and Human Services (HHS)
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Participating Organization(s) |
U.S. Food and Drug Administration (FDA) |
Office of Regulatory Affairs |
|
Funding Opportunity Title |
Conformance with the Manufactured Food Regulatory Program Standards (MFRPS) (U18) |
Activity Code |
U18 Research Demonstration Cooperative Agreements |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-FD-12-007 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.103 |
FOA Purpose |
The intended outcome of this FOA is to advance efforts for a nationally integrated food safety system by assisting State manufactured food regulatory programs to achieve and maintain full conformance with the Manufactured Food Regulatory Program Standards (MFRPS). The MFRPS are intended to ensure that State manufactured food regulatory programs develop and maintain best practices for a high-quality regulatory program. Also, the program standards are intended to enhance food safety by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. Conformance with these program standards will help Federal and State programs better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods. In addition, State manufactured food regulatory programs that expect to achieve significant to full conformance with the MFRPS before Year 5 of the cooperative agreement may choose to develop and implement a Standard Enhancement Project (SEP). The SEP will further enhance the capacity of the State manufactured food regulatory program to protect public health and safeguard the food supply. |
Posted Date |
February 9, 2012 |
Open Date (Earliest Submission Date) |
February 15, 2012 |
Letter of Intent Due Date |
February 29, 2012 |
Application Due Date(s) |
April 16, 2012 |
AIDS Application Due Date(s) |
NA |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date(s) |
July 1, 2012 |
Expiration Date |
April 17, 2012 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the HHS Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
1. Program Objectives
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA),
Division of Federal-State Relations (DFSR) is announcing the availability of up
to $11,000,000 to be awarded under Limited Competition to State manufactured
food regulatory programs. The intended outcome of this FOA is to advance
efforts for a nationally integrated food safety system through the conformance
and advancement of the Manufactured Food Regulatory Program Standards (MFRPS) by State manufactured food regulatory programs.
The MFRPS allows for the development of risk-based food safety programs by establishing a uniform basis for measuring and improving the performance of State manufactured food regulatory programs in the United States. By achieving and sustaining conformance with these program standards, Federal and State programs can better direct their regulatory activities toward reducing foodborne illness hazards in food plants. Consequently, the safety and security of the United States food supply will improve.
The program standards are comprised of ten standards that establish requirements for the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. These elements include the program’s regulatory foundation, training program, inspection program, inspection audit program, food-related illness outbreak response, compliance and enforcement, industry and community relations, program resources, program assessment, and laboratory support.
Achieving and sustaining conformance with the program standards will require comprehensive self-assessment on the part of a State program and will encourage continuous improvement and innovation. FDA recognizes that the time required for full conformance of the program standards will vary between States. However, all State manufactured food regulatory programs will be expected to implement strategic plans to ensure continuous improvement and demonstrate that they are moving towards full conformance. State manufactured food regulatory programs receiving funds under this cooperative agreement will be expected to achieve significant to full conformance by Year 5 of the cooperative agreement.
Some programs may be able to achieve significant to full conformance with the MFRPS before Year 5 of the cooperative agreement based on previous enrollment in the MFRPS and current level of conformance. Programs that expect to be in significant to full conformance with the MFRPS before Year 5 of the cooperative agreement may choose to apply for less than 5 years of funding or may choose to develop and implement a Standard Enhancement Project (SEP). The SEP will be related to a standard that the State program is in significant to full conformance with. The SEPs are designed to help the State move their program further into public health protection and enhance the capacity they have established through conformance with a standard. The SEPs will also help to advance the MFRPS and integration of the national food safety system. The SEPs will vary in design, scope, and complexity. Possible project areas include: environmental sampling, collaboration through IT information sharing, Rapid Response Team (RRT) prototypes, risk based modeling, FDA certified State trainers, community outreach to targeted audiences, and innovative methods to capture, document, analyze and trend consumer complaint or enforcement action.
The outcomes of the work provided under this cooperative agreement are as follows:
1. State manufactured food regulatory programs will achieve and sustain significant to full conformance with the Manufactured Food Regulatory Program Standards (MFRPS), which is recognized as a critical element to creating a national, fully integrated food safety system.
2. State manufactured food regulatory programs will contribute to the continuous improvement of the MFRPS through attendance at an annual face-to-face meeting and active participation in committees supporting MFRPS.
3. Develop strategies for achieving and sustaining conformance with the MFRPS that can be duplicated on a national basis.
4. Provide FDA the foundation for pursuing regulatory action based upon the findings of State manufactured food regulatory programs.
5. Provide the State manufactured food regulatory program the ability to further enhance capability and protect public health through the development and implementation of Standard Enhancement Projects (SEP).
Only the following State manufactured food regulatory programs will be eligible to apply:
State manufactured food regulatory programs with current FDA food safety inspection contracts (providing funding to State agency food protection regulatory programs), or those that agree to enter into a food safety inspection contract with FDA at the earliest possible date, are eligible to apply for funding under this cooperative agreement. A condition of the award will be maintaining a current food safety inspection contract with FDA throughout the cooperative agreement project and budget periods. State manufactured food regulatory programs currently receiving funds through the Food Protection Rapid Response Team (RRT) Infrastructure Improvement Conformance (or Prototype) Project (referred to as the RRT Project) are not eligible to apply since achieving significant compliance with the Manufactured Food Regulatory Program Standards (MFRPS) is an expected outcome of the RRT Project.
A technical review session will be held for prospective recipients in February/March 2012. The conference call information will be provided to prospective grantees that submit a letter of intent. The technical review session will provide an overview of the submission requirements and allow prospective grantees an opportunity to ask questions regarding the application process. Participation in the technical review session is optional, but strongly encouraged.
The FDA will provide one year of funding with the possibility of up to four years of additional, non-competitive support, contingent on performance and continued availability of federal funds.
These funds are intended to supplement, not replace, State funding for program improvement and activities. State manufactured food programs funded under these cooperative agreements will be required to provide the previous, current, and subsequent years of State funding to demonstrate that these funds have not replaced State allocations.
2. Background
Over the past several years, the food safety system has continually encountered risks and emergencies of significant national concern. Multiple efforts have been undertaken at all levels, including consumers, industry, regulators, and even international organizations, to identify and implement improvements to the food safety system.
a. President’s Food Safety Working Group
An indication of the significant, national interest in food safety is the President’s Food Safety Working Group (FSWG), initiated in March of 2009. The charge of the FSWG is: To have safe food that does not cause us harm and to enhance our food safety systems by fostering coordination throughout the government including enhancing our food safety laws for the 21st century. These laws will be designed to keep the American people safe and will be enforced. Chaired by the Secretary of Health and Human Services and the Secretary of Agriculture, the FSWG recommends a public health-focused approach to food safety that prioritizes prevention, strengthens surveillance and enforcement, and improves response and recovery.
Furthermore, the FSWG has committed to work to modernize food safety by building collaborative partnerships with consumers, industry and our regulatory partners and through a transparent process, build a food safety system that will meet the challenges posed by a global food supply in the 21st century. These cooperative agreements will help to further achieve these goals by strengthening the food safety system in a way that will ultimately extend beyond state borders to have an impact on both national food safety and the associated international food supply.
b. National Integrated Food Safety System
FDA is continuing to work with its state partners to create a national, fully integrated food safety system that is characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system. Various initiatives, such as the Food Safety Task Force Program, Innovative Food Defense Program, and the programs supported by these cooperative agreements, work to engage partners across multiple sectors of the food safety system to collaborate to identify means to improve and optimize the nation’s food safety system.
c. Food Safety Modernization Act
The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. It also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. These include authorities such as mandatory recall, expanded administrative detention, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk foods. FSMA also gives FDA important new tools to hold imported foods to the same standards as domestic foods.
FSMA directs FDA to build an integrated national food safety system in partnership with State and local authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas, such as: reliance on Federal, State, and Local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and Local food safety and defense capacities.
d. Food and Drug Administration Amendments Act of 2007 (FDAAA)
FDAAA amended the FD&C Act to require FDA to work with the States to undertake activities to assist in improving food safety. Section 1004 of FDAAA states:
SEC. 1004. STATE AND FEDERAL COOPERATION
(a) IN GENERAL. The Secretary shall work with the States in undertaking activities and programs that assist in improving the safety of food, including fresh and processed produce, so that State food safety programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage States to
(1) Establish, continue, or strengthen State food safety programs, especially with respect to the regulation of retail commercial food establishments; and
(2) Establish procedures and requirements for ensuring that processed produce under the jurisdiction of State food safety programs is not unsafe for human consumption.
(b) ASSISTANCE. The Secretary may provide to a State, for planning, developing, and implementing such a food safety program
(1) Advisory assistance;
(2) Technical assistance, training, and laboratory assistance (including necessary materials and equipment); and
(3) Financial and other assistance.
(c) SERVICE AGREEMENTS. The Secretary may, under an agreement entered into with a federal, State, or local agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under this subsection may provide for training of State employees.
e. Import Safety Action Plan (ISAP)
The Import Safety Action Plan acknowledges the value of mutual leveraging of State and Federal resources and recommends consideration of cooperative agreements to increase information sharing. Specifically, the ISAP provides as follows:
Federal-State Rapid Response
Recommendation 12 Maximize Federal-State Collaboration.
The roles of and the resources used by the federal government and the States in import safety are complementary. States possess legislative authority and resources to respond to unsafe imported products within their jurisdiction. The federal government can take steps to interdict unsafe imported goods at ports-of-entry. Should an unsafe product enter domestic commerce, federal departments and agencies often work with State authorities to track it down, seize it, notify the public if it has already been purchased by consumers, and impose appropriate penalties on domestic entities who violate U.S. law. Also, both the federal government and States may have access to information relevant to protecting consumers that the other does not possess. For example, federal departments and agencies may have relevant information about the foreign source of the imported product and about the importer. This information can help State officials track down an unsafe imported product within their jurisdiction. On the other hand, State officials may identify an unsafe imported product during transport or at the point-of-sale, if the product does get into the country, and can tip-off federal officials to prevent future shipments from entering domestic commerce.
Several federal departments and agencies already collaborate closely with State authorities to protect consumers. For example, FDA has contracts and cooperative agreements with State governments to share information, conduct joint inspections, and collaborate on laboratory analyses. Greater mutual leveraging of State and federal resources can further enhance consumer protection.
12.1 Consider cooperative agreements between the federal inspection agencies and their State counterparts for greater information-sharing. Such cooperative agreements would not infringe on the statutory authorities of federal or State regulators and would encourage a coordinated effort that would result in a more rapid and effective response. Establishing clear procedures and points-of-contact for information sharing and joint enforcement efforts can further enhance the effectiveness of federal-State actions to limit exposure and potential harm to consumers if an unsafe imported product makes it into domestic commerce.
The food safety regulatory system in the United States is a tiered system that involves Federal, State, Local and Tribal governments. The Food and Drug Administration (FDA) is responsible for ensuring that all foods moving in interstate commerce, except those under United States Department of Agriculture jurisdiction, are safe, wholesome, and labeled properly.
State agencies conduct inspection and regulatory activities that help ensure that safe food is produced, processed, or sold within their jurisdictions. Many State agencies also conduct food plant inspections under contract with the FDA. These inspections are performed under the States' laws and authorities or the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or both. To maximize the use of resources among the FDA and the State governments, particularly when their jurisdictions overlap, their inspection programs should be equivalent in effect.
In June 2000, the Department of Health and Human Services' Office of the Inspector General (OIG) released a report of FDA's oversight of State contracts. In this report, the OIG recommended that FDA take steps to promote "equivalency among Federal and State food safety standards, inspection programs, and enforcement practices." In response to their findings, FDA established a committee to develop a set of quality standards for manufactured food regulatory programs. The committee was comprised of officials from FDA and from State agencies responsible for the regulation and inspection of food plants.
The Manufactured Food Regulatory Program Standards (MFRPS) establish a uniform foundation for the design and management of State programs responsible for the regulation of food manufacturing plants. The elements of the program standards describe best practices of a high-quality regulatory program. Achieving conformance with them will require comprehensive self-assessment on the part of a State program and will encourage continuous improvement and innovation.
The program standards are comprised of ten standards that establish requirements for the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. These elements include the program’s regulatory foundation, training program, inspection program, inspection audit program, food-related illness outbreak response, compliance and enforcement, industry and community relations, program resources, program assessment, and laboratory support.
FDA will use the program standards as a tool to improve food safety inspection contracts with jurisdictions. The program standards will assist both FDA and the State jurisdictions in fulfilling their regulatory obligations. FDA recognizes that full use and conformance of the program standards by State jurisdictions will take several years. Such jurisdictions will, however, be expected to implement strategic plans to demonstrate that they are moving toward full conformance. The goal is to implement a risk-based food safety program by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. The development and conformance of these program standards will help Federal and State programs better direct their regulatory activities at reducing foodborne illness hazards in food manufacturing plants. Consequently, the safety and security of the United States food supply will improve.
Leads: HHS / FDA, USDA, CPSC, EPA Time Frame: Long Term
12.2 Review admissibility policies to improve the use of evidence and laboratory results from State investigations of imported products. Currently, there are limitations on the use of State-developed evidence in federal court cases due to the gathering, analysis and retention of such evidence by non-federal government entities. Being able to use this evidence would make it easier for federal departments and agencies to take enforcement actions against bad actors.
Leads: DOJ, HHS / FDA, USDA, CPSC Time Frame: Short Term
These cooperative agreements are intended to follow the constructs of all the above in supporting the infrastructure of the State manufactured food regulatory programs and supporting laboratories to implement those activities and sustain them into the future.
FDA is offering these cooperative agreements to State manufactured food regulatory programs to achieve conformance with the manufactured food regulatory programs, which also consists of the implementation of a continuous assessment and improvement system within the State program. This includes work to revise strategic plans to achieve and sustain conformance with the 2010 version of the MFRPS in addition to future versions.
Funding Instrument |
Cooperative Agreement |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon FDA appropriations, and the submission of a sufficient number of meritorious applications. FDA intends to fund an estimate of 30 - 50 awards, corresponding to a total of up to $11,000,000, for fiscal year 2012. Future year amounts will depend on annual appropriations. FDA intends to commit up to $11,000,000 in FY 2012. Awards of no more than $300,000 per year will be given. Award is contingent upon FDA appropriations, and the submission of a meritorious application. Future year amounts will depend on annual appropriations and performance. |
Award Budget |
Application budgets are limited to up to $300,000 (direct and indirect costs) but need to reflect actual needs of the proposed project. |
Award Project Period |
The total project period for an application requesting support may not exceed five years. |
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.
Governments
This opportunity is only available to the following State food safety programs:
States manufactured food regulatory programs with current FDA food safety inspection contracts (providing funding to State agency food protection regulatory programs), or those that agree to enter into a food safety inspection contract with FDA at the earliest possible date, are eligible to apply for funding under this cooperative agreement. Competition is limited to these State manufactured food regulatory programs because the foundational work conducted under the current FDA food safety inspection contracts is necessary for the completion of significant improvements in a nationally integrated food safety system.
State programs receiving funds through the Food Protection Rapid Response Team (RRT) Infrastructure Improvement Conformance (or Prototype) Project (referred to as the RRT Project) are not eligible to apply since achieving significant compliance with the Manufactured Food Regulatory Program Standards (MFRPS) is an expected outcome of the RRT Project.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS
Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Director(s)/Principal Investigator(s) (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
least 4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(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 PD(s)/PI(s), visit the Multiple
Program Director(s)/Principal Investigator(s) Policy and submission details in
the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application
Guide.
This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.
Applicant organizations may submit only one application.
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.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Yemisi Akinneye
5630 Fishers Ln, Room 1098
Rockville, MD 20857
Telephone: (301) 827-0079
Email: Oluyemisi.Akinneye@fda.hhs.gov
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirement:
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, the electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Pre-award costs are allowable only as described in the HHS Grants Policy Statement.
These awards may only be used for achieving and sustaining conformance with the MFRPS and the development and implementation of Standard Enhancement Projects (SEPs) within State manufactured food regulatory programs currently under contract, or that will be entering into a contract at the earliest possible date, with the FDA to perform food safety inspections.
Allowable costs include:
1) Audiovisual materials such as videotapes, DVDs, public service announcements, etc.
2) Consultant services
3) Employee salaries, wages and fringe benefits
4) Rental, purchasing, calibration, and maintenance of supplies and equipment
5) Indirect costs
6) Recruitment costs for hiring new employees
7) Registration fees
8) Purchase or development of IT equipment, software, and support
9) Shipping and mailing of equipment and supplies
10) Travel
11) Speaker fees
12) Subcontracting to third parties (other than local/county/tribal agencies conducting work on behalf of the State manufactured food regulatory agency) is allowed but limited to 25% of each year's award.
Non-allowable costs:
1) Facilities, work, and training reimbursed under the FDA food safety inspection contract and other funding mechanisms must remain distinct and separate from the cooperative agreement. The State must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, under the food safety inspection contracts and other funding mechanisms and these cooperative agreements.
2) Vehicle purchases are not permitted.
3) Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.
4) Please also refer to the HHS Grants Policy Statement for additional information regarding costs.
Funding Plan:
Funding for years 2 through 5 will be noncompetitive continuation of support and depend on performance, program progress, and the availability of Federal funds.
Funds should be requested in the budget for key project personnel to travel to meetings, on-site visits, and audits with FDA program staff to discuss the project. A portion of budgeted travel funds should also be set aside for key personnel to attend an annual face-to-face meeting (as determined by FDA DFSR) and committee meetings supporting the MFRPS. Training needs should also be anticipated and budgeted for accordingly.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to FDA.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and responsiveness by the FDA. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the ORA Project Officer by email at wendy.campbell@fda.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
For applicants enrolled in the MFRPS for a minimum of 12 months, a copy of the baseline program self-assessment, strategic plan, and a description of the progress and accomplishments of the program in achieving conformance with the MFRPS should be included in the application. The baseline program self-assessment and strategic plan may be included as appendices. Also, applicants enrolled in the MFRPS for a minimum of 12 months should describe any identified or potential obstacles in achieving and sustaining significant to full conformance with the MFRPS and approaches to overcome these obstacles.
The applicant must specifically address the ability to achieve the following objectives in the cooperative agreement:
1. Demonstrate the ability to develop and implement a comprehensive strategic plan that will result in significant to full conformance with the MFRPS and sustainability after the cooperative agreement.
2. Demonstrate the ability to fully participate in initiatives supporting the MFRPS, such as an annual face-to-face meeting (as determined by FDA DFSR), committees, DFSR MFRPS conference calls, sharing of best practices, annual on-site visits, program assessment validation audits (PAVA), and full program audits.
3. Demonstrate the availability of adequately trained staff and the criteria and ability to hire and/or train personnel to meet the deliverables of the cooperative agreement.
4. Provide a properly detailed budget (one for each of the five years) that is intended to achieve conformance with the MFRPS. For applicants that choose to pursue a SEP, the budget should include funds for developing and implementing the SEP.
5. Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this announcement.
6. Provide the previous year and current funding level certification for the manufactured food regulatory program from State funding appropriations.
7. Outline a detailed methodology for program assessment, improvement, and collaboration to accomplish the work, as described in this announcement, and ensure program sustainability.
8. Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.
The project milestones provided below are based on new programs enrolling in the MFRPS. The FDA recognizes that achieving significant to full conformance with the MFRPS will vary by program based on multiple factors, such as previous enrollment in the MFRPS and current level of conformance. Applicants should adjust their project milestones to reflect their previous accomplishments and current conformance level with the Manufactured Food Regulatory Program Standards (MFRPS). In addition, for applicants that expect to achieve significant to full conformance prior to Year 5 of the cooperative agreement, the applicant may choose to apply for less than 5 years of funding or to propose a Standard Enhancement Project (SEP).
Project Milestones:
Year 1:
1. The State manufactured foods program must agree to enter into a food safety inspection contract with the FDA at the earliest possible date if not under a current food safety inspection contract. A current food safety inspection contract must be maintained throughout the cooperative agreement.
2. Participation in an on-site visit consisting of key State food regulatory program and FDA personnel to discuss the requirements of the MFRPS. Participation includes providing meeting space, accessibility of key State food regulatory program management and staff, and access to records, databases, and other materials supporting MFRPS conformance.
3. Attendance and participation of key State manufactured food program managers and staff in an annual face-to-face meeting, committee meetings, and other initiatives supporting national and program specific conformance with the MFRPS.
4. Conduct a comprehensive baseline self-assessment, including completion of all applicable appendices, worksheets, and other documents (or equivalent documents), required in each Standard.
5. Develop a strategic plan that will result in significant to full conformance with the MFRPS by Year 5 of the cooperative agreement. The strategic plan should include the following, at a minimum:
Year 2:
1. Participation in a program assessment validation audit (PAVA) conducted by FDA. Participation includes providing meeting space, accessibility of key State food program management and staff, and access to records, databases, and other materials supporting MFRPS conformance. The audit should reveal that FDA agrees with the program's self assessments and strategic plan.
2. Participation in an outreach training session led by FDA DFSR consisting of key State food regulatory program and FDA personnel to discuss the requirements of the MFRPS. Participation includes providing meeting space, accessibility of key State food regulatory program management and staff, and access to records, databases, and other materials supporting MFRPS conformance.
3. Attendance and participation of key State manufactured food regulatory program managers and staff in an annual face-to-face meeting, committee meetings, and other initiatives supporting national and program specific conformance with the MFRPS.
4. Implementation of the strategic plan. The strategic plan should be updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full conformance with the MFRPS. Progress achieved should indicate significant to full conformance with the MFRPS can be expected by Year 5. The strategic plan should include the following, at a minimum:
Year 3:
1. Participation in a program assessment validation audit (PAVA) conducted by FDA. Participation includes providing meeting space, accessibility of key State manufactured food regulatory program management and staff, and access to records, databases, and other materials supporting MFRPS conformance. The audit should reveal that FDA agrees with the state's self assessments, and strategic plan.
2. Participation in an outreach training session led by FDA DFSR consisting of key State food regulatory program and FDA personnel to discuss the requirements of the MFRPS. Participation includes providing meeting space, accessibility of key State food regulatory program management and staff, and access to records, databases, and other materials supporting MFRPS conformance.
3. Attendance and participation of key State manufactured food regulatory program managers and staff in an annual face-to-face meeting, committee meetings, and other initiatives supporting national and program specific conformance with the MFRPS.
4. Implementation of the strategic plan. The strategic plan should be updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full conformance with the MFRPS. Progress achieved should indicate significant to full conformance with the MFRPS can be expected by Year 5. The strategic plan should include the following, at a minimum:
Year 4:
1. Attendance and participation of key State manufactured food regulatory program managers and staff in an annual face-to-face meeting, committee meetings, and other initiatives supporting national and program specific conformance with the MFRPS.
2. Participation in an outreach training session led by FDA DFSR consisting of key State food regulatory program and FDA personnel to discuss the requirements of the MFRPS. Participation includes providing meeting space, accessibility of key State food regulatory program management and staff, and access to records, databases, and other materials supporting MFRPS conformance.
3. Implementation of the strategic plan. The strategic plan should be updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full conformance with the MFRPS. Progress achieved should indicate significant to full conformance with the MFRPS can be expected by Year 5. The strategic plan should include the following, at a minimum:
Year 5:
1. Attendance and participation of key State manufactured food regulatory program managers and staff in an annual face-to-face meeting, committee meetings, and other initiatives supporting national and program specific conformance with the MFRPS.
2. Participation in a comprehensive audit of the State manufactured food program to verify significant to full conformance with the MFRPS. Participation includes providing meeting space, accessibility of key food program staff, and access to records, databases, and other materials supporting the State program's full conformance with the MFRPS. Nonconformities identified in the audit should be addressed in the subsequent self-assessment and strategic plan.
3. Development of a plan identifying personnel, funding, and resources necessary to sustain significant to full conformance with the MFRPS.
Applicants are required to follow the instructions for post-submission materials, as described in HHS Grants Policy Statement.
Acceptable post submission materials include:
All applications submitted to the FDA are evaluated for scientific and technical merit through the FDA peer review system.
Only the review criteria described below will be considered in the review process.
1. The rationale and design to meet the goals and project milestones of the cooperative agreement (weight = 60%);
2. Have adequate program resources (especially staff) and infrastructure to complete project needs, or the ability to obtain adequate program resources (weight = 20%);
3. Demonstration that capabilities that can be sustained after the conclusion of the project period. Expected challenges should be documented and addressed (weight = 20%).
Note: Only the criteria and scoring described above will be used for scoring during the review of applications for this announcement. Reviewers may consider the additional criteria described under "Overall Impact" (below) as they relate to the criteria described above, but scores will not be given for the items described below.
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 preceding review criteria and additional review criteria (as applicable for the project proposed).
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.
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Panel, in accordance with HHS peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications:
Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will receive a copy of his or her Summary Statement (written critique).
Information regarding the disposition of applications is available in the HHS Grants Policy Statement.
If the application is under consideration for funding, FDA
will request "just-in-time" information from the applicant as
described in the HHS Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for HHS Grants website.
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
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 NIH grant administration policies.
Support will be in the form of a cooperative agreement. Substantive
involvement by the awarding agency is inherent in the cooperative agreement
award. Accordingly, FDA will have substantial involvement in the program
activities of the project funded by the cooperative agreement.
Substantive involvement includes, but is not limited to, the following:
The program project officer will monitor the recipient periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the recipient organization may also occur. There may be other regular meetings with recipients to assist in fulfilling the requirements of the cooperative agreement.
The purpose of these cooperative agreements is to advance efforts for a nationally integrated food safety system by assisting State manufactured food regulatory programs to achieve and maintain full conformance with the MFRPS. The MFRPS are intended to ensure that State manufactured food regulatory programs develop and maintain best practices for a high-quality regulatory program. In addition, State manufactured food regulatory programs that expect to achieve significant to full conformance with the MFRPS before Year 5 of the cooperative agreement may choose to develop and implement a SEP. The SEP will further enhance the capacity of the State manufactured food regulatory program to protect public health and safeguard the food supply. The cooperative agreements will provide funding for additional personnel, equipment, supplies, and training to support activities related to achieving conformance with the MFRPS and implementation of a SEP, if pursued.
The grantee must maintain a food safety inspection contract with the FDA throughout the cooperative agreement. State manufactured food programs funded under these cooperative agreements will be required to provide the previous, current, and subsequent years of State funding to demonstrate that these funds have not replaced State allocations. Key personnel (minimum of 2) will attend an annual face-to-face meeting (as determined by FDA DFSR) as a condition of the award. Facilities, work, and training reimbursed under the FDA food safety inspection contract and other funding mechanisms must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, under the food safety inspection contracts and other funding mechanisms and these cooperative agreements. Future funding will be dependent on recommendations from the Project Officer. The scope of the recommendation will confirm that acceptable progress has been made in achieving conformance with the MFRPS, implementation of a SEP (if pursued), continued compliance with all FDA regulatory requirements, and, if necessary, a corrective action plan has been implemented.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement for additional information on this reporting requirement.
Mid-year progress reports must contain the elements below as applicable to their proposal and award, but are not limited to, the following:
1. Detailed progress report on the grantee meeting the project milestones detailed in the cooperative agreement and identified in the proposal.
2. Status report on the hiring and training of food program personnel.
3. Certification of current State appropriation funding levels for the State manufactured food regulatory program.
Annual progress reports must contain the elements below as applicable to their proposal and award, but are not limited to, the following:
1. A strategic plan that accurately reflects when specific objectives and tasks have been, or will be, completed and/or implemented and when new objectives and tasks are identified to achieve full conformance with the MFRPS. Submission of a strategic plan will include the following at the minimum to demonstrate program advancement in achieving conformance with the MFRPS:
Note: For programs with less than 12 months of enrollment in the MFRPS, this information will be required after 12 months of enrollment in the MFRPS.
2. Description of program improvements and demonstration of measurable conformance with the MFRPS. Note: For programs with no previous enrollment in the MFRPS, this information will not be required until Year 2.
3. Detailed progress report on the grantee meeting the project milestones detailed in the cooperative agreement and identified in the proposal.
Additional reporting requirements: For programs with less than 12 months of enrollment in the MFRPS, submission of the baseline self-assessment, including applicable appendices, worksheets, and other documents required for each Standard, or equivalent alternate forms, and a strategic plan is required to be submitted after 12 months of enrollment in the MFRPS. Programs previously enrolled in the MFRPS for a minimum of 12 months should have submitted this information with their application.
The final program progress report must provide full written documentation of the project and summaries of accomplishments and goals, as described in the grant application. The documentation must be in a form and contain sufficient detail such that other State, local, and tribal governments could reproduce the final project. The final program progress report should also detail the strategy, including commitment of personnel, resources, and funding, to sustain conformance with the MFRPS (current and future versions). An independent audit of the program by FDA should verify the program is in significant conformance with the MFRPS.
Monitoring Activities
The ORA Project Officer and Technical Advisor will monitor award recipients periodically. The monitoring may be in the form of face-to-face meetings, telephone conversations, e-mails, or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the recipient organization will occur, including program assessments and audits. The results of these monitoring activities will be recorded in the official cooperative agreement file and will be made available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the Project Officer and Technical Advisor.
The scope of the recommendation will confirm that:
(1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; and (3) if necessary, there is an indication that corrective action has taken place.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Wendy Campbell
Project Officer
Food & Drug Administration
Office of Regulatory Affairs, Division of Federal-State
Relations
Phone: 615-310-0483
Email: Wendy.Campbell@fda.hhs.gov
Yemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: Oluyemisi.Akinneye@fda.hhs.gov
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov
Wendy Campbell
Project Officer
US Food & Drug Administration
Office of Regulatory Affairs, Division of Federal-State
Relations
Telephone: 615-310-0483
Email: Wendy.Campbell@fda.hhs.gov
NA
Yemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: Oluyemisi.Akinneye@fda.hhs.gov
Recently issued HHS policy notices may affect your application submission. A full list of policy notices published by HHS is provided in the HHS Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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