Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institute of Allergy and Infectious Diseases (NIAID)
Funding Opportunity Title	Accelerating Medicines Partnership (AMP) in Rheumatoid Arthritis and Lupus: Network Research Sites (UH2/UH3)
Activity Code	UH2/UH3 Phase Innovation Awards Cooperative Agreement
Announcement Type	New
Related Notices	September 12, 2019 - Request for Information (RFI) on the Lessons Learned from the Accelerating Medicines Partnership Rheumatoid Arthritis and Lupus (AMP RA/SLE Program). See Notice NOT-AR-19-039. April 2, 2014 - See Notice NOT-AR-14-019. Notice of Pre-Application Webinar.
Funding Opportunity Announcement (FOA) Number	RFA-AR-14-016
Companion Funding Opportunity	RFA-AR-14-015, UM2 Program Project or Center with Complex Structure Cooperative Agreement
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.846, 93.855, 93.856
Funding Opportunity Purpose	The purpose of this FOA is to solicit applications for the Accelerating Medicines Partnership (AMP) in Rheumatoid Arthritis (RA) and Lupus Network Research Sites. The AMP RA and Lupus Network is designed to ascertain and define shared and disease-specific biological pathways in order to identify relevant drug targets for the treatment of autoimmune diseases. This program will involve an enhanced systems-level understanding of gene expression and signaling in target tissues from affected end organs and peripheral blood cells. Awards made through this FOA will support an initial milestone-driven UH2 (Exploratory) funding period, with possible rapid transition to the UH3 (Implementation) funding period for a large validation project. UH3s will be awarded after administrative review of eligible UH2s that have met the scientific milestones and feasibility requirements necessary for the UH3, depending on the availability of funds. The UH2/UH3 projects must be submitted as part of a single application. Applications may be submitted for (i) Clinical Research Sites to assemble patient cohorts and obtain comprehensive clinical and laboratory data and relevant specimens to enable deconstruction of key events in cells and tissues related to disease, disease severity, and response to therapy, (ii) Technology Research Sites to develop, test, standardize and validate advanced and new technologies to identify critical signaling pathways in cells and tissues, or (iii) Combined Clinical and Technology Research Sites to conduct clinical and early validation studies of novel technologies and analytics in RA, lupus and related autoimmune diseases. The Network Leadership Center will: (i) direct and coordinate the scientific activities of the Network; (ii) monitor and evaluate scientific progress and performance; (iii) define Network research priorities; (iv) develop the Network research agenda; (v) provide centralized scientific/technical research resources for data management/coordination, statistical design/analyses and tissue acquisition; and (vi) conduct systems biology and bioinformatics research. Awardees under both FOAs will work collaboratively to establish the AMP RA and Lupus Network.

Posted Date	March 21, 2014
Open Date (Earliest Submission Date)	April 21, 2014
Letter of Intent Due Date(s)	April 21, 2014
Application Due Date(s)	May 21, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	July/August 2014
Advisory Council Review	August 2014
Earliest Start Date	September 20, 2014
Expiration Date	May 22, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) is one of two FOAs that implement the Accelerating Medicines Partnership in Rheumatoid Arthritis and Systemic Lupus Erythematosus (AMP RA/SLE) Program (http://www.niams.nih.gov/Funding/Funded_Research/AMP_RA_Lupus/default.asp). The goal of the Program is to ascertain and define shared and disease-specific biological pathways in order to identify relevant drug targets for the treatment of RA, lupus and related autoimmune diseases. The NIAMS and the NIAID, as participating members of the AMP RA/SLE Program, will promote this goal by publishing two FOAs to solicit applications for the development of a Network Leadership Center (LC) and Network Research Sites (RS). The LC and the RS awardees will work collaboratively within a network structure to implement the AMP RA/SLE Program. The Network will be established by the NIH in collaboration with industry partners that will co-fund, guide and advise on the scientific direction of the project.

This FOA solicits applications specifically for the Network Research Sites award. Applicants interested in the Leadership Center must use the companion FOA.

A critical program goal of the AMP initiative is to advance research in specific disease areas by creating a community resource of data, analyses, and other research resources which are publicly available and accessible to the broad biomedical community. In order to maximize scientific exchange and accelerate research in that field, it is expected that all information, data, protocols, resources, and methods developed by AMP investigators will be shared in a rapid and timely way with other investigators in the consortium and with the research community at-large. Given the amount and complexity of the data, success will require rapid and broad access across the biomedical community to allow for further analyses and collaborative research efforts.

The AMP initiative envisions that all data generated (including processed/analyzed data) will be deposited in a rapid and timely way into a repository that is accessible for use by the broad biomedical community, and that these data will remain available to all qualified investigators, consistent with applicable laws, regulations, and policies and unencumbered by any intellectual property claims. While the NIH encourages patenting of technology suitable for subsequent private investment that may lead to the development of products that address public needs, the NIH discourages premature claims on pre-competitive information that may impede research. It should be recognized that the research supported under the AMP initiative is intended to be precompetitive and will neither make use of proprietary pre-existing intellectual property nor is expected itself to produce patentable findings. Similarly, other research resources developed under the AMP initiative are expected to be made available to the research community.

Research supported and conducted by the NIAMS and the NIAID strives to better understand, treat, and ultimately prevent autoimmune diseases.

Rheumatoid arthritis (RA) and lupus are relatively common, severe autoimmune diseases and are examples of a larger number of such diseases, e.g., multiple sclerosis, Crohn’s Disease, ulcerative colitis, juvenile arthritis, Type 1 diabetes, and psoriasis, among many others. Basic and clinical studies have shown that these diseases share in common abnormalities in adaptive and innate immune function and regulation, resulting in inflammation that impairs end organ function. The ability to target specific immune cells or inflammatory mediators (cytokines) has resulted in the first real advances in treatments for RA in decades. However, the clinical benefit achieved so far is limited. In lupus, no effective targeted therapies exist for the most severe forms of the disease, including CNS lupus and lupus nephritis. Therefore, a major challenge remains to find new targeted therapies that can achieve a high degree of disease activity reduction (i.e., remission) or disease cure, have fewer immunosuppressive side effects, and/or offer oral alternatives to biologics. Progress has been hampered by the current fragmented research focus on peripheral blood immune cells with limited emphasis on changes in affected target organs and few integrated analyses combining findings in multiple cells and tissues.

The NIH, pharmaceutical companies and nonprofit organizations have together created the Accelerating Medicines Partnership (AMP) to develop new models for identifying and validating promising biological targets for new diagnostics and drug development. A major goal is to generate pre-competitive, disease-specific data that will be publicly accessible to the broad biomedical community for further research (http://www.nih.gov/science/amp/).

The partners jointly formed the AMP RA/SLE SC (see http://www.nih.gov/science/amp/autoimmune.htm), which developed a project plan to address relevant challenges for RA and lupus. Like other autoimmune diseases, these offer a special opportunity for molecular deconstruction because the majority of the complex cellular components of the immune system are available for study in the peripheral blood. In addition, the major target tissues for RA and lupus (including synovium and kidney, respectively, and potentially other tissues) can be biopsied, and emerging technologies allow for a detailed analysis of even small amounts of tissue, down to the single cell level. The overarching vision is that these detailed studies would identify key targets (with initial in vitro validation) that regulate the pathways that drive the diseases. The approach developed here can be subsequently applied to other autoimmune or inflammatory diseases. The central feature of the proposed research program is its ability to compare across autoimmune diseases in which similar immune cells are involved, but where their functions and interactions result in distinct inflammatory outcomes.

This program aims to achieve an enhanced systems-level understanding of gene expression and signaling in target tissues and cells from affected end organs (synovium for RA, kidney, or other tissues such as skin for lupus) and peripheral blood. The initial focus of research will be on RA and lupus, with the flexibility to expand in the future to related autoimmune diseases contingent on scientific feasibility and availability of resources.

The overall goal of the AMP RA and Lupus Network (Network) is to define shared and disease-specific biological pathways in order to identify relevant drug targets for the treatment of RA, lupus and related autoimmune diseases. Towards achieving this goal, a unique and novel infrastructure will be established, that uses a collaborative trans-disciplinary, integrated team science approach, to test high impact ideas that will: lay the foundation for a new and comprehensive understanding of mechanisms driving disease; stimulate early and applied research on cutting-edge technologies; and, advance the research enterprise by accelerating the discovery of disease pathways involved in autoimmune diseases. The initial focus will be on RA and lupus. The Network will be built with the flexibility to expand the scope of research to emerging new technologies and methods for systems analysis and to related autoimmune diseases.

Major outcomes of this collaborative effort include:

• An integrated data set of changes at the molecular level obtained by extensive profiling of gene expression and signaling in immune and tissue-resident cells, potentially including synovium for RA, and kidney and skin for lupus.
• Characterization of modules and pathways, and how they can be used to understand differences between autoimmune diseases, between early and established disease and between responders and non-responders to therapy.
• Identification of changes in circulating cells in blood that correlate with activation of specific pathways in the tissues or predict response to specific therapies, which can be used to improve therapeutic targeting and serve as surrogate biomarkers for diagnostic or treatment decisions.
• A data set shared by the Network and others for exploration of potential therapeutic targets.
• Preliminary steps towards validation of the biological relevance of druggable targets and other key regulatory molecules by in vitro functional assays, RNAi, and other methods.
• Application of existing and development of new computational tools to permit a systematic approach to integration of the datasets into pathways.
• A research model that may be extended to other autoimmune diseases.

Research Phases. The success of this research program will depend on careful progression of individual projects along a predetermined set of steps to ensure standardization of procedures to minimize technical variability. Projects are expected to progress in three phases:

Research Phase 0. Testing of different means of obtaining and prepping tissue and some initial analytic runs will be conducted with the goal of developing standardized methods in a small number of homogenous samples in at least two diseases. Samples must include affected organ specimens in addition to peripheral blood and could be newly obtained or already available.

Research Phase I. Analysis of a standardized analytic(s) successfully established in Research Phase 0, in blood and tissue cells, plus trial runs of other selected analytics. The number of samples will be sufficient to inform power calculations and establish the feasibility of larger studies of the tissue analytic and sample type, source and acquisition approach. At least one Research Phase I study in RA and one Research Phase I study in lupus are expected to be completed by the end of the second year of the project. Research Phase I will include analysis of samples from individuals without RA or lupus, such that a systems biology approach can be used to identify pathways that distinguish disease and non-disease tissue.

Research Phase II. Testing in larger patient populations will be conducted as determined by power calculations, priority, and budget. Patient stratification is expected for comparison within a disease (e.g., RA: treatment responder vs. non-responder, early vs. established RA, comparison among disease-modifying anti-rheumatic drugs (DMARD) treated groups; lupus: before vs. after treatment, comparison among types of kidney disease, etc.).

This new research infrastructure will be established using two interrelated FOAs to support the Network Leadership Center (LC), and the Network Research Sites (RS), which together will form the Network. The Network is defined as the consortium of investigators and institutions funded under both FOAs and will provide the framework for the AMP RA/SLE Program. A diagram of the organizational structure can be found at (http://www.niams.nih.gov/Funding/Funded_Research/AMP_RA_Lupus/default.asp).

The LC, to be awarded under the companion FOA, RFA-AR-14-015, will lead and coordinate all the scientific activities of the Network and provide key centralized resources and services to the RS projects, pilot and feasibility and other Network collaborative projects.

The RS, to be awarded under this FOA, will support three additional organizational entities within the Network.

Clinical Research Sites (CRS) will assemble patient cohorts and obtain comprehensive clinical and laboratory data and relevant specimens to enable measurements of key events in cells and tissues related to disease, disease severity and response to therapy.

Technology Research Sites (TRS) will develop, test, standardize and validate advanced and new technologies to identify critical signaling pathways in cells and tissues.

Combined Clinical and Technology Research Sites (CTRS) will support institutions to perform clinical studies and to conduct early validation studies of novel technologies and analytics.

Awards to Network Research Sites will be made using the UH2/UH3 (Phase Innovation Awards Cooperative Agreement) mechanism, a cooperative agreement that supports a phased approach to new research activities. The UH2 (Exploratory) funding period will provide support for Research Phases 0 and I activities in years 1 and 2. The UH3 (Implementation) funding period will provide support for meritorious research activities initiated during the UH2 funding period transitioning to Research Phase II in years 3 through 5.

The NLC will serve as the primary governing body for the scientific activities conducted by the Network. The composition and major functions of the NLC are described below.

NLC Composition

Voting members of the NLC may include:

• The Program Directors/Principal Investigators (PDs/PIs) of the Research Sites
• The PD/PI of the LC
• The Directors of the Systems Biology and Bioinformatics Group (SBG) and the Tissue Acquisition Research Group (TRG)
• The NIH Project Scientists (together representing a minority of voting members - not to exceed 1/3 of NLC membership). Other NIH Program staff may attend the meeting as non-voting members.

In addition, outside consultants may be appointed to serve as non-voting NLC members to provide expert advice and assistance with respect to research priorities, specific new and transitioning research projects, technologies, standards, etc. The use of such outside consultants may be recommended by any of the voting NLC members and their participation in NLC scientific activities will require consensus among the voting members of the NLC.

During the first year of the award, the Chair of the NLC is the PD/PI of the LC. Starting in year 2, the NLC will have the option to elect a new chair.

NLC Functions

The NLC will be the primary governing body for all Network scientific activities. The NLC will provide the collaborative environment to coordinate all projects awarded under the two FOAs.

The role of NLC includes:

• Foster collaboration, synergy and sharing among the projects and investigators in the Network.
• Provide the primary mechanism for interactions with NIH.
• Oversee the planning of Network scientific activities, including dynamic adjustment as needs and opportunities arise.
• Guide the development and documentation of the Network standards and guidelines.
• Prioritize the use of LC resources including systems biology analyses and bioinformatics.
• Evaluate progress in the LC and RS and recommend adjustments in approaches if necessary, including implementation of new projects and changes to ongoing studies and termination of projects and sites.
• Foster partnerships and collaborations that will facilitate the extension of the approach to new technologies and their application to related autoimmune disease.
• Review Network Resource Sharing Plan to ensure consistency and appropriateness for achieving the goals of the Network.
• Develop and approve Network-wide intellectual property agreements consistent with the terms and conditions of the cooperative agreement awards, applicable regulations, and the policies and practices of the awardee institutions.

The NLC functions will be supported by the LCMP.

Additional details about the governance structure will be outlined in the Notice of Award.

Network Clinical Research Sites (CRS)

Clinical Research Sites will assemble patient cohorts and obtain comprehensive clinical and laboratory data and relevant specimens to enable documentation of key events in cells and tissues related to disease, disease severity and response to therapy. The Sites will become part of the Network and work collaboratively with other Clinical and Technology Sites and with the functional components of the LC.

Research Objectives of the CRS include but are not limited to:

• Design effective approaches to characterize informative RA and lupus patient cohorts and subsets.
• Identify best methods for obtaining tissue from homogenous and informative patient cohorts by comparing different tissue collection techniques (e.g., shaver vs. guided needle biopsy for synovium), or types of samples (e.g., biopsy vs. surgical).
• Compare different processing techniques that use whole (e.g., for histology or laser capture microdissection RNA-seq analysis) vs. disaggregated (e.g., for high-throughput single cell RNA-seq or mass cytometry analysis) tissue.
• Conduct pilot and feasibility projects to establish the feasibility of proposed tissue acquisition and processing techniques for collaborative analytics in relevant patient cohorts and patient subsets.

Research Scope

The UH2/UH3 must be submitted as a single application but the approach should be clearly organized into two stages: UH2 (Exploratory) and UH3 (Implementation).

UH2

The UH2 (Exploratory) funding period will support planning and infrastructure building activities, as well as highly innovative projects that use novel approaches for tissue acquisition and cell preparations in samples from RA and lupus patients. During the UH2 period the goal will be to establish best methods of biopsy collection (RA) and to demonstrate the feasibility of single cell analysis by a range of tissue analytics (including RNA-seq) in tissue. CRS for RA must include approaches for collection of synovium with suggestions for collection of additional tissues encouraged; CRS for lupus must include approaches for collection of kidney biopsies, but consideration of collection of other tissues such as skin is also encouraged.

Projects in Clinical Research Sites should be focused on RA or lupus. A statement describing the site's capability to extend the approaches to a third related autoimmune disease is encouraged but not required.

Activities will generally include, but are not limited to:

• Establish the infrastructure for recruitment and characterization of patient cohorts and controls for Research Phase 0 and Phase I studies. Applications that propose projects on both RA and lupus must indicate a primary focus on either RA or lupus.
• Enroll patients with RA or lupus and controls to obtain relevant tissue specimens for Research Phase 0 and Phase I studies. Identify and plan for the selection of patient cohorts and controls that are most advantageous for Research Phase II studies.
• Include plans for patient phenotyping and make arrangements for genotyping. The projects will include a description of and the rationale for the clinical, laboratory, and other parameters that will be determined for each patient population. Templates and SOPs for collecting data and possibly extracting information directly from the electronic medical record would be needed and linked to individual samples.
• Test different approaches for tissue acquisition. Analysis of tissue samples from different sources (e.g., biopsy, surgically removed, or post-mortem tissue, etc.) to provide an indication about the quality and instructiveness in relation to other factors such as disease status (e.g., biopsy from patients with active disease, surgically removed tissue from patients with end-stage disease, etc.). Applications should include specific plans to collect appropriate and scientifically justified tissue samples from controls and describe samples at hand from patients and controls.
• Compare different processing techniques that use whole tissue or disaggregated preparations, to establish the best methods to match the requirements of different technologies or tissue analytics to be conducted by other Research Sites in the Network (e.g., high-throughput single cell RNA-seq or mass cytometry) while maximizing the yield and informative potential of each specimen.
• Together with other Network Research Sites and the LC, implement data management, statistical plans and analyses that are consistent with the standards agreed by the NLC.
• Conduct a Pilot and Feasibility Research Project.

Preliminary Data. The application should include data documenting experience in assembling relevant patient cohorts and sufficient information relevant to the site's capability to obtain relevant tissue specimens from patients and controls.

The projects are expected to produce results to establish the feasibility of validation studies of analytic technologies, as applied to blood and tissue cells, and to identify specific areas of focus for the analyses to be conducted on additional cohorts in Research Phase II. Advancement into Research Phase II will be contingent upon demonstrating that the quality of the data is sufficient to produce a meaningful systems analysis, following administrative review, and depending on availability of funds.

Network Technology Research Sites (TRS)

Technology Research Sites will develop, test, standardize, and validate one or more advanced and/or new technologies to identify critical signaling pathways in cells and tissues. These sites will work closely with the Clinical Research Sites to develop the most effective strategies for tissue and sample handling to maximize the yield, reproducibility and utility of the proposed analytic methods. They will collaborate with the relevant teams of LC on data coordination, statistical research as well as the Systems Biology and Bioinformatics Group to ensure the quality and consistency of the experimental approaches, statistical plans and analyses, and to ensure that data, data platforms, and data analysis plans are in compliance with Network standards for quality assurance/control.

Research Objectives may include but are not limited to the following (new emerging technologies that are not listed here are encouraged):

• Conduct RNA-seq of multiple distinct immune cell subsets from blood and disease tissue.
• Perform single cell RNA sequencing of tissue-resident cells from biopsies.
• Evaluate the epigenetic landscape, including methylation, histone modifications, and DNase hypersensitivity in specific cell subsets of interest.
• Conduct multiparameter cell phenotyping and phospho-flow analysis using mass cytometry approaches in cells from RA and lupus patients.
• Identify the immunoglobulin repertoire by application of single cell RNA-seq from plasmablasts.
• Study proteomics and metabolomics in serum and urine.
• Describe the microbiome and its correlation with diseases.

Research Scope

The UH2/UH3 must be submitted as a single application but the approach should be clearly organized into two stages: UH2 (Exploratory) and UH3 (Implementation).

UH2

Activities supported during this stage include:

• Adapt new analytic technologies for molecular analysis of single cells or rigorously defined subsets of cells in disease tissues, including standardized methods.
• Compare the results of applying single cell analytic technologies (e.g., single-cell RNAseq) using materials obtained from fresh, frozen, or fixed tissue and cells; or isolated by in-situ laser capture microdissection vs. disaggregation of tissues.
• Systematic examination of relevant adaptive and innate leukocyte subpopulations in the peripheral blood including (but not limited to): CD4+ T cells (Treg, Th17, na ve, effector memory, central memory), CD8+ T cells (na ve, memory), B cells (na ve, transitional, IgM and switched memory, marginal zone-like, regulatory, plasmablasts/plasma cells), monocytes/macrophages (M1, M2), and dendritic cells (subpopulations based on the expression of surface markers CD103, CD11c, CD11b).
• Develop approaches to study small populations of rigorously defined, highly purified subpopulations in the blood to allow comparisons between profiles (e.g., mRNA expression or other 'omic' data) of circulating cells and those in the tissue, with the goal of identifying profiles in circulating cells that correlate with specific changes in the tissue.
• Together with other RS and the LC, implement the Network data management, statistical plan and analysis that are consistent with the standards agreed by NLC.
• Develop approaches to ensure quality of data and consistency of the experimental approaches, the statistical plans and the proposed analysis.
• Conduct a Pilot and Feasibility Research Project.

Preliminary Data. Suitable technologies or assays to be proposed for development/adaptation must be based on a working prototype (for new technologies) or an existing technology (which will serve as basis for adaptation) demonstrating a general feasibility of the proposed approaches. Data demonstrating applicability to the autoimmune diseases is not a prerequisite for application. The application should describe plans for standardization and validation. In Research Phase 0 and I (UH2), a variety of tissue/cell types, collection methods and analytic techniques can be applied and compared.

Advancement into Research Phase II will be contingent upon demonstrating that the quality of the data is sufficient to produce a meaningful systems analysis, following administrative review, and depending on availability of funds.

Network Combined Clinical and Technology Research Sites (CTRS)

The Combined Clinical and Technology Research Sites will validate new and/or existing technologies in clinically meaningful contexts. The CTRS applications should have 1) sufficient infrastructure and necessary arrangements in place at the time of award to enroll large numbers of patients with either disease; 2) have acquired relevant peripheral blood and tissue samples to begin Research Phase I studies; and 3) have generated enough preliminary data to establish the feasibility and relevance of the proposed tissue analytic or platform. These sites are also appropriate when there is a requirement to conduct tissue analytics experiments at a site nearby or within the facility of tissue acquisition.

Research Objectives include those described for the CRS and the TRS above, with combined activities of tissue acquisition and analytics.

Research Scope

UH2

The UH2 will support primarily the Research Phase I activities and the planning for Network-wide Research Phase II studies. However, limited activities for Research Phase 0 are also allowed. During the UH2 funding period the goal will be to demonstrate the feasibility of one or more single cell analytics in blood and tissue samples in one disease. Activities that can be supported during this stage include combination of those described for the CRS and the TRS above.

Preliminary Data. The application should include sufficient and detailed description of the Preliminary Data supporting the proposed Research Phase I study.

All Research Sites

Pilot and Feasibility (P&F) Project

Applicants must state the rationale they will use to develop the P&F projects that are innovative and exploratory to allow the exploration of new or alternative approaches, tissue analytics, tissue acquisition strategies or tissue types that may enhance the overall goal of the main project proposed in the application or the goals and objectives of the Network. Preliminary data are not required. Description of specific P&F projects will not be included in the application. Following award, the Network LC will coordinate the planning and implementation of P&F projects to ensure efficient utilization of research resources and funding. P&F projects will also be milestone driven, limited to two years and they may be extended, expanded, or replaced after two years based on the NLC s evaluation of progress.

UH3

The UH3 funding period will support Network collaborative Research Phase II scaled-up validation studies. The goal is to produce results that will allow for analysis of the heterogeneity, at the molecular and cellular level, among patients with different characteristics. Power calculations obtained during the UH2 period will be used to define the size of the cohorts and the number of variables allowed within the cohort needed to get meaningful data for comparison among patients. Cohort size will range between 50 to 200 patients and controls and may include, for example, patients starting anti-TNF therapy, RA patients with established disease starting a new DMARD treatment, or early RA cohorts. Differences in disease pathways could also be investigated by patient subphenotypes (e.g., response or lack of response to DMARD treatments, effect of prior DMARD treatment, serum positivity of anti-citrullinated protein antibodies (ACPA), etc.). Examples for scaled-up studies in lupus may include, but are not limited to, new onset lupus nephritis before and after therapy, or treatment response in patients with skin disease. Control cohorts may also be included as appropriate and feasible. It is recognized that applicants will NOT know in advance with whom they will be collaborating because the members of the Network will not be known before award; therefore, applicants should make reasonable assumptions as to the types of collaborations that will be available and build flexibility into their research plan.

Milestones and UH2/UH3 transition

The UH2 section must include milestones that will be reached at the end of the UH2 funding period. To be eligible to successfully transition to the UH3, the project must reach the following milestones, in addition to those specifically outlined in the application:

• The rate of sample acquisition in Research Phase I demonstrates feasibility of proceeding to Research Phase II within the proposed budget and timelines.
• The tissue-derived data is sufficiently robust to:
• Identify cells of the same type within and among samples.
• Generate a significant disease-specific signature derived from results of single cell analyses.
• Establish the number of samples required to successfully execute Research Phase II study.
• Development and documentation of all collaboration and partnerships necessary for conduct of the scaled-up validation study. These may include selection of clinical sites and execution of agreements on data use.
• Finalization of protocols, manuals of procedure, and data collection forms. These should have all necessary approvals including Institutional Review Boards (IRB) and protocol review committees. If data collection forms are to be integrated into an existing electronic record, demonstration of the integration must be provided. If data will be collected from existing electronic sources, demonstration of validated methods to collect such data should be provided.
• All necessary human subject protection approvals and procedures are in place. This includes IRB approval, review and approval of final informed consent documents or waiver of informed consent, and selection of medical monitors/data safety monitoring boards.
• Provide documentation of a potential study population adequate to meet the sample size of the proposed Research Phase II study. Demonstrate ability to recruit potential participants to enroll in the clinical study.

Transition from UH2 to UH3:

Proposed UH3 projects will undergo administrative review by NIH program staff.

At the completion of the Research Phase I project or the UH2 exploratory funding period, whichever comes first, the applicant will be required to submit a detailed transition request for the UH3 (Implementation) project. UH3 transition requests will undergo an administrative review to determine whether the request will be approved. It is anticipated that not all funded UH2 projects will transition to the UH3 stage. Prospective applicants should note that funding of the UH2 stage of the UH2/UH3 Phase Innovation cooperative agreement does not guarantee support of the UH3 Implementation project. UH3 Implementation projects are expected to require the collaborative efforts of multiple or all UH2 awardees in the Network.

Criteria used to determine which UH2 projects will be continued into the UH3 will include the following:

• Successful achievement of milestones specified by the investigator for the UH2 period of the project.
• Feasibility based on proposed patient populations and statistical considerations.
• Potential for meeting the goals of the AMP RA/SLE Program.
• Availability of funds.

Existing consortia and networks are encouraged to apply.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	Issuing ICs and AMP partners intend to commit an estimated total of up to $4 million in fiscal year 2014 to fund 3-6 awards.
Award Budget	The application budgets for UH2 and UH3 stages are not limited but need to reflect the actual needs of the proposed project.
Award Project Period	The total project period for an application in response to this FOA may not exceed five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City 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. Territory or Possession

Other

• 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
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Justine Buschman
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800
6701 Democracy Blvd.
Bethesda, MD 20892-4872
Telephone: 301-496-4811
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Other Attachments: The application should contain the following information uploaded as a pdf attachment with the file name "Central IRB". The filename provided for each will be the name used for the bookmark in the electronic application in eRA Commons.

Central Institutional Review Board. Document the experience of the applicant organization with the use of Centralized IRB models and services, including a list of ongoing studies and studies completed over the past five years in which the applicant organization participated using centralized or mixed IRB models. Provide documentation regarding any centralized IRB services provided by the applicant organization and include a list of ongoing and recently completed studies (with participant Institution contact Information) under the oversight of the Central IRB at the applicant Institution.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

• Applicants must budget to travel several key persons (at a minimum the project PD(s)/PI(s)) to attend two separate, one and a half day meetings of the NLC annually in the DC Metropolitan/Bethesda MD area.
• There must be an appropriate mix of time allocated for senior and junior scientists to ensure the successful conduct of the study.

Budget Justification: The UH2 budgets should clearly identify Research Phase 0 costs and Research Phase I costs. The UH2 budgets for the Combined Clinical and Technology Sites should clearly identify clinical and tissue analytics costs for both Research Phase 0 and for Research Phase I.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Applicants should address the scientific questions to be answered and what specifically will be done during each of the funding periods (UH2 and UH3). Specific aims should be scientifically appropriate for the distinct research phases of the project and should be presented as follows:

UH2 (Exploratory)

Research Phase 0 Specific Aims

Research Phase I Specific Aims

UH3 (Implementation)

Research Phase II Specific Aims

Research Strategy: Organize the Research Strategy as described below.

Background, Significance and Innovation

• Define the problem to be solved and the specific gaps in knowledge that the project will address.
• Outline the rationale for the selection of the technology and/or patient cohorts.
• Describe the potential to improve understanding of critical pathways and relevance to the targeted disease and other autoimmune diseases.

Preliminary data

• Clinical Research Site and Combined Clinical and Technology Research Site applications should summarize preliminary data documenting experience in assembling relevant patient cohorts and provide sufficient information about the capability to obtain relevant tissue specimens from patients and controls. The CTRS applications should include a description of samples at hand.
• Technology Research Sites and Combined Clinical and Technology Research Site applications should summarize preliminary data documenting the technology’s potential to achieve both analytical and clinical sensitivity and specificity comparable to currently used technology. Preliminary data obtained applying a new analytic using cells from RA or lupus patient are desirable but not mandatory.

Approach

The Approach section should be divided in two parts corresponding to the UH2 and UH3 stages. All sites should address Research Phase 0, Research Phase I, Pilot and Feasibility Projects, Milestones and Timeline, and UH3 (Implementation) stage. It is recommended that the UH3 Research Strategy not exceed one page.

UH2 (Exploratory) - address each of the items listed below.

• Research Phase 0:

CRS should address the following critical areas:

• Overall research rationale and design for the selection of patient cohorts and relevant controls.
• Description and justification for the selection of tissue acquisition and processing approach.
• Plans for start-up activities, organization and development of SOPs.
• Plans for replication/small scale validation studies.
• Plans for standardization.
• Plans for patient phenotyping, including clinical, laboratory and other parameters.
• Strategies, pitfalls and alternative approaches to expedite IRB review and approval and for timely recruitment and tissue acquisition.
• Establish the methods of tissue and other specimen collections in patients and controls.
• Establish milestones and timelines to assess research progress.

TRS should address the following critical areas:

• Rationale for the selection and description of cutting-edge technologies.
• Plans for standardization and validation to ensure quality of data and consistency of the experimental techniques.
• Statistical justification for study design and approach (the number of subjects/samples needed and a clear scientific rationale for the range and types of subjects/samples to be used).
• Data management plans for the proposed analyses.
• Plans for replication/small scale validation studies.
• Plans for standardization.
• Strategies, pitfalls and alternative approaches to demonstrate the feasibility of applying newly emerging analytic techniques to study tissue, blood and other samples from participants with RA or lupus (including synovium and kidney, with suggestions for additional tissues encouraged).
• Establish milestones and timelines to assess research progress.

CTRS should address the following critical areas:

• Plans and scientific rationale for the proposed Research Phase I study.
• Overall research rationale and design for the selection of patient cohorts and relevant controls.
• Description and justification for the selection of tissue acquisition and processing approach.
• Plans for start-up activities, organization and development of SOPs.
• Plans for standardization.
• Plans for patient phenotyping, including clinical, laboratory and other parameters.
• Strategies, pitfalls and alternative approaches to expedite IRB review and approval and for timely recruitment and tissue acquisition.
• Establish the methods of tissue and other specimen collections in patients and controls.
• Rationale for the selection and description of cutting-edge technologies.
• Plans for standardization and validation to ensure quality of data and consistency of the experimental techniques.
• Statistical justification for study design and approach (the number of subjects/samples needed and a clear scientific rationale for the range and types of subjects/samples to be used).
• Data management plans for the proposed analyses.
• Plans for replication/small scale validation studies.
• Strategies, pitfalls and alternative approaches to demonstrate the feasibility of applying newly emerging analytic techniques to study tissue, blood and other samples from participants with RA or lupus (including synovium and kidney, with suggestions for additional tissues encouraged).
• Establish milestones and timelines to assess research progress.
  
  
• Research Phase I:
  All sites
• Research design and plans for demonstrating disease specific pathway maps for RA or lupus; provide rationale for selection of patient cohorts and approaches for tissue acquisition and tissue analytics; and compare samples from RA or lupus patients with controls to permit systems biology analysis to identify pathways that distinguish disease and non-disease tissue.
• Strategies, pitfalls and alternative approaches to enroll clinical study cohorts; validate analytic technologies as applied to tissue and peripheral blood cells; and analyze sufficient samples to inform power calculations and establish the feasibility of larger studies.

Pilot and Feasibility Project (P&F)

All sites: Applicants must state the rationale they will use to develop Pilot and Feasibility Projects (P&F). Pilot and Feasibility projects may be proposed when the approach (i) requires additional resources to be provided by the Network (e.g., systems analysis), (ii) is at a very early stage of development, or (iii) it represents an alternative to the approach proposed for the main project of the UH2 funding period. Description of specific P&F projects will not be included in the application. This section is limited to half page.

Milestones and timeline

All sites: A timeline, including milestones, is required. The application must include well-defined milestones: e.g., appropriate objective performance targets, quantitative indicators for go/no go decision points such as an appropriate level of detection and coefficient of variation, or sensitivity and specificity (for examples of appropriate milestones, see http://imat.cancer.gov/resources/milestones.asp); and timelines for assessing progress, including specific milestones for progressing from the UH2 to the UH3 funding periods. Address each of the items listed below:

• Define a timeline for the anticipated attainment of each milestone and the overall goal.
• Describe any impediments that could require an addendum to the research plan, milestones, or timeline with a discussion of alternative approaches.

UH3 (Implementation)

All sites:

• Research Phase II
• Provide an overall brief preliminary plan to assess the validity of the technology in the relevant patient cohorts and the relevance of the biological hypothesis in each of the disease areas proposed.
• Identify plans for any additional work required for scaling the approach to Research Phase II (implementation), for example:
  - Engineering or development to optimize the analytic.
  - Modifying approaches to accommodate the larger number of patients to be recruited and data to be managed.

It is recognized that applicants will NOT know in advance with whom they will be collaborating because the members of the Network will not be known before award; therefore, applicants should make reasonable assumptions as to the types of collaborations that will be available and build flexibility into their research plans. Applicants must not propose work that duplicates efforts already funded or underway. When possible, applicants should adopt or adapt resources of ongoing NIH supported efforts in informatics as well as other national efforts including but not limited to the many federal investments in the Knowledge Portal, CTSAs, REDCap, PROMIS, NIH Toolbox, eMERGE, ImmPort, NCBI/GenBank, etc.

Regulatory Considerations

All applicable laws and regulations for shipment should be satisfied. For example, ISBER Best Practices and International Air Transport Association (IATA) regulations (ISBER 2008; IATA 2009) should be consulted for information concerning international transport regulations and classifying samples for shipment. Variation in national and regional standards regarding biospecimen transport should be considered when shipping biospecimens to or from an international location.

Letters of Support: A letter from the institution describing the relevant expertise, experience and accomplishments of the applicant organization in planning, coordinating and managing the activities and functions provided for in the FOA, particularly with respect to autoimmune diseases. Document, as appropriate, institutional commitment to the resource, any other sources of funding (and amounts) expected to be available to maintain full operation, business plans for actions related to cost recovery, documentation of relevant partnerships, etc.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide

• All applications under the AMP will be required to submit a data sharing plan. Applicants and their institutions are expected to describe their plans for making data and other research resources broadly available to the biomedical community. Applicants should include in their data sharing plan the assurance that data will be made available as soon as quality control procedures have been completed at the local institution. Any sharing plans by the institution represent a commitment by the institution (and its subcontractors, if any) to support and abide by the plan. Reviewers will be asked to comment on the plan. After completion of the initial review, NIH program staff will be responsible for any additional administrative review of the plan for sharing data. The adequacy of any data sharing plan will be considered by program staff when making recommendations about funding applications. Any final accepted data sharing plan will become a term and condition of the award of the cooperative agreement. The effectiveness of the data sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

Applications will be assigned a single impact score for both UH2 and UH3 phases.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

Clinical Research Sites & Combined Clinical and Technology Research Sites Applications: Does the investigative team have the clinical expertise and competencies relevant to recruitment and characterization of large cohorts of patients with RA and/or lupus and relevant controls? Do they demonstrate understanding or have the expertise to carry out the approach for the tissue acquisition?

Technology Research Sites & Combined Clinical and Technology Research Sites Applications: Is there evidence of strong expertise in the proposed technologies?

All Research Sites Applications: Is there a plan to collaborate with Network investigators to test an analytic or technology on one or more patient populations?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Specific to this FOA:

Clinical Research Sites and Combined Clinical and Technology Research Sites Applications: Is the scientific rationale for the selection of patient cohorts and relevant controls adequately justified and most advantageous for Research Phase 0, I and II studies? Is there a robust strategy for expedited IRB review and approval, timely recruitment and tissue acquisition in meeting the objectives for each research phase? Are plans for patient phenotyping, including clinical, laboratory and other parameters, for each population adequately described?

Technology Research Sites and Combined Clinical and Technology Research Sites Applications: Is there a sound rationale for the selection of cutting edge technologies? Is there evidence of technical excellence and capacity for the proposed analytics, demonstrating general feasibility of the proposed approaches? Data demonstrating applicability to RA and lupus are not a prerequisite for applying. Are there plans for standardization and validation? Are procedures in place to ensure quality of data and consistency of the experimental techniques as well as adequate data management and statistical plans for the proposed analyses?

Combined Clinical and Research Sites Applications: Is there evidence of an existing infrastructure and resources and preliminary data to enable rapid transition to Research Phase I activities?

All Research Sites Applications: Are the milestones and timeline for Research Phase 0 and I quantitative, feasible, and appropriate to assess continued research progress or emerging difficulties? Are the activities of each of the Research Phases clearly defined? Are they appropriate to establish the feasibility of Phase II studies? Is there potential to contribute to scaled up Phase II studies? Does the application include a rationale for the development of Pilot and Feasibility Projects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA:

Does the application include plans to provide and use a central IRB?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

UH2/UH3 Milestones and Timeline

Is the overall plan for the progression from UH2 exploratory to the UH3 implementation funding periods well thought out? Is the sequence of elements/steps in the phased UH2 project clearly defined, logical, and complete? Are milestones provided for the UH2 stage properly objective and quantitative whenever appropriate? Are these milestones well aligned with the specific aims of the Research Phases? How realistic are these milestones and associated timelines? Do the proposed milestones and timelines clearly identify benchmarks for successful completion of the UH2 stage? Are other critical go/no go decision points and timelines well defined and appropriate?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Sample and Biospecimen Shipping

If applicable, is there sufficient consideration of issues related to shipment and receipt of samples and biospecimens from overseas sites?

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIAMS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

1. Prior to funding an application, the Program Official will contact the applicant to discuss the proposed UH2 and UH3 milestones and potential changes suggested by NIH staff or the NIH review panel. The Program Official and the applicant will negotiate and agree on a final set of approved UH2 milestones which will be specified in the Notice of Award. Revision to the milestones will be expected following the first meeting of the NLC. These revised milestones will be the basis for judging the successful completion of the work proposed in the UH2 stage.

2. For funded UH2 applications, projects that have met the scientific milestones and feasibility requirements will be eligible for rapid transition to the UH3 stage after NIH administrative review.

3. The release of UH3 funds will be based on successful completion of the approved scientific milestones, program priorities, and the availability of funds.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.

The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) will have the primary responsibility for the scientific and administrative leadership and coordination of the project at the awardee institution. The PD/PI will have primary responsibility for defining the details for the projects within the guidelines of this FOA and for performing all scientific activities. The awardee institution will agree to accept the close coordination, cooperation, and participation of the NIH Project Scientists (PS) and the NIH Program Official (PO), in those aspects of scientific and technical management of the project as described below.

• Determine experimental approaches, design protocols, set project milestones, conduct experiments, and analyze and interpret research data.
• Provide goals for projects and protocols and costs to the PO and PS, at the outset of the award, following re-negotiation of the milestones after the first meeting of the NLC and at six months intervals thereafter.
• Ensure that all projects involving human subjects have the appropriate clearances (e.g., IRB, FWA, human subject’s research training, and other required documentation) prior to implementation.
• Serve as a voting member of the NLC, and participate, along with critical staff, in NLC meetings including two face-to face meetings in the Bethesda-MD/metropolitan Washington, DC area.
• Adhere to Network guidelines and other policies that might be established, as agreed upon by the NLC, and the PO to the extent consistent with the applicant’s submitted statements and applicable grant regulations.
• Apprise the PO and the PS of any potential impediments to execution of the goals of the Project.
• Ensure that primary and secondary data, protocols, and procedures are made available to Network participants to meet the goals of the Network (e.g., deposited in a centralized database, as specified by the NIH PO and the PS) according to a timeline agreed upon by NLC and the PO and to the extent consistent with the applicant’s submitted statements and applicable grant regulations.
• Agree not to disclose confidential information obtained from other members of the Network.
• Be prepared for annual administrative site visits by NIH staff.
• Be solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the awardee to perform the project.
• Be required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sec. 200-212 (Bayh-Dole Act).
• Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
• The PD/PI is responsible for selecting and implementing Pilot and Feasibility Projects in accordance to guidelines developed and approved by the NLC, by the PS and by the PO.

NIH staffs have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH Project Scientists (PS)

The role of PS in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s).

The PS will:

• Work closely with the PD(s)/PI(s) and other Network investigators to facilitate collaborations and to leverage the resources available to the sites and the network. They will assist in the integration of the individual RS and LC components into a collaborative research network.
• Monitor the progress of the LC, help coordinate research approaches, and contribute to the shaping of research projects or approaches as warranted. The PS will support and facilitate this process but will not direct it.
• Assist in avoiding unnecessary duplication of effort across the Network, and help coordinate collaborative research efforts that involve multiple sites.
• Keep the PDs/PIs informed about other ongoing studies supported by NIH to avoid duplication of effort and encourage resource sharing and collaborations. The PS will coordinate access to other NIH resources, as well as assist the research efforts of the LC and RS by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.
• Serve as voting members of the NLC and assist in developing the network priorities and research agenda, operating guidelines and consistent policies for dealing with situations that require coordinated action.
• Retain the option to recommend to the PO the withholding or reduction of support from any cooperative agreement that substantially fails to achieve its goals according to the milestones agreed to at the time of the award or fails to comply with the Terms and Conditions of the award.
• Serve as scientific liaison between the awardees and other NIH program staff.
• Review and comment on critical stages of the Network progress.
• Share opportunities and discuss strategies and potential avenues of collaborations (such as with industry, private foundations and/or NIH intramural scientists).

NIH Program Official (PO)

The PO is responsible for the normal scientific and programmatic stewardship of the award. The PO will:

• Provide approval for transition of projects to Phase II.
• Have the option to recommend, following consultation with the Network, NIH PSs and NIH officials, the possible withholding, reduction, or reallocation, as appropriate, of support from any center component that substantially fails to achieve its goals according to the milestones agreed to by the center at the time of the award or fails to comply with the Terms and Conditions of the award, at the appropriate times.
• Have the option to recommend, following consultation with the PS and the NIH officials, an increase in support to engage in further research efforts within the original research scope, as appropriate, for any center component showing that additional research would be substantially exceeding its goals according to the milestones agreed to by the center and substantially improving state-of-the-art capabilities, at the appropriate times.
• Participate in the NLC meetings as an ex officio (non-voting) member.
• Retain the option to recommend, with the advice of the NIH PSs re-allocation of NIH support among awardees, as scientific goals evolve.
• Carry out continuous review of all activities to ensure objectives are being met.
• Serve as the official NIH representative in all communications with the NLC.

Areas of Joint Responsibility Include:

The NLC will be the primary governing body for all Network scientific activities. The NLC will provide the collaborative environment to coordinate all projects awarded under these FOAs and recommend the projects that should progress from Research Phase I to Phase II. The voting membership of the NLC will include: one PD/PI from each award made under this and the companion FOA, the Directors of the SBG and the TRG. During the first year of award, the Chair of the NLC is the PD/PI of the LC. Starting on year two, the NLC will have the option to elect a new Chair that will serve for a period of one year. Face-to-face meetings of this committee will occur at least twice a year. At least a portion of the NLC meeting will be open to the public.

NLC Composition - Voting members of the NLC may include:

• The Program Directors/Principal Investigators (PDs/PIs) of the Research Sites
• The PD/PI of the LC
• The Directors of the Systems Biology and Bioinformatics Group (SBG) and the Tissue Acquisition Research Group (TRG)
• The NIH Project Scientists (together representing a minority of voting members - not to exceed 1/3 of NLC membership). Other NIH Program staff may attend the meeting as non-voting members.

NLC Functions

The NLC will be the primary governing body for all Network scientific activities. The NLC will provide the collaborative environment to coordinate all projects awarded under the two FOAs.

The role of NLC includes:

• Foster collaboration, synergy and sharing among the projects and investigators in the Network.
• Provide the primary mechanism for interactions with NIH.
• Oversee the planning of Network scientific activities, including dynamic adjustment as needs and opportunities arise.
• Guide the development and documentation of the Network standards and guidelines.
• Prioritize the use of LC resources including systems biology analyses and bioinformatics.
• Evaluate progress in the LC and RS and recommend adjustments in approaches if necessary, including implementation of new projects and changes to ongoing studies and termination of projects and sites.
• Foster partnerships and collaborations that will facilitate the extension of the approach to new technologies and their application to related autoimmune disease.
• Review Network Resource Sharing Plan to ensure consistency and appropriateness for achieving the goals of the Network.
• Develop and approve Network-wide intellectual property agreements consistent with the terms and conditions of the cooperative agreement awards, applicable regulations, and the policies and practices of the awardee institutions.

Responsibilities of the NLC include:

• The NLC will convene at least two 1 to 2 day in person meetings annually in the Bethesda MD-Washington DC area. Additional regular meetings will be conducted by teleconference or videoconference. Prior to each meeting, teleconference or videoconference, the NLC Chair will prepare an agenda for review and approval, and distribute to members of the NLC and the LC. Following these meetings a list of participants and summary of discussion, action items, and recommendations will be prepared and submitted to the PO. Part of these meetings may be open to the public. The NLC Chair may convene additional teleconferences, videoconferences, or electronic reviews to avoid delays in addressing key issues that cannot be evaluated at the regularly scheduled meetings.
• Regularly scheduled NLC meetings will be convened in order to:
• Review progress of Network-sponsored ongoing clinical and technology and tissue analytics studies; review progress of standardization and validation studies, other performance assessments, and future plans and take remedial actions to address delays or other problems.
• The NLC may establish subcommittees or project-specific working groups, or assign responsibility to key staff for other specific Network-related activities.
• Review new tissue acquisition and analytics studies.
• Oversee protocol development for projects approved for implementation by the NLC. Identify need for protocol amendments and/or remedial actions to ensure adequate patient accrual and retention, adherence to protocol requirements and overall progress of studies in collaboration with the NIH PSs; make recommendation to the NIH staff for appropriate actions.
• Coordinate data collection and analysis. Assess requirements for data collection, validation, analysis and security. Make recommendations to the LC about the Network informatics and data and/or information management processes.
• Review and approve outreach and dissemination efforts as proposed by the LC.
• Review governance and fiscal policies and procedures; enforce conflict of interest procedures and policies. The NLC should engage with the PO to ensure that identified conflicts are appropriately addressed.
• Manage publications and communications. Review and approve policies and procedures for authorship, preparation, review, and final approval of manuscripts resulting from Network studies, and for submission of manuscripts for publication in peer reviewed journals.
• Review Data and Safety Monitoring Plans. For each clinical study, the NLC will review recruitment and the Data and Safety Monitoring Plans to ensure adequate enrollment and monitoring of human subjects research. The LC, working with the Network investigators, will solicit, prepare and distribute reports and information for review by the NLC. The LC will follow up on the recommendations of the NLC regarding data and safety monitoring to ensure their adequate implementation.
• Review the data and resource sharing statements, consistent with achieving the goals of the Network. The NLC will review and summarize Network IP management, and develop agreements to be approved by the NLC consistent with the terms and conditions of the NIH awards and applicable regulations. The NLC will work in consultation with the NIH PSs as well as institutional officials from the participating institutions to ensure the effectiveness of any such agreements.
• Awardee members of the Network will be required to accept and implement policies approved by the NLC.

Data Sharing

• The data sharing plan will be referenced as a term and condition of award. Applicant organization must comply with the Public Health Service (PHS) policies relating to distribution of unique research resources produced with PHS funding and sharing of research data and other research resources, as well as the grantee’s data sharing plan subject to decisions of the Network Leadership Committee. For further information, see the NIH Data Sharing Policy at http://grants.nih.gov/grants/policy/data_sharing/.
• The effectiveness of the data sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report.
• The NIH intends for the resource sharing plans for the data generated under the AMP initiative to follow the policy and goals stated in the FOA. Specifically, consistent with achieving the goals of the AMP program, all data generated (including processed/analyzed data) are expected to be deposited in a rapid and timely way into an accessible repository for use by the broad biomedical community, and for these data to remain available to all qualified investigators, consistent with applicable laws, regulations, and policies and unencumbered by any intellectual property claims. The NIH, in consultation with the Network Leadership Committee for this project, will make all final decisions concerning data deposition and data access policies, and all policies are subject to change by the NIH as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.
• Applicant organization will comply with and implement the recommendations and decisions of the Network Leadership Committee with respect to the sharing of information, data, protocols, resources, and methods developed by AMP investigators under the AMP initiative.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the NLC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

Additional details about the governance structure will be outlined in the Notice of Award.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Reporting requirements for both progress and financial reports may be requested more frequently, under the AMP Program, than the standard annual reporting requirements. The details for the reporting requirements will be outlined in the Notice of Award.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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Yan Wang, M.D., Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: [email protected]

Su-Yau Mao, Ph.D.
National Institute for Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
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Nancy Coulter
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:301-496-1886
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Kan Ma, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-451-4838
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Andrew Jones
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Leslie Boggs
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-6450
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Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.