request for proposal clinical research

5 Tips for Creating a Request for Proposal (RFP) for Clinical Trial Services

August 30, 2021

If you’re looking for a contract research organization (CRO) to provide clinical trial services, chances are you’ll need to create a request for proposal (RFP). In the complicated world of outsourcing clinical trials, using RFPs to gather comparable bids from CROs can be incredibly challenging. The good news is, with a little planning and time, you can create RFPs that will reduce inconsistencies among bidders and ultimately help you identify the CRO that is truly the right partner for the job.

Here are five tips for creating RFPs that will help you compare “apples to apples” and help the CROs better understand your needs, values, and selection criteria for your clinical trial services:

• Provide background information on your compound and program. Information about other clinical studies completed or in progress, outcomes from preclinical work, regulatory strategy and even funding and marketing plans can provide context that will help a CRO understand your needs and give you a proposal that best addresses all of your concerns.
• Provide a protocol or protocol synopsis. Details about the study, such as number of clinical trial sites, number of subjects, and type and frequency of procedures and assessments are important cost drivers and providing them will help ensure a more accurate proposal. Also, an experienced CRO should also be able to make valuable recommendations based on your protocol.
• Project specifications – What are the important details of your program? (Use our RFP specifications tool )
• Project timelines – By when do you expect certain milestones to be met?
• Responsibilities (CRO, sponsor, other vendors) – For which segments of your program do you need a CRO to provide clinical trial services?
• Provide site locations if you have already determined which sites you want to use. If you aren’t sure, ask for recommendations based on your target enrollment and timelines.
• If you’ve already determined which sites you’ll be using, it is helpful to know whether they will use a central lab or local lab and also will they use a local or central IRB. This can have an impact on timelines and costs.
• Make note of any additional vendors you need such as specialty labs, Electronic Patient Reported Outcomes (ePRO), translations, meeting planners, or imaging services.
• If you are planning an interim analysis or will need support for a DSMB, make sure to include this information.
• What are your plans for IP logistics and distribution (IP management)?
• Will you use an IRT system for automated subject randomization and/or trial supply management?
• Risk based quality management services help you align with ICH E6 (R2) guidance. Will you be meeting RBQM requirements in-house or are you interested in your CRO providing this service?
• Do you want the CRO to be responsible for the TMF? If so, ask about whether they use an eTMF and if so which one.
• If you know you want to use specific vendors (i.e. you know you want to use Medidata Rave for EDC), be sure to include that information.
• Project team CVs including the project manager, clinical team lead, lead data manager, medical monitor, and lead statistician
• Summary of team therapeutic experience and experience running similar trials
• Relevant company information

Not sure where to start? Rho’s RFP Specification Tool was designed to help sponsors identify and organize requirements around their upcoming development program. We see it as an important step toward building our collaborative relationship.

How to Write a Winning Clinical Research Proposal?

• First Online: 02 February 2019

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• Christian Lattermann 8 &
• Janey D. Whalen 9  

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This chapter addresses general approaches towards writing a clinical research proposal. The landscape in research has changed in the last decade and has become more translational in nature. Therefore, research proposals are read and evaluated by scientists from various fields that may not be intricately familiar with specific techniques and technique-related jargon. This chapter is designed to address the need for more translational and reviewer-friendly proposal writing and is built on errors and mistakes commonly seen in research proposals.

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Lattermann, C., Whalen, J.D. (2019). How to Write a Winning Clinical Research Proposal?. In: Musahl, V., et al. Basic Methods Handbook for Clinical Orthopaedic Research. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-58254-1_27

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5 Best Practices for Designing Your RFP Package

• February 11, 2020 June 11, 2021

In this video recorded on February 2020, we discuss 5 Best Practices for Designing Your Request for Proposal (RFP) Package Within Clinical Trials.

TRANSCRIPT FROM VIDEO

Hi everyone and welcome to another episode of ClinBiz, where we love connecting with you on the business aspects of clinical trials. So, in today’s video, we’re actually going to be talking about some best practices. The things you need to include when you’re designing and putting together an RFP package out for your vendors within your clinical trials. So, if this topic interests you, make sure you stay tuned for the video and also make sure you subscribe to our newsletter at ClintBiz.com. Because we’re going to be having a full course rolling out in the next few weeks and that way, we can let you know whenever the course opens up. Alright, so stay tuned.

Hi everyone! Welcome back. So, let’s talk about some of these best practices and things you need to include when you’re designing and putting together an RFP package out for your vendors. So, just as a background for those that are not very familiar with the process, for clinical trial usually a study sponsor will engage with a vendor, a CRO or a different vendor. To accomplish actually a specific task or service within the clinical trial that the sponsor does not want or doesn’t have the people internally to actually complete that, those tasks. So, they engage with a vendor with a CRO for those tasks to be completed. And in that process, a procurement or sourcing process needs to take place in order to source out which vendors are the best, to get they’re costing and information.

And in that whole process there’s the RFP stage. There’s a Request for Proposal stage. That’s where to study sponsor is actually sending out an official request for all the vendors that they’re interested in engaging. So, that they can the vendors can actually provide to the sponsor an official proposal how much their services would cost if they were to be performing them for the sponsor for that trial, right. So, just with a little bit of a background there, let’s jump in to the things that you should be including. Alright, so number one well you should be including in the RFP package that you’re sending out to your vendors is some type of a project definition.

And by that we mean, what are the timelines associated with this RFP process or to contact people that your vendors should be reaching out to if there are any questions in the process. Are you going to be allowing any questions throughout the RFP timeline? Are going to be allowing any questions from your vendors? Are you going to be allowing them to know who their competitors are or not? So, really defining the rules of the game, you need to be talking about those things in some type of a project definition area within a document or it doesn’t have to be a full document itself. But just in some type of way you need to be defining how this project or this RFP process is going to look like for your vendor, so that they know exactly the expectations that you have within this.

The second thing you need to be making sure you’re including in this package is especially for a clinical trial it is the protocol or the study assumptions. And by that we mean you need to be including things such as a protocol draft or a synopsis within that package to your vendors. You need to be including things such as the schedule of events, obviously would be in a protocol if you’re including that your investigator brochures depending on the services your vendors will be providing for you. Also, the things such as number of patients, number of sites, countries. They are going to be using for that clinical trial. So, again some of these can be tailored for the type of vendor you have in the type of service they are going to be providing.

But these things absolutely need to be included in your RFP package out to your vendors. Because it’s really going to help them to provide the best costing the best proposal out to you. And it also brings up additional questions that you need to be asking throughout the process, right. So, the number three thing you need to be including in there, and again this is not a complete list of things you need to include, will have that complete list and that complete information within our course. But for here today, at least these are some top things you need to include in your RFP package.

Number three would be to include some type of a racy document. And my RACI I mean RACI the acronym that stands for. Who is going to be responsible for a task within that relationship? Who is going to be approving? Who’s going to be consulted and who’s only going to be informed of certain tasks and situations in that relationship? So, you really need to be including some type of a document or some at least an area within that full document providing to your vendors in this package. You need to be including a section that is a RACI section. Because this is really going to be telling your vendor exactly the expectations and their responsibilities for each task.

This is very important, because let’s say for example you as a study sponsor are under the assumption that the vendor is only going to be informed about a certain thing in a trial. And your vendor is actually under the incorrect assumption that they’re going to be actually responsible for that task. Well, that makes a huge difference when you’re actually providing numbers for you and they’re actually providing costs of how much that would cost for them to do that task. Because they’re thinking they need to employ more resources, they need to employ more time because they are actually responsible for that task.

So, very important that you define these expectations and these responsibilities via some type of a RACI document or RACI section within your request for proposal package that you’re sending out to your vendors. Okay, the next thing is very important that you include in this package is, some type of a budget grid or a budget grid guidance. And by that, I mean, if you have a standardized template a budget template that you as a study sponsor have that you send out to your vendors when you’re doing the RFP process, that’s great. And you can send those out with that package and your vendors will be able to send all that information back in your own little format. And you’ll be able to compare it easily.

You can also ask for the vendors to provide in their own format, their budget grids and their proposals. And there are upsides and downsides to both, I’ll say for the standardized way whether it’s a template or whether it’s a system you’re using. Obviously, you’re able to as a study sponsor compare much easier apples to apples when the different vendor proposals come back in the different vendor budget grids. You’re able to better compare those things, because everyone has done it in the same similar format. Whereas if you don’t if you have the vendor providing in their own format, well then it may be a little bit quicker for the vendor to turn that around for you. Because they are used to the format, but it may take you more time as a study sponsor to actually evaluate all of those different proposals and different formats. And so much more difficult to pick through much more time-consuming.

So, there are pros and cons to each, but just make sure that you have some type a budget grid or a guidance on what your expectations are regarding the vendor providing some type of a budget back to you. Whether it needs to be in a standardized format or it could be in a non-traditional or non-standard format, okay. And then the last point will cover for this video, again not a full list we’ll have that in our course. But for the purposes of this video something I think it’s very important that you also include. If you did not include this earlier within that conversation with your vendor is to include any specific sponsor requests. And by that, I mean, if you have a specific request let’s say you want people that are going to be associated with a certain task that that vendor is going to be doing. That you want them to have a certain level of education or you want them to have a certain level of experience or certain degrees.

Let’s say you want their resume there’s TV. You want to be able to include this if you have not done so earlier in an RFI stage, which is something we’ll cover in the full course. You want to make sure you’re including here in the RFP stage. And you’re including this in the package out to your vendors. Saying any special requests, you may have. This is important. Why? Because some of the things may not really have a budget impact, it may simply be something that you know may have a little bit of the time concerning your vendor will have to search out from some information. But some things may actually have a budget impact if you’re requesting them to do that.

So, it’s very important. It may have other impacts; it may have some logistical impacts. So, you want to make sure any special requests they are going to be needing during this process and also later in the study that you’re including as much information as you have at that point for your vendor. Because it’s really going to help them to cost out the proper things for you and later down the stream not have as many hopefully change orders coming through for things that we’re miscommunicated in the beginning. All right, so there you have it just a couple of best practices for when you’re designing sending out your RFP package all to your vendors.

Related Terms: clinical outsourcing, clinical trial outsourcing, clinical trials, clinical research organization, cro, request for proposal, rfp, bid grid, rfi, RFI, strategic sourcing, sourcing, clinical vendors, clinical study

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Let’s Make It Clear-Part 3: Submitting Your Clinical Trial RFP – 5 Tips to Get the Proposal You Need

Let’s make it clear:, a series about strengthening the sponsor-cro relationship.

Connor Edlefsen Director, Budgets & Proposals

April 12, 2022

While each of these interactions plays a crucial role in the decision process, this blog post is focused on one element of the CRO selection process that rides on the Sponsor – the Request for Proposal (RFP) document. Here are 5 tips (and a bonus) to consider when developing a clinical trial RFP document to maximize its effectiveness, and in return, receive a thorough, well-thought-out proposal from your potential CRO partner:

1. Provide clear background information and your objectives

During the clinical trial RFP process, it is important to keep in mind that you are looking for a partner for your upcoming trial. The RFP document sent out to the CROs selected for the bidding process should provide a brief background on your company, the investigational product, and ultimately your objectives for this product/trial. A CRO is there to solve your problems – not be one. Be upfront about what your concerns are with the study and what keeps you up at night. An experienced CRO will offer potential solutions to minimize those risks, as well as others you may not have considered. Understanding the history and the WHY behind your decisions will allow the CRO partner to make better recommendations and tailor their approach to better fit your needs. For example – if this is your company’s very first clinical trial with limited in-house resources versus being a seasoned pro with a large staff looking for very targeted needs – a CRO would have different approaches to executing these varied scenarios.

2. Set clear expectations

In addition to providing big picture information, it is important to set expectations for the clinical trial RFP process. What is the deadline for confirming a proposal will be submitted, for submitting questions and for submitting the final proposal? Do you want the CRO to bid to your specifications or their own recommendations? Do you need a ballpark budget for fundraising purposes or a full proposal to be used for final CRO selection? The RFP process is labor intensive for all parties involved, being clear about your needs and what you are asking from your CRO will allow them to better address your needs.

3. Include a responsibilities matrix

A must-have in a complete clinical trial RFP document is a responsibilities matrix. With multiple organizations typically involved in a clinical trial (Sponsor, CRO, and other 3rd party providers), a responsibilities matrix is a great way to clearly show who is responsible for each service and what is being asked of each party. It should outline how all of the moving pieces will fit together to effectively execute the upcoming trial.

4. Provide a protocol with schedule of events

Providing a protocol is key when requesting a proposal from a CRO, and without one, a budget cannot be developed. While the protocol does not need to be final (a draft or synopsis can work in a pinch), it will be important as a Sponsor to understand that costs may change by the time the protocol is finalized. If you are only providing a synopsis or a rough draft, the Schedule of Events (SOE) is critical. This will allow the CRO to estimate the CRF count and Site fees that you can expect. Changes to the SOE can have dramatic cost impact as the more data that is being collected equates to increased monitoring time (SDV) and data cleaning. In a typical study design, the study timeline, number of sites, and the amount of data you are collecting are a few of the largest cost drivers in a CRO budget.

5. Provide key assumptions / specifications

CROs tend to use multi-layered spreadsheets and/or budgeting tools with complex algorithms in order to develop a budget. In addition to the responsibilities matrix mentioned previously, a clinical trial RFP should outline the critical specifications for your upcoming trial. Having your CRO build their budget to the specifications provided while also requesting that they provide their recommendations in the proposal document gives you the opportunity to more easily compare budgets across CROs (and their complex algorithms) while still netting valuable advice from experienced professionals. While it is extra leg-work upfront for the outsourcing lead, the more details you can provide, the easier the evaluation process is as you compare costs between organizations, and the more confidence you can have that the budget you are receiving aligns with your expectations. Assumptions should include, but not be limited to, the following:

• Timeline expectations, including where in the process you are with IND and key milestones

• Number of sites (noting those you have already identified)

• Number of patients

• Number of treatment cycles to include in bid

• Countries, and if possible, the number of expected sites/patients per country

• CRF Count – while often overlooked in an RFP, the size of the case book has a ripple effect across functional areas. More data means a more complex build, more monitoring, more cleaning, etc. A 12-month study with 21,000 CRFs is an entirely different level of effort than a 12-month study with 3,000 CRFs. A CRO can estimate a CRF count based on a schedule of events, but there will be some variation in these estimates depending on the Data Management team.

• Desired monitoring strategy (e.g. all on-site, remote, 100% SDV, etc.)

*Bonus tip:  Be available during the RFP process

While not part of the clinical trial RFP document itself, even the most well-written clinical trial RFP document is likely to bring up questions when under the intense scrutiny of 5-10 functional areas and therapeutic experts at each CRO. With so many eyes on the RFP and protocol, there are bound to be inconsistencies identified or differing interpretations of the RFP materials provided. Making yourself available to answer questions or provide clarifications in a timely manner during the process will go a long way to ensuring a quality bid is received. Most CROs require a minimum of 10 business days to develop a full-service proposal. Sponsors who lob over a protocol synopsis and are then unavailable for the rest of the process are unlikely to net an accurate proposal.

The clinical trial RFP document is one of the first steps in the development of the Sponsor-CRO partnership. By putting in the up-front time and effort to provide clear instruction and clarify expectations, it will make for a more concrete comparison across CROs and fruitful ongoing discussions as you narrow down your choice of CRO partner.

New to Aperio’s  Let’s Make It Clear  series? Check out Part 2 “ Not a Time for Speed Dating ” to discover 5 tips you can use to avoid a speed dating situation and get the information you need to make an educated decision when selecting a CRO partner.

About the Author

As Director of Budgets and Proposals, Connor Edlefsen is responsible for all proposals and study budgets at Aperio.

Connor has 12 years of CRO experience supporting pharma and biotech companies of all sizes in a variety of capacities. He has served in a number of different roles on both the clinical and corporate operations sides, including vendor management and oversight, project management, account management and finance. For the past five years, he has focused on leading the budgets, proposals and contracts teams with a passion for quality and accuracy.

When he is not pouring through spreadsheets, Connor spends his free time watching sports, working out and wrestling with his kids.

About Aperio Clinical Outcomes

Aperio Clinical Outcomes provides full, customizable clinical research services across multiple therapeutic areas. Dedicated to transparent interactions with clients, Aperio also offers consulting services in Quality Assurance, Strategic Resourcing, and practical application of the latest Clinical Trial Technology.

In an industry flooded with data, metrics and technology, Aperio remains steadfastly focused on the most important part of the process: people. From start-up to close out and every point in between, Aperio works with its partners to deliver outcomes that will improve patient care and save lives.

Aperio Clinical Outcomes. We make it clear.

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You may also like…, let’s make it clear-part 1: the sponsor-cro relationship, let’s make it clear-part 2: not a time for speed dating-5 tips for selecting a cro that is ‘the one’, clinical outsourcing video series part 1, clinical research outsourcing: building strong cro partnerships.

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Writing the Best RFP to Attract the Relevant Service Providers

Karim Bagaté, Associate Director, Clinical Studies, VECTURA UK LIMITED, explains the keys to writing a successful RFP

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Request for Information (RFI): “Get to know your provider”

The purpose of the RFI is to gain the maximum information about potential partners (contract research organizations – CROs) and determine if they have the capabilities to be included in a more formal request for proposal (RFP) process. Receiving information from the partners might not be enough. The sponsor should ideally invite partners for a formal presentation.

During the RFI process, sponsors should identify which CROs should receive the RFP and what information should be gleaned from each.

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Clinical studies, ltd., the avoca group, rfi corporation, which cros should receive the rfi cros different sizes – different strengths.

CRO partners are basically classified as large, mid-size and small, all of whom possess different strengths. A survey conducted by The Avoca Group in 2011 revealed a close correlation in the size of a sponsor company and the size of the CRO. In fact small and mid-sized sponsors tended to dedicate their outsourcing mainly to small (beyond Top 15) and mid-sized CROs (or specialty CROs).

What information should be gleaned?

When requesting information or when inviting the partner for a presentation, sponsors should include a brief background on the organization and pipeline, in order to guide prospective partners through the process. Essentially, the following information should be requested:

• CRO corporate overview
• Drug/Medical device experience
• Therapeutic experience
• Trial type experience
• Staff training, continuing education and turnover
• Regulatory expertise
• Current and former client references

Define your Outsource Strategy: Do your homework

From the start, define what kind of vendor you’re looking for– a preferred provider or project specific vendor? Full service or functional service provider? Sponsors should define the services they need to complement their internal resources. Determine what core competencies you need to manage the outsourcing process, as well as the relationship with the CRO. Ideally you should set your oversight management plan (i.e. how much do you want to be involved during the clinical trial? Site visits, investigator relationship, meetings, data review etc.).Define your outsourcing budget and implement a CRO evaluation team

Potential partners pre-Selection: What type of CRO would fit the project/the company?

Based on the RFI responses received, create a shortlist of CROs to move to the next phase. The creation of this list should be guided by one key question: What type of CRO would fit the project/the company? Assess the below parameters:

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• Expertise : Does the CRO have the expertise to undertake the duties the sponsor requires?
• Compatibility : Can the CRO fulfill its duties in a manner that is compatible with the sponsor (i.e., is there a good fit)?
• Capacity : Does the CRO have the ability to commit the manpower and resources needed in the Sponsor’s timeframe?

RFP Content and Related Documents

The RFP initiates business discussion and defines the sponsor-defined tasks on which you bid. The more details included in the RFP, the more accurate the bid. The sponsor should provide key information, such as background information on the compound, a protocol summary, specific project timelines, a schedule of assessment, and which clinical services they need.

An inadequate document leads to inconsistencies among bidders, a poor project, bad budget management and a problematic relationship between the sponsor and the selected vendor. (Debora Dongo-Soria, 2015 clinicaltrialarena.com)

• RFP document

Avoid sending an isolated protocol synopsis or emails with minimal information to the CROs. You have to write/compile your full RFP document. This document must contain at least:

• Purpose of the Request for Proposal (RFP) and project/sponsor Background
• The scope of the project
• Study Objectives

The sponsors should provide some guidance about the RFP process and their expectations, especially for project management and meetings. The other element, such as key bidding assumptions, clinical trial services and responsibilities, and pricing should be detailed in the Bid Grid.

Bid Grid: The Key to the Proposal

Usually compiled in an excel workbook with three sheets – Study Assumptions; Tasks and Responsibility Matrix, and the Budget

Study Assumptions : Details — The More the Better

This section should provide the maximum information and should describe the study requirements. The content should include but not be limited to:

• Study design and phase
• Number of subjects (screening, randomize and completers)
• Study timelines (enrolment, treatment durations, end of Study timelines)
• Countries and Sites
• Project Management and Monitoring strategy
• Pharmacovigilance
• Start-up and Regulatory
• Contract/Legal Services
• Laboratories
• Medical Writing

Sponsor should allow prospective CRO partners to provide comments on the study assumptions.

Tasks and Responsibility Matrix : Who does what?

The sponsor should provide the list of study activities and clearly specify the responsibilities among the parties involved (i.e. Sponsor, Clinical CRO and any third party vendor).

The Budget : Precision and Clarity

The budget is often the source of conflict between the sponsor and the selected vendor. Therefore get it right from the beginning. The budget sheet must contain all the study activities, with maximum details including a section for pass-through cost.

For the costing purpose, for each task the sponsor should describe the unit. The prospective CRO partner should provide an accurate cost by including the number of unit requested per task, the cost of each unit, and the time needed to achieve one unit. This should lead to a clear cost per task.

The total project cost should clearly specify the CRO direct cost, the pass-through cost, any discount, and the total cost.

Your RFP should contain:

• Bid Grid (i.e. Study Assumptions; Tasks and Responsibility Matrix; Budget)
• Study Synopsis including the Schedule of assessment

The RFP is a very important process that initiates business with a partner. Therefore, as described by Brad Anderson, there are five mistakes to avoid when preparing the RFP:

• Lack of proper preparation
• Omitting vital information
• Not verifying CRO qualifications
• Over reliance on bid grids
• Failure to properly evaluate pricing

However, to achieve the best RFP, sponsors must clearly describe their needs in the RFP that will allow the CROs to develop a realistic project proposal and accurate budget

Karim Bagaté

Associate Director – Clinical Studies

VECTURA UK LIMITED

1) The Avoca Group: 2011 Avoca Clinical Outsourcing and Relationship Management Survey: Sponsor Needs and Challenges in Clinical Development Outsourcing Executive Summary, 2011

2) Debora Dongo-Soria, Planning your RFP; Clinical Trials Arena, 2015

3) Brad Anderson, Top 5 Mistakes of RFP Writing; Applied Clinical Trials, 2009

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Grant Proposal Development

Eligibility as principal investigator on proposals.

The UVA policy Grants and Contracts – Definition, Solicitation, Clearance, and Acceptance states that proposals may only be submitted by elected members of the faculty: Professors, Associate and Assistant Professors, Instructors and Lecturers. Other individuals may serve as PIs, if allowed by the funding program and approved by the Office of Grants and Contracts.

Types of awards (grants, cooperative agreements, contracts, and clinical trials agreements)

• Grants provide assistance to the investigator with relatively few restrictions. The PI is responsible for deciding the direction of the research program on a day-to-basis, within the general scope approved by the sponsor. The sponsor believes that the proposed work scope can be accomplished. Federal grant opportunities are announced by program announcements or more focused Requests for Applications (RFAs). Purchased equipment generally vests with the grantee. Intellectual property developed during the course of the research is owned by the grantee institution, and may be developed and licensed by it to other entities.
• Cooperative agreements are similar to grants, and are announced via RFAs. The sponsor’s technical contact is substantially involved in assisting or managing the agreement. Sponsor and awardee responsibilities are spelled out in the notice of award. The terms of the award determine ownership of purchased equipment, intellectual property rights, and the (generally greater) reporting requirements.
• Contracts are agreements with clearly defined work scopes, the results of which (“deliverables”) are generated for the direct benefit or use of the sponsor. By accepting a contract, the awardee is agreeing to provide those deliverables. Contract scopes of work are established by the sponsor. The contract specifies applicable regulations, reporting requirements, approvals that must be obtained prior to initiating work, review of manuscripts prior to submission for publication, title to equipment, and so on. Reporting requirements for contracts generally are more substantial than for cooperative agreements or grants. Reimbursement is effected by invoicing the sponsor.
• Clinical trials agreements are contracts for the study, in human subjects, of devices, therapies, or preventatives for a particular disease or medical condition. Clinical trials may be investigator- or, more commonly, sponsor-initiated. The latter are required for the licensure of a product for sale to the public. The scope of work and study procedures are defined in the study protocol, which must be approved by the UVA IRB for Health Sciences Research prior to the onset of recruitment. Multi-site studies may be managed by a clinical research organization (CRO) under contract from the sponsor. Reimbursements in clinical trials agreements often are driven by the number of patients enrolled, specific study visits/procedures/evaluations, and data forms completed. Multi-site study data are controlled by the sponsor, though the University retains the right to publish reports based on subjects enrolled at its own site. Intellectual property generated within the scope of the protocol generally is owned by the company; title to other IP belongs to the University, generally with the sponsor receiving an option to negotiate an exclusive license.

Industry-academia collaborations

There are many ways to collaborate with industry. Each carries responsibilities that differ from the traditional relationship between academic institutions and foundations, professional associations, or government agencies. Unless otherwise indicated, the SOM contact for these agreements and collaborations is the  Office of Grants and Contracts . The most common agreements with industry are:

• Sponsored Research. Investigator-initiated research projects supported by industry. The Office of Grants and Contracts will negotiate a research agreement covering ownership and licensing of intellectual property (IP), publication rights, confidentiality, and ownership of data.
• Collaboration Agreement. Projects in which University and company both contribute to the development and performance of the scope of work.
• Subcontract. Company asks PI to perform a specified subproject embedded within a larger project. If the subcontract will be awarded by a company in which the faculty member has ownership or other financial interest (e.g., SBIR or STTR), a conflict-of-interest waiver or management plan must be obtained to comply with the Virginia conflict of interest statute.
• Clinical Trial. Industry-generated protocol to evaluate safety, pharmacokinetics, or efficacy of a company product. The Clinical Trials Office can help with budget development and post-award monitoring.
• Clinical Services Agreement. A fee-for-service arrangement such as radiograph review, MRI screening, specialized clinical laboratory assay.
• Materials Transfer Agreement (MTA). The company provides materials required for your research, or vice versa. If outgoing UVA materials are covered by an invention disclosure, the UVA Licensing and Ventures Group will participate in the negotiation process. Ownership of derivatives and modifications of the original material may slow negotiations; this is less problematic if the agreement does not allow the recipient to create derivatives or modifications of the original material.
• Consulting Agreement. PI provides professional expertise to the company. All consulting agreements must be approved by one’s chair and the Office of Grants and Contracts, per SOM consulting policy . Proposed consulting agreements may be routed through the University (allowing the use of UVA facilities) or as a direct agreement between faculty and company (proscribing the use of UVA resources, staff, space, etc.) Faculty should exercise care that their level of consulting activities remains consistent with out-of-office allowances under UVA policy  and that remuneration rates reflect fair market value.
• Licensing Agreement. Company licenses the use of UVA intellectual property, often for further commercial development. Contact the UVA Licensing and Ventures Group if you receive such a request. Inventors should help identify potential licensees for the invention; once a licensee has been identified, inventors should work only with the Patent Foundation.
• Gift. Industry provides funds or equipment for use in faculty research. Gifts may not be associated with deliverables such as reports or data, use of human subjects or animals, or assignment of rights to intellectual property per UVA policy. When in doubt, contact the Office of Grants and Contracts. Gifts generally are donated to the Health System Development Office .

Whom to notify, and when, during proposal development

The following proposals require that you notify one or more administrative offices prior to submission:

• Proposals requiring additional space. Contact the Office for Research .
• Funding programs allowing a restricted number of proposals per institution. Contact Dr. Steven Wasserman , Assistant Dean for Research. The Office for Research or the Office of the VP for Research conduct internal competitions when the number of potential applicants exceeds the allowable number of nominees. Pre-proposals will be requested approximately two months prior to the agency deadline.
• Proposals requiring increases in numbers of research animals. Discuss your potential animal needs with Dr. Sanford Feldman , Director, Center for Comparative Medicine and then obtain written approval from the Dean’s Office.
• Proposals with unusual requirements, such as restrictions on publication or on intellectual property. Contact the  Office of Grants and Contracts .
• Proposals requiring institutional support or a letter from the Dean. Contact the Office for Research with sufficient time to review your request for support and to generate a support letter.

Help with proposal development

• With your research mentor, develop a strategy for obtaining funding, a timeline for seeking funds, and the structure of your proposals. Arrange an in-house pre-review of your proposal prior its submission.
• Your department/center research administrator can help develop required forms, the budget, and budget justification. The Office for Research has developed “boilerplate” descriptions of resources such as core facilities and computer network capabilities. Also see “Materials for the development of grant proposals” on that page.
• The Health Sciences Library provides expertise in searching the scientific literature, production of graphics, interlibrary loan, etc.
• Clinical Trials Office provides support in budget development, statistical design, assistance in developing clinical trials proposals (budgets, protocol design, IRB issues), and study coordination for clinical trials.
• The Office for Research administers internal competitions for limited funding opportunities and provides letters of institutional support for applications.
• The Office of Grants and Contracts provides advice on agency regulations and requirements, negotiates inter-institutional agreements (e.g., Materials Transfer Agreements, consortium agreements) prior to submission, etc. Contact: Stewart Craig . The office also can provide assistance in the development and submission of complex proposals (program projects, cooperative agreements, R&D contracts).
• NIH RePORTER allows you to search current or previously-funded NIH projects. You can filter a search by key words, general topics, sponsoring Institutes/Centers, year of award, etc. Consider how your proposal would build on prior or current NIH projects and how your work will be relevant to public health. The site also can be used to locate potential collaborators.

Resources for proposal development and writing

• NIH has posted videos associated with the peer review process:  What Happens to Your NIH Grant Application.
• Also see the NIH site on grant writing tips .
• The NIH Center for Scientific Review has posted a “ CSR Insider’s Guide to Peer Review for Applicants ,” which includes a video designed to help applicants better navigate the peer review process.
• Attend the SOM grant and research support workshop, conducted by the Office for Research and Office of Grants and Contracts, under the auspices of SOM Faculty Affairs and Faculty Development. This workshop is designed to help participants prepare effective grant proposals, and includes strategies for writing applications, identifying available NIH and foundation grants, grant submission procedures, and human subjects and animal use requirements.

Timeline for proposal development

The following schedule was adapted from SK Inouye & DA Fiellin 2005 Ann. Intern. Med. 142 :274-282). Their timeline is appropriate for programs with predictable annual cycles. More experienced investigators can work on a shorter timeline.

• 1 year before submission. Conceptualize the project. Begin generating preliminary data. It may help to start developing your specific aims. Discuss the broad outlines of your proposal with the agency’s program officer, your mentor, and colleagues. The program officer may offer advice on how to shape your proposal to increase its chance of being funded or refer you to other programs that better fit its direction and scope.
• 10 to 12 months before submission. Obtain and review program guidelines and forms.
• 10 to 11 months before submission. Review recent awards from the funding agency and determine potential reviewers. Abstracts of NIH awards can be obtained using the NIH RePORTER system.
• 10 months before submission. Outline and draft your proposal.
• 8 to 9 months before submission. Consult with your mentor and collaborators. Obtain statistical input (also useful in designing preliminary experiments).
• 6 months before submission. Check whether your funding program requires regulatory approvals (IRB, IACUC, radiation safety) prior to submission. If so, apply to the appropriate committee(s).
• 3 months before submission. Develop budget/justification. If your scope of work changes later, revisit both to ensure appropriate funding before routing it to the Office of Grants and Contracts . The SOM Clinical Trials Office  must review clinical studies budgets to ensure proper billing to study vs. insurance providers.
• 2 months before submission. Have your working draft and abstract reviewed by your mentor, collaborators, and colleagues. Some departments or centers require that the PI participate in a structured review session before submission. Continue to revise the proposal.
• Two weeks before submission. Begin the internal approval process.
• Other. Inform your research administrator of your intention to submit the proposal (including agency, program, and deadline), as early as possible. He or she may recommend different administrative timelines than the above.

The NIH application cover letter

NIH proposals generally are submitted to the Center for Scientific Review (CSR), which conducts the review process. CSR staff decide which Institute or Institutes are most appropriate to administer your project, if awarded. They also determine the study section best suited to review your proposal. By default, these decisions are made on the basis of your title and abstract. You can influence these decisions by including with your proposal a cover letter describing which Institute(s) and study section(s) you feel are most appropriate. Remember to justify such a request. Names and areas of scientific interest for study sections can be found on the CSR web site. Your cover letter also can list individuals who should not review your proposal due to conflicts of interest. Finally, cover letters can be used to justify late submission of a proposal (e.g., due to inclement weather or participation on an NIH study section).

Clinical study budgets

The Clinical Trials Office (924-8530; [email protected] ) assists investigators and clinical coordinators in the development of clinical studies budgets and budget negotiation.

Help with other NIH-required sections

• Human subjects:  See  NIAID’s Human Subjects Resources .
• Use of animals. See NIAID’s How to Write an Application Involving Research Animals . Contact the IACUC office  for help with crafting particular sections of a protocol.
• Sharing of biomedical research resources. The NIH Office of Technology Transfer provides information on this policy, which addresses “terms for disseminating and acquiring unique research resources developed with federal funds and is intended to assist recipients in complying with their obligations under the Bayh-Dole Act and NIH funding policy.”
• Data sharing plans. Model plans are posted by the NIH Office of Extramural Research and NIAID . Tailor your plan to the specifics of your project.
• Sharing of model organisms for biomedical research:  see the model plans posted at the NIH Office of Extramural Research .
• Intellectual property (IP) plans (required for NIH-supported projects that entail product development). Model IP plans are posted at the NCI Technology Transfer Center .
• Scientific rigor.  NIH requires that many applications for research or training awards describe how scientific rigor will be maintained, addressing:  scientific premise of proposed research, rigorous experimental design, consideration of sex and other relevant biological variables, and authentication of key biological and/or chemical resources.  The agency has posted sample sections at  http://grants.nih.gov/reproducibility/index.htm#resources .  Additional resources:   NIH-developed training modules to enhance data reproducibility;  NIH Office of Disease Prevention methodological resources  for developing clustered randomized clinical trials, including best practices for calculating sample sizes; and Medical Research Council Experimental Design Assistant for pre-clinical research involving laboratory animals.
• Post-award Administration
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• Unmatched MSSRP projects – 2024
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External-Sponsored Research

We are committed to generating and supporting critical, high-quality research that has an impact on clinical decision-making and patients’ lives. Our External-Sponsored Research Program provides funding and/or study drug support for research efforts conducted by third parties on Gilead products or therapeutic areas. For research on cell therapy, please visit Kite Cell Therapy External Research Program .

We support two primary types of research, Investigator-Sponsored Research and Collaborative Research. We also support research where the study sponsor is a government organization, nonprofit organization or a pharmaceutical company.

In addition, we support research focused on and led by community organizations. Information is available on the Community-Based Participatory Research page .

Types of External-Sponsored Research

Investigator-Sponsored Research (ISR) is initiated, designed, and led by independent researchers. For an ISR project, an investigator or institution outside of Gilead is the study sponsor. If the research concerns a Gilead product, the study must occur after regulatory approval of the product in the country where the study will be conducted. Gilead’s only involvement in an ISR project is solely funding and/or study drug support. We request to check the study protocol to confirm the study design and safety reporting requirements. We also request a courtesy review of all abstracts and publications.

Collaborative Research is similar to ISR where the study sponsor is an investigator or institution outside of Gilead. However, Gilead is typically involved in Collaborative Research beyond providing funding and/or study drug, such as developing the study design, protocol development/review, conduct of study, providing data/biological samples, data/sample analysis, and publication preparation/authorship. Abstracts and publications may be co-authored with Gilead.

RFP Opportunities

A Request for Proposal (RFP) aims to address unmet patient needs in specific populations such as through innovative methods for screening, diagnosis, and care access initiatives, while also garnering insights on disease epidemiology and treatment.

There are two types of RFP:

RFP Program is a call for research on a specific topic and question of interest described in detail, usually with additional instructions regarding the application process. They are highly competitive and typically have a submission window of only a few weeks.

RFP Topic of Interest is a brief posting of a specific area of research need without great detail about the topic or additional instructions regarding the application process. They may have a longer submission window or remain posted until funds are exhausted.

If you're interested in applying to an RFP Program , review the research question ask and follow the instructions within the program descriptions about submitting a Letter of Interest and about next steps if invited to submit a full proposal. For any queries, contact the email listed in the RFP Program description or your local Gilead contact.

If you apply for an RFP Topic of Interest, review the research topics below and indicate the topic you are applying for in your Letter of Interest submission. Submit a full proposal after you receive an invitation. For queries on the listed topics, contact your local Gilead contact.

RFP Programs

HIV Treatment: RESONATE 2024 RFP Program  (Deadline Oct 14, Nov 18) RESONATE supports the development of additional scientific data to improve clinical and community decisions and medical management of HIV.

Hepatitis D: SPEARHEAD 2024 RFP Program  (Deadline Sep 27) SPEARHEAD was relaunched in 2024 and is open to global submissions. It aims to enhance understanding and address challenges related to HDV screening and linkage to care. 

Hepatitis D: DETER 2024 RFP Program (Deadline Sep 27) There remains a need for robust real-world data to inform and guide clinical practice for the treatment of HDV. The aim of this program is to generate real-world treatment data to supplement findings from clinical trials.

Primary Biliary Cholangitis: HANDLE RFP Program  (Deadline Sep 1) This program was launched to characterize and address the unmet medical needs in PBC. Research topics of interest include elucidating the natural history and outcomes of PBC, optimizing the care cascade, validating non-invasive tests and characterizing and addressing the symptom burden.

RFP Topics of Interest

To be announced in Fall 2024.

How to Apply for Research Funding

To submit an application for any External-Sponsored Research funding or other study support, visit Gilead’s online proposal submission portal, Gilead OPTICS (G.OPTICS). If you are applying to an RFP Program or RFP Topic of Interest, start with a Letter of Interest submission. Submit a full proposal once you receive an invitation.

Collaborative Research should also start with a Letter of Interest — which can be related to an RFP or independent of an RFP — unless you have been invited by Gilead to submit a full proposal. Research with study sponsor that is a government or nonprofit organization or other pharmaceutical company should also start with a Letter of Interest unless invited to submit a full proposal.

How To Register In Gilead OPTICS We support External-Sponsored Research contingent on the proposal's scientific merit. The research must be intended to contribute knowledge to the medical community and the budget must be reasonable and appropriate for the proposed work. We evaluate applications considering the expertise of the principal investigator and any sub-investigators, including their proficiency in the relevant therapeutic field, track record in conducting successful clinical trials, and available resources.

Our cross-functional committees review all External-Sponsored Research proposals. If either an ISR or Collaborative Research study is awarded support, the principal investigator, as the study sponsor, will have full discretion and responsibility for all aspects of study design, implementation, analysis, data dissemination and compliance with relevant laws. The terms of Gilead's support will be outlined in a written agreement; funding is not guaranteed for your proposal as funding will be provided specifically to support research activities.

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Description

How Well Written Proposals Affect Clinical Research Organization Selection

Selecting the right Clinical Research Organization (CRO) is vital to the success of any clinical study. Get it right and the months that follow will be that much more enjoyable because the study is more likely to run smoothly and stay within budget . Those sponsors who have had to transition a clinical study away from a poorly performing CRO to an alternative supplier, mid-study, will be acutely aware of the pain that this can cause and the need for a thorough vendor selection process. The Request For Proposal (RFP) is a vital component of that process. A well-defined and comprehensive RFP creates the best chance of selecting the most appropriate CRO, or combination of CROs, to complete the project.

There is great variety in the way RFPs are presented to CROs by pharmaceutical, biotech and medical devices companies. They range from a dozen bullet points in an email to a detailed RFP specification sheet complete with final study protocol and “bid grid” spreadsheet. Some companies choose to host their RFPs on e-procurement platforms. For those sponsors who really want to explore the market for the most suitable CRO for their study, a well prepared RFP makes for the best chance of an informed and correct decision. It can also avoid the need to spend time on further evaluation (bid defence, reference checks, audit etc.) of CROs who could have been weeded out at the RFP stage.

RFP Structure

There are a range of RFP manuals and templates available. However, sponsors should be wary of over-reliance on a generic template because it generally needs to be heavily adapted to the particular type of study in mind. Ideally the clinical research organization selection process should only start when a final protocol is available. Although ballpark pricing is often required for budgeting purposes, sponsors should be cautious when requesting a quote based on a draft protocol. Budgets can be revised dramatically on receipt of a final protocol which can alter funding and time requirements.

There is always merit in asking a CRO to review the RFP prior to finalization so that they can include a standard set of assumptions. CROs have seen so many RFPs it makes sense to tap into their experience by asking one to help construct the content and format of the RFP. They may be delighted to get the opportunity to lead the way.

RFPs should not be just about doing a cost comparison. They are an excellent opportunity to ask focused questions about the CRO’s experience, approach and expertise related to the planned clinical study. Questions can also be included that will encourage the CRO to suggest important tweaks or improvements to the study design.

The RFP should always request a detailed Project Plan thereby ensuring that tendering CROs think through the resourcing and timeline requirements. It should also request curriculum vitae (résumés) of the key personnel who will be assigned to the study. Unfortunately it is not unheard of in the industry for a CRO to present their highly experienced “bid defence” team at the vendor evaluation stage and then deploy a less experienced team, that the sponsor has never met, when the business has been won and the study starts. The sponsor should seek assurances that they will receive the team presented and that they will not be moved mid-study to another sponsor’s project. Any change of personnel should be limited to unavoidable reasons, such as long-term illness or change in employment status.

Cost Comparison and Assumptions

On the cost side, the absence of like-for-like comparisons continues to be an issue in the industry. CRO cost models vary from company to company and sponsors often only provide the key parameters, leaving it up to the CROs to create their own assumptions in areas such as number of sites, statistical outputs, data management queries, concomitant medications, adverse events and so on. It is better to have all vendors quote using exactly the same assumptions.

Where a CRO feels the assumptions are incorrect based on their experience of the particular study type, these should be listed separately in the proposal with the cost implications. If the sponsor expects the CRO to work to their own SOPs and standards these documents should be provided in time for them to be analysed and the implications understood prior to a formal response to the RFP. Sometimes CROs apply a “complexity” factor within their quote models which affects the overall pricing. This “complexity” factor may increase or decrease depending on the processes and tools to be used. Sponsors should also be clear about those aspects of the study that they plan to handle themselves.

Some sponsors have developed detailed bid grids to enable comparison across submitted budgets from competing CROs. Occasionally sponsors request a price per additional item/task e.g. per additional patient, month, query etc. Because pricing is usually hourly driven CROs often find it difficult to match or ‘fit’ pricing into a particular grid. Sponsors and CROs alike should be aware that such pricing for additional items can become inaccurate especially if some of the study parameters change.

Rating CROs

Once a sponsor has received the completed proposals, the decision process can be made easier by very simply giving a rating of 1 to 10 for each of the key selection criteria within the study such as: price per function; basis for stated recruitment rates; monitoring expertise; breadth of service; technology; therapeutic experience; geographical reach; capacity; scalability; financial stability; understanding of the study etc. It usually helps the CRO, and improves the overall quality of the proposal, if the sponsor outlines its key selection criteria within the RFP. If a CRO has a niche focus or speciality (whether it is a therapeutic area, biometrics, technology or any other specialist expertise) this should also be taken into account. The total score for each CRO can be displayed in a single matrix. This is a useful decision making tool, but that said, a sponsor should never ignore their gut feeling either.

Various Vendors

It is not always the best idea to contract the whole study to one CRO . Though this might initially seem like the simplest solution, it can also be a risky one. Splitting out the clinical data services and the clinical aspects of a study allows a sponsor to use two separate CROs that are specialists in their own areas. There is very little additional project management time because data focused CROs that handle the collection, management, analysis and reporting of clinical and safety data are adept in liaising with another CRO to obtain data and feedback on queries.

RFPs for Multiple Studies

When writing an RFP for a programme of studies, sponsors should ask CROs to seek out efficiencies should there be similarities from one study to the next. Consideration should be given to centralizing the clinical data services  for multiple studies into a single vendor to avoid repeated set-up costs and to receive volume discounts on technology license fees. This approach also enables sponsors to obtain maximum CRF/eCRF re-use from one study to the next and to hold onto the same programmers, statisticians and medical writers so that the CRO builds up a familiarity and efficiency with that particular sponsor’s templates and requirements. With such a foundation it makes it easier to use multiple CROs for the clinical aspects of studies where geographical diversity and specific therapeutic expertise cannot be found within the same CRO every time. With these benefits in mind, the RFP should be designed in such a way that the clinical can be separated from the data handling functions.

The value of obtaining references can never be underestimated. RFP's should request contact details of the CRO's customers who have placed similar projects with that CRO. Questions regarding the CRO's financial stability do not necessarily need to be included in the initial RFP but should certainly be assessed prior to contract signature. Such an assessment should be done by one of the sponsor’s financial experts who will be best qualified to spot warning signals when evaluating 3 years’ worth of audited accounts.

In summary, a well designed RFP will allow sponsors to assess value over price. It can avoid a lot of unnecessary heartache over the life of the study, making the sponsor’s experience of the CRO one that meets or exceeds expectations in terms of study duration, efficiency, expertise, delivery, quality and adherence to the original budget.

Related Blog Posts

• The Benefits of Centralizing Clinical Data Services
•   Making a Clinical Research Organization Project Smoothly
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4 tips for planning the rfp process for clinical trial services.

By Jamie Hahn

Before you request bids from contract research organizations (CROs) for clinical trial services, it’s important to spend time planning your request for proposal (RFP) process. It’s easy to neglect this planning step, especially since the other deadlines and pressures of the drug development and/or research process often take precedence. However, even the smallest amount of planning prior to the RFP process can reduce the amount of time you spend reviewing proposals and increase your ability to request clarifications from participating CROs.

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May 24, 2022

Related Announcements

National Institute of Mental Health ( NIMH )

National Institute of Neurological Disorders and Stroke ( NINDS )

The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified organizations (NAICS Code 541715) having in-house capability to support and provide resources to the participating grantees for regulatory affairs services that can support medical device development projects from pre-clinical through clinical phases. BP MedTech requires a contract research organization (CRO) to provide resources to the participating grantees in support of regulatory documentation and regulatory compliance. This contractor will provide support for regulatory consulting advice, preparation and submission of regulatory documents, interaction with US Food and Drug Administration, establishment of a Quality System, and setup of regulatory compliance program.

The Blueprint MedTech (BPMT or BP MedTech) initiative is a collaborative program through which 11 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/ ).

Innovators developing groundbreaking medical device technologies face a number of challenges along the translational path from bench to bedside. The BP MedTech program aims to address such challenges and support the innovators by accelerating the development of cutting-edge medical devices to diagnose and treat disorders of the nervous system. The mission of the program is to catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to:

• Planning resources to support concept development, team building, needs assessment, and other early translational activities.
• Streamlined access to translational services and expertise (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, medical monitoring).
• Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).
• Advice from industry experts (e.g., meetings with an external oversight committee).

The overarching goal of BP MedTech is to accelerate patient access to groundbreaking, safe, and effective medical devices. The initiative will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.

The Contractor shall provide NIDA with a full range of services to support regulatory documentation and compliance for medical devices in the BP MedTech program. Tasks orders will be tailored to the needs of the specific grantee and may include some or all of the following activities:

• Preparation of regulatory submissions including Q-submissions, Investigational Device Exemption (IDE), 510(k), De Novo, Pre-market approval (PMA), Humanitarian Device Exemption (HDE), and post-approval studies. Support for interactions with US Food and Drug Administration (FDA) as necessary;
• Establishing a Quality System;
• Development of regulatory compliance program;
• Assistance with market/user research and commercialization strategy;
• Assistance with evaluating and obtaining reimbursement/payer coverage.

The Contractor shall provide services related to regulatory affairs support and strategies for medical devices under development in the following areas: preparation of regulatory submissions; support for interactions with the US FDA as necessary; establishing a Quality System; development of regulatory compliance program; assistance with market/user research and commercialization strategy; assistance with evaluating and obtaining reimbursement/payer coverage. Examples of activities in these areas are provided below. Task orders may include activities in one or more areas.

The following requirements apply to every task order issued under this ID/IQ as applicable.

• Defining a regulatory strategy and providing support to the device development plan that is clearly aligned to meet project goals, including a Target Product Profile (TPP) and gap analysis as requested.
• Optimizing preclinical and clinical regulatory timelines and costs, providing risk mitigation plans.
• Ensuring that all key studies required for regulatory filings are included and strategically planned at the appropriate stage of development.
• Ensuring compliance with all regulations, policies, and protocols.
• Providing proven SOPs, templates, and industry best practice for regulatory services.
• Conducting appropriate communication with regulatory agencies and different stakeholders that is accurate and timely.
• Submitting documents to appropriate regulatory body(ies) in the required format (e.g., electronic submission).
• Adhering to the requisite quality control for all documents and activities.

Performance Area 1: Preparation of Medical Device Pre-Submissions and 513(g) Request for Information

The Contractor shall provide services related to the preparation of all necessary pre-market regulatory submissions for medical devices including traditional pre-submissions, breakthrough device designation requests, study risk determination requests, and 513(g) Request for Information. Anticipated activities under this area include but are not limited to:

• Obtaining and reviewing preclinical and clinical information needed for the submission.
• Preparing, drafting, reviewing, and/or submitting the pre-submission meeting request and briefing package and other supporting documentation as needed.
• Managing post-meeting responses and communications.
• Conducting a debriefing meeting.

Performance Area 2: Preparation and Filing of Investigational Device Exemption (IDE) Submissions

The Contractor shall provide services related to the preparation and filing of an IDE. Anticipated activities under this area include but are not limited to:

• Conducting IDE kick-off meeting.
• Defining IDE filing strategy, scope, timeline, and responsibilities.
• Preparing all modules of the IDE, which includes tasks such as:
• Collecting all study reports, summaries, synopses, and other required documentation.
• Drafting and writing regulatory documents of the submission.
• Preparing all forms necessary for submission.
• Providing post-IDE filing support, including formal responses and maintenance activities as needed.

Performance Area 3: Regulatory Services for Clinical Studies

The Contractor shall provide regulatory services related to clinical studies. Such studies may be clinical trials, natural history studies, patient finding studies, or others. Anticipated activities under this area include but are not limited to:

• Planning, requesting, and preparing materials for additional types of informal and formal meetings.
• Tracking and managing study-related regulatory documentation (e.g., protocol amendments, severe adverse event [SAE] reporting).
• Supporting clinical protocol(s) and clinical trial(s) to ensure compliance with Good Clinical Practice (GCP). This may include tasks such as reviewing study regulatory files and subject specific documents such as informed consent, case report forms, medical records, and communication with the regulatory agency and Investigational Review Board (IRB).

Performance Area 4: Regulatory Support for Medical Device Marketing Submissions

The Contractor shall provide services related to marketing submissions including 510(k), De Novo, PMA, HDE, Q-submissions, and post-approval studies. Anticipated activities under this area include but are not limited to:

• Determining the regulatory requirements.
• Preparing, drafting, reviewing, and/or submitting documentation to the appropriate regulatory body (e.g., FDA/CDRH, ).
• Providing post-submission filing support including communications, responses, and maintenance activities as needed.
• Providing technical guidance and subject matter expertise, which may include tasks such as reviewing data, overseeing studies at Clinical Research Organization (CROs) , and preparing and reviewing study reports and summaries.

Performance Area 5: Regulatory Support for Establishing a Quality System

The contractor shall provide regulatory services related to establishment of a Quality System. Anticipated activities under this area may include but are not limited to:

• Creation / establishment of Quality System.
• Improvement of existing Quality System.
• Quality System software validation.
• Audit and Inspection preparation.
• Design change support.

Performance Area 6: Establishing a Regulatory Compliance Program

The contractor shall provide regulatory services related to establishment of a regulatory compliance program. Anticipated activities under this area may include but are not limited to:

• Development of compliance program.
• Compliance and ethics training for staff.
• Conflict of Interest management.
• Preparation for audits and investigations.
• Establishing a compliance manual.
• Assisting with compliance management outsourcing, if applicable.

Performance Area 7: Assistance with market/user research and commercialization strategy

The contractor shall provide assistance with market and user research and commercialization strategy for the medical device product. Anticipated activities under this area include but are not limited to:

• Market analysis, including market size, market drivers and barriers to entry.
• Competitive landscape analysis.
• Clinical adoption analysis.
• Commercialization/marketing strategy.

Performance Area 8: Assistance with evaluating and obtaining reimbursement/payor coverage.

The contractor shall provide assistance with assessing strategies for reimbursement and payor coverage of the medical device. Anticipated activities under this area include but are not limited to:

• Engaging with CMS and private payors to obtain necessary information about the organization’s needs for coverage decisions.
• Developing evidence generation plan to support payor coverage.
• Establishing medical coverage codes.

NIDA anticipates that one (1) indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded for a period of performance of five (5) years. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. These individual task orders may include options and/or option quantities. If options or option quantities are utilized for an individual task order the will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award. NIDA anticipates that at least one or more task orders will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds. Various task orders will be issued to support distinct tasks and studies which will support the BP MedTech Initiative.

The RFP will be available electronically on or about May 13, 2022. You can access the RFP through the SAM.gov (URL: https://www.sam.gov ) or through the NIDA website: (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps ). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 45 days from the release date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

Please direct all inquiries to:

Tracy Cain, Contracting Officer NIDA/OA Phone: (301) 443-6677 [email protected]

Secondary Point of Contact:

KJ Shaikh, Contracting Officer NIDA/OA Phone: (301) 443-6677 [email protected]

9 September 2024

ABOUT GARDP

The Global Antibiotic Research & Development Partnership (GARDP) accelerates the development and access of treatments for drug-resistant infections. Together with private, public and non-profit partners, GARDP works to preserve the power of antibiotics for generations to come. GARDP is acting now to counter antibiotic resistance and save lives. Antimicrobial resistance (including antibiotic resistance) is one of the top 10 global health threats. In 2019, nearly 1.3 million people died as a result of drug-resistant bacterial infections, more than HIV (~860,000) or breast cancer (~700,000). If left unchecked, antibiotic resistance may kill as many as 10 million people each year from 2050.

Responding to a global health crisis: the story of GARDP The headlines in 2015 were alarming. A deadly superbug was spreading in hospitals in Australia. An outbreak of drug-resistant gonorrhoea threatened public health in England. The superbug “NDM-1” had reached 70 countries. The BBC warned, “Antibiotic resistance: World on cusp of ‘post-antibiotic era’.” For years, the problem had been growing. Even as bacteria were becoming more and more resistant to antibiotics, pharmaceutical companies were exiting the antibiotic development industry. The work had become more difficult and expensive, so now the risks outweighed the rewards. And the antibiotics that were being introduced were not particularly innovative—there had been no new class of antibiotics in about 30 years. In this context, the World Health Assembly, the decision-making body of the World Health Organization (WHO), adopted the Global Action Plan on Antimicrobial Resistance (2015). To deliver on this plan, GARDP was created in 2016 by the WHO and the Drugs for Neglected Disease initiative (DNDi). Like the WHO, GARDP drives a global response to antimicrobial resistance. Like DNDi, GARDP engages in public and private sector partnerships to research and develop new drugs that fit public health needs. Following an initial incubation period in DNDi, GARDP was legally established in 2018 as a Swiss foundation (GARDP Foundation). Three years later, in 2021, the Swiss government granted GARDP legal privileges and immunities to facilitate GARDP’s collaboration with others working in the field of public health and in recognition of GARDP’s major role in the fight against antibiotic resistance.

Today, GARDP is a not-for-profit organization with over 50 staff. They are part of the GARDP global network, including GARDP North America Inc., representation in Australia, DNDi-GARDP Southern Africa NPC, the Drugs for Neglected Diseases initiative, and associated DNDi regional offices in India, Japan, South America, Southeast Asia and Kenya. Together with essential support from donors and key research and development partnerships, the GARDP global network makes it possible to carry out global research and drug development trials, as well as expand access to antibiotics for appropriate use, in close connection with communities around the world.

GARDP R&D strategy for Neonatal sepsis aims at delivering, an affordable ’empirical’ treatment for neonatal sepsis and meningitis in settings with high resistance rates to the WHO first line empiric therapy of ampicillin and gentamicin, where the pathogenic bacteria have not been formally identified. The objective of the GARDP Neonatal sepsis project is to meet the public health needs to identify novel regimens from existing generic antibiotics that provide broader coverage against multi-drug resistant pathogens to improve clinical outcomes for neonatal sepsis globally.

PROJECT BACKGROUND

The service provider will assess the investment it would take for GARDP to apply and maintain the Establishment License for Foreign Trade with Swissmedic, according to Art. 18 (1) (c) of the Swiss Therapeutic Products Act (“TPA”). The aim is to quantify the human and financial investment to acquire and maintain such a license. The envisaged scenario is that GARDP acts as a buyer of production batches of its products and resells these batches to distributors. GARDP would not distribute these products to end users.

PURPOSE OF THE RFP

To quantify the human and financial investment to acquire and maintain such a license. To provide a concept on how GARDP could meet the requirements with a minimal investment, including by outsourcing key tasks.

SCOPE OF WORK

Initial Consultation and Assessment

• Conduct an initial meeting with GARDP to understand the business operations, scope of foreign trade activities, and specific needs.
• Assess the current state of the organization’s documentation, processes, and compliance with Swissmedic regulations.
• Identify gaps or areas requiring improvement and resources to meet the licensing requirements.

Documentation and Compliance Review

• Review all relevant documents, including organization registration, quality management system (QMS) documentation, Standard Operating Procedures (SOPs), and other necessary documentation.
• Provide a detailed list of required documents and assist in gathering any missing information.
• Ensure all documents are in compliance with Swissmedic’ s guidelines and requirements.

Organization Improvement

• Elaborate and propose an organization-wide setup, which is compliant with Swissmedic’ s regulations and guidelines for foreign trade license authorization.
• Produce an assessment regarding the requirement for a Responsible Person.

Internal Audit and Compliance Check

• Conduct an internal audit to evaluate GARDP compliance with Swissmedic regulations.
• Produce a report detailing any non-conformities and recommended corrective actions.

Minimum experience expected from the Service provider’ representative

• Extensive knowledge of Swissmedic regulations and requirements for foreign trade establishments.
• Proven experience in preparing companies for successful license applications to Swissmedic.
• Strong project management and communication skills.

Responsibilities of GARDP Make available to the service provider, all necessary documents, data, and resources required to complete the investment assessment for GARDP to apply and maintain the Establishment License for Foreign Trade with Swissmedic.

DELIVERABLES

• Initial assessment report outlining the current compliance status and required actions.
• Cost assessment on investment needed (FTEs and financial investment)
• Internal audit report and corrective action plan.
• Final compliance checklist and review report.
• Assessment regarding the requirement for a Responsible Person.

CRITERIA FOR SELECTING SERVICE PROVIDERS

The decision to award any contract as a result of this RFP process will be based on Suppliers’ responses and any subsequent negotiations or discussions. The decision-making process will consider the ability of each supplier to fulfil GARDP’s requirements as outlined within this RFP and the total cost of the offer. Proposals will be assessed against the main following criteria but not limited to:

Technical criteria Technical criteria will weight maximum 70% of the award decision and are composed of criteria such as technical expertise, project experience, team structure, project plan proposal, project management capabilities, client recommendations, values and cultural fit.

Financial criteria Financial criteria will weight minimum 30% of the award decision and are composed of criteria such as competitiveness and completeness of the offer, payment schedule based on deliverables, special discount for non for profit organization.

Proposals evaluation and bid defense meeting Based on a pre-aligned selection grid, GARDD selection committee will evaluation all written proposals to determine which suppliers shall be invited to a virtual meeting with GARDP Selection committee. The duration of each meeting will be around 1 hour, including follow-up questions and answers. Agenda and expectations/questions expected for the meeting will be shared together with the invitation to participate.

Value-add and Insight Please list/describe any additional services that you feel would be have benefit to GARDP and associated costs if any.

Data Privacy GARDP is committed to protecting and respecting your privacy in compliance with the European General Data Protection Regulation (GDPR). Our Privacy Notice ( Annex 3 ) sets out the basis on which the personal data collected from you, or that you provide to us, will be processed by us in connection with your relationship with at GARDP, as vendors, suppliers or third parties. By responding to our RFP, you explicitly consent to our Data Privacy Notice and confirm your understanding on how your personal data will be stored and treated by GARDP.

If you are interested to participate, please send a request to: [email protected] to receive complete documentation of this RFP

Due/closing date: September 30th 2024

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Request for proposals: clinical research organization.

March 11, 2022

Request for Proposal Objective This Request for Proposal has been prepared to facilitate collecting bids from a qualified contract research organization (CRO) with staff appropriate for supporting regulatory and ethics approval, securing import and export permits, providing monitoring services, project management, data management, building an EDC system, PV services, Statistics and Medical Writing for an upcoming trial.

• Bid should be based on Protocol Synopsis only, can be provided upon request to interested parties. 
• A capabilities statement, including (a) relevant institutional experience, (b) the specific personnel who will complete the described work and their relationship to the bidder (i.e., employee of bidder or subcontractor), and (c) curriculum vitae of key personnel who will complete the work (e.g., principal investigator, study coordinator, statistician, etc.).   
• Relevant assumptions
• Definition of the scope of work
• Time for routine meetings with TB Alliance for each activity
• Timeline for deliverable(s)
• Fixed costs and projected Pass Through for completing work.
• Request for information should be submitted to: [email protected]  

Timeline for RFP The deadline to submit a proposal is June 06, 2022.  Please contact TB Alliance for more information. 

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2023 Request for Proposals: Broad Clinical Research Fellow Program

In this section, read this next.

2023 Call for Applications: CIRM Clinical Research Fellowship in Stem Cell Biology and Regenerative Medicine

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A gift from The Eli and Edythe Broad Foundation established the Eli and Edythe Broad Clinical Research Fellows at USC. We plan to fund up to 3 positions, and successful applicants will receive a $77,000 stipend + $12,000 health insurance for a minimum of 80% effort this year. The fellows must have completed their MD or MD/PhD training, currently be in a good standing in a USC/CHLA residency program or a fellowship program, and hold a license to practice medicine within the United States.

Successful candidates will be notified by April 30, 2023. The fellowship will provide one full-year salary support for clinical residents or fellows engaged in a minimum 80% effort on a research project broadly related to stem cell biology and regenerative medicine. We strongly encourage the development of translational research projects. The research fellowship project will be conducted at the Department of Stem Cell Biology and Regenerative Medicine (SCRM) or in a collaborative effort with SCRM department faculty. Fellowships will be awarded for one year only. The funding period may commence any time from May 15 to July 1, 2023.

To apply, please submit a single, merged PDF document that includes the following material to Dr. Juliane Glaeser at [email protected] by 5 p.m. on April 27, 2023 :

Research Proposal (3 pages, single spaced, one-inch margins, 12-point Arial font)

• Aims, Background, Significance/Innovation and Impact (1 page)
• Approach and Expected Outcomes (2 pages)

Research Statement (1 page)

• Previous training and research experience
• How does proposed research fit into career goals?
• Proposed mentoring plan

Biosketch (1-2 pages)

Each applicant must propose two mentors. Awardees are required to sign an award agreement for 80% minimum effort with signatures from the relevant Department Chair(s).

For questions, please contact:

Juliane Glaeser, PhD Program Director [email protected]

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Active funding opportunity

Nsf 24-576: gen-4 engineering research centers, program solicitation, document information, document history.

• Posted: May 20, 2024
• Replaces: NSF 22-580

Program Solicitation NSF 24-576

Letter of Intent Due Date(s) (required) (due by 5 p.m. submitting organization’s local time):

     September 03, 2024

Preliminary Proposal Due Date(s) (required) (due by 5 p.m. submitting organization’s local time):

     September 30, 2024

Full Proposal Deadline(s) (due by 5 p.m. submitting organization’s local time):

By Invitation Only

Important Information And Revision Notes

This solicitation encourages proposals addressing a broad spectrum of engineering topics, including but not limited to advanced manufacturing, advanced wireless, artificial intelligence, biotechnology, microelectronics and semiconductors, net-zero technologies, quantum engineering, and systems engineering for healthcare.

This solicitation is updated to clarify the definition of underrepresented students in STEM and to welcome proposal submissions that broaden geographic and demographic participation. More details are provided in Section IV. ELIGIBILITY INFORMATION .

Cost Sharing: Cost sharing is required. The formula for required cost sharing is described in the full text of this solicitation.

Any proposal submitted in response to this solicitation should be submitted in accordance with the NSF Proposal & Award Policies & Procedures Guide (PAPPG) that is in effect for the relevant due date to which the proposal is being submitted. The NSF PAPPG is regularly revised and it is the responsibility of the proposer to ensure that the proposal meets the requirements specified in this solicitation and the applicable version of the PAPPG. Submitting a proposal prior to a specified deadline does not negate this requirement.

Summary Of Program Requirements

General information.

Program Title:

Gen-4 Engineering Research Centers (ERC) Convergent Research and Innovation through Inclusive Partnerships and Workforce Development

Founded in 1984, the Engineering Research Centers (ERC) program brings technology-based industry and universities together in an effort to strengthen the competitive position of American industry in the global marketplace. These partnerships are expected to establish cross-disciplinary centers focused on advancing fundamental engineering knowledge and engineered systems technology while exposing students to the integrative aspects of engineered systems and industrial practice. The goal of the ERC program has traditionally been to integrate engineering research and education with technological innovation to transform and improve national prosperity, health, and security. Building upon this tradition, NSF is interested in supporting ERCs to develop and advance engineered systems, which if successful, will have a high Societal Impact. The ERC program supports convergent research (CR) that will lead to strong societal impact. Each ERC has interacting foundational components that go beyond the research project, including engineering workforce development (EWD) at all participant stages, where all participants gain mutual benefit, and value creation within an innovation ecosystem (IE) that will outlast the lifetime of the ERC. These foundational elements are integrated throughout ERC activities and in alignment with the Center's vision and targeted societal impact. The overall impact of the ERC program is expected within the Engineering Community, the Scientific Enterprise, and Society.

Cognizant Program Officer(s):

Please note that the following information is current at the time of publishing. See program website for any updates to the points of contact.

Sandra Cruz-Pol, telephone: (703) 292-2928, email: [email protected]

Dana L. Denick, telephone: (703) 292-8866, email: [email protected]

Randy Duran, telephone: (703) 292-5326, email: [email protected]

Nadia A. El-Masry, telephone: (703) 292-4975, email: [email protected]

Paul Torrens, telephone: (703) 292-2473, email: [email protected]

Lan Wang, telephone: (703) 292-5098, email: [email protected]

• 47.041 --- Engineering

Award Information

Anticipated Type of Award: Cooperative Agreement

Up to 4 depending on the quality of the proposals and the availability of funds. ERCs are generally funded for ten years, with an initial award for the first five years and second award based on performance and review of a renewal proposal. This solicitation seeks to make awards for the first five years for new ERCs.

See Section III of this solicitation for additional information about the allowable maximum annual budget for years one through five.

NSF expects to make the ERC awards in the summer of 2026. The budget distribution among the lead and core partners should be appropriate for the scope of work and activities planned for each foundational component.

Note that ERCs will not be granted no-cost extensions (NCE).

Co-funding:

NSF is currently in negotiations with other government agencies to form partnerships in support of ERC awards. These partnerships have the potential to expand the total number of awards. This is contingent upon realization of these partnerships, and budgets provided to these organizations by Congress for FY 2026 and 2027.

Eligibility Information

Who May Submit Proposals:

Proposals may only be submitted by the following:

Only U.S. Institutions of Higher Education (IHEs), also referred to in this solicitation as universities and academic institutions, accredited in, and having a campus located in the US, that grant engineering degrees at the undergraduate, masters, and doctoral engineering level may submit proposals as the lead university. The Lead university submits the proposal, and the award is made to the lead university. Support is provided to core partner universities and any affiliated faculty from other partner institutions through subawards. NSF welcomes proposal submissions that broaden geographic and demographic participation. Proposals from STEM-minority-serving institutions (STEM-MSI*), non-R1 schools, emerging research institutions, and IHEs in EPSCoR-eligible jurisdictions, as lead or core partners, as well as IHEs that primarily serve populations of students with disabilities or women in engineering interested in STEM, are encouraged.

Invited full proposals must meet all the following organizational requirements or they will be returned without review:

• The Lead must be an Institution of Higher Education per the Carnegie Foundational Attribute: https://carnegieclassifications.acenet.edu/
• A proposed ERC must be multi-institutional, with a lead university and additional domestic university core partners. There is no maximum number of partner institutions.
• To qualify as a core partner institution, there must be financial support for a minimum of three faculty participating in the ERC along with financial support for a minimum of three students (Postdoctoral scholars may not be included as students).
• The lead or at least one of the core partner universities must be a STEM-MSI* university.
• Commitments from lead and core partner universities for cost sharing must be in place.

*For this solicitation STEM-MSI is defined by the Department of Education as institutions of higher education enrolling populations with significant percentages of undergraduate minority students, or that serve certain populations of minority students under various programs created by Congress.

Eligibility may be determined by reference to the Integrated Postsecondary Education Data System (IPEDS) of the US Department of Education National Center for Education Statistics ( https://nces.ed.gov/ipeds/ ).

Who May Serve as PI:

The Lead PI must be a faculty member at the Lead university. Non-Lead PIs are the co-PIs listed on the Cover Sheet after the Lead PI and may be from institutions other than the lead university. In order to provide more flexibility for the Center's management, the Lead PI and the ERC Director are not required to be the same person, however, both must be affiliated with the lead institution.

Limit on Number of Proposals per Organization:

If an institution has two active ERC awards, it does not qualify to submit an ERC preliminary proposal as a lead institution. There are no other restrictions or limits on the number of preliminary proposals submitted by a Lead institution. Full Proposals may be submitted only by invitation and only by the lead institution designated in the preliminary proposal.

Limit on Number of Proposals per PI or co-PI:

There are no restrictions or limits.

Proposal Preparation and Submission Instructions

A. proposal preparation instructions.

Letters of Intent: Submission of Letters of Intent is required. Please see the full text of this solicitation for further information.

Preliminary Proposals: Submission of Preliminary Proposals is required. Please see the full text of this solicitation for further information.

Full Proposals:

• Full Proposals submitted via Research.gov: NSF Proposal and Award Policies and Procedures Guide (PAPPG) guidelines apply. The complete text of the PAPPG is available electronically on the NSF website at: https://www.nsf.gov/publications/pub_summ.jsp?ods_key=pappg .
• Full Proposals submitted via Grants.gov: NSF Grants.gov Application Guide: A Guide for the Preparation and Submission of NSF Applications via Grants.gov guidelines apply (Note: The NSF Grants.gov Application Guide is available on the Grants.gov website and on the NSF website at: https://www.nsf.gov/publications/pub_summ.jsp?ods_key=grantsgovguide ).

B. Budgetary Information

Cost Sharing Requirements:

Cost Sharing is required. Please see the full text of this solicitation for further information.

Indirect Cost (F&A) Limitations:

Not Applicable

Other Budgetary Limitations:

Other budgetary limitations apply. Please see the full text of this solicitation for further information.

C. Due Dates

Letter of Intent Due Date(s) (required) (due by 5 p.m. submitting organization's local time):

Preliminary Proposal Due Date(s) (required) (due by 5 p.m. submitting organization's local time):

Proposal Review Information Criteria

Merit Review Criteria:

National Science Board approved criteria. Additional merit review criteria apply. Please see the full text of this solicitation for further information.

Award Administration Information

Award Conditions:

Additional award conditions apply. Please see the full text of this solicitation for further information.

Reporting Requirements:

Additional reporting requirements apply. Please see the full text of this solicitation for further information.

I. Introduction

The National Science Foundation (NSF) created the Engineering Research Centers (ERC) program in 1984 to bring technology-based industry and universities together in an effort to strengthen the competitive position of American industry in the global marketplace. These partnerships established cross-disciplinary centers focused on advancing fundamental engineering knowledge and engineered systems technology while exposing students to the integrative aspects of engineered systems and industrial practice. As a result, ERCs have produced a wide range of new fundamental knowledge, engineered systems and other technologies aimed at spawning whole new fields or industries or radically transforming the product lines, processes, and practices of current industries. At the same time, they have produced a new generation of engineering graduates who are highly innovative, diverse, globally engaged, and effective as technology leaders in academia and industry.

NSF has continually refined the goals and purposes of the ERC program to meet shifting needs. The NSF-requested 2017 study from the National Academies of Sciences, Engineering, and Medicine (NASEM) "A New Vision for Center-Based Engineering Research" ( https://www.nap.edu/catalog/24767/a-new-vision-for-center-based-engineering-research ) recommends that NSF places a greater emphasis on forming research centers focused on convergent research and education approaches that address challenges with significant societal impact. Complex societal problems require a convergent approach for the deep integration of knowledge, tools, and ways of thinking across disciplinary boundaries. A detailed explanation of the convergence concept can be found in a 2014 National Academies report, "Convergence: Facilitating Transdisciplinary Integration of Life Sciences, Physical Sciences, Engineering and Beyond" ( https://www.nap.edu/catalog/18722/convergence-facilitating-transdisciplinary-integration-of-life-sciences-physical-sciences-engineering ).

This current iteration of the ERC program reflects the recommendations from the NASEM study as well as other sources. The program continues to focus on advancing an engineered system through inclusive cross-disciplinary and cross-sector partnerships, while placing greater emphasis on research with high- risk/high-payoff ideas that lead to societal impact through convergent approaches, engaging broader stakeholder communities, and using team science concepts for their team formation.

II. Program Description

A. ERC Program Model

The ERC program is grounded by the four foundational components of the ERC: Convergent Research (CR), Engineering Workforce Development (EWD), Diversity and Culture of Inclusion (DCI), and the Innovation Ecosystem (IE) (Figure 1). These foundational components are connected by an integrated, holistic ERC vision and strategic plan. The whole of the ERC has added value and synergies that require a center or institute-like approach as opposed to individual projects.

Convergent Research (CR): High-risk/high-payoff research ideas and discoveries that push the frontiers of engineering knowledge; ERC convergent research is a highly collaborative and interdisciplinary approach that leads to positive impacts on society. Convergence involves the integration of various fields in engineering and science, including all branches of science, in a coordinated and interdependent manner. This approach fosters strong collaborations that are essential for successful inquiry.

Engineering Workforce Development (EWD): In addition to training opportunities for ERC participants, the Center engages in human resource capacity development aligned with the targeted engineered system. ERC EWD strengthens a robust spectrum of engineering education pathways and technical workforce opportunities. EWD occurs at all levels of the Center and provides opportunities for engagement by all ERC members including students, faculty, and external partners as appropriate. The ERC EWD program is driven by the future education, workforce development, and labor market needs relevant to the proposed Center.

Diversity and Culture of Inclusion (DCI): In addition to fomenting a diverse team, the culture of the ERC and teams within the ERC demonstrate an environment of inclusion in which all members feel valued and welcomed, creatively contribute, and gain mutual benefit from participating. Because of the ERC's attention to diversity and culture of inclusion, participation from members of groups traditionally underrepresented in engineering as well as diverse scientific and other perspectives is required. The ERC DCI program ensures diversity at all levels of the Center and employs an intentional and evidence-based approach to developing a culture of inclusion.

Innovation Ecosystem (IE): Trusted partners that work together to create and enhance the capacity for innovation and new ways for delivering value with positive societal impact. ERC innovation ecosystems (IE) include effective translational efforts from ideation to implementation, workforce development that creates the workforce needed for the enterprise, and deliberate efforts to attract funding and resources. ERCs articulate plans for strategic engagement of stakeholder communities while including the legal, ethical, civic, and societal acceptance frameworks needed to protect the participants.

The ERC foundational elements are carried out in concert through ERC activities and in alignment with the Center's vision and targeted societal impact. The overall impact of the ERC program is expected within the Engineering Community , the Scientific Enterprise , and Society , shown in Figure 1 (above). These may be thought of as nested regions of increasing influence, where the largest scale of impact is on society itself. Potential outcomes of ERCs are organized within each of the four ERC foundational components.

Engineering Community: ERCs not only create fundamental knowledge and technology, but also impact the engineering community, preparing students and researchers by highlighting new engineering approaches and best practices for engineering workforce development, diversity and inclusion, and academic-industrial partnerships.

Scientific Enterprise: ERCs should be exemplars of how cohesive, high-performing teams engage in convergent research and innovative approaches to create major impact that informs and inspires the scientific community, engineering and beyond.

Society: ERCs enable society to have a better quality of life, and be more resilient, productive, and safe. Each ERC is expected to have a transformational positive impact on significant societal challenges and opportunities. This is the level where the introduction of value creation and technology innovation requires an understanding of socio-technical interactions and how they might impact society at large. In response, new strategies, concepts, ideas and/or re- organizations may be needed to shore-up, extend, or strengthen society. The desired outcome is the ERC's ability to assist society in its drive to advance the national health, prosperity, welfare, and to secure the national defense.

The goal of the ERC program has traditionally been to integrate engineering research and education with technological innovation to transform and improve national prosperity, health, and security. Building upon this tradition, NSF is interested in supporting ERCs to develop and advance engineered systems, which if successful, will have a high Societal Impact .

ERCs create inclusive cultures not only to integrate scientific discovery with technological innovation through convergent engineered systems research and education, but also to include the participation of the full spectrum of diverse talent in engineering. ERCs build partnerships with industry, practitioners, and other key stakeholders to strengthen the innovative capacity of the United States in a global context. In addition to building capacity for research, innovation, and a diverse workforce, ERCs are expected to produce significant outcomes within the 10-year timeframe of NSF support and beyond.

ERCs should realize a vision of advancing an engineered system driven by clearly articulated societal impact and should have strong synergies or value-added rationale that justifies a center or institute-like approach. As part of creating sustainable positive impacts on society and communities, ERCs should focus on positive outcomes that can be seen within engineering communities and build and empower human resource capacity for their targeted engineering challenges. Beyond this, ERCs should contribute to the scientific enterprise by advancing research, science, engineering fundamentals, and research communities. This should be demonstrated with benchmarks against the state-of-the-art. ERCs should build knowledge, prepare students and researchers that respect and flourish in an environment with diverse perspectives, impact how engineering research is conducted and provide value for society. The ERC program encourages proposals addressing a broad spectrum of engineering topics, including but not limited to advanced manufacturing, advanced wireless, artificial intelligence, biotechnology, microelectronics and semiconductors, net zero technologies, quantum engineering, and systems engineering for healthcare.

C. Key Elements of an ERC

Vision: The ERC vision guides discovery and technology to uniquely transform US prosperity, health, and/or security in 10 years. The vision describes the compelling new idea, explains how it relates to national needs, and makes the connection to engineering.

Strategic Plan: The ERC strategic plan connects and leverages research, engineering workforce development, diversity and culture of inclusion, and innovation ecosystem to address the chosen societal challenge. The overall plan should employ three strategic approaches:

Convergence : "Convergence is an approach to problem solving that cuts across disciplinary boundaries. It integrates knowledge, tools, and ways of thinking across disciplinary boundaries in STEM fields to form a comprehensive synthetic framework for tackling scientific and societal challenges that exist at the interfaces of multiple fields." ( https://www.nap.edu/catalog/18722/convergence-facilitating-transdisciplinary-integration-of-life-sciences-physical-sciences-engineering ). This is also stated in another report by the National Academies of Sciences, Engineering, and Medicine (NASEM) from the Committee on a Vision for the Future of Center-based Multidisciplinary Engineering Research, which defined convergent engineering as a deeply collaborative, team-based engineering approach for defining and solving important and complex societal problems ( https://www.nap.edu/catalog/24767/a-new-vision-for-center-based-engineering-research ). Hence, convergent research blends scientific disciplines in a coordinated, reciprocal way and fosters the robust collaboration needed for successful inquiry and has the strong potential to lead to transformative solutions and new fields of study. The research thrusts, testbeds, team formation, and other major aspects of the research plan should support a convergent approach.

Stakeholder Engagement : The intentional and early-stage engagement of all parties who may contribute to the ERC or may be impacted by the ERC along its capacity-building and value creation responsibilities. Stakeholders can include, but are not limited to, relevant researchers across partner institutions with complementary research and education expertise; undergraduate and graduate students, postdoctoral researchers; industry leaders who can guide the innovation effort; partners for innovation, education, workforce development, and diversity and culture of inclusion of all participants; and beneficiaries of the ERC outcomes (e.g., community members, users, customers, patients, and watchdog organizations).

Team Formation : The process by which all necessary disciplines, skills, perspectives, and capabilities are brought together. Successful teams are interdependent, multidisciplinary, and diverse and can work and communicate effectively even when geographically dispersed. Team formation includes evidence-based strategies and team science training to overcome barriers to effective, collaborative teaming, including the integration of members with different areas of expertise, different vocabularies and core values and ways of approaching problems, different understanding of the problems to be addressed, different values, and different working styles. This is especially needed during the early stages of the Center.

Organization and Management Structure:

Effective Leadership: ERC leaders have intellectual vision, demonstrable leadership, successful entrepreneurial experience, a track record of delivering results, and the ability to communicate clearly and effectively with diverse audiences such as team members, sponsors, partners, host institutions, stakeholders, press and media, and the public. Below are some example practices desired for effective ERC leadership and management teams:

• Empowers all team members to contribute;
• Builds consensus around goals and problem definition;
• Facilitates communication to ensure a common understanding among all stakeholders; and resolves conflicts and builds trust.

It is rare that a single individual will have all of these attributes; thus, a strong leader will need to assemble an executive team that covers this broad spectrum of skills. The Center Director should understand their strengths and limitations, should be effective in assembling an executive leadership team that fills in the gaps of their limitations, and should be supported by an effective Council of Deans (See Section II.C. for details of the formation of the Council of Deans).The Director does not need to be a faculty member.

Organization and Management: An effective management structure begins with a clear understanding of the goals of the ERC and how the structure (including the ERC four foundational components) will support those goals. The structure should have the flexibility to adapt as the needs of the ERC change, as key people transition into or out of the ERC, or change roles, and to handle other changes as the ERC matures.

It is critical to have one person or team that has clear responsibility for each foundational component of the ERC. However, each ERC participant and each of the core participants should also understand the importance of each foundational component and be engaged in their role in carrying it out. Core partner institutions must meet the eligibility requirements of at least 3 faculty and 3 students participating in the ERC; postdoctoral scholars may not be included as students. Proposing teams will determine the funding source(s) of student support and nature of participation, whether graduate or undergraduate. Typically, ERC’s have many more fully/partly funded graduate and undergraduate students engaged in the ERC, in addition to faculty or postdocs.

ERC program experience has shown that an important role in the ERC structure is that of an administrative director, as described below. This remains a mandatory piece of the management structure.

Administrative Director: An experienced staff member at the lead university who is responsible for operational management, financial management, data collection, publicity, and reporting, etc. for the ERC. Post-award NSF training is available for this position given the ERC reporting complexities.

Lead Institution: The lead institution effectively guides the multiple elements of the ERC. The ERC headquarters are located at the lead institution, and the lead institution is the NSF recipient and is ultimately responsible for the financial and reporting obligations of the ERC award.

Core Partners: To qualify as a core partner university, there must be a minimum of three faculty participating in the ERC along with a minimum of three students; postdoctoral scholars may not be included as students. Core partners are included in the Cost Sharing requirements and in the Council of Deans (See Section II.C. for details of the formation of the Council of Deans.)

Other potential partners may include universities contributing affiliated faculty, federal laboratories, private-sector or non-profit organizations, educational partners, and/or foreign collaborators' universities or institutions. While not considered core partners, the involvement of such partners can be valuable.

Industrial/Practitioner Member: An organization that satisfies all requirements for membership according to the Center's membership agreement which may include financial support (cash or in-kind).

ERCs should engage industrial/practitioner members from sectors such as the Federal Government, State government, local government, quasi-government research, industry, industry association, policy organization, regulatory agency, medical facility, private foundation, nonprofit, venture capitalists, community organizations, professional/trade union, and other stakeholders as appropriate for the center's mission.

Affiliated Faculty Member: The ERC may include affiliated faculty members, which are faculty members who are contributing to the ERC from institutions other than the lead or core partner universities and are included in the budget.

Institutional Commitment: The lead and all core partner institutions must augment support for the ERC through cost-sharing and other allowed means and sustain the ERC once NSF's support ceases. Lead, core, and other partner academic institutions must commit to:

• Joining in partnership to support the ERC's vision, strategic plans, and activities in CR, EWD, DCI, IE and their integration across the institutions.
• Assuring cross-university industrial membership and intellectual property (IP) policies that recognize shared rights for joint work.
• Adopting institutional policies to reward faculty, particularly those in the promotion and tenure process, for participating in convergent research and innovation, technological advance, mentoring, university and pre-college education activity, and delivering on the ERC's plans for workforce development and creating an inclusive and diverse culture. NSF strongly encourages the full spectrum of diverse talent that society has to offer.
• Official recognition for university students engaged in mentoring of other university students and in pre-college outreach. This recognition is crucial to acknowledge their efforts and motivate them to continue their valuable work

Community Feedback: Broad-based stakeholder feedback to the ERCs is one of the important mechanisms used by the ERC to provide continual monitoring of the Center's health.

Advisory Boards: Advisory boards are formed to reinforce and support the proper functioning of the ERC's foundational components which are CR, EWD, DCI, and IE, as described above. Careful consideration must be given to defining each advisory board's functional role and selecting quality board members capable of overseeing that role. An example of a generic ERC feedback loop structure is illustrated in Figure 2. As part of the NSF Management/Oversight, the NSF Program Director and the NSF Site Visit Team (SVT) typically interact with the ERC and give feedback to the ERC once a year at a minimum. The advisory boards provide feedback at least twice a year; usually more often on an as needed basis. It may occasionally be necessary to form additional special committees to support special needs of the Center's vision. The staffing of these committees may be either internal or external. The Council of Deans and Student Leadership Council, as defined below, are mandatory advisory groups; however, the ERC is expected to propose appropriate advisory groups beyond these two.

Student Leadership Council (SLC): Undergraduate and graduate students from all partner universities responsible for coordinating their various activities in support of the ERC. A student president and a student co-president lead the SLC. The SLC will prepare a written Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis and present the SWOT findings during the annual visit of the NSF Site Visit Team (SVT).

Council of Deans: Led by the Dean of Engineering from the Lead university, this Council includes the Deans from the lead and each core partner institution. They meet collectively to provide administrative support of the ERC and to help facilitate multiple ERC elements across the lead and core partner universities. The Dean may not designate an alternate unless a PI, Co-PI, Director, or any senior personnel is also a Dean at the Institution. The two roles cannot be performed by the same person.

III. Award Information

Estimated program budget, number of awards, and average award size/duration are subject to the availability of funds. The maximum annual budget allowed is shown in the table below.

Year 1 budget will be committed upon award, and subsequent year budgets are subject to satisfactory annual review of accomplishments and availability of funds. After a gradual ramp up, years three through five are projected to level off at $6,000,000 in each of those years. Pending performance and outcome of a renewal review in the fourth year, support for years six to eight will continue at $6,000,000 per year until the eighth year. Support for years nine and ten will be phased down, with $4,000,000 in year 9 and $2,600,000 in year 10. No-cost extensions (NCEs) will not be granted.

IV. Eligibility Information

Proposals may only be submitted by the following: Only U.S. Institutions of Higher Education (IHEs), also referred to in this solicitation as universities and academic institutions, accredited in, and having a campus located in the US, that grant engineering degrees at the undergraduate, masters, and doctoral engineering level may submit proposals as the lead university. The Lead university submits the proposal, and the award is made to the lead university. Support is provided to core partner universities and any affiliated faculty from other partner institutions through subawards. NSF welcomes proposal submissions that broaden geographic and demographic participation. Proposals from STEM-minority-serving institutions (STEM-MSI*), non-R1 schools, emerging research institutions, and IHEs in EPSCoR-eligible jurisdictions, as lead or core partners, as well as IHEs that primarily serve populations of students with disabilities or women in engineering interested in STEM, are encouraged. Invited full proposals must meet all the following organizational requirements or they will be returned without review: The Lead must be an Institution of Higher Education per the Carnegie Foundational Attribute: https://carnegieclassifications.acenet.edu/ A proposed ERC must be multi-institutional, with a lead university and additional domestic university core partners. There is no maximum number of partner institutions. To qualify as a core partner institution, there must be financial support for a minimum of three faculty participating in the ERC along with financial support for a minimum of three students (Postdoctoral scholars may not be included as students). The lead or at least one of the core partner universities must be a STEM-MSI* university. Commitments from lead and core partner universities for cost sharing must be in place. *For this solicitation STEM-MSI is defined by the Department of Education as institutions of higher education enrolling populations with significant percentages of undergraduate minority students, or that serve certain populations of minority students under various programs created by Congress. Eligibility may be determined by reference to the Integrated Postsecondary Education Data System (IPEDS) of the US Department of Education National Center for Education Statistics (https://nces.ed.gov/ipeds/).

V. Proposal Preparation And Submission Instructions

Letters of Intent (required) :

1. LETTER OF INTENT

A Letter of Intent (LOI) is required to facilitate the NSF review process. The LOI must be submitted via Research.gov no later than the LOI deadline date. Please note the following conditions:

• LOIs must be submitted through Research.gov (not Grants.gov). A Minimum of one PI and up to four co-PIs are allowed.
• A list of all anticipated Core Partner Universities is required.
• The lead university cannot change after submission of the Letter of Intent.

Title: The title should begin with "NSF Engineering Research Center for ( insert the rest of the title and the Center's acronym )". The title should reflect the engineered system of the proposed ERC.

Lead PI and/or Center Director: The Lead PI's information is automatically included when the LOI is created. If the Lead PI and the Center Director are different individuals, please include the Center Director's name, university, department, phone number, and e-mail address at the beginning of the Synopsis section.

Anticipated ERC Non-Lead PIs (co-PIs): Identify up to four co-PIs. For the LOI, the participating team (Senior/Key Personnel) will be limited to the lead PI and up to four co-PIs who may come from any or all the domestic core partner universities.

Anticipated Core Partner Universities: The Lead university (not PI) is binding throughout the process. Other partners may change. The anticipated core partner universities should be included in the Manage Participating Organizations section of the LOI.

Synopsis (not to exceed one page): Upload brief statements of the vision and goals of the ERC, its potential for societal impact, and an integrated plan for the Center. Include an overview of the research program, such as research thrust titles, goals, and fundamental gaps or barriers in knowledge/technology that it meets. Although the EWD, DCI, and the IE are also critical foundational components of an ERC, they do not need to be described in detail in the LOI.

Other Comments (an additional max 2,500 characters including any blank spaces): Continue Synopsis as needed in this section.

Keywords: In order of decreasing emphasis, list up to ten keywords that represent the scientific interdisciplinary content in the proposal.

Letter of Intent Preparation Instructions :

When submitting a Letter of Intent through Research.gov in response to this Program Solicitation please note the conditions outlined below:

Submission by an Authorized Organizational Representative (AOR) is not required when submitting Letters of Intent.

A Minimum of 0 and Maximum of 4 Other Senior Project Personnel are permitted

A Minimum of 0 and Maximum of 6 Other Participating Organizations are permitted

• Keywords is required when submitting Letters of Intent
• Submission of multiple Letters of Intent is permitted

Preliminary Proposals (required) : Preliminary proposals are required and must be submitted via Research.gov, even if full proposals will be submitted via Grants.gov.

2. PRELIMINARY PROPOSAL

Submission of a Preliminary Proposal is required to be eligible for an invitation to submit a Full Proposal.

Preliminary Proposal Preparation Instructions:

Preliminary proposals must explicitly address the following questions in the project description:

• What are the compelling new ideas and what is the potential for high societal impact?
• What is the ERC engineered system? Is it high-risk but high payoff? Is the 3-plane chart well-conceived and justified?
• Why is an ERC necessary to tackle the idea?
• What is the proposed management structure for the ERC? How will the ERC's organization and management structure integrate and implement the four foundational components (CR, EWD, DCI, and IE) and foster the desired team formation?
• What are the proposed strategies for engaging and developing the appropriate stakeholder community?
• Does the proposed ERC create an inclusive environment where all the ERC participants learn to work in a team towards a common goal?

Preliminary Proposal Set-Up: Select "Prepare New Preliminary Proposal" in Research.gov. Search for and select this solicitation title in Step One of the Preliminary Proposal wizard. The information in Step 2 is pre-populated by the system. In Step 3 select "Single proposal (with or without subawards). Separately submitted collaborative preliminary proposals will be returned without review.

Title: The title should begin with "NSF Engineering Research Center for ( insert the rest of the title and the Center's acronym )". The rest of the title and acronym can change from the LOI to the submitted preliminary proposal as long as it is in the same topic area. The title should reflect the system focus of the proposed ERC.

The required components of the preliminary proposal are given below. Page limitations given here will be strictly enforced. Proposers should review the most current PAPPG for specific information and format for the required sections. No other sections are required or may be included in the preliminary proposal.

Cover Sheet: Select the proposed start date and proposed duration.

Project Summary (1 page): The Project Summary must have three separate section headers entitled "Overview", "Intellectual Merit", and "Broader Impacts"; each heading must be on its own line with no other text on that line. Within the Overview section, include a separate sub-section entitled "Proposed Vision". The summary should be informative to those working in the same or related fields and understandable to a scientifically or technically literate reader.

Project Description: Maximum 10 pages, total, containing the following sections, not necessarily in this order. All figures and tables must be included within the 10-page limit.

The proposing team (Participant Table) should be submitted as a supplementary document.

The Intellectual Merit and Broader Impacts of the ERC must be addressed and described throughout the narrative as an integral part of the Project Description. Between Sections IV and V, include a separate header for Broader Impacts, as specified below. In addition, Results from Prior Support is not a required section for the preliminary proposal.

Outline for the Preliminary Proposal Project Description (up to 10 pages)

II. Strategic Plan

III. Organization and Management Structure

IV. Convergent Research

BROADER IMPACTS ( Please note: The Project Description must include a separate section header labeled Broader Impacts and the heading must be on its own line with no other text on that line. )

V. Engineering Workforce Development

VI. Diversity and Culture of Inclusion

VII. Innovation Ecosystem

I. Vision: The proposed vision for the ERC must be explained, with a discussion of the convergent engineering research theme and the anticipated societal impact. Explain the proposed transformative engineered system and the potential for impact on society, the engineering community and the greater scientific community.

II. Strategic Plan: The plan must define the engineered system and describe how the features of the ERC will be integrated to achieve the vision, in particular the cohesive plan for involving participants at all levels in the four foundational components:

• Convergent Research (CR)
• Engineering Workforce Development (EWD)
• Diversity and Culture of Inclusion (DCI)
• Innovation Ecosystem (IE)

III. Organization and Management Structure: Describe the proposed management, including the functions of key personnel and the role of any advisory committee (including the required Student Leadership Council and the Council of Deans), executive committee, program committee, or their equivalent. Note that there is no recommendation for how ERCs should be managed. This solicitation provides for flexibility on organization structure and management and is part of the review criteria – as such the proposal should clearly justify the proposed structure.

IV. Convergent Research (CR): The role of convergence and team formation in the proposed research must be described. Research activities must address any gaps and barriers to achieve the proposed vision. Research must advance fundamental knowledge and support the development of technology that is proven through proof-of-concept testbeds as part of a well-defined engineered system. Integration of research activities must be graphically depicted on a clearly legible version of the ERC Program's 3-Plane Strategic Planning Chart ( http://erc-assoc.org/content/three-plane-diagram ) that is tailored to the proposed ERC. The chart should be at least half a page, but a full page is recommended for legibility, as this chart is used at several stages of the NSF review process. This section should clearly state what new knowledge is expected that would advance the state of the art in key research areas.

V. Engineering Workforce Development (EWD): A proposed evidence-based program for human capacity development for the future engineering and technical workforce must be described. The program goals and expected outcomes must be described. Proposed activities should logically lead to targeted outcomes and support diverse pathways and experiences for participants. Existing programs and partnerships may be leveraged to support the ERC EWD program and provide opportunities to engage with potential participants.

VI. Diversity and Culture of Inclusion (DCI): Preliminary ideas to create and nurture a culture of inclusion to foster the engagement of all ERC participants. This section should include evidence-based and intentional programming approach.

VII. Innovation Ecosystem (IE): An innovation ecosystem development effort must be proposed. However, DO NOT list potential or committed industrial or other supporters.

In addition, the preliminary proposal must also include these documents and information.

References Cited (required): See PAPPG for format guidelines.

Senior/Key Personnel Documents: The Lead PI, Center Director (if different from the Lead PI) and up to four co-PIs) must be designated as Senior/Key Personnel and must provide the following documents in accordance with the guidance contained in PAPPG Chapter II.D.2.h.

• Biographical Sketches
• Collaborators & Other Affiliations (COA)Information

Supplementary Documents:

A letter of commitment from the Dean of Engineering of the lead institution must be submitted which describes the support for and commitment to the ERC (including space for the ERC headquarters) should it be funded. While the Lead PI does not need to be from the School of Engineering, this letter must be from the Dean of Engineering to demonstrate the Engineering Dean's support for the proposed impact of the ERC on the engineering community.

The Dean should NOT include any financial commitments. Instead, the Dean should make a statement as to how the proposed ERC will align with the strategic directions of the college or the university. Proposals submitted without a letter of commitment from the Dean of Engineering will be returned without review. No letters of collaboration are allowed.

Participant Table (one page maximum): Provide a participant table that includes all committed ERC personnel: (1) Name of the Lead PI (and ERC Director, if different from the Lead PI) and Non-Lead PIs, (2) Institution(s), (3) Department(s), and (4) Most Relevant Field(s) of Expertise. In addition, please list all committed senior/key personnel. Do not identify members of advisory boards. The team table should include only those personnel who would receive NSF funds. This table is used by NSF in the merit review process to manage reviewer selection.

Single Copy Documents:

Collaborators & Other Affiliations Information: Information regarding collaborators and other affiliations (COA) must be separately provided for all members of the ERC Leadership Team and key faculty who are not designated as Senior/Key Personnel. Proposers must follow the guidance contained in PAPPG Chapter II.D.2.h. and include the COA information in the Additional Single Copy Documents section of the preliminary proposal. The accuracy of this section is very important to the integrity of the ERC review process. Please be accurate, up to date, and complete with the entries, including professional email addresses.

Institutional Affiliations: Beyond the affiliations captured on the COA form for individual ERC participants, the ERC Lead University must report any institutional affiliations arising from partnerships including any government agencies, international partners, industry partners or other non-academic institutional partners. The institutional affiliation information must be entered into the ERC Preliminary Proposal Institutional Conflict template (See bullet #2 on http://erc-assoc.org/content/templates-proposal-preparation-0 ) and uploaded into the Additional Single Copy Documents section.

DO NOT SUBMIT other documents, including letters of commitment or collaboration from the domestic partner universities, prospective industrial members, or other future partners. The only allowed item is the required letter of commitment from the Dean of Engineering at the Lead Institution.

RELIMINARY PROPOSAL REQUIREMENTS

(Note: This is NOT a total list of the ERC preliminary proposal requirements. Refer to the ERC Solicitation and the PAPPG for complete requirements).

Full Proposal Preparation Instructions : Proposers may opt to submit proposals in response to this Program Solicitation via Research.gov or Grants.gov.

• Full Proposals submitted via Research.gov: Proposals submitted in response to this program solicitation should be prepared and submitted in accordance with the general guidelines contained in the NSF Proposal and Award Policies and Procedures Guide (PAPPG). The complete text of the PAPPG is available electronically on the NSF website at: https://www.nsf.gov/publications/pub_summ.jsp?ods_key=pappg . Paper copies of the PAPPG may be obtained from the NSF Publications Clearinghouse, telephone (703) 292-8134 or by e-mail from [email protected] . The Prepare New Proposal setup will prompt you for the program solicitation number.
• Full proposals submitted via Grants.gov: Proposals submitted in response to this program solicitation via Grants.gov should be prepared and submitted in accordance with the NSF Grants.gov Application Guide: A Guide for the Preparation and Submission of NSF Applications via Grants.gov . The complete text of the NSF Grants.gov Application Guide is available on the Grants.gov website and on the NSF website at: ( https://www.nsf.gov/publications/pub_summ.jsp?ods_key=grantsgovguide ). To obtain copies of the Application Guide and Application Forms Package, click on the Apply tab on the Grants.gov site, then click on the Apply Step 1: Download a Grant Application Package and Application Instructions link and enter the funding opportunity number, (the program solicitation number without the NSF prefix) and press the Download Package button. Paper copies of the Grants.gov Application Guide also may be obtained from the NSF Publications Clearinghouse, telephone (703) 292-8134 or by e-mail from [email protected] .

See PAPPG Chapter II.D.2 for guidance on the required sections of a full research proposal submitted to NSF. Please note that the proposal preparation instructions provided in this program solicitation may deviate from the PAPPG instructions.

3. FULL PROPOSAL

Full Proposal Preparation Instructions :

As a multi-university ERC, the proposal must be submitted as a single integrated proposal by the Lead university, with proposed subawards to the other partner institutions. Separately submitted collaborative proposals from each partner will not be accepted.

Select "Prepare New Full Proposal" in Research.gov. Search for and select this solicitation title in Step One of the Full Proposal wizard. Select "Center" as the proposal type. In the proposal details section, select "Single proposal (with or without subawards)." Separately submitted collaborative proposals will be returned without review.

Title: Research.gov will pre-pend the title with "Center." The remainder of the title should begin with "NSF Engineering Research Center for ( insert the rest of the title and the Center's acronym )". The title should reflect the engineering system of the proposed ERC.

Cover Sheet: For planning purposes, September 1, 2026 should be shown as the requested start date. The award duration should be 60 months.

Project Summary (1 page): The Project Summary must have three separate section headers entitled "Overview", "Intellectual Merit", and "Broader Impacts"; each heading must be on its own line with no other text on that line. Within the Overview section, include a separate sub-section entitled "Proposed Vision".

The summary should be informative to those working in the same or related fields and understandable to a scientifically or technically literate reader. Full proposals that do not contain the Project Summary as described above will be returned without review.

Project Description: Maximum 26 pages, total, containing the following sections, not necessarily in this order. Figures and tables must be included within the 26-page limit.

Intellectual Merit and Broader Impacts: The intellectual merit and broader impacts of the ERC must be addressed and described throughout the narrative as an integral part of the Project Description. Between Sections IV and V, include a separate header for Broader Impacts, as specified below.

Outline for the Full Proposal Project Description (up to 26 pages)

BROADER IMPACTS ( Please note: The Project Description must include a separate section header labeled Broader Impacts and the heading must be on its own line with no other text on that line .)

VIII. Evaluation Plan

IX. Financial Support and Functional Allocation of Resources

X. Results from Prior NSF Support

The proposed vision for the ERC must be explained, with a discussion of the convergent engineering research theme and the anticipated societal impact. Explain the proposed transformative engineered system and the potential for impact on society, the engineering community and the greater scientific community.

Rationale: Make the case for why the proposed ERC is appropriate and why a convergent approach is needed for the targeted societal impact. Articulate why this vision cannot be realized with a series of individual investigators awards, the additional value of the proposed ERC compared with the sum of its parts.

The plan must clearly define the engineered system and describe how the features of the ERC will be integrated to achieve the vision, in particular the cohesive plan for involving participants at all levels in the four foundational components:

The Strategic Plan should include the high-level goals within each of these foundational components that will be described in more detail in later sections and the interrelationships among those goals, as well as the strategic role of partner institutions in integrating the foundation components and achieving these goals. The plan should also include the high-level expected progress of the ERC efforts across the 10-years of support in these four fundamental components, including ERC growth. The plan should further include discussions on the overarching convergent approach, the engagement of the stakeholder community, and the plans for convergent team formation. The ERC Strategic Plan should provide a roadmap with major milestones and describe how the ERC will know when it has been successful in meeting its goals. Finally, the ERC Strategic Plan should also articulate the logical reasoning that connects the proposed activities to the identified goals as well as the connections between the goals and the desired impacts expressed in the ERC Vision. The overall strategy must have the flexibility and the agility to evolve over time. An ERC needs to continually refine its vision based on a reliable feedback mechanism to focus on core advances, prune less compelling ERC elements, and refine as necessary the level of detail of its strategic plan over time.

Leadership Team: To properly address the four foundational components of the ERC, among the ERC Leadership Team, there must be identified individuals with: (a) deep expertise in the fundamental science/engineering areas envisioned by the ERC; (b) strategic leadership in innovation including intellectual property; (c) expertise in engineering workforce development and (d) experience in diversity and inclusion. Provide a chart summarizing the composition and expertise of the leadership team. Justify how each of the disciplines in this spectrum is needed for the convergent approach.

Management Plan: Proposals must include a management plan that describes the administration of the Center, including the functions of the leadership team, key personnel, and the role of any advisory committees, including the required Student Leadership Council and the Council of Deans, executive committee(s), and/or program committees or their equivalent. While the details of the structure are left to the proposers, the management structure should be designed to facilitate and integrate the ERC's critical and foundational components (CR, EWD, DCI, and IE). In addition, the proposed management plan should address the roles, authorities, and accountability for the leadership team that will ensure no bottlenecks in decision making.

Specifically, the successful proposal will delineate:

• The overall management and reporting structure of the ERC.
• Which personnel or groups will be responsible for CR, EWD, DCI, and IE. Please explain the relevant experience and expertise of these individuals and how they fit their assigned roles.
• These individuals should be included in the leadership team.
• An organizational chart, including advisory boards and the reporting/feedback loops involved.

The accompanying narrative for the organization chart should define the functional roles and responsibilities of each leadership position, and how these positions support the integrated strategic plan described earlier. It should also define the functional purpose of any additional advisory bodies that are deemed necessary to support the four foundational components, accomplish the proposed ERC vision, and achieve the desired long-term societal impact. Note that the functional roles of the two mandated ERC Advisory Bodies, the Council of Deans and the Student Leadership Council, are defined earlier in the section on Community Feedback. Since the quality of team member interaction is critical to team effectiveness, describe the managerial processes overlaying the organization chart that will be used to integrate the team. Please provide sufficient detail to allow critical evaluation.

Institutional Configuration: Describe the institutional configuration given the proposed vision for the ERC. Discuss the value added by each core partner university in meeting the goals of the four foundational components. Discuss the value added by any partnerships as described in the Key Elements of an ERC – Partners section.

IV. Convergent Research (CR)

ERCs are expected to have center-scale convergent engineering research that will support the ERC's overall potential for societal impact. The research program is the core of the ERC from which all ERC activities evolve.

Research Strategy: Clearly describe the proposed engineered system (a combination of components and elements that work together to perform a useful function) for the ERC. This section must include detailed research strategies, such as the 3-plane diagram (described below), research thrusts, and testbeds. A 10-year roadmap must illustrate the critical path, milestones, contributions from research projects, interdependence of research activities, short- and long-term deliverables, and overarching objectives in knowledge, technology, and proof of principle testbeds included in the ERC's vision. Impacts of the proposed research and technology outcomes on society, stakeholders, and the scientific and engineering communities must be included. Discuss how the research strategy will support the proposed societal impact of the ERC, including any potential negative consequences that would arise from the development of new technologies. Include risk mitigation strategies if appropriate. This section should also include strategies for building and maintaining teams appropriate for the proposed convergent approach and the process for starting, managing, and potentially ending research projects throughout the lifetime of the ERC. This section should clearly state what fundamental knowledge is expected within each thrust to advance the state of the art, including engineering as a whole discipline.

ERC 3-Plane Strategic Planning Chart: Identify and characterize interdependent research thrusts and activities at fundamental knowledge, enabling technology, and systems-level testbed(s) scales. Integration of research activities must be graphically depicted on a clearly legible version of the ERC Program's 3-Plane Strategic Planning Chart ( https://erc-assoc.org/content/strategic-planning-research-3-plane-chart ) that is tailored to the proposed ERC. The chart should be at least half a page, but a full page is recommended for legibility, as this chart is used at several stages of the NSF review process.

Research Thrusts: Each thrust description should start with a table that lists the thrust leader and other faculty/research participants by name, department, and institution. International partners, if any, who may be involved in the early stages of the thrust efforts must also be listed. Discuss the goals and objectives of the thrust vis-à-vis the goals of the ERC and the convergent research strategic plan and how these thrusts will support each other. Provide information on fundamental knowledge and technology deliverables. Identify the gaps and barriers the thrust will address in the context of the ERC's strategic plan. Discuss the convergent cross-disciplinary mix of expertise needed to achieve the goals of the thrust, as well as how the proposed team fulfills that need. Describe how future team building will support the convergent approach. Benchmark the research proposed for the thrust with respect to the state-of-the-art. Discuss the role of the thrust's research relative to the ERC's 3- Plane Strategic Planning Chart.

Project-level descriptions of specific research activities for each thrust must describe the proposed research and link it to the thrust goals. Describe a few exemplar projects in depth to allow judgment of the quality of the effort proposed, rather than superficially describing all projects. For these projects, provide examples of fundamental barriers the research will address, the need for a convergent approach, and project-level methods to address the barriers.

Demonstrate that the desired results constitute breakthroughs and are attainable in ten years. Discuss how projects support and integrate with other thrusts, enabling technologies, and systems-level testbeds in an overall convergent research approach.

Testbeds: Enabling- and systems-level testbeds must include a description of proposed proof-of-concept demonstration(s) in each testbed and personnel needed to construct and implement each proposed testbed. The research program budget should support technical staff to work with students and faculty to build these testbeds.

Note: NSF funds may not be used to support clinical trials. If the research involves vertebrate animals or includes human subjects, PAPPG requirements must be followed for the full proposal.

V. Engineering Workforce Development (EWD)

The ERC EWD program is driven by the future education, workforce development, and labor market needs relevant to the proposed Center. A proposed evidence-based program for building human capacity for the future engineering and technical workforce must be described. The proposed program should provide strategic goals for the ERC as well as targeted and specific outcomes related to workforce development and education.

Workforce Development occurs at all levels of the Center and provides opportunities for all ERC members including students, faculty, and external partners as appropriate. Proposed activities should logically lead to targeted outcomes and support diverse pathways and experiences for participants. Engineering workforce activities should contribute to a diverse, globally competitive, and team-oriented engineering workforce that has experience in convergent research, technology advancement, industrial practice, and innovation. Rather than a comprehensive set of training opportunities (general public, faculty, professional, vocational, graduate students, undergraduate students, and K-12), EWD programs should include a strategic selection of targeted activities that logically connect to each other and that will enable the long-term vision of the Center ERCs should leverage team and institutional expertise and resources to maximize impact with targeted activities.

At least 6 non-ERC students must enroll in a Research Experiences for Undergraduates (REU) program budgeted at a minimum of $80K per year from the ERC base budget, as well as at least 6 participants must be engaged in a Research Experiences for Teachers (RET) program budgeted at a minimum of $60K per year from the ERC base budget. Awarded ERCs are encouraged to submit proposals to the annual Research Experiences for Undergraduates (REU) Site and Research Experiences for Teachers (RET) Site competitions to expand the Center's workforce development impact. Partnerships with inner city, rural, or other high needs schools are especially encouraged, as is participation of the full spectrum of diverse talent in STEM. Suitable metrics to assess progress towards meeting the ERC's goals should be described, and feedback loops should be in place for continuous program improvement.

Describe how the leadership team will effectively support workforce development and educational programming and their growth. This section should also clearly describe how the proposed workforce development program will interact with existing educational or training systems at all partner institutions. Include a description of plans for engaging with partners, recruiting participants, and anticipated participant experiences. Educational partnerships may be leveraged to support the program and provide opportunities to engage with potential participants. All Engineering Workforce Development program participants, whether internal or external to the ERC, should have opportunities that are unique and would otherwise not be possible without the ERC.

VI. Diversity and Culture of Inclusion (DCI)

Describe the vision and plans for nurturing a culture that ensures participation of the full spectrum of diverse talent in STEM. A culture of inclusion has many important aspects that are essential for deep collaboration, including the participation of members from diverse scientific backgrounds and training which is necessary for true convergent research and innovation. A culture of inclusion must also foster participation of a diversity of partner institutions, including industry and practitioners, that will bring different perspectives to bear on the goals of the ERC. At least one core partner institution that enrolls and graduates a high percentage of underrepresented students in engineering and STEM fields must be included.

Describe preliminary ideas to create and nurture a culture that fosters the engagement of all ERC participants, including those from a diverse range of scientific backgrounds. This section should include evidence-based and intentional programming to support the inclusion of all talent that integrates and strengthen convergent research efforts across all institutions. Suitable metrics to assess the ERC's goals should be described, and feedback loops should be in place for independent assessment and continuous improvement in all dimensions of ERC operation.

In this section, describe how the leadership team will effectively create an inclusive culture for the ERC in which all members feel valued and welcomed, creatively contribute, and gain mutual benefit from participating. Include a description of plans for recruiting, mentoring, and retaining undergraduates, graduate students, and members of the research and leadership team from full spectrum of diverse talent in engineering. Describe the role of all partners, including plans to connect with ERC’s research and innovation goals in meaningful way, benefiting the students and faculty in the Center.

The ERC program is committed to including the participation of the full spectrum of diverse talent in STEM.

VII. Innovation Ecosystem (IE)

At its core, the innovation ecosystem is a network formed among trusted partners working together towards the common goal of creating and enhancing the capacity for innovation within the ecosystem.

In this section, discuss how the ERC will foster the creation of societal value from innovations (e.g., inventions, goods, services, businesses) that benefit society in a sustainable fashion (i.e., value creation). Identify the innovation ecosystem stakeholders relevant to realizing the proposed vision and societal impact.

Describe the strategy to form relationships with stakeholders to garner support for the Center's vision. Specifically, include the ERC's plans for developing and fostering industrial/practitioner memberships and involvement; technology transfer to member and non-member firms; if included, the role of university and state and local government as facilitators of entrepreneurship, civics, economic/workforce development and innovation; or regulatory agencies as influencers of the ERC innovation , end users or customers as beneficiaries of the ERC innovation, and plans for supporting translational research when appropriate.

To maximize positive social impact, any anticipated potential negative consequences caused by the introduction of the ERC technology should be addressed. In these cases, make sure to include stakeholder(s) that will work to mitigate the negative impacts, such as through consideration of regulation and ethics.

Provide a description of how the proposed member firms (e.g., innovation partners, facilitators, influencers, and beneficiaries) align to the proposed ERC's technology area. That is, as the ERC's research program evolves, note at which points in time in the ERC development over its 10-year lifespan different types of stakeholders engage with the ERC to enable success and create societal value. Some stakeholders may be engaged for the entire 10 years, and others may be involved with focused research activities at critical points in time (e.g., testbed development).

Discuss the integration of all stakeholders into the governance and operations of the ERC. Include a letter of collaboration ( please make sure to use the template provided in the PAPPG ) from each stakeholder that identifies their commitment to work with the ERC as described in the project description. The letters should be uploaded in the Supplementary Documents section.

Legal Frameworks: The different stakeholder groups/organizations/partners operate under very different legal frameworks that can make seamless collaboration difficult. Consequently, the ERC must work within the university structure to create an environment where the frameworks can be modified so that the different entities can come together for productive interaction. In advance of anyone joining the ERC, it is important to put in place legal agreements that protect the interests of the stakeholder entities and the university partners. Therefore, at a minimum, all ERCs require two legal frameworks to handle (1) intellectual property and (2) industry/practitioner membership agreements. The specifics of the ERC vision and the nature of the stakeholder community will determine whether additional legal frameworks are necessary.

• Intellectual Property: Describe the overall Intellectual Property (IP) strategy consistent with planned value creation in the ERC, and the corresponding management of the ERC IP across the lead and partner institutions and the approaches that will enable licensing of ERC's IP and/or adopting of other ERC outcomes. This plan must discuss management of possible conflicts-of-interest of any ERC researchers and the ERC's technology transfer endeavors. If an award is made, the IP policy must be prepared and submitted within 90 days of the award.
• Industry/Practitioner Membership Agreement: Discuss the terms of the draft membership agreement including the proposed fee structure and benefits. Describe the type(s) of support to be received. A letter of commitment (one page maximum for each) from each firm/practitioner organization committed to joining the ERC as a member and providing (cash and/or in-kind) support in the event that an award is made must be uploaded in Supplementary Documents.

Based on the goals and desired outcomes of the ERC strategic plan, a proposed evaluation plan is required that includes all four foundational components as well as a risk analysis . The purpose of ERC evaluation is to provide feedback on progress towards meeting Center goals. The evaluation plan should include formative aspects that allow the Center to make evidence-based decisions about changes in its activities and summative aspects to provide evidence of impact across all elements of the ERC. This section should include the evaluation questions, as well as, a description of the type of evaluation design and methods that will be used to address each question. This section should specify the mechanisms and timeline for how the results and recommendations from evaluation and assessment will be fed back into ERC goals, objectives, and milestones to ensure continual progress and attainment of goals, targets, and impacts during the project period. It should also identify the person(s) who will lead the ERC evaluation and briefly describe their academic training and professional experience that qualifies them to serve as an evaluator. Evaluator(s) may be internal or external to ERC institutions but should be positioned to carry out the evaluation plan as objectively as possible.

Awardees may be required to participate in program-level evaluation activities by which NSF can assess implementation processes and progress toward program level outcomes. NSF, an NSF contractor, or a grantee on behalf of NSF, may periodically conduct program evaluations or special projects that necessitate access to project level staff and data. This activity may occur at any time during the award period and could occur after NSF support has ended. ERC participation includes responding to inquiries, interview and other methods of common data collection and/or aggregation across ERCs. In addition, PIs and ERC evaluators may be asked to assist in developing program evaluation activities that will mutually benefit the agency and ERC participants.

Discuss the plans for financial and in-kind support from all sources, except cost sharing. Include plans for allocation of those resources to fulfill the goals of the ERC. Include a functional budget table, showing only the estimated proportional distribution of effort across the ERC in its first 5 years without showing the support levels from any sources. The table must not show the sources of support, since the reviewers cannot have access to the level of academic support. A template of the table can be found on bullet #3: http://erc-assoc.org/content/templates-proposal-preparation-0 .

This section of the proposal must also include a pie chart showing the allocation of resources and committed levels of support for the first five years from industrial or practitioner member firms and any additional non-member commitments from state and/or local governments for cash and/or in-kind support. A template of the table for Pie Chart Showing Allocation of Resources and Committed Levels of Support can be found on bullet #4: http://erc-assoc.org/content/templates-proposal-preparation-0 .

Provide a pie chart showing the planned distribution of the requested NSF funds for year one between the lead, each domestic partner university, and each university contributing affiliated faculty.

If the Director and Lead PI (if different) identified on the proposal have received prior NSF support, including any award with an end date in the past five years or current funding including any no-cost extensions, the intellectual merit and broader impacts accomplished under that award should be discussed. In cases where the Director and Lead PI have received more than one award (excluding amendments to existing awards), they should only report on the award that is most closely related to the proposal (for each, if the Director and Lead PI are different people) . See PAPPG II.D.2.iii for the required format of this section. Recommended length – no more than one page.

In addition, the proposal must also include these documents and information.

References Cited: See PAPPG for format guidelines.

Budgetary Information: Travel Funds for ERC Leadership Team's Participation in Biennial Meetings: Members of the ERC Leadership Team are required to participate in the ERC Biennial Meeting (typically held in odd years) and the cross- ERC Leadership Team retreats (which are typically held annually). The purpose of biennial meeting is to share successes and failures across the ERCs, receive updates on the ERC Program, and provide input for future ERC Program improvements. The purpose of the retreats is to focus on issues and best practices specific to the different leadership team groups. The biennial meetings are held in the Washington DC area for 2.5 days. Retreats are held in various locations for 1-2 days. Travel funds must be included in each annual budget to support participation in alternating biennial and leadership retreats for each person identified.

Note: The budget justification section should only identify items that are not cost shared. A justification and explanation of cost shared items needs to be appended to the cost sharing tables that are submitted in the single-copy documents section of the proposal.

Cost sharing is mandatory and is specific to the ERC solicitation . The percentage of cost share is determined using the Cost Sharing Formula in the Budgetary Information section of this solicitation. Lead and core partner institutions are responsible for cost share on their entire portion of NSF funds, including sub-awards from their institutions to affiliate partners or other payees. Please see the Budgetary Information section of this solicitation for additional information.

Facilities, Equipment and Other Resources . In this section, please include ONLY facilities, equipment, and personnel that are directly relevant and unique to the proposed ERC. Briefly discuss such laboratories, facilities, cyberinfrastructure, personnel, and equipment, particularly those shared by the ERC team members. Distinguish existing facilities and equipment from any that will be acquired by the ERC (see PAPPG Chapter II.C.2.i). Space must be identified on the campus of the lead academic institution for the ERC headquarters. Describe the headquarters, including the size, functionality, and features. Discuss how the cyberinfrastructure, facilities, and equipment of the ERC will be used to form and sustain a collaborative ERC team with shared resources and information.

Letters of commitment should be included in the supplementary documents for facilities, equipment, etc. that are being provided by institutions or collaborators which are not from the lead institution or the core partners.

Senior/Key Personnel Documents

In accordance with the guidance in the PAPPG, the following information must be provided for all individuals designated as Senior/Key Personnel. This includes the Lead PI, Center Director if different from the Lead PI, co-PIs, all members of the ERC Leadership Team and key faculty.

• Biographical Sketch
• Current and Pending (Other) Support
• Collaborators & Other Affiliations Information
• Synergistic Activities

Supplementary Documents . In addition to the requirements contained in the PAPPG, the following items must be provided as supplementary documents.

Table of Academic/Other Participants and Industrial/Practitioner Members: The table should be created using the table format available on the ERC Association website on bullet #5 at: http://erc-assoc.org/content/templates-proposal-preparation-0 . Download and use the Word file named " ERC Participants Table Template for Inclusion in Full Proposal. " Provide all the required information in each section of the table.

Letters of Commitment : These letters should express commitment, but should not praise or advocate for the project, and must follow the format for letters of collaboration given in the PAPPG. Submit the following required letters as indicated:

• Lead university: Senior university administrators (Dean of Engineering plus one other higher-level university official) for the lead university attesting to the institutional commitment to the goals of the ERC and a commitment to headquarters space in both letters. The letters should not mention cost sharing, as that information cannot be revealed to reviewers. The letters should indicate the institutional commitment to all major aspects of the ERC, including each of the four foundational components, and assure the development of a cross-ERC IP policy within 90 days, if an award is made.
• Each Core Partner University: A senior administrator (Dean or equivalent) attests to the partner's institutional commitment to the goals of the ERC.
• If applicable, officials from any participating federal laboratories indicating their involvement in the ERC and their commitment to provide support for their staff participating in the ERC.
• Member Organizations: A letter of commitment (one page maximum for each) from each firm/practitioner organization committed to joining the ERC as a member and providing (cash and/or in-kind) support.

Letters of Collaboration

The following Letters of Collaboration are required if applicable to the proposed ERC. These letters should state generic willingness to collaborate, but should not provide specific details on types or amounts of contributions and must follow the format for letters of collaboration given in the PAPPG:

• Officials of firms and agencies able to commit to membership.
• An administrator of each proposed pre-college or community college partners committing to their roles in the ERC as described in the Project Description.
• State or local government agencies and other organizations committed to partnership with the ERC.
• Domestic affiliated facult y if their projects are planned to be in place during years one through five. Note that no letters are required from the administrators of the universities providing affiliated faculty.
• Foreign collaborators , if any.

All letters should be addressed to:

ERC Program

Division of Engineering Education and Centers

U.S. National Science Foundation

All signed letters must be scanned and uploaded in the Other Supplementary Documents section of the proposal. Please instruct the letter writers not to mail, email, or fax copies to the NSF, as they will not be considered.

Draft Membership Agreement . Submit draft industry/practitioner membership agreement.

Data Management and Sharing Plan . Provide a Data Management and Sharing Plan according to guidance in the PAPPG. Go to ENG Data Management Plans | NSF - National Science Foundation ( https://www.nsf.gov/eng/general/dmp.jsp ) for Engineering-specific guidance.

Mentoring Plan . If applicable, provide a mentoring plan for postdoctoral scholars or graduate students who will be supported by ERC funds.

Single Copy Documents . Viewable only by NSF (also refer to the PAPPG Chapter II.C.1 on "Single-Copy Documents" for additional information):

Optional List of Suggested Reviewers or Reviewers Not to Include: Proposers may include in the single copy documents section a list of suggested reviewers who they believe are especially well qualified to review the proposal. Proposers also may designate persons they would prefer not to review the ERC proposal, indicating why. These suggestions are optional. PAPPG Exhibit II-2 contains information on conflicts of interest that may be useful in the preparation of this list. The cognizant Program Officer handling the proposal considers the suggestions and may contact the proposer for further information. However, the decision whether to use the suggestions remains with the Program Officer.

Required Cost Sharing Tables and Justification: Complete and submit the following tables: " Committed Cash and In-Kind Academic Support, Years 1-5 " and, if applicable, a table showing the " Nature of In-Kind Support " identifying any in-kind commitments and the sources of the commitments. A template of those tables can be found at (bullet #6): http://erc-assoc.org/content/templates-proposal-preparation-0 . The tables should be uploaded into the single copy documents section of the full proposal. Appended to the cost sharing tables will be a justification/explanation of the source, nature, amount, and availability of any proposed cost sharing. The Proposers are directed not to include these tables and the cost sharing justification in any other part of the proposal, as cost sharing commitments are not provided to the reviewers. Refer to the section on Budgetary Information and Cost Sharing in this solicitation for information on cost sharing requirements and policies.

Proposal Update: If the proposed ERC is evaluated by a Site Visit Team (SVT), a 10-page reply that integrates changes in the proposed ERC based on comments from the SVT members and the Site Visit Report will be requested to facilitate the final stages of the review process.

INVITED FULL PROPOSAL REQUIREMENTS

(Note: This is NOT a total list of the ERC proposal requirements. Refer to the ERC Solicitation and the PAPPG for complete requirements).

Post Proposal Submission to NSF: Other Required Documents

Cost Sharing:

Cost Sharing is required.

Invited full proposals will include a budget for each of the five years. Research.gov or Grants.gov will automatically provide a cumulative budget. Provide separate budgets for subawards to the domestic core partner institutions and any affiliated institutions whose faculty and students would be supported by the ERC's budget. Allowable budgets for the first five years are as follows: The budget for year one may be no more than $3,500,000, no more than $4,500,000 for year two, no more than $6,000,000 for year three, no more than $6,000,000 for year four, and for year five.

Cost Sharing: Mandatory Cost Sharing is required but inclusion of voluntary committed cost sharing is prohibited.

Mandatory Cost Sharing Requirements and Policies: Cost sharing is required of the lead university and core partner university(ies) to support and sustain the ERC. Cost sharing is not a review criterion for the ERCs; it is an eligibility criterion. Because cost sharing is not a review criterion, details on cost sharing will not be shared with the reviewers.

Upon issuance of the award, the lead university is responsible to secure, retain, manage, and certify to NSF the ERC cost sharing (cash and in-kind), at the level stated in the cooperative agreement. The total level of cost sharing proposed must be calculated using the "Cost Sharing Formula" below.

Cost sharing must not exceed the mandatory level stated in the ERC cost sharing formula. This would be considered "voluntary committed cost sharing" which is specifically prohibited according to NSF's cost sharing policies. ERC proposals that include cost sharing amounts in excess of the specified formula will be returned without review or declined.

Instructions for Disclosure and Non-Disclosure of Cost Sharing within the Proposal:

Cost Sharing and Letters of Commitment: Since cost sharing is not to be seen or considered by reviewers, any letters of commitment should not mention any cost sharing (cash or in-kind), since the reviewers will see these letters. See Section V.A for details concerning the letters of commitment.

Cost Sharing in the Budget Submission: The proposed cost sharing (including the estimated value of any in-kind cost sharing), according to the formula below, must be shown on Line M of the NSF proposal budget form. (Line M is masked from reviewers.)

Cumulative cost sharing should be entered for all 5 years on Line M of the first-year budget. Do not include the cost sharing figures on Line M of the budget for years 2-5. Do not include the justification / explanation for any cost-shared items in the budget justification section of the proposal. Only the non-cost shared items should be explained in the budget justification section, identifying the source, nature, amount and availability of non-cost shared items.

Cost Sharing Tables and Justification: The cost sharing commitment of the ERC must be documented in the proposal and the details presented in the tables of committed support. The lead institution is instructed to provide a table of "Committed Cash and In-Kind Academic Support, Years 1-5" (including any partner university providing cash for years 1-5). Proposers must also complete the table "Nature of In-Kind Support" identifying in-kind commitments and the sources of the commitments. A template of those tables can be found at (bullet #6) http://erc-assoc.org/content/templates-proposal-preparation-0 . The tables should be uploaded into the "Single Copy Documents" section of the proposal. Append to the cost sharing tables a justification / explanation of the source, nature, amount and availability of any proposed cost sharing. Do not include these tables and the cost sharing justification in any other part of the proposal, as cost sharing commitments are not to be provided to reviewers.

Cost Sharing Formula:

ERC cost sharing requirements are determined based on classification at the time of the LOI submission deadline as defined in the "Carnegie Foundation's Classification of Institutions of Higher Education." Limited financial resources at smaller colleges and universities that lack high research activity may present significant challenges to cost sharing. Therefore:

• RU/VH: Research Universities - required cost sharing level is 20% of the allocation of the NSF budget to the lead or core partner university;
• RU/H: Research Universities - required cost sharing level is 15% of the allocation of the NSF budget to the lead or core partner university;
• DRU: Doctoral/Research Universities - cost sharing level is 10% of the allocation of the NSF budget to that core partner university.
• Master's L: Master's Colleges and Universities - cost sharing level is 10% of the allocation of the NSF budget to that core partner university/college;
• Bac/Diverse: Baccalaureate Colleges--Diverse Fields - cost sharing level is 5% of the allocation of the NSF budget to that core partner college.

If the university is classified in more than one Carnegie category, it must cost share at the highest cost sharing category as described above. The Carnegie classification shall remain throughout the duration of the competition and any subsequent award. The total ERC cost share shall be 20% or less, depending upon the Carnegie classifications for each of the partners.

ERC Support Cost-Sharing Sources:

The proposed cost sharing must be shown on Line M on the proposal budget. For purposes of budget preparation, the cumulative cost sharing amount must be entered on Line M of the first year’s budget. Should an award be made, the organization’s cost sharing commitment, as specified on the first year’s approved budget, must be met prior to award expiration.

Such cost sharing will be an eligibility, rather than a review criterion. Proposers are advised not to exceed the mandatory cost sharing level or amount specified in the solicitation.

When mandatory cost sharing is included on Line M, and accepted by the Foundation, the commitment of funds becomes legally binding and is subject to audit. When applicable, the estimated value of any in-kind contributions also should be included on Line M. An explanation of the source, nature, amount and availability of any proposed cost sharing must be provided in the budget justification. Contributions may be made from any non-Federal source, including non-Federal grants or contracts, and may be cash or in-kind. 2 CFR § 200.306 describes criteria and procedures for the allowability of cash and in-kind contributions in satisfying cost sharing and matching requirements. It should be noted that contributions derived from other Federal funds or counted as cost sharing toward projects of another Federal agency must not be counted towards meeting the specific cost sharing requirements of the NSF award.

Failure to provide the level of cost sharing required by the NSF solicitation and reflected in the NSF award budget may result in termination of the NSF award, disallowance of award costs and/or refund of award funds to NSF by the awardee.

The overall ERC-level budget should be prepared to assure sufficient funding from all sources to achieve the goals of the ERC. Hence, this budget would include faculty and staff to support the research, education, diversity and culture of inclusion, industrial collaboration/innovation, and management of the ERC. Budgets should include resources for reporting, site visit costs, and travel for cross-ERC collaboration and NSF meetings. The budget submitted to NSF will include an allocation plan for the NSF funding only.

     May 09, 2025

D. Research.gov/Grants.gov Requirements

For Proposals Submitted Via Research.gov:

To prepare and submit a proposal via Research.gov, see detailed technical instructions available at: https://www.research.gov/research-portal/appmanager/base/desktop?_nfpb=true&_pageLabel=research_node_display&_nodePath=/researchGov/Service/Desktop/ProposalPreparationandSubmission.html . For Research.gov user support, call the Research.gov Help Desk at 1-800-381-1532 or e-mail [email protected] . The Research.gov Help Desk answers general technical questions related to the use of the Research.gov system. Specific questions related to this program solicitation should be referred to the NSF program staff contact(s) listed in Section VIII of this funding opportunity.

For Proposals Submitted Via Grants.gov:

Before using Grants.gov for the first time, each organization must register to create an institutional profile. Once registered, the applicant's organization can then apply for any federal grant on the Grants.gov website. Comprehensive information about using Grants.gov is available on the Grants.gov Applicant Resources webpage: https://www.grants.gov/applicants . In addition, the NSF Grants.gov Application Guide (see link in Section V.A) provides instructions regarding the technical preparation of proposals via Grants.gov. For Grants.gov user support, contact the Grants.gov Contact Center at 1-800-518-4726 or by email: [email protected] . The Grants.gov Contact Center answers general technical questions related to the use of Grants.gov. Specific questions related to this program solicitation should be referred to the NSF program staff contact(s) listed in Section VIII of this solicitation.

Submitting the Proposal: Once all documents have been completed, the Authorized Organizational Representative (AOR) must submit the application to Grants.gov and verify the desired funding opportunity and agency to which the application is submitted. The AOR must then sign and submit the application to Grants.gov. The completed application will be transferred to Research.gov for further processing.

The NSF Grants.gov Proposal Processing in Research.gov informational page provides submission guidance to applicants and links to helpful resources including the NSF Grants.gov Application Guide , Grants.gov Proposal Processing in Research.gov how-to guide , and Grants.gov Submitted Proposals Frequently Asked Questions . Grants.gov proposals must pass all NSF pre-check and post-check validations in order to be accepted by Research.gov at NSF.

When submitting via Grants.gov, NSF strongly recommends applicants initiate proposal submission at least five business days in advance of a deadline to allow adequate time to address NSF compliance errors and resubmissions by 5:00 p.m. submitting organization's local time on the deadline. Please note that some errors cannot be corrected in Grants.gov. Once a proposal passes pre-checks but fails any post-check, an applicant can only correct and submit the in-progress proposal in Research.gov.

Proposers that submitted via Research.gov may use Research.gov to verify the status of their submission to NSF. For proposers that submitted via Grants.gov, until an application has been received and validated by NSF, the Authorized Organizational Representative may check the status of an application on Grants.gov. After proposers have received an e-mail notification from NSF, Research.gov should be used to check the status of an application.

VI. NSF Proposal Processing And Review Procedures

Proposals received by NSF are assigned to the appropriate NSF program for acknowledgement and, if they meet NSF requirements, for review. All proposals are carefully reviewed by a scientist, engineer, or educator serving as an NSF Program Officer, and usually by three to ten other persons outside NSF either as ad hoc reviewers, panelists, or both, who are experts in the particular fields represented by the proposal. These reviewers are selected by Program Officers charged with oversight of the review process. Proposers are invited to suggest names of persons they believe are especially well qualified to review the proposal and/or persons they would prefer not review the proposal. These suggestions may serve as one source in the reviewer selection process at the Program Officer's discretion. Submission of such names, however, is optional. Care is taken to ensure that reviewers have no conflicts of interest with the proposal. In addition, Program Officers may obtain comments from site visits before recommending final action on proposals. Senior NSF staff further review recommendations for awards. A flowchart that depicts the entire NSF proposal and award process (and associated timeline) is included in PAPPG Exhibit III-1.

A comprehensive description of the Foundation's merit review process is available on the NSF website at: https://www.nsf.gov/bfa/dias/policy/merit_review/ .

Proposers should also be aware of core strategies that are essential to the fulfillment of NSF's mission, as articulated in Leading the World in Discovery and Innovation, STEM Talent Development and the Delivery of Benefits from Research - NSF Strategic Plan for Fiscal Years (FY) 2022 - 2026 . These strategies are integrated in the program planning and implementation process, of which proposal review is one part. NSF's mission is particularly well-implemented through the integration of research and education and broadening participation in NSF programs, projects, and activities.

One of the strategic objectives in support of NSF's mission is to foster integration of research and education through the programs, projects, and activities it supports at academic and research institutions. These institutions must recruit, train, and prepare a diverse STEM workforce to advance the frontiers of science and participate in the U.S. technology-based economy. NSF's contribution to the national innovation ecosystem is to provide cutting-edge research under the guidance of the Nation's most creative scientists and engineers. NSF also supports development of a strong science, technology, engineering, and mathematics (STEM) workforce by investing in building the knowledge that informs improvements in STEM teaching and learning.

NSF's mission calls for the broadening of opportunities and expanding participation of groups, institutions, and geographic regions that are underrepresented in STEM disciplines, which is essential to the health and vitality of science and engineering. NSF is committed to this principle of diversity and deems it central to the programs, projects, and activities it considers and supports.

A. Merit Review Principles and Criteria

The National Science Foundation strives to invest in a robust and diverse portfolio of projects that creates new knowledge and enables breakthroughs in understanding across all areas of science and engineering research and education. To identify which projects to support, NSF relies on a merit review process that incorporates consideration of both the technical aspects of a proposed project and its potential to contribute more broadly to advancing NSF's mission "to promote the progress of science; to advance the national health, prosperity, and welfare; to secure the national defense; and for other purposes." NSF makes every effort to conduct a fair, competitive, transparent merit review process for the selection of projects.

1. Merit Review Principles

These principles are to be given due diligence by PIs and organizations when preparing proposals and managing projects, by reviewers when reading and evaluating proposals, and by NSF program staff when determining whether or not to recommend proposals for funding and while overseeing awards. Given that NSF is the primary federal agency charged with nurturing and supporting excellence in basic research and education, the following three principles apply:

• All NSF projects should be of the highest quality and have the potential to advance, if not transform, the frontiers of knowledge.
• NSF projects, in the aggregate, should contribute more broadly to achieving societal goals. These "Broader Impacts" may be accomplished through the research itself, through activities that are directly related to specific research projects, or through activities that are supported by, but are complementary to, the project. The project activities may be based on previously established and/or innovative methods and approaches, but in either case must be well justified.
• Meaningful assessment and evaluation of NSF funded projects should be based on appropriate metrics, keeping in mind the likely correlation between the effect of broader impacts and the resources provided to implement projects. If the size of the activity is limited, evaluation of that activity in isolation is not likely to be meaningful. Thus, assessing the effectiveness of these activities may best be done at a higher, more aggregated, level than the individual project.

With respect to the third principle, even if assessment of Broader Impacts outcomes for particular projects is done at an aggregated level, PIs are expected to be accountable for carrying out the activities described in the funded project. Thus, individual projects should include clearly stated goals, specific descriptions of the activities that the PI intends to do, and a plan in place to document the outputs of those activities.

These three merit review principles provide the basis for the merit review criteria, as well as a context within which the users of the criteria can better understand their intent.

2. Merit Review Criteria

All NSF proposals are evaluated through use of the two National Science Board approved merit review criteria. In some instances, however, NSF will employ additional criteria as required to highlight the specific objectives of certain programs and activities.

The two merit review criteria are listed below. Both criteria are to be given full consideration during the review and decision-making processes; each criterion is necessary but neither, by itself, is sufficient. Therefore, proposers must fully address both criteria. (PAPPG Chapter II.C.2.d(i). contains additional information for use by proposers in development of the Project Description section of the proposal). Reviewers are strongly encouraged to review the criteria, including PAPPG Chapter II.C.2.d(i), prior to the review of a proposal.

When evaluating NSF proposals, reviewers will be asked to consider what the proposers want to do, why they want to do it, how they plan to do it, how they will know if they succeed, and what benefits could accrue if the project is successful. These issues apply both to the technical aspects of the proposal and the way in which the project may make broader contributions. To that end, reviewers will be asked to evaluate all proposals against two criteria:

• Intellectual Merit: The Intellectual Merit criterion encompasses the potential to advance knowledge; and
• Broader Impacts: The Broader Impacts criterion encompasses the potential to benefit society and contribute to the achievement of specific, desired societal outcomes.

The following elements should be considered in the review for both criteria:

• Advance knowledge and understanding within its own field or across different fields (Intellectual Merit); and
• Benefit society or advance desired societal outcomes (Broader Impacts)?
• To what extent do the proposed activities suggest and explore creative, original, or potentially transformative concepts?
• Is the plan for carrying out the proposed activities well-reasoned, well-organized, and based on a sound rationale? Does the plan incorporate a mechanism to assess success?
• How well qualified is the individual, team, or organization to conduct the proposed activities?
• Are there adequate resources available to the PI (either at the home organization or through collaborations) to carry out the proposed activities?

Broader impacts may be accomplished through the research itself, through the activities that are directly related to specific research projects, or through activities that are supported by, but are complementary to, the project. NSF values the advancement of scientific knowledge and activities that contribute to achievement of societally relevant outcomes. Such outcomes include, but are not limited to: full participation of women, persons with disabilities, and other underrepresented groups in science, technology, engineering, and mathematics (STEM); improved STEM education and educator development at any level; increased public scientific literacy and public engagement with science and technology; improved well-being of individuals in society; development of a diverse, globally competitive STEM workforce; increased partnerships between academia, industry, and others; improved national security; increased economic competitiveness of the United States; and enhanced infrastructure for research and education.

Proposers are reminded that reviewers will also be asked to review the Data Management Plan and the Postdoctoral Researcher Mentoring Plan, as appropriate.

Additional Solicitation Specific Review Criteria

PRELIMINARY Proposal Additional Review Criteria:

Reviewers should consider these high-level questions:

How well does the preliminary proposal narrative address the following in the project description?

• What is the compelling new idea and what is the potential high societal impact?
• What is the engineered system? Is it high-risk but high payoff?
• Is the 3-plane chart well-conceived and justified?
• How does the proposed Center's research benchmark against the state-of-the-art?
• What is the proposed management structure for the ERC? How will the proposed organization and management structure integrate and implement the four foundational components (CR, EWD, DCI, and IE) and foster team-formation?
• Does the proposed ERC create an inclusive environment where all the ERC participants learn to work on a team towards a common goal?

FULL Proposal Additional Review Criteria:

• What is the engineered system?
• Why is the proposed vision compelling?
• Why is the proposed research competitive when benchmarked against the state-of-the-art?
• How well does the proposed ERC justify the need for a center or institute-like approach?

High Societal Impact

• What is the potential for high societal impact?
• How realistic is the proposed plan for high societal impact?
• If the proposed strategy is high-risk does the potential payoff from anticipated impacts justify the investment?

Convergence Research

• Does the proposed research require a convergent approach and is its implementation well documented?
• How well justified is the argument that convergence is necessary for the desired impact?
• How well has the convergent approach been fully integrated into the proposal?
• What is the likelihood the research will lead to significant fundamental advances, new discoveries, and technological developments?
• How well does the proposed research use the testbeds to integrate and to advance proofs-of-concept to achieve the proposed vision?
• Are there well-defined implementation milestones for convergence research?

Stakeholder Engagement

• Are effective mechanisms to gather, engage, and implement feedback from appropriate stakeholders in place (i.e., collaborators, supporters, advisory boards, external committees)?

Team Formation

• How does the team formation and the implementation of team science support the proposed convergent research?
• How well has the ERC demonstrated strategies to overcome barriers for effective, dynamic teaming?

Strategic Plan

• How well does the Center present an integrated strategic plan for the ERC to address the key elements of each foundational component and their integration?
• How well does the proposal present an appropriate and compelling management structure and plan to carry out Center activities?

Management and Organization

• How appropriate are the qualifications of proposed leadership and management team?
• How well does the proposal present appropriate and compelling management structure and plan to carry out Center activities?
• Are effective mechanisms to gather and implement feedback from appropriate stakeholders in place, including advisory boards and external committees?

Engineering Workforce Development

• To what extent is the proposed program coherent and aligned with the overall goals and vision of the ERC?
• Do the proposed Engineering Workforce Development plans include appropriate strategies for recruiting participants and engaging with partners?
• Are the proposed Engineering Workforce Development plans evidence-based and likely to achieve the desired experiences, outcomes, and impact described?

Diversity and Culture of Inclusion

• How well does the discussion include a clear strategy to support Diversity and Culture of Inclusion?
• To what extent does the program propose evidence-based approaches for Diversity and Culture of Inclusion that are integrated with all dimensions of ERC operation?
• How well does the management plan include clear accountability for Diversity and Culture of Inclusion aspects of the ERC across all partners?

Innovation Ecosystem

• How well does the proposal describe a plan to build a network of trusted partners for innovation capacity?
• How appropriate is the proposed structure and processes for value creation to move from ideation to implementation?

Evaluation Plan

• How well has the Center developed a logic evaluation framework to guide the implementation of the strategic plan and evaluate Center performance?
• How well does the evaluation plan include formative aspects that allow the Center to make evidence-based decisions about changes in its activities and summative aspects to provide evidence of impact across all elements of the Center?

Financial Support and Resources

• Are the estimated budget allocations reasonable to achieve the proposed ERC vision?
• Does the Center have adequate capital (i.e., facilities, equipment, cyberinfrastructure) and procedural (i.e., safety, environmental) resources?
• Does the Center have a convincing plan for data sharing and management?

B. Review and Selection Process

Proposals submitted in response to this program solicitation will be reviewed by

Ad hoc Review and/or Panel Review, Site Visit Review, or Reverse Site Review.

For Additional Review Criteria (see above listing)

Reviewers will be asked to evaluate proposals using two National Science Board approved merit review criteria and, if applicable, additional program specific criteria. A summary rating and accompanying narrative will generally be completed and submitted by each reviewer and/or panel. The Program Officer assigned to manage the proposal's review will consider the advice of reviewers and will formulate a recommendation.

After scientific, technical and programmatic review and consideration of appropriate factors, the NSF Program Officer recommends to the cognizant Division Director whether the proposal should be declined or recommended for award. NSF strives to be able to tell proposers whether their proposals have been declined or recommended for funding within six months. Large or particularly complex proposals or proposals from new recipients may require additional review and processing time. The time interval begins on the deadline or target date, or receipt date, whichever is later. The interval ends when the Division Director acts upon the Program Officer's recommendation.

After programmatic approval has been obtained, the proposals recommended for funding will be forwarded to the Division of Grants and Agreements or the Division of Acquisition and Cooperative Support for review of business, financial, and policy implications. After an administrative review has occurred, Grants and Agreements Officers perform the processing and issuance of a grant or other agreement. Proposers are cautioned that only a Grants and Agreements Officer may make commitments, obligations or awards on behalf of NSF or authorize the expenditure of funds. No commitment on the part of NSF should be inferred from technical or budgetary discussions with a NSF Program Officer. A Principal Investigator or organization that makes financial or personnel commitments in the absence of a grant or cooperative agreement signed by the NSF Grants and Agreements Officer does so at their own risk.

Once an award or declination decision has been made, Principal Investigators are provided feedback about their proposals. In all cases, reviews are treated as confidential documents. Verbatim copies of reviews, excluding the names of the reviewers or any reviewer-identifying information, are sent to the Principal Investigator/Project Director by the Program Officer. In addition, the proposer will receive an explanation of the decision to award or decline funding.

VII. Award Administration Information

A. notification of the award.

Notification of the award is made to the submitting organization by an NSF Grants and Agreements Officer. Organizations whose proposals are declined will be advised as promptly as possible by the cognizant NSF Program administering the program. Verbatim copies of reviews, not including the identity of the reviewer, will be provided automatically to the Principal Investigator. (See Section VI.B. for additional information on the review process.)

B. Award Conditions

An NSF award consists of: (1) the award notice, which includes any special provisions applicable to the award and any numbered amendments thereto; (2) the budget, which indicates the amounts, by categories of expense, on which NSF has based its support (or otherwise communicates any specific approvals or disapprovals of proposed expenditures); (3) the proposal referenced in the award notice; (4) the applicable award conditions, such as Grant General Conditions (GC-1)*; or Research Terms and Conditions* and (5) any announcement or other NSF issuance that may be incorporated by reference in the award notice. Cooperative agreements also are administered in accordance with NSF Cooperative Agreement Financial and Administrative Terms and Conditions (CA-FATC) and the applicable Programmatic Terms and Conditions. NSF awards are electronically signed by an NSF Grants and Agreements Officer and transmitted electronically to the organization via e-mail.

*These documents may be accessed electronically on NSF's Website at https://www.nsf.gov/awards/managing/award_conditions.jsp?org=NSF . Paper copies may be obtained from the NSF Publications Clearinghouse, telephone (703) 292-8134 or by e-mail from [email protected] .

More comprehensive information on NSF Award Conditions and other important information on the administration of NSF awards is contained in the NSF Proposal & Award Policies & Procedures Guide (PAPPG) Chapter VII, available electronically on the NSF Website at https://www.nsf.gov/publications/pub_summ.jsp?ods_key=pappg .

Administrative and National Policy Requirements

Build America, Buy America

As expressed in Executive Order 14005, Ensuring the Future is Made in All of America by All of America’s Workers (86 FR 7475), it is the policy of the executive branch to use terms and conditions of Federal financial assistance awards to maximize, consistent with law, the use of goods, products, and materials produced in, and services offered in, the United States.

Consistent with the requirements of the Build America, Buy America Act (Pub. L. 117-58, Division G, Title IX, Subtitle A, November 15, 2021), no funding made available through this funding opportunity may be obligated for an award unless all iron, steel, manufactured products, and construction materials used in the project are produced in the United States. For additional information, visit NSF’s Build America, Buy America webpage.

Special Award Conditions:

TBD - Programmatic Terms and Conditions: TBD - Financial and Administrative Terms and Conditions:

C. Reporting Requirements

For all multi-year grants (including both standard and continuing grants), the Principal Investigator must submit an annual project report to the cognizant Program Officer no later than 90 days prior to the end of the current budget period. (Some programs or awards require submission of more frequent project reports). No later than 120 days following expiration of a grant, the PI also is required to submit a final annual project report, and a project outcomes report for the general public.

Failure to provide the required annual or final annual project reports, or the project outcomes report, will delay NSF review and processing of any future funding increments as well as any pending proposals for all identified PIs and co-PIs on a given award. PIs should examine the formats of the required reports in advance to assure availability of required data.

PIs are required to use NSF's electronic project-reporting system, available through Research.gov, for preparation and submission of annual and final annual project reports. Such reports provide information on accomplishments, project participants (individual and organizational), publications, and other specific products and impacts of the project. Submission of the report via Research.gov constitutes certification by the PI that the contents of the report are accurate and complete. The project outcomes report also must be prepared and submitted using Research.gov. This report serves as a brief summary, prepared specifically for the public, of the nature and outcomes of the project. This report will be posted on the NSF website exactly as it is submitted by the PI.

More comprehensive information on NSF Reporting Requirements and other important information on the administration of NSF awards is contained in the NSF Proposal & Award Policies & Procedures Guide (PAPPG) Chapter VII, available electronically on the NSF Website at https://www.nsf.gov/publications/pub_summ.jsp?ods_key=pappg .

NSF requires ERCs to submit annual reports that are more extensive in scope than those required of single investigator awards. NSF provides guidelines for these reports. NSF also requires ERCs to collect and submit to NSF data on indicators of progress, outcome, impact, and financial management. NSF provides data definition guidelines and templates for the recording and submission of these data through a secure web site.

VIII. Agency Contacts

Please note that the program contact information is current at the time of publishing. See program website for any updates to the points of contact.

General inquiries regarding this program should be made to:

For questions related to the use of NSF systems contact:

• NSF Help Desk: 1-800-381-1532
• Research.gov Help Desk e-mail: [email protected]

For questions relating to Grants.gov contact:

Grants.gov Contact Center: If the Authorized Organizational Representatives (AOR) has not received a confirmation message from Grants.gov within 48 hours of submission of application, please contact via telephone: 1-800-518-4726; e-mail: [email protected] .

IX. Other Information

The NSF website provides the most comprehensive source of information on NSF Directorates (including contact information), programs and funding opportunities. Use of this website by potential proposers is strongly encouraged. In addition, "NSF Update" is an information-delivery system designed to keep potential proposers and other interested parties apprised of new NSF funding opportunities and publications, important changes in proposal and award policies and procedures, and upcoming NSF Grants Conferences . Subscribers are informed through e-mail or the user's Web browser each time new publications are issued that match their identified interests. "NSF Update" also is available on NSF's website .

Grants.gov provides an additional electronic capability to search for Federal government-wide grant opportunities. NSF funding opportunities may be accessed via this mechanism. Further information on Grants.gov may be obtained at https://www.grants.gov .

About The National Science Foundation

The National Science Foundation (NSF) is an independent Federal agency created by the National Science Foundation Act of 1950, as amended (42 USC 1861-75). The Act states the purpose of the NSF is "to promote the progress of science; [and] to advance the national health, prosperity, and welfare by supporting research and education in all fields of science and engineering."

NSF funds research and education in most fields of science and engineering. It does this through grants and cooperative agreements to more than 2,000 colleges, universities, K-12 school systems, businesses, informal science organizations and other research organizations throughout the US. The Foundation accounts for about one-fourth of Federal support to academic institutions for basic research.

NSF receives approximately 55,000 proposals each year for research, education and training projects, of which approximately 11,000 are funded. In addition, the Foundation receives several thousand applications for graduate and postdoctoral fellowships. The agency operates no laboratories itself but does support National Research Centers, user facilities, certain oceanographic vessels and Arctic and Antarctic research stations. The Foundation also supports cooperative research between universities and industry, US participation in international scientific and engineering efforts, and educational activities at every academic level.

Facilitation Awards for Scientists and Engineers with Disabilities (FASED) provide funding for special assistance or equipment to enable persons with disabilities to work on NSF-supported projects. See the NSF Proposal & Award Policies & Procedures Guide Chapter II.F.7 for instructions regarding preparation of these types of proposals.

The National Science Foundation has Telephonic Device for the Deaf (TDD) and Federal Information Relay Service (FIRS) capabilities that enable individuals with hearing impairments to communicate with the Foundation about NSF programs, employment or general information. TDD may be accessed at (703) 292-5090 and (800) 281-8749, FIRS at (800) 877-8339.

The National Science Foundation Information Center may be reached at (703) 292-5111.

The National Science Foundation promotes and advances scientific progress in the United States by competitively awarding grants and cooperative agreements for research and education in the sciences, mathematics, and engineering. To get the latest information about program deadlines, to download copies of NSF publications, and to access abstracts of awards, visit the NSF Website at 2415 Eisenhower Avenue, Alexandria, VA 22314 (NSF Information Center) (703) 292-5111 (703) 292-5090 Send an e-mail to: or telephone: (703) 292-8134 (703) 292-5111 Privacy Act And Public Burden Statements The information requested on proposal forms and project reports is solicited under the authority of the National Science Foundation Act of 1950, as amended. The information on proposal forms will be used in connection with the selection of qualified proposals; and project reports submitted by proposers will be used for program evaluation and reporting within the Executive Branch and to Congress. The information requested may be disclosed to qualified reviewers and staff assistants as part of the proposal review process; to proposer institutions/grantees to provide or obtain data regarding the proposal review process, award decisions, or the administration of awards; to government contractors, experts, volunteers and researchers and educators as necessary to complete assigned work; to other government agencies or other entities needing information regarding proposers or nominees as part of a joint application review process, or in order to coordinate programs or policy; and to another Federal agency, court, or party in a court or Federal administrative proceeding if the government is a party. Information about Principal Investigators may be added to the Reviewer file and used to select potential candidates to serve as peer reviewers or advisory committee members. See System of Record Notices , NSF-50 , "Principal Investigator/Proposal File and Associated Records," and NSF-51 , "Reviewer/Proposal File and Associated Records.” Submission of the information is voluntary. Failure to provide full and complete information, however, may reduce the possibility of receiving an award. An agency may not conduct or sponsor, and a person is not required to respond to, an information collection unless it displays a valid Office of Management and Budget (OMB) control number. The OMB control number for this collection is 3145-0058. Public reporting burden for this collection of information is estimated to average 120 hours per response, including the time for reviewing instructions. Send comments regarding the burden estimate and any other aspect of this collection of information, including suggestions for reducing this burden, to: Suzanne H. Plimpton Reports Clearance Officer Policy Office, Division of Institution and Award Support Office of Budget, Finance, and Award Management National Science Foundation Alexandria, VA 22314 171 IMAGES FREE 10+ Clinical Research Proposal Samples in MS Word 19+ SAMPLE Clinical Research Proposal in PDF 19+ SAMPLE Clinical Research Proposal in PDF 19+ SAMPLE Clinical Research Proposal in PDF FREE 10+ Clinical Research Proposal Templates in PDF FREE 10+ Clinical Research Proposal Samples in MS Word VIDEO Presentasi Proposal Penelitian Clinical Pathway Lecture 7: Writing a Grant Proposal or A Research proposal CPRS Decision Support -- Innovation #182 Proposal development videos Orthopedic Management in Traditional Medicine 2024 GP2 Session 2 (ORM in TM) Romanza Andaluza COMMENTS Tips for Creating a Clinical Trial Request for Proposal (RFP) 5 Tips for Creating a Request for Proposal (RFP) for Clinical Trial Services. August 30, 2021. 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PDF REQUEST FOR PROPOSAL REQUEST FOR PROPOSAL by The University of Texas Health Science Center at San Antonio for Selection of a Vendor to Provide a Clinical Trial Management System related to The Office of Clinical Research RFP No. 745 - 11 P04 Submittal Deadline: Thursday, November 18, 2010, 3:00 p.m., Central Prevailing Time Pre-Proposal Conference: PDF REQUEST FOR PROPOSALS (RFP) confused with general research grants which are focused on the development or refinement of specific and defined medical knowledge. Research projects answer questions about best practice, whereas Quality Improvement projects implement best practices. Research projects (e.g., clinical trials) will not be considered under this RFP. It is expected Request for Proposals: Broad Clinical Research Fellows 2020-2021 The fellowship will provide $65,000 of salary support (plus fringe benefits), $7,500 for supplies and a $1,500 meeting allowance for clinical research fellows engaged in a minimum of 75% effort on a research project broadly related to stem cell biology and regenerative medicine. NOT-DA-22-061: Request for Proposals (RFP) Notice: Clinical Research NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Request for Proposals (RFP) Notice: Clinical Research Organization (CRO) Support for Blueprint MedTech (BPMT) Regulatory Affairs Support and Related Services NOT-DA-22-061. ... overseeing studies at Clinical Research Organization (CROs), and preparing and reviewing ... PDF REQUEST FOR PROPOSAL (RFP) BioMedSA Clinical Trial Central Hub Design BioMedSA Clinical Trial Central Hub Design and Development Through Launch. July 21, 2022. 3463 Magic Dr., Suite 245 | San Antonio, TX 78229 | 210-468-1848 | www.biomedsa.orgPROJECT OVERVIEWVision: To provide the most efficient, easy to implement, high quality, cutting-edge, accessible clinical t. ntry to advance the healthcare of our people in ... REQUEST FOR PROPOSAL for Preparation for the application of an Proposals evaluation and bid defense meeting Based on a pre-aligned selection grid, GARDD selection committee will evaluation all written proposals to determine which suppliers shall be invited to a virtual meeting with GARDP Selection committee. The duration of each meeting will be around 1 hour, including follow-up questions and answers. Request for Proposals: Clinical Research Organization Request for Proposal Objective This Request for Proposal has been prepared to facilitate collecting bids from a qualified contract research organization (CRO) with staff appropriate for supporting regulatory and ethics approval, securing import and export permits, providing monitoring services, project management, data management, building an EDC system, PV services, Statistics and Medical ... 2023 Request for Proposals: Broad Clinical Research Fellow Program Posted March 16, 2023. Reading Time 2 minutes. (Photo by Chris Shinn) A gift from The Eli and Edythe Broad Foundation established the Eli and Edythe Broad Clinical Research Fellows at USC. We plan to fund up to 3 positions, and successful applicants will receive a $77,000 stipend + $12,000 health insurance for a minimum of 80% effort this year. NSF 23-519: Major Research Instrumentation (MRI) Program: NSF 23-519: Major Research Instrumentation (MRI) Program NSF 24-576: Gen-4 Engineering Research Centers Full Proposal Preparation Instructions: Proposers may opt to submit proposals in response to this Program Solicitation via Research.gov or Grants.gov. Full Proposals submitted via Research.gov: Proposals submitted in response to this program solicitation should be prepared and submitted in accordance with the general guidelines contained in the ... assignment essay homework paper phd report resume review speech thesis