Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The Food and Drug Administration's (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP), is announcing the availability of a Cooperative Agreement to be awarded under a Limited Competition. The estimated amount of funds available for support of this cooperative agreement is $300,000 (direct and indirect costs) for fiscal year 2016. It is anticipated an additional four years of support will be available, depending on annual appropriations and successful performance.

The entities eligible to apply for funding under this Cooperative Agreement shall represent state Departments of Agriculture as a primary purpose.

As FDA stated in the final PCAF rule ("Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals"), 80 Fed. Reg. 56170 (Sept 17, 2015)), FDA anticipates that some States may choose to adopt requirements modeled after the provisions of a final federal PCAF rule and may choose to perform inspections under their own authorities to enforce those provisions of their State laws. Such actions would be beneficial to public (human and animal) health because they would further drive compliance with a final federal PCAF rule, would help ensure consistency of implementation throughout the United States, and would leverage existing expertise, knowledge, and enforcement authorities of state regulatory staff.

This Cooperative Agreement’s purpose is to obtain information to assist States in improving their efforts to address animal food safety by aligning their requirements and enforcement mechanisms with those of FDA. Better knowledge of State capabilities and intentions also will assist FDA in planning for implementation of its PCAF rule. The information will assist FDA and States in making long term improvements to the national integrated food safety system by strengthening federal and State collaboration and enhancing State program capacity and capability relating to animal food safety.

The primary objective of this cooperative agreement is to obtain information relating to:

(1) Current State requirements applicable to animal food and State legal authority to conduct inspections, collect samples, perform training, provide education and technical assistance, and execute enforcement action relating to compliance with animal food safety requirements.

(2) The resources needed by States to conduct these activities as part of their implementation of State requirements that are aligned with FDA’s PCAF rule.

The application shall include the following activities:

1) Compare the requirements referenced below of selected States (determined by FDA in collaboration with awardee) concerning the requirements in FDA’s PCAF rule.

• Compare State authorities regarding inspections, sampling, and enforcement to FDA's authorities for such activities.
• Identify the responsibilities and jurisdiction of state Departments of Agriculture that have roles related to animal food safety, including inspections, sampling, enforcement, training, and technical assistance.
• Identify areas where major revisions of State laws and/or regulations would be needed to align State requirements with FDA’s PCAF rule.

2) Identify, for selected States (determined by FDA in collaboration with awardee), the resources needed to conduct activities under a State animal food safety rule that has been aligned with FDA’s PCAF rule. Identify metrics and develop models using those metrics to identify resources needed for:

• Training, technical support, and technical assistance
• Information Technology and laboratory capabilities
• Inspection and compliance activities

3) Draft a strategic plan that includes goals and milestones for developing information to assist States in aligning their requirements with FDA's PCAF rule and identifying the specific resources and/or funding model needed for implementation of the aligned requirements. The plan shall address state resource gaps in implementing the PCAF rule and shall include collaboration with relevant state associations.

4) Assemble a group of leaders (representing both Policy and Operations) from state Departments of Agriculture or other state departments with animal food safety responsibility to create a state Resource Assessment Task Force or Working Group to identify state program resource needs so that states can serve the leadership role envisioned by FDA in implementing the PCAF rule. FDA will provide subject matter experts to participate in the Task Force/Working Group. Task Force or Working Group responsibilities will include, but not be limited to:

• Conducting an assessment of a representative sample of State animal food regulatory programs (sample determined in collaboration with FDA) interested in implementing the PCAF rule to identify the resources, capacities and capabilities necessary to conduct FSMA related inspections under state law;
• Identifying metrics and developing funding models based on the metrics to build capacity and capability in state programs to conduct PCAF inspections, sampling, and enforcement activities;
• Broadly identifying the resources and finances needed to meet the training needs of state regulatory personnel related to PCAF inspections;
• Identifying the broad data sharing needs, to feed into existing data sharing efforts in FDA, regarding sharing of inspection, sampling, and compliance/enforcement actions;
• Identifying the resources and finances to support state program training and technical assistance to facilitate compliance with the PCAF rule;
• Collaborating with FDA on the co-development and implementation of inspection, compliance and enforcement strategies for use by both state regulatory programs and FDA;
• Collaborating with FDA to outline a process for work sharing that includes protocols for the joint planning and prioritization of inspections, the sharing of inspection and laboratory data, and coordinated compliance and enforcement actions between FDA and state programs.
• Identifying partner associations and academia to participate in the identification of resource and funding needs and development of models, plans and processes to address resource and funding gaps.
• Up to 15% of the overall award provided under this Cooperative Agreement may be utilized in support of face-to-face meetings of the Task Force. Allowable costs will include travel, per diem, meeting room/AV rental, and material duplication as appropriate to each meeting.
• Providing a comprehensive report to FDA detailing the outcomes of the Task Force or Working Group, including goals and milestones, for addressing state resource needs to partner with FDA in implementation of the PCAF rule.
• Communicating working group outcomes to state regulatory program stakeholders to build consensus on path forward in implementing the PCAF rule.
• Developing, initiating, and monitoring short and/or long term pilot programs in coordination with FDA to assess viability of processes developed under this Cooperative Agreement.

By way of example, project activities also could include:

• Draft a strategy for increasing State capacity to assume primary responsibility for a comprehensive animal food safety program.
• Develop pilot programs to assess the usefulness to States of specific information developed under this Cooperative Agreement.
• Draft a plan for work sharing between FDA and States that addresses joint work planning and prioritization of inspections, the sharing of inspection and laboratory data, and coordinated compliance and enforcement actions.

Applicants are strongly encouraged to identify additional activities that will support the goals and objectives of this cooperative agreement. Baseline data, outcome targets and performance measures for project activities should be included in the application.

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.

• National Associations/Organizations

The entities eligible to apply for funding under this Cooperative Agreement shall represent state Departments of Agriculture as a primary purpose and have the membership, resources, structure and expertise in issues related to agriculture production. The competition is limited because these entities have a unique role in working with States and fostering federal-State collaboration in the areas covered by this Cooperative Agreement. Further, the entities must have existing relations with state departments of agriculture or related state entities, and have members that are actively involved in agriculture programs including, but not limited to animal food safety, public health protection, agriculture production, environmental stewardship, or development of national agriculture policy and be knowledgeable of state laws and regulations related to agricultural production and animal food safety.

The national association/organization must be able to show a history of collaboration with stakeholders including state public health/communicable disease agencies, farmers, ranchers, academia, and state legislatures.

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

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial objective review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as the one already reviewed.

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

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

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

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

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

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

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

Allison Mandel
Grants Management Specialist
Email: Allison.Mandel@fda.hhs.gov

A technical session will be held for prospective applicants in May 2016. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged.

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

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

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

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

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

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

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

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

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• 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.
• Funds should be requested in the budget for key project personnel to travel to meetings, on-site visits, and audits with FDA program staff to discuss the project. A portion of budgeted travel funds should also be set aside for key personnel to attend face-to-face meetings and committee meetings supporting the cooperative agreement. Key personnel (minimum of 2) must attend an annual face-to-face meeting (as determined by FDA OP and CVM) as a condition of the award. The face-to-face meeting will be held in the continental US for a minimum of 2 days. The grantee should budget accordingly to cover all travel expenses using cooperative agreement funds.
• Training needs should also be anticipated and budgeted for accordingly.
• Up to 15% of the overall award provided under this Cooperative Agreement may be utilized in support of face to face meetings of the Task Force. Allowable costs will include travel, per diem, meeting room/AV rental, and material duplication as appropriate to each meeting.

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

• Strong collaboration between the awardee and other associations representing state departments of agriculture and/or animal food safety programs as a primary purpose is heavily encouraged. Therefore, up to 15% of the overall award may be sub-awarded to no more than two other national organizations.

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

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

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

This award may only be used for activities associated with achieving the goals and objectives of the cooperative agreement and work proposed by the grantee. Work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under this cooperative agreement shall remain distinct and separate from other projects and funding sources. The grantee shall be able to account separately for fund expenditures.

Strong collaboration between the awardee and other associations representing state departments of agriculture and/or animal food safety programs as a primary purpose is heavily encouraged. Therefore, up to 15% of the overall award may be sub-awarded to no more than two other national organizations.

Non -allowable costs:

1. Facilities and work covered under current contracts, cooperative agreements/grants, partnership funds, and other sources cannot be counted towards the fulfillment of the cooperative agreement and shall remain distinct and separate from the cooperative agreement. The grantee shall be able to account separately for fund expenditures other sources of FDA funding and these cooperative agreements.

2. Vehicle purchases are not permitted.

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

4. Food is not an allowable cost.

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

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

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

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

Significance (10 points):

1. Demonstrates the strategy addresses an important problem or a critical barrier to progress in the cooperative agreement.

2. Demonstrates how successful completion of the objectives and goals will change the concepts, methods, technologies, or services that drive the cooperative agreement.

Approach (10 points):

1. Demonstrates the overall strategy, methodology, and analyses are well-reasoned and appropriate to accomplish the specific goals and objectives of the cooperative agreement.

2. Demonstrates the strategy ensures a robust and unbiased approach, as appropriate for the work proposed.

3. Demonstrates potential problems, alternative strategies, and benchmarks for success are identified.

4. Demonstrates the strategy establishes feasibility and management of risk throughout the project development.

Rationale and Design (40 points):

1. Demonstrates the strategy will achieve the goals of the cooperative agreement.

2. Demonstrates the methods of evaluation are thorough, feasible and appropriate to the goals, objectives and outcomes of the proposed project and will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes.

Cooperation (20 points):

1. Demonstrates effectiveness in working with state Departments of Agriculture to accomplish the goals of this cooperative agreement.

Collaboration (20 points):

1. Demonstrates effectiveness in working with other associations.

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.

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

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

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

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

Not Applicable

Not Applicable

Not Applicable

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

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).

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

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

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

As part of the objective review, all applications:

• Will receive a written critique.

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

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

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.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.

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities, including guiding, coordinating, and participating in project activities. Under the cooperative agreement, the FDA's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

The Project Director (PD)/Principal Investigator (PI) will have the primary responsibility for:

The technical and programmatic aspects of the grant, and for day-to-day management of the project or program are the responsibilities of the Project Director (PD)/Project Investigator (PI). 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 has sufficient clearance and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient organization to prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements. The awardee is required to participate in a cooperative manner with FDA. The awardee is responsible for submitting interim progress reports, when requested, to the FDA PO including baseline data and summary data on progress to date.

The awardee will retain custody of, and have primary rights to, the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies.

FDA Project Officer (PO) and staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The responsibilities of the designated support staff include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities that is above and beyond normal program stewardship for grants. As appropriate, the designated support staff will participate in the definition of objectives and approaches, and in planning, conducting, analyzing, publishing, interpretations, and conclusions of the project activity.

However, the dominant role and prime responsibility for the activity reside with the awardee for the project as a whole, but not necessarily for each task.

In addition to, or in the absence of the PO, a separate FDA PO will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

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 project. However, awardees will retain custody of and have primary rights to all data developed under these awards.

A representative from, Center for Veterinary Medicine, Office of Surveillance and Compliance, will act as an FDA Technical advisor to this cooperative agreement. The Technical Advisor is an FDA official responsible for evaluating the work of a cooperative agreement pertaining to the scientific or technical subject matters. Responsibilities of the Technical Advisor include, but are not limited to serving as a focal point for technical questions, assisting in recommending and reviewing the goals, milestones, and expected outcomes of the program on a continuing basis, and helping to ensure that yearly recommendations are consistent with the goals of the program.

Areas of Joint Responsibility include:

As relevant, the PO/PI will work collaboratively with the designated support staff in evaluating the most appropriate methods, data quality control strategies and implementation, data analysis and interpretation, publication, and dissemination of project activity and results. During performance of the award, the PO, with assistance from other scientific program staff who are designated based on their relevant expertise, may provide appropriate assistance, advice and guidance. The role of the PO will be to facilitate and not to direct the activities. It is anticipated that decisions regarding activities will be agreed upon by the awardee and PO, and that selected FDA staff and selected state department of agriculture staff will be given the opportunity to offer input into this process. The PO will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services.

The PO/PI will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement. Manuscripts shall be submitted to FDA PO within two weeks of acceptance for publication. Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of FDA support. Timely publication is encouraged as appropriate

Delineation of Substantive Involvement:

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

2. FDA will collaborate and work closely with awardees' continued development.

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

As resources permit, FDA will continue to support the Cooperative Agreement with input from FDA staff and other Subject Matter Experts (SMEs).

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. Any travel cost incurred by the awardee to meet with FDA is the responsibility of the awardee under this grant.

Any FDA curriculum or course content provided by FDA will remain the property of FDA and any proposed changes are not to be made without concurrence from FDA. Curriculum and course content developed under this Cooperative Agreement such as objectives, learning outcomes, presentations, manuals, scripts, exercises, handouts, reports, documents or other tangible materials produced by the awardee shall be free of copyrights and be free domain for use by FDA.

The awardee is expected to remain flexible in support of the overall purpose of the Cooperative Agreement. This may include delivery of training to FDA, State, Local, territorial, and tribal regulators as well as academia and regulated industry personnel. Credentials (e. g. certificates, certifications, licenses, continuing education units) should be developed under the appropriate standards such as those found under American National Standards Institute (ANSI).

The awardee should not previously or presently be involved in legal suits against the Federal Government.

PROGRAMMATIC TERMS AND CONDITIONS:

• Key personnel (minimum of 2) must attend an annual face-to-face meeting (as determined by FDA OP and CVM) as a condition of the award. The face-to-face meeting will be held in the continental US for a minimum of 2 days. The grantee should budget accordingly to cover all travel expenses using cooperative agreement funds.
• Facilities, work, training, and other expenses reimbursed under other funding mechanisms must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, equipment, supplies, and other costs, from other funding mechanisms and this cooperative agreement.
• Fully participate in initiatives supporting the cooperative agreement, such as an annual face-to-face meeting, committees, conference calls, sharing of best practices and resources, on-site visits, and full program audits. During on-site visits and program audits, all key personnel, records (electronic and paper-based), facilities, and other resources necessary for FDA to conduct a complete program assessment will be made available.
• All resources, records, and other documents will be made available upon request to FDA for purposes of monitoring program progress towards meeting the goals of the cooperative agreement
• Future funding will be dependent on recommendations from the Project Officer and the availability of funds. The Project Officer will base the recommendation on whether acceptable progress has been made in achieving full conformance with the cooperative agreement within the required timeframes, and, if applicable, whether a corrective action plan has been developed and corrective actions are being satisfactorily implemented. The grantee must implement corrective action plans for all observations reported by the FDA officials during full program audits.
• A determination of the grantee's conformance with the cooperative agreement will be made based upon multiple factors, including the grantee's assessment, progress reports, on-site visits, and audits. If progress concerns are identified, then the grantee will be placed in special condition status and required to implement corrective actions. Failure to implement corrective actions may result in reduction of funding or termination of the cooperative agreement.
• The grantee will ensure accessibility and awareness of all resources developed as a result of this cooperative agreement to FDA personnel.
• Prioritization of activities, specific benchmarks, timelines, and responsible personnel should be identified for all of the objectives/activities outlined in the proposal and prepared within the first 60 calendar days to be discussed at the site visit meeting. Progress updates will be provided during quarterly meetings held with the grantee.

Funding restrictions:

This award may only be used for achieving and sustaining conformance with the goals and projects that support the intended outcomes of the cooperative agreement program.

Prior approval:

All requests that require prior approval must include the award number and bear the signature of an authorized official of the grantee business office as well as that of the PI/PD. Any requests involving budgetary issues must include a new proposed budget and a narrative justification of the requested changes. If there are any questions regarding the need or requirement for prior approval for any activity or cost, the grantee is to contact the assigned Grants Management Specialist prior to expenditure of funds. Below are activities that require prior approval from FDA/ORA:

• CHANGE IN SCOPE OR OBJECTIVES
• CHANGE IN KEY PERSONNEL
• CHANGE IN GRANTEE ORGANIZATION
• CHANGE IN KEY PARTNER ORGANIZATION(S)
• ANY DEVIATION FROM TERMS AND CONDITIONS OF THE AWARD
• CARRYOVER OF UNOBLIGATED BALANCES
• NO COST EXTENSIONS
• SIGNIFICANT REBUDGETING: for budget modifications great than 10% of the total yearly award

Monitoring Activities:

• The program project office will monitor the recipient periodically.
• The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project office and the principal investigator. Periodic site visits with officials of the recipient organization may also occur.
• An on-site visit (minimum of 2 days) by OP and CVM will be held with the applicant within 60 days of the award. The on-site visit will consist of a program assessment, further development of the strategic plan, and other technical assistance as required for the applicant to achieve the goals of the cooperative agreement. There may be other regular meetings with recipients to assist in fulfilling the requirements of the cooperative agreement.
• The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations.
• Also, the grantee organization must comply with all 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.

Reporting requirements:

Mid-year and annual program progress reports are required. When multiple years are involved, awardees will be required to submit the annual progress reports as part of the Research Performance Progress Report (RPPR).

Mid-year and annual progress reports must contain the elements below as applicable to their proposal and award. Elements include, but are not limited to, the following:

• Detailed 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. Baseline data should be provided.
• Status report on the hiring and training of cooperative agreement funded personnel.
• Contributions of personnel, especially for 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.
• Status report on the purchasing, development, and operational readiness of any equipment, computers, or software purchased.
• Identify any pending issues or concerns that may affect accomplishing the objectives and goals of the cooperative agreement.
• 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.
• Summary of grant expenditures and obligations during the current budget period.
• Summary report on the surveys conducted in support of cooperative agreement goals, including data, analysis, and response rates.
• Status report on the support and identification of pilot programs.
• Status report on networking activities, collaboration with the FDA, and Reports Shared with FDA and/or Other Parties.

Annual Progress Reporting Requirements:

The annual report will include all of the above mentioned items in the Mid-year report, as well as the following additional requirements for the end of year progress report:

• A strategic plan that accurately reflects when specific objectives and tasks have been, or will be, completed and/or implemented and when new objectives and tasks are identified to achieve or maintain full conformance with the goals of the cooperative agreement project period, if included. The strategic plan must be updated within the current budget period.
• Submission of a strategic plan updated within the current budget period will include the following at the minimum to demonstrate program advancement in achieving conformance with the goals of the cooperative agreement:

1. Specific objectives and tasks that once completed and/or implemented will result in full conformance with the overall goals of the cooperative agreement within the project period of the cooperative agreement. Previously completed objectives and tasks should also be included. Objectives and tasks should include specific metrics which will demonstrate their completion and implementation.

2. Timelines, responsible personnel, and dedication of any additional resources (such as IT, training, etc.) assigned to each objective and task.

3. Identification of objectives and/or tasks completed during the current project year, including metrics that will demonstrate how the objectives and/or tasks are being completed and tracked.

4. Summary of grant expenditures and obligations during the current budget period and those anticipated to occur during the budget period. The grantee is strongly encouraged to submit the carryover request with the continuation application.

ADDITIONAL TERMS AND CONDITIONS:

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 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 FSR/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.

Program Income:

1. The grantee is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee’s Federal Financial Report (FFR) SF-425.

2. Examples of Program Income include (and not limited to): fees for services performed during the grant or sub-grant period, proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.

3. Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee is subject to the Addition Alternative for Program Income and, therefore, must only be used to further the goals of the project for which this grant was awarded.

Failure to comply with the above stated Terms and Conditions could result in the suspension or termination of this grant project.

THE EXPANDED AUTHORITIES DO NOT APPLY TO THIS GRANT.

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement. The final program progress report must provide full written documentation of the project and summaries of accomplishments and goals, as described in the grant application.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: 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 submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

Jeannette Murphy - Technical Advisor
Office of Surveillance and Compliance
Food and Drug Administration/FDA, Center for Veterinary Medicine
Telephone: 240-402-6246
Email: jenny.murphy@fda.hhs.gov

Brenita Walker - Project Officer
Office of Partnerships
Food and Drug Administration/FDA, Office of Regulatory Affairs
Email: Brenita.Walker@fda.hhs.gov

Allison Mandel
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7602
Email: Allison.Mandel@fda.hhs.gov

Allison Mandel
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7602
Email: Allison.Mandel@fda.hhs.gov

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

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