Department of Health and Human Services

Part 1. Overview Information
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

  • 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.  

Key Dates
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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

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.

Background

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. 

AMP RA and Lupus Network

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:

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.).

Structure

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.

Network Leadership Committee (NLC)

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:

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:

The NLC functions will be supported by the LCMP.

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

Research Objectives

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:

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:

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):

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:

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:

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:

Existing consortia and networks are encouraged to apply.  

Section II. Award Information
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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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.

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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:

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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:

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: buschmanj@mail.nih.gov

Page Limitations

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

Required and Optional Components

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.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

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. 

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Preliminary data

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.

CRS should address the following critical areas:

TRS should address the following critical areas:

CTRS should address the following critical areas:

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:

UH3 (Implementation)

All sites:

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

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

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.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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?

Additional Review Criteria

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

Additional Review Considerations

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.

2. Review and Selection Process

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:

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:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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.

Milestones and UH2/UH3 Transition

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.

Prior Approval of Pilot Projects

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 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.

2. Administrative and National Policy Requirements

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.

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:

NIH Program Official (PO) 

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

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:

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:

Responsibilities of the NLC include:

Data Sharing

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.

3. Reporting

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.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Yan Wang, M.D., Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: AMPRALupus@mail.nih.gov    

Su-Yau Mao, Ph.D.
National Institute for Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: AMPRALupus@mail.nih.gov

Nancy Coulter
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:301-496-1886
Email: ncoulter@mail.nih.gov

Peer Review Contact(s)

Kan Ma, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-451-4838
Email: mak2@mail.nih.gov

Financial/Grants Management Contact(s)

Andrew Jones
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301435-0610
Email: jonesan@mail.nih.gov

Leslie Boggs
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-6450
Email: boggsl@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.


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