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Bryan Clark: Hello. I'm Bryan Clark, Chief Grants Management Officer at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. I'm here today to talk to you about grant award management. So in managing an award, the main goal is to accomplish the programmatic goals as stated in the application. And with this in mind, the approved budget, both in the amount and scope, must be used in accomplishing these goals. The amount is awarded after it's reviewed and any unallowable costs are removed. And the scope must be within the scope of the originally submitted award. So there are different types of situations where you can request it to be out of scope. But these are if you're changing the animal model to a human subjects model, for instance. Or if the direction of the sciences is changing significantly, then you would need to request a change in scope. Otherwise, the grant must be accomplished within the scope of the original application. Now in managing the award, there are many federal laws. There's DHHS, Department of Health and Human Services, regulations. There are also NIH regulations and NICHD terms and conditions. The terms and conditions you'll see on the notice of grant award. And it's very important to look to see what types of terms and conditions may be on an award so that you're following these as well as the other federal laws, regulations, and the like. Also the program announcement includes any terms and conditions of the award as well. There are caps on the award. There are special requirements that may be included with a program announcement. Also the RFA, Request for Application, is similar in that there may be specific guidance that's included that must be followed with that particular award. The NIH Grants Policy Statement, this is the primary policy document that you want to use. And it incorporates all of the federal laws and HHS regulations as well as NIH regulations. And it's condensed into one policy statement. So I'd advise that you use this for your primary source for policy. But also use your resources in contacting us at the NIH. There are two contacts on every notice of grant award. There's the financial grants management contact. This person is the grants management specialist, who can be contacted for policy questions, budgetary questions. If it's more scientific or programmatic, the program official is included on the notice of grant award. And you can contact that individual for those types of questions. And then the award terms and conditions; as I've mentioned, these are specific to the award. For instance, if you are including the human subjects in your research, and let's say the initial review board date approval hasn't been approved at the time of the award, the award may be issued with a restricted term and condition on the award. So it's very important to know if there are any of these types of terms and conditions on the notice of grant award. And in managing the award, it's important to note that these awards are institutional grants. The grant is made to the institution and not directly to the individual. Sometimes PIs, principal investigators, will believe that the award is theirs, that they own it, that if they leave their particular institution that they would -- they want to take their award with them. They believe that they can do that without the institution's approval. That's actually not the case. The institution, if there is a situation such as that, they could decide to change the PI or not allow the award to continue, and possibly not let the award change institutions. Most often, though, institutions will agree and it's a mutual agreement to transfer the award. But again, it's important to note that the award is made to the institution and that the institution is also responsible for the award. In submitting for the award on the grant application, there's an authorized signing official. And this is the signing official for the institution. The PI also signs the award. But the signing official is noting that they are aware of all of the policies and regulations that come with accepting a notice of grant award. Having said that, the PI is responsible for all aspects of the award: the science, proper use of funds, and timely reporting. Certainly, the science; since the principal investigator has put together the scientific proposal as to what the research will entail and then in managing the award, the PI is following what the proposed application has included and conducting the scientific research. Also the proper use of funds; the PI has to be very aware of what constitutes the proper use of funds. And this is where there's a lot of collaboration between the research administration office and the PI. And so the PI needs to rely on that office, but also needs to know what it means to properly use the funds. In the worst case scenario, we may see waste, fraud, and abuse. But we also want to make certain that the PIs are aware of the rules and regulations so that they don't unknowingly use the funds in an improper way. Also the timely reporting is very important. There are many reports that need to be submitted to be within compliance of the award. Certainly the progress report is the number one document for a PI to be concerned with. This is submitted each year for the non-competitive phase of the award and is primarily written by the PI, the principal investigator, that's in charge of the research and is able to report the progress during that period. The other reporting is the federal financial report, which basically includes what funding has been expended and what funds may be unobligated. There are other financial reports that are also submitted, such as the cash transaction report. So this also is done in collaboration with the grants officer and the accounting office at any particular grantee institution. So I mentioned prior approvals previously. And one of these is a no-cost extension. So what is a no-cost extension? At the end of a project period, you may need additional time to complete the data analysis, publications, and so forth. So what is a project period? A project period is a set of budget periods. Let's say you're awarded a five-year grant award. Each of the years is considered a budget period. And the combined five years is considered the project period. So at the end of that project period, you may resubmit an application for a continuation of the award. But again, if you need additional time, you can request a no-cost extension. This, actually, in the first phase, the first no-cost extension, it does not require a prior approval. So it would be a notification that you're going to extend for up to 12 months. You can actually do this as a grantee through the e-Commons. So the e-Commons is electronic access to your account or your grant. And then you would be able to initiate the first no-cost extension yourself through the e-Commons. Let's say that you would need even additional time beyond that first year. You would be able to request a second no-cost extension. This would require prior approval, a countersigned letter signed by the PI and the business official, the authorized official at the institution, with an explanation as to why it's needed, also the scientific rationale and a plan, and a categorical budget. This is then reviewed by the program official along with the grants management specialist for approval. Once it's approved, then you would receive a revised notice of grant award. There is another type of extension. We refer to it as a mid-year no-cost extension. These typically are done administratively by NIH officials, by grants management specialists and in coordination with the program official. These work well in situations where a project may not be progressing at the rate that either the PI or the program official is expecting or has been included in the application. So essentially what happens is that during the middle of a budget period, the budget period is extended for the additional time that's needed. And that can be for up to one year. What's needed for this? It is also a prior-approval requirement. As I mentioned, this is typically initiated by NIH officials. So we would request that you send in a categorical budget and an explanation documenting why it's needed. And then the budget and project periods are extended. So, carryover. This is another type of prior approval. Carryover happens when there are additional funds, unobligated funds, from a budget period that a grantee would like to use in a successive budget period. This requires a prior approval. And so that if there are funds that are requested, they're requested again with a countersigned letter and an application explaining why the funds are needed. If there's not enough funds in the current budget period, that then these funds would be utilized as carryover, also making certain that the work is not being duplicated. So the carryover funds would have to be for another purpose, but still within the scope of the research. And also we need to be certain that the federal financial report has been received and accepted. This is done so that we can be certain of the actual unobligated balance that is available for carryover. Having unobligated funds is not a justification for a carryover. It's not -- it can't be the sole justification. So oftentimes, grantees believe that if they have an unobligated balance that that's funding that is theirs, they're entitled to it, and that they're just requesting that it be carried over. That alone can't be a justification. We need the reason and then the purpose for the funds in the successive period that's above and beyond what the funds that are provided in that grant period will cover. So in the carryover packet, there needs to be a signed written request. And this is countersigned both by the PI and the grants administration office, an explanation as to why the funds remain, and a scientific rationale and plan and use for the funds, as well as a detailed categorical budget totaling the amount that you're requesting in carryover. So as a carryover review, when it's reviewed, they're looking to see whether the request is justified, if the funds are available, if the request duplicates funding already provided in the current year support. Also, if the request overlaps with a previous request -- sometimes we get multiple carryover requests, so we need to be certain that this funding hasn't been carried over previously. Also, if the request signifies program expansion, it may not be approved. This is also carried out during the review of a carryover request. If the approval will generate a recurring cost in future years, it wouldn't be approved, because what the carryover is approving are just costs in that year for which the funds are being carried over. So with closeout, the closeout of any award is very important because we essentially need to document the final progress so that the data can be captured and reported. The other reason is that you don't want to jeopardize the receipt of another award, which can happen if you don't have the proper closeout of the previous awards that you've received. There are basically three documents that are required. It's the final federal financial report, the FFR, the final progress report, and then the final invention statement. And this basically states whether there's a pending invention submitted, or if there is none, that you would state that as well on this final invention statement certification And these are due within 90 calendar days after the last day of the final budget period. And within the eRA Commons, it provides you with the procedures to submit these through the eRA Commons. There are grantee audits that are required. They are required for those grantees that are expending $500,000 or more under one or more awards from the U.S. Department of Health and Human Services. And this can also be under a consortium or subcontract arrangement as well. So some of the details of that type of an audit; foreign organizations have two options. You can either have an audit conducted. That's the financial-related audit of HHS awards as defined and in accordance with the government auditing standards. And this is commonly known as the Yellow Book. More details on this information can be accessed through the NIH website. Or an audit that meets the requirement of OMB Circular A-133, and A-133 is -- it's the Office of Management and Budget circular on audits. It has very detailed information about the requirements. And this is where you can find the other option of having an audit performed. So whether you choose the Yellow Book form or the OMB audit, your audit would be done by an independent auditor. And NIH does not perform these audits directly. And the cost of hiring an independent auditor can be recovered as part of the 8 percent F&A rate that's included for all foreign awards. So with audits, it's imperative that grantees submit required audits within the specified time limits. And audit reports of foreign organizations should be submitted to the address provided on this slide. So there are some other helpful websites that are listed here. But I also wanted to stress again that through managing your award that you can contact us. We welcome that. You can pick up the phone or send an email to us at the -- and the contacts are included on every notice of grant award, both the grants management specialists and the program official. If you have a question about a specific grant award, you want to look at those contacts and contact those individuals. Since they are managing that particular award, they would be the best contact for any questions that you have about the award. That is also kind of one of the other myths, that if you contact a grants official that somehow in submitting an award that you're going to affect the chances of receiving that award or that we don't -- we're too busy to be bothered. There's nothing further than the truth about that; that, yes, we do want you to contact us. And we see this as a collaboration between NIH and our grantees. So thank you very much.