GrantForecasted — not yet open✓ Small businesses may apply
Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed
Food and Drug Administration
Award ceiling
$300,000
Award floor
$300,000
- Opportunity #
- FOR-FD-24-003
- Agency
- Food and Drug Administration
- ALN (CFDA)
- 93.103
- Status
- forecasted
- Posted
- Nov 24, 2023
- Funding instrument
- Cooperative Agreement
- Category
- Agriculture, Consumer Protection, Food and Nutrition
- Cost sharing required
- No
Who can apply
- •For profit organizations other than small businesses
- •County governments
- •Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- •Private institutions of higher education
- •Small businesses
- •Public and State controlled institutions of higher education
- •Public housing authorities/Indian housing authorities
- •State governments
- •Native American tribal governments (Federally recognized)
- •Native American tribal organizations (other than Federally recognized tribal governments)
- •Independent school districts
- •Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- •Special district governments
- •City or township governments
- •Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Contact
Terrin Brown Grantor · terrin.brown@fda.hhs.gov