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

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 (FDA), Office of Regulatory Affairs (ORA) is announcing the availability of up to $2,000,000in FY 2022 to be awarded under Limited Competition to state egg regulatory programs. The intended outcome of this FOA is to advance efforts for a nationally integrated food safety system through the implementation and advancement of the Egg Regulatory Program Standards (ERPS), sharing regulatory data, and building a holistic state egg regulatory program.

The ERPS allow for the development of risk-based egg regulatory programs by establishing a uniform basis for measuring and improving the performance of these programs in the United States. By achieving and sustaining conformance of these program standards, federal and state egg regulatory programs can better direct their regulatory activities toward reducing egg and egg product related incidents attributed to hazards at egg producers and egg handlers. Consequently, the safety and security of the United States egg supply will improve.

The ERPS are comprised of ten standards which establish foundations for the critical elements that serve as an objective framework to evaluate and improve components of a state egg regulatory program. These elements cover the egg program's regulatory foundation, training, inspection program, auditing, egg-related illness, outbreak and emergency response, enforcement program, outreach activities, program resources, program assessment, and laboratory support.

Achieving and sustaining conformance with the ERPS will require comprehensive self-assessment on the part of a state program and will encourage continuous improvement and innovation. The FDA recognizes that the time required for achieving full conformance with the ERPS will vary between states.

However, all state egg regulatory programs will be expected to implement strategic improvement plans to ensure continuous improvement and demonstrate that they are moving towards full conformance of the ERPS. State egg regulatory programs receiving funds under this cooperative agreement will be expected to achieve full conformance by the conclusion of five years, although this cooperative agreement award cycle will be for three.

For this funding opportunity, "full conformance" is defined as the fulfillment of a requirement, specifically a state program is using and can demonstrate the use of a particular element, system or program listed in the ERPS. If full conformance is not achieved by the conclusion of the cooperative agreement, the state program has a detailed strategic improvement plan on how to achieve conformance with the remaining ERPS elements and documentation requirements not yet met. The strategic improvement plan will include: identification of the individual element or documentation requirement not met, what improvements are needed to meet the program element or documentation requirement, personnel responsible for completing the task(s), projected and actual completion date of the task(s).

The outcomes of the work provided under this cooperative agreement are as follows:

1. State egg regulatory programs will assess and build upon their regulatory foundation, which is recognized as a critical element to creating a national, fully integrated egg safety system.

2. State egg regulatory programs will contribute to the continuous improvement of the ERPS through attendance at an annual face-to-face or virtual meeting, active participation in committees, and other initiatives supporting the ERPS.

3. Develop strategies for achieving and sustaining full conformance of the ERPS that can be duplicated on a national basis.

4. Develop and implement an agreement and protocol for electronically sharing state and federal egg regulatory information, such as inspections and findings, firm information, and compliance actions, between the state and the FDA. Information shared under this agreement is for the purpose of furthering the egg inspection contract program and is subject to the nondisclosure agreement executed between the contractor and the FDA.

5. Provide the FDA and other regulatory and public health agencies the foundation for pursuing regulatory action and conducting outbreak investigations based upon the findings of state egg regulatory programs.

6. Provide outreach, training technical assistance, and regulatory oversight to all egg producers, including those not subject to the Egg Rule, within an awardee's jurisdiction.

7. Building a holistic egg regulatory program dedicated to obtaining full conformance of the ERPS.

Only the following state egg regulatory programs will be eligible to apply:

Current FDA egg inspection contract states or those willing to enter into a contract in 2022 are eligible to apply for funding under this cooperative agreement. Entering into this agreement will also require a current long-term 20.88 information sharing agreement.

The FDA will provide one year of funding with the possibility of up to two years of additional non-competitive support, contingent on performance and continued availability of federal funds. For ERPS, it is anticipated that full conformance of the ERPS will be achieved within three total funding years under an ERPS Cooperative Agreement, based on an FDA assessment of your program to ensure the elements are in conformance.

Egg Regulatory Program Standards (ERPS)

All applicants must specifically address the ability to achieve the following objectives in the cooperative agreement:

1. Determine the scope of its legal authority and regulatory provisions to ensure the protection of shell eggs within its jurisdictions including how the state's legal authority and regulatory provisions correspond to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Code of Federal Regulations (CFRs).

2. Develops and implements a written training plan that promotes development and demonstrates that all inspectors who will conduct egg inspections complete course work, field training, and continuing education to adequately perform their work.

3. Develops and implements written shell egg inspection procedures for inspecting egg producers and egg handlers to determine compliance with the laws administered by federal and state jurisdictions. These procedures additionally include state recall systems, industry and consumer complaints, and sampling programs.

4. Develops and implements a written process for conducting audits to assess the effectiveness and accuracy of its inspections and sample collections.

5. Develops and implements written procedures to detect, identify, and respond to alleged egg and egg product related incidents and emergencies.

6. Develops and implements enforcement strategies that includes procedures and actions to enforce laws and regulations to achieve industry compliance.

7. Provides technical assistance and regulatory oversight for all shell egg producers within the state, including those not subject to the Egg Rule. Participates in outreach activity events that support communication and information exchange among regulators, industry, academia, small producers, and consumer representatives.

8. Develops a written workplan and sampling plan to conduct an assessment of resource needs for staffing, equipment, and funding for the egg regulatory program.

9. Conducts periodic self-assessments of the egg regulatory program against the criteria established in each program standard and develops a strategic improvement plan for making improvements.

10. Demonstrates the program has access to the laboratory services needed to support program functions and documents its laboratory capabilities including agreements with external laboratories and has a sampling program.

11. Ability to support the continuous improvement of the ERPS through meeting attendance (including annual face-to-face or virtual meeting), active participation in committees, sharing best practices, strategies, and other resources that can be utilized by other programs, and other initiatives supporting the ERPS.

12. Develop and implement an agreement and protocol for electronically sharing state and federal egg regulatory information, such as inspections and findings, firm information, and compliance actions, between the state and the FDA.

The project goals, especially for the completion of the self-assessment and improvement plan, are designed for new enrollees in the ERPS. Currently enrolled programs should adjust their project goals accordingly.

Project Goals

Year 1:

1. A current egg inspection contract must be maintained in satisfactory condition throughout the cooperative agreement, as agreed upon by the state and the FDA during contract negotiations.

2. Participation in a visit consisting of key state egg regulatory program and FDA personnel to discuss the conformance of program elements of the ERPS. Participation includes providing meeting space, accessibility of key state egg regulatory program management and staff, and access to records, databases, and other materials supporting ERPS conformance.

3. Attendance and participation of key state egg program managers and staff in an annual face-to- face or virtual meeting, active participation in committee meetings, and other initiatives supporting national and program specific conformance of the ERPS.

4. Conduct a comprehensive baseline self-assessment, including completion of all applicable appendices, worksheets, and other documents (or equivalent documents), as described in Standard 9.

5. Following the baseline self-assessment, develop a strategic improvement plan that will result in conformance with the ERPS. Review and update the strategic improvement plan on an annual basis. Documentation related to the self-assessment and strategic improvement plan must be maintained. Strategic improvement plan(s) must include the following, at a minimum:

a. The individual element or documentation requirement for the standard that was not fully met;

b. Improvements needed to fully implement the program element or documentation requirement(s) of the standard;

c. A projected and actual completion date for each task; and

d. Personnel responsible.

6. Draft a mutually agreed upon protocol for electronic sharing state and federal egg regulatory information, such as inspections and findings, firm information, and compliance actions, between the state and the FDA Division.

7. Communicate and exchange egg safety and regulatory information exchange among regulators, industry, academia, small producers, and consumer representatives.

8. Provide outreach, training, technical assistance, and regulatory oversight for all egg producers within the state, including those not subject to the Egg Rule.

Year 2:

1. Participation in an assessment conducted by the FDA/ORA/Office of Human and Animal Food Operations (OHAFO) Audit Staff. Participation includes providing meeting space, accessibility of key state egg program management and staff, and access to records, databases, and other materials supporting ERPS conformance.

2. Participation in a visit consisting of key state egg regulatory program and FDA personnel to discuss the implementation of program elements of the ERPS. Participation includes providing meeting space, accessibility of key state egg regulatory program management and staff, and access to records, databases, and other materials supporting ERPS conformance.

3. Attendance and participation of key state egg regulatory program managers and staff in a required annual face-to-face or virtual meeting, active participation in any required training, committee meetings, and other initiatives supporting national and program specific conformance of the ERPS.

4. Implementation of the strategic improvement plan. The strategic improvement plan should be updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve full conformance of the ERPS. Progress achieved should indicate that conformance of the ERPS can be expected by the completion of five years while this award cycle will only be for three years.

5. Review and updated strategic improvement plan on an annual basis. Documentation related to the evaluation and strategic improvement plan must be maintained. The strategic improvement plan must include the following, at a minimum:

a. The individual element or documentation requirement for the standard that was not fully met;

b. Improvements needed to fully meet the program element or documentation requirement(s) of the standard;

c. A projected and actual completion date for each task; and

d. Personnel responsible.

6. Implement the protocol for electronically sharing state and federal egg regulatory information, such as inspections and findings, firm information, and compliance actions, between the state and the FDA Division.

7. Communicate and exchange egg safety and regulatory information exchange among regulators, industry, academia, small producers, and consumer representatives.

8. Provide outreach, training, technical assistance, and regulatory oversight for all shell egg producers within the state, including those not subject to the Egg Rule.

Year 3:

1. Participation in a visit consisting of key state egg regulatory program and FDA personnel to discuss the conformance of program elements of the ERPS. Participation includes providing meeting space, accessibility of key state egg regulatory program management and staff, and access to records, databases, and other materials supporting ERPS conformance.

2. Attendance and participation of key state egg regulatory program managers and staff in a required annual face-to-face or virtual meeting and any required training, committee meetings, and other initiatives supporting national and program specific conformance of the ERPS.

3. Implementation of the strategic improvement plan(s). The strategic improvement plan(s) should be updated to accurately reflect when specific objectives and tasks have been met and when new objectives and tasks are identified to achieve conformance with the ERPS. Progress achieved should indicate that conformance with the ERPS can be expected by the completion of five years.

4. Review and update strategic improvement plan(s) on an annual basis. Documentation related to the self-assessment and strategic improvement plan(s) must be maintained. The strategic improvement plan(s) must include the following, at a minimum:

a. The individual element or documentation requirement for the standard that was not fully met;

b. Improvements needed to fully meet the program element or documentation requirement(s) of the standard;

c. A projected and actual completion date for each task; and

d. Personnel responsible.

6. Continue the electronic sharing of state and federal egg regulatory information, such as inspections and findings, firm information, and compliance actions, between the state and the FDA Division.

7. Communicate and exchange egg safety and regulatory information exchange among regulators, industry, academia, small producers, and consumer representatives.

8. Provide outreach, training, technical assistance, and regulatory oversight for all egg producers within the state, including those not subject to the Egg Rule.

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

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

Governmental:

Subtitle A of Title III Protection of Food Supply, Section 311 Grants to States for Inspections, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 1009, which authorizes the Secretary of Health and Human Services to award grants to states, territories, localities, Indian tribes, and nonprofit food safety training entities that collaborate with one or more institutions of higher education to enhance food safety. Only these entities, subject to FSMA, are eligible to apply. Further, eligibility depends on the entity submitting to FDA an application including (A) an assurance that the eligible entity has developed plans to engage in the types of activities described in this RFA; (B) a description of the types of activities to be funded by the cooperative agreement; (C) an itemization of how funds received under this agreement will be expended; (D) a description of how activities will be monitored; and (E) an agreement by the eligible entity to report information required by FDA to conduct evaluations under this agreement.

Full text: http://www.fda.gov/RegulatoryInformation/Legislation/ucm155769.htm.

Egg Inspection Contracts:

This opportunity is only available to current egg inspection contract program states, or those willing to enter into an egg inspection contract along with this cooperative agreement. Competition is limited to these egg regulatory programs because the foundational work conducted under the current FDA egg safety inspection contracts is necessary for the completion of significant improvements in a nationally integrated food safety system.

20.88 Information Disclosure Agreement:

Awardees must have or be willing to enter into a long-term 20.88 information sharing agreement with the FDA.

https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/communications-outreach

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) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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.

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.

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

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

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 to:

Kiara Farmer
Telephone: 240-402-3099
Email: kiara.farmer@fda.hhs.gov

A technical session will be held for prospective applicants in January. 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 12 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.

Where personnel costs are requested, documentation must be provided to associate these costs with the specific goals and deliverables.

Funds should be requested in the budget for key project personnel to travel to meetings, on-site visits, assessments, and audits with FDA program staff to discuss the state self-assessment and conformance with the ERPS. All anticipated meetings for attendance should be listed and referenced by name in the application.

A portion of budgeted travel funds should also be set aside for key personnel to attend required annual face-to-face or virtual meetings and any required training (as determined by the FDA/OP) and committee meetings supporting the ERPS.

All anticipated meetings and trainings, to include the required annual meeting and required training, for attendance should be listed and referenced by name in the application.

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 requirements:

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

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

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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 and 45 CFR 75.

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

Selected list of allowable costs that have limitations specific to this announcement (including but not limited to):

1) Audiovisual materials such as videotapes, DVDs, public service announcements, etc. when identified as a necessary expense that directly impacts the goals and deliverables of this award.

2) Travel and per diem to trainings, exercises and meetings with ERPS members (other state agencies, local agencies, and the FDA).

3) Subcontracting to third parties (other than local/county/tribal agencies conducting work on behalf of the state egg regulatory agency) is allowed but limited to 25% of each year's award.

Non-allowable costs:

1) Facilities, work, and training reimbursed under the FDA egg inspection contract and other funding mechanisms must remain distinct and separate from the cooperative agreement. The state must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, as well as sub-contractor and/or primary servicing laboratory expenditures, under the egg inspection contracts and other funding mechanisms and these cooperative agreements.

3) Vehicle purchases are not permitted.

4) 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.

5) Clothing purchases, with the exception of PPE, are not permitted.

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 How to Apply Application Guide. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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.

Demonstrates ability to achieve the objectives and goals of the cooperative agreement and project proposed.

Demonstration of effectiveness in working with federal, state, and local partners and other appropriate organizations to implement the goals of the cooperative agreement.

Demonstration of plans to facilitate the incorporation and sustainability of project developed capabilities into the entity’s egg regulatory system. Expected challenges are documented and addressed.

Demonstration of adequate program resources (including staff) and infrastructure, or the ability to obtain the resources necessary, to complete the project.

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.

For research that involves human subjects but does not involve one of the 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 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.

When the proposed project involves human subjects and/or 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 individuals of all ages (including children and older adults) 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.

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

Not applicable

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).

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).

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.

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) appropriate Objective Review Committee using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

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

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 recipient’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions and in the Notice of Award. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement, this FOA, and Notice of Award.

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

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should you successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/forproviders/provider-obligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals. See https://www.hhs.gov/civil-rights/forindividuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on your specific legal obligations for serving qualified individuals with disabilities, including reasonable modifications and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sexdiscrimination/index.html. For information about FDA's commitment to supporting a safe and respectful work environment and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see https://www.fda.gov/science-research/about-science-research-fda/fda-sexual-harassment-policy-concerning-extramural-research.
• For guidance on administering your program in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religiousfreedom/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

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

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

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

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

Termination provisions in 2 CFR 200.340 (a) (1-4) are applicable to awards issued under this Notice of Funding Opportunity

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

Reporting Requirements:

All FDA grants require both Financial and Performance reporting.

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. All annual FFRs must 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. If a grant is under expanded authorities, the grantee must indicate the carryover amount in Section 12. Remarks of the annual FFR.

Performance Progress Reporting:

When multiple years (more than one budget period) are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually as required in the Notice of Award. Annual RPPRs must be submitted using the RPPR module in eRA Commons. The annual RPPR must include a detailed budget. Annual RPPRs are due no later than 60 days prior to the start of the next budget period.

Failure to submit timely reports may affect future funding. Additional Financial and Performance Progress reports may be required for this award. Any additional reporting requirements will be listed under Section IV Special Terms and Condition of the Notice of Award.

Salary Caps:

None of the funds in this award shall be used to pay the salary of an individual at a rate in excess

of the current Executive Level II of the Federal Executive Pay Scale.

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

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

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

Acknowledgment of Federal Support:

When issuing statements, press releases, publications, requests for proposal, bid solicitations and other documents --such as tool-kits, resource guides, websites, and presentations (hereafter statements )--describing the projects or programs funded in whole or in part with FDA federal funds, the recipient must clearly state:

1. the percentage and dollar amount of the total costs of the program or project funded with federal money; and,

2. the percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.

When issuing statements resulting from activities supported by FDA financial assistance, the recipient entity must include an acknowledgement of federal assistance using one of the following statements.

If the FDA Grant or Cooperative Agreement is NOT funded with other non-governmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

If the FDA Grant or Cooperative Agreement IS partially funded with other nongovernmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with XX percentage funded by FDA/HHS and $XX amount and XX percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

The federal award total must reflect total costs (direct and indirect) for all authorized funds (including supplements and carryover) for the total competitive segment up to the time of the public statement. Any amendments by the recipient to the acknowledgement statement must be coordinated with FDA. If the recipient plans to issue a press release concerning the outcome of activities supported by FDA financial assistance, it should notify FDA in advance to allow for coordination.

Additional prior approval requirements pertaining to Acknowledgement of Federal Support, publications, press statements, etc. may be required, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Prior Approval:

All prior approval requests must be submitted using the Prior Approval module in eRA Commons. 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.

For grant awards not covered under Expanded Authorities, Carryover and No Cost Extension (NCE) requests will require prior approval. All Carryover and NCE requests should be submitted using the Prior Approval module in eRA Commons. ****Please review the section on Expanded Authorities to determine if this award is covered/not covered under Expanded Authorities and whether prior approval is needed for carryover and no cost extension requests.****

The following activities require prior approval from FDA on all awards:

1. Change in Grantee Organization

2. Significant Rebudgeting

3. Change in Scope or Objectives

4. Deviation from Terms and Conditions of Award

5. Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.

6. Disengagement from the project for more than three months, or a 25 percent reduction in time devoted to the project, by the approved PD/PI. No individual may be committed to more than 100% professional time and effort. In the event that an individual's commitment exceeds 100%, the grantee must make adjustments to reduce effort. For FDA-sponsored projects, significant reductions in effort (i.e., in excess of 25% of the originally proposed level of effort) for the PD/PI and key personnel named on named on this Notice of Award must receive written prior approval from FDA.

Additional prior approval requirements may be required for this award, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Audits and Monitoring:

Audit Requirements:

1. Recipients of Federal funds are subject to annual audit requirements as specified in 45 CFR 75.501 (https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=8040c4036b962cc9d75c3638dedce240&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1501). Grantees should refer to this regulation for the current annual Federal fund expenditure threshold level which requires audit.

2. Foreign recipients are subject to the same audit requirements as for-profit organizations (specified in 45 CFR 75.501(h) through 75.501(k).

3. For-profit and foreign entities can email their audit reports to AuditResolution@hhs.gov or mail them to the following address:

U.S. Department of Health and Human Services

Audit Resolution Division, Room 549D

Attention: Robin Aldridge, Director

200 Independence Avenue, SW

Washington, DC 20201

Monitoring:

Recipients are responsible for managing the day-to-day operations of grant-supported activities using their established controls and policies, as long as they are consistent with Federal, DHHS and FDA requirements. However, to fulfill their role in regard to the stewardship of Federal funds, FDA monitors our grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the recipient, audit reports, site visits, and other information available to FDA.

1. Desk review: FDA grants monitoring specialists will periodically reach out to recipients to request information for the completion of desk reviews. Requested information may include:

Policies and procedures

List of grant expenditures

Accounting records

Supporting documents (e.g., invoices, receipts, paystubs, timesheets, contracts, etc.)

Financial statements

Audit reports

Other related documentation

2. Site visits: FDA will conduct site visits when necessary and will notify the recipient with reasonable advance notice of any such visit(s).

3. Foreign entities: All Foreign entities are subject to the same monitoring requirements as domestic entities. Foreign entities covered under immunity Executive Orders will provide supporting documents for monitoring requirements unless such an action is a violation of the Executive Orders. Recipients may discuss with the FDA to come up with an alternate approach to satisfy the award monitoring requirements.

All recipients will make reasonable efforts to resolve issues found, including audit findings. Successful resolutions to issues are important as they are part of the grant performance review. All recipients are responsible for submitting all requested information in an expeditious manner. Failure to submit timely reports and/or respond to inquiries from FDA may affect future funding or enforcement actions, including withholding, or conversion to a reimbursement payment method.

Financial Conflict of Interest (FCOI):

This award is subject to the Financial Conflict of Interest (FCOI) regulation at 42 CFR Part 50 Subpart F.

Closeout Requirements (when applicable):

A Final Research Performance Progress Report (FRPPR), Final Federal Financial Report SF-425, Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 90 days after the expiration date of the project period. All closeout documents must be submitted electronically in eRA Commons.

The Final FFR must indicate the exact balance of unobligated funds and may not reflect unliquidated obligations. There must be no discrepancies between the Final FFR expenditure data and FFR cash transaction data in the Payment Management System (PMS). The expended funds reported on the Final FFR must exactly match the disbursements reported on the grantee's report to the Payment Management System and the charge advances in PMS. It is the recipient's responsibility to reconcile reports submitted to PMS and to the FDA.

Program Income:

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.

Examples of Program Income include (but are 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.

Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee will be treated as identified below.

Treatment of Program Income:

Prohibition on certain telecommunications and video surveillance services or equipment:

(a) As described in CFR 200.216, recipients and subrecipients are prohibited to obligate or spend grant funds (to include direct and indirect expenditures as well as cost share and program) to:

(1) Procure or obtain,

(2) Extend or renew a contract to procure or obtain; or

(3) Enter into contract (or extend or renew contract) to procure or obtain equipment, services, or systems that use covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. As described in Pub. L. 115-232, section 889, covered telecommunications equipment is telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities).

i. For the purpose of public safety, security of government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).

ii. Telecommunications or video surveillance services provided by such entities or using such equipment.

iii. Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise, connected to the government of a covered foreign country.

Other:

This award is subject to the requirements of 2 CFR Part 25 for institutions to maintain an active registration in the System of Award Management (SAM). Should a consortium/subaward be issued under this award, a requirement for active registration in SAM must be included.

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 with cumulative total value greater than $10,000,000 must report and maintain information 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 the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.

You must administer your project in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/providerobligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

• You must take reasonable steps to ensure that your project provides meaningful access to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals, see https://www.hhs.gov/civilrights/for-individuals/special-topics/limited-english-proficiency/fact-sheetguidance/index.html and https://www.lep.gov.
• For information on your specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and taking appropriate steps to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sexdiscrimination/index.html.
• For guidance on administering your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscienceprotections/index.html and https://www.hhs.gov/conscience/religiousfreedom/index.html.

Additional Reporting Requirements:

All FDA grants require annual financial and performance progress as stated in Section III. This award has additional performance reporting requirements as outlined below.

Performance

Mid-year interim performance progress reports are required for this award. The interim performance progress reports should be submitted via email to the listed Grants Management Specialist and Program Official by [October 30th.

The Research Performance Progress Report (RPPR) will be considered the annual program progress report for the budget period.

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

1. Detailed progress report on the grantee meeting the project goals detailed in the cooperative agreement and identified in the application.

2. Status report on the current hiring and training of egg regulatory program personnel.

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

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

5. 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.

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

Required for mid-year progress report only:

7. Submission of the following documents in the most current version of the ERPS. These documents must be current and fit for use.

Appendix 1.1, or alternate form that is equivalent.

Appendix 1.2 Regulatory Foundation Worksheet, or alternate form that is equivalent.

Appendix 2.1 and 2.2 or alternate forms that are equivalent

Listing of staff trained (basic, advanced, field) to conduct egg inspections.

Appendix 3.1 or alternate form that is equivalent

Inventory listing and frequency of inspections of registered egg producers and egg handlers for which the state has regulatory oversight

Appendix 4.1 or alternate forms that are equivalent

Appendix 5.1 or alternate form that is equivalent

Appendix 6.1 or alternate form that is equivalent

Listing of description of state enforcement strategies (Standard 6)

Appendix 7.1 or alternate form that is equivalent

Appendix 8.1 and 8.4 or alternate forms that are equivalent

Appendix 9.1 and 9.2 or alternate forms that are equivalent

Appendix 10.1 or alternate forms that are equivalent

Annual progress reports must contain the elements below as applicable to their application and award, but are not limited to, the following:

1. A strategic improvement 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 full conformance of the ERPS. Progress achieved should indicate full conformance of the ERPS can be expected by completion of five years. Review and update strategic improvement plan(s) on an annual basis. Documentation related to the evaluation and strategic improvement plan(s) should be maintained.

Submission of a strategic improvement plan will include the following at a minimum to demonstrate program advancement in achieving conformance with the ERPS:

a. The individual element or documentation requirement for the Standard that was not fully met.

b. Improvements needed to fully meet the program element or documentation requirement(s) of the Standard.

c. Lists of individual tasks that will be used to address the improvement

d. A projected completion date for each task.

e. Personnel responsible for the overall responsibility of implementing the improvement plan(s).

Note: For programs with less than 12 months of enrollment in the ERPS, this information will be required after 12 months of enrollment in the ERPS, with the annual progress report

2. Description of program improvements and demonstration of measurable conformance with the ERPS, providing outreach, training, technical assistance, and regulatory oversight of egg producing facilities (including those not subject to the Egg Rule), and information sharing with the FDA.

Note: This information will not be required until Year 2.

3. An estimate (in total dollars) of in-kind contributions toward accomplishing the goals of the cooperative agreement during the reporting period.

Additional reporting requirements: For programs with less than 12 months of enrollment in the ERPS, submission of the baseline self-assessment, including applicable appendices, worksheets, and other documents required for each Standard, or equivalent alternate forms, and a strategic improvement plan is required to be submitted after 12 months of enrollment in the ERPS, with the first annual progress report.

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 documentation must be in a form and contain sufficient detail such that other state, local, and tribal governments could reproduce the final project. The final program progress report should also detail the strategy, including commitment of personnel, resources, and funding, to sustain conformance with the ERPS (current and future versions). An assessment of the program by the FDA should verify the program has made significant progress with achieving full conformance with the ERPS.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and FDA grant administration policies.

FDA Responsibilities

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. 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.

Substantive involvement by the awarding agency is inherent in the cooperative agreement award. Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement.

The PO and Project Manager/Technical Advisors 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. Substantive involvement may include, but is not limited to, the following:

1. Provide guidance, direction, and technical assistance in project planning, implementation, and evaluation;

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

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

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

5. The FDA hosting meetings when needed for programs enrolled in the ERPS, and participating in the meetings with awardees;

6. The FDA conducting technical sessions with the grantee, as deemed necessary by FDA;

7. Post-award monitoring of project/program performance, including review of progress reports and conducting visits and verification assessments to verify grantee progress in achieving conformance of the ERPS;

8. The FDA hosting monthly (or at a frequency chosen by FDA) conference calls/webinar meetings with all programs enrolled in the ERPS;

9. The FDA assistance in the sharing of information developed by the grantee and collaboration to achieve conformance of the ERPS with other programs enrolled in the ERPS in addition to FDA and other federal agencies. Examples may include SOPs, MOUs, training programs, and record keeping systems;

10. Development of programs to meet the FDA and state missions; and

11. The FDA assistance in coordination of multi-program pilot projects.

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

The purpose of this cooperative agreement is to advance efforts for a nationally integrated egg regulatory system by assisting state egg regulatory programs to achieve and maintain full conformance of the ERPS. The ERPS are intended to ensure that state egg regulatory programs develop and maintain best practices for a high-quality regulatory program.

Funding is encouraged to be utilized for inspections and outreach for all egg producers within an awardee's jurisdiction. It is expected that application of the ERPS will apply to all small and large egg firms.

The cooperative agreements will provide funding for additional personnel, equipment, supplies, and training to support activities related to achieving full conformance of the ERPS.

Key personnel (maximum of 2) will attend a required annual face-to-face or virtual meeting, annual meeting, and any required training (as determined by the FDA/OP) as a condition of the award. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, as well as sub-contractor and/or primary servicing laboratory expenditures, under the egg inspection contracts and other funding mechanisms and these cooperative agreements. Future funding will be dependent on recommendations from the Project Officer. The scope of the recommendation will confirm that acceptable progress has been made in achieving conformance with the ERPS, continued compliance with all of the FDA regulatory requirements, and, if necessary, a corrective action plan has been implemented.

State egg regulatory programs that provide funding to such laboratories should commit to continued support of the laboratory as necessary to accomplish project goals, for the life of the project. Ideally the primary servicing laboratory will support the awardee with report data to demonstrate progress in achieving the project goals listed, as applicable. Continued funding may be subject to adequate program support toward other FDA Cooperative agreements that support laboratory accreditation, testing, method development, and/or other relevant initiatives.

Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, or programmatic aspects of the grant and for day-to-day management of the project or program. The PD/PI(s) 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 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 and organizational requirements.

The PD(s)/PI(s) will have the primary responsibility for:

Overall management of the study and agree to work cooperatively with the FDA.

Developing and implementing systems necessary for communications among the various study organizational components. All data and samples to be shared freely by methods and within time periods to be specified by the Program Official.

The FDA staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The awardees agree to accept assistance from the designated FDA Project Manager/Technical Advisors. These persons will participate in the monitoring of issues relating to recruitment, follow-up, and adherence to protocols and will assist in the development and/or adjustment of project activity.

Additionally, an agency Program Official may be responsible for the normal scientific and programmatic stewardship of the award.

The reporting and monitoring activities may include a review of budget modification requests from the grantee. The grantee and any sub-grantees are expected to utilize the approved funding respectively as indicated in the original submitted separate budget and cost estimates. The letter of agreement will be submitted by the grantee with the aforementioned budget modification request to the Program Official and Project Manager.

Equipment may be loaned by the FDA to an awardee pursuant to FDA policy. Such equipment will remain the property of the FDA under loan to the awardee for a specified time period with a review every twelve months. The FDA may terminate the loan at any time. Unless approved by ORA/OP, the FDA provided equipment may not be transferred by the awardee to a third party, and the awardee assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardee.

Monitoring Activities

The Program Official and Project Manager/Technical Advisor(s) will monitor award recipients periodically. The monitoring may be in the form of face-to-face or virtual meetings, telephone conversations, e-mails, or written correspondence between the Program Official/Grants Management Officer/Technical Advisor(s) and the principal investigator. In addition, periodic site visits with officials of the recipient organization may also occur to assess progress. 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 shall comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the Program Official and Project Manager/Technical Advisor(s).

The scope of the recommendation will confirm that:

(1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; and (3) if necessary, there is an indication that adequate corrective actions have taken place to address any identified problems.

The evaluation of performance includes but is not limited to: technical meetings, committee/workgroup, and annual face-to- face meeting attendance and participation, progress of achieving conformance with the ERPS according to the work and schedules identified in the application and strategic improvement plan submissions, verification of progress through FDA verification assessments and technical visits, responsiveness to the FDA, conference call participation, and the general progress of the cooperative agreement deliverables as determined by the FDA.

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

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

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

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

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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Gerald Berg
Food and Drug Administration/ORA
Telephone: 612-758-7183
Email: Gerald.Berg@fda.hhs.gov

Kiara Farmer
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-3099
Email: kiara.farmer@fda.hhs.gov

Kiara Farmer
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-3099
Email: kiara.farmer@fda.hhs.gov

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement, 45 CFR 75 and Notice of Award.

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