Funding Wizard

The purpose of this funding opportunity is to solicit applications for UH2/UH3 cooperative agreements to support and inform the future development and use of COAs for cBCIs in patients with amyotrophic lateral sclerosis (ALS). The UH2/UH3 cooperative agreement involves two milestone driven phases: 1) the UH2 Phase will include a systematic landscape analysis of the available literature, relevant data sources, and interviews with key opinion leaders (KOLs) to document COAs for cBCIs used clinically and identify gaps between current COAs used in cBCI studies and other outcome measures that could demonstrate functional benefits for ALS patients with severe communication limitations; 2) the UH3 phase will consist of patient and caregiver focus groups to collect information about symptoms, functional status, and perceived benefits/risks of cBCIs.Each phase will have a limit of 1 year for a total award period of 2 years. The UH2/UH3 application must be submitted as a single application, and applicants should note specific instructions for each phase in this FOA.

The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetylgalactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereochemically-controlled synthesis and biological activity assessment using in vitro and animal models. The proposed studies will focus on 1) synthesis of each diastereomer of LEQVIO (Inclisiran) in stereochemically pure form; 2) assessment of the biological activity of each stereochemically pure diastereomer in inhibiting PCSK9 activity using in vitro assays and in a transgenic mouse model; 3) development of analytical methods to identify and characterize the stereochemical structure of each diastereomer in LEQVIO; and 4) assessment of the individual contribution of each diastereomer to the overall pharmacological activity of LEQVIO. Tools developed in this research can also be applied to other similar GalNAc-conjugated siRNAs specifically, and other siRNAs in general. Knowledge gained from this research will also contribute to the sameness evaluation of generic siRNAs, and to the quality control of oligonucleotide drugs.

The purpose of this Funding Opportunity Announcement (FOA) is to address topics related to FDA's Real-World Evidence (RWE) Program and to enable FDA to assess the potential utility of real-world data (RWD) in generating RWE.

The purpose of this FOA is to support a series of conferences and workshops developed with substantial FDA input to explore challenges regarding site selection of clinical trials sites in studies that are submitted to FDA for regulatory approval of oncology indications.

FDA announces the availability of fiscal year (FY) 2022 funds to support studies that identify the most common drivers for antimicrobial use in animal agriculture and identify potential alternatives to antimicrobials that may reduce the need for antimicrobial use. The funded studies are intended to 1) provide information about animal diseases that are the most significant drivers for antimicrobial use in various animal production settings (i.e., cattle, swine, turkeys, and chickens), and 2) provide information about alternative practices that may help reduce the reliance on such drugs while addressing animal health needs. Such alternatives can include changes in husbandry, biosecurity, vaccination, and other practices. This grant will support the continued advancement of FDA's initiatives related to supporting antimicrobial stewardship in veterinary settings and will support the National Action Plan objectives to engage the animal health community and relevant stakeholders to advance strategies intended to foster antimicrobial stewardship and to improve understanding of antimicrobial use practices in animal agriculture

Orally Inhaled Drug Products (OIDPs) are complex drug-device combination products. To establish bioequivalence for locally acting OIDPs, FDA is currently using a weight-of-evidence approach which generally includes a combination of in vitro BE studies; in vivo pharmacokinetic (PK) studies and comparative clinical endpoint (CCEP) or pharmacodynamic (PD) studies; along with formulation sameness and device similarity. For some OIDPs, both CCEP and PD studies can pose a challenge due to a lack of sensitivity to detect formulation differences. The purpose of this funding opportunity is to support research that will use modeling and simulation to investigate the feasibility of assessing formulation differences in regional lung exposure based on systemic PK concentration data to establish BE for OIDPs with different drug and product properties.

The intended goal of this FOA is to facilitate the development, production, and distribution of pediatric medical devices. Although the FOA is issued by the FDA's Office of Orphan Products Development, the grant application is intended to encompass devices for all pediatric diseases and conditions, not just those that are rare. Applicants will request funding to serve as a nonprofit consortium to provide expert advising and support services to innovators of pediatric medical devices. The advising and services will focus on the total product life cycle for medical devices from concept, through pre-market development, to commercialization, and replacement by subsequent generations of devices. In addition, consortia should also provide expertise on evidence generation, including use of real-world evidence (RWE), for pediatric device development. As the consortia execute their mission, they are encouraged to collaborate with each other and the broader community and to maintain a commitment to health equity, diversity, and inclusion to foster innovation, development, and improve access to medical devices for all pediatric patients.Pediatric medical devices treat or diagnose diseases and conditions in individuals who are 21 years of age or younger (that is, up to but not including the 22nd birthday) at the time of diagnosis or treatment (21 CFR 814.3(s)).

The purpose of the funding opportunity is to expand and advance FDA's Office of Minority Health and Health Equity (OMHHE) work with stakeholders and partners for education, outreach, and public awareness activities on the use of and potential risks from skin lightening products (e.g., hydroquinone).Applicants will propose innovative and community-based strategies and activities that have the potential to strengthen the science base for education and public health awareness on the use of and potential risks from skin lightening products.

The purpose of this NOFO is to encourage new approaches to support therapeutic development in ultra-rare pediatric and adult cancers, including molecularly-defined subsets of more common cancers.

The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies and/or biomarker studies that fill unmet needs for rare neurodegenerative diseases for children and adults. Through the support of prospective natural history and/or biomarker studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology, and facilitate rare disease product development.