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 "Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01)" 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 23, 2018.
  • Applicants must submit their applications by Jun 04, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2022.)
  • Each selected applicant is eligible to receive up to $5,000,000.00 in funding.
  • The number of recipients for this funding is limited to 3 candidate(s).
  • Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
Apply for RFA FD 18 011
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Funding Opportunity
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
Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed)

Funding Number: RFA FD 19 008
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $500,000
Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required)

Funding Number: RFA FD 19 009
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $1,000,000
Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed)

Funding Number: RFA FD 19 010
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $1,500,000
Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional)

Funding Number: RFA FD 19 003
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $10,000,000
Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional

Funding Number: RFA FD 19 011
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $3,000,000
Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional

Funding Number: PAR 19 190
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $2,500,000

 

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