Center for Global Mental Health Research Webinar Series: Grants Management: Pre-Award

Transcript

ANNOUNCER: Good day and welcome to the Center for Global Mental Health Research 2022 Webinar Series.

TAMARA KEES: Thank you very much. My name is Tamara Kees. Today, I am going to be going over rules and responsibilities, registration, budget information, unique to foreign. We need things that do not apply to domestic grantees but we work through with our foreign applicants. Heather will be going over the just-in-time process and the notice of award. I really want to take off from where Leo left and say that he is the director of the Mental Global Health Group here at the NIMH and he is directly responsible for all of these webinars. He and his team have gathered people from all over the NIH to come and assist people with understanding why we ask for what we need, explain certain technical issues, and guide you through the police issues that we face every single day. I hope that he is able to rejoin. But if not, we are going to go ahead and continue.

My name is Tamara Kees. I work within the Grants Management Branch at the NIMH. It is under the Division of Extramural Activities. We are an office within and we take care of all of – actually, we are the last group that reviews your grants and ensures compliance prior to issuing an award. A lot of things happen before it actually comes to our desk. We call this a pre-reward. But we also understand that it has taken a long time for it to get to our desk. For pre-award for you begins when you have an idea that you want to submit an application to the NIH, which can be maybe two years before we get it. Once submitted, it can take 9 to 12 months before we actually get your application. Pre-award for all intents and purposes is based on what we do and why we do it so that you have a better understanding of why we ask for certain documentation prior to issuing grant awards to your institution.

I saw this quote and it resonated with me especially because we have all been living with COVID. I know that we focus on mental health here. But the reason I decided to put this on a slide is because I would like to drive home the fact that what we do together, the extramural community submitting grant applications, and what we do within the NIH is really important. It matters. You just need to look at COVID-19. We might be separated by borders and water and laws and policies. But when it comes to our health and well-being, we are connected and there is no way around that. Everything that we do whether it is in the United States or Africa or Europe or South America, it is very important. That is why I appreciate you all being here so much. We are just going to try to make the process a little more easy when you do apply.

Roles and responsibilities. Every time I do a webinar or a presentation, I bring in roles and responsibilities and each time I am like do I really need to go through this. I decided – last night I was going through my slides and I was like well, everybody should know what their role is. But the reason I want to bring it up is because our roles are unique and distinct but we all work together. If any one of those roles is missing then we cannot fund research.

I am going to go through the NIH extramural team first starting with the scientific reviewer. I wrote down exactly what these people do because I can never just remember off the top of my head. A scientific review officer and if you watched Nick Gaiano’s webinar last month then you have a better understanding of exactly what scientific review officers do. They assist the policy office with preparing NIH announcements. Long before you see an announcement, we have gone through it. It has taken months and months to put everything together in such a way that it makes sense and that the guide will actually accept it. Once they accept it, we can publish it. It starts probably six months before we actually hit the street. Sometimes even longer.

SRO is what we call a scientific review officer. Recruits and selects reviewers that review your application and then they score your application. Manages study section and project site visits. Prepares summary statements. This is really important to you because all of the critiques submitted in a summary statement should be reviewed and internalized to see if there is any way that you can better the science based on expertise and their advice. Responds to grantee and NIMH program and grants management on policy and technical questions. This is a big one for me because I am constantly asking questions because I get questions about the submission process or where an application is or they did not submit a letter of intent to the NIH. Does that make me ineligible? I am constantly in contact with the scientific review office to ensure that we have what we need and the grantee has what they need in order to feel comfortable and know that their application is in the system and we are working on it.

The program officer is responsible for the scientific programmatic and technical aspects of the grant. It is usually the first person a PI will talk to just to go over the science and get an idea of what the mission of NIH is. Initiates and encourages interests in areas of scientific importance and they assist, in fact, write much of the program announcements that you see published. It is familiar with the peer review process and also assists when needed. I do not think they all go to every review. But I have been in plenty of review meetings where the program officer is there as a resource. Discusses review issues with the applicant. If you have successfully been awarded a grant then you know how much time and effort goes into having discussions with the program officer prior to getting your grant awarded.

He or she ensures that the science in your application meets the programmatic mission of the NIH. That is a big deal because we have – we are on a journey and each year or ever five years, depending on what is going on, we fine tune our mission. Prepares funding recommendation and works with you and grants management for implementation. Sometimes what is put in an application may not be streamlined and program will identify certain parts of the application that they would like to have funded or if an application is submitted and funds are not requested, enough funds are not requested to complete the science. We may take money from the grant and have you a focus. It depends on what you are going to be doing but they negotiate this with you and with branch management to better the science.

Also, the program officer reviews your progress report which is due annually once you have a competing grant awarded. The one thing that many recipients do not know because it happens behind the scenes always is that the program officer is really an advocate for the application and the science in it. It is not a question of it comes to the NIH and then peer reviewed and then it goes to program and then it goes to council and then it is funded. The program officer has to review it and he or she has to defend the science in the application not so much defend but answers questions. It comes from our leadership. It comes from council members. If they are really enthusiastic about the project, that is very exciting. I think it is really important for our PIs to know how hard our program officers work to get the science that is super exciting through. Definitely an advocate in your court.

GMO. The grants management officer monitors the grant’s administrative and fiscal aspects, makes sure that all regulations, congressional mandates, executive orders, and policies are implemented prior to funding your reward and thereafter as we all have annual reviews. I will say she because my grants management officer is a she. She is the NIH official authorized to obligate change funds, funding amounts, change budget and project period dates, and implement additional terms on the notice of award. She is responsible for making sure that the file is documented well.

It may seem very administrative and of course it is but a grants management officer is responsible for a grant and is really one of the two people who is held accountable for any missteps we may take. When we come back and we say we need documentation for this or we need documentation for that, it is because we have to document that file to show why we allowed something to happen or when we said no. It is very important and the job that she does is really I think stressful. Thankful I do not have it. But she is an excellent chief GMO here at the NIMH.

And grants specialists basically have all the authorities that the grants officer has except it is delegated by the chief grants management officer, meaning we have the day-to-day monitoring. We review the grant. We implement the policies. We negotiate with the institution and with you. But at the end of the day, what we do is a reflection on her. She is one who has to deal with any repercussions for what we do not do.

The recipient institution team. A grant is given to a recipient institution. I know it is not fair to PIs who have their life’s work in a grant application or several. But the NIH or the federal government felt it was a less risk to give money to an institution that has the infrastructure that has a financial component that has an administrative component who has standard operating procedures that can be implemented rather than just giving $100,000 or $500,000 to an individual and hoping that they can do what they say they are going to do. We look to make sure the resources are available at that institution.

The NIH awards grants to the institution, which is what I just said and then legally responsible for proper conduct and execution of the project, provides fiscal management of the project, oversight and allocation decisions, and ensures compliance with laws, regulations, and policies.

The authorized organizational representative, we call them AORs, is the designated representative of the university or institution, is accountable for information presented in the grant application and signs official correspondence and assures compliance with federal law and regulation and NIH policies and procedures.

The principal investigator has many different roles outside of just conducting science to meet the aims of the research. They are designated by the grantee institution, which means that if you want to leave an institution, we need to have a relinquishing statement from the institution that says you can go or the science can go. You can go whenever you want but the science may have to stay there depending on what is happening at that institution. Responsible for scientific and technical aspects of the application, assures compliance with all federal laws and regulations, assures scientific compliance, should work with designated officials within     recipient organizations, to create, maintain technical and administrative documentation. If ever the NIH comes to one of your labs and wants to see documentation, we want to – you want to have that information available to us. You do not want to have to go searching in a box down the hall for it. You want to have a system in place that you know that this is for your supply expenses and this is for your participant expenses and you can justify what you have spent money on at least from a financial standpoint.

Prepares justifications. Generally, when we make a query, the PI is asked to provide a justification. It goes through the AOR so we have official documentation from the AOR that this is, yes, true and the institution agrees. You have to comply with organizational and federal requirements and acknowledge federal support and publications.

A research administrator acts as a local agent of the AOR and the PI, is basically the counterpart to grant specialists here at the NIH, can provide essential grant-related support but cannot sign off as the AOR.

Everything we do is interdependent. I cannot make an award unless I have all the approvals in hand from all of the people that I mentioned from the NIH and your application and with all the signatures and all of the paperwork that comes from the research administrator. We all work together. If anyone of us is not included in that process, it can really stop the process.

I am going to be going over registration. I have to tell I am not really comfortable with this part of the presentation. I tried to be but this is almost like a black hole for people who work in the NIH or a grant specialist because unfortunately we just cannot see what you guys see. When we get questions from a grantee, we are not able to go into the system and see exactly what you are looking at and then give you direction. It is very frustrating because it can put a whole project in limbo. These registrations are very important and I do want to highlight them and tell you what they are for, but how you go in and do it. Once you get into that site, I cannot explain.

My personal recommendation is that everybody start early. For our foreign grantees, it is really important to start early because you have technical issues sometimes. Sometimes the time difference can interfere with who is available to answer what questions. And make sure that you contact the health desk if you need help right away.

I am going to talk about the System for Award Management, SAM, and the eRA Commons, grants.gov, and then the EIN. The EIN is a little different. I will explain that in a moment.

The System for Award Management is an official website of the US Government used to establish a Unique Entity ID. That used to be called the DUNS number and you would have to go to a different system to get it. But most recently, they have changed that. Now, when you go into the SAM website, you can do everything for that number in that system. They have streamlined the process, which I think is really good and hopefully it will make things a lot faster. Any time you do not have to go to another site to register for another ID, it is going to be faster.

The CAGE and NCAGE number. US citizens I believe are just assigned a CAGE code when they go into SAM. But international grantees have to go to another site and then register with NATO. This is called a NATO Commercial and Governmental Entity Number. And what this does is it allows foreign entities to sell products internationally. The SAM site above and beyond – you have to register in order to do business with the government and that is what it is for. You are registered in it. They know who you are. They know where you are and they know about your company.

SAM is run, I believe, by the GSA, which is another agency within our government. The NIH does not have anything to do with how it is run. That is another reason to start early.

Grants.gov is an online portal to use by federal grant-making agencies and their applicants to find and apply for federal grant funding. This site – again, we cannot see what is going on in it. If you need any help, you have to go to the help desk. I have yet been able to make anything move faster through that system. Your best deal is to go to the help desk and get the help you need there and be persistent as persistent as you can possibly be if you run into problems. This system is maintained by the Department of Health and Human Services. But that does not mean that they gave us the ability to go into the system and manipulate or do anything there. They did not.

The eRA Commons. This system is managed by the NIH, which makes it better. It allows applicants, recipients, and federal staff to securely share, manage, and process grant-related information. You have to register in eRA Commons in order to submit just-in-time supplement applications, extend your grant for no cost extensions. There is just a bunch of different ways you can utilize this system. Again, we cannot see what you see but we at least have access to the people who run it. If we are having a really difficult time, we can contact them and say we need to get this grant award out. Is there anything we can do? Most of the time, the institutions have it all taken care of. They delegate authority to the PIs and certain people within the organization and it is not a problem. But sometimes when you are trying to submit something through the system, there can be a glitch. At least we can help you with that one. There is a positive system in place here.

The Entity Identification Number. This is called an EIN and every institution needs one in order to draw down money from our Office of Financial Management. It is established by us. If you are a new institution and you are applying, we are going to ask you for your W9 if you a domestic applicant. If you are foreign, you do not need to worry about sending us a W9. You just enter 44444 into your application. We know you are foreign and we submit a request and it comes back to us and you will have an EIN assigned to you. This is one thing that is a little easier for foreign applicants rather than domestic. But this is done on our end and there is nothing you need to do except give us a W9. Maybe answer questions if we get questions about it from the office that creates the EIN.

Now, we are going to talk about the budget. This is really kind of fun. I do not have a lot of time where I work on individual grants. I am usually up here dealing with issues, trying to find policies that work, helping my staff get their work out, and coordinating with divisions.

Going through this was kind of fun and let me tell you why I think it is fun. It is because when we give a presentation, it is an opportunity for us to tell you – at least give you an idea of why when we are going through your budget, we ask so many questions and also help defray having to maybe get good questions if you know beforehand. This is kind of fun to just tell you what we are doing and why we are doing it and kind of give you a guidance on what to include in your budget.

I will be going over all of these: cost consideration, getting started, budget-allowable direct and indirect costs, modular versus detailed, modular budget, detailed budget, personnel, equipment, travel, tuition, other direct costs, budget justification, consortium, out years, and then I have a section on unique to foreign and then I will be closing with resources.

Direct cost must be allowable, allocable, reasonable, and consistently treated. When you are sitting down to do your budget, you need to know that these four words and their meaning is what we use when we are looking at your budget. Is this cost allowable? We have to make sure before we can issue the grant. I will get into those a little more deeply in a couple more slides. Reflecting a bona fide need means you need that money. You need the money to do the research that you have proposed to do in your application.

Must confirm to any FOA limitation. You have to read your program announcement. We have sections in there. One is the award. We will tell you how much money you can ask for in each year in direct costs. We will tell you how long your budget period can be. We will tell you if there are any costs that are not allowed in that announcement. It is important. Additionally, you want to look at the science of course because program writes these, the science portion of the announcement. They are sometimes very pointed about exactly what they want. It is very important for you to incorporate all of that. A lot of times we will get applications where they really did nail the science portion. But when we get the budget, not so much. All of that announcement has to be incorporated into the grant application.

Appropriation dictates salary cap. Right now, our salary cap is $203,700. This is given to us every year. It is mandated by Congress. Basically, this dollar amount is pretty consistent as it goes up every year because it is the minimum amount that a Congress person will make each year. You can bet. This goes up. I think we had a couple of years a long time ago where it did not go up. But it was a long time ago. We send out a notice alerting the extramural community that this is what we can pay now. You incorporate that into your grant application.

Graduate student costs are awarded at zero-level postdoc and that rate is currently $26,353. This is the notice for that.

Some ICs have type 2 caps. And what that means is you have already had one segment of your grant awarded five years. Let us just say it is five years and you come in because you want to renew the science. You want to move forward. That type 2 would be capped. One IC I worked at – it was 20 percent over the direct cost of the previous year, the last year of the first segment. NIMH does not have this rule. But if you plan on submitting applications to other institutions or institutes, it is really good to know that not all of our policies are the same when it comes to funding. And I have had many times people say that is not the way they do it over here. We all have the same policies that are musts and then we make our own standard operating procedures based on what happens in our IC. That is the reason and things will not be the same across the board.

F&A rates are based on a rate agreement generally, negotiated by the Division of Cost Allocation at the Department of Health and Human Services. This is not always the case. If you do most of your business with the Department of Energy or the Department of Defense, you will have a negotiated rate with that agency. It is the agency that you do most of your business with. We will use that negotiated rate to issue awards to our grantees. An 8 percent is what is allowed for foreign applicants. I will go over that in later slides.

Getting started. Read the Funding Opportunity Announcement. I went over that. Look for limits on types of expenses. That is really important. For instance, travel. Sometimes they cap travel. They do not see a reason why you need to spend $10,000 or $20,000 on travel so they will say you can spend up to this amount in this category in your budget.

Overall funding limits. It depends on the mechanism. We have some grant mechanisms that are two-year awards and they allow you to have $275,000 over two years. That is specified in your opportunity announcement as well.

And the bottom line. When you are starting your budget, the way to think about it is you ask for what you need to complete the aims of the research. In every instance when we are looking at a budget and what we are going to be paying out, our question to program is always can they complete the science with what they have asked for. Most of the time, yes. It is a yes. Sometimes no. As I stated before, we may have to negotiate to make sure that some of the aims of the research can be done if you did not ask for enough because once it goes to peer review, we do not have the option to increase funds prior to award. You might be able to come in later and ask for a supplement but that is a big if, depending on funding and the reasons.

Direct costs should be identified specifically with a particular activity to meet the aims of the project. Only request what you need. It is hard for us to know with the way things are as far as costs. I have no idea how much it costs to buy items for a lab because I do not work in a lab. We rely on program to confirm that what you put in your budget will support your science.

We will know if it has been overfunded eventually. If we have a five-year grant and we have – we are in year three and you have a large, unobligated balance, we are going to come back to you and say what is going on with this and we are going to expect a justification. Either your science is behind or your science is not behind and you have a lot of money and we want to know why. Eventually, it catches up. Only ask for what you need.

Going over the four words that I said I would do later, you want to make sure you ask yourself is it allowable. If you do not know for sure, you could go to the NIH grants policy statement. I really want to stress that this tool because that is what it is has everything you need to know about grants. I often tell my own staff when we are training is you do not need to know everything verbatim in order to be a grant specialist. What you need to know is where to find the information you are going to need. This policy statement will tell you line by line – they have a select items of cost and will tell you every single cost whether or not it is allowable or not. It is a great resource. If you do not have it, I really encourage you to get it because it will help you.

Is it allocable? What that means is when you buy supplies for your grant, is that cost being applied to your grant? You may have two other NIH grants. You cannot charge those costs to those other two grants. You have to keep it on this grant. Allocable means incurred solely to advance the work under this grant, the one that it is for.

Is it reasonable and necessary? This one is weird because it depends on what you think reasonable and necessary means. Most people have common sense. If you cannot complete the science without it, it is necessary. Is it reasonable to buy it? Of course. Do you want it? I want it but I could get by without it. That is not reasonable and necessary. You just want to ask yourself the question. Do I need it to complete the science? That is the question for almost everything you do in your budget.

Is it applied consistently? Applied in the same manner across the board to all researchers regardless of sponsors. This is particularly important because the US Federal Government and Heather and I and everybody we work with – we are all stewards of the public trust, which means that we have to answer to all of our taxpayers. We apply our policies as consistently as we possibly can. We do not do something different for domestic institutions that we would not do with a foreign grant unless it is specifically stated no in the policy statement. We expect the same from our grantees. If you are charging $50,000 for a piece of equipment for the US Government then I would expect that if you have the same need in a Gates Foundation grant, you would ask for – the cost would be $50,000 and that is what that means.

F&A costs are necessary costs incurred by a recipient for a common or joint purpose, meaning that for a cost of doing business to pay the lights and the rent and all the things we all pay for every single day to live in our homes. We apply the F&A rate to a modified direct cost base. We will not pay F&A on equipment, tuition, patient care costs. Patient care costs are different than participant costs., Patient care costs have to do with the US Government because we have Medicare. We rarely see those in foreign grants and I just want to put that there, rent and sub recipient charges after the first $25,000. These items are in the grants policy statement and they really lay out what it is we will pay F&A on.

Domestic institutions negotiate their F&A rate with the Division of Cost Allocation or another cognizant agency. And foreign institutions receive F&A except for American University of Beirut and the World Health Organization.

I put this in here just as a guide in case you want to know about modulars. Modular versus detailed. This little slide will walk you through when you need to ask for a modular budget. If you are outside the United States, you cannot submit a budget using the modular format, which is a streamlined process of getting money paid on your grant, which does not include the detailed budget. We offer the money in $25,000 increments. If your grant is – let us say you add up all your costs and it is $46,000, you would ask for two modules and that would be $50,000. It is just a way to streamline the process for grants that do not have a really high dollar amount.

As I said – maybe I did not say this. Modular budgets can be used to request up to $250,000 in direct costs per year. If you have a grant that is $250,000, you will be using a detailed budget. Foreign applicants must use a detailed budget.

Budget justification, which I will go over in more detail for the detailed budget. Modular budgets. You only need a personnel justification for all of the people working on the grant, a consortium justification to explain what they are doing, and additional narrative in case you are — each year the actual dollar amount in modules is different. Let us say you ask for $100,000 in year 1, $150,000 in year 2 and $50,000 in year 3. You will need add additional narrative to explain why are you buying something in your two that you did not need to purchase in the first year. We just want to know what it is that is making the budget go up and down from year to year.

Detailed budgets. You must use a detailed budget if you are applying for more than $250,000 in direct costs. F&A is added on top of direct cost for the prime institution and for the subcontract. The detailed budget and R&R budget terms are used interchangeably. Depending on which site you go to, they use it all the time. Back in the day when I first started R&R, we did not use that a lot. We use detailed budget. But now, this is it. Do not get confused if you see those two words.

The 500K rule. If you are requesting a budget with $500,000 or ore in direct costs for any budget period or budget period, meaning any year of your grant, you must contact the awarding agency for prior approval unless otherwise noted in the announcement. RFAs do not require prior approval. And that is because those announcements have a dollar amount written into the announcement. We know how much money we have and that these applications cannot be more than that.

The reason that we ask for the 500,000-dollar letter is just really to alert us to the fact that you are asking for over that. If we have limited funds and we wanted to pay six grants and your grant would chew up half of that, we want to know about it and we want to know what the science is. It is really a heads up and a courtesy just to let us know what you are thinking.

I am going to through these a little fast because I know Heather has to give her presentation as well. I am going to go through each category and I am going to try and tell you why it is important. All personnel from the application organization dedicating effort to the project should be listed on the budget. We need to have their base salary and their effort even if they are not requesting salary support. Why is this important? We need to know who is working on the grant, what their expertise level is. We need to know how much money they are going to get and from a programmatic standpoint outside of the expertise, we need to know do you have enough people working on that grant in order to complete the aims of the project. When you submit anything in your budget, there are things we are thinking about that maybe others do not really consider when they are putting it together.

The NIH will not pay a requested salary above the annual salary cap, which I went over. And fringe benefits. You can ask for fringe benefits based on your institution’s internal policies. Sometimes there is a rate negotiated in the indirect cost rate that we will use if it is there. That is how we deal with fringe benefits based on your – mostly based on your institution’s internal policies.

Equipment, travel, and tuition. Equipment is defined as an item of property that costs $5000 or more and is expected service life of more than one year. If you are ordering a big computer – I see this all the time where people will put their computer costs or tablets in the equipment category. That should be put in other because it is not more than $5000. This is for the big stuff that you might need for your lab. A refrigerator, generator, something of that magnitude. If you are foreign, we see generators quite a lot. It is excluded from the F&A base and significant justification is required when requesting your equipment.

Travel. It must be clearly justified in the budget. Sometimes we will see travel, $10,000 and that is all. We need more information than that. We need to know where you are going, why you are going, who is going with you and how long you are staying. There are all kinds of things we need to look into when we are looking at a line item in one budget.

Tuition is excluded from the F&A costs. There is nothing that says exactly why. But outside of the fact that tuition is given to help someone continue their education and benefits the university. I am assuming they just decided that paying F&A on top of that was not something they were going to do.

Other direct costs. These are the examples of other direct costs. You have in an R&R budget pretty much a line for most of these. Animal cost and human subjects. I believe we add that in the other category, meaning that you have a place down below that is not categorized as materials and supplies or consulting costs. That is put into the other direct cost area.

ADP/computer services. Usually this is a shared cost, meaning that the institution has it. Years ago, they did not have it. It became a huge expense. They negotiated with the NIH to be able to put this as a line item on their budget. And normally it is charged per FTE, full time effort, for the people on that grant because everybody is using it, using the internet throughout the day. It is a shared cost but it is not covered completely under F&A.

Budget justification. This is the most important part to me as a grants management specialist because this is the opportunity you have to communicate to me about what you put in your budget. Personnel. Who are they, what are they doing, how much time are they spending, and how much money do they want for it? And if they do not want any money, why? Why don’t they want that money? Are they employed by the government in your country and they are working at your clinic or are they working for the VA in a domestic – if you are a domestic grantee? Is there pay covered by the federal government already? There are things that we need to know in order to have an understanding of what you have asked for and why you need it.

A lot of people do not itemize their materials. If you are going to have materials and in year 1, it is going to be a certain price and it goes up and down in the out years, we need to know why. What is going on in year 3 that your cost has jumped by $5000? What are you doing? Is it supporting what you said you were going to be doing in your timeline in the application? This is very important.

I would encourage everybody to take the opportunity and the slide is busy and I made it busy on purposes because I wanted everybody to be able to refer back and see that these are the questions we are asking. We are reviewing your budget. If you can preempt and put this information in your budget justification, it will streamline the process to award because every single time we have to come back, it takes another week. Things do not always appear all at once. Sometimes we are going back and forth several times and that can add a whole month before we can even issue the award. This portion is just an integral part of what a grants management specialist is looking at and this information is definitely needed.

Consortiums must have an independent detailed budget and budget justification. We look at it the exact same way that we look at the prime budget. You need to have itemized costs and budget justification in your detailed budget.

Consortium F&A. They are not part of the direct cost base, which we have talked about. The budget justification is exactly the same as what I just explained on the previous slide. We want to know what they are doing and when and why.

It should not be a conduit of funds. The prime recipient must have a substantial role in the project. We do not see this a lot but we have seen instances where the prime institution that put the application in the system is doing nothing for the science. They are the administration or administrative portion of the grant and that is just an allowable. Whoever is submitting the grant application must be something substantial in the science. They must have a role. Keep that in mind. Like I said, I do not see it very often but it does happen occasionally. Just be aware of that.

Out years. I am going to sum this one up pretty quickly and say that we know that when you put your budget together, there is no way for you to know what is going to happen in the future. We have experienced that again and again. In fact, we are still living through it. We do not expect that you will be dead on for every single thing. But we do expect that you look into perhaps previous grants that have been issued to your institution and kind of see what kind of trend you have going on at the institution. What is your burn rate? How often do you have to replace your supplies? There are ways to figure this out. I am sure that the institutions have a much better way than I can even think about. It is a guesstimation. Your best guesstimation is what we expect.

Any large year to year variation from one budget to the next needs to be explained because the NIH does not give you inflationary increases anymore. If your budget goes for animals in year 1 from $30,000 to year 2 to $100,000, we do not know why that is. We need to know exactly in the budget justification what is happening because we will pay you what you ask for as long as it does not include inflation and it meets the needs of the science.

Recipients are given latitude in re-budgeting. All of our grant recipients regardless if you were domestic or foreign have re-budgeting authority. The rule of thumb is you cannot change the scope of your grant. If you are moving a large portion of money from one category to another, we may as you about that because we just want to make sure the science stays on track or that something has not happened that could disable you from being able to move forward in a smooth way.

Unique to foreign. The first thing I want to say and I did not already is that there is no difference between domestic and foreign when it comes to submitting your application. There are certain requirements in policy that foreign grantees cannot have. There is only a handful.

You have to have the registrations, as I explained, earlier. You have to have a detailed budget. You have to ask for the dollars in US dollars. It cannot be your own country’s currency. Like I said, costs are generally the same costs allowable for domestic grants. Items normally covered under full F&A. What that means is because you get 8 percent F&A and you – someplace else in the US may just cover their rent charges in their F&A because they have 50 percent or 70 percent F&A rate depending on where they are. You can charge that cost directly to your grant as a direct cost. Not getting the full F&A is a bummer. Eight percent does not go very far. But you can itemize and put some costs that are disallowed in a domestic institution on your grant and that is also covered in the grants policy statement that I keep mentioning.

You can apply for supplements and visa costs as a recruiting cost if the institution has an employee relationship with the individual. Employee/employer. It used to be that we did not allow visa costs. Now we do. This is an improvement and makes life a little easier.

Fluctuation in currency. This is another one. Years ago, I had grants that the country’s economy would tank and there would be nothing that we could really do to help them because we had already given them money to complete science and we were not going to give them more money to complete the science, the same science. It is a rule we have that we do not pay twice for the same thing. We had to be very creative in how we dealt with this. But now, it is an allowable cost that you can come in and talk to us about and we will find a way to – find a solution to the problem. Those are some new policies and positives for foreign grantees.

Unallowable costs. There are only three, which is you get limited F&A at 8 percent. We do modify the direct costs ad apply that 8 percent, meaning we take out equipment and all of that is laid out in the NIH grants policy statement. I believe two years ago they changed it and put the language of what modified direct costs mean and what it entails in the F&A portion of the policy statement.

No longer limited to compliance costs only. Back in the day, you used to only be able to spend that 8 percent on complying with US federal laws. For instance, if you needed an IRB, you would use that 8 percent for that and nothing else. Now, you can use it for what you need to use it on, which kind of unties the hand of many of our international grantees to not have to worry about that. It does not cost you all that 8 percent to comply with US laws but then you cannot really use that money. This is a plus for everybody.

Other items normally treated as F&A costs may be requested as direct costs. I went over that. You can put it in your budget. If we have issue with anything that you put in your budget as a direct cost, we will get in touch with you and talk to you about it and let you know if we have to remove it. But generally, I do not see a lot of people taking things out of a direct cost budget or of the categorical budget in order to comply with policy. It is very broad.

Patient care costs. Again, that is a Medicare cost which happens in the United States apparently and has happened in other countries. I do not know how but it is allowable and – circumstances. I have never personally seen that.

Major alterations and renovations greater than $500,000 means this. We are not going to build a new clinic or a research facility and really that is what that means. Small alterations and renovations. We will look into if we see that in the budget and make sure we understand what you are trying to do before we obligate funds.

This is your resource page. And what I have done is I have put links to all of the registration sites and to the grants policy statement. And I have pointed out for foreign grantees, this 16 to 16.7.5, which is all about foreign organizations and the policies that they must follow in addition to the other policies within the grants policy statement. You need to be familiar with the SF-424 and I put in the R&R budget forms so that you can look through there and find out what the instructions are. They do detail out exactly what you need in your budget and what you are supposed to put in your budget justification. You have the tools to do this with absolutely no problem.

If you need anything, you can contact me, contact Leo. You can contact our grants management branch and we will answer your questions to the best of our ability. So far, I think we have been pretty good about answering and finding out the answers to complicated and strange questions. It seems every day something else comes up and we have not dealt with it before. Always interesting. Always intriguing. I wish you all the best.

I guess we are going to questions and answers now.

HEATHER WEISS: Yes. We have a couple of questions, Tamara. The first one is for foreign recipients of NIH funds, is there any process for adopting an NICRA instead of the standard 8 percent.

TAMARA KEES: No. Not at this time. I do not know – there have been discussions I know at higher levels that I am not involved in. It has been going back for a lot of time back and forth. I am always hopeful that they are going to raise the indirect cost rate for foreign grantees. But so far, they have not. And my understanding is that they have a working group. It is still on everybody’s radar and they are discussing it but no changes have come about just yet. I am sorry to say. At this point, sorry.

HEATHER WEISS: Can you explain why NIH sometimes cuts the out years like 5 percent, 10 percent? Can you explain why this happens and if there is any negotiation around these cuts?

TAMARA KEES: Yes. Every year – well, it is very complicated because we have to project the future for our portfolio within the NIMH. Every institute within the NIH, every agency has to do that. The cuts are made based on our projected projections. Like I asked you all to guestimate what your out-year expenses would be, that is similar to what we are doing based on all the feedback that we are receiving about our next year’s budget. Every year we have to by law award competing new science so competing applications.

What we do is that we generally will fund if we have enough money in the current fiscal year at 100 percent but because there is such a variance in what we know we are getting in the out years, we cut it by 5 percent maybe in year 2 or 10 percent in year 3 because we have to plan to pay for competing research. A lot goes into it. I am not privy to all the conversations that happen. But that is the reason. If it is the IC’s funding plan that means that it is consistently applied. Under some circumstances if it would be a hardship, I suppose you could call and talk to your program officer and your grant specialist to discuss that. But by and large when we have our funding plan, it has been published – that is what we do. And we cannot – it is really hard to pick and choose because, as I said, we have to be consistent with our policies as well. I hope that answers your question. If not, you can email me and I can go further.

HEATHER WEISS: We have another question but I am not sure how to answer. It is great that visa costs for recruitments are included. However, why are the visa renewals not considered? Experienced candidates are required more and more.

TAMARA KEES: I do not know. I have no idea why. Nobody has given me any indication as to why it was decided that we would go ahead and pay for it if you already have an employee/employer relationship but not if you are going out and recruiting people. I do not have an answer for you. But if you would send me an email, I will look into and see what I can find and send you a response.

HEATHER WEISS: That is all I have for now.

TAMARA KEES: Sorry, Heather, to cut into your time. Thank you, everybody. This is Heather Weiss and she is going to be going over like I said just in time procedures and the notice of award. I kind of cut into her time just a bit. Sorry. We will see if we can make it up here. Go ahead, Heather.

HEATHER WEISS: I am going to actually spend the majority of time with my just in time information. The notice of award is more of a post-award after you receive the award. Basically, you are not going to miss too much because I just go over what is included in that. I would like to start with just in time and go over that.

When pre-award – when we are reviewing the application, these procedures allow certain elements of their application to be submitted later in the application process after review when the application is still under consideration for funding. The standard application elements that I am talking about is animal and human research assurances, certification of human subjects’ education, and other support. In addition to explaining these components, I am going to go over these in terms of what it means for international organizations because the JIT letter is sent to everybody. It is a template. It is sent out by default for requirements for domestic sites within the United States. There are certain things that I am going to point out that international organizations need to be aware of to submit as the equivalent that will be accepted.

First, we are going to take a look at animals. I am going to back to that slide but first, I am going to go over this. There are two things. The animal assurance and then there is the approval. The Animal Welfare Assurance is a document submitted by an institution assuring compliance of policy.

The IACUC, which is the Institutional Animal Care and Use Committee, is for United States recipients. The international organizations if animals are – if work is conducted there is not required. However, the Office of Laboratory of Animal Welfare, which is OLAW, encourages foreign recipients to use the standards and the Guide for the Care and Use of Laboratory Animals.

Here, the foreign organizations will state that they are complying with the International Guiding Principles for Biomedical Research Involving Animals, which is the United States equivalent over here. These guiding principles include all of the laws and regulations and policies for that country in which the research will be conducted. For example, in Germany, a German institution or performance site should adhere to the German laws governing the care and use of laboratory animals.

The animal assurances are usually approved for up to five years. If you were working on a domestic – if you have a domestic sub-award, for instance, you will have a sub-recipient from the United States. That domestic institution must provide verification of their IACUC approval for activities.

NIH defines human subjects as a living individual about whom an investigator whether professional or student is conducting research and obtains that information by interacting or contacting the individual and/or obtains, uses, studies, analyzes, or generates information identifiable biospecimens.

The revised common rule requires that both domestic and foreign international organizations have a federal-wide assurance registered with the Office for Human Research Protections. And that applies to the prime organization. Any sub-award sites and performance sites that are conducting human subjects’ research.

When the JIT letter goes out, it requests that you provide an IRB if you had human subjects. However, it does not specify what you are supposed to do for an international organization. For international institutions, I am saying that the equivalent to that is an IEC, which is also accepted in the place of an IRB.

This sums up what I just said about the IEC. It is the Independent Ethics Committee. That is approval of what you will submit in place – it takes the place of the IRB. But when you read the letter, that is how you will read it.

The next slide just goes over terms. The just-in-time letter also mentions a single IRB and so does the application. This only applies to domestic sites when there are multiple research sites within the project that are in the United States and they are all following the same protocol. It does not apply to any foreign organizations whether you are the sub-recipient or the prime. You would check no for that if it asks you.

Here, we just say we expect that all investigators be trained in good clinical practice. I have a website here. Any questions you have about certifying for human subjects’ education for key personnel, which is linked here as well.

The next component – third component is other support. We have had a lot of changes in policy over the past year for other support and the biosketch and there are a lot of questions. These links are to NIH guide notices that have gone out to the community. They give you a lot of good information in there and will link to instructions and other details about this policy and what is supposed to be submitted.

In summary, this guide notice 19-114 will give you definitions and separates foreign and domestic requirements. The guide notice for 21-073 goes over changes in the formats between the old format if that is what you are used to and now, we are changing to the new format for biosketch and other support.

And then consulting agreements where the PD and PI and senior key personnel will be conducting research or providing samples. It is now going to be part of the activities that should be reported. Also, we are asking that in-kind contributions be reported as well. Keep in mind. These are tangible items as values such as office, laboratory space, equipment, supplies, or employees/students that are supported by an outside source may require documentation.

What it does not include are training awards, prizes and gifts, which means there is no expectation of anything in return. However, an item or service given like your time and effort is considered in-kind and should be reported in other support.

Startup support provided to an individual by the applicant is not considered other support. And for consulting, if the PI or PD is not conducting research and there is no authorship involved, that is not considered other support and should not be reported.

There are questions about in the past about supporting documentation because this is also a new feature. This just defines what we mean by you might be asked or you might have to submit supporting documentation. These are copies of contracts, grants, or any other specific agreements you have with the other institutions or foreign institutions that your reporting is other support. If the agreements are not in English, the recipients must provide translated copies. This supporting documentation must be provided as part of the other support following the other support format depending on what that other support is.

Here, I mentioned before that there were new biosketch formats and policies concerning this. These are the guide notice links that will help you determine there. I wanted to point out for sure that these guide notices do say that SciENcv templates are available and they are supposed to be available in 2022. And some of them even say early 2022. I would like to point out that as of today and NIH is still finalizing the template for their support. Meanwhile recipients, please use the word format page to prepare other support and then convert to a PDF. I just want to point that out because it does say in these guide notices that it is available, which it is not currently available.

Here are some other supports and biosketch resources that go to frequently asked questions. Here are the FAQs for other support and biosketch. I encourage you to read through those. There are instructions that are at least a page long for those. Please read those.

Now, we are at the notice of award. I would like to mention that there are components. A notice of award, as you know, is a legally binding document. All of the terms and conditions that are set forth in this document are binding to the organization receiving the award and they are also responsible for applying those conditions onto the sub-recipients. It will include the grantee organizations, the PI. It will establish the funding, the budgets they are awarded, the period of support, the terms and conditions, like I said, the NIH contact information, program officer, and the grants management specialist contact. I do not have a copy of one to share with you because, A, it would be in really small print because these documents are pages long and it would need to be redacted. I do not have a copy for you to share. The award is divided up into sections by Roman numerals. They are divided up by how they are listed here on the slide.

When you receive the award, recipients indicate the acceptance of the terms and conditions of the award by drawing down funds. If you have any questions, please look over the award first and we can answer any questions for you.

These are standard terms and conditions. Some of what you will see on there are NIH public access policies. They must comply with the financial conflict of interest. The Federal Funding Accountability and terms and conditions of the NIH. It will also reference the Grants Policy Statement.

These, again, are just some more things that will be incorporated into the award. And then for cooperative agreements like UO1s, for instance, there will be probably additional terms because they have significant involvement with the program. And then any restrictive terms we will put into the top section of the terms and conditions.

And then these are just a list of resources that go over the policies that are included. And then the next slide also has additional resources specifically for foreign grants, conflict of interest, public access policy like I mentioned before. And this link right here, information for new recipient organizations – if you are new to federal words or words from NIH, this is a good one because it answers questions about how to apply the application process and questions after you get the award such as how to ask for prior approvals, no cost extensions, things like that.

That is all I have. Let us go to questions and answers.

TAMARA KEES: Can you clarify or confirm that if a foreign investigator is employed at a foreign institution as their primary appointment, employment contracts are not required for that appointment.

HEATHER WEISS: Confirm. Yes. Correct.

TAMARA KEES: Please advise the process for new postgraduate students from university outside the USA who may want to apply. Is this grant applicable to individual PG students?

HEATHER WEISS: Yes. I believed I answered – I answered some of those, Tamara. That one – I gave a link for fellowships at NIH. There is an F05 specifically for international early-stage investigators that are doing research in the US that want to have their grant.

TAMARA KEES: What are the criteria for determining if an award is eligible for SNAP? I have seen awards at my institution that are not eligible for SNAP.

HEATHER WEISS: In the grants policy statement, it goes over which mechanisms apply to SNAP and which ones do not. It will list out. You have to look at the mechanisms. In general, R01s will be considered apply as SNAP. In general, UR1s will be considered non-SNAP. Also center grants like P50s are considered excluded from SNAP.

TAMARA KEES: -- it is higher risk science. That is the determining factor. If you have a very large dollar R01 and you are recruiting participants and there are very technical things going on, we will ask for it too. The specialist will make a determination what program to determine if that grant should be under SNAP or if we want to see more details every year so that we can assess progress.

HEATHER WEISS: For every single word that is issued, it does say in the notice of award whether or not that grant is complies under SNAP or not.

TAMARA KEES: I understand for students in US but what of students registered in doing research outside the USA. I am not quite sure I understand the question.

HEATHER WEISS: If they are not doing the work of the United States but they are doing it at a foreign site, do you mean grants where they are the prime or grants that are given to a domestic site where you are working on it in a foreign country?

TAMARA KEES: We need more clarification before we can answer that question. We are happy to take your question via email if you would like.

Right now, that is all the questions we have. I think we have pretty much come to the conclusion of our webinar. I hope that we have been able to give you some information that you can use.

The just-in-time process. I just want to close out what Heather said and went over in the just in time. The just-in-time process is clarification and actually just everything to gather all the documentation that we can before we start reviewing your grant award. Everything you put in that folder, the just-in-time folder in the eRA Commons, we have access to. We look at it. We review it and we will ask you questions if we have additional questions about what you have submitted.

But the more thorough that it is, again, that helps streamline the process to award. Basically, the more information we have upfront shortens the period of time from when we get a grant on our desk to when we can actually release that award for funding and issue the notice of award.

Just to kind of wrap up the theme of this is the more information we have, the faster things get done. If you take away nothing else, that is something to keep in your head. As I said, we are both available for questions if you did not have time to ask here.

I also wanted to thank you very much for spending your time with us this morning. We do not in grants management often have a chance to reach out to our extramural grant recipients and tell them all the things that we have been able to say today. We hope that you will join us in the fall because we will be doing a post-award webinar. We will go over items of interest once you have your award, which are always – actually, they are probably more interesting and complicated than just getting your grant through the system and getting a notice of award.

We hope that you will join us in June. Join Dr. Susannah Allison for the Training Mechanisms for Grad Students and Postdocs in Global Mental Health. The date will be published on our website. Just to iterate, this webinar will be going put on the website – I do not know how long it takes before it gets up. It will be available for you if you want to check back in when you are actually submitting your budgets or just in time.

Thank you very much. We appreciate your time and it has been a pleasure.

HEATHER WEISS: Thank you, everyone. This concludes today’s session and you may now disconnect.