Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

Components of Participating Organizations

Office of Critical Path Programs, Office of the Chief Scientist, Office of the Commissioner

Funding Opportunity Title

Advancing Regulatory Science through Novel Biomarker Research and Science-Based Technologies (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-11-016

Companion FOA
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic
Assistance (CFDA)
Number(s)

93.103

FOA Purpose

Purpose. As a key component of FDA's Advancing Regulatory Science initiative, the Office of Critical Path Programs (OCPP) supports innovation in the development, evaluation, and manufacture of new safe and effective medical/veterinary products for diagnosing, treating, and preventing diseases. OCPP harnesses new science and new technologies to further this goal.

This FDA-issued Funding Opportunity Announcement (FOA) invites applications from institutions/organizations that propose applying novel technologies and approaches to developing new biomarkers for well-defined human or veterinary diseases and toxicity in areas where an unmet need exists, particularly where such biomarkers show substantial promise to enable or speed product development and evaluation or improve patient effectiveness and healthcare outcomes as well as ensure product availability to patients in a timely manner. (See biomarker definition and descriptions under Research Objectives below).

Applications should address the Critical Path Initiative's mission to facilitate the development of new safe and effective products for diagnosing, treating, and preventing disease.

Key Dates
Posted Date

April 28, 2011

Open Date (Earliest Submission Date)

May 15, 2011

Letter of Intent Due Date

May 15, 2011

Application Due Date(s)

June 15, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June, 2011

Advisory Council Review

September,  2011

Earliest Start Date(s)

September 15, 2011

Expiration Date

June 16, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA). Conformance to all requirements (both in the Application Guide and the FOA) 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.

Note:  The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. 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. Funding Opportunity Description

1.  Research Objectives

FDA is announcing an FOA for research into the discovery of biomarkers to facilitate the development of new treatments and interventions in areas of unmet need. This FOA is part of the Critical Path Initiative's (CPI's) long-term strategic effort to drive innovation in product development.  CPI forms a key component of a broader FDA initiative, Advancing Regulatory Science, which focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products.

Recent breakthroughs in science and technology offer new opportunities to transform the ways in which medical/veterinary products are developed and evaluated to prevent, diagnose, and treat disease. These developments may enable improvements in the efficiency of clinical trials and potentially accelerate the availability of new products in areas of medical need. Developments may also enhance our ability to characterize both the safety and efficacy of new products and facilitate the tailoring of treatments to individual patients.  Such personalized interventions will maximize the benefit of treatments while decreasing their safety risks. 

To help these advances reach their full potential, FDA is supporting the discovery of biomarkers to facilitate the development of new treatments and interventions in areas of unmet need, thus advancing the timely development of safe and effective innovative products for the patients who need them.  Efforts should also help to modernize the evaluation and approval processes.

The discovery and qualification of new biomarkers will stimulate bench–to-bedside translation by providing measures of the biological effects of potential new treatments. The ideal biomarker can be measured in a minimally invasive way; has good performance characteristics; and correlates well with the clinical observation in question.

FDA's Office of Critical Path Programs (OCPP) is soliciting grant proposals for programs aimed at discovery, characterization, and qualification of new biomarkers in areas of unmet need, using new or existing technologies.

For the purposes of this funding opportunity, a biomarker is a biological test that correlates with a clinical observation. Biomarkers may play different roles in the development of medical products including but not limited to:

Diagnostic biomarkers – to identify the presence of a disease

Toxicity biomarkers – to serve as early sensitive indicators of treatment-induced toxicity, before significant harm occurs

Response predictive biomarkers – to differentiate between patients/animal populations that have a greater potential to respond to the particular treatment in question (favorably or unfavorably), as opposed to those that are physiologically unlikely to have that response.  These may identify subpopulations that can respond to a medical treatment in different ways. For example, they may correlate with an increased risk of drug toxicity, or an increased chance of drug benefit. Such biomarkers serve as a cornerstone in personalizing medicine, enabling practitioners to select the most appropriate treatment for individual patients/animal populations.

Prognostic biomarkers – that identify a baseline patient/animal or disease characteristic that categorizes patients by degree of risk for disease occurrence or progression. A prognostic biomarker informs about the natural history of the disorder in that particular patient/animal in the absence of a therapeutic intervention. Prognostic biomarkers may assist in targeting appropriate populations for inclusion in clinical trials or general practice treatment with the approved therapy.

Response identification biomarkers (pharmacodynamic biomarkers) – early post-treatment biomarkers that indicate the particular patient has shown some biological response to the treatment, and thereby has the potential to receive benefit as compared to those who have not shown that biological response and cannot benefit.

Biomarkers as surrogate endpoints in clinical trials – to predict the clinical efficacy response to a treatment intervention. Surrogate endpoints may be of particular value in diseases where prolonged follow-up is required to determine the clinical outcome, such as Alzheimer’s and other neurodegenerative diseases, cancer, metabolic diseases, and infectious diseases that cause morbidity and mortality over a prolonged period of time. Surrogate endpoints may replace hard clinical end points as a measure of the effect of new therapies.

Biomarkers of risk – which may identify subpopulations that respond to a medical/veterinary treatment in different ways. For example, they may correlate with an increased risk of drug toxicity, or a risk of reduced drug efficacy. Such biomarkers serve as a cornerstone in personalizing medicine, enabling practitioners to select the most appropriate treatment for individual patients.

This FOA encourages the development of candidates with significant potential to improve medical product development, particularly in areas of unmet need.

This initiative includes but is not limited to:

Studies of biomarkers that support OCPP's mission, namely, to facilitate the development of new safe and effective products for diagnosing, treating, and preventing disease, as noted below.

Studies of biomarkers that describe the natural history of disease, the pathogenesis of disease or biomarkers for post-market evaluation of approved products may or may not be of value in facilitating the development of new medical/veterinary products. Such studies will be evaluated in terms of their relevance to the mission.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

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.

Office of Critical Path Programs intends to commit $1,000,000 in FY 2011.

Award Budget

For this funding opportunity, budgets up to $250,000 (direct costs), for a time period of up to 3 years can be requested.

Award Project Period

This funding opportunity can be requested for a time period of up to 3 years. Each year, funding will depend on annual appropriations and performance.

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

An eligible organization that wishes to enter into a collaborative agreement must provide an assurance that the entity 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 the entity 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.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities 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 SF 424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility
 
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

Letter of Intent

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be emailed to:

Elizabeth Callaghan
Project Officer
Office of the Chief Scientist
Food and Drug Administration
Email: elizabeth.callaghan@fda.hhs.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Organizations

Not Applicable.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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, FDA’s electronic system for grants administration.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

  All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

4. Project Work Plan

The Project Work Plan (WP) should describe the activities to be performed in response to the FOA requirements and include a single Gantt Chart with all activities described in the WP. The Work Plan should include a schedule of activity based on an appropriate time scale and should be task linked to the budget. The level of detail necessary in the WP and the corresponding Gantt chart should be sufficient to successfully manage and execute the cooperative agreement: 

Include a well-defined project scope that aligns with the goals of the FOA.

Provide all relevant letters of commitment that must describe how the inscribing institution will benefit from the project and will commit personnel and/or other resources if the proposal is funded.

Identify appropriate resources such as equipment, facilities, and raw materials necessary for the project and how they will be used in the project. In addition, ensure that these resources are appropriately aligned in the budget.

Provide a project management plan documenting how the project will be executed, monitored, and controlled. The management plan must include a project schedule with sufficient detail of all proposed major tasks, events, or actions that are required to fulfill the goal of the FOA.

Provide a proposed 2-year budget by completing SF424 and SF424A. In addition, provide a budget narrative/justification explaining the use of funds for major categories of resources such as labor, salaries, raw materials, and equipment.

5. Measurable Outcomes

As a component of the cooperative agreement, the applicant will be required to document measurable outcomes that align to the goal of this cooperative agreement.  The application should identify and articulate measurable outcomes, but also include the following measurable outcomes that are at  minimum expected in the quarterly progress report and final report. The cooperative agreement is milestone-driven and funding is expected to occur in phases at completion of major milestones. Periodic assessment of progress will be conducted by the project officer.

Other Special Performance Requirements:

The research project will be a collaborative effort between the awardee and the FDA.  The applicant must explicitly indicate their willingness to:

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. 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 FDA.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). 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 responsiveness by the Office of Critical Path Programs (OCPP) and the Grants Management staff. Applications that are incomplete will not be reviewed.

To expedite review, applicants are requested to notify Elizabeth Callaghan in the Office of Critical Path Programs by e-mail at elizabeth.callaghan@fda.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described below:

Acceptable post-submission materials include:

Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)

Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)

Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator

Adjustments resulting from natural disasters (e.g., loss of an animal colony)

Adjustments resulting from change of institution (e.g., PI moves to another university)

News of an article accepted for publication (a copy of the article should not be sent)

All post-submission materials must conform to FDA policy on font size, margins, and paper size as referenced in Part I.2.6 of the applicable application instructions.  FDA additional form pages such as budget, biographical sketches, and other required forms must follow application form standards for required form pages.  

If post-submission material is not required on a form page, each explanation or letter is limited to one page (see Acceptable Late Materials above).  

If the application has subprojects or cores, each subproject or core is allowed explanations or letters (see Acceptable Late Materials above), but each explanation or letter is limited to one page.

Unacceptable post-submission materials (for all applications except those listed under Exceptions below) include:

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the OCPP mission, all applications submitted to the FDA for research are evaluated for scientific and technical merit through the FDA peer review system.

Overall Impact

Reviewers will provide an overall impact/priority 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).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field? Does the research address an important area of regulatory science and will it inform future medical product development and regulatory decision-making? If the project's aims are achieved, how will technological advances, regulatory practice, and/or health be improved? Will the new approach/methodology have a competitive advantage over existing/alternate approaches? Does the proposed research address an unmet area in regulatory science?  

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well-suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the applicant have the necessary ability to address regulatory issues? Do project team members and/or associated collaborators have prior experience and/or necessary qualifications to successfully execute and implement the proposed research including, where appropriate, the ability to partner and collaborate with other scientists or organizations? Are the relationships of the key personnel to the applicant organization and, if applicable, to other partnering organizations (e.g., Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), academic laboratories, clinical sites and/or strategic partners) appropriate for the work?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by using novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the research outcome have the potential to solve the identified problem and create significant value in informing the product evaluation pathway and regulatory decision-making process? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies?

Approach

Are the overall strategies, methodologies, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Are the technologies or experimental approaches state of the art?

Environment

Will the 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 project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Is the applicant organization concentrating on its core competencies to maximize its chances of success?  Has the applicant established alliances/collaborative partnerships where they are appropriate or needed to facilitate achievement of the research goals?

Additional Review Criteria

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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS) as applicable.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Ad Hoc Review Group(s), in accordance with FDA Ad Hoc review policy and procedures, using the stated review criteria.

As part of the Ad Hoc review, all applications:

Applications will be assigned to the appropriate FDA OCPP Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NCI, National Cancer Advisory Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via e-mail. 

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

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 grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the FDA Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement.

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 (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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, the FDA 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.

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

The scientific, technical, and programmatic aspects of the grant and for day-to-day management of the project or program.  The PD/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff has sufficient clearance and/or background checks to work on this project or program.  This individual will work closely with designated officials within the recipient organization to prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

All applicants will be required to participate in a cooperative manner with FDA.

FDA staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An FDA Project Scientist (PS) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

In addition to the PS, a separate FDA Program Official (PO) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  The Government, via the PO, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports.  The FDA PO may use information obtained from the data for the preparation of internal reports on the activities of the study.  However, awardees will retain custody of and have primary rights to all data developed under these awards.

Areas of Joint Responsibility include:

As relevant, the PI(s) and the PS in collaboration with PO, will work collaboratively in evaluating the most appropriate research methods, data quality control strategies, safety issues, study design and implementation, data analysis and interpretation, publication and dissemination of study results.

During performance of the award, the PS, with assistance from other scientific program staff who are designated based on their relevant expertise, may provide appropriate assistance, advice and guidance.  The role of the PS will be to facilitate and not to direct the activities.  It is anticipated that decisions in all activities will be reached by consensus between the PI and the PS, PO and that the FDA staff will be given the opportunity to offer input into this process.  The PS will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services.

The PI(s) will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement.  Manuscripts shall be submitted to FDA PO within two weeks of acceptance for publication.  Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of FDA support.  Timely publication of major findings is encouraged.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members who are not involved in the study will be convened. It will have three members: a designee of the Steering Committee chosen without FDA staff voting, one FDA designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the HHS Grants Policy Statement for additional information on this reporting requirement.

In addition to the awardees reporting requirements, the applicant will be required to collaborate with the Secretary on the Secretary's annual report to the Committee on Health, Education, Labor, and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives.  This report with review the operations and activities of the Critical Path Public-Private Partnerships of the preceding year, including any collaboration with the awardee.

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding FDA grant resources)
Telephone 301-827-7175
TTY 301-480-0434
Email: gladys.bohler@fda.hhs.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Elizabeth Callaghan
Office of the Commissioner
Office of Critical Path Programs
Food and Drug Administration
10902 New Hampshire Avenue
Bldg 32, Room 4160
Silver Spring, MD 20993
Phone:  301-796-8488
Fax:  301-847-8614
Email: elizabeth.callaghan@fda.hhs.gov

Peer Review Contact(s)

Elizabeth Callaghan
Office of the Commissioner
Office of Critical Path Programs
Food and Drug Administration
10902 New Hampshire Avenue
Bldg 32, Room 4160
Silver Spring, MD 20993
Phone:  301-796-8488 

Financial/Grants Management Contact(s)

Gladys M. Bohler
Office of Acquisitions & Grants Support
Food and Drug Administration
FHSL Rm 1078, HFA-500
5630 Fishers Lane
Rockville, MD 20857
Phone:  301-827-7175
Fax:  301-827-7039
Email: gladys.bohler@fda.hhs.gov

Section VIII. Other Information

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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