Developing the Business of Technology

Developing the Business of Technology NIH Proposal Prep Part 3 The Details: Budget, Registration, Submission and JIT April 2018 Deadline Presenter: Becky Aistrup Managing Partner 734.930.9741 becky@bbcetc.com bbcetc.com / @BBC_etc Copyright BBC Entrepreneurial Training & Consulting, LLC DEVELOPING THE BUSINESS OF TECHNOLOGY 1

Now for the Details.. Budget Registration Electronic submission Just-In-Time (JIT) Award Notification 3 Components of an NIH SBIR/STTR Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Bibliography and Refs Cited Facilities & Other Resources Equipment Biographical Sketches (5 pg ea.) Project Budget Subaward Budget Introduction to Application (resubmission only -1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Progress report/publication List (Phase II only) Vertebrate Animals Select Agent Research Multiple PD/PI Leadership Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Authentication of Key Biological and/or Chemical Resources Appendix Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) PHS Assignment Request PHS Human Subjects and Clinical Trials Information Clinical Trials PA: Includes inclusion enrollment information No Clinical Trails PA: Does not include inclusion enrollment information 2

Budget limitations Guidelines: $150,000 Phase I, $1,000,000 Phase II Limits max 150% of guidelines, therefore: $225,000 Phase I, $1,500,000 Phase II 2018 Topics eligible for budget waiver Read the solicitation carefully: NIH has a salary cap ($185,100) be real in your request REMINDER: Outsourcing Limits SBC (applicant organization) must do required minimum (% of direct + indirect) SBIR - Phase I - 67% SBIR - Phase II - 50% STTR - Phase I & II - 40% Therefore total of Consultants + Subcontractor Costs must be: SBIR - Phase I - <33.3% SBIR - Phase II - <50% STTR - Phase I & II - 30% for primary subcontractor; <30% for all other consultants + subcontractors 6 3

Project Budget Approach Build the budget as you build the project. Determine the task or milestone and then consider: Who will do the work? Wow long will it take? What materials or supplies will be needed? What equipment will be used and is it available? Will a portion need to be done by a collaborator? Where will the work be performed? Are there special services needed? Is travel required? Tuition/stipends? 7 Budgets Direct Costs E.g., Salaries, supplies, equipment, travel, consultants fees, subcontract costs Indirect Costs (F&A) Fee 40% of TOTAL direct costs for Phase I (Includes fringe benefits) OR Request higher rate IF you can support it through a negotiation with DFAS 7% of total costs (direct and indirect) Unallowable Costs Make sure to justify your direct costs extremely well. 8 4

SBIR Preliminary Budget # Hours Who Where Cost Objective #1 Task A 800 Company In-house $68,000 Task B 600 Subcontract Out-source $36,000 Objective #2 Task A 200 Company In-house $17,000 Consultant 160 AJ Burns Out-source $12,000 Supplies - - - $5,000 Other - - - $12,000 = $48K $48k/$150K = 32% Total $150,000 9 Budget approach When a cap or restriction is enforced Work backwards to determine the direct dollars Budget Cap $100,000 $150,000 $225,000 Direct (67%) 67,000 100,500 150,750 Indirect (40%) 26,800 40,200 60,300 Fee (7%) 6,566 9,849 14,773 Total $100,366 $150,549 $225,823 5

Direct Costs Any item, service or labor that is used for the sole purpose of any one particular project. The item cannot be used on any other contract or corporate purposes. 11 Direct Costs Examples Salaries/wages (senior key persons and other personnel) Equipment (items that will have more than 1 year of life and more than $5k) Travel Materials/Supplies Consultants Sub Award/Consortium 12 6

Salaries/Wages Salary for Senior/Key Persons and Other Personnel Who will do the work? What will be their role? What amount of time will they commit? Is the proposed labor cost appropriate for the scope of the work? 13 Roles - Senior/Key Person vs Other PD/PI is always considered a senior/key person Technical lead Listed on company budget auto filled from cover page Key persons must have a role on the project, Sr. Scientist, Programmer, etc. Other Personnel Technicians, junior staff 14 7

Roles: Contract Employee Self-employed individuals, paid by the hour. Set their own schedule Not managed by a supervisor Use their own equipment, maintain their own benefits and licenses 15 Roles -- Consultants Individual or organization retained to provide professional advice or services for a fee but usually not an employee of the company. Rate must be reasonable in relation to the service rendered Rate comparable to other consultants in the industry Consulting agreement includes individual/organization name, nature of service, relevance to project, period of service, rate per hour. 16 8

Roles - Subcontractor Conducts work with their employees in their facilities Whose award it is? Make sure to agree to scope of work and deliverables Why use a subcontractor? Specialized facilities Complimentary expertise Potential for jointly developed IP Discuss any IP contingencies up front 17 Roles - Fee for Service A fee for service is an arrangement between the primary organization and another organization Vendor provides a routine service to the primary organization. No shared IP 18 9

Materials/Supplies Direct cost when used directly on the project Indirect supplies those that can be used on multiple projects Office supplies are an indirect General supplies are an indirect: Gloves Screws Wires Beakers 19 Travel Direct cost where such travel will provide direct benefit to the project No foreign travel When the company does not have an established policy use government travel policy found at www.gsa.gov varies by state Must be related to the needs of the project 20 10

Indirect costs Any item, service or labor that is used to support or complete the project but also benefits other projects/activities. E.g. Utilities Rent Benefits 21 Indirect Costs (F & A/Overhead) Fringe Benefits Payroll taxes Insurance health, disability, workers compensation Retirement plan contributions Paid leave vacation, sick, holiday General & Administrative (overhead) Office supplies Rent Phone Technology web, email Administrative wages 22 11

Unallowable Costs Costs necessary for a business but can not be paid with federal dollars. Patent costs Interest expense Advertising/Marketing www.acquisition.gov/far/html/subpart%2031_2.html 23 Budget Direct Costs Indirect Costs FEES 24 12

Budget Justification Every line item in your budget should have a subheading and corresponding paragraph in the Budget Justification. Include all justification information for all years in the same file. List the names, employment status, project role, calendar months (% effort), and salary for ALL project personnel. If the application includes a subaward/consortium budget, a separate budget justification is submitted for that budget. Should be a stand-alone document. 25 Budget Justification 26 Direct Costs by item Indirect Costs (F&A) 40% Phase I, 40% Phase II or be prepared for an IDC rate negotiation Basis is total direct costs A rate of 40% of total direct costs is requested. This amount is appropriate to cover the company s current projected indirect costs and is consistent with NIH s policy for Phase I SBIR proposals when the company does not already have a previously negotiated indirect cost rate. Fee A fee of 7% of total costs (direct and indirect) is requested. This fee contributes to the growth of the small business concern by allowing expansion of resources and personnel development. The fee is consistent with a normal profit margin provided for research and development work. 13

Subaward What do you need from the sub award? Biosketches of all key persons Budget and budget justification Facilities description and equipment lists Letter(s) of commitment 27 Budget Best Practices** 1. Develop your budget early 2. Make sure that your direct costs are consistent with the work proposed 3. Request indirect costs 4. Request fee 5. Understand the difference between direct costs, indirect costs and fee! **Refer to BBC June 2012 Pursuit Newsletter 28 14

Electronic Submission Three CRITICAL steps: 1. You must be REGISTERED 2. You must submit** ON TIME 3. You should VERIFY ** an error free application 29 Overview of Electronic Application @ NIH Company registers to use ASSIST PI completes application & AOR submits to Grants.gov through ASSIST era retrieves application from Grants.gov, checks for compliance PI and AOR/SO view assembled application in era Commons or through ASSIST. 30 15

https://sbir.nih.gov/apply/electronic-submission https://sbir.nih.gov/infographic 16

Registrations All organizations submitting proposals to NIH must have the following: Prerequisites: EIN Employee Identification Number (IRS) DUNS Data Universal Number (D&B) Bank Account SAM System for Award Management Three required registrations: 1. Grants.gov registration 2. NIH Electronic Research Administration (ecommons) registration 3. SBIR.gov Company registry 33 Getting Started Employer Identification Number (EIN) Issued by the IRS No cost to apply Apply via internet, phone, fax, mail Complete form SS-4 www.irs.gov/businesses/small-businesses-&-self-employed/employer-id- Numbers-(EINs)- 17

Registrations DUNS # What is it? Data Universal Number System (DUNS) FREE unique 9 digit id number for your organization Where do I get it? Dun & Bradstreet at http://fedgov.dnb.com/webform Use the page for US Federal Government Contractors and Grantees Why? The federal government has adopted the use of DUNS numbers to track how federal grant money is allocated. How long will it take? Same Day. You will receive DUNS # information online. 35 DUNS# getting started 36 18

System for Award Management What is SAM? SAM is a federal government owned and operated free web site that combines several procurement systems and the Catalog of Federal Domestic Assistance into one common system. Central Contractor Register (CCR) Federal Agency Registration (Fedreg) Online Representation and Certifications Application (ORCA) Excluded Parties List System (EPLS) 37 Registrations System for Award Management (SAM) You need a DUNS number to register at SAM. www.sam.gov. Designate an E-Business Point of Contact (E-Biz POC). How long will it take? Three to five days. SAM registration must be renewed annually 38 19

SAM Registration cont d. What to I need? Company name, address, entity Name, address, phone, email of POC Checking account and bank information Commercial account EFT contact person/email Company annual revenue - estimates SAM.gov 1 2 3 20

SAM Support SAM.gov is supported by the Federal Service Desk https://www.fsd.gov SBIR.gov Company Registry http://sbir.gov/registration 21

Company Registry 1. Certification Tool 22

2. Have you registered? Yes or No If Yes on this screen search for your company, when found click proceed button If No proceed to # 3. #3. DUNS/EIN/Email Check 23

4. SBC Information Provide any additional information including: 1. Company Name 2. Mailing address 3. DUNS number 4. EIN number 5. Ownership information 6. No. of employees 7. Point of contact information (the email address provided should match one of the POC at SAM) 5. Registration Finished 24

Two Separate, but Linked Systems Grants.gov Federal-wide portal to find and apply for Federal grant funding Used by all 26 Federal grant-making agencies era Commons NIH Agency system that allows applicants, grantees and Federal staff to share application/grant information Used by NIH and a few other HHS divisions IMPORTANT: Each system has its own registration and validations requirements. 49 25

Grants.gov registration assistance Know your role - @ Grants.gov E-Business Point of Contact (POC) Responsible for the administration and management of grant activities in the organization. Authorized Organization Representative (AOR) Submits a grant application to Grants.gov on behalf of a company, or institution. Authority to sign grant applications and the required certifications and/or assurances. 26

Register Create account using contact information and account details Register your organization Create AOR profile epoc receives email requesting acknowledgement of AOR epoc must log in and assign role of AOR era Commons Registration What is era Commons? ecommons is an online interface where grant applicants, grantees and federal staff at NIH and grantor agencies can share information relating to research applications/grants. 27

era Commons Agency system that allows applicants, grantees and federal staff to share application/grant information Used by NIH and a few other HHS divisions AHRQ, CDC, FDA As part of the registration process you will assign roles NIH has a 2-week good faith effort for Commons registrations 56 28

57 How to Register https://public.era.nih.gov/commons/public 29

Registration era Commons Process: 1. Add Institutional and Accounts Information 2. Submit notice of successful submission 3. SO receives verify email address 4. SO receives user name and password 5. SO assigns roles PI, AA, FSR Know your role - @ eracommons The PI/Principal Investigator (PI) Directs the project or activity being supported by the grant. Accountable to the grantee for the conduct of the project or activity. Can view information for all their applications at NIH The SO/Signing Official Authority to legally bind the institution in grants administration matters. May have any number of titles in the grantee organization. Can register the institution, and create and modify the institutional profile and user accounts. 60 30

Registration era Commons SO creates or affiliates the PI's Commons account Only a signing official (SO) can create PI accounts in NIH Commons. For PIs new to the institution, the SO registers them. For PIs registered at another institution, the SO must affiliate them with the SO's organization. Note: If you are both the SO and a PI, you need a separate Commons account for each role. 61 Registration Tips for Success Begin at least 8 weeks before the deadline Once you have a DUNS number and registered at SAM, Grants.gov and era Commons registrations can be done in tandem NIH 2-week good faith effort for Commons registration Set-up multiple AOR and SO accounts Log in to accounts prior to deadline to check your access Update System for Award Management (SAM) information annually 62 31

Registration More Tips for Success Do not combine SO and PI roles on single Commons account PIs get one Commons account that follows them throughout their careers If PI is already registered, affiliate their existing account rather than creating a new one PIs should update their Commons profile prior to submitting How to Apply 64 32

2018 Omnibus Funding Opportunities 65 SBIR Omnibus Solicitation FOA FOA # 66 33

NIH PHS 2018-02 Omnibus Solicitation 67 Follow the Guidelines 1. Notices in the NIH Guide for Grants and Contracts Precedence / Importance 2. Funding Opportunity Announcement Section IV. Application and Submission Information 3. Application Guide (SF424) Including Supplemental Instructions 68 34

NIH SBIR/STTR Application Guide SF424 (R&R) Application Packages. Read and follow application guide instructions Instructions are specific to SBIR/STTR applicants Revised 12/29/17 69 NIH SBIR/STTR Application Guide Changes 70 35

Electronic Application the process Prepare to apply Find opportunity and INITIATE in ASSIST Prepare application Submit application to grants.gov Check status in eracommons (NIH) Check assembled application 71 What is ASSIST? Application Submission System & Interface for Submission Tracking ASSIST is NIH s online system for the preparation, submission & tracking of grant applications through grants.gov to NIH 72 36

Path to NIH ASSIST 73 About ASSIST Secure web-based data entry Collaboration of multiple users Pre-submission validation of many NIH and Grants.gov business rules Pre-population of data from era Commons profiles Pre-submission print/preview of application in NIH format Submission status tracking for both Grants.gov and era Commons within a single system Ability to import subaward budget data from external sources Ability to copy application data (excluding attachments) from one announcement to another 74 37

ASSIST Login 75 https://public.era.nih.gov/assist ASSIST User Guide 38

Initiate an Application 77 Getting Started Enter the FOA # Form Fields Application Project Title Lead Applicant Organization Lead Applicant Org Address Lead Applicant DUNS Optional- Contact Project PI What to enter Description title of project (max 200 characters) Make selection for drop-down menu Review info comes from commons account Review comes from commons account Pre-fill Application from User name button Select the Initiate Application button to continue 78 39

Automatic Application Access ASSIST automatically provides application access to some individuals based on their role in era Commons or role on the application Examples: Users with era Commons accounts that have the Signing Official (SO) or Administrative Official (AO) role have access to all applications for their organization PD/PIs have access to all their applications Application initiator has access to that application 79 Manage Access Read vs Edit Budget vs Non-Budget data 80 40

Step by Step ASSIST 1. Find the funding announcement, select Apply Online Using ASSIST 2. Make a submission plan, who will be responsible for entering data 3. Login in to ASSIST & initiate your application 4. Provide application access to your team 5. Enter application data 6. Finalize your application and prepare for submission 7. Submit your application 8. Track your application and view assembled image 81 ASSIST Interface 82 41

Intuitive Screen Layout Access online help ASSIST messages Screen tips 83 Actions vary based on application context and access Form navigation How to Navigate and Enter Data Must complete all Components/Tabs 84 42

1/31/2018 Completing the Application General Tips: Follow Application Guide requirements Complete the R & R cover section first info from this form populates fields in other forms within the package Use simple PDF-formatted files Do not use Portfolio or similar features to bundle multiple files into a single PDF Disable security features such as password protection Keep file names to 50 characters or less Do not include headers or footers Use only section headings as part of the text 85 Electronic Submission Format Fonts: 11pt or larger Arial, Helvetica, Palatino Linotype, Georgia Standard 8.5 x 11 > ½ inch margins (all sides) No type in margins including PI name and pg #s No columns or landscape Use no headers/footers These will be system generated on submission Graphs, figures small type/black, same font type, color can be used in the figure 86 43

Optional Forms 87 Start with the SF424 Cover Page Use these fields correctly! 88 44

Research Plan Upload file name limit 50 characters Appendices are not allowed for SBIR/STTR Senior/Key Person Profile PI s eracommons ID goes here. You must give the Organizational Name for EVERY Key Person 45

1/31/2018 Research & Related Other Project Information NIH required: #9 - Bibliography #10 - Facilities #11 - Equipment #12 - Other Attach SBIR.gov company registry pdf here R&R Other Project Information Other Attachments: SBIR.gov Registration Confirmation Download pdf from SBA registry DO NOT CHANGE OR ALTER THE FILE NAME! SBC_123456789.pdf (where SBC_123456789 is your firm s SBC control ID) SBIR (only) Application Certification Majority-owned by multiple VC, hedgefunds, equity firms 92 46

Research and Related Budget R&R Budget Form is the budget component for SBIR/STTR. Sections A & B Sections C E Sections F K Company Budget Summary Complete components only for your own organization (the Company). Subawardees will complete separate sub-award budget form for their organization and provide to applicant organization. 93 R&R Budget Sections A & B Senior/Key Person Only Company Employees here Allows 8 named individuals PD/PI field must be completed Provide time in personmonth units, not percent effort Other Personnel Only the number of personnel required, not specific names or responsibilities. 47

Additional Notes on Personnel R&R Budget Form Include only personnel employed by (e.g., receiving salary from) your organization. Consultants should be included in Section F Line 3 or Section A (if they are both senior/key and employed by the application organization). Do not include other significant contributors in personnel section of R&R Budget. Senior/Key Personnel Form Include all personnel considered senior or key, regardless of employer. Include if considered senior or key, regardless of employer. Effort commitments not relevant to this section. Budget Sections C - E C. Equipment. Only items over $5k Large items of equipment rarely approved in Phase I D. Travel Domestic only for SBIR/STTR Travel to conferences allowed Recommend ~$2k E. Participant/Trainee Costs Not applicable to SBIR/STTR 48

Budget Section F - K Fee for Service or Other Direct Costs 8, 9 & 10 Indirect Type: Total Direct Costs Budget Justification Budget Justification 98 49

R&R Subaward Budget Form Used for detailed budget from consortia Applicant sends R&R Subaward budget component to Subawardee who completes and returns Applicant attaches it in to this form Allows up to 10 separate subaward budget attachments Each subaward budget requires a separate budget Justification 99 Subaward Budget Form Assignment Request Form Inclusion Enrollment Report Subaward Budget Form 100 50

Project/Performance Site Location The Primary Site is ALWAYS the SBC! Additional sites start at #1 Company Subcontractors Consultants Others Introduction (resub)? Project Narrative Abstract Specific Aims Research Strategy? Human Subjects? Vertebrate Animals? Bibliography?? Budget? Budget Justification Biographical Sketches? Facilities & Resources? Equipment? Select Agents? Subcontactor Arrangements Letters of Support? Cover Letter Commercialization Plan (PH II)? Forms 51

Additional items These attachments are only required under certain conditions. Read the instructions to know when to include them. o Introduction Resubmission only o Protection of Human Subjects o Data Safety Monitoring Plan checked yes clinical trial o Inclusion of Women and Minorities o Inclusion of Children o Select Agent Research use of hazardous biological agents o Multiple PI Leadership Plan o Resource Sharing Plan 103 Before you submit - Validate 104 52

Tracking and Viewing in ASSIST Once an error-free application is received by NIH, the era system will: Assemble the grant application image Insert headers (PI name) and footers (page numbers) on all pages Generate Table of Contents and bookmark important sections Post the assembled application image in the PD/PI s era Commons account Send notification - email 105 Avoiding Common Errors Top 5 errors Calendar months on budget must be >0 Credential field for PD/PIs on R&R Sr./Key Person Profile form Organization for all entries on R&R Sr./Key Person Profile form Attachments must be pdf Missing federal identifier (when appropriate) 106 53

Application Viewing Window You have two(2) business days to view your assembled application image before it automatically moves forward for further processing SO can Reject application in era Commons within viewing window and submit a Changed/Corrected application before the submission deadline. 107 Electronic Submission Advice Don t wait until last minute to submit Don t rely on email Be proactive in checking verifications Do be patient Expect errors and warnings Build in time to fix what is wrong Do keep the tracking and accession numbers 108 54

JIT Just in Time Information This is NOT a notice of grant award Financial Statements Line of Credit Chart of accounts Demonstrate the ability to record costs by project Time & Reporting Internal Controls Procurement Policy Travel Policy Conflict of Interest Lab notebooks Update Other Support (all key persons) Human Subjects Assurance Number IRB Approval Document of required education of human subjects IACUC verification/letter SBIR/STTR Verification Budget Signed lease 110 55

NIH - Just In Time Awarding agencies use Just-in-Time procedures for SBIR/STTR applicants. These procedures allow certain elements of an application to be submitted later in the process, after review when the application is under consideration for funding. JIT When and How Applicants are notified (usually by email) Do not respond to era Commons JIT notice until requested Only submit JIT when requested JIT must be submitted via era Commons 56

JIT Just in Time Information This is NOT a notice of grant award nor should it be construed as an indicator of possible award. Financial Statements Accounting System Time & Effort Reporting Internal Controls PI employee status and annual salary Cap table company ownership Sub award agreement Indirect cost analysis Other Current and Pending Support (all key persons) Human Subjects Assurance # IRB Approval Education of human subjects IACUC verification/letter SBIR/STTR Verification Budget Facilities - lease A Funding Myth Awarded funds are paid in full at the beginning of the project. FALSE! Timeline Recommended for funding notice Submit JIT Additional information request Notice of award or contract Funding request or invoice Reimbursement draw Invoice or request 57

Financial Assurances Grantee organizations are required to have: - policies and procedures for managing funds - policies and procedures for personnel - Roles and responsibilities for financial mgmt. - accounting, internal controls, and budgetary controls - Demonstration of management capabilities "Evaluation of Financial Management Systems." 45 CFR 74.14. Key Elements of Accounting Systems Separate cost by cost type Accumulate costs by project/grant/contract Capture and allocate indirect costs in a consistent equitable manner Segregate unallowable costs (per FAR part 31.2) Provide ability to calculate indirect costs rate(s) Time & effort reporting by project Provide reports by project 58

Financial Management System Provide answers to: Chart of Accounts Cost ledgers Time & effort system Financial statements annually Line of credit Budget controls Internal controls Current & Pending Support Purpose: Sufficient levels of effort are committed to support the approved project. There is no scientific, budgetary, or commitment overlap. Required for all senior key persons Support of research Federal Commercial Insitutional 59

SBIR/STTR Verification Form Eligibility is at time of award Ownership 51% owned by individuals Small business size standards Company controlled research space Research performed in the US PI employment Will not use funds for market research/literary search Policy and procedures in place Animals & Human Assurances IACUC Approval date Imposed changes IRB Certification date Human subjects education 60

Other Assurances Awarding IC may also request: Lease Budget Proof of employment Proof of company Human subject or animal revisions Where s my money? 1. Just-in-time Information submitted and approved ~2 3 weeks (IRB can take much longer) 2. Notice of Award issued ~2 3 weeks after all JIT approved 3. Division of Payment Management account ~2 3 weeks after NOA has been issued 4. EFT established and user account set up ~1 2 weeks 61

Wrap it Up Be prepared for a short turn around JIT request is not a guarantee of funding Get your house in order policies/procedures Prepare protocols for IRB Identify faculties lease PI employment Success Notice of Award Document 62

READ CAREFULLY Performance Period Key Persons Contracts may refer to CFR sections.read the sections Special Terms and Conditions Audit requirements Reporting requirements Close out requirements Notice of Award Grant Number: 5R42MH077362-04 REVISED Principal Investigator(s): JOEY AMLIE, PHD Project Title: Enhancement and Improvement of something to treat disease Signing Official: (as indicated on the application) Award e-mailed to: Signing official email Budget Period: 07/01/2012 12/31/2012 Project Period: 04/01/2006 12/31/2012 Section I award dollars data Direct, F&A, Fee Section II Payment information Section II - Terms & Conditions Section IIII Special Terms & Conditions (incl reporting requirements) Section V Agency staff contacts 63

Reporting Requirements Federal Financial Report http://www.dpm.psc.gov/ Final Progress Report no form; 90 days post expiration Final Invention Statement and Certification HHS 568 Annual Invention Utilization Reports Phase II Data Collection Requirement for Government Tech-Net Database http://technet.sba.gov Register prior to applying for Phase II 127 Bayh-Dole Act https://sbir.nih.gov/policy/invention-reporting The Bayh-Dole Act requires a grantee institution to disclose an invention to the granting agency 128 64

How do you report inventions? 129 When to Contact NIH Program Staff Pre-Application Assess the fit What s New: FOAs Review Issues: Dos/Don ts Post Review Review Summary Statement What the rating means Strengths and weaknesses Likelihood of funding Next steps 130 65

When to Contact NIH Review Staff Point of contact during review process Concerns about I/C or Study Section Assignment Recruitment/Assignment of Reviewers 131 When to contact NIH Grants Management Pre-Award Steps: Just-in-time (JIT) information Eligibility verification statement Human and Animal subjects training and approvals Documentation of PD/PI s employment Other support for key personnel Verification of access to performance site Consortium/subcontract information Post-Award Advice/Guidance Annual Progress Reports Financial Status Reports Invention Reporting Updated approvals Closeout activities 132 66

Questions? 67