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Alliance to Support Integrated Public Health System Activities (U2F) Clinical Trials Not Allowed
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP) is announcing the availability of a cooperative agreement to be awarded under a Limited Competition.
FDA can guarantee one year of funding with the possibility of up to two years of additional,
non-competitive support, dependent on performance and continued availability of federal funds.
Only National Associations/Organizations representing State food regulatory programs as a primary purpose are eligible to apply for this funding opportunity.A primary goal of the FDA/ORA's Cooperative Agreement Program is to facilitate long-term improvements to the national food safety system by strengthening interagency collaboration, improving States' regulatory and surveillance protection programs for manufactured foods, conducting research, and promoting the Manufactured Food Regulatory Program Standards (MFRPS).
The FDA Food Safety Modernization Act (FSMA) gave FDA a new public health mandate.
The law applies to human food as well as to food for animals, including pets.
It directed FDA to establish standards for adoption of modern food safety prevention practices by those who grow, process, transport, and store food.
Congress recognized that the more than 3,000 state, local, and tribal government agencies involved in food safety which must be fully integrated in FDA’s work to fulfill FSMA’s mandate that consumers be protected by a food safety system based on prevention and risk.
This National Integrated Food Safety System will ensure the quality, consistency, and effectiveness of local, state, and federal efforts to protect the food supply.Effective leveraging of resources and harmonization of efforts will require extensive cooperation and coordination with FDA, national organizations and initiatives, State and local regulatory programs, and other food safety stakeholders.The Manufactured Food Regulatory Program Standards establish a uniform foundation for the design and management of State programs responsible for the regulation of food plants.
The elements of the program standards describe best practices of a high-quality regulatory program.
Conformance with these program standards will help Federal and State agencies better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods.The primary objectives of this cooperative agreement are:1) Assist FDA in meeting provisions of the FDA Food Safety Modernization Act;2) Support the efforts of Federal, State, and local government agencies to build a National Integrated Food Safety System;3) Establish systems for sharing, promotion, and collaboration of best practices, guidance documents, sampling plans, procedures, memorandums of understanding, and other tools to foster mutual reliance between Federal, State and local, manufactured food regulatory programs and public health agencies;4) Assist FDA in the identification, development, delivery, promotion, and/or attendance of food safety and defense training programs to support conformance with the MFRPS, training and stakeholder support provisions of FSMA;5) Support the advancement of the MFRPS and the Manufactured Food Regulatory Program Alliance (Alliance).Specific activities of this cooperative should be:1) Building an on-line program portal to serve as a learning exchange, subject matter expert registry, topical index of regulatory guidance, regulatory updates, and other information that impacts manufactured food regulatory programs.2) Building a user community and support data management and exchange between FDA and state regulatory agencies to promote conformance with human and animal food regulatory program standards.3) Providing forums to elicit, discuss and address concerns identified by State manufactured food regulatory programs relative to the MFRPS, food safety inspection contract, training, FSMA, and other activities impacting Federal-State relations.4) Updating and continuous improvement of a web-based directory of State and local food protection officials for use by Federal, State, local, tribal and territorial regulatory agencies.
Continuous improvement activities include expanding the directory to include new agencies and individual roles.
The directory should be maintained in an electronic format that is publicly available.
A system for maintaining the accuracy of the data should be developed and maintained.
At minimum, semi-annual verification of data and updates is anticipated.5) Providing support to the Manufactured Food Regulatory Program Alliance and other initiatives that advance an integrated public health system by:- Supporting a committee structure environment and encouraging involvement from State food program managers to assist in technical guidance solutions, implementing changes, and increasing sharing of best practices for the Manufactured Food Regulatory Program Standards.- Scheduling and hosting meetings (in-person and remote), establishing workgroups, recruiting members, recording meeting minutes, and other duties necessary to support the goals of the Alliance.- Maintaining the official repository of all documents created by the Alliance, such as meeting minutes, by-laws, governance structure, suggested changes to the MFRPS, and position statements.- Hosting of at least one annual face-to-face meeting (minimum of 3 days) to assist State and local manufactured food regulatory programs in achieving conformance with the MFRPS, including scheduling, meeting facilities, invitations, registration, materials, and AV needs and support.
Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda.
Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.- Providing administrative support to the Rapid Response Teams (RRT) Program’s annual face to face meeting (minimum of 3 days), including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting.
Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda developed by the RRT Face to Face Meeting Planning Committee.
Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.6) Providing administrative support to other meetings the grantee identifies that will support the advancement of an integrated food safety system, including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting.
Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda developed in conjunction with FDA.
Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.7) Providing administrative support to other meetings the grantee identifies, such as those of the Partnership for Food Protection (PFP) and Food Protection Task Force Alliance, that will support the advancement of an integrated food safety system, including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting.
Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda developed in conjunction with FDA.
Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.8) Supporting the training needs for State and local regulatory program’s conformance with regulatory standards and best practices in human and animal food by:Identifying, developing, delivering, and/or promoting food safety and defense training programs to support conformance with the MFRPS and provisions of FSMA.Providing financial assistance to State and local food regulatory programs to attend manufactured food training courses and other meetings, as needed.Conducting research in the form of surveys of State and local food regulatory programs and performing data analysis to determine the capabilities and capacity of an Integrated National Food Safety System.
The research should aim to quantify State and local food safety efforts, such as surveillance activities, regulatory actions pursued, and outbreak and emergency response activities.
Information on the infrastructure of State and local manufactured food programs may also be collected and studied, such as program resources, funding streams, regulatory structures and authorities, IT support, licensing protocols, use of general funds, and training requirements.
The grantee should anticipate performing at least 1 national survey including State and local food regulatory programs per budget period.
This information will be important for establishing an Integrated Food Safety System that is better able to control foodborne disease.Developing task-oriented guidelines to address issues that can be adopted or referenced by manufactured food regulatory programs.9) In support of FSMA, working with FDA to establish, participate, and promote operational partnerships that assist in building an Integrated National Food Safety System.
Operational partnerships may include other national associations, alliances (such as the Seafood HACCP Alliance and Preventative Controls Alliance), PFP, and Food Protection Task Forces (FPTF).10) Providing financial support for manufactured food regulatory programs to develop, host, or attend training courses, meetings, conferences, and other events that support building an integrated food safety system.
Examples include the MFRPA meeting, RRT meeting, Seafood HACCP Alliance, and training courses that support conformance with the MFRPS.
An application and approval process for subawarding of funds must be performed in collaboration with and approved by FDA.11) Provide support and outreach to colleges and universities to promote career paths and experiential learning in regulatory affairs and sciences.12) Provide support for advanced training or fellowship programs to promote experiential learning, applied research and mentorship in manufactured food regulation.13) Establish a system for continuous improvement of all activities being performed under this cooperative agreement.
The grantee should actively request feedback from State manufactured food programs on activities being performed under this cooperative agreement.
The feedback solicited should then be used to identify future activities.Other program objectives may be supported upon mutual agreement between FDA and the grantee.Applicants are strongly encouraged to identify additional activities that will support the goals and objectives of this cooperative agreement.
Baseline data, targets and performance measures for each activity should be included in the application.
The applicant should also suggest the reporting criteria for each activity
FDA can guarantee one year of funding with the possibility of up to two years of additional,
non-competitive support, dependent on performance and continued availability of federal funds.
Only National Associations/Organizations representing State food regulatory programs as a primary purpose are eligible to apply for this funding opportunity.A primary goal of the FDA/ORA's Cooperative Agreement Program is to facilitate long-term improvements to the national food safety system by strengthening interagency collaboration, improving States' regulatory and surveillance protection programs for manufactured foods, conducting research, and promoting the Manufactured Food Regulatory Program Standards (MFRPS).
The FDA Food Safety Modernization Act (FSMA) gave FDA a new public health mandate.
The law applies to human food as well as to food for animals, including pets.
It directed FDA to establish standards for adoption of modern food safety prevention practices by those who grow, process, transport, and store food.
Congress recognized that the more than 3,000 state, local, and tribal government agencies involved in food safety which must be fully integrated in FDA’s work to fulfill FSMA’s mandate that consumers be protected by a food safety system based on prevention and risk.
This National Integrated Food Safety System will ensure the quality, consistency, and effectiveness of local, state, and federal efforts to protect the food supply.Effective leveraging of resources and harmonization of efforts will require extensive cooperation and coordination with FDA, national organizations and initiatives, State and local regulatory programs, and other food safety stakeholders.The Manufactured Food Regulatory Program Standards establish a uniform foundation for the design and management of State programs responsible for the regulation of food plants.
The elements of the program standards describe best practices of a high-quality regulatory program.
Conformance with these program standards will help Federal and State agencies better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods.The primary objectives of this cooperative agreement are:1) Assist FDA in meeting provisions of the FDA Food Safety Modernization Act;2) Support the efforts of Federal, State, and local government agencies to build a National Integrated Food Safety System;3) Establish systems for sharing, promotion, and collaboration of best practices, guidance documents, sampling plans, procedures, memorandums of understanding, and other tools to foster mutual reliance between Federal, State and local, manufactured food regulatory programs and public health agencies;4) Assist FDA in the identification, development, delivery, promotion, and/or attendance of food safety and defense training programs to support conformance with the MFRPS, training and stakeholder support provisions of FSMA;5) Support the advancement of the MFRPS and the Manufactured Food Regulatory Program Alliance (Alliance).Specific activities of this cooperative should be:1) Building an on-line program portal to serve as a learning exchange, subject matter expert registry, topical index of regulatory guidance, regulatory updates, and other information that impacts manufactured food regulatory programs.2) Building a user community and support data management and exchange between FDA and state regulatory agencies to promote conformance with human and animal food regulatory program standards.3) Providing forums to elicit, discuss and address concerns identified by State manufactured food regulatory programs relative to the MFRPS, food safety inspection contract, training, FSMA, and other activities impacting Federal-State relations.4) Updating and continuous improvement of a web-based directory of State and local food protection officials for use by Federal, State, local, tribal and territorial regulatory agencies.
Continuous improvement activities include expanding the directory to include new agencies and individual roles.
The directory should be maintained in an electronic format that is publicly available.
A system for maintaining the accuracy of the data should be developed and maintained.
At minimum, semi-annual verification of data and updates is anticipated.5) Providing support to the Manufactured Food Regulatory Program Alliance and other initiatives that advance an integrated public health system by:- Supporting a committee structure environment and encouraging involvement from State food program managers to assist in technical guidance solutions, implementing changes, and increasing sharing of best practices for the Manufactured Food Regulatory Program Standards.- Scheduling and hosting meetings (in-person and remote), establishing workgroups, recruiting members, recording meeting minutes, and other duties necessary to support the goals of the Alliance.- Maintaining the official repository of all documents created by the Alliance, such as meeting minutes, by-laws, governance structure, suggested changes to the MFRPS, and position statements.- Hosting of at least one annual face-to-face meeting (minimum of 3 days) to assist State and local manufactured food regulatory programs in achieving conformance with the MFRPS, including scheduling, meeting facilities, invitations, registration, materials, and AV needs and support.
Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda.
Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.- Providing administrative support to the Rapid Response Teams (RRT) Program’s annual face to face meeting (minimum of 3 days), including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting.
Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda developed by the RRT Face to Face Meeting Planning Committee.
Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.6) Providing administrative support to other meetings the grantee identifies that will support the advancement of an integrated food safety system, including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting.
Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda developed in conjunction with FDA.
Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.7) Providing administrative support to other meetings the grantee identifies, such as those of the Partnership for Food Protection (PFP) and Food Protection Task Force Alliance, that will support the advancement of an integrated food safety system, including scheduling, meeting facilities, invitations, registration, materials, AV needs, and on-site support during the meeting.
Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda developed in conjunction with FDA.
Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination to identify strengths and opportunities for improvement in future meetings.8) Supporting the training needs for State and local regulatory program’s conformance with regulatory standards and best practices in human and animal food by:Identifying, developing, delivering, and/or promoting food safety and defense training programs to support conformance with the MFRPS and provisions of FSMA.Providing financial assistance to State and local food regulatory programs to attend manufactured food training courses and other meetings, as needed.Conducting research in the form of surveys of State and local food regulatory programs and performing data analysis to determine the capabilities and capacity of an Integrated National Food Safety System.
The research should aim to quantify State and local food safety efforts, such as surveillance activities, regulatory actions pursued, and outbreak and emergency response activities.
Information on the infrastructure of State and local manufactured food programs may also be collected and studied, such as program resources, funding streams, regulatory structures and authorities, IT support, licensing protocols, use of general funds, and training requirements.
The grantee should anticipate performing at least 1 national survey including State and local food regulatory programs per budget period.
This information will be important for establishing an Integrated Food Safety System that is better able to control foodborne disease.Developing task-oriented guidelines to address issues that can be adopted or referenced by manufactured food regulatory programs.9) In support of FSMA, working with FDA to establish, participate, and promote operational partnerships that assist in building an Integrated National Food Safety System.
Operational partnerships may include other national associations, alliances (such as the Seafood HACCP Alliance and Preventative Controls Alliance), PFP, and Food Protection Task Forces (FPTF).10) Providing financial support for manufactured food regulatory programs to develop, host, or attend training courses, meetings, conferences, and other events that support building an integrated food safety system.
Examples include the MFRPA meeting, RRT meeting, Seafood HACCP Alliance, and training courses that support conformance with the MFRPS.
An application and approval process for subawarding of funds must be performed in collaboration with and approved by FDA.11) Provide support and outreach to colleges and universities to promote career paths and experiential learning in regulatory affairs and sciences.12) Provide support for advanced training or fellowship programs to promote experiential learning, applied research and mentorship in manufactured food regulation.13) Establish a system for continuous improvement of all activities being performed under this cooperative agreement.
The grantee should actively request feedback from State manufactured food programs on activities being performed under this cooperative agreement.
The feedback solicited should then be used to identify future activities.Other program objectives may be supported upon mutual agreement between FDA and the grantee.Applicants are strongly encouraged to identify additional activities that will support the goals and objectives of this cooperative agreement.
Baseline data, targets and performance measures for each activity should be included in the application.
The applicant should also suggest the reporting criteria for each activity
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $3,000,000
Office: Food and Drug Administration
Estimated Funding: $3,000,000
Who's Eligible
Obtain Full Opportunity Text:
Full Announcement of RFA-FD-21-029 on NIH Guide for Grants and Contracts
Additional Information of Eligibility:
Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) This opportunity is only available to the following nonprofit food safety training entities that collaborate with 1 or more institutes of higher education:National organization/associations whose membership includes, but is not necessarily limited to, state, local, territorial, and/or tribal regulatory manufactured food professionals or government agencies and who collaborate with one or more institutions of higher education as defined in 21 USC §399(b).
Competition is limited to these national organizations/associations for the following reasons: National organizations/associations with membership that includes, but is not necessarily limited to, SLTT regulatory manufactured food safety professionals or government agencies will have the relationships and communication systems to effectively promote the objectives established under this cooperative agreement.
These national organizations/associations have a vested interest and share FDA’s visions to advance safety of manufactured foods and improve public health outcomes.
These national organizations/associations can best collaborate with FDA.
These national organizations/associations can provide a platform for sharing information and national implementation of the projects through national and regional meetings, web sites, listservs, and other communications.
Most national associations/organizations also have committees that may further advance the projects pursued by the subawardees
Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-21-029.html
Contact:
Agency Email Description:
gordana.zuber@fda.hhs.gov
Agency Email:
Date Posted:
2021-02-18
Application Due Date:
Archive Date:
2021-05-23
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