NIH Weekly Funding Opportunities and Policy Notices
Funding Opportunity RFA-FD-18-014 from the NIH Guide for Grants and Contracts. Current product-specific bioequivalence (BE) guidance published by the Office of Generic Drugs for dry powder inhalers (DPIs) include in vitro testing recommendations for single actuation content and aerodynamic particle size distribution, as well as recommendations for a pharmacokinetic study and a pharmacodynamic or clinical endpoint study. Given the extensive nature of current DPI BE guidance, it is desirable that current in vitro testing for DPIs be more reflective of in vivo performance. Computational fluid dynamics (CFD) and discrete element modeling (DEM) have been used to predict dry powder aerosol behavior, including the effects of agglomeration and deagglomeration. The purpose of the study will be to develop a CFD-DEM model which can be used to evaluate the impact of various physicochemical properties and device performance properties on regional deposition, to identify potentially biorelevant ranges for these properties that may be useful for future BE recommendations.
Funding Opportunity RFA-FD-18-012 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., spectroscopic/ imaging tomography) technologies, methods, study designs, and methods of data analysis to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that measures the amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis or dermis) by repeated measurements over time. The ultimate intent is to support the eventual development of an alternative, scientifically valid, cutaneous PK-based approach to efficiently evaluate the bioequivalence (BE) of topical products in vivo in human subjects.
Funding Opportunity PAR-18-717 from the NIH Guide for Grants and Contracts. The purpose of this FOA is to encourage applications for research training programs to strengthen the scientific capacity of institutions in low- and middle-income countries (LMICs) to conduct HIV research relevant to the evolving HIV epidemic in their country
Funding Opportunity PAR-18-716 from the NIH Guide for Grants and Contracts. The overall goal of this initiative is to support the development of a sustainable critical mass of bioethics scholars in low and middle-income country (LMIC) research intensive institutions with the capabilities to conduct original empirical or conceptual ethics research that addresses challenging issues in health research and research policy in these countries as well as provide research ethics leadership to their institutions, governments and international research organizations. FIC will support LMIC-U.S. collaborative institutional bioethics doctoral and postdoctoral research training programs that incorporate didactic, mentored research and training components to prepare a number of individuals with ethics expertise for positions of scholarship and leadership in health research institutions in the LMIC.
Funding Opportunity RFA-FD-18-020 from the NIH Guide for Grants and Contracts. FDA's CDER is seeking a computational modeling approach to study the effects of mucociliary clearance on localized drug absorption in the nasal cavity. The modeling approach would utilize computational fluid dynamics (CFD) simulations of inhalation and droplet/particle transport to provide regional nasal spray deposition data, while the three-dimensional mucociliary clearance model would demonstrate localized drug absorption and indicate the efficacy of drug products that target specific nasal regions. The model should be adaptable to cases of interindividual variability, which may include variations in mucociliary clearance rates, changes in nasal geometry, and the presence of relevant disease states (e.g., nasal inflammation, changes in mucus properties, etc.).
Funding Opportunity RFA-FD-18-019 from the NIH Guide for Grants and Contracts. The purpose of this project is to incorporate drug product quality attributes into dermal physiologically-based pharmacokinetic models developed for dermatological topical dosage forms and transdermal delivery systems. The developed models will be utilized to identify drug-product specific critical quality attributes (model qualification) and perform virtual bioequivalence assessments between brand name and generic drug products to inform regulatory decisions relating to the development of dermatological drug products.
Notice NOT-HL-18-609 from the NIH Guide for Grants and Contracts
Funding Opportunity PAR-18-715 from the NIH Guide for Grants and Contracts. This FOA invites existing Alzheimer's Disease Patient Registry cooperative agreements that are described in Part 2, Section I to submit revision and or renewal applications. Potential applicants are strongly encouraged to contact their current program officer prior to submission to discuss the application.
Notice NOT-NS-18-041 from the NIH Guide for Grants and Contracts
Funding Opportunity RFA-DA-19-004 from the NIH Guide for Grants and Contracts. The purpose of this FOA is to fund a single interdisciplinary Coordinating Center to formalize and centralize support of the rural opioid initiative administered by NIDA and co-funded by CDC, SAMHSA, and ARC. This initiative was funded under RFA-DA-17-014 and RFA-DA-17-023 The Coordinating Center will provide scientific, technical, regulatory, ethical, and logistical support of data comparability, new data collection, and data integration; developing integrated rural opioid initiative datasets; assisting grantees with acquisition and analysis of local administrative and/or research datasets that enable evaluation of their implementation activities or augment their community assessments; conducting requested analyses that relate to the integrated rural opioid initiative datasets; developing and executing a rural opioid initiative publication and dissemination plan; and providing logistical support for in-person meetings, conference calls, and webinars that include the rural opioid initiative grantees and funders. The Coordinating Center will be represented on the rural opioid initiative executive steering committee, along with the funders and rural opioid initiative grantees.
Notice NOT-AG-18-007 from the NIH Guide for Grants and Contracts
Funding Opportunity RFA-FD-18-017 from the NIH Guide for Grants and Contracts. The purpose of this project is to identify skin physiology characteristics that differ between healthy and skin disease population groups and incorporate them into dermal physiologically-based pharmacokinetic models to improve their predictability. The models developed will be utilized to perform virtual bioequivalence assessments between brand name and generic drug products to inform regulatory decisions relating to the development of generic topical dermatological drug products and transdermal delivery systems.
Notice NOT-AG-18-005 from the NIH Guide for Grants and Contracts
Notice NOT-EB-18-012 from the NIH Guide for Grants and Contracts
Funding Opportunity RFA-FD-18-010 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity is to support the research necessary to elucidate how systematic alterations to the qualitative (Q1) and/or quantitative (Q2) composition of topical formulations impacts their physical, structural, and functional properties. A key aspect of the research relates to understanding how the thermodynamic properties of a topical dosage form change as it undergoes metamorphosis during dose application and drying on the skin, how the drug's thermodynamic activity profile during the metamorphosis of the dosage form may compare between compositionally different (non-Q1 and/or non-Q2) topical formulations, and how these and other forces may modulate the rate and extent to which topically applied drugs may become available at or near their site(s) of action in the skin. Another key aspect of the research relates to identifying and understanding other potential failure modes for bioequivalence (BE) and/or therapeutic equivalence (TE) (e.g., differences in irritation potential) that may arise between compositionally different (non-Q1 and/or non-Q2) topical formulations.
Notice NOT-CA-18-057 from the NIH Guide for Grants and Contracts
Notice NOT-RM-18-016 from the NIH Guide for Grants and Contracts
Notice NOT-NR-18-005 from the NIH Guide for Grants and Contracts
Notice NOT-DK-18-011 from the NIH Guide for Grants and Contracts
Notice NOT-NR-18-006 from the NIH Guide for Grants and Contracts