NHLBI Small Biz Hangout: Taking Care of Business – Managing SBIR/STTR Grants

Good afternoon, and thank you for joining the National Heart, Lung, and Blood Institute for today’s Small Biz Hangout. I’m Jennifer Shieh the small business coordinator and program director at the NHLBI and I’ll be moderating today’s session on managing SBIR/STTR grants. Our presenter is Andre Walker, grants management specialist with the NHLBI and we’ll also be joined by grants management specialist Ann Marie Brasile Mejac for the Q&A portion. Andre is a grants management specialist at the NHLBI with more than a decade of experience in the field of grants management. He spent much of his time managing all aspects of pre-award and post-award functions for large portfolios, diverse and complex Mechanisms. He also knows about grants management on the academic side and other complex program project grants. Between 2011 and 2014 Andre served as the Office of Grants Management SBIR/STTR coordinator and chair for the trans NIH Grants Management Advisory Committees SBIR/STTR subcommittee – where he promoted consistent procedures and best practices across the NIH for the administration of SBIR/STTR grants, as well as serving as a resource for NIH-wide initiatives related to the SBIR/ STTR programs. You may have met Andre at one of the HHS SBIR/STTR annual conferences. If you haven’t, you can come join us in Milwaukee next Fall! Before joining NHLBI Andre was the grants technical assistant at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). He’s also just a wonderful person to work with and we’re lucky to have such experienced and dedicated grants experts with us today. I’m going to turn this over now to Andre. Thank you Jennifer for a very nice introduction. By the end of this presentation it is my goal to help you understand the general eligibility requirements, budget guidelines, just-in-time preparedness, and post-award activities. In order for your business to be eligible for a SBIR/STTR award it must be a for-profit entity legally formed in the United States. It must also be more than fifty percent owned and controlled by citizens or permanent resident aliens in the United States. No more than 500 employees can be employed at the company. Since the reauthorization act was mandated, if an SBIR is backed by multiple venture capital companies it must be more than fifty percent owned and this actually only applies to the SBIR. So if there are any concerns if there’s a concern of small business that is more than 50-percent owned by multiple VCs, there will be a VCOC form that the small business will need to fill out. That will come when the just-in-time information is requested. Another area we will play close attention to is your budget request. It is our job to make sure the costs requested are appropriate for the project and are within the guidelines set in the funding announcement. For the Phase 1 SBIR award, applying from the Omnibus, you have a limit of $150,000. That includes direct costs, indirect costs, and fee. If you request more than the $150,000 dollar threshold, but less than the $225,000 dollar hard cap, that will require strong justification and approval from your Program Official. If your budget exceeds the $225,000 hard cap for Phase 1, $225,000 hard cap, and the $1.5 million hard cap for Phase II, your project will need to fit within the approved NIH topic waivers. As always applicants are strongly encouraged to contact NIH Program Officials prior to submitting any application in excess of the guidelines. Also, they should also speak with the Program Official during the planning phases. In all cases applicants should propose a budget that is reasonable and appropriate for completion of the research project. Regarding third-party involvement, in Phase 1, normally a minimum of 67% of the research or analytical effort must be carried out by the small business concern. In the Phase 2 SBIR, normally a minimum of analytical effort must be carried out by the small business concern. In the Phase 1 and Phase 2 STTR at least 40% of the research or analytical effort must be performed by the small business concern at least 30% of the research or analytical effort must be performed by the single partnering research institute. The basis of determining the percentage of work performed by each of the parties will be the total of the direct cost, the indirect costs, and the fee. So if you have received any indication that you will, or you may be, receiving funding from NHLBI you should be prepared to submit just-in-time when requested by your Grants Management Specialist. In general, you need to submit items like other support, various certifications, or verifications like your SBIR funding agreement, your financial questionnaire, your vertebrate animal certifications, SBA registry, your office of research integrity assurance certification, and your VC or venture capital certification if necessary. Other support includes financial resources – whether federal, non-federal, commercial or institutional. available in direct and of an individual’s research endeavors including but not limited to research grants, cooperative agreements, contracts and or institutional awards. When providing other support, it should be for all personnel involved. NIH does administrative review before the award is issued and NIH looks for over-commitment of any key personnel. It also checks for possible duplication of scientific goals, financial support of same projects from other sources. Here I provide an example of what your other support should look like. As you can see, it should reflect information such as the grant number. Do we have a cursor? So, it should reflect the grant number, the name of the PI, the person months, performance dates, and your annual direct costs. In addition to the approved support, you should show the applications that you have submitted and are pending review or approval. After listing the active and pending awards, please identify if there is overlap with a pending award. Any and all overlap will need to be identified and removed prior to the award. Your program and grants management specialist will contact you if that needs to take place. If we need to get in contact with you, we will do so via the just-in-time or basically prior to the award. All small businesses that are selected for SBIR funding must complete the SBIR funding agreement certification at the time of award. This includes checking all boxes and having an authorized officer of the awardee sign and date the certification each time it is requested. So with this form, I will cover the one question that seems to cause the most confusion. That is question number 14. Number 14 asks if your business is a covered small business that was not majority-owned by multiple VCs when it submitted the application in response to the SBIR solicitation and on the date of the SBIR award, which is made around nine months after the closing date of the solicitation, is majority-owned by multiple VC’s. So by answering yes you’re stating that yes, from the time that I submitted – when I submitted my application I was not covered by multiple VCs but now that I’m about to receive the award which usually is a 9-12-month period things have changed and I am now covered by multiple VCs. In that case again you will need to fill out the VCOC certification and normally we will identify that and we will send that certification over to you once we see that you’ve checked yes to this question. Again, in order for this certification to be accepted you must respond to all the questions and complete this, filling out the box. Grantee organizations are expected to have certain systems, policies, and procedures in place for managing their own funds, equipment, and personnel. A system of clear roles and responsibilities should be delineated in each grantee organization and should include a financial management system. These systems include, but are not limited to, accounting internal controls and budgetary controls. Demonstrating the grantees management capabilities is one of the evaluation or criteria used in the administrative review process prior to issuance of award. To encourage uniformity, and in the review of the grantees financial management system, NIH has developed a questionnaire entitled “Evaluations of Financial Management Systems”. The questionnaire is a tool designed to assist both grantee and NIH staff in assisting or assessing the grants management capabilities. Concerns related to the grantee organization management capabilities may result in determination to withhold an award, or issuing the award with special terms and conditions. If there are any concerns again we will – we meaning the Grants Specialist and Program Officials – will do our best to resolve those concerns prior to the award being issued. If your research requires the involvement of humans, you submit your human subjects research assurances. You should submit the IRB (the Institutional Review Board) approval, and your human subjects and certifications for key personnel. Please note that your institution must have a separate human subjects assurance even though the work will be completed at a different performance site. We cannot issue the award unless your small business has that assurance. If your research requires the involvement of animals you must submit your institutional care animal care and use committee approval. You must also have your vertebrate animals research assurances. So with the animal assurances again you will need to have your own. If you do not have your own assurance, what grants management will do is submit a request to OLAW to initiate this inter- institutional agreement process. So basically we even if you know the process don’t go out and start yourself until OLAW contacts you to get the institutional agreement or agreement started. So now that you have received your Notice of Award you should always review it. That is very important. It will show you how to set up your accounts to receive funding. It also reflects the terms and conditions and how to appropriately close out your award. Just like during the pre-award phase, you should speak to your Program Official and Grants Management Specialist whenever you have any questions during the post-award phase. Also you should also update your SAM registration. We cannot issue any awards unless that registration is current. I’ll say it again. it is always important, whenever you have any uncertainty about anything regarding your award, please consult your Grants Management Specialist
and the NIH Grants Policy Statement. If you are still uncertain, please contact your Grants Management Specialist and Program Official – we are here to help in any way possible – trying to keep you out of that orange jumpsuit, you
know that’s one of our goals. And finally, the closeout. These are some of the general close out requirements: your final progress report, the final invention statement and certifications, and your final FFR. Again, this information will be provided in the Notice of Award. There’s a special section that tells you how to properly close out your grants. That’s everything we have for you. Thank you Andre. We’re going to move on. We wanted to leave plenty of time for the Q&A section. Just making that little disclaimer again – that these are for educational purposes not necessarily specific to your award or application and to reach out at that contact NHLBI SBIR link for any questions you might have. That is also where you can submit your request for slides. If you’re not working in the NHLBI mission space, certainly reach out to the appropriate Institute contact that can be found down here. And again, submit your questions through the Q&A Panel. We got a few questions so we’ll definitely be going through them. I’m going to leave this up here again the listserv, sign up for any future Small Biz Hangouts or in-person events. We also do try to send out useful information like deadlines coming up and other tips and tricks and resources. If you go to this link here it will bring you to the website where you can submit your questions or request slides. And, I guess, a couple of things I wanted to raise. Well, OK, I will leave this up here for a couple minutes while I talk. Then what we’re going to do is switch over to cameras. You can actually see that the government is not just we’re not just faceless bureaucrats here – we are actual people, we really want to help you. I’d also like to make sure to introduce our other special guests here! We have Andre – you just heard from, we also have Anne Marie Brasile Mejac – who’s also a Grants Management Specialist at the NHLBI. She’s been a Grants Management Specialist for over 20 years. She has her bachelor’s in business from Johns Hopkins, and has been a certified research administrator since 2008. So we’ve got a wealth of experience here and you’ll find that at the NIH there often is a lot of flexibility. There are a lot of different rules and so it can be very complex to navigate these things. In particular, we know that the small business program has a lot of different little nuances. Certainly we want you to reach out when you have questions. I am going to switch over. Hopefully you’ve written down those – just sign up while you’re seeing it! alright so we are we live? I think so. Alright so we start with some questions and I guess one of the items I wanted to mention, just make sure that it was it was clear, that you know the period. Especially because in the advertising I talked about how to get your award faster. So when you get an email from your Grant Specialist that’s asking for just-in-time information, or that “JIT”, then that’s what you want to reply to because they need that information before an award can be made. Generally that information is requested between
the time you apply and before you can actually get an Award. Sometimes you know that as soon as Council can approve awards that we try to get Awards made relatively quickly after that. And so we need this information for that. I’ve got a bunch of questions about the just-in-time, and the first one is “We’ve been requested to submit JIT documents. How do we submit them? Do you need this in what format? Do they have to be uploaded as a single PDF if you have to put a cover page listing all the documents?” Either Andre or Ann Marie -whether it’s one PDF or several I mean that’s kind of a preference for the Grant Specialist that’s listed in the Commons for that grant i mean if you have everything except for like the IACUC, or IRB is pending, then you could send what you have and then email the rest when it comes in. But again, you should check with that Grant Specialist that’s listed in the eRA Commons to be sure of their preference. Thank you. We have a couple questions actually now about OLAW. “If OLAW hasn’t contacted us yet about inter-institutional animal assurance numbers, but all the documents were requested to be submitted in seven business days… If we can’t submit all of the documents in time what should we do? Should we still wait for OLAW? Should we wait for all of the information before we submit those documents?” With regards to OLAW – if we have requested for the just-in-time and you’re trying to respond back to us; first definitely if you’re waiting for an inter- institutional agreement that normally takes longer and that’s not going to come from you, that’s going to come from OLAW and they will notify everyone once that agreement has been approved. As far as the other documentation, excluding the institutional agreement information, you should definitely submit that to your Grants Management Specialist. Thank you. To add to that, because I think that person’s request for just-in-time came from the eRA commons, so their Grant Specialist may not even be aware that they’ve been asked for information. In that case, they should check with the Grant Specialist because that Specialist could say whether this grant’s even in range for funding. If they are, the specialist can check with OLAW to start
the process. Another couple of questions around that. You know if you haven’t had the animal assurance yet but your academic institution partner has IACUC approval do you need to submit documents, do you just wait for what OLAW
is going to request of you at that point? usually if they have IACUC approval, when I email OLAW to start the process I may send them a copy or at any rate the IACUC approval will speed up the process for the assurance because the partner institutions IACUC chair needs to sign that assurance and put down the IACUC
approval date. Then they send it back to OLAW. Without IACUC approval that assurance will take as long as it takes to get IACUC approval. Then sending the form that can take longer. So i guess about timing again if somebody’s been asked for just-in-time information but obviously funding decisions haven’t yet been made… Is there different jit information that’s required immediately and jit information that can wait until funding decisions have actually been made? If so if the request for just-in-time is coming from the grants management specialist, I would submit that information as soon as possible and it’s normally everything. So prior to award we’re basically making sure that everything when you submit is appropriate, everything is current. If there are any concerns regarding – whatever the case may be – eligibility requirements, or maybe the form, we will ask you to update. However, for the most part please submit everything as soon as possible. Just to add a comment from the peanut gallery over here – the point of the just-in-time information is, in providing that information, is to let you also…. Sorry – asking for the just-in-time information before funding decisions are made. The reason is so that your award can actually be made as soon as possible. A lot of the information that you’re being requested, it can take some time to put together. So we’re trying to give you the lead in time. One of the things you can do is certainly based on your score and the funding and operating guidelines that NHLBI publishes you can make that determination and talk to your Program Officer about how likely is it? Do you want to spend the time to put together the JIT information? Generally, if you’ve been requested it’s at least likely enough where we know where we’re not just trying to give you extra work, or ourselves extra work, we’re trying to really speed up that process. So another question is about “Do you have to correct all the warnings in ERA commons if JIT documents have been requested?” Sounds like a help desk question. Yeah, though I think if either warnings that came up when you submitted an application, then no. I mean in terms of, not exactly – so those warnings were warnings about the application itself. If you have questions about the specific warnings you should reach out to the ERA Commons Help Desk. So there’s one more thing that I want to add with that. A majority of us, I believe, prefer to have everything uploaded into the ERA commons that is required. So if you are receiving error issues and you can’t upload this information in a timely manner – meaning you have contacted the helpdesk and they’re trying to work everything out but you still want to get things, it’s just taking longer than expected; I would suggest probably contacting your Grants Management Specialist and including maybe a PDF email and attaching the Just-in-time information to the email. Letting them know that I’ve taken the steps to get whatever the concerns are resolved with the help desk. I’ll be taking longer than expected so here you go. Basically I will go from there, as far as determining how we want to move forward. If You, I guess we’re going to dig in a little bit also around the timing for IRB approvals and end dates so; how would you respond to the IRB approval and date section if the planned clinical study isn’t supposed to start until several months after funding would start? Do you still have to have it already right at that time and submitted? With IRB approval, if the human work is going to be done within the first year or the first six months of the grant, then they you should have IRB approval before the award is issued. So don’t put a date in there, upload the just-in-time and put a note in there that says IRB approval is pending and we expect it in “a timeframe” and that’s I guess majority so i guess it comes to timing also. If it takes more than expected let’s say we’re in the fourth quarter it’s about doing our reviewing, issuing these awards before September 30 a deadline. We will take into consideration how long it will take and then, once we are it are able to, we can place a restriction on that award and issue it with the restriction. Another question on the ERA commons, the JIT panel, asks for an IRB date. If you don’t have any human subjects, or let’s say you don’t have animal work, are those questions on ERA commons – do you just leave them blank or do you notify the Grants Management Specialist that you don’t need those? It should be just blank or NA, if you’re not doing human or animal work that then that should just be blank or NA. Another question – around human subjects there’s an exemption, what is the exemption four where can I find information about this and whether it applies to me or not? There is on the NIH Office of Extramural Research but I believe there’s frequently asked questions on human subjects. If anything, the NIH is very thorough about trying to document all of this Information. I think if you were to Google search “NIH human subjects exemption” you will find the NIH website all about human subjects. It explains that also in the SF424 application guide. There are instructions about how to fill out the human subjects portion of the application – which has a kind of supplementary PDF guide that goes along with describing when does something apply to you. But I believe there’s actually been, on an NIH website, sort of a flowchart for how to decide what human subjects apply to. Here’s where can one find more information about what’s considered appropriate accounting, and internal and budgetary controls. I’ve had all types of good examples. I’ve seen Excel sheets, I don’t know if I can direct you to a particular application or what – but do you have any suggestions? You mean what are the accounting system? yeah what are the right like what’s a good, does NIH Specify? No. We don’t, no. I mean usually the small businesses have accounting software that they buy to keep track of books, so it’s not just buying the software, it’s also like I said,
I’ve seen them as basic as an Excel spreadsheet – which was acceptable. It is to the discretion of the small businesses. NIH doesn’t specify what is appropriate accounting or internal budgetary control. That is left up to the small business. If you want to learn more you may be able to reach out to previous awardees. They may have a system in place. Generally, people who had Phase 2 awards because they may have been audited. but it actually is a financial questionnaire does talk about Do you have these things in place. Like check signing – that if you’re signing the check, someone else should be looking at it first, to have oversight. I’m trying to make sure I am covering these Questions. There is a question “When do you need to get approval from NIH and when not? So there is a list list of prior approval items that’s in the NIH grants policy statement. In the NIH grants policy statement, I remember, I think it was under administrative requirements, include the number? If you search prior approval…. That is correct, if you search on prior approvals it will show you within the NIH grants policy statement, I believe it is 2016,
the actual requirements order – what is required to ask for approval from NIH, and again if that does not give you the answer that you need definitely speak out or reach out to us and we will help you with providing whatever guidance we can. If you’re so lucky to get the Notice of Grant Award, there’s a lot of information in terms and references in the Notice of Grant Award to specific policies of the grants policy Statement. So that’s actually a good resource for you, for what do you need to make sure you’re doing or not doing, is looking at your Notice of Grant Award. If we resubmit an SBIR application and received a good score, when does the original submission get killed? I’ll only answer this. If you have a submission and a resubmission in the same fiscal year: let’s say you know your original submission will not be considered for funding, how does that work? I think that’s the core of the question. So if, for example, you submitted in to last April’s omnibus receipt date and you are submitting to this January – you’re submitting a resubmission to this January receipt date. Both of those applications will be considered for FY wasn’t discussed, that one will not get funded. If one of them, the other one scored well then it will definitely be considered for funding it’s both of them scored in the within the Select pay zone or within the pay line, if one of them scored in the payline that one will, very likely that will get funded, and selected. If it scored better than the other one but both of them will still be considered, so it will not really get killed
– it won’t no longer be considered for funding until the next fiscal year. I mean I think though, with that, when we have you submit your original application and then you submit and amended application that if we pay the amended application let’s say when we’ve awarded that amended application part of that process is the original application then is automatically withdrawn. Correct. Or if we pay the original and the amended then we award the original, the amended is automatically Withdrawn. Yes, thank you for that clarification. There’s actually now a question about intellectual property So, I don’t know if you’d be okay to cover this but what happens with IP that’s developed as part of an SBIR Award? Would you like me to just talk about that? You can. Intellectual property that’s developed as part of an SBIR award is covered under the Bayh-Dole Act and so you know the person asking the questions is concerned does the government
get the license and any IP that’s developed under the award? Do it have to be manufactured in the US? That’s not completely true. Under the Bayh-Dole Act you know the government, anything that’s federally funded, we technically have “march-in” Rights. But I’ve never heard of any situation where that is actually been exercised. And as far as manufacturing in the US, the fine point there is really your SBIR award dollars are intended to be used in the United States. If you have any foreign components there needs to be some special, very special cases, where that’s allowed, and there needs to be permissions and other additional administrative work that needs to be done to make sure that every thing is ok, and the State Department has to clear things. But the SBIR dollars that you’re getting for your award should be used in the US. If you’ve now commercialized your Product, you know we would strongly encourage you to find a way to manufacture the product in the US – but it is not a requirement because of intellectual property rights. There is an invention reporting requirements – through iEdison we do ask that if you made any intellectual property during the course of your award that you report that information to us. Another question about whether a resubmission, can you only submit a resubmission during the designated period for application submissions for a particular RFA. So if an RFA has only one submission date per year does that mean any submission resubmission has to be one year later? Yes, if you are resubmitting to a specific funding opportunity Announcement, and RFAs and PRs is often have their own unique dates, you can only submit for the dates that are open for that particular funding opportunity. With the Omnibus solicitation that is more open – we have three receipt dates each Year. While I’m trying to scroll through more of the questions, do either of you feel like there’s something really core that you get a lot of questions about? or you’ll see a lot of mistakes that you – what’s the one thing that you would hope that people listening would know? I think one of the main things or the most really, moments, that I get is when a grantee for small business…. Basically my suggestion is always read your Notice of Award. Where I think that’s very important. I want to stay at least each Council round when I’m issuing an award, a grantee will give me a call later and say hey i received my Notice of Award, how do i get my funds, or can I start now, or when can I start? And all that information is provided in that Notice of Award so, if anything, I would say definitely read your Notice of Award and again always contact your Grants Management Specialist and Program Official for any assistance or clarifications or whatever your concerns are – just contact us, we are here to help you. That’s our goal – so I echo what Andre said. Please review your Notice of Grant Award carefully and actually with regard to drawing down funds and payment management and getting access. If your company is not had grants before with NIH there is a separate webinar on YouTube under the NHLBI section with Nicole Dunning from the HHS office of Payment Management talking about just that. I actually think we weren’t able to get that one up but, but, the payment management system they have regular webinars pretty much every cycle and so is probably best to sign up for a more recent one anyway. Last year we had a great a Small Biz Hangout with Nicole Dunning from the Payment Management System to really talk about the nuts and bolts of how you actually get your money. We have a couple more questions and one is whether or just in time does the small business need to resubmit their budget so the overall budget? No, unless it’s requested by the Grants management Specialist, no they should not resubmit their budget. This is a popular question that I get asked quite frequently what it is outside testing by a CRO considered a part of the thirty-three percent for phase 1 SBIR subcontract limit. Yes. No. So it depends. This is also something where there is, there can actually be some differences across the different Institute’s about what is considered part of the company’s cost versus what is considered outside subcontractor award. One of the things that, kind of a couple of things I want to consider. Sometimes, fee-for-service type activities can count towards the company’s cost when it’s listed in the company’s budget and is where the intellectual effort and input is really being driven by the company itself. So one example is, you have paid for a company a third party to produce your drug. That may be listed, for Example, as a material costs because you are purchasing the production of materials and that would be part of the company’s cost. Service types you know maybe animal testing for example, if the studies are being run by a third party but the data is going to be analyzed by the company – that type of outside testing may be considered for part of the company’s costs. You need to think about, for example, things like are you paying indirect costs to the third party? Because if you are paying indirect costs that’s probably more likely
to be a sub-award. Is that company interchangeable with other or other providers of this service that might also be considered something that could count towards the company’s cost because it’s more it’s more like it’s a vendor, right? As opposed to somebody who is really putting in the intellectual input effort. But that is something that you should reach out about if you have questions about your specific situation. Alright we have more questions! Pay lines are published? When do we expect to have pay lines for SBIR phase 1 and phase 2? Currently we do not have the FY 17 funding and operating guidelines for the SBIR and STTR program at NHLBI. We are hoping and expecting them soon so I’ll be sure to include the link to the page with the funding and operating guidelines in the follow-up email. Another question for you guys. How do you view large items of equipment on Phase 1 and 2 budgets? If that equipment is necessary for the project, and you have it justified in your budget justification, then it’s fine. Agreed. We may have covered all the questions! For people who have been asking about the slides, you need to submit a request for the slides they are not just posted right now. I think we may have covered all the questions. Perhaps send it again if you haven’t heard. OK, so actually we have another question about pay lines. How do Fast Track’s get considered? If you look at the former (last year’s – FY16) funding and operating guidelines, you’ll see that we had separate pay lines for SBIR phase 1 R43 and a pay line for R44 applications which are fast track and direct to Phase 2. Those all use the R44 mechanism so Fast Track is considered with the Phase 2 pay line in the funding operating and operating guidelines. The STTR is had a separate zone of consideration because the budget for STTR is much smaller than the SBIR pool and so we really needed to manage that in a different way. There’s another question about whether you know work for a small business that is not owned by venture capital are we eligible? Yes. Just to clarify some of the comments or notes about venture capital owned companies. The majority of awardees are not, do not have any funding from venture capital. It was in the reauthorization of 2011 that it was allowed for companies that were, that did have some venture capital backing and some ownership, but not a majority ownership, that they were allowed to apply to the SBIR program – because previously they were just not allowed at all. Companies, small businesses that are majority-owned by a single venture capital operating company, are still not eligible for SBIR or STTR funding. Companies that are majority-owned by multiple venture capital operating companies are eligible as long as no single VC owns a majority of that company and they’re eligible for SBIR funding only not for STTR. To request slides, because we’re getting more questions about, that we just share this again…. If you would like to request slides we submit your inquiry here and when you log out here you’re going to get a little feedback form. We really do appreciate your comments and thoughts, and thank you very much for joining us. I think this concludes our webinar.

, , , , , , , , , , ,

Post navigation

One thought on “NHLBI Small Biz Hangout: Taking Care of Business – Managing SBIR/STTR Grants

Leave a Reply

Your email address will not be published. Required fields are marked *