Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (RFA FD 18 013)

 

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 "Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act" 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 Apr 24, 2018.
  • Applicants must submit their applications by Jun 25, 2018.
  • Each selected applicant is eligible to receive up to $4,200,000.00 in funding.
  • The number of recipients for this funding is limited to 1 candidate(s).
  • Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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Previous opportunity: FY18 Announcement of Availability of Funds for Phase I Replicating Programs (Tier 1) Effective in the Promotion of Healthy Adolescence and the Reduction of Teenage Pregnancy and Associated Risk Behaviors

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Applicants also applied for:

Applicants who have applied for this opportunity (RFA FD 18 013) also looked into and applied for these:

Funding Number Funding Title
RFA FD 18 022 Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01)
RFA FD 18 025 Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19)
RFA FD 18 018 Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01)
RFA FD 18 024 Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01)
PAR 18 827 Minor Use Minor Species Development of Drugs (R01)
RFI NOT FD 18 014 Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints
RFA FD 19 002 Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed)
RFA FD 19 005 Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional
RFA FD 19 014 Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code
RFA FD 19 008 Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed)
RFA FD 19 009 Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required)
RFA FD 19 010 Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed)
RFA FD 19 003 Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional)
RFA FD 19 011 Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional
PAR 19 190 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
PAR 19 216 Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional
RFA FD 19 021 Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed)
RFA FD 19 018 Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories (U18 Clinical Trial Not Allowed)
RFA FD 19 020 Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional)
RFA FD 19 019 Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed)

 

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