>> I'll be your host this afternoon, I am Patricia Swayne, Communications Specialist at the NIH SBIR/STTR Central Office. Dr. Matt Portnoy be presenting and I want to remind you that the webinar is being recorded and we'll make the slides and recording and transcript available on SBIR.NIH.GOV our website and also the slide should be available to you in the handout of your growth Webinar control panel -- Thank you, Patti. Good afternoon everyone, my name is Matt Portnoy and I’m NIH SBIR STTR program Manager. In today's Webinar we will be covering that giving some SBIR 101 and covering the reauthorization's and status of that, we will discuss our new omnibus solicitations and are deadlines for the year and other aspects of our program that are of interest, we will also have plenty of time at the end for questions and answers. I know many of you sent questions in and the registration and we put some of them on the slide at the end and you are able to ask us questions in the question box on your control console. Because this is a Webinar with hundreds of people attending, all attendees are muted and you can ask watch a question console and we will do our best to get to as many as we can wintertime runs out at 330 as Patty said this Webinar will be recorded and we will provide the slides which you have in the handout console and recording on SBIR and after this Webinar and with that I want to think while pretending today and we will get started. I want to start with a pitch for attending our annual SBIR STTR conference and this is a large three-day conference where we have a variety of sessions on SBIR peer-review, success stories, commercialization, and one on ones with 100 so federal staff from all over institutes in this year's conference is in Milwaukee Wisconsin November 7-9 in registration has opened -- and so everything you want to know about our programs can be found better central website SBIR.NIH.gov and this is the starting point for you to find all information and if you have time, and if needed, then I can show you some website live after we're done. And we have people saying they are not receiving audio via computer please go ahead and try logging in again and then meet your computer or also perhaps calling and by phone and Thank you, Kurt Our website SBIR and STTR programs are to congressionally mandated programs that are designed to fund early-stage small businesses seeking to commercialize innovative biomedical technologies but are these programs allow for-profits small business to participate in federal research and development in SBIR and STTR are companion program STTR is similar to SBIR but requires a formal partnership between a small business and a not-for-profit research institution and talk about that a moment. If you are new to the program I know many folks typically are for Webinars, I recommend that you go to our interactive infographics on our websites at the SBIR.NIH.gov/infographics -- in this provides you a step-by-step overview of the program and how greater clicking on any of these and the one below it will give you much more detailed information and walk you through the process from beginning to end. So to step back a minute SBIR stands for small business innovation research and STTR stand for small business technology transfer and these are two companion programs which are set-aside programs for the federal government what does a set-aside mean? It means that agencies that are participating a required to separate a portion of their extramural research for these programs and only that money can be used to support these programs so we are currently in fiscal year 17, and poor SBIR we have set-aside 3.2% of our extramural budget for BIR and 0.45% of our budget for STTR and I will show you in a moment what those numbers are. The SBIR program started in 1982 35 years ago by an act of Congress which the Board listed congressional goals to stimulate technological innovation, to use small business to meet federal R&D needs, to foster and encourage participation by minorities and disadvantaged persons in technological innovation, and increase private sector commercialization innovations derived from federal research and development to as an active congress the Congress is required to reauthorize the program from time to time and at current reauthorization of talk again in a minute shown at the bottom currently reauthorize the program through the fiscal year 2022 which is about 5 1/2 years from now. STTR was started 10 years later in 1992 and has similar goals to SBIR but does require a partnership collaboration between small business concerns which is a for profit and a nonprofit research institution with the goal being fostering technology transfer between small businesses and research institutions. Although however SBIR small business is strictly partnered with University's and talk about that in a few moments. As I said the programs are authorized by Congress and must be real authorized. In December 2016, Congress passed a five-year SBIR STTR reauthorization as part of Senate Bill 2943 and was this Bill was attacked in the 2017 national Defense authorization act in VA and this reauthorization extensive program for five years and they were set to expire on the end of September and 2017 but now programs are extended from fiscally team through fiscal 2022 a five-year extension. This extension was a simple one line reauthorization with a date change theirs several pilot programs that many of you are familiar with as part of the reauthorization from six years ago -- which have their own separate expiration date due to expire this coming September and all of those programs are not included in the reauthorization passed by Congress six months ago. So the SBIR direct phase to position the commercialization ready pilot program CRP the 3% agency SBIR administrative funds, in the NIH phase 0 Proof of Concept centers all have authorities that expire at the end of this coming September and they were not included in the reauthorization passed for the five-year extension so all four of these provisions will expire in some said at the end of the current fiscal year 2017 and in fact we have all radiata lasted a for direct phase 2 in the CRP program and having said that there are bills currently sex circulated in counts Congress in the house and soon to be in the Senate that addresses extension of these provisions and other areas since that is pending legislation, we cannot comment on it but the bills that are passing through the house are publicly available and you can find them and so we are hopeful that these authorities will be extended and if they are, and when they are, then we will revise and reissue these programs and that will take off a little time depending on when and if the direct phase 2 in the CRP program get extended so if you hear that those get extended, then please we will be reassuring those programs as soon as we are able. Stay tuned to reauthorization bills passing through Congress that affect SBIR and STTR then we of course will be doing the same. The SBIR NST TR programs are federal government programs currently supported by 11 federal agencies all shown on the slide on the right side they are listed out in order of size and this is based on 2015 data which is now course two years old and I will show you our current numbers on the next slide or two -- but there's five federal agencies that have both SBIR and STTR programs Department of Defense, Department of Health and Human Services of which NIH is the largest part 90% and we will talk about the other parts of HHS in a minute that are part of SBIR that Department of Energy, NASA, and the National Science Foundation and the amounts of their programs are shown on the right and under the portion of the program is shown on the left and you can see these top five agencies DOD HHS DOE NASA and NSF comprise approximately 95% of the annual two and-a-half billion dollars available to SBIR and STTR by agency. The other remaining six agencies on the lower right USDA, Department of Homeland security, Department of Commerce, with the national oceanic and atmospheric administration know a and National Institute of Standards and Technology nest Department of transportation Department of Education, and the Environmental Protection Agency EPA all have SBIR programs at the amount shown on the right as of two years ago and compromise the remaining 5% of the overall program combined. This chart also color codes agencies as to whether they are primarily a granting agency or contracting agency and so you can see Department of Defense is a contracting SBIR agency they are coded below NIH in and HHS are coded green as a granting agency but as you will hear the moment we actually are the only agency that does both grants and contracts and determine about 90% of our overall budget is in the form of grants and 10% is in the form of SBIR contracts. So we have a lot of flexibilities in which you can apply. This program is federal wide and some of the areas that we cover in life science research to have overlapped another agencies and so I encourage you to visit the central SBIR website at the central SBIR website@SBIR.gov and the site is run by the small business administration or SBA as the coordinating agency for all of SBIR and you can learn about all the other agency SBIR programs that SBIR.gov. Within the Department of Health and Human Services HHS theirs for compliments that have SBIR programs -- NIH and National Institute of Health, Centers for Disease Control and Prevention, administration on community living ACL and the feud and Doug ministration all have SBIR at the approximate amount shown on the slide they do not currently have STTR programs and so while NIH may represent 90% of the overall departments programs by budget there are funding opportunities available through the CDC ACL and if the eighth and you will see in the month that NIH and FDA are combined in collaborating on solicitations and you will hear about those in a minute the ACL or administrative on committee lemon living was transferred SBIR program was transferred to HHS from the Department of Education two years ago they were on a separate SBIR program that has grants in that can be funded ransacked of additionally you can link to ACL from the NIH SBIR website and I will show you that as well later on when I have a little bit of time after the formal presentation. The program eligibility are very important program in terms of what constitutes ineligible for-profit small business -- not all types of businesses that the SBIR roles and these rules are set in law and through what SBA calls a size role in size refers to more than just the number of employees, and so first off all SBIR and STTR forms must be organized as for-profit US owned and operated small businesses. Small is defined by the SBA as 500 or fewer employees including all affiliates, most of our and many of our small business SBIR and DTRs art quite small and 100 employees or less fifth-year employees or less many companies with 10 or less and we are many companies that apply that have one or two or three employees in the vast majority of our companies are 20 or less employees. The word must be done in the United States and United States collaborates with a few rare exceptions pertaining to foreign working uniqueness of foreign expertise and resources. The ownership structure of the company can tend to be relatively complicated for most folks but it also most modes well under the most simple definition of eligibility the first bullet is that eligible SBIR and STTR forms must be greater than 50% US owned by individuals who are US citizens for permanent residence. I will say that again greater than 50% majority-owned by US citizens or permanent residence. The vast majority of companies fall into that it does not mean 50% owned it must be greater than maybe 50.1% or 51% or greater but it is not equal to 50%. It has to be majority-owned. Or a small business firm can be majority greater than 50% owned by another business which is itself greater than 50% owned by individuals who are you to citizens or permanent residents or any combination of these first two bullets . That is for both SBIR SBIR and STTR the third goal is specific only to SBIR and not applicable to STTR in that's a BIR firm might also be a firm which is majority-owned greater than 50% owned by multiple centric Apple operated companies hedge funds private equity firms or any combination of these this is a chance to be called the VC role that it is a US small business can be a business owned by multiple two or more VC firms and no single PC or for firm listed here can own more than 50% so you can have two or more VC firms each owning 30% for a total of SAFETYNET firm can be eligible provided the VC firms are US-based.'s all of our funding solicitations Lessie and Villanova OSHA criteria and have definitions about what all this means and they citations to look up at the vast vast majority of our companies fall under the first bullet majority-owned by individuals who are US citizens or permanent residents and as we get to a moment the ownership of the company and the percent ownership has nothing to do with the effort or employment of the PI or the principal investigator or staff on the grant -- it the eligibility is determined that time of award not time of application so firms who may not be a put -- eligible at time of application will have to certify at time of award and throughout the award lifecycle that they are majority has a proper ownership and other certification areas. MTTR has similar set of criteria that the bullets on the side except the last one which is specific to SBIR but STTR requires a formal cooperative agreement between a small business and a US not-for-profit research institution typical University but not necessarily other nonprofit research organization federal R&D national laboratories also can't in this area. If STTR rules by law setting minimum of 4% of the budget and effort to go to the small business and a minimum of 30% of the budget to go to the celebrity nonprofit research institution -- the remaining 30% could go either to the small business, the academic partner, split between them or be subcontract out to a third or fourth party that is not a stipulation and the two-party SPE Small Business Lending not-for-profit institution develop an intellectual property agreement between the two of them to determine the allocation of intellectual property rights and I should also say importantly than the intellectual property rights and data rights of work done under all SBIR and STTR belong to the awardee small business the government does not take any intellectual property rights allocations percent ownership of the company, or royalties it isn't truly non-deluded funding to support your small business R&D needs for technology development So the nuts and bolts of the actual program , the SBIR and STTR programs are phased research programs phase 1 phase to phase 3 -- this is not to be confused with the phases of the clinical trial so of course there's clinical trial faces 1, 2 and 3 and SBR has faces 1, 2 and 3 and these are not related in any way. However clinical trials can insert circumstances and in certain institutes be supported under SBIR and we will talk about that a little later. So the entry point of the program for most firms they phase 1 application for phase 1 award phase 1 is a small short feasibility study and budget is typically $150,000 total cost direct cost indirect cost for FNA and profit or -- SBIR project areas are typically six months STTR projects are typically one year, although longer terms and longer money can be asked for under these programs these are guidelines not hard caps. Phase 2 of the program is a more full R&D effort typically $1 million or 1 1/2 billion dollars over two years each bearing the STTR firms have to have a phase 1 to apply for phase 2 and so you have to demonstrate feasibility in phase 1 through an award and then you can apply for phase 2. NIH offers a second full sequential competing phase 2 week collie phase 2 competing or phase to be -- and this is a different nature from the National Science Foundation phase to be award which so maybe then I was or perhaps other 2B at other agencies and NIH phase to be as a full second phase 2 up to three years up to one dollars per year so firms can receive up to $3 million as a second phase 2 effort following their initial phase 2 and this is typically for clinical R&D complex instrumentation perhaps clinical trials typically work that has to go through regulatory approval but not necessarily. Many but not all of our institutes participate in phase 2 B because of the budget size and you will understand when we show you the size of the institutes and this is a good question that you will want to speak to a Program Officer about is about the phase 2B program and speak to a Program Officer this is something I will mention to reiterate in the end it is incredibly important to have discussions over email and over the phone with program officials and SBIR program that can be a great resource for you and help you along the way in many different ways and in the end they are the ones that have the funding authority to grant you the awards. They can also provide a lot of advice about which of the red mechanisms and what is he right phase etc. -- and we have a first phase 2 and second phase 2 phase 3 of SBIR is called the commercialization phase in this phase of the SBIR STTR program federal agencies are not allowed to provide funding in the form of using SBIR and STTR funds. We have to if we provide this refunding it is typically non-SBIR funds and tends to happen when the agency is going to be the primary customer of the technology developed by the small businesses. NIH and NHS us is generally not going to be the primary customer for your SBIR and STTR technology or expectation is that you commercialize your technology into the open marketplace, if you're applied to other federal agencies typically what we call contracting agencies like the part Department of Defense for NASA they may find phase 3 to a certain extent with non-SBR dollars because they're going to be the primary customer for your technology initially NIH and NHS will not be and you need to consider your partnering strategy and exit strategy in your follow-on funding after the SBIR phases thoroughly be a venture-capital be at Angel investing be it strategic partnerships or other types of arrangements you need to be thinking about these types of things early and we will talk about a few programs at the end that can help you along the way in those thoughts. We get a lot of questions about the difference between SBIR and STTR one of the fundamental differences in which one do I apply for the programs are I large and almost every respect the same and treated the same here at NIH and NHS with the two exceptions on the slide regarding partnering and regarding the principal investigator and SBIR on the left side of the panel permits partnering it is optional and firms can outsource up to one third of their budget in phase 1 and half their budget in phase 2 were collaborating party subcontract a consultant collaborator etc. Under STTR it requires a partnership of formal partnership with a nonprofit institution partner at the 4030 split we talked about before and SBIR and SBR firm has all the capability in-house it doesn't have to so outsource and keep the money within DuPont company employees to do the work but STTR requires an outsource MSC first difference. The second difference is in the employment of the principal investigator or PI in charge of the project under SBIR, the primary employment which is defined defined as greater than 50% greater than half-time must be what the small business and we calculate that based on a 40 hour workweek here at the agency and at all agencies while we certainly understand and appreciate no one including ourselves worked 40 hour work weeks this is how we calculate more than primary employment. And SBIR PI must be employed greater than half-time at the small business and this precludes full-time employment elsewhere -- what that means necessarily is that your typical entrepreneurial University professor who is cannot be the PI and SBIR unless they plan to go part-time at the University or take a sabbatical all of which are possible but is not the typical case. Usually those type of post like to keep their day jobs with the benefits and the STTR may be a good option for that in their STTR on the right bottom the PI may be employed either by the research institution at the University or the small business but they do up to have primary employment either at the University or small business -- In STTR you can have a situation where the University academic partner is getting 60% of the budget, which it can do -- excuse me -- 30% is required to get can also get the other 30% that's a small business -- in the PI can be from the University but in this case the award is always made to the small business and the University gets his fortune in the PI does the a subcontract these are small business awards so we do get many questions from sponsored projects and grants office is about STTR and the applicant and awardee is always small business in all cases. When you come to the NIH, we are a collection of 27 institutes and centers and the National Institutes of Health emphasis on the -- my office the coordinating office is in the office of the Dir. shown at the top of the slide in the blue boxes shall be 24 although 27 centers that have SBIR and STTR programs and typically when you contact us we will refer you to one or more of our institutes based on what you plan to do with your technology and in fact some of them do have some overlap and so it is useful to tell us a little bit about what you are doing and we can refer you to the right place . We will also refer you to the CDC the ACL or the FDA as appropriate based on their interest as well and I will tell you when we talk about the funding where you can find out the institutes are ingested in. This fiscal year 2017 as used on the slide but will aggregate it NIH has a total amount available for SBIR and STTR of $982 million in change -- as you can appreciate quite a bit from a fuse ago on the earlier slide when we had about $800 million and when the beginning of the 2011 reauthorization we had about $640 million we add in the CDC and the ACS the ACL and FDA we are approaching very close to a $1 billion SBIR agency. So we have a substantial amount of funding every single year that is set aside only for for-profit small businesses to the type of work we are talking about within NIH we take that $982 million and split it Roger Weisberg partially to our 24 institutes and centers in proportion to their own congressionally appropriated budget that and so there is no such thing per se as an NIH budget -- we have 27 line item budget one for each Institute and 24 institutes that do and SBR have the line item budget and they receive a proportion of SBIR in relation to that budget and so you can see the size of the time by Institute is quite differential and on the upper right we start with the National Cancer Institute that is he largest Institute by budget and it guess he largest proportion of SBIR funds around 15 or so percent -- and clockwise national Institute of allergy and infectious diseases NHLBI and a STMS along the way around the left side national Institute on aging and national Institute on drug abuse moving around back to 12:00 in national Institute on nursing research and an INR and at 12:00 is national Library of medicine NLM -- and you can see the very sized theirs to order magnitude range in budget size national Library of medicine is the top 12:00 new and has an SBR budget STTR budget about $1 million they be little more and NCI natural cancer has about $150 million and so there's a large order magnitude and difference in the size of the budget -- so we have larger institutes medium and small by budget however because NASA dude has a small to medium-sized budget, does not necessarily mean that the success rate there is worse for harder or different I will show you moment NIH wide success rates that averages all this together but an individual Institute success rate in your chances in general are dependent on the three things one is how well you do in technical merit review or scientific peer review which we will talk about later -- the available budget they have -- and programmatic priority and so the larger institutes as you can imagine also tend to get a large amount of applications and so the overall success rates more or less hold steady across e-Board but they can fluctuate from year to year and agency to agency. We talked about how NIH SBIR program is a three-phase program along across the top phase 1 we talked about, phase 2 we talked about the phase 2 and second phase 2 months phase 3 and below that we have additional programs that it's somewhere available and some I Touch Base on because they were here and expired and may come back that can help with the process. We have a fast-track program shown and I will talk about in a minute which is combination phase 1 to 2 and phase 1 to 2 funding gap below that we have an SBIR direct phase 2 authority that allows for firms who did the phase 1 Gravano applied directly to face 2X congressional authority has expired and we had a commercialization pilot that expired that provide additional funds and so it's important to know that whatever you're looking for you want to talk to a Program Officer because in certain of these programs not all institutes participate because of typically for budgetary reasons -- so the fast-track program is a simultaneous submission and review of a phase 1 and 2 and this is all done within a phase 2 page limit and so we won't get into the deep weeds of applications formatting and submission but a phase 1 research plan is typically six pages a phase 2 research plan is 12 pages and phase 2 also requires a separate webpage commercialization plan and a fast-track is a combination phase 1 and two is a 12 page research plan and you have to fit phase 1 and two approach significance and innovation and to 12 pages. So that is reviewed together as a unit in peer review and if it does well, the phase 1 is awarded. The firm does the phase 1 and since in their milestones and final progress report of phase 1 to their Program Officer and program can make a staff decision to issue the phase 2 typically within weeks to a month after the end of the phase 1 which really shortens the funding app between phase 1 and two as applied for a whole cycle. Fast-track, which you’ll see in a minute or -- are hard to get they are roughly 10% of our volume and are typically hard to get into phase 1 and you will see those in a moment success rates -- direct phase 2 I touched on and I will say that it comes back we will work through to reissue the option for your applicants we do know that it was a well received in popular program and we are -- it is expired because the congressional authority for us to offer it expires and [ Indiscernible] Talked a little bit about phase 2 being $3 million up to three years and not all of our institutes participate many but not all typically the medium to larger sizes Institute mainly for budgetary reasons and you always want to talk to a Program Officer what you get a phase 2 Dr. Program Officer about phase 2 so you can begin planning for it. All of our funding opportunities at NIH SBIR can be found on or funny website SBIR.NIH.gov/funding -- this page is broken into several areas the most important part typically in the is a top section that list the Omnibus solicitation in the screenshot shows this year we have it in a minute we have one for SBIR one for STTR we also post our topics document and you can see that below this is our 200 some odd page topics broken up by Institute where they all list their interests and priorities -- but as a general Omnibus solicitation and NIH as a whole and NHS is investigator initiated agency and general announcements are will except any SBIR and STTR submission as long as it's within our mission it don't necessarily have to respond to a specific topic under the parent solicitations additionally we will talk about in a minute budget there are budgetary limitations at some point above the guidelines and we have approval and a subset of those topics are available for higher budgets and we list those topics here on the approved a budget waiver list. And the lower parts of the funny page we are keeping up the direct space phase 2 area in case we get later and have targeted solicitations which are other solicitations not the parents so/funding get you everything you need to know and we also crosspost all of our funding solicitation NSBA central site SBIR.gov and so you can fighter solicitations that SBIR.gov and at any actions website here -- NIH website -- two kinds of solicitation to get questions that we ever parent solicitations and also called Omnibus and these you standard two dates three times a year and I will talk about that and the minute -- these are reviewed in special emphasis SBIR and STTR panels at the United Center for scientific review and all of these follow applications and structures that are interapplication guide in annotated forms that and I will show you where these are on a website to find easily in a minute -- back we have many other types of funding opportunities we call targeted solicitations, these are specific funding opportunities by one or more institutes they may have our standard today's three times a year or they may have custom dates and my be a one date only request for applications or artifact these might be reviewed at Center for scientific review or they might be reviewed at an Institute review panel. There also may be additional instructions in the special funding opportunities that you need to address in your application the bottom line is no matter which one you apply for you need to use all of our resources and read the funding opportunity announcement or FOA or FOA carefully and provides information you need to prepare an application -- >> Now some of the brass tacks of our main solicitation the parent solicitation for this year which was issued on June 5 we call it a PA or program announcement the SBIR one is PA -- 17 -- 3002 -- the STTR one is called PA -- 17 -- 303 and these are hyperlinks in the slide deck and you can click on and Google them or find the minor website and we issue that in early June this year and we should it June 5 this year and we typically issued these 432 dates per year September 5, January 5 and the following April or following January and April this particular set of parent announcements anybody who's looked at them will know we only issued them for two dates we issued them for September 5, 2017 and January 5, 2018 we did not issue it for April 5, 2018 that third date that was on purpose it was not an oversight or mistake, and know the programs are not going away after that which is a question we get every year after the end of the Omnibus these were issued with only two dates due to the fact that the entire federal government including NIH's switching a form type that underlie Grants.gov forms and moving from what's called phone Steve to forms the and for the past year and a half or two years this has the type basically the forms and questions that are asked within the forms packages on top of the research plan and things like that so NIH wide not just SBIR and these reissue our funding opportunities to switch between forms D Andy and D and E and Omnibus solicitation's after January 5 didn't then she would for several do this one inch wood for April issue it for probably April in the whole following year and gone his questions on what is the difference between DND -- and is NIH's changing how we collect information about clinical trials in our funding opportunities and we all have key changes will be a new clinical trials form and also for that reason we are we issuing an clinical trials will come in with institutes that will accept them as is in the current way under current instructions and the two do they say we will be issued the solicitations in early to mid January for the next year or so with a new set application package and instructions and I promise we will do a new Webinar at that time to like this one that will cover the basics and cover all the new differences and all the new things you have to know when we read issue and the current payments are open for September 5 deadline only 17 and the January 5 deadline for 2018 and they will -- reissue after that it's a little short and we apologize for that but like the rest of NIH we will reissue those solicitations these are good to go and you'll be able to do renewals and re-submissions as well on the new solicitation and want to let everyone understand it is to do dates when they are reissued. All said that's a grand solicitation -- and talk about the targeted solicitations I mentioned up front that we also issued contracts and around 10% of our overall budget is spent on SBIR contracts we issue an annual once a year with one do they contract solicitation with a couple of our institutes I think this year will be four or five institutes in the CDC participate in our SBIR contract solicitation this is very different than our grand solicitation contracts and grants are different funding vehicles that have to follow different regulations and laws and so grants follow grants policies and grants regulation contracts follow the Federal acquisition regulations or the FA or so we issue a separate contract solicitation with very specific narrowly defined detailed topics online a grand solicitation can be investigator initiated contracts issued very specific and information is last year's because we are currently working on this year solicitation and they'll be issued within a few weeks in July and will post on our website with the details and do a separate Webinar for the SBIR contract solicitation so stated for that as well if you are interested in SBIR contracts. You can always find out about what is going on at the NIH what we are publishing in terms of updated policy and our funding opportunities for SBIR grants and contracts in the publication and online publication we call the NIH guide for grants and contracts and the link takes you to a place to sign up for the listserv for a weekly email republish every day per but every Friday afternoon is a weekly digest and summary of everything we issued in the past week. On any given week there may or may not be SBIR funding opportunities but certainly can find out about it in this weekly digest by signing up for the grant NIH guide listserv everything is automatically posted daily when we post them on SBIR website this gives a summary by week. With the current Omnibus parent solicitation, and with the upcoming changes I alluded to in clinical trials and if you're interested in the upcoming changes, we have you can go to the NIH central website@NIH.gov or grants and look up funding and related to clinical trial changes that are in effect yet that they are coming as a result there several institutes that will not accept clinical trial SBIR and STTR applications under the parent solicitation under PA, -- 17 -- 302 for SBIR and not under PA -- 17 -- 303 STTR the national eye Institute national human genome research Institute national Institute of allergy and infectious disease national Institute of arthritis and musculoskeletal and skin diseases national Institute of dental and craniofacial research, national Institute of diabetes and digestive and kidney diseases National Institute of Environmental Health Sciences, national Institute of neurological disorders and stroke, national Library of medicine, national Center for advancing translational sciences, the office of research infrastructure programs and the US Food and Drug Administration FDA these components will not accept clinical trials under the parent . They may accept clinical trials under different funding opportunities be at SBIR or otherwise, and so if you're interested in funding and requesting support under SBIR or STTR for clinical trials and NIH defines that you would definitely need to contact the Program Officer and ask what's the right funding opportunity to submit that clinical trial to peer They won't fix up the phase 1 grant or phase 2 grant clinical trials under the Omnibus these entities but they may have other funding options for you other solicitations you might apply to you definitely want to contact them and this will likely change when we reissue new solicitations? Calendar year but for the moment these will not accept clinical trials under the current Omnibus so please be sure to contact them if you're going to do clinical trials and they will give you advice on what you can do and what your options are per to (Solicitations as I said has a topic list that has the better part of 200 pages probably more of Institute topics and priorities and they cover the gamut of all biomedical research and biobehavioral research. Assembly can do that helps you can search obvious about hitting control after keyword searches and find your area but even if you don't find a topic that hits for this close to what you are going to do you still may be able to apply as long as what you're proposing is a mission of HHS and so we strongly recommend especially if you don't find the topic to write us by email and request a conversation with the Program Officer with a short summary of your application. And I should also say that the grants and Omnibus you can always contact us at any time there's no blackout period, you can call us email us, and your conversations with federal program staff or confidential conversations we do ask you to send a little information about what you're doing in a nonconfidential abstract but our conversations are confidential and privileged. And additionally your grant submission or contract submission to the agency is not a disclosure in the terms of an intellectual property your grant proposal and contract application are only access to government officials who need to know and review staff in peer reviewers so submitting does not compromise your intellectual property and is a privilege government communication and so we take that very seriously. >> On to success rates -- I've talked about the different parts of the program the phase 1 and two and different person now we look at success rates this chart shows us the x-ray for less fiscal year and if we have time I will show you where we the [ Indiscernible] blue SBIR blues STTR look at moving from left to right fast-track program and phase 1 into last year had a 13 to 15% success rate for fast-track that tends to attract along with the phase 1 success rate and neck set shows phase 1A 13 to 14% success rate in them 50 to 18% depends on the budget we have and find move applications that is phase 1 fast-track success rates around of 13 or 14 1516 fluctuates from year-to-year depending on applications and budget the phase 2 success rate the regular phase 2 success rate is in the next set of bars and you can see that's about 30% and that fluctuates between 30 and 40% a year depends on by and you might be a little surprised to see that the phase 2 success rate is so much higher than a phase 1 success rate is typically double or more the reason for that is that the phase 2 applicable is phase 1 award is and so it's a preselected applicant pool of phase 1 awardees can apply for phase 2 and an new applications are open essentially to anyone who was to apply eligible small business but phase 2 are from phase 1 awardees and in fact to be a phase 1 award he both from NIH make address or any other federal agency if you have a phase 1 award from NSF and want to apply for phase 2 to NIH, we can do that and we can accept that provided that it is within the United Nations your phase 2 work you can switch agencies between phases you can switch programs between phases you might apply for a phase 1 in when the phase 1 STTR and apply for a phase 2 SBIR and vice versa provided that you meet the program that follow the rules of the program and that's a phase 2 success rate and phase to be success rate more or less follows the regular phase success rate around 30% or you can CSPR phase 2 regular phase success rate around 30% or you can CSPR phase 2B 32% last year and we had one in the lower right you can see our outlier we had one happen to get just one application agency-wide for an STTR phase 2B in Tidwell and received word that application for phase 2B was 100% however was one application we didn't want to put that in the chart necessarily and push all the bars down but we did provided here for you so you understand we did get one application and one award for STTR. The direct phase 2 provision would be made awards in fiscal 15 and 60 will make our final words and 17 unless we get that authority back that has success of around 17 or 18% that SBIR only that is not applicable to STTR and direct phase 2 has about a phase 1 success rate or so and that is mainly because it's a new application and it is no prior award. The commercialization readiness pilot program CRP has a success rate last year of around 22% we will make award for the CRP this year in 2017 and then that authority also expires unless we get it back and all this information about success rates in the number of applications and awards is publicly available information@SBIR.NIH.gov and if you hit the award statistics button you will see that it is also available in the NIH reporter database@reportsthatNIH.gov and I will show you on the website when I go live with a little time where you can find all this information available to you. >> So I will take a small Segway before I get to the other parts of the talk about when it's -- might be appropriate by highlighting a few companies use program very well and so an example of success company is a company called live labs is a company designed to develop new technologies to provide proactive care for people with a central tremors in Parkinson's disease they apply for phase 1 and two of the program several years ago and participated in Technical Training programs and talk about at the end and this company was acquired by Google in 2014 and is still in business working within Google to continue to develop and refine their technology and so we essentially they have graduated and SBIR eligible but did very well by the program -- another firm that we've funded that's doing well is called Sennis tech and this firm is has technology that as infertility nonlethal in environmental way funded through SBIR program went through additional programs and they were now with transit systems and programs around the world web rotor problems and technology is used to manage rodent issues in very careful way. And it is a firm that is not very well by the program and you can already see a diversity of the types of things we find. Another key aspect of SBIR program in NIH is your ability to what we call resubmit and that is the ability to if you apply and not funded the first time, and of course under phase when you see about 85% of our phase 1 is not funded you have the ability to fix your application in response of the disincentive improved application at a future did it recall that a resubmission and it does take a persistence and learning the art of writing grants and how to respond appropriately in paperwork for a peer review in the program and so what does you are allowed to picture application and resubmit it which is a unique ability at the NIH other agencies typically have one received a the year and you cannot fix it and send it again you are able to picture application and send it forward again and that's unique ability should definitely advantage of -- we also fund a lot of different types of research and this one is to highlight that we find educational research and we also are interested in funding a variety of firm background to group including women and minorities on firms and talk about what that means an amended in terms of how important that is it rolled back to one of the three congressional goals of the program about increasing women and minority participation in SBIR and STTR and we do find educational curriculum development we fund healthcare apps and IT as long as is within the realm of healthcare, and not actual healthcare of course -- biomedical and bio research can be applied -- and so applying requires Electronic Submission of your application to the agency and when electronic years ago there systems federal wide that you have to apply for it to be able to register for to be able to submit a you tend to be to do this in order because once it's -- [ Indiscernible] take 6 to 8 weeks to register in total and definitely recommend to start early and get it DUNS number which is a free federal ID number and all of our solicitations have information that links and instructions on how to get all this that you have to register in the system for word management or SAM and need a DUNS number to register for SAM. SAM registration tends to be the longest point of registration and can take a week or two and some cares okay surely longer and you definitely need to start early to register in salmon then you can register essentially simultaneously in Grants.gov, ERA comments and ERA stands for electronic research administration ERA comments is NIH system NSBA country company registry SBR.gov and these registrations are required for a firm to submit an application. And start early. We have a registration infographics that lease this out here in our -- all grant submissions to NIH CDC FDA and ACL for grants -- omnibus or any targeted grant solicitation -- contracts for SBIR contracts I talked about we run when electronic two years ago using a separate electronic contract proposal submission system called ECPS and so contracts are now submit electronically but the place where you find the information most about your application and status as an ERA comments in NIH system that tells you everything about the tracking where the review is what your score is how to get your reviewer comments called summary statement and word -- [ Indiscernible] available in an ERA comments -- and you submit your grant application to the agency you have a choice of a couple of options and I will recommend using option number one which is the assist system NIH developed an online submission system called assist several years ago it is an as this does an acronym stands for applications submission system and interface for submission tracking which is why it's much easier to say assist and you can still apply to Grants.gov using the work space option and technically can use Adobe forms using the download forms package and uploading that to the system Grants.gov that will be available for September and January but those Grants.gov is discontinuing those forms after our January 5 to date only be able to use a 4 g I double space I strongly recommend that you use the assist system it is online and allows you to check for errors and pass information around the team and view your application before you submit it into really is a good content flow Manager for your application process. We have done Webinars on assist in the past and both for SBIR in general and train on assist debtor Annual Conference and if you ever applied for it's your first time I recommend you do the assist system or convert to it especially if using forms because the forms will be going away but they will be here for the next two cycles I want everyone to understand that. Who has to use assist? Or Grants.gov to submit the applicant small business signing official is a one-way place in a sea application of the University so your business signing official is the one who does that pushes the buttons in the end to submit and include the application for the agency on behalf of the company. Timeline for receipt toward the next two cycles -- typically we are talking about 6 to 8 months it depends on the time of year in whether NIH has a budget and continuing to work for lease up for instance if you are applying September 5 deadline they'll go to peer review in October or November and go to secondary counsel review in January February 4 first date of March and from their -- The overall process shown from receipt toward it is a long process and it is follows rest of NIH submission process for awards and submit@ goes to Center for scientific review for assignment to visited IC Stanford Institute Center and is a peer review study section IRG integrated review group that goes to peer review by external panel of experts made up of both academic and industry reviewers goes to secondary review, programs that makes funny recommendations, ultimately the Institute Dir. makes the ultimate funny decision and we issue the awards after a pre=award process whereby we have to work with you to certified that you are an eligible small business that there's no human subjects [ Indiscernible] other certifications and issued the award to do the work -- We assess grants in these areas we look at five review criteria significance investigators, innovation, approach, and environment. And these each receive an individual impact criteria score of 110 nine and one is the best and nine is the worst and so low numbers are good in NIH reviews. Your application also receives an overall impact score between 10 and 90. Your application also receives an overall impact score between 10 and 9010 is the best and 90 is the worst and that is based on the overall feeling of the panel and your review. The review criteria in the questions that are asked of the reviewers are addressed in every single applicant -- funding opportunities so you can read the questions that reviewers will be looking at and you can write your application to make sure those questions are answered in your proposal. Additionally we look at other areas of your application and not necessarily scored but protection of human subjects if it's relevant for your work, inclusion of women minorities and children if relevant, vertebrate animal protection the Flovent and biohazard profession development -- The peer review process is a whole other Webinar whole number -- information the website at or Annual Conference to provide an hour to an hour and a half presentation on peer review we do my study sections and so there's more on peer review we don't have the scope to talk about it in this type of overview Webinar. The most important piece of advice that I can give anyone listening or else is I mentioned a few times is to talk to us engage us -- at least a month in it if not the deadline if not sooner write us if you don't know who to talk to for Program Officer you can write the central office or emails at the bottom SBR@OD.NHS.gov and best way to do it is to send an email with request for phone call conversation the vast majority of folks would get back to quite quickly and it's the summertime we tend to take leave and so there's a backup if you cannot get the first person, or not getting answer you can always look up someone else or contact us will get you someone to respond to you quite quickly to answer questions and give you advice. >> Touch on two points I mentioned earlier about women-owned small businesses and socially and economically disadvantaged businesses this is part of the mandate we have in Congress and one of the four congressional goals is to increase participation by these groups are we track that at the application and award level and every single agency you apply for on the cover sheet or whatever the equivalent says you have a checkbox of RUO woman owned business in or are you a socially and comically does it damage business that's used to be called minority on business but definitions are broader and check one or both that not depending on the situation definitions are shown on the slide -- relatively easy to understand the socially economically and disadvantaged business as a bit of a complicated definition NSBA has information on that and we want to know for tracking purposes only what is the flex of applications for women and minority businesses into our system and what is a flex of awards out the door that we know that women owned in my note on small businesses have a lower percentage of our awards that is proportionate to their participation in the workspace and the small business space, and we want to use this information to help us conduct different types of outreach and to better training to increase participation. Most importantly whether you are a woman or small business or socially economic as advantage business and whether you check the boxes and you should check them if they are relevant for you for tracking purposes -- that has no bearing at all in our decision to accept your application and our decision to review your application that is what happens in peer review and in any final decision -- having a woman owned minority owned small business provides neither an advantaged way disadvantaged in any aspect of our process from receipt toward the Arsenal used for aggregate reporting of applications and awards at an aggregate level so we know how we are doing and how we can better tailor our outreach efforts to increase participation and there's many concerns about this, but I hear to tell you that it is used for tracking purposes only we have berms that sometimes do not understand or know if they are and we can perhaps help you with that as well -- but we would like you to check the boxes if appropriate. Now even in SBIR contracts some of you of course are aware that women won't associate socioeconomic disadvantaged better this [ Indiscernible] in applying for government contracts that is true when you're applying for a service contract from the government does not apply to research and development or R&D contracts the decision for SBIR contracts in SBIR grants are based solely on the scientific merits of the proposed regard regardless of the status of the company and I want to make that point. Touch on the budget -- talked about the guidelines are 150,000 phase 1 in 1 million for phase do we have authority to go over these and as applicants to 225,000 in phase 1 and 1.5 million for this 2 if you propose a budget and want to propose a budget over these hard caps you can, we have a budget waiver list that allows us to issue awards to firms that are overly hard caps if appropriate and so we do not give permission in advance for large budgets but we do recommend you talk to the Program Officer about your project in about budget you think you need and you get advise whether not we could accommodate that should it do well in peer review but please talk to us if you think regardless of what kind of budget -- talk to us so we can give you advice on how you can come into us. In addition as I wrap up in a few minutes in addition to the awards we have other programs available to support you to help you a bit with the BN SBIR business we have a innovation gore ICOR program of visible to phase 1 awardees that we have a funding announcement on that once a year for our phase 1 awardees and we have facilitate partnerships we send many of our awarded firms to partnering on investor form events across the country most of us got back from the annual file technology industry organization bio form in San Diego last week in which we sent 60 NIH and CDC firms to exhibit in bio and we help our firms in other ways. Lastly, in addition, we provide technical assistance program for phase 1 and two awardees once you get an award and we can assist you in phase 1 we call the initial assessment program that program is provided on or behalf by foresight technology and this is a program that helps firms give them inside into the market analysis of their technology were other markets might be out there and helps them develop competitive market strategy and helps and perhaps of their phase 2 commercial plan and out it application are phase 2 program is called the commercialization accelerator program that is provided to us by our LA RTA which we work with one that program that is phase 2 awardees and this is hands-on Internet most training program in any number of areas on the bottom of the slide this can is a very much a tailored program specific to the need of the firms of which we help support the programs are free to you participative whatsoever toward we put our calls interested firms once a year in each proposal typically in the late summer fall when the awards go up the door for the stated that if your phase 1 or two awardees also contact your Program Officer ask up in this program to catalog and the ICOR program we can give you the information you need -- To wrap up and go to questions we have a listserv many of you might've found out send email to the email on the first bullet we will get you on that about a 20,000 member listserv you can register for the NIH grants and contracts for our weekly emails we have a Twitter account at NIH SBIR and at the bottom a central office email at SBIR at and at the bottom a central office email at SBIR@OD.NIH.gov and I both of these five people who are incredibly talented people who work with me in the central office to quit the SBIR program that's me in the upper left Patty who will come in a minute to help facilitate questions and the lower right and Rob Vincent and Julie beaver Rob Vincent on various aspects of the problem of program and what that I will as bad gets a couple questions queued up these are some questions that were sent in by you in advance of Webinar and I will roll to some of these relatively quickly and Patty can come on and we will go through as many as we can get through before 330 and we have about 20 minutes I know we have a large set of questions in Q and so we will help out and go through these quickly required of a company to apply yes it is -- company has to be legally formed IRS and registered in the systems in order to apply the way it is nowadays with electronic systems will do directs phase to return what it a go wait -- it went away because the congressional authority expires in Congress must pass a new law to make a comeback and there's bills in progress that might do that and stay tuned for that -- are there significant tactical changes to the Omnibus solicitation since the last round the only difference really is that we had to do to do this in stead of three and several were not accepting clinical trials and the net other than that basically exactly the same -- >>: Easy approval process assuming everything is Semitic directly at depends on but around six but around 6 to 8 months from or received toward his or any special preference for socially or economically disadvantaged or minority owned just address out a few minutes ago -- planning on fast-track for September 5 to new talk is about it I covered that it's a combination phase 1 to application within a phase 2 half guidelines on this -- What is the easiest way to submit through grants.gov or using the system it that's a loaded question with super 14 may be more difficult for another firm we recommend NIH assist us it's a program that a system that we run in control and spend a lot of time or working on it and we do a training on as well Your updates allowed after submission this is a very good question the answer is that you can update your application and resubmit it if it is before the deadline -- if it is before the deadline -- the deadlines are always 5 PM on the due date, your local time, for your company is located in California West Coast it is 5 PM your time it is a DM is both enough B a firm in Hawaii it is 5 PM Hawaii time than of course all the other time zones but it has to be submitted here are free by the deadline anything after that will be subject for late policy and regular updates are not allowed so we strongly encourage applicants to submit several days early . The system is open 30 days before the deadline we know most folks wait until the last day we know most folks wait until the last hour we know most folks wait until the last two minutes when you submit several days early you have the opportunity to ensure that everything is exactly how you want it and you do allow yourself the time if you miss something for whatever reason you can't reject your application and send in a fixed one as long as it is all in before the deadline Please do yourself a lot of help and do not wait until the last five minutes before the deadline the last half-hour submit hours days, before the deadline -- Importance of literary results so phase 1 will have language in every agency solicitation that preliminary results are not required in phase 1 -- all of that said many firms have preliminary results and protect go to peer review will have preliminary results and you are competing against firms that typically may have preliminary results. So if you don't have them, that can be fine but you have to have a solid research plan and solid background in significant compensate for that in it should be crystal-clear what you hope to do and what will come out of it. If you have preliminary results you want to include them. >> What helps torture qualifying score what are reviewers looked for an submission does academic partnership increase the odds -- you cannot really ensure anything you can do your best and hope that it does well and so talking with program writing a quality application meaning you to tell a convincing story is all the sections are important but significant innovation approach tend to drive that that you need to have a strong strong significance and explain where your technology will fit in the market what the problem is your try to solve them why what's out there is not doing that and then tell them how you will do that and what the outcome will be with projected outcomes will be an especially in phase 2 and little in phase 1 that customers out there who are interested it's important to develop solutions for problems that people have not solutions for problems you think people have -- it's important to talk to potential customers and collaborators and talk and build something that meet the needs of customers. Then just practice. Doing need to apply the answer is everything comes into central NIH and referred from the Institute center you can request in your assignment request form assignment to a part or parts of NIH and we will assign it based on that in based on where your science is appropriate. Next question interested in CDC and NIHS and whether multiple grants of different topics can be applied in the same grant cycle -- you can apply for two or more grant applications in the same cycle if they are for different projects products in projects you can at the same submit the same project to parts of NIH we don't allow that you can submit different projects to different agencies you consummate the NIH and you can submit to the National Science Foundation or Department of Defense that within HHS you cannot some of the same two -- back if an application is submitted to a specific funding opportunity announcement or in phase 1 can of be renewed in seven into another [ Indiscernible] phase 2 -- any funding opportunity accepts phase 2 will can come from phase 1 application [ Indiscernible] Last question and go to the questions fatty moderates do I need an indirect cost rate agreement before applying for SBR SBIR grants -- no, we do not and in fact NIH will not negotiate indirect rates with phase 1 firms that phase 1 firms can request an indirect rate up to 40% of total direct costs and NIH will grant that without negotiation but you cannot of course request more than the actual indirect cost happens to be less important percent in I told negotiate indirect rates for phase 2 awards and that takes a little bit of time and we will negotiate although in phase 2 you can request and accept up to 40% rate without negotiation -- that covers many of the questions that came in. Not all but many that came in in now I will ask Patty to go ahead and the questions that came in and won't get them all but do our best and if you don't answer any questions we don't answer question we can't get to it -- send an email to SBIR at OD send an email to SBIR@OD.NIH.gov after-the-fact and we will definitely get your questions answered or refer to the person who can answer the question Patty are you there Yes. Thank you for participating in your feedback in tried to answer. Your questions along the way some that have not answered grant types SBIR phase 1 phase 2 and fast start allow for resubmission? >> The grant types can be resubmitted and resubmission is where you are not funded the first time then you picture application in response to reviews and add a one-page introduction and send you back in as -- you can resubmit Is it possible to receive to SBIR phase 2 DBs by one from another agency and one from NIH? That is not going to happen. For anyone phase 2 back anyone phase 2 award received one second phase 2 -- back what if What if your phase 1 to set up clinical trials but your phase 2 will can you go in under the Omnibus? If you're applying for a fast-track and do a combo phase 1 to then no if you're going to just apply for phase 1 for preclinical work or other work or whatever yes you could come in under just phase 1 nonclinical under the fast -- phase one's Omnibus and apply to the right funding opportunity will have some special clinical trials next year and applied to the phase 2 it under the right funding opportunity -- back to let Researchers at government labs? Can collaborating labs be researchers at government labs? It depends -- depends and they could be -- if you are talking about national laboratories, like Department of Energy national laboratories that can be formal as teacher partners and receive a portion of the budget if you are talking about collaborating with NIH intramural laboratory they could be collaborators but they have to be unpaid collaborators we cannot have that money come back to the leave the NIH and come back to NIH for intramural labs that could be non-pundit collaborators were they do their work with their funding in the company does its work with its funny but if it's a formal federally funded research and development center has to RCC national average to be a formal collaborator -- back >> Clarify your statement that the small business owns all resulting data and intellectual property a participating research institution or other sub awardee is allowed to retain ownership of the data and intellectual property created by its project team members but is not required to assign ownership to a small business concern through That in general is correctly by Dole act does allow the data length was small business but sub awardees have rights for the work they do under the award as well. Government does not get the data rights. Please explain funding guidelines versus funding caps for phase 1 and phase 2 and how NIH treats them The guideline funding award size coming from SBIR is 150,000 phase 1 in 1 million for phase 2 total cost direct -- that's called the guideline -- menu could go over. The law says of funding hard Cap at 50% over the guideline so 50% over 150,000 is 225,000 of funding hard Cap at 50% over the guideline so 50% over 150,000 is 225,050% over 1 million phase 2 is 1.5 million 225,000 phase 1 to 1.5 million for phase 2 is a hard Cap and we are not allowed by law to make awards over those hard caps except there's an exception where we can make awards over that if it is under a topic that has a waiver to go over that hard Cap and so we have a subset of our topics as waivers to go better we have guidelines the hard caps and then above the hard caps is the waiver area and those are all three and there's flexibility to fund [ Indiscernible] we can give you advice contact us. >> One is that the research institution he or she must have some relationship of the small business concern -- back Freshly typically that PI might be the own of the co-owner of the business in formal relationship but typically means a letter of support the academic collaborator doesn't have to have a formal -- has love relationship doesn't have to be part of the company so typically all be a letter of support if they are not a member of the Board of the company -- [ Indiscernible] University entrepreneurs who have small businesses and apply for SBIR have to manage conflict of interest under NIH Conflict of Interest what's or academic institution in small business in those conflict offenses rules or exemption phase 1 but in place of phase 2 -- back Can a small business appoint to University Celsius ETR partnering institution that PI would be the one year and recently occur at the other? The general answer is no -- they can only be one formal STTR partnering University. The company at 40% that one partnering University has a minimum of 30% for could be a second University yes but that would not be the formal STTR partner and that second University cannot have the PI added it has to be at the former partner with the first 30% Can we use words for patent office or FDA please? The answer is you cannot use the -- only use the fee it is not an global cost not allowable costs to use direct or indirect cost for those types of fees and expenses but the profit/the 7% is unrestricted can be is there anything including that -- Of the PDF forms going away to electronic online version only? Yes. The PDF forms and the latest information we have progress eyecup note that NIH is not in charge of the PDF Adobe forms Grants.gov is. They will go away in the new calendar year after the January 5 deadline in the forms are available in our current Omnibus and in all NIH funding opportunities through them through the January 5 deadline and our next Omnibus or reissue will not in ASP across an item not have the forms available it will be online and the fifth online with PANSS workspace or online with organization own system to system operation -- back Can we apply for two phase 1 proposals for NIH on the same cycle? The same cycle yes, same project no could be two different topics and that's fine Could go to the same Institute if two different topics and projects but have to be aware we know that and will look at your pending applications from here and all other funding sources before you make an award for [ Indiscernible] budget duplication -- back >> Allow resubmission in a manner typical of NIH peer review? All SBIR grants get some statements summary statements in summary statements not the same format across NIH so you get the summary statement in order to get the peer review comments by three or more in order to respond to interviews and a resubmission -- Provisional patent necessary before applying No not necessary nor required -- you want to -- I encourage firms not cost neutral should definitely talk with patent counsel but any of all those types of issues and of course applying to NIH any federal agency is not a disclosure -- of your technology. I don't see any new questions coming in. I want to reiterate that this PowerPoint presentation the transcript of the Webinar and a recording of the Webinar will be available sometime next week on our website SBIR.NIH.gov. You will be able to find it in the news section and we will also put a message on or Twitter when the information is available for any additional questions you have or if your question was not answered, I suggest we welcome you to contact us at OD -- SBR at OD. -- SBR@OD.NIH.gov and we will circle back with your answer. Thank you very much everyone in this concludes today's Webinar. [ Event Concluded ]