Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

U.S. Food and Drug Administration (FDA)

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

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

Components of Participating Organizations

Office of Regulatory Affairs (ORA)

Funding Opportunity Title

Development, Implementation, and Management of a Funding System to support the Grade “A” Milk Safety Program and National Shellfish Sanitation Program (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-19-004

Companion Funding Opportunity

None

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

 93.103

Funding Opportunity Purpose

 The objective of this FOA is the development, implementation, and management of a funding system in which State, Tribal, and Territorial Grade “A” Milk Safety and National Shellfish Sanitation regulatory programs can apply and be subawarded funds to support technical training and equipment purchases, and to improve the implementation of the Grade "A" Milk Safety Program and the National Shellfish Sanitation Program (NSSP). Funds may be awarded to up to two non-profit association/organization(s), upon which they will subsequently administer and subaward funds to State, Tribal, and Territorial regulatory agencies for facilitating improvements to and advancing the Grade “A” Milk Safety Program and the National Shellfish Sanitation Program.

Key Dates

 

Posted Date

February 19, 2019

Open Date (Earliest Submission Date)

March 1, 2019

Letter of Intent Due Date(s)

March 20, 2019

Application Due Date(s)

April 30, 2019, by 11:59 PM Eastern Time.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2019

Advisory Council Review

Not Applicable

Earliest Start Date

August 1, 2019

Expiration Date

May 1, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


Table of Contents

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

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Purpose

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships is announcing the availability of a cooperative agreement to be awarded under Limited Competition to up to two non-profit association/organizations whose membership includes, but may not be limited to, State, Tribal, and/or Territorial employees, who work in either the Grade “A” Milk Safety program and/or the National Shellfish Sanitation programs.

The objective of this FOA is the development, implementation, and management of a funding system in which those State, Tribal, and Territorial agencies that have primary responsibility for regulating Grade “A” Milk and/or Molluscan Shellfish may apply and be subawarded funds to facilitate training, equipment purchases, or provide for other priorities needed to implement the Grade "A" Milk Safety program and the National Shellfish Sanitation Program (NSSP) within their respective jurisdictions. The cooperative agreement includes one year of funding with up to four years of additional non-competitive support, dependent on performance and continued availability of funds. The funds are to be subawarded through a funding system developed by the grantee.

The following are the goals of this cooperative agreement:

1.  Support State, Tribal, and Territorial Grade “A” Milk Safety and National Shellfish Sanitation regulatory programs to participate in technical training, including FDA/Office of Training, Education and Development (OTED)-supported Grade “A” Milk training courses, FDA/OTED-supported Shellfish training courses, Milk or Shellfish seminars, LEO Milk or LEO Shellfish training courses; and

2.  Provide equipment to assist the States, Tribes, and Territories with their implementation of the Grade "A" Milk Safety program and/or NSSP.

The funding system developed by the grantee for issuing the subawards shall meet the following criteria:

1. Ensures strong cooperation, coordination, and continuous involvement of the FDA, including Milk or Shellfish Specialists, National Milk and Shellfish Teams, Milk and Shellfish Steering Committees, State Cooperative Program Directors, Office of Partnerships, and Office of Foods and Veterinary Medicine.

2. Establishes a joint advisory group including the grantee, FDA, and other stakeholders in order to establish priorities and ensure the goals of the cooperative agreement are achieved.

3. Contains a communications strategy that includes advertising the availability of funds, projects funded, and project goals.

4. Describes in detail the process for selecting subawardees that includes active, direct involvement of the FDA Milk and/or Shellfish Specialists and other FDA stakeholders.  Also, describes a clear process or management with unbiased methods for solicitation/recruitment of applications, review of submissions, and selection of sub-awardees to ensure distribution of funds over a wide range of State, Tribal, and Territorial regulatory jurisdictions in keeping with FDA program priorities.

5. Establishes a system for monitoring the progress of sub-awardees to include the periodic verification of project goals and reporting of the project results/goals to FDA.

6. Establishes a system for the management, distribution, and verification of the use of funds sub-awarded to State, Tribal, and Territorial Grade "A" Milk Safety and/or National Shellfish Sanitation regulatory agencies, including providing a software program to manage and track awards.

7. Establishes a system for development of corrective action plans when subawardees are not completing the projects proposed or using the funds appropriately.

8. Ensures, through working cooperatively with FDA, that the projects proposed by sub-awardees have not been reimbursed under other cooperative agreements, grants, contracts, and other funding mechanisms.

Sub-awarded funds will be made available by the grantee in support of training and equipment categories:

Projects proposed by the sub-awardees should target support of training in Grade “A” Milk Safety and National Shellfish Sanitation programs including FDA/OTED -supported Grade “A” Milk Safety training courses, FDA OTED-supported Shellfish training courses, Milk or Shellfish Seminars, Lab Evaluation Officer (LEO) Milk or LEO Shellfish training and equipment to assist in the implementation of the Grade "A" Milk Safety Program and/or NSSP. Programs applying for subawards shall submit a proposal detailing the use and goals of the funds requested and a progress report at the conclusion of the project.

FDA/OTED-supported Grade “A” Milk or Shellfish training courses, Milk or Shellfish seminars, LEO Milk or LEO Shellfish training are all specific needs of staff for program implementation.  Equipment shall be tools needed to conduct the programs.

Other sub-award categories may be supported upon mutual agreement with FDA and the grantee(s).

Background

This funding opportunity furthers FDA's efforts to enhance State, Tribal and Territorial Grade “A” Milk Safety and National Shellfish Sanitation programs.  Recent legislative and strategic initiatives have been created to enhance FDA's relationship with State, Tribal and Territorial officials in food protection activities.

FDA standardization/certification is a requirement to function as a state standard in the Grade “A” Milk Safety program and National Shellfish Sanitation program.  Successful completion of OTED-supported training courses and attendance at specified seminars in these programs is required for state standardization.

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

Under FDAAA, FDA is required to work with the states to improve food safety. Section 1004 of FDAAA states:

SEC. 1004. STATE AND FEDERAL COOPERATION

(a) IN GENERAL. —The Secretary shall work with the states in undertaking activities and programs that assist in improving the safety of food, including fresh and processed produce, so that state food safety programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage states to—

(1) Establish, continue, or strengthen state food safety programs, especially with respect to the regulation of retail commercial food establishments; and (2) Establish procedures and requirements for ensuring that processed produce under the jurisdiction of state food safety programs is not unsafe for human consumption.

(b) ASSISTANCE. —The Secretary may provide to a state, for planning, developing, and implementing such a food safety program—

(1) Advisory assistance;

(2) Technical assistance, training, and laboratory assistance (including necessary materials and equipment); and

(3) Financial and other assistance.

(c) SERVICE AGREEMENTS. —The Secretary may, under an agreement entered into with a federal, state, or local agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to carry out the responsibilities of the agency under this section. An agreement entered into with a state agency under this subsection may provide for training of state employees.

b. Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. It also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. These include authorities such as mandatory recall, expanded administrative detention, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk foods. FSMA also gives FDA important new tools to hold imported foods to the same standards as domestic foods. FSMA directs FDA to build an integrated national food safety system in partnership with state and local authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas such as: reliance on federal, state, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and Local food safety and defense capacities.

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

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New

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

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for four (4) additional years contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

FDA/ORA/Office of Partnerships intends to fund up to $6,000,000.00, for fiscal year 2019 in support of this grant program.

It is anticipated that up to two (2) awards will be made, not to exceed $3,000,000.00 in total costs (direct plus indirect), per award.

Award Budget

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

YR 01: $3,000,000.00

YR 02: $3,000,000.00

YR 03: $3,000,000.00

YR 04: $3,000,000.00

YR 05: $3,000,000.00

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is five (5) years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)

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

This opportunity is only available to the following nonprofit organizations/associations:

Organizations/associations whose focus of membership include, but are not necessarily limited to, State, Tribal, and/or Territorial Grade “A” Milk Safety and/or National Shellfish Sanitation program regulators.

Foreign Institutions

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

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

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

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent by email to:

Dan Lukash
FDA Grants Specialist
Telephone: 240-402-7596
Email: daniel.lukash@fda.hhs.gov

A technical session will be held for prospective applicants in January 2019.  The conference call information will be provided to prospective applicants that submit a letter of intent.  The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process.  Participation in the technical session is optional, but strongly encouraged. 

Page Limitations

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

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

  • ·        Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
  • ·        If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission.  This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
  • ·        If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed.  MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract.  MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

The applicant shall specifically address the ability to achieve the following objectives in the cooperative agreement:

1. Demonstrate the ability to develop and implement a comprehensive strategic plan that includes goals and project milestones that will result in the development, implementation, and management of a program to administer and award funds to Grade “A” Milk Safety and/or National Shellfish Sanitation regulatory programs. The funds awarded will result in assisting with implementation of the Grade "A" Milk Safety Program and/or NSSP.

2. Demonstrate the ability to engage and collaborate with Grade “A’ Milk Safety and/or National Shellfish Sanitation regulatory programs, FDA, and other stakeholders to meet the goals and objectives of this cooperative agreement and proposed project.

3. Demonstrate the availability of adequately trained staff and the criteria and ability to hire and/or train personnel to meet the deliverables of the cooperative agreement. If needed, provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.

4. Provide a properly detailed budget (one for each of the five years) that is intended to promote, award, and administer funds for the advancement of the Grade “A’ Milk Safety and/or National Shellfish Sanitation regulatory programs.

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

6. Outline a detailed methodology for program assessment, improvement, and collaboration to accomplish the work, as described in this announcement.  Provide a software program to manage subawardee applications, review and monitoring of processes.

7. Describe in detail the process for selecting which training, equipment, or other related priorities are funded.  Such description should include, but not limited to, describing how applications for funding from the states, tribes, or territories will be handled, describing how the most merit-worthy requests will be determined, describing how sub-awardees will be identified and informed of their obligations, describing how sub-awardees will report their accomplishments, etc.

8. Demonstrate the ability to provide administrative oversight for funds awarded to Grade “A’ Milk Safety and/or National Shellfish Sanitation regulatory programs (subawardees) through this cooperative agreement, including distribution of funds, monitoring project deliverables and expenditures, and implementing corrective actions when necessary.

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

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

Appendix:

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

PHS Human Subjects and Clinical Trials Information

When involving FDA-defined 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 with the following additional instructions:  Not applicable

Delayed Onset Study

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

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

PHS Assignment Request Form

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

Foreign Institutions

Not applicable

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

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

1. Subawards/contracts to third parties: A minimum of 75% of the cooperative agreement funds shall be subawarded to State, Tribal, and/or Territorial regulatory agencies with primary responsibility for Grade “A” Milk Safety program and/or National Shellfish Sanitation program, or to agencies with substantial control and responsibility over such agencies. Substantial control and responsibility includes conducting standardization and training, promulgating regulations, providing significant funding, and/or directing the activities of agencies with primary responsibility for regulating Grade "A" Milk or National Shellfish Sanitation programs.

Non-allowable costs:

1. Pre-award costs are not allowable for this announcement.

2. Facilities, work, training, and other expenses reimbursed under other cooperative agreements, grants, contracts, and other funding mechanisms shall remain distinct and separate from this cooperative agreement.

3. Vehicle purchases are not permitted.

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

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

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

Scored Review Criteria

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

1. Plan (40 points): The proposed system, strategies, and approach to meet the intended goal of the cooperative agreement are well-reasoned, appropriate, and complete.

2. Cooperation (20 points).   Demonstration of effectiveness in working with federal, state, territorial, and/or tribal regulatory jurisdictions on Grade “A” Milk or Molluscan Shellfish safety issues that positions the applicant to successfully implement the intended goal of the cooperative agreement.

3. Personnel (20 points): Demonstration that the PI/PD, collaborators, and other key personnel are well-suited to the project with the appropriate experience and training. (Total Weight = 20%)

4. Resources (20 points): Demonstration of adequate program infrastructure and resources to accomplish the intended goal of the cooperative agreement, including providing adequate administration and oversight to subawards issued.

Additional Review Considerations

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

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan 

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.

Vertebrate Animals

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

Biohazards

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.

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

Not applicable

Applications from Foreign Organizations

Not applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the objective review, all applications:

  • ·        Will receive a written critique.

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

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

  • ·        Scientific and technical merit of the proposed project as determined by objective review.
  • ·        Availability of funds.
  • ·        Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

2. Administrative and National Policy Requirements

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

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

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

The goal of this FOA is the development, implementation, and management of a funding system in which State, Tribal, and Territorial Grade “A” Milk Safety and/or National Shellfish Sanitation regulatory programs can apply and be subawarded funds to support training including but not limited to FDA/OTED-supported Grade “A” Milk training courses, FDA/OTED-supported Shellfish training courses, Milk or Shellfish seminars, and LEO Milk or LEO Shellfish training courses, which are all specific needs of staff for program implementation.  Equipment shall be the tools needed to conduct the programs.

A minimum of 75% of the cooperative agreement funds awarded shall be subawarded to State, Tribal and/or Territorial regulatory agencies to assist with implementation of the Grade "A" Milk Safety Program and/or the National Shellfish Sanitation Program.

Support will be in the form of a cooperative agreement. Substantial 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 and subawards funded by the cooperative agreement, including participating, guiding, coordinating, and participating in project activities.

Substantive involvement includes, but is not limited to, the following:

• FDA review and approval of task-oriented guidelines and other documents developed under the award.

• FDA assistance and coordination in the sharing of information to Federal, State, and local agencies and other stakeholders.

• FDA review and approval of publications/web applications or any revisions to existing systems.

• FDA review and approval of subawards made using cooperative agreement funds.  FDA has discretion when making final subaward decisions, and can approve changes to funding amount, priority, and other aspects to ensure the subaward meets the FDA’s intended goals.

• Other assistance or collaboration as requested by associations and State/local agencies.

• Minimum of one (1) meeting per year with the Program Office to review grantee progress and discuss cooperative agreement goals and objectives.    

The program project officer, grants management officer, technical advisor, FDA Milk Specialists, FDA Shellfish Specialists, FDA National Milk and Shellfish Teams, FDA Milk and Shellfish Steering Committees, FDA Office of State Cooperative Program Directors, FDA/Office of Partnerships Milk and Shellfish Specialists, and representatives from other components within FDA will monitor the recipient and subawardees. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the FDA and the principal investigator. Periodic site visits from representatives of ORA with officials of the recipient organization or subawardees may also occur. There may be other regular meetings with the recipient and subawardees to assist in fulfilling the requirements of the cooperative agreement.

Mid-year reports are required.  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 proposal. Goals and objectives should be itemized and reported accordingly.

2. Status report on the hiring and training of any personnel.

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

4. Summary of funding requests received and subawards issued with the following information, at a minimum: name and contact information of agency, summary project proposed, funds requested, funding decision, and progress of the projects/subawardees selected for funded.

5. Identify any pending issues or concerns that may affect accomplishing the objectives and goals of the cooperative agreement, including any subawards made. If the objectives and goals of the cooperative agreement are not being met, then a corrective action plan shall be submitted. The corrective action plan should detail the tasks, responsible personnel, and updated timeframes to ensure satisfactory performance and meet the deliverables required under the grant.

6. Detailed program budget demonstrating that a minimum of 75% of funds are being subawarded to state, tribal, and/or territorial regulatory agencies with primary regulatory responsibility for Grade “A’ Milk products and/or Molluscan Shellfish in their respective jurisdictions, or to agencies with substantial control and responsibility for such agencies.

The final program progress report shall provide full written documentation of the project and summaries of accomplishments and goals, as described in the grant application. The documentation shall be in a form and contain sufficient detail such that other entities could reproduce the final project.

In addition, work proposed and conducted under this cooperative agreement, including subawards issued, may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed and conducted under this cooperative agreement and the funding provided shall remain distinct and separate from other projects and funding sources. The grantee shall be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

3. Reporting

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

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

Scientific/Research Contact(s)

Project Officer: 

Gerald J. Berg
FDA/ORA/Office of Partnerships
Telephone: 612-758-7183
Email: gerald.berg@fda.hhs.gov

Technical Advisor:

Belinda Clifton
FDA/ORA/Office of Partnerships
Telephone: 206-713-6172
Email: belinda.clifton@fda.hhs.gov

Technical Advisor: 

Michael Antee
FDO/ORA/Office of Partnerships
Telephone: 206-340-8215
Email: michael.antee@fda.hhs.gov

Objective Review Contact(s)

Dan Lukash
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7596
Email: daniel.lukash@fda.hhs.gov

Financial/Grants Management Contact(s)

Dan Lukash
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7596
Email: daniel.lukash@fda.hhs.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241), Section 1009 of the Food. Drug and Cosmetic Act (21 U.S.C. 399) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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