The National Institutes of Health (NIH), pharmaceutical companies and nonprofit organizations have together created the Accelerating Medicines Partnership® (AMP®) program to develop new ways of identifying and validating promising biological targets for diagnostics and drug development.
1. General:
Where can I get answers to additional questions?
You can email the scientific contacts of the AMP RA and Lupus project at: AMPRALupus@mail.nih.gov.
Where can I learn more about the Accelerating Medicines Partnership (AMP)?
Accelerating Medicines Partnership
Autoimmune Diseases Rheumatoid Arthritis and Lupus component of AMP
List of Acronyms:
AMP: Accelerating Medicines Partnership
CNS: Central Nervous System
CRS: Clinical Research Sites
CTRS: Combined Clinical and Technology Research Sites
DMARD: Disease-Modifying Anti-Rheumatic Drugs
FNIH: Foundation for the National Institutes of Health
FOA: Funding Opportunity Announcement
IP: Intellectual Property
IRB: Institutional Review Board
LC: Network Leadership Center
LCMP: Leadership Center Research, Coordination, Management, and Statistics Program
NIAID: National Institute of Allergy and Infectious Diseases
NIAMS: National Institute of Arthritis and Musculoskeletal and Skin Diseases
NIH: National Institutes of Health
NLC: AMP RA and Lupus Network Leadership Committee
P & F : Pilot and Feasibility
PD: Program Director
PI: Principal Investigator
PO: NIH Program Official
PS: NIH Project Scientists
RA: Rheumatoid Arthritis
RS: Network Research Sites
SBG: Systems Biology and Bioinformatics Group
SC: AMP RA/SLE Steering Committee
SLE: Systemic Lupus Erythematosus
SOP: Standard Operating Procedure
TRG: Tissue Acquisition Research Group
TRS: Technology Research Sites
UH2/UH3: Phase Innovation Awards Cooperative Agreement
UM2: Program Project or Center with Complex Structure Cooperative Agreement
2. Participation:
- Who is eligible to apply?
UM2: Domestic non-profit, for-profit, private, government, and academic researchers/organizations/companies are eligible to directly apply. Non-domestic entities are not eligible to directly apply, but are allowed to be components of an application. Detailed information may be found in the RFA, under Section III Eligibility Information.
UH2/UH3: Non-profit, for-profit, private, government, and academic researchers/organizations/companies, both foreign and domestic are eligible to directly apply. Applications from existing research consortia/networks are encouraged.
- Can non-US organizations participate in the AMP Network?
UM2: Foreign organizations/institutions/companies may participate as components/collaborators of a domestic-led application.
UH2/UH3: Foreign organizations/institutions/companies may directly apply to the UH2/UH3 RFA or participate as components/collaborators of a domestic-led application.
- Is there any limit on the number of applications from a single institution?
UM2: Only one application per institution is allowed.
UH2/UH3: Multiple applications from an eligible organization may be submitted if the proposed science in each application is distinct.
- Can I apply for my own grant if I am going to be a co-investigator on a colleague’s application for the same RFA?
This may be allowable as long as there are sufficient levels of effort committed to each project and there is no scientific, budgetary, or commitment overlaps.
- Can I apply for both the UH2/UH3 and the UM2?
Yes. Institutions/PIs may apply for both the UH2/UH3 and the UM2.
- Can multi-PI applications be submitted?
Yes. Both UM2 and UH2/UH3 applications may propose multiple PIs.
- Can I collaborate with investigators in the NIH Intramural programs?
Yes. Collaborations with investigators in the NIH Intramural programs are strongly encouraged.
3. Logistics:
- What are the dates for submission and review?
Letter of Intent Due Date: 21-April-2014 Applications Due Date: 21-May-2014 Scientific Merit Review: July-August 2014 Earliest Start Date: 20-September-2014 - Do I have to submit a letter of intent? What should be in it? How should I send it?
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 NIH to estimate the potential review workload and plan the review. Letters of intent can be e-mailed, faxed, or sent as hard copy (e-mail is preferred). There is no need to send a hard copy of a letter that has already been sent via e-mail or fax.
Please include as much of the following information as possible:
Information regarding disease focus, technologies to be used, specific aims, etc. is welcomed.
Letters 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
Email: buschmanj@mail.nih.gov- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel, including potential collaborators
- Participating institution(s)
- Number and title of the funding opportunity
- How are the applications submitted?
Please note that the submission mechanisms are different between the UM2 and UH2/UH3.
UM2:
UM2 applications must be submitted as paper applications and may not be submitted electronically. Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)Personal deliveries of applications are no longer permitted.
At the time of submission, two additional copies of the application and all appendix material must be sent to:
Kathy Salaita, Sc.D.
Chief, Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
DHHS/National Institutes of Health
6701 Democracy Blvd. Rm. 818
Bethesda, MD 20892-4872 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)UH2/UH3:
UH2/UH3 applications must be submitted electronically. Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Paper applications will not be accepted. Applicants must then complete the submission process by tracking the status of the applications 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.
- When is the receipt date for submitting an application?
The application due date for both the UM2 and UH2/UH3 is Wednesday, May 21, 2014. There will be no extension to the deadline. If you have served recently as a reviewer or advisory council member, normally you get an extension to your own submission deadline; however, extensions do not apply for these RFAs. The continuous submission policy does not apply to these RFAs.
UM2:
Paper applications must be received by the NIH no later than Wednesday, May 21, 2014.
UH2/UH3:
Electronic applications must be submitted no later than Wednesday, May 21, 2014 by 5:00 p.m. local time of the applicant. 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.
- What is the page limit for the RFAs?
UM2:
All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application:
UH2/UH3:
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
- Overall: 30 pages
- Leadership Center Research, Coordination, Management, and Statistics Program:
- Research Project Management: 6 pages
- Operational Management: 6 pages
- Data Coordination and Management: 12 pages
- Statistical Research: 12 pages
- Systems Biology and Bioinformatics Group: 12 pages
- Tissue Acquisition Research Group: 12 pages
- Research Strategy for the combined UH2 (Research Phases 0-I) and UH3 (Research Phase II) is limited to 12 pages. This total page limit can be divided between the UH2 and UH3 components as applicants deem appropriate though it is recommended that the UH3 Research Strategy not exceed one page.
- Who will review the applications?
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review. Completeness criteria may be found in Section IV of the RFAs. Applications will be evaluated for scientific and technical merit by a NIAMS-convened review panel as outlined in Section V.
- Will there be an opportunity to resubmit an application if it is not successful?
Neither the UH2/UH3 nor the UM2 RFAs allow resubmissions.
4. Budget
- What funds are available and what is the anticipated number of awards?
UM2:
The NIH intends to commit up to $1.4 million in total costs in FY 2014 to fund one award.
UH2/UH3:
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.
- What is the award budget?
UM2:
The UM2 budget is limited to $2 million per year in total costs for years 1 and 2, and limited to $3 million per year in years 3, 4 and 5.
UH2/UH3:
The UH2/UH3 budget is not limited, but needs to reflect the actual need of the proposed project.
- How should the project budget be presented in the UH2/UH3 application?
The UH2 budget 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 Research Phase I. The UH3 budget will undergo reassessment during the UH2 exploratory funding period. A budget table, similar in format to the examples shown below, should be included in the Budget Justification section (section K) of the SF424 R&R Form.
SAMPLE: Clinical Research Sites Direct Cost Budget for All Proposed Years of Support
Component Year 1 Year 2 Year 3 Year 4 Year 5 All Years Research Phase 0/UH2 250,000 0 0 0 0 250,000 Research Phase 1/UH2 100,000 350,000 0 0 0 450,000 Pilot Project/UH2 100,000 100,000 0 0 0 200,000 Research Phase II/UH3 0 0 850,000 850,000 500,000 2,200,000 Total Direct 450,000 450,000 850,000 850,000 500,000 3,100,000 SAMPLE: Technology Research Sites Direct Cost Budget for All Proposed Years of Support
Component Year 1 Year 2 Year 3 Year 4 Year 5 All Years Research Phase 0/UH2 100,000 0 0 0 0 100,000 Research Phase 1/UH2 150,000 325,000 0 0 0 475,000 Pilot Project/UH2 100,000 100,000 0 0 0 200,000 Research Phase II/UH3 0 0 1,400,000 1,400,000 1,000,000 3,800,000 Total Direct 350,000 425,000 1,400,000 1,400,000 1,000,000 4,575,000 SAMPLE: Combined Clinical and Technology Research Sites Direct Cost Budget for All Proposed Years of Support
Component Year 1 Year 2 Year 3 Year 4 Year 5 All Years Research Phase 0 Clinical/UH2 50,000 0 0 0 0 50,000 Research Phase 0 Analytics/UH2 50,000 0 0 0 0 50,000 Research Phase 1 Clinical/UH2 100,000 175,000 0 0 0 275,000 Research Phase 1 Analytics/UH2 150,000 425,000 0 0 0 575,000 Pilot Project/UH2 100,000 100,000 0 0 0 200,000 Research Phase II/UH3 0 0 2,700,000 2,700,000 1,500,000 6,900,000 Total Direct 450,000 700,000 2,700,000 2,700,000 1,500,000 8,050,000 - Do I need to include a travel budget for the Research Leadership Committee meetings to be held in the Washington, DC metropolitan area?
Yes. Applications should budget for travel of several key persons (at a minimum the project PD(s)/PI(s)) to attend two separate, one and one half day meetings annually in the DC metropolitan/Bethesda, Md., area.
5. UH2/UH3 Award:
Criteria used to determine which UH2 projects will be continued into the UH3 will include the following:
- What are the different research phases and how do they fall within the UH2 / UH3 mechanism?
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:
The UH2 funding period will provide support for Research Phases 0 and I activities in years 1 and 2. The UH3 funding period will support Research Phase II in years 3 through 5.
- Research phase 0: Testing of different means of obtaining and prepping tissue and 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 drug (DMARD) treated groups, etc.; Lupus: pre- vs. post-treatment, comparison among types of kidney disease, etc.).
- How will the UH2/UH3 grant mechanism work?
The UH2/UH3 (Phase Innovation Awards Cooperative Agreement) mechanism is 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 UH2 section of the proposal must include milestones to be accomplished by the end of the UH2 funding period. At the completion of the Research Phase I project or the UH2 exploratory funding period, whichever comes first, the investigator(s) 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.
- 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.
- Will there be a funding gap during the UH2/UH3 transition?
Projects that successfully make the transition from the UH2 to the UH3 mechanism will not experience a funding gap.
- What sort of sample sizes should be proposed for the UH2 funding period?
Applications should indicate, and provide rationale for, the sample size that would be required for both the standardization of the methodology and to demonstrate feasibility of the approach to move to Research Phase II (UH3 funding period). While desirable, it is not mandatory for individual RS applications to demonstrate access to the total number of patients and specimens required to complete Research Phase I; we expect that other Network sites may contribute additional samples and tissue specimens.
- Can I propose both RA and lupus studies for the Clinical Research Sites?
The applicants can propose to include both RA and lupus studies, but need to indicate which disease is the primary focus.
- Is it required for the Technology Research Site (TRS) applications to propose analyses for both RA and lupus specimens?
TRS applications are not required to propose analyses for both RA and lupus specimens. Applications that include experiments in samples from both diseases must indicate the primary disease focus.
- Is the TRS expected to perform a broad range of technologies?
The applicants are encouraged to propose one or more technologies based on their strength and capability. There is no requirement to propose more than one tissue analytic approach.
- Do I need to have tissues in hand in order to apply for the Combined Clinical and Technology Research Site (CTRS)?
Applications to the CTRS need to provide evidence (existing infrastructure, resources, and preliminary data, etc.) to enable rapid transition to Research Phase I activities (during the first year of the award). While having tissue samples at hand is not a requirement, evidence demonstrating i) previous experience, or ii) the ability to obtain and process such samples must be included in the application.
FAQs will be added as questions are received.
Please contact AMPRALupus@mail.nih.gov if you have questions.
Accelerating Medicines Partnership and AMP are registered service marks of the U.S. Department of Health and Human Services.