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

AFRPS Development Phase and Maintenance Phase Tracks

Governments

• State Governments

This opportunity is only available to the following State animal food safety programs:

Animal food regulatory programs with current FDA animal food safety inspection contracts (providing funding to State agency animal food production regulatory programs), or those that meet the eligibility requirements and apply for and agree to enter into an animal food safety inspection contract with FDA at the earliest possible date, are eligible to apply for funding under this cooperative agreement.  Competition is limited to State animal food regulatory programs because the foundational work conducted under the current FDA animal food safety inspection contracts is necessary for the completion of significant improvements in a nationally integrated food safety system.

Applicants will be categorized under one of two funding tracks:  AFRPS Development or AFRPS Maintenance (see eligibility criteria below). 

The applicant must hold a nonpublic information sharing agreement with FDA pursuant to 20 CFR 20.88 ( 20.88 agreement ) or agree to enter into a 20.88 agreement with FDA by the end of grant year one (June 30, 2025).

Funding Track 1: AFRPS Development Phase

Applicants must have received less than five (5) years of funding under a past AFRPS cooperative agreement or have never received an AFRPS cooperative agreement.  Applicants may request up to $300,000 per year for this funding track.  State programs will move to AFRPS Maintenance funding levels in the sixth year of funding under AFRPS cooperative agreements.  Applicants with less than five (5) years of funding under a past AFRPS cooperative agreement may elect to move to Funding Track 2 (AFRPS Maintenance Phase) for the award year after full implementation of the AFRPS has been achieved (as determined by an FDA verification audit).

Funding Track 2: AFRPS Maintenance Phase

Applicants must have received five (5) years of funding under a past AFRPS cooperative agreement.  Applicants with less than five (5) years funding under a past AFRPS cooperative agreement may elect to move to Funding Track 2 (AFRPS Maintenance Phase for the award year after full implementation of the AFRPS has been achieved (as determined by an FDA verification audit).  If the state program is not currently deemed to be in full implementation and their corrective actions are still pending (as documented in the most recent verification audit by FDA/ORA/OHAFO/Audit Staff), then the program must address the corrective actions in their strategic improvement plan submitted as part of the application.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply - 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, please reference HHS Grants Policy Statement for additional information.

• 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.
  • 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.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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 How to Apply - Application Guide.

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

Overlapping Cooperative Agreements

• If an applicant is the recipient of a current AFRPS cooperative agreement with a project period extending beyond 2024 and the applicant applies for this cooperative agreement under either Funding Track 1 or Funding Track 2, the pre-existing AFRPS cooperative agreement will be subject to termination, pending determination of awards funded under Funding Track 1 or 2 of this Cooperative Agreement instead of through a previous cooperative agreement award.

 

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most FDA opportunities. Conformance to the requirements in the How to Apply - 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), 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:

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov

 

A technical session will be tentatively held for prospective applicants in March 2024. The 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 How to Apply Application Guide and the Table of Page Limits must be followed.

Available Components	Component Type for Submission	Page Limit	Required/Optional	Minimum	Maximum
Overall	Research Strategy	See Application Guide	Required	1	6
Administrative Core	Research Strategy	See Application Guide	Optional	0	6
Cores	Research Strategy	See Application Guide	Optional	0	6
Projects	Research Strategy	See Application Guide	Required	1	30

For this specific NOFO, the Research Strategy section is limited to 30 pages total, for all components listed above.

The following section supplements the instructions found in the How to Apply Application Guide , and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core
• Cores
• Projects: required

When preparing your application, use Component Type Overall .

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

• Applications must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested, as well as for each track that the applicant request funding for within application
• 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'.
• Applicants may also apply for personnel, training, and surveillance sample analysis if they have the necessary equipment, and it will be available for these projects.
• Where personnel costs are requested, documentation must be provided to associate these costs with the specific goals and objectives.
• 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 implementation of the AFRPS.  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 (a minimum of 2) to attend required annual face-to-face meeting and any required training (as determined by FDA/OP) and committee meetings supporting the AFRPS.
• All other anticipated meetings and trainings, to include required annual meeting(s) and required training, for attendance, should be listed and referenced by name in the application.
• Funding Plan:  Grantees whose State human or animal food regulatory program receives funding from an FDA Rapid Response Team (RRT) cooperative agreement are required to participate in the RRT and should ensure that their efforts to meet the program elements of the AFRPS Standard 5 are aligned/integrated with the existing RRT and their participation therein.  Funds from the AFRPS Cooperative Agreement are to be used for the program elements indicated under each Standard.  RRT-specific activities support the program elements under Standard 5, but it is not a requirement of Standard 5.
• Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. (With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement). Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

 

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Research Strategy (aka Project Plan):

Page one of the Research Strategy must be a cover sheet with the following table indicating funding track selected for the cooperative agreement.  For the year, list the amount requested under the eligible option, and the total award amount for the year.

Year	AFRPS Development Phase	AFRPS Maintenance Phase	Total Amount Requested
1	$	$	$

• Identify specific personnel responsible for implementation of the funding track selected in the application (e.g. AFRPS Development or Maintenance).  These personnel may be different from the Principal Investigator (PI) on the overall cooperative agreement.
• For the AFRPS Development or Maintenance Funding Tracks, there must be at least one dedicated full-time employee/equivalent (FTE) to lead day-to-day oversight, such as an AFRPS Coordinator.
• Demonstrate the availability of adequately trained staff and the ability to hire and/or train personnel to meet the outputs of this cooperative agreement.  This should include a description of training needs to support AFRPS implementation, as well as requirements of the FDA animal food safety inspection contract (allowable expenses under this cooperative agreement).
• Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.
• Demonstrate the ability to satisfy the reporting requirements outlined in section VI.4 of this announcement.
• Demonstrate the ability to fully participate in initiatives supporting this cooperative agreement, such as annual face-to-face meetings (as determined by FDA), committees, conference calls, sharing of data and best practices, coordination and planning events, on-site visits, and verification audits.
• Applicants will describe their information sharing agreement status with the FDA under 21 CFR 20.88 and if one does not exist, describe plan to be able to obtain an agreement prior to the start date of the award.
• For applicants enrolled in the AFRPS for a minimum of twelve (12) months, a copy of the program self-assessment, improvement plan, and a description of the progress and accomplishments of the program in achieving implementation of the AFRPS must be included in the application.  The program self-assessment and improvement plan should be included as appendices following the directions in the SF-424 Guide.
• An Improvement Plan means a type of improvement plan that includes the following information: (1) the individual element or documentation requirement of the standard that was not met, (2) improvements needed to meet the program element or documentation requirement of the standard, (3) projected completion dates for each task, and (4) date completed.
• Describe any identified or potential obstacles in achieving and maintaining implementation with the AFRPS and approaches to overcome these obstacles.
• If the applicant is located in a state with a supporting laboratory that receives funding under an active FDA cooperative agreement for analysis of animal foods, the applicant must demonstrate the ability to provide for the collection of samples (FDA regulated animal food only) to support laboratory capacity development and product surveillance.  The applicant must also demonstrate the ability to perform any enforcement or other follow-up activities based on sample results.  Sampling plans will be developed in cooperation with the laboratory to support the objectives of both programs. Outline a detailed methodology to accomplish the work, as described in this announcement.
• There must be a separate and distinct methodology section for each funding option included in the application. See page limitations (Section IV of the NOFO).

Additional items to be included in AFRPS Development Phase Funding Track (Funding Track 1) and AFRPS Maintenance Phase Funding Track (Funding Track 2) Applications:

Demonstrate the ability to implement a comprehensive improvement plan that results in the program achieving and maintaining implementation with the AFRPS, including new versions.

• Submit your most recent verification audit report provided by the Audit Staff (if applicable) as an appendix following the directions in the SF-424 Guide.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide, with the following modification:

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

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - 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 How to Apply - Application Guide must be followed

All instructions in the How to Apply - Application Guide must be followed.

When preparing your application, use Component Type Insert Name.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

 

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide, with the following modification:

 

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by FDA) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

 

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - 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 How to Apply - Application Guide must be followed

Paste Other Components here

Foreign (non-U.S.) Organizations must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout the How to Apply - Application Guide.

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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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. FDA 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. Applications that miss the due date and time are subjected to the HHS Grants Policy Statement .

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 How to Apply - 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, 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.

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 AFRPS members (other State agencies, local agencies, FDA Divisions and Districts), FDA Headquarters, and annual AFRPS meetings.

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

Non-allowable costs:

Non-allowable costs:

1) Facilities, work, and training reimbursed under the FDA animal food safety 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 animal food safety inspection contracts and other funding mechanisms and these cooperative agreements.

2) Vehicle purchases are not permitted.

3) Food may not be purchased.

4) Clothing/uniforms may not be purchased.

5) 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.

Only primary servicing laboratories are eligible to receive funds through the awardee, in order to help the State animal food regulatory program to implement the AFRPS.  Primary servicing laboratories are defined as State funded regulatory laboratories, funded by the same State as the State animal food regulatory program, which perform 51% or more of the analyses on all samples collected by the State animal food regulatory program.  Grantees may provide no more that 25% of annual award funds from the AFRPS track funding to primary servicing laboratories for the purpose of achieving or expanding accreditation for animal food analyses under the current version of ISO/IEC 17025.

The funds provided under this NOFO shall be available to an eligible entity that receives a grant under this NOFO only to the extent such entity funds the food safety programs of such entity independently of any grant under this NOFO in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.

Grant funds received under this NOFO shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this NOFO.

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

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review 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 the policy. Any instructions provided here are in addition to the instructions in the policy.

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 provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Demonstrates ability to achieve the 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. RFA/PAR only: Additional Questions may be added and should be explained to the applicant in Section IV.2.For components, replace PD(s)/PI(s) with the title indicated (Lead, Director, etc.) in Section IV. 

Demonstration of plans to facilitate the incorporation and sustainability of project developed capabilities into the entity’s animal food safety 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 and sustain the project beyond the project period (typically 5 years).

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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, convened by the FDA}, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer 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 at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the HHS Grants Policy Statement. 

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

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

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that FDA 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 NOFO.

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 System for Award Management (SAM.gov) requirements.  SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award.  An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. FDA will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants.   This provision will apply to all FDA grants and cooperative agreements except fellowships. 

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 Grants Project Team may consist of a Grants Management Specialist, Program Official, Project Manager, and Technical Advisor(s).  The Grants Project team collaborates to review the progress of the grantee, and 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:

The Grants Project Team may utilize the grantee's progress reports, site visits, audit reports, FDA animal food safety contract data, and other supporting documentation to determine if the terms and conditions of the award are met and satisfactory progress is being made.  Each team member works in consultation with each other, as needed, throughout the duration of the project.  A description of each team member involved with the program are described below.

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

• Provides guidance on administrative, business, fiscal aspects of grants management to grantees and FDA program staff
• Monitors and manages applications and required reports on eRA Commons
• Monitors administrative and financial aspects of grantee activities
• Maintains the official grantee file
• An FDA Program Official (PO) will be assigned and named in the Notice of Award.  The PO is accountable for the programmatic oversight of the grant to include coordination, with the Project Manager, on the technical aspects of the grant.  S/he ensures the budget of grantees are reasonable and costs are allowable and allocable.  The PO reviews the progress reports to verify the budget proposed includes only allowable expenses that support the project goals and objectives.   The PO also assists with post-award monitoring and establishing a corrective action plan, if necessary.
• An FDA Project Manager (PM) will be assigned to the program. The FDA PM is the responsible official for the programmatic, scientific, and/or technical aspects of assigned applications and cooperative agreements. The FDA PM will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.
• The PM will have substantial involvement in the design, implementation, and evaluation of program activities, and dissemination of program results and outcomes, above and beyond routine grant monitoring. Substantial involvement by FDA/ORA includes, but is not limited to, the following:
• Provide guidance, direction, and technical assistance in project planning, implementation, and evaluation;
• Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;
• Actively monitor the supported program via telephone conversations, webinars, e-mails, written correspondence, or periodic site visits;
• Evaluate the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols;
• FDA hosting annual face-to-face meetings for programs enrolled in the AFRPS, and participating in the meetings with awardees.
• FDA conducting technical sessions with the grantee, as deemed necessary by FDA.
• Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing;
• Participate in data analysis, interpretation of findings, and where appropriate, co-authorship of publications;
• Development of programs to meet the FDA mission;
• Provision of programmatic technical assistance;
• Post-award monitoring of project/program performance, including review of progress reports and conducting visits and verification audits to verify grantee progress in achieving implementation of the AFRPS; and
• FDA assistance in coordinating multi-program pilot projects.

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

• Provide guidance and technical assistance in project planning, implementation, and evaluation;
• Actively monitor the supported program via telephone conversations, webinars, e-mails, written correspondence, or periodic site visits;
• FDA hosting annual face-to-face meetings for programs enrolled in the AFRPS, and participating in the meetings with awardees.
• FDA conducting technical sessions with the grantee, as deemed necessary by FDA.
• FDA hosting monthly (or at a frequency chosen by FDA) conference calls/webinar meetings with all programs enrolled in the AFRPS.
• FDA assistance in the sharing of information developed by the grantee and collaboration to achieve implementation of the AFRPS with other programs enrolled in the AFRPS in addition to FDA and other federal agencies. Examples may include SOPs, MOUs, training programs, and record keeping systems.
• Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing;
• Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;
• Development of programs to meet the FDA mission;
• Provision of programmatic technical assistance;
• Post-award monitoring of project/program performance, including review of progress reports and conducting visits and verification audits to verify grantee progress in achieving implementation of the AFRPS; and
• FDA assistance in coordinating 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 project planning for milestones/objectives.

The purpose of this cooperative agreement is to advance efforts for a nationally integrated animal food safety system by assisting State animal food regulatory programs to achieve and maintain full implementation of the AFRPS. The AFRPS are intended to ensure that State animal food regulatory programs develop and maintain best practices for a high-quality regulatory program. The cooperative agreements will provide funding for additional personnel, equipment, supplies, and training to support activities related to achieving implementation of the AFRPS.

The grantee must maintain an animal food safety inspection contract with the FDA throughout the cooperative agreement.  Key personnel (minimum of 2) will attend a required annual face-to-face meeting and any required training (as determined by FDA/OP) as a condition of the award. Facilities, work, and training reimbursed under the FDA animal food safety inspection contract and 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, as well as sub-contractor and/or primary servicing laboratory expenditures, under the animal food safety 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 implementation of the AFRPS, continued compliance with all FDA regulatory requirements, and, if necessary, a corrective action plan has been implemented.

If the grantee is located in a state with a supporting laboratory that receives funding under an active FDA cooperative agreement for animal food sample analyses or other purposes (e.g., Laboratory Flexible Funding Model), the regulatory program grantee will provide for the collection of samples (FDA regulated animal food only) to support laboratory capacity development and product surveillance.  The applicant must also demonstrate the ability to perform appropriate enforcement or other follow-up activities based on sample results.  Sampling plans will be developed in cooperation with the laboratory to support the objectives of both programs.  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.

Continued funding under a future Cooperative agreement may be subject to the grantee demonstrating appropriate progress with the following terms and conditions for this project:

All awards under this cooperative agreement are subject to the condition that applicant organizations must have an executed non-public information sharing agreement under 21 CFR Part 20.88 no later than the start date of the grant award.

The grantee must agree to participate in mentoring partnerships to develop, advance, share, and implement best practices for regulatory activities.

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 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.

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 FDA to an awardee pursuant to FDA policy.  Such equipment will remain the property of FDA under loan to the awardee for a specified time period with a review every twelve months. 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

Reporting

Initial, Mid-year, and Annual reports are required. 

In accordance with 5 CFR 1320.5(b), the approved OMB CONTROL NUMBER: 0910-0909 will be displayed on all the required forms used by grantees to report information and data for this cooperative agreement program, including but not limited to: AFRPS Program Report (excel workbook).

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 hiring and training of animal food program personnel.

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

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

Appendix 1.1 or alternate form that is equivalent

Appendix 2.1 or alternate form that is equivalent

Appendix 3.1 or alternate form that is equivalent

Appendix 4.1, 4.3, 4.6, 4.8, 4.10, 4.11 or alternate forms that are equivalent

Appendix 5.1 or alternate form that is equivalent

Appendix 6.1 or alternate form that is equivalent

Appendix 7.1 or alternate form that is equivalent

Appendix 8.1 or alternate form that is equivalent; Workplan for Inspections and Samples, including FTE Formula and Calculator/Calculations

Appendix 9.1, 9.2, and 9.3 or alternate forms that are equivalent

Appendix 10.1 or alternate form that is equivalent

Appendix 11.1 or alternate form that is equivalent

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

1. An 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 implementation of the AFRPS. Progress achieved should indicate full implementation of the AFRPS can be expected by completion of Year 5. Review and update improvement plan(s) on an annual basis. Documentation related to the evaluation and improvement plan(s) should be maintained.

Submission of an improvement plan will include the following at the minimum to demonstrate program advancement in achieving implementation of the AFRPS:

• The individual element or documentation requirement for the Standard that was not fully met.
• Improvements needed to fully meet the program element or documentation requirement(s) of the Standard.
• Lists of individual tasks that will be used to address the improvement
• Projected and actual completion dates for each task

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

2. Description of program improvements and demonstration of measurable implementation of the AFRPS.

Note: For programs with no previous enrollment in the AFRPS, this information will not be required until Year 2 of funding.

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 AFRPS, submission of the baseline self-assessment, including applicable appendices, worksheets, and other documents required for each Standard, or equivalent alternate forms, and an improvement plan is required to be submitted after 12 months of enrollment in the AFRPS, with the first annual progress report.

Additional Reporting templates have been developed and are required for use when reporting progress achieved and/or data elements from the project goals (or outputs) listed in this NOFO. The reporting templates will be available for grantees to use after awards are made, and are required for use by the grantees to aid in improving the monitoring for the progress and objectives of this Cooperative Agreement.

The Reporting templates are required for final program progress reporting that 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 reporting should also detail the strategy, including commitment of personnel, resources, and funding, to sustain implementation of the AFRPS (current and future versions).  An independent audit of the program by FDA should verify the program is in implementation of the AFRPS.

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 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 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 meeting and annual face-to face meeting attendance and participation, implementation progress of the AFRPS according to the work and schedules identified in the application and improvement plan submissions, verification of implementation progress through FDA verification audits, responsiveness to FDA, conference call participation, and the general progress of the cooperative agreement deliverables as determined by FDA.  Funding under a future funding opportunity announcement may be subject to implementation status based on review of program reports and documentation, and verification audit findings.

Consistent with the 2023 FDA Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the HHS Grants Policy Statement.

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 HHS Grants Policy Statement. FDA NOFOs outline intended research goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the HHS Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 ( Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 Award Term and Condition 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: https://www.era.nih.gov/need-help (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

Isaiah Isakson
Office of Regulatory Affairs (ORA)
Office of Partnerships (OP)
Telephone: 303-236-3087
Email: isaiah.isakson@fda.hhs.gov

Shannon Lowe
Office of Regulatory Affairs (ORA)
Office of Regulatory Management Operations (ORMO)
Telephone: 214-253-5304
Email: shannon.lowe@fda.hhs.gov

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov

Recently issued trans-FDA policy notices may affect your application submission. A full list of policy notices published by FDA is provided in the Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.