Follow Just-in-Time Procedures to Get Your Award Faster

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1 Follow Just-in-Time Procedures to Get Your Award Faster Mindy Bixby NICHD November 08 09, 2017 What is Just Time? Just in Time (JIT) refers to the information that NIH requests after an application has been per reviewed and is within a range of possible funding. JIT information is not part of the application, it is important time sensitive information that is prepared separately prior to an award being made this process is call Just in Time (JIT) o Receiving a JIT request should not be construed to be an indicator as possible funding. At most IC s if funding is likely you will receive another request from the Grant Specialist, which may include additional items being requested. To view a sample JIT request from era Commons 1

Instructions how to submit JIT https://era.nih.gov/erahelp/commons/commons/status/jit.htm When and Why Should I Submit JIT?

2 Who Can Submit JIT? All JIT documentation must be submitted via era Commons using the JIT module. PI s can upload and save JIT information into era Commons However, only Signing Officials/Authorized Organization Representatives may submit JIT to NIH Instructions how to submit JIT When and Why Should I Submit JIT? Timely submission of JIT enables NIH Staff to expedite your award When to Send: After you receive an from era Commons due to the impact application score or After you receive a JIT from the IC grants management specialist 2

SBC must be eligible at time of award As part of JIT review process, Grants Management may request company ownership information such as the following: o Company must be primarily owned by U.S. citizens or permanent resident aliens.

3 SBC must be eligible at time of award As part of JIT review process, Grants Management may request company ownership information such as the following: o Company must be primarily owned by U.S. citizens or permanent resident aliens. o Business operates primarily in U.S. o Organized for profit; Has fewer than 500 employees. o NIH uses a SBIR or STTR Funding Agreement Certification Form. PI Primary Employment SBIR Contact PI must be primarily employed by SBC at time of award and for duration of the project period if unclear Grants Management may ask questions STTR PI does not need to have primary employment at SBC. NIH permits the PI to have his/her primary employment with either the SBC or collaborating research institution. PI must devote at least 10% effort (1.2 PM) to the project 3

4 What is Other Support; How Do I Submit It? Other Support. Other Support includes all financial resources, whether Federal, non Federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes, or gifts do not need to be included. Other Support is REQUIRED for all JIT Submissions What is Other Support? All Other Support includes active and pending support in Person Months (PM) Program and Grants staff will review this information to ensure: There is no scientific, budgetary, or commitment overlap You cannot have zero/none or as needed commitment on any active/pending support listed. Should a total effort commitment exceed 12 PM if pending applications are funded, an explanation on how effort will be adjusted is required so that effort does not exceed 12 PM. For STTRs the PI is REQUIRED to be at 1.2 PM or 10% effort. 4

5 IRG Human Subject Concerns Center for Scientific Review s (CSR) Initial Review Group (IRG) Human Subjects review guidelines: Review_of_the_Human_Subjects.pdf During the peer review, the scientific and technical merit of the application is discussed. o This discussion will include whether the human subjects protection plan is adequate and whether any of the reviewers had concerns. If reviewers are unable to make a determination regarding human subjects involvement or have concerns regarding the human subjects plan the application will be coded as Unacceptable for human subjects Work with your Program Officer to resolve the Code 44 can take several weeks to get code changed Read your Summary Statement s Scientific Review Officer (SRO) and Reviewers comments. Contact Grants Management regarding SRO budgetary concerns Human Subjects and JIT Requirements If your application involves Human Subjects you will need: FWA An Institutional Federal Wide Assurance with OHRP IRB Annual Institutional Review Board (IRB) approval EDU Human Subject education*even for exemptions Are you unsure if you are conducting Human Subject Research? Take the Questionnaire For additional information see a HS walk through at award#sbir sttr 5

6 Animal Research and JIT Requirements For most Small Business Concerns (SBC) conducting animal research an Interinstitutional Assurance is required because the SBC does not have its own: Animal care and use program Facilities to house animals IACUC (Institutional Animal Care and Use Committee) approval and does not conduct animal research on site Applicants work with their Grants Specialists to obtain an Interinstitutional Assurance through The Office of Laboratory Animal Welfare (OLAW). If you are a New Recipient Your Grant Manager will contact you for your Entity Identification Number (EIN). Documentation requirements currently include a IRS W 9 and official IRS EIN establishment letter. An award cannot be made until your EIN information is established in NIH systems. YM([17 6

7 Slide 12 YM([17 Don't understand what this means. Young, Margaret (NIH/NICHD) [E], 9/28/2017

End of Year Procedures Sometimes near the end of the

submit JIT materials If so, except for eligibility

award pending the missing information NIH SBIR/STTR JIT

8 End of Year Procedures Sometimes near the end of the Federal fiscal year (9/30) there may not be time to submit JIT materials If so, except for eligibility concerns, NIH ICs may issue a provisional, restricted award pending the missing information NIH SBIR/STTR JIT PROCEDURES TOOL 7

Thank you for Coming Questions? Contact Mindy Bixby mindy.bixby@nih.gov or 301 402 3204 References NIH SBIR/STTR Website https://sbir.nih.gov/ NIH SBIR/STTR SF 424 Application Guide (updated 3/24/17) https://grants.

9 Thank you for Coming Questions? Contact Mindy Bixby or References NIH SBIR/STTR Website NIH SBIR/STTR SF 424 Application Guide (updated 3/24/17) to apply applicationguide/forms d/sbir sttr forms d.pdf NIH era Commons JIT Website m There is a YouTube video, Accessing Just in Time (So & PD/PI) Available Video 8 8

10 References NIH Grants Policy Statement (Revised 11/2016): ion.htm There is a YouTube video, Accessing Just in Time (So & PD/PI) Available Video 8 SBA eligibility regulations criteria References Other Support Information Office for Human Subjects Protections (OHRP) Human Subjects information Office of Laboratory Animal Welfare (OLAW) Animal Assurance 9

Ins and Outs of SBIR Grants and Contracts. A Grants Manager Perspective

Ins and Outs of SBIR Grants and Contracts A Grants Manager Perspective Andre D. Walker Outline Differences Between a Grant and Contract Eligibility Budget Just In Time Post Award Activities 1 So What s