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) in coordination with the Center for Veterinary Medicine(CVM

Funding Opportunity Title

FDA Drug Residue Prevention Program (U18)

Activity Code

U18 Research Demonstration Cooperative Agreements

Announcement Type


Related Notices


Funding Opportunity Announcement (FOA) Number


Companion Funding Opportunity


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


Funding Opportunity Purpose

The intended outcome of this program is to advance efforts to improve and develop state drug residue prevention programs. It is necessary to provide assistance to state drug residue programs that need a stronger foundation to promote the prevention of illegal drug residues in animal derived foods through educational outreach and training.

This program is intended to ensure drug residue prevention programs are developed to protect consumer exposure to drug residues in the edible products of food animals and support activities related to drug residue prevention. In addition, these awards will assist state agencies to better direct their programs to reduce the outcomes of illegal drug residues in animal derived foods.

This cooperative agreement program (CAP) will focus on outreach, education and training. In addition, grantees will focus on performing targeted on-site assessments related to drug residue violations and best practice visits to industry and individuals to communicate proper drug use and promote effective management practices for drug residue prevention.

Key Dates

Posted Date

March 12, 2018

Open Date (Earliest Submission Date)

March 16, 2018

Letter of Intent Due Date(s)

April 2, 2018

Application Due Date(s)

May 16, 2018 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 and eRA Commons errors) by 11:59 PM Eastern Time on the application due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2018

Advisory Council Review

Not Applicable

Earliest Start Date

September 2018

Expiration Date

May 17, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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)/Office of Partnerships (OP) is announcing the availability of a cooperative agreement to be awarded under Limited Competition. This cooperative agreement is intended to develop, complement and enhance state drug residue prevention programs. This will be accomplished through the provision of funding for training and outreach given to individuals and parties involved with treating and/or managing treated food producing animals, support activities related to legal Extralabel Drug Use in Animals (21 CFR 530) and other measures related to drug residue prevention in state governments.

This cooperative agreement program (CAP) will focus on outreach, education and training. In addition, grantees will focus on performing targeted on-site assessments related to drug residue violations and best practice visits to industry and individuals to communicate proper drug use and promote effective management practices for drug residue prevention. This CAP will allow for state program development in drug residue prevention, encourage resource utilization, enhance information sharing and provide infrastructure building.

Under this CAP, the state governments would initiate or improve drug residue prevention programs that communicate proper drug use and effective management practices to prevent drug residues in animal derived foods in their jurisdiction. Funds to be used on educational outreach activities and training can include, but not be limited to the following: developing materials needed to increase knowledge of, and compliance with, approved drug use; education in effective management practices and on-farm practices; recordkeeping; developing materials or events for drug residue prevention and awareness; provide information on extralabel drug use regulations and prohibitions; understanding of treated food-producing animal management; fund adequate control measures; and distribution of materials at meetings, websites and other broad efforts to reach the industry.

The primary goal of this program is to emphasize drug residue prevention though the activities mentioned above. A proactive approach in preventing drug residue violations is more effective than the reactive approach of responding to violations.

There are three objectives required to be performed and completed as specific activities under the effort of drug residue prevention in animal derived foods:

(1) Industry-Wide Education Development and Outreach: Conduct educational outreach activities and develop materials needed to further enhance industries' knowledge of proper drug use, treated food-producing animal management and compliance with extralabel drug use regulations.

(2) Assessments: Follow-up on current violative (illegal) drug residues, provided by FDA and of non-FDA interest, with intent to evaluate the sources' drug use and treated animal practices for purposes of identifying ineffective and/or improper practices; and to communicate best residue prevention practices with intent to prevent future violations and protect food derived from animals from violative drug residues.

A. Current violations (< 1 yr.)

1. Current Food Safety and Inspection Service (FSIS) violator information provided by FDA

2. Non-regulatory follow-up

3. Evaluate current drug use and treated animal practices in general; and specifically

evaluate the violation(s)

4. Communicate best practices

(3) Best Practice Visits: Perform on-site visits at industry associated with veterinary drug use to treat food producing animals and/or industry that holds treated animals that produce human food.

A. Historical violations (> 1 yr.)

1. Historical FSIS violator

2. Non-regulatory visits

3. Communicate best practices

4. Evaluate current drug use and treated animal practices in general


Effective management of animal treatment by laypersons (i.e. producers) and practitioners is expected as a result of initiating or enhancing drug residue prevention programs, and increasing knowledge of proper drug use and extra label drug use regulations. A reduction in illegal drug residues is anticipated in food producing animals.

These cooperative agreement funds are intended to supplement, not replace, current funding for program improvement and activities. Agencies funded under this cooperative agreement may be

required to provide the previous and subsequent years of state, local, territorial, or tribal funding to

demonstrate that these funds have not replaced previous allocations.

The FDA recognizes that there is variability in each state program and have different levels of infrastructure regarding drug residue prevention. There are some state programs that may have existing resources that could be leveraged to enhance their drug residue prevention activities.

Performance Measures:

Consistent with the Uniform Guidance, codified at 2 CFR Part 200, an emphasis will be placed on the applicant's ability to measure progress and track performance using objective, proven, and measurable data. As such, applicants will propose how they will develop and implement a performance measurement system, plan, and/or process and will carefully consider the Scored Review Criteria listed in Section V of this announcement when submitting their application.

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


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

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 two (2) additional years contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

FDA/ORA intends to fund up to $1,275,000 for fiscal year 2018 in support of this grant program.

It is anticipated that up to 9 awards will be made, not to exceed $175,000 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).
Section III- Eligibility Information in this FOA determines which funding tier and associated options applicants shall apply for.
Applicants will be categorized under one of three funding tiers:




$125,000 Total Award (Annual Maximum)


Total Award (Annual Maximum)


Total Award (Annual Maximum)

The application budget award limits are the same for future funding year amounts.

An applicant can apply for one (1) funding tier, up to a three (3) year program, depending on the scope of the proposed project and the classification category table listed in Section III-Eligibility Information.

Applicants must refer to Section III- Eligibility Information in this FOA for more information on the categories of the funding tiers applicants are eligible for applying.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is three (3) years.

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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

This opportunity is only available to state government agencies that have current FDA tissue residue inspection contracts or have previously been awarded an FDA tissue residue inspection contract between FY2014-2017. Competition is limited to these organizations to improve their current drug residue prevention program(s) and/or develop a stronger foundation to prevent drug residues in animal-derived foods through educational outreach, training, on-site assessments, best practice visits to industry and individuals to communicate proper drug use and promote effective management practices for drug residue prevention.

These state governments have demonstrated regulatory authorities and responsibility to eliminate the illegal use of drugs in food producing animals. Grantees will be expected to conduct on-site assessments related to drug-residue violations. Grantees will also perform best practice visits to industry and individuals to communicate proper drug use and promote effective management practices for drug residue prevention.

These state governments have demonstrated the experience and knowledge to identify practices resulting in illegal residues by previously conducting investigations to determine the cause of illegal drug residues.

These state governments have demonstrated experience conducting training and outreach with industry to identify on-farm husbandry practices and educational needs to prevent future residues.

FDA has also provided on-line, classroom, and in-field training to these state programs.

These state governments also experience a minimum number of tissue residue violations to maximize the public health benefit of the funding.

Applicants will be categorized under one of three funding tiers:


Tier 1: $125,000 (total costs)

Tier 2: $150,000 (total costs)

Tier 3: $175,000 (total costs)

Applicants have been classified into three (3) levels of funding tiers based on a variety of factors unique to that state (See data sources below). This approach establishes funding levels proportional to the applicant's jurisdictional work volume for this program area. To determine which funding level of which applicants can apply, please refer to the table below.



Total Award ( Annual



Total Award ( Annual Maximum)


Total Award

( Annual











North Dakota

New York



South Dakota




Data sources used to determine eligibility:

- FDA tissue residue state contract holder: 2014-2015 (FY15), 2015-2016 (FY16) or 2016-2017 (FY17)

- total number of violations per state for FY15, FY16 and FY17

- average annual number of violations per state (total violations for FY15+FY16+FY17, then divided by 3)

Applicants are encouraged to apply for the funding that reflects their jurisdiction's needs both in funding level amounts and the number of project years for the cooperative agreement program.

Year 1

Year 2

Year 3

Maximum Total Project


















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) (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 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.
  • Applicants must have an active DUNS number and SAM registration in order to complete the 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 more than one application, provided that each application is scientifically distinct.

The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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 instructions in the Research 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.

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)
  • Number and title of this funding opportunity

The letter of intent should be sent by email to:

Daniel Lukash, Grants Management Specialist
Telephone: 240-402-7596

A technical session will be held for prospective applicants in April 2018. 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.

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.


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

PHS Human Subjects and Clinical Trials Information

The PHS Human Subjects and Clinical Trials Information form replaces the Human Subjects section of the Research Plan form. FOAs that do not allow clinical trials use this form for human subjects.

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.

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

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 (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 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 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.

Non-allowable costs:

1. Investigations or inspections that are under contract with a government regulatory agency.

2. Facilities and work covered and funded under current FDA feed safety inspection contracts shall not be counted towards fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement. The state must be able to account separately for fund expenditures under the feed safety inspection contracts and this cooperative agreement.

3. Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.

4. Vehicle purchases are not permitted.

5. Uniforms and clothing not considered 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 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.

Post Submission Materials

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

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 (25 Points)

The rationale to achieve the goals of the cooperative agreement and project proposed. Describe how

successful completion of the project aims will improve the methods of treated animal management by

laypersons (i.e. producers) and practitioners, improve the knowledge of proper drug use and extra label drug use regulations, and/or change the preventative interventions in this field. In addition, explain how your project objectives will reduce the outcomes of illegal drug residues in animal derived foods.

Program Design (20 Points)

Demonstration of adequate program resources (including staff) and infrastructure, or the ability to obtain the resources necessary, to complete project needs. Project plans with listed timeframes shall be identified.

The project plans under this section may include:

  • Expected outcomes for each objective completed during the project period
  • Identify measures to monitor effectiveness of implemented initiatives as a result of this cooperative agreement program
  • Explanation of how data results, progress and the evaluation of the total project will be measured
  • Address the expected challenges in the project
  • Type of feedback process to improve the development of the project each year, assess the knowledge of the participants or target audiences; monitor the program at mid-year and/or end of the year for improvements
  • Individuals that will conduct the work and how it will impact responsibilities that are outside the
  • normal job duties of staff. Identify the individual's availability in current role and to perform
  • additional tasks specifically for this project
  • Description where the information for these resource materials are obtained from
  • The level of expertise and background knowledge of personnel staff you anticipate to use. Include the qualification reviews of personnel, which includes collaborative partners involved in completing the project needs
Communication (15 Points)

Application outlines a plan of action for the dissemination and sharing of ideas, techniques, and solutions with relevant parties. Explain in detail the type of communication methods or strategies (i.e. internet, software, web design, printed material, seminars, events, professional networks, assessments, site visits). Include the frequency of the type of communication that will provide a consistent delivery of the uniform message. Describe the means of reaching your target audience utilizing what type of resources to disseminate the information.

Implementation (25 Points)

Demonstration of the effectiveness of the drug residue prevention program can be sustained in the long-term (after the conclusion of the project period). This includes plans to achieve the incorporation of project-developed capabilities, practices and/or activities into long-term program work. The expected challenges should be addressed.

The proposed plan should contain evidence to show the effectiveness or success of the drug residue

prevention program's sustainability in the long-term (i.e. funding or maintenance of resources). Can the working relationships established during the project continue to effectively conduct educational outreach? How about the impact on maintaining materials, supplies, assessments, site visits or other resources after the conclusion of the project period, when funding is complete?

Budget Assessment (15 Points)

The budget is fair and reasonable. The budget plan does not contain unnecessary expenditures. The

application includes a detailed budget plan for each year of the project with justification. Funds can

include, but are not limited to the following: staff salaries; travel to events and/or facilities; infrastructure building; printed materials; and event fees..

Additional Review Criteria

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

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.


Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.


Not Applicable


Not Applicable


Not Applicable .

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

2. Review and Selection Process

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.
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.

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 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 The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see; and Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at 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

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 judgment 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.

Additional terms and conditions regarding FDA regulatory and ORA 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 them 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 as a whole, although specific tasks and activities may be shared between the awardee and the FDA as

defined below.

a) Cooperative Agreement--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 sufficient clearance and/or background checks 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.

b) Cooperative Agreement--FDA Responsibilities:

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

The PO 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, direction, 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.

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.

c) Monitoring Activities

Periodic program monitoring will be conducted by FDA on an ongoing basis which may include telephone conversations between the Principal Investigator and the Project Officer/Grants Management Officer/Grants Management Specialist, site visits and the review of written reports.

The Annual Progress Report will be due as part of the Research Performance Progress Report (RPPR) and is due no later than 60 days prior to the start date of the next budget period start date.

Grants with Multiple Years: In order to receive future funding, the grantee is required to submit the Research Performance Progress Report (RPPR). The Annual Progress Report will be due as part of the Research Performance Progress Report (RPPR) and is due no later than 60 days prior to the start date of the next budget period start date. This report should cover all activities/work that took place

during the current budget performance period noted in your Notice of Grant Award (NoGA).

d) Financial Reporting:

A. Cash Transaction Reports

The Federal Financial Report (FFR) has a dedicated section to report Federal cash receipts and disbursements. For recipients this information must be submitted quarterly directly to the Payment Management System (PMS) using the web-based tool. Quarterly reports are due 30 days following the end of each calendar quarter. The reporting period for this report continues to be based on the

calendar quarter. Questions concerning the requirements for this quarterly financial report should be directed to the PMS.

B. Financial Expenditure Reports

A required Federal Financial Report (FFR) must be submitted annually. FDA now requires all annual financial expenditure reports to be submitted electronically using the Federal Financial Report (FFR) system located in the eRA Commons. This includes all initial FFRs being prepared for submission and any revised FFRs being submitted or re-submitted to FDA. Paper expenditure/FFR reports will not accepted.

Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. Failure to submit timely reports may affect future funding.

Closeout Requirements (when applicable): A Final Program Progress Activity Report, Final Federal Financial Report SF-425, Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428, and Statement of Disposition of Equipment (if applicable) must be submitted within 90 days after the expiration date of the project period.

A non-Federal entity that expends $750,000 or more during the non-Federal entity's fiscal year in Federal awards must have a single or program-specific audit conducted for that year in accordance with the provisions of 45 CFR 75, Subpart F-Audit Requirements. Audits must be completed and submitted electronically to the Federal Audit Clearinghouse (FAC) within 30 days after receipt of the auditor's report(s), or 9 months after the end of the audit period, i.e., the end of the organization's fiscal year, whichever is earlier. If you need information on your organization's obligations, please visit the following website: Valuable information is included under the "Frequently Asked Questions" section of that website.

The grantee organization must comply with all special terms and conditions of the cooperative agreement. Future funding will be dependent on recommendations from the Project Officer. The scope of the recommendation will confirm an acceptable level of performance and continued compliance with all FDA regulatory requirements and conditions of the award. Specific project milestones, reporting requirements, and other project deliverables may be included as a condition of your award. If FDA determines that the state is unable to make adequate progress, FDA may place them in special condition status and may require a corrective action plan.

If a recipient of multiple FDA awards (cooperative agreements, grants, contracts), the State must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, under those funding mechanisms and this cooperative agreement.

The Government, via the PO, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. The FDA PO may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees shall retain custody of and have primary rights to all data developed under these awards.

3. Reporting

Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report using the RPPR are posted at

Mid-year reports are required and should be submitted by email to the Grant Specialist and Program Officer. The Research Performance Progress Report (RPPR) will be considered

the annual program progress report for the budget period.

Mid-year, annual progress and final reports shall contain the elements below as applicable to the grantee proposal and award, but are not limited to, the following:

1. Progress report that covers accomplishments for each specific goal and objective outlined in grant

application. Goals and objectives should be broken out and reported against actual results.

2. Summary of improvements (identify and quantify) or developments in the overall drug residue

prevention program resulting from the cooperative agreement. Baseline data must be provided,

when appropriate. A set range to accomplish the goals of the project or to gauge the success of the

proposed project must be identified. Examples can include personnel hiring, personnel training,

increase in outreach materials and/or events, metrics to determine the progress of on-site

assessments and best practice visits.

3. Certification of current appropriation funding levels for the regulatory program.

4. Status report on the installation, operational readiness, and monitoring activities of any analytical

equipment or software that is purchased.

5. Status report on hiring and training personnel that are involved in the existing drug residue

prevention program or developing new programs.

6. A strategic plan that accurately reflects when specific objectives and tasks have been, or will be,

completed and implemented and when new objectives and tasks are identified to support

achievement of the objectives outlined in this FOA. The strategic plan should include significant

goals or action items, anticipated completion dates, responsible personnel, and other required


7. Summary report on any outreach materials offered and events provided consisting of

educating outreach relating to proper drug use, effective management practices, compliance of

extra-label drug use regulations, and other related activities in support of drug residue prevention.

8. Summary report on the amount of training services and the number of outreach programs provided. The activity or event must produce measurable outcomes. The data results, progress, and the evaluation of the project covering the applicable reporting period must be measured and reported.

A finalPR, 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.

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 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.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free) Customer Support (Questions regarding registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system:

Scientific/Research Contact(s)

Jocelyn Ramos, Project Officer
FDA/ORA/Office of Partnerships
Telephone: 510-337-6894

Bruce Cooper, Technical Advisor
FDA/Center for Veterinary Medicine
Telephone: 240-402-5631

Objective Review Contact(s)

Daniel Lukash. Grants Management Specialist
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7596

Financial/Grants Management Contact(s)

Daniel Lukash. Grants Management Specialist
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7596

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 1009 of the Federal Food, Drug, and Cosmetic Act (21 USC 399), 21 USC 2104, and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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