Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration (FDA)

The FDA does not follow the NIH Page Limitation Guidelines or the 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

Office of Regulatory Affairs (ORA)

Funding Opportunity Title

Assisting the Integrated Food Safety System's  National Food/Feed Training Program (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-11-028

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

FDA, the United States Department of Agrictulture, the Centers for Disease Control, and our State, local, territorial, and tribal regulatory and public health partners are working collaboratively to establish an integrated food safety system. One of the critical elements to this integrated food safety system is to ensure a competent work force doing comparable work at the international, federal, state, local, territorial, and tribal levels. FDA will work with its regulatory partners to develop uniform national standards, including inspection, investigation, and testing protocols; training and certification requirements; program audit criteria; and performance metrics to ensure program objectives are met.

For successful implementation of a training and certification system of this magnitude, the federal/state/local/territorial/tribal regulators must have a clear understanding of knowledge and skills necessary to support the various career tracks (e.g., investigator/inspector, compliance officer, and manager), as well as the necessary training standard and the necessary requirements for each career track.

Key Dates
Posted Date

July 7, 2011

Letter of Intent Due Date

 Not Applicable

Application Due Date(s)

July 30, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August, 2011

Advisory Council Review

September, 2011

Earliest Start Date(s)

September, 2011

Expiration Date

July  31 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. 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.

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

FDA will work to plan and implement an inspection and enforcement program to ensure high rates of compliance with the Agency's food safety standards.  By working with federal, state, territorial, and local regulatory and public health partners, FDA aims to establish a fully integrated food safety system (IFSS) built on collaboration among all of these partners.  The system will encompass inspections, laboratory testing, and response and will place priority on preventing foodborne illness, in both food for humans and animals, through the adoption and uniform application of model programs, such as Manufactured Food and the Retail Food Regulatory Program Standards and other appropriate program standards.  This collaboration will result in 1) better ability to assess potential risk at domestic food facilities and greater and more consistent inspectional coverage of these facilities across the entire food supply chain, 2) greater food surveillance through integration of food facility inspection and testing information, and 3) improved rapid response capacity and efficiency.

Under this system, FDA and Federal, State, territorial, tribal, and local regulatory agencies will conduct food facility inspections under the same set of standards.  FDA will work with its regulatory partners to develop uniform national standards, including inspection, investigation, and testing protocols; training and certification requirements; program audit criteria; and performance metrics to ensure program objectives are met.  System integrity and credibility will be maintained through regular program oversight and accountability at all levels.  Federal and state inspections will be conducted in accordance with a public health risk driven national work plan that FDA will develop with its regular partners.  An integrated system will result in more coordinated response efforts to better respond to multi-state outbreaks when they occur.

For successful implementation of a training and certification system of this magnitude, the federal/state/local/territorial/tribal regulators must have a clear understanding of knowledge and skills necessary to support the various career tracks (e.g., investigator/inspector, compliance officer, and manager), as well as the necessary training standard and the necessary requirements for each career track.

The expectation is that the awardee will work to assist FDA and our other regulatory and public health partners in reaching the goal of ensuring a competent workforce doing comparable work at all levels of the integrated food system via the national food/feed training system.  The awardee will have the opportunity to assist the IFSS in the design, development, delivery, and maintenance of a national food/feed training program.

Proposed Projects for the awardee:

The awardee will pursue American National Standards Institute (ANSI)/International Association for Continuing Education and Training (IACET) accreditation.  Through the pursuit of this accreditation, the awardee will establish the quality standards that must be met for both individual training courses and instructors. These quality standards will be used to identify Centers of Excellence that would provide training courses to satisfy core curriculums.  ANSI/IACET accreditation will serve as the standard to be met for all courses requiring CEU (CONTINUING EDUCATION UNITS) credits.

The awardee will develop an implementation plan detailing how it will assist in meeting the goals of the national food/feed training system. The plan will address the resources necessary to support the awardee's activities.  Information such as budget, staffing, record retention and storage will be addressed in the plan.  The plan will serve as a focal point for administrative functions, including, but not limited to, administering the registration of students and assisting in the maintenance of training records.  Included in the plan will be the type of learning management system envisioned and the security and integrity measures needed to implement the system nationwide.

The awardee will develop and maintain an inventory of available food/feed training courses.  All courses listed will be required to have course objectives and must meet specific competencies and tasks identified in an existing core curriculum or national standard.  Each course will be identified as far as the specific core curriculum or standard being addressed and the level it is addressing (Entry, Journeyman, Specialist/Expert).

The awardee will develop an application process for qualifying courses in accordance with the quality standards.  This will allow the awardee to identify "Best Training Programs".  The awardee will review the courses based on the application process to identify those that meet the quality standard.  Courses listed in the inventory will address:  Food GMPs, Food Security, Food Sanitation, Manufacturing Food Standards, and Retail Food Standards, the manufacturing of Low Acid Canned Food Products, Acidified Food Products, and Seafood HACCP.  The awardee will maintain a list of training courses that meet the quality standard.  The courses will list the specific competencies and tasks covered by the appropriate curriculum.

The awardee will identify those training courses in the inventory that could be offered through distance learning.  This would also include courses that could be shortened as far as face to face time by the incorporation of distance learning.  The awardee will address how the information would be marketed and delivered nationwide and will include the estimated resource costs.  This distance learning plan should be consistent with the blended learning approach outlined in FDA's "Visionary Plan for Food Safety Training and Certification".

The awardee will work with FDA and other partners to identify the core competencies and job tasks associated with food safety inspections at the basic, journeyman, and specialty/expert levels.  Once identified The awardee will use the information to ensure that their approved training courses are appropriate for the specific competencies and tasks required.

The awardee will identify core competencies and tasks that are not covered by approved existing training.  Once the gaps are identified the awardee will work with FDA to identify and/or develop the necessary courses to address the gap(s).

The quality standard developed by the awardee will provide qualifications for instructors.  Qualified instructors must be knowledgeable/technically competent in specific fields of expertise as dictated by the course objectives identified in the blue print for the training course being presented.  The awardee will maintain a list or registry of qualified instructors by subject area.

The awardee will maintain a list of approved training courses and instructors.  The list will be published and made readily available for Federal, State, local and tribal Food Safety personnel, when requested.

**Awardees are required to accept and implement the common protocol and procedures approved by the FDA"

The primary focus of the awardee/FDA collaborative venture is to design, develop and disseminate food/feed safety training programs that are consistent with the Manufactured and Retail Food Standards, as well as 3rd party criteria for accreditation.  This collaborative venture will have a special emphasis on public health safety according to the needs of the FDA and our regulatory and public health counterparts. The primary areas of training will be technical and management areas.  If the IFSS training program is to be successful, there must be a recognized standard curriculum that every Federal, State, local, tribal and territorial public health agency should have access to and complete.

This cooperative agreement will define the necessary projects, quarterly updates, continued partnerships with academia, and trade organizations for continued FDA and awardee collaboration toward a fully functional national integrated food safety training program.  This cooperative agreement will also provide continued support with the result that FDA and awardee can:

Design, develop, and implement the IFSS related to training and development;

Develop a National Food Safety Curriculum at all programmatic levels (inspector, management, leadership) and build/improve existing course contents to meet or exceed 3rd party accreditation standards, as necessary;

Create networking and trust among members of the food protection community, a necessary foundation when developing a national integrated food safety training program.

There is a growing need for food safety training programs with a specific emphasis on assisting in the development of a national curriculum at inception of the IFSS program.  FDA is committed to the IFSS approach and the support of a national food/feed training program.  This project should also incorporate, where possible, the requirements for training set forth in section 209(a) of the FDA Food Safety Modernization Act, which is consistent with the IFSS Training and Certification vision.

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
Revisions

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Office of Regulatory Affairs intends to award up to three awards up to $1,300,000.00 each in FY11.  Additional FY funding subject to availability of funds.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

The maximum possible project period is 5 years contingent upon the availability of funds, performance, and project progress.

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

Higher Education Institutions

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

For profit Organizations

Governments

Other

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

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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 PHS398 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. 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 PHS398 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.

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, to:

Gladys M. Bohler
Grants Management Officer/Specialist
Food and Drug Administration
Office of Acquisitions and Grant Services
5630 Fishers Lane, Rm. 1078; HFA 500
Rockville, MD 20857
Telephone: 301-827-7175
Email: gladys.bohler@fda.hhs.gov

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

James Fear
Food and Drug Administration
ORA/DHRD Training Manager
11919 Rockville Pike
Rockville, Maryland  20852
301-796-4513 (office)
301-827-8708 (fax)
Email: james.fear@fda.hhs.gov

Page Limitations

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:

Research Plan

All instructions in the PHS398 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, an d Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

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 PHS398 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

Upon receipt, applications will be evaluated for completeness by the Grants Management contact and responsiveness by ORA. Applications that are incomplete and/or nonresponsive will not be reviewed.

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., 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.

Section V. Application Review Information

1. Criteria
 
Overall Impact - Overall

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 - 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.

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?

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?

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 

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? 


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?

Additional Review Criteria - Overall

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

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

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/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

As applicable or relevant, 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

As applicable or relevant, 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).

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 Scientific Review Group(s), in accordance with FDA Ad Hoc review policy and procedures, using the stated review criteria.

As part of the scientific peer reviews, all applications:

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

3. Anticipated Announcement an d 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. 

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 awardee 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 as noted on the Award Conditions and Information for NIH Grants website.

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 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 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 awardees 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.

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

The FDA PS 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, interpretations, and conclusions of the project activity. 

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, or in the absence of  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 project.  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 PD/PI(s) and the PS in collaboration with PO will work collaboratively in evaluating the most appropriate methods, data quality control strategies, and implementation, data analysis and interpretation, publication and dissemination of project activity and 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 PD/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 is encouraged as appropriate.

Dispute Resolution:

Any disagreements that may arise in 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 academic members who are not involved in the study will be convened.  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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH 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.

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

Scientific/Research/Ad Hoc Review Contact(s)

James Fear
Food and Drug Administration
ORA/DHRD Training Manager
11919 Rockville Pike
Rockville, Maryland  20852
301-796-4513 (office)
301-827-8708 (fax)
Email:  james.fear@fda.hhs.gov

Financial/Grants Management Contact(s)

Gladys M. Bohler
Grants Management Officer/Specialist
Food and Drug Administration
Office of Acquisitions and Grant Services
5630 Fishers Lane, Rm. 1078; HFA 500
Rockville, MD 20857

Section VIII. Other Information

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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