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.

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

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 and projects developed within the purpose of this funding announcement. Grant funding is available to state, local, and tribal and territorial 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. 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 Research Demonstration and Dissemination Projects (R18), is to solicit applications from organizations that propose to develop, test, and evaluate food safety and food defense health service activities and to foster the application of existing knowledge for the control of categorical and food related diseases and illnesses.

Grantees will also organize Food Protection Task Force meetings and support related research activities, foster communication, cooperation and collaboration within the States among federal, state, local, tribal and territorial food protection, public health, agriculture, and regulatory agencies.

The Food Protection Task Force meetings/activities/projects 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 to improve food safety and defense.

(2) Communicate and disseminate key agency (FDA) objectives and mandates (e.g. Food Safety Modernization Act [FSMA], etc.) to relevant stakeholders.

(3) Collect, compile, and communicate stakeholder interests, concerns, and communication to the agency regarding information and activities covered under this funding opportunity.

(4) Assist in adopting or implementing the Food Code and other food protection regulations (e.g. FSMA, etc.).

(5) Promote the concept of an Integrated Food Safety System (IFSS) by communicating and supporting agency and related federal, state, local, tribal and territorial objectives that maximize the protection of the public health through prevention, intervention and response including the early detection and containment of foodborne illness.

(6) Conduct and present findings to stakeholders regarding research, investigations, demonstrations (etc.), relating to the causes or prevention of food related illnesses and injuries in the context of food safety and defense.

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 response; 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 1009, 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, Michael O. Leavitt, Secretary of Health and Human Services, and Andrew C. Von Eschenbach, M.D., Commissioner of Food and Drugs, charged FDA with developing a comprehensive and integrated FDA Food Protection Plan (herein "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.

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. It also includes 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 informing the public of what is safe to consume.

(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:

(a) capacity and resource needs;

(b) outbreak coordination and investigations;

(c) information sharing and data collection;

(d) uniform regulatory standards;

(e) communications and education;

(f) state/local laboratory operations and coordination;

(g) adoption and implementation of the FDA Food Code and other food protection regulations;

(h) uniform standards for foodborne illness and outbreak reporting investigation and response;

(i) state and local training needs; and

(j) food defense activities and coordination.

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 to promote food defense education and planning.
• Integrate food safety and food defense among public health, food and agriculture sectors and stakeholders for cohesive food protection integration (i.e. IFSS).
• Establish best practices for collaboration and alignment of resources among public and private sectors.

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

• 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.

• 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. Improve recall coordination activities between stakeholders.
• 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.

• 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.

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• U.S. Territory or Possession

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Applicant Organizations

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

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.

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

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

Grant funding is available to state, local, and tribal and territorial 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

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.

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), email address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent via electronic mail as a PDF file with the FOA Number and the Institution's Name in the message subject heading to:

Martin Bernard, Grants Management Specialist
Email: [email protected]

A technical session will be held for prospective applicants around one (1) month prior to the application due date of the current fiscal year. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged.

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:

• For this specific FOA, the submission is limited to 15 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• Applicants should submit a detailed budget breakdown for each budget category listed in the Budget Component form and provide a detailed narrative justification for all costs requested including any proposed per diem/subsistence rates, transportation, printing, supplies and facility rental costs.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.

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

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

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Note: Generally, Resource Sharing Plans are expected, but not 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.

See Part 2, Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. 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.

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Additional funding restrictions may be part of the Notice of Award.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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. See Section III of this FOA for information on registration requirements.

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. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process.

Reviewers will consider each of the review criteria below in the determination of scientific merit.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Are the PD(s)/PI(s), 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 training, education, and communication practices involving key agency objectives by utilizing novel approaches to support a FPTF? Does the applicant plan to reproduce developed material to make available for all stakeholders to access and benefit? Does the applicant plan to communicate and share resources and information developed from this grant support to other FPTFs and within their FPTF's jurisdiction? Are the meetings and FPTF activities novel and able to be reutilized by their stakeholders and colleagues?

Does the applicant's application sufficiently cover communicating and supporting the concept of a national Integrated Food Safety System (IFSS) and key agency objectives, rules, and regulations (e.g. FSMA implementation, etc.)? Does the applicant adequately cover communicating FPTF activities throughout their jurisdiction? Does the applicant work with existing FPTFs to maximize efficiency and cohesiveness within an IFSS structure? How does the applicant plan to broaden their current communication effort to increase overall outreach? Does the applicant plan to utilize novel methods of outreach to ensure effective communication to stakeholders?

Does the application clearly demonstrate collaboration within their jurisdiction among FPTF member and leadership? Does the applicant plan to collaborate with other FPTFs? Does the application plan to include local federal partners? Does the application include collaboration with applicable state, local, territorial, and tribal entities (as appropriate)? Does the application include academia, industry, consumers, and applicable private sector stakeholders?

As applicable for the project proposed, reviewers will evaluate the following additional items, but will not give separate scores for these items and should not consider them in providing an overall score.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by an Objective Review Committee using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

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

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

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.6. 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 terms and conditions found in the HHS Grants Policy Statement.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please seehttp://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and www.hhs.gov/ocr. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at the information located at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

Additional terms and conditions regarding FDA regulatory and Office Of Regulatory Affairs programmatic requirements may be part of the Notice of Award.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

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 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.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]

Graham N. Giesen, Project Officer
Food and Drug Administration (FDA)
Office of Regulatory Affairs
Telephone: 214-790-4986
Email: [email protected]

Martin Bernard
Office of Acquisitions & Grants Services (OAGS)
Telephone: 240-402-7564
Email: [email protected]

Martin Bernard
Office of Acquisitions & Grants Services (OAGS)
Telephone: 240-402-7564
Email: [email protected]

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

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.