Opportunity Information: Apply for RFA FD 18 018

  • 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 "Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (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 May 23, 2018.
  • Applicants must submit their applications by Jun 20, 2018 RFA was posted on 04/20/2018 - due to a an error it was posted as RFD-FD-18-018. This is a correction on the title of the RFA. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2024.)
  • Each selected applicant is eligible to receive up to $1,800,000.00 in funding.
  • The number of recipients for this funding is limited to 2 candidate(s).
  • Eligible applicants include: State governments, Independent school districts, 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, Private institutions of higher education, Others (see text field entitled Additional Information on Eligibility for clarification).
Apply for RFA FD 18 018

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Funding Opportunity
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
Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005

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 Apply for RFA FD 19 014

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) Apply for RFA FD 19 008

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) Apply for RFA FD 19 009

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) Apply for RFA FD 19 010

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) Apply for RFA FD 19 003

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 Apply for RFA FD 19 011

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 Apply for PAR 19 190

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
Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional Apply for PAR 19 216

Funding Number: PAR 19 216
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $6,000,000
Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed) Apply for RFA FD 19 021

Funding Number: RFA FD 19 021
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $300,000
Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories (U18 Clinical Trial Not Allowed) Apply for RFA FD 19 018

Funding Number: RFA FD 19 018
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $310,000
Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional) Apply for RFA FD 19 020

Funding Number: RFA FD 19 020
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $3,000,000
Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 019

Funding Number: RFA FD 19 019
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $750,000
Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required Apply for RFA FD 19 015

Funding Number: RFA FD 19 015
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $37,500,000
Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities. (U01) Clinical Trial Not Allowed Apply for RFA FD 19 013

Funding Number: RFA FD 19 013
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $3,500,000
Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 19 016

Funding Number: RFA FD 19 016
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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