Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional

Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional is sponsored by Food and Drug Administration (FDA). This Notice of Funding Opportunity (NOFO) invites applications for a cooperative agreement to support, manage, and facilitate Public-Private Partnerships and Collaborative activities as part of the Critical Path Initiative and to support regulatory science efforts.

Expired RFA-FD-24-029: Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) U.S. Food and Drug Administration ( FDA ) The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

of Participating Organizations Food and Drug Administration ( CDER ) Funding Opportunity Title Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional Research Demonstration Cooperative Agreements February 8, 2024 - Notice of Change to Funding Opportunity: RFA-FD-24-029 Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional.

See Notice NOT-FD-24-005 January 25, 2024 - Notice of Change to Funding Opportunity: RFA-FD-24-029 Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional. See Notice NOT-FD-24-003 January 22, 2024 - Notice of Change to Funding Opportunity: RFA-FD-24-029 Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional. See Notice NOT-FD-24-001 .

Notice of Funding Opportunity (NOFO) Number Companion Notice of Funding It is anticipated that up to 6 awards (3 per collaboration category) will be made, not to exceed $5,000,000 in total costs (direct plus indirect) in total. Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) invites applications for a cooperative agreement to support, manage and facilitate Public-Private Partnerships and Collaborative activities as part of the Critical Path Initiative and to support regulatory science efforts.

FDA and grantees will work together to develop innovative, collaborative projects in research, education, and outreach.

These projects can help foster drug product innovation to 1) support efforts to accelerate drug product development; 2) support approaches to advanced manufacturing; 3) facilitate translation of basic science discoveries into therapeutics; and 4) facilitate approaches to enhance the safety, efficacy, quality, and performance of drug products. Projects are identified by FDA.

Multiple awards may be funded under this NOFO and are directly dependent on drug development priorities and subject to the availability of funding.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) All applications are due by 11:59 PM local time of Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission AIDS Application Due Date(s) New Date April 3, 2024 (Original Date: March 5, 2023) per issuance of NOT-FD-24-005 It is critical that applicants follow the Research (R) Instructions in How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of the Announcement I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I.

Notice of Funding Opportunity Description The Center for Drug Evaluation and Research seeks to advance regulatory science efforts and continue the Critical Path Initiative per 21 USC 360bbb-5: Critical Path Public-Private Partnerships by engaging in collaborations to develop innovative, collaborative projects in research, education, and outreach for fostering drug product innovation, enabling the acceleration of development, advanced manufacturing, and translational therapeutics, enhancing safety, efficacy, quality, and performance.

These partnerships include collaborations with one or more non-profit groups to support common objectives. The amount of funding provided under this opportunity is dependent upon drug development priorities and subject to the availability of funds.

The FDA is responsible for advancing public health by helping speed innovations that make medicines more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines to improve their health.

In 2004, the US Food and Drug Administration (FDA) acknowledged a gap between the rate of basic science discovery and the translation of these discoveries into the development of medical products. To address this gap, the FDA instituted the Critical Path Initiative (CPI), which called for increased efforts to catalyze innovation in product development through the launch of several initiatives.

This is documented in the Challenges and Opportunities Report.

The goal of these initiatives and of regulatory science as a whole is to make the drug development process more efficient and effective, and more likely to result in safe products that benefit patients enabling early identification of those products that do not hold promise, thus reducing time and resource investments, and facilitating the process for development of medical products that hold the most promise for patients.

In addition, outputs from regulatory science support education by sharing best practices through guidance with national and international stakeholders. the Critical Path Opportunities List (CPOL) identified specific priorities to facilitate the CPI vision. Since then, the FDA's Center for Drug Evaluation and Research has directed considerable effort to achieve the goals of CPI and CPOL through collaboration with non-profit groups.

Collaborations and Public Private Partnerships (PPPs) helped address several CPOL priorities to yield meaningful results to benefit public health. The CPI further emphasized that a joint effort between the research community, drug development industry, and FDA scientists was essential to realize the vision. Collaboration and sharing data are essential to accomplish our common goal of a robust regulatory science infrastructure.

Public-Private Partnerships (PPP) convened by neutral non-profit conveners (501c3) are able to bring together stakeholders from government, academia, professional societies, patient advocacy groups, and industry in the pre-competitive space to address these regulatory science needs.

In drug development, a PPP may be established upon emergence and identification of a public health regulatory or drug development need and can include global collaborations that engage international government entities, academia, industry, patient advocacy groups, nonprofit institutions, and professional organizations. In this collaborative effort, FDA is a participant and/or an advisor to support specific scientific projects.

The resulting outcomes benefit all stakeholders and can take many forms, such as best practices, scientific recommendations, patient registries, databases, disease models, training modules, and advancement of drug development tools (DDT). Once completed, the PPP outcomes are shared in the public domain to be broadly applied towards streamlining drug development and increasing the efficiency of regulatory decision-making.

Examples of some areas of interest (not limited to): -Assay development/laboratory assays -Predictive animal models -Digital Health Technologies -Public health preparedness and response inclusive of emerging health priorities -Clinical outcome assessment instruments -Genetic tests/Personalized medicine -State-of-the art information technology -Analytical and computational methods (Examples: Develop and use of computational methods and in-silico modeling; Simulation-based approaches; Advanced quantitative methods-based modeling; Predictive modeling, Model-informed drug development) -New approach methodologies (NAMs) in toxicology -Advanced manufacturing approaches -Approaches to incorporate patient and consumer input and perspectives in drug development -Methods to assess real-world data to serve as real-world evidence -Applications of artificial intelligence and machine learning approaches in drug development -Develop and deliver training/education to support emerging needs in regulatory science -Other drug development innovations Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science Report Role of Public Private Partnerships in Catalyzing the Critical Path While FDA may provide funding for the initial phases of the projects undertaken as part of this grant, FDA will review a sustainability plan to demonstrate they are capable of securing ongoing funding for the project, when applicable.

The applicant must also provide assurance that it will not accept funding for a project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless it provides assurances in its agreement with the Food and Drug Administration that the results of the project will not be influenced by any source of funding.

The Grantees are expected to function independently but are encouraged to network with other Grantees in the program when possible or when it will improve the project outcomes. Collaboration Categories: There are two Collaboration Categories that have been identified: 1) Partnerships/Collaborations 2) Consortia Formation and Maintenance. Capabilities for each are described below.

Applicants must identify EACH Collaboration Category they would like to be considered for and provide justification of their capability and expertise specific for each. All grantees who are approved for each Collaboration Category be considered for new projects within that category if and when the drug development need arises, and funds are available.

Capabilities required for both Collaboration Categories: -Scientific expertise or ability to identify partners that can address FDA’s regulatory science needs and drug development priorities -Ability to establish partnerships and collaborations with diverse stakeholders such as health care practitioners and other providers of health care goods or services; pharmacists; pharmacy benefit managers and purchasers; health maintenance organizations and other managed health care organizations; health care insurers; government agencies; patients and consumers; manufacturers of prescription drugs, biological products, diagnostic technologies, and devices; academic scientist; and others as needed -Ability to establish an adequate administrative and scientific infrastructure to implement all related projects and to rapidly scale up/hire -Scientific expertise (or ability to identify partners) across multiple therapeutic areas/scientific fields to lead and run consortia or other types of partnerships and collaborations -Development, conduct, and oversight of projects -Preparation/reporting of project findings including the regulatory and public health impact of the project outcomes -Ability to identify and/or build, and effectively leverage databases and/or resources for the conduct of identified projects as -Development of periodic and final reports that include the project progress, findings, and regulatory and public health impact of the project outcomes; submission of these report(s) reviews and acceptance by FDA, and for subsequent distribution in the public domain In completion of a given project, propose related studies/projects, if needed, to build on the findings in conjunction with FDA, develop plans for the conduct of identified research projects -Demonstrate the capability to address regulatory science issues that define FDA’s public health mission and priorities.

-Willingness to develop a sustainability plan that identifies sources of funding that are expected Collaboration Categories: Descriptions and Capabilities are 1. Partnerships/Collaborations: This category applies to applicants who can lead collaborations to address a specific drug development priority for the FDA. Project objectives and goals may be more targeted.

These collaborations may be completed with a smaller number of organizations that collaborate to address the FDA’s need.

-Pre-consortia activities -A pre-consortium can be used to explore the feasibility, goals, structure, members, vision, and deliverables -Collaborative teams that partner to address the drug -Partnership can be with one or multiple stakeholders (FDA is considered a stakeholder) -Evidence of organizational support to ensure the success in coordinating collaborations at this level -The ability to manage data needs of the collaboration as -Capabilities in training/education development and delivery- Develop and deliver training, workshops, programs and/or educational materials for relevant emerging regulatory science topics.

It is possible that some of these educational programs may be relevant to the public and may need to be posted for no charge or a minimal charge. 2. Consortia Formation and Maintenance: This category applies to applicants who have the capability and expertise in the formation and maintenance of consortia.

A consortium is a collaborative group managed by a convening or coordinating organization involving multiple stakeholder organizations including at least one non-profit or 501(c)(3) organization (e.g., academia, government, or foundation) and at least one for-profit organization (e.g., pharmaceutical, biotechnology, or medical device company).

It may involve multiple committees Consortia are utilized in the development of tools, methods, approaches, and standards such as (but not limited to) database development, development, and support for the FDA Drug Development Tool Qualification process, breaking new ground with collaborative data sharing approaches, model development, data standards development, data repository development, biomarker and clinical outcome assessment development, clinical trial designs, addressing specific public health needs and priorities, and training and education -Evidence of organizational support and governance to ensure the success of consortia established as part of this grant FDA anticipates approving up to three (3) grantees for each Collaboration Category.

Initially funding will be project-based. FDA is open to suggestions Initial Award: FDA provides funding at the time of initial award of a cooperative agreement which is based on timing of the project need, availability of funding and the scope of the applicant's application.

Post-Award Projects: FDA anticipates providing funding for additional projects to be conducted in collaboration with the identified grantee(s) after the initial award of a cooperative agreement.

These post-award projects will be funded consistent with applicable law, and are intended to proactively further drug development and regulatory science efforts of FDA in response to public health needs that may not be known or identified at the time of the initial award. These projects will be conducted collaboratively with FDA.

In some cases, FDA will serve in an advisory role for these projects and in other cases, FDA will participate in the projects in hands-on collaboration with the grantee. In the latter case, internal support for the FDA portion of the project will be provided by the Agency separately from the cooperative agreement support provided for the grantee. It is also possible that a project could be supported, in part, by a third party.

When a new project is identified, it will be categorized by collaboration category and those grantees who qualified for that collaboration category will be considered for the award. There will be a process giving all grantees who qualified for each collaboration category an opportunity to provide documentation of how they would approach and be successful in executing the project.

The funding Office will determine which grantee will ultimately be awarded the project. To be successful, an applicant will be evaluated by- Review Criteria within this NOFO in the context of the Funding Opportunity Description and collaboration category capabilities. VIII.

Other Information for award authorities and regulations. Section II. Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI. 2 for additional information about the substantial involvement for Application Types Allowed and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s) determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications.

FDA/CDER intends to fund up to total of $5,000,000, for fiscal year 2024 in support of this grant program. It is anticipated that up to 6 awards (3 per collaboration category) will be made, not to exceed $5,000,000 in total costs (direct plus Awards pursuant to this NOFO may be funded incrementally throughout the budget period to: support new projects. Application budgets should reflect the needs of the proposed program annually.

These should not exceed the listed amounts in total costs (direct and indirect): The maximum project period is 5 years.

described in the HHS Grants Policy Statement will apply to the applications submitted and awards (A) an institution of higher education (as such term is defined in section 1001 of title 20) or a consortium of such institutions; (B) an organization described in section 501(c)(3) of title 26 and exempt from tax under section 501(a) of such title.

(2) The entity has experienced personnel and clinical and other technical expertise in the biomedical sciences, which may include graduate training programs in areas relevant to priorities of the Critical Path Initiative.

(3) The entity demonstrates they are capable of- (A) developing and critically evaluating tools, methods, (i) to increase efficiency, predictability, and productivity or medical product development; and (ii)to more accurately identify the benefits and risks of new and existing medical products (B) establishing partnerships and collaborations with health care practitioners and other providers of health care goods or services; pharmacists; pharmacy benefit managers and purchasers; health maintenance organizations and other managed health care organizations; health care insurers; government agencies; patients and consumers; manufacturers of prescription drugs, biological products, diagnostic technologies, and devices; and academic (C) securing funding for the projects of a Critical Path Public-Private Partnership from Federal and nonfederal governmental sources, foundations, and private individuals.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the HHS Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

The FDA Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late Award Management (SAM) Applicants must complete and maintain an active registration, at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.

gov registration process. The same UEI must be used for all registrations, as well as on the grant application. - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an Applicants must have an active SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role.

Obtaining an eRA Commons account can Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement . 3.

Additional Information Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed. Institutions interested in involving multiple offices/departments (within their institution) should internally coordinate and choose one (1) entity to apply. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.

3. 7. 4 Submission of Resubmission Application .

This means that the FDA will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). Section IV.

Application and Submission 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system 2.

Content and Form of Application It is critical that applicants follow the Research (R) Instructions (R&R) Application Guide , except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

A letter of intent is required, but is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: General description of organization's capabilities relevant to this Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Office of Acquisitions & Grants Services (OAGS) Food and Drug Administration All page limitations described in the SF424 Application Guide of Page Limits must be followed.

For this specific NOFO, the Research Strategy section is limited to 30 pages Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application All instructions in the SF424 (R&R) Application Guide must SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must All instructions in the SF424 (R&R) Application Guide must PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must does NOT apply to a study that can be described but will not start immediately All instructions in the SF424 (R&R) Application Guide PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide 3.

Unique Entity Identifier and System for Award See Part 1. Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.

gov 4. Submission Dates and Times Part I. Overview Information contains information about Key Dates and times.

Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants.

gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , electronic system for grants administration. and Grants.

gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time.

If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the FDA Policy on Late Application Submission. are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5. Intergovernmental Review (E.

O. This initiative is not subject to intergovernmental All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement . Pre-award costs are allowable only as described in the HHS Grants Policy Statement .

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, Apply Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to the FDA. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned FDA Grants Management Specialist and responsiveness by components of participating organizations . Applications that are incomplete, non-compliant and/or nonresponsive will not Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy .

Any instructions provided here are in addition to the instructions in the Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review.

Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Section V.

Application Review Information Only the review criteria described below will be considered The applicant must identify one or more of the collaboration categories from the Funding Opportunity Description section of this NOFO. They must satisfy the specific requirements for each Collaboration Category they have identified in order to qualify for each.

Collaboration Categories: (See description and requirements in Full Text Section of this NOFO.) 1. Partnerships/Collaborations 2.

Consortia Formation and Maintenance The applicant must also provide assurance that it will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless it provides assurances in its agreement with the Food and Drug Administration that the results of the Critical Path Public-Private Partnership project will not be influenced by any source of funding.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). Reviewers will consider each of the review criteria below in the determination of scientific/technical merit of each applicant.

The applications will be evaluated on needs and requirements identified in the full text section and the review criteria. Does the applicant address the needs of the consortiums and other collaborations that it will coordinate to advance FDA's regulatory science needs that will lead to meaningful public health impact?

Is the scope of activities proposed appropriate to meet those Does the applicant bring unique advantages or capabilities Investigator(s) (20 Points) Is there evidence that PD(s)/PI(s) Is there evidence that well suited for the collaboration category identified? Do proposed staff, (PD/PI, researchers, collaborators) have the bandwidth to fully fulfill their role in the collaboration category(s) identified?

Does the applicant have scientific and technical expertise (or ability to obtain) across multiple therapeutic areas/scientific/biomedical fields to lead the collaboration category (consortia,