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This PA is designed to solicit research projects that anticipate, analyze and address the ethical, legal, and social implications (ELSI) of the discovery and use of new information and technologies resulting from human genetic and genomic research. Of particular interest are studies that examine issues and, where appropriate, develop policy options in the following areas: 1) intellectual property issues surrounding access to and use of genetic information; 2) the ethical, legal and social factors that influence the translation of genetic information to improved human health; 3) the issues surrounding the conduct of genetic and genomic research; 4) the use of genetic and genomic information and technologies in non-health care settings; 5) the impact of genetics and genomics on concepts of race, ethnicity, kinship and individual and group identity; 6)the implications, for both individuals and society, of uncovering genetic and genomic contributions to not only disease, but also ‘normal’ human traits and behaviors; and 7) how different individuals, cultures and religious traditions view the ethical boundaries for the uses of genetics and genomics. This Program Announcement is complemented by PA-04-051, the ELSI Small Grant (R03) Program (http://grants.nih.gov/grants/guide/pa-files/PA-04-051.html). The R03 program is limited to applications requesting up to $50,000 in direct costs per year for no more than two years, makes use of a streamlined application process, and is designed to encourage the development of small, focused research projects by legal, historical, ethics and social sciences scholars. It is also designed to support smaller exploratory studies that may provide preliminary findings for larger research proposals.

The goal of this program announcement is to invite research applications investigating the role of diet composition in energy balance, including studies in both animals and humans. Both short and longer-term studies would be encouraged, ranging from basic studies investigating the impact of micro-or macronutrient composition on appetite, metabolism, and energy expenditure through clinical studies evaluating the efficacy of diets differing in micro- or macronutrient composition, absorption, dietary variety, or energy density for weight loss or weight maintenance.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS) provide Ruth L. Kirschstein National Research Service Awards (Kirschstein-NRSA) to individuals for doctoral-level training. These Institutes award Kirschstein-NRSA individual predoctoral fellowships (F31) to promising applicants with the potential to become productive, independent investigators in their scientific mission areas. Each Institute has a unique scientific purview and different program goals and initiatives that evolve over time. Therefore, it is critical that all applicants consult the appropriate Institute website and contact the appropriate Institute office, both listed under “Where to Send Inquiries,” prior to preparing an application to obtain current information about each Institute's program priorities and policies with regard to fellowships. This action is of utmost importance since applications with marginal or no relevance to NIAAA, NIBIB, NIDCD, NIDA, NIMH, or NINDS programs will not be accepted for review or funding by the participating Institutes.

The National Institute of Neurological Disorders and Stroke (NINDS) invites cooperative agreement applications from qualified institutions for support of a Parkinsons Disease Data Organizing Center (PD-DOC), designed to serve as a shared research resource to facilitate research in Parkinsons disease (PD). This resource is intended to compile clinical data, as well as to provide virtual catalogues for both basic scientific and clinical research in PD. Parkinsons disease research would benefit from analysis of combined data collected systematically from existing PD Centers (Udall Centers, NIEHS centers, NIA Alzheimers Disease Centers) and, eventually, from other sources where longitudinal data are collected. Such data on patients and unaffected, age-matched controls would support 1) clinical, molecular and pathological research on disease natural history, heterogeneity, diagnosis, and clinical-pathological correlations; and 2) epidemiological research related to the identification of risk factors, neuroprotective factors or biomarkers. As clinical components are built into the Morris K. Udall Parkinsons disease Centers of Excellence and other PD Centers, the advance funding of this data coordination initiative will function to systematize data collection and analysis across centers. In addition, existing databases should be assessed as to their relevancy and incorporation into this national resource. Data from all PD center resources can thus be combined, coordinated, and made available to researchers from PD centers as well as the wider PD research community. The primary objectives will be to: 1) Establish, maintain, and disseminate a data base of clinical, pathological and biochemical information collected at Udall Centers, Collaborative Centers for Parkinsons Disease Research (CCPDER), or other PD centers, from persons with Parkinsons disease and related disorders and from unaffected age-matched controls; 2) Assess availability and potential use of existing databases and how they could be incorporated or made compatible, as well as provide training and data quality control across all participating sites. 3) Provide assistance to investigators in planning and conducting research studies using the database; 4) Make available virtual data and a catalog of tissues and other biological samples collected from PD patients and controls for use in epidemiological, clinical, molecular and pathological studies by qualified investigators, and 5) Coordinate annual meetings of its steering committee and the annual Udall (and other) PD Centers meeting to discuss progress and collaborations. With the establishment of this data coordinating center, important and novel research issues can be addressed which would not be possible with the individual resources available at any one individual center. Research activities that use PD-DOC resources may be supported through the usual National Institutes of Health (NIH) and other federal and non-federal sources for the funding of investigator-initiated applications.

The National Institute of Dental and Craniofacial Research (NIDCR), along with the National Institute of Neurological Disorders and Stroke (NINDS), invites applications to stimulate and support innovative, interdisciplinary research studies to elucidate the molecular mechanisms underlying orofacial pain, particularly the discovery of proteins and protein networks critical to processing nociceptive information. The purpose of this RFA is to encourage the use of genomic and proteomic approaches and imaging techniques to clarify the molecular events involved in: 1) acute orofacial pain, 2) the transition from unrelieved acute pain to chronic pain (i.e. neuroplasticity), 3) neuronal hyperexcitability as manifested by hyperalgesia and allodynia, and 4) chronic orofacial pain disorders of an inflammatory and neuropathic origin. This improved understanding could lead to new therapeutic interventions to effectively treat chronic pain conditions. Collaborative projects involving interdisciplinary teams of investigators are strongly encouraged. This Request for Applications contributes to the goals of the NIH Pain Consortium, which is co- chaired by NIDCR, NINDS, and the National Institute of Nursing Research (NINR).

Participating Institutes and Centers (ICs) of the National Institutes of Health (NIH) invite applications for R01 awards to support Bioengineering Research Partnerships (BRPs) for basic, applied, and translational multi- disciplinary research that addresses important biological or medical research problems. In the context of this program, a partnership is a multi- disciplinary research team that applies an integrative, systems approach to develop knowledge and/or methods to prevent, detect, diagnose, or treat disease or to understand health and behavior. The partnership must include appropriate bioengineering or allied quantitative sciences in combination with biomedical and/or clinical components. The Principal Investigator (PI) also serves as the project manager and must be capable of leading the proposed effort. A BRP may propose design-directed, developmental, discovery-driven, or hypothesis-driven research at universities, national laboratories, medical schools, large or small businesses, or other public and private entities or combinations of these entities. It is expected that a BRP will have a well-defined goal or deliverable that will be achieved based on objective milestones specified in the initial application. On October 11, 2001, the NIH issued a related program announcement (PA) PA-02-011 (http://grants.nih.gov/grants/guide/pa-files/PA-02-011.html) for Bioengineering Research Grants (BRGs). The BRGs differ from the BRPs in that the research will be performed in a single laboratory, by a single investigator, or by a small group of investigators. On January 16, 2003, the NIH issued another related program announcement PA-03-058 (http://grants.nih.gov/grants/guide/pa-files/PA-03-058.html) for Exploratory/Developmental (R21) Bioengineering Research Grants (EBRG). The EBRGs differ from the BRPs in that (1) the research will be performed in a single laboratory, by a single investigator, or by a small group of investigators and (2) the projects are high-risk/high-payoff in nature (R21 mechanism) as compared to the R01-type grants supported by the BRP program.

The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH) invite investigator-initiated research applications for mechanistic studies in clinical trials of: (1) immunomodulatory interventions for immune system mediated diseases, including, but not limited to: asthma and allergic diseases; graft failure in solid organ, cell, tissue and stem cell transplantation; and chronic inflammatory, autoimmune, and immunodeficiency diseases; and (2) preventative and therapeutic, vaccines for non-HIV/AIDS infectious diseases, including NIAID Category A, B, and C agents of bioterrorism and emerging/re-emerging infectious diseases. This Request for Applications (RFA) is a continuation and modification of RFA AI-02-003 (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-02-003.html ). In order to review and confer awards to grant applications received in response to this RFA in a timely fashion, without delay of the parent clinical trial, NIAID has developed a pilot project in collaboration with the NIH Center for Scientific Review (CSR): NIAID/CSR PILOT OF HYPERACCELERATED REVIEW/AWARD. All applications responding to this RFA will be subject to this hyperaccelerated review/award process. Highly meritorious applications selected for funding under this RFA will receive their awards thirteen weeks after the application receipt date. Holidays and other circumstances may alter this schedule slightly.

The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Deafness and Other Communication Disorders (NIDCD) invite qualified investigators to submit grant applications for the establishment of National Centers for Neurofibromatosis Research. Recent discoveries have created important opportunities for basic, translational, and clinical research on the neurofibromatoses. The purpose of this Program Announcement (PA) is to encourage the formation and development of research centers that can capitalize on these opportunities, and ultimately develop therapeutic interventions for neurofibromatosis patients. These centers are intended to provide focused expertise and resources, and establish a multi-disciplinary environment that will accelerate research progress.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Allergy and Infectious Diseases (NIAID), National Eye Institute (NEI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), and National Institute of Child Health and Human Development (NICHD) encourage the scientific community to use proteomics technologies to study type 1 diabetes (T1D) and its complications. Proteomic technologies have been successfully used for the identification of cancer biomarkers, for the identification of novel drug targets and for studying several biological processes relevant to human health. High throughput metabolic profiling has been recently implemented for metabolomic studies. However, as of today these technologies have been applied to study T1D and its complication only in a limited way. Moreover, currently available proteomic and metabolomic technologies represent a great opportunity for advancing the field of T1D and its complications. This RFA intends to promote the use of these technologies to study T1D and its complications emphasizing the importance of collaborative efforts between investigators with expertise in proteomics or metabolomics and investigators with expertise in T1D.

The purpose of the NIH Clinical Trial Planning Grant (R34) is to provide support for the development of a Phase III clinical trial, including the establishment of the research team, the development of tools for data management and oversight of the research, the definition of recruitment strategies, and the finalization of the protocol and other essential elements of the study included in a manual of operations/procedures. The Clinical Trial Planning Grant is not designed for the collection of preliminary data or the conduct of pilot studies to support the rationale for a clinical trial. An NIH-defined Phase III clinical trial is a broadly based prospective clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or control intervention or comparing two or more existing treatments. Often, the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis or therapy. Community- and other population-based intervention trials also are included. The planning grant is designed to permit early peer review of the rationale and design of the proposed clinical trial and to provide support for the development of a detailed Manual of Procedures (MOP) including all elements essential to the launching of a trial. Investigators wishing to apply for an R34 grant should be aware that individual ICs may have specific requirements for this funding mechanism and, therefore, should consult IC staff to determine if an application is appropriate. NIH Offices that participate in this PA (ORWH, OBSSR, ORD, ODS) are listed but do not have funding authority and must work through an Institute or Center.