Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Office of Regulatory Affairs (ORA)

Funding Opportunity Title

Retail Food Safety Association Collaboration (U18) Clinical Trial Not Allowed

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-20-028

Companion Funding Opportunity

None

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

 93.103

Funding Opportunity Purpose

 The intended outcome of this FOA is to collaboratively advance retail food initiatives to reduce foodborne illness. This cooperative agreement is intended to advance practices in retail food protection, conduct research related to such practices and identify opportunities for collaboration to reduce the occurrence of foodborne illness risk factors.

Key Dates

 

Posted Date

March 13, 2020

Open Date (Earliest Submission Date)

March 12, 2020

Letter of Intent Due Date(s)

March 26, 2020

Application Due Date(s)

May 13, 2020, 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.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2020

Advisory Council Review

Not Applicable

Earliest Start Date

August 2020

Expiration Date

May 14, 2020)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) 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.


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

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) is announcing the availability of cooperative agreements to be awarded under Limited Competition to non-profit membership national food safety regulatory associations focused on retail food safety initiatives.  The intended outcome of this Funding Opportunity Announcement (FOA) is leveraging the resources and strengths of national retail food safety associations to collaboratively advance retail food protection and reduce foodborne illness. The resulting cooperative agreements will provide additional support to advance retail food safety by reviewing existing research on the effectiveness of intervention strategies designed to reduce foodborne illness risk factors, conducting research to assess the current use of intervention strategies by state, local, tribal, and territorial (SLTT) retail food regulatory programs and industry, developing outreach programs to promote use of effective intervention strategies and other best practices, promoting implementation and full conformance of the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by state, local, tribal, and territorial (SLTT) jurisdictions, supporting full adoption of the most recent FDA Food Code, and improving foodborne illness outbreak response. 

The resulting cooperative agreements will include one year of funding with up to one year of additional non-competitive support, dependent on grantee performance and continued availability of federal funds.   

Program Goals:

The intended outcome of this FOA is to assist retail food regulatory programs in reducing foodborne illness by conducting research and implementing effective intervention strategies designed to reduce the occurrence of foodborne illness risk factors; implementing and achieving full conformance with VNRFRPS; performing risk-based inspections to effectively identify foodborne illness risk factors, assess gaps in active managerial control, and promote regulatory compliance; adopting the most recent version of the FDA Food Code; effectively responding to foodborne illness outbreaks; and responding to emerging food safety trends.      

Objectives:

Applicants may choose to submit a research strategy that addresses a portion or all of the objectives for this FOA.  The following are the objectives of this FOA:

  • Identify, assess, and promote implementation of effective intervention strategies. Intervention strategies are defined as a comprehensive set of activities, initiatives, or specific tools implemented on the part of industry and/or regulators that are designed to bring about immediate and/or long-term control of foodborne illness risk factors. Intervention strategies that have undergone field testing to prove effectiveness in changing long-term behavior of food employees are ideal for marketing to SLTT/industry partners.
  • Develop and implement toolkits and subsequent strategies to promote full, complete adoption of the most recent FDA Food Code by SLTT retail food regulatory programs.
  • Assess application of risk-based inspection methods by SLTT regulatory jurisdictions, identify barriers preventing application of risk-based inspection methods, and coordinate with the FDA to implement strategies to overcome the barriers.  
  • Build upon the FDA’s VNRFRPS technical assistance strategy to provide a “multiplier effect” to promote participation and implementation of the VNRFRPS by SLTTs.
  • Develop and promote strategies to improve active managerial control at the retail level. Active managerial control means the purposeful incorporation of specific actions or procedures by industry management into the operation of their business to attain control over foodborne illness risk factors. It embodies a preventive rather than reactive approach to food safety through a continuous system of monitoring and verification.  
  • Identify and issue joint recommendations with the FDA on emerging retail food safety issues and coordinate with the FDA to implement the recommendations, as appropriate.
  • Implement strategies to promote availability and usage of best practices, tool kits, research, and other information sharing among retail food safety stakeholders.
  • Develop and implement training, outreach, educational materials and opportunities, and other innovative approaches to assist SLTT regulatory jurisdictions with reducing the occurrence of foodborne illness risk factors in food establishments and responding more effectively to foodborne illness outbreaks.
  • Develop and implement effective communication strategies to advance retail food safety initiatives across all stakeholders.
  • Develop and promote tools that can be used nationally to meet objectives above.

BACKGROUND

Foodborne illness remains a major public health concern in the United States. Foodborne diseases cause approximately 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths each year (Scallan et al., 2011). The annual economic burden from health losses due to foodborne illness is estimated at 77.7 billion dollars (Scharff, 2012).

According to the Centers for Disease Control and Prevention (CDC, 2014) more than half of foodborne illness outbreaks that occur each year are associated with food from restaurants. When considering incidents in 2014 involving a single location of food preparation, for example, restaurants accounted for 485 outbreaks (65%) and 4,780 illnesses (44%) (CDC, 2014).

In a study of restaurant-associated outbreaks in the United States from 1998-2013, Angelo, Nisler, Hall, Brown and Gould (2016) identified 9,788 restaurant-associated outbreaks, with a median of 620 outbreaks per year. Norovirus caused 46% of the 3,072 outbreaks associated with a single, confirmed etiology. Activities related to food handling and preparation practices were the most commonly reported contributing factors within restaurant-associated outbreaks.

Surveillance data from the CDC have consistently identified five major risk factors related to food safety practices within the retail food industry that contribute to foodborne illness. Most regulatory retail food inspection programs throughout the United States monitor these risk factors in their routine inspections, and each necessitates specific food safety behaviors and practices. These risk factors include:

• Poor personal hygiene

• Improper food holding/time and temperature

• Contaminated equipment/lack of protection from contamination

• Inadequate cooking

• Food obtained from unsafe sources

This FOA furthers the FDA's support of SLTT retail food safety programs’ efforts to reduce the occurrence of foodborne illness risk factors. The purpose of this support system will be to leverage FDA’s association partners in assisting SLTT agencies conduct research and other activities in their efforts to reduce the occurrence of foodborne illness risk factors and advance a nationally integrated food safety system.

Recent legislative and strategic initiatives have addressed FDA's relationship with state, local, territorial and tribal authorities in retail food protection activities.  Please visit https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/retail-food-protection  for more information.

a. Retail Food Safety Initiative

Announced in October 2010, the Retail Food Safety Initiative is part of the Food and Drug Administration’s (FDA) overall prevention-based, farm-to-table food safety strategy to reduce foodborne illness. The FDA actions in this initiative are prompted by a 10-year study of more than 800 retail food establishments to determine compliance with five key risk factors in nine types of retail operations.

FDA's partnerships with the retail food industry; state, local, territories and tribal authorities; and other government agencies are a foundational building block of the initiative and key to its success in four action areas:

•          Make the presence of certified food protection managers common practice.

•          Strengthen active managerial controls at the retail level and ensure better compliance.

•          Encourage widespread, uniform, and complete adoption of the most recent version of the FDA            Food Code.

•          Create an enhanced local regulatory environment for retail food operations.

To help create an enhanced local regulatory environment for retail food operations, FDA is committed to:

(1) Promoting wider implementation by state, local and tribal regulatory programs of the FDA Voluntary National Retail Food Regulatory Programs Standards.

(2) Ensuring universal participation by local regulators in consistent, high quality training through increased access and increased portability and transferability of FDA courses; and

(3) Seeking increased multi-year funding for the state, local and tribal programs as part of an integrated food safety system.

For more information:  https://www.fda.gov/food/retail-food-protection/retail-food-safety-initiative

b. Food and Drug Administration Amendments Act of 2007 (FDAAA)

Under section 1004 of FDAAA (21 U.S.C. 2104), the Secretary of the Department of Health and Human Services (which includes FDA) is required to work with the states to improve food safety.

Section 1004(a) of FDAAA (21 U.S.C. 2104(a)) states that the Secretary shall provide assistance to encourage states to:

(1) Establish, continue, or strengthen state food safety programs, especially with respect to the regulation of retail commercial food establishments; and

(2) Establish procedures and requirements for ensuring that processed produce under the jurisdiction of state food safety programs is not unsafe for human consumption.

This assistance to plan, develop, and implement such a food safety program may include:

(1) Advisory assistance;

(2) Technical assistance, training, and laboratory assistance; and

(3) Financial and other assistance (21 U.S.C. 2104(b)).

c. FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. It also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. These include authorities such as mandatory recall, expanded administrative detention and suspension of facility registration. FSMA also gives FDA important new tools to hold imported foods to the same standards as domestic foods.

FSMA directs FDA to build an integrated national food safety system in partnership with state and local

authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas such as: reliance on federal, state, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and Local food safety and defense capacities.

d. New Era for Smarter Food Safety

On April 30, 2019, the FDA announced a new approach to food safety, one that recognizes and builds on the progress made in the past but looks towards what processes and tools will be needed for the future. The agency is currently developing a Strategic Blueprint that will outline how the FDA plans to leverage technology and other tools to create a more digital, traceable, and safer food system. This work will build on the advances that have been and are being made in FDA’s implementation of FSMA while advancing the use of technologies that are currently used in society and business sectors all around us, such as blockchain, sensor technology, the Internet of Things, and artificial intelligence.

Priority areas include:

•Tech-Enabled Traceability and Foodborne Outbreak Response: Looking at technologies, data streams, and processes that will greatly reduce the time it takes to track and trace the origin of a contaminated food and respond to public health risks.

•Smarter Tools and Approaches for Prevention: Enhancing the use of new knowledge from traceback, data streams and tools for rapidly analyzing data.  The ability to use new data analysis tools and predictive analytics will help FDA and stakeholders better identify and mitigate potential food safety risks and advance the preventive controls framework that FSMA established.

•Adapting to New Business Models and Retail Food Safety Modernization: Advancing the safety of both new business models, such as e-commerce and home delivery of foods, and traditional business models, such as retail food establishments.

•Food Safety Culture: Promoting and recognizing the role of food safety culture on farms and in facilities. This involves doing more to influence what employees and companies think about food safety and how they demonstrate a commitment to this work. Strengthening food safety cultures also extends to the home and FDA is working to educate consumers on safe food handling practices.

For more information: https://www.fda.gov/food/food-industry/new-era-smarter-food-safety.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

 

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications.  Award(s) will provide one (1) year of support and include future recommended support for one (1) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

FDA/ORA intends to fund up to $1,500,000, for fiscal year 2020 in support of this grant program.

It is anticipated that up to five (5) awards will be made, not to exceed $750,000 in total costs (direct plus indirect), per award.

Award Budget

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $750,000

YR 02: $750,000

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is two years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

This opportunity is only available to national organizations/associations:

1. National organizations/associations that represents state and local retail food regulatory programs as a primary purpose.  National Associations/Organizations have the membership, resources, structure, and expertise necessary to build national consensus amongst state and local agencies on key food safety issues.  They are the primary means for communication and collaboration on issues of national significance for state and local agencies.  The outcomes are position statements, resolutions, and legislation that are uniformly supported by state and local agencies.  National Associations/Organizations are also viewed as primary sources for educational opportunities and current information, such as proposed legislation and emerging food safety issues.

2. These national organizations/associations have a vested interest and share the FDA’s vision to leverage the resources and strengths of national retail food safety associations to collaboratively advance retail food initiatives and activities to reduce foodborne illness. 

3. The association’s principle purpose must be to act as a leader and a resource to state and local retail food regulatory agencies in developing strategies to resolve and promote public health and consumer protection related to the regulation of retail foods.  Additionally, the association must have knowledge on the infrastructure, capacity, strengths, and needs of SLTT regulatory programs.  The association must have successful experience in carrying out national efforts to build an integrated food safety system, which includes Federal, State, and local agencies. The association must be comprised of regular members that are officials of State and Local regulatory agencies that administer retail foods inspection programs in conjunction and in collaboration with FDA.

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.

  • 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)– 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.
  • o   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 to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

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

Applicant organizations may submit only one application.

Section IV. Application and Submission Information
1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) 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.

Letter of Intent

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), including any proposed subawards
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Gordana Zuber
Telephone: 301-348-1747
Email: Gordana.Zuber@fda.hhs.gov

A technical session will be held for prospective applicants in April 2020.  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. 

Page Limitations

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

For this specific FOA, the Research Strategy section is limited to 30 pages.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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:

  • 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.
  • 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.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: The Research Strategy should address the following:

1. Demonstrate ability to develop and deliver trainings, workshops, meetings, tool kits, and other educational materials and resources, including any online courses and in-person workshops or seminars. 

2. Demonstrate technical knowledge of the VNRFRPS, FDA Food Code, foodborne illness risk factor studies, and other aspects of retail food regulatory programs. Include efforts to design, develop, document, deliver, manage, and implement programs and initiatives supporting SLTT regulatory retail food programs commensurate with the objectives of this FOA.

3. Demonstrate ability to conduct research on the use of effective intervention strategies, risk-based inspection methods, and emerging trends.  

4. Demonstrate ability to develop and implement effective communication strategies to promote and assist with implementation of retail food safety initiatives across all stakeholders. 

5. Demonstrate ability to collaborate with national initiatives, such as Partnership for Food Protection and Food Protection Task Forces.

7. Provide a properly detailed budget to meet the project objectives. 

8. Outline the plan, resources available, and qualifications of the personnel that will support this project.

9. Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this

Announcement.

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:

  • Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. 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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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 cost includes but not limited to:

1.  Subawards/contracts to third parties, including eligible applicant organizations.

2.  Audiovisual materials.

3.  Employee salaries, wages, and fringe benefits.

4.  Rental, purchasing, and maintenance of supplies and equipment.

5.  Indirect costs based on a signed, current federal indirect cost rate agreement.

6.  Recruit costs for hiring new employees.

7.  Registration fees.

8.  Purchase or development of IT equipment, software, and support.

9.  Shipping and mailing of equipment and supplies.

10. Travel.

11. Speaker fees.

12. Training programs.

Non-allowable costs:

1) Facilities, work, and training reimbursed under other cooperative agreements, grants, contracts, and other funding mechanisms shall remain distinct and separate from the cooperative agreement.

2) Vehicle purchases are not permitted.

3) Cooperative agreement funds may not be utilized for new building construction or remodeling of existing facilities.

4) Cooperative agreement funds may not be utilized for uniforms or clothing except Personal Protective Equipment (PPE).

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

7. Other Submission Requirements and Information

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 How to Apply – Application Guide. 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.

Post Submission Materials

Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review.  Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials.  Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

Section V. Application Review Information
1. Criteria

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

Scored Review Criteria

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

Significance (30 Points)

Are the proposed system, strategies, and approach to meet the intended outcome of the cooperative agreement well-reasoned, appropriate, and complete?  Does the proposed project(s) address an important problem or a critical barrier related to reducing retail risk factors?   Will the projects promote reduction of retail foodborne illness risk factors?

Approach (30 Points)

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposal address how the grantee will demonstrate effectiveness and return-on-investment (ROI) of the outputs?

Cooperation and Collaboration (25 Points)

Does the applicant demonstrate a history and/or an ability to be effective in working with retail food regulatory programs, industry, allied associations, FDA, and other stakeholders to accomplish the goals of the project?

 
Investigator(s) and Environment (15 Points)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Is the leadership approach, governance and organizational structure appropriate for the project? Will the environment in which the work will be done contribute to the probability of success?     

Additional Review Considerations

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.

Protections for Human Subjects

Generally not applicable.  Reviewers should bring any concerns to the attention of assigned Grants Management Specialist.

Inclusion of Women, Minorities, and Individuals Across the Lifespan 

Generally not applicable.  Reviewers should bring any concerns to the attention of assigned Grants Management Specialist.

Vertebrate Animals

Generally not applicable.  Reviewers should bring any concerns to the attention of assigned Grants Management Specialist.

Biohazards

Generally not applicable.  Reviewers should bring any concerns to the attention of assigned Grants Management Specialist.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Select Agent Research

Generally not applicable.  Reviewers should bring any concerns to the attention of assigned Grants     Management Specialist.

Resource Sharing Plans

Generally not applicable.  Reviewers should bring any concerns to the attention of assigned Grants Management Specialist.

Authentication of Key Biological and/or Chemical Resources:

Generally not applicable.  Reviewers should bring any concerns to the attention of assigned Grants Management Specialist.

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 scientific and technical merit by (an) appropriate 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.
3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information
1. Award Notices

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 terms and conditions found in the HHS Grants Policy Statement, this FOA, and Notice of Award. 

2. Administrative and National Policy Requirements

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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.  For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all FDA grants and cooperative agreements.

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.

Certificates of Confidentiality – 42 U.S.C. 241(d)

Awardees are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government.  See 42 U.S.C. 241(d).  All research funded by FDA, in whole or in part, that is within the scope of these requirements is deemed to be issued a “Certificate of Confidentiality” through these Terms and Conditions.   Certificates issued in this manner will not be issued as a separate document. 

Awardees are expected to ensure that any investigator or institution not funded by FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d).  Awardees are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

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

Cooperative Agreement Terms and Conditions of Award

The administrative and funding instrument used for this program is the cooperative agreement, an assistance instrument (rather than an acquisition instrument), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FDA’s objective is to support and stimulate the recipient’s activities by involvement in and otherwise working jointly with the award recipient 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 awardee for the project although specific tasks and activities may be shared between the awardee and the FDA as defined below.

Project Director/Principal Investigator Rights and Responsibilities:

The Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA/ORA staff being substantially involved as a partner with the PD/PI, as described below.

The PD/PI will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff have the necessary training and clearance to work on this project. This individual will work closely with designated officials within the recipient organization and with partner organizations to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal, regulatory, and organizational requirements.

The awardee is also responsible for

1. Submitting progress reports as determined by FDA.

2. Travel and preparing materials for meetings with FDA personnel in the Washington, D.C. metro area or other designated area.

3. Participating in a cooperative manner with FDA.

4. Timely submission of all training content and/or reviews by subject matter experts (co)authored by members of the grant and/or reviews authored by others working for FDA. Manuscripts are to be submitted to the PO within two weeks of acceptance for publication.

Acknowledgement of federal support:

When issuing statements, press releases, publications, promotional materials, presentations, agendas, and internet postings or printing training content such as course manuals, presentations, web courses, reference material and/or other documents describing projects or programs funded in whole or in part with federal money, the awardee needs to clearly indicate:

"Funding for this (insert appropriate venue, i.e.: conference, training, manuals, presentations, credentials, etc.) was made possible, in part, by the Food and Drug Administration through grant (insert grant number). Views expressed in written materials or publications (where course manuals/publications  and presentations have been reviewed and approved by FDA, it may be appropriate to remove “in written materials or publications” – seek input from the PO for appropriate verbiage for each project) and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government."

Property rights (if the awardee develops something tangible):

The awardee will retain custody of, and have primary rights to, the data and software (including all source files) developed under these awards, subject to government rights of access consistent with current DHHS, PHS, and FDA policies. In all cases, FDA must be given a royalty-free, nonexclusive, and irrevocable license for the federal government to reproduce, publish, or otherwise use the material and to authorize others to do so for federal purposes. Curriculum and course content developed under this cooperative agreement grant such as objectives, learning outcomes, presentations, manuals, scripts, exercises, handouts, reports, documents or other tangible materials produced by the awardee must be guaranteed free of copyrights from outside sources and be free domain for use by FDA. Any FDA curriculum or training course content provided by FDA will remain the property of FDA and any proposed changes are not to be made without concurrence from FDA.

Other rights, requirements and expectations:

The Government, via the PO, will have access to data generated under this cooperative agreement grant and may periodically review the data, progress reports and/or prepare internal project reports, however awardees will retain custody of and have primary rights to all data developed under these awards.

FDA retains the right to conduct audits and/or request meetings with the awardee management to discuss training programs and other related activities. FDA shall be responsible for funding the travel and travel related costs for FDA personnel (or other federal employees). Any travel cost incurred by the awardee to meet with FDA is the responsibility of the awardee under this grant.

The awardee is expected to remain flexible in support of the overall purpose of the cooperative agreement grant.

FDA Responsibilities:

The Grants Project Team may consist of a Grants Management Specialist, Program Official (PO), Project Manager (PM) and Technical Advisor.  The Grants Project Team collaborates to review the progress of the grantee.  The Grants Project Team may utilize the grantee’s progress reports, site visits, audit reports and other supporting documentation to determine if the condition of the award was met and satisfactory progress is being made.  Each team member works in consultation with each other, as needed, throughout the duration of the project. A description of each team member involved with the program are described below.

An FDA Grants Management Specialist (GMS) will be assigned and named in the Notice of Award.  The GMS oversees the administrative, financial, business and other non-programmatic aspects of the program.  These activities include, but are not limited to the following: 

  • Provides guidance on administrative, business, fiscal aspects of grants management to grantees and FDA program staff
  • Monitors and manages applications and required reports on eRA Commons
  • Monitors administrative and financial aspects of grantee activities
  • Maintains the official grantee file

An FDA Program Official (PO) will be assigned and named in the Notice of Award.  The PO is accountable for the programmatic oversight of the grant to include coordination, with the Project Manager, on the technical aspects of the grant.  S/he ensures the budget of grantees are reasonable and costs are allowable and allocable.  The PO reviews the progress reports to verify the budget proposed includes only allowable expenses that support the project goals and objectives.   The PO also assists with post-award monitoring and establishing a corrective action plan, if necessary.

An FDA Project Manager (PM) will be assigned to the program. The FDA PM is the responsible official for the programmatic, scientific, and/or technical aspects of assigned applications and cooperative agreements. The FDA PM will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.

The PM will have substantial involvement in the design, implementation, and evaluation of program activities, and dissemination of program results and outcomes, above and beyond routine grant monitoring. Substantial involvement by FDA/ORA includes, but is not limited to, the following:

  • Provide guidance and technical assistance in project planning, implementation, and evaluation;

Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;

Actively monitor the supported program via telephone conversations, webinars, e-mails, written correspondence, or periodic site visits;

Evaluate the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols;

Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing;

Participate in data analysis, interpretation of findings, and where appropriate, co-authorship of publications;

Development of programs to meet the FDA mission;

Provision of programmatic technical assistance;

Post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the FDA. 

An FDA Technical Advisor(s) will be assigned to each enrolled program. The Advisor will work cooperatively with the PO to help monitor and report grantee status/progress including sharing of information and historical backgrounds. The FDA Technical Advisor will have programmatic involvement as described below including but not limited to the following:

  • Provide guidance, direction, and technical assistance in project planning, implementation, and evaluation;
  • Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing;
  • Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;
  • Provision of programmatic technical assistance;
  • Post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the FDA.

Unless another governance structure is mutually agreed upon, the PO will serve as the primary point of contact for the dissemination of FDA policy and milestones/objectives work planning.

Delineation of substantive involvement:

1. FDA will monitor and evaluate the overall performance of the awardee under this cooperative agreement grant

2. FDA will collaborate and work closely with awardee’s continued development

3. FDA will take any action that may be necessary to ensure compliance with this cooperative agreement grant

4. FDA may choose not to have significant input or control on some projects/tasks as it may be deemed more suitable for the awardee to lead and control the design, methodology, analysis, development and/or delivery of work.

3. Reporting

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 RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the terms and conditions of award and the HHS Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. 

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Mid-year progress and end of year reports shall contain the elements below as applicable to the application and award, including but not limited to, the following:

1.  Detail progress report on the grantee meeting the project milestones detailed in the cooperative agreement, proposal, strategic plan, conditions of the award, etc. Goals and objectives should be broken out and specific progress reported. 

2. Status report on the hiring and training of cooperative agreement funded personnel.

3. Contributions of personnel, especially employees receiving salary and/or benefits through the cooperative agreement or identified as key personnel, towards the goals of the cooperative agreement should be reported against.  Contributions should be directly related to the objectives of the funding agreement.

4.  Status reporting on the purchasing, development, and operational readiness of any equipment, computers, or software purchased.

5.  Identifying any pending issues or concerns that may affect accomplishing the objectives and goals of the cooperative agreement.

6. A corrective action plan must be submitted if the objectives and goals of the cooperative agreement are not being met. The corrective action plan must detail the tasks, responsible personnel, and updated timeframes to ensure satisfactory performance and meet the deliverables required under the grant.

7.  Summary of grant expenditures and obligations during the current budget period.

8.  Summary report on surveys, field testing, assessments, and other activities conducted in support of the cooperative agreement goals, including evaluation of effectiveness, response rates, impact, analysis, and recommendations.

9.  Status report on the support and identification of any pilot projects implemented. 

10.  Status report on networking activities, collaboration with the FDA, best practices, studies, technical assistance and outreach and reports shared with FDA and other stakeholders, including the following:

  • Efforts to support and enhance VNRFRPS technical assistance
  • Development of strategies to promote best practices, food protection success stories and joint recommendations between FDA and grantee associations.
  • Activities to promote adoption of the FDA Food Code among SLTT regulatory agencies.
  • Results of identification and assessment of industry intervention strategies.

The final program progress report shall provide a complete written narrative covering the entire project and summaries of accomplishments and goals, as described in the grant application.  The final program progress report shall include a final action plan, an updated current self-assessment for the Retail Program Standard areas advanced during the project period.  The report shall detail the strategy to continue advancing conformance with the Retail Program Standards.  The documentation shall be in a form and contain sufficient detail such that other agencies could reproduce the final project.

MONITORING ACTIVITIES

The Project Official, ORA Project Manager, and Technical Advisor will monitor award recipients periodically. The monitoring may be in the form of face-to-face meetings, telephone conversations, e-mails, or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the recipient organization will occur, including program assessments and audits.

The results of these monitoring activities will be recorded in the official cooperative agreement file and will be made available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations.  Also, the grantee organization shall comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the Project Officer and Technical Advisor.

The scope of the recommendation will confirm that: (1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; and (3) if necessary, there is an indication that corrective action has taken place.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://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 Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Jenice Butler

Office of Regulatory Affairs (ORA), Office of Partnerships

Food and Drug Administration

Telephone: 240-402-6384

Email: jenice.butler@fda.hhs.gov

Suzanne Webb

Office of Regulatory Affairs (ORA), Office of Management

Food and Drug Administration

Telephone: 240-402-3069

Email: suzanne.webb@fda.hhs.gov

Objective Review Contact(s)

Gordana Zuber
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-348-1747
Email: Gordana.Zuber@fda.hhs.gov

Financial/Grants Management Contact(s)

Gordana Zuber
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 301-348-1747
Email: Gordana Zuber@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) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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