Group items tagged

The intended outcome of this program is to advance efforts to improve and develop state drug residue prevention programs. It is necessary to provide assistance to state drug residue programs that need a stronger foundation to promote the prevention of illegal drug residues in animal derived foods through educational outreach and training. This program is intended to ensure drug residue prevention programs are developed to protect consumer exposure to drug residues in the edible products of food animals and support activities related to drug residue prevention. In addition, these awards will assist state agencies to better direct their programs to reduce the outcomes of illegal drug residues in animal derived foods. This cooperative agreement program (CAP) will focus on outreach, education and training. In addition, grantees will focus on performing targeted on-site assessments related to drug residue violations and best practice visits to industry and individuals to communicate proper drug use and promote effective management practices for drug residue prevention.

This Funding Opportunity Announcement (FOA) encourages applicants to develop innovative research applications on prescription drug abuse, including research to examine the factors contributing to prescription drug abuse; to characterize the adverse medical, mental health and social consequences associated with prescription drug abuse; and to develop effective prevention and service delivery approaches and behavioral and pharmacological treatments. Applications to address these issues are encouraged across a broad range of methodological approaches including basic science, clinical, epidemiological, and health services research to define the extent of the problem of prescription drug abuse, to characterize this problem in terms of classes of drugs abused and combinations of drug types, etiology of abuse, and populations most affected (including analyses by age group, race/ethnicity, gender, and psychiatric symptomatology). Studies on individual- and patient-level factors, prescriber factors, and/or health system factors are encouraged, as are studies on all classes of prescription drugs with high abuse liability, including analgesics, stimulants, sedative/hypnotics and anxiolytics. Researchers are further encouraged to study the relationship between the prescription medication, the indication for which the medication was prescribed (e.g., pain, sleep disorder, anxiety disorder, obesity), and the environmental and individual factors contributing to abuse.

Background Generic drug products demonstrate BE to the (brand name) reference listed drug (RLD) and/or reference standard (RS) product by showing that they can deliver the same amount of the same drug to the site(s) of therapeutic action at the same rate and to the same extent as the RLD/RS drug product. For many systemically-acting drug products, BE is evaluated based upon plasma PK studies, which U.S. regulations consider to provide the most accurate, sensitive and reproducible evidence for establishing BE. This PK-based evaluation of BE also has the potential to be relatively efficient, and is well suited to generic drug development. Evaluating the PK of a locally-administered drug in a solid tissue like the skin can be scientifically and technically challenging. An in vitro cutaneous PK-based approach has been developed to support the evaluation of BE using an in vitro permeation test (IVPT) with excised human skin mounted in diffusion cells. In vivo cutaneous PK-based approaches have also been explored over the last several decades, including some using microdialysis/microperfusion probes inserted in the skin, or using non-invasive spectroscopic/imaging technologies. However, there is currently no in vivo cutaneous PK-based method that has been established to evaluate topical BE, and further research is needed.

The goal of this FOA is to enhance the diversity of the drug abuse research workforce by providing dissertation awards on topics related to the study of basic and clinical neuroscience, development, epidemiology, prevention, treatment, services, or women and sex/gender differences as they relate to drug abuse. This support will enhance the pool of highly talented drug abuse scientists who conduct research within the funding priority areas (http://www.drugabuse.gov/funding/funding-priorities) or in the NIDA strategic plan (https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan). Applications are encouraged from doctoral candidates in a variety of academic disciplines and programs. This program will ultimately facilitate the entry of promising new investigators into the field of drug abuse research and promote transdisciplinary collaborations. This award is for up to two years of support for the completion of the doctoral dissertation research project.

The goal of this FOA is to enhance the diversity of the drug abuse research workforce by providing dissertation awards on topics related to the study of basic and clinical neuroscience, development, epidemiology, prevention, treatment, services, or women and sex/gender differences as they relate to drug abuse. This support will enhance the pool of highly talented drug abuse scientists who conduct research within the funding priority areas (http://www.drugabuse.gov/funding/funding-priorities) or in the NIDA strategic plan (https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan). Applications are encouraged from doctoral candidates in a variety of academic disciplines and programs. This program will ultimately facilitate the entry of promising new investigators into the field of drug abuse research and promote transdisciplinary collaborations. This award is for up to two years of support for the completion of the doctoral dissertation research project.

Since 1998, ADDF has provided more than $29 million in funding for early stage clinical drug trials for Alzheimer's disease and related dementias. To help propel novel drugs into the clinic, ADDF also has provided over $6.5 million in support of final preclinical studies required by regulatory agencies for the initiation of clinical research studies. The goal of the foundation's PACT program is to increase the number of innovative treatments tested in humans for Alzheimer's disease and related dementias. To that end, the program will fund clinical trials through Phase 2a of novel drug candidates, including small molecules and biologics (antibodies, oligonucleotides, peptides, gene therapies, cell therapies); proof-of-concept biomarker-based trials in patients for repurposed/repositioned drugs; and regulatory studies for investigational new drug (IND)/clinical trial application preclinical packages that are required before testing novel drugs in human subjects. Proposed molecular targets will be evaluated based on the strength of available evidence linking the target to the disease and demonstrating that modulating its biological activity will improve symptoms or modify disease progression. Current target areas of interest include but are not limited to neuroprotection, inflammation, vascular function, mitochondria and metabolic function, proteostasis, ApoE, epigenetics, and synaptic activity and neurotransmitters.

To that end, grants of up to $5 million will be awarded in support of research on innovative pharmacologic interventions for Alzheimer's disease and related dementias, including clinical trials, regulatory studies for novel drugs (small molecules and biologics, including antibodies, peptides, gene therapies), repurposed drugs (existing drugs that are approved for other diseases and conditions), repositioned drugs (existing drugs that have entered clinical trials for other indications and have not yet been approved), and natural products.

The Office of National Drug Control Policy (ONDCP), Executive Office of the President, is seeking applications from public nonprofit institutions/organizations (includes institutions of higher education and hospitals) to perform research and analysis of data to inform drug policy. This project seeks to further refine a methodology for obtaining drug early warning indicators from expanded testing of urine samples that were previously collected and tested as part of an existing drug test protocol. This method was initially developed using local criminal justice populations - including persons in pre-trial or lock-up, parolees or probationers, and drug court participants. In addition, this method was also tested in two trauma units, with promising results. This project will use similar methodology in criminal justice, health care, and other venues, to include opioid treatment admissions, trauma units or emergency departments, and criminal justice programs such as parole or probation, where biological samples are often collected from clients.

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications proposing the innovative analysis of existing social science, behavioral, administrative, and neuroimaging data to study the etiology and epidemiology of drug using behaviors (defined as alcohol, tobacco, prescription and other drug) and related disorders, prevention of drug use and HIV, and health service utilization. This FOA encourages the analyses of public use and other extant community-based or clinical datasets to their full potential in order to increase our knowledge of etiology, trajectories of drug using behaviors and their consequences including morbidity and mortality, risk and resilience in the development of psychopathology, strategies to guide the development, testing, implementation, and delivery of high quality, effective and efficient services for the prevention and treatment of drug abuse and HIV.

To that end, grants of up to $5 million will be awarded in support of research on innovative pharmacologic interventions for Alzheimer's disease and related dementias, including clinical trials, regulatory studies for novel drugs (small molecules and biologics, including antibodies, peptides, gene therapies), repurposed drugs (existing drugs that are approved for other diseases and conditions), repositioned drugs (existing drugs that have entered clinical trials for other indications and have not yet been approved), and natural products.

The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to identify and quantify drugs and their metabolites in biological fluids and tissues such as plasma/serum, urine, sweat, saliva, hair and brain and other tissues. These drugs may include cannabinoids, opiates, amphetamines, l alpha acetyl methadol (LAAM), naltrexone, methadone, cocaine, phencyclidine, anabolic steroids, opioid peptides and peptidomimetics, benzodiazepines, and other drugs and their metabolites. The concentrations of such drugs and metabolites usually appear in biological materials at ng/g or ng/ml levels and therefore require the use of state-of-the-art chromatography methods for separation and highly sensitive instrumentations for identification and quantification, such as gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), and liquid chromatography-tandem mass spectrometry (LC-MS-MS).

The Office of National Drug Control Policy (ONDCP), Executive Office of the President, is seeking applications from public nonprofit institutions/organizations (includes institutions of higher education and hospitals) to perform research and analysis of data to inform drug policy. This project seeks to further refine a methodology for obtaining drug early warning indicators from expanded testing of urine samples that were previously collected and tested as part of an existing drug test protocol. This method was initially developed using local criminal justice populations - including persons in pre-trial or lock-up, parolees or probationers, and drug court participants. 

The purpose of this project to develop physiologically based absorption and pharmacokinetic (PK) models for complex drug products, such as locally acting drug products and non-biological complex parenteral drug products. Research should target the general purpose of impacting generic drug product guidance preparation, development of generic formulations by industry, and generic drug product evaluation for the areas described in Section I, Funding Opportunity Description.

The purpose of this study is to: 1) collect information on practice patterns in special populations to assess possible barriers to generic substitution ; 2) compare clinical practice (e.g., drug product manipulation prior to administration, co-administration with another food or drug) with labeled drug administration information in the assessed populations to identify factors that raise issues for safety and effectiveness with generic substitution; and 3) analyze the impact of product-level, patient-level, and provider-level factors on generic drug substitution. The outcome of this study will help identify research needs, support FDA's regulatory science efforts to monitor and ensure successful generic substitution, and provide evidence to assure the public on generic drug safety and effectiveness.

Despite significant scientific advancements made in substance use disorder research over the last century, the causes and consequences of drug use in later life remain poorly understood. The intent of this funding opportunity announcement is to support innovative research that examines aspects of marijuana and prescription opioid and benzodiazepine use in adults aged 50 and older. This FOA encourages research that examines the determinants of these types of drug use and/or characterizes the resulting neurobiological alterations, associated behaviors, and public health consequences. This initiative will focus on two distinct populations of older adults: individuals with earlier onset of drug use who are now entering this stage of adult development or individuals who initiate drug use after the age of 50. Applications are encouraged to utilize broad methodologies ranging from basic science, clinical, and epidemiological approaches. The insights gleaned from this initiative are critical to our understanding of the determinants of drug use in later life, as well as its consequences in the aging brain and on behavior. This knowledge may have the potential to identify risk factors and to guide clinical practices in older populations.

Despite significant scientific advancements made in substance use disorder research over the last century, the causes and consequences of drug use in later life remain poorly understood. The intent of this funding opportunity announcement is to support innovative research that examines aspects of marijuana and prescription opioid and benzodiazepine use in adults aged 50 and older. This FOA encourages research that examines the determinants of these types of drug use and/or characterizes the resulting neurobiological alterations, associated behaviors, and public health consequences. This initiative will focus on two distinct populations of older adults: individuals with earlier onset of drug use who are now entering this stage of adult development or individuals who initiate drug use after the age of 50. Applications are encouraged to utilize broad methodologies ranging from basic science, clinical, and epidemiological approaches. The insights gleaned from this initiative are critical to our understanding of the determinants of drug use in later life, as well as its consequences in the aging brain and on behavior. This knowledge may have the potential to identify risk factors and to guide clinical practices in older populations.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs or drug candidates for the treatment of psychiatric disorders in areas of unmet medical need. The FOA will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase Ib studies of novel Agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drug's impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The FOA also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private funding for further clinical development as FDA-approved treatments.

There is a lack of compendial or biorelevant in vitro drug release assays for long-acting periodontal dosage forms. These products include biodegradable microspheres, in situ forming implants and matrix tablets. The purpose of this study is to develop a bio-relevant dissolution method for a long-acting periodontal dosage form and to identify the drug product's key physicochemical attributes that affect the drug dissolution behavior and bioavailability. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic long-acting periodontal drug products.    

As a key activity, INL promotes the development of substance use disorder studies programs at universities around the world to further develop a trained professional workforce for prevention, treatment and recovery programs. In addition, INL encourages applied research to assess the effectiveness of drug demand reduction efforts, advocates government and community support for evidence based drug demand reduction programs, and fosters the development of a worldwide network including professionals and academic experts focused on drug use. The purpose of this project is to promote the creation and networking of substance use disorder studies researchers and programs in universities in Latin America and the Caribbean, Asia and the Pacific, Africa and Eastern Europe. The recipient will also support existing drug use studies programs with technical assistance and mentoring of program directors. In addition, the recipients will advocate for government use of evidence based substance use disorder prevention programs and treatment as well as work towards applied research to advance the substance use disorder field for prevention, treatment and recovery.

This Funding Opportunity Announcement (FOA) for R34 applications seeks to support: (a) pilot and/or feasibility testing of innovative new, revised, or adapted prevention intervention approaches to prevent or delay the initiation and onset of drug and alcohol use, the progression to misuse or problem use or alcohol and other substance use disorder, reduce drinking and driving and deaths related to impaired driving, and the drug- or alcohol-related acquisition or transmission of HIV infection and viral hepatitis among diverse populations and settings; and, (b) pre-trial feasibility and acceptability testing for prevention services and systems research. It is expected that research conducted via this R34 mechanism will consist of studies that are a pre-requisite for preparing and submitting subsequent applications for larger scale drug or alcohol abuse prevention and/or drug- or alcohol-related HIV prevention intervention studies. This R34 FOA does not support applications for which the sole focus is development of intervention protocols, manuals, or the standardization of protocols. Any intervention development work must be imbedded within a pilot/feasibility study. Of particular interest is prevention research that addresses current public health priorities and priority settings and systems.

This Funding Opportunity Announcement (FOA) for R34 applications seeks to support: (a) pilot and/or feasibility testing of innovative new, revised, or adapted prevention intervention approaches to prevent or delay the initiation and onset of drug and alcohol use, the progression to misuse or problem use or alcohol and other substance use disorder, reduce drinking and driving and deaths related to impaired driving, prevent suicide attempts (nonfatal and fatal), and the drug- or alcohol-related acquisition or transmission of HIV infection and viral hepatitis among diverse populations and settings; and, (b) pre-trial feasibility and acceptability testing for prevention services and systems research. It is expected that research conducted via this mechanism will consist of studies that are a pre-requisite for preparing and submitting subsequent applications for larger scale drug or alcohol abuse prevention and/or drug- or alcohol-related HIV prevention intervention studies. This FOA does not support applications for which the sole focus is development of intervention protocols, manuals, or the standardization of protocols. Any intervention development work must be imbedded within a pilot/feasibility study. Of particular interest is prevention research that addresses current public health priorities and priority settings and systems.