Grants for Public Housing Authorities

Reissue of PA-18-350. The NIMH Exploratory/Developmental Grant program supports exploratory and high-risk research projects that fall within the NIMH mission by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough or to the development of novel techniques, agents, methods, measures, models, or strategies, or to the generation of pilot or feasibility data. The preliminary work from these studies could lead to a major impact on biomedical, behavioral, or clinical mental health research, or on the delivery of mental health care.

This Funding Opportunity Announcement (FOA) encourages formative research, intervention development, and pilot-testing of interventions. Primary scientific areas of focus include the feasibility, tolerability, acceptability and safety of novel or adapted interventions that target HIV prevention, treatment or services research for people who use drugs. For the purposes of this FOA, "intervention" may include behavioral, social, or structural approaches, as well as combination biomedical and behavioral approaches that prevent the acquisition and transmission of HIV infection, or improve clinical outcomes for persons living with HIV.

Rapid advances in genotyping and next generation sequencing technologies have led to the identification of genetic variants that are associated with a wide variety of congenital defects including structural birth defects (SBDs), intellectual developmental disabilities (IDDs) and inborn errors of metabolism (IEMs). Large quantities of genomic data collected from pediatric birth defects cohorts are available to the research community through several databases such as the Database of Genotypes and Phenotypes (dbGaP), the Gabriella Miller Kids First Data Resource Portal, the European Genome-Phenome Archive and Clinical Genome Resource (ClinGen). The purpose of this initiative is to promote the screening, functional validation and characterization of birth defects-associated genetic variants identified through public facing databases and individual efforts using in-silico tools, appropriate animal models, in vitro systems or multi-pronged approaches. This initiative addresses a challenging gap between identifying sequence variations of potential interest and recognizing which of those variations have functional effects on the phenotype of interest.

(Reissue of PAR-18-490) The purpose of the NINDS Faculty Development Award to Promote Diversity in Neuroscience Research (K01) is to diversify the pool of independent neuroscience research investigators by providing junior faculty with research cost support, protected research time and career stage appropriate professional development mentorship in neuroscience research. Individuals from backgrounds underrepresented in biomedical research are eligible for support under this award if they have doctoral research degrees (Ph.D. or equivalent) and are in the first 3 years of a faculty tenure track or equivalent position at the time of application. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

The NICHD Small Research Grant Program (Clinical Trial Required) supports clinical trials that fall within the NICHD mission. This funding opportunity announcement is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the appropriate Clinical Trials Required FOA.

The NICHD Small Research Grant Program (R03 Clinical Trial Required) supports clinical trials that fall within the NICHD mission. The R03 activity code supports small research projects that can be carried out in a short period of time with limited resources. The R03 program may be used for different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology.

(Reissue of PAR-18-486) The purpose of the NINDS Faculty Development Award to Promote Diversity in Neuroscience Research (K01) is to diversify the pool of independent neuroscience research investigators by providing junior faculty with research cost support, protected research time and career stage appropriate professional development mentorship in neuroscience research. Individuals from backgrounds underrepresented in biomedical research are eligible for support under this award if they have doctoral research degrees (Ph.D. or equivalent) and are in the first 3 years of a faculty tenure track or equivalent position at the time of application. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. NINDS will only accept applications to this FOA that propose human mechanistic trials/studies that meet NIH's definition of a clinical trial and that fall within the NINDS research priorities. Applicants are strongly advised to consult with NINDS program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.

This funding opportunity announcement (FOA) is issued by the National Institute of Neurological Disorders and Stroke to enable submission of program project grant applications that propose to conduct innovative, interactive research to answer significant scientific questions that are important for the mission of NINDS, via a synergistic collaboration between outstanding scientists who might not otherwise collaborate. The program project grant is designed to support research in which the funding of several interdependent highly meritorious projects as a group offers significant scientific advantages over support of these same projects as individual research grants.

This Funding Opportunity Announcement (FOA) invites applications specific to sample acquisition, genome wide association studies, whole genome sequencing, quality control checking, variant calling, data calling, data sharing, data harmonization, and analysis that will support the generation of data from multi-ethnic cohorts for the Alzheimer's Disease Sequencing Project Follow-Up Study 2.0: The Diverse Population Initiative.Funding Opportunity Description Background This Funding Opportunity Announcement (FOA) is issued in response to National Alzheimer's Project Act (NAPA) milestones for the genetics of Alzheimer's disease (AD) and AD-related dementias (ADRD) in order to support the ongoing Alzheimer's Disease Sequencing Project (ADSP). The overarching goals of the ADSP are to: 1) identify new genes involved in AD/ADRD; 2) identify gene alleles contributing to increased risk for, or protection against, the disease; 3) provide insight as to why individuals with known risk factor genes escape from developing AD/ADRD; 4) identify potential avenues for therapeutic approaches and prevention of the disease; and 5) fully reveal the genetic architecture of AD/ADRD in multiple race and ethnicity categories. The samples for the ADSP were selected from well-characterized, diverse study cohorts of individuals both with and without an AD diagnosis as well as with and without known risk-factor genes. This study of human genetic variation and its relationship to health and disease involves a large number of study participants and aims to capture not only common single nucleotide variations, but also rare copy number and other structural variants that are increasingly thought to play an important role in complex diseases. This FOA uses the Office of Management and Budget (OMB) official categories of race and ethnicity. For the purposes of this FOA, ethnic categories (i.e., Hispanic/Latino) and racial categories (i.e., American Indian/Alaska Native; Asian; and Black/African American) will be referred to as diverse populations . Cohorts of participants from individual ethnic or race categories will be referred to as diversity cohorts . Individuals in diversity cohorts will be referred to as diversity participants . The ADSP has identified a large number of variations in the genomes of individuals affected with AD. The study population for these analyses was predominantly White. Lack of diversity in the sample set limits the possible clinical utility of emerging tools and methodological approaches for identifying potential therapeutics for a large proportion of the population. This, in turn, underscores the urgency to ensure appropriate representation of diverse populations to prevent potential gaps in the translation of research efforts to these populations. To this end, the initial ADSP findings will be pursued in diverse populations in the next phase of the study, called the ADSP Follow-Up Study (FUS) 2.0: The Diverse Population Initiative and referred to here as ADSP FUS 2.0. The long-term goals of the ADSP FUS 2.0 are to: 1) move the field closer to enabling prediction of who will develop AD; 2) fully characterize AD subtypes by studying endophenotypes in diverse populations; 3) better understand the differences in the genetic underpinnings of AD pathogenesis among diverse populations; and 4) identify specific therapeutic targets based upon diverse population. Important instances of unique AD/ADRD genetic variation have already been identified in epidemiological cohorts with Hispanic/Latino and Black/African American participants. Variants for AD are rare and can only be identified with a larger number of study participants. Variants occur at different frequencies in different populations, and certain risk variants may be much easier to detect in some populations. US diversity groups are not represented in ADSP data in sufficient numbers to enable meaningful study, so the genetics of these populations remain largely unstudied. Hispanics/Latinos, Blacks/African Americans, and Asians are the largest and fastest-growing minority groups in the US, and AD/ADRD imposes a high economic and social burden upon the US population. US Asian population ADSP genetic data are completely absent. Numbers of Hispanic/Latino and Black/African American participants in the US remain insufficient to provide statistical significance for identification of rare or very rare variants. Variants in the Alzheimer’s genome are largely rare or very rare in the population. It is estimated that for 80% certainty for single variant testing for rare variants, ~16,100 cases and ~16,100 controls are needed for a variant with a minor allele frequency of 0.5% in the population; single variant testing for rare variants indicate that for 90% certainty, ~18,500 cases and ~18,500 controls are needed for each population for a variant with a minor allele frequency of 1% in the population. To ensure that there are sufficient numbers of study participants to achieve statistical power for analysis of rare or vary rare variants in the three largest diversity cohorts AD/ADRD genome given the available funding, the primary focus of the ADSP FUS 2.0 will be on Hispanic/Latino, Black/African American, and Asian populations. Consortia should take advantage of cohorts already recruited or in planning for recruitment to obtain sufficient numbers; sharing diversity data across consortia is essential to the success of this effort. Investigators with cohorts representing other racial/ethnic categories, such as American Indians/Alaskan Natives, are encouraged to apply for funding separately under other NIA-supported FOAs. Sequencing of participants from founder populations such as those from Africa and Asia is allowed under this FOA in order to understand population substructure and ancestry-informative markers. A small amount of sequencing of Whites to bring significance to the 90% certainty of significance level will be allowed for rare or very rare variants for the US population; however, it is expected that the vast majority of sequencing in the ADSP FUS 2.0 will be done in Hispanics/Latinos, Blacks/African Americans, and Asians. Accelerated identification of AD/ADRD genes, gene clusters, and endophenotypes driven by genetic and ethnic/racial characteristics will move the field toward selection of participants with similar endophenotypes to improve outcomes of clinical trials. The community is now able to layer different types of data to identify these endophenotypes. Analytic approaches are being developed for analysis of structural and rare variants, endophenotypes, and cross-phenotype genetic analyses to modify and/or apply analytic methods to data that are increasingly complex. In order to identify optimal drug targets, the full landscape of genetic variants must be identified and characterized. Much work remains to develop analytic methods and resources to understand the functional significance of variants, particularly noncoding variants, in diverse populations. Under this funding opportunity announcement, studies that perform analysis of sequence data may include analysis of the functional genomic studies of regions of interest. Diversity datasets will need to be integrated and harmonized to fully annotate the AD genome. This may mean assembling annotation data such as that provided by ENCODE and similar approaches to help understand whether clusters of genes in the same network or with common function may be a component of the disease etiology that varies by ethnic and racial category. Applicants are encouraged to devise analysis plans to include data from genome wide association studies (GWAS) for AD; imputation analysis; ADSP whole exome and exome chip data, and whole genome AD sequencing efforts; related genetic data such as in deep (long read) sequencing analyses generated on AD subjects; and functional genomics data. Research Objectives NIA intends to support studies most likely to meet a major goal of this FOA: to identify and confirm a full set of rare variants contributing to AD/ADRD endophenotypes in diversity cohorts to enhance the probability of identifying potential therapeutic approaches for risk and prevention. Both sequencing and data analysis will be supported under this FOA. Applicants to this FOA for the ADSP FUS 2.0 should propose to: 1) sequence particular diverse study cohorts; 2) analyze either the entire dataset (cases and controls) or components of the dataset; or 3) both sequence and analyze these data. Justification for the choice of the approach must be provided. Applicants proposing to analyze only a component of the total cohort (i.e., selected cohorts or diverse subpopulations) should propose power calculations that support the likelihood of gene discovery. Applicants should design plans that clearly define which ADSP FUS 2.0 datasets, diverse subpopulations, and/or endophenotypes will be analyzed. Along with analysis of data funded under the present FOA, analysis plans for the ADSP FUS 2.0 should include data from diversity cohorts in the ADSP FUS funded under PAR-17-214, PAR-18-890, and PAR-19-234 where possible. The design and use of large-scale storage capacity with appropriate security and backup measures to support analytical capabilities should be considered. Successful applications are anticipated to involve research conducted by multidisciplinary teams of investigators and should describe a comprehensive plan to develop leading-edge, innovative approaches for the analysis of whole genome sequence (WGS) and related genetic data. Analysis should encompass the criteria set out by the ADSP FUS funded under PAR-17-214, "Analysis of Data from NIA's Alzheimer's Disease Sequencing Project Follow-Up Study (U01)." In particular, these criteria include ethnic/racial diversity; autopsy-confirmed cases/controls, especially for non-European ancestry; availability of longitudinal data; no age limit for cases; cases unrelated to each other; and availability of comparable controls. It is expected that the scientific environment in which the work will be done will contribute to the probability of success of the project and of the ADSP as a whole. Institutional support, equipment and other physical resources available to the investigators should be adequate for the project proposed, leveraging existing NIA-funded resources. Both the project itself and the ADSP should benefit from unique features of the scientific environment, subject populations, or collaborative arrangements. For applicants performing data analysis, it is expected that they will have the capacity to analyze whole-genome sequence data from sufficient numbers of affected and unaffected individuals to achieve statistical significance for rare or very rare variants in diverse groups. The successful milestone-driven ADSP FUS 2.0 application would consist of a group of researchers with expertise in the genetics of complex neurological diseases, including AD, and the field of whole genome sequencing, as well as statisticians and other experts who will participate in study design and analysis. Successful applicant(s) may be expected to collaborate not only within their own study, but also with other PD(s)/PI(s) funded under this and related FOAs. Engagement of existing NIA-supported infrastructure is considered essential to the success of the project, so applicants should plan to financially support the National Central Cell Repository for Alzheimer’s Disease (NCRAD); The American Genome Center (TAGC) at the Uniformed Services University for the Health Sciences (USUHS) or another NIA-approved, large-scale sequencing center; the Genome Center for Alzheimer's Disease (GCAD); and the NIA Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS) for their efforts in the ADSP. Applicants should develop key quantitative milestones with a timeline for accomplishment. Quality control (QC) and data harmonization will be performed by GCAD. The order and process for data transfer, quality control checking, and data harmonization will be agreed upon by the ADSP as a whole and will follow closely the existing paradigm. Under the present FOA, the ADSP will improve the likelihood of analyzing sequence data on enough different examples of events that change the genetic architecture of AD such that these data, when analyzed with existing ADSP datasets, will enhance the ability to better understand the genetic underpinnings of AD and to obtain a better understanding of rare risk and protective variants. The availability of high-quality, extensive phenotypic information on study participants is a critical consideration. Study design should include analysis of data from study participants with quantitative trait measures to more clearly define endophenotypes. Similarly, participants whose data will be used as controls should be well characterized. Applications considered for funding must effectively leverage NIA and NIH investments in infrastructure to support studies related to the genetics of Alzheimer’s disease. The investigators funded under this FOA may utilize information from existing NIA- and NIH-funded research resources or other federal websites such as: The NIA Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS) The Genome Center for Alzheimer's Disease (GCAD) The National Central Cell Repository for Alzheimer’s Disease (NCRAD) The National Alzheimer's Coordinating Center (NACC) The Alzheimer's Disease Genetics Consortium (ADGC) The Alzheimer's Disease Research Centers (ADRCs) Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) The Collaborative for Alzheimer’s Disease Research (CADRE) The Alzheimer's Disease Neuroimaging Initiative (ADNI) Alzheimer's Disease Related Dementias (ADRD) The National Alzheimer’s Project Act (NAPA) Other websites designed to store and distribute data related to AD

This R21 funding opportunity encourages projects that test, in animals and/or humans, whether modifying electrophysiological patterns can improve cognitive, affective, or social processing. This R21 has a companion R01 (TEMP-10327). The proximal goal of this FOA (and its companion R01) is to encourage investigators to test whether modifying specific patterns of coordinated neural activity in vivo can improve cognitive, social, or affective processes. These studies should be based on a rational understanding of the role of specific neural activity rhythms in, for example, the routing of information among brain regions or in improving the ability of afferent information to affect local processing via coherence of underlying oscillatory activity.

This R01 funding opportunity encourages projects that test, in animals and/or humans, whether modifying electrophysiological patterns can improve cognitive, affective, or social processing. This R01 FOA is expected to have a companion R21 version. The proximal goal of this FOA (and its companion R21 version) is to encourage investigators to test whether modifying specific patterns of coordinated neural activity in vivo can improve cognitive, social, or affective processes. These studies should be based on a rational understanding of the role of specific neural activity rhythms in, for example, the routing of information among brain regions or in improving the ability of afferent information to affect local processing via coherence of underlying oscillatory activity.

This funding opportunity announcement (FOA) encourages innovative research to develop, characterize, and improve animal models, biological materials, and novel technologies to better understand human health and disease. This FOA also seeks projects aimed at improving the diagnosis and control of diseases that interfere with animal use for biomedical research. The proposed project must have broad application to multiple NIH Institutes or Centers (ICs) to align with the Office of Research Infrastructure Programs (ORIP) trans-NIH mission. The proposed studies must explore multiple body systems or evaluate diseases that impact multiple body systems. Applications that develop models focused on a specific disease or area of research, or only propose studies primarily relevant to a single NIH IC will be considered not acceptable to this FOA.

The "Innovation Grants to Nurture Initial Translational Efforts (IGNITE)" program supports the development of in vitro and ex vivo assays to identify and characterize new therapeutic agents for neurological and neuromuscular disorders, with a focus on creating robust screening methods for promising neurotherapeutics.

This Funding Opportunity Announcement (FOA) seeks innovative grant applications in nonmalignant hematology research that will steer the field in new directions. Applications to this FOA should propose proof of principle research that is tightly focused into one specific aim, which can be accomplished within a 1-3 year project period, and is directed at validating novel concepts and approaches that promise to open new pathways for discovery.The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute on Aging (NIA) have joined together to build research activities in nonmalignant hematology. This Funding Opportunity Announcement (FOA) is intended to promote innovative research projects in nonmalignant hematology that explore high impact and new directions of inquiry. While each Institute shares interests in nonmalignant hematology research, they also bring different perspectives, thereby expanding the scope of the SHINE II program beyond a single Institute's research mission. This "New Directions in Hematology Research (SHINE-II)" program invites investigator-initiated grant applications for basic or early translational, proof of principle research projects that are tightly focused and directed at validating novel concepts and approaches that promise to advance new pathways for discovery. This program may include clinical research involving human subjects that is directed at understanding disease pathogenesis and prognosis. Research applications submitted under this FOA should be more limited in scope (single aim with sub-aims, as appropriate) and duration (1-3 years) than typical R01 grant applications. The SHINE-II FOA seeks specifically to promote and support new directions of research in their early stages. Applications submitted to this FOA should include preliminary data that support the conceptual basis of the research proposed and the technical approaches to be used. Moreover, while research applications submitted under this FOA are expected to be more limited in scope and shorter in duration than typical R01 applications, achievement of the research objective(s) proposed should validate novel pathways of discovery and provide the basis for future high impact research endeavors. Principal areas of interest for this collaborative FOA include: (1) hematopoietic stem cell biology, (2) lineage fate determinants, (3) aging-related immune dysfunction and lymphocyte biology, (4) myeloid cell biology, and myelopoiesis, (5) platelet biology and dysfunction, (6) erythroid cell biology and erythropoiesis, (7) the molecular biology of heme and hemoglobin, (8) acquired and congenital disorders of red blood cell production and survival leading to chronic anemia or bone marrow failure, (9) and the uptake, utilization, storage, and transport of iron in health and disease. Inquiries to Scientific/Research staff prior to submission of an application to this FOA are strongly encouraged to discuss programmatic relevance and potential time tables for funding (see below, Section VII. Agency Contacts). The limited scope and shorter duration of the SHINE II R01 are not optimal for Early Stage Investigators (ESIs) and New Investigators (NIs), who should contact Scientific/Research staff prior to submission of an application to this FOA.

This funding opportunity supports U.S.-based organizations in hosting conferences and workshops that promote research and dialogue on improving workplace safety and health across various industries.

This FOA invites applications that propose research projects that test promising digital healthcare interventions aimed at improving quality of care and healthcare services delivery at the point of care. This FOA will use the Phased Innovation Award (R21/R33) mechanism to provide up to 2 years of R21 support for initial developmental activities, and up to 3 years of R33 support for expanded activities.The Agency for Healthcare Research and Quality's (AHRQ) mission is to produce evidence to make health care safer, of higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. This FOA invites applications that propose research projects that test promising digital healthcare interventions aimed at improving quality of care and healthcare services delivery at the point of care. This FOA will use the Phased Innovation Award (R21/R33) mechanism to provide up to 2 years of R21 support for initial developmental activities, and up to 3 years of R33 support for expanded activities. Transition to the R33 phase is not guaranteed for all grants awarded under this FOA. Continuation from the R21 phase to the R33 phase will be determined by AHRQ staff based on progress achieved in the R21 phase and factors such as program priorities and availability of funds.

The objective of the NIA Academic Leadership Career Award (K07) is to provide support for senior investigators who have the expertise and leadership skills to enhance aging and geriatric research capacity within their academic institution. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by another investigator.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage pilot and/or feasibility research in the following areas: 1) the development and pilot testing of new or adapted interventions to prevent or delay the initiation of substance use and/or the progression from use to misuse or disorder and 2) pre-trial feasibility and acceptability testing of services and service system research relevant to the prevention of substance use. In addition to the prevention of substance use, misuse and disorder, other outcomes of interest for the research supported through FOA include a reduction in negative sequalae such as deaths related to impaired driving, suicidal behavior (e.g., nonfatal and fatal attempts), and drug- or alcohol-related acquisition or transmission of HIV infection and viral hepatitis among diverse populations and settings.

The purpose of this funding opportunity announcement is to provide tailored support for early stage investigators (ESIs) to initiate basic or translational research with nonhuman primates (NHPs). These awards will allow ESIs additional funds, time to generate preliminary data, and the opportunity to establish all skills needed to set up and run an NHP laboratory independently. It is expected that these awards will thereby improve an ESIs ability to secure larger research awards (e.g., R01) and will facilitate their transition to independent tenure-track positions.

This Funding Opportunity Announcement (FOA) invites applications to develop and implement Phase Ib to III clinical trials of promising pharmacological and non-pharmacological interventions that may prevent, delay, or treat the symptoms of Alzheimer's disease (AD) and other age-related dementias using the Alzheimer's disease Clinical Trials Consortium (ACTC) trial coordination and management infrastructure.Research Objectives Utilizing the ACTC, the goal of this FOA is to invite research grant applications that provide clinical testing (Phases Ib-III) of promising pharmacological and/or non-pharmacological interventions for cognitive and neuropsychiatric symptoms in individuals with AD or other aging-related dementias across the spectrum from pre-symptomatic to more severe stages of disease. Working with the ACTC is a cooperative venture between the applicant, the NIA, and the ACTC network. NIA and the ACTC leadership will provide guidance to potential applicants. Potential applicants are strongly encouraged to contact NIA Scientific/Research Contacts (see Agency Contacts, Section VII) and the ACTC study team in order to discuss the feasibility of conducting the proposed trial through the ACTC infrastructure before considering an application. The ACTC infrastructure is welcoming of the following: Academic and industry applicants Pharmacological and non-pharmacological interventions Applications are encouraged that propose the following: Testing candidate therapeutic compounds against novel therapeutic targets Testing repurposed drugs derived from data-driven approaches, including candidates coming from NIA's translational bioinformatics FOA (PAR-17-032) Logistical guidance: Potential applicants undergo initial vetting of proposed study by the ACTC protocol evaluation committee and final review by the steering committee. Applicants should contact the ACTC study team at least 5 months prior to their desired NIA submission cycle. Contact details and more information may be found at actcinfo.org. Applications should anticipate using a centralized IRB. Applicants should be aware of the data and resource sharing requirements. The use of common contract language is strongly encouraged. Note, the ACTC infrastructure is not appropriate for: Single site clinical trials Routine Phase Ia first-in-human Clinical trials funded from this FOA will be implemented through the ACTC. The clinical trials approved for funding will develop their final protocols in conjunction with the ACTC. All ACTC sites will have the option to request participation and will be selected based on their capabilities specific to the individual protocols. Investigators are strongly encouraged to collect blood and other biosamples for future genomic and other 'omic' analyses aimed at interrogating treatment responsiveness and examining predictors of decline and progression. See Section VIII. Other Information for award authorities and regulations.