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

Alliance for Advancing a National Integrated Food Safety System (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-11-031

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

This Funding Opportunity Announcement (FOA) is issued to announce the availability of cooperative agreements to be awarded under a Limited Competition. 

The 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, and providing assistance to state legislatures.  This will be accomplished through the provision of funding for program improvement and will require extensive cooperation and coordination with FDA program offices.  Effective leveraging of resources and harmonization of efforts will require collaboration with relevant initiatives, including those of federal partners, national initiatives and associations, state, and local partners.

Key Dates
Posted Date

June 14, 2011

Open Date (Earliest Submission Date)

June 14, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

July 13, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

Standard dates

Advisory Council Review

Standard dates

Earliest Start Date(s)

August 15, 2011

Expiration Date

July 14, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or the 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 cooperative agreements to be awarded under a Limited Competition.  Only National Associations/Organizations that currently or previously have received funding under a cooperative agreement with a federal agency such as FDA, CDC or USDA to support food safety are eligible to apply for this five year award.   National Associations/Organizations have the membership, resources, structure, and expertise necessary to build national consensus amongst state and local agencies on key food safety issues.  They are the primary means for communication and collaboration on issues of national significance for state and local agencies.  The outcomes are position statements, resolutions, and legislation that are uniformly supported by state and local agencies.  National Associations/Organizations are also viewed as primary sources for educational opportunities and current information, such as proposed legislation and emerging food safety issues.  Up to two associations will be selected for funding under this cooperative agreement.  FDA can guarantee one year of funding with the possibility of up to four years of additional, non-competitive support, dependant on performance and continued availability of federal funds. 

The goal of this cooperative agreement program is to facilitate long term improvements to the national food safety system by strengthening collaborations, improving the states regulatory and surveillance protection programs for manufactured foods and provide assistance to state legislatures.  This will be accomplished through the provision of funding for program improvement and will require extensive cooperation and coordination with FDA/ORO/ORA/DFSR, FDA District Offices and other FDA program offices.  The outcome of the work provided under this cooperative agreement would be as follows:

1.  Assist FDA in meeting provisions of the Food Safety Modernization Act;

2. Support the efforts of federal, state, and local government agencies to

integrate the national food safety system;

3. Implement pilot projects between states and FDA Districts for the purpose

of demonstrating effective integration of resources and authorities;

4. Establish a network system to better access and share food safety

information and data;

5. Assist FDA in the identification, development, and/or delivery of food safety and

defense training programs;

6. Support the advancement of the Manufactured Food Regulatory Program

Standards (MFRPS); and

7. Conduct a national meeting of state food safety manufactured food

program managers and FDA officials as needed, but not less than

annually to address Alliance issues.

The national associations /organizations eligible to apply for funding under this cooperative agreement should have the unique qualifications detailed below that will enable them to conduct the work specified under this cooperative agreement.  The association must meet the unique qualifications as specified in either category below to include: 

Category 1.  The association/organization must be a national organization that represents State and Local food protection regulatory agencies.  The association’s principle purpose must be to act as a leader and a resource to state and local regulatory agencies in developing strategies to resolve and promote public health and consumer protection related to the regulation of foods, drugs, medical devices and consumer products.  Additionally, the association must have a unique perspective on the infrastructure, capacity, strengths and needs of State and Local food protection programs.  The association must have successful experience in carrying out national efforts that focus on the needs of State and local regulatory agencies and have developed training programs or other initiatives with CDC, USDA and others.   The association must have developed, maintain and house a web based directory such as one for state and local officials for use by federal, state, local, tribal and territorial regulatory agencies as well as regulated industry to obtain up-to-date contact information for state and local regulatory agencies.  The association must be comprised of regular members that are officials of State and Local regulatory agencies that administer manufactured foods inspection programs in conjunction and in collaboration with FDA.

Category 2.  The association/organization must serve as a bipartisan organization of, by and for state legislatures.  The association must be dedicated to serving all state legislators and legislative staff through research, publications, consulting assistance, meetings, seminars and electronic services.  The association must serve to improve the quality and effectiveness of state legislatures and promote policy innovation and communication among state legislatures.  The association must have demonstrated work toward improving the quality and effectiveness of state legislatures and promoting policy innovation and communication among state legislatures.  Additionally, the association must have demonstrated partnering with federal agencies such as CDC, EPA and USDA to improve state policymaking and aid state legislatures in food safety efforts.

Through this cooperative agreement the selected associations shall furnish the necessary personnel, materials, services, facilities do all things necessary for or incidental to provide FDA assistance in governing regulatory food programs in the United States and Territories.  This will support the state adoption and implementation of Manufactured Food Regulatory Program Standards by soliciting inclusion from any state jurisdiction which has regulatory authority for a manufactured food program. 

As described in greater detail in section IV. 6 below, the associations/organizations will provide through this cooperative agreement, some but not all of the following:

a.  Establish a network of State manufactured food program managers to include annual  program managers meetings.

b.  Conduct surveys of State manufactured foods programs.

c.  Tracking of state and local food Laws and Regulation that extend beyond the requirements of the Food, Drug and Cosmetic Act and regulations enforced by FDA.

d.  Develop Task Oriented Guidelines to Address Issues that can be adopted or into State/Local/Tribal food manufacturing programs.

e.  Identify and Support pilot programs in  manufactured food programs as needed.

f.  Provide community - building/networking structure to serve as a learning exchange, subject matter expert registry, maintain topical index of regulatory guidance and program manager portal. 

g.  Identify and coordinate training activities with FDA or other entities such as IFPTI or Cooperative Extension offices.

h.  Update, enhance and improve a web based directory such as one for state and local officials for use by federal, state, local, tribal and territorial regulatory agencies and maintain it in an electronic format available to all interested parties.

i.  In support of FSMA, work with FDA to establish operational partnerships that assist in the capacity building of state and local agencies as well as establishing and implementing strategies for improving state and local food safety efforts.

j. Maintain a legislative tracking service to provide up to date information on legislation on key food safety and food infrastructure bills in state legislatures.

k.  Provide a report/book of best practices for state legislators and policy makers to identify promising approaches by states to improve food safety based on research and review conducted by the association on approaches undertaken by states to address food safety. 

m.  Hold meetings for state legislators to offer insights and observations on food safety to develop a best practices report. 

n.  Publish reports, web briefs, news letters and magazines geared to legislators on topics specific to food safety.

o.  Provide technical assistance to state legislatures on committee testimony, bill drafting support and insight upon request by legislative leadership to provide expert advice on issues of concern to the state. 

p. Present at national food safety conferences on state legislative practices and food safety legislation. 

q.  Serve as information clearinghouse on state legislative issues and provide insight and intelligence  to FDA of state legislative concerns regarding the food safety system including food borne illness outbreaks, recalls and regulatory changes. 

2.  Background:

In 2007 and 2008, the Food and Drug Administration Amendments Act of 2007 (FDAAA), the Food Protection Plan and the Import Strategic Action Plan outlined other specific activities or goals in the working relationships with the states in food protection activities.  The Food Protection Plan lays out new goals specific to protecting the food supply and responding to incidents in a rapid and coordinated manner.

Food Protection Plan 2007

In May 2007, Secretary of Health and Human Services Michael O. Leavitt and Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, charged FDA with developing a comprehensive and integrated FDA Food Protection Plan to keep the nation's food supply safe from both unintentional and deliberate contamination. Driven by science and modern information technology, the Plan aims to identify potential hazards and counter them before they can do harm.  A cornerstone of this forward-thinking effort is an increased focus on prevention.

FDA’s integrated approach, within the Food Protection Plan, encompasses three core elements:  prevention, intervention and response. 

The prevention element means promoting increased corporate responsibility so that food problems do not occur in the first place.  By comprehensively reviewing food supply vulnerabilities and developing and implementing risk reduction measures with industry and other stakeholders, we can best address critical weaknesses. 

The intervention element focuses on risk-based inspections, sampling, and surveillance at high risk points in the food supply chain.  These interventions must verify that the preventive measures are in fact being implemented, and done so correctly. 

The response element bolsters FDA's emergency response efforts by allowing for increased speed and efficiency. They also include the idea of better communication with other federal, state, and local government agencies and industry during and after emergencies.  Whether contamination is unintentional or deliberate, there is a need to respond quickly and to communicate clearly with consumers and other stakeholders.  The communication should emphasize identifying products of concern as well as assuring the public of what is safe to consume.

Food and Drug Administration Amendments Act of 2007

Under the FDAAA, FDA will work with the states to develop food borne illness rapid response teams.  In FDAAA Section 1004: Secretary shall work to coordinate the function of federal and state food safety programs.

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.

Import Safety Action Plan

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 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 food borne illness and injury. These elements include the program's regulatory foundation, staff training, inspection, quality assurance, food defense preparedness and response, food borne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources, and program assessment.

FDA will use the program standards as a tool to improve 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 implementation of the program standards by State jurisdictions will take several years. Such jurisdictions will, however, be expected to implement improvement plans to demonstrate that they are moving toward full implementation. 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 implementation of these program standards will help Federal and State programs better direct their regulatory activities at reducing food borne illness hazards in food plants. Consequently, the safety and security of the United States food supply will improve.

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
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 total amount of funding available is $500,000. 

The anticipated number of awards is up to 2.  The maximum amount available for a single award is $500,000. 

Award is contingent upon FDA appropriations, and the submission of a meritorious application.  Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $500,000 (direct and indirect costs) and 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

National associations/organizations
Non-domestic (non-U.S) Entities (Foreign Organizations) are not eligible to apply.

Required Registrations

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 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 SF 424 (R&R) 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. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Required and Optional Components

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 application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed.

Resource Sharing Plan

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

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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, 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.

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.

This award may only be used for the continued development and enhancement of implementation of the Manufactured Foods Regulatory Program Standards, to enhance and supplement existing food safety infrastructures and provide assistance to state legislatures. 

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, the application will be evaluated for completeness by the FDA Grants and Assistance Agreement Team.

In order to expedite review, applicants are requested to notify the FDA Grants Management Specialist by email at stephanie.bogan@fda.hhs.gov when the application has been submitted. Please include the Grants.gov tracking number, FOA number and title, PD/PI name, and title of the application.

The application must specifically describe the ability to perform some but not all of the following in the cooperative agreement application:

1. Establish a network of state manufactured foods program managers:

2. Conduct surveys of State/Local/Tribal Manufactured Foods Program:

3. Identifying and Tracking of State Laws and Regulations that extend beyond the requirements of the Food, Drug and Cosmetic Act of regulations enforced by FDA and adopted by State Food Program Jurisdiction. Includes unique statues and regulations by jurisdiction.

4. Develop Task Oriented Guidelines to address issues which can be adopted into State food manufacturing programs. Potential subjects for guidelines:

5. Identify and Support Pilot programs in States as needed to support implementation of MFRPS.  Potential areas for pilot programs:

6.  Community Relations - Building /Networking:

Provide structure to serve as a learning exchange, subject matter expert registry, maintain topical index of regulatory guidance and program manager portal. 

7.  Training:

Identify and coordinate training activities with FDA or other entities such as IFPTI or Cooperative Extension offices.

8.  Update, enhance and improve a web based directory such as one for state and local officials for use by federal and state regulatory agencies and maintain it in an electronic format available to all interested parties. 

Included is the maintenance of an electronic searchable format for the information with linkage to FDA, other federal, state or local websites, for the public information that can be accessed freely by any interested party looking for contact information for state or local agencies that regulate foods, drugs, cosmetics, medical devices including radiological health, laboratory, animal health, feed and others related to the Federal Food Drug and Cosmetic Act, regulations enforced by FDA that are found in title 21 of the CFR, and state or local equivalent laws.

9.   Food Safety Modernization Act:

Work with FDA to establish operational partnerships that assist in the capacity building of state and local agencies as well as establishing and implementing strategies for improving state and local food safety efforts.

10.  Legislative Tracking Service: Maintain a legislative tracking service to provide up to date legislation on key food safety and food infrastructure bills in state legislatures.  The project should include the creation of a comprehensive Food Safety Legislation Database focusing on key topics and issue areas of food safety. 

11.  Best Practices Report on Food Safety: Provide a report and/or book for state legislators and policy makers to identify promising approaches by states to improve food safety based on research and review conducted by the association on approaches undertaken by states to address food safety.  The research conducted by the association should focus on state level policies, either advanced or encouraged by state policy makers that advance policies and initiatives to improve food safety.  The resulting book and/or report will be distributed to chairs of the legislative agriculture and health committees as well as to their staffs and offered free to legislators and staff on request. 

12.  Annual meeting for state legislatures:  Hold meetings for state legislators to offer insights and observations on food safety to develop a best practices report.  These meetings will be ancillary to annual legislative summit events and the outcome of the meetings will be a "best practices" report developed by association staff for subsequent distribution. 

13.  Publications:  Publish reports, web briefs, newsletters and magazines geared to legislators on topics specific to food safety.  Publishing options should include:

o. Technical Assistance to State legislatures:  Provide committee testimony, bill drafting support and insight for legislatures upon request by legislative leadership to provide expert advice on food safety issues of concern to the state; 

p. Meetings and Presentations:  Present at national food safety conferences on state legislative practices and food safety legislation.   Organize sessions of experts to review model best practices report developed by association to gain insight on practices and develop approaches for policy makers to adopt best practices;

q. Information Clearinghouse and Providing Insight/Intelligence on State Policy Concerns:  Serve as a research service to state legislatures to provide information, on request, such as:  background information on an issue and information on state responses to issues.  The association will provide FDA with information on state legislative concerns regarding food safety system, food borne illness outbreaks, recalls, federal agency regulatory changes, as well as any other concerns regarding food safety. 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the FDA mission, this application will be are evaluated for technical merit through the FDA peer review system.

1.  The rationale and design to meet the goals of the cooperative agreement (total weight = 60%)

2.  Demonstration of effectiveness in working with federal, state, and local partners to implement goals of the cooperative agreement (total weight = 20%)

3.  Demonstration of plans to facilitate the incorporation of project developed capabilities into state programs (total 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 separate scores will not be give for the items described below. 

Overall Impact

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 state manufactured foods inspection programs, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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 problems or barriers to progress in the state implementation of manufactured food regulatory standards and the advancement of an integrated food safety system? If the aims of the project are achieved, how will regulatory knowledge, technical capability, and/or state/local/tribal inspection programs be improved?

Investigator(s)     

Are the PD/PIs and other collaborators well suited to the project and have the appropriate experience and training? Have they demonstrated an ongoing record of accomplishments?

Innovation

Does the application challenge and seek to shift current paradigms by utilizing innovative concepts and approaches to increase adoption and successful implementation of manufactured food regulatory program standards and advancement of an integrated food safety system?

Approach

Are the overall strategy and processes well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems and benchmarks for success presented?

Environment

Will the project benefit from unique features of the Federal-state regulatory community and other collaborative arrangements?   

Additional Review Criteria

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards

Not applicable.

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

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

Not applicable.

Resource Sharing Plans

Not applicable.

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 project.

2. Review and Selection Process

Applications will be evaluated for technical merit by (an) appropriate Review Group(s), in accordance with FDA/ORA, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the peer review, all applications:

The application will compete for available funds. Following initial peer review, recommended applications will receive a second level of review by the ORA project officer for programmatic relevance. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will receive his or her Summary Statement (written critique) via email. 

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee 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 in the application instructions. 

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the DHHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement

Cooperative Agreement Terms and Conditions of Award

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:

·          FDA assistance and coordination in the sharing of information to FDA, other federal, State agencies and network of program managers.

·          FDA review, approval and coordination of surveys conducted of state manufactured food programs and laws and regulations.

·          FDA review and approval of task oriented guidelines and pilot programs developed under the award.

·          FDA review and approval of publications/web applications or any revisions existing systems.

·          Other assistance and or collaboration as requested by associations, state/local agencies.

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 promote the development and enhancement of existing State Food regulatory programs in providing support for the and integrated food safety system that includes the adoption and implementation of the manufactured foods regulatory program standards. The cooperative agreements will provide funding for additional personnel, equipment, supplies, and training to support activities related to the FDA MFRPS. Allowable costs are delineated below; non-allowable costs are described under “Funding Restrictions” (see Section IV, 5).

Allowable costs:

1.  Salaries

2.  Accounting services

3.  Travel for non government staff to attend meetings related to the award

4.  Travel for speakers to meetings related to the award

5.  Supplies for office

6.  Supplies for meetings related to the award

7.  Printing for support of award and meetings related to the award

8.  Shipping/mailing expenses

9.  Web site server, software, hosting, development and integration

10.  Telephone services for program manager and conference calls (cellular and landline)

11.  Laptop computer

12.  Blackberry

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 and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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. 

An annual Financial Status Report (FSR) (SF-269) must be sent to FDA's grants management officer within 90 days of the budget period end date of each twelve month cooperative agreement.  Failure to file the annual FSR in a timely fashion will be grounds for suspension or termination of the cooperative agreement. 

For continuing cooperative agreements, mid year reports and an annual program progress report are also required.  For such cooperative agreements, the Non-Competing Continuation Progress Report (PHS-2590) will be considered the program progress report for the fourth quarter of the budget period. 

Mid-year progress reports must contain the elements below as applicable to their proposal and award, but are not limited to, the following:

1. Report on the progress toward the establishment of a network and list of State Manufactured Food Program managers, a web portal for information sharing and development of committees to support MFRPS.

2.  Summary report on the meetings related to the award. 

3.  Summary report on the surveys conducted to assess state manufactured food programs.

4.  Status report on the surveys conducted to assess state laws.

5.  Status report on the task oriented guidelines and best practices developed in support of the award. 

6.  Status report on the support and identification of pilot programs.

7.  Status report on community building and networking activities and training activities. 

8.  Status report on the coordination of training activities.

9.  Report on the progress toward the establishment of operation partnerships with FDA, assistance to capacity building of state/local/tribal agencies to improve food safety efforts in the implementation of FSMA.

10.  Status report on the legislative tracking services.

11.  Summary report on status of or copy of the "Best Practices" report on Food Safety policies and initiatives.

12.  Summary of legislative reports, web briefs, newsletters and magazines targeting state legislatures as well as summary of technical assistance provided to state legislatures.

The recipient must file a final program progress report, and FSR, within 90 days after the end date of the project period as noted on the notice of the cooperative agreement award.

The final program progress report must provide full written documentation of the project, and summaries of accomplishments and goals, as described in the cooperative agreement application. The documentation must be in a form and contain sufficient detail. 

Monitoring Activities

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 results of these monitoring activities will be recorded in the official cooperative agreement file and will be 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.

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.

Section VII. Agency Contacts

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

Each IC may add information describing the topics for which applicants should contact staff. ICs cannot require prior approvals in this section.

Application Submission Contacts

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 301-435-0714
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

Scientific/Research Contact(s)

Wendy Campbell
Food and Drug Administration
Division of Federal-State Relations
12420 Parklawn Drive
Rockville, MD 20857
Telephone: 615-310-0483
Email: wendy.campbell@fda.hhs.gov

Financial/Grants Management Contact(s)

Stephanie Bogan
Grants Management Specialist
Food and Drug Administration
Telephone: 301-827-6802
Email: stephanie.bogan@fda.hhs.gov

Section VIII. Other Information

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 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.


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