Opportunity Information: Apply for RFA FD 18 005
The National Laboratory Curriculum Framework Development opportunity is a limited-competition cooperative agreement run by the FDA's Office of Regulatory Affairs, Office of Training, Education and Development (OTED). Its central purpose is to strengthen the Integrated Food Safety System (IFSS) by building out a standardized, competency-based national curriculum for state and local regulatory laboratories that test human food and animal feed, and by supporting the eventual development and delivery of training that aligns with that standard. The program is designed to help FDA and its partners meet workforce and training expectations tied to the Food Safety Modernization Act (FSMA), particularly the need for a more consistent, national approach to preparing and verifying the competence of the large, distributed food and feed safety workforce operating across thousands of jurisdictions.
Funding is structured as a cooperative agreement, meaning the awardee is expected to work closely with FDA rather than operate independently. FDA indicates it can guarantee one year of support, with the possibility of up to four additional years of continued, noncompetitive funding if performance is strong and federal funds remain available. The expected award count is one, with an annual award ceiling listed at $750,000. The opportunity (RFA-FD-18-005; CFDA 93.103) was published by HHS/FDA, with the original posting in February 2018 and an original closing date in April 2018.
Eligibility is narrowly targeted to a national association or organization that represents state and local laboratories conducting food and/or animal feed testing for state and local regulatory programs. A major structural requirement is that the prime awardee must subaward at least 25% of the funds to at least two different associations to accomplish the cooperative agreement goals. One of those associations must represent state manufactured food regulatory officials, and the other must represent state animal feed regulatory officials. FDA must approve these subawards in advance, reinforcing that the agency will play an active oversight role in how the partnership is organized and how work is distributed.
The technical heart of the project sits within the Partnership for Food Protection (PFP), described as the action arm of IFSS. In particular, PFP's Training and Certification Workgroup is charged with developing the National Curriculum Standard (NCS) for a workforce estimated at more than 30,000 feed and food safety professionals nationwide. This grant focuses on the laboratory component of that broader NCS effort, with the intent of creating a coherent curriculum framework that can be adopted and used across jurisdictions while still allowing agencies to add jurisdiction-specific training content where needed.
The work is organized into two major parts. Part 1 centers on developing the IFSS Laboratory National Curriculum Standard itself. The laboratory curriculum framework spans five professional levels: entry, mid-level, expert, supervisor/manager, and senior administration. The idea is to define what competency looks like at each level and to structure progression so that laboratorians can move from foundational readiness into increasingly complex responsibilities across lab tracks such as chemistry and microbiology. A key expectation is that competencies will be written and refined in a way that supports outcome-based training, with supporting elements like key performance indicators and field or bench application exercises to reinforce learning and improve proficiency.
OTED places heavy emphasis on instructional integrity and disciplined instructional design. The awardee is expected to use best practices in adult learning and to rely on the kinds of professional roles that typically support high-quality training systems, including instructional systems specialists and designers, technical editors, subject matter experts, program and project managers, and specialists in fields like industrial/organizational psychology and psychometrics. The development process described is systematic: it begins with analysis of needs and learner starting points, moves through design and development using clear learning taxonomies (Bloom, Krathwohl, Harrow) and performance-based objective writing practices (such as Mager-style criterion-referenced objectives), and then requires review, pilot testing, and evaluation. Behavioral components are also explicitly called out, reflecting the view that effective regulatory work depends not only on technical tasks but also on professional conduct and sound decision-making habits.
The curriculum framework is expected to include competency domains that go beyond purely technical lab methods. Domain topic areas specifically include communication (working effectively with diverse populations using verbal, written, and non-verbal communication), core competencies that cut across domains, critical thinking (defensible, repeatable analytical reasoning), organizational awareness (understanding regulatory authority, structure, mission, and activities), and technical competencies tied directly to food and feed regulatory control. The grant text also sets a fairly granular expectation for competency development: competency statements should be developed down to level 5, described as enabling learning objectives for units within a course, and validated at least down to level 4, described as terminal learning objectives for each unit. In other words, the awardee is expected to take broad competency concepts and work them down into specific, teachable, assessable statements that can anchor real course design later.
Content must be built using FDA/OTED-provided templates and standards, including course design documents, storyboards, web course templates (notably referencing Lectora 12), and style guides. Legal and compliance requirements are also part of the build environment, including Section 508 accessibility, FOIA considerations, Privacy Act requirements, plain language expectations, and copyright and fair use rules. The lifecycle approach described includes checkpoints requiring FDA approval before moving forward, periodic reviews with subject matter experts and instructional designers, technical and instructional reviews for online interfaces, course walk-throughs for classroom content, and pilot offerings to validate effectiveness before full rollout.
Part 1 application expectations are concrete: the applicant must commit to OTED's instructional design approach, develop annual work plans (defining which level and which domains will be addressed, plus the associated competency statements and performance indicators), recruit IFSS laboratory subject matter experts to participate in development alongside FDA, and validate competency statements to the required level. A notable restriction is that training should not be developed, delivered, or posted until the standard is completed for each of the five levels, which signals that FDA is prioritizing the integrity and completeness of the national standard before broad training dissemination.
Part 2 addresses the development and/or delivery of training that meets the IFSS Laboratory NCS once the relevant competencies and performance indicators are validated. FDA highlights that the current model for laboratory training for state and local regulatory agencies is not sufficient to meet FSMA and IFSS-driven demand, so the cooperative agreement contemplates scaled delivery using web-based and classroom-based courses and other learning events that conform to the national standard. Delivery work can include training needs assessments for IFSS laboratories, preparing instructors through an instructor skills training program, providing course-specific instructor training for particular offerings (examples given like LB101, LB102), auditing or overseeing instructors to ensure they follow FDA-intended delivery, collecting evaluations, and recommending course updates based on feedback and assessed needs. Subcontractors may be used for pieces of this work as needed.
Cost efficiency is explicitly built into the delivery model. The grant emphasizes thoughtful course site selection to reduce travel costs and maximize productive delivery, weighing tradeoffs between having instructors travel to states or localities (often cheaper for state/local participants) versus hosting locations that may reduce instructor travel and lodging. It also encourages the use of low-cost or no-cost training space options such as government facilities or hotel arrangements that reduce conference room fees through room blocks.
Allowable funded costs include the direct and indirect costs of course delivery and related support, such as instructor training (both general instructor skills and course-specific training), instructor travel, lodging and per diem, instructor wages or salary, materials and supplies, shipping, transportation for field components, needs assessments, training certificates and recordkeeping, and costs to update or develop courses as agreed. At the same time, the opportunity draws a clear boundary around participant support: funds are not intended to cover course participant travel, lodging, per diem, or participant salary or wages. Participants also cannot be charged registration or entrance fees, which preserves equitable access for state and local staff while placing the logistical burden of participant travel on their home organizations.
Part 2 application requirements mirror those responsibilities: adhere to OTED's approach, recruit subject matter experts and prepare them through instructor skills training, provide course-specific instructor preparation for each course delivered, oversee instructor performance to prevent deviations from FDA-approved content and delivery methods, maintain training records for participants and instructors, and share rosters with FDA so FDA can issue completion certificates. The awardee is also expected to develop annual work plans for course design and blended learning events in coordination with FDA and provide monthly status reports to the OTED point of contact, along with annual work plans for training needs assessments and a course delivery schedule.
FDA's role is described as active and collaborative. The agency provides subject matter experts for FDA-centric content such as FDA regulations and policy, and it supplies project oversight, scientific input, and content review. The overall picture is a tightly managed national workforce development effort in which FDA sets the instructional standards and maintains approval checkpoints, while the awardee coordinates national partners, builds and validates competency frameworks, and supports scalable training development and delivery once standards are in place.Apply for RFA FD 18 005
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "National Laboratory Curriculum Framework Development" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Feb 15, 2018.
- Applicants must submit their applications by Apr 16, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $750,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, For profit organizations other than small businesses, Small businesses.
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| Funding Opportunity |
|---|
| Cooperative Agreement to Support the Western Center for Food Safety (U19) Apply for RFA FD 18 008 Funding Number: RFA FD 18 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Data Standards for Clinical Research and Drug Development (U24) Apply for RFA FD 18 015 Funding Number: RFA FD 18 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01) Apply for RFA FD 18 010 Funding Number: RFA FD 18 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems (U01) Apply for RFA FD 18 019 Funding Number: RFA FD 18 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Three-Dimensional Approach for Modeling Nasal Mucociliary Clearance via Computational Fluid Dynamics (CFD) (U01) Apply for RFA FD 18 020 Funding Number: RFA FD 18 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $280,000 |
| Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery (U01) Apply for RFA FD 18 014 Funding Number: RFA FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $380,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01) Apply for RFA FD 18 012 Funding Number: RFA FD 18 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 18 011 Funding Number: RFA FD 18 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Assuring Radiation Protection (U18) Apply for RFA FD 18 021 Funding Number: RFA FD 18 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24) Apply for RFA FD 18 016 Funding Number: RFA FD 18 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
| Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) Apply for RFA FD 18 022 Funding Number: RFA FD 18 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) Apply for RFA FD 18 025 Funding Number: RFA FD 18 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 18 827 Funding Number: PAR 18 827 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints Apply for RFI NOT FD 18 014 Funding Number: RFI NOT FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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