Part I Overview Information
Department of Health and Human Services
Food and Drug Administration (FDA)
Components of Participating Organizations
Center for Food Safety and Applied Nutrition (CFSAN)
Funding Opportunity Title
Strengthen and Promote the Role of Local Health Departments in Retail Food Safety Regulation (U-50)
U50 Special Cooperative Investigations and Assessments of Control and Prevention Methods (Cooperative Agreement)
Announcement Type: New
Related Notices: None
Funding Opportunity Announcement (FOA) Number: RFA-FD-11-020
Companion FOA: None
Number of Applications
Only one application is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)
This FOA, issued by the Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Safety (OFS), announces FDA's intention to receive and consider a sole source cooperative agreement grant application from the National Association of County and City Health Officials (NACCHO). The purpose of this Cooperative Agreement is to conduct work that will strengthen the role of local health departments and promote effective city and county regulatory programs responsible for retail food protection in the United States (U.S.).
Letters of Intent Due Date: Not Applicable
Application Due Dates(s): June 15, 2011
AIDS Application Due Date(s): Not Applicable
Scientific Merit Review: June, 2011
Advisory Council Review: Not Applicable
Earliest Start Date(s): August, 2011
Expiration Date: June 16, 2011.
Due Dates for E.O. 12372: Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Table of Contents
- Eligible Applicants
- Cost Sharing
- Additional Information on Eligibility
- Address to Request Application Package
- Content and Form of Application Submission
- Submission Dates and Time
- Intergovernmental Review (E.O. 12372)
- Funding Restrictions
- Other Submission Requirements and Information
- Review and Selection Process
- Anticipated Announcement and Award Dates
- Award Notices
- Administrative and National Policy Requirements
CFSAN/OFS desires to work cooperatively with NACCHO to increase partnerships and collaboration with our regulatory partners at local and state health and agriculture departments that represent city and county health departments, to identify best practices and innovative approaches used to implement the FDA Food Code and Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) and begin to examine the impact they have on the reduction of foodborne illness risk factors. NACCHO has the expertise needed to provide expert advice and recommendations to FDA that can be shared and used by multiple local and state health and agriculture departments to help improve the risk of foodborne illness in retail and food service settings.
This cooperative agreement will also help FDA examine how the Retail Program Standards can most effectively be integrated with broadening efforts to establish accreditation for health departments as guided by the Public Health Accreditation Board.
Other possible areas for collaboration with NACCHO include working to identify how to improve prevention, performance, and response at the local government level; establishing peer mentoring opportunities that pair local health department officials who have experience implementing the Retail Program Standards with those who have struggled or are just beginning the process; and doing a comprehensive study to assess the effectiveness of food inspection grading and scoring systems used by local health departments.
The cooperative agreement will support the personnel needed to conduct research among local health departments, to participate in meetings with local health departments that participate in this project, analyze data and findings, produce a final report on findings and recommendations, disseminate and make findings and recommendations available to local health departments, and convene (at least) monthly calls with the FDA project officer to ensure regular communication and elicit input and feedback on the work conducted under the cooperative agreement.
CFSAN regulates $417 billion worth of domestic food, $49 billion worth of imported foods, and over $60 billion worth of cosmetics sold across state lines. This regulation takes place at any point from the products' point of U.S. entry or processing to their point of sale. There are over 377,000 registered food facilities (including approximately 154,000 domestic facilities and 223,000 foreign facilities) that manufacture, process, pack, or hold food consumed by humans or animals in the United States and several thousand cosmetic firms. However, these figures do not include restaurants, institutional food service establishments, or supermarkets, grocery stores, and other food outlets over which FDA has jurisdiction but which are traditionally primarily regulated by almost 3,000 state, local, and tribal agencies. FDA strives to promote the application of science-based food safety principles in retail and food service settings to minimize the incidence of foodborne illness. FDA assists regulatory agencies and the industries they regulate by providing a model Food Code, scientifically-based guidance, training, program evaluation, and technical assistance. This cooperative agreement will further FDA's ability to work collaboratively with the agencies that primarily regulate retail and food service establishments.
The CFSAN/OFS Retail Food and Cooperative Programs Coordination Staff, as part of FDA’s National Retail Food Team, works to promote the sharing of best practices, including those regulatory and industry interventions that are targeted at improving the management of food safety practices in the retail setting. CFSAN/OFS desires to work cooperatively with NACCHO to increase partnerships and collaboration with our regulatory partners at the local level that represent city and county health departments, to identify innovative approaches used to implement the FDA Food Code and Retail Program Standards and begin to examine the impact they have on the reduction of foodborne illness risk factors.
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
The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
CFSAN intends to fund one award, for up to $400,000, for fiscal year 2011.
The estimated amount of support in FY11 will be for up to $ 400,000.00 (direct plus indirect costs) with the possibility of four additional years of support for up to $ 400,000.00 per year, subject to the availability of funds. Future year amounts will depend on annual appropriations and successful performance.
Award Project Period
The award will provide one year of support and include future recommended support for four additional years, contingent upon satisfactory performance in the achievement of project and program reporting objectives during the preceding year and the availability of Federal fiscal year appropriations.
FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
1. Eligible Applicants
National Association of County and City Health Officials (NACCHO)
Competition is limited to NACCHO because it has unique capacity found nowhere else. NACCHO has the expertise needed to provide expert advice and recommendations to FDA that can be shared and used by multiple local and state health and agriculture departments to help improve public heath in retail and food service settings.
NACCHO is the only national organization representing local health departments, to include county, city, and district, metro and tribal agencies. Membership in NACCHO is limited to the executive officer of the department of health of any local health department. NACCHO supports efforts that protect and improve the health of all people and all communities by promoting national policy, developing resources and programs, seeking health equity, and supporting effective local public health practice and systems.
In performing an internet search for national organizations whose members are local governmental health officials, and whose mission includes efforts to support and work with local health departments to improve food safety and prevent foodborne illness, no other organizations were discovered. There are organizations that represent local boards of health, but no other organization whose membership is comprised of local governmental health officials. NACCHO has been in existence since 1994 and has always been exclusively associated with local health officials.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
- Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
- eRA Commons
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Only one application is allowed.
FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.
1. Address to Request Application Package
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, package to:
Gladys M. Bohler
Food and Drug Administration
Office of Acquistion and Grant Support
5630 Fisher's Lane - Rm. 1078, MSC 500
Rockville, MD 20857
E-mail: gladys.bohler @fda.hhs.gov
At the time of submission, three additional paper copies of the application and all copies of the appendix files must be sent to:
Perter A. Salsbury, Project Officer
Center for Food Safety and Applied Nutrition (CFSAN)
CPK1 Rm. 3A017 - HFS-320
5100 Paint Branch Pkwy
College Park, MD 20740
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
- Research Strategy section is limited to 30 pages.
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
- Resource Sharing Plan
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.
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 PHS398 Application Guide, with the following modifications:
3. Submission Dates and Times
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.
4. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Pre-award costs are allowable only as described in the HHS Grants Policy Statement.
6. Other Submission Requirements and Information
Applications must be postmarked on or before the due dates in Part I. Overview Information.
Upon receipt, applications will be evaluated for completeness by CFSAN and responsiveness by the Grants Management contact.. Applications that are incomplete and/or nonresponsive will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described below:
Acceptable post-submission materials include:
Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)
Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)
Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator
Adjustments resulting from natural disasters (e.g., loss of an animal colony)
Adjustments resulting from change of institution (e.g., PI moves to another university)
News of an article accepted for publication (a copy of the article should not be sent)
All post-submission materials must conform to policy on font size, margins, and paper size as referenced in Part I.2.6 of the applicable application instructions. Additional form pages such as budget, biographical sketches, and other required forms must follow standards for required form pages.
If post-submission material is not required on a form page, each explanation or letter is limited to one page (see Acceptable Late Materials above).
If the application has subprojects or cores, each subproject or core is allowed explanations or letters (see Acceptable Late Materials above), but each explanation or letter is limited to one page.
Unacceptable post-submission materials include:
Updated Specific Aims or Research Strategy pages
Late-breaking research findings
New letters of support or collaboration that do not result from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator.
Only the review criteria described below will be considered in the review process. As part of the FDA mission, all applications submitted to the FDA in support of research are evaluated for scientific and technical merit through the FDA Ad Hoc Review process.
Overall Impact - Overall
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria - Overall
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
The application will receive a merit description (outstanding, acceptable, or unacceptable) that reflects the progress of the FDA program working cooperatively with NACCHO.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice are improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Do the PD/PIs, collaborators, and other researchers understand the purpose and objectives of the cooperative agreement regarding the collaborative research, education, and outreach programs?
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Has NACCHO proposed to use appropriate innovation working in cooperation with FDA and local health departments to perform special investigations that will support efforts that protects and improves the health of all people and all communities by promoting national policy, developing resources and programs and supporting effective local public health practices and systems?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does NACCHO develop and use appropriate methods to investigate and assess control and prevention methods with local health departments to improve food safety and prevent foodborne illness?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria - Overall
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
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.
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.
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.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions: Not Applicable.
Renewals: Not Applicable.
Revisions: Not Applicable.
Additional Review Considerations - Overall
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Have past investigations and assessments conducted by NACCHO demonstrated the ability to achieve the objectives outlined in Section I of the RFA?
Has NACCHO described how it will achieve success in promoting the development of collaborative interactions with FDA scientists and local health departments?
Were results from past similar cooperative agreements between NACCHO and other federal agencies used in the design and plans for this project?
Select Agent Research
As applicable, reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
As applicable, reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for programmatic and technical merit by (an) appropriate Ad Hoc Review Group(s), in accordance with FDA Ad Hoc review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications:
- Will receive a written critique.
3. Anticipated Announcement and Award Dates
After Ad Hoc review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via e-mail.
Information regarding the disposition of applications is available in the HHS Grants Policy Statement.
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 Terms and Conditions of award and the HHS Grants Policy Statement.
2. Administrative and National Policy Requirements
All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: 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 OMS administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an “acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role of activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the FDA as defined below.
2. A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for and dominant role in planning, directing, and executing the proposed project, with the FDA staff being substantially involved as a partner with the PI.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.
2. A.2. FDA Responsibilities
An FDA Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The program project officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the project officer/grants management officer and the PI. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request, consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those that state that future funding will depend on recommendations from the project officer. In addition,
- FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee.
- FDA will be directly involved in the guidance and development of the program.
FDA scientists and subject matter experts will participate, with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications.
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 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
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)
Peter A. Salsbury, Project Officer / Contracting Officer Technical Representative (COTR)
Center for Food Safety and Applied Nutrition (CFSAN)
5100 Paint Branch Parkway
CPK1 Rm. 3A017 - HFS-320
College Park, MD 20740
Financial/Grants Management Contact(s)
Office of Acquisition and Grant Services (OAGS)
Food and Drug Administration
5630 Fishers Lane - Rm. 1078; HFA 500
Rockville, MD 20857
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.