Abstract
Components of Participating Organizations
National Heart, Lung, and Blood Institute
Application Receipt Date(s): May 08, 2012
The purpose of this U54 program issued by the National Heart, Lung, and Blood Institute (NHLBI) is to encourage interdisciplinary approaches to translational research in the hemoglobinopathies, providing opportunities for potentially high-impact research, which will translate basic observations to applied clinical research. Applicants will be required to propose research that will, by the end of the project period, develop candidate potentially therapeutic molecules, biomarkers, or imaging modalities. Applicants are expected to assemble interactive, multidisciplinary teams that have the combined expertise to formulate a plan for successful translation. Research teams are not required to have prior collaborative experience but must be able to demonstrate an integrated, practical approach that will result in the effective progression of mechanistic/basic concepts toward application in the clinic.
The proposed project should focus on the development of a specific discovery or deliverable (e.g., small molecules, biologics, biomarkers, and other methodologies) to be used in the diagnosis or treatment of sickle cell disease or the thalassemias.
The hemoglobinopathies, sickle cell disease and the thalassemias, are the most common clinically significant human monogenetic diseases globally. Although the causative mutations primarily affect the qualitative or quantitative production of hemoglobin, the resultant pathophysiologies result in dysregulation of inflammatory and thromboregulatory pathways leading to damage of numerous organ systems, a process beginning shortly after birth.
Research in the hemoglobinopathies has traditionally focused on the red cell and the hemoglobin molecule. During the past decade, investigators have contributed new insights through work in genomics and epigenetics, drug development, the neurobiology of pain, iron metabolism, vascular biology, patient-reported outcomes (PROs), and comparative effectiveness research (CER). However, there have been few opportunities for broad-based programs that would benefit from collaboration among hematologists and investigators in relevant areas. Attracting new investigators to the hemoglobinopathies field is increasingly important because the potential scientific opportunities are expanding while the number of individuals choosing to pursue careers in academic hematology is contracting.
In 2008, a Subcommittee of the National Heart, Lung, and Blood Advisory Council (NHLBAC) issued a Report recommending a reprioritization of the Institute's research program in sickle cell disease (SCD) that would permit a broad spectrum of investigators in relevant biomedical disciplines to collaborate with hematologists in addressing high priority areas in basic, translational, and clinical research.
Prioritized areas for research as determined by the NHLBI Workshop on Sickle Cell Disease, (October 2008), and the NHLBAC Subcommittee Review of the NHLBI Sickle Cell Disease Program (February 2008) may be found at http://www.nhlbi.nih.gov/meetings/workshops/scd_workshop.htm;http://bloodjournal.hematologylibrary.org/cgi/content/full/111/10/4852; and http://www.nhlbi.nih.gov/resources/docs/scd_program.htm) Prioritized areas for research in the thalassemias, as determined by the NHLBI Workshop on Clinical Priorities in Thalassemia may be found at http://www.nhlbi.nih.gov/meetings/workshops/thal_workshop.htm.
NHLBI has been engaged in an ongoing process to reinvigorate the programs in sickle cell disease and the thalassemias to respond to the recommendations from the Advisory Committee and workshops. The Excellence in Hemoglobinopathies Research Awards (EHRA) represents the next major phase in this process. The EHRA program will focus on basic research and early translational (T1) trials involving small numbers of subjects. “Basic” may include the pre-clinical toxicological and pharmacological studies required prior to a Phase I trial. It differs from the Specialized Centers of Clinically Oriented Research (SCCOR) program in that there are no prescriptive requirements for clinical trials. A separate FOA that provided funding for planning grants for phase II and III clinical trials was issued in 2010 (HL-11-009: “Planning Grants for Pivotal Clinical Trials in Hemoglobinopathies”) and awards were made in 2011. It is anticipated that EHRA – funded projects will generate data that will serve as the basis to advance earlier development of diagnostic, prognostic, and therapeutic interventions.
Seven to ten research centers will be funded, in accordance with the Congressional mandate for sickle cell disease. The EHRA extends the definition of a traditional Center program by encouraging the formation of Centers composed of qualified basic and early translational components and investigators each of whom may be in different institutions. This allowance for multiple institution/multiple site centers will facilitate interdisciplinary collaboration, since the availability of scientific expertise will not be constrained by geographic boundaries. Applicants are expected to assemble interactive, cooperative multidisciplinary teams that have the combined expertise to formulate a plan for successful translation. Research teams are not required to have prior collaborative experience but must be able to demonstrate an integrated, rational experimental approach that will result in the effective progression of mechanistic/basic concepts toward clinical applications.
Description of a Center
An innovative collaboration among investigators in at least two disciplines.
Multiple PD(s)/PI(s) or PD/PI with co-investigators. The complex nature of a multi-disciplinary, multi-institutional project may require collaboration between two or more PD(s)/PI(s) to achieve specific aims within the funding period. Alternatively, an organizational plan where a single PD/PI works with co-investigators may be preferable.
The resources to accomplish significant work in basic/pre-clinical, and translational studies.
A program for skills development in translational medicine for new investigators, and opportunities for summer high school students.
To enhance the potential success of translational studies, the Centers will be required to leverage existing infrastructure and resources at their institutions through collaborations with their Clinical and Translational Science Awards (CTSA) programs or comparable institutional programs to enable timely and cost-effective completion of proposed translational research.
Projects responsive to this FOA:
Develop or refine innovative, high impact translational findings with direct relevance to the hemoglobinopathies.
Employ an interdisciplinary collaboration that benefits from close cooperation among basic and translational investigators.
Delineate a clear development plan based on study results that specifically inform translational pathways for new diagnostic, prognostic or therapeutic strategies for sickle cell disease or the thalassemias.
Applications not responsive to this FOA:
Applications that address basic mechanistic questions of disease pathology without identification of a specific translational milestone(s) or without a plan for reaching that milestone(s) are not appropriate for this FOA.
Clinical trials without a basic and translational component.
Phase II and phase III clinical trials.
Selected research examples include, but are not limited to:
Pre-clinical and early clinical trials of novel therapeutics to modulate fetal hemoglobin production.
Development of biomarkers and novel imaging modalities for diagnostic and therapeutic monitoring of at risk organ systems.
Phenotype/genotype correlations in emerging thalassemia populations in the US (e.g. Thalassemia/HbE).
Development of pain phenotypes and translational, interventional drug studies.
Sickle cell trait: Development of candidate biomarkers to stratify subgroups potentially at risk for sudden death/multiple organ failure.
Program Structure
All of the Centers will form a consortium, with an Administrative Coordinating Center (ACC) and a Steering Committee.
Multidisciplinary Research Project (Required)
An application must propose a single project that approaches a common scientific theme through innovative collaborations among investigators in two or more relevant disciplines, providing opportunities for high-impact research which will translate basic observations to applied clinical research in the hemoglobinopathies. Research teams are not required to have prior collaborative experience but must be able to demonstrate an integrated, practical approach that will result in the effective progression of mechanistic/basic concepts toward application in the clinic.
Translational Research Skills Development Core (TRC) (Required): Applications must include a description of plans to develop and direct a translational research skills development component for new investigators. The core should be directed by an investigator with translational research and mentoring credentials. To facilitate multidisciplinary developmental activities, active involvement by other senior investigators in the TRC is encouraged. Each TRC must budget for providing skills development for two or more new investigators.
Summer Student Program (Optional): A program directed at high school students to support summer hemoglobinopathies-related research for up to three qualified and interested high school students per year. If this program is offered by the Center, funds for it should be included in the budget. The review of the Summer Student Program will be based on a recommendation to approve or disapprove and will not be considered in the overall score of each Center.
Administrative Coordinating Center (ACC) Required: There will be one ACC to serve all the Centers which will perform a range of administrative functions including organizing investigator and External Advisory Committee meetings, arranging conference calls, and designing and maintaining a website for the program. This website would be for use by the EHRA investigators to communicate and share data. The ACC director does not have to be a project scientist. A proposal for the ACC, which will service all the Centers, must be included in each EHRA application. The ACC budget will include travel costs for the External Advisory Committee and for the ACC director to attend Steering Committee meetings. The ACC budget is not to exceed $150,000 in direct costs. The ACC is to be reviewed and scored separately and will be awarded to one of the funded Centers.
Steering Committee: The Consortium will have a Steering Committee responsible for overall scientific direction, coordination and oversight. The Steering Committee will be composed of the Research Center PD(s)/PI(s), the Administrative Coordinating Center (ACC) director, and the NHLBI Project Scientist. The Steering Committee will be chaired by an investigator selected by the NHLBI. In the first year of funding, the Steering Committee will meet in person for an implementation meeting at the start of the project period and by conference call at least quarterly. In the second through fifth year of funding, the Steering Committee will meet at least twice a year throughout the project period. One meeting will be held in or near Bethesda, MD and one meeting will be held at an EHRA grantee site. Each EHRA program should include funds for Principal Investigators(s) travel to the Steering Committee meetings.
Investigators’ Meetings: Investigators from individual Centers will meet annually in or near Bethesda, MD, to present updates on progress, to exchange ideas, and to discuss problems encountered. In the second through fifth year, the Investigators’ Meeting will be held in conjunction with a Steering Committee meeting. The agenda for the meetings will be determined by the Steering Committee composed of the Principal Investigators of the Centers and the NHLBI Program Scientist. Each Centers budget should include funds for investigators to attend the investigators’ meeting.
External Advisory Committee: An External Advisory Committee (EAC) made up of three members will oversee this basic and translational program. This Committee will consist of non-Consortium affiliated scientists and other experts appointed by the NHLBI to provide annual reviews of progress. The EAC will attend one meeting per year in or near Bethesda, MD. Applicants do not have to identify the EAC members. Travel funds and honoraria for the EAC should be included in the ACC budget.
Collaborative Activities: Collaborations, standardization and sharing of data, and sharing and banking of biospecimens following review by the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) (https://biolincc.nhlbi.nih.gov/home/) will be expected and enabled by the Administrative Coordinating Center, a sub-committee of the investigator membership of the Steering Committee, and NIH program staff.
Clinical and Translational Science Awards (CTSA): Applicants must use resources available through their CTSA program or similar Institutional program to maximize intellectual and physical resources.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; county or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(S) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-13-005.html.
Nutrition Obesity Research Centers (P30): Rfa-Dk-12-004
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date(s): June 29, 2012
The objective of the Nutrition Obesity Research Centers program is to bring together basic science and clinical investigators from relevant disciplines to enhance and extend the effectiveness of research related to nutritional sciences and/or obesity, and related disorders, with clinical and/or translational applications in these areas. The NIDDK-supported Nutrition and Obesity Research Centers (NORC) are part of an integrated program of nutritional sciences and obesity research. The NORC program combines the previously supported NIDDK Clinical Nutrition Research Units (CNRUs) and the Obesity Nutrition Research Centers (ONRCs) into one centers program.
Institution and Research Base
A Center must be an identifiable unit within a university or medical center or a consortium of cooperating institutions, including an affiliated university. An existing program of excellence in biomedical basic and clinical research in the areas of nutritional sciences and/or obesity, and related disorders, is required. The research must be in the form of research project grants (R01), program project grants (P01), Resource-Related Research Project Grant (R24), or other peer-reviewed research that is already funded by NIH, other Federal Agencies, or non-federal groups at the time of submission of the Center grant application. It is required that at least fifty percent of the nutritional sciences and obesity or other related disorders research comprising the research base be supported by Federal Agencies. Close cooperation, communication, and collaboration among all involved personnel of various professional disciplines are ultimate objectives.
Administrative Core
NORC applications must include an administrative core that will be responsible for allocation and oversight of Center resources. The Administrative core will also be responsible for planning an enrichment program and for implementing a process for solicitation, review and selection of projects for the Pilot and Feasibility Program within the Center. In addition, all Nutrition Obesity Research Centers will be required to maintain a Center website, with the administrative core taking primary responsibility for its creation and oversight, as well as for ensuring proper and seamless integration of the Center website with the NIDDK Center program website.
The NORC Director, who is the Program Director/Principal Investigator on the P30 application and Director of the Administrative Core, must be a scientist who can provide effective administrative and scientific leadership and who has demonstrate proficiency in managing a large, multi-component project. The Director will be responsible for the organization and operation of the NORC and for communication with the NIDDK on scientific and operational matters. Center Directors are required, and their administrators are strongly encouraged, to attend Center Director's meetings to be held at a location to be determined by the NIDDK. Funds for travel to this meeting should be included in the budget of the Administrative Core of the Center. The Core Center Director should provide at least 1.2 person months (calendar year) effort on the Administrative Core and a total of 2.4 person months (calendar year) effort distributed among the Administrative and other components of the Center. One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and who will serve as Acting Center Director in the absence of the Director. A process must be in place that would be used to recommend a successor to the Director, if needed. An administrative assistant may also be proposed.
Research Cores
The NORCs are based on the core concept. Four to six cores are usually included in a Center. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in nutritional sciences and/or obesity and related disorders research to accomplish the stated goals of the Center. Examples of such resources include biostatistics, imaging, biotechnology, and instrumentation facilities. It is appropriate and may be beneficial to have one or more central themes around which core center research investigations are focused.
Centers are encouraged to foster clinical and/or translational research. This clinical component can exist in multiple formats, as a stand-alone core, a ‘clinical component’ as part of the administrative core, a combination of the two, or some other format that supports clinical research. Besides leading to a better understanding of disease etiology and natural history of disease, such cores might provide biostatistics support; enhance clinical study design; enhance collaboration among researchers and recruitment of subjects for clinical studies; provide for epidemiological studies; or provide modest funding for tissue, DNA, or serum storage. In addition, a clinical or epidemiology core may more effectively address NIH policies concerning issues of children, women, and ethnic minority participation in clinical studies.
In responding to this FOA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators at the applicant institutions. Particular emphasis should be placed on services that support and foster interdisciplinary, integrated and translational approaches to research in Nutrition Obesity Research Center topic areas. Preference will be given to core support services that are not readily available or cost-effective when supplied from commercial sources, and techniques or technologies that may be technically challenging or require specialized expertise, equipment or infrastructure.
Proposed NORC research cores may be an institutional shared research core. In such cases, the research core support provided by the NORC should be proportional to the use of the institutional research core by NORC members. As with other research cores, details about access and prioritization of center members to the shared research core(s) should be provided. Moreover, the applicant should document that the NORC will be in a position to have some input to, and oversight of, the shared institutional core with respect to its management, planning for future changes and improvements, etc.
The need for core support from the NORC must be well-justified, with clear documentation of a broad user base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as nutrition and/or obesity researchers with other sources of peer-reviewed support. Participants in the NORC program are encouraged to become fully integrated into, and synergistic with, other NIDDK- and NIH-funded Core Centers within their institutional setting. This includes the clinical research homes being established by the Clinical and Translational Science Awards supported by the National Institutes of Health (http://www.ctsaweb.org/) and other NIH Common Fund activities, and any related NIDDK-funded Center programs: http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/. Applicants should provide information on other programs supporting related resources at their institution, including other P30s, and describe the nature of synergy and integration between the NORC and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.
Two other types of activities should also be supported with Center funding: a pilot and feasibility (P/F) program and an enrichment program.
Pilot and Feasibility Program
The P/F program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to obesity or nutritional sciences research, and at established investigators who wish to make a substantial change in the direction of their nutritional sciences or obesity-related research. It is expected that the majority of P/F project investigators will fall into the first category and only in exceptional circumstances will investigators in the third category be supported. In addition, temporary salary support for one Named New Investigator in a specified area of research with a defined P/F study may be requested for up to 24 months, with subsequent individuals to be named by the Center Director and approved by the Center's External Advisory Board and the NIDDK.
Enrichment Program
The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. The NORC enrichment program should be designed to advance translational research in nutrition and obesity and promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between nutrition and obesity researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops.
Applicants should describe any training opportunities afforded by the NORC for Center participants, and document ways the Center may facilitate, enhance or foster the institutional training environment. Specifically, Center applicants should provide information on any related NIDDK T32 training programs at the Center institution(s), and describe how the NORC will help to integrate, facilitate and enhance activities of T32-supported trainees. A letter from the PD/PI of any related NIDDK-funded T32 at the Center institution should be included that acknowledges and details how the PD/PI of the T32 intends to promote cohesive interactions between the two programs. Training postdoctoral fellows to conduct research in nutrition and obesity is an associated activity of a NORC. While stipends for fellows cannot be funded from the Center, the establishment of a Center should provide an enhanced environment for research training.
Clinical Component
NORCs are encouraged to support clinical and translational research. A NORC may support clinical research through a ‘clinical component’ housed in the Administrative Core, through one or more stand-alone research cores, or through some other mechanism. Services should be budgeted through the core in which they would be performed. For a description of the expectations related to clinical research, please see the NORC Administrative Guidelines available at http://www2.niddk.nih.gov/NR/rdonlyres/B71C69B0-F1C6-465A-AA20-D05193FAECCC/0/2011_NORC_GuidelinesFinal_112911_508.pdf.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; county or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
The NORC Director, who is the Program Director/Principal Investigator of the P30 application and Director of the Administrative Core, must be a scientist who can provide effective administrative and scientific leadership and who has demonstrated his/her proficiency in managing a large, multi-component program. The Director will be responsible for the organization and operation of the NORC and for communicating with the NIDDK on scientific and operational matters. Center Directors are required, and their administrators are strongly encouraged, to attend an annual meeting to be held at a location to be determined by the NIDDK.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.
Only institutions at which there is an ongoing, strong base of nutrition and/or obesity-related research are eligible. At least 50 percent of the already funded research base in a new application must be Federally-funded. In renewal applications, the NIH-supported research base may be less than 50 percent due, typically, to a growing number of investigators entering nutrition and/or obesity research from other fields.
Applications for NORC grants must propose themes for the center that is relevant to nutrition and/or obesity and is supported by the research projects which comprise the research base for the NORC. The research base grants should be summarized in accordance with the NORC guidelines found at: http://www2.niddk.nih.gov/NR/rdonlyres/B71C69B0-F1C6-465A-AA20-D05193FAECCC/0/2011_NORC_GuidelinesFinal_112911_508.pdf.
Scientific personnel and institutional resources capable of supporting the research base must be available. In addition, the institution and pertinent departments must show a strong commitment to supporting the center. Such commitment may be provided as dedicated space, staff recruitment, salary-support for investigators, dedicated or shared equipment, or other financial support for the proposed center.
Each proposed core must be utilized by a minimum of two federally-funded investigators. A detailed description of each core proposed must be provided, including a detailed budget and budget justification. A well-qualified core director must be named for each core. The description of each core should include a rationale indicating how it will support the center's research effort in a cost-effective manner. Facilities must be available for the primary needs of the NORC because funds for new construction are not available from the P30 grant.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-004.html.
Partnerships for Development of Vaccine Technologies (R01): Rfa-Ai-12-014
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases
Application Receipt Date(s): June 26, 2012
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents. In response to threats presented by bioterrorism and emerging infectious diseases, the NIAID Division of Microbiology and Infectious Diseases (DMID) has established research programs to facilitate development of countermeasures for certain pathogens and toxins.
Through this FOA, the NIAID invites research applications for projects focused on preclinical development of candidate technologies (including adjuvants) that would improve vaccine effectiveness and/or simplify vaccine delivery to patient populations during a natural outbreak of an infectious disease or following the intentional release of an infectious agent. For the purpose of this FOA “candidate technology” is defined as a vaccine technology for which proof-of-concept data have been obtained. Examples of research areas may include, but are not limited to: technology/platform optimization; safety evaluation; stability testing; manufacturing; product characterization; adaptation of technologies or products to biodefense applications; development of broad spectrum platforms and/or production technologies; optimization of product safety, efficacy, or delivery; process development; scale-up; and production of quantities sufficient for preclinical regulatory requirements.
Industrial Participation
All applications submitted to this FOA must demonstrate substantive investment in the project by at least one industry participant. For the purpose of this FOA, “industry” is defined as a large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical company, or a related non-profit entity with an established track record in product development. “Substantive investment” is defined as a significant commitment of one or more resources to the project including, but not limited to: product development support/guidance, personnel, in kind contributions of materials and/or reagents (i.e. chemical libraries, innovative biotechnology platforms, scale up of GMP chemical synthesis or production, etc.), provision of animal or other laboratory models for evaluation, subcontracts, data management resources, regulatory support, or alterations/renovations of facilities or provision of equipment to address biohazard concerns. The Program Director(s) /Principal Investigator(s) (PD(s)/PI(s)) of the project may be affiliated with either industry or an academic organization; however, if the PD(s)/PI(s) is from academia, an industrial partner must be identified in the application.
Background
The NIH and other agencies in the Department of Health and Human Services (DHHS) support development of countermeasures to protect the public from emerging infectious diseases and bioterrorist threats. The NIAID Strategic Plan for Biodefense Research (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/about/Pages/strategicplan.aspx) outlines strategies for identifying medical countermeasure requirements and establishes priorities for their research, development and acquisition. One component of this plan is the development of new or improved vaccines against targeted NIAID Category A–C priority pathogens (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm). Consistent with this objective is the need for new and improved technologies that would facilitate production, storage, transport, delivery, and efficacy of these vaccines.
Research Goals and Objectives
The objective of this FOA is to support preclinical development of new or improved vaccine technologies to improve and facilitate the production, delivery, stability and/or efficacy of vaccines. As part of the Research Strategy section, each application must propose a research and development project whose goal is to advance an already identified vaccine technology or adjuvant. Research projects are not required to result in a “final” product, nor is it necessary to propose to complete the product development process up to the point of readiness for clinical trials or validation within the time frame of the project. Projects that would benefit production, delivery, stability and/or efficacy of non-biodefense-related vaccines are responsive provided that the targeted technology would be applicable to biodefense-related products.
Vaccine Technologies
Development of improved vaccine technologies is a high priority. Applications focused on preclinical development of technologies such as delivery platforms, antigen targeting, stability and cold-chain minimization, production characterization or formulation methodologies are encouraged. Proposed projects must pair the candidate technology with one or more appropriately mature, well-characterized vaccine(s)/antigen(s) for which models and assays exist to allow evaluation of the technology. Vaccine technology projects may include, but are not limited to, one or more of the following activities:
Development and/or optimization of innovative antigen production platforms;
Development and/or optimization of innovative delivery platforms;
Development of non-needle vaccine delivery systems, such as transdermal, intradermal, oral, sublingual, or nasal delivery;
Development of antigen targeting technologies that enhance vaccine efficacy;
Development of formulation methodologies that obviate the need for cold-storage of the resulting product and/or extend shelf-life;
Improved evaluation of safety, toxicity and immunogenicity in animals;
Improved evaluation of efficacy in challenge models where appropriate animal models are available;
Optimization of dose and delivery platforms in preclinical evaluation;
Optimization of production and/or characterization methodologies including process and assay development; and
Performance of pre-clinical testing for safety and efficacy in animal models and other benchmarks required for successful submission and review of an IND application by the FDA (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm) or for moving into future Phase I clinical trials.
Adjuvants
The development of an enhanced immune response may require the administration or co-administration of an adjuvant or immunostimulatory compound. Applications for development of novel adjuvants that could be used in conjunction with specific pathogen components are invited. Adjuvants are broadly separated into two classes based upon their primary mechanism of action: vaccine delivery systems (e.g., emulsions, microparticles, immune stimulating complexes, and liposomes) that target associated antigens to antigen presenting cells, and immunostimulatory adjuvants (e.g., LPS, MLP, or CpG DNA) that directly activate innate immune responses. In order to advance the development of vaccine adjuvants, this solicitation focuses on optimization and preclinical testing of candidate lead adjuvants that previously showed promise in early stages of discovery and development. Proposed projects must pair the prospective adjuvant(s) with one or more appropriately mature, well-characterized vaccine(s)/antigen(s) for which models and assays exist to allow evaluation of enhanced immunogenicity. Adjuvant projects may include, but are not limited to, one or more of the following product development activities:
Optimization of lead compounds with a high potential as adjuvant candidates based upon their antigen targeting capability, receptor binding capacity, and effect on immune signaling;
Testing of previously evaluated adjuvants for their capacity to stimulate desired immune responses;
Testing mixtures of adjuvants to evaluate additive or synergistic potential to safely stimulate desired immune responses (prior to clinical testing);
Optimization of delivery platform(s), including antigen and adjuvant combinations/formulations;
Reiterative design, synthesis, and analysis to improve adjuvant performance;
Pre-clinical testing for safety and stimulatory capacity in animals;
Optimization of dose, dosing interval, and route of delivery in pre-clinical evaluation;
Process development for the manufacturing of adjuvant components, including QA/QC methods for product recovery, characterization, purification, identity, stability etc.;
Scale-up under GLP or cGMP to provide sufficient quantities for preclinical FDA-required animal studies and future Phase I clinical trials;
GLP or cGMP production; and
Performing pre-clinical testing for safety and efficacy in animal models and other benchmarks required for successful submission and review of an IND application by the FDA (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm) or for moving into future Phase I clinical trials.
NOTE: While clinical development strategies may be included within an overall project, this FOA will NOT support clinical trials. Applications requesting support for clinical trials will be deemed unresponsive to this FOA and will not be reviewed. Utilization of human-derived material with necessary approvals in pre-clinical studies in support of compliance with regulatory requirements is permitted and encouraged.
NOTE: PD(s)/PI(s) are strongly encouraged to obtain expertise in the areas of product development planning and target product profile development in general and regulatory matters in particular. Expertise may be retained as defined effort or may be included as periodic consultation on specific issues.
NOTE: Applications failing to propose work focusing on candidate technology with proof-of-concept data will be deemed non-responsive and will not be reviewed.
NOTE: Applications failing to meet the requirement for industrial participation, as described, will be deemed non-responsive and will not be reviewed.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; county or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) entities (foreign institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-014.html.
New Technologies for Viral Hepatitis Sbir (R43/R44): Pa-12-090
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
National Cancer Institute
National Heart, Lung, and Blood Institute
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Application Receipt/Submission Date(s): Multiple dates, see announcement.
Despite advances in the treatment of chronic viral hepatitis B and C, the persistence of these and the emergence of other hepatitis viruses continue to remain a public health challenge in the United States. Currently, it is estimated that 3.5 to 5.3 million persons in the United States are afflicted by viral hepatitis. The consequences of acute and chronic viral hepatitis vary, but can be severe and lead to acute liver failure, cirrhosis of the liver, and predispose afflicted persons to hepatocellular carcinoma. Once liver failure ensues from either acute or chronic viral hepatitis or if liver cancer emerges due to chronic viral hepatitis, liver transplantation becomes the only viable option, a costly and resource intensive therapy. Even with advances in medical care, approximately 12,000 to 15,000 Americans succumb to the complications of acute or chronic viral hepatitis each year.
In January 2010, the Institute of Medicine (IOM) released the report “Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C” (http://www.iom.edu/). This report identified and highlighted viral hepatitis as a national health concern and outlined barriers that hinder health care delivery for viral hepatitis patients. In response to the Institute of Medicine report, the Department of Health and Human Services under the direction of Dr. Howard Koh, Assistant Secretary for Health, convened a working group that generated the report “Combating the Silent Epidemic of Viral Hepatitis: U.S. Department of Health and Human Services Action Plan for the Prevention, Care and Treatment of Viral Hepatitis” (Viral Hepatitis Action Plan), which was released on May 12, 2011 (http://www.hhs.gov/ash/initiatives/hepatitis/). The Viral Hepatitis Action Plan represented an integrated Federal government response to the public health implications of acute and chronic viral hepatitis. Furthermore, the Viral Hepatitis Action Plan provided a framework to coordinate the Federal government wide approach to address the challenges raised in the IOM report regarding the public health implications of acute and chronic viral hepatitis.
Integrated into the Viral Hepatitis Action Plan were several action items germane to the research mission of the National Institutes of Health. The topics ranged from basic, translational, and clinical research to coordination of disseminating research findings into the clinical realm. Specific research topics assigned to the National Institutes of Health can be found in the Viral Hepatitis Action Plan.
This FOA encourages small business establishments to submit applications that address any of the specific research topics in the Viral Hepatitis Action Plan that are assigned to the NIH and germane to the research mission of the respective NIH Institutes and Centers in order to facilitate the development, evaluation, and validation of products that would be implemented in the public health efforts to reduce the burden of viral hepatitis in the United States. Applications that propose clinical trials beyond Phase I studies will be beyond the scope of this FOA.
A sampling of research objectives and strategies appropriate for this FOA from the Viral Hepatitis Action Plan include, but are not limited to:
Develop point-of-care rapid screening tests that would allow for screening of patients or individuals for ongoing hepatitis virus infection (HCV, HBV, HDV, HEV) or immunity to infection (particularly hepatitis B) that could be used to screen patients or individuals, including pregnant women, for evidence of acute or chronic hepatitis or presence of immunity.
Develop new diagnostic tests for viral hepatitis that would aid in clinical management, such as tests that would discriminate between acute and chronic infection, identify viral hepatitis infected infants among infants born to women with viral hepatitis, or would allow for better assessment of need for treatment and monitoring, such as tests for IgM antibodies to hepatitis C, D or E, or means of measurement of HBV, HCV, HDV and HEV levels that are as reliable but less expensive and resource demanding than current molecular assays.
Develop non-invasive and practical tests that could be used to monitor patients for complications of chronic viral hepatitis, such as portal hypertension, esophageal varices and hepatocellular carcinoma.
Develop practical models of care that would be applicable to the unique issues faced by populations with viral hepatitis.
Develop new therapies for viral hepatitis or its complications, particularly interventions that are better tolerated and less expensive than currently licensed or late-stage investigational regimens.
Develop therapies that ameliorate the symptoms or complications of viral hepatitis or its antiviral therapies.
Develop new and better therapies for hepatocellular carcinoma.
Develop genetic tests that might help in patient management of viral hepatitis, including tests that assess risk of complications as well as likelihood of success of specific therapies.
Develop computer algorithms that would help in the practical diagnosis, management, monitoring and therapy of viral hepatitis.
Develop candidate vaccines for hepatitis C or innovative means of prevention.
Develop more effective or more practical HAV and HBV vaccines and vaccine strategies.
Develop means of pathogen reduction for blood components that might be practical particularly for resource limited countries.
Develop vaccines, anti-viral and other strategies that can be safely used in pregnant women and their infants to prevent perinatal transmission of viral hepatitis.
Develop more effective or more practical HAV and HBV vaccines and vaccine strategies, candidate vaccines for hepatitis C, and therapies that ameliorate the symptoms or complications of viral hepatitis or its antiviral therapies for infants, children and pregnant women.
Develop a model of treatment and medical care that integrates antiviral therapy with alcohol treatment and that could be successfully implemented in a hepatology clinic with significant favorable impact on vitral titers, alcohol use and abstinence among patients with chronic HCV.
Develop tests for the frequency of aberrant hypermethylation and hypomethylation of specific genes that are associated with alcohol use, HCV infection and the development of HCC tumors and that may be useful in prognosis and treatment.
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;
Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD(s)/PI(s) must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD(s)/PI(s), at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PD(s)/PI(s), see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide.
A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.
Contractual/Consortium Arrangements
In Phase I, normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and fee).
In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).
The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS398 Research Plan component of SF424 (R&R) application forms.
Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-014.html.
New Technologies for Viral Hepatitis Sttr (R41/R42): Pa-12-091
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
National Cancer Institute
National Heart, Lung, and Blood Institute
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Application Receipt/Submission Date(s): Multiple dates, see announcement.
Despite advances in the treatment of chronic viral hepatitis B and C, the persistence of these and the emergence of other hepatitis viruses continue to remain a public health challenge in the United States. Currently, it is estimated that 3.5 to 5.3 million persons in the United States are afflicted by viral hepatitis. The consequences of acute and chronic viral hepatitis vary, but can be severe and lead to acute liver failure, cirrhosis of the liver, and predispose afflicted persons to hepatocellular carcinoma. Once liver failure ensues from either acute or chronic viral hepatitis or if liver cancer emerges due to chronic viral hepatitis, liver transplantation becomes the only viable option, a costly and resource intensive therapy. Even with advances in medical care, approximately 12,000 to 15,000 Americans succumb to the complications of acute or chronic viral hepatitis each year.
In January 2010, the Institute of Medicine (IOM) released the report “Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C” (http://www.iom.edu/). This report identified and highlighted viral hepatitis as a national health concern and outlined barriers that hinder health care delivery for viral hepatitis patients. In response to the Institute of Medicine report, the Department of Health and Human Services under the direction of Dr. Howard Koh, Assistant Secretary for Health, convened a working group that generated the report “Combating the Silent Epidemic of viral Hepatitis: U.S. Department of Health and Human Services Action Plan for the Prevention, Care and Treatment of Viral Hepatitis” (Viral Hepatitis Action Plan,) which was released on May 12, 2011 (http://www.hhs.gov/ash/initiatives/hepatitis/). The Viral Hepatitis Action Plan represented an integrated Federal government response to the public health implications of acute and chronic viral hepatitis. Furthermore, the Viral Hepatitis Action Plan provided a framework to coordinate the Federal government wide approach to address the challenges raised in the IOM report regarding the public health implications of acute and chronic viral hepatitis.
Integrated into the Viral Hepatitis Action Plan were several action items germane to the research mission of the National Institutes of Health. The topics ranged from basic, translational, and clinical research to coordination of disseminating research findings into the clinical realm. Specific research topics assigned to the National Institutes of Health can be found in the Viral Hepatitis Action Plan.
This FOA encourages small business establishments to submit applications that address any of the specific research topics in the Viral Hepatitis Action Plan that are assigned to the NIH and germane to the research mission of the respective NIH Institutes and Centers in order to facilitate the development, evaluation, and validation of products that would be implemented in the public health efforts to reduce the burden of viral hepatitis in the United States. Applications that propose clinical trials beyond Phase I studies will be beyond the scope of this FOA.
A sampling of research objectives and strategies appropriate for this FOA from the Viral Hepatitis Action Plan include, but are not limited to:
Develop point-of-care rapid screening tests that would allow for screening of patients or individuals for ongoing hepatitis virus infection (HCV, HBV, HDV, HEV) or immunity to infection (particularly hepatitis B) that could be used to screen patients or individuals, including pregnant women, for evidence of acute or chronic hepatitis or presence of immunity.
Develop new diagnostic tests for viral hepatitis that would aid in clinical management, such as tests that would discriminate between acute and chronic infection, identify viral hepatitis infected infants among infants born to women with viral hepatitis, or would allow for better assessment of need for treatment and monitoring, such as tests for IgM antibodies to hepatitis C, D or E, or means of measurement of HBV, HCV, HDV and HEV levels that are as reliable but less expensive and resource demanding than current molecular assays.
Develop non-invasive and practical tests that could be used to monitor patients for complications of chronic viral hepatitis, such as portal hypertension, esophageal varices and hepatocellular carcinoma.
Develop practical models of care that would be applicable to the unique issues faced by populations with viral hepatitis.
Develop new therapies for viral hepatitis or its complications, particularly interventions that are better tolerated and less expensive than currently licensed or late-stage investigational regimens.
Develop therapies that ameliorate the symptoms or complications of viral hepatitis or its antiviral therapies.
Develop new and better therapies for hepatocellular carcinoma.
Develop genetic tests that might help in patient management of viral hepatitis, including tests that assess risk of complications as well as likelihood of success of specific therapies.
Develop computer algorithms that would help in the practical diagnosis, management, monitoring and therapy of viral hepatitis.
Develop candidate vaccines for hepatitis C or innovative means of prevention.
Develop more effective or more practical HAV and HBV vaccines and vaccine strategies.
Develop means of pathogen reduction for blood components that might be practical particularly for resource limited countries.
Develop vaccines, anti-viral and other strategies that can be safely used in pregnant women and their infants to prevent perinatal transmission of viral hepatitis.
Develop more effective or more practical HAV and HBV vaccines and vaccine strategies, candidate vaccines for hepatitis C, and therapies that ameliorate the symptoms or complications of viral hepatitis or its antiviral therapies for infants, children and pregnant women.
Develop a model of treatment and medical care that integrates antiviral therapy with alcohol treatment and that could be successfully implemented in a hepatology clinic with significant favorable impact on vitral titers, alcohol use and abstinence among patients with chronic HCV.
Develop tests for the frequency of aberrant hypermethylation and hypomethylation of specific genes that are associated with alcohol use, HCV infection and the development of HCC tumors and that may be useful in prognosis and treatment.
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;
Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For the STTR program, the PD(s)/PI(s) may be employed with the SBC or the single, “partnering” non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual. Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration.
The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PD(s)/PI(s), see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide.
A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.
In Phase I and Phase II, at least 40% of the work must be performed by the small business concern and at least 30% of the work must be performed by the single, “partnering” research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS398 Research Plan component of the SF424 (R&R) application forms.
A small business concern may subcontract a portion of its STTR award to a Federally Funded Research and Development Center (FFRDC), either in its capacity as the Research Institution or as a participant in the STTR project in another capacity. However, STTR funds may not be used to pay for laboratory resources of non-FFRDCs, and no STTR funds may be used to pay for subcontracting any portion of the STTR award back to the issuing agency or to any other Federal government unit unless a waiver is granted by the Small Business Administration.
The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS398 Research Plan component of SF424 (R&R) application forms.
Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PA-12-091.html.
Exploratory/Developmental Grants Program for Basic Cancer Research in Cancer Health Disparities (R21): Par-12-094
Components of Participating Organizations
National Cancer Institute
Application Receipt/Submission Date(s): June 20, 2012; November 20, 2012; June 20, 2013; November 20, 2013; June 20, 2014; November 20, 2014
Through this funding opportunity announcement (FOA), the Center to Reduce Cancer Health Disparities (CRCHD) and the Division of Cancer Biology (DCB), at the National Cancer Institute (NCI), invite grant applications from investigators interested in conducting basic research studies into the causes and mechanisms of cancer health disparities. These awards will support pilot and feasibility studies, development and testing of new methodologies, secondary data analyses, and innovative mechanistic studies that investigate biological/genetic bases of cancer health disparities among various racial and ethnic populations. This FOA is also designed to aid and facilitate the growthof a nationwide cohort of scientists with a high level of basic research expertise in cancer health disparities research and to provide resources for those investigators that may need additional support on their path to successfully compete for R01 funding in basic biological research in understanding cancer health disparities.
This FOA will use the NIH Exploratory/Developmental (R21) grant mechanism and runs in parallel with an FOA of identical scientific scope, PAR-12-095, which utilizes the U01 cooperative agreement grant mechanism.
Cancer health disparities represent a major public health concern in the United States. Even when socioeconomic factors are accounted for, minority populations have higher overall incidence rates and worse outcomes than the overall population. Several recent studies suggest there may be a biological basis for the observed unequal burdens of cancer across the racial/ethnic populations. Understanding the impact of genomic/genetic/epigenetic variability between ethnic groups that may affect cancer susceptibility and/or response to therapy is vital to reducing the observed cancer outcome gaps in this country. The NCI specifically encourages evidence-based mechanistic investigations of factors that are designed to increase our understanding of the biological factors and mechanisms that play a role in cancer health disparities.
Specific Research Objectives
Research applications should focus on basic cancer research and cancer health disparities, consistent with the research interests of both the Division of Cancer Biology (DCB, http://dcb.nci.nih.gov/), and the Center to Reduce Cancer Health Disparities (CRCHD, http://crchd.cancer.gov/). The DCB supports research in the broad areas of cancer cell biology, cancer etiology, cancer immunology and hematology, DNA and chromosome aberrations, structural biology, and the tumor microenvironment.
The CRCHD supports cancer health disparity research focused on basic, hypothesis-driven studies that explicitly address the unequal burden of cancer amongst racial/ethnic minorities or other underserved populations across the cancer continuum (prevention, early detection, diagnosis, treatment and survivorship).
For this FOA, the NCI is particularly interested in the interplay of race/ethnicity with cancer biology, and the underlying biological factors that contribute to cancer health disparities. Investigators may include the use of biospecimens from different racial/ethnic groups and/or the use of ancestral markers in determining more genetically defined measures of race and ethnicity for their studies. These awards will provide support for pilot or feasibility studies, for development and testing of new methodologies, development and testing of new research technology, secondary analysis of existing data, self-contained research projects, and innovative studies that provide a basis for more extended basic research in cancer disparities.
Research topics of interest include but are not limited to:
Examination of ethnic differences in HPV strain types/infection prevalence;
Studies of polymorphisms in liver detoxification enzymes among racial and ethnic groups;
Examination of differences in gene expression profiles of triple negative breast tumors in African-American women compared to other ethnic groups;
Examination of Androgen receptor signaling in aggressive prostate tumors in African-American men;
Examination of differences in DNA methylation profiles in premenopausal African American or Hispanic women for breast cancer;
Studies on the role of TP53 haplotypes in lung cancer among African-Americans;
Genetic/epigenetic/metabolic susceptibility differences between ethnic populations; and
New animal and cell culture models/systems designed to investigate cancer disparities
Please note that applications that focus on Genome-Wide Association Studies (GWAS), or behavioral and community/ population based studies are not appropriate for this FOA. In addition, applications that investigate carcinogenic mechanisms not associated with a disparate cancer burden in various racial and ethnic groups are not appropriate for this FOA.
The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance cancer disparities-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area on the biological studies in cancer health disparities. These studies may involve considerable risk but may lead to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on cancer disparities research.
Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; county or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) entities (foreign institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-094.html.
Basic Cancer Research in Cancer Health Disparities (U01): Par-12-095
Components of Participating Organizations
National Cancer Institute
Application Receipt/Submission Date(s): June 20, 2012; November 20, 2012; June 20, 2013; November 20, 2013; June 20, 2014; November 20, 2014
Through this Funding Opportunity Announcement (FOA), the Center to Reduce Cancer Health Disparities (CRCHD), the Division of Cancer Biology (DCB) and the Division of Cancer Prevention (DCP), at the National Cancer Institute (NCI), invite cooperative agreement research (U01) grant applications from investigators interested in conducting basic, mechanistic research into the biologic/genetic causes of cancer health disparities. These awards will support innovative studies designed to investigate biological/genetic bases of cancer disparities, and may include the development and testing of new methodologies and models, secondary data analyses, and mechanistic studies of identified biological factors associated with cancer disparities, including those related to basic research in prevention strategies. This FOA is also designed to aid and facilitate the development of a nationwide cohort of scientists with a high level of basic research expertise in cancer health disparities research who can develop resources and tools, such as biospecimens, cell lines and methods that are necessary to conduct basic research in cancer health disparities.
This FOA will use the U01 cooperative agreement grant mechanism and runs in parallel with an FOA of identical scientific scope, PAR-12-094, which utilizes the Exploratory/Developmental (R21) grant mechanism.
Cancer health disparities represent a major public health concern in the United States. Even when factors such as socioeconomic status, carcinogen exposure, and access to care are accounted for, disparities persist in the form of higher overall incidence rates and worse clinical outcomes for minority populations than for the overall population. Several recent studies suggest there may be a biological basis for the observed unequal burdens of cancer across the racial/ethnic populations. Understanding the impact of genomic/genetic/epigenetic variability between ethnic groups that may affect cancer susceptibility and/or response to therapy is vital to reducing the observed cancer outcome gaps in the US. The NCI specifically encourages evidence-based mechanistic investigations that are designed to increase our understanding of the biological factors and mechanisms that play a role in cancer health disparities.
Specific Research Objectives
Research applications should focus experimental aims on mechanistic studies related to cancer health disparities that are consistent with the research interests of the Division of Cancer Biology (DCB, http://dcb.nci.nih.gov/), the Division of Cancer prevention (DCP, http://prevention.cancer.gov/), and the Center to Reduce Cancer Health Disparities (CRCHD, http://crchd.cancer.gov/). The DCB supports research in the broad areas of cancer cell biology, cancer etiology, cancer immunology and hematology, DNA and chromosome aberrations, structural biology, and the tumor microenvironment.
The DCP supports research that will generate new information about molecular processes that are susceptible to intervention, developing effective prevention/chemoprevention agents, discovering early detection biomarkers, and pinpointing mechanistically targeted nutrients in cancer prevention.
The CRCHD supports cancer health disparity research focused on basic, hypothesis-driven studies that explicitly address the unequal burden of cancer amongst racial/ethnic minorities or other underserved populations across the cancer continuum (prevention, early detection, diagnosis, treatment and survivorship).
For this FOA, the NCI is particularly interested in research focused on the interplay of race/ethnicity with cancer biology, and the underlying biological factors that contribute to cancer health disparities.
Investigations may include the use of biospecimens from different racial/ethnic groups or the use of ancestral markers in determining more genetically defined measures of race and ethnicity. These awards will provide support for basic research projects that will develop and test new methodologies and new research technologies focused on cancer health disparities and disparity prevention strategies. They may also support secondary analysis of existing data sets, self-contained research projects, and development of innovative in vitro and in vivo models to conduct research in cancer disparities.
Research topics of interest include but are not limited to:
Examination of ethnic differences in HPV strain types/infection prevalence;
Studies of polymorphisms in liver detoxification enzymes among racial and ethnic groups;
Examination of differences in gene expression profiles of triple negative breast tumors in African-American women compared to other ethnic groups;
Studies of polymorphism and copy number variations in key cellular processes related to cancer disparities
Examination of Androgen receptor signaling in prostate tumors in African-American men;
Studies on the role of TP53 haplotypes in lung cancer among African-Americans;
Genetic/epigenetic or metabolic susceptibility differences between ethnic populations; and
New animal and cell culture models/systems designed to investigate cancer disparities
Please note that applications that focus on Genome-Wide Association Studies (GWAS), or behavioral and community/ population based studies are not appropriate for this FOA. In addition, applications that investigate carcinogenic mechanisms not associated with a disparate cancer burden in various racial and ethnic groups are not appropriate for this FOA.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(c)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; county or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) entities (foreign institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
Grants.gov
eRA Commons
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4–6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide. http://grants.nih.gov/grants/multi_pi/.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-095.html.