Notice NOT-CA-18-058 from the NIH Guide for Grants and Contracts

Notice NOT-AA-18-008 from the NIH Guide for Grants and Contracts

Notice NOT-NS-18-042 from the NIH Guide for Grants and Contracts

Notice NOT-DE-18-015 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-RM-18-010 from the NIH Guide for Grants and Contracts. The NIH Directors Early Independence Award supports exceptional investigators who wish to pursue independent research essentially directly after completion of their terminal doctoral/research degree or end of post-graduate clinical training, thereby forgoing the traditional post-doctoral training period and accelerating their entry into an independent research career. Applications are welcome from individuals of diverse backgrounds and perspectives and in any topic of relevance to the broad mission of NIH. The NIH Directors Early Independence Award is a component of the High-Risk, High-Reward Research program of the NIH Common Fund.

Notice NOT-MH-18-030 from the NIH Guide for Grants and Contracts

Notice NOT-MH-18-029 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-FD-18-021 from the NIH Guide for Grants and Contracts. Food and Drug Administration/ Center for Devices and Radiological (CDRH) is announcing its intention to accept and consider a single source application for the award of a cooperative agreement in fiscal year 2018 to Conference of Radiation Control Program Directors, Inc. (CRCPD) in support of coordination of Federal and State actions to assure radiation protection of the American public. The primary purpose of this cooperative agreement is to assist CRCPD members (State radiation control programs) in their efforts to protect the public, radiation workers and patients from unnecessary radiation exposure. Its goals will include: 1.Producing radiation protection solutions that meet community needs. 2.Assisting States with improving tools for radiation control. 3.Coordinate Federal, State and Tribal activities to achieve effective solutions to present and future radiation control problems. 4.Be expected to obtain the States cooperation and participation on committees and working groups established to deal with individual problems. 5.Plan and facilitate an annual meeting, and develop and offer educational activities to demonstrate mutually beneficial techniques, procedures, and systems relevant to the mission of assuring radiation protection. 6.Establish committees to address, evaluate, and offer solutions for a wide range of radiation health and protection issues. 7. Providing training in radiation control for CRCPD members.

Funding Opportunity RFA-FD-18-011 from the NIH Guide for Grants and Contracts. As part of FDA's Advancing Regulatory Science Initiative, the Office of the Chief Scientist supports innovation aimed at development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. This funding opportunity will provide support, depending on availability of FDA funding, for one or more of the following existing Centers of Excellence in Regulatory Science and Innovation (CERSIs): Yale University-Mayo Clinic, University of Maryland at College Park and Baltimore and Johns Hopkins University. The CERSI(s) will serve to advance the Agency's regulatory science goals predominantly through cutting-edge collaborative research with FDA; they may also provide training in regulatory science.

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