Closed · RFA-FD-22-013 · CFDA 93.103 · Discretionary
Development of advanced analytical methods for the characterization of complex generics
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- $50K-$300K
- Award range
- Closed
- Status
- March 7, 2022
- Close date
- -
- Expected awards
The verdict
Development of advanced analytical methods for the characterization of complex generics is a closed discretionary listing from Food and Drug Administration that offered $50,000 -- $300,000. Future funding cycles may be published under the same CFDA number.
- $50K-$300K
- award range
- Closed
- application status
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - Development of advanced analytical methods for the characterization of complex generics - is cataloged under number RFA-FD-22-013 and tied to CFDA assistance listing 93.103, posted by Food and Drug Administration. Grants.gov currently shows the opportunity as closed, first posted on January 12, 2022. The funding category is Discretionary, delivered as a cooperative agreement.
Award economics. The award range on file is $50,000 -- $300,000. The agency has projected $300,000 in total estimated funding for this announcement. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.
Deadline and action path. This opportunity closed on March 7, 2022. Future funding cycles may be published under the same CFDA number, so monitoring the parent program page is the most reliable way to catch re-announcements. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully, federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed, it helps clarify scope and scoring priorities. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.
Award Range
$50,000 -- $300,000
Close Date
March 7, 2022
Posted
January 12, 2022
Est. Total Funding
$300,000
Instrument
Cooperative Agreement
Description
Advanced analytical methods for characterization and comparative analysis of complex products, which help to link product attributes to product quality, safety and efficacy, are useful for facilitating the development of generic complex products. The purpose of this study is to develop advanced analytical methods for analyzing the diastereomer compositions in phosphorothioate (PS) oligonucleotides using either TEGSEDI (inotersen) or SPINRAZA (Nusinersen) as the model product. The proposed studies will focus on 1) understanding the diastereomer composition in TEGSEDI or SPINRAZA (Nusinersen), and 2) determining whether and how the manufacturing process may affect the diastereomeric distributions in the drug product. Methods developed through this research may also be applied in cases of other synthetic oligonucleotides, and could greatly facilitate the development and assessment of generic oligonucleotide drug products. Knowledge gained from this research may also contribute to quality control of oligonucleotide drugs.
Eligibility
Grants.gov lists this opportunity under eligibility category codes 00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 22, 23, 25. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Food and Drug Administration Research
U.S. Department of Health and Human Services
Agency Contact
Shashi Malhotra Grants Management Specialist Phone 2404027592
Key Dates
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Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.
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| Sources | the SAM.gov Assistance Listings and Grants.gov |