH, CDC, etc.) Title VI Centers (US Dept of Ed) Program project grants (NIH, JDRF, ACS, others) Core facility grants (CMRR) Infrastructure grants Construction grants

6. Proposal Preparation and Processing • Reviewing the RFA/RFP • Preparing to prepare the proposal • Preparing the proposal • Cross-checking for errors • Proposal submission • Proposal routing from (PRF) requirements • Submitting to SPA and sponsor • SPA review

7. Reviewing the RFP/RFA Pay particular attention to: • Award mechanism (i.e., co-op agreement, PPG, federal contract) • One-time RFA or multiple receipt dates? • Limited submissions? (determine coordinating office at UMN) • http://www.collaborate.umn.edu/explore/external_coordinated_funding.cfm • Total funding available and funding limitations • direct or total cost limits? with or without sub F&A? • inflation limits • budget category limits, salary limits • Multiple PIs allowed? Collaborative awards or subs required?

8. Reviewing the RFP/RFA Pay particular attention to: Allowable and unallowable costs F&A allowability or limitations Cost sharing and matching requirements Resource sharing plans required (data, biologicals, software) Proposal preparation instructions (read RFA and instructions cover to cover first time for overall understanding) Make no assumptions

9. EXAMPLE—MECHANISM OF SUPPORT AND DATES Part I Overview Information Department of Health and Human ServicesParticipating OrganizationsNational Institutes of Health (NIH), (http://www.nih.gov)Components of Participating OrganizationsNational Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)Title: Case Ascertainment to Estimate the U.S. Prevalence of Fetal Alcohol Spectrum Disorders in Young Children (U01) Announcement TypeNewRequest For Applications (RFA) Number: RFA-AA-10-005Catalog of Federal Domestic Assistance Number(s) 93.273 Key Dates Release Date: October 23, 2009Letters of Intent Receipt Date: November 22, 2009Application Receipt Date: December 22, 2009Peer Review Date: March-April 2010Council Review Date: May 2010.Earliest Anticipated Start Date: July 2010Additional Information To Be Available Date (Url Activation Date): Expiration Date: December 23, 2009

10. EXAMPLE—FUNDING AMOUNTS AND PROJECT PERIOD Executive Summary Purpose. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks grant applications from institutions that propose to determine within defined geographical areas of the U.S. a prevalence rate for fetal Alcohol spectrum disorders (FASD), including fetal alcohol syndrome (FAS), partial FAS and alcohol-related neurodevelopmental disorders, among young children in the United States. …… Mechanism of Support. This FOA will utilize the cooperative agreement (U01)grant mechanism . Funds Available and Anticipated Number of Awards. Depending on the availability of funds and the number and quality of applications received, a total of $2 million is to be awarded and one to three awards are anticipated. Budget and Project Period.The total project period for an application submitted in response to this funding opportunity may not exceed five years. Direct costs may range between $500,000 and $1.4 million per yearfor a five-year period. Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply. Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application Number of Applications.Applicants may submit more than one application, provided they are scientifically distinct Resubmissions. Resubmission applications are not permitted in response to this FOA. Renewals.Renewal applications are notpermitted in response to this FOA. Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates Application Materials. See Section IV.1 for application materials. Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

11. EXAMPLE—MECHANISM DETAILS, BUDGET FORMAT Part II - Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information 1. Mechanism of Support This funding opportunity will use the Cooperative Agreement (U01) award mechanism(s).The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). This funding opportunity will use a cooperative agreement award mechanism. In the cooperative Agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

12. Section II. Award Information (continued) 2. Funds Available The estimated amount of funds available for support of 1-3 Collaboration on FASD (CoFASP) projects awarded as a result of this announcement is $2 million for fiscal year 2010. Future year amounts will depend on annual appropriations. Applicants may request a project period of up to five years. The direct costs budgeted for each cooperative agreement award may range from $500,000 to $1.4 million per year, depending on the number of final awards made. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

13. EXAMPLE—ALLOWABLE COSTS • Section II. Award Information (continued) • The U01 award will provide support for: • Administrative costs for managing the effort such as salaries for key personnel, travel for key • personnel, equipment, and supplies to support an administrative structure • Research costsfor the conduct of collaborative research projects • Recruitment costsfor study participants and agency referrals • Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004. • NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications • submitted and awards made in response to this FOA.

14. EXAMPLE—COST SHARING/MATCHING • Section III – Eligibility Information • Eligible Applicants • 1.A Eligible Institutions • 1.B Eligible Individuals • 2. Cost Sharing or Matching • This program does not require cost sharingas defined in the current NIH Grants Policy Statement. • 3. Other-Special Eligibility Criteria • Number of Applications. Applicants may submit more than oneapplication, provided they are scientifically distinct. • Resubmissions. Resubmission applications are not permittedin response to this FOA. • Renewals. Renewal applications are not permittedin response to this FOA.

15. Mandatory Cost Sharing Budget Example (15% of Agency Costs)

16. Mandatory Cost Sharing Budget Example (15% of Total Project Costs)

17. Mandatory Cost Sharing Budget Example (Separate Cost-Share Budget)

18. Section IV. Applicant and Submission Information 3. Submission Dates and Times Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A. 3.A. Receipt, Review and Anticipated Start DatesLetters of Intent Receipt Date: November 22, 2009 Application Receipt Date: December 22, 2009 Peer Review Date: March-April 2010 Council Review Date: May 2010 Earliest Anticipated Start Date: July 2010

19. Section IV. Applicant and Submission Information (cont.) 3.B. Sending an Application to the NIH Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail) Bethesda, MD 20817 (for express/courier service; non-USPS service) Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html). At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Abraham Bautista, Ph.D. Director, Office of Extramural Activities National Institute on Alcohol Abuse and Alcoholism National Institutes of Health, DHHS 5635 Fishers Lane, Room 2089 Bethesda, MD 20892

20. MY SHIPPING INSTRUCTIONS FedEx on Thursday, February 26th to arrive Friday morning, February 27th. Place the following label in two places on the outside of each package and one inside: (print 9 labels) RFP No. NHLBI-HB-10-03 NHLBI Production Assistance for Cellular Therapies (PACT) Program – Cell Processing Facilities TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY Receipt Time/Date = Monday, March 2, by 3:00 p.m. EST Photocopy each FedEx label and place inside each package as well. FedEx labels for: Technical Proposal Original plus 2 paper copies (mark each as original or copy, make sure original is on top, easily accessible for date stamping):

21. Section IV. Applicant and Submission Information (cont.) 5. Funding Restrictions All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

22. Section IV. Applicant and Submission Information (cont.) 6. Other Submission Requirements Budget:Investigators should budget for travel to the Washington, DC area to attend twoface to-face Steering Committeemeetings in the first year and one meeting per year for the remainder of the project period. Research Plan Page Limitations All applications and proposals for NIH funding must be self contained within specified page limitations: 25 page limit per CoFASP project and 12 page limit per DACC component. Appendix Materials All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDsin the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html. Do not use the Appendix to circumvent the page limitationsof the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

23. Preparing to Prepare Strategize the process within your department/unit • Who needs to be involved? Roles • What needs to be done? Responsibilities • When? Timeline with firm/enforced milestone-based deadlines

24. Preparing to Prepare Prepare a one-page project description to be used for information sharing and in securing resources/cost-sharing/matching. Be sure to: • List participant names/departments/colleges • Identify academic and financial benefit to department/college/UMN/State of MN/community • Identify interdisciplinarity/multidisciplinarity aspects • Present a basic prioritized budget (including anticipated cost-sharing) • Include an org chart/governance chart • Indicate how the PI and PI’s department will deal with a reduced award or reduced time frame.

25. Preparing to Prepare • With the PI, discuss the project first with immediate division/department head (use draft of one-pager). • Determine PI capability (especially relevant if jr. faculty) • Project must be within the department’s priorities else department head will not be advocate • Determine how this project fits in with other departmental proposals already scheduled • Identify two key support staff • If additional resources/cost-sharing needed, head approaches dean, deans approach VPs/Provosts/President (do not suggest PIs contact any directly) • Contributions are often divided three or more ways.

26. Preparing to Prepare • PI must contact agency program officer to confirm suitability of project and of PI. • Identify similar projects at the UMN already—search for awards by mechanism # (e.g., P50, U54, P01, P30). • Request advice from those PIs, Administrators, and SPA GA of these similar awards. • Ask if PI is willing to share a copy of the successful proposal.

27. Preparing to Prepare • Study ALL terms and conditions, sample contracts/awards (if available) and compliance requirements (including IT security, IP) before beginning preparation. International typically has additional terms. • Discuss these with SPA GA who will forward any questionable terms to OGC and/or OTC as necessary. • For federal contracts, know what the official window is for questions and inform your GA so that questionable terms can be discussed and if necessary, negotiated.

28. Preparing to Prepare • Read ALL review criteria and assist PI to incorporate into the structure of the proposal (use criteria word for word in headings, etc.). • Prepare checklist of review criteria and index reference pages. • Discuss those that are vague with agency contact for clear understanding. • Read RFA and instructions for second time, highlighting major items or items unfamiliar to you. • Mock up a Table of Contents and indicate page # from instructions corresponding to each section as necessary.

29. Example Review Criterion: “Ability to address related biological measures of alcohol effect on the mothers and their children.” Narrative: “Thus, the results of the blood tests proposed above, once analyzed, will clearly allow us to determine whether measure A or measure B provides more accurate information regarding alcohol effect on the mothers and their children, a major review criterion of this RFA.”

31. Index of Review Criteria and Corresponding Pages Adequacy of documentation of the patient population as outlined in supplemental ........................................……………………………………10, 13, 16 Adequacy of ability to implement clinical, biological, or epidemiological studies, based upon links to low and high-risk communities…………………………………………..…………………………………………………………………….…21 Ability to address related biological measures of alcohol effect on the mothers and their children………………………..……………..……………………….18, 19 Ability to address culturally sensitive neuropsychological and psychosocial measures on mothers and their children……….…………………………….34-36 Adequacy of existing collaborative arrangements with communities in which the studies will take place, or plans to develop such arrangements………………………………………………………..…….…………………26, 29 Adequacy of plans for scientific and operational collaboration between the CoFASP and the DACC……………………………………………….……….………………………41

32. Preparing to Prepare • Begin development of timeline (today –> deadline date) • Develop a grid of participant roles and responsibilities; distribute to all and ask for confirmation that each understands • Schedule weekly (adjust as needed) check-ins with PI, Co-investigators and other administrative people (budgeting person). Prepare agenda of discussion and action items and record outcomes. Follow up with summary e-mail to all.

33. Preparing to Prepare • Determine departments, colleges, centers and VP units with participants. Determine who will need biosketches, other support, etc. • Determine the space (and owner of space) to house the project(s) for use in F&A sharing negotiations. • If agency limits F&A to below UM negotiated rate, assure that departments/colleges are aware and willing to accept. • Determine F&A sharing plan (inter and/or intra-collegiate) • Identify resources not in the budget but essential and available, either cost-shared or not (administrative assistance; tuition; equipment (including maintenance; training; shipping; calibration); drugs; data sets; remodeling; travel)

34. Preparing to Prepare F&A Waiver • If TOTAL COST limit PI more likely to request reduction of F&A (they see as flexible) thereby increasing direct costs. • Complex grants by nature require high indirect costs so dept/dean/SPA approval of waiver unlikely. • If waiver pursued, begin immediately with department head/chair who will pursue with dean(s). Process is time consuming (many weeks) and requires much justification, fully-vetted budgets, and agreement among multiple administrative levels. • Must have Plan B in place. Deans and VPs are typically willing to contribute in other ways if project is considered a priority.

35. Preparing to Prepare Budgeting • Request only the most justifiable costs in budget. Use easily-cut items as cost-sharing if necessary. Make it difficult for agency to line-item veto anything. • Justify items in terms of the goals/strategies of each aim and refer to review criteria. • When necessary, provide subawardees a total cost limit rather than a direct cost limit—they can choose to reduce their F&A (or not). • Multiple subs to the same institution are counted separately (and therefore each is assessed F&A on first $25K). • Composite budgets needed for multi-project proposals.

36. As CRIS Clinical Manager, Ms. *** directly supports CRIS goals 1 and 3, the development of a flexible, mobile support structure; … • … . Thus, TTR will help CTS investigators maximize the use of these limited resources. Due to the critical nature of their contributions, the technology experts directly support all TTR goals. … • Pilot grant funding: In support of goal 2 (develop mechanisms to encourage use of methodologies) two $30,000 grants will be awarded semi-annually to CTS investigators (i.e., $120K annually). • … . Specifically, the co-leaders will identify key performance indicators that will be built into the management dashboard (goal 1) and the mechanisms that will feed process activities, outputs and outcomes into the dashboard for efficient tracking (goal 2). Drs. *** and *** will interpret the meaning of collected evaluation data and formally summarize findings on a scheduled cycle (goals 3 and 4). Every three years they will convene and facilitate, via video conferencing, a team of experts who will advise on the quality of research produced under the CTSI in terms of innovation, collaboration, and impact on the field of CTS research (goal 3). …

37. Preparing to Prepare • Resources and Facilities: Identify all facilities that are available and indicate in description how the project would utilize the facility. • Scientific Peer-Review: Identify several faculty colleagues and secure commitments. • Administrative Peer-Review: Identify a senior colleague and secure commitment.

38. Preparing to Prepare • Securing consortia agreements • Securing and determining value of 3rd party in-kind contributions • Business & Industry (e.g., pharmaceuticals) • Individuals • Associations/Foundations

39. Preparing to Prepare • Letters of Support • University Resource Contributors (can be combined in one letter) • State of Minnesota, Political Leaders • Community Partners • Philanthropy • Business & Industry • Letters must be substantive yet concise and describe benefit of project to their area

40. Preparing to Prepare • Contact letter writers early • Follow up with a draft for his/her editing • Request signed .pdf document on their letterhead to be returned by specific deadline. • Send multiple reminders, document conversations (who, when, etc.)

41. Preparing the Proposal • Read the RFA and instructions for the third time (in detail). Make notes on instructions of reminders or questions. • If electronic, are all necessary registrations in place on the agency electronic system (NIH Commons, HRSA Handbooks, NSF FastLane, DOD eReceipt)? • Confirm that you downloaded the correct forms/application package? Check version #s, CFDA#, RFA title, etc. • If electronic (grants.gov in particular) physically confirm that anyone who will have access to the electronic forms has the correct version of software on all of their computers.

42. Preparing the Proposal Must haves: Shared server with automatic daily backup File management system File naming protocol Prepare written instructions and distribute to all with access THESE ARE ESSENTIAL Else you should not be able to sleep at night

43. Example File Management Jones 2009-12-22 NIH U01 JJU01 BiosFinal JJU01BioJones 2009-11-15 JJU01BioWilson 2009-12-01 JJU01 BiosFromThem JJU01 Budget JJU01BudgJust 2009-12-17 JJU01 Letters JJU01LtrBaker 2009-12-01 JJU01LtrSmith 2009-12-18 JW JJU01 Research Plan JJU01Section1 2009-12-20 JJ JJU01Section2 2009-12-17 LW JJU01Section2 2009-12-18 8PM JJ Alternative GrantFinal_ReplacementFinal_ReallyFinal_ReallyReallyFinal_Mondaynight_810PM

44. Preparing the Proposal • Letter of Intent often requires: • Anticipated key personnel (assists review center with potential reviewer list). • Anticipated sites/consortia arrangements • Brief description, potential milestones • How the project is responsive to the RFA • Preliminary budget • Send signed LOI via e-mail (copy self/PI). Request acknowledgement if LOI is mandatory. • Typically LOI is not considered a pre-proposal and typically neither needs to be submitted via SPA. Look for language contrary to this and submit via SPA if an institutional signature is required.

45. Preparing the Proposal Confirm margin and font requirements—check all narrative sections Confirm page limitations (see draft TOC)—literally count the pages Confirm if appendices allowed and if so are there special requirements Other special requirements?

46. Preparing the Proposal Provide all writers with a style guide so that narratives are consistently formatted (define headings, numbering, indenting, use of bold/italics, etc.) Confirm agency naming protocol and format (i.e., .pdf) for attachment files has been followed. If electronic, confirm that size of individual graphics and total file size is within limitations. Check again at actual time of submission.

47. Cross-checking for Errors • Proposal title (check PRF, IRB/IACUC documents, letters, narratives). • Total budget request (check budget pages, cover page, F&A checklist, and PRF) • Budget (manually check all budget periods for each project and composites—including all subs). • F&A-exempt items and F&A calculations on budget (manually check—assure you are aware of how exemptions are calculated).

48. Cross-checking for Errors • Budget justifications (check each against agency requirements. Identify F&A exclusions in budget narrative to assure SPA and sponsor understand.) • Roles (check that roles of participants align with agency definitions (e.g., NIH OSCs)) • Performance site(s) (check that sub sites are properly documented)

49. Cross-checking for Errors Biosketches • Cross-check included biosketches against listing of key personnel (or those that agency requires); do not add any additional • Cross-check biosketch research support section against other support documents, if both included • Cross-check current rank/position on biosketch against budget justification or other forms that identify participants • Check instructions for biosketch format and page limits

50. Proposal Submission PRF completed and fully signed by: • All PIs • All PI departments • All PI deans • All departments of paid or cost-shared personnel • All deans of paid or cost-shared personnel • Directors of facilities that provide non-ISO services (e.g., CTSI) • Providers of space if not in the above • Providers of non-personnel cost-sharing if not in the above OK to have combination of ink and electronic