HEAL Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) FOA Technical Assistance Webinar-Video

Video length: 1:02.49

Transcript

Jacqueline Lloyd speaking:  Good afternoon, everyone.  My name is Jacqueline Lloyd and I am the Deputy Branch Chief of Prevention Research Branch at the National Institute on Drug Abuse.  

Welcome to the Technical Assistance Webinar for the HEAL Initiative, Preventing Opioid Use Disorder in the Older Adolescents and Young Adults, ages 16 through 30.  

This will provide an overview of the two RFAs that are listed here: RFA-DA-19-035 and RFA-DA-19-034.  

NIDA is the lead institute on these RFAs for this initiative.  

I just want to acknowledge the other participating institutes are NIAAA, NIMH, NCCIH, NICHD, and NIDCR.  

This will be a brief technical orientation and this – please note that this webinar is being recorded and will be available after the webinar.  

Questions will be taken at the end and read by a moderator.  I ask you to please submit your questions to all panelists using the Q&A feature.  

Again, please submit your questions to all panelists using the Q&A feature.  We'll answer questions about eligibility, technical requirements, and budget requirements.  

We will not answer questions about specific designs or study ideas.  

If you have questions pertaining to those topics, please email me at the email there, Jacqueline Lloyd, to set up a time to discussion such questions.  I'm happy to discuss.  

If you experience technical difficulties during the webinar, please send a chat to all panelists.  

Again, if you experience technical difficulties, please send a chat to all panelists.  And today's slides and the recording will be posted at the website listed on this slide, and also listed at the end.  

Here is the agenda for the webinar today.  We'll have welcome and opening remarks, and then you'll hear an overview of the two FOAs.  

You'll hear a general overview for the budget and overview of the review.  And then we'll open it up for questions and the moderator for the Q&A will be Belinda Sims.

Before we get into the overview, I just want to do some very brief introductions.  

First, I want to acknowledge that we have our new branch chief in the room, that's the new branch chief for the Prevention Research Branch.  Her name is Dr. Amy Goldstein.  

Presenters on the – for this webinar will be me, Jacqueline Lloyd, who will give a general overview; Carol Alderson, who is the Deputy Chief Grants Management Officer in the Grants Management Branch.  

You'll also hear from Gerald McLaughlin who is the Chief Scientific Review – who is the Chief of the Scientific Review Branch.  And then, again, the moderator will be Belinda Sims.  

And I also want to acknowledge that we have technical support here from Phil Sean Hanse [spelled phonetically] from the Information Resource Management Branch.

Just a little bit of background.  This initiative is part of the NIH Helping to End Addiction Long-term Initiative, which is the HEAL Initiative.  

And the objectives of the HEAL Initiative are to improve treatment for opioid misuse and addiction and to enhance pain management.  

An estimated 11.4 million people misused opioids in 2017, of which 11.1 million misused prescription opioid analgesics.  

Illicit opioids, including fentanyl and heroin, accounted for more than 60 percent of opioid-related overdose deaths in 2016.  

This initiative focuses on older adolescents and young adults, specifically ages 16 to 30, which are two of the populations at highest risk for initiation and misuse of opioids, opioid use disorder and related consequences including overdose fatalities.  

There is a gap in the evidence for interventions and strategies to prevent non-medical use of opioids and opioid use disorder in the transition from adolescence to young adulthood.

So, the urgency of the opioid crisis call for research to produce evidence-based interventions and strategies to prevent older adolescents and young adults from initiating non-medical use of opioids and from escalating from initiation to misuse and progressing from misuse and opioid use disorder.

Just want to share a couple of key definitions.  First, opioids include prescription opioids and illicit opioids such as heroin and illicitly made fentanyl and related analogs.  

For this initiative, older adolescents and young adults refers to individuals ages 16 to 30.  

For this initiative, we're defining prevention as interventions that occur prior to the onset of opioid use disorder and are intended to prevent or reduce the risk for opioid use disorder.  

And for opioid use disorder, this refers to the clinical diagnoses that's defined in the Diagnostic and Statistical Manual of Mental Disorders in the Fifth Edition.

The funding instrument for this initiative is a cooperative agreement.  And this is an assistance mechanism in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities.  

The cooperative agreement will include up to 10 research projects, one coordinating center, a steering committee which will include a steering committee chairperson to be identified by NIDA and one or more scientific officers from NIDA and other institutes and NIDA and other institute program officers.

The organization of the cooperative continued will include a steering committee which will include a minimum of a representative from each research project, a NIDA project scientist, a NIDA or NIH program officer, and could include select key leaders/stakeholders from the systems or settings that are named as key personnel and the research projects that are awarded under this initiative.  

And again, NIDA will appoint one steering committee chairperson with relevant expertise to coordinate the activities of the Steering Committee.

The objectives of this research cooperative are to support rigorous research in five areas:  

One, to develop strategies to identify, reach and engage older adolescents and young adult populations that are at risk for opioid misuse and opioid use disorder and prevention interventions and services;

two, to develop and adapt interventions and strategies to prevent initiation of opioid misuse, escalation from initiations and misuse, and also escalation from misuse and opioid use disorder;

three, to test the effects of prevention strategies and interventions on initiation of opioid use, opioid misuse and opioid use disorder and other opioid related outcomes;

four, to develop and test strategies to facilitate implementation and sustainability of prevention interventions and strategies in healthcare, justice and other systems that are identified in the RFA, better settings that are opportune for accessing and engaging at-risk older adolescents and young adults;

and finally, to conduct an economic evaluation.  So for example, to include to quantify programmatic costs and cost-effectiveness of interventions and strategies.  I just want to mention that the research projects are expected to address all five objectives as mentioned in the RFAs.

At this point, I'm going to move on and talk specifically about RFA-DA-19-035, which is for the UG3/UH3 research projects.  

The title of this RFA is listed here, again, HEAL Initiative, Preventing Opioid Use Disorder in Older Adolescents and Young Adults, ages 16 to 30.  

The funding mechanism is an exploratory/developmental Phase Award Cooperative Agreement, and I'll talk a little bit – I'll talk more about that a little later.  

The expected number of awards is eight to 10 and the approximate cost for award is listed here.  

So, it's up to 500K per year in direct cost for the first phase, for the UG3 phase, and then up to 1 million per year in direct cost for the second phase which is the UH3 phase.  

And for the award project period, it's a maximum of five years which can be for one or two years for the UG3 phase one – so for up to two years – and up to four years for the UH3 phase two phase.  

So, the period for the UH3 phase will depend on the number of years for phase one for the UG3 phase.  And the period for the UG3 phase will be dependent on the research to be performed.

In terms of the UG3/UH3 Research Projects, the UG3 phase supports exploratory-developmental activities with specific milestones that are to be accomplished by the end of the first or the second year budget period, depending on the period for that UG3 phase.  

The UH3 phase provides funding for up to three to four additional years, again, depending on the period for the UG3 phase, and that is to those projects that successfully complete the milestones that are set forth in the UG3 phase.

The UH3 phase will support the conduct of the clinical trial to test the efficacy, effectiveness, mechanisms of action of the proposed interventions, in addition to implementation and economic evaluation relevant to the research that is proposed.  

And applications must provide the overall goals and hypotheses for the entire project and indicate separate specific aims to be accomplished in each, the UG3 phase and the UH3 phase.

Research studies that are funded under this FOA will yield efficacious or effective interventions and strategies to prevent initiation of opioid misuse and development of opioid use disorder in older adolescents and young adults.  

And studies for the research project may span the range of efficacy, effectiveness, and implementation research and/or propose hybrid study designs that are relevant to the intervention and to the research questions and aims that are proposed.  

Of interest are research studies that are designed to test whether an intervention engages a proximal target or specified mechanism that is presumed to underlie the intervention's effect on distal outcomes.  

And applications that are proposing effectiveness trials are encouraged to address the use of scalable and sustainable approaches to improve the uptake of promising interventions.  

There are very interesting interventions that we know can be implemented and sustained.  And study designs proposed should be rigorous and appropriate for addressing the research questions proposed within the project timeline.  

Projects must include clearly identified transition milestones to be assessed at the end of the UG3 phase.  

And please note that funding of the UG3 phase, that is for phase one, does not guarantee support of the UH3 phase award, so for the award for phase two.  

Transition to the UH3 phase, phase two, will be determined by programmatic evaluation by NIH staff.  And projects that agree to work – projects must agree to work cooperatively with other awardees and with the Coordinating Center which you will hear about – more about a little later.

Listed in the RFA are specific topics of research interest which are listed here.  And research is encouraged in these areas but not limited to these topics listed here.  

I'll just highlight a few: development of theory-based prevention interventions that can be integrated into healthcare, justice or other human service systems and settings for high-risk individuals; interest and studies to test models of integrating existing substance use prevention and other risk reduction modalities into healthcare, justice, or other human service systems, or other opportune systems for accessing high-risk older adolescents and young adults; research on the interventions designed to address known risk factors for risk behaviors such as sensation seeking, impulsivity, and other risk factors.

Again, just highlighting a few topics: research that utilizes high-risk profiles in dental, orthopedic, surgical, pain, primary care and other clinical settings that facilitate case identification, active referral and linkage to prevention interventions and/or consultation models; development and testing of public awareness and communication strategies as part of a broader intervention or strategy targeted to high-risk populations in healthcare, justice and other settings delivered through mobile technology, social media and other novel platforms; research to address system fragmentation and gaps for persons transitioning from pediatric or adolescent medicine practices to adult medicine practices or for persons in specialty care settings or social services systems who need linkage to services.  

And then, finally, testing of strategies to implement preventive interventions in ways that overcome stigma related to substance use and its consequences, such as discrimination based on substance using behaviors.  

And again, all of these topics are listed in the RFA.

On to the research strategy.  

Applications should clearly detail inclusion and the role of a collaborator or a stakeholder as co-investigator from the system or the settings where the research will be conducted, and who will play a role in assisting with the adoption of the intervention or strategy in that system or setting if it is found to be successful.

Applications also should include a clear description of the theoretical basis for the intervention, strategy or model proposed and the process or steps for development, adaptation, tailoring to the population and system or setting proposed; strategies for identifying, reaching, and engaging at-risk population, the at-risk population identified for the project, and also strategies for linkage to prevention intervention and services; a clear description of the primary and secondary outcomes that will be evaluated and the proposed measures for both phases, for the UG3 and the UH3 phases.  

A description of the analytic plan for the UG3 and the UH3 phases of the research, including statistical and other methods that are to be employed should be included.

Continuing.  Applications should clearly detail a description of the team's experience with developing, testing, implementing prevention interventions, working with the identified study population and the systems or settings that will be included in the research; a description of previous experience working with cooperative agreements or with multi-site studies; plans to protect the security of participants' personally identified information; a discussion of any impediments or challenges that could require an addendum to the research plan, milestone or timeline with a discussion of alternative approaches to address them; a strategy to engage and create partnerships with likely end users or implementers of the intervention or strategy proposed, and letters of support indicating commitment from end users to implement the intervention or strategies if the outcomes are favorable.

And in terms of resource sharing, all applications should include a resource sharing plan, regardless of the amount of direct cost requesting for only – for only one year should provide a plan for sharing data with other research sites and the coordinating center and a plan to make publicly – plan to make data publicly available.  Excuse me for that.

At this point, I'm going to move on and talk about the Coordinating Center.  

The Coordinating Center is RFA-DA-19-034.  Title for the Coordinating Center listed here.  Expected number of awards is we expect to award one.  

The approximate cost per award is 1.5 million per year in direct costs.  And the funding mechanism is the U24 which is a resource-related research projects, cooperative agreement mechanism.

The Coordinating Center will be funded under the cooperative agreement and will work collaboratively with NIH and with the investigators that are associated with the individual research projects that are awarded.  

The Coordinating Center will provide centralized support for the research projects supported under the HEAL Prevention Initiative.  

The center will be responsible for activities in the following areas: coordination and communication, data collection and management, implementation design and methodology consultation and economic evaluation.

The Coordinating Center will participate on the cooperative Steering Committee to include research project PIs and Federal Staff and will manage the overall direction of the collaborative.  

The center will also facilitate activities of the cooperative internal working group which will include the projects PIs, their staff, collaborators, and Federal Staff.

Going to talk a little more specifically about the coordination and communication activities of the Coordinating Center.  

The Coordinating Center will support collaborations and communication across the cooperative research projects and other components.  So for example, across NIDA, the Steering Committee, workgroups, research partners.  

And the application should describe a clear and detailed plan for providing operational, logistic, and technical support for meetings that are held across the sites that are participating in the research projects, including in-person meetings, virtual meetings and webinars.  

And these are identified in the RFA, providing logistical support for annual in-person meetings that will take place in the Washington D.C. area or other locations that are designated by the Steering Committee and NIH staff; identifying and providing software platforms to enable conference calls, document sharing, webinars related to the work of the internal working group in core areas of the project, such as measures development and harmonization, publication and presentation procedures, et cetera; working with the Steering Committee to organize and facilitate meetings of an External Advisory Board, which will meet periodically and will provide input and feedback regarding the research projects funded under the UH3/UG3 mechanisms.

A continuation of the coordination and communication activities for the Coordinating Center; this will include developing and maintaining a web-based platform to facilitate sharing and monitoring of study protocols, recruitment, data collection, progress study, findings and publications; maintaining up-to-date versions of policies and procedures developed by the Steering Committee and make them available to the cooperative in a timely manner; overseeing coordination of collaborative publication activities, facilitating engagement of local and national stakeholders and relevant cooperative activities.  

So for example, external scientific workgroups; providing methodological and statistical support specifically in the areas of study design, complex statistical analyses, economic evaluation and implementation design and methodology consultation, as needed; and providing expertise and coordinating ethical, regulatory, and other required activities for research involving human subjects.

Now I will talk about the data collection and management activities.  

The Coordinating Center will provide data infrastructure and support across the cooperative and also conduct foundational analyses to inform and support the cooperative research projects.  

The application should include a detailed plan for developing standard formats for data collection instruments using measures identified by the research projects and the cooperative; providing logistical, scientific and technical support for data collection and management, including identification of common data elements, data harmonization, and data sharing across projects, as relevant; managing and monitoring data across cooperative projects, including cleaning and maintaining data files, monitoring data quality, and performing systematic checks for completeness and comparability, and developing and executing a plan for sharing data across projects and to investigators who are not part of the cooperative, so external to the cooperative.

Continuation of data collection and management activities include providing a federally compliant online infrastructure to support the submission/transmission of research data, including clinical data, and this includes addressing issues such as HIPAA compliance; compiling integrated datasets, developing codebooks and other data file documentation across projects and support individual research projects with these activities as needed, and preparing de-identified public use data files and documents for submission into the NIDA-supported repository, which is NAHDAP, and work with grantees on project-specific sharing plans.

And the Coordinating Center will be expected – excuse me.  

Moving on to data collection and management.  The Coordinating Center will be expected to conduct two systematic reviews.  

The application should include a plan for conducting the systematic reviews described on this slide.  Oh, excuse me.  Okay, I'm on the right slide now.  Sorry about that.  

So again, the application should include a plan for conducting two systematic reviews.  They're identified on the slide here.  

So, one pertaining to risk and protective factors specific to the populations and settings targeted for the research projects.  

So, this could be a systematic review and/or survey and descriptive analyses to characterize developmental and context-specific risk and protective factors and pathways for initiations of opioid use – I'm sorry – opioid use – opioid misuse and opioid use disorder, particularly in the age group under study.  

And these analyses will be designed to inform the research that is performed in the UG3 phase, so to inform the intervention and strategy development.

And then the second is conducting a systematic review pertaining to existing preventive strategies that are already in place in the kinds of systems and settings where the research will be conducted.  

So, this work will – I'm sorry.  With this work, the Coordinating Center will work collaboratively with the cooperative research projects during the UG3 phase to assess what prevention interventions and strategies are already in place in the kinds of systems and settings where the – where the research is proposed to be conducted.

Moving on to Implementation Design and Methodology Consultation and Economic Evaluation.  

The Coordinating Center is responsible for providing expertise, scientific and analytical support to the cooperative in the areas of implementation design and methodology consultation and economic evaluation.  

The application should include a detailed plan for coordinating with the research projects to provide support and consultation pertaining to implementation design and methods for individual projects to inform implementation aspects of the UH3 phase research; working with research projects to facilitate harmonization of implementation data and meaningful ways to compare outcomes across research projects, and working with individual research projects to develop and execute economic evaluations.  

So for example, to determine programmatic costs, cost-effectiveness and conduct budget impact analysis.  And this will be for the interventions and strategies that are studied.  

And this could include – this should result in common metrics and methods where applicable across the cooperative.

At this point, I'm going to turn it over to Carol Alderson who will talk about the budget.

Carol Alderson speaking:

Thank you. This is Carol Alderson from the Grants Management Branch in NIDA and I'm going to go over a couple of points about the budget and some of the points you've heard before from Dr. Lloyd.  

As a reminder, this is a cooperative agreement.  The UG3/UH3, and the approximate cost for the award is up to $500,000 per year direct cost for the UG3, phase one.  

And then, the direct cost request can go up to $1 million per year in direct cost for the UH3 for phase two.  

As mentioned, the maximum project period is five years, up to two years for the UG3 for phase one, and up to four years for the UH3 for phase two, with the total project period for both the UG3 and the UH3 not to exceed five years.

The U24 have an approximate – a direct cost ceiling per year of $1.5 million in direct cost per year and the maximum project period is five years.  Your direct cost ceiling doesn't include consortium F&A.  

A couple of reminders about – in preparing your budget:  Your reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.  

Your budget should include funds for travel for the program director, for the PI, and other key personnel.  

For example, key project staff, stakeholders, collaborators from the systems, and settings where the settings will be implemented to participate in an in-person Steering Committee meeting one time per year every year of the award to be held in Rockville, Maryland.  

An additional in-person kickoff meeting will be held in Rockville and that should be included in the – in the year-one budget of the award.

Please include all appropriate letters of support to demonstrate the commitment and support of your collaborators and stakeholders and users and others in your application.  

Some more gentle reminders on your budget.  Your budget is the fiscal expression of your science and we're looking for clarity and a strong justification.  Any escalation in future years should be programmatic.  

That means it should be connected to an increase in your research activities.

About four or five years ago, NIH stopped providing cost-of-living increases.  

So, if you request salary and fringe benefit increases, we won't be able to include that.  If you – any increases in future years should be connected to an increase in science.  

If your key personnel and your research staff need to increase their effort for phase two of the award, please explain clearly what's changing and how their efforts are increasing.  

So, we need a clear expression of what you're asking for.  Justify, justify, justify.

I've included in this slide a URL to an NIH website on how to prepare a competing grant application.  I hope this is helpful.  

And a gentle reminder; these two FOAs have a requirement that we don't see often in NIH funding opportunities, and that's a matching requirement for for-profit organizations.  

If the application is coming from a for-profit organization, then the organization must match funds or provide documented in-kind contributions at a rate of not less than 50 percent of the total Federal award amount.  

And that's stipulated in the public law that was signed last spring by our President and our appropriations.  

The for-profit applicants must include a letter of support confirming that the required secured matching cost, whether it be cash or in-kind commitments, is available.  

We're happy to provide advice on that if a for-profit organization is preparing an application.  Please feel free to call Edith Davis or myself with questions on this.  

And if you're a non-profit organization, a university, or a non-profit and you're planning to include a for-profit entity as a consortium, this requirement does not apply to your award at all.  

So I hope this is helpful.  And again, please call Edith Davis or me if you have a question.

Jacqueline Lloyd speaking:

Thank you, Carol.  Before we move on, I just want to remind you if you have questions, please send them to the Q&A box.  

If you have questions, please send them to the Q&A box.  At this point, we're going to move on and talk about the review process and you will hear from Gerald McLaughlin.

Gerald McLaughlin speaking:

Thank you.  Starting at 35, letter of intent.  This is kind of an optional but highly encouraged step.  

And it basically helps the assigned SRO to get a feeling for who not to pre-consider or invite to the review.  And it's not binding.  

If you don't make it, well we just don't have you.  If you do make it, that'll give us a little prep as to what types of things are coming in.  

And on 35, the information – as most of you know, if you're experienced NIH reviewers, we have kind of an upside down scoring – initiative reviewers score at either – anywhere from a one to a nine, a single integer.  

In this case, the one means the best possible, really known – notable weaknesses are high, likely, positive impact.  Nine means pretty bad [laughs].  

My 10-year-old could have done better or something like that.

We don't usually go to too many of those, but then they are multiplied by 10.  

And what you will see on the – a few days – within a few days after the review is a score coming in.  

And if it's – if it's in the 10 to 20s or so, you are very happy.  If it's in the 30s or 40s, well, then who knows?  It depends on how the others did and so forth.  

If you're worse than that or if you get one of the dreaded star – that star – that means you're not discussed, and that does depend on how many we get.  

If we get a lot of them, the general NIH guideline is somewhere around half of them being not discussed.  

The internal NIDA guideline is if there's over about 10 of them, we consider it for extremely poor scores and it is a matter of – so a judgement call, which we also discuss with the chair and others, to be thought about that.

So the review information as mentioned, it is exploratory.  And you don't have to have preliminary data.  

One of the things I always caution, if you do have preliminary data, it is a little helpful to – the reviewer's consideration is somewhat supportive of your working hypothesis, so things like that.  

I'm not saying lie that you have the opposite results than your hypothesis is.  But it becomes a bit of a sin of omission if you decide to omit it.  

And indeed, solid preliminary data and related papers are always helpful.  But again, not required, but if you submit it, it's going to be evaluated.  

And you will get a single impact score for the overall.  We will – within each of the reviewer's critiques, they'll be that one denying score.  

You'll see it for the significance, for the investigators, for the innovation and so forth, as defined for the particular initiative.  

Within NIH – NIDA review, we're very attentive to the particular sort of context of the initiative and the particular definitions, which for these two initiatives, they are very well integrated within the definitions of the evaluation criteria.  

I always say start with the end in mind.  Look at those evaluation criteria.  That's the wording that we'll largely encourage reviewers to use.  

And – okay, is your investigator seasoned, of what type?  They can lead the sucker, if they are into leading; they can coordinate and communicate if they're in that role.  If they're a data management guru, a statistical type person; they know something about implementation; they know something about economics, the cost benefit of the likely intervention that's being proposed and this sort of thing.

And we'll probably be looking for some type of expertise along each of these lines for each of these applications to the extent that we know that – they're also going to say, "Have you ever dealt with – cooperatively on this sort of thing?"

And we'll try to get reviewers who've also been in that role.  I will mention that some of our best reviewers turn out to be people – "Oh, I could have applied for that.  

I listened to the webinar but I didn't get around to it," we might be after you [laughs].  And always at NIH review, we say, "When asked, please serve," and we appreciate it if you can.

Okay.  And we do give you the score, when – so the breakdown, you know where sort of the overwhelming strengths or the near fatal weaknesses were within the subparts of it.  

From at least three, four – three reviewers for this one, I'm thinking we might need four because there's a pretty good span of expertise, both within the projects and the data Coordinating Center.  

So you probably get that many critiques, each saying somewhat differently, depending on what the reviewer's specialty is and so forth, and what their emphasis is. 

There are additional criteria, indeed, integrated with the human subjects – with the approach as to human subjects, but it's also separate.  

So it's – there have been many cases where NIH is redundant.  You will, in some sense, be aware that you're not causing great harm.  

You're attending to adverse events and outcomes and things like that, that you're attending to – in other words, the highest risk is the risk to the population, a loss of personal identifying; they know they have a drug addict in their local town or something like that.  

But also, a contrary outcome; they die instead of getting better.  

You'll know that and you'll let people know and they'll stop that particular intervention a little earlier and modify it.  

So that's the type of thing to consider.  

Risk and then inclusions where, in this case, we've got to narrow age spectrum, and hopefully the populations will be those reflecting the potentially affected population among those you're trying to prevent for.  

So that's some of the main things I wanted to mention about in review.  

Okay?  I think back to slide 41, maybe?  And – yeah.

Jacqueline Lloyd speaking:  Okay.  Thank you, Jerry.

Gerald McLaughlin speaking:  Thank you.

Jacqueline Lloyd speaking:  Just want to reiterate the cooperative agreement terms and conditions, which is in the RFA as a cooperative – as cooperative agreement.  

The FOAs outline the responsibilities for the principle investigators, the NIDA project scientists, the NIDA program officials, NIH funder – as funder, and also areas of joint responsibility.  

So, I encourage you to take a close look at that.  And also note that grantees accepting an award under this FOA agree to the terms and conditions that are specified in the RFA.

Key dates which are in the RFA – two dates that I want to note that are coming up, the letter of intent due date is February 13th.  

And as Jerry mentioned, the reason – the importance of the letter of intent for informing the composition of the review panel is to let us know what types of applications might be coming in.  

And then the application due date, which is March 13th.  And then there are other proposed dates listed on the slide for the review, advisory council and the earliest start date.

Listed on this slide and also in the RFAs are the contacts.  Again, I'm Jacqueline Lloyd, the Scientific and Research contact.  

The review contact is Jerry McLaughlin who you heard from, and the Financial Grants Management contact is Edith Davis.

At this point, we are going to open it up for questions, and Belinda Sims will be our moderator.  

I just want to remind you that this webinar is to answer questions about eligibility, technical requirements, and budget requirements.  

We will not answer questions about specific designs or study areas.  Please contact program.  

Contact me if you have those types of questions.  

And just to remind you here, to answer your questions are Carol Alderson regarding budgets; Gerald McLaughlin regarding review; me, Jacqueline, regarding general effects of the RFA.  

And then we also have Sarah Duffy who is the Associate Director of Economics Research, if you have any questions that might be relevant to her.  

So at this point, we are going to open up for questions.

Belinda Sims speaking:  Okay.  Thank you, Jacqueline.  

And I will be reading the questions that were submitted in the Q&A box, which is in the upper righthand corner of your screen.  

You can submit questions that way.  

And the first question you may have addressed at the beginning or just now at the end, and I was reading the question and didn't hear it; "Will these slides be available for download after today's webinar?"

Jacqueline Lloyd speaking:  Yes.  Good question.  Yes, the slides will be available.

I'm not sure how soon, but we'll get them up as soon as possible.

Belinda Sims speaking: Okay.  And I'm going out of order, the way they came in, just to make it – have it make a little more sense here.  

Jacqueline Lloyd speaking:  If I can also add that the recording for this webinar also will be available. 

Belinda Sims speaking: Great.  Thank you.  "Do all projects need to address all of the objectives, the five objectives that you read, or can projects focus on the subset of those objectives?"

Jacqueline Lloyd speaking:  Yes.  As specified in the RFA, the projects are expected to address all of those objectives to the extent relevant, depending on the research that is being proposed, the population and the setting.  

So, yes.  And just want to remind that the Coordinating Center will play a key role in providing consultation and expertise and guidance pertaining to the implementation research and the economic evaluation.

Belinda Sims speaking: Okay.  This next question is, I think, a grant management question.  

And you mentioned it in your slides, Carol, but it will be good to mention it again.  "Are consortium indirects included in the 500,000/1 million in the yearly direct cost limits?"

Jacqueline Lloyd speaking:

No.  Consortium S&A are not included in the direct cost ceiling for these – for these applications.

Belinda Sims speaking: And here is another one that may be a Jacqueline or Carol question.  "Can a year be split between UG3 and UH3 efforts?"

Jacqueline Lloyd speaking:  The budget periods should be presented as 12-month budget periods.  

It's – if you've got an initiative or a portion of your research that doesn't fall into a 12-month increment, which makes absolute sense, please explain that in your research plan and your budget justification, when efforts may ebb and flow.

Belinda Sims speaking: Okay.  And here is another budget related question.  "The initial application includes detailed budgets for both the UH3 and – I'm assuming they mean UG3 efforts, correct?"

Jacqueline Lloyd speaking:  Correct, for the combined phase one and phase two.

Belinda Sims speaking: Okay.  Here is a question for Jacqueline.

 "Even though there is a Coordinating Center, I assume that our grant, UG3/UH3, will need its own personnel for data analyses and cost evaluations.  Is that correct?"

Jacqueline Lloyd speaking:  Yes.  The expectation is that you will include, on your research team, team members who have analytic expertise.  

And since you are expected to address the objective related to economic evaluation, the expectation is that you would want to have someone on your team who has that expertise because your team will need to be coordinating your efforts in that area with the Coordinating Center.

Belinda Sims speaking: All right.  "Is the UG3/UH3 only for primary prevention?  Would applications that intervene to get older adolescents into opioid use disorder treatment be considered responsive?"

Jacqueline Lloyd speaking:  The focus of this initiative is on prevention.  And prevention was defined earlier and it's also defined in the RFA.  

And, so the focus is on prevention, preventing opioid misuse initiation, preventing progression to misuse, and also preventing opioid use disorder.  

And in the RFA, we use the terms "universal, indicative, selective," and those are defined.

But I think what I just explained is relevant to the question. 

Belinda Sims speaking: Okay.  And here is a question about stakeholder involvement.  

"For the requirement to include a stakeholder from the system as a coinvestigator, is it required that this be via a subaward or is consultant okay?  

Many community system partners aren't prepped for NIH grant submissions and/or may not have a PhD."

Jacqueline Lloyd speaking:  Is there – I have a question.  Is there a requirement for the stakeholder?  Is there an effort requirement for the stakeholder?  

If not, I was going to respond that it's not specified in the RFA the extent to which the stakeholder should be involved and what the question ask.  

So it really depends, again, on who the stakeholder is, what the setting is and the research that you're proposing, what makes the most sense and what's most feasible.

Belinda Sims speaking: So they do or do not need to be listed as a coinvestigator?  Could they be a consultant?

Jacqueline Lloyd speaking:  Oh, the question about – the RFA specifies that they should be a coinvestigator.

Belinda Sims speaking: Okay.  "Does the letter of intent need to go through any internal submission review process prior to being submitted to NIDA?"  For example, I'm just going to assume this might be – can the potential PI submit the letter of intent or does it need to come from a business official?

Gerald McLaughlin speaking:  No.  It can come directly from anyone on the team actually.  

And I always say redundancy is helpful.  If you send it to a key program officer, you then – they ship it on to us.  

And there's also a letter of intent to email, which I think they'll probably add to the PowerPoints to send it.  And if we see it's the same one, we don't do it twice.  

But also, a draft of it to them; second eyes never hurts before it actually goes into a pile of things to look at.

Belinda Sims speaking: Okay.  "For the UG3/UH3 award, can an institution be the recipient of more than one award under this funding opportunity?"

Carol Alderson speaking:  There's nothing to prohibit that.  

The two – if a single organization submitted two applications, we would expect them to be completely distinct.

Jacqueline Lloyd speaking:  Yes, I would agree with that.  There is nothing in the RFA that prevents or prohibits that.  

But we would expect them to be different, distinct applications, no overlap.  Thank you.

Belinda Sims speaking: Okay.  "If our 501(c)(3) status is pending, are we eligible to apply for this grant?"

Jacqueline Lloyd speaking:  The eligibility would be determined at time of award.  

And the time – the award that – we may be looking at making these awards in September of this year.  

We – these awards will be issued before September 30th.  

Gerald McLaughlin: [laughs]

Jacqueline Lloyd speaking:  There's no May in the picture.  These awards will be issued before September 30th, 2019.  So, the status must be firm before an award is issued.

Belinda Sims speaking: Okay.  There is a question here about some issue with the dates and I – for the person who asked that question, we will look at the dates.  

I think the dates that Jacqueline showed on the slide about the receipt date and the letter of intent date, those are the ones to pay attention to.  

The statement is, "The RFA for the UG3/UH3 is dated as December 2019; is that correct?"  I think the slide is dated October 2019.  But as Jacqueline presented, the receipt date is March 13th.

Jacqueline Lloyd speaking:  Yes.  And we'll take a look at that.  And if it needs to be corrected in the slides, we will correct that.  

And we have – I also want to mention that we have the email addresses of people who are sending questions, so if we need to follow-up with individuals, we can do that.

Belinda Sims speaking: Okay.  This is a question that I'll read as though – it seems like a budget question.  

"If a year is split – so one and half years for phase three instead of one or two years, what direct cost cap apply?"  [inaudible] 150,000.

Jacqueline Lloyd speaking:  We can't accept the budget presented as an 18-month budget.  

While you may be planning your – while your phase one may logically fit in 18 months, NIH grant awards are issued in 12-month increments.  

So please present the second half of phase one as a 12-month budget period.  

And you can explain in your narrative that you expect it to take less than 12 months, and explain what you need to accomplish the second year of phase one.

Belinda Sims speaking: Okay.  Those are all the questions we have received at this point.  

If people have other questions, please submit them now.

Jacqueline Lloyd speaking:  So, we'll give a couple of minutes as people are thinking of questions or in the process of submitting your questions.  

Belinda Sims speaking: Here's a question.  "Can the stakeholder co-PI and the PI come from the same organization if the project is implemented in the applicant's institution?"

Carol Alderson speaking:  If that sounds like it would make sense in that case, it could, yes, as long as the – you have – as long as the person has a stakeholder from the setting where the study will be conducted.

Belinda Sims speaking: Just pausing for additional questions, as people may be formulating them now.  Okay.  

"Because this is – because this is two phases within a single application, does a single Specific Aims page have both sets of Aims?"

Jacqueline Lloyd speaking:  Yes.  The RFA specifies that Specific Aims should be identified for each of the phases, for phase one, phase two, UG3, UH3, on the same page.

Belinda Sims speaking: Okay.  "Does the entire age range need to be addressed?"

Jacqueline Lloyd speaking:  The entire age range does not need to be addressed, but the age range that you propose needs to be within the age range specified, which is 16 to 30.

Belinda Sims speaking: This is a question and I'll read it, but I don't know that I fully understand it.  "Can the stakeholder co-PI" – oh, excuse me.  

That's not it.  I'll go back to the question.  "Does this RFA require an existing service center, an applicant's institution, or PI could set up one center through this RFA?"  [unintelligible]

Jacqueline Lloyd speaking:  I'm not – we're not understanding that question.  

We have your email address, so you can either reach out to me to follow-up on that, or I can try to reach out to you.

[inaudible commentary]

Belinda Sims speaking: We are pausing and still waiting for questions for people who might be formulating questions.  

Okay.  "Are both phases described within the 12-page limit?"

Jacqueline Lloyd speaking:  Yes.  And the page limits – there is a length to the page limits in the RFA which takes you to a page for the pages by mechanisms.  

And you will see the UH3/UG3 and the U24 listed, and it is 12 for the recent strategy.  Yes. 

Belinda Sims speaking: Okay.  "Can you talk again" – excuse me.  Hold on one second.  "Can you talk again about the need to address the five objectives?  

First you said, yes, all objectives need to be addressed.  But then I – if I understood correctly, you said they need to be addressed within what makes sense, given the proposed research."

Jacqueline Lloyd speaking:  Right.  So, there are five objectives and the expectation is that all objectives will be addressed as a part of the proposed research.  

I said that for – so for example, for the implementation of economic analysis objectives, what is proposed for that would depend on the research that is being proposed.  

So for example, if an application is proposing to do – develop an intervention and do efficacy research, the implementation questions might be different from an application where an individual is using existing evidenced based intervention adapt in that intervention.  

For the economic analyses, again, it depends on the research that is proposed.  

And the Coordinating Center would provide guidance and expertise around the economic evaluation.  

And I'm mentioning this because this has come up a couple of times.  

The Coordinating Center would provide guidance in that area.  

And the expectation would be that applicants would include someone with expertise in those areas, implementation, and economic evaluations, because the expectation is that the research projects would be coordinating efforts with the Coordinating Center.

Belinda Sims speaking: Okay.  

Jacqueline Lloyd speaking:  And if that person has specific questions and if that's not clear, please follow-up with me.

Belinda Sims speaking: Okay.  There is a question coming through this Q&A about our notice that was posted about administrative supplements.  

That is not being discussed in today's webinar.  So, any questions about administrative supplements, please direct them to Jacqueline Lloyd directly.

Jacqueline Lloyd speaking:  Thank you.

Belinda Sims speaking: Oh, "Does the UH3 phase focus more on the implementation research?"

Jacqueline Lloyd speaking:  Again, it depends on what is being proposed.  

The – and in the RFA, it talks specifically about the different phases, so the phase one, UG3 activities focused on development, adaptation, feasibility, pilot testing, et cetera.  

It might be appropriate to include some preliminary implementation questions in that first phase that will be informative for the second phase, for effectiveness testing or implementation activities that might occur in the second phase.  

Yeah, we would expect that you would include implementation questions for the second phase because, again, the expectation that's here that we will come out of this with interventions that are ready to be implemented and that are sustainable and that will be adopted if they are found to work.

Belinda Sims speaking: We're silent here just awaiting your questions.  

Still waiting for people to formulate their questions.  Jacqueline, how long will it take to get the slides and the audio posted on the website?  Do we have any idea?

Jacqueline Lloyd speaking:  I don't have a specific date.  I know that we'll work on getting them up as soon as possible.  I'm hoping by mid-next week.

Belinda Sims speaking:

How many awards to you plan to fund in the UH3 phase?

[inaudible commentary]

Jacqueline Lloyd speaking:

Yeah.  The RFA specifies that we'll be awarding eight to 10.  And what was that, UG3 or UH3?

Belinda Sims speaking:

UH3.

Jacqueline Lloyd speaking:

Oh.  That really depends on the projects meeting the milestones.  

So just to reiterate, the importance of those milestones, being clear about the milestones and the expectation is that projects will achieve those milestones in order to progress to the UH3 phase, to not give a specific number at this point because it depends on what happens.  We can be optimistic.  

We'll give another two minutes.  It's sounding like we – it's seeming that we don't need to go the full hour and half.  Just give another two to three minutes in case anyone is thinking of questions.  

Belinda Sims speaking:

Here is one more.  "Does the milestone of the UG3 phase need to be demonstration of efficacy of the intervention in the UG3 phase?"

Jacqueline Lloyd speaking:

For the UG3, again, it depends on the research that is being proposed.  

No, that does not have to be a milestone.  Actually, in the UG3 phase, most of that work pertains to development, adaptation, feasibility, pilot testing, et cetera, again, depending on the research that is being proposed.  

And if that person has specific questions about that, about, you know, what might be – just questions about that, they can reach out to me about that.

Okay.  Calling once, calling twice.  Last call if there are any additional questions.  If not, we're going to bring the webinar to a close.  

Belinda Sims speaking:

I'm not seeing any other questions.

Jacqueline Lloyd speaking:

Okay.  I want to thank you all for participating in this webinar, all of our listeners and viewers.  

And I also want to thank our presenters for presenting and answering questions.  The slides and the recording, we will get them posted as soon as possible.  

And I have the website here for the link where those slides should be posted.  And if you have any questions, I'm more than happy to talk with you.  

Best way to reach me is by email.  And my email is listed here on this slide on the contacts list.  And again, look for peer review contact and also grants management are listed here as well.  

Thank you so much.  Best wishes.