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

Food Protection Task Force Conference (R13)

Activity Code

R13 Support for Conferences and Scientific Meetings

Announcement Type

Reissue of PAR-09-123

Related Notices

  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

PAR-13-200

Companion Funding Opportunity

Not Applicable

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), issued by the Food and Drug Administration under the support for Conferences and Scientific meetings Grant mechanism (R13), is to solicit applications from organizations that propose to organize Food Protection Task Force meetings to foster communication, cooperation and collaboration within the States among State, local, tribal and territorial food protection, public health, agriculture, and regulatory agencies. The meetings should: (1) Provide a forum for all the stakeholders of the food protection system—regulatory agencies, academia, industry, consumers, State legislators, Boards of Health and Agriculture, and other interested parties; (2) assist in adopting or implementing the Food Code and other food protection regulations; and (3) promote the integration of an efficient statewide food safety/defense system that maximizes the protection of the public health through prevention, intervention and response including the early detection and containment of foodborne illness.

Key Dates
Posted Date

April 16, 2013

Open Date (Earliest Submission Date)

May 1, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

July 1, 2013 by 11:59 PM Eastern Time.
July 1, 2014 by 11:59 PM Eastern Time.
July 1, 2015 by 11:59 PM Eastern Time

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2013, July 2014, July 2015

Advisory Council Review

Not Applicable

Earliest Start Date

September 2013, September 2014, September 2015

Expiration Date

July 2, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH 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.


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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

Program Objectives
FDA views State-based Food Protection Task Forces as an important mechanism for providing food safety and food defense program coordination, and information exchange within each State.  ("Food" includes human food and animal feed and is defined in 21 USC 321(f)). This grant announcement is intended to encourage the development of a Task Force within each State and to provide funding for Task Force meetings.  Conference grant funding is available to State, local, and tribal agencies that have an existing Food Safety and Food Defense Task Force, as well as to State agencies that are in the process of developing a new Food Protection Task Force.  State Food Protection Task Force meetings should foster communication and cooperation among State, local, and tribal public health and food safety agencies and other interested parties.

This Funding Opportunity Announcement (FOA), issued by the Food and Drug Administration under the support for Conference and Scientific meetings Grant mechanism (R13), is to solicit applications from organizations that propose to organize Food Protection Task Force meetings to foster communication, cooperation and collaboration within the States among State, local, tribal and territorial food protection, public health, agriculture, and regulatory agencies. The meetings should: (1) Provide a forum for all the stakeholders of the food protection system—regulatory agencies, academia, industry, consumers, State legislators, Boards of Health and Agriculture, and other interested parties; (2) assist in adopting or implementing the Food Code and other food protection regulations; and (3) promote the integration of an efficient statewide food safety/defense system that maximizes the protection of the public health through prevention, intervention and response including the early detection and containment of foodborne illness.

Background

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 (http://www.foodsafetyworkinggroup.gov/Home.htm). The charge of the FSWG is the following: “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.

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 Protection Task Force Program, Innovative Food Defense Program, Rapid Response Team 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

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. FSMA directs FDA to build an integrated national food safety system in partnership with State, local, territorial, and tribal 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. Full text of the law: http://www.fda.gov/Food/FoodSafety/FSMA/ucm247548.htm 

d. Bioterrorism Act

Alongside the increased national focus on food safety has been the increased focus on emergency preparedness and response since 2001. The events of September 11, 2001 reinforced the need to enhance the safety and defense of the U.S. food supply. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act"), which President Bush signed into law on June 12, 2002. The Bioterrorism Act is divided into five titles, detailed here: http://www.fda.gov/regulatoryinformation/legislation/ucm148797.htm.

Subtitle A of Title III—Protection of Food Supply, Section 311—Grants to States for Inspections, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 909, which authorizes the Secretary of Health and Human Services to award grants to States, territories, and Indian tribes that undertake examinations, inspections, and investigations, and related activities under section 702 of the FD&C Act. The grant funds are only available for the costs of conducting these examinations, inspections, investigations, and related activities. Full text: http://www.fda.gov/RegulatoryInformation/Legislation/ucm155769.htm.

e. 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.

This requirement is contained within Title X (Food Safety) Section 1004 of the FDAAA (Full text: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm).

f. Import Safety Action Plan

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 contains Recommendation 12 to maximize federal-state collaboration for federal-state rapid response (http://archive.hhs.gov/importsafety/report/actionplan.pdf; pages 37-38).

g. FDA Food Protection Plan

Although the United States has one of the safest food supplies in the world, the public health burden of foodborne disease in the nation is substantial. CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases http://www.cdc.gov/foodborneburden/. New challenges continue to arise, including the globalization of the food supply and the emergence of new pathogens in foods.

These facts reinforce the importance of this State Food Protection Task Force program. Task Forces should consider the plans and activities listed below as a part of their goal for planning meetings and activities:

(1) FDA is responsible for the safety of the vast range of food Americans eat; about 80 percent of all food sold in the United States. This includes everything except for meat, poultry, and processed egg products, which are regulated by the U.S. Department of Agriculture (USDA).

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 those before they can do harm.  A cornerstone of this forward-thinking effort is an increased focus on prevention.

The Plan builds in safety measures to address risks throughout a product’s life cycle, from the time a food is produced to the time it is distributed and consumed.  The Plan focuses FDA efforts on preventing problems first, and then uses risk-based interventions to ensure preventive approaches are effective.  The Plan also calls for a rapid response as soon as contaminated food or feed is detected or when there is harm to people or animals.  

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

(3) The focus of these grant sponsored meetings should be to discuss and resolve issues at the State and local levels relating to the following areas:

State/local agency roles and responsibilities: (1) capacity and resource needs; (2) outbreak coordination and investigations; (3) information sharing and data collection; (4) uniform regulatory standards; (5) communications and education; (6) State/local laboratory operations and coordination; (7) adoption and implementation of the FDA Food Code and other food protection regulations; (8) uniform standards for foodborne illness and outbreak reporting investigation and response; (9) State and local training needs; and (10) food defense activities and coordination.

1. Food Defense Activities:

The following should be considered by the task forces in planning and group facilitation of meetings within their respective states: 

Target (hard-to-reach) stakeholders focusing on specialized ethnic and small to moderate (medium) sized establishments.

Integrate food safety and food defense among public health, food, and agriculture sectors and stakeholders for a cohesive food protection integration.

Establish best practices for collaboration and alignment of resources among public and private sectors.

Prevention Activities:

Awareness/Outreach – to include the FDA messages related to food defense awareness, ALERT, and FIRST.

Criticality/Key Resources – promotion and use of the Department of Homeland Security State Guidance tool (FASCAT) to identify and prioritize critical infrastructure and key resources within their State borders and possible regional-to-national effects.

Food Code/Regulatory Measures – Roles/Responsibilities – to include local, state, regional and national issues in prevention and preparedness for both natural and man-made disasters.

Training/Education – to include the FDA messages related to food protection, ALERT, and FIRST.

Intervention Activities:

GAPs/Needs Assessment – related to what resources will be needed to assist in recovering from an event based on what is needed on the local level, the state level, and the regional/national level.

Reporting/Follow-Up – best practices recommendations for reporting structures and needed follow-up activities (as well as roles and responsibilities) after an event has occurred to return to a steady-state as it was prior to an event. 

Response Activities:

Communication – evaluate communication processes and identify gaps within regulatory agencies and industry, and also coordination of public messages.

Recalls – including development of improved procedures to communicate significant public health recall information to a broader audience within the state.

Traceability – to improve processes for tracing food through the distribution chain efficiently and rapidly to minimize consumer exposure.

Reporting – initiate improved information sharing and reporting mechanisms within States and among/between States and federal agencies.

2. Foodborne Illness Activities:

Develop processes that will facilitate the investigation, prevention, and control of foodborne disease outbreaks, e.g., guidelines for responding to multi-jurisdictional outbreaks, and guidelines for sharing results between and among key stakeholders including Federal, State, and local governmental agencies, industry, and consumers. Establish a risk-based profile of foods implicated in foodborne outbreaks and monitor the trends of implicated foods.  Identify and monitor contributing factors and their environmental antecedents, establish the chemical/biologic agent responsible for foodborne outbreaks. 

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

FDA intends to commit up to$150,000 to this grant in program in FY 2013. Future year amounts will depend on annual appropriations.

The number of awards is contingent upon FDA appropriations, and the submission of a sufficient number of meritorious applications.

It is anticipated that up to 15 awards will be made, not to exceed $10,000 in total costs per award, per year.

Award Budget

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total cost.

Year 1: $10,000
Year 2: $10,000
Year 3: $10,000
Year 4: $10,000
Year 5: $10,000

Awards are contingent upon the availability of funds. Future year amounts will depend on the annual appropriations and performance

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

Note:  Only one grant under this FOA will be awarded per State, Territory, or Possession.  Agencies within a State, Territory, or Possession are urged to collaborate among themselves to submit a single application.

Eligible Entities

Grants are available in States, Territories, and Possessions that have an existing Food Protection Task Force, as well as those that are in the process of developing a new Food Protection Task Force.  Due to the nature of this program and the fact that it is designed to foster communication among State, Local, Tribal, and Territorial agencies, this FOA is not being extended to other entities.  Additionally, only government health and food regulatory agencies have the authority within their respective jurisdictions to implement and enforce food protection measures.  

Grantees currently receiving funding under the FDA Food Protection Task Force Conference grant (PAR-09-123) are not eligible to apply under this FOA unless they are in the final budget year of their current grant.

Existing Food Protection Task Forces seeking to develop and implement specific projects may also consider applying for the Food Protection Task Force Improvement Project FOA under RFA-FD-13-028.

Foreign Institutions

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.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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(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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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

Only one application per organization (normally identified by having a unique TIN number) is allowed.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial objective 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

SF424(R&R) Cover (REQUIRED)

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

SF424(R&R) Project/Performance Site Locations(REQUIRED)

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

SF424(R&R) Other Project Information(REQUIRED)

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

SF424(R&R) Senior/Key Person Profile(REQUIRED)

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

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

PHS 398 Cover Letter(optional)

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

PHS 398 Cover Page Supplement(REQUIRED)

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

PHS 398 Research Plan Component(REQUIRED)

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

The Research Strategy (line item #3) otherwise known as the "Conference Plan" is where applicants should attach their narrative responses to the selection criteria and requirements published in this FOA. 

The following information must be included and addressed in the Research Strategy (Conference Plan):

Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible: Budget, meeting topics, tentative dates, locations, participants, and contingency plans for future meetings dependent upon, for example, the outcome of the first year’s conference/meeting or developments in the field.

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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, FDA's electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  Late applications will not be accepted for this FOA.

Applicants are responsible for viewing their application before the due date 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.

Allowable Costs

Conference grant funds will be awarded only for direct costs incurred to secure meeting facility rental expenses, supplies, publication costs, and in-State travel expenses for meeting attendees. Regional travel may be permitted in certain circumstances. Federal agency representatives may be invited to be non-member liaisons or advisors at the meetings however Conference Grant funds may not be used to support federal employee(s) attendance of the meetings. Allowable costs consist of: (1) salaries in proportion to the time or effort spent directly on the conference; (2) rental of necessary equipment; (3) travel and per diem; (4) supplies needed to conduct the meeting; (5) conference services; (6) publication costs; and (7) speaker’s fees.

Conference Services: Grant funds may be used for necessary recording of proceedings, simultaneous translation, and subsequent transcriptions.

Consultant Services: Grant funds may be used to pay consultant fees, including travel and supporting costs (per diem; subsistence is not allowable).

Equipment Rental:  Grant funds may be used for the rental of necessary equipment.

Publication Costs:  When grant funds are awarded to pay for either the entire or partial cost of publication of proceedings or a book or pamphlet, allowable costs include special plates, charts, diagrams, printing, distribution, mailing, postage, and general handling, unless otherwise specified at the time the grant is awarded.

Salaries:  In accordance with the policy of the grantee organization, grant funds may be used for all or part of the salaries of professional personnel, clerical assistants, editorial assistants, and other non-professional staff in proportion to the time or effort directly related to the conference.

Speakers Fees:  Speakers’ fees for services rendered are allowable.

Supplies:  Grant funds may be used for the purchase of supplies for the conference if the supplies are received and used during the budget period.

Travel:  Funds may be used for the travel of staff, speakers, participants, and attendees, if identified in the application and approved at the time of award. Travel expenses for employees of the grantee organization are governed by the grantee’s travel policies, consistently applied regardless of the source of funds. 

Any U.S. foreign travel restrictions that are in effect at the time of the award will be followed, such as

A.   Limitations or restrictions on countries to which travel will be supported or

B.   Budgetary or other limitations on availability of funds for foreign travel.

Proposed per diem allowances must be reasonable and limited to the days of attendance at the conference plus the actual travel time to reach the conference location by the most direct route. Local mileage costs only may be paid for local participants. Where lodgings are furnished without charge or at a nominal cost (e.g., as part of the registration fee), the proposed per diem allowance must take this into consideration.  Per Diem must not include any food and/or meals.

Transportation costs for attendees and participants at the conference may not exceed coach class fares. In all cases, U.S. flag carriers will be used where possible.

Non-allowable Costs

Include but are not limited to: Travel or expenses other than local mileage for local participants; organization dues; travel or per diem costs for federal employees.  Purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment; tips; bar charges; personal telephone calls; laundry charges; dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; facilities and administrative costs/indirect costs. Please also refer to the HHS Grants Policy Statement for additional information regarding costs.

Registration Fees:  Not allowable.

Indirect Costs:  Not allowable. 

Alterations and Renovations (A&R):  Not allowable.

Membership Dues:  Not allowable.

Entertainment and Personal Expenses:  Costs of amusement, diversion, social activities, ceremonials, and related incidental costs related thereto, such as meals, lodging, rentals, transportation gratuities, bar charges, tips, personal telephone calls, and laundry charges of participants or guests, are not allowable.

Food:  All meals or light refreshments, regardless if certain meals are an integral and necessary part of a conference (i.e., a working meal where business is transacted), are not allowable and grant funds may not be used for such costs.

Equipment Purchase:  Grant funds may not be used for the purchase of equipment.

Facilities and Administrative (F&A) Costs:  Not allowable.

Federal Employees:  Grant funds may not be used to pay for travel costs, or any payment to a Federal employee, except when the employee is on leave without pay status from his or her employing office.

Visas and Passports:  Costs associated with obtaining visas and passports are not allowable.

Honoraria:  Honoraria or other payments given for the purpose of conferring distinction or to symbolize respect, esteem, or admiration are not allowable.

Local Participants’ Expenses:  With the exception of local mileage as indicated under “allowable costs under Travel” grant funds may not be used to pay per diem or expenses for local participants in the conference.

Research Patient Care:  Not allowable.

A decrease in the amount of the non-competitive segment may occur if there is an unobligated balance from the prior year, in which case prior year funds can be used as an offset for the current year award.

Continued funding of a noncompetitive segment is contingent upon satisfactory progress as determined annually by FDA procedures, the receipt of a non-competing continuation application, submission of a satisfactory annual report, and the availability of Federal funds.

6. Other Submission Requirements and Information

Prior to submission of an application, the applicant and cooperating agencies shall designate one public health or food safety agency to lead, coordinate, and host the Food Protection Task Force and its meetings. The formation of Food Protection Task Forces and meetings shall not interfere with existing Federal-State advisory mechanisms or state required committees or advisory groups.

Applications must be submitted electronically following the instructions described in the SF424 (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 SF424(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 System for Award Management (SAM). 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 by the Office of Acquisition and Grants (OAGS) and responsiveness by the FDA Office of Regulatory Affairs (ORA).  Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are reminded that failure to include all required documents as part of the application may result in an application being considered as incomplete or non-responsive.

Applicants are strongly encouraged to contact FDA to resolve any questions regarding criteria prior to submission of their application.  All questions of a technical or programmatic nature must be submitted to the FDA program staff.  All questions of an administrative or financial nature must be submitted to the Grants Management Staff.

The applicant must provide assurance that plans have been developed to engage in the types of activities outlined in the grant application using these grant funds, an itemization of how grant funds will be expended, a description of how grant activities will be monitored, and ability to report information required by the Secretary to conduct evaluations.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:

Acceptable post submission materials include:

Revised budget pages

Biographical sketches

Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator.

News of an article accepted for publication (a copy of the article should not be sent).

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. All applications submitted to the FDA in support of the Agency's mission are evaluated for scientific and technical merit through the FDA objective review system.

Overall Impact

Reviewers will provide an overall impact 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

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

The content/subject matter and how current and appropriate it is for the mission of FDA.

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 be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? (Total weight=20%)

Investigator(s)    

Is (are) the PD/PI(s) well suited for organizing and fulfilling the goals of this conference/scientific meeting? Are the qualifications and past performance of the PD/PI(s) appropriate, and are they well suited for their described roles in the conference/scientific meeting? Are the key personnel and selected speakers appropriate and well suited for their described roles in the conference/scientific meeting? (Total weight=20%)  

Innovation

Does the conference/scientific meeting draw together appropriate experts who may otherwise not have an opportunity to meet? Is the conference topic original and innovative? For example: Does the conference address an innovative hypothesis or critical barrier to progress in the field? Does the conference develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? (Total weight=20%)  

Approach

Are the format and agenda for the conference/meeting appropriate for achieving the specified goals? Is the conference/meeting timely for the subject matter? For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the topics of the conference/meeting and the expertise of each of the PD/PIs? (Total weight=20%)  

Environment

Is the conference/scientific meeting site appropriate? Does the applicant organization have the ability to contribute to the probability of success? Do the proposed meetings, exhibits, interactions, etc., take advantage of unique features of the environment or employ useful collaborative arrangements? Is institutional support evident?   (Total weight=20%)  

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 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 conference(s).

2. Review and Selection Process

All applications determined to be complete and responsive will undergo an objective review process.  An objective review panel will evaluate complete and responsive applications according to the criteria listed in the Scored Review Criteria section above.

As part of the objective review, all applications:

Appeals of initial objective review will not be accepted for applications submitted in response to this FOA.

Applications will be ranked on the basis of their Composite Score and will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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’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, SAM Registration, and Transparency Act requirements as noted in 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.

Grant Terms and Conditions of Award

All conference material (promotional materials, agenda, publications and internet sites) related to this project must include an acknowledgement of FDA grant support and a disclaimer stating the following: “Funding for this conference was made possible [in part] by [insert grant number] from [insert FDA name]. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

An FDA Program Official or Center Program Director/Project Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA.

Additional terms and conditions regarding FDA regulatory and Programmatic requirements may be part of the Notice of Award.

3. Reporting

Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the conference.

Program monitoring of recipients will be conducted on an ongoing basis and written reports will be reviewed and evaluated at least annually by the project officer. Project monitoring may also be in the form of email and telephone conversations between the project officer/grants management specialist and the project director/principal investigator.

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. Reports must be submitted two months prior to the next budget period start date. The Progress Report should include a report of the previous meeting supported by the current grant, as well as a full description of the next planned meeting.

A final Progress Report detailing the project activities/outcomes and a final Federal Financial Report (SF-425) are required within 90 days of the expiration date of the project period as noted on the Notice of Grant Award, or when an award is relinquished, when a recipient changes institutions or when an award is terminated. The report of the meeting should include: (a) the grant number; (b) the title, date and place of time of the meeting; (c) the name of the person shown on the application as the conference director, principal investigator, or program director; (d) the name of the organization that conducted the meeting; (e) a list of individuals who participated as speakers or facilitators in the formally planed sessions of the meeting;  and their institutional affiliations, (f) a summary of topics discussed, next steps and conclusions.

Grantees are expected to publish their conference minutes and project outcomes/tools developed under this grant to their Food Protection Task Force website and include a hyperlink in their final report to FDA. Information should be available to other food protection organizations to adopt and utilize for their own use. These websites are available to all Food Protection Task Forces at no charge through FDA’s Office of Partnerships. Please contact Travis.Goodman@fda.hhs.gov for more information regarding websites.

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 sub awards 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 Sub award Reporting System (FSRS) available at www.fsrs.gov on all sub awards over $25,000.  See the HHS Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

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 NIH 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)

William J. Foust
FDA/ORA/Office of Partnerships
12420 Parklawn Drive, Room 3017
Rockville, MD 20857
Telephone: 301-796-3470
E-mail: william.foust@fda.hhs.gov

Objective Review Contact(s)

Martin Bernard
Office of Acquisitions and Grants Services (OAGS)
5630 Fishers Lane
Rockville, MD 20857
Telephone: 301-443-5869
Fax: 301-827-0505
Email: martin.bernard@fda.hhs.gov

William J. Foust
FDA/ORA/Office of Partnerships
12420 Parklawn Drive, Room 3017
Rockville, MD 20857
Telephone: 301-796-3470
E-mail: william.foust@fda.hhs.gov

Financial/Grants Management Contact(s)

Martin Bernard
Office of Acquisitions and Grants Services (OAGS)
5630 Fishers Lane
Rockville, MD 20857
Telephone: 301-443-5869
Fax: 301-827-0505
Email: martin.bernard@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 Section 301 of the Public Health Service Act as amended (42 USC 241), under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92, and section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188) (42 USC § 247b-20).

All awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement. The DHHS Grants Policy Statement can be found at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.


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