Notice Number: NOT-FD-16-006
Release Date: March 3, 2016
Estimated Publication Date of Announcement: March 2016
First Estimated Application Due Date: May 2016
Earliest Estimated Award Date: September 2016
Earliest Estimated Start Date: September 2016
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration, Office of Regulatory Affairs, intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for 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 Molluscan Shellfish programs.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The proposed objective of the FOA is the development, implementation, and management of a funding system to support State, Tribal, and Territorial agencies that have primary responsibility for regulating Grade “A” Milk and/or Molluscan Shellfish. Through the proposed funding system, State, Tribal, and Territorial agencies will be to apply and be subawarded funds to facilitate employee training, purchase equipment, or provide for other priorities needed to implement the Grade "A" Milk Safety program and/or the National Shellfish Sanitation Program (NSSP) within their respective jurisdictions. The cooperative agreement may potentially include one year of funding with up to two years of additional non-competitive support, dependent on performance and continued availability of funds. The funds may potentially be subawarded to State, Tribal, and/or Territorial agencies through a funding system developed by the grantee.
This proposed opportunity may potentially be available only to the following nonprofit organizations/associations:
- 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)
- Organizations/associations whose focus of membership include, but are not necessarily limited to, State, Tribal, and/or Territorial Grade “A” Milk Safety and/or Molluscan Shellfish program regulators.
Applicants may potentially need to 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 in support of Grade “A” Milk Safety and/or Molluscan Shellfish 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 Molluscan Shellfish regulatory programs, FDA, and other stakeholders to meet the goals and objectives of the cooperative agreement.
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 detailed budget (one for each of the three years) that is intended to promote, award, and administer funds for the advancement of the Grade “A’ Milk Safety and/or Molluscan Shellfish regulatory programs.
5. Outline a detailed methodology for program assessment, improvement, and collaboration to accomplish the work, as described in this notice.
6. 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 will be 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 subawardees will be identified and informed of their obligations, describing how subawardees will report their accomplishments, etc.
8. Demonstrate the ability to provide administrative oversight for funds awarded to Grade “A’ Milk Safety and/or Molluscan Shellfish regulatory programs (subawardees) through the cooperative agreement, including distribution of funds, monitoring project deliverables and expenditures, and implementing corrective actions when necessary.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Please direct all inquiries to:
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration (FDA)