Opportunity Information: Apply for RFA FD 22 026

  • The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional" 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 04, 2022.
  • Applicants must submit their applications by May 09, 2022. (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 $1,000,000.00 in funding.
  • The number of recipients for this funding is limited to 5 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).
Apply for RFA FD 22 026

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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for FOR FD 23 007

Funding Number: FOR FD 23 007
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $650,000
Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models Apply for RFA FD 23 016

Funding Number: RFA FD 23 016
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $500,000
Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 23 012

Funding Number: RFA FD 23 012
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $1,200,000
Evaluation of oral modified release drug tablet to support the approval of additional strengths Apply for RFA FD 23 013

Funding Number: RFA FD 23 013
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $450,000
Novel approaches to support therapeutic development in ultra-rare cancers Apply for RFA FD 23 008

Funding Number: RFA FD 23 008
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $2,500,000
In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed Apply for RFA FD 23 014

Funding Number: RFA FD 23 014
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $1,000,000
Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional Apply for RFA FD 23 006

Funding Number: RFA FD 23 006
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $2,500,000
Site Selection in Oncology Clinical Trials: Considerations for Selecting Sites in Limited Geographic Regions or Areas of Political Unrest, Limiting Inspection Capabilities (U13) Clinical Trial not allowed. Apply for RFA FD 23 007

Funding Number: RFA FD 23 007
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $300,000
Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional Apply for RFA FD 23 015

Funding Number: RFA FD 23 015
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $750,000
Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional Apply for RFA FD 23 024

Funding Number: RFA FD 23 024
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $5,000,000
Natural History and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 23 028

Funding Number: RFA FD 23 028
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $2,000,000
Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed Apply for RFA FD 23 029

Funding Number: RFA FD 23 029
Agency: Department of Health and Human Services, Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $5,500,000
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for RFA FD 23 001

Funding Number: RFA FD 23 001
Agency: Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $650,000
Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed Apply for RFA FD 23 017

Funding Number: RFA FD 23 017
Agency: Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $500,000
Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 23 026

Funding Number: RFA FD 23 026
Agency: Food and Drug Administration
Category: Consumer Protection, Science and Technology and other Research and Development
Funding Amount: $2,000,000

 

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