Opportunity Information: Apply for RFA FD 24 001
The Food and Drug Administration (FDA), through its Center for Tobacco Products (CTP), is offering a discretionary cooperative agreement opportunity called "Data Standards for Tobacco Research and Scientific Review Phase 2" (RFA FD 24 001; CFDA 93.103). The focus of this program is to fund projects that build, refine, and encourage adoption of data standards and terminologies that make tobacco-related research data easier to compare, combine, review, and analyze. In practical terms, CTP is looking for open, consensus-based standards that can be used consistently across studies of tobacco products, with the larger goal of improving the quality and usefulness of evidence that informs tobacco regulation and public health decisions.
The main objective is the development and support of standardized data structures and shared vocabularies for tobacco product research. By creating common ways to represent key data elements, definitions, and concepts, the program aims to reduce the current fragmentation where different studies and organizations collect similar information in incompatible formats. Better alignment on standards is intended to streamline scientific review and evaluation work, since reviewers and analysts can interpret and integrate submissions and research outputs more efficiently when they follow shared conventions. Over time, this should also support more robust cross-study analyses and faster synthesis of evidence related to tobacco product characteristics, exposure, use patterns, and other domains relevant to regulatory science.
A secondary objective is outreach and education around these standards. CTP is not only interested in the technical work of building terminologies and data models, but also in helping federal regulators, the tobacco industry, and global organizations understand and use standardized data practices. This emphasis on promotion and training reflects the reality that standards only deliver value when they are implemented widely, so projects may include documentation, guidance, implementation resources, and efforts that encourage data sharing and interoperability across institutions and sectors.
CTP signals flexibility in the types of projects it will consider. Applicants may propose efforts that address broader challenges in developing and implementing standards (for example, barriers to adoption, tooling, governance, mapping between existing schemas, or best practices for implementation), and/or they may target specific high-need concepts, domains, or topic areas where standardization is missing or incomplete. The common thread is that the work should advance practical, consensus-driven standards and terminologies that can be applied to real-world tobacco research and scientific review workflows.
The opportunity is offered as a cooperative agreement, which generally indicates substantial involvement from the funding agency during the project period, such as collaboration, technical input, or coordination to ensure alignment with program goals. The award ceiling is $250,000, and FDA anticipates making two awards. The posting lists an original closing date of December 13, 2023, with the opportunity created on October 13, 2023.
Eligibility is broad and includes many types of domestic organizations: state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses, plus other entities as described in the announcement’s additional eligibility information. Overall, the grant is designed to bring together technical expertise and stakeholder engagement to strengthen the foundation of standardized data in tobacco research and the regulatory review process.Apply for RFA FD 24 001
- 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 "Data Standards for Tobacco Research and Scientific Review Phase 2" 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 Oct 13, 2023.
- Applicants must submit their applications by Dec 13, 2023. (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 $250,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), 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, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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| Funding Opportunity |
|---|
| Manufacturing Sector Research Initiative Apply for RFA FD 17 009 Funding Number: RFA FD 17 009 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $35,000,000 |
| Cooperative Agreement to Support the Joint Institute for Food Safety and Applied Nutrition, JIFSAN (U19) Apply for RFA FD 17 003 Funding Number: RFA FD 17 003 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,300,000 |
| National Laboratory Curriculum Framework Development Apply for RFA FD 17 012 Funding Number: RFA FD 17 012 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,750,000 |
| Developing Biomarkers for Trastuzumab-induced Cardiotoxicity Apply for RFA FD 17 006 Funding Number: RFA FD 17 006 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $140,000 |
| CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18) Clinical Trials Apply for PAR 22 063 Funding Number: PAR 22 063 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| Implementation of U.S. Food Safety Modernization Act - Identifying, Researching and Implementing Alternative Methods to Expand the Reach Across the Global Supply Chain (U01) - Clinical Trials Not Allowed Apply for RFA FD 24 013 Funding Number: RFA FD 24 013 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Strengthening Regulatory Systems to Improve Global Food and Medical Product Quality and Safety (U01) Clinical Trials Not Allowed Apply for RFA FD 24 014 Funding Number: RFA FD 24 014 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 24 024 Funding Number: RFA FD 24 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Public Health Regulatory Systems Strengthening - U01 Clinical Trials Not Allowed Apply for RFA FD 24 015 Funding Number: RFA FD 24 015 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| National Project to Support and Promote Consistent Implementation of the Regulatory Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption and Produce Regulatory Standards (PRPS) (U2F) -Cooperative Agreements Apply for RFA FD 24 012 Funding Number: RFA FD 24 012 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Produce Safety Alliance-U01 Clinical Trials Not Allowed Apply for RFA FD 24 018 Funding Number: RFA FD 24 018 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed Apply for RFA FD 24 022 Funding Number: RFA FD 24 022 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed Apply for RFA FD 24 020 Funding Number: RFA FD 24 020 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 026 Funding Number: RFA FD 24 026 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 023 Funding Number: RFA FD 24 023 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required) Apply for RFA FD 24 025 Funding Number: RFA FD 24 025 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional Apply for RFA FD 24 029 Funding Number: RFA FD 24 029 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Critical Path Public Private Partnerships Clinical Trials Optional Apply for RFA FD 24 027 Funding Number: RFA FD 24 027 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $20,000,000 |
| Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed Apply for RFA FD 24 007 Funding Number: RFA FD 24 007 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional Apply for RFA FD 24 006 Funding Number: RFA FD 24 006 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
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