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

Section 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

 

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.

Background:

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.

In 2006, 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

-Data analysis tools

-Digital Health Technologies

-Public health preparedness and response inclusive of emerging health priorities

-Complex Trial designs

-Novel biomarkers

-Imaging tools

-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

Additional Resources:

2022: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science Report

The 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 as necessary.

-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 appropriate

-Plan for data sharing

-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 described below.

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.

This includes:

-Pre-consortia activities -A pre-consortium can be used to explore the feasibility, goals, structure, members, vision, and deliverables for a full consortium

-Collaborative teams that partner to address the drug development priority

-Partnership can be with one or multiple stakeholders (FDA is considered a stakeholder)

Capabilities:

-Evidence of organizational support to ensure the success in coordinating collaborations at this level

-The ability to manage data needs of the collaboration as appropriate

-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 and working groups.

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 efforts.

Capabilities:

-Evidence of organizational support and governance to ensure the success of consortia established as part of this grant

POST AWARD FUNDING:

FDA anticipates approving up to three (3) grantees for each Collaboration Category. Initially funding will be project-based. FDA is open to suggestions of core funding needs.

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.

See Section VIII. Other Information for award authorities and regulations.

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Eligible Organizations

(1) The entity is-

(A) an institution of higher education (as such term is defined in section 1001 of title 20) or a consortium of such institutions; or

(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, and processes-

(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 scientists; and

(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 not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

 

Applicant Organizations

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 submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal 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.
  • NATO Commercial 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.
• eRA Commons - 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 application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program 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 take up to 2 weeks.

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) Application Guide.

This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement.

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 not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• 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 Information

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 solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (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 review.

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 announcement
• 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:

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. For this specific NOFO, the Research Strategy section is limited to 30 pages

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan:

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.

 

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

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 form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

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.

Applicants 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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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, visit How to 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 VII.

Important reminders:

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 Guide.

See more tips 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 be reviewed.

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 policy.

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 Management Specialist.

Only the review criteria described below will be considered in the review process.

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 needs?

Does the applicant bring unique advantages or capabilities to these projects?

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, collaborations, or partnerships)?

Does the applicant have a demonstrated an ongoing record of relevant accomplishments for the identified collaboration category(s)?

Does the applicant have complementary and integrated expertise; is their leadership approach, governance, and organizational structure appropriate for the identified collaboration category(s)?

Does the applicant provide innovative approaches to facilitating the collaborations and outcomes for each identified collaboration category?

Does the application provide viable plans for gaining additional funding from sources beyond FDA (

Does the applicant employ a sound and effective approach/methodology for each collaboration category to accomplish its goals and objectives?

Has the applicant included plans to evaluate feasibility of a given project?

Does the applicant have a plan to assess for and address weaknesses and risks identified for each project?

Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the identified collaboration category?

Are potential problems, alternative strategies, and benchmarks for success presented?

Does the applicant have a plan for measuring outcome metrics and impacts to public health for identified collaboration category?

Does the applicant have the ability to identify and/or hire sufficient number of qualified personnel to conduct the necessary research and project-manage all related activities, including review of project milestones for degree of completion, preparation/reporting of project findings, periodic and final reports, all for approval by FDA, and for subsequent distribution in the public domain.

Will the administrative and scientific environment in which the work will be done contribute to the probability of success?

Are the institutional support, equipment, and other physical resources available to the investigators adequate for the identified collaboration category?

Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Has the applicant established alliances/collaborative partnerships to facilitate achievement of objectives of each collaboration category?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

If applicable, included:

Has the applicant and/or PD(s)/PI(s) worked collaboratively with FDA? Were the projects conducted by the applicant well aligned with FDA interests; did they have an impact on FDA? Did they resolve any problems in a timely and appropriate manner?   

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

NA

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Committee convened by the FDA, using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

Appeals of objective review will not be accepted for applications submitted in response to this NOFO.

Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

 

Successful applicants will be notified of additional information that may be required for other actions leading to an award. The decision not to award a grant or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found in the HHS Grants Policy Statement

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see  https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about FDA's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see FDA's Anti-Harassment and Inappropriate Conduct Policy
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.  

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. 

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FDA's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

Awardee Responsibilities

The PD(s)/PI(s) will have the primary responsibility for:

1. Participate in site visits or attend meetings as requested by the FDA. A portion of the budget should be reserved for such travel.

2. Coordination with FDA, as they may request data be made available through speaking engagements and publications, presentations at scientific symposia and seminars, while making sure that confidentiality and privacy of the data is protected.

3. The awardees will provide FDA any data obtained from investigations if requested by FDA.

4. Any publication or oral presentation of regarding outcomes of this grant must undergo FDA Office of Research and Center review and approval process. This process can take 30-90 days.

5. Providing Board Briefings to the OTS Program

6. The awardee is responsible for preparing materials for meetings involving participants from FDA. Some meetings occur at FDA while others are conducted via teleconference.

7. Providing effective and efficient program and project management for each AIM

8. Ensure publications follow HHS Grant Policy in regard to approvals and acknowledgment of federal support

FDA Responsibilities:

1. The FDA Program Office will be responsible for the normal scientific and programmatic stewardship of the award and an individual from this office will be named in the award notice.

2. An FDA Project Officer (PO) will have substantial programmatic involvement as described below.

3. The PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited to, post- award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the Grants Management Officer (GMO). The PO and the GMO work as a team in many of these activities.

6. FDA will assist and approve (as deemed appropriate) the substance of publications, co- authorship of publications and data release.

Areas of Joint Responsibility include:

1. Projects will require FDA Program Office approval prior to implementation/ initiation.

2. During performance of the award, the FDA Program Office, in consultation with FDA SMEs, may provide appropriate assistance, advice and guidance. The role of the FDA Program Office will be to facilitate and not to direct the activities. The FDA/ Program Office will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services

3. At the start of and throughout each project, the FDA Lead and grantee will assess the need for additional agreements (i.e., Material Transfer Agreements, Data Transfer Agreements) and come to an understanding on how to best make project outcomes available for public benefit.

PROGRAM INCOME:

1. The grantee is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee's Federal Financial Report (FFR) SF-425.

2. Examples of Program Income include (but are not limited to): fees for services performed during the grant or sub-grant period, proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.

3. Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee is subject to the Addition Alternative for Program Income and, therefore, must only be used to further the goals of the project for which this grant was awarded.

PRIOR APPROVAL:

All requests that require prior approval must include the award number and bear the signature of an authorized official of the grantee business office as well as that of the PI/PD. Any requests involving funding issues must include a new proposed budget and a narrative justification of the requested changes. If a grantee questions whether prior approval is required for an activity or cost, they should contact the assigned Grants Management Specialist prior to expenditure of funds for clarification.

Below are activities that require prior approval from FDA:

-Change in scope or objectives

-Change in key personnel

-Change in grantee organization

-Deviation from terms and conditions of the award

-Carryover of unobligated balances

-No cost extensions

-Significant rebudgeting

Not Applicable

The awardee is responsible for timely publication and public release and dissemination of results, Data (under this cooperative agreement, Data is as defined in the HHS Grants Policy Statement to mean recorded information, regardless of the form or media on which it may be recorded, and includes writings, films, sound recordings, pictorial reproductions, drawings, designs or other graphic representations, procedural manuals, forms, diagrams, work flow charts, equipment descriptions, data files, data processing or computer programs (software), statistical records, and other research data) and other products of the study, concordant with an approved plan for making Data and materials available to the scientific community and FDA.

FDA will assist and approve (as deemed appropriate) the substance of publications, co- authorship of publications and data release.

FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community. Please see the FDA Public Access Policy.

Awardees will retain custody of and have primary rights to the Data developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies. Any publications, Data or other copyrightable works developed under this grant may be copyrighted without prior FDA approval. In all cases, whether FDA funded all or part of the project or program resulting in the Data or other copyrightable work, FDA must be given a royalty-free, nonexclusive, and irrevocable license for the Federal government to reproduce, publish, or otherwise use the material and to authorize others to do so for Federal purposes.

At the start of and throughout each project, the FDA and grantee will assess the need for additional agreements (i.e., Material Transfer Agreements, Data Transfer Agreements) and come to an understanding on how to best make project outcomes available for public benefit.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the HHS Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement. FDA NOFOs outline intended research goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the HHS Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Additional Reporting Requirements:

All FDA grants require annual financial and performance progress as stated in Section III. This award has additional performance reporting requirements as outlined below.

Performance:

Annual Progress Reports for each year of the cooperative agreement along with monthly status reports are required. All these reports should contain the content needed by FDA and documented in an agreed upon format between FDA and the Grantee. FDA will review the progress of the Program and take into account the following as we complete overall reporting, RPPR checklists and data calls related to this grant:

1) overall management and accomplishments of the Program,

2) interactions with FDA,

3) achievement of project milestones and deliverables, and

4) impact of projects on FDA’s public health mission.

The following Reports are required to assess the Grant activities:

1. Monthly status reports

2. Annual Budget Planning Report

3. The Annual Progress Report (reported in the RPPR) reports on the entire past year of the cooperative agreement and includes all projects/Aims that were started, in progress and projects that were completed during the time period.

It will include:

-Summary information on each project

-Public Health Impact-defined as how outputs from the project/aim were utilized/applied and how they impacted product development and FDA s Public Health Mission. If still in progress, it is acceptable to describe how it will impact public health

-Accomplishments-defined as what activities were completed

-Issues and concerns encountered

-Solutions used to resolve issues

4. Cumulative Accomplishments and Impact Report: Includes a listing of the accomplishments from the current year, cumulative impact on product development and FDA’s Public Health Mission of current and previous years.

 

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Patricia Koussis
CDER
Email: Patricia.Koussis@fda.hhs.gov

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov

Recently issued policy notices may affect your application submission. A full list of policy notices published in the Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.