Participating Organization(s)	U.S. Food and Drug Administration (FDA) The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult Part 2 Sections IV.2 and V.2 respectively for additional information regarding page limits and the FDA Objective Review Process.
Components of Participating Organizations	Office of the Commissioner - Office of the Chief Scientist
Funding Opportunity Title	Collaborating Centers of Excellence in Regulatory Science and Innovation (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	February 22, 2013 - See Notice NOT-FD-13-008. Request for Information (RFI): FDA Collaborating Centers of Excellence in Regulatory Science and Innovation (FDA-CERSI).
Funding Opportunity Announcement (FOA) Number	RFA-FD-11-033
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
FOA Purpose	As part of the FDA's Advancing Regulatory Science Initiative, the Office of Chief Scientist supports innovation to improve the development and evaluation of new, safe, and effective medical products for diagnosing, treating, and preventing conditions and diseases. This Funding Opportunity Announcement (FOA) will provide support for one or more Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI) in the national capitol region. The CERSI's will be established to foster an innovative and thematically coherent approach to advance the field of regulatory science (including laboratory, population, behavioral, and manufacturing sciences) and the Critical Path Initiative toward more effective and efficient product development and evaluation.

Posted Date	July 15, 2011
Open Date (Earliest Submission Date)	July 15, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	August 15, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	August, 2011
Advisory Council Review	Standard dates
Earliest Start Date(s)	September, 2011
Expiration Date	August 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. 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.

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

FDA is announcing an FOA to provide support for one or more Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI). The CERSI’s will be established to foster an innovative and thematically coherent approach to advance the field of Regulatory Science (Regulatory Science encompasses laboratory, population, behavioral and manufacturing sciences) and the Critical Path Initiative toward more effective and efficient product development and evaluation. CERSI efforts will focus on promoting innovation in support of the development and evaluation of safe and effective products through training, applied collaborative science, professional development and scientific exchanges. The CERSI's should be academic, MD and PhD degree granting institutions with both strong life science and clinical medical science activities and be located within a 50 mile radius of FDA's Silver Spring, Maryland Campus. Candidate CERSI's may apply either as single institutions or as consortia of more than one institution. FDA is presently focusing its available resources on the nearby region to facilitate the ability of both the CERSI institution staff, students and trainees and of FDA to visit and work at each others sites to enable training, research, scientific exchanges and other collaboration.

1. Scientific exchanges and training for participating FDA and academic scientists. This can include proposed training interactions and opportunities for both University and FDA scientists and trainees at both institutions as well as broader efforts by the University to engage other potential partners. This may involve, for example, providing opportunities for FDA staff to participate in University continuing professional education and relevant degree programs.

This may also include potential for University scientists, including clinicians, to work, following appropriate screening, either voluntarily or potentially with FDA support through Intergovernmental Personnel Act agreement and other mechanisms, part time at FDA to support review, regulatory science and policy activities in areas of needed cutting edge expertise. This may also include opportunities for FDA and University scientists to spend time at each others institutions in scientific training and collaboration exchanges working on projects of importance to FDA's public health mission (see 2, below). Opportunities for graduate students and Fellows from participating universities may be provided by FDA for training and joint projects and mentorship at the FDA, including both clinical and populations sciences. Continuing clinical and teaching opportunities for qualified FDA staff at participating academic institutions and their affiliates are desirable. Specific proposals should be provided for the above and other suggested types of scientific and professional development opportunities and, in addition, of proposed training and exchange programs, which can also include public workshops and other activities, intended to advance excellence both generally and in at least 2 of the following specific areas of emphasis for FDA's Science and Innovation Strategy:

• Improving pre-clinical assessments of safety and efficacy
• Improving clinical studies and evaluation
• Supporting new approaches to improving product manufacturing and quality
• Ensuring readiness to evaluate innovative and emerging technologies
• Harnessing diverse data through information sciences to improve health outcomes
• Strengthening social and behavioral science to help consumers and professionals make informed decisions about FDA regulated products

2. Creation of new opportunities for collaborative regulatory scientific research with high public health impact, including both an infrastructure for collaboration to enable and support such work both generally, as well as specifically, with a proposal for candidate specific scientific work. The work must encompass at least 2 of the above identified areas of scientific focus for which the academic institution has recognized national level expertise In addition to support for training (see 1 above) and basic support for the Centers (see 3 below), FDA expects each to carry out agreed upon specific regulatory science research projects at University based and/or collaboratively, which could include other partners both within and outside of FDA. It is expected that whether or not FDA directly collaborates in scientific activities, it will interact with the CERSI in project planning and evaluation both to provide scientific input and enhance the utility of the work for FDA’s public health mission.

Core program support infrastructure at the CERSI for the above activities, including support for a responsible administrative staff point of contact/coordinator (expected to be 50-100% time), a training liaison, and for a scientific principal investigator, and, potentially, co-investigators (expected to be part-time support) to develop and enable work in the chosen training and regulatory science programmatic areas. The application needs to justify the configuration and numbers of components proposed and to demonstrate that the proposed center infrastructure would facilitate effectively the achievement of the desired level of integration and synergy. The center mechanism is not appropriate to support a set of complex unitary investigations that would be best supported as individual R01s. Applicants should explicitly discuss the integration of work in the center in the introductory section of the application. Further, it is expected to be demonstrated that the use of the research center mechanism is essential to accomplishing the scientific aims set forth in the application. In addition to narrative, evidence of components' interdependency should be summarized in a table. Organizational structure should be summarized in a diagram.

Funding Instrument	Cooperative Agreement
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	FDA intends to fund an estimate of 1-2 awards, corresponding to a total of $2,000,000 depending on the availability of funds.
Award Budget	Application budgets may request funding in the amount of up to $1,000,000 per budget year for up to 3 years. Awards are contingent upon the availability of funds. Future year amounts will depend on annual appropriations and performance.
Award Project Period	Maximum project period is 3 years. Future year amounts will depend on annual appropriations and performance.

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

MD and PhD granting institutions of higher education within a 50 mile radius of FDA's Silver Spring, Maryland campus, including:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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.

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.

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

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 objective review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.

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.

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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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 submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

PHS 398 Research Plan Components

• Introduction is limited to 1 page
• Specific Aims is limited to 1 page
• Research Strategy section is limited to 12 pages

Applicants must follow the instructions in the SF424 (R&R) Application Guide to develop the proposed project budget (not to exceed 3 years). Applicants must also provide a budget narrative/justification explaining the use of funds for major categories including, but not limited to salaries, raw materials, and equipment.

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

The research strategy section is limited to 12 pages and should include:

1. Clear benchmarks or milestones indicating progress.

For the purposes of this FOA, 3 components must be defined: core program support infrastructure, scientific exchanges/training for participating FDA and academic scientists and creation of new opportunities for collaborative regulatory scientific research with high public health impact. The guiding principle of milestone-driven research is to remain focused on a well-defined goal, thus achieving that goal with greatest efficiency. The use of milestones provides clear indicators of a project s continued success or emergent difficulties. Milestones are different from specific aims. The milestones must provide objectives and quantitative outcomes by which to justify advancing the project. The application must include a strong rationale for the choice of models, parameters, and quantitative go/no-go decisions to be made by those involved in the project, based upon accepted practices in the specific field. Once an application is funded, these benchmarks/milestones will be reviewed and evaluated by FDA as part of the non-competing award process.

2. Research Project Work Plan

The Research 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 WP 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, including a letter from the institution’s training/professional development director.

Identify appropriate resources such as equipment, facility, 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.

3. 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 the minimal 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 FDA Project Scientist and will include other FDA Project Scientist.

4. 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:

• Work with FDA to arrange for two meetings (agenda will be developed and approved with the FDA), during the course of the grant award to be held in the Washington, DC greater metro area;
• Cooperatively interact with FDA in support of the project and activities;
• Actively seek input from FDA regarding resource needs or expertise needs that may arise during the performance of the project.

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

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:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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.

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, NIH’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.

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.

Eligible organizations must provide an assurance that they will not accept funding for a CERSI project from any organization that manufactures or distributes products regulated by the Food and Drug Administration.

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.

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., PD/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:

• Updated Specific Aims or Research Strategy pages
• Late-breaking research findings
• New letters of support or collaboration that do not result from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator.

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

Reviewers will provide an overall score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence advancing regulatory science through all components of the project, including training and professional development/scientific exchanges and 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 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.

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 preventative interventions that drive this field? Do the training, professional development and research proposals address important needs and areas of regulatory science and will they inform future medical product development and regulatory decision-making? If the project 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?

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? Is there clear commitment, experience and capacity in the area of scientific/professional development, training and scientific exchanges? 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?

Does the application challenge and seek to shift current regulatory science and product development and evaluation paradigms by utilizing 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? Are there clear health benefits that would accrue from success of the program?

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?

Will the scientific and educational 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 and educational 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?

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.

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.

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.

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.

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.

Not Applicable

Not Applicable

Not Applicable.

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.

Not Applicable.

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 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.

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

Upon receipt, applications will be evaluated for completeness and compliance with this FOA by an assigned member of the FDA Grants and Assistance Agreements Team. Applications that are incomplete, nonresponsive, or otherwise not compliant with this FOA will not be forwarded for review.

Applications forwarded for review will be evaluated for scientific and technical merit by the appropriate Objective/Scientific Review Group(s), in accordance with FDA application review policies and procedures, using the stated review criteria.

As part of the objective review process, each application forwarded for review will receive a score and written critique.

Applications will be assigned to the appropriate FDA Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following objective review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. 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.

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

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

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’s 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.

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

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, 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 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.

• The awardee is responsible for submitting interim progress reports, when requested, to the FDA Project Scientist (PS) including summary data on progress to date.
• The awardee is responsible for preparing material for the two meetings involving participants from the FDA, to occur in the Washington, D.C. metro area.
• The awardee is encouraged to publish and publicly release and disseminate results, data and other products of the study, concordant with the study protocol and governance and the approved plan for making data and materials available to the scientific community and FDA. Awardee will work with the appropriate FDA staff to develop and implement an appropriate rapid data release policy.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies.

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) and other members of the FDA staff like the FDA Training/Exchange Liaison) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The responsibilities of the PS include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities that is above and beyond normal program stewardship for grants.

As appropriate, the PS will participate in the definition of objectives and approaches, and in planning, conducting, analyzing, and publishing results, interpretations, and conclusions of their studies.

However, the dominant role and prime responsibility for the activity reside with the awardees(s) for the project as a whole, but not necessarily for each task.

• In addition to the PS, a separate FDA Program Official (PO) will be responsible for the normal scientific and programmatic stewardship of the awar d 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 un der these awards.

The FDA Training/Exchange Liaison will be involved in the programmatic coordination and management of training, professional development and training-related scientific exchanges through mechanisms such as Fellowships. The responsibilities of the Liaison include involvement in identifying and developing training as well as developing and coordinating mechanisms for professional development and training-related scientific exchanges.

Areas of Joint Responsibility include:

As relevant, the PD/PIs 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 PD/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 PD/PIs 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.

The FDA and CESRI will work collaboratively to identify and coordinate training, professional development and training-related scientific exchange opportunities.

Dispute Resolution Process

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 a dispute resolution panel composed of three FDA staff members not involved in the study. One member will have voting rights, and the other two FDA designees will have expertise in the relevant area of experience. If there is a decision is unable to be reached, the first member may be chosen by the individual awardees.

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.

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

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 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 $25,000. See the HHS Grants Policy Statement for additional information on this reporting requirement.

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

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 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.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

Email: OC-OCS-Grants@fda.hhs.gov

Stephanie D. Bogan
Grants Management Specialist
Email: stephanie.bogan@fda.hhs.gov

Stephanie D. Bogan
Grants Management Specialist
Email: stephanie.bogan@fda.hhs.gov

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 Parts 74 and 92.