August 24, 2016, HHS SBIR PHS 20171 contract webinar. 
     
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     >> The broadcast is now starting.  All attendees are in listenonly mode. 
     >> Hi, everyone.  Thank you for logging in to today's webinar.  We are going to get started in just two minutes. 
     >> Hi, everyone.  Thank you so much for joining today's webinar, titled HHS SBIR Contract RFP Informational Webinar PHS 20171.  My name is Betty Royster and I will be your moderator today.  
     And just a few things before we get started.  We are recording this webinar and the recording and the slides and the transcript will be posted online.  And whenever these materials are ready, we'll send out a listserv notice so you will be able to know when they're available.
     And we also are planning to have a question and answer at the end, so you can submit your questions in the question and chat box on your webinar console, and we will get to those at the end.
     And last, but not least, Dr. Matthew Portnoy, the HHS SBIR STTR program coordinator, will be our first presenter today.  And with that I will turn it over to Matt. 
     >> Thank you very much, Betty.  Good morning and afternoon.  My name is Matt Portnoy and I am the host for today.  And the NIH, HHS, SBIR STTR program coordinator.
     In today's webinar I will be discussing an overview of the SBIR program and this contract, request for proposal, or RFP.  I will be discussing the differences from the HHS SBIR grant program and this contract program.  I'll be discussing the deadlines for submitting your questions and answers and for submission of proposals.  Then we'll turn it over to NIAID for a demo of the electronic proposal submission system called eCPS, a live demo of that.
     And lastly, we'll have the institutes and centers that are participating present each of their topics.  And then we'll close out and we should have plenty of time for questions and answers, which you can send to the question box on your console.
     With that we will get started.
     The SBIR and STTR programs are congressional mandated Federal live programs.  There are 11 agencies that have the programs shown on this slide on the right.  HHS of which NIH and CDC are a part, have the largest program last fiscal year of nearly $800 million.  Then I'll show you what this year is.  We are about 33% or so of the Federal live program.  Other agencies have SBIR and STTR programs.  They have grants, they have contracts and they have their own submission solicitations.
     For other questions about other SBIR programs besides ours, please go to www.SBIR.gov. 
     Within the Department of Health and Human Services there are five operating divisions that have SBIR and STTR programs, shown on this slide.  NIH, Centers for Disease Control and Prevention, CDC, Administration on Community Living, ACL, Food and Drug Administration, FDA, Administration on Children and Families, ACF.  All of those have SBIR programs at the amounts shown above for the current fiscal year.
     NIH has a separate STTR program at $114 million for this year.
     The SBIR and STTR programs, and from now on I'll just say SBIR since that's the focus of our current RFP.  The SBIR programs are a phase research program.  Phase I is a short feasibility study of six months to one year, typically 150 to $200,000 in budget, for the budget period.
     Phase II is a full R&D effort, typically one million, one and a half million dollars over two years.  Phase two b is an NIH second sequential sole Phase II, up to one million dollars or three million dollars, but not all of our centers participate in Phase IIB.
     Phase III is called the commercialization stage of the SBIR program where agencies are not allowed to spend SBIR or STTR money on the specialization stage.
     As NIH is a  primarily a grantee, although we will be discussing contracting agencies, NIH will not be your customer, will not be your primary customer.  And so NIH typically does not fund Phase III., although occasionally.  So when you're playing for Phase I and Phase II awards you need to be thinking about your downstream sources of funding and your exit strategy from the SBIR program, be it followon funding from venture, angel, strategic partners, other sources, device companies, pharma companies and other partners that you might need to work with downstream. 
     I should also say that during some of the topics you will be hearing and in general for the SBIR program, we do allow clinical trials for certain topics.  Clinical trial phases, Phase I, II and III, clinical trials are not to be confused with SBIR phases.  So they are two different uses of the same words.  So while we have Phase I and II grants, in contracts, some topics will allow clinical trials, maybe perhaps a Phase I trial on a Phase II grant and things like that.  So just be careful of what you are looking at.
     All of the information about the HHS and NIH SBIR program can be found on the our program, SBIR.NIH.gov. 
     If you can see on the upper left we have a blue main navigation menu that will get you to our funding, our application process, review policy, and resources.
     If you are new to the program we recommend hitting the yellow button new to SBIR/STTR and that will lead you to a new info graphic explaining the program.
     We have a number of solicitations available to you for SBIR and STTR within the agency.  We'll be discussing today the middle one, the SBIR contract solicitation for this coming year, PHS 20171.
     We also have many grant solicitations.  At the top you can see we have parent grant solicitations, we call omnibus, one for SBIR and one for STTR.  And they are PA16302.  For SBIR.  And PA16303.  They have released that in June of every year and there are three dates, due dates for our grant solicitation, September 5, January 5, April 5.  Very important for you to note and understand, upcoming September 5th, which is Labor Day, but the Tuesday September 6th, is not the contract solicitation deadline.  That deadline we'll talk about in a little bit is October 21st.
     Contracts will not be accepted through the grant submission deadline, so please keep that in mind.  It's just the grant deadline.
     Likewise grants are not due on October 21st.  If you want to find out about all of the solicitations we issue at NIH, including SBIR and STTR and grants and contracts, I strongly recommend you sign up for the third bullet, the NIH Guide for grants and contracts, in which you will get a weekly email on a Friday afternoon with all of the solicitations the agency has issued in the past week.  We issue solicitations every day of the week, but Friday is the summary that has everything in there.
     So on to the current SBIR contract request for proposal solicitation.  There are several sources by which you can access the solicitation itself.  One of which is on our main SBIR website, SBIR.NIH.gov.  If you push the funding button we have a section of our funding page that is designed for the contract solicitation shown here.  It's available in PDF and Word format.  If you click the button at the bottom, contract proposal forms, that takes you to the second source of the RFP on the main NIH grants page, grants.NIH.gov.  Get into the small business page.  At the bottom of that you will see we have a full listing of all the forms for SBIR.  The contract PDF and MS Word, which is identical to the previous screen.  Additionally all of the form appendices that are required in your submission, the form appendices A, B, C and F and the Phase II and fasttrack appendices, B, C, D, F and G.  And for fasttrack it is required.
     So the solicitation instructions tell you what to do with each of those in turn. 
     The final source of where you can find the RFP is in FedBizOpps, which is the Federalwide portal for all contracting solicitations and proposals.  We issued a presolicitation several weeks before the solicitation, and all of this is linked from the slides and from our policy notes, which went out at the beginning of solicitation.
     The solicitation itself is the same in all of the three places.  Additionally all of the appendices found here are linked within the solicitation.  So you can grab everything you need by downloading the PDF or Word of the solicitation and then you will have direct links to everywhere you need.
     This, when you download the SBIR solicitation, this is the top of the front page.  It should look like this.  It should say program solicitation PHS 20171 with the current closing date of October 21st, 2016.  Front page in most of the RFP looks similar from year to year.  Please be sure you're using the correct RFP and not last year's.
     And now we're going to dig a little bit into the body of the RFP.  The RFP is broken up into 12 sections, introduction, program description, the definitions, proposal fundamentals, contract requirements, method of evaluation, proposal submission, proposal prep and instructions, HHS components and anticipated number of awards, contracting officer contacts, technical information sources, and 12  section 12 is the actual full technical topic descriptions.
     In the next few slides I'm going to talk about bits and pieces of the RFP that are relevant for us to talk about today, but the absolute number one piece of advice that we can offer to you today is that we encourage you to read the full RFP several times.  Even if you've applied before in prior years, we do update some of the definitions, we update the instructions.  We have new areas of the solicitation that are there.  So even if you've applied before in prior years, please read the current solicitation.
     Section 2.6 in the solicitation talks about the awarding components.  This year we have five institutes from the National Institutes of Health.  The National Cancer Institute, national center for advancing transitional sciences, national institute of allergy and infectious disease, the National Heart, Lung and Blood Institute and the national institute on drug abuse.
     And we have two centers from the Centers for Disease Control and prevention, the national center for chronic disease prevention and health promotion, and the national center for emerging zoonotic and infectious diseases.
     So there's a total of seven components of HHS are participating.  Not all institutes participate, unlike the grant omnibus.
     Section 1 and section 12 within the topics talk about the types of proposals that are allowed for each given topic.  This solicitation is inviting several types of proposals.  Phase I proposals, which only include the Phase I.  Fasttrack, which is a Phase I plus a Phase II, and direct Phase II that only is a Phase II proposal.
     In the table in section 1 and in each individual topic listed in section 12 it talks about what is allowed.  And this is basically a cut and paste from the top of the table.  For instance, we see NCI's first topic 355, cell and animalbased models to advance cancer and health disparity research is accepting all options, Phase I, fasttrack and direct Phase II.
     While the next topic, 356, is only accepting Phase I and will not accept a fasttrack or a direct Phase II.  And if you as I understand one of those in it will be rejected.
      if you send one of those in it will be rejected.  In some cases any and all will be acceptable.  Some may only have fasttrack and not Phase I and direct to Phase II.  So please read what typical of proposal they are accepting before you begin work on a proposal. 
     Section 8.3 in the solicitation talks about what constitutes a complete Phase I submission.  And they're summarized on this slide.
     On any of these submissions a full submission is in two parts.  The technical proposal, which is itself one PDF of all the parts listed below, and the business proposal, which is itself a separate PDF. 
     The technical proposal is what we call technical element, item one.  It includes the proposal cover sheet, Appendix A, a table of contents, which you create.  The abstract, which is Appendix B.  The content of the technical element.  This is the meat of the proposal, your research strategy, letters of support, bios, literature, all of that.  That's the content of the technical elements.  And summary of related activities, Appendix F, that's your support.
     All of that gets put together into one PDF.  I say it's in the solicitations, but the PDFs should be simple, not password or others encrypted.  So use standard PDF generating software when you do this.
     The business proposal is essentially the budget section of the proposal.  And it is the pricing proposal is Appendix C.  It also includes other required forms such as the SBIR application venture capital operating company certification if that applies to you, and all are required a proof of registering in the SBA company register try.
     This slide talks about what's a complete Phase II submission in section 8.4.  It is essentially the same, a technical proposal PDF and a business proposal PDF with the exception that the business proposal PDF has a few extra parts to it.  The cover sheet is a different Appendix.  Still a table of contents, abstract Appendix B, the content, which is the bulk of the work.  A draft statement of work is Appendix E.  Summary of related activities is Appendix F.  And a proposal summary and data record Appendix G.  All of this constitutes the technical proposal in a Phase II  whether a Phase II is part of a fasttrack or Phase II direct to submission.
     The business proposal is the same.  A pricing proposal, Appendix C, the SBIR venture capital form, if applicable, and the SBA proof of registry.
     If you are proposing work with human subjects or vertebrate animals, then I'm going to highlight the sections of RFP that you should take extra care to read.  Section 3 provides definitions to all of these  everything in the RFP, but especially these areas.  Section 4.9 summarizes what's involved in human subjects research.  Section 4.10, information about the inclusion of women, minorities and children in clinical research when doing human subjects research.
     Section 4.11, background on the care of vertebrate animals.
     Section 8.10 are the instructions for providing information if you're doing human subjects research.  Section 8.11 are the instructions on what to provide to address inclusion of women, minorities and children in clinical research.  Section 8.12 is the inclusion enrollment reports for sex, gender, race and ethnicity for human subjects research.  8.13 is instructions for research involving human fetal tissue.
     Section 8.14 is instructions for research involving vertebrate animals.  All of these, if you're doing all of that, of course you have to pay attention to all of this.
     It is certainly worth reading all of it, even if you think you're not proposing work on human subjects and vertebrate animals, just to make sure.
     This is something new this year.  I mentioned that we update the RFP every year.  Section 8.9 is new instructions on enhancing reproducibility through rigor and transparency.  This is a new requirement on all NIH grants and contracts and we provide instructions in section 8.9 on what you have to provide in your proposal to address this.
     For more information it's linked in the RFP, but also here in this slide presentation to NIH notice NOTOD151003, which has overall NIH guidance that we issued last year on enhancing reproducibility.  And it does apply to contracts and it does apply to this SBIR solicitation, so there are instructions for everyone to follow.
     Page limits are addressed in section 7.3 and this is of course quite important.
     If you're very familiar with our grant program where we have a sixpage research strategy limit for Phase I and 12 pages for Phase II, that does not apply to contracts.  The SBIR Phase I technical proposals, all of item one, the technical elements, is limited to a total of 50 pages.  That's for everything in a Phase I it technical elements.
     The appendices, the abstract, the table of contents, all of the work, literature, et cetera.  It does not include the budget in the pricing proposal, that section, in the business proposal.
     Phase II technical proposal Page limit is 150 pages.  A fasttrack is a complete Phase I plus a complete Phase II.  So 50 pages plus a 150 pages in two separate submissions, which you will hear about shortly.  A direct to Phase II is as you saw, 150 pages.
     The RFP provides instructions as to single side and single space and inclusive of all the things shown here.  There are no exclusions to page limits.  Any technical element over the page limits will have the excess pages deleted, removed and will not be evaluated.
     Please stick to the page limits.
     That covers the overview of the SBIR program and the contract RFP.  I did not discuss many of the sections of the RFP.  There isn't time to go into that detail, but I wanted to highlight the important areas for you to pay attention to in addition to of course reading the entire thing.
     Now I want to discuss the differences between this RFP and SBIR contracts versus our grant mechanism, which is currently 90% of our funding goes to grants and 10% to contracts.
     Overall differences between contracts and grants:  Contracts is an acquisition mechanism and grants are an assistance mechanism.
     So in a contract the government is acquiring something.  We are not acquiring your technology, but the government is acquiring in an SBIR contract is your R&D to the specific topics that we have out there.
     Grants are an assistance.  We're providing an assistance mechanism to allow you to do the work.
     Contracts follow the Federal acquisition regulations for the FAR and the SBIR policy directive which the Small Business Administration puts out.
     Grants policy our NIH grants policy statement and SBIR policy directive.  Contracts are not investigator initiated.  You must respond exactly and very specifically to a topic if you're going to apply.  As you will hear about later we provide Phase I deliverables, Phase II deliverables and a great detailed description of what we expect you to provide in your proposal.
     Grants, most of our grants are investigator initiated and our program announcements in our omnibus we put out a broad list of topics, but you don't have to respond to a specific topic to reply to the omnibus solicitation as long as it's within the agency.  Contracts are not that.
     Contracts will almost always have relatively narrow, welldefined topics with quite a bit of text to describe what we the government are looking for.
     Grants can be broad or narrow topics, but even on the narrow topics they're not nearly as narrow or prescribed as a contract topic is.
     The terminology and lingo is also different.  In a contract our solicitation is called a request for proposals.  When you are applying to us you are called the offeror.  If we make an award to you, you are our contractor.  And you submit a proposal to us for a bid for that matter.
     On the grants side, we have several flavors of funding solicitations.  Program announcement, PA.  Program announcement with special view, PAR.  Request for applications, RFA.  An RFA is not an RFP.  It is a grant mechanism for a specific topic.  You apply to us, you are the applicant.  If we make an award to you, you are our grantee and you send us an application.
     While this may seem like very arbitrary and finegrind distinctions, this terminology is important in terms of distinguishing contracts versus grants.
     Additionally your contact with the agency is very different.  Under the contract solicitation you only contact before an award is made is with the contracting officer.  The contracting officer contacts are listed in section 10 of the RFP.  You want to only you are only allowed to contact the contracting officer for all of your questions preaward. 
     Grants, as you are probably aware, you can call or email your Program Officer any time for anything before, during and after awards.  But with contracts, everything is through the contracting officer and if the contracting officer needs to contact a program, they will, but if you call a Program Officer or email them with respect to this contracting RFP, they will and they should refer you back to the contracting officer.
     Lastly on this slide, submission.  Contracts, we are using the strong contract proposal submission system at NIH, eCPS.  This was new as of last year and we used to have paper submissions.
     Grants, you apply for grants, you're using our SF 424 forms, using grants Governor and using the eRA Commons.  That's for grants. 
     And lastly in this section, what types of things are required for a contract.  Do you have to still register in the SBIR company registry or if you are already registered do you industrial to provide your SBIR registry sheet?  Yes.  If you're a venture owned company do you have to provide the VCOC form?  Yes.  Do you have to have a DUNS number, yes?  Do you have to be registered in SAM or the system for award management?  Yes, but at time of award.  For grants you have to be registered upfront in order to submit the application in for contract at that time of award.
     [Phone ringing].
     That's my phone.  Sorry, it's not able to be muted.
     Do you have to be registered in Grants.gov to submit under this RFP?  No.  Do you have to be registered in eRA Commons either with an PIA account?  No.  However, you can use your eRA Commons account to register in the eCPS.  So if you have an eRA Commons account you can use it to get into the eCPS without having to register separately.
     Are you required to use the electronic contract proposal submission, eCPS?  Yes.  You are required to submit all proposals to that system.  We will not accept paper proposals, we will not accept email proposals to the contracting officer.  It must all go through this system.
     And so that concludes the section on differences between grants and contracts. 
     Now important deadlines. 
     We have section 7.1 of the RFP discusses the question and answer deadline.  A reminder as to what I just said, that the only contact allowed under contract is with the contracting officer listed in section 10.  All of your contracts must be submitted in writing or email to the contracting officer. 
     The deadline for submitting questions is next Thursday, September 1st, 2016 close of business.
     We will take all of the questions that come in to the contracting officers and in addition to all of the questions that we answer here today, and we will put them together and publish a question and answer amendments to the solicitation in roughly mid September, a couple of weeks from now.  Both in FedBizOpps and on the NIH websites that I showed you before.  So yes, your questions that you asked and the answers provided will be posted to the public?  That's very different from our grants, but that is what is required under contracting regulations for fair and open competition.
     If you ask very, very specific technical questions about the topic or about your particular science may or may not get answered at the discretion of the contracting officer.  All of the answers will come from the contracting officer.
     Any questions you send in after September 1st date may be answered at the discretion of the contracting officer.  They may also point you to the Q and A amendment, but that will be at their discretion.  And the Q and A amendment will be posted roughly four weeks before the deadline so there's plenty of time for everybody to see.
     The deadline.  The big date.  Friday, October 21st, 2016, 5:00 p.m. Eastern Daylight Time.  That is the deadline.  It is different from the grants deadline, which is 5:00 p.m. your local time.  The deadline for contracts is 5:00 p.m. east coast daylight time.  Two p.m. if you're on the west coast.
     Electronic submission must be complete.  No paper submissions.  And you will hear about in a few minutes from Mike Kapsilis from that you cannot be in progress.  You have to ensure that you are through submission with the date and time stamp before 5:00 p.m.  At 5:00 p.m. the system will  the submission system will shut down.  There are no late submissions.
     So if you get the little spinning circle in progress and it's not 5:00 p.m., that's not a submission.  You want to give yourself plenty of time.  It only takes a few minutes to submit, as you'll hear.  It's much simpler than submitting grants through Grants.gov.  But you must have complete submission for any and all of your proposals if you're submitting more than one by 5:00 p.m. eastern time, Friday October 21st.
     And so now we're going to go into a demo of the eCPS system.  Again, before I turn it over to Mike, remind everyone electronic submission through the system is required for all proposals.  Paper proposals are no longer accepted.  Section 7.4 of the solicitation describes in detail the submission process, how to do modifications and all these things and all of these will be summarized in the demo.
     This link shown here, eCPS.NIH.gov/SBIRSTTR is provided in the RFP and is the main portal for electronic submission.
     And with that I'm going to turn it over to Mike Kapsilis in NIAID on the eCPS team for the live demo. 
     >> Thank you, Matt.  This is Mike Kapsilis and I am going to, as Matt said, give you a live demo of the eCPS electronic contract proposal submission site.
     As Matt stated, this is for the contract solicitation.  This is where you're going to go in and upload your proposals against the SBIR contract solicitation.
     I am using for this purpose today a contract site, it's an internal site, but it's identical to the site that is shown and is hyperlinked on the solicitation.  So please use the site that's on the solicitation.
     Do not use this URL here.
     When you click on that URL you will be taken to this site, this site that looks identical to this.  And if you're familiar with this from last year we have an eCPS summary section at the top.  We have instructions on how  on various ways to register, and I'll tell you about that in a moment.  We have our frequently asked questions here on the righthand side.  And you also can access them through the FAQ at the top.  And at the bottom we have added an SBIR filter which you will select and you will see all of the topics under the currently opened contract  SBIR contract solicitation. 
     So when you're taken here, you have this year a few new options to log in.
     So we have our eRA Commons, as Matt stated, you can use if you have an existing eRA Commons account, you can use that to log in.  You can now use your Google account.  If you use gmail, and we authenticate through Google so you can use your Google account and log in via your Google account.
     You request also log in through federated  you can also log in through federated login and that's another option we've added.
     If you do not have any of these accounts you can of course quickly create a Google account.  You can also quickly create an NIH EXT, external active directory account, by clicking here.
     When you click here it takes you to a simple interface where you will be asked just a few questions.
     And you would hit submit.  And we ask that you do that fairly far in advance, but we regularly turn over those very quickly.  We ask that you do it within three days of closing, but we do recommend that you make that request as soon as possible.
     But you have several options here for logging in.
     I'm going to go ahead and  let me show you this first.  When you click down here and you click on SBIR, the SBIR filter, you're going to see all of the topics for the currently open SBIR solicitation.
     You will see all of the topics listed.  Once I log in with my login, you will see some more options here.  So I'm going to go ahead and log in with my NIH login.
     So the interface now shows a submit button next to every topic.
     What you want to do is filter for SBIR again after the login.  And you're going to get all the open topics.
     I have submitted some test proposals and we're going to go ahead and submit a new fasttrack Phase I and Phase II proposal against a particular topic.  So when I scroll down here I submitted mine against this.  That's why I'm getting several buttons here.  I've submitted one, two, three, four proposals already and we're going to submit a new proposal against topic number 44.  As a sample.  Make sure you use the correct topic.  You would hit submit.  Let me show you, when you click on the  these are all hyperlinked.  It reaches out to FedBizOpps and shows you the original solicitation.
     So when you verify the topic you want to submit against you would hit submit.  And this is the window that pops open.  It has your  the topic you're submitting against I recommend that you verify that once you hit that submit button.  We're submitting on the sample against topic 44.  It has your account information and it states the closing date and time.  As Matt said, you can only upload up to that date and time, up to that second five p.m. eastern time.
     In the solicitation we do give guidance on how to name your proposals.
     Like I said, we're going to do a Phase I and Phase II fasttrack.
     So if we're going to go ahead and do a Phase I, we would name this and you will see this in the instructions, Phase I fasttrack, then your company name, the awarding component and the topic number.
     Then you would go ahead and upload your technical proposal, and we do recommend that on the technical proposals you state your company name, the awarding component and the topic number.
     And then you upload your business proposal.  Again, company name, awarding component, topic number business.
     And again, this is going to be one PDF and one PDF.  You have the option to upload an excel spreadsheet of your costs.  If you do that it must be identical to the cost break down in your business proposal.
     Then you would hit submit.  And once you submit two things happen.  You would get a confirmation message here and you're going to get an automated email that states  that confirms if the upload was successful or not and it gives you the date and time.  So I'm going to hit submit.
     I have my confirmation message here, and I also have an automated email.  It comes into your email box for when you set up your account that email that you set up the account with and it shows your date  it shows the actual date and time of receipt of the proposal. 
     I'll show you this in a minute.  You can go in my history on eCPS and see a log of your submissions.
     Again, you also get this message here, confirmation that the upload was successful and the date and the time.
     So what we've done is we've submitted a Phase I fasttrack proposal with two PDFs against topic 44.
     To submit a Phase II fasttrack against the same topic you would do that through the submit new alternate proposal.  I'm going to go ahead and hit submit the alternate.  And there's a message that pops up at this point that says you have chosen to submit a new alternate proposal.  If you would like to revise an existing proposal, click cancel below and click revise under your action.  Do you wish to submit a new alternate?  I'm going to hit cancel here.  If you would like to revise your existing proposal, you would go in and hit replace here and revise your existing.
     You do have one last chance to view the proposal.  Once you hit  once you hit submit, you can not view the proposal that you submitted.
     The only way to revise your proposal is to replace it with an updated proposal.  eCPS does not keep, does not track previous versions of proposals.
     So for Phase II we hit new alternate.  We would say okay.  And this would be for topic 44. 
     We would name it and then upload the technical and business proposal for Phase II.
     And again upload an optional Excel spreadsheet if needed.  You would hit submit.  You get the verification message and you get the email verifying that it was uploaded successfully., that it was received successfully and the date and time.
     And you have a history log at the bottom.  If we close out of this window what you will see now is when you scroll down we just submit it against topic 44, so you're given two options now.  You can revise your existing submission, you can upload another proposal as needed.  If you want to revise your proposal, of course you can do that up until the date and time of the closing.  The closing date and time.
     So you have another  the other option to revise from here.  If you want to revise any of these two documents under Phase I you would hit revise.
     I apologize.  This is supposed to be called 44 here, topic 44.
     You would replace with the revised proposal and update, and that's the way you would revise it.
     Once you log in you will see all of your submission history for that particular account that you log in with.
     If you have multiple accounts for whatever reason, make sure if you're viewing your history and you do not see and you're sure that you uploaded and you do not see the upload history, it may be because you uploaded it against a different account.
     So make sure that you track.
     When you get the automated email it verifies, it sends it to the email that you set up your account with.
     So when you go to the top here, when you look at my submission history, it will be your submission history for all of the submissions that you have done under your particular login or gmail, example, or eRA Commons, for example.  If you uploaded via eRA Commons and you go in next time through a gmail you won't see the eRA Commons uploads.
     That is it for the upload process.  And I will now turn it back to Matt.  Thank you. 
     >> Thank you very much, Mike.  I'm going to flip this back to my screen. 
     All right.  And so I just want to say that this is of course being recorded.  You can watch the demo.  The site is, as you hopefully saw, quite simple and very intuitive.  And there is an eCPS help desk button and link there on most of the pages.  If you have any questions or problems you can definitely contact them as needed.
     And so now we will turn to the last section of our presentation, where the institutes will give short  short overviews of their specific topics.  So Kory, are you ready? 
     >> I am.
     >> Okay.  First up will be the National Cancer Institute, SBIR topics. 
     >> All right.  Thank you, Matt.
     So I am Kory Hallet from the NCI SBIR program and I'm going to talk to you about our contract funding opportunities.  Matt, I don't think I have presenter.
     >> No, you won't.  I'll be doing it for you.
     >> Great, thank you.
     So about 30% of the NCI SBIR budget is awarded through our new contracts.  We develop our contract topics for solicitation by gathering input from across NCI to identify areas of need or technology gaps that we think can be filled by small businesses.
     So for example, one of our topics this year is soliciting new research models for cancer health disparity.  It is a priority area for NCI.  We believe that a technology gap exists with available models, making research in this area more difficult and small businesses can help fill this technology gap.
     Next slide, please.
     So in FY2017 we have issued 15 topics in this solicitation in a range of technology areas.  And I'll briefly go through each one of them. 
     Next slide. 
     The next topic is NCI topic 355, cell and animalbased models to advance cancer health disparity research.
     So this topic is eligible for a 300,000dollar Phase I.  And fasttrack and direct to Phase II applications will be accepted.  The goal here is to develop new commercially available models relevant to diverse racial and ethnic populations.  These models can be used to enhance research capabilities of basic scientists or provide novel tools to pharmaceutical companies for preclinical studies.  For this topic it's really critical that the proposed models be from racially and ethnically diverse populations and offerers must clearly demonstrate access to human samples from minority populations with informed consent in place.
     Next slide, please.
     The next topic by NCI is NCI topic 356, tools and technologies for monitoring RNA.  This award is a 250,000dollar Phase I.  Fasttrack proposals and direct to Phase II proposals will not be accepted.  The goal here is to incentivize small businesses to generate tools, technologies and products for monitoring covalently modified eukaryote RNA, including messenger RNA and regulatory RNA.
     NCI topic 357, innovative tools for interrogating tumor microenvironment dynamics.
     This solicitation is a 300,000dollar Phase I.  Fasttrack proposals are accepted and direct to Phase II proposals are accepted. 
     We're looking for people to develop noninvasive, in vivo platforms that can image, assess or interrogate TME dynamics over time for tumor diagnosis and/or treatment prediction and response.
     And it's really critical that offerers recognize that we are looking for ways to interrogate the tumor microenvironment over time.  That's a critical thing to take away.
     It's expected that small businesses will generate enough data to confirm clinical potential of the proposed agent by completing the Phase I activities and deliverables.  Next slide, please.
     NCI topic 358, modulating the microbiome to improve therapeutic efficacy of cancer therapeutics.  These applications can go up to $300,000 for Phase I.  We are not accepting fasttrack proposals or direct to Phase II proposals under this topic.
     The goal is to develop effective adjuvant strategies that specifically target critical microbial activities or populations that affect drug efficacy and/or tolerability.
     So a few of the key activities and deliverables here is to define and characterize a host microbe interaction and develop targeted microbiota that can work in directive intervention strategy.
     Next slide. 
     NCI topic 359, technologies for differential isolation of exosomes and oncosomes.  Again a 300,000dollar cap on the Phase I award.  No fasttrack or direct to Phase II proposals will be accepted. 
     The goal is to accelerate the use of exosomes from body fluids for cancer research and clinical care and develop technology for differential isolation of tissue, specifically exosomes and oncosomes in serial collections of archived body fluids to enable assessment of cancer initiation, progression, risk, aggressiveness, prognosis and/or treatment outcomes.
     So it's expected by completing the Phase I activities and deliverables that the small business will develop a technology and benchmark its function against some existing technologies.
     Next slide, please.
     NCI topic 360, manufacturing innovation for the production of cellbased cancer.
     I believe that's supposed to be biologics.  So a 300,000dollar Phase I fasttrack proposals, but direct to Phase II proposals will not be accepted.
     So the goal here is to facilitate the development of innovative methods and technologies capable of improving and modernizing product manufacturing processes for cellbased cancer immunotherapies.  And by greeting the Phase I activities and deliverables it's expected that the small business will develop a relevant manufacturing advancement and take it through some beta testing.
     Next slide, please.
     NCI topic 361, highly innovative tools for quantifying redox effector dynamics in cancer.  Phase I are capped at 225 under this topic.  And fasttrack proposals are not accepted, direct to Phase II proposals are not accepted.
     So the goal is to develop tools to measure redox dynamics in biological systems.  So ideally probes or bio sensor tools should be minimally invasive so as to not significantly perturb the system.  And the technical approach should do two things.  One, allow for in vivo measurements of redox effector spatiotemporal dynamics, and/or be able to use in a high throughput system. 
     Next slide, please.
     NCI topic 362, informatics tools to measure cancer care coordination.  Proposals under this topic are capped at 225,000.  Fasttrack proposals are accepted, but direct to Phase II proposals are not accepted. 
     The importance here is that it's expected that the small business  excuse me, sorry.
     Will ease the burden of measurement in cancer care coordination and ensure that the tool or platform can be used as widely as possible.  So we were really looking for flexible and usercentered designs that can meet the needs of diverse organizations with different I.T. architectures.  So that's important to take into account when developing your proposal.
     Next slide, please.
     NCI topic 363, connecting cancer caregivers to care teams, digital platforms to support informal cancer care giving.
     So here we're looking for two things predominantly.  One, we're looking for performs that focus on care give, not just on patients.  And platforms that directly connect caregivers to the patient's care teams.  So for example, medical task instruction, assistance with activities of daily living, et cetera.
     This topic proposals are capped at 225,000 for Phase I proposals and fast tracks are accepted.  Direct to Phase II's are not accepted.
     Next slide, please.
     NCI topic 364, methods and software for integration of cancer metabolomic data with other omic and imaging data.
     By completing the Phase I deliver activities and deliverables here it is expected that the small business will develop a tool to integrate big data and that's the important part here.  Phase I is capped at 225 and direct to Phase II proposals will not be accepted, but fasttrack proposals will. 
     Next slide, please.
     NCI topic 365, imaging informatics tools and resources for clinical cancer research.  Phase I's under this topic are capped at 225.  Fasttrack proposals are accepted, and direct to Phase II proposals are not accepted.
     The goal is to develop and implement solutions for sustained support for the advancement  advanced development, evolution and broad adoption of cancer imaging informatic tools and resources.  With this topic, the term sustaining is really a key word in the goal.  We're not looking for new systems.  We're looking for tools such as algorithms or other tools that can be added to existing systems so that these systems can be modified and commercialized.
     Next slide, please.
     NCI topic 366, clonogenic high throughput assay for screening anticancer agents and radiation modulators.  The budget for Phase I is 300,000, and neither fasttrack nor direct to Phase II proposals will be accepted.
     Here we're looking for screening as says that more effectively and more precisely screen anticancer agents in radiation modulators.  We're really seeking what we consider next generation high throughput as say screening technologies.
     Next slide, please.
     NCI topic 367, predictive biomarkers to improve radiation treatment.  Phase I awards are capped at 300,000.  Fasttrack proposals are accepted.  Direct to Phase II proposals will not be accepted.
     And the goal here is to develop simple cost effective test that can be used by clinicians to personalize radiation, chemical mow radio therapy treatment regimens.  This includes a description of components that must be in the Phase I proposal.  So this ranges from a quantitative active estimate of the patient population, including the cancer type and/or began site.  A plan for generating evidence that the proposed bio marker or buy 84 markers are relevant, a description of assay characteristics and a proposed regulatory pathway, including a plan for a pre IDE presentation with FDA.  There are also additional requirements for the proposals within the solicitation so read the solicitation carefully.
     Next slide, please.
     NCI topic 368, molecularly targeted radiation therapy for cancer treatment.  Phase I is 300,000.  We are accepting fasttrack proposals.  We're not accepting direct to Phase II proposals.
     Here the takeaway is that with  by completing the Phase I activities and deliverables, it's expected that the small business will demonstrate technical feasibility of the innovative approach.
     Next slide, please.
     Finally, NCI topic 369, development of pediatric cancer drug delivery devices.
     Phase I proposals under this topic are capped at 300,000.  Fasttrack proposals will be accepted, direct to Phase II proposals will not be accepted.
     The goal is to develop technologies to aid the administration of cancer therapies to pediatric patients, taking into account pediatric specific issues which include, but are not limited to dosage limitation, size restraints, comfort level and mobility.
     For this topic it's critical that the proposed delivery devices is taken into account unique needs of pediatric patients that are not being met currently with available technologies.
     So my final slide, I think I give the contact information for Tiffany Chadwick, who is the contracting officer on all of these topics.
     She can be contacted at NCIOASBIR@mail.NIH.gov.  And then please remember to refer to the topic number with my questions because NCI has quite a few topic numbers.
     With that I will let the next person go.  Thanks, Matt.
     >> Thanks, Kory, appreciate it.  Next will be Lili Portilla from NCATS to present their topics.
     >> Hi, everyone.  This is Lili Portilla from the NCATS office of strategic alliances.  I wanted to talk to you about our one topic that we have on the street right now, which is the development of a drone to be used in laboratory automation projects.  The idea behind this topic is that being that we have a significant amount of screening facilities here at NCATS, we are trying to figure out better ways to conduct these screens.  Our current robot arms that are used in high throughput screening environments has certain limitations in terms of range of motion and their cost and safety associated with that.
     So we want to experiment and try out the idea of developing drones that are able to pick up microplates from one station and move them to another station along a predetermined flight path and drop it off, and do this on a pretty much  on a an uninterrupted 24 hour per day basis.
     So these contract topics, we will not be accepting any fasttrack proposals under this particular topic.  And the Phase I award is capped at 225 K for nine months.  And the Phase II is 1.5 million for up to two years.
     And we anticipate giving one to two awards in this particular topic area.
     And if you have any questions about the topics, please contact Jeff Schmidt, who is listed as our contracting officer on the solicitation. 
     Thanks, Matt. 
     >> Thank you, Lili. 
     Next up is Jennifer Shieh for the national heart lung and blood institute.
     >> Hi, I'm Jennifer Shieh for the National Heart, Lung and Blood Institute.  I'll be talking about five contract topics in this year's solicitation.  But please read the full solicitation for all of the details.  If you have any questions regarding the NHLBI topic, please contact John Taylor, the contracting officer.
     If you want to learn any more about grant funding opportunities or any other resources available to innovators working on heart, lung or blood technologies, you can visit our website and follow us on Twitter.
     Next slide, please. 
     So the first topic is about the transNIH interagency collaborative aging in place research using technology or C.A.R.T. demonstration project, which aims to develop and test the feasibility of a research infrastructure that supports inhome care that utilizes innovative technology targeted to reduce hospitalizations, emergency room visits or admissions to a nursing home for older populations and facilitate aging in place.
     This contract solicitation supports the testing and validation of existing technologies that are focused on cardiovascular, respiratory, hematological or sleep technologies within the context of the C.A.R.T. demonstration project.
     This topic will not accept Phase I only proposals.  This topic is only accepted either fasttrack or direct to Phase II proposals.  And any proposal that is submitted through this topic should provide some evidence that there are significant development milestones for a specific, remote, mobile or wireless technology or system that that's been achieved that can demonstrate some readiness for a Phase II SBIR contract.  And any of the proposed technology must be compatible with the C.A.R.T. platform requirements.
     Next slide, please.
     Topic 99 is an SBIR technology transfer topic where an invoice recognition from the NHLBI intervention of intramural research is licensed to a small business with the intent of developing the invention into a commercial product that benefits the public.
     So this solicitation is for the development of an inhalational formulation of the 5 A appear policy protein A1 mimetic peptide for the treatment of asthma.  They will work closely with the NHLBI inventors who will assist in preclinical experiments and offers to perform a clinical trial using the offeror's product.
     The NHLBI inventor will provide assistance in a collaborative manner, providing the 5 A APOE A1 mimetic peptide for the studies, experimental designs and techniques, clinical considerations and discussions throughout the entire award period.
     This topic will accept pays one or fasttrack proposals, but will not accept direct to Phase II proposals.
     Next slide, please.
     NHLBI topic 100 is  the goal of NHLBI topic 100 is to develop an endomyocardial injection needle chemo ablation catheter that is safe for operation of MRI to help in delivery of caustic agents.  It would require testing and development in Phase I and support for regulatory clearance with a final deliverable of either the IDE or 510 K clearance.
     NHLBI offers to work with awardees to provide design feedback and test the final deliverable in vivo in swine and to perform clinical testing at no charge to the contractor.
     Both fasttrack and direct to Phase II proposals will be accepted. 
     Next slide, please. 
     NHLBI topic 101 supports early stage preclinical and clinical development of a trans catheter device system to treat one of the most common congenital heart defects, membraneous ventricular septal defect without surgery.
     The NHLBI division of intramural research offers, but does not require working with the awardees to perform in vivo proof of permits to participate in the development of the clinical protocol and perform the clinical trial at no expense to the awardee.  Both fasttrack and direct to Phase II proposals will be accepted.
     Next slide. 
     NHLBI topic 102 supports the early stage preclinical and clinical developments of a purpose built trans catheter occluder device to address the problem of paravalvular leaks that can occur around a prosthetic heart valve.  Must be included is the regulatory strategy, including plans for presubmission meeting with the FDA and key personnel with appropriate and relevant regulatory experience.
     Team members should have demonstrated experience with cardiovascular device product development, including permanent implants.  Both fasttrack and direct to Phase II proposals will be accepted.
     And again, this was just highlighting a few  a few of the highlights from the five NHLBI contract topics, but please read the full solicitations for all of the details and contact John Taylor, the contracting officer, for NHLBI, if you have any additional questions.
     And that's it for me.  Thanks, Matt.
     >> Thank you, Jennifer.  Next up we have Wolfgan Leitner from the NIAID to present their topics. 
     >> Hi.  My name is Wolfgan Leitner.  And I'm going to introduce the 10 SBIR contract topics from the National Institute of Allergy and Infectious Diseases.
     Whether or not fasttrack proposals are allowed as well as the budget caps for each of the topic areas can be found in the full program solicitation documents.
     Direct to Phase II proposals are actually accepted for all of the 10 topic areas, which are on the screen right now.
     Please note that while for many of the topic areas the use of human samples is not only acceptable, but is strongly encouraged, however the NIAID does not support clinical trials through the regular SBIR mechanism.
     So if clinical trials are included in the proposals in response to any of those 10 topic areas, the proposal would be rejected.
     Next slide.
     The first research area is the development of platform technologies to deliver RNA in vivo.  The objective here is to improve HIV vaccines and therapeutics.  These RNAs could include self [indiscernible] RNA, microRNA or microRNA antagonists, but also messenger RNA as well as plasma DNA that's encoding specific RNA sequences for transcription regulatory sequences.
     The technology that's being developed needs to address current limitations of RNA based vaccines as well as RNA based therapeutics.  These are mainly stability, manufacturing problems or the efficiency of the delivery.
     The shortterm goal of this program are feasibility studies of delivery mechanisms  the longterm goal is to bring novel RNA delivery platforms to the clinic.
     Next topic.
     The topic number 41 is the development of cheap and easy to use sequence based diagnostics for TB drug resistance testing.
     The background for this is the WHO recommendation for routine drug sensitivity testing of new TB patients.  This is frequently not done because of poor lab infrastructure and high costs. 
     The new diagnostic has to work in a setting of HIV coinfection.  It needs to require minimal information technology and lab resources.
     It must be capable of generating sequence data even from a single smear negative  a single smear negative, but culture positive sputum sample.
     It has to be fast, accurate, and it has to predict resistance to full first and second line TB drugs.
     The ultimate objective is the availability of a selfcontained system that performs highly accurate analysis of sequence data.
     Next topic.
     Topic number 42 calls for the development of qualitative home test for HIV.  Specifically to monitor for viral rebound that could be due to nonadherence to drug treatment regimens or viral [indiscernible].  The system does not have to be quantitative, but it has to meet sensitivity criteria that are outlined in the solicitation.
     The kit must be easy to use, similar to, for example, a glucose monitoring system for diabetes.  It should consist of a small unit and which should ideally be disposable.
     However, if it's a handheld unit with test strip or a cartridge, that would also be acceptable.  Ideally the units would not require refrigeration, and all the materials that are necessary to conduct the test should be supplied with the kit.
     Untrained individuals should be able to use the kit at home. 
     Next.
     So the next two solicitations complement the NIAID's existing vaccine adjuvant program.  Topic number 43 is the development of a vaccine adjuvant and specifically this program supports the preclinical development as well as optimization of a vaccine adjuvant combination for prevention of human diseases that are caused by any infectious pathogen other than HIV.
     And please note that NIAID uses the FDA definition of vaccine adjuvants, which is different from the NCI definition.
     In the context of this solicitation, the vaccine adjuvants can either be single compounds or formulations or they can be combinations of adjuvants that are existing of individual I am money know [indiscernible] compounds that work to enhance genome responses.
     The solicitation does not support the development of, for example, immunological [indiscernible].  The adjuvant must not already be part of a licensed vaccine and it must be studied and advanced together with a vaccine antigen.  This could either be an already licensed vaccine or new investigational vaccine. 
     The development of a standalone therapeutic is not permitted in the context of this solicitation.
     Topic number 44 is the discovery of novel adjuvants and this includes the screening of compound libraries to identify novel immuno stimulatory mules, they're characterization as well as the early stage optimization and testing in animal models and/or with human cells.
     Next topic.
     Topic number 45 supports the development of a data retrieval and discovery system that would allow the integration  the integrate the access to bioinformatics resources that the dissemination and [indiscernible] currently funds.  And these include importingen or in trial share.  And the objective of this system is to help the research community in accessing existing databases for immunology research.
     Next topic.
     Topic number 46 is the development of rapid point of care diagnostic tests to identify the presence of antibodies to herpes simplex virus or to cytomegalovirus.
     These symptoms should be simple, self contained with a very small amount of blood and provide a result immediately, which is defined as in less than 30 minutes.
     The test would initially be used to screen volunteers in vaccine trials and subsequently to determine eligibility for immunization with a vaccine that would be licensed for women.
     Next topic.   
     Topic number 47 is the development of microbiomebased products for infectious diseases.  And this call is targeting small businesses that already have an existing microbiome based product for treating existing diseases.  It has the product development for further studies.  Applicants should focus on IND enabling studies.  To conduct quality control studies to very specific product parameters and these include the identity, genetic stability or the purity of the microorganisms that are being developed as well as mechanism of action of the product.
     The field also requires new methods to be able to set specifications and manufacture complex approximate microbial cocktails.  Finally the solicitation supports novel formulations that would improve the longterm stability of microbiome based products.
     The applicants are strongly encouraged to look at the FDA guidance document that is cited in the full solicitation.
     Next slide. 
     Topic number 48 is  calls for the development of noninvasive rapid diagnostics for pediatric respiratory diseases.  The diagnostics should be able to rapidly and with very high expense activity identify infections of the lower respiratory tract of children using noninvasive methods for collecting the specimen.
     And these specimens could be inhaled breaths, could be saliva or a swab form, bodily secretions.  The diagnostic device should be easy to use, should be compatible with point of care use by health care personnel.  And that would exclude any method that requires, example, culture bottles or street plate incubations.  The reagents used by the device should be reliable under ambient conditions and it should be compatible with regulatory guidelines for testing and validation.
     Next topic. 
     So finally, topic number 49 supports phagebased diagnostic platforms for the rapid detection of the bacterial pathogens and this addresses the urgent need for highly sensitive, quick, easy to use and cost effective clinical diagnostics, so to identify bacterial pathogens and to determine antibiotics.
     And for a list of pathogens of interest, please consult the CDC list of criteria that are classified as antibiotic resistance threats.
     Diagnostic systems are preferred which can both identify the pathogen as well as provide an assessment of the antibiotic susceptibility.
     And these systems should be based on bacteria phages or their relevant biochemical components.  Since phages exhibit very high specificity for certain bacterial species.
     And these are the NIAID SBIR contract topics, and if you have any questions please contact the contracting officer, Charles Jackson, listed on the current slide.  Thank you.
     >> Thank you very much, Wolfgang. 
     Next I'll briefly present topics for the national institute on drug abuse.  They are unfortunately not able to make the webinar today.  So NIDA has two topics this year and they are listed in section 12, so please find that.  NIDA topic 161, virtual reality tools to enhance evidencebased treatment of substance use disorders.  This topic will accept Phase I only.  It will not accept fasttrack and not accept direct to Phase II.
     NIDA topic 162, analytical tools and approaches for multidimensional scholarly research for assessment and decision support in the enterprise that will help all options, Phase I and fasttrack and direct to Phase II.  Again, the full descriptions are in section 12 of the RFP and any questions about these topics can go to Andrew Hotaling, who is the contracting officer for NIDA.
     And last, but certainly not least, we will have Sean Griffith from CDC present a short overview of CDC and their topics for this year.  Sean?
     >> Hi, Matt.  Thank you very much.  My name is Sean Griffiths, the SBIR program manager for CDC and I'm going to cover a short piece about CDC as a separate operational division within the Department of Health and Human Services and then discuss two short topics from the agencies that are in the contract solicitation.
     Next slide.  The CDC's office of the associate director for science manages the SBIR program and works with CDC's centers, institutes and offices to make determinations as to where SBIR funds would best be used to support high quality, high impact SBIR projects that will be of overall benefit to public health.  The CDC participates in the SBIR omnibus grant and contract solicitations.  The CDC does not participate in the STTR program at this time, but CDC has opted into the majority VC ownership authority as of FY15.
     As Dr. Portnoy presented earlier, CDC's budget is approximately $9 million in FY16.  Next slide.
     The CDC's SBIR program is oriented around CDC's mission and vision, so there's a uniqueness to CDC's program around life sciences, public health, emergency response, which is both domestic and international. 
     As far as CDC's SBIR awards, we fund approximately 25 Phase I's, up to $150,000 each.  And approximately five to six Phase II's per year, up to one million dollars each.
     We've done a breakdown of grants versus contracts for FY13 through FY15.  You can see from FY13, 58 to 42.  FY14, 25% grants to 75 contracts.
     And FY15, 30% grants and 70% contracts. 
     Next slide, please.
     CDC's strategic priorities are those that are developed, our topics are developed around our strategic priorities as well as what we call winnable battles.  CDC's strategic priorities are to strengthen surveillance, epidemiology, laboratory services, improve the ability to support state, tribal Al, local and territorial public health.  Improve global health impact.  Increase policy impact as well as better prevent illness, injury, disability and death.
     Next slide.
     To keep pace with emerging public health challenges and to dress the leading causes of death and disability, CDC initiated an effort to achieve measurable impact quickly in a few targeted areas.  These are CDC's winnable battles.  And they're considered public health priorities with large scale impact on health and with known effective strategies to address them. 
     These key winnable battles in public health are tobacco, health care associated infections, teen pregnancy, nutrition, physical activity, obesity and food safety, motor vehicle injuries and HIV.
     Next slide.  Where CDC's SBIR program intersects with small business concerns, VCs and entrepreneurs, help CDC as we confront the many public health challenges before us.  CDC supports groundbreaking health and medical research and realtime emergency response activities to keep the US safe, healthy and secure.
     The CDC will promote and fund research and development that supports the mission, strategic priorities and winnable battles of CDC.
     CDC has a role at the local, state, Federal and global levels.  And the SBIR program is a way for innovators and entrepreneurs to contribute to making not only the US, but the world a healthier and safer place.
     Next slide.
     So now I'm going to take a few minutes and talk about CDC's two topics listed in the solicitation.  The first coming from CDC's national center of emerging and zoonotic infectious diseases, NCEZID, topic 14, multiplexed digital counting of single molecules for advanced molecular diagnosis.  Number of anticipated awards, two.  Budget Phase I up to $150,000 for up to six months.
     Project goals.  The goals of the proposed research are to rapidly, simultaneously and cost effectively detect and accurately quantify multiple antigen, protein and carbohydrate, and nucleic acid, DNA and RNA, target molecules used in the primary diagnosis of vector borne infectious diseases caused by viruses, bacteria and parasites.  The technology should ultimately incorporate innovations which enable large numbers of clinical samples and pools of vectors to be analyzed.  Phase I activities and deliverables and specific project goals include:  Develop as says suitable for use of pools with separate effecters and obtain quantitative data from assays.  Develop assays suitable for use with clinical samples obtained from different vector borne skis and obtain quantitative data from the as says.  Expand the range of as says available and move toward a commercialization subset of those as says.
     The next topic is from the national center for chronic diseases and prevention and health promotion, NCCDPHP, topic 38, improve contextual awareness using social network data.  Number of anticipated awards equals two.  Budget Phase I, up to 150,000 for up to six months.  The project goals, CDC seeks to support the development of an analytics platform that harnesses web and social network data and delivers novel surveillance capabilities for chronic disease indicators.  The proposal seeks to build large nationally representative cohorts of social network users for each indicator by unique key characteristics that are systematically inferred from user profiles, sweets and posts and  tweets and posts and search behaviors.  Phase I activities and deliverables include conduct a review of the data access and use policy of Twitter, Facebook and other social media.  Conduct a preliminary study to determine applicable social network data streams and public health indicators.  Identify appropriate informatics solutions, for example, natural language processing algorithms, to access, monitor and extract data.  Develop a prototype analytics platform with, quote, cohort builder function and demonstrate the creation of at least one nationally representative cohort in the chronic disease domain.  
     The CDC. 
     CDC works 24/7 saving lives and protecting people.  You can learn more at CDC.gov.  Thank you.
     >> Thank you very much, Sean.  And thank you to all the NIH program managers for presenting on all of their topics.  Now as we wrap up and move towards the Q and A I would just like to remind everybody that the deadline  and we will keep pushing this.  Friday, October 21st, 5:00 p.m. Eastern Daylight Time for a complete submission.  No paper submissions.
     Additionally, if you want to stay connected to the SBIR program, you can email us at our listserv and we will subscribe you to our 20,000 plus member listserv.
     If you wanted to register to get the weekly email notification about the NIH Guide you can go to the second link here, grants.NIH.gov/grants/guide/listserv.htm.  Follow us on Twitter, @NIHSBIR.  And you can submit your questions to SBIR at OD.NIH Governor.  Any questions will likely be sent to the contracting officer.
     With that I am going to leave this up and we're going to go to questions.  And so I'm going to  we're going to start with the couple of questions about eCPS and submissions proposals and then we will go to everything else.
     I do want to say that we've gotten many questions that are very technical and specific about a specific topic, and we are not going to answer them here because you need to send those questions with specific questions about specific topics to the contracting officer.
     We've gotten certain questions like where can I get more details about the topics?  You get the RFP and each topic has about a page to a page and a half of specific detail.  If you need more than that or have questions, you can ask the contracting officer then in the section.
     So also this is being recorded.  We will be posting the slides, the recording and the transcript on our NIH SBIR website under the events page for webinars within a few days and we will send out an email to everyone when that is available.
     So with that, Mike, are you available? 
     >> Yes, I am.
     >> So I'm going to scroll through very quick and look for some eCPS questions.  There aren't too many, but I think we did get one which I know we got last year, in that  give me one second here.
     Should a proposal are submitted by the principal investigator or PI or by an authorized official of the submitting organization? 
     >> It can be submitted by either.  That's up to the organization.  So eCPS does not distinguish.  And that's more of a policy question from the offeror.  Yes. 
     >> So while the system doesn't validate on whether the submitter is the PI or the authorized official, you of course should have the person who is authorized to submit proposals to the government to do that for you, although we don't 
     >> That's correct. 
     >> I don't think there was too many other eCPS specific questions related to submission.  Let me just check real quick.
     >> Matt, this is Betty.  I think there's one, are Phase II contract proposals from previous solicitations still submitted through the electronic portal even if the Phase I was mailed in?
     >> Yes.  That's a question, if they've sent in a Phase I proposal on an older solicitation, can they send a Phase II in under this solicitation?  And so the general answer is no.  This solicitation is very specific topics that tend to be different from past solicitation.  And if an offeror  if a contractor has a Phase I contract award from a previous topic, they should contact their contracting officer about Phase II submission possibilities.  The Phase II submissions allowed under this solicitation are either as part of a fasttrack for a given topic or a direct Phase II submission, meaning that the offeror doesn't have Phase I support for that work prior.
     That's a very good question.
     All right.  We're just going to kind of  Betty, do you want to go ahead and ask some of them and we'll signed out about answering them. 
     >> Sure.  What about how does the funding break down by IC or component for the contracts  so how does the funding breakdown work for ICs, like what percentage of the budget, how does that get allocated between ICs?
     >> So this is a higher level question.  Each institute gets a congressional appropriation, a percentage of that is available for SBIR.  The institute determines how they want to break that down in contracts versus grants, but you can actually tell from the solicitation how much money they plan to spend on any given topic.  They tell you what the budget is for Phase I and two and they tell you how many awards they're planning to make.  So offerers can get a sense of how much money is available for a given topic by reading each topic.
     >> So our next one is about the page limits.
     So is the entire proposal 50 pages, which includes everything including the business proposal? 
     >> Excluding the business proposal.  The, proposal, which is the budget  the business proposal, which is the budget, the SBA registry form and the venture capital form if that's applicable.
     >> So this is about Phase I and Phase II submissions.  If topics allow both Phase I and Phase II, if you submit a Phase I this year, could you submit a Phase II next year? 
     >> So the way a regular Phase II works, and the answer is not to the solicitation.  If you are awarded a Phase I contract, your contracting officer will contact you when and where and how to submit a regular Phase II to that Phase I.
     With the guidelines, guidance and how to do it.
     >> So we have nor question about the scope.  So if some of the Phase I deliverables, the question  the person asking the question feels like they're overly ambitious, since the small business can't modify the scope, how do you propose to achieve deliverables?
     >> Well, that's essentially your job as an offeror.  The government has put out a list of topics with deliverables and the budget we are willing to spend on it.  And it's the offeror's job to craft something that will fit all of that.  It happens  we ask for a lot, but we're always not surprised that contractors deliver.  And so it's up to you to determine how to craft what we are asking with the budget and time allowed.  If there are specific questions then you can certainly ask the contracting officer.
     >> Here's a good question.  Can a small business submit more than one proposal involving different investigation teams?  To a given opportunity? 
     >> So I think they can submit  if they're proposing different approaches to the same problem, then I think they can submit different proposals to the same topic from the same company.  They can't just submit the same proposal with two separate sets of teams on it.  They need to provide distinctive applications with distinctive approaches. 
     >> So how does the contract policy on intellectual property ownership differ from that of the SBIR grant policy? 
     >> The intellectual property and data rights rules under SBIR are identical for contracts and grants.  So the data and int property rights belong to the company as they do in grants. 
     >> So here's one.  Once a proposal is submitted, who decides if the proposal is significant, ie peer review committee or contracting officer at NIH?
     >> Well, you know, if they're asking about significance in the peer review context, it will be the technical evaluation panel.  So peer review is in some cases the same and in some cases slightly different.  And I believe section 5 in the RFP describes that.
     The contracting officer will check to ensure all the parts of the proposal are there.  And if anything is missing then it may be sent back or kicked out.  But the technical review, peer review panel will satisfies the scientific merit of all the parts of the proposal.  Assess the scientific merit of all the parts of the proposal.
     >> How are new companies without a prior track record viewed?  For example, if the company currently doesn't have revenue or prior SBIR grants? 
     >> And so they are  all applications are evaluated based on the scientific merit of the proposal.  And that's  and then it's against available budget and programmatic priorities of the institute and best value to the government in some cases in terms of contracts.
     >> Must the PI be an MD or Ph.D or can anyone with relevant experience apply as PI?
     >> It's the latter.  Anyone with  that can demonstrate through their bio and experience that they have the educational background, whatever that may be, and the experience to lead the project, they'll be evaluated on that basis.  
     >> So this one is about review.  Can you speak to the review structure for NIH contracts and how does this differ from SBIR grants?
     >> Is George on the line, George Kennedy?
     >> Yes, I'm here.
     >> Do you want to handle this in general?
     >> That's fine.  While I can't speak to grant side, the contract review happens very specifically as it is laid out in the solicitation.  The evaluation criteria is made available in the solicitation and when the peer review takes place the proposals are reviewed literally against the evaluation criteria as written in the solicitation.
     >> Great.  And also it's important for note that every topic in this solicitation is its own review panel essentially.
     Even if there's  NCI has 15 topics, there will be 15 panels. 
     >> Matt, this is Jennifer.  I just wanted to chime in also that the review panels at least for NHLBI are at the NCI scientific review.
     >> That's an important point also.  All the contract reduce are done within the institute's review offices, not for the center for scientific review. 
     >> Can equipment be purchased under a contract?  And if so, can the equipment be purchased from a European company that if it's the only one offering the equipment? 
     >> So in general equipment can be acceptable if necessary for the research.  If it's only available or that can be considered, I recommend that you send that question to the contracting office for the topic you're thinking about and let them best address it.
     So it's possible. 
     >> So this one is just about page numbers again.  Can you just reiterate where to find that information?
     >> For the page limits? 
     >> Yes. 
     >> The page limits are  give me a second here.  The page limits are in section 7.3 of the solicitation.  I don't know what page that happens to be, but it's section 7.3. 
     >> Okay.
     >> So there's some page questions about are there page number guidelines to each section?  Within the technical proposal, like in grants.  And the answer is no.  You choose how you want to allocate your 50 or 150 pages.  While under a grant a Phase I research strategy is six pages, in a contract you decide how much space you need to allocate to your technical solution given all else you need to put into the proposal.
     >> Okay.  So will the roster for the review panel be available like it is for SBIR grants? 
     >> I don't believe so, but George, can you address that? 
     >> So I can speak for NIAID.  And I believe this would be consistent across the ICs.  That's not information that we would make available.
     >> Right.  So contracts and grants are very different beasts.  And so it's important to also note that unlike in grants, you will not receive a summary statement after the review with the reviewer comments.  However you can request a debriefing from the contracting officer.  And there is information on that in the solicitation. 
     >> This one is about PI employment requirements.  Can the PI become greater than 50% employed by the company after they've received SBIR funding? 
     >> So the answer is no.  It must be before award, not after.  So at time of application and review, the PI does not need to be greater than 50 percent employed by the company.  But we won't make an award, a contract award until we have certification that the PI will be employed 50% at the time we make the contract award.  So it's at time of award.
     >> So is a fee allowed as part of the budget? 
     >> Yes.  There's instructions on the fee and that's also included in the total costs.  And there's another question, does the maximum amount mentioned in the contract include both direct and indirect?  And the answer is yes. 
     And the fee.  Direct, indirect and the fee. 
     >> Great. 
     So several of these are specific to topics.
     >> Right.
     >> For these just contact the contracting officer. 
     >> Right.  I see a few others generally related to review.  Are contracts scored like grants?  Significance, innovation, et cetera? 
     The answer is yes and no.  Section 5 lists the technical review criteria and percentage of points allocation to each of those areas.  So it's done as essentially a percentage basis to each of the areas, which is different than in grants. 
     I'm going to go back to the RFP and see where that is.
     I'll just leave this up.  This is the place where you can find everything and get to.
     Are PHS dB 1 are those contract contracts or grants?  I wonder if this person is asking we have every year we have 20171, which is our contract, and 2016162, which is the omnibus.  So the dash 1 will be the contracts every year and the dash 2 are the grants. 
     Let me see if we missed anything?
     >> So there's a question about including a nonprofit or academic partner in your proposal. 
     >> Right.  I saw that.  Can you just read the question verbatim?
     >> Right.  So can you speak to how a small business might include a nonprofit or academic in their proposal and/or whether the nonprofit or academic would also need to register for these government websites? 
     >> So the applicant  the offering small business can subcontract some of the work to anybody, any organization, be it a university or other nonprofit, up to 1third in Phase I and onehalf in Phase II.  Those organizations do not need to be registered in eCPS or the other systems.  They need to be in SAM, but they won't get the money directly, they will get it through the subcontractor as a subcontract.  But it is not required and these are not STTRs so there's no requirement for any subcontract.  But if there is a subcontract in an SBIR, it's up to onethird in Phase I and one half in Phase II based on total contract costs.
     Go ahead.
     >> I was just going to say are you expecting all deliverables from the offeror or only some of them, some of the important ones? 
     >> I can maybe let a few Program Officers answer that on the line, but I would suspect all of them.  Anyone want to speak up? 
     >> This is Jennifer.  I mean, I guess from NHLBI's viewpoint, we would like to see your proposal for how you can achieve the deliverables and the activities that are specified, but it is a competition and so we look to our technical review to be able to adjust those expectations based on the proposals that come in. 
     >> I think you'll find that similar across the board. 
     >> Is there a sample contract application available for Phase I and Phase II like there is the R43, R44 grant application samples available on NIAID's website? 
     >> There are not.
     How about subcontract on a forprofit company, the percentages?
     >> The applicant or small business is the prime essentially and they have to do two thirds of the work in Phase I and half of the work minimum in Phase II.  How you sub out the onethird and one half is up to you.
     Can a grant that uses both a small company and subcontract to a for profit company?  These are contracts.  The applicant small business could subcontract to another forprofit company, but that counts against the subcontracting percentage.
     We have a question, where can we learn about the technical differences, formatting deliverables between an SBIR grant and if it's a contract application?  Basically you have to read the RFP and I would say if you are familiar with applying for SBIR grants that will help you somewhat, but contracts and  what we require in a contract is  the parts are generally the same, but it looks different.  And you determine how you're going to lay it out as a small business, if you bid for other work it's going to be a contract bid.  So we don't  we have some  you can read the RFP.  We have a site on the differences between grants and contracts, but it doesn't get into super detail. 
     One section in the RFP talks about budget allocation for personnel, subcontracts, et cetera.  The  probably section 4 talks about the overall  let me just punch it up and see what they're called up here.
     I want to find this page.  I think section 4 or 5 will have the subcontracting requirements.  How you split personnel and supplies and travel and materials, all of that is up to you within the subcontracting rules.
     Again, a couple of questions about availability.  This is recorded.  We will post it within a few days.  The recording.  The slides and the transcript on our SBIR site under events and you will be able to find it all there. 
     The RFP  there may be two or three more.  The RFP language sounds in places like R&D, more like a grant.  What distinguishes the expectation on deliverables between a grant and a contract?
     Quite simply, grants have no deliverables.  We do ask for an annual progress report, but we don't require deliverables on a grant.  And as you saw, these contract topics have very specific deliverables. 
     Will all the proposals be made available to everyone once it's closed?  No.  This is a contract competition for the government.  It's closed.  It's open to all offerers, but the proposals are not open to everyone. 
     If we make an award, certain pieces of information will go public into a public database like the title, the amount of the award, the abstract, the company name, the PI, but that's it.
     Are there guidelines or limitations to salaries covered by the contract?  The answer is yes and there's details on what it covers.  It uses the overall NIH salary information and that is in the RFP. 
     And with that, I think we will close.  And I'd like to thank everyone for attending and sticking with us through the end.  We will be posting this again, as I said.  Have a nice day, everyone.  This concludes the webinar. 
     [End of webinar].