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Cooperative Agreement to Support the Western Center for Food Safety (U19)

Part 1. Overview Information


Department of Health and Human Services

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 with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

Components of Participating Organizations

Center for Food Safety and Applied Nutrition (CFSAN)

Funding Opportunity Title

Cooperative Agreement to Support the Western Center for Food Safety (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

New

Related Notices

None  

Funding Opportunity Announcement (FOA) Number

RFA-FD-13-023

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.103

Funding Opportunity Purpose

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2013 to the University of California-Davis to support the Western Center for Food Safety. The purposes of this continued support are to:

  1. Carry out multidisciplinary applied research that addresses "real world" issues related to food safety and food defense, agricultural practices , and the impact of agricultural practices on subsequent food processing associated with FDA-regulated products;

  2. Develop and implement outreach and communication programs with stakeholders to identify research needs and to facilitate the utilization of the knowledge produced by the research program;

  3. Provide opportunities to leverage additional resources among U.S. government agencies, non-governmental organizations, universities, industry, and consumers to achieve real-world solutions that address food safety and food defense issues.

  4. Support the implementation of the Food Safety Modernization Act through research, education, and outreach with particular emphasis on the science behind preventive controls associated with produce safety and good manufacturing practices

Key Dates

Posted Date
Date Published in the Federal

Letter of Intent Due Date(s)
Not Applicable

Application Due Date(s)
July 15, 2013)

AIDS Application Due Date(s)
Not Applicable

Scientific Merit Review
July, 2013

Advisory Council Review
Not Applicable

Earliest Start Date
September, 2013

Expiration Date
July 16, 2013

Due Dates for E.O. 12372
Not Applicabe

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate FDA’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contractsand on NIH’s Applying Electronically website.

Table of Contents


Part 1. Overview Information
Part 2. Full Text of 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  

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Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

The partnership between the WCFS and FDA over the past five years has been very productive in supporting FDA’s public health mission by conducting studies that address knowledge gaps surrounding the safe production of agricultural foods and education/outreach activities that provide the agricultural sector with information about food safety best practices.  With the enactment of the FDA Food Safety Modernization Act (FSMA) in 2011, the partnership has become increasingly important as FDA works to fulfill its mandate to develop a prevention based modern food safety system.  FSMA directs the Agency to develop and implement risk and science-based enforceable standards and enhance partnerships with its food safety stakeholders.  The Agency’s research strategy is focused on building the scientific foundation it needs to support the development and implementation of science based standards.   The strategy involves identifying and prioritizing its research needs based on its policy-making and implementation activities.  WCFS has played a critical role in conducting studies that were used to inform policy, including regulations that are being developed under FSMA, and will continue to do so as the Agency further implements FSMA activities.

FDA regards the development and strengthening of public- private partnerships to be a key element of its FSMA implementation strategy, which involves providing education and outreach to private industry about its food safety standards in order to build industry capacity to comply with these standards prior to conducting enforcement activities.  The Agency has a limited history with the agricultural community and seeks to use the strong relationships that academia has with this sector to facilitate education and outreach activities. The demonstrated ability of WCFS to successfully leverage resources through existing partnerships will continue to maximize the ability to achieve research, education and outreach objectives domestically and internationally with available funds.  The Agency is developing a technical assistance network that will be critical in providing technical assistance to the farming community in adopting and complying with components of FSMA. The WCFS is optimally situated to be a key player in this network to deliver quality technical assistance to a broad range of food safety stakeholders in the agricultural community.

A proposal is being solicited to assist FDA with fulfilling its strategic goal of protecting and promoting public health. This cooperative agreement will provide continued support so that WCFS can meet the following objectives:

Continue to conduct multidisciplinary applied laboratory, field, and educational research regarding the safety of agriculture production to generate practical solutions that can be implemented by the agricultural community and consequently, enhance food safety and food defense for FDA-regulated products.

Continue to develop and maintain communication with various stakeholders, domestic and international, involved in food production and food safety in order to identify food safety knowledge gaps and opportunities to leverage resources.

Continue to enhance technical assistance outreach and educational efforts through various channels, including seminars, presentations, serving on technical advisory boards and committees, and outreach through agriculture extension appointments.

Continue to engage in multi institutional collaborations to ensure that FDA has the most current, scientific thinking on best agricultural practices across varying agro-ecological landscapes.

Continue to assist the Agency in implementing food safety standards under FSMA.

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, FDA staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

CFSAN intends to commit up to $2 million in FY 2013

Award Budget

The estimated amount of support in FY2013 will be up to $ 2 million (direct plus indirect costs) with the possibility of four additional years of support, subject to the availability of funds.  Allowable cost increases of up to 4.6% per annum is allowed with an estimated amount of support of up to $ 2.4 million for the final year of the award.  Future year amounts will depend on annual appropriations and successful performance.

Award Project Period

The award will provide one year support and include future recommended support for four additional years, contingent upon satisfactory performance in the achievement of project and program objectives during the preceding year and the availability of federal fiscal year appropriations.

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.  

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Section III. Eligibility Information


1. Eligible Applicants

Eligible Organizations

The University of California - Davis (Davis), Western Center for Food Safety (WCFS)

Competition is limited to the WCFS because FDA feels that WCFS is uniquely qualified to fulfill the objectives outlined in the proposed cooperative agreement.  The program has demonstrated the adaptability necessary to address FDA’s evolving high priority public health issues.  This adaptability allows WCFS to successfully leverage resources across a variety of organizations including the United States Department of Agriculture – National Institute of Food and Agriculture, Center for Produce Safety, numerous industry boards, and also with universities across the country.  This has led to the expansion of the program and has also increased their visibility as a food safety resource thus propagating additional collaborations.  In addition, the WCFS locations at the Davis main campus and experimental stations provide invaluable access to one of the leading food production and food safety research institutions in the country with prominent researchers and access to agricultural producers, along with other public and private stakeholders.  This established Davis network allows WCFS to offer technical assistance that will aid in the protection of public health by increasing the adoption and understanding of guidance and policy.   

The WCFS has conducted research on diverse agriculture production issues of importance to the FDA including common routes of contamination on a farm, environmental contamination, and agricultural practices and possesses the ability to further expand their research into other production areas. The location of WCFS affords FDA the opportunity to obtain data from meaningful, field-based trials in an important food-producing area of the country.  WCFS access to field sites for experimental trials is instrumental to FDA receiving the most current scientifically validated information that relates to actual agricultural conditions.  The WCFS has established research collaborations with research institutions throughout the US including Florida, Arizona, Georgia, Ohio, and Hawaii to study the agro ecological differences that may impact food safety in the agricultural sector.  WCFS has also made available research tools that can be utilized by all research institutions that could facilitate industry compliance with preventive control standards.  Information gleaned from this research has been made publicly available and has been useful to domestic and international stakeholders and often translates into proactive, science-based preventive controls.  FDA has utilized this information when developing policy aimed at fulfilling its public health mission.  Industry boards and grower groups have also incorporated WCFS generated information into their national and regional food safety guidance documents.

The WCFS has also effectively provided extensive technical outreach and education through participation on high profile advisory boards/panels covering diverse agricultural topics including but not limited to good agricultural practices, tree nuts, veterinary science, and specialty crops that span across the US.   Additionally, the WCFS regularly outreaches to the agricultural community through conferences and meetings to provide information about best practices.  Finally, the WCFS and FDA have also provided opportunities for post-graduates to be trained and mentored by WCFS and FDA scientists in areas of field, laboratory, and educational research. 

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 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.

  • System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations.  See the Grants Registration User Guide at SAM.gov for additional information.

  • eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) 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 least6 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(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 PHS 398 Application Guide.

This cooperative agreement program requires that the applicant substantially share in the project costs if an award is made, including, but not limited to, partial salary support for administrative staff and in-kind support (e.g., faculty salaries and facilities costs).

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number) is allowed. 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.

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Section IV. Application and Submission Information


1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 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

Not applicable

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

  • Overall: 12 pages
  • Research Project: 12 pages
  • Core: 12 pages
Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

  1. Gladys Melendez
    Food and Drug Administration
    Division of Acquisition and Grant Services
    5630 Fishers Lane, Rm. 1078
    Rockville, MD 20857
    240-731-3905; Email: gladys.bohler@fda.hhs.gov

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

  1. Kevin W. Robinson
    Extramural Resource Specialist
    Food and Drug Administration
    Center for Food Safety and Applied Nutrition (CFSAN)
    CPK1, Rm. 4C035, HFS-650
    5100 Paint Branch Parkway
    College Park, MD 20740
    Telephone: 240-402-2118
    Kevin.robinson@fda.hhs.gov

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall
  • Administrative Core
  • Cores
  • Projects

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

  1. Face Page (Overall)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

    Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Table of Contents (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Detailed Budget for Initial Budget Period (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Budget for Entire Proposed Period of Support (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Biographical Sketch (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Resources (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Research Plan (Overall)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

    Specific Aims:

    Research Strategy:

    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 PHS 398 Application Guide.

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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Core or Project

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

  1. Face Page (Core or Project)

    All instructions in the PHS 398 Application Guide must be followed.

    Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Core or Project)

    All instructions in the PHS 398 Application Guide must be followed.

    Table of Contents (Core or Project)

    All instructions in the PHS 398 Application Guide must be followed.

    Detailed Budget for Initial Budget Period (Core or Project)

    All instructions in the PHS 398 Application Guide must be followed.

    Budget for Entire Proposed Period of Support (Core or Project)

    All instructions in the PHS 398 Application Guide must be followed.

    Biographical Sketch (Core or Project)

    All instructions in the PHS 398 Application Guide must be followed.

    Resources (Core or Project)

    All instructions in the PHS 398 Application Guide must be followed.

    Research Plan (Core or Project)

    All instructions in the PHS 398 Application Guide must be followed.

    Specific Aims:

    Research Strategy:

    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 PHS 398 Application Guide.

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix for the Entire Applicatoin

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide, with the following modifications:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 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.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Food Safety and Applied Nutrition components of participating organizations, FDA. Applications that are incomplete and/or nonresponsive will not be reviewed.

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Requests of $500,000 or more for direct costs in any year 
Post Submission Materials

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

For the majority of applications submitted for the September 25, 2010 receipt date and thereafter, the only post-submission grant application materials that the FDA will accept are those resulting from unforeseen administrative issues?  Post-submission grant application materials are those submitted after submission of the grant application but prior to the initial peer review.  This option is to be used when an unexpected event such as the departure of a participant, natural disaster, etc. has occurred, not to correct oversights/errors discovered after submission of the application.

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 policy on font size, margins, and paper size as referenced in Part I.2.6 of the applicable application instructions.  Additional form pages such as budget, biographical sketches, and other required forms must follow 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
Exceptions:

Applications submitted in response to Requests for Applications (RFAs) that have only one due date:
Updated Specific Aims or Research Strategy pages, late-breaking research findings and new letters of support or collaboration will be allowed.

If the application has subprojects or cores, the page limits for post-submission materials follow the page limit of the Research Strategy of each subproject or core, as indicated above.

Deadline

Post-submission materials must be received by the FDA CFSAN Project Officer one month (30 calendar days) prior to the peer review meeting. Post-submission materials will not be accepted if fewer than 30 calendar days remain before the peer review meeting.

Authorized Organization Representative (AOR) concurrence:

Concurrence from the Authorized Organization Representative (AOR) of the applicant organization is required.  Although the content of post-submission materials may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or organizational officials, the AOR must send the materials directly to the PO, or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the PO.  A communication from the PD/PI only or with a “cc” to the AOR will not be accepted.

Instructions

Submission via email of post-submission materials as a PDF attachment is strongly encouraged, whether the original application was submitted on paper or through Grants.gov. FDA recommends producing the documents electronically using text or word-processing software and then converting the documents to PDF. This will allow the text to be searched electronically (i.e., do not scan files that have text as an image, scan as text file only).

Section V. Application Review Information


1. Criteria

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 in support of biomedical and behavioral research are evaluated for scientific and technical merit through the FDA Ad Hoc Review Process.

Overall Impact - Overall

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).

Scored Review Criteria - Overall

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.

  1. 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 are improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

  2. Investigator(s)

    Are the PD(s)/PI(s), 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?  

  3. Innovation

    Does the application challenge and seek to shift current research or clinical practice 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?   

  4. Approach

    Are the overall strategy, methodology, 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?   

  5. 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?

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Additional Review Criteria - Overall

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific and technical merit and the priority score. The ad hoc panel of experts will evaluate the application based on the extent to which it demonstrates or advances the following scientific and technical criteria:

An understanding of the purpose and objectives of the cooperative agreement regarding the collaborative research, education, and outreach programs;

A clear description of the processes and structures that will be used for administering, planning, implementing, and accomplishing the activities to be carried out under the cooperative agreement;

The applicant's documented ability to perform the responsibilities under the cooperative agreement, including the availability of appropriate staff and sufficient funding;

How the applicant will monitor progress of the work under the cooperative agreement and how progress will be reported to FDA;

The interactions that will take place with FDA throughout the life of the project;

The formation and role of an external advisory/oversight board or panel; if any are proposed

A business plan that includes a long-term program to ensure sustainability of the program; and

A clear and detailed budget that, at a minimum, captures the anticipated costs allowable and allocable to the project and the sources of funds that will meet those needs.

  1. 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

    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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

    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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    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 - Overall

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.

  1. 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 Plan

    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.

    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 Committee in accordance with FDA review policy and processes, using the stated review criteria.

As part of the Ad Hoc review, all applications:

  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned to the appropriated Center. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.

  • Availability of funds.

  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

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

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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’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, SAM Registration, and Transparency Act requirements.

Prior Approval of Pilot Projects

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by FDA prior to initiation. 

  • The awardee institution will provide FDA with written study protocols that address risks and protections for human subjects in accordance with PHS 398 Application Instructions.

  • The awardee institution will provide FDA with specific plans for data and safety monitoring, and will notify the IRB and FDA of serious adverse events and unanticipated problems, consistent with the policies noted on the attached NIH information resources NIH DSMP policies.

2. Administrative and National Policy 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 OMS administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74, 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 of 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 the FDA as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for and dominant role in planning, directing, and executing the proposed program, with the FDA staff being substantially involved as a partner with the PI.

The Principal Investigator will have primary responsibility for the financial management of program funds to adhere to the mission of the program as determined by the bilateral partnership.

Awardees will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.

2. A.2. FDA Responsibilities

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

The program project officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the project officer/grants management officer and the Principal Investigator.  Periodic site visits with officials of the grantee organization may also occur.  The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request, consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those that state that future funding will depend on recommendations from the project officer.  In addition,

  1. FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee, as well as, any collaborative structure between WCFS and any other entities.

  2. FDA will be directly involved in the guidance and development of the program and the collaborative structure for the program.

  3. FDA scientists will participate, with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) 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.

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Section VII. Agency Contacts


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

Application Submission Contacts

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)
Telephone 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Samir K. Assar, PhD
Project Officer
Food and Drug Administration
5100 Paint Branch Parkway
CPK1, Rm. 3A0001, HFS-317
College Park, MD 20740
Telephone: 240-402-1636
samir.assar@fda.hhs.gov

Peer Review Contact(s)

Kevin W. Robinson
Extramural Resource Specialist
Food and Drug Administration
Center for Food Safety and Applied Nutrition (CFSAN)
5100 Paint Branch Parkway
College Park, MD 20740
Telephone: 240-402-2118
Kevin.robinson@fda.hhs.gov

Financial/Grants Management Contact(s)

Gladys Melendez Bohler
Grants Management Specialist
Food and Drug Administration
Division of Acquisition Support and Grants
5630 Fishers Lane, Rm. 1078, HFA 500
Rockville, MD 20857
Telephone: 301-827-7175
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 Part 52 and 45 CFR Parts 74 and 92.

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