Notice Number: NOT-FD-20-010
Key Dates
Release Date: March 9, 2020
RFA-FD-20-020
Issued by
FOOD AND DRUG ADMINISTRATION (FDA)
Purpose
This Notice is to extend the Application Due Date and update the Award Budget for RFA-FD-20-020 "Renewal - Investigation of impact of manufacturing difference and formulation variation on drug release for Levonorgestrel Intrauterine System (U01) Clinical Trials Not Allowed. The following sections are updated:
New Application Due Date(s)
March 31, 2020, by 11:59 PM Eastern Time.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date.
Late applications will not be accepted for this FOA.
New Funds Available and Anticipated Number of Awards
The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.
FDA/CDER/OGD intends to fund up to $425,000, for fiscal year 2020 in support of this grant program.
It is anticipated that 1 award will be made, not to exceed $425,000 in total costs (direct plus indirect).
New Award Budget
Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):
YR 06: $425,000
YR 07: $300,000
YR 08: $300,000
YR 09: $115,000
YR 10: $115,000
Inquiries
Please direct all inquiries to:
Shashi Malhotra
Grants Management Specialist
Office of Operations, Office of Finance Budget & Acquisitions
Office of Acquisitions and Grants Services, HFA-500
U.S. Food and Drug Administration
Tel: 301-402-7592
shashi.malhotra@fda.hhs.gov
and Human Services (HHS)
