Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Dental and Craniofacial Research (NIDCR)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Research on Women's Health (ORWH)
UC2 High Impact Research and Research Infrastructure Cooperative Agreement Programs
The purpose of this FOA is to establish Disease Teams for the Accelerating Medicines Partnership Autoimmune and Immune-Mediated Diseases (AMP AIM) Program. Disease Teams (DTs) will focus on one of the following diseases: rheumatoid arthritis, lupus, psoriatic spectrum disease, or Sj gren’s syndrome. The goal of the AMP AIM Program is to gain a comprehensive understanding of cellular and molecular disease pathways and to identify novel targets for intervention. Disease Teams will lead the research efforts to define the most significant scientific opportunities that can be addressed with state of the art and next-generation tissue interrogation technologies in the context of disease de- and reconstruction approaches of AMP AIM. DTs will work collaboratively to identify molecular and cellular pathways of disease by probing the structural, functional and molecular complexities of end organ tissue in relevant patient populations with state-of the art and next generation analytics provided by the Technical and Analytic Cores (RFA-AR-21-016). DTs will work to harmonize, integrate and optimize all aspects of the data generation pipeline, from tissue collection to data analysis and interpretation.
June 15, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| July 15, 2021 | Not Applicable | Not Applicable | September 2021 | January 2022 | November 2021 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
No late applications will be accepted for this Funding Opportunity Announcement.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.
Purpose
This Funding Opportunity Announcement (FOA) is one of two FOAs that implement the Accelerating Medicines Partnership in Autoimmune and Immune Mediated Diseases (AMP-AIM) Research Network. The goal of the planned AMP Autoimmune and Immune Mediated Diseases (AMP AIM) Program is to ascertain and define shared and disease-specific biological pathways in order to identify relevant drug targets for the treatment of rheumatoid arthritis (RA), systemic lupus erythematosus, psoriatic spectrum diseases (PSD), Sj gren’s syndrome (SS), and related autoimmune and immune mediated diseases. The NIAMS, the NIAID, the NIDCR and the ORWH as participating members of the AMP AIM Program, are promoting these goals by publishing two FOAs to solicit applications for the development of AMP AIM Disease Teams (AMP AIM DTs), AMP AIM Technology and Analytic Cores (AMP AIM TACS), and an AMP AIM Research Management Unit (AMP AIM RMU). The DT, TAC and RMU award recipients will form the AMP AIM Network and will work collaboratively to implement the AMP AIM Research Program. The Research program will be developed by the AMP AIM Network in collaboration with the NIH and industry partners that will guide and advise on the scientific direction of the project.
This FOA solicits applications specifically for the AMP AIM Disease Team awards. Each Disease Team (DT) will focus on one of the following diseases: rheumatoid arthritis, systemic lupus erythematosus, psoriatic spectrum disease, or Sj gren’s syndrome. Applicants interested in the AMP TACs or RMU must use the companion FOA (RFA-AR-21-016).
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 protocols that are publicly available and accessible to the broad biomedical community. In order to maximize scientific exchange and accelerate research, it is expected that all information, data, protocols, and methods developed by AMP AIM investigators will be shared in a rapid and timely way with other investigators in the AMP AIM Network and with the research community at-large.
The vision for the AMP AIM Program is to gain a comprehensive understanding of molecular and cellular disease pathways and to identify novel targets for intervention.
Background
Autoimmune diseases in aggregate affect more than 25 million Americans and recent studies suggest that the prevalence and incidence of these diseases are increasing. Rheumatoid arthritis (RA), psoriatic spectrum diseases, Sj gren’s syndrome and systemic lupus erythematosus (SLE) are chronic autoimmune diseases characterized by profound abnormalities in the innate and adaptive immune responses that result in persistent damage to multiple tissues and organ systems. They feature a self-propagating feedback loop that maintains and perpetuates systemic and local inflammation and tissue injury. Differences and complexity in genetics, immune dysregulation and environmental contributors result in disease heterogeneity, delay drug development and complicate patient care. Defining shared and unique mechanisms of disease at the systemic and organ level is critical for the design of new and specific interventions.
The NIH, pharmaceutical companies and nonprofit organizations 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 data that will be publicly accessible to the broad biomedical community for further research. Over the last 6 years, the Accelerating Medicines Partnership rheumatoid arthritis and systemic lupus erythematosus (AMP RA/SLE) program has brought together public and private communities to make unprecedented progress in understanding the cell populations, pathways and potential novel drug targets that drive these diseases.
The AMP RA/SLE program has advanced the concept of disease deconstruction by establishing the value and feasibility of using high dimensional analytics on biopsy samples in RA and systemic lupus erythematosus to discover the molecular and cellular pathways active in the tissues from patients with these diseases. In order to deconstruct disease components, AMP RA/SLE has generated multi omics data (protein, mRNA, open chromatin) to characterize thousands of single cells in >100 synovial biopsies from rheumatoid arthritis patients and >200 renal biopsies from lupus nephritis patients. These studies have led to the discovery of new cell populations and states and biomarkers. Careful phenotyping and longitudinal follow-up of patients have allowed discovery of linkages between patients and disease mechanisms.
AMP AIM will extend the concept of disease deconstruction that was established by the AMP RA/SLE Program to psoriatic spectrum diseases and Sj gren’s syndrome. The AMP AIM Program will bring in novel multi-modal analytics to elucidate how innate and adaptive cells of the immune system and tissue-resident cells network with each other to cause inflammation, abnormal function, tissue injury, and clinical disease. The new cornerstone of AMP AIM will be the concept of disease reconstruction based on high dimensional study of cell interactions in RA, systemic lupus erythematosus, Sj gren’s syndrome and psoriatic spectrum diseases. A major strategic goal of the AMP program is to create standardized, open-source data structures and platforms that will aid the accessibility and ease of analysis of autoimmune diseases biological data.
AMP AIM
To carry out the goals of AMP AIM, a discovery infrastructure will be created to strengthen clinical phenotyping protocols; implement diversified, nimble workflows; streamline the selection and optimization of emerging technologies and their application to tissue; expand systems level analysis capacity; and, expedite the steps to operate under the open science principles of the AMP initiative. The new infrastructure will maintain steady patient enrollment opportunities, technology cores and services, allowing optimization and execution of clinical and molecular analyses.
Objectives
Major Expected Outcomes
Structure
The AMP AIM Program will be carried out within a research infrastructure to be established using two interrelated FOAs (RFA-AR-21-015, RFA-AR-21-016) that will support research teams which will form the AMP AIM Network. The Network is defined as the consortium of investigators and institutions funded under both FOAs. A diagram of the organizational structure can be found on the NIAMS website.
Components
1. Disease Teams (DTs). Each DT will lead the development of the research agenda and research priorities for one disease: RA, lupus, psoriatic spectrum disease or Sj gren’s syndrome. The teams will identify critical opportunities and, select, recruit and deep phenotype the most informative patient populations to implement disease de- and reconstruction strategies of the AMP AIM program. They will establish cross-sectional and longitudinal cohorts and collect biopsy tissue and biosamples for research projects. (RFA-AR-21-015)
2. Technology and Analytics Cores (TACs). TACs will test, optimize and apply innovative technologies to interrogate and analyze human biopsy tissue and biosamples (e.g.,single-cell metabolomics and lipidomics). The TACs include the Technology Cores (TCs) and specialized Tissue Repository Core (TRC) and Systems Biology Core (SBC). All TACs will be aligned to work collaboratively to support Network-wide activities and priorities. (RFA-AR-21-016)
3. Research Management Unit (RMU). The RMU will provide centralized management and operational support to the network including providing and/or overseeing clinical monitoring for the entire AMP AIM program. (RFA-AR-21-016)
4.Knowledge Portal (KP). The KP will provide an interface for storage, analysis aggregation and visualization of all data generated by the DTs and TACs. (To be established separately by NIH)
Research Activities
It is anticipated that the AMP AIM Program research goals and objectives will be fulfilled through a series of prioritized projects collaboratively designed by the AMP AIM Network Investigator Committee (NIC) and the AMP AIM Steering Committee. (SC). Thus, all studies proposed in the applications will be a starting point for discussions regarding the research to be undertaken following a short planning period. Activities may include, but not limited to:
Planning:
Pilot:
Scale-Up Pipelines:
Pilot and Scale-Up pipeline projects will be conducted collaboratively.
In order to achieve the goals of AMP AIM, the academic grant award recipients are expected to engage in collaborative and broad sharing of biological data, analytical methodologies, and disease models prior to publication consistent with the overarching goals of the program.
The sharing of data, integrated pathway models and analytical tools and the data integration activities will be provided by a Knowledge Portal (KP) to be established separately by NIH. The KP will provide the infrastructure, resources and management for sharing data, network models, and analytical tools, as well as the data integration activities for the AMP AIM Program.
To provide a community resource for advancing research in this area, all AMP AIM activities must meet rigorous data sharing and quality control standards. All of the AMP AIM activities will be overseen by an Observational Safety Monitoring Board (OSMB) convened by the NIH.
Coordination and Collaboration
To achieve the research goals of AMP AIM Program, successful applicants will be expected to work collaboratively with all members of the Network to contribute to developing SOPs, data and metadata standards, metrics for data generation, participate in cross-site studies, engage in cross-training, and guide development of data analysis that can be used by the broader scientific community.
Coordination of cross-network activities will be carried out by various committees which include:
AMP AIM Network Investigator Committee (NIC): Composed of principal investigators of the DTs, Technology Cores (TCs), SBC, TRC and KP and NIH staff, the NIC will formulate research priorities and implement all collaborative scale-up pipelines and projects, as well as develop and implement Network policies, and guide overall direction of the Network to meet the goals of the program. The NIC will meet regularly and be complemented by an Executive Group and a set of working groups.
AMP AIM Network Executive Group (EG): Composed by representatives from the NIC and NIH project scientists, the EG will be responsible for ensuring the objectives and priorities of the AMP AIM Program are achieved.
AMP AIM Steering Committee (SC):A Steering Committee will be convened by FNIH and include representatives from sponsoring organizations including NIH, industry and not-for-profit organizations. The AMP AIM SC will provide scientific guidance and oversight to the project.
Objectives for Disease Teams
Disease Teams (DTs) will lead the disease research efforts AMP AIM Network. DTs will identify key questions and conduct deep phenotyping of relevant patient populations. They will work together with the Technology and Analytics Cores (TACs) (as described in the companion RFA-AR-21-016) to prioritize disease-specific strategies to inform data collection, data analysis and contribute biologic and clinical insights and analysis to interpret findings that emerge from molecular data generated by analytic pipelines.
Applicant teams should have documented experience with patient recruitment and safely obtaining biopsies for clinical and/or research purposes for the disease selected as the focus of the application. Projects proposed in response to this FOA will require multidisciplinary teams including relevant disciplines such as dermatologists, rheumatologists, nephrologists, image specialists, pathologists, radiologists, clinical nurses and coordinators, statisticians, outcomes data analysis experts, etc. Disease Teams are encouraged to include collaborators / co-investigators with expertise in understanding of the cellular and molecular mechanisms of disease proposed in the application.
NIH expects that studies proposed in the applications will be a starting point for discussions regarding the research to be undertaken to achieve the AMP AIM program objectives. It is unlikely that any study proposed in the application will be undertaken exactly as planned, or at an individual site. This FOA is intended to support discovery.
Clinical trials are anticipated within the period of award but definite plans for these studies will be made by the AMP AIM Network as collaborative projects. Applicants may include a discussion of the use of clinical trials as a potential approach, but clinical trial details are not expected to be described in the application. For this FOA, these studies are considered "Delayed Onset Study . This FOA is intended to support only human studies; applications that include animal or model systems are not responsive.
Specific objectives include:
1.Research focus
2. Recruitment and tissue collection
3. Collaboration and sharing
4. Opportunities Fund (OF)
OF. To capitalize on emerging opportunities and sharing of resources and expertise consistent with the goals of AMP AIM, an OF will be made available. Examples of activities that might be supported by the OF include collaborative and pilot/feasibility projects among AMP AIM Network members; early stage investigator projects; and new and emerging technologies and collaborations. OF projects must be within the scope of the AMP AIM Research Program and may be submitted by members of AMP AIM Network or by outside investigators.
OF Management. One institution will be chosen by NIH after award from the successful applicants to manage the OF for the entire AMP AIM Network This institution must agree to take responsibility for managing the OF, including establishing an administrative structure for disbursement and tracking funds, and under the advice of the AMP AIM EG and AMP AIM NIC establishing procedures for reporting status of OF projects to NIH and the Steering Committee.
5. AMP Chair (this component is optional)
PIs of the DT may propose to serve as the AMP AIM Network Chair. The Chair (and co-Chair) will organize and lead meetings of the Executive Group. With the leadership of the Chair, the Executive Group will be responsible for development of the research strategy, oversight of working groups organized by the NIC, and for approval of Network policies. As part of this process, the Chair will engage with other stakeholders, including funders and FNIH. NIH will name the Chair from nominations made in applications in response to this or companion FOA (RFA-AR-21-016) or delegate that to the Executive Group. Applicants who wish to serve as Chair may request support for additional effort for themselves and for administrative support.
Disease Team Project Activities
Following a short planning and harmonization period, teams will conduct initial, pilot, exploratory projects with existing tissue samples to demonstrate the feasibility of scaling up interrogation methods. Large-scale analytic pipelines will be implemented once samples become available.
Planning Activities (up to six months),
Pilot Activities: The primary objective of the pilot period will be to demonstrate that the site can recruit participants and obtain high-quality research biopsies, while ensuring safety, minimizing risk and conforming to the highest ethical, research and clinical standards followed by continued recruitment into successively larger cohort studies.
The Scale-Up will begin once the research plan and priorities are approved by the SC. Specific activities for this phase include:
During the pilot or the scale-up phases DTs will be eligible to conduct proof of concept (POC) studies that advance and are consistent with the goals and objectives of the AMP Program. The POCs will be expected to enhance the innovation and robustness of the clinical and analytic pipelines.
See Section VIII. Other Information for award authorities and regulations.
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. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Issuing IC and partner components intend to commit an estimated total of $5,000,000 to fund four awards, one each for rheumatoid arthritis, lupus, Sj gren’s syndrome and psoriatic spectrum diseases.
Pre-Application Webinar
NIH will hold a pre-application informational webinar for this FOA on May 5, 2021, 12:00-2:00 p.m. E.T. Other details for the webinar and FAQs will be posted at NIAMS website.
The UC2 is limited to five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
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
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
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.
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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
Telephone: 301-496-4811
Email: buschmanj@mail.nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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.
Applicants must provide the following Other Attachments:
The filename Team.pdf should be used and will be reflected in the final image bookmarking for easy access for reviewers
Team (Limit to 3 pages)
Opportunities Fund (OF) Management Plan (Limit to 1 page)
The filename OF.pdf should be used and will be reflected in the final image bookmarking for easy access for reviewers.
Optional
The following attachment is optional. The filename Chair.pdf should be used and will be reflected in the final image bookmarking for easy access for reviewers.
AMP AIM Network Chair Nomination. (Limit to 1 page)
Include a description of:
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.
Applications should budget for the following:
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, with the following additional instructions:
Disease Teams
Specific Aims: Provide the overall goals for the entire application, and indicate separately, specific aims for the planning, pilot and the scale up phase. This FOA is intended to support only human studies and applications that include animal studies are not responsive.
Research Strategy: Organize the Research Strategy in the subsections identified below.
1. Background and Significance
2. Preliminary Data
3. Proposed Design
4. Management of the Multidisciplinary Team
5. Timelines of Goals and Milestones
A timeline including milestones is required. Milestones should function as indicators of continued progress. Timelines must state when metrics for assessment of progress will be achieved, including specific milestones for progressing to the scale up project. The AMP AIM Program Timeline can be found at AMP Autoimmune and Immune Mediated Diseases (AMP AIM) Program.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
To this end:
Award recipients will be expected to have all data and analytical results deposited in the Consortium space of the Knowledge Portal after they have undergone basic quality control (within 6 months after completion of data QC).
Data and analytical results will be made available broadly to all qualified users via the AMP-AIM Knowledge Portal twice a year and no later than 6 months after deposition. Data will be accessible via open or controlled access depending on the data type and data source and as determined by the informed consent documents for each study guided by the local IRB. There will be no publication embargo imposed on the use of data after they have been made available through the Knowledge Portal.
Applicants need to provide a timeline of data deposition as part of a complete Resource Sharing Plan. Program staff may negotiate modifications to the plan prior to funding.When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
AMP AIM research priorities will be established collaboratively by the AMP AIM NIC and AMP AIM SC. To allow time for Planning, Pilot and Optimization activities prior to establishing the design of clinical trials, applicants should define their projected Clinical Trial study as a Delayed Onset Study . Please include Study Title; Anticipated Clinical Trial? Yes; and a Justification Attachment.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
NIH expects that studies proposed in the applications will be a starting point for discussions regarding the research to be undertaken to achieve the AMP AIM program objectives. It is unlikely that any study proposed in the application will be undertaken exactly as planned, or at an individual site. This FOA is intended to support discovery.
Investigators may consider studies that meet the NIH definition of a clinical trial. Those studies may be discussed in the application but approaches for the conduct of specific clinical trials are not expected to be included. Clinical trials for this FOA are "Delayed Onset Study" only.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?
Specific for this FOA:
Are the proposed disease cohorts appropriate to address the challenges and opportunities in disease de- and reconstruction of AMP AIM? Does the project address disease heterogeneity?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 for this FOA:
Has the applicant demonstrated the ability to work with large collaborative groups?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific for this FOA:
Does the application discuss challenges (if any) of obtaining biopsies for research, especially from underrepresented groups? Are options for patient phenotyping and deep phenotyping within the DT collaborating sites adequately described?
Are patient enrollment sites capacities, including number and characteristics of the patients followed (i.e. private insurance, Medicaid), resources available (personnel) and cohorts demographics adequately described?
Does the application describe the number of clinical and research biopsies performed previously and provide statistics regarding complications?
Are milestones reasonable? Do milestones include metrics for assessment of progress?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Team
Has a plan been developed to facilitate the interaction of PD/PIs and key personnel at different sites or institutions? Are the plans for ensuring the collaboration-readiness of the proposed team and for resolving conflicts between team personnel adequate to ensure the success of the project? Is the proposed team willing to work cooperatively with the AMP AIM Network, the NIH and the AMP AIM SC to further the overall goals of the Program?
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the 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 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 Individuals Across the Lifespan
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 individuals of all ages (including children and older adults) 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
Not Applicable.
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.
As described, does the OF plan propose an adequate plan to successfully administer the funds to indicate a high potential for successful tracking, distribution and management of the funds?
Does the applicant provide evidence of expertise to serve as AMP AIM Chair?
Applications from Foreign Organizations
Not Applicable.
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) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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{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 will receive a written critique.
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.
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 appropriate National Arthritis, Musculoskeletal and Skin Diseases Advisory Council. The following will be considered in making funding decisions:
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 recipient's business official.
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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
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 Part 75, 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 award recipients 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 award recipients for the project as a whole, although specific tasks and activities may be shared among the award recipients and the NIH as defined below.
The primary responsibility of the PD(s)/PI(s) will be:
NIH staff 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 the 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:
An NIH Grants Management Specialist will be named in the award notice. A Grants Management Official will attend the NIC meetings as a non-voting member.
AMP AIM Network Investigator Committee
Voting members of the NIC may include:
The NIC will be the primary governing body for all the AMP AIM scientific activities.
Responsibilities of the AMP AIM NIC include:
The AMP AIM Executive Group will coordinate all projects awarded under the AMP AIM FOAs.
The role of the AMP AIM EG includes:
A final RPPR, 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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Ricardo Cibotti, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Telephone: (301) 451-5888
Email: ricardo.cibotti@nih.gov
Su-Yau Mao, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email:maos2@mail.nih.gov
Yan Wang, M.D., Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Telephone: (301) 594-5032
Email: wangy1@mail.nih.gov
Lisa Begg, Dr.P.H., R.N.
Office of Research on Women’s Health (ORWH)
Telephone: 301-496-3975
Email: beggl@od.nih.gov
John A. Peyman, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3544
Email: peymanj@niaid.nih.gov
Preethi Chander, PhD
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: 301-443-7230
E-mail: preethi.chander@nih.gov
Kathy Salaita, Sc.D.
National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5033
Email: Kathy.salaita@nih.gov
Stephanie Kreider
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-402-1691
Email:skreider@mail.nih.gov
Jenna Briggs
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-5137
Email: jenna.briggs@nih.gov
Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: rutbergd@nih.gov
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 Part 75.
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