Considerations for the Australian UDI

Michelle van Wijk

Welcome to our second webinar. We're delighted to have even more registrations this time. And if you did miss the first webinar, you can see it on our website. And we'll give you details on where to find it later on in the chat. Also, I wanted to start with a huge thank you to Tracey Duffy, who stepped in at the last minute for the June webinar. Today, we want to cover three areas in particular. Firstly, to provide you with a progress update.

Second, to talk through some of the considerations for the Australian UDI and that will answer some of the questions we already have and some of the questions that you've asked for this webinar as well. And at the end, hopefully, we'll get opportunity for some questions. But if not, we'll take them on notice and provide responses as well. First of all, I really want to talk about something we've done at the end of June, since our last webinar.

UDI is going to be a multi-year journey for Australia. And it's really important that we keep you informed and updated as the project progresses over time. We now have a dedicated UDI hub on the TGA website. What we're going to do is continually update that with information, with resources, with links to the webinars and the consultations as they happen. It's a place you can come and check and see what's going on and what's changing.

We've also established the UDI mailbox for correspondence, which is great because we're getting lots of emails and consultations and suggestions through that. And we'll also update the hub with questions. Really, we'll put the questions and answers on the hub as we go so that everyone can see them. We'll anonymise them, of course so they'll be anonymous. We found the format is evolving for webinars.

As we get through the process, we'll actually start to evolve the process. We'll start with a project update every time. We'll end with questions and answers. But one of the things we're really excited about is bringing guest speakers to the webinars, hence my face with a question mark over the top. Next month, we are delighted to have a guest speaker who's a global manufacturer. But also, if you've got questions or suggestions for guest speakers, please let us know and we'll build that into our webinar content going forward.

Since June, we've engaged a technology partner at the end of May and we've made significant progress together since that time. We've now got an initial version of the Australian UDI database. Those two screens on the right-hand side are from our live version of the database. We can now use that initial version to actually have early-adopter projects. But from that foundational version, we'll continue to evolve over time.

We've uploaded a subset of the U.S. UDI data. If you look on the National Library of Medicine, the U.S. data is available through the global UDI database. We've taken some of that data which you can download and put it into our initial version. We have the ability now to search for devices and view or download the results, to access the data from a desktop a phone or a tablet. Everyone is much more mobile now.

We've started with that in mind. We also have a function on there that we can scan a barcode and it brings back device information. If you can't scan it, you can type it in manually as well. One of the things that Tracey talked about at the last webinar that we're very excited about is an early project to start to use the UDI through other health systems. We now have agreement from Queensland Health. We're working with the Commission on Safety and Quality in Health Care to look at and start to scope our pilot going forward.

And some of the things you can see on your screen now are the things that we're considering, we're talking about, we're engaging around what the scope of that might be. For example, hospitals inventory control system, invoicing, registries, working with some manufacturers, the patient e-health record, discharge papers, patient implant cards, the national product catalogue perhaps for the device information, which devices we'll be looking at and recalls.

They're some of the things we are looking at now to actually start to plan out our pilot with Queensland Health and look at what the outcomes might be from that that will inform our planning, but also support the adoption of UDI through the healthcare system more broadly. We're continuing our work with international alignment. In September, we're going to be presenting at one of the joint workshops.

And that joint workshop will be with the International Medical Device Regulators Forum, IMDRF, and the Global Diagnostic Imaging Healthcare IT and Radiation Therapy Trade Association, otherwise known as DITTA, which is much easier to say. There'll be a joint workshop there and we're going to be presenting along with other regulators, manufacturers and industry groups on our work in implementing the Australian UDI database.

Today, we want to talk about four of the areas in relation to our considerations for the Australian UDI. These reflect a lot of the questions that have come out, but really start to look at how we save the information, what we need to know early, how we plan the information and feedback we need to start to move forward at pace. If you remember from last time's presentation, just wanted to bring this diagram up as a reminder, perhaps if you weren't there at the first one.

Really, at a high level, our model for Australia will look something like this. We'll have issuing agencies who will be responsible for creating the device identifiers based on global standards. And at the moment, across the U.S. and the EU, there are three or four of those agencies. The Health Industry Business Communications Council is one and International Council for Commonality in Blood Banking Automation.

Those organisations at the moment in the U.S. and the EU are providing the device identifiers to manufacturers, who are then responsible for placing them on the packaging, at the device level and for all levels of packaging, except at the pallet level. There'll be data associated with that in terms of both the device identifiers' information about the devices. And that will go into an Australian repository. And we'll talk a bit later about what data may be included in that repository and how it might get in there.

In Australia, we have a sponsor who is legally responsible for the devices in Australia. And then the devices, as they go into a hospital system, for example, will have the labels with the device on. They can be scanned or read from a human perspective. And that will go into the hospital systems. If, from a surgical perspective, there's data that needs to go into the registry about the patient and the device, that can go through to the registry.

And the Australian UDI database will be publicly available. users will be able to access the public data and see that and download it and view it and look up devices in there. So really, how do we focus on that global alignment piece? We're going to be aligned with the International Medical Device Regulators Forum guidance from 2013 and the second application paper in 2019. There are some areas that aren't covered in there, so we're in the process of identifying those gaps. We had feedback from our second consultation paper that closed in December about the possibility of leveraging the U.S. data that's publicly available and how we might leverage it, but also how we might use it for the early-adopter project, which is what I just talked about from Queensland. Singapore Health Sciences Authority has just closed a consultation around potentially using both U.S. and EU labels in Singapore.

And they're looking at the logistics about perhaps implementing a system like that and how that might align with Singapore. We're looking forward to hearing more about that when we talk with them a little bit later in the month. One of the challenges around EU alignment in particular is that European Union has identified or has created two additional identifiers to date. And one of the questions for us is, will they be of benefit to Australia?

Should we collect them or should we require them? The first one is the EU Basic identifier. And its purpose is to connect devices with the same intended purpose, risk class, essential design and manufacturing characteristics. It's the main key in the database and it also is included on relevant documentation, but it's not on the packaging. It's separate to the packaging and it doesn't appear on any of the trade items or devices.

And really, the identifier which is the Basic UDI-DI needs to identify those devices covered by it in a unique manner. In our second consultation, we asked for feedback on whether there would be benefits to Australia in collecting that data. Some of the benefits that we got feedback on were the ability to easily share data with the EU, that it facilitates harmonisation, but it also allows for reliance on CE certificates from EU-notified bodies to support local device registrations.

Many suggested the need for a grouping mechanism and some suggested the concept of a product family. Other feedback recognised that the Australian Register of Therapeutic Goods, the ARTG, already has an ID for registration which provides that grouping mechanism. But the comments also included the EU implementation is still unclear and the Basic UDI identifier complicates the UDI model.

The other thing that the EU has as a separate identifier now is an additional Master identifier. And that's a response to a challenge that's been identified, including by the IMDRF, which is the challenge around many low-risk devices that are of high volume, that create complexity in terms of volumes in the database. But also an administrative overhead on the part of the manufacturer or the sponsor. And the EU has just implemented a Master identifier, which groups similar devices.

And they've started with spectacle lenses and ready readers. And the intent is that it groups them together and reduces the volume of data that needs to be provided to the EU database, which is known as EUDAMED. The EU is in the process of looking at the contact lens solution that's being developed. And that might be extended to spectacle frames as well. And the first compliance date for that labelling, for most of those devices, is in 2023. So that is likely to evolve over time as well.

One of the other areas that there's been questions around and there's some challenges around in other implementations globally is around, when do you need a new identifier for the same device? It's been identified to us as one of the pain points and one of the challenges around aligning globally. But generally, it is where there's been a significant change to a device or its characteristics.

Changes that might change the product safety and/or the performance, that could lead to the misidentification of the medical device and/or ambiguity in its traceability or might impact manufacturers or other organisations. And if you think about company mergers, acquisitions or divestitures, they're examples of what that change might look like. Some of the challenges to date have been the IMDRF identified a significant challenge with the assignment of multiple identifiers to the same device with the same essential design and manufacturing characteristics.

And also, there are different requirements or triggers in different countries, which makes it more challenging from a manufacturer perspective. And I'll talk a bit more about those in the next slide. If you look across the IMDRF, the U.S. FDA and the EU, there are seven of those triggers that are essentially the same. They include the brand name, the need for sterilisation, whether device is packaged sterile or not, critical warnings such as the MRI or the materials.

Whether it's labelled as single-use, the quantity in a package and the device version or model. But after that, they actually start to diverge a little bit. And in total, the IMDRF talks about eight data elements, the U.S. talks about 12 and the EU, ten. And they differ a little around software, the regulations in the EU, for example, about when you need to create a new identifier for a software device. Where the changes to a device result in a new version or number is something the U.S. does.

Whether there's a change around misidentification. New packaging configurations has also been one that's been said to us is a pain point that we've heard from manufacturers. Clinical size. One of the ones the U.S. has includes the kit status. And one of the challenges we have is that across multiple countries, the definition of a kit or a procedure pack and some of those systems, for example, are slightly different.

Even if the trigger was the same, the definition of those does vary across the different countries. I wanted to give you an idea of where some of those differences are. And it's something that we will need to look at and consult on as part of our implementation here in Australia. Why does this matter? Really, if you think about it from a post-market perspective, it starts to become much more difficult to identify what is essentially the same device over time.

If you think about a ten-year or a 15-year timespan, then as that device identifier changes for something that is essentially the same device, it starts to become much more difficult to identify the device over time. Linking them together in some way starts to become really important from a post-market surveillance perspective. And it can become very complex. It's something that we're going to look at very closely in our implementation.

But also, it's a burden on manufacturers. So as you have to manage those changes over time, then those things need to be built into systems. New labels need to be created. And it can be very challenging from that perspective as well. If I look more broadly at the global alignment question, we did receive feedback in our second consultation about the U.S. or the EU scheme and where we might align. We got strong feedback that a system that mirrors the U.S. FDA or the EU schemes would be important.

But there was about a 50/50 split between the two in terms of what should be the baseline or reference. There were strong concerns if Australia does vary from either of those, particularly in terms of the burden on manufacturers and sponsors, for example. Many noted that the U.S. is already in use and has been since 2014, which was the first compliance date. Really, it's a system that's matured over time. While the EU is not in the process of being implemented at that time, that was late December.

We got some feedback on how to best leverage the U.S. implementation, including using the data which I've already spoken about. There were also feedback that we consider leveraging the benefits of the data from other sources, including the U.S., the National Product Catalogue and going forward, something like EUDAMED, which would open the opportunities for those early and simple experiments across the health environment.

I'm going to talk a little bit now about Global Medical Device Nomenclature to give you a little bit of the background to it and talk about its implementation in UDI, particularly because it's already part of what we're capturing ARTG as part of the application and inclusion process. The Global Medical Device Nomenclature or the GMDN is a standard for naming and grouping medical devices. And it consists of three different areas.

First, a term name, which is short, a code, which is a five-digit number and then a definition, which is a broader text definition about the device. It's integral to Australia's regulatory framework. We've been using it since 2002. It's included in the International Medical Device Regulators Forum UDI guidance. It's included in there. It's used by other regulators such as the U.S. We're planning for it to be required in the Australian UDI database.

We want to leverage some of our learnings. We've used it since 2002 so there's some learnings there about how to implement it in a system. We'll be looking carefully at those. And it needs to be noted that it will be at the model of device level for the UDI. We need to give consideration about how we best align it with the ARTG, which also includes the GMDN. How does it work? As I mentioned before, the GMDN underpins the Australian regulatory framework.

And we've been using it since 2002. Sponsors must provide the GMDN code as part of the application process to supply a device into Australia. The GMDN Agency, which is a not-for-profit in the UK, manages the codes and has about 24,000 in the data set. In the early years, the code matured very rapidly. That was from 2002. And it's become more stable by the recent times. But it needs to continue to evolve to align with the emergence of new devices and new technologies, new materials, etc.

So it's something that's emerging over time and evolving as well. The GMDN Agency creates monthly download files, which includes new codes, modifications to current codes and codes that have been made obsolete. They get loaded into our TGA systems and become available for selection as part of the application process. We also use it very much in our post-market work and other work we do internally around the devices.

Over time, the TGA business systems have become out of sync with the GMDN Agency code set. And one area that is a known pain point is it makes it difficult for sponsors to make a new application where the GMDN code that is part of the GMDN code set doesn't actually exist in the TGA system. We're running a project right now to better align the TGA systems with the GMDN Agency code set, starting by putting those new codes in on a much more regular basis than we have in the past.

We know that there are some issues with the GMDN data in our systems and we're going to be cleaning those up as much as we can, because there'll be benefits to us in our UDI implementation if we're able to do that. But also, it will start to reduce some of those pain points that we know our stakeholders are managing. The UDI database in the U.S. is available through the National Library of Medicine. And you can see this is one of the screens that you can see for a device, for example.

The regulator's database only contains static information. If you think about devices, there's core information that stays the same. Where other information like an expiry date or batch number, for example, or lot number, manufacturer date, they will change with every batch or production run of one of those devices. The plan is that the regulator's database will contain the static information and other systems will store that production information, so supply chain, hospitals, registries, for example.

What data are we proposing to store? The intent is that we'll minimise the use and the requirement for additional data wherever possible. We're doing some initial exploration of the U.S. data to see how closely it matches the devices that we already have supplied into Australia. And we're not planning to store the production information, so the batch number, expiry date, etc.. We do need to link the ARTG ID to the UDI data.

That gives us an opportunity. Because the UDI will be a separate database, we need to make sure that we have a way of linking our devices in the Australian Register of Therapeutic Goods with our UDI database. And there's three different scenarios that will apply and I just wanted to talk about that briefly. We've had lots of feedback on this through our first and second consultations. I want to just talk a minute about this.

In the ARTG, it's possible to have multiple devices included. And that's because our regulations stipulate a kind of device needs to be included. It can have multiple devices, provided they have the same GMDN information, the same purpose and code, etc.. And you might have a scenario where we have an ARTG inclusion, but just has a single device. But it's also possible for an ARTG inclusion to have multiple models of device.

From a UDI perspective, we will have a model of device level of granularity in our database. You can see there's some slight differences there. There's three different scenarios we'll need to take into account when we're looking at how we will link our ARTG ID to the UDI identifier. One is where we have a single device or model on the ARTG that will match directly to a single model of device on our UDI database.

The second will be where we have a single inclusion on the ARTG that includes multiple models of device. In that scenario, we'll have a single ARTG ID that will relate to multiple UDI-register entries of devices. And it will appear three times in our database for each of those devices. And the third is the scenario where we might have a single model of device that we have multiple sponsors supplying that device into the Australian market.

And in that scenario, those three ARTG IDs would link to a single UDI model or device. And it would be a multiple of the ARTG against a single UDI identifier. We know, as we're building our model, to work out how we link those two, that we need to take all of those scenarios into account.

Here's some information about data that we're proposing to store that aligns with the IMDRF guidance. And we've broken it into those four areas.

Information about the device itself, including the ARTG ID, the device identifier, the Issuing Agency, brand name, catalogue number, software version number for software that's a medical device, for example. And then how the device is controlled. We've talked about a serial number or a lot number. That's not the information itself. It's just an indicator of the information that will be on the label. And the UDI as well. We'll also capture the GMDN.

There's a range then of clinical characteristics related to that device. Clinical size, storage conditions, handling conditions, critical warnings around materials, whether it's MRI-compatible, for example, number of reuses and whether it's single-use or sterile. We'll have manufacturing sponsor basic information and contact information. And then supply chain information around device packaging and the levels and layers of packaging there as well.

As I mentioned before, a lot of that needs further consultation. So we really need feedback and to understand the benefits of potentially using additional data that's captured in the U.S. or the EU, for example. There's additional identifiers. For example, the European Union has a European Medical Device Nomenclature, rather than the GMDN that we use. One of the questions is, if that's something that there would be benefits to storing in Australia as well.

And the U.S. have a number of different data fields that we're looking at in terms of the benefits to us in the provision of that data or storing it or sourcing it from that second data set, either the U.S. or the EU. What data will be publicly available? The plan is to make the majority of the data publicly accessible, free of charge, not requiring a login or any authorisation. And we think this is going to be useful for consumers, healthcare organisations or research organisations and other organisations and we want to really understand how it might be used to understand how to best build the interface for searching and for the download of that data.

It's likely to be a web-accessible portal that allows the download of search results as well. But we're looking at the benefits of more automated tools, so where it might be machine to machine. And that might be a scenario for a software provider or to build in a catalogue, where it might be a regular update from our system directly into a second system that reduces the need for manual intervention in that process.

I'm going to talk a bit about data submission. That's really around, how does the data get to the Australian UDI database? We explored this in our second consultation, really to understand and get some feedback about how that might happen, how that might be aligned with data that's already being provided to the U.S. and potentially the EU. We got some key messages around reducing the regulatory burden, so minimising the differences where possible.

Again, feedback on exploring the use of U.S. data, perhaps to pre-populate something in the Australian UDI database. There was strong feedback about the ability to bulk upload and download data rather than just individual scenarios. And also the feedback that the ability to bulk upload changes, for example, would be of benefit. And that would be to correct unintentional errors in the data, for example. The feedback from the consultation was the ability to bulk upload, download and the changes would be important.

That different formats should be supported such as structured formats, like Health Level Seven's Structured Product Labelling, which is being used in the U.S., for example. And unstructured such as comma-separated values that are easy to read in Excel and able to support Excel use of those. The ability to edit data and correct errors without the requirement of a change in a device identifier was considered important.

And triggers were raised there as well, both in terms of the administrative overhead and the differences across jurisdictions. There was a requirement for an environment to correct data in. And there was equal support for either the manufacturer who creates the data or the sponsor, who's the Australian legal entity, to be responsible for the provision of that data to Australia.

I don't know how many of you've tried searching the ARTG. But we've had feedback as part of our consultations that there is room for improvement. And so as part of the UDI work, we need to get feedback and collaboration to understand how it might be used to help us create that intuitive search function. We're looking at the potential of using the Global Medical Device Nomenclature collective terms. They're ways of grouping the GMDN data to perhaps assist with navigation and searching.

And we're interested in learning more about how it's going to be used to make sure we design in a way that aligns with that use. I wanted to thank everybody who has given us feedback, questions from the last webinar we didn't get to, questions ahead of time, questions to our UDI email. And apologies for not yet having provided responses to those. We are looking at publishing, after every webinar, responses to all the questions in one point where the webinar is now.

You can access the recording of the webinar, a translation, but also we're planning to put the questions up. We'll make them anonymous. There won't be any indication on who they come from. And we'll put the answers there. We'll get going on that very quickly after this one and finalise the first one as well. We've had some great questions like, will the implementation of UDI barcodes into product labels be considered a substantial change?

And will there be a requirement for a conformity assessment review or can this be assessed at your next surveillance audit? Great question. Not something we have an answer to yet. But we have a list of all of these questions and things we need to consider. That one has gone very much on that list. We had another question from the last webinar, which is, can low-risk devices submit their UDI data at the same time as high-risk devices, on the assumption that our transition process will start with high-risk devices and move through those risk class over time?

That's a question we're looking at as well. And that is really around, can voluntary provision of data ahead of a compliance date be accommodated in the Australian implementation?

Hi, again, everyone. Thank you so much for all of the questions you've sent through. We've had a look at them and there's a few that we'll start with. And we'll see how we go for time. And there's some that will be covered in a broader discussion.

I'll cover that as well. Really, we've had a lot of enthusiasm for the working groups, a lot of emails to say, how do I get involved? I'd like to be included. Here's the areas that I'm particularly looking at. We're in the process of putting that framework together. And we anticipate by the end of August, we should have some more information around that and start those off. If you'd like to be involved in the short term, can you please send us an email to our UDI email box?

But also, just generally indicate on there if you're just generally interested or if there are specific topics you'd particularly like to be included in. And we'll get that up and running over the next month and start those groups going. It's good to mention we've got a lot of questions around the same area and there are a lot cover areas that we're still consulting on that we need to consider that we don't have answers to yet.

Things like around how we manage GMDN versus the EMDN going forward. Our IVD GMDNs, how we might link those. That will be an area that we'll really be likely to cover off as a working group. We'll get people together. We'll start to talk about it. We'll understand some of the complexities. That's a really good candidate for one of those working groups, for example. We have a lot of those questions on GMDN.

Thank you very much for those. They'll be fed into our collaborative process around there. Again, if you've got other topics that you think we'll need to cover in those working groups, then please let us know. We've had lots of questions around the timing for Australia. And I wanted to cover off a little bit around where we're up to in terms of our timing, what it might look like over time. We're really still in our very early stages of planning.

We don't yet have any firm implementation dates, but it's not likely to be in the short term. As I mentioned earlier, it's a multi-year project. We are considering leveraging some of the experience from the other implementations around, for example, starting with the high-risk classes of devices. And then staging it down through to the lower risk. Noting that we had a question about, if I have my data ready early for the lower devices, would I provide that ahead of a compliance date?

They're all the things that we'll need to take into account in a transition plan. But we understand that there's an overhead at the moment for everybody who needs to comply with the new EU regulations. And we don't plan to go ahead of that timeframe. We understand there's a burden there. There's been some questions around when the guidance will be ready. We're not at the point yet where we have specific regulations in place or we've made decisions around most of these areas.

As those decisions are made and the regulations are put in place, we'll develop guidance and resources and other documents. And we'll be really keen to get feedback and input from you on the best way to communicate those things. Whether it continues to be webinars, whether it's documents, whether it's all of those things. Really looking for your feedback on the best way to go about that.

From a timing perspective, as part of our feedback from our second consultation particularly and in discussions that we've had with some of the manufacturers, there's a requirement for at least a 12-month period between when we make the regulations final and firm and when they're going to be implemented. That's required to make those necessary changes to processes and IT systems. That's something we'll take into account when we look at the timing and finalise those first compliance dates.

But as yet, we don't have any of those things. We're just in our early stages of planning. One of the other questions that we've got that I thought would be worth talking about this morning as well is… It's afternoon now. Is there a plan to create a broader database such as the EUDAMED? Really around that single database that includes all of the information. And it's a really good question. At the moment, the TGA collects a range of device data and that gets stored across various databases.

We have the ARTG, the Register of Therapeutic Goods. We have databases that contain information around adverse events, incident reports, for example. And we'll have an additional data store that will be used for UDI data. At the moment, the linking will be, the linking of the data, through the ARTG ID, but not the two data sets in their entirety. You may not be aware, but the TGA is also undertaking broader transformation activities related to a range of our processes and our IT systems.

And particularly focussing on the experience of our stakeholders and how we might modernise some of our systems. It would be useful, if you haven't had a look already, we'll provide you with some data around the workshops, transformation, where you can find that data on our website. And you can start to engage more broadly with that transformation piece. But that is a question that sits outside the UDI project specifically.

I also had quite a lot of questions around the Queensland pilot and really wanted to say that we've shared as much as we know at the moment with you. That is something that is evolving. We're working over the coming months to look at the scope of the pilot, which devices will be included. Therefore, which manufacturers might be involved and what the processes might look like. And how we can leverage that then for other implementations potentially in other hospitals or states and territories.

We're in the process of creating a fact sheet as those decisions get made. When that becomes available, we'll let you know. That's going to be finalised over the coming months, but we'll continue to share updates on where we're up to as part of these webinars and on our website. As soon as we're able to share things as those decisions are made, then we will actually do that with you quickly. I might take some of the other questions now. I noticed we have just a few minutes left.

One of the questions is, would you please clarify who is responsible to provide the UDI data to the TGA sponsor or manufacturer? It's a really good question. In our second consultation, we asked that question and we found we had a 50/50 split between the sponsor and the manufacturer. There's benefits from the manufacturer's perspective in that they're responsible for creating and storing the UDI data.

Whereas in Australia, the sponsor is the legal representative and responsible for the data, the device in Australia. As part of our consultation, we will be looking at that. It's likely to be another one of those working group areas because it will encompass not only who needs to provide it, but how the mechanisms of doing that as well. It's a great question. It's one we are still looking into and going to continue working on.

I have another question around, there is a UDI requirement for patient implant cards for new and existing devices. When is this expected to be made mandatory? Again, it's something that we will have a look at in terms of the requirement for it to be mandatory in the UDI data and how that will work together. That's something that we'll come back to you on. Another question is, will a sponsor be required to submit a variation for each ARTG to provide a copy of the updated labels with the UDI on it?

Again, that's something we'll look at. Because we're in our early stages, we take all these questions, and we build a list of things we need to explore and look at. And that will feed into our working group conversations. But at perhaps the next consultation or other ways, we have to work with our stakeholders to understand what it might look like and start to really finalise and discuss some of those requirements.

Again, they're things that we're capturing. Thank you. Please keep sending your questions and ideas to us, because they go on our list, and we make sure that we cover all of them off. But that will start to happen over time now, because we're very early stages. I might leave it there. Hopefully, today's webinar was just as useful as the first one. And we'd really appreciate any feedback you have on how we could make these better and different topic areas.

Really, they're designed to share that information. Appreciate your feedback on how well we're doing on that front. Have a wonderful Tuesday and I will now hand back to our moderator. Thank you.