Opportunity Information:

  • 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 Clinical Research and Drug Development (U24)" 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 Mar 15, 2018.
  • Applicants must submit their applications by May 15, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2023.)
  • Each selected applicant is eligible to receive up to $750,000.00 in funding.
  • The number of recipients for this funding is limited to 3 candidate(s).
  • Eligible applicants include: State governments, County governments, City or township governments, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), 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.
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Applicants who have applied for this opportunity (RFA FD 18 015) also looked into and applied for these:

Funding Opportunity
Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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

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)

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)

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)

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)

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)

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

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)

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
Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional

Funding Number: RFA FD 19 005
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $2,000,000
Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code

Funding Number: RFA FD 19 014
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $2,000,000

 

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