OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration

trials draft guidance webinar Townline today's event the webinar and its entirety will run approximately one hour which includes a q a session and if you have questions now or during the webinar please enter those questions into the Q a chatbot we'll answer as many questions as time allows it's our pleasure to welcome our speakers first we welcome Captain Matt on brencozio branch chief policy and Operations

Branch division of user fee management Office of Management seeder our next presenter is Lieutenant Commander Tamara Dam program management officer polishing Operations Branch division of user fee management officer management Cedar and our final presenter is Lieutenant Commander Jason 2. program management officer policy and operations grants also the division of user fee management Office of Management and Cedar please join me to welcome our first presenter Captain

bran kazio hello my name is Captain Matt brancasio and I'm presenting today with Lieutenant Commander tramara Dam and Lieutenant Commander Jason 2. we are going to go through the presentation OTC monograph drug user fee program or a mufa understanding fiscal year 2023 user fees the agenda today covers what is a mufa registration and listing a mufa user fee types in fiscal year 2023 key dates covid-19

hand sanitizer manufacturers omufa fiscal year 2023 Target revenue and fee rates penalties for failure to pay fees fee payment process refund eligibility in an overview of the amufa draft guidance first we have a poll question my favorite kind when there are no wrong answers what is your knowledge and experience regarding the amufa user fee program it could be a I consider myself an expert on a

move for user fees understanding the amoofa fee structure and fee paying process B is limited knowledge C no knowledge and hopefully at the end of this presentation we'll get some of those C's up to B's and maybe some of those B's up to A's so what is a mufa the coronavirus Aid relief and Economic Security Act was enacted on March 27 2020. the cares act included

an important legislative initiative that reformed the way that we look at OTC monograph drugs and how they're regulated in the United States it added sections 744l and M of the fdnc ACT which authorized a user fee program amufa dedicated to over-the-counter monograph drug activities what is the amufa user fee program well it's congressionally authorized program of Industry paid fees to help fda's regulatory activities for OTC

monograph drugs in the amufa program it was informed by an industry agreement with FDA embodied in a commitment letter and in this commitment letter the FDA agreed to adhere to performance goals including to review submissions within specific time frames again these fees support fda's o2c monograph drug activities which are detailed in section 744l6 of the fdnc act for those that would like to read the statute

and include FDA very sorry various FDA activities associated with OTC monograph drugs and inspection of facilities associated with such products there are some common terms for a movement or important to understand early on OTC monograph drugs and I'm going to read verbatim on this so read along with me it is a non-prescription drug without an approved new drug application which is governed by the provisions of

section 505 G of the fdnc ACT this is also found in section 744l5 of the ftnc ACT an OTC monograph drug facility is a facility also referred to as an MDF is a 400 domestic business or other entity that in addition to meeting other criteria is engaged in the manufacturing or processing of the finished doses form of an OTC monograph drug again section 744l10 of the

fdnc ACT and lastly we have OTC contract manufacturing organization we also refer this to as a CMO no CMO is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers retailers or consumers in the United States again section 744 L2 of the fdnc ACT is important to note

that CMOS pay two-thirds of the amount of the fee paid by an MDF it's a set in statute as well registration and listing all facilities are requested to review and update registration within the electronic drug registration and listing system or edurlis using the current structured product labeling or SPL to accurately describe the facility's operations registering the facility using the appropriate SPL codes will help FDA determine

whether the facility is subject to applicable a move of facility fees you may visit the e-dourless SPL webpage to review these SPL codes and see which are more applicable to your own facility at this point in the presentation we're going to talk about registration listing a little further the FDA has updated the SPL business operation qualifiers that manufacture OTC monograph drug products these include and I'm

not going to go through the numbers but whether you manufacture human OTC drug products produced under a monograph or you manufacture human over the drug over-the-counter drug products produced under an approved drug application or whether you manufacture human over-the-counter drug products not produced under an approved drug application or under a monograph it would also include contract manufacturing for human over-the-counter drug products produced under a monograph

now this does include those facilities with the business operations of analysis Pac label repack and relabel I'm going to turn the presentation over to Lieutenant Commander tramara Dam to discuss emufa user fees among other topics on our agenda thank you thank you sir for the past 15 minute you have learned about the umufa background and registration and listing now you will learn about the umufa Yusuf

feeds under the keriff's ACT fds authorized to assess and collect used to feed dedicated to OTC monograph drug activities for each of fiscal year 2021 through fiscal year 2025 and these fees are facility feeds and OTC monograph order request feeds also known as Omar and we will discuss about the Omar later in later slide the facility fees are due annually for qualifying manufacturers of OTC monogram

drugs and are included on the target Revenue calculation a full facility fee will be assessed to each qualified person that owns a facility that is identified as an MDF and the fee raped very yearly and the rate is dependent on how the facility registered in a journalist system as mentioned it previously registering the facility in a journal system is self-registering facilities need to identify which definition

they meet whether DMF CMO or both how does omufa facility fee assessed each person that owns a facility identified as an OTC monogram drug facility as of December 31st of the fiscal year or any time during the precedent 12-month period shall be assessed on annual facility fee be facility fee will be assessed purposely please note that there is no waivers or reductions in fees available for

the emufa program a facility fee for fiscal year 2023 will be assessed for any OTC monograph facility registered in a journalist during the fee liable period from January 1st 2022 through December 31st 2022 and during this period if the facility registers as MDF then the facility will pay MDF fee if the facility register as CMO then the facility pays CMO fee and if the facility register

as both DMF and CMO the facility will pay the higher fee which is the MDF does the FY 2023 amufa facility fee apply to facilities that manufacture or process hand sanitizer products during the covid-19 public health emergency consistent to the Department of Health and Human Service notice published on January 12 2021 FDA will not assess or move for facility feeds for those firms that first registered

with FDA on or after the January 27 2020 solely for purposes of manufacturing OTC hand sanitizer products during the public health emergency even though the public health emergency end on May 11 2023 it does not impact the FY 2023 fee liable period and therefore those facilities that meet the criteria set forth will remain not fee liable for FY 2023 omufa facility fee as in FY 2021

and FY 2022 FDA will provide further guidance via our listserv and our website what facilities are not subject to the mufa facility fee facilities that manufacture human OTC drug products produce under on approved applications or manufacture human OTC drug products that are neither produced under approved drug application nor are they produced under monograph or seized activities related to OTC monogram drugs prior to December 31st of

the Year immediately preceding the applicable fiscal year and have update their registration to reflect that change and for the purpose of fiscal year 2023 this date was December 31st 2021 so you must see sees all activities um by December 31st 2021 to not be fee liable for fiscal year 2023 and also only manufacture active pharmaceutical ingredients for further use in the manufacturing or processing of the

finished dosage form of an OTC monogram drug products additionally facilities that are not or move for a few libel includes facility that engage in manufacturing or processing the finished dosage form only for clinical research supplies or testing or facilities who only manufacture or process an activity or the placement of outer Packaging over packaging on products already in final package form FDA considers over packaging is where

the individual drug products contained within our label with a complete drug facts label and could be Market independently of the apply it over Packaging what is an Omar Omar stands for OTC monogram order request and refers to a request for an administrative order the purpose of an Omer is to add change or remove a generally recognized as safe and effective known at Grace conditions for an

OTC drug monograph under Section 744m the agency is authorized to assess and collect fees from each person that submit an Omer with exceptions for omers that request certain safety changes which I will go through later there are two types of Omar Tier 1 and tier 2. the slides provides a breakdown of Omar tiers I will only highlight a few examples and for a more detailed list

please refer to the move for draft guidance for industry which can be found on the FDA umufa website for tier one over it's basically any umer that is not determined to be adhered to Omar examples include like adding a new ingredient to a monograph that already has one or more ingredients that have been found to be Grays also adding a new indication and a new monograph

therapeutic category for tier 2 Omar examples include reordering of resistant informations in the drug facts label or additions of information to the other information sections of the drug facts label or modification to the directions for use sections of the drug facts label consistent with a minor change I mean dosage form change Omer feeds are due on the day of the submissions of the Omar except for

omers that requester and safety related changes which I will discuss in more detail on the next slide omor fees are not included on the Omer Target Revenue calculations and only the facility fees are included in these calculations and again there are two types of Omar T1 and tier two and each has its own fee rate exceptions to the Omer fee include any Omar seek to make

certain safety changes and also if FDA defines that Omar seeks to change the drug facts labeling of an OTC monogram drug in a way that would add to or strengthen a contraindication warning or precautions a statement about risks associated with misuse or abuse or on instructions about dosage and administration that is intended to increase the save use of the OTC monograph drug as mentioned it in

previous slide only the facility fees are included in this calculation therefore for FY 2023 the umufa target revenue is 25 million 421 000 rounded the amufa facility fee is due on June 1st 2023. for any qualifying facilities that engage in the manufacturing or processing of the finished dosage form of an OTC monograph drug we please refer to the move of Federal Register notice that was published

on March 27 2023 announcing the rates for the over-the-counter monograph drug use of feeds for a fiscal year 2023 for more information as you can see on the slide it gives a breakdown of the fee schedules for fiscal year 2023 for facility fee rates and Omar fee rates for MDF it is 26 153 for CMO is 17 435. a CMO pays two-thirds of the amount of

the VP by an MDF and a for all Murphy rates if the facility or company decided to submit an Omer for the agencies to review for tier one is 517 381 tier 2 is 103 476. and uh that pretty much conclude my presentations uh thank you for your time and now I would like to pass the floor over to Lieutenant Commander Jason 2. thank you ma'am

hello my name is Lieutenant Commander Jason II I will be going over the penalties for failure to pay or more for user fees fee payment process and refund eligibility there are penalties for failure to pay or more for user fees for all more fee if a person owing fees fails to pay the appropriate fees when submitting an omor that Omar shall be considered incomplete and shall

not be accepted for filing for facility fee if a facility does not pay the annual facility fee either an MDF fee or a CMO fee within 20 calendar days of the due date FDA will place the facility on a publicly available arrears list all autism monograph drug products produced at that facility shall be deemed misbranded furthermore omers will not be accepted from persons own fees in

arrears and OTC monograph drug meeting requests from persons own fees will be denied or canceled so what is the fee payment process to submit payment to fulfill your fiscal year 2023 omofa user fee obligations you may access the FDA user fee system to create an homophone yourself fee cover sheet you need to provide specific information for each fee type for example I feel number of the

facility on the cover sheet submit the cover sheet to generate a user fee ID number also known as covership number and then pay the appropriate fees payment must be made in U.S currency from a U.S Bank by pay.gov or wear transfer for payments made by pay.gov you may use either an automated Clearinghouse electronic tag or E-Check or a credit card with a limited amount of under

25 000 dollars for payments made by wear transfer include the unique user vid number to ensure that the payment is applied to the correct fees the originating financial institution May charge a wear transfer fee applicable where transfer fees must be included with payment to ensure fees are fully paid who is entitled to a refund any homework that is refused for filing or withdrawn before being accepted

or refused for filing shall be refunded 75 percent of the omor fee if FDA will characterizes the Omar from a tier 1 request to a tier 2 request the difference in the omor fee shall be refunded the above situations do not require written refund requests unlike the refunds we discussed in the previous slide which do not require a written refund request refunds for overpayments or payments

made in error must be requested in writing within 180 calendar days of payment a written request along with a completed form FDA 3913 should be submitted to the division of user fee management at the cedar collections at fda.hhs.gov if you are assessed a fiscal year 2023 a moving facility fee and believe your facility is not an OTC monograph drug facility as described in fda's March 27

2023 FRN please contact us at Cedar collections at fda.hhs.gov in conclusion I'd like to summarize the key takeaways from today's presentation we have discussed the amufa statutory background and common amufa terms registration and listing within the electronic drug registration and listing system using current structured product label being user fee types and theories which include the MDF and CMO facility fee and Tier 1 and tier 2

move Omar fees penalties for failure to pay or more for user fees lastly the fee payment process and refund eligibility if you would like more information here is a list of useful resources we've reached the end of the presentation and now I have two Challenge questions challenge question number one the fiscal year 2023 a new facility fee is due a 180 calendar days after the publication

of the fiscal year 2023 FRN B by September 30th 2023 C 20 calendar days after the publication of the fiscal year 2023 FRN D June 1st 2023 the correct answer is D June 1st 2023 challenge question number two via move for user free types include select all applicable a application C B facility fee C program fee B OTC monograph order request or Omar fee e All

the Above f b and d G a b c and d the correct answer is f b and d this concludes our presentation thank you for your time and attention now we'd be happy to answer any questions thank you all for the great presentations we'll now transition to our q a session as a reminder to our attendees if you haven't had a chance to enter your

questions in the Q a chat pod please do so now we'll answer as many questions as time allows looks like we do have some questions coming in right now in the first group of questions are addressed to Captain Brian Casio and here is the first question our Factory hasn't been able to produce since 2020. can we get a refund on user fees for years where no

production occurred thank you that's a great question and one we receive pretty often it really depends on your facility but first and foremost it's important for me to read off and I know this sounds very statutory but it is the person will need to submit a written request justifying the return of what they consider to be an erroneous payment within 100 and count 180 calendar days

after the fee was paid otherwise you would not qualify for the return of a fee claimed to have been paid an error you should provide a written request and a completed FDA form 3913 to the division of user view management at our email address which is found throughout this presentation on our mufo website but I'll say it here as well Cedar collections all one word and

it's with an S at the end at fda.hhs.gov thank you for responding to that question would you have a few more questions for captain brancazio and here's the next question if a company manufactures an OTC that is also a generic are they subject to omufa and gadufa foreign yes so godufa and amufa are independent user fee programs and they have their own fee obligations payment of

a gadufa fee or any other user fee program does not remove your obligation for a mufa user fees I hope this answers your question thank you for responding to that question our next question for captain brancosio are repackagers and re-labelers liable for an FY 2023 amufa facility fee thank you I get to talk a lot today um so this one is definitely a little more scripted

but I'm going to read Because I want to emphasize the importance of it as described in our March 27 27 Yeah March 27 2023 FRN it's also rooted in 21 CFR 207.1 manufacturer means each step in the manufacturer preparation propagation compounding or processing of a drug and indicating that the term manufacturer preparation propagation compounding or processing as used in section 510 of the FD and C

includes relabeling repackaging and salvaging activities however if you're still unsure about your facilities operations as a repackager or a relabeler and if those operations meet the definition of fee libel please email us so we can assist you again I mentioned earlier it's throughout our presentation on our move a website but the email is Cedar collections plural all one word at fda.hhs.gov thank you thank you for

responding to that question we have one more question for Captain brand Casio in this round and here's the question do large companies and small companies pay different fees and why isn't there a small business waiver thank you very much uh great question all companies pay the same applicable fee and that is facility fees and Orem Omar fees regardless of size in addition there is no statutory

Authority Under a mufa for any waiver or reduction of facility fees based on the business size or business Revenue all facilities are liable for the same facility fees amounts as calculated under seven sorry sorry section 744 MC of the fdnc ACT except for those contract manufacturing facilities which are assessed a two-third facility fee thank you thank you for responding to that group of questions moving on

to our next panelists we've got a few questions that came in for Commander tram and here is the first question is this the first time this fee is being charged foreign thank you for that questions um as discussed in our presentations and also on um on March 27 2020 the care acts was signed into law Which authorized omufa under Section 744l and 744m of the fdnc

ACT uh for fiscal year 2021 was the first year that umufa fees were applicable um hope this helped thank you thank you for responding to that question our next question for Commander tram is the following what if a facility registers with FDA but doesn't produce any products will they be exempt from paying amufa fees for that year also great questions and we get a lot of

this questions through from external stakeholders so if you believe your facility is not an OTC monograph drug facility as described in the March 27 2023 Federal Register notice please contact the amufa use of feed staff at Cedar collections at fda.hhs.gov thank you thank you for responding that question we have one final question that came in for Commander tram and here's the question will FDA send a

reminder to the mdfs and CMOS for the facility fee and is there a penalty if the MDF or CMO fails to pay the facility fee um thank you and yes we do have a lot of questions uh so it is FDA expectations that a facility meeting the definitions of an OTC monogram drug facility that owes fees under section 744m of the FD and C act I

will be registered in the FDA electronic drug registration and listing system known as the journalist and make the appropriate payment through FDA use the fee system by the payment due date which is June 1st 2023. FDA will send invoices to those facilities that have not fully satisfied the fee obligations when the payment is past due in accordance with section 744me1a of the fdnc ACT FD will

place those facilities that have failed to fulfill the a move for facility fee applications within 20 20 calendar days again 20 calendar days of the due date which is June 1st again on a police a publicly available arrear list um thank you thank you for responding to that group of questions moving on to our next panelist we've got a few questions that came in for Commander

two and here is the first question can a mufa facility registration be submitted via Cedar direct or only through edrls thank you for the question uh yes we receive a lot of questions for a drug except the establishment registration so the drug facility registration Falls outside of the use of fee area of expertise so for specific uh facility registration or drug listing questions please contact the

electronic drug registration and listing system or the Dallas team at idlers at fda.hhs.gov thank you thank you for responding to that question the next question for Commander two is the following how do I request a formal meeting to discuss an omor submission with FDA thank you that's a great question um so if you wish to speak to FDA regarding over-the-counter monograph other requests or Omars please

submit those meeting requests to monograph Dash meeting dice requests at fda.hhs.gov thank you thank you for responding to that question the next question for Commander 2 where is the arrears list published thank you that's also a great question so the arrears list is published on the omufa website under the tab user-free lists as with other FDA user Fleet programs this list will assist companies on the

verification of their affiliate Affiliates fulfillment of their mufa facility fee applications thank you thank you for responding to that question we have one more question and for Commander two in this round and here's the question I have questions about making a payment after I've created my muffa cover sheet who do I talk to thank you for the question yes we received a lot of questions regarding

uh the the how to make a homophage payment so please email user fee help desk at your fees at fda.gov for questions following the creation of you uh or mufa coverage seat but prior to or during the creation of your mobile cover sheet you can email omufa user-free stuff that's us at Cedar collections at fda.hhs.gov and we can assist you thank you thank you for responding

that group of questions moving back up to the beginning of our panel we have a few more questions that came in for Captain bran kazio and here is the first question when will the FY 2024 a moofa fee user fees be published that's a great question and one we get often because FDA is still in the processing process of assessing and collecting the fiscal year 2023

and move facility user fees we actually can't comment on the timing or rates of the fiscal year 2024 and move for user fees however we highly encourage accessing the Mofi user a mufo user fee website subscribing to our listserv to receive the most up-to-date information regarding the move for user fee program this isn't like other listeners that I know I'm on as well we only send

information when it's pertinent to a mufa you will not get flooded so when that information is available it is the first time you'll hear of it not to mention our latest news section in the emufa user fee website which I strongly encourage looking at quite often will provide updates to this point as well thank you thank you for responding to that question moving on to our

next question we've got a couple more questions that came in from Captain brincazio and here's the next question is there a cost over and above the facility fee per each OTC that is manufactured at the facility thank you I noticed this question came in a couple times during the presentation I did briefly touch on it before so regardless of business size regardless of Revenue whether you

manufacture one or a thousand products the annual mufa fee for whether it's an MDF or CMO Remains the Same thank you thank you for responding to that question next question for Captain Brian causeio will there ever be a notice sent directly to a moofa facilities for the annual fees okay thank you you definitely have to have a bottle of water ready for this um so essentially

the first notice is the fist is the FRN that we post announcing the fees now that does trigger a lot of other options again it happens at that point if you're liable for a fee then you would be eligible to pay that fee which means that the system to open up and create cover sheets around that time also becomes available and you're able to go in

and make those payments now the FRN serves as the first notice invoices are not sent until the due date has passed so if you've already have passed which means you're now overdue for the fee um So based on the statute and we can I don't think I want to bore everybody with getting into that very deep so once you get that invoice it's actually already passed

the due date which means you definitely need to pay attention to it and go from there we do try to make sure we send out enough notices to everybody involved especially those fee liable facilities so that no one misses that due date thank you thank you Captain brand concert we do have one more question in this in this round and here's the next question for you

how do I know if I'm an MDF or a CMO foreign thank you very much for that question so in short it's based on a definition definitions found in our statute and as we kind of reiterated in our March 27 2023 FRN you are an MDF if you or your partners or Affiliates sell directly to wholesalers retailers or consumers you are a CMO if your facility

or your partners or Affiliates sell to another entity who then sells the wholesalers retailers or consumers so truly the answer is based on those definitions and that is for the individual facility to decide thank you thank you for responding this group of questions moving on to our next panelist we have a few more questions that came in for Commander tram and here's the first question can

we get an installment plan to pay user fees uh thank you for that questions and it's a great questions um so just to um going back to the presentations so basically um all companies pay the same uh applicable fee um and regardless of size right in additions there is no statutory Authority Under amufa for any waivers uh installment or reductions of facility fees uh thank you

thank you for responding to that question we have a few more questions for Commander tram and here's the next question is there any online portal to pay the amufa facility fee or can it only be submitted via the ESG Gateway as a correspondence to FDA uh thank you and that's a great question too especially for um new uh people just uh getting to know omufa um

so there is a a portal uh so please submit payment uh to fulfill your uh FY 2023 a move of facility obligations by assessing the FDA Yusuf VA system to create an amoofa facility fee cover sheet for your facility uh using the step-by-step instructions so we do have a step step by step instructions uh submitting your creative cover sheet to receive a pinned and um you

can access all these to the um the the FDA yusufi system and you can find that in the Federal Register notice that that provide you a link and then also we do have the step-by-step instructions that you can follow for the time being I won't go through step by step so so thank you for that question thank you for responding to that question we've got a

couple more questions for Commander Dam here's the next question I am a brand new OTC monograph drug facility and plan to register my company now does this mean I have to pay an FY 2023 a mufa facility fee uh thank you and that's a great questions um so for the FY 2020 V uh 2023 emufa fee is applicable to those that were involved in the manufacturing's

OR processing of Ott monograph drugs during January 1 2022 through December 31st 2022. if you register today you would not be fee liable for physical year 2023 however you may be liable for the fiscal year 2024 umufa facility fee based on your registrations and Manufacturing processes uh thank you thank you for responding that question we have one more question for Commander Dam in this in this

round and here's the question I have two facilities do I need to pay to omufa facility fees that is also a great questions and we get a lot of that questions uh so to answer the questions it depends on the geographic uh um so if the same companies uh have two locations uh and manufacture an OTC monograph drug products and they are in different Geographic locations

each facility would pay on annual facility however if there's separate buildings within close proximities are considered to be at one Geographic locations or address for example if one the activities in this in them are closely related to the same visited Enterprise and two there are under the supervisions of the same local management and three there are a cable being inspected by after doing a single inspections

um if that me if you meet the case uh then please do reach out to Ora to consolidate that thank you thank you for responding to that that group of questions moving on to our next panelist got a few more questions that came in for Commander two and here is the first question I received an invoice from a company that isn't the FDA what do I

do thank you that's a great question the FDA is aware of third-party companies who may have invoice companies during the fiscal year 2023 almost 5c assessment and collection so utilizing these companies to complete your fiscal year 2023 or more facility fee obligation is at the discretion of the company however if you pay directly with FDA per the instruction in our March 27 2023 FRN FDA does

not charge handling fees or additional service fees thank you thank you for responding to that question we've got a few more questions that came in for Commander two and here's the next question what happens if I choose not to not pay the fee when I'm invoice by FDA thank you for the question so please note that an unpaid invoice is an obligation to the U.S government

and the failure to pay the fee may result in collection activities by the government pursuant to applicable laws thank you thank you for responding to that question we have one more question for Commander two and here's the question is a distributor or seller liable for the emufa facility fee that's a great question we received this question often and though if you facility does not meet the

definition of an or of an MDF or a CMO and meets the definition of a distributor or seller then your facility is not liable for omofa facility fee thank you thank you for responding that group of questions moving them up to the beginning of our panel we've got a couple more questions that just came in for Captain bran kazio and here is the first question in

checking the arrears list it appears only the previous two years are shown are there penalties for example meetings applicable Beyond two years thank you for the question first I'm excited that the you went to the website and were able to find the rares list I know that uh it's going to matter to mentioned how to get there earlier in the in the Q a section um

well as of right now there are only two years that would be qualified would qualify for a facility being on the arrears list if they did not pay fiscal year 21 or fiscal year 22 then you would go in the arrears but as of the June date the June 1st due date for fiscal year 23 has not yet passed then technically no facilities could be overdue

for their obligation which means they aren't technically in arrears yet now after June 1st if a facility were to fail to pay their amufa of the obligation then at that point you would see the reverse lists change and then there were all three fiscal years would be listed and those that were on no errors for those who would at that point show up thank you thank

you for responding to that question Jeff we have just a couple minutes left and we'll try to squeeze in one more question with Captain brancazio and here's the question if my facilities both an MDF and a CMO do we pay both fees thank you and I'll actually try to do this one quickly if there's any more time um if you operate as both an MDF and

a CMO you are only liable for the MDF fee not both thank you well that's all the time we have for questions we have just barely over a minute left and we want to give a huge thanks to our presenters and uh panelists for answering um the great presentations and answering numerous questions that came in